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<table><col/><col/><col/><col/><tbody><tr><td><p>4.3.2021   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 74/27</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2021/384
of 3 March 2021
on the suitability of the denominations of varieties of agricultural plant species and vegetable species and repealing Regulation (EC) No 637/2009
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Directive 2002/53/EC of 13 June 2002 on the common catalogue of varieties of agricultural plant species ( 1 ) , and in particular the second subparagraph of Article 9(6) thereof,
Having regard to Council Directive 2002/55/EC of 13 June 2002 on the marketing of vegetable seed ( 2 ) , and in particular the second subparagraph of Article 9(6) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Directives 2002/53/EC and 2002/55/EC lay down general rules in relation to the suitability of variety denominations by means of a reference to Article 63 of Council Regulation (EC) No 2100/94 <a>(<span>3</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>In accordance with Article 63 of Regulation (EC) No 2100/94 in order for a plant variety to be approved, its variety denomination needs to be considered suitable by the Community Plant Variety Office (CPVO). A variety denomination is suitable if there is no impediment in accordance with paragraphs 3 or 4 of that Article.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Commission Regulation (EC) No 637/2009 <a>(<span>4</span>)</a> establishes detailed rules for the application of certain criteria set out in Article 63 of Regulation (EC) No 2100/94 as to the suitability of denominations of varieties of agricultural species and vegetable plant species for purposes of the application of the first subparagraph of Article 9(6) of Directive 2002/53/EC and of the first subparagraph of Article 9(6) of Directive 2002/55/EC.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>The CPVO and the Member States established an expert group, which developed and amended guidelines on the suitability of denominations under Article 63 of Regulation (EC) No 2100/94 (‘Guidelines on variety denominations’ <a>(<span>5</span>)</a>. In order to ensure consistency as regards the application of the criteria provided for by Article 63 of Regulation (EC) No 2100/94, it is appropriate to provide for further clarifications resulting from the Guidelines on variety denominations.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>Regulation (EC) No 637/2009 has been amended several times. In view of the need to amend the existing rules and in the interest of legal certainty, that Regulation should be repealed and replaced by this Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>A variety denomination is to be approved, unless it is unsuitable due to impediments. Under Article 63 of Regulation (EC) No 2100/94 the use of a variety denomination is to be precluded in case of a prior right of a third party, difficulties as regards recognition or reproduction, identical denominations to a variety of the same or closely related species, designations commonly used for the marketing of goods, where the denomination is liable to give offence in one of the Member States or is contrary to public policy, in case of confusion due to visual, phonetical or conceptual similarity or of misleading content.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>In order to give sufficient time to competent authorities for the application of the new rules, this Regulation should apply from 1 January 2022.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
Subject matter
This Regulation establishes detailed rules for the application of the criteria set out in Article 63 of Regulation (EC) No 2100/94 as to the suitability of the denominations of varieties of agricultural plant species and vegetable species, for the purposes of the first subparagraph of Article 9(6) of Directive 2002/53/EC and of the first subparagraph of Article 9(6) of Directive 2002/55/EC.
Article 2
Suitability of variety denominations
1. A variety denomination shall be suitable, if there is no impediment related to its designation.
2. There is an impediment related to the designation of a variety denomination in cases where:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the use of the variety denomination in the territory of the Union is precluded where an objection of a third party holding a prior right is upheld, as set out in Article 3(1);</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the variety denomination conflicts with geographical indications, designations of origin or traditional specialties guaranteed, as set out in Article 3(2);</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the variety denomination may cause its users difficulties as regards its recognition or reproduction, as set out in Article 4;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>the variety denomination is identical or may be confused with a variety denomination under which another variety of the same or of a closely related species is entered in an official register of plant varieties or under which material of another variety has been marketed, as set out in Article 5;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>the variety denomination could cause confusion due to its visual, phonetical or conceptual similarity with the denomination of a variety of the same or closely related species, as set out in Article 5;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>the variety denomination is identical or may be confused with designations commonly used for the marketing of goods, or which have to be kept free under other legislation, as set out in Article 6;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>the variety denomination is liable to mislead or to cause confusion, as set out in Article 7.</p></td></tr></tbody></table>
Article 3
Prior right of a third party
1. There is an impediment due to the prior right of a third party, where an objection of a third party, holding a trademark, against the designation of the variety denomination in the territory of the Union, is upheld by any competent authority. That impediment concerns trademarks which:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>have been registered in one or more Member States or in the Union before the registration of the variety denomination;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>are identical or similar to the variety denomination; and</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>are registered in relation to goods consisting of the same or closely related species of the variety concerned.</p></td></tr></tbody></table>
2. In the case of geographical indications, designations of origin or traditional specialties guaranteed for agricultural products and foodstuffs, spirit drinks, aromatised wines and wine products as a prior right of a third party, a variety denomination in the territory of the Union shall be precluded where the variety denomination would breach:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>Article 13 or 24 of Regulation (EU) No 1151/2012 of the European Parliament and of the Council <a>(<span>6</span>)</a>;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>Article 103 of Regulation (EU) No 1308/2013 of the European Parliament and of the Council <a>(<span>7</span>)</a>;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>Article 20 of Regulation (EU) No 251/2014 of the European Parliament and of the Council <a>(<span>8</span>)</a>;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>Article 21(2) of Regulation (EU) 2019/787 of the European Parliament and of the Council <a>(<span>9</span>)</a>.</p></td></tr></tbody></table>
3. An impediment to the suitability of a denomination due to the prior right referred to in paragraph 1 shall cease to exist where a written consent of the holder of the prior right to the use of the denomination in relation to the concerned variety has been obtained, provided that such a consent is not liable to mislead the public as to the true origin of the product.
4. In the case of a prior right of the applicant in respect of the whole or part of the proposed variety denomination, Article 18(1) of Regulation (EC) No 2100/94 shall apply mutatis mutandis .
Article 4
Difficulties as regards recognition or reproduction of a variety denomination
1. There is an impediment due to difficulties as regards recognition or reproduction of a variety denomination where a variety denomination causes its users difficulties as regards its recognition or reproduction.
2. It shall be considered that a variety denomination causes its users difficulties as regards its recognition or reproduction in the following cases:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>it consists of, or contains, comparatives or superlatives;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>it consists of, or contains, botanical names of species within the group either of agricultural plant species or of vegetable plant species, to which the variety belongs;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>it consists of, or contains, breeding and technical terms, unless their use in combination with other terms would not prevent the recognition of the variety denomination as such;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>it consists exclusively of a geographical name that has acquired a reputation for the species concerned;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>it consists of a single letter or numeral or numerals only, unless this represents an established practice for designating certain varieties;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>it consists of, or contains, too many words or elements, unless the flow of the wording makes it easily recognizable;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>it contains a punctuation mark or other symbol, an upper and lower case mixture (except where the first letter is in upper case and the rest of the denomination in lower case), subscript, superscript or a design or a figurative element (except the apostrophe (’), the comma (,), up to two non-adjacent exclamation marks (!), the period or full-stop (.), or the hyphen (-), the forward slash (/) or backward slash (\) symbols);</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(h)</p></td><td><p>it contains, or consists of, a subscript, a superscript or a design, a logo or a figurative element.</p></td></tr></tbody></table>
Article 5
Denomination that is identical or may be confused with the denomination of another variety
1. There is an impediment for the designation of a variety denomination where it is identical or may be confused with:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>a variety denomination under which another variety of the same or a closely related species is entered in an official register of varieties; or</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>a variety denomination under which material of another variety has been marketed in a Member State or in the territory of a contracting party of the International Union for the Protection of New Varieties of Plants (‘UPOV’);</p></td></tr></tbody></table>
unless the other variety no longer remains in existence and its denomination has acquired no special significance.
2. In order to establish whether there is a confusion for the purposes of paragraph 1, the competent authority shall first analyse each of the visual, phonetical and conceptual aspects separately and then make an overall assessment, taking also into account denominations of varieties of the same or a closely related species, provided that the varieties concerned referred to in this paragraph and in paragraph 1 have been either the subject of a plant variety right or of an application thereof, or officially accepted for marketing, in the territory of one of the following:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the Union;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the European Economic Area;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>a contracting party of the UPOV;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>a Member of the Organisation for Economic Cooperation and Development (OECD).</p></td></tr></tbody></table>
3. For the purposes of this Article, the following definitions apply:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>‘closely related species’ means the species listed in the Annex;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>‘official register of varieties’ means the Common catalogue of Varieties of Agricultural Plant Species, referred to in Article 17 of Directive 2002/53/EC or in Article 17 of Directive 2002/55/EC, or the OECD Variety List, or a plant variety register of a Member of UPOV’;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>‘a variety no longer remains in existence’ means a variety of which material no longer exists;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>‘the denomination has acquired no special significance’ means a situation where the denomination of a variety which has been entered in an official register of varieties is considered to have lost special significance on the expiry of a 10-year period after deletion from that register, unless there are exceptional circumstances.</p></td></tr></tbody></table>
Article 6
Designations commonly used for the marketing of goods
1. There is an impediment to the designation of a variety denomination where a variety denomination is identical or may be confused with designations which are commonly used for the marketing of goods or which have to be kept free under other legislation.
2. Designations which are commonly used for the marketing of goods or which have to be kept free under other legislation shall be:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>currency denominations;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>terms associated with weights and measures;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>expressions and terms that are not to be used for other purposes than those envisaged by the legislation of the Union or of a Member State.</p></td></tr></tbody></table>
Article 7
Misleading content
1. There is an impediment for the designation of a variety denomination where it is liable to mislead or to cause confusion concerning the characteristics, the value or the identity of the variety, or the identity of the breeder or of any other party to the proceedings.
2. It shall be considered that a variety denomination is liable to mislead or to cause confusion if:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>it conveys a false impression that the variety is related to, or derived from, another specific variety;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>it conveys a false impression that the variety has a particular characteristic or value;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>it refers to a specific characteristic or value in a way which conveys a false impression that only that variety possesses that specific characteristic or value, whereas other varieties of the same species may possess the same characteristic or value;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>it is similar to a well-known trading name other than a registered trademark or variety denomination;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>it suggests that the variety is another variety;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>it conveys a false impression concerning the identity of the applicant, the person responsible for the maintenance of the variety or the breeder;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>it consists of, or contains:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>comparatives or superlatives which may be deceptive as to the characteristics of the variety;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>the botanical or common names of species, within the group either of agricultural plant species or of vegetable plant species, to which the variety belongs;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>the name of a natural or legal person, or a reference thereto, so as to convey a false impression concerning the identity of the applicant, the person responsible for the maintenance of the variety or the breeder;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(h)</p></td><td><p>it includes a geographical name that is likely to deceive the user as to the characteristics or the value for cultivation and use of the variety.</p></td></tr></tbody></table>
Article 8
Repeal of Regulation (EC) No 637/2009
Regulation (EC) No 637/2009 is repealed.
However, it shall continue to apply to variety denominations which have been proposed by the applicant to the competent authority for their approval before 1 January 2022.
Article 9
Entry into force and application
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
It shall apply from 1 January 2022.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 3 March 2021.
For the Commission
The President
Ursula VON DER LEYEN
( 1 ) OJ L 193, 20.7.2002, p. 1 .
( 2 ) OJ L 193, 20.7.2002, p. 33 .
( 3 ) Council Regulation (EC) No 2100/94 of 27 July 1994 on Community plant variety rights ( OJ L 227, 1.9.1994, p. 1 ).
( 4 ) Commission Regulation (EC) No 637/2009 of 22 July 2009 establishing implementing rules as to the suitability of the denominations of varieties of agricultural plant species and vegetable species ( OJ L 191, 23.7.2009, p. 10 ).
( 5 ) CPVO Guidelines on variety denominations, Meeting 1-of the Administrative Council of (2018), DOC-AC-2018-1-7.
( 6 ) Regulation (EU) No 1151/2012 of the European Parliament and the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs ( OJ L 343, 14.12.2012, p. 1 ).
( 7 ) Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 ( OJ L 347, 20.12.2013, p. 671 ).
( 8 ) Regulation (EU) No 251/2014 of the European Parliament and of the Council of 26 February 2014 on the definition, description, presentation, labelling and the protection of geographical indications of aromatised wine products and repealing Council Regulation (EEC) No 1601/91 ( OJ L 84, 20.3.2014, p. 14 ).
( 9 ) Regulation (EU) 2019/787 of the European Parliament and of the Council of 17 April 2019 on the definition, description, presentation and labelling of spirit drinks, the use of the names of spirit drinks in the presentation and labelling of other foodstuffs, the protection of geographical indications for spirit drinks, the use of ethyl alcohol and distillates of agricultural origin in alcoholic beverages, and repealing Regulation (EC) No 110/2008 ( OJ L 130, 17.5.2019, p. 1 ).
ANNEX
Definition of closely related species within the meaning of Article 5(3)
For the purpose of defining ‘closely related species’, as referred to in Article 5(3), the following shall apply:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>if there is more than one class within a genus, the list of classes in part I shall apply;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>if classes encompass more than one genus, the list of classes in part II shall apply;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>as a general rule, for genera and species not covered by the lists of classes in parts I and II, a genus is considered to be a class.</p></td></tr></tbody></table>
PART I
CLASSES WITHIN A GENUS
<table><col/><col/><tbody><tr><td><p><span>Classes</span></p></td><td><p><span>Botanical names</span></p></td></tr><tr><td><p>Class 1.1:</p></td><td><p><span>Brassica oleracea</span></p></td></tr><tr><td><p>Class 1.2:</p></td><td><p><span>Brassica</span> other than<span>Brassica oleracea</span></p></td></tr><tr><td><p>Class 2.1:</p></td><td><p><span>Beta vulgaris</span> L. var.<span>alba</span> DC.,<span>Beta vulgaris</span> L. var.<span>altissima</span></p></td></tr><tr><td><p>Class 2.2:</p></td><td><p><span>Beta vulgaris</span> ssp.<span>vulgaris</span> var.<span>conditiva</span> Alef. (syn.: B. vulgaris L. var. rubra L.), B.<span>vulgaris</span> L. var.<span>cicla</span> L., B.<span>vulgaris</span> L. ssp.<span>vulgaris</span> var.<span>vulgaris</span>.</p></td></tr><tr><td><p>Class 2.3:</p></td><td><p><span>Beta</span> other than classes 2.1 and 2.2.</p></td></tr><tr><td><p>Class 3.1:</p></td><td><p><span>Cucumis sativus</span></p></td></tr><tr><td><p>Class 3.2:</p></td><td><p><span>Cucumis melo</span></p></td></tr><tr><td><p>Class 3.3:</p></td><td><p><span>Cucumis</span> other than classes 3.1 and 3.2</p></td></tr><tr><td><p>Class 4.1:</p></td><td><p><span>Solanum tuberosum</span> L.</p></td></tr><tr><td><p>Class 4.2:</p></td><td><p>Tomato & Tomato rootstocks:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p><span>Solanum lycopersicum</span> L. (<span>Lycopersicon esculentum</span> Mill.)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p><span>Solanum cheesmaniae</span> (L. Ridley) Fosberg (<span>Lycopersicon cheesmaniae</span> L. Riley)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p><span>Solanum chilense</span> (Dunal) Reiche (<span>Lycopersicon chilense</span> Dunal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p><span>Solanum chmielewskii</span> (C.M. Rick et al.) D.M. Spooner et al. (<span>Lycopersicon chmielewskii</span> C. M. Rick et al.)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p><span>Solanum galapagense</span> S.C. Darwin & Peralta (<span>Lycopersicon cheesmaniae</span> f. minor (Hook. f.) C. H. Müll.) (<span>Lycopersicon cheesmaniae</span> var. minor (Hook. f.) D. M. Porter)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p><span>Solanum habrochaites</span> S. Knapp & D.M. Spooner (<span>Lycopersicon agrimoniifolium</span> Dunal) (<span>Lycopersicon hirsutum</span> Dunal) (<span>Lycopersicon hirsutum</span> f.<span>glabratum</span> C. H. Müll.)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p><span>Solanum pennellii</span> Correll (<span>Lycopersicon pennellii</span> (Correll) D’Arcy)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p><span>Solanum peruvianum</span> L. (<span>Lycopersicon dentatum</span> Dunal) (<span>Lycopersicon peruvianum</span> (L.) Mill.)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p><span>Solanum pimpinellifolium</span> L. (<span>Lycopersicon pimpinellifolium</span> (L.) Mill.) (<span>Lycopersicon racemigerum</span> Lange)</p><p>and hybrids between those species</p></td></tr></tbody></table></td></tr><tr><td><p>Class 4.3:</p></td><td><p><span>Solanum melongena</span> L.</p></td></tr><tr><td><p>Class 4.4:</p></td><td><p><span>Solanum</span> other than classes 4.1, 4.2 and 4.3</p></td></tr></tbody></table>
PART II
CLASSES ENCOMPASSING MORE THAN ONE GENUS
<table><col/><col/><tbody><tr><td><p><span>Classes</span></p></td><td><p><span>Botanical names</span></p></td></tr><tr><td><p>Class 201:</p></td><td><p><span>Secale, Triticosecale, Triticum</span></p></td></tr><tr><td><p>Class 203<a> (<span>*</span>)</a>:</p></td><td><p><span>Agrostis, Dactylis, Festuca, Festulolium, Lolium, Phalaris, Phleum</span> and<span>Poa</span></p></td></tr><tr><td><p>Class 204<a> (<span>*</span>)</a></p></td><td><p><span>Lotus, Medicago, Ornithopus, Onobrychis, Trifolium</span></p></td></tr><tr><td><p>Class 205:</p></td><td><p><span>Cichorium, Lactuca</span></p></td></tr></tbody></table>
<note>
( * ) Classes 203 and 204 are not solely established on the basis of closely related species
</note> | ENG | 32021R0384 |
<table><col/><col/><col/><col/><tbody><tr><td><p>1.5.2015   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 113/58</p></td></tr></tbody></table>
POLITICAL AND SECURITY COMMITTEE DECISION (CFSP) 2015/711
of 28 April 2015
on the acceptance of a third State's contribution to the European Union military operation to contribute to the deterrence, prevention and repression of acts of piracy and armed robbery off the Somali coast (Atalanta) (ATALANTA/4/2015)
THE POLITICAL AND SECURITY COMMITTEE,
Having regard to the Treaty on European Union, and in particular the third paragraph of Article 38 thereof,
Having regard to Council Joint Action 2008/851/CFSP of 10 November 2008 on a European Union military operation to contribute to the deterrence, prevention and repression of acts of piracy and armed robbery off the Somali coast ( 1 ) , and in particular Article 10 thereof,
Having regard to Political and Security Committee Decision ATALANTA/3/2009 of 21 April 2009 on the setting up of the Committee of Contributors for the European Union military operation to contribute to the deterrence, prevention and repression of acts of piracy and armed robbery off the Somali coast (Atalanta) (2009/369/CFSP) ( 2 ) ,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Pursuant to Article 10(2) of Joint Action 2008/851/CFSP, the Council authorised the Political and Security Committee (PSC) to take the relevant decisions on acceptance of the proposed contributions by third States.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>On 29 April 2014, the PSC adopted Decision ATALANTA/2/2014 <a>(<span>3</span>)</a> which amended Decision ATALANTA/3/2009.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Following the letter dated 10 December 2014 from the Chairman of the European Union Military Committee, the recommendation on a contribution from the Republic of Korea by the Deputy EU Operation Commander on 9 April 2015 and the recommendation by the European Union Military Committee on 15 April 2015, the contribution from the Republic of Korea should be accepted.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>The participation of the Republic of Korea is subject to the entry into force of the Agreement between the European Union and the Republic of Korea establishing a framework for the participation of the Republic of Korea in European Union crisis management operations <a>(<span>4</span>)</a>, signed on 23 May 2014.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>In accordance with Article 5 of Protocol No 22 on the position of Denmark, annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union, Denmark does not participate in the elaboration and implementation of decisions and actions of the Union which have defence implications,</p></td></tr></tbody></table>
HAS ADOPTED THIS DECISION:
Article 1
1. The contribution from the Republic of Korea to the European Union military operation to contribute to the deterrence, prevention and repression of acts of piracy and armed robbery off the Somali coast (Atalanta) is accepted and is considered to be significant.
2. The Republic of Korea is exempted from financial contributions to the budget of Atalanta.
Article 2
This Decision shall enter into force on the date of its adoption.
Done at Brussels, 28 April 2015.
For the Political and Security Committee
The Chairperson
W. STEVENS
<note>
( 1 ) OJ L 301, 12.11.2008, p. 33 .
( 2 ) OJ L 112, 6.5.2009, p. 9 .
( 3 ) Political and Security Committee Decision Atalanta/2/2014 of 29 April 2014 on the acceptance of a third State's contribution to the European Union military operation to contribute to the deterrence, prevention and repression of acts of piracy and armed robbery off the Somali coast (Atalanta) and amending Decision ATALANTA/3/2009 (2014/244/CFSP) ( OJ L 132, 3.5.2014, p. 63 ).
( 4 ) OJ L 166, 5.6.2014, p. 3 .
</note> | ENG | 32015D0711 |
<table><col/><col/><col/><col/><tbody><tr><td><p>25.6.2018   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 160/6</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING DECISION (EU) 2018/896
of 19 June 2018
laying down the methodology for the calculation of the annual consumption of lightweight plastic carrier bags and amending Decision 2005/270/EC
(notified under document C(2018) 3736)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste ( 1 ) , and in particular Article 4(1a) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Directive 94/62/EC requires Member States to take measures to reduce the consumption of lightweight plastic carrier bags, and provides that these measures are to ensure that a certain number of lightweight plastic carrier bags per person per year, or an equivalent target set in weight is not exceeded.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>It is necessary to use a harmonised reporting system and a harmonised methodology for the calculation of the consumption of lightweight plastic carrier bags per person, to monitor that consumption at Union level, and to assess whether a sustained reduction of consumption of these bags has been achieved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Member States may define their national measures either by reference to numbers of lightweight plastic carrier bags or by reference to weight. The approaches used to measure consumption of lightweight plastic carrier bags are intrinsically linked to the measures put in place with the objective to reduce consumption. Therefore the methodology for calculating consumption should provide for calculation based on numbers as well as on weight in order to take account of the Member States' choice between the two types of reduction measures.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>Where measures are taken to reduce the annual consumption of lightweight plastic carrier bags in terms of weight, information on the average weight of lightweight plastic carrier bags should be reported in order to enable conversion of figures for consumption into numbers, so that the data reported by different Member States based on weight or on numbers of lightweight plastic carrier bags can be compared.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>Member States may exclude very lightweight plastic carrier bags from national consumption reduction measures. Nevertheless, these bags qualify as lightweight plastic carrier bags for the purposes of the reporting obligations and are to be included in the reporting of annual consumption of lightweight plastic carrier bags. Calculation methodologies based on revenues from mandatory taxes, charges or levies may not capture these exempt bags. In order to take account of this, Member States should require that economic operators report the number or weight of all lightweight plastic carrier bags placed on the market, also those that are exempt from any such taxes, charges or levies.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>Formats for reporting on packaging and packaging waste are set out in Commission Decision 2005/270/EC <a>(<span>2</span>)</a>. New formats are necessary for the purposes of reporting on the consumption of lightweight plastic carrier bags. Decision 2005/270/EC should therefore be amended accordingly.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>The measures provided for in this Decision are in accordance with the opinion of the Committee established pursuant to Article 21 of Directive 94/62/EC,</p></td></tr></tbody></table>
HAS ADOPTED THIS DECISION:
Article 1
Methodology for the calculation and reporting of annual consumption
The annual consumption of lightweight plastic carrier bags per person shall be calculated and reported using either the methodology for reporting by numbers laid down in Article 2 or the methodology for reporting by weight laid down in Article 3.
Article 2
Methodology for reporting by numbers
1. Where a Member State calculates and reports the annual consumption of lightweight plastic carrier bags by numbers, it shall use either of the following:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the total number of lightweight plastic carrier bags placed on its national market;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the sum of:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>the number of lightweight plastic carrier bags calculated on the basis of the revenues from mandatory taxes, charges or levies charged to consumers per unit of lightweight plastic carrier bags as declared or reported by economic operators in accordance with national law; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>the number of lightweight plastic carrier bags exempt from those taxes, charges or levies, placed on its national market as reported by economic operators in accordance with national law.</p></td></tr></tbody></table></td></tr></tbody></table>
2. Member States reporting the annual consumption of lightweight plastic carrier bags in accordance with paragraph 1(a) shall require economic operators to report the number of lightweight plastic carrier bags placed by them on the market in their territory for each calendar year.
3. Member States reporting the annual consumption of lightweight plastic carrier bags in accordance with paragraph 1(b) shall require economic operators to report the number of lightweight plastic carrier bags that are exempt from the taxes, charges or levies placed by them on the market in their territory for each calendar year.
4. Member States using the methodology laid down in paragraph 1(a) shall report the annual consumption of lightweight plastic carrier bags using Table 4 in the Annex to Decision 2005/270/EC.
5. Member States using the methodology laid down in paragraph 1(b) shall report the annual consumption of lightweight plastic carrier bags using Table 5 in the Annex to Decision 2005/270/EC.
Article 3
Methodology for reporting by weight
1. Where a Member State calculates and reports the annual consumption of lightweight plastic carrier bags by weight, it shall use either of the following:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the total weight of lightweight plastic carrier bags placed on its national market;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the sum of:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>the weight of lightweight plastic carrier bags calculated on the basis of the revenues from mandatory taxes, charges or levies charged to consumers per unit of lightweight plastic carrier bags as declared or reported by economic operators in accordance with national law; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>the weight of lightweight plastic carrier bags exempt from those taxes, charges or levies, placed on its national market as reported by economic operators in accordance with national law.</p></td></tr></tbody></table></td></tr></tbody></table>
2. Member States reporting the annual consumption of lightweight plastic carrier bags in accordance with this Article shall require economic operators to provide information about the average weight of lightweight plastic carrier bags.
3. Member States reporting the annual consumption of lightweight plastic carrier bags in accordance with paragraph 1(a) shall require economic operators to report the total weight of lightweight plastic carrier bags placed by them on the market of their territory for each calendar year.
4. Member States reporting the annual consumption of lightweight plastic carrier bags in accordance with paragraph 1(b) shall require economic operators to report the total weight of lightweight plastic carrier bags that are exempt from the taxes, charges or levies placed by them on the market of their territory for each calendar year.
5. Member States using the methodology laid down in paragraph 1(a) shall report the annual consumption of lightweight plastic carrier bags using Table 6 in the Annex to Decision 2005/270/EC.
6. Member States using the methodology laid down in paragraph 1(b) shall report the annual consumption of lightweight plastic carrier bags using Table 7 in the Annex to Decision 2005/270/EC.
Article 4
Amendments to Decision 2005/270/EC
Decision 2005/270/EC is amended as follows:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Article 9 is replaced by the following:</p><p>‘Article 9</p><p>1.   The Member States shall provide the data on generation, import, export and treatment of packaging waste using the formats set out in Tables 1, 2 and 3 of the Annex.</p><p>2.   The Member States shall provide the data on the consumption of lightweight plastic carrier bags using the format set out in Table 4 or Table 5 of the Annex, as appropriate, for reporting by numbers and the format set out in Table 6 or Table 7 of the Annex, as appropriate, for reporting by weight.’;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>the Annex is amended as set out in the Annex to this Decision.</p></td></tr></tbody></table>
Article 5
This Decision is addressed to the Member States.
Done at Brussels, 19 June 2018.
For the Commission
Karmenu VELLA
Member of the Commission
( 1 ) OJ L 365, 31.12.1994, p. 10 .
( 2 ) Commission Decision 2005/270/EC of 22 March 2005 establishing the formats relating to the database system pursuant to Directive 94/62/EC of the European Parliament and of the Council on packaging and packaging waste ( OJ L 86, 5.4.2005, p. 6 ).
ANNEX
Tables 4 to7 are inserted in the Annex to Decision 2005/270/EC:
‘ TABLE 4
The annual consumption of lightweight plastic carrier bags calculated in accordance with the methodology laid down in Article 2(1)(a) of Commission Implementing Decision (EU) 2018/896 ( *1 )
<table><col/><col/><tbody><tr><td><p>Number of lightweight plastic carrier bags placed on the market</p></td></tr><tr><td><p> </p></td></tr><tr><td><p>Of which bags having a wall thickness of</p></td></tr><tr><td><p>< 15 micron</p></td><td><p>15 < 50 micron</p></td></tr><tr><td><p> </p></td><td><p> </p></td></tr></tbody></table>
Notes:
<table><col/><col/><tbody><tr><td><p>1.</p></td><td><span>White box: Provision of data is mandatory</span></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>2.</p></td><td><span>Shaded boxes: Provision of data is voluntary</span></td></tr></tbody></table>
TABLE 5
The annual consumption of lightweight plastic carrier bags calculated in accordance with the methodology laid down in Article 2(1)(b) of Implementing Decision (EU) 2018/896
<table><col/><col/><col/><col/><tbody><tr><td><p>Number of lightweight plastic carrier bags calculated from mandatory taxes, charges or levies</p></td></tr><tr><td><p>Number of lightweight plastic carrier bags calculated from mandatory taxes, charges or levies as declared or reported by economic operators</p></td><td><p>Number of lightweight plastic carrier bags exempt from mandatory taxes, charges or levies as reported by economic operators</p></td></tr><tr><td><p>(a)</p></td><td><p>(b)</p></td></tr><tr><td><p>(a) + (b)</p></td></tr><tr><td><p>Of which bags having a wall thickness of</p></td></tr><tr><td><p>< 15 micron</p></td><td><p>15 < 50 micron</p></td><td><p>< 15 micron</p></td><td><p>15 < 50 micron</p></td></tr><tr><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr></tbody></table>
Notes:
<table><col/><col/><tbody><tr><td><p>1.</p></td><td><span>White box: Provision of data is mandatory</span></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>2.</p></td><td><span>Shaded boxes: Provision of data is voluntary</span></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>3.</p></td><td><span>Where no exemption is in place, the value for (b) shall be indicated as 0.</span></td></tr></tbody></table>
TABLE 6
The annual consumption of lightweight plastic carrier bags calculated in accordance with the methodology laid down in Article 3(1)(a) of Implementing Decision (EU) 2018/896
<table><col/><col/><col/><col/><tbody><tr><td><p>Weight of lightweight plastic carrier bags placed on the market</p></td></tr><tr><td><p>Weight of lightweight plastic carrier bags placed on the market</p></td><td><p>Weighted average weight per lightweight plastic carrier bag as reported by economic operators</p></td></tr><tr><td><p> </p></td><td><p> </p></td></tr><tr><td><p>Of which bags having a wall thickness of</p></td><td><p>Having a wall thickness of</p></td></tr><tr><td><p> </p></td></tr><tr><td><p>< 15 micron</p></td><td><p>15 < 50 micron</p></td><td><p>< 15 micron</p></td><td><p>15 < 50 micron</p></td></tr><tr><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr></tbody></table>
Notes:
<table><col/><col/><tbody><tr><td><p>1.</p></td><td><span>White box: Provision of data is mandatory</span></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>2.</p></td><td><span>Shaded boxes: Provision of data is voluntary</span></td></tr></tbody></table>
TABLE 7
The annual consumption of lightweight plastic carrier bags calculated in accordance with the methodology laid down in Article 3(1)(b) of Implementing Decision (EU) 2018/896
<table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Weight of lightweight plastic carrier bags calculated from mandatory taxes, charges or levies</p></td></tr><tr><td><p>Weight of lightweight plastic carrier bags calculated from mandatory taxes, charges or levies as declared or reported by economic operators</p></td><td><p>Weight of lightweight plastic carrier bags exempt from mandatory taxes, charge or levies as reported by economic operators</p></td><td><p>Average weight per lightweight plastic carrier bag as reported by economic operators</p></td></tr><tr><td><p>a</p></td><td><p>b</p></td><td><p> </p></td></tr><tr><td><p>a + b</p></td></tr><tr><td><p>Of which bags having a wall thickness</p></td></tr><tr><td><p>< 15 micron</p></td><td><p>15 < 50 micron</p></td><td><p>< 15 micron</p></td><td><p>15 < 50 micron</p></td><td><p>(a)</p><p>15 < 50 micron</p></td><td><p>(b)</p><p>15 < 50 micron</p></td></tr><tr><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr></tbody></table>
Notes:
<table><col/><col/><tbody><tr><td><p>1.</p></td><td><span>White box: Provision of data is mandatory</span></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>2.</p></td><td><span>Shaded boxes: Provision of data is voluntary</span></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>3.</p></td><td><span>Where no exemption is in place, the value for (b) equals 0’</span></td></tr></tbody></table>
<note>
( *1 ) Commission Implementing Decision (EU) 2018/896 of 19 June 2018 laying down the methodology for the calculation of the annual consumption of lightweight plastic carrier bags and amending Decision 2005/270/EC ( OJ L 160, 25.6.2018, p. 6 ).
</note> | ENG | 32018D0896 |
<table><col/><col/><col/><tbody><tr><td><img/></td><td><p>Official Journal<br/>of the European Union</p></td><td><p>EN</p><p>Series L</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>2023/2777</p></td><td><p>15.12.2023</p></td></tr></tbody></table>
COMMISSION DELEGATED REGULATION (EU) 2023/2777
of 3 October 2023
amending the Annex to Regulation (EU) 2020/2170 of the European Parliament and of the Council as regards the application of Union tariff rate quotas and other import quotas to certain steel products transferred to Northern Ireland
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2020/2170 of the European Parliament and of the Council of 16 December 2020 on the application of Union tariff rate quotas and other import quotas ( 1 ) , and in particular Article 1a, and Article 1b thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>The Annex to Regulation (EU) 2020/2170 contains a list of goods originating in the United Kingdom and being subject to safeguard measures under Commission Implementing Regulation (EU) 2019/159 <a>(<span>2</span>)</a> that are brought into Northern Ireland by direct transport from other parts of the United Kingdom and shall be eligible for treatment pursuant to Union import tariff rate quotas if those goods are released for free circulation in the territory of Northern Ireland.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>As set out in recital (4) of Regulation (EU) 2023/1321 of the European Parliament and of the Council <a>(<span>3</span>)</a>, the United Kingdom had provided evidence showing that certain steel products originating in the United Kingdom that are currently subject to safeguard measures under Implementing Regulation (EU) 2019/159 (‘the products concerned’) had been transferred in significant quantities to Northern Ireland from other parts of the United Kingdom. In order to ensure the economic viability of those transfers, and in view of the specific circumstances in Northern Ireland, it was considered appropriate to allow for the products concerned to also benefit from the relevant Union tariff rate quotas when they are released for free circulation in Northern Ireland.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Subsequent to the adoption of Regulation (EU) 2023/1321, the United Kingdom has provided evidence similar to the evidence mentioned under recital (2) above, showing that five additional categories of the products concerned have also been transferred in significant quantities to Northern Ireland from other parts of the United Kingdom. The United Kingdom has therefore asked that these five categories of the products concerned be also eligible for treatment pursuant to Union import tariff rate quotas if they are released for free circulation in the territory of Northern Ireland.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>The Commission has examined whether, in order to ensure the economic viability of those transfers, and in view of the specific circumstances in Northern Ireland, it is appropriate to allow for these five additional categories of the products concerned to also benefit from the relevant Union tariff rate quotas when they are released for free circulation in Northern Ireland.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>The Commission is satisfied that the evidence provided by the United Kingdom demonstrates that there is a need for these five categories of the products concerned to be released for free circulation in Northern Ireland,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>The Annex to Regulation (EU) 2020/2170 should therefore be amended,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
The Annex to Regulation (EU) 2020/2170 is replaced by the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union .
It shall apply from 1 January 2024.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 3 October 2023.
For the Commission
The President
Ursula VON DER LEYEN
( 1 ) OJ L 432, 21.12.2020, p. 1 .
( 2 ) Commission Implementing Regulation (EU) 2019/159 of 31 January 2019 imposing definitive safeguard measures against imports of certain steel products ( OJ L 31, 1.2.2019, p. 27 ).
( 3 ) Regulation (EU) 2023/1321 of the European Parliament and of the Council of 14 June 2023, amending Regulation (EU) 2020/2170 on the application of Union tariff rate quotas and other import quotas ( OJ L 166, 30.6.2023, p. 1 ).
ANNEX
‘ANNEX
<table><col/><col/><tbody><tr><td><p><span>Tariff Rate Quota (TRQ) Description</span></p></td><td><p><span>Combined Nomenclature (CN) Codes</span> <a> (<span>1</span>)</a></p></td></tr><tr><td><p>Steel category 7</p></td><td><p>7208 51 20 , 7208 51 91 , 7208 51 98 , 7208 52 91 , 7208 90 20 , 7208 90 80 , 7210 90 30 , 7225 40 12 , 7225 40 40 , 7225 40 60 , 7225 99 00</p></td></tr><tr><td><p>Steel category 8</p></td><td><p>7219 11 00 , 7219 12 10 , 7219 12 90 , 7219 13 10 , 7219 13 90 , 7219 14 10 , 7219 14 90 , 7219 22 10 , 7219 22 90 , 7219 23 00 , 7219 24 00 , 7220 11 00 , 7220 12 00</p></td></tr><tr><td><p>Steel category 9</p></td><td><p>7219 31 00 , 7219 32 10 , 7219 32 90 , 7219 33 10 , 7219 33 90 , 7219 34 10 , 7219 34 90 , 7219 35 10 , 7219 35 90 , 7219 90 20 , 7219 90 80 , 7220 20 21 , 7220 20 29 , 7220 20 41 , 7220 20 49 , 7220 20 81 , 7220 20 89 , 7220 90 20 , 7220 90 80</p></td></tr><tr><td><p>Steel category 13</p></td><td><p>7214 20 00 , 7214 99 10</p></td></tr><tr><td><p>Steel category 17</p></td><td><p>7216 31 10 , 7216 31 90 , 7216 32 11 , 7216 32 19 , 7216 32 91 , 7216 32 99 , 7216 33 10 , 7216 33 90</p></td></tr><tr><td><p>Steel category 25A</p></td><td><p>7305 11 00 , 7305 12 00</p></td></tr><tr><td><p>Steel category 28</p></td><td><p>7217 10 10 , 7217 10 31 , 7217 10 39 , 7217 10 50 , 7217 10 90 , 7217 20 10 , 7217 20 30 , 7217 20 50 , 7217 20 90 , 7217 30 41 , 7217 30 49 , 7217 30 50 , 7217 30 90 , 7217 90 20 , 7217 90 50 , 7217 90 90</p></td></tr></tbody></table>
’ ( 1 ) As defined in Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff ( OJ L 256, 7.9.1987, p. 1 ).
ELI: http://data.europa.eu/eli/reg_del/2023/2777/oj
ISSN 1977-0677 (electronic edition) | ENG | 32023R2777 |
<table><col/><col/><col/><col/><tbody><tr><td><p>28.7.2016   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 202/17</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2016/1229
of 27 July 2016
on the issue of licences for importing rice under the tariff quotas opened for the July 2016 subperiod by Implementing Regulation (EU) No 1273/2011
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 ( 1 ) , and in particular Article 188 thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Commission Implementing Regulation (EU) No 1273/2011 <a>(<span>2</span>)</a> opened and provided for the administration of certain import tariff quotas for rice and broken rice, broken down by country of origin and split into several subperiods in accordance with Annex I to that Implementing Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>July is the third subperiod for the quota provided for under Article 1(1)(a) of Implementing Regulation (EU) No 1273/2011 and the second subperiod for the quotas provided for under Article 1(1)(b), (c) and (d) of that Implementing Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>The notifications sent in accordance with point (a) of Article 8 of Implementing Regulation (EU) No 1273/2011 show that, for the quotas with order number 09.4154 and 09.4166, the applications lodged in the first 10 working days of July 2016 under Article 4(1) of that Implementing Regulation cover a quantity greater than that available. The extent to which import licences may be issued should therefore be determined by fixing the allocation coefficient to be applied to the quantities requested under the quotas concerned, calculated in accordance with Article 7(2) of Commission Regulation (EC) No 1301/2006 <a>(<span>3</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>Those notifications also show that, for the quotas with order number 09.4127 — 09.4128 — 09.4129 — 09.4148 — 09.4149 — 09.4150 — 09.4152 and 09.4153, the applications lodged in the first 10 working days of July 2016 under Article 4(1) of Implementing Regulation (EU) No 1273/2011 cover a quantity less than that available.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>The total quantity available for the following subperiod should also be fixed for the quotas with order number 09.4127 — 09.4128 — 09.4129 — 09.4130 — 09.4148 — 09.4112 — 09.4116 — 09.4117 — 09.4118 — 09.4119 and 09.4166, in accordance with the first subparagraph of Article 5 of Implementing Regulation (EU) No 1273/2011.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>In order to ensure sound management of the procedure of issuing import licences, this Regulation should enter into force immediately after its publication,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
1. For import licence applications for rice under the quotas with order number 09.4154 and 09.4166 referred to in Implementing Regulation (EU) No 1273/2011 lodged in the first 10 working days of July 2016, licences shall be issued for the quantity requested, multiplied by the allocation coefficient set out in the Annex to this Regulation.
2. The total quantity available for the following subperiod under the quotas with order number 09.4127 — 09.4128 — 09.4129 — 09.4130 — 09.4148 — 09.4112 — 09.4116 — 09.4117 — 09.4118 — 09.4119 and 09.4166 referred to in Implementing Regulation (EU) No 1273/2011 is set out in the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 27 July 2016.
For the Commission,
On behalf of the President,
Jerzy PLEWA
Director-General for Agriculture and Rural Development
( 1 ) OJ L 347, 20.12.2013, p. 671 .
( 2 ) Commission Implementing Regulation (EU) No 1273/2011 of 7 December 2011 opening and providing for the administration of certain tariff quotas for imports of rice and broken rice ( OJ L 325, 8.12.2011, p. 6 ).
( 3 ) Commission Regulation (EC) No 1301/2006 of 31 August 2006 laying down common rules for the administration of import tariff quotas for agricultural products managed by a system of import licences ( OJ L 238, 1.9.2006, p. 13 ).
ANNEX
Quantities to be allocated for the July 2016 subperiod and quantities available for the following subperiod under Implementing Regulation (EU) No 1273/2011
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>Quota of wholly milled or semi-milled rice covered by CN code 1006 30 as provided for in Article 1(1)(a) of Implementing Regulation (EU) No 1273/2011:</p><table><col/><col/><col/><col/><tbody><tr><td><p>Origin</p></td><td><p>Order number</p></td><td><p>Allocation coefficient for July 2016 subperiod</p></td><td><p>Total quantity available for September 2016 subperiod (kg)</p></td></tr><tr><td><p>United States</p></td><td><p>09.4127</p></td><td><p>—<a> (<span>1</span>)</a></p></td><td><p>18 693 108</p></td></tr><tr><td><p>Thailand</p></td><td><p>09.4128</p></td><td><p>—<a> (<span>1</span>)</a></p></td><td><p>570 921</p></td></tr><tr><td><p>Australia</p></td><td><p>09.4129</p></td><td><p>—<a> (<span>1</span>)</a></p></td><td><p>502 800</p></td></tr><tr><td><p>Other origins</p></td><td><p>09.4130</p></td><td><p>—<a> (<span>2</span>)</a></p></td><td><p>0</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>Quota of husked rice covered by CN code 1006 20 as provided for in Article 1(1)(b) of Implementing Regulation (EU) No 1273/2011:</p><table><col/><col/><col/><col/><tbody><tr><td><p>Origin</p></td><td><p>Order number</p></td><td><p>Allocation coefficient for July 2016 subperiod</p></td><td><p>Total quantity available for October 2016 subperiod (kg)</p></td></tr><tr><td><p>All countries</p></td><td><p>09.4148</p></td><td><p>—<a> (<span>3</span>)</a></p></td><td><p>578 000</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>Quota of broken rice covered by CN code 1006 40 00 as provided for in Article 1(1)(c) of Implementing Regulation (EU) No 1273/2011:</p><table><col/><col/><col/><tbody><tr><td><p>Origin</p></td><td><p>Order number</p></td><td><p>Allocation coefficient for July 2016 subperiod</p></td></tr><tr><td><p>Thailand</p></td><td><p>09.4149</p></td><td><p>—<a> (<span>4</span>)</a></p></td></tr><tr><td><p>Australia</p></td><td><p>09.4150</p></td><td><p>—<a> (<span>5</span>)</a></p></td></tr><tr><td><p>Guyana</p></td><td><p>09.4152</p></td><td><p>—<a> (<span>5</span>)</a></p></td></tr><tr><td><p>United States</p></td><td><p>09.4153</p></td><td><p>—<a> (<span>4</span>)</a></p></td></tr><tr><td><p>Other origins</p></td><td><p>09.4154</p></td><td><p>8,905159 %</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>Quota of wholly milled or semi-milled rice covered by CN code 1006 30 as provided for in Article 1(1)(d) of Implementing Regulation (EU) No 1273/2011:</p><table><col/><col/><col/><col/><tbody><tr><td><p>Origin</p></td><td><p>Order number</p></td><td><p>Allocation coefficient for July 2016 subperiod</p></td><td><p>Total quantity available for September 2016 subperiod (kg)</p></td></tr><tr><td><p>Thailand</p></td><td><p>09.4112</p></td><td><p>—<a> (<span>6</span>)</a></p></td><td><p>7 410</p></td></tr><tr><td><p>United States</p></td><td><p>09.4116</p></td><td><p>—<a> (<span>6</span>)</a></p></td><td><p>0</p></td></tr><tr><td><p>India</p></td><td><p>09.4117</p></td><td><p>—<a> (<span>6</span>)</a></p></td><td><p>23 603</p></td></tr><tr><td><p>Pakistan</p></td><td><p>09.4118</p></td><td><p>—<a> (<span>6</span>)</a></p></td><td><p>7 334</p></td></tr><tr><td><p>Other origins</p></td><td><p>09.4119</p></td><td><p>—<a> (<span>6</span>)</a></p></td><td><p>5 239</p></td></tr><tr><td><p>All countries</p></td><td><p>09.4166</p></td><td><p>0,597830 %</p></td><td><p>0</p></td></tr></tbody></table></td></tr></tbody></table>
<note>
( 1 ) Applications cover quantities less than or equal to the quantities available: all applications are therefore acceptable.
( 2 ) No quantity available for this subperiod.
( 3 ) No allocation coefficient applied for this subperiod: no licence applications were notified to the Commission.
( 4 ) Applications cover quantities less than or equal to the quantities available: all applications are therefore acceptable.
( 5 ) No allocation coefficient applied for this subperiod: no licence applications were notified to the Commission.
( 6 ) No quantity available for this subperiod
</note> | ENG | 32016R1229 |
<table><col/><col/><col/><col/><tbody><tr><td><p>5.4.2016   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 88/24</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2016/525
of 30 March 2016
entering a name in the register of protected designations of origin and protected geographical indications (Ternera de los Pirineos Catalanes/Vedella dels Pirineus Catalans/Vedell des Pyrénées Catalanes (PGI))
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs ( 1 ) , and in particular Article 52(2) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, France and Spain's application to register the name ‘Ternera de los Pirineos Catalanes’/‘Vedella dels Pirineus Catalans’/‘Vedell des Pyrénées Catalanes’ was published in the<span>Official Journal of the European Union</span><a> (<span>2</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Ternera de los Pirineos Catalanes’/‘Vedella dels Pirineus Catalans’/‘Vedell des Pyrénées Catalanes’ should therefore be entered in the register,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
The name ‘Ternera de los Pirineos Catalanes’/‘Vedella dels Pirineus Catalans’/‘Vedell des Pyrénées Catalanes’ (PGI) is hereby entered in the register.
The name specified in the first paragraph denotes a product in Class 1.1. Fresh meat (and offal), as listed in Annex XI to Commission Implementing Regulation (EU) No 668/2014 ( 3 ) .
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 30 March 2016.
For the Commission,
On behalf of the President,
Phil HOGAN
Member of the Commission
<note>
( 1 ) OJ L 343, 14.12.2012, p. 1 .
( 2 ) OJ C 344, 17.10.2015, p. 4 .
( 3 ) Commission Implementing Regulation (EU) No 668/2014 of 13 June 2014 laying down rules for the application of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs ( OJ L 179, 19.6.2014, p. 36 ).
</note> | ENG | 32016R0525 |
<table><col/><col/><col/><col/><tbody><tr><td><p>8.1.2015   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 4/18</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2015/24
of 7 January 2015
establishing the standard import values for determining the entry price of certain fruit and vegetables
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 ( 1 ) ,
Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors ( 2 ) , and in particular Article 136(1) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the<span>Official Journal of the European Union</span>,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
The standard import values referred to in Article 136 of Implementing Regulation (EU) No 543/2011 are fixed in the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 7 January 2015.
For the Commission,
On behalf of the President,
Jerzy PLEWA
Director-General for Agriculture and Rural Development
( 1 ) OJ L 347, 20.12.2013, p. 671 .
( 2 ) OJ L 157, 15.6.2011, p. 1 .
ANNEX
Standard import values for determining the entry price of certain fruit and vegetables
<table><col/><col/><col/><tbody><tr><td><p>(EUR/100 kg)</p></td></tr><tr><td><p>CN code</p></td><td><p>Third country code<a> (<span>1</span>)</a></p></td><td><p>Standard import value</p></td></tr><tr><td><p>0702 00 00</p></td><td><p>AL</p></td><td><p>69,6</p></td></tr><tr><td><p>IL</p></td><td><p>104,4</p></td></tr><tr><td><p>MA</p></td><td><p>89,1</p></td></tr><tr><td><p>TN</p></td><td><p>130,5</p></td></tr><tr><td><p>TR</p></td><td><p>108,0</p></td></tr><tr><td><p>ZZ</p></td><td><p>100,3</p></td></tr><tr><td><p>0707 00 05</p></td><td><p>TR</p></td><td><p>160,8</p></td></tr><tr><td><p>ZZ</p></td><td><p>160,8</p></td></tr><tr><td><p>0709 93 10</p></td><td><p>MA</p></td><td><p>96,9</p></td></tr><tr><td><p>SN</p></td><td><p>80,8</p></td></tr><tr><td><p>TR</p></td><td><p>157,6</p></td></tr><tr><td><p>ZZ</p></td><td><p>111,8</p></td></tr><tr><td><p>0805 10 20</p></td><td><p>EG</p></td><td><p>41,2</p></td></tr><tr><td><p>MA</p></td><td><p>68,6</p></td></tr><tr><td><p>TR</p></td><td><p>74,1</p></td></tr><tr><td><p>ZA</p></td><td><p>40,1</p></td></tr><tr><td><p>ZW</p></td><td><p>32,9</p></td></tr><tr><td><p>ZZ</p></td><td><p>51,4</p></td></tr><tr><td><p>0805 20 10</p></td><td><p>MA</p></td><td><p>58,8</p></td></tr><tr><td><p>ZZ</p></td><td><p>58,8</p></td></tr><tr><td><p>0805 20 30, 0805 20 50, 0805 20 70, 0805 20 90</p></td><td><p>IL</p></td><td><p>89,3</p></td></tr><tr><td><p>JM</p></td><td><p>106,8</p></td></tr><tr><td><p>TR</p></td><td><p>80,9</p></td></tr><tr><td><p>ZZ</p></td><td><p>92,3</p></td></tr><tr><td><p>0805 50 10</p></td><td><p>TR</p></td><td><p>53,0</p></td></tr><tr><td><p>ZZ</p></td><td><p>53,0</p></td></tr><tr><td><p>0808 10 80</p></td><td><p>AR</p></td><td><p>164,5</p></td></tr><tr><td><p>BR</p></td><td><p>62,9</p></td></tr><tr><td><p>CL</p></td><td><p>82,5</p></td></tr><tr><td><p>MK</p></td><td><p>39,8</p></td></tr><tr><td><p>US</p></td><td><p>145,8</p></td></tr><tr><td><p>ZA</p></td><td><p>147,0</p></td></tr><tr><td><p>ZZ</p></td><td><p>107,1</p></td></tr><tr><td><p>0808 30 90</p></td><td><p>US</p></td><td><p>171,4</p></td></tr><tr><td><p>ZZ</p></td><td><p>171,4</p></td></tr></tbody></table>
<note>
( 1 ) Nomenclature of countries laid down by Commission Regulation (EU) No 1106/2012 of 27 November 2012 implementing Regulation (EC) No 471/2009 of the European Parliament and of the Council on Community statistics relating to external trade with non-member countries, as regards the update of the nomenclature of countries and territories ( OJ L 328, 28.11.2012, p. 7 ). Code ‘ZZ’ stands for ‘of other origin’.
</note> | ENG | 32015R0024 |
02018D0907 — EN — 01.03.2020 — 001.001
This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document
<table><col/><col/><tr><td><p><a>►B</a></p></td><td><p>COUNCIL DECISION (CFSP) 2018/907</p><p>of 25 June 2018</p><p><a>extending the mandate of the European Union Special Representative for the South Caucasus and the crisis in Georgia</a></p><p>(OJ L 161 26.6.2018, p. 27)</p></td></tr></table>
Amended by:
<table><col/><col/><col/><col/><col/><tr><td><p> </p></td><td><p> </p></td><td><p>Official Journal</p></td></tr><tr><td><p>  No</p></td><td><p>page</p></td><td><p>date</p></td></tr><tr><td><p><a>►M1</a></p></td><td><p><a>COUNCIL DECISION (CFSP) 2020/254 of 25 February 2020</a></p></td><td><p>  L 54I</p></td><td><p>11</p></td><td><p>26.2.2020</p></td></tr></table>
COUNCIL DECISION (CFSP) 2018/907
of 25 June 2018
extending the mandate of the European Union Special Representative for the South Caucasus and the crisis in Georgia
Article 1
European Union Special Representative
The mandate of Mr Toivo KLAAR as the European Union Special Representative (EUSR) for the South Caucasus and the crisis in Georgia is extended until 28 February 2021. The Council may decide that the mandate of the EUSR be terminated earlier, based on an assessment by the Political and Security Committee (PSC) and a proposal from the High Representative of the Union for Foreign Affairs and Security Policy (HR).
Article 2
Policy objectives
The EUSR's mandate shall be based on the policy objectives of the Union for the South Caucasus, including the objectives set out in the conclusions of the extraordinary European Council meeting held in Brussels on 1 September 2008 and the Council conclusions of 15 September 2008, as well as those of 27 February 2012. Those objectives include:
(a) in accordance with the existing mechanisms, including the Organisation for Security and Cooperation in Europe (OSCE) and its Minsk Group, to prevent conflicts in the region, to contribute to a peaceful settlement of conflicts in the region, including the crisis in Georgia and the Nagorno-Karabakh conflict, by promoting the return of refugees and internally displaced persons and through other appropriate means, and to support the implementation of such a settlement in accordance with the principles of international law;
(b) to engage constructively with the main interested actors regarding the region;
(c) to encourage and to support further cooperation between Armenia, Azerbaijan and Georgia, and, as appropriate, their neighbouring countries;
(d) to enhance the Union's effectiveness and visibility in the region.
Article 3
Mandate
In order to achieve the policy objectives, the EUSR's mandate shall be to:
(a) develop contacts with governments, parliaments, other key political actors, the judiciary and civil society in the region;
(b) encourage the countries in the region to cooperate on regional themes of common interest, such as common security threats, the fight against terrorism, illicit trafficking and organised crime;
(c) contribute to the peaceful settlement of conflicts in accordance with the principles of international law and facilitate the implementation of such settlement in close coordination with the United Nations, the OSCE and its Minsk Group;
(d) with respect to the crisis in Georgia:
(i) help prepare for the international talks held under point 6 of the settlement plan of 12 August 2008, the Geneva International Discussions, and its implementing measures of 8 September 2008, including on arrangements for security and stability in the region, the issue of refugees and internally displaced persons, on the basis of internationally recognised principles, and any other subject, by mutual agreement between the parties;
(ii) help establish the Union's position and represent it, at the level of the EUSR, in the talks referred to in point (i); and
(iii)
facilitate the implementation of the settlement plan of 12 August 2008 and its implementing measures of 8 September 2008;
(e) facilitate the development and implementation of confidence-building measures in coordination with Member States' expertise where available and appropriate;
(f) assist in the preparation, as appropriate, of Union contributions to the implementation of a possible conflict settlement;
(g) intensify the Union's dialogue with the main actors concerned regarding the region;
(h) assist the Union in further developing a comprehensive policy towards the South Caucasus;
(i) in the framework of the activities set out in this Article, contribute to the implementation of the Union's human rights policy and the Union Guidelines on Human Rights, in particular with regard to children and women in areas affected by conflicts, especially by monitoring and addressing developments in this regard.
Article 4
Implementation of the mandate
1. The EUSR shall be responsible for the implementation of the mandate, acting under the authority of the HR.
2. The PSC shall maintain a privileged link with the EUSR and shall be the EUSR's primary point of contact with the Council. The PSC shall provide the EUSR with strategic guidance and political direction within the framework of the mandate, without prejudice to the powers of the HR.
3. The EUSR shall work in close coordination with the European External Action Service (EEAS) and its relevant departments.
Article 5
Financing
1. The financial reference amount intended to cover the expenditure related to the EUSR's mandate for the period from 1 July 2018 to 29 February 2020 shall be EUR 4 340 000 .
The financial reference amount intended to cover the expenditure related to the EUSR's mandate for the period from 1 March 2020 to 28 February 2021 shall be EUR 2 900 000 .
2. The expenditure shall be managed in accordance with the procedures and rules applicable to the general budget of the Union.
3. The management of the expenditure shall be subject to a contract between the EUSR and the Commission. The EUSR shall be accountable to the Commission for all expenditure.
Article 6
Constitution and composition of the team
1. Within the limits of the EUSR's mandate and the corresponding financial means made available, the EUSR shall be responsible for constituting a team. The team shall include the expertise on specific policy issues as required by the mandate. The EUSR shall keep the Council and the Commission promptly informed of the composition of the team.
2. Member States, the institutions of the Union and the EEAS may propose the secondment of staff to the EUSR. The salary of such seconded personnel shall be covered by the Member State, the institution of the Union concerned or the EEAS, respectively. Experts seconded by Member States to the institutions of the Union or the EEAS may also be posted to work with the EUSR. International contracted staff shall have the nationality of a Member State.
3. All seconded personnel shall remain under the administrative authority of the sending Member State, the sending institution of the Union or the EEAS and shall carry out their duties and act in the interest of the EUSR's mandate.
4. The EUSR staff shall be co-located with the relevant EEAS departments or Union delegations in order to ensure coherence and consistency of their respective activities.
Article 7
Privileges and immunities of the EUSR and the staff of the EUSR
The privileges, immunities and further guarantees necessary for the completion and smooth functioning of the EUSR's mission and the members of the EUSR's staff shall be agreed with the host countries, as appropriate. Member States and the EEAS shall grant all necessary support to such effect.
Article 8
Security of EU classified information
The EUSR and the members of the EUSR's team shall respect the security principles and minimum standards established by Council Decision 2013/488/EU ( 1 ).
Article 9
Access to information and logistical support
1. Member States, the Commission and the General Secretariat of the Council shall ensure that the EUSR is given access to any relevant information.
2. The Union delegations in the region and/or the Member States, as appropriate, shall provide logistical support in the region.
Article 10
Security
In accordance with the Union's policy on the security of personnel deployed outside the Union in an operational capacity under Title V of the Treaty, the EUSR shall take all reasonably practicable measures, in accordance with the EUSR's mandate and the security situation in the area of responsibility, for the security of all personnel under the EUSR's direct authority, in particular by:
(a) establishing a specific security plan based on guidance from the EEAS, including specific physical, organisational and procedural security measures, governing the management of the secure movement of personnel to and within the area of responsibility, as well as management of security incidents and providing for a contingency and evacuation plan;
(b) ensuring that all personnel deployed outside the Union are covered by high-risk insurance, as required by the conditions in the area of responsibility;
(c) ensuring that all members of the EUSR's team to be deployed outside the Union, including locally contracted personnel, have received appropriate security training before or upon arriving in the area of responsibility, based on the risk ratings assigned to that area by the EEAS;
(d) ensuring that all agreed recommendations made following regular security assessments are implemented and providing the Council, the HR and the Commission with written reports on their implementation and on other security issues within the framework of the progress report and the report on the implementation of the mandate.
Article 11
Reporting
The EUSR shall regularly provide the HR and the PSC with oral and written reports. The EUSR shall also report to Council working parties as necessary. Regular reports shall be circulated through the COREU network. The EUSR may provide the Foreign Affairs Council with reports. In accordance with Article 36 of the Treaty, the EUSR may be involved in briefing the European Parliament.
Article 12
Coordination
1. The EUSR shall contribute to the unity, consistency and effectiveness of the Union's action and shall help ensure that all Union instruments and Member States' actions are engaged consistently, to attain the Union's policy objectives. Liaison with Member States shall be sought where appropriate. The activities of the EUSR shall be coordinated with those of the Commission. The EUSR shall provide regular briefings to Member States' missions and the Union's delegations.
2. In the field, close liaison shall be maintained with the Heads of Union delegations and Member States' Heads of Mission. They shall make every effort to assist the EUSR in the implementation of the mandate. The EUSR, in close co-ordination with the Head of Union Delegation to Georgia, shall provide the Head of the European Union Monitoring Mission in Georgia (EUMM Georgia) with local political guidance. The EUSR and the Civilian Operation Commander for EUMM Georgia shall consult each other as required. The EUSR shall also liaise with other international and regional actors in the field.
Article 13
Assistance in relation to claims
The EUSR and the EUSR's staff shall assist in providing elements to respond to any claims and obligations arising from the mandates of the previous EUSRs for the South Caucasus and the crisis in Georgia, and shall provide administrative assistance and access to relevant files for such purposes.
Article 14
Review
The implementation of this Decision and its consistency with other contributions from the Union to the region shall be kept under regular review. The EUSR shall present the Council, the HR and the Commission with a progress report by 31 October 2018 and a comprehensive mandate implementation report by 30 November 2019.
The final comprehensive mandate implementation report of the EUSR shall be presented by 30 November 2020.
Article 15
Entry into force
This Decision shall enter into force on the date of its adoption.
<note>
( 1 ) Council Decision 2013/488/EU of 23 September 2013 on the security rules for protecting EU classified information (OJ L 274, 15.10.2013, p. 1).
</note> | ENG | 02018D0907-20200301 |
<table><col/><col/><col/><col/><tbody><tr><td><p>6.4.2017   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 92/36</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2017/646
of 5 April 2017
amending Implementing Regulation (EU) 2015/378 laying down rules for the application of Regulation (EU) No 514/2014 of the European Parliament and of the Council with regard to the implementation of the annual clearance of accounts procedure and the implementation of the conformity clearance
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 514/2014 of the European Parliament and of the Council of 16 April 2014 laying down general provisions on the Asylum, Migration and Integration Fund and on the instrument for financial support for police cooperation, preventing and combating crime and crisis management ( 1 ) , and in particular Article 47(6) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>The first annual accounts clearance exercise carried out pursuant to Article 1 of Commission Implementing Regulation (EU) 2015/378 <a>(<span>2</span>)</a> highlighted the need to clarify the situation of annual pre-financing amounts that are not fully cleared by the annual accounts submitted.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>It is necessary to establish arrangements for the implementation of the conformity clearance and in particular rules on criteria for determining the level of financial correction that the Commission can apply pursuant to Article 47 of Regulation (EU) No 514/2014 following the completion of that procedure.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>To ensure legal certainty and equal treatment of all Member States, it is essential to clarify the criteria for determining deficiencies in the effective functioning of the management and control systems, define the main types of such deficiencies and set out the criteria for determining the level of financial correction.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>Implementing Regulation (EU) 2015/378 should therefore be amended.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>The measures provided for in this Regulation are in accordance with the opinion of the ‘Asylum, Migration and Integration and Internal Security Funds’ Committee,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
Implementing Regulation (EU) 2015/378 is amended as follow:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Article 1 is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>paragraph 6 is replaced by the following:</p><div><p>‘6.   Where the amount accepted by the Commission in the decision on the clearance of annual accounts for financial year N is lower than the annual pre-financing amount for financial year N, the latter amount shall be cleared against the former. Any outstanding pre-financing amount shall be cleared in the course of subsequent clearance exercises.</p><p>The first subparagraph shall apply also in cases where a Member State submits annual accounts reporting zero payment.’;</p></div></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>paragraph 7 is deleted;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>the following articles are inserted:</p><div><p>‘Article 3a</p><p>Criteria for determining deficiencies in the effective functioning of the management and control system</p><div><p>1.   The Commission shall base its assessment of the effective functioning of the management and control system on the results of all available audits carried out by the Member States, the Commission services and the Court of Auditors, the results of investigations carried out by European Anti-Fraud Office or any other information on compliance with the designation criteria referred to in Article 2(1) of Commission Delegated Regulation (EU) No 1042/2014<a> (<span>*1</span>)</a>.</p><p>The Commission's assessment shall cover the internal control environment of the national programme, the management and control activities of the Responsible Authority, and the control and audit activities of the Audit Authority and shall be based on verification of compliance with the key requirements set out in Table 1 of the Annex.</p></div><div><p>2.   Compliance with the key requirements referred to in paragraph 1 according to the categories set out in Table 2 of the Annex shall be used to assess the effective functioning of each competent authority and to reach an overall conclusion on the management and control system. Any mitigating or aggravating factors shall be taken into account in the overall conclusion on the management and control system.</p></div><div><p>3.   Wherever it is assessed that any of the key requirements 2, 4, 5, 8, 11, 12 or 14 in Table 1 of the Annex, or two or more of the other key requirements in that Table fall into categories 3 or 4 set out in Table 2 of the Annex, it shall be considered as a type of serious deficiency in the effective functioning of the management and control system.</p></div></div><div><p>Article 3b</p><p>Criteria for applying and determining the level of financial corrections</p><div><p>1.   The Commission shall apply financial corrections where it identifies one or more individual or systemic irregularities or one or more deficiencies in the effective functioning of the management and control system (‘system deficiencies’).</p><p>For the purpose of this Regulation, an irregularity means any infringement of Union or national law or any infringement of national rules resulting from an act or omission by a beneficiary or beneficiaries which has, or would have, the effect of prejudicing the general budget of the European Union by charging to it an unjustified item of expenditure.</p><p>The amount of the financial correction shall be determined on a case-by-case basis wherever possible and shall be equal to the exact amount of expenditure wrongly charged to the general budget of the Union.</p><p>Where the Commission identifies irregularities in a representative sample of expenditure in all or part of a national programme, but it is not cost-effective to verify the regularity of the other expenditure, the correction may be determined by extrapolating the results of the examination of the sample to the rest of the population from which it was drawn.</p><p>Where the Commission identifies systemic irregularities or system deficiencies but where it is not possible, even by extrapolation, to quantify the correction precisely, a flat-rate financial correction shall be applied to the expenditure declared for the part of the system affected in accordance with the indicative criteria and scales set out in paragraphs 2 and 3.</p><p>Flat-rate corrections may also be applied in respect of individual irregularities.</p></div><div><p>2.   The level of flat-rate correction shall be determined taking into account the following factors:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the degree of seriousness of the irregularity or of the system deficiency in relation to the overall system or part of it, or to the types of expenditure declared;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the degree of risk of loss to which the Union budget was exposed as a result of the irregularity or system deficiency;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the vulnerability of the expenditure to fraud due to the irregularity or system deficiency;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>any mitigating or aggravating factors.</p></td></tr></tbody></table></div><div><p>3.   The level of correction shall be determined as follows:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>where the irregularity or irregularities or the system deficiency or deficiencies is/are so fundamental, frequent or widespread that it/they represent(s) a complete failure of the system that puts at risk the legality and regularity of all the expenditure concerned, a flat rate of 100 % shall be applied;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>where the irregularity or irregularities or the system deficiency or deficiencies is/are so frequent and widespread that it/they represent(s) an extremely serious failure of the system that puts at risk the legality and regularity of a very high proportion of the expenditure concerned, a flat rate of 25 % shall be applied;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>where the irregularity or irregularities or the system deficiency or deficiencies is/are due to the system functioning partially, poorly or infrequently so as to put at risk the legality and regularity of a high proportion of the expenditure concerned, a flat rate of 10 % shall be applied;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>where the irregularity or irregularities or the system deficiency or deficiencies is/are due to the system functioning inconsistently so as to put at risk the legality and regularity of a significant proportion of the expenditure concerned, a flat rate of 5 % shall be applied.</p></td></tr></tbody></table><p>In accordance with the principle of proportionality, the rate may be reduced to 2 % where the nature and gravity of the irregularity or system deficiency are not considered to justify a 5 % correction rate.</p></div><div><p>4.   Where, due to a competent authority's failure to take adequate corrective measures following the application of a financial correction in a financial year, the same irregularity or irregularities or deficiency or deficiencies is/are identified in a subsequent financial year, the rate of flat rate correction may, due to the persistence of the irregularity or irregularities or deficiency or deficiencies, be raised to a level not exceeding the next level in the scale set out in paragraph 3.</p></div></div><p><a>(<span>*1</span>)</a>  Commission Delegated Regulation (EU) No 1042/2014 of 25 July 2014 supplementing Regulation (EU) No 514/2014 with regard to the designation and management and control responsibilities of Responsible Authorities and with regard to status and obligations of Audit Authorities (<a>OJ L 289, 3.10.2014, p. 3</a>).’;"</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>a new annex is added as set out in the Annex to this Regulation.</p></td></tr></tbody></table>
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties.
Done at Brussels, 5 April 2017.
For the Commission
The President
Jean-Claude JUNCKER
( 1 ) OJ L 150, 20.5.2014, p. 112 .
( 2 ) Commission Implementing Regulation (EU) 2015/378 of 2 March 2015 laying down rules for the application of Regulation (EU) No 514/2014 of the European Parliament and of the Council with regard to the implementation of the annual clearance of accounts procedure and the implementation of the conformity clearance ( OJ L 64, 7.3.2015, p. 30 ).
ANNEX
‘ANNEX
Key requirements of the management and control systems and their classification with regard to their effective functioning
(referred to in Article 3a of Implementing Regulation (EU) 2015/378)
Table 1
Key requirements
<table><col/><col/><col/><col/><tbody><tr><td><p> </p></td><td><p>Key requirements of the management and control systems</p></td><td><p>Bodies/authorities concerned</p></td><td><p>Scope</p></td></tr><tr><td><p>1</p></td><td><p>Adequate description and separation of functions and adequate systems for reporting and monitoring where the Responsible Authority entrusts execution of tasks to another body</p></td><td><p>Responsible Authority/Delegated Authority</p></td><td><p>Internal environment</p></td></tr><tr><td><p>2</p></td><td><p><span>Appropriate selection of projects</span></p></td><td><p>Responsible Authority/Delegated Authority</p></td><td><p>Control activities</p></td></tr><tr><td><p>3</p></td><td><p>Adequate information to beneficiaries, potential beneficiaries and the public</p></td><td><p>Responsible Authority/Delegated Authority</p></td><td><p>Internal information and communication</p></td></tr><tr><td><p>4</p></td><td><p><span>Adequate controls</span></p></td><td><p>Responsible Authority/Delegated Authority</p></td><td><p>Control activities</p></td></tr><tr><td><p>5</p></td><td><p><span>Effective systems and procedures to ensure that all the documents regarding expenditure and controls are held to ensure an adequate audit trail</span></p></td><td><p>Responsible Authority/Delegated Authority</p></td><td><p>Control activities</p></td></tr><tr><td><p>6</p></td><td><p>Reliable computerised systems for accounting, for the storage and transmission of financial data and data on indicators, for monitoring and for reporting</p></td><td><p>Responsible Authority/Delegated Authority</p></td><td><p>Control activities/Internal information and communication</p></td></tr><tr><td><p>7</p></td><td><p>Effective implementation of procedures for the prevention, detection and correction of irregularities including proportionate anti-fraud measures</p></td><td><p>Responsible Authority/Delegated Authority</p></td><td><p>Control activities</p></td></tr><tr><td><p>8</p></td><td><p><span>Appropriate procedures for drawing up the annual accounts, the management declaration and the annual summary of final audit reports and of controls carried out</span></p></td><td><p>Responsible Authority/Delegated Authority</p></td><td><p>Control activities</p></td></tr><tr><td><p>9</p></td><td><p>Appropriate and complete account of amounts recoverable, recovered and cancelled</p></td><td><p>Responsible Authority/Delegated Authority</p></td><td><p>Control activities</p></td></tr><tr><td><p>10</p></td><td><p>Adequate description and separation of functions, functional independence from the Responsible Authority and adequate systems for ensuring that any other body that carries out audits has the necessary functional independence and takes accounts of internationally accepted audit standards</p></td><td><p>Audit Authority</p></td><td><p>Internal environment</p></td></tr><tr><td><p>11</p></td><td><p><span>Adequate system audits</span></p></td><td><p>Audit Authority</p></td><td><p>Control activities</p></td></tr><tr><td><p>12</p></td><td><p><span>Adequate audits of expenditure</span></p></td><td><p>Audit Authority</p></td><td><p>Control activities</p></td></tr><tr><td><p>13</p></td><td><p>Adequate audits of accounts</p></td><td><p>Audit Authority</p></td><td><p>Control activities</p></td></tr><tr><td><p>14</p></td><td><p><span>Adequate procedures for providing reliable audit opinions and audit reports</span></p></td><td><p>Audit Authority</p></td><td><p>Control activities</p></td></tr></tbody></table>
Table 2
Classification of key requirements for the management and control systems with regard to their functioning
<table><col/><col/><tbody><tr><td><p>Category 1</p></td><td><p>Works well. No, or only minor improvement(s) needed</p></td></tr><tr><td><p>Category 2</p></td><td><p>Works. Some improvement(s) needed</p></td></tr><tr><td><p>Category 3</p></td><td><p>Works partially. Substantial improvements needed</p></td></tr><tr><td><p>Category 4</p></td><td><p>Essentially does not work</p></td></tr></tbody></table>
’ | ENG | 32017R0646 |
02016D0016 — EN — 13.01.2017 — 001.001
This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document
<table><col/><col/><tr><td><p><a>►B</a></p></td><td><p>DECISION (EU) 2016/948 OF THE EUROPEAN CENTRAL BANK</p><p>of 1 June 2016</p><p><a>on the implementation of the corporate sector purchase programme (ECB/2016/16)</a></p><p>(OJ L 157 15.6.2016, p. 28)</p></td></tr></table>
Amended by:
<table><col/><col/><col/><col/><col/><tr><td><p> </p></td><td><p> </p></td><td><p>Official Journal</p></td></tr><tr><td><p>  No</p></td><td><p>page</p></td><td><p>date</p></td></tr><tr><td><p><a>►M1</a></p></td><td><p><a>DECISION (EU) 2017/103 OF THE EUROPEAN CENTRAL BANK of 11 January 2017</a></p></td><td><p>  L 16</p></td><td><p>57</p></td><td><p>20.1.2017</p></td></tr></table>
DECISION (EU) 2016/948 OF THE EUROPEAN CENTRAL BANK
of 1 June 2016
on the implementation of the corporate sector purchase programme (ECB/2016/16)
Article 1
Establishment and scope of the outright purchase of corporate bonds
The CSPP is hereby established. Under the CSPP specified Eurosystem central banks may purchase eligible corporate bonds from eligible counterparties in the primary and secondary markets, while public sector corporate bonds, as defined in Article 3(1), may only be purchased in the secondary markets, under specific conditions.
Article 2
Eligibility criteria for corporate bonds
In order to be eligible for outright purchase under the CSPP, marketable debt instruments issued by corporations shall comply with the eligibility criteria for marketable assets for Eurosystem credit operations pursuant to Part 4 of Guideline (EU) 2015/510 of the European Central Bank (ECB/2014/60) ( 1 ) and the following additional requirements.
1. The issuer of the marketable debt instrument:
(a) is incorporated in a Member State whose currency is the euro;
(b) is not a credit institution as defined in point (14) of Article 2 of Guideline (EU) 2015/510 (ECB/2014/60);
(c) does not have a parent undertaking as defined in point (15) of Article 4(1) of Regulation (EU) No 575/2013 of the European Parliament and of the Council ( 2 ) that is also a credit institution as defined in point (14) of Article 2 of Guideline (EU) 2015/510 (ECB/2014/60);
(d) does not have a parent company which is subject to banking supervision outside the euro area;
(e) is not a supervised entity as defined in point (20) of Article 2 of Regulation (EU) No 468/2014 of the European Central Bank (ECB/2014/17) ( 3 ) or a member of a supervised group as defined in subpoint (b) of point (21) of Article 2 of Regulation (EU) No 468/2014 (ECB/2014/17), in each case, as contained in the list published by the ECB on its website in accordance with Article 49(1) of Regulation (EU) No 468/2014 (ECB/2014/17), and is not a subsidiary, as defined in point (16) of Article 4(1) of the Regulation (EU) No 575/2013, of any of those supervised entities or supervised groups;
(f) is not an investment firm as defined in point (1) of Article 4(1) of Directive 2014/65/EU of the European Parliament and of the Council ( 4 );
(g) has not issued an asset-backed security within the meaning of point (3) of Article 2 of Guideline (EU) 2015/510 (ECB/2014/60);
(h) has not issued a multi cédula within the meaning of point (62) of Article 2 of Guideline (EU) 2015/510 (ECB/2014/60);
(i) has not issued a structured covered bond within the meaning of point (88) of Article 2 of Guideline (EU) 2015/510 (ECB/2014/60);
(j) is not an asset management vehicle resulting from the application of an asset separation tool in a resolution action pursuant to Article 26 of Regulation (EU) No 806/2014 of the European Parliament and of the Council ( 5 ) or national legislation implementing Article 42 of Directive 2014/59/EU of the European Parliament and of the Council ( 6 );
(k) is not a national asset management and divestment fund established to support financial sector restructuring and/or resolution ( 7 ); and
(l) is not an eligible issuer for the PSPP.
2. The marketable debt instrument has a minimum remaining maturity of 6 months and a maximum remaining maturity of 30 years and 364 days at the time of its purchase by the relevant Eurosystem central bank.
3. In deviation from Article 59(5) of Guideline (EU) 2015/510 (ECB/2014/60), only credit assessment information that is provided by an external credit assessment institution accepted within the Eurosystem credit assessment framework will be taken into account for the assessment of the credit quality requirements of the marketable debt instrument.
4. The marketable debt instrument is denominated in euro.
5. Purchases of nominal corporate bonds at a negative yield to maturity (or yield to worst) equal to or above the deposit facility rate are permitted. Purchases of nominal corporate bonds at a negative yield to maturity (or yield to worst) below the deposit facility rate are permitted to the extent necessary.
Article 3
Limitations on the execution of purchases of public sector corporate bonds
1. For the purposes of this Decision, a ‘public sector corporate bond’ means a corporate bond that fulfils the requirements of Article 2 and is issued by a public undertaking within the meaning of Article 8 of Council Regulation (EC) No 3603/93 ( 8 ).
2. To permit the formation of a market price for eligible public sector corporate bonds, no purchases shall be permitted of a newly issued or tapped public sector corporate bond, or of public sector corporate bonds issued by the same entity or by the entities within the issuer's group with maturities that expire close in time to, either just before or after, the maturity of the marketable debt instruments to be issued or tapped, over a period to be determined by the Governing Council.
Article 4
Purchase limits
1. An issue share limit per international securities identification number (ISIN) shall apply under the CSPP, after consolidating holdings in all of the portfolios of the Eurosystem central banks. The issue share limit shall be 70 % per ISIN for all corporate bonds other than public sector corporate bonds.
A lower issue share limit may apply in specific cases, including for public sector corporate bonds or for risk management reasons. Public sector corporate bonds shall be dealt with in a manner consistent with their treatment under the PSPP.
2. The Eurosystem shall conduct appropriate credit risk and due diligence procedures on eligible corporate bonds on an ongoing basis.
3. The Eurosystem shall define additional purchase limits for issuer groups based on a benchmark allocation related to an issuer group's market capitalisation to ensure a diversified allocation of purchases across issuers and issuer groups.
Article 5
Purchasing Eurosystem central banks
The Eurosystem central banks purchasing corporate bonds under the CSPP shall be specified in a list published on the ECB's website. The Eurosystem shall apply a specialisation scheme for the allocation of corporate bonds to be purchased under the CSPP based on the issuer's country of incorporation. The Governing Council shall allow ad hoc deviations from the specialisation scheme if there are objective considerations obstructing the scheme's implementation or if such deviations are advisable in order to achieve the CSPP's overall monetary policy objectives. In particular, each specified Eurosystem central bank shall only purchase eligible corporate bonds issued by issuers incorporated in specified Member States within the euro area. The geographical allocation of eligible corporate bond issuers' countries of incorporation in relation to the specified Eurosystem central banks shall be set out in a list published on the ECB's website.
Article 6
Eligible counterparties
The following shall be eligible counterparties for the CSPP, both for outright transactions and for securities lending transactions involving corporate bonds held in the CSPP Eurosystem portfolios:
(a) entities that fulfil the eligibility criteria to participate in Eurosystem monetary policy operations pursuant to Article 55 of Guideline (EU) 2015/510 (ECB/2014/60); and
(b) any other counterparties that are used by Eurosystem central banks for the investment of their euro-denominated investment portfolios.
Article 7
Securities lending transactions
The Eurosystem central banks purchasing corporate bonds under the CSPP shall make securities purchased under CSPP available for lending, including repos, with a view to ensuring the effectiveness of the CSPP.
Article 8
Final provisions
This Decision shall enter into force on 6 June 2016.
<note>
( 1 ) Guideline (EU) 2015/510 of the European Central Bank of 19 December 2014 on the implementation of the Eurosystem monetary policy framework (ECB/2014/60) (OJ L 91, 2.4.2015, p. 3).
( 2 ) Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and investment firms and amending Regulation (EU) No 648/2012 (OJ L 176, 27.6.2013, p. 1).
( 3 ) Regulation (EU) No 468/2014 of the European Central Bank of 16 April 2014 establishing the framework for cooperation within the Single Supervisory Mechanism between the European Central Bank and national competent authorities and with national designated authorities (SSM Framework Regulation) (ECB/2014/17) (OJ L 141, 14.5.2014, p. 1).
( 4 ) Directive 2014/65/EU of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Directive 2002/92/EC and Directive 2011/61/EU (OJ L 173, 12.6.2014, p. 349).
( 5 ) Regulation (EU) No 806/2014 of the European Parliament and of the Council of 15 July 2014 establishing uniform rules and a uniform procedure for the resolution of credit institutions and certain investment firms in the framework of a Single Resolution Mechanism and a Single Resolution Fund and amending Regulation (EU) No 1093/2010 (OJ L 225, 30.7.2014, p. 1).
( 6 ) Directive 2014/59/EU of the European Parliament and of the Council of 15 May 2014 establishing a framework for the recovery and resolution of credit institutions and investment firms and amending Council Directive 82/891/EEC, and Directives 2001/24/EC, 2002/47/EC, 2004/25/EC, 2005/56/EC, 2007/36/EC, 2011/35/EU, 2012/30/EU and 2013/36/EU, and Regulations (EU) No 1093/2010 and (EU) No 648/2012, of the European Parliament and of the Council (OJ L 173, 12.6.2014, p. 190).
( 7 ) A list of such entities is published on the ECB's website at www.ecb.europa.eu
( 8 ) Council Regulation (EC) No 3603/93 of 13 December 1993 specifying definitions for the application of the prohibitions referred to in Articles 104 and 104b(1) of the Treaty (OJ L 332, 31.12.1993, p. 1).
</note> | ENG | 02016D0016-20170113 |
<table><col/><col/><col/><col/><tbody><tr><td><p>22.12.2022   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 328/91</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2022/2535
of 21 December 2022
authorising the placing on the market of the freeze-dried powder form of Antrodia camphorata mycelia as a novel food and amending Implementing Regulation (EU) 2017/2470
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 ( 1 ) , and in particular Article 12(1) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list of novel foods may be placed on the market within the Union.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 <a>(<span>2</span>)</a> has established a Union list of novel foods.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>On 5 November 2018, the company Golden Biotechnology Corp (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place freeze-dried powder form of<span>Antrodia camphorata</span> mycelia on the Union market as a novel food. The applicant requested for freeze-dried powder form of<span>Antrodia camphorata</span> mycelia to be used in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council <a>(<span>3</span>)</a> at a maximum dose of 990 mg per day, for the general population.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>On 12 May 2020, the Commission requested the European Food Safety Authority (‘the Authority’) to carry out an assessment of the freeze-dried powder form of<span>Antrodia camphorata</span> mycelia as a novel food.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>On 18 May 2022, the Authority adopted its scientific opinion on the ‘Safety of freeze-dried mycelia of<span>Antrodia camphorata</span> as a novel food pursuant to Regulation (EU) 2015/2283’ <a>(<span>4</span>)</a> in accordance with Article 11 of Regulation (EU) 2015/2283.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>In its scientific opinion, the Authority concluded that the freeze-dried mycelia of<span>Antrodia camphorata</span> were safe for adults and adolescents above 14 years old when added to food supplements at a maximum daily dose of 990 mg/day. However, the Authority has not established the safety of the novel food in food supplements intended for individuals younger than 14 years at the maximum intake level of 990 mg/day as proposed by the applicant, because the intake would exceed the safe level (16,5 mg/kg bw per day) established by the Authority. Therefore, the opinion of the Authority gives sufficient grounds to establish that the freeze-dried mycelia of<span>Antrodia camphorata</span>, when used at a maximum daily dose of 990 mg/day in food supplements, intended for individuals aged 14 years and above, fulfil the conditions for their placing on the market in accordance with Article 12(1) of Regulation (EU) 2015/2283.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>In its scientific opinion, the Authority considers that although there is no evidence available of an allergenicity risk, given the protein content of the novel food, some risk cannot be excluded. A literature search performed by the applicant did not identify any published evidence concerning the allergenic potential of<span>Antrodia camphorata</span>, and other information or data normally needed to confirm or exclude the potential risk of allergenicity, is lacking. The Commission however, considers that at present, the potential of<span>Antrodia camphorata</span> mycelia powder to cause allergenicity is unlikely to manifest itself in real life and consequently no specific labelling requirement should be included in the Union list of novel foods in this regard.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>A clear designation of the novel food and a labelling requirement should be laid down for food supplements containing freeze-dried powder form of<span>Antrodia camphorata</span> mycelia, in order to ensure that those food supplements are not consumed by children and adolescents of less than 14 years of age.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>It is therefore appropriate that the inclusion of freeze-dried powder form of<span>Antrodia camphorata</span> mycelia as a novel food in the Union list of novel foods contains the information referred to in Article 9 of Regulation (EU) 2015/2283.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>The freeze-dried powder form of<span>Antrodia camphorata</span> mycelia should be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470. The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
1. The freeze-dried powder form of Antrodia camphorata mycelia is authorised to be placed on the market within the Union.
The freeze-dried powder form of Antrodia camphorata mycelia shall be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470.
2. The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 21 December 2022.
For the Commission
The President
Ursula VON DER LEYEN
( 1 ) OJ L 327, 11.12.2015, p. 1 .
( 2 ) Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods ( OJ L 351, 30.12.2017, p. 72 ).
( 3 ) Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements ( OJ L 183, 12.7.2002, p. 51 ).
( 4 ) EFSA Journal 2022; 20(6):7380.
ANNEX
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>in Table 1 (Authorised novel foods), the following entry is inserted:</p><table><col/><col/><col/><col/><col/><tbody><tr><td><p>Authorised novel food</p></td><td><p>Conditions under which the novel food may be used</p></td><td><p>Additional specific labelling requirements</p></td><td><p>Other requirements</p></td></tr><tr><td><p>‘<span><span>Antrodia camphorata</span> mycelia powder</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><table><col/><col/><tbody><tr><td><p>1.</p></td><td><p>The designation of the novel food on the labelling of food supplements containing it shall be ‘<span>Antrodia camphorata</span> mycelia powder’.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>2.</p></td><td><p>The labelling of the food supplements containing<span>Antrodia camphorata</span> mycelia powder shall bear a statement that this food supplement should not be consumed by infants, children, and adolescents younger than 14 years of age.’</p></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><p>Food supplements as defined in Directive 2002/46/EC, excluding infants, children, and adolescents younger than 14 years of age</p></td><td><p>990 mg/day</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>in Table 2 (Specifications), the following entry is inserted:</p><table><col/><col/><tbody><tr><td><p>Authorised novel food</p></td><td><p>Specification</p></td></tr><tr><td><p>‘<span><span>Antrodia camphorata</span> mycelia powder</span></p></td><td><p><span>Description/Definition:</span></p><p>The novel food is the freeze-dried mycelia of the fungus<span>Antrodia camphorata</span> (strain BCRC 39106), which has been grown by solid-state cultivation. The freeze-dried mycelia are then milled into a powder.<span>Antrodia camphorata</span> is a synonym of<span>Taiwanofungus camphoratus</span> (family: Fomitopsidaceae).</p><p><span>Characteristics/Composition:</span></p><p>Loss on drying (Moisture): < 10 %</p><p>Carbohydrates: ≤ 80 g/100 g</p><p>Protein: ≤ 20 g/100 g</p><p>Ash: ≤ 6 g/100g</p><p>Fat: ≤ 6 g/100 g</p><p>Total triterpenoids: 1,0 – 10,0 g/100 g</p><p>Antroquinonol: 1,0 – 20,0 mg/g</p><p><span>Heavy metals:</span></p><p>Arsenic: < 0,5 mg/kg</p><p><span>Microbiological criteria:</span></p><p>Total aerobic microbial count: ≤ 10<span>3 *</span>CFU/g</p><p>Total yeast and mould count: ≤ 100 CFU/g</p><p><span>Escherichia coli</span>: Not detected in 10 g</p><p><span>Salmonella</span> spp.: Not detected in 25 g</p><p><span>Staphylococcus aureus</span>: Not detected in 10 g</p><p>*CFU: Colony Forming Units’</p></td></tr></tbody></table></td></tr></tbody></table> | ENG | 32022R2535 |
<table><col/><col/><col/><tbody><tr><td><img/></td><td><p>Official Journal<br/>of the European Union</p></td><td><p>EN</p><p>Series L</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>2023/2834</p></td><td><p>21.12.2023</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2023/2834
of 10 October 2023
laying down rules for the application of Regulation (EU) No 1308/2013 of the European Parliament and of the Council as regards imports in the sectors of rice, cereals, sugar and hops
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 ( 1 ) , and in particular Article 5, Article 178, Article 180, Article 182(1) and (4), Article 190(4) and Article 223(3) thereof,
Having regard to Regulation (EU) 2021/2116 of the European Parliament and of the Council of 2 December 2021 on the financing, management and monitoring of the common agricultural policy and repealing Regulation (EU) No 1306/2013 ( 2 ) , and in particular Article 64(4) thereof,
Having regard to Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code ( 3 ) , and in particular Article 213 thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Regulation (EU) No 1308/2013 repealed and replaced Council Regulation (EC) No 1234/2007 <a>(<span>4</span>)</a>. Regulation (EU) No 1308/2013 lays down rules on trade with third countries of agricultural products, conversion rates for rice and empowers the Commission to adopt delegated and implementing acts in that respect. In order to ensure the smooth functioning of the trade of the products from sectors of rice, cereals, sugar and hops in the new legal framework, certain rules have to be adopted by means of such acts. Those acts should replace Commission Regulations (EC) No 3330/94 <a>(<span>5</span>)</a>, (EC) No 2810/95 <a>(<span>6</span>)</a>, (EC) No 951/2006 <a>(<span>7</span>)</a>, (EC) No 972/2006 <a>(<span>8</span>)</a>, (EC) No 504/2007 <a>(<span>9</span>)</a>, (EC) No 1375/2007 <a>(<span>10</span>)</a>, (EC) No 402/2008 <a>(<span>11</span>)</a>, (EC) No 1295/2008 <a>(<span>12</span>)</a>, (EC) No 1312/2008 <a>(<span>13</span>)</a>, (EU) No 642/2010 <a>(<span>14</span>)</a>, which were repealed by Commission Delegated Regulation (EU) 2023/2835 <a>(<span>15</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Article 5 of Regulation (EU) No 1308/2013 provides that the Commission may fix the conversion rates for rice at various stages of processing (paddy, husked, semi-milled or milled), when applying that Regulation, for the purpose of converting values or quantities relating to those stages.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Pursuant to the Agreement in the form of an Exchange of Letters between the European Community and India pursuant to Article XXVIII of the GATT 1994 relating to the modification of concessions with respect to rice provided for in EC Schedule CXL annexed to the GATT 1994, approved by Council Decision 2004/617/EC <a>(<span>16</span>)</a>, the duty applicable to imports from India of husked rice of certain Basmati varieties is fixed at zero.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>Pursuant to the Agreement in the form of an Exchange of Letters between the European Community and Pakistan pursuant to Article XXVIII of the GATT 1994 relating to the modification of concessions with respect to rice provided for in EC Schedule CXL annexed to the GATT 1994, approved by Council Decision 2004/618/EC <a>(<span>17</span>)</a>, the duty applicable to imports of husked rice of certain Basmati varieties originating in Pakistan is fixed at zero.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>Those Agreements provide for the introduction of a Union control system based on DNA analysis at the border and transitional arrangements for imports of Basmati rice of the varieties laid down in Delegated Regulation (EU) 2023/2835 pending the entry into force of that control system. Since the definitive control system has not yet been introduced, special transitional rules should be laid down.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>To be eligible for zero import duty, Basmati rice is to belong to a variety specified in those Agreements. In order to ascertain that Basmati rice imported at a zero rate of duty meets those characteristics, it should be covered by an authenticity certificate drawn up by the competent authorities.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>In order to prevent fraud, provision should be made for measures to check the variety of Basmati rice declared. To that end, the provisions on sampling laid down in the customs Union legislation should be applied.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>The import arrangements included in the Agreements with India and Pakistan for Basmati rice provide for a procedure for consulting the exporting country in the event of a market disturbance and possibly applying the full rate of duty if a satisfactory solution has not been found at the end of the consultations. The point at which the market may be considered to be disturbed should be defined.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>To ensure the sound administrative management of imports of Basmati rice, special rules, additional to those laid down in Commission Implementing Regulation (EU) 2016/1239 <a>(<span>18</span>)</a>, should be adopted concerning the lodging of applications, the issue of import licences and the use thereof. A derogation from that Implementing Regulation should be provided for as far as the amount of the security relating to import licences for Basmati rice is to be lodged. Applicability of Commission Delegated Regulation (EU) 2016/1237 <a>(<span>19</span>)</a> should be indicated as regards tolerance on quantity.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>Imported cereal products are, in certain cases, to be classed in several standard qualities. The standard qualities to be used should therefore be determined using objective grading criteria. Tolerance rates should also be set allowing products to be given the most appropriate quality grading. Of the possible objective quality grading criteria for common wheat, protein content, specific weight and miscellaneous impurity (<span>Schwarzbesatz</span>) content are those most commonly used in trade and also the easiest to use. Imported cereals are to be subjected to analysis accordingly to determine these parameters for each lot imported. However, where the Union has established an official recognition procedure for quality certificates issued by an authority of the country of origin of the cereals, it should be made possible that those analyses are carried out merely by way of verification on a sufficiently representative number of imported lots.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>The use of quotations for the various wheat types and for other cereals on the commodity exchanges of the United States should provide a both transparent and objective basis for establishing representative cost, insurance and freight (CIF) import prices. Given the volume of freight passing through and the amount of trade at the port of Rotterdam, this port is the destination in the Union for which sea freight quotations are most widely known, most transparent and the easiest available. The port of destination to be selected for the Union should therefore be Rotterdam.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(12)</p></td><td><p>Accordingly, for the sake of transparency, the representative CIF import prices are to be established from commodity exchange quotations for the cereal in question and the commercial premium assigned to the cereal and sea freight costs between the Gulf of Mexico or the Great Lakes and the port of Rotterdam. However, freight cost differences by port of destination justify flat rate adjustment of the import duty for Union ports located on the Mediterranean and on the Black Sea, on the Atlantic coast of the Iberian Peninsula, in Ireland, in the Nordic countries, in the Baltic States and in Poland. The factors of calculation of the representative CIF import prices so established should be monitored daily so that the trend of these prices can be followed. In the case of barley, sorghum and rye, the representative CIF import price calculated for wheat allows the market situation for those three cereals to be estimated and consequently the representative CIF import price determined for wheat should apply to those three products.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(13)</p></td><td><p>For the purpose of setting import duties on cereals in accordance with Article 180 of Regulation (EU) No 1308/2013, a period of 10 working days recording of the representative CIF import prices for each cereal should reflect market trends without uncertainty. The factors taken into account for the calculation of import duties for those products should be published.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(14)</p></td><td><p>In the case of imports of flint maize, the exchange quotation used for the calculation of the representative CIF import price may not, either because of the particular quality of the goods or because their price includes a quality premium over the normal price, take account of the existence of such a premium over normal market terms. To take account of that quality premium over prices or quotations, importers who show that they have used the goods to produce high quality products justifying the existence of such a premium should be reimbursed, at a flat rate, for a part of the import duty paid.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(15)</p></td><td><p>In order to maintain representative exchange quotations for maize on the market of the United States, and given that, over the years, activity in the market for Yellow Corn No 3 has significantly decreased, a new reference variety that offers assurances of sufficient market liquidity for the calculation of import duties is necessary. This new maize reference variety should be Yellow Corn No 2.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(16)</p></td><td><p>Within the framework of the GATT, the Union and the United States have agreed to clarify the tariff definition of residues from the manufacture of starch from maize. Imports of these products into the Union are subject to laboratory analysis to verify their conformity with the tariff definition. The Federal Grain Inspection Service (FGIS) of the United States Department of Agriculture and the United States wet milling industry, under the regular review of the United States’ authorities, are to certify that imports of those products from the United States into the Union are in conformity with the agreed definition.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(17)</p></td><td><p>In order to ensure that importers respect the specific provisions of this Regulation as regards import, guarantee should be required from them.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(18)</p></td><td><p>Conformity of imports of residues from the manufacture of starch from maize from the United States should be continued to be checked by customs authorities on the basis of a certificates system as established by this Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(19)</p></td><td><p>In order to reduce the administrative burden on Member States to a minimum, while continuing to ensure the effective implementation of the provisions in this Regulation, the requirement on Member States to communicate to the Commission the quantities and the value of products imported on a monthly basis under cover of certificates of conformity should be removed.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(20)</p></td><td><p>By Council Regulation (EC) No 2008/97 <a>(<span>20</span>)</a>, the Council adopted rules for the application of special arrangements for imports of rye from Türkiye laid down in the Additional Protocol to the Agreement establishing an Association between the European Community and Turkey.</p><p>Those special arrangements provide, under certain conditions, for a reduction of import duty on rye from Türkiye. To that end, operators should furnish the proof that a special export tax payable by the exporter has in fact been paid.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(21)</p></td><td><p>It is appropriate to fix, in accordance with Article 5 of Regulation (EC) No 2008/97, the procedure for proving payment of the special export charge.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(22)</p></td><td><p>In order to prevent or counteract adverse effects on the Union market which may result from imports of products in the sugar sector when those imports are made at a price below the level notified by the Union to the World Trade Organisation, it is necessary to apply additional import duties.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(23)</p></td><td><p>For the application of the additional import duties for the products of the sugar sector, the CIF import price of the consignment in question has to be taken into consideration. For the purposes of this Regulation, the CIF import price should be the cost, insurance and freight price of the consignment delivered at the frontier of the importing country. The CIF import price has to be determined and checked against the representative prices for the product concerned on the world market and on the Union import market for that product. To that end, it is necessary to establish the criteria for determining the representative CIF import prices for the products to which an additional import duty may be applied. For the determination of the representative CIF import prices, the Commission should take account of all the information available to it.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(24)</p></td><td><p>Part II of Annex II to Regulation (EU) No 1308/2013 provides the technical definitions concerning the sugar sector.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(25)</p></td><td><p>Article 190(1) of Regulation (EU) No 1308/2013 provides that products of the hops sector from third countries may be imported only if their quality standards are at least equivalent to those adopted for like products harvested and/or produced within the Union. Article 190(2) of that Regulation provides, however, that those products are to be considered as meeting those standards if they are accompanied by an attestation of equivalence issued by the competent authorities of the country of origin and recognised as equivalent to the certificate required for the marketing of hops and hop products of Union origin. In order to facilitate the checking of the attestations of equivalence issued by third countries for the import into the Union of products of the hop sector, the Commission should list and make public the competent bodies notified by third countries for the purpose of drawing up such documents.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(26)</p></td><td><p>The attestation of equivalence should be drawn up in electronic form and bear the electronic signature of the issuing body.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(27)</p></td><td><p>To ensure traceability, the information to be stamped on each unit of packaging covered by an attestation of equivalence should be provided for in order to provide some information about the characteristics of the product as well as a link to the attestation covering the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(28)</p></td><td><p>In order to ensure full traceability of products of the hop sector, rules should be adopted for cases where a consignment covered by an attestation of equivalence is split up before its entry into free circulation. If a consignment is resold or split up after it has been released for free circulation, the product should be accompanied by a commercial document drawn up by the vendor which contains certain information from the attestation of equivalence of the original consignment.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(29)</p></td><td><p>Trade of certain agricultural products between the EU and certain third countries often requires that the products are accompanied for imports by documents that certify the implementation of certain formalities (so-called ‘non-customs formalities’) required by the EU agricultural legislation, currently predominantly in the paper form. The Commission intends to digitise the whole process by establishing an electronic system for DG AGRI non-customs formalities (ELAN) based on TRACES.NT and linked to the EU Single Window Environment for customs as established by Regulation (EU) 2022/2399 of the European Parliament and of the Council <a>(<span>21</span>)</a>. ELAN will define the digital processes in the future and will allow users to issue, store, and retrieve the necessary documents. ELAN will be divided into two parts and Part 2 called ELAN2-C is to include, among others, also different documents covered by this Regulation and by Delegated Regulation (EU) 2023/2835. After defining those digital processes the legal provisions of the two Regulations will be amended accordingly.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(30)</p></td><td><p>The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of Agricultural Markets,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
CHAPTER 1
RICE SECTION 1
Conversion rates for rice
Article 1
Conversion rates
1. The conversion rate between husked rice and paddy rice shall be as follows:
<table><col/><col/><tbody><tr><td><p>Husked rice</p></td><td><p>Paddy rice</p></td></tr><tr><td><p>1</p></td><td><p>1,25</p></td></tr></tbody></table>
2. The conversion rate between husked rice and milled rice shall be as follows:
<table><col/><col/><col/><tbody><tr><td><p> </p></td><td><p>Husked rice</p></td><td><p>Milled rice</p></td></tr><tr><td><p>Round-grained rice</p></td><td><p>1</p></td><td><p>0,775</p></td></tr><tr><td><p>Medium-grained or long-grained rice</p></td><td><p>1</p></td><td><p>0,69</p></td></tr></tbody></table>
3. The conversion rate between milled rice and semi-milled rice shall be as follows:
<table><col/><col/><col/><tbody><tr><td><p> </p></td><td><p>Milled rice</p></td><td><p>Semi-milled rice</p></td></tr><tr><td><p>Round-grained rice</p></td><td><p>1</p></td><td><p>1,065</p></td></tr><tr><td><p>Medium-grained or long-grained rice</p></td><td><p>1</p></td><td><p>1,072</p></td></tr></tbody></table>
Article 2
Processing costs
1. The processing costs to be taken into consideration when paddy rice is converted into husked rice shall be EUR 47,13 per tonne of paddy rice.
2. The processing costs to be taken into consideration when husked rice is converted into milled rice shall be EUR 47,13 per tonne of husked rice.
3. The processing costs for converting semi-milled rice into milled rice shall not be taken into consideration.
Article 3
Value of the by-products
1. The value of the by-products obtained from processing paddy rice into husked rice shall be considered to be zero.
2. The value of the by-products obtained from processing husked rice into milled rice shall be:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>EUR 41,00 per tonne of husked round grain rice;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>EUR 52,00 per tonne of husked medium-grained or long-grained rice.</p></td></tr></tbody></table>
3. The value of the by-products obtained from processing semi-milled rice into milled rice shall be:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>EUR 12,62 per tonne of semi-milled round grain rice;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>EUR 14,05 per tonne of semi-milled medium-grained or long-grained rice.</p></td></tr></tbody></table>
Article 4
Value conversion
1. The conversion of the value of a quantity of husked rice into the value of the same quantity of rice at another stage of processing shall be done on the basis of husked rice containing 3 % broken rice. If the husked rice contains more than 3 % broken rice, the conversion shall be done after an adjustment is made on the basis of a value of EUR 110 per tonne of broken rice.
2. The conversion of the value of a quantity of semi-milled rice or milled rice into the value of the same quantity of rice at another stage of processing shall be done on the basis of semi-milled or milled rice containing no broken rice. If any semi-milled or milled rice contains broken rice, the conversion shall be done after an adjustment is made on the basis of a value of EUR 150 per tonne of broken rice.
3. The adjustments provided for in paragraphs 1 and 2 shall not be effected when the prices of husked rice and the prices of semi-milled or milled rice taken into consideration for fixing the levies are lower than:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>EUR 110 per tonne of husked rice;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>EUR 150 per tonne of semi-milled or milled rice.</p></td></tr></tbody></table>
Article 5
Value conversion
1. The conversion of the value of a quantity of husked rice into the value of the same quantity of paddy rice shall be done by:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>dividing the value to be converted by the rate fixed in Article 1(1) for paddy rice; and</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>reducing the amount thus obtained by the processing costs fixed in Article 2(1).</p></td></tr></tbody></table>
The conversion of the value of a quantity of paddy rice into the value of the same quantity of husked rice shall be done by:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>increasing the value to be converted by the processing costs fixed in Article 2(1); and</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>multiplying the amount thus obtained by the rate fixed in Article 1(1) for paddy rice.</p></td></tr></tbody></table>
2. The conversion of the value of a quantity of husked rice into the value of the same quantity of milled rice shall be done by:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>increasing the value to be converted by the processing costs fixed in Article 2(2);</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>reducing the value to be converted by the value of the by-products fixed in Article 3(2); and</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>dividing the amount thus obtained by the rate fixed in Article 1(2) for milled rice.</p></td></tr></tbody></table>
The conversion of the value of a quantity of milled rice into the value of the same quantity of husked rice shall be done by:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>multiplying the value to be converted by the rate fixed in Article 1(2) for milled rice;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>reducing the amount thus obtained by the processing costs fixed in Article 2(2); and</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>increasing the amount thus obtained by the value of the by-products fixed in Article 3(2).</p></td></tr></tbody></table>
3. The conversion of the value of a quantity of milled rice into the value of the same quantity of semi-milled rice shall be done by:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>dividing the value to be converted by the rate fixed in Article 1(3) for semi-milled rice; and</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>increasing the amount thus obtained by the value of the by-products fixed in Article 3(3).</p></td></tr></tbody></table>
The conversion of the value of a quantity of semi-milled rice into the value of the same quantity of milled rice shall be done by:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>reducing the value to be converted by the value of the by-products fixed in Article 3(3); and</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>multiplying the amount thus obtained by the rate fixed in Article 1(3) for semi-milled rice of the group in question.</p></td></tr></tbody></table>
Article 6
Quantity conversion
1. The conversion of a quantity of husked rice into a corresponding quantity of paddy rice or milled rice shall be done by multiplying the quantity to be converted by the rate fixed in Article 1(1) for paddy rice, or by the rate fixed in Article 1(2) for milled rice, as the case may be.
The conversion of a quantity of paddy rice or milled rice into a corresponding quantity of husked rice shall be done by dividing the quantity to be converted by the rate fixed in Article 1(1) for paddy rice or by the rate fixed in Article 1(2) for milled rice, as the case may be.
2. The conversion of a quantity of milled rice into a corresponding quantity of semi-milled rice shall be done by multiplying the quantity to be converted by the rate fixed in Article 1(3) for semi-milled rice.
The conversion of a quantity of semi-milled rice into a corresponding quantity of milled rice shall be done by dividing the quantity to be converted by the rate fixed in Article 1(3) for semi-milled rice.
SECTION 2
Special rules for imports of Basmati rice
Article 7
Applicable rules
Implementing Regulation (EU) 2016/1239 shall apply, unless otherwise provided for in this Regulation.
Article 8
Import licences applications
Import licence applications for Basmati rice as referred to in Article 176(1) of Regulation (EU) No 1308/2013 shall contain the following details:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>in box 8, indication of the country of origin and the word ‘yes’ marked with a cross;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>in box 20, one of the entries set out in Annex I.</p></td></tr></tbody></table>
Article 9
Authenticity certificate
1. The authenticity certificate referred to in Article 4 of Delegated Regulation (EU) 2023/2835 shall be drawn up on a form in accordance with the specimen set out in Annex II.
The text of the form in the other Union languages shall be published in the C series of the Official Journal of the European Union .
The authenticity certificates may be stored and made available in the electronic system ELAN to be set up by the Commission.
2. The licence issuing authority issuing the import licence shall keep the original of the authenticity certificate and give the applicant a duplicate.
The authenticity certificate shall be valid for 90 days from the date of issue.
It shall be valid only if the boxes are duly completed and it is signed.
Article 10
Import licences
1. Import licences for Basmati rice shall contain the following details:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>in box 8, indication of the country of origin and the word ‘yes’ marked with a cross;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>in box 20, one of the entries set out in Annex III.</p></td></tr></tbody></table>
2. The duplicate of the authenticity certificate referred to in Article 9(2) shall be annexed to the import licence. If the licence is issued as an electronic document, the authority issuing the licence may transfer the duplicate of the authenticity certificate to the customs authorities by electronic means.
3. By derogation from Article 5(1) of Implementing Regulation (EU) 2016/1239, the security relating to import licences for Basmati rice shall be EUR 70 per tonne.
Article 11
Tolerance on quantity
In accordance with Article 5(5), first subparagraph, of Delegated Regulation (EU) 2016/1237, the tolerance on quantity shall be 0 %.
Article 12
Notification of quantities
Member States shall notify the Commission:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>no later than 2 working days following a refusal, of the quantities in respect of which applications for import licences for Basmati rice have been refused, with an indication of the date of refusal and the grounds, the CN code, the country of origin, the issuing body and the number of the authenticity certificate, as well as the holder’s name and address;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>no later than 2 working days following their issue, of the quantities in respect of which applications for import licences for Basmati rice have been issued, with an indication of the date, the CN code, the country of origin, the issuing body and the number of the authenticity certificate, as well as the holder’s name and address;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>in the event of the cancellation of a licence, no later than 2 working days after cancellation, of the quantities in respect of which licences have been cancelled and the names and addresses of the holders of the cancelled licences;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>on the last working day of each month following the month of release for free circulation, of the quantities actually released for free circulation, with an indication of the CN code, the country of origin, the issuing body and the number of the authenticity certificate.</p></td></tr></tbody></table>
The notifications shall be made in accordance with Commission Delegated Regulation (EU) 2017/1183 ( 22 ) and Commission Implementing Regulation (EU) 2017/1185 ( 23 ) .
Article 13
Sample checks of imported Basmati rice
1. In the context of random checks or checks targeted at operations entailing a risk of fraud, Member States shall take representative samples of imported Basmati rice in accordance with Article 238 of Commission Implementing Regulation (EU) 2015/2447 ( 24 ) . The samples shall be sent to the competent body in the country of origin, as made public by the Commission on its website, for a DNA-based variety test.
The Member States may also carry out variety tests on the same sample in an Union laboratory.
2. If the results of one of the tests referred to in paragraph 1 show that the product analysed does not correspond to what is indicated on the authenticity certificate, the import duty on husked rice falling within CN code 1006 20, provided for by the Agreement in the form of an Exchange of Letters between the European Community and the United States relating to the method of calculation of applied duties for husked rice, approved by Council Decision 2005/476/EC ( 25 ) , shall apply.
However, the presence up to 5 % of husked rice falling within CN code 1006 20 17 or CN code 1006 20 98 not corresponding to any of the varieties listed in Article 2(1) of Delegated Regulation (EU) 2023/2835 shall be accepted.
3. If the tests referred to in paragraph 1 or other information available to the Commission indicate a serious and lasting problem as regards the control procedures applied by a competent body in the country of origin, the Commission may contact the competent authorities in the country concerned. If such contacts fail to yield a satisfactory solution, the Commission may decide to apply the rate of import duty for husked rice falling within CN code 1006 20, provided for by the Agreement in the form of an Exchange of Letters between the European Community and the United States of America relating to the method of calculation of applied duties for husked rice, approved by Decision 2005/476/EC and under the conditions laid down in this Regulation and in Delegated Regulation (EU) 2023/2835.
Article 14
Market disturbances
1. The rice market shall be considered to be disturbed when, inter alia, a substantial increase in Basmati rice imports is noted for one quarter of the year as compared to the previous quarter and there is no satisfactory explanation.
2. If a disturbance of the rice market persists and if the Commission’s consultations of the exporting countries concerned fail to yield a satisfactory solution, the import duty on husked rice falling within CN code 1006 20, provided for by the Agreement in the form of an Exchange of Letters between the European Community and the United States of America relating to the method of calculation of applied duties for husked rice, approved by Decision 2005/476/EC, may also be applied to imports of Basmati rice, by a Commission decision, subject to the conditions laid down in Section 2 of Chapter 1 of this Regulation and in Section 2 of Delegated Regulation (EU) 2023/2835.
CHAPTER 2
CEREALS
SECTION 1
Import duties on cereals
Article 15
Import duties
1. By way of derogation to the rates of import duty in the Common Customs Tariff, the import duty on cereal products falling within CN codes 1001 11 00, 1001 19 00, ex 1001 91 20, ex 1001 99 00, 1002 10 00, 1002 90 00, 1005 10 90, 1005 90 00, 1007 10 90 and 1007 90 00 shall be equal to the intervention price on importation, increased by 55 %, minus the CIF import price determined in accordance with Article 16(1) applicable to the consignment in question. However, that import duty may not exceed the conventional rate of duty as determined on the basis of the Combined Nomenclature.
2. For the purpose of calculating the import duty referred to in paragraph 1, representative CIF import prices shall be established on a regular basis for the products referred to in that paragraph.
3. The Common Customs Tariff duty rates referred to in paragraph 1 shall be those applicable on the date referred to in Article 172(2) of Regulation (EU) No 952/2013.
Article 16
Fixing of import duties
1. The Commission shall calculate on a daily basis the import duty referred to in Article 15(1).
The intervention price to be used for the calculation of import duty shall be EUR 101,31 per tonne.
The CIF import price for the calculation of the import duty shall be the daily CIF representative import price determined by using the method provided for in Article 19.
2. The import duty for the cereal products referred to in Article 15(1) fixed by the Commission shall be fixed equal to the average of the import duties calculated during the previous 10 working days.
The Commission shall fix the import duty if the average of the import duties calculated during the previous 10 working days differs by more than EUR 5 per tonne compared to the duty that is in force, including when the import duty is zero.
The amount of the fixed import duty and the factors used for their calculation shall be published in the Official Journal of the European Union .
The import duty fixed shall apply from the date of publication and until a new import duty is fixed and enters into force.
3. Where the port of unloading in the Union is located:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>on the Mediterranean (beyond the Strait of Gibraltar) or on the Black Sea and where the goods arrive through the Atlantic Ocean or the Suez Canal, the Commission shall reduce the import duty by EUR 3 per tonne;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>on the Atlantic coast of the Iberian Peninsula, in Ireland, in Denmark, in Estonia, in Latvia, in Lithuania, in Poland, in Finland and in Sweden and where the goods arrive through the Atlantic Ocean, the Commission shall reduce the import duty by EUR 2 per tonne.</p></td></tr></tbody></table>
The customs authority at the port of unloading shall issue a document of unloading in accordance with the model set out in Annex IV attesting the quantity of each product unloaded. For the import duty reduction provided for in the first subparagraph to be granted, the document of unloading shall accompany the goods until completion of the customs import formalities.
The above document may be stored and made available in the electronic system ELAN to be set up by the Commission.
4. With regard to cereal products originating in Canada and falling within CN codes 1001 11 00, 1001 19 00, ex 1001 99 00 (high quality common wheat other than seed), 1002 10 00 and 1002 90 00, the import duty shall be equal to a percentage of the duty fixed in accordance with paragraph 2 and, if appropriate, paragraph 3. The percentage to be applied is set out in Annex V. The import duty shall be rounded down at least to the nearest EUR 0,001.
Article 17
Flint maize
1. Import duties shall be reduced by EUR 24 per tonne on flint maize meeting the specifications laid down in Annex VI.
2. In order to benefit from the reduction provided for in paragraph 1, flint maize shall be processed into a product of CN codes 1904 10 10, 1103 13 or 1104 23 within 6 months from the date of acceptance of entry for free circulation in the Union.
3. The provisions on the end-use of imported products from Article 254(1), (4) and (5) of Regulation (EU) No 952/2013 shall apply accordingly.
4. The guarantee referred to in Article 6 of Delegated Regulation (EU) 2023/2835 shall be EUR 24 per tonne.
If, however, the import duty applicable on the date of the acceptance of the declaration of release for free circulation in the Union is less than EUR 24 per tonne of maize, the specific guarantee shall be equal to the amount of the import duty.
Article 18
Quality standards for common wheat, durum wheat, and flint maize
The product quality classification standards to be met on importation into the Union, and the tolerances acceptable in the analysis applied towards this classification, shall be those set out in Annex VI.
Article 19
Determination of representative CIF import prices for high quality common wheat and maize other than seed
1. For high quality common wheat and maize other than seed falling within the CN codes referred to in Article 15(1), the components determining the CIF representative import prices referred to in Article 15(2) shall be:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the representative exchange quotation on the market of the United States;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the known commercial premiums and discounts attached to that quotation in the United States market on the quotation day;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>sea freight and associated costs between the United States (Gulf of Mexico or Duluth) and the port of Rotterdam for a vessel of at least 25 000 tonnes.</p></td></tr></tbody></table>
2. The Commission shall record each working day:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the component referred to in paragraph 1, point (a), from the exchanges and using the reference varieties laid down in Annex VII;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the components referred to in paragraph 1, points (b) and (c), from publicly available information.</p></td></tr></tbody></table>
3. With a view to calculating the component referred to in paragraph 1, point (b), or the relevant free on board quotation, a premium of EUR 14 per tonne of high quality common wheat shall apply.
4. The representative CIF import prices for high quality common wheat and maize other than seed shall be the sum of the components referred to in paragraph 1.
The representative CIF import prices for high quality durum wheat, durum wheat seed and common wheat seed shall be the price calculated for high quality common wheat.
The representative CIF import price for medium quality durum wheat and low quality durum wheat shall be the price calculated for high quality common wheat, to which a discount of EUR 10 per tonne shall apply for medium quality durum wheat, and a discount of EUR 30 per tonne for low quality durum wheat.
The representative CIF import price for sorghum other than seed, sorghum seed falling within CN code 1007 10 90, rye other than seed, rye seed and maize seed falling within CN code 1005 10 90 shall be the price calculated for maize other than seed.
Article 20
Guarantee for importation
1. For high quality common wheat, the specific guarantee referred to in Article 6 of Delegated Regulation (EU) 2023/2835 to be lodged with the customs authority on the date of acceptance of the declaration of release for free circulation in the Union shall be at the amount of EUR 95 per tonne.
2. For durum wheat, the amount of the specific guarantee referred to in Article 7 of Delegated Regulation (EU) 2023/2835 shall be the difference on the day of acceptance of the declaration of release for free circulation in the Union between the highest import duty and that applicable to the quality shown, plus a supplement of EUR 5 per tonne.
Article 21
Sampling for import duty calculation
1. The customs office of release for free circulation in the Union shall take representative samples, in accordance with Annex I to Commission Regulation (EC) No 152/2009 ( 26 ) , of every consignment of high quality common wheat (other than seed), of durum wheat and of flint maize. However, sampling shall not take place where the import duty for the different qualities is the same.
If, however, the Commission officially recognises a quality certificate for high quality common wheat, durum wheat or flint maize issued by the country of origin of the cereals, samples shall be taken for verification of the certified quality only from a sufficiently representative number of consignments.
2. The following certificates of conformity shall be officially recognised by the Commission pursuant to the principles laid down in Articles 58 and 59 of Implementing Regulation (EU) 2015/2447:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>certificates issued by the Servicio Nacional de Sanidad y Calidad Agroalimentaria (Senasa) of Argentina for flint maize;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>certificates issued by the Federal Grains Inspection Services (FGIS) of the United States for high quality common wheat and high quality durum wheat;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>certificates issued by the Canadian Grain Commission (CGC) of Canada for high quality common wheat and high quality durum wheat.</p></td></tr></tbody></table>
Annex VIII contains a blank specimen of the certificates of conformity issued by Senasa. Reproduction of the stamps authorised by the government of Argentina shall be published in the Official Journal of the European Union .
Annex IX contains blank specimens of the certificates of conformity and stamps issued by the FGIS.
Annex X contains blank specimens of the certificates of conformity, export specifications and stamps issued by the CGC.
The certificates of conformity may be stored and made available in the electronic system ELAN to be set up by the Commission.
When the analytical parameters entered in the certificates of conformity issued by the entities referred to in the first subparagraph show conformity with the high quality common wheat, durum wheat and flint maize quality standards set out in Annex VI, samples shall be taken of at least 3 % of the cargoes arriving at each entry port during the marketing year.
The goods shall be classified in the standard quality for which all the requirements laid down in Annex VI are met.
3. The standard] reference methods laid down in Commission Implementing Regulation (EU) 2016/1240 ( 27 ) shall apply to the classification of the imported cereals by standard quality.
For the purpose of this paragraph, ‘flint maize’ means maize of the species Zea mays indurata the grains of which present a dominantly vitreous endosperm (hard or horny texture). They are generally orange or red. The upper part (opposite the germ), or crown, shows no fissure.
Vitreous grains of flint maize are defined as grains meeting two criteria:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>their crown shows no fissure;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>when cut lengthwise their endosperm shows a central mealy part completely surrounded by a horny part. The horny part must account for the dominant part of the total cut surface.</p></td></tr></tbody></table>
The vitreous grain percentage shall be established by counting in a representative sample of 100 grains the number meeting the criteria referred to in the third subparagraph.
The reference method for determining the flotation index for flint maize is set out in Annex XI.
4. If the analysis results show the imported high quality common wheat, durum wheat and flint maize to be of a lower standard quality than entered on the declaration of release for free circulation in the Union, the importer shall pay the difference between the import duty applicable to the product shown on the declaration and that on the product actually imported. In this case, the specific guarantee provided for in Article 17(4) of this Regulation and in Article 7(1) and (2) of Delegated Regulation (EU) 2023/2835 shall be released, except for the EUR 5 supplement provided for in Article 7(2), second subparagraph, of that Delegated Regulation.
If the difference referred to in the first subparagraph is not paid within 1 month, the specific guarantee provided for in Article 17(4) of this Regulation and in Article 7(1) and (2) of Delegated Regulation (EU) 2023/2835 shall be forfeit.
5. Representative samples of imported cereals taken by the competent authority of the Member State shall be retained for 6 months.
SECTION 2
Imports of residues from the manufacture of maize starch from the United States
Article 22
Laboratory analysis
1. A laboratory analysis shall be carried out, under the responsibility of the competent authority of the Member State, to verify the conformity of residues from the manufacture of maize starch imported into the Union from the United States of America under CN code 2309 90 20 with the definition of this code for all shipments not accompanied by a certificate issued by the FGIS and a certificate issued by the United States wet milling industry as set out in Annex XII.
The above certificates may be stored and made available in the electronic system ELAN to be set up by the Commission.
2. Shipments from the United States of America which are accompanied by the two certificates referred to in paragraph 1 shall be subject to the customs measures for checking imports.
SECTION 3
Procedures for the importation of rye from Türkiye
Article 23
Proof of payment of the special export charge
Proof that the special export charge referred to in Article 5 of Regulation (EC) No 2008/97 has been paid shall be furnished by the operator to the competent authority of the Member State of import by presentation of A.TR movement certificate. In that case, the respective entry referred to in Annex XIII to this Regulation shall be made in the ‘Remarks’ section by the competent authority.
CHAPTER 3
SUGAR
Trade with third countries in the sugar sector
Article 24
Determination of CIF representative prices for white sugar and raw sugar
1. The Commission shall determine the CIF representative prices for white sugar and raw sugar on the basis of the most favourable purchasing opportunities on the world market.
2. When establishing the most favourable purchasing opportunities on the world market, the Commission shall take into account the relevant information available to it, in particular:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>quotations on exchanges which are important to the international sugar trade;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>sales concluded in international trade.</p></td></tr></tbody></table>
3. Paragraph 2 shall not apply where:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the sugar is not of sound and fair marketable quality; or</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>if the possibility of obtaining sugar at the price indicated in the offer relates only to a small quantity which is not representative of the market; or</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>if the general trend of prices or the information available to the Commission leads the Commission to assume that the price indicated in the offer is not representative of actual market trends.</p></td></tr></tbody></table>
4. When establishing the most favourable purchasing opportunities on the world market, the Commission may take an average of several prices as a basis, provided that this average can be regarded as being representative of actual market trends.
5. Representative prices for white sugar and raw sugar on the world market or on the Union import market as referred to in Article 182(3) of Regulation (EU) No 1308/2013 shall mean the CIF representative prices established in accordance with this Article.
6. The CIF representative prices shall be fixed for each marketing year in accordance with the procedure referred to in Article 183 of Regulation (EU) No 1308/2013. The Commission may amend those prices during that period if the fluctuation in the elements of the calculation produces a rise or fall of EUR 2,5 per 100 kilograms or more in relation to the CIF representative prices fixed previously.
7. The CIF representative price for sugar products falling within CN code 1702 90 95 shall be the representative price fixed for white sugar applied per 1 % of sucrose content per 100 kilograms net of the product in question.
Article 25
Determination of CIF representative prices for molasses
1. The Commission shall determine the CIF representative prices for molasses on the basis of the most favourable purchasing opportunities on the world market.
2. When establishing the most favourable purchasing opportunities on the world market, the Commission shall take in to account the relevant information available to it, in particular:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>offers on the world market;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>sales concluded in international trade.</p></td></tr></tbody></table>
3. Paragraph 2 shall not apply where:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the molasses are not of sound and fair marketable quality; or</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>if the possibility of obtaining molasses at the price indicated in the offer relates only to a small quantity which is not representative of the market; or</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>if the general trend of prices or the information available to the Commission leads the Commission to assume that the price indicated in the offer is not representative of actual market trends.</p></td></tr></tbody></table>
4. When establishing the most favourable purchasing opportunities on the world market, the Commission may take an average of several prices as a basis, provided that this average can be regarded as being representative of actual market trends.
5. Representative prices for molasses on the world market or on the Union import market as referred to Article 182(3) of Regulation (EU) No 1308/2013 shall mean the CIF representative prices established in accordance with this Article.
6. The CIF representative prices shall be fixed for each marketing year in accordance with the procedure referred to in Article 183 of Regulation (EU) No 1308/2013. The Commission may amend them during that period if the fluctuation in the elements of the calculation produces a rise or fall of EUR 1,5 per 100 kilograms or more in relation to the CIF representative prices fixed previously.
Article 26
Additional import duties for certain sugar products
If imposed, the additional import duties referred to in Article 182(1) of Regulation (EU) No 1308/2013 shall be applied to sugar products falling within CN codes 1701 13 10, 1701 14 10, 1701 13 90, 1701 14 90, 1701 12 10, 1701 12 90, 1701 91 00, 1701 99 10, 1701 99 90 and 1702 90 95.
Article 27
Additional import duties for molasses
If imposed, the additional import duties referred to in Article 182(1) of Regulation (EU) No 1308/2013 shall be applied to molasses falling within CN codes 1703 10 00 and 1703 90 00.
Article 28
Trigger prices for certain sugar products
For 100 kilograms of net sugar product, the trigger price referred to in Article 182(1), point (a), of Regulation (EU) No 1308/2013 shall be equivalent to:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>EUR 53,10 for white sugar falling within CN codes 1701 99 10 and 1701 99 90 of the standard quality referred to in Point B II of Annex III to Regulation (EU) No 1308/2013;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>EUR 64,70 for sugar falling within CN code 1701 91 00;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>EUR 54,10 for raw beet sugar falling within CN code 1701 12 90 of the standard quality referred to in Point B III of Annex III to Regulation (EU) No 1308/2013;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>EUR 41,30 for raw beet sugar falling within CN code 1701 12 10 of the standard quality referred to in Point B III of Annex III to Regulation (EU) No 1308/2013;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>EUR 55,20 for raw cane sugar falling within CN codes 1701 13 90 and 1701 14 90 of the standard quality referred to in Point B III of Annex III to Regulation (EU) No 1308/2013;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>EUR 41,80 for raw cane sugar falling within CN code 1701 13 10 and 1701 14 10 of the standard quality referred to in Point B III of Annex III to Regulation (EU) No 1308/2013;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>EUR 1,184 for the products falling within CN code 1702 90 95 per 1 % of sucrose content.</p></td></tr></tbody></table>
Article 29
Trigger prices for molasses
For 100 kilograms of molasses of the standard quality referred to in Article 31 of this Regulation, the trigger price referred to in Article 182(1), first subparagraph, point (a), of Regulation (EU) No 1308/2013 shall be equivalent to:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>EUR 7,90 for molasses falling within CN code 1703 10 00;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>EUR 8,20 for molasses falling within CN code 1703 90 00.</p></td></tr></tbody></table>
Article 30
Provisions on proofs, guarantee, release of the guarantee and recovery of import duties
1. The amount of the additional import duties for each type of molasses referred to in Article 27 and the sugar products referred to in Article 26 shall be established on the basis of the CIF import price of the consignment in question in accordance with Article 33.
For molasses, the CIF import price of the consignment in question shall be converted into the price of molasses of standard quality in accordance with Article 32.
In the case of white and raw sugar, the CIF import price of the consignment in question shall be converted into the equivalent price of sugar of standard quality as defined, respectively, in Point B II and III of Annex III to Regulation (EU) No 1308/2013 or the equivalent price for the product falling within CN code 1702 90 95, as the case may be.
2. When the CIF import price per 100 kilograms of a consignment is higher than the applicable CIF representative price determined in accordance with Articles 24 and 25, the importer shall present to the customs authorities of the Member State of import at least the following proofs:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the purchasing contract, or any other equivalent document;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the insurance contract for the consignment;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the invoice;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>the certificate of origin (where applicable);</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>the transport contract;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>in the case of sea transport, the bill of lading.</p></td></tr></tbody></table>
For the verification of the CIF import price of the consignment in question, the authorities of the Member State of import may require any other information and documents they deem necessary.
3. In the case referred to in paragraph 2, the importer shall provide a guarantee referred to in Articles 89 to 100 of Regulation (EU) No 952/2013, equal to the difference between the amount of additional import duty calculated on the basis of the CIF representative price applicable to the product in question and the amount of additional import duty calculated on the basis of CIF import price of the consignment in question.
4. The importer shall have 2 months from the sale of the products in question, subject to a limit of 9 months from the date of acceptance of the declaration of release for free circulation, to prove that the consignment was disposed of under conditions confirming the correctness of the information referred to in paragraph 2. Failure to meet one or other of these deadlines shall entail the loss of the guarantee provided. However, the time limit of 9 months may be extended by the customs authorities by a maximum of 3 months following a duly substantiated request of the importer. If the products are under the end-use procedure, Article 254 of Regulation (EU) No 952/2013 shall apply.
The guarantee provided in accordance with paragraph 3 shall be released to the extent that proof of the conditions of disposal is provided to the satisfaction of the customs authorities. Otherwise, the guarantee shall be forfeit by way of payment of the additional import duties.
5. If, on verification, the customs authorities establish that the requirements of this Article have not been met, they shall recover the duty due in accordance with Article 105 of Regulation (EU) No 952/2013. The amount of the duty to be recovered or remaining to be recovered shall include interest from the date the products were released for free circulation up to the date of recovery. The interest rate applied shall be that in force for recovery operations under national law.
Article 31
Standard quality of molasses
The standard quality molasses shall:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>be of sound and fair marketable quality;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>have a total sugar content of 48 %.</p></td></tr></tbody></table>
Article 32
Adjustments of CIF import prices to that of the standard quality for molasses
CIF import prices for molasses which do not relate to the standard quality shall be:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>increased by one forty-eighth for each percentage point of total sugar content where the sugar content of the molasses concerned is less than 48 %;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>reduced by one forty-eighth for each percentage point of total sugar content where the sugar content of the molasses concerned is more than 48 %.</p></td></tr></tbody></table>
Article 33
Calculation of the additional import duty referred to in Articles 26 and 27
Where the difference between the trigger price determined in accordance with Article 28 for certain sugar products and in accordance with Article 29 for molasses and the CIF import price of the consignment in question:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>is 10 % or less than the trigger price, the additional duty shall be zero;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>is more than 10 % but less than or equal to 40 % of the trigger price, the additional duty shall be 30 % of the amount over and above 10 %;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>is more than 40 % but less than or equal to 60 % of the trigger price, the additional duty shall be 50 % of the amount over and above 40 %, to which shall be added the additional duty referred to in point (b);</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>is more than 60 % but less than or equal to 75 % of the trigger price, the additional duty shall be 70 % of the amount over and above 60 %, to which shall be added the additional duties referred to in points (b) and (c);</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>is more than 75 % of the trigger price, the additional duty shall be 90 % of the amount over and above 75 %, to which shall be added the additional duties referred to in points (b), (c) and (d).</p></td></tr></tbody></table>
Article 34
Adjustment of the import duty for imported raw sugar
If the yield of imported raw sugar as determined in accordance with Point B III of Annex III to Regulation (EU) No 1308/2013 differs from the yield fixed for the standard quality, the import duty for products falling within CN codes 1701 12 10, 1701 13 10 and 1701 14 10, and the additional duty for products falling within CN codes 1701 12 10, 1701 12 90, 1701 13 10, 1701 13 90, 1701 14 10 and 1701 14 90 to be levied per 100 kilograms of the said raw sugar shall be calculated by multiplying the corresponding duty fixed for raw sugar of the standard quality by a correcting coefficient. The correcting coefficient shall be obtained by dividing the percentage of the yield of the imported raw sugar by 92.
CHAPTER 4
HOPS Imports of products of the hops sector
Article 35
Subject matter
1. Entry into free circulation in the Union of products of the hops sector from third countries referred to in Article 1(2), point (f), of Regulation (EU) No 1308/2013 shall be conditional upon proof being furnished that the requirements specified in Article 190(1) of that Regulation have been met.
2. The proof referred to in paragraph 1 shall be furnished through the presentation of the attestation provided for in Article 190(2) of Regulation (EU) No 1308/2013 (‘attestation of equivalence’).
Article 36
Use of terms
For the purposes of this Chapter, ‘consignment’ means a quantity of a product having the same characteristics and sent by the same consignor at the same time to the same consignee.
For the purposes of this Chapter, the products of the hop sector include hop cones CN code: 1210 10, hop powders or pellets CN code: 1210 20, saps and extracts of hops CN code: 1302 13 00.
Article 37
Agencies authorised to issue an attestation of equivalence
1. Attestations of equivalence accompanying imported hops and hop products shall be issued by an agency authorised by the third country of origin or, where non-existent in the country of origin, an already authorised agency outside the product’s country of origin.
2. On the basis of notifications from the competent authorities of third countries pursuant to Article 190 of Regulation (EU) No 1308/2013, the Commission shall draw up and update a list of agencies authorised to issue attestations of equivalence in the hop product’s country of origin, containing the name, postal and email address of those agencies.
3. The Commission shall make public on its website the name and address of the agencies notified by the competent authorities of third countries.
Article 38
Attestation of equivalence of imported products of the hops sector
1. The attestation of equivalence shall be issued for each consignment and shall consist of an original and a copy to be drawn up on a form corresponding to the model set out in Annex XIV and in accordance with the rules set out in Annex XVI.
2. The attestation of equivalence shall be valid only if it is duly completed and authenticated by one of the agencies referred to in the list drawn up and made public by the Commission in accordance with Article 37(3).
3. A duly authenticated attestation of equivalence is one which shows the place and date of issue, and which has been signed and bears the stamp or electronic signature of the issuing agency.
The attestation of equivalence may be stored and made available in the electronic system ELAN to be set up by the Commission.
Article 39
Labelling of the packaging of products of the hops sector
1. Each unit of packaging covered by an attestation of equivalence shall bear the following particulars in one of the official languages of the Union:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the description of the hop or hop product;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the variety or varieties;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the country of origin;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>the marks and numbers indicated in Section 9 of the attestation of equivalence or the extract.</p></td></tr></tbody></table>
2. The particulars provided for in paragraph 1 shall appear in legible, indelible characters of uniform size on the outside of the package.
Article 40
Customs procedure and keeping attestations of equivalence
For products of the hop sector, when they are presented to customs in accordance with Article 139 of Regulation (EU) No 952/2013 or at the latest before their release for free circulation in the Union, the original of the related attestation of equivalence shall be submitted to the customs authorities who shall countersign and retain it.
The customs authorities shall transmit, where available, an electronic copy of the attestation of equivalence to the competent authority of the Member State in which the product is brought into the customs territory of the Union.
A copy of the countersigned attestation of equivalence issued by the competent authority of the third country shall be returned to the importer, who must keep it for at least 3 years.
Article 41
Splitting up of consignments of hop products before release for free circulation in the Union
1. Where, before its entry into free circulation in the Union, a consignment covered by an attestation of equivalence is split up and redispatched, an attestation extract shall be drawn up in respect of each new consignment resulting from such splitting.
The attestation of equivalence shall be replaced by the necessary number of attestation extracts.
Each attestation extract shall be drawn up by the party concerned in an original on a form corresponding to the model set out in Annex XV and in accordance with the rules set out in Annex XVI and shall be sent to the customs authorities.
2. The customs authorities shall endorse accordingly the original of the attestation of equivalence and shall countersign the original of the extract.
For this purpose, the customs authority shall enter the quantities indicated in the extracts in the sections provided for this purpose on the attestation of equivalence and shall confirm the entry or confirm, where provided for by national administrative provisions, the quantities indicated by the declarant in the relevant sections.
The customs authorities shall retain the original of the endorsed attestation of equivalence and of the countersigned extract, send a copy of the endorsed attestation and each countersigned extract to the competent certification authority of the Member State and return a copy of each extract to the operator concerned.
Article 42
Splitting up of consignments of hop products after entry into free circulation in the Union
If the consignment of the products of the hop sector is resold or split up after it has been released for free circulation in the Union, the product must be accompanied by an invoice or other commercial document drawn up by the vendor, giving the reference number of the attestation of equivalence or of the extract, together with the name of the authority which issued them.
The following information from the attestation of equivalence or, as the case may be, the extract shall also be included on the invoice or commercial document:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>for hop cones:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>the description of the product;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>the gross weight;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>the place of production;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iv)</p></td><td><p>the year of harvest;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(v)</p></td><td><p>the variety;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(vi)</p></td><td><p>the country of origin;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(vii)</p></td><td><p>the markings and identification numbers set out in section 9 of the attestation of equivalence;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>for hop products, in addition to the particulars listed under point (a): the place and date of processing.</p></td></tr></tbody></table>
Article 43
Controls on imported products of the hops sector and reporting
1. The Member States shall regularly carry out checks on a random basis to verify whether hop products under CN code 1210 entering the customs territory of the Union in order to be imported pursuant to Article 190 of Regulation (EU) No 1308/2013 comply with the minimum marketing requirements for hop cones set out in Annex I to Commission Regulation (EC) No 1850/2006 ( 28 ) for those purposes.
2. The Member States shall report to the Commission, every year by 30 June, the frequency, type and result of the checks which were carried out over the year preceding that date. The checks shall cover at least 5 % of the number of consignments of hops expected to be imported from a third country into the Member State in question during the year.
3. If the competent authorities of the Member States find that the samples examined do not satisfy the minimum marketing requirements referred to in paragraph 1, the corresponding consignments shall not be marketed in the Union.
CHAPTER 5
FINAL PROVISIONS
Article 44
Entry into force
This Regulation shall enter into force on the seventh day following that of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 10 October 2023
For the Commission
The President
Ursula VON DER LEYEN
( 1 ) OJ L 347, 20.12.2013, p. 671 .
( 2 ) OJ L 435, 6.12.2021, p. 187 .
( 3 ) OJ L 269, 10.10.2013, p. 1 .
( 4 ) Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) ( OJ L 299, 16.11.2007, p. 1 ).
( 5 ) Commission Regulation (EC) No 3330/94 of 21 December 1994 on the tariff classification of certain poultry cuts and amending Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff ( OJ L 350, 31.12.1994, p. 52 ).
( 6 ) Commission Regulation (EC) No 2810/95 of 5 December 1995 on the tariff classification of pig carcases and half- carcases and amending Council Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff ( OJ L 291, 6.12.1995, p. 24 ).
( 7 ) Commission Regulation (EC) No 951/2006 of 30 June 2006 laying down detailed rules for the implementation of Council Regulation (EC) No 318/2006 as regards trade with third countries in the sugar sector ( OJ L 178, 1.7.2006, p. 24 ).
( 8 ) Commission Regulation (EC) No 972/2006 of 29 June 2006 laying down special rules for imports of Basmati rice and a transitional control system for determining their origin ( OJ L 176, 30.6.2006, p. 53 ).
( 9 ) Commission Regulation (EC) No 504/2007 of 8 May 2007 laying down detailed rules for the application of the arrangements for additional import duties in the milk and milk products sector ( OJ L 119, 9.5.2007, p. 7 ).
( 10 ) Commission Regulation (EC) No 1375/2007 of 23 November 2007 on imports of residues from the manufacture of starch from maize from the United States of America ( OJ L 307, 24.11.2007, p. 5 ).
( 11 ) Commission Regulation (EC) No 402/2008 of 6 May 2008 on procedures for the importation of rye from Turkey ( OJ L 120, 7.5.2008, p. 3 ).
( 12 ) Commission Regulation (EC) No 1295/2008 of 18 December 2008 on the importation of hops from third countries ( OJ L 340, 19.12.2008, p. 45 ).
( 13 ) Commission Regulation (EC) No 1312/2008 of 19 December 2008 fixing the conversion rates, the processing costs and the value of the by-products for the various stages of rice processing ( OJ L 344, 20.12.2008, p. 56 ).
( 14 ) Commission Regulation (EU) No 642/2010 of 20 July 2010 on rules of application (cereal sector import duties) for Council Regulation (EC) No 1234/2007 ( OJ L 187, 21.7.2010, p. 5 ).
( 15 ) Commission Delegated Regulation (EU) 2023/2835 of 10 October 2023 supplementing Regulation (EU) No 1308/2013 of the European Parliament and of the Council as regards rules on import in the sectors of rice, cereals, sugar and hops, and repealing Commission Regulations (EC) No 3330/94, (EC) No 2810/95, (EC) No 951/2006, (EC) No 972/2006, (EC) No 504/2007, (EC) No 1375/2007, (EC) No 402/2008, (EC) No 1295/2008, (EC) No 1312/2008 and (EU) No 642/2010, (EEC) No 1361/76, (EEC) No 1842/81, (EEC) No 3556/87, (EEC) No 3846/87, (EEC) No 815/89, (EC) No 765/2002, (EC) No 1993/2005, (EC) No 1670/2006, (EC) No 1731/2006, (EC) No 1741/2006, (EC) No 433/2007, (EC) No 1359/2007, (EC) No 1454/2007, (EC) No 508/2008, (EC) No 903/2008, (EC) No 147/2009, (EC) No 612/2009, (EU) No 817/2010, (EU) No 1178/2010, (EU) No 90/2011 and Commission Implementing Regulation (EU) No 1373/2013 ( OJ L, 2023/2835, 21.12.2023, ELI: http://data.europa.eu/eli/reg_del/2023/2835/oj ).
( 16 ) Council Decision 2004/617/EC of 11 August 2004 on the conclusion of an Agreement in the form of an Exchange of Letters between the European Community and India pursuant to Article XXVIII of the GATT 1994 relating to the modification of concessions with respect to rice provided for in EC Schedule CXL annexed to the GATT 1994 ( OJ L 279, 28.8.2004, p. 17 ).
( 17 ) Council Decision 2004/618/EC of 11 August 2004 on the conclusion of an Agreement in the form of an Exchange of Letters between the European Community and Pakistan pursuant to Article XXVIII of the GATT 1994 relating to the modification of concessions with respect to rice provided for in EC Schedule CXL annexed to the GATT 1994 ( OJ L 279, 28.8.2004, p. 23 ).
( 18 ) Commission Implementing Regulation (EU) 2016/1239 of 18 May 2016 laying down rules for the application of Regulation (EU) No 1308/2013 of the European Parliament and of the Council with regard to the system of import and export licences ( OJ L 206, 30.7.2016, p. 44 ).
( 19 ) Commission Delegated Regulation (EU) 2016/1237 of 18 May 2016 supplementing Regulation (EU) No 1308/2013 of the European Parliament and of the Council with regard to the rules for applying the system of import and export licences and supplementing Regulation (EU) No 1306/2013 of the European Parliament and of the Council with regard to the rules on the release and forfeit of securities lodged for such licences, amending Commission Regulations (EC) No 2535/2001, (EC) No 1342/2003, (EC) No 2336/2003, (EC) No 951/2006, (EC) No 341/2007 and (EC) No 382/2008 and repealing Commission Regulations (EC) No 2390/98, (EC) No 1345/2005, (EC) No 376/2008 and (EC) No 507/2008 ( OJ L 206, 30.7.2016, p. 1 ).
( 20 ) Council Regulation (EC) No 2008/97 of 9 October 1997 laying down certain rules for the application of the special arrangements for imports of olive oil and certain other agricultural products originating in Turkey ( OJ L 284, 16.10.1997, p. 17 ).
( 21 ) Regulation (EU) 2022/2399 of the European Parliament and of the Council of 23 November 2022 establishing the European Union Single Window Environment for Customs and amending Regulation (EU) No 952/2013 ( OJ L 317, 9.12.2022, p. 1 ).
( 22 ) Commission Delegated Regulation (EU) 2017/1183 of 20 April 2017 on supplementing Regulations (EU) No 1307/2013 and (EU) No 1308/2013 of the European Parliament and of the Council with regard to the notifications to the Commission of information and documents ( OJ L 171, 4.7.2017, p. 100 ).
( 23 ) Commission Implementing Regulation (EU) 2017/1185 of 20 April 2017 laying down rules for the application of Regulations (EU) No 1307/2013 and (EU) No 1308/2013 of the European Parliament and of the Council as regards notifications to the Commission of information and documents and amending and repealing several Commission Regulations ( OJ L 171, 4.7.2017, p. 113 ).
( 24 ) Commission Implementing Regulation (EU) 2015/2447 of 24 November 2015 laying down detailed rules for implementing certain provisions of Regulation (EU) No 952/2013 of the European Parliament and of the Council laying down the Union Customs Code ( OJ L 343, 29.12.2015, p. 558 ).
( 25 ) Council Decision 2005/476/EC of 21 June 2005 on the conclusion of an Agreement in the form of an Exchange of Letters between the European Community and the United States of America relating to the method of calculation of applied duties for husked rice and amending Decisions 2004/617/EC, 2004/618/EC and 2004/619/EC ( OJ L 170, 1.7.2005, p. 67 ).
( 26 ) Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed ( OJ L 54, 26.2.2009, p. 1 ).
( 27 ) Commission Implementing Regulation (EU) 2016/1240 of 18 May 2016 laying down rules for the application of Regulation (EU) No 1308/2013 of the European Parliament and of the Council with regard to public intervention and aid for private storage ( OJ L 206, 30.7.2016, p. 71 ).
( 28 ) Commission Regulation (EC) No 1850/2006 of 14 December 2006 laying down detailed rules for the certification of hops and hop products ( OJ L 355, 15.12.2006, p. 72 ).
ANNEX I
Entries referred to in Article 8, point (b)
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Bulgarian: ориз басмати с код по КН 1006 20 17 или 1006 20 98, внесен с нулева ставка на митото в съответствие с Делегиран регламент (ЕС) 2023/2835 на Комисията и Регламент за изпълнение (ЕС) 2023/2834 на Комисията, прид…ружен от сертификат за автентичност № …, издаден от [наименование на компетентния орган]</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Spanish: arroz Basmati de los códigos NC 1006 20 17 o 1006 20 98 e importado con un tipo de derecho nulo en virtud del Reglamento Delegado (UE) 2023/2835 de la Comisión y del Reglamento de Ejecución (UE) 2023/2834 de la Comisión, acompañado del certificado de autenticidad n.°... expedido por [nombre de la autoridad competente]</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Czech: rýže Basmati kódu KN 1006 20 17 nebo 1006 20 98, která se dováží za nulové clo na základě nařízení Komise v přenesené pravomoci (EU) 2023/2835 a prováděcího nařízení Komise (EU) 2023/2834, a ke které se připojí osvědčení o pravosti č. … vydané [název příslušného subjektu]</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Danish: Basmati-ris henhørende under KN-kode 1006 20 17 eller 1006 20 98 og importeret med nultold i henhold til Kommissionens delegerede forordning (EU) 2023/2835 og Kommissionens gennemførelsesforordning (EU) 2023/2834, ledsaget af ægthedscertifikat nr. … udstedt af [den kompetente myndigheds navn]</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In German: Basmati-Reis des KN-Codes 1006 20 17 oder 1006 20 98, eingeführt zum Zollsatz Null gemäß der Delegierten Verordnung (EU) 2023/2835 der Kommission und der Durchführungsverordnung (EU) 2023/2834 der Kommission und begleitet vom Echtheitszeugnis Nr. …, ausgestellt durch [Name der zuständigen Behörde]</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Estonian: CN-koodi 1006 20 17 või 1006 20 98 alla kuuluv basmati riis, mida imporditakse tollimaksu nullmääraga vastavalt komisjoni delegeeritud määrusele (EL) 2023/2835 ja komisjoni rakendusmäärusele (EL) 2023/2834 ning millele on lisatud [pädeva asutuse nimi] koostatud autentsussertifikaat nr..</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Greek: Ρύζι μπασμάτι του κωδικού ΣΟ 1006 20 17 ή 1006 20 98 εισαγόμενο με μηδενικό δασμό κατ’ εφαρμογή του κατ’ εξουσιοδότηση κανονισμού (ΕΕ) 2023/2835 της Επιτροπής και του εκτελεστικού κανονισμού (ΕΕ) 2023/2834 της Επιτροπής, συνοδευόμενο από το πιστοποιητικό γνησιότητας αριθ. … που εκδόθηκε από την/τον [ονομασία της αρμόδιας αρχής]</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In English: Basmati rice falling within code of CN 1006 20 17 or 1006 20 98 and imported at a zero rate of duty under Commission Delegated Regulation (EU) 2023/2835 and Commission Implementing Regulation (EU) 2023/2834, accompanied by authenticity certificate No … drawn up by [name of the competent authority]</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In French: riz Basmati du code NC 1006 20 17 ou 1006 20 98 importé à droit nul en application du règlement délégué (UE) 2023/2835 de la Commission et du règlement d’exécution (UE) 2023/2834 de la Commission, accompagné du certificat d’authenticité n° … établi par [nom de l’autorité compétente]</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Irish: rís Basmati atá faoi chód AC 1006 20 17 nó 1006 20 98 agus a allmhairítear ar ráta nialasach dleachta faoi Rialachán Tarmligthe (AE) 2023/2835 ón gCoimisiún agus Rialachán Cur Chun Feidhme (AE) 2023/2834 ón gCoimisiún, a mbeidh deimhniú barántúlachta Uimh. ... arna tharraingt suas ag [ainm an údaráis inniúil] ag gabháil léi</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Croatian: basmati riža oznake KN 1006 20 17 ili 1006 20 98 i uvezena uz nultu stopu carine u skladu s Delegiranom uredbom Komisije (EU) 2023/2835 i Provedbenom uredbom Komisije (EU) 2023/2834, popraćena potvrdom o autentičnosti br. … koju je izdao [naziv nadležnog tijela]</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Italian: Riso Basmati di cui al codice NC 1006 20 17 o 1006 20 98 importato a dazio zero ai sensi del regolamento delegato (UE) della Commissione 2023/2835 e del regolamento di esecuzione (UE) della Commissione 2023/2834, corredato del certificato di autenticità n. … rilasciato da [nome dell’autorità competente]</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Latvian: basmati rīsi ar KN kodu 1006 20 17 vai 1006 20 98, kas importēti ar nulles nodokļa likmi saskaņā ar Komisijas Deleģēto regulu (ES) 2023/2835 un Komisijas Īstenošanas regulu (ES) 2023/2834 un kam pievienota [kompetentās iestādes nosaukums] sagatavota autentiskuma apliecība Nr. ....</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Lithuanian: Basmati ryžiai, kurių KN kodas 1006 20 17 arba 1006 20 98 ir kurie importuoti taikant nulinę muito normą pagal Komisijos deleguotąjį reglamentą (ES) 2023/2835 ir Komisijos įgyvendinimo reglamentą (ES) 2023/2834, prie kurių pridėtas [kompetentingos institucijos pavadinimas] parengtas autentiškumo sertifikatas Nr. …</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Hungarian: az 1006 20 17 vagy az 1006 20 98 KN-kód alá sorolt, az (EU) 2023/2835 felhatalmazáson alapuló bizottsági rendelet és az (EU) 2023/2834 bizottsági végrehajtási rendelet alkalmazásában nulla vámtétel mellett behozott basmati rizs, a/az [illetékes hatóság neve] által kiállított, … számú eredetiségigazolással együtt</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Maltese: ross Basmati li jaqa’ taħt il-kodiċi NM 1006 20 17 jew 1006 20 98 u importat b’rata ta’ dazju żero skont ir-Regolament Delegat tal-Kummissjoni (UE) 2023/2835 u r-Regolament ta’ Implimentazzjoni tal-Kummissjoni (UE) 2023/2834, akkumpanjat miċ-ċertifikat ta’ awtentiċità Nru... imfassal minn [isem l-awtorità kompetenti]</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Dutch: Basmati-rijst van GN-code 1006 20 17 of 1006 20 98, ingevoerd met nulrecht overeenkomstig Gedelegeerde Verordening (EU) 2023/2835 van de Commissie en Uitvoeringsverordening (EU) 2023/2834 van de Commissie, vergezeld van het echtheidscertificaat nr. …, opgesteld door [naam van de bevoegde instantie]</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Polish: ryż Basmati objęty kodem CN 1006 20 17 lub 1006 20 98 i przywożony z zastosowaniem zerowej stawki celnej zgodnie z rozporządzeniem delegowanym Komisji (UE) 2023/2835 i rozporządzeniem wykonawczym Komisji (UE) 2023/2834, któremu towarzyszy świadectwo autentyczności nr... sporządzone przez [name of the competent authority]</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Portuguese: arroz basmáti do código NC 1006 20 17 ou 1006 20 98 e importado com um direito nulo ao abrigo do Regulamento Delegado (UE) 2023/2835 da Comissão e do Regulamento de Execução (UE) 2023/2834 da Comissão, acompanhado do certificado de autenticidade n.°..., emitido por [nome da autoridade competente]</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Romanian: orez Basmati de la codul NC 1006 20 17 sau 1006 20 98 importat cu o rată a taxelor vamale egală cu zero în temeiul Regulamentului delegat (UE) 2023/2835 al Comisiei și al Regulamentului de punere în aplicare (UE) 2023/2834 al Comisiei, însoțit de certificatul de autenticitate nr. … întocmit de [denumirea autorității competente]</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Slovak: ryža Basmati s kódom KN 1006 20 17 alebo 1006 20 98 dovážaná s nulovou sadzbou cla v súlade s delegovaným nariadením Komisie (EÚ) 2023/2835 a vykonávacím nariadením Komisie (EÚ) 2023/2834, sprevádzaná osvedčením o pravosti č. … vystavenom [názov príslušného orgánu]</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Slovenian: Riž basmati iz oznake KN 1006 20 17 ali 1006 20 98, uvožen po stopnji nič v skladu z Delegirano uredbo Komisije (EU) 2023/2835 in Izvedbeno uredbo Komisije (EU) 2023/2834, s priloženim potrdilom o pristnosti št. …, ki ga je izdal [naziv pristojnega organa]</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Finnish: komission delegoidun asetuksen (EU) 2023/2835 ja komission täytäntöönpanoasetuksen (EU) 2023/2834, mukaisesti tullivapaasti tuotu CN-koodiin 1006 20 17 tai 1006 20 98 kuuluva Basmati-riisi, jonka mukana on [toimivaltaisen viranomaisen nimi] myöntämä aitoustodistus nro …</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Swedish: Basmatiris med KN-nummer 1006 20 17 eller 1006 20 98 som importeras tullfritt i enlighet med kommissionens delegerade förordning (EU) 2023/2835 och kommissionens genomförandeförordning (EU) 2023/2834, åtföljt av äkthetsintyg nr … som utfärdats av [den behöriga myndighetens namn].</p></td></tr></tbody></table>
ANNEX II
Specimen authenticity certificate referred to in Article 9(1)
The form shall measure approximately 210 × 297 millimetres. The original shall be drawn up on a paper which shows up any tampering by mechanical or chemical means.
The forms shall be printed and completed in English.
The original and the duplicate thereof shall be either typewritten or handwritten. In the latter case, they shall be completed in ink and in block capitals.
Each authenticity certificate shall contain a serial number in the top right-hand box. The duplicate shall bear the same number as the original.
<table><col/><col/><col/><tbody><tr><td><table><col/><col/><tbody><tr><td><p>1.</p></td><td><p>Exporter (Name and full address)</p></td></tr></tbody></table></td><td><p>CERTIFICATE OF AUTHENTICITY</p><p>BASMATI RICE</p><p>for export to the European Union</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>2.</p></td><td><p>Consignee (Name and full address)</p></td></tr></tbody></table></td></tr><tr><td><p>No<a> (<span>1</span>)</a></p></td><td><p>ORIGINAL</p></td></tr><tr><td><p>issued by (Name and full address of issuing body)</p></td></tr><tr><td><p> </p></td><td><table><col/><col/><tbody><tr><td><p>3.</p></td><td><p>Country and place of cultivation</p></td></tr></tbody></table></td></tr><tr><td><p> </p></td><td><table><col/><col/><tbody><tr><td><p>4.</p></td><td><p>FOB value in US dollars</p></td></tr></tbody></table></td></tr><tr><td><p> </p></td><td><table><col/><col/><tbody><tr><td><p>5.</p></td><td><p>Number and date of invoice</p></td></tr></tbody></table></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>6.</p></td><td><p>Marks and numbers – Number and kind of packages – Description of goods<a> (<span>2</span>)</a></p></td></tr></tbody></table></td><td><table><col/><col/><tbody><tr><td><p>7.</p></td><td><p>Gross weight (kg)</p></td></tr></tbody></table></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>8.</p></td><td><p>Net weight (kg)</p></td></tr></tbody></table></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>9.</p></td><td><p>DECLARATION BY EXPORTER</p><p>The undersigned declares that the information shown above is correct.</p></td></tr></tbody></table></td></tr><tr><td><p>Place and date:</p></td><td><p>Signature:</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>10.</p></td><td><p>CERTIFICATION BY THE ISSUING BODY</p><p>It is hereby certified that the rice described above is BASMATI RICE and that the information shown in this certificate is correct.</p></td></tr></tbody></table></td></tr><tr><td><p>Place and date:</p></td><td><p>Signature:</p></td><td><p>Stamp:</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>11.</p></td><td><p>CERTIFICATION BY COMPETENT CUSTOMS OFFICE OF COUNTRY OF EXPORT</p><p>Customs formalities for export to the European Union of the rice described above have been completed.</p><p>Type, number and date of export document: Name and country of customs office:</p></td></tr></tbody></table></td></tr><tr><td><p> </p></td><td><p>Signature:</p></td><td><p>Stamp:</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>12.</p></td><td><p>FOR COMPETENT AUTHORITIES IN THE UNION</p></td></tr></tbody></table></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>NB:</p></td><td><p>This certificate is issued in conformity with the national legislation.</p></td></tr></tbody></table></td></tr></tbody></table>
( 1 ) The number of the certificate of authenticity shall be a number of a continuous series given by the country delivering the certificate.
( 2 ) The operator shall specify:
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>for marks and numbers: the reference and number of the batch,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>for number and kind of packages: the number and weight of packages,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>for the description of goods: the information on the rice, the CN code as well as the variety or varieties, which shall be on the list provided for in Commission Delegated Regulation (EU) 2023/2835. The description of goods should correspond to the information included in the invoice, the number and date of which is specified in box 5.</p></td></tr></tbody></table>
ANNEX III
Entries referred to in Article 10(1), point (b)
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Bulgarian: ориз басмати с код по КН 1006 20 17 или 1006 20 98, внесен с нулева ставка на митото в съответствие с Делегиран регламент (ЕС) 2023/2835 на Комисията и Регламент за изпълнение (ЕС) 2023/2834 на Комисията, придружен от дубликат на сертификат за автентичност № …, издаден от [наименование на компетентния орган],</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Spanish: arroz Basmati de los códigos NC 1006 20 17 o 1006 20 98 e importado con un tipo de derecho nulo en virtud del Reglamento Delegado (UE) 2023/2835 de la Comisión y del Reglamento de Ejecución (UE) 2023/2834 de la Comisión, acompañado de un duplicado del certificado de autenticidad n.°... expedido por [nombre de la autoridad competente]</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Czech: rýže Basmati kódu KN 1006 20 17 nebo 1006 20 98, která se dováží za nulové clo na základě nařízení Komise v přenesené pravomoci (EU) 2023/2835 a prováděcího nařízení Komise (EU) 2023/2834, a ke které se připojí duplikát osvědčení o pravosti č. … vydaného [název příslušného subjektu]</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Danish: Basmati-ris henhørende under KN-kode 1006 20 17 eller 1006 20 98 og importeret med nultold i henhold til Kommissionens delegerede forordning (EU) 2023/2835 og Kommissionens gennemførelsesforordning (EU) 2023/2834, ledsaget af en genpart af ægthedscertifikat nr. … udstedt af [den kompetente myndigheds navn]</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In German: Basmati-Reis des KN-Codes 1006 20 17 oder 1006 20 98, eingeführt zum Zollsatz Null gemäß der Delegierten Verordnung (EU) 2023/2835 der Kommission und der Durchführungsverordnung (EU) 2023/2834 der Kommission und begleitet von einem Duplikat des Echtheitszeugnisses Nr. …, ausgestellt durch [Name der zuständigen Behörde]</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Estonian: CN-koodi 1006 20 17 või 1006 20 98 alla kuuluv basmati riis, mida imporditakse tollimaksu nullmääraga vastavalt komisjoni delegeeritud määrusele (EL) 2023/2835 ja komisjoni rakendusmäärusele (EL) 2023/2834 ning millele on lisatud [pädeva asutuse nimi] koostatud autentsussertifikaadi nr... duplikaat</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Greek: Ρύζι μπασμάτι του κωδικού ΣΟ 1006 20 17 ή 1006 20 98 εισαγόμενο με μηδενικό δασμό κατ’ εφαρμογή του κατ’ εξουσιοδότηση κανονισμού (ΕΕ) 2023/2835 της Επιτροπής και του εκτελεστικού κανονισμού (ΕΕ) 2023/2834 της Επιτροπής, συνοδευόμενο από αντίτυπο του πιστοποιητικού γνησιότητας αριθ. … που εκδόθηκε από την/τον [ονομασία της αρμόδιας αρχής]</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In English: Basmati rice falling within code of CN 1006 20 17 or 1006 20 98 and imported at a zero rate of duty under Commission Delegated Regulation (EU) 2023/2835 and Commission Implementing Regulation (EU) 2023/2834, accompanied by a duplicate of authenticity certificate No … drawn up by [name of the competent authority]</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In French: riz Basmati du code NC 1006 20 17 ou 1006 20 98 importé à droit nul en application du règlement délégué (UE) 2023/2835 de la Commission et du règlement d’exécution (UE) 2023/2834 de la Commission, accompagné d’une copie conforme du certificat d’authenticité n° … établi par [nom de l’autorité compétente]</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Irish: Rís Basmati atá faoi chód AC 1006 20 17 nó 1006 20 98 agus a allmhairítear ar ráta nialasach dleachta faoi Rialachán Tarmligthe (AE) 2023/2835 ón gCoimisiún agus Rialachán Cur Chun Feidhme (AE) 2023/2834 ón gCoimisiún, a mbeidh dúblach de dheimhniú barántúlachta Uimh. ... arna tharraingt suas ag [ainm an údaráis inniúil] ag gabháil léi</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Croatian: basmati riža oznake KN 1006 20 17 ili 1006 20 98 i uvezena uz nultu stopu carine u skladu s Delegiranom uredbom Komisije (EU) 2023/2835 i Provedbenom uredbom Komisije (EU) 2023/2834, popraćena duplikatom potvrde o autentičnosti br. … koju je izdao [naziv nadležnog tijela]</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Italian: Riso Basmati di cui al codice NC 1006 20 17 o 1006 20 98 importato a dazio zero ai sensi del regolamento delegato (UE) della Commissione 2023/2835 e del regolamento di esecuzione (UE) della Commissione 2023/2834, corredato di una copia del certificato di autenticità n. … rilasciato da [nome dell’autorità competente]</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Latvian: basmati rīsi ar KN kodu 1006 20 17 vai 1006 20 98, kas importēti ar nulles nodokļa likmi saskaņā ar Komisijas Deleģēto regulu (ES) 2023/2835 un Komisijas Īstenošanas regulu (ES) 2023/2834 un kam pievienots [kompetentās iestādes nosaukums] sagatavotas autentiskuma apliecības Nr. .... dublikāts</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Lithuanian: Basmati ryžiai, kurių KN kodas 1006 20 17 arba 1006 20 98 ir kurie importuoti taikant nulinę muito normą pagal Komisijos deleguotąjį reglamentą (ES) 2023/2835 ir Komisijos įgyvendinimo reglamentą (ES) 2023/2834, prie kurių pridėtas [kompetentingos institucijos pavadinimas] parengto autentiškumo sertifikato Nr. … dublikatas</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Hungarian: Az 1006 20 17 vagy az 1006 20 98 KN-kód alá sorolt, az (EU) 2023/2835 felhatalmazáson alapuló bizottsági rendelet és az (EU) 2023/2834 bizottsági végrehajtási rendelet alkalmazásában nulla vámtétel mellett behozott basmati rizs, a/az [illetékes hatóság neve] által kiállított, … számú eredetiségigazolás másolatával együtt</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Maltese: ross Basmati li jaqa’ taħt il-kodiċi NM 1006 20 17 jew 1006 20 98 u importat b’rata ta’ dazju żero skont ir-Regolament Delegat tal-Kummissjoni (UE) 2023/2835 u r-Regolament ta’ Implimentazzjoni (UE) 2023/2834, akkumpanjat minn duplikat taċ-ċertifikat ta’ awtentiċità Nru... imfassal minn [isem l-awtorità kompetenti]</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Dutch: Basmati-rijst van GN-code 1006 20 17 of 1006 20 98, ingevoerd met nulrecht overeenkomstig Gedelegeerde Verordening (EU) 2023/2835 van de Commissie en Uitvoeringsverordening (EU) 2023/2834 van de Commissie, vergezeld van een duplicaat van het echtheidscertificaat nr. …, opgesteld door [naam van de bevoegde instantie]</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Polish: ryż Basmati objęty kodem CN 1006 20 17 lub 1006 20 98 i przywożony z zastosowaniem zerowej stawki celnej zgodnie z rozporządzeniem delegowanym Komisji (UE) 2023/2835 i rozporządzeniem wykonawczym Komisji (UE) 2023/2834, któremu towarzyszy duplikat świadectwa autentyczności nr... sporządzony przez [name of the competent authority]</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Portuguese: arroz basmáti do código NC 1006 20 17 ou 1006 20 98 e importado com um direito nulo ao abrigo do Regulamento Delegado (UE) 2023/2835 da Comissão e do Regulamento de Execução (UE) 2023/2834 da Comissão, acompanhado de um duplicado do certificado de autenticidade n.°..., emitido por [nome da autoridade competente]</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Romanian: orez Basmati de la codul NC 1006 20 17 sau 1006 20 98 importat cu o rată a taxelor vamale egală cu zero în temeiul Regulamentului delegat (UE) 2023/2835 al Comisiei și al Regulamentului de punere în aplicare (UE) 2023/2834 al Comisiei, însoțit de un duplicat al certificatului de autenticitate nr. … întocmit de [denumirea autorității competente]</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Slovak: ryža Basmati s kódom KN 1006 20 17 alebo 1006 20 98 dovážaná s nulovou sadzbou cla v súlade s delegovaným nariadením Komisie (EÚ) 2023/2835 a vykonávacím nariadením Komisie (EÚ) 2023/2834, sprevádzaná duplikátom osvedčenia o pravosti č. … vystavenom [názov príslušného orgánu]</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Slovenian: Riž basmati iz oznake KN 1006 20 17 ali 1006 20 98, uvožen po stopnji nič v skladu z Delegirano uredbo Komisije (EU) 2023/2835 in Izvedbeno uredbo Komisije (EU) 2023/2834, s priloženim dvojnikom potrdila o pristnosti št. …, ki ga je izdal [naziv pristojnega organa]</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Finnish: komission delegoidun asetuksen (EU) 2023/2835 ja komission täytäntööpanoasetuksen (EU) 2023/2834 mukaisesti tullivapaasti tuotu CN-koodiin 1006 20 17 tai 1006 20 98 kuuluva Basmati-riisi, jonka mukana on [toimivaltaisen viranomaisen nimi] myöntämän aitoustodistuksen nro … kaksoiskappale</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Swedish: Basmatiris med KN-nummer 1006 20 17 eller 1006 20 98 som importeras tullfritt i enlighet med kommissionens delegerade förordning (EU) 2023/2835 och kommissionens genomförandeförordning (EU) 2023/2834, åtföljt av ett duplikat av äkthetsintyg nr … som utfärdats av [den behöriga myndighetens namn].</p></td></tr></tbody></table>
ANNEX IV
Model of document of unloading referred to in Article 16(3)
Product unloaded (CN code and, for common wheat, durum wheat and maize, quality declared in accordance with Article 18 of Commission Implementing Regulation (EU) 2023/2834): …
Quantity unloaded (in kilograms): …
ANNEX V
Percentage referred to in Article 16(4)
<table><col/><col/><tbody><tr><td><p>Year</p></td><td><p>Percentage</p></td></tr><tr><td><p>2023</p></td><td><p>12,5</p></td></tr><tr><td><p>2024 and each subsequent year</p></td><td><p>0 (duty-free)</p></td></tr></tbody></table>
ANNEX VI
Classification standards for imported products referred to in Article 18
(on the basis of a moisture content of 12 % by weight or equivalent)
<table><col/><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Product</p></td><td><p>Common wheat</p></td><td><p>Durum wheat</p></td><td><p>Flint maize</p></td></tr><tr><td><p>CN code</p></td><td><p>ex 1001 99 00</p></td><td><p>ex 1001 19 00</p></td><td><p>ex 1005 90 00</p></td></tr><tr><td><p>Quality<a> (<span>1</span>)</a></p></td><td><p>High</p></td><td><p>Medium</p></td><td><p>Low</p></td><td><p>High</p></td><td><p>Medium</p></td><td><p>Low</p></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>1.</p></td><td><p>Minimum protein percentage</p></td></tr></tbody></table></td><td><p>14,0</p></td><td><p>11,5</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>2.</p></td><td><p>Minimum specific weight kg/hl</p></td></tr></tbody></table></td><td><p>77,0</p></td><td><p>74,0</p></td><td><p>—</p></td><td><p>76,0</p></td><td><p>76,0</p></td><td><p>—</p></td><td><p>76,0</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.</p></td><td><p>Maximum impurity percentage (<span>Schwarzbesatz</span>)</p></td></tr></tbody></table></td><td><p>1,5</p></td><td><p>1,5</p></td><td><p>—</p></td><td><p>1,5</p></td><td><p>1,5</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>4.</p></td><td><p>Minimum vitreous grain percentage</p></td></tr></tbody></table></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>75,0</p></td><td><p>62,0</p></td><td><p>—</p></td><td><p>95,0</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>5.</p></td><td><p>Maximum flotation index</p></td></tr></tbody></table></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>25,0</p></td></tr></tbody></table>
Tolerances
<table><col/><col/><col/><tbody><tr><td><p>Permitted tolerance</p></td><td><p>Common/durum wheat</p></td><td><p>Flint maize</p></td></tr><tr><td><p>Protein percentage</p></td><td><p>–0,7</p></td><td><p>—</p></td></tr><tr><td><p>Minimum specific weight</p></td><td><p>–0,5</p></td><td><p>–0,5</p></td></tr><tr><td><p>Maximum impurity percentage</p></td><td><p>+0,5</p></td><td><p>—</p></td></tr><tr><td><p>Vitreous grain percentage</p></td><td><p>–2,0</p></td><td><p>–3,0</p></td></tr><tr><td><p>Flotation index</p></td><td><p>—</p></td><td><p>+1,0</p></td></tr><tr><td><p>‘—’: not applicable.</p></td></tr></tbody></table>
( 1 ) The methods of analysis provided for in Implementing Regulation (EU) 2016/1240 are applicable.
ANNEX VII
Quotation exchanges and reference varieties referred to in Article 19(2), point (a)
<table><col/><col/><col/><tbody><tr><td><p>Product</p></td><td><p>Common wheat</p></td><td><p>Maize</p></td></tr><tr><td><p>Standard quality</p></td><td><p>High</p></td><td><p> </p></td></tr><tr><td><p>Reference variety (type/grade) for exchange quotation</p></td><td><p>Hard Red Spring No 2</p></td><td><p>Yellow Corn No 2</p></td></tr><tr><td><p>Quotation exchange</p></td><td><p>Minneapolis Grain Exchange</p></td><td><p>Chicago Mercantile Exchange</p></td></tr></tbody></table>
ANNEX VIII
Blank certificate of conformity from Senasa authorised by the Government of Argentina
(referred to in Article 21(2), first subparagraph, point (a))
ANNEX IX
Blank certificate of conformity authorised by the Government of the United States of America for common wheat
(referred to in Article 21(2), first subparagraph, point (b))
Blank certificate of conformity authorised by the Government of the United States of America for durum wheat
(referred to in Article 21(2), first subparagraph, point (b))
ANNEX X
Blank certificate of conformity authorised by the Government of Canada for common and durum wheat and export grade specifications
(referred to in Article 21(2), first subparagraph, point (c))
Export grade specifications for Canadian common and durum wheat
COMMON WHEAT
<table><col/><col/><col/><tbody><tr><td><p>Canada Western Red Spring</p><p>(CWRS)</p></td><td><p>Test weight</p></td><td><p>Total foreign material including other cereal grains</p></td></tr><tr><td><p>No 1 CWRS</p></td><td><p>(Min.) 79,0 kg/hL</p></td><td><p>(Max.) 0,4 % including 0,2 % other seeds</p></td></tr><tr><td><p>No 2 CWRS</p></td><td><p>(Min.) 77,5 kg/hL</p></td><td><p>(Max.) 0,75 % including. 0,2 % other seeds</p></td></tr><tr><td><p>No 3 CWRS</p></td><td><p>(Min.) 76,5 kg/hL</p></td><td><p>(Max.) 1,25 % including 0,2 % other seeds</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>Canada Western Extra Strong Red Spring</p><p>(CWES)</p></td><td><p>Test weight</p></td><td><p>Total foreign material including other cereal grains</p></td></tr><tr><td><p>No 1 CWES</p></td><td><p>(Min.) 78,0 kg/hL</p></td><td><p>(Max.) 0,75 % including 0,2 % other seeds</p></td></tr><tr><td><p>No 2 CWES</p></td><td><p>(Min.) 76,0 kg/hL</p></td><td><p>(Max.) 1,5 % including 0,2 % other seeds</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>Canada Prairie Spring Red</p><p>(CPSR)</p></td><td><p>Test weight</p></td><td><p>Total foreign material including other cereal grains</p></td></tr><tr><td><p>No 1 CPSR</p></td><td><p>(Min.) 77,0 kg/hL</p></td><td><p>(Max.) 0,75 % including 0,2 % other seeds</p></td></tr><tr><td><p>No 2 CPSR</p></td><td><p>(Min.) 75,0 kg/hL</p></td><td><p>(Max.) 1,5 % including 0,2 % other seeds</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>Canada Prairie Spring White</p><p>(CPSW)</p></td><td><p>Test weight</p></td><td><p>Total foreign material including other cereal grains</p></td></tr><tr><td><p>No 1 (CPSW)</p></td><td><p>(Min.) 77,0 kg/hL</p></td><td><p>(Max.) 0,75 % including 0,2 % other seeds</p></td></tr><tr><td><p>No 2 (CPSW)</p></td><td><p>(Min.) 75,0 kg/hL</p></td><td><p>(Max.) 1,5 % including 0,2 % other seeds</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>Canada Western Red Winter</p><p>(CWRW)</p></td><td><p>Test weight</p></td><td><p>Total foreign material including other cereal grains</p></td></tr><tr><td><p>No 1 CWRW</p></td><td><p>(Min.) 78,0 kg/hL</p></td><td><p>(Max.) 1,0 % including 0,2 % other seeds</p></td></tr><tr><td><p>No 2 CWRW</p></td><td><p>(Min.) 74,0 kg/hL</p></td><td><p>(Max.) 2,0 % including</p><p>0,2 % other seeds</p></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td><p>Canada Western Soft White Spring</p><p>(CWSWS)</p></td><td><p>Test weight</p></td><td><p>Total foreign material including other cereal grains</p></td></tr><tr><td><p>No 1 CWSWS</p></td><td><p>(Min.) 78,0 kg/hL</p></td><td><p>(Max.) 0,75 % including 0,2 %</p><p>other seeds</p></td></tr><tr><td><p>No 2 CWSWS</p></td><td><p>(Min.) 75,5 kg/hL</p></td><td><p>(Max.) 1,0 % including</p><p>0,2 % other seeds</p></td></tr><tr><td><p>No 3 CWSWS</p></td><td><p>(Min.) 75,0 kg/hL</p></td><td><p>(Max.) 1,5 % including</p><p>0,2 % other seeds</p></td></tr></tbody></table>
DURUM WHEAT
<table><col/><col/><col/><tbody><tr><td><p>Canada Western Amber Durum</p><p>(CWAD)</p></td><td><p>Test weight</p></td><td><p>Total foreign material including other cereal grains</p></td></tr><tr><td><p>No 1 CWAD</p></td><td><p>(Min.) 80,0 kg/hL</p></td><td><p>(Max.) 0,5 % including 0,2 % other seeds</p></td></tr><tr><td><p>No 2 CWAD</p></td><td><p>(Min.) 79,5 kg/hL</p></td><td><p>(Max.) 0,8 % including 0,2 % other seeds</p></td></tr><tr><td><p>No 3 CWAD</p></td><td><p>(Min.) 78,0 kg/hL</p></td><td><p>(Max.) 1,0 % including 0,2 % other seeds</p></td></tr><tr><td><p>No 4 CWAD</p></td><td><p>(Min.) 75,0 kg/hL</p></td><td><p>(Max.) 3,0 % including 0,2 % other seeds</p></td></tr></tbody></table>
Notes:
<table><col/><col/><tbody><tr><td><p>‘Other Cereal Grains’:</p></td><td><p>In these grades, include only oats, barley, rye and triticale.</p></td></tr><tr><td><p>‘Common wheat’:</p></td><td><p>For common wheat exports, the Canadian Grain Commission will supply documentation with the certificate specifying the protein percentage for the cargo in question.</p></td></tr><tr><td><p>‘Durum wheat’:</p></td><td><p>For durum wheat exports, the Canadian Grain Commission will supply documentation with the certificate attesting to the vitreous kernel percentage and specific weight (kilograms/hectolitre) of the cargo in question.</p></td></tr></tbody></table>
ANNEX XI
Standard method for determining the flotation index for flint maize
(referred to in Article 21(3))
Prepare an aqueous solution of sodium nitrate of specific weight 1,25 and conserve it at 35 °C.
Place in the solution 100 grains of maize from a representative sample of maximum moisture content 14,5 %.
Shake the solution at 30 second intervals for 5 minutes to eliminate air bubbles.
Separate the floating from the submerged grains and count them.
Flotation index for trial = (number of floating grains/number of submerged grains) × 100
Repeat five times.
The flotation index is the arithmetic means for the five trials excluding the two extreme values.
ANNEX XII
Certificate issued by the Federal Grain Inspection Service (FGIS) and certificate issued by the United States wet milling industry referred to in Article 22(1)
ANNEX XIII
Entries referred to in Article 23
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Bulgarian: Специална експортна такса съгласно Регламент (ЕО) № 2008/97 платена в размер на …;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Spanish: Tasa especial aplicable a la exportación según el Reglamento (CE) no 2008/97 satisfecha con la suma de …</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Czech: Zvláštní vývozní dávka podle nařízení (ES) č. 2008/97 zaplacena ve výši …</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Danish: Særlig udførselsafgift i henhold til forordning (EF) nr. 2008/97, betalt med et beløb på …</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In German: Besondere Ausfuhrabgabe gemäß Verordnung (EG) Nr. 2008/97 in Höhe von … entrichtet</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Estonian: Ekspordi erimaks makstud summas … vastavalt määrusele (EÜ) nr 2008/97</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Greek: Ειδικός φόρος κατά την εξαγωγή σύμφωνα με τον κανονισμό (ΕΚ) αριθ. 2008/97 που πληρώθηκε για ποσό …</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In English: Special export tax under Regulation (EC) No 2008/97 paid to an amount of …</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In French: Taxe spéciale à l’exportation selon le règlement (CE) no 2008/97 acquittée pour un montant de …</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Irish: Dleacht onnmhairiúcháin speisialta faoi Rialachán (CE) Uimh. 2008/97 a íoctar suas le ...</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Croatian: Posebna izvozna pristojba u skladu s Uredbom (EZ) br. 2008/97 plaćena u iznosu od …</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Italian: Tassa speciale per l’esportazione pagata, secondo il regolamento (CE) n. 2008/97, per un importo di …</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Latvian: Saskaņā ar Regulu (EK) Nr. 2008/97, samaksāta speciālā izvešanas nodeva … apmērā</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Lithuanian: Vadovaujantis Reglamentu (EB) Nr. 2008/97, sumokėtas … dydžio specialusis eksporto mokestis</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Hungarian: A 2008/97/EK rendelet szerinti különleges exportadó … összegben megfizetve</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Maltese: Taxxa speċjali fuq l-esportazzjoni, skond ir-Regolament (KE) Nru 2008/97, imħallsa għall-ammont ta’ …</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Dutch: Speciale heffing bij uitvoer bedoeld in Verordening (EG) nr. 2008/97 ten bedrage van … voldaan</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Polish: Specjalny podatek eksportowy według rozporządzenia (WE) nr 2008/97 zapłacony w wysokości …</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Portuguese: Imposição especial de exportação, nos termos do Regulamento (CE) n.o 2008/97, paga num montante de …</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Romanian: Taxă specială de export, conform Regulamentului (CE) nr. 2008/97, achitată pentru o valoare de …</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Slovak: Osobitný vývozný poplatok podľa nariadenia (ES) č. 2008/97 vo výške …</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Slovenian: Posebna izvozna dajatev v skladu z Uredbo (ES) št. 2008/97, plačilo za znesek …</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Finnish: Asetuksen (EY) N:o 2008/97 mukainen erityisvientivero määrältään …</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In Swedish: Särskild exportskatt i enlighet med förordning (EG) nr 2008/97, betalt med ett belopp på …</p></td></tr></tbody></table>
ANNEX XIV
Attestation of equivalence referred to in Article 38(1)
<table><col/><col/><col/><tbody><tr><td><table><col/><col/><tbody><tr><td><p>1.</p></td><td><p>Consignor (full name and address)</p></td></tr></tbody></table></td><td><table><col/><col/><tbody><tr><td><p>2.</p></td><td><p>No</p></td></tr></tbody></table></td><td><p><span>ORIGINAL</span></p></td></tr><tr><td><p> </p></td><td><p><span>ATTESTATION OF EQUIVALENCE FOR THE IMPORTATION OF HOPS AND HOP PRODUCTS INTO THE EUROPEAN UNION</span></p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.</p></td><td><p>Consignee (full name and address)</p></td></tr></tbody></table></td></tr><tr><td><p> </p></td><td><p>Виж превода на гърба – Véase traducción al dorso – Viz překlad na druhé straně – Oversættelse se bagsiden – Übersetzung siehe Rückseite – Vaata tõlget pöördel – Δείτε μετάφραση στην πίσω σελίδα – See translation overleaf – Voir traduction au verso – Féach an t-aistriúchán ar an taobh thall – Vidjeti prijevod na poleđini – Vedi traduzione a tergo – skatīt tulkojumu nākamajā lappusē – Žr. vertimą kitame puslapyje – a fordítást lásd a túlsó oldalon – Ara t-traduzzjoni mniżżla fuq wara – Zie vertaling aan ommezijde – Zob. tłumaczenie na odwrocie – Ver tradução no verso – A se vedea traducerea pe verso – Pozri preklad na druhej strane – Glej prevod na hrbtni strani – Katso kääntöpuolella oleva käännös – För översättning se baksidan</p></td></tr><tr><td><p><span>IMPORTANT NOTES</span></p></td><td><table><col/><col/><tbody><tr><td><p>4.</p></td><td><p>Country of Origin</p></td></tr></tbody></table></td><td><p> </p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>A.</p></td><td><p>This attestation must be submitted to the customs authorities in the Union when the products are released for free circulation in the Union or when the consignment is split up before it is released for free circulation.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>B.</p></td><td><p>When the consignment is split up, the customs authorities, after endorsing the attestation, shall retain the original and forward a copy to the authorities responsible for hops in the Member State concerned.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>C.</p></td><td><p>When the products are released for free circulation, after endorsing the attestations, the customs authorities should retain the original, return one copy to the declarant and forward one copy to the authorities responsible for hops in the Member State concerned.</p></td></tr></tbody></table></td><td><table><col/><col/><tbody><tr><td><p>5.</p></td><td><p>Place of production of hops</p></td></tr></tbody></table></td><td><table><col/><col/><tbody><tr><td><p>6.</p></td><td><p>Harvesting year</p></td></tr></tbody></table></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>7.</p></td><td><p>Place of processing</p></td></tr></tbody></table></td><td><table><col/><col/><tbody><tr><td><p>8.</p></td><td><p>Date of processing</p></td></tr></tbody></table></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>9.</p></td><td><p>Marks, numbers, number and kind of packages – description of products – variety</p></td></tr></tbody></table></td><td><table><col/><col/><tbody><tr><td><p>10.</p></td><td><p>Gross weight (kg)</p></td></tr></tbody></table></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>11.</p></td><td><span>ATTESTATION BY ISSUING AUTHORITY</span><p>I the undersigned certify that the products described above comply with the rules on hops and hop products applicable in the European Union.</p></td></tr></tbody></table></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>12.</p></td><td><p>Issuing authority (full name and address)</p></td></tr></tbody></table></td><td><p>At …,</p></td><td><p>on …</p></td></tr><tr><td><p> </p></td><td><p>…</p><p>(Signature)</p></td><td><p>(Stamp)</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>13.</p></td><td><span>RESERVED FOR THE CUSTOMS AUTHORITIES IN THE UNION</span><p>The products described above have been released for free circulation<a> (<span>1</span>)</a></p><p>This attestation has been replaced by the extracts noted in Section 18<a> (<span>1</span>)</a></p></td></tr></tbody></table></td></tr><tr><td><p>At …, on …</p></td><td><p>…</p><p>(Signature)</p></td><td><p>(Stamp)</p></td></tr></tbody></table>
back side
<table><col/><col/><col/><col/><tbody><tr><td><table><col/><col/><tbody><tr><td><p>14.</p></td><td><span>ATTRIBUTIONS</span><p>Indicate the quantity available in part 1 of column 16 and the quantity attributed in Part 2 thereof.</p></td></tr></tbody></table></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>15.</p></td><td><p>Gross weight (kg)</p></td></tr></tbody></table></td><td><table><col/><col/><tbody><tr><td><p>18.</p></td><td><p>Extract No</p></td></tr></tbody></table></td><td><table><col/><col/><tbody><tr><td><p>19.</p></td><td><p>Name, Member State, stamp and signature of the attributing authority</p></td></tr></tbody></table></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>16.</p></td><td><p>In figures</p></td></tr></tbody></table></td><td><table><col/><col/><tbody><tr><td><p>17.</p></td><td><p>In words for the quantity attributed</p></td></tr></tbody></table></td></tr><tr><td><p>1</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>2</p></td></tr><tr><td><p>1</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>2</p></td></tr><tr><td><p>1</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>2</p></td></tr><tr><td><p>1</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>2</p></td></tr><tr><td><p>1</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>2</p></td></tr><tr><td><p>1</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>2</p></td></tr><tr><td><p>1</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>2</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>20.</p></td><td><p>Extension to be attached hereto.</p></td></tr></tbody></table></td></tr></tbody></table>
( 1 ) Delete as appropriate.
ANNEX XV
Extract of attestation of equivalence referred to in Article 41(1)
<table><col/><col/><col/><tbody><tr><td><table><col/><col/><tbody><tr><td><p>1.</p></td><td><p>Consignor (name and full address)</p></td></tr></tbody></table></td><td><table><col/><col/><tbody><tr><td><p>2.</p></td><td><p>No</p></td></tr></tbody></table></td><td><p><span>ORIGINAL</span></p></td></tr><tr><td><p> </p></td><td><p><span>EXTRACT FROM AN ATTESTATION OF EQUIVALENCE FOR THE IMPORTATION OF HOPS AND HOP PRODUCTS INTO THE EUROPEAN UNION</span></p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>3.</p></td><td><p>Consignee (name and full address)</p></td></tr></tbody></table></td></tr><tr><td><p> </p></td><td><p>Виж превода на гърба – Véase traducción al dorso – Viz překlad na druhé straně – Oversættelse se bagsiden – Übersetzung siehe Rückseite – Vaata tõlget pöördel – Δείτε μετάφραση στην πίσω σελίδα – See translation overleaf – Voir traduction au verso – Féach an t-aistriúchán ar an taobh thall – Vidjeti prijevod na poleđini – Vedi traduzione a tergo – skatīt tulkojumu nākamajā lappusē – Žr. vertimą kitame puslapyje – a fordítást lásd a túlsó oldalon – Ara t-traduzzjoni mniżżla fuq wara – Zie vertaling aan ommezijde – Zob. tłumaczenie na odwrocie – Ver tradução no verso – A se vedea traducerea pe verso – Pozri preklad na druhej strane – Glej prevod na hrbtni strani – Katso kääntöpuolella oleva käännös – För översättning se baksidan</p></td></tr><tr><td><p><span>IMPORTANT NOTES</span></p></td><td><table><col/><col/><tbody><tr><td><p>4.</p></td><td><p>Country of origin</p></td></tr></tbody></table></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>A.</p></td><td><p>This extract must be submitted to the customs authorities in the Union when the products are released for free circulation.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>B.</p></td><td><p>After endorsing the documents, the customs authorities in the Union shall retain the original, return one copy to the declarant and forward the other copy to the authorities responsible for hops in the Member State concerned.</p></td></tr></tbody></table></td><td><table><col/><col/><tbody><tr><td><p>5.</p></td><td><p>Place of production of hops</p></td></tr></tbody></table></td><td><table><col/><col/><tbody><tr><td><p>6.</p></td><td><p>Harvesting year</p></td></tr></tbody></table></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>7.</p></td><td><p>Place of processing</p></td></tr></tbody></table></td><td><table><col/><col/><tbody><tr><td><p>8.</p></td><td><p>Date of processing</p></td></tr></tbody></table></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>9.</p></td><td><p>Marks, numbers, number and kind of packages – description of products – variety</p></td></tr></tbody></table></td><td><table><col/><col/><tbody><tr><td><p>10.</p></td><td><p>Gross weight (kg)</p></td></tr></tbody></table></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>11.</p></td><td><span>DECLARATION BY THE CONSIGNOR</span><p>I the undersigned declare that the products above were covered by the attestation of equivalence issued on… (date), reference No … by the following issuing authority… (name and full address)</p></td></tr></tbody></table></td></tr><tr><td><p>At …, on …</p></td><td><p> </p></td><td><p>…</p><p>(Signature)</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>12.</p></td><td><span>ENDORSEMENT BY THE CUSTOMS AUTHORITIES</span><p>Declaration certified as correct. The information on this extract corresponds to that given relevant attestation of equivalence.</p></td></tr></tbody></table></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>13.</p></td><td><p>Customs office (full name and address)</p></td></tr></tbody></table></td><td><p>At …,</p></td><td><p>on …</p></td></tr><tr><td><p> </p></td><td><p>…</p><p>(Signature)</p></td><td><p>(Stamp)</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>14.</p></td><td><span>RESERVED FOR THE CUSTOMS AUTHORITIES IN THE MEMBER STATE WHERE THE PRODUCTS ARE RELEASED FOR FREE CIRCULATION</span><p>The products described above have been released for free circulation</p></td></tr></tbody></table></td></tr><tr><td><p>At …, on …</p></td><td><p>…</p><p>(Signature)</p></td><td><p>(Stamp)</p></td></tr></tbody></table>
ANNEX XVI
Rules governing the forms referred to in Articles 38 and 41
I. PAPER
The paper to be used is a white paper weighing at least 40 g/m 2 .
II. SIZE
The size is: 210 × 297 mm.
III. LANGUAGES
<table><col/><col/><col/><tbody><tr><td/><td><p>A.</p></td><td><span>The attestation of equivalence must be printed in one of the official languages of the Union; it can also be printed in the official language or one of the official languages of the issuing country.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>B.</p></td><td><span>The extract of the attestation of equivalence must be printed in one of the official languages of the Union designated by the competent authorities of the issuing Member State.</span></td></tr></tbody></table>
IV. COMPLETION OF THE FORMS
<table><col/><col/><col/><tbody><tr><td/><td><p>A.</p></td><td><span>The forms shall be completed in typescript or by computerised means or by hand; in the latter case, they shall be completed legibly in ink and in printed characters.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>B.</p></td><td><span>Each form is individualised by a number given by the issuing authority.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>C.</p></td><td><span>In the case of the attestation of equivalence and its extracts:</span><table><col/><col/><tbody><tr><td><p>1.</p></td><td><p>Section 5 shall not be completed for hop products made from blends of hops;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>2.</p></td><td><p>Sections 7 and 8 shall be completed for all products made from hops;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>3.</p></td><td><p>the description of the products (Section 9) shall be one of the following:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>‘unprepared hops’: i.e. hops which have only undergone preliminary drying and packaging;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>‘prepared hops’: i.e. hops which have undergone final drying and packaging;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>‘hop powder’ (which shall include hop pellets and enriched hop powder);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>‘isomerised hop extract’: i.e. an extract in which the alpha acids have been almost totally isomerised;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>‘extract of hops’: i.e. other extracts than isomerised extract of hops;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>‘mixed hop products’: i.e. a mixture of the products referred to in points (c), (d) and (e), excluding hops;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>4.</p></td><td><p>the description ‘unprepared hops’ or ‘prepared hops’ shall be followed by the word ‘seedless’ if the seed content is less than 2 % of the weight of the hops, and by the word ‘seeded’ in other cases;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>5.</p></td><td><p>in cases where products made from hops are obtained from hops of different varieties and/or different places of production, these different varieties and/or places of production shall be stated in Section 9, followed by the percentage by weight of each variety from each production area making up the blend.</p></td></tr></tbody></table></td></tr></tbody></table>
V. SPACE
If the space for making attributions in case of a paper-based attestation of equivalence is not sufficient, the customs authorities may attach extension pages, validated through allongement stamping.
ELI: http://data.europa.eu/eli/reg_impl/2023/2834/oj
ISSN 1977-0677 (electronic edition) | ENG | 32023R2834 |
<table><col/><col/><col/><col/><tbody><tr><td><p>29.9.2023   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 242/350</p></td></tr></tbody></table>
DECISION (EU) 2023/1900 OF THE EUROPEAN PARLIAMENT
of 10 May 2023
on the closure of the accounts of the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) for the financial year 2021
THE EUROPEAN PARLIAMENT,
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to the final annual accounts of the European Monitoring Centre for Drugs and Drug Addiction for the financial year 2021,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to the Court of Auditors’ annual report on EU agencies for the financial year 2021, together with the agencies’ replies <a>(<span>1</span>)</a>,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to the statement of assurance <a>(<span>2</span>)</a> as to the reliability of the accounts and the legality and regularity of the underlying transactions provided by the Court of Auditors for the financial year 2021, pursuant to Article 287 of the Treaty on the Functioning of the European Union,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to the Council’s recommendation of 28 February 2023 on discharge to be given to the Centre in respect of the implementation of the budget for the financial year 2021 (06248/2023[19] – C9-0092/2023),</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to Article 319 of the Treaty on the Functioning of the European Union,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 <a>(<span>3</span>)</a>, and in particular Article 70 thereof,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to Regulation (EC) No 1920/2006 of the European Parliament and of the Council of 12 December 2006 on the European Monitoring Centre for Drugs and Drug Addiction <a>(<span>4</span>)</a>, and in particular Article 15 thereof,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to Commission Delegated Regulation (EU) 2019/715 of 18 December 2018 on the framework financial regulation for the bodies set up under the TFEU and Euratom Treaty and referred to in Article 70 of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council <a>(<span>5</span>)</a>, and in particular Article 105 thereof,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to Rule 100 of and Annex V to its Rules of Procedure,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to the opinion of the Committee on Civil Liberties, Justice and Home Affairs,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>having regard to the report of the Committee on Budgetary Control (A9-0107/2023),</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>1.</p></td><td><span>Approves the closure of the accounts of the European Monitoring Centre for Drugs and Drug Addiction for the financial year 2021;</span></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>2.</p></td><td><span>Instructs its President to forward this decision to the Director of the European Monitoring Centre for Drugs and Drug Addiction, the Council, the Commission and the Court of Auditors, and to arrange for its publication in the<span>Official Journal of the European Union</span> (L series).</span></td></tr></tbody></table>
The President
Roberta METSOLA
The Secretary-General
Alessandro CHIOCCHETTI
<note>
( 1 ) OJ C 412, 27.10.2022, p. 12 .
( 2 ) OJ C 399, 17.10.2022, p. 240 .
( 3 ) OJ L 193, 30.7.2018, p. 1 .
( 4 ) OJ L 376, 27.12.2006, p. 1 .
( 5 ) OJ L 122, 10.5.2019, p. 1 .
</note> | ENG | 32023B1900 |
<table><col/><col/><col/><col/><tbody><tr><td><p>24.4.2020   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 130/1</p></td></tr></tbody></table>
REGULATION (EU) 2020/558 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 23 April 2020
amending Regulations (EU) No 1301/2013 and (EU) No 1303/2013 as regards specific measures to provide exceptional flexibility for the use of the European Structural and Investments Funds in response to the COVID-19 outbreak
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 177, 178 and point (a) of Article 322(1) thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the Court of Auditors ( 1 ) ,
After consulting the European Economic and Social Committee,
After consulting the Committee of the Regions,
Acting in accordance with the ordinary legislative procedure ( 2 ) ,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Member States have been affected by the consequences of the COVID-19 outbreak in an unprecedented manner. The current public health crisis hampers growth in Member States, which in turn aggravates the serious liquidity shortages due to the sudden and significant increase in public investments needed in their healthcare systems and other sectors of their economies. That has created an exceptional situation which needs to be addressed with specific measures.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>In order to respond to the impact of the public health crisis, Regulations (EU) No 1301/2013 <a>(<span>3</span>)</a> and (EU) No 1303/2013 <a>(<span>4</span>)</a> of the European Parliament and of the Council have already been amended, by Regulation (EU) 2020/460 of the European Parliament and of the Council <a>(<span>5</span>)</a>, to allow for more flexibility in the implementation of the programmes supported by the European Regional Development Fund (the ‘ERDF’), the European Social Fund (the ‘ESF’) and the Cohesion Fund (collectively ‘the Funds’) and the European Maritime and Fisheries Fund (the ‘EMFF’). In order to contribute to an effective response to the current public health crisis, the scope of support from the ERDF was considerably expanded.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>However, the serious negative effects on Union economies and societies are becoming worse. It is therefore necessary to provide for exceptional additional flexibility to Member States to enable them to respond to this unprecedented public health crisis by enhancing the possibility to mobilise all non-utilised support from the Funds.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>With a view to alleviating the burden on public budgets responding to the public health crisis, Member States should be given the exceptional possibility to request, for cohesion policy programmes, a co-financing rate of 100 % to be applied for the accounting year 2020-2021, in accordance with budget appropriations and subject to available funding. Based on an assessment of the application of that exceptional co-financing rate, the Commission could propose an extension of this measure.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>In order to provide additional flexibility to Member States for the reallocation of resources with a view to providing tailor-made responses to the public health crisis, possibilities for financial transfers under the Investment for growth and jobs goal between the ERDF, the ESF and the Cohesion Fund should be introduced or enhanced. Furthermore, transfer possibilities between categories of regions should also be exceptionally increased for Member States given the widespread impact of the public health crisis, while respecting Treaty objectives for cohesion policy. Such transfers should not affect the resources under the European territorial cooperation goal, the additional allocations to outermost regions, support to the Youth Employment Initiative (YEI) or the Fund for European Aid to the Most Deprived.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>In order to enable Member States to deploy quickly available resources to respond to the COVID-19 outbreak and taking into account that, given the advanced stage of implementation of the 2014-2020 programming period, the reallocation of resources can only concern resources available for programming for the year 2020, it is justified to exempt, on an exceptional basis, Member States from the need to comply with thematic concentration requirements for the remainder of the programming period.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>In order to enable Member States to concentrate on the necessary response to the COVID‐19 outbreak and to reduce administrative burdens, certain procedural requirements linked to programme implementation and audits should be simplified. In particular, Partnership Agreements should no longer be amended for the remainder of the programming period, whether to reflect prior changes in operational programmes or to introduce any other changes. The deadlines for the submission of the annual implementation reports for the year 2019 and for the transmission of the Commission’s summary report based on those annual implementation reports should be postponed. As regards the Funds and the EMFF, an extended possibility for audit authorities to make use of a non-statistical sampling method should also be explicitly provided for in respect of the accounting year 2019-2020.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>It is appropriate to specify that eligibility of expenditure should be exceptionally allowed for completed or fully implemented operations that foster crisis response capacities in the context of the COVID-19 outbreak. It should be possible for such operations to be selected even before the necessary programme amendment is approved by the Commission. Specific arrangements for invoking the COVID-19 outbreak as a reason of<span>force majeure</span> in the context of decommitment should be provided.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>In order to reduce administrative burdens and delays in implementation where changes in financial instruments are necessary to provide for an effective response to a public health crisis, the review and update of the<span>ex ante</span> assessment and updated business plans or equivalent documents, as part of the supporting documents demonstrating that support provided was used for its intended purpose, should no longer be required for the remainder of the programming period. The possibilities for the support for working capital through financial instruments under the European Agricultural Fund for Rural Development (EAFRD) should be extended.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>In order to ensure that Member States can make full use of support from the Funds and the EMFF, additional flexibility should be provided for the calculation of the payment of the final balance at the end of the programming period.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>In order to facilitate the transfers authorised under this Regulation, the condition laid down in point (f) of Article 30(1) of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council <a>(<span>6</span>)</a> regarding use of appropriations for the same objective should not apply in respect of transfers proposed under this Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(12)</p></td><td><p>In order to ensure consistency between the approach taken under the Temporary Framework for State aid measures to support the economy in the current COVID-19 outbreak and<span>de minimis</span> aid, on the one hand, and the conditions for providing support to undertakings in difficulty under the ERDF, on the other, Regulation (EU) No 1301/2013 should be amended to allow for the grant of support to such undertakings in those specific circumstances.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(13)</p></td><td><p>Since the objectives of this Regulation, namely to respond to the impact of the public health crisis by introducing flexibility measures in the field of providing support from the European Structural and Investment Funds (‘ESI Funds’), cannot be sufficiently achieved by the Member States but can rather, by reason of the scale and effects of the proposed action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union (‘TEU’). In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary to achieve those objectives.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(14)</p></td><td><p>Given the urgency of the situation related to the COVID-19 outbreak, this Regulation should enter into force on the day of its publication in the<span>Official Journal of the European Union</span>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(15)</p></td><td><p>In view of the COVID-19 outbreak and the urgent need to address the associated public health crisis and its social and economic consequences, it was considered to be appropriate to provide for an exception to the eight-week period referred to in Article 4 of Protocol No 1 on the role of national Parliaments in the European Union, annexed to the TEU, to the Treaty on the Functioning of the European Union and to the Treaty establishing the European Atomic Energy Community.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(16)</p></td><td><p>Regulations (EU) No 1301/2013 and (EU) No 1303/2013 should therefore be amended accordingly,</p></td></tr></tbody></table>
HAVE ADOPTED THIS REGULATION:
Article 1
Amendment to Regulation (EU) No 1301/2013
In Article 3(3) of Regulation (EU) No 1301/2013, point (d) is replaced by the following:
<table><col/><col/><tbody><tr><td><p>‘(d)</p></td><td><p>undertakings in difficulty as defined in Union State aid rules; undertakings receiving support complying with Temporary Framework for State aid measures<a> (<span>*1</span>)</a> or Commission Regulations (EU) No 1407/2013<a> (<span>*2</span>)</a>, (EU) No 1408/2013<a> (<span>*3</span>)</a> and (EU) No 717/2014<a> (<span>*4</span>)</a> shall not be regarded as undertakings in difficulty for the purpose of this point;</p></td></tr></tbody></table>
Article 2
Amendments to Regulation (EU) No 1303/2013
Regulation (EU) No 1303/2013 is amended as follows:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>in Part Two, Title II, the following Chapter is added:</p><p>‘<span>CHAPTER V</span></p><p><span><span>Exceptional measures for the use of the ESI Funds in response to the COVID-19 outbreak</span></span></p><div><p>Article 25a</p><p>Exceptional measures for the use of the ESI Funds in response to the COVID-19 outbreak</p><div><p>1.   By way of derogation from Article 60(1) and the first and fourth subparagraphs of Article 120(3), at the request of a Member State, a co-financing rate of 100 % may be applied to expenditure declared in payment applications during the accounting year starting 1 July 2020 and ending 30 June 2021 for one or more priority axes in a programme supported by the ERDF, the ESF or the Cohesion Fund.</p><p>Requests for modification of the co-financing rate shall be submitted in accordance with the procedure for the amendment of programmes set out in Article 30 and shall be accompanied by a revised programme or programmes. The co-financing rate of 100 % shall apply only if the relevant amendment of the operational programme is approved by the Commission before the submission of the final application for an interim payment in accordance with Article 135(2).</p><p>Before submitting the first payment application for the accounting year starting 1 July 2021, Member States shall notify the table referred to in point (d)(ii) of Article 96(2) confirming the co-financing rate which was applicable during the accounting year ending 30 June 2020 for the priorities concerned by the temporary increase to 100 %.</p></div><div><p>2.   In response to the COVID-19 outbreak, the resources available for programming for the year 2020 for the Investment for growth and jobs goal may, at the request of a Member State, be transferred between the ERDF, the ESF and the Cohesion Fund, irrespective of the percentages referred to in points (a) to (d) of Article 92(1).</p><p>For the purpose of those transfers, the requirements laid down in Article 92(4) shall not apply.</p><p>Transfers shall not affect resources allocated to the YEI in accordance with Article 92(5) or to the aid for the most deprived under the Investment for growth and jobs goal in accordance with Article 92(7).</p><p>Resources transferred between the ERDF, the ESF and the Cohesion Fund under this paragraph shall be implemented in accordance with the rules of the Fund to which the resources are transferred.</p></div><div><p>3.   By way of derogation from Article 93(1) and in addition to the possibility provided for in Article 93(2), resources available for programming for the year 2020 may, at the request of a Member State, be transferred between categories of regions in response to the COVID-19 outbreak.</p></div><div><p>4.   Requests for transfers under paragraphs 2 and 3 of this Article shall be submitted in accordance with the procedure for amendment of programmes set out in Article 30, shall be duly justified and shall be accompanied by the revised programme or programmes identifying the amounts transferred by Fund and by category of region, where relevant.</p></div><div><p>5.   By way of derogation from Article 18 of this Regulation and the Fund-specific Regulations, financial allocations set out in requests for programme amendments submitted or transfers notified pursuant to Article 30(5) of this Regulation, on or after 24 April 2020, shall not be subject to the requirements on thematic concentration set out in this Regulation or the Fund-specific Regulations.</p></div><div><p>6.   By way of derogation from Article 16, as from 24 April 2020, Partnership Agreements shall not be amended and programme amendments shall not entail the amendment of Partnership Agreements.</p><p>By way of derogation from Articles 26(1), 27(1), 30(1) and 30(2), as from 24 April 2020 the consistency of programmes and of their implementation with the Partnership Agreement shall not be verified.</p></div><div><p>7.   For operations that foster crisis response capacities in the context of the COVID-19 outbreak as referred to in the second subparagraph of Article 65(10), Article 65(6) shall not apply.</p><p>By way of derogation from point (b) of Article 125(3), such operations may be selected for support by the ERDF or the ESF prior to the approval of the amended programme.</p></div><div><p>8.   For the purposes of point (b) of Article 87(1), where the COVID-19 outbreak is invoked as a reason of<span>force majeure</span>, information on the amounts for which it has not been possible to make a payment application shall be provided at an aggregate level by priority for operations whose total eligible cost is less than EUR 1 000 000.</p></div><div><p>9.   The annual report on implementation of the programme referred to in Article 50(1) for the year 2019 shall be submitted by 30 September 2020 for all ESI Funds, by way of derogation from the deadlines set out in the Fund-specific Regulations. The transmission of the summary report to be prepared by the Commission in 2020, in accordance with Article 53(1), may be postponed accordingly.</p></div><div><p>10.   By way of derogation from point (g) of Article 37(2), no review or update of the<span>ex ante</span> assessments shall be required where changes in financial instruments are necessary to provide an effective response to the COVID-19 outbreak.</p></div><div><p>11.   Where financial instruments provide support in the form of working capital to SMEs pursuant to the second subparagraph of Article 37(4) of this Regulation, new or updated business plans, or equivalent documents, and evidence allowing verification that the support provided through the financial instruments has been used for its intended purpose as part of the supporting documents, shall not be required.</p><p>By way of derogation from Regulation (EU) No 1305/2013, such support may also be provided by the EAFRD under measures referred to in Regulation (EU) No 1305/2013 and relevant to the implementation of financial instruments. Such eligible expenditure shall not exceed EUR 200 000.</p></div><div><p>12.   For the purposes of the second subparagraph of Article 127(1), the COVID-19 outbreak shall constitute a duly justified case that audit authorities may invoke, based on their professional judgement, to use a non-statistical sampling method for the accounting year starting 1 July 2019 and ending 30 June 2020.</p></div><div><p>13.   For the purposes of application of point (f) of Article 30(1) of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council<a> (<span>*5</span>)</a>, the condition that appropriations are for the same objective shall not apply in respect of transfers under paragraphs 2 and 3 of this Article.</p></div></div><p><a>(<span>*5</span>)</a>  Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (<a>OJ L 193, 30.7.2018, p. 1</a>).’;"</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>in Article 130, the following paragraph is added:</p><div><p>‘3.   By way of derogation from paragraph 2, the contribution from the Funds or the EMFF through payments of the final balance for each priority per Fund and per category of regions in the final accounting year shall not exceed, by more than 10 %, the contribution from the Funds or the EMFF for each priority per Fund and per category of regions as laid down in the decision of the Commission approving the operational programme.</p><p>The contribution from the Funds or the EMFF through payments of the final balance in the final accounting year shall not exceed the eligible public expenditure declared or the contribution from each Fund and category of regions to each operational programme as laid down in the decision of the Commission approving the operational programme, whichever is the lower.’.</p></div></td></tr></tbody></table>
Article 3
Entry into force
This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 23 April 2020.
For the European Parliament
The President
D.M. SASSOLI
For the Council
The President
G. GRLIĆ RADMAN
<note>
( 1 ) Opinion of 14 April 2020 (not yet published in the Official Journal).
( 2 ) Position of the European Parliament of 17 April 2020 (not yet published in the Official Journal) and decision of the Council of 22 April 2020.
( 3 ) Regulation (EU) No 1301/2013 of the European Parliament and of the Council of 17 December 2013 on the European Regional Development Fund and on specific provisions concerning the Investment for growth and jobs goal and repealing Regulation (EC) No 1080/2006 ( OJ L 347, 20.12.2013, p. 289 ).
( 4 ) Regulation (EU) No 1303/2013 of the European Parliament and of the Council of 17 December 2013 laying down common provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund, the European Agricultural Fund for Rural Development and the European Maritime and Fisheries Fund and laying down general provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund and the European Maritime and Fisheries Fund and repealing Council Regulation (EC) No 1083/2006 ( OJ L 347, 20.12.2013, p. 320 ).
( 5 ) Regulation (EU) 2020/460 of the European Parliament and of the Council of 30 March 2020 amending Regulations (EU) No 1301/2013, (EU) No 1303/2013 and (EU) No 508/2014 as regards specific measures to mobilise investments in the healthcare systems of Member States and in other sectors of their economies in response to the COVID-19 outbreak (Coronavirus Response Investment Initiative) ( OJ L 99, 31.3.2020, p. 5 ).
( 6 ) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 ( OJ L 193, 30.7.2018, p. 1 ).
</note> | ENG | 32020R0558 |
<table><col/><col/><col/><col/><tbody><tr><td><p>13.11.2018   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 285/82</p></td></tr></tbody></table>
COMMISSION DECISION (EU) 2018/1702
of 8 November 2018
establishing the EU Ecolabel criteria for lubricants
(notified under document C(2018) 7125)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on the EU Ecolabel ( 1 ) , and in particular Article 8(2) thereof,
After consulting the European Union Eco-labelling Board,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Under Regulation (EC) No 66/2010, the EU Ecolabel may be awarded to those products with a reduced environmental impact during their entire life cycle.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Regulation (EC) No 66/2010 provides that specific EU Ecolabel criteria are to be established according to product groups.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Commission Decision 2011/381/EU <a>(<span>2</span>)</a> established the criteria and the related assessment and verification requirements for lubricants. The period of validity of those criteria and requirements was extended to 31 December 2018 by Commission Decision (EU) 2015/877 <a>(<span>3</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>The EU Ecolabel Fitness check (REFIT) of 30 June 2017, reviewing the implementation of Regulation (EC) No 66/2010 <a>(<span>4</span>)</a>, concluded on the need to develop a more strategic approach for the EU Ecolabel, including streamlined criteria for selecting products. In line with those conclusions, and in consultation with the EU Ecolabelling Board, it is appropriate to revise the criteria for lubricants product group, taking into consideration the current success, stakeholders' interest in the product and potential future windows of opportunity for increased uptake and market`s demand on sustainable products. The definition of the product group ‘lubricants’ should be modified to include a reference to the functionality of the product instead of its composition. This is to ensure that the definition clearly covers all relevant lubricant compositions.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>In order to take into account recent market developments and innovations that have taken place in the intervening period, it is appropriate to establish a new set of EU Ecolabel criteria for the product group ‘lubricants’. The aim of those criteria should be to promote products that have a limited impact on the aquatic environment, contain a limited amount of hazardous substances and performance as well as or better than a conventional lubricant available on the market. In line with the objectives of the European strategy for plastics in a circular economy <a>(<span>5</span>)</a>, the criteria should also seek to facilitate the transition to a more circular economy by encouraging improved design and by further incentivising the demand for recycled materials.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>The new criteria, as well as the related assessment and verification requirements, should remain valid until 31 December 2024, taking into account the innovation cycle for that product group.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>For reasons of legal certainty, Decision 2011/381/EU should be repealed.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>A transitional period should be allowed for producers whose products have been awarded the EU Ecolabel for lubricants on the basis of the criteria set out in Decision 2011/381/EU, so that they have sufficient time to adapt their products to comply with the revised criteria and requirements. For a limited period after adoption of this Decision, producers should also be allowed to submit applications based either on the criteria established by Decision 2011/381/EU or on the revised criteria established by this Decision. Where the EU Ecolabel was awarded on the basis of the criteria established by Decision 2011/381/EU, use of it should not be permitted after 31 December 2019.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 16 of Regulation (EC) No 66/2010,</p></td></tr></tbody></table>
HAS ADOPTED THIS DECISION:
Article 1
The product group ‘lubricants’ shall comprise any lubricant falling within one of the following sub-groups:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the Total Loss Lubricants (TLL) sub-group, which shall comprise chainsaw oils, wire rope lubricants, concrete release agents, total loss greases and other total loss lubricants;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the Partial Loss Lubricants (PLL) sub-group, which shall comprise gear oils intended for the use in open gears, stern tube oils, two-stroke oils, temporary protection against corrosion and partial loss greases;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the Accidental Loss Lubricants (ALL) sub-group, which shall comprise hydraulic systems, metalworking fluids, closed gear oils intended for the use in closed gears and accidental loss greases.</p></td></tr></tbody></table>
Article 2
For the purposes of this Decision, the following definitions shall apply:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>‘lubricant’ means a product that is capable of reducing friction, adhesion, heat, wear or corrosion when applied to a surface or introduced between two surfaces in relative motion, or is capable of transmitting mechanical power. The most common ingredients are base fluids and additives;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>‘base fluid’ means a lubricating fluid which flow, ageing, lubricity and anti-wear properties, as well as its properties regarding contaminant suspension, have not been improved by the inclusion of additive(s);</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>‘additive’ means a substance or mixture which primary functions are the improvement of one or several of the following aspects: flow, ageing, lubricity, anti-wear properties and contaminant suspension;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>‘substance’ means a chemical element and its compounds in the natural state or obtained by any production process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>‘total loss’ means that the lubricant is fully released to the environment during use;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>‘partial loss’ means that the lubricant is partially released to the environment during use and the non-released part can be recovered for re-processing, recycling or disposal;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>‘accidental loss’ means that the lubricant is used in a closed system and can be released to the environment only incidentally and, after use, can be recovered for re-processing, recycling or disposal;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>‘chainsaw oil’ means a lubricant that is used to lubricate the bar and chain on one or more types of chainsaw;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>‘wire rope lubricant’ means a lubricant that is used to lubricate wire ropes which consist of several strands of metal wire held together to form a rope;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>‘concrete release agent’ means a lubricant that is used in the construction industry to prevent freshly placed concrete adhering to a surface, usually plywood, overlaid plywood, steel or aluminium;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>‘grease’ means a solid or semi-solid lubricant which contains a thickener in order to thicken or modify the rheology of the base fluid;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(12)</p></td><td><p>‘gear oil’ means a lubricant made specifically for transmissions, transfer cases, and differentials in automobiles, trucks, and other machinery;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(13)</p></td><td><p>‘stern tube oil’ means a lubricant used in the stern tube of a ship;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(14)</p></td><td><p>‘two-stroke oil’ means a lubricant used in two-stroke engines;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(15)</p></td><td><p>‘temporary protection against corrosion’ means a lubricant that is applied to a metal surface as a thin film in order to prevent water and oxygen from coming into contact with the metal surface;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(16)</p></td><td><p>‘hydraulic systems’ means a lubricant by means of which power is transferred in hydraulic machinery;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(17)</p></td><td><p>‘metalworking fluid’ means a lubricant designed for metalworking processes, such as cutting and forming, and whose main functions are cooling, reducing friction, removing metal particles, and protecting the work pieces, the tool, and the machine tool from corrosion.</p></td></tr></tbody></table>
Article 3
In order to be awarded the EU Ecolabel under Regulation (EC) No 66/2010, a lubricant shall fall within the product group ‘lubricants’ as defined in Article 1 of this Decision and shall comply with the criteria and related assessment and verification requirements set out in the Annex to this Decision.
Article 4
The criteria for the product group ‘lubricants’ and the related assessment and verification requirements shall be valid until 31 December 2024.
Article 5
For administrative purposes, the code number assigned to the product group ‘lubricants’ shall be ‘027’.
Article 6
Decision 2011/381/EU is repealed.
Article 7
1. Notwithstanding Article 6, applications for the EU Ecolabel for products falling within the product group ‘lubricants’ submitted before the date of adoption of this Decision shall be evaluated in accordance with the conditions laid down in Decision 2011/381/EU.
2. Applications for the EU Ecolabel for products falling within the product group ‘lubricants’ submitted within two months from the date of adoption of this Decision may be based either on the criteria set out in Decision 2011/381/EU or on the criteria set out in this Decision. Those applications shall be evaluated in accordance with the criteria on which they are based.
3. Where the EU Ecolabel is awarded, in accordance with the criteria set out in Decision 2011/381/EU, the EU Ecolabel may be used only until 31 December 2019.
Article 8
This Decision is addressed to the Member States.
Done at Brussels, 8 November 2018.
For the Commission
Karmenu VELLA
Member of the Commission
( 1 ) OJ L 27, 30.1.2010, p. 1 .
( 2 ) Commission Decision 2011/381/EU of 24 June 2011 on establishing the ecological criteria for the award of the EU Ecolabel to lubricants ( OJ L 169, 29.6.2011, p. 28 ).
( 3 ) Commission Decision (EU) 2015/877 of 4 June 2015 amending Decisions 2009/568/EC, 2011/333/EU, 2011/381/EU, 2012/448/EU and 2012/481/EU in order to prolong the validity of the ecological criteria for the award of the EU Ecolabel to certain products ( OJ L 142, 6.6.2015, p. 32 ).
( 4 ) Report from the Commission to the European Parliament and the Council on the review of implementation of Regulation (EC) No 122/2009 of the European Parliament and of the Council on 25 November 2009 on the voluntary participation by organisations in a Community eco-management and audit scheme (EMAS) and the Regulation (EC) No 66/2010 of the parliament and of the Council of 25 November 2009 on the EU Ecolabel (COM(2017) 355).
( 5 ) COM(2018) 28 final.
ANNEX
FRAMEWORK
EU ECOLABEL CRITERIA
Criteria for awarding the EU Ecolabel to lubricants
CRITERIA
<table><col/><col/><tbody><tr><td><p>1.</p></td><td><p>Excluded or limited substances</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>2.</p></td><td><p>Additional aquatic toxicity requirements</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>3.</p></td><td><p>Biodegradability and bioaccumulative potential</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>4.</p></td><td><p>Renewable ingredients requirements</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>5.</p></td><td><p>Packaging/container requirements</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>6.</p></td><td><p>Minimum technical performance</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>7.</p></td><td><p>Consumer information regarding use and disposal</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>8.</p></td><td><p>Information appearing on the EU Ecolabel</p></td></tr></tbody></table>
ASSESSMENT AND VERIFICATION
(a) Requirements
The specific assessment and verification requirements are indicated within each criterion.
Where the applicant is required to provide the competent bodies with declarations, documentation, analyses, test reports, or other evidence to show compliance with the criteria, these may originate from the applicant and/or their supplier(s), as appropriate.
Competent bodies shall preferentially recognise attestations which are issued by bodies accredited in accordance with the relevant harmonised standard for testing and calibration laboratories (General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2005)) or with the principles of Good Laboratory Practice (GLP); and verifications by bodies that are accredited in accordance with the relevant harmonised standard for bodies certifying products, processes and services. Accreditation shall be carried out in accordance with Regulation (EC) No 765/2008 of the European Parliament and of the Council ( 1 ) .
Where appropriate, test methods other than those indicated for each criterion may be used if the competent body assessing the application accepts their equivalence.
Where appropriate, competent bodies may require supporting documentation and may carry out independent verifications or site visits.
As a prerequisite, the product shall meet all applicable legal requirements of the country or countries in which the product is intended to be placed on the market. The applicant shall declare the product's compliance with this requirement.
The Lubricant Substance Classification list (LuSC list), available on the EU Ecolabel website ( 2 ) , contains substances and brands that have been assessed by a competent body with regard to the relevant requirements included in this Decision and the data can be used directly in the application process.
A Letter of Compliance issued by one of the EU Ecolabel competent bodies can be used directly in the application process.
A list of all intentionally added substances and/or formed intentionally after any chemical reaction in the applied lubricant at or above the concentration of 0,010 % weight by weight in the final product shall be provided to the competent body, indicating the trade name (if existing), the chemical name, the CAS No, the ingoing quantity, the function and the form present in the final product formulation. All listed substances present in the form of nanomaterials shall be clearly indicated on the list with the word ‘nano’ written in brackets.
For each substance listed, the Safety Data Sheets (SDS) in accordance with Regulation (EC) No 1907/2006 of the European Parliament and of the Council ( 3 ) shall be provided. Where an SDS is not available for a single substance because it is part of a mixture, the applicant shall provide the SDS of the mixture.
(b) Measurement thresholds
Compliance with the ecological criteria is required for the final product and its constituent substances that are intentionally added and/or formed intentionally after any chemical reaction in the applied lubricant as indicated within each criterion.
In addition, the total fraction of the listed substances where the formulated criteria 2 and 3 do not apply shall remain below 0,5 % (w/w).
Note: Where grease can be used as both TLL and PLL (as in the case of multifunctional grease), criteria applicable to the TLL sub-group shall apply. If grease can be used as PLL and ALL, but not as TLL, then the criteria applicable to the PLL sub-group shall apply.
For gear oils used in open gears criteria applicable to the PLL sub-group shall apply while for gear oils used in closed gears criteria applicable to the ALL sub-group shall apply. When a gear oil can be used in both types of gears criteria applicable to the PLL sub-group shall apply.
CRITERION 1 — EXCLUDED OR LIMITED SUBSTANCES
For the purpose of criterion 1 impurities stated in the SDS, whose presence in the final product equals or exceeds 0,010 %, shall comply with the same requirements as the intentionally added substances.
1(a) Hazardous substances
(i) Final product
The final product shall not be classified in accordance with any of the hazard statements included in Table 1.
(ii) Substances
Substances that meet the criteria for classification with the hazard statements listed in Table 1 shall not be intentionally added or formed in the final product as specified by the respective limit values.
Where stricter, the generic or specific concentration limits determined in accordance with Article 10 of Regulation (EC) No 1272/2008 of the European Parliament and of the Council ( 4 ) shall take precedence.
Table 1
Restricted hazard statements
<table><col/><col/><tbody><tr><td><p>Hazard statement</p></td><td><p>Limit value</p></td></tr><tr><td><p>H340 May cause genetic defects</p></td><td><p>≤ 0,010 % weight by weight per substance in the final product</p></td></tr><tr><td><p>H350 May cause cancer</p></td></tr><tr><td><p>H350i May cause cancer by inhalation</p></td></tr><tr><td><p>H360F May damage fertility</p></td></tr><tr><td><p>H360D May damage the unborn child</p></td></tr><tr><td><p>H360FD May damage fertility. May damage the unborn child</p></td></tr><tr><td><p>H360Fd May damage fertility. Suspected of damaging the unborn child</p></td></tr><tr><td><p>H360Df May damage the unborn child. Suspected of damaging fertility</p></td></tr><tr><td><p>H341 Suspected of causing genetic defects</p></td></tr><tr><td><p>H351 Suspected of causing cancer</p></td></tr><tr><td><p>H361f Suspected of damaging fertility</p></td></tr><tr><td><p>H361d Suspected of damaging the unborn child</p></td></tr><tr><td><p>H361fd Suspected of damaging fertility. Suspected of damaging the unborn child</p></td></tr><tr><td><p>H362 May cause harm to breast-fed children</p></td></tr><tr><td><p>H300 Fatal if swallowed (oral)</p></td></tr><tr><td><p>H310 Fatal in contact with skin (dermal)</p></td></tr><tr><td><p>H330 Fatal if inhaled (inhal.)</p></td></tr><tr><td><p>H304 May be fatal if swallowed and enters airways</p></td><td><p>≤ 0,5 × Final product classification limit for H304</p></td></tr><tr><td><p>H301 Toxic if swallowed</p></td><td><p>< Final product classification limit for H301</p></td></tr><tr><td><p>H311 Toxic in contact with skin</p></td><td><p>< Final product classification limit for H311</p></td></tr><tr><td><p>H331 Toxic if inhaled</p></td><td><p>< Final product classification limit for H331</p></td></tr><tr><td><p>EUH070 Toxic by eye contact</p></td><td><p>≤ 0,010 % weight by weight per substance in the final product</p></td></tr><tr><td><p>H370 Causes damage to organs</p></td></tr><tr><td><p>H372 Causes damage to organs through prolonged or repeated exposure</p></td></tr><tr><td><p>H371 May cause damage to organs</p></td></tr><tr><td><p>H373 May cause damage to organs through prolonged or repeated exposure</p></td><td><p>< Final product classification limit for H373</p></td></tr><tr><td><p>H335 May cause respiratory irritation</p></td><td><p>≤ 0,010 % weight by weight per substance in the final product</p></td></tr><tr><td><p>H336 May cause drowsiness or dizziness</p></td><td><p>< Final product classification limit for H336</p></td></tr><tr><td><p>H317: May cause allergic skin reaction</p></td><td><p>< Final product classification limit for H317</p></td></tr><tr><td><p>H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled</p></td><td><p>≤ 0,010 % weight by weight per substance in the final product</p></td></tr><tr><td><p>H314 Causes severe skin burns and eye damage</p></td><td><p>< Final product classification limit for H314</p></td></tr><tr><td><p>H315 Causes skin irritation</p></td><td><p>< Final product classification limit for H315</p></td></tr><tr><td><p>H318: Causes serious eye damage</p></td><td><p>< Final product classification limit for H318</p></td></tr><tr><td><p>H319 Causes serious eye irritation</p></td><td><p>< Final product classification limit for H319</p></td></tr><tr><td><p>H400 Very toxic to aquatic life</p></td><td><p>≤ 0,5 × Final product classification limit for H400</p></td></tr><tr><td><p>H410 Very toxic to aquatic life with long-lasting effects</p></td><td><p>≤ 0,5 × Final product classification limit for H410</p></td></tr><tr><td><p>H411 Toxic to aquatic life with long-lasting effects</p></td><td><p>< Final product classification limit for H412 and H413</p></td></tr><tr><td><p>H412 Harmful to aquatic life with long-lasting effects</p></td></tr><tr><td><p>H413 May cause long-lasting effects to aquatic life</p></td></tr><tr><td><p>H420 Harms public health and the environment by destroying ozone in the upper atmosphere</p></td><td><p>≤ 0,010 % weight by weight per substance in the final product</p></td></tr><tr><td><p>EUH029 Contact with water liberates toxic gas</p></td></tr><tr><td><p>EUH031 Contact with acids liberates toxic gas</p></td></tr><tr><td><p>EUH032 Contact with acids liberates very toxic gas</p></td></tr><tr><td><p>EUH066 Repeated exposure may cause skin dryness or cracking</p></td><td><p>< Final product classification limit for EUH066</p></td></tr></tbody></table>
Note: where final product classification limit (or 0,5 × Final product classification limit) is mentioned, the maximum total concentration of all classified substances with the specific hazard statement(s) shall be considered.
This criterion does not apply to substances covered by Article 2(7)(a) and (b) of Regulation (EC) No 1907/2006 which sets out criteria for exempting substances within Annexes IV and V to that Regulation from the registration, downstream user and evaluation requirements. In order to determine whether that exclusion applies, the applicant shall screen any intentionally added/formed substance at or above the concentration of 0,010 % weight by weight in the final product.
1(b) Specified restricted substances
The substances listed below shall not be intentionally added or formed at or above the concentration of 0,010 % weight by weight in the final product:
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substances appearing in the Union List of priority substances in the field of water policy in Annex X to Directive 2000/60/EC of the European Parliament and of the Council <a>(<span>5</span>)</a> as amended by Decision No 2455/2001/EC <a>(<span>6</span>)</a> and the OSPAR List of Chemicals for Priority Action (http://www.ospar.org/work-areas/hasec/chemicals/priority-action),</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Organic halogen compounds and nitrite compounds,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Metals or metallic compounds with the exception of sodium, potassium, magnesium and calcium. In the case of thickeners, also lithium and/or aluminium compounds may be used up to concentrations limited by the other criteria included in the Annex to this Decision.</p></td></tr></tbody></table>
1(c) Substances of very high concern (SVHCs)
The final product shall not contain any intentionally added/formed substances that have been identified in accordance with the procedure described in Article 59(1) of Regulation (EU) No 1907/2006, which establishes the candidate list for substances of very high concern at or above the concentration of 0,010 % weight by weight in the final product.
Assessment and verification
The applicant shall provide a signed declaration of compliance with above sub-requirements, supported by declarations from suppliers, if appropriate; and the following supporting evidence:
To demonstrate compliance with 1(a)(i) the applicant shall provide the SDS of the final product.
To demonstrate compliance with 1(a)(ii), 1(b) and 1(c) the applicant shall provide:
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>SDS of intentionally added mixtures and their concentration in the final product,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>SDS of intentionally added substances and their concentration in the final product.</p></td></tr></tbody></table>
For substances exempted from requirement 1(a)(ii) (see Annexes IV and V to Regulation (EC) No 1907/2006), a declaration to this effect by the applicant shall suffice to comply.
For requirement 1(c) reference to the latest list of substances of very high concern shall be made on the date of application.
The above evidence can also be provided directly to Competent Bodies by any supplier in the applicant's supply chain.
CRITERION 2 — ADDITIONAL AQUATIC TOXICITY REQUIREMENTS
The applicant shall demonstrate compliance by meeting the requirements of either criterion 2.1 or 2.2.
2.1. Requirement for the lubricant and its main components
The critical concentration for the aquatic toxicity for both the freshly prepared lubricant and for each main component shall not be lower than the values specified in Table 2.
Main component means any substance accounting for more than 5 % by weight of the lubricant.
Table 2
Aquatic toxicity values for both freshly prepared lubricant and for each main component
<table><col/><col/><col/><col/><col/><tbody><tr><td><p> </p></td><td><p>ALL</p></td><td><p>PLL</p></td><td><p>TLL</p></td></tr><tr><td><p>Aquatic toxicity for the freshly prepared lubricant</p></td><td><p>Critical concentration for acute aquatic toxicity OR</p></td><td><p>> 100 mg/l</p></td><td><p>> 1 000 mg/l</p></td><td><p>> 1 000 mg/l</p></td></tr><tr><td><p>Chronic aquatic toxicity</p></td><td><p>> 10 mg/l</p></td><td><p>> 100 mg/l</p></td><td><p>> 100 mg/l</p></td></tr><tr><td><p>Aquatic toxicity for each main component</p></td><td><p>Critical concentration for acute aquatic toxicity OR</p></td><td><p>> 100 mg/l</p></td></tr><tr><td><p>Chronic aquatic toxicity</p></td><td><p>> 10 mg/l</p></td></tr></tbody></table>
Available acute aquatic toxicity test data for each main component shall be provided on each of the following two trophic levels:
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>crustacean (daphnia preferred),</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>aquatic plants (algae preferred).</p></td></tr></tbody></table>
In case acute aquatic toxicity test data is missing in one or both trophic levels, available test data on chronic aquatic toxicity for both the crustacean (daphnia preferred) and fish trophic level shall be accepted.
QSARs could be used to fill data gaps for chronic toxicity or for acute toxicity in only one of the relevant trophic levels.
In case the aforementioned test data is not available for each main component, a test shall be performed to generate data for acute toxicity in the missing trophic level/s (i.e. crustacean and/or aquatic plants).
Available acute aquatic toxicity test data for the lubricant shall be provided on each of the following three trophic levels:
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>crustacean (daphnia preferred),</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>aquatic plants (algae preferred),</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>fish.</p></td></tr></tbody></table>
In case acute aquatic toxicity test data for the applied lubricant is missing for any of the mentioned trophic levels available test data on chronic aquatic toxicity shall be accepted for the missing trophic level/s.
In case the above data is not available for the applied lubricant, a test shall be performed to generate data on acute aquatic toxicity for the missing trophic level/s.
2.2. Requirement for each intentionally added or formed substances at or above 0,10 % weight by weight in the final product
Substances exhibiting a certain degree of aquatic toxicity are allowed up to a cumulative mass concentration indicated in Table 3.
Table 3
Cumulative mass percentage (% w/w) limits for substances present in the product with respect to their aquatic toxicity
<table><col/><col/><col/><col/><tbody><tr><td><p> </p></td><td><p>Cumulative mass percentage (% weight by weight in the final product)</p></td></tr><tr><td><p>ALL</p></td><td><p>PLL</p></td><td><p>TLL</p></td></tr><tr><td><p>Acute aquatic toxicity > 100 mg/l or</p><p>Chronic aquatic toxicity > 10 mg/l</p></td><td><p>Not limited</p></td></tr><tr><td><p>Acute aquatic toxicity > 10 to ≤ 100 mg/l or</p><p>1 mg/l < Chronic aquatic toxicity ≤ 10 mg/l</p></td><td><p>≤ 10</p><p>(≤ 20 for ALL greases)</p></td><td><p>≤ 10</p><p>(≤ 15 for PLL greases)</p></td><td><p>≤ 2</p><p>(≤ 10 for TLL greases)</p></td></tr><tr><td><p>Acute aquatic toxicity > 1 to ≤ 10 mg/l or</p><p>0,1 mg/l < Chronic aquatic toxicity ≤ 1 mg/l</p></td><td><p>≤ 2,5</p><p>(≤ 1 for ALL greases)</p></td><td><p>≤ 0,6</p></td><td><p>≤ 0,4</p></td></tr><tr><td><p>Acute aquatic toxicity≤ 1 mg/l or</p><p>Chronic aquatic toxicity ≤ 0,1 mg/l</p></td><td><p>≤ 0,1/M<a> (<span>*1</span>)</a></p></td><td><p>≤ 0,1/M<a> (<span>*1</span>)</a></p></td><td><p>≤ 0,1/M<a> (<span>*1</span>)</a></p></td></tr></tbody></table>
Available chronic aquatic toxicity test data for each substance (each intentionally added or formed substances at or above 0,10 % weight by weight in the final product) shall be provided for each of the following two trophic levels:
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>crustacean (daphnia preferred), and</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>fish</p></td></tr></tbody></table>
In case chronic aquatic toxicity test data is missing in one or both trophic levels, available data on acute aquatic toxicity for both trophic levels, crustacean (daphnia preferred) and aquatic plants (algae preferred) shall be accepted.
QSARs could be used to fill data gaps for chronic toxicity or for acute toxicity in only one of the relevant trophic levels.
In case the above data is not available for each substance, a test shall be performed to generate data for acute toxicity in the missing trophic level/s (i.e. crustacean and/or aquatic plants).
Assessment and verification applicable to criteria 2.1 and 2.2
In case of self-assessment by the applicant, for each substance, main component or for the lubricant, the applicant shall provide test reports or literature data including the references demonstrating compliance with the requirements set in sub-criterion 2.1 or 2.2.
For each substance or main component where the assessment is based on a valid letter of compliance (LoC), a copy of the letter shall be provided. For each substance or main component selected from the Lubricant Substance Classification list (LuSC-list) the assessment can be based on the information reported in said list and no documents need to be submitted.
Either marine or freshwater toxicity data are accepted.
Acute aquatic toxicity data (available or generated for the application) shall originate from tests carried out according to:
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>ISO 10253 or ISO 8692 or OECD Test Guideline 201 or Part C.3 of the Annex to Commission Regulation (EC) No 440/2008 <a>(<span>7</span>)</a> for algae,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>ISO 6341 or OECD Test Guideline 202 or Part C.2 of the Annex to Regulation (EC) No 440/2008 for daphnia,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>ISO 7346 or OECD Test Guideline 203 or Part C.1 of the Annex to Regulation (EC) No 440/2008 for fish (only applies to available existing data),</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>fish embryo toxicity (FET) (non-animal alternative) test according to OECD Test Guideline 236 or part C.49 of the Annex to Regulation (EC) No 440/2008 for fish (only applies when a test needs to be performed for the application).</p></td></tr></tbody></table>
Only acute aquatic toxicity (72 or 96 hr) ErC 50 for algae, (48hr) EC 50 for daphnia and (96hr) LC 50 for fish are accepted.
Chronic aquatic toxicity data (available) shall originate from tests carried out according to:
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>ISO 10253 or ISO 8692 or OECD Test Guideline 201 or Part C.3 of the Annex to Regulation (EC) No 440/2008 for algae,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Part C.20 of the Annex to Regulation (EC) No 440/2008 or OECD Test Guideline 211 for daphnia,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>OECD Test Guideline 215 or Part C.14 of the Annex to Regulation (EC) No 440/2008 or ISO 12890 or OECD Test Guideline 212 or part C.15 of the Annex to Regulation (EC) No 440/2008 or OECD Test Guideline 210 for fish.</p></td></tr></tbody></table>
Only chronic toxicity data in the form of No Observed Effect Concentration (NOEC) data shall be accepted.
When QSARs are used to fill data gaps, the applicant shall provide the prediction generated for the target chemical. Results of (Q)SARs shall only be accepted if documentation on the validity and applicability domain of the applied model is provided by the applicant.
In the case of slightly soluble substances or mixtures (< 10 mg/l) the method of the water-accommodated fraction (WAF) can be used in the aquatic toxicity determination. The established loading level referred to as LL50 and related to the lethal loading or the EL50 related to the effective loading for acute aquatic toxicity and NOELR related to the no observable effect loading rate for chronic aquatic toxicity may be used directly in the classification criteria. The preparation of a water-accommodated fraction shall follow the recommendations set out according to one of the following guidelines: Appendix C to ECETOC Technical Report No 26 (1996), OECD 2002 Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures (OECD Series on Testing and Assessment, No 23), ISO 5667-16 Water quality — Sampling — Part 16 (Guidance on biotesting of samples), ASTM D6081-98 (Standard practice for Aquatic Toxicity Testing for Lubricants: Sample Preparation and Results Interpretation) or equivalent methods. In addition, demonstration of the absence of toxicity for a substance at its limit of water solubility shall be deemed to have met the requirements of this criterion.
The following substances are exempted from requirements 2.1 and 2.2:
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>any substance which is unlikely to cross biological membranes MM > 800 g/mol and with a molecular diameter > 1,5 nm (> 15 Å), or</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>any substance which is a polymer and whose molecular weight fraction below 1 000 g/mol is less than 1 %, or</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>any substance which is highly insoluble in water (water solubility < 10 μg/l)</p></td></tr></tbody></table>
The water solubility of substances shall be determined where appropriate according to OECD Test Guideline 105 or Part A.6 of the Annex to Regulation (EC) No 440/2008 or equivalent test methods.
A polymer molecular weight fraction below 1 000 g/mol shall be determined according to Part A.19 of the Annex to Regulation (EC) No 440/2008 or OECD Test Guideline 119 or equivalent test methods.
CRITERION 3 — BIODEGRADABILITY AND BIOACCUMULATIVE POTENTIAL
Requirements for the biodegradability of organic compounds and bioaccumulative potential shall be fulfilled by each intentionally added or formed substance at or above the concentration of 0,10 % weight by weight in the final product.
The lubricant shall not contain substances that are both non-biodegradable and (potentially) bioaccumulative. However, the lubricant may contain one or more substances with a certain degree of degradability and potential or actual bioaccumulation up to a cumulative mass concentration as indicated in Table 4.
Table 4
Cumulative mass percentage (%w/w) limits for substances present in the product with respect to their biodegradability and bio-accumulation potential
<table><col/><col/><col/><col/><col/><tbody><tr><td><p> </p></td><td><p>ALL</p></td><td><p>PLL</p></td><td><p>TLL</p></td><td><p>Greases</p><p>(ALL,PLL,TLL)</p></td></tr><tr><td><p>Readily aerobically biodegradable</p></td><td><p>> 90</p></td><td><p>> 75</p></td><td><p>> 95</p></td><td><p>> 80</p></td></tr><tr><td><p>Inherently aerobically biodegradable</p></td><td><p>≤ 10</p></td><td><p>≤ 25</p></td><td><p>≤ 5</p></td><td><p>≤ 20</p></td></tr><tr><td><p>Non-biodegradable and non-bioaccumulative</p></td><td><p>≤ 5</p></td><td><p>≤ 20</p></td><td><p>≤ 5</p></td><td><p>≤ 15</p></td></tr><tr><td><p>Non-biodegradable and bioaccumulative</p></td><td><p>≤ 0,1</p></td><td><p>≤ 0,1</p></td><td><p>≤ 0,1</p></td><td><p>≤ 0,1</p></td></tr></tbody></table>
Assessment and verification
For each substance where the assessment is carried out by the applicant, test reports or literature data including the references on the biodegradability and when required on the (potential) bioaccumulation shall be provided.
For each substance where the assessment is based on a valid letter of compliance (LoC), only a copy of the letter shall be provided.
For each substance selected from the Lubricant Substance Classification list (LuSC-list) the assessment can be based on the information reported in said list and no documents need to be submitted.
Biodegradation
<table><col/><col/><tbody><tr><td><p> </p></td><td><p>‘<span>Inherently biodegradable</span>’ means a substance, which achieves the following level of degradation:</p><table><col/><col/><tbody><tr><td><p> </p></td><td><p>> 70 % after 28 days for inherent biodegradation test, or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p> </p></td><td><p>> 20 % but < 60 % after 28 days in tests based on oxygen depletion or carbon dioxide generation.</p></td></tr></tbody></table><p>Inherent biodegradability shall be measured in accordance with the following tests:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regulation (EC) No 440/2008 (Part C.9 of the Annex), OECD 302 or equivalent methods,</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>tests based on oxygen depletion or carbon dioxide generation: Regulation (EC) No 440/2008 (Part C.4 of the Annex), OECD 306, OECD 310, or equivalent methods.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p> </p></td><td><p>‘<span>Readily biodegradable</span>’ means an arbitrary classification of chemicals which have passed certain specified screening tests for ultimate biodegradability; these tests are so stringent that it is assumed that such compounds will rapidly and completely biodegrade in aquatic environments under aerobic conditions. Substances are considered rapidly degradable in the environment if one of the following criteria holds true:</p><table><col/><col/><tbody><tr><td><p>1.</p></td><td><p>if, in 28-day ready biodegradation studies, at least the following levels of degradation are achieved:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>tests based on dissolved organic carbon: 70 %,</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>tests based on oxygen depletion or carbon dioxide generation: 60 % of theoretical maximum.</p></td></tr></tbody></table><p>These levels of biodegradation must be achieved within 10 days of the start of degradation which point is taken as the time when 10 % of the substance has been degraded, unless the substance is identified as an UVCB or as a complex, multi-constituent substance with structurally similar components. In this case, and where there is sufficient justification, the 10-day window condition may be waived and the pass level applied at 28 days; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>2.</p></td><td><p>if, in those cases, where only BOD and COD data are available, when the ratio of BOD5/COD is ≥ 0,5; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>3.</p></td><td><p>if other convincing scientific evidence is available to demonstrate that the substance can be degraded (biotically and/or abiotically) in the aquatic environment to a level > 70 % within a 28-day period.</p></td></tr></tbody></table><p>Ready biodegradability shall be measured in accordance with the following tests:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regulation (EC) No 440/2008 (Part C.4, C.5 in conjunction with C.6 and C.42 of the Annex), OECD 301, OECD 306, OECD 310, or equivalent methods.</p></td></tr></tbody></table><p><span>Note:</span> Within the frame of this criterion, the 10-day window principle will not necessarily apply. If the substance reaches the biodegradation pass level within 28 days but not within the 10-day time-window a slower degradation rate is assumed.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p> </p></td><td><p>‘<span>Non-biodegradable</span>’ means a substance which fails the criteria for ultimate and inherent biodegradability.</p><p>The applicant may also use read-across data to estimate the biodegradability of a substance. ‘Read-across’ for the assessment of the biodegradability of a substance shall be acceptable if the reference substance differs by only one functional group or fragment from the substance applied in the product. If the reference substance is readily or inherently biodegradable and the functional group has a positive effect on the aerobic biodegradation, then the applied substance may also be regarded as readily or inherently biodegradable. Functional groups or fragments with a positive effect on the biodegradation are: aliphatic and aromatic alcohol [-OH], aliphatic and aromatic acid [-C(= O)-OH], aldehyde [-CHO], Ester [-C(= O)-O-C], amide [-C(= O)–N or -C(= S)–N]. Adequate and reliable documentation of the study on the reference substance should be provided. In case of a comparison with a fragment, not included above, adequate and reliable documentation of the studies should be provided on the positive effect of the functional group on the biodegradation of structurally similar substances.</p></td></tr></tbody></table>
Bioaccumulation
The (potential) bioaccumulation does not need to be established when the substance:
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>has a MM > 800 g/mol and has a molecular diameter > 1,5 nm (> 15 Å), or</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>has an octanol-water partition coefficient, log K<span>ow</span>, value of < 3 or > 7, or</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>has a measured BCF of ≤ 100 l/kg, or</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>is a polymer and its molecular weight fraction below 1 000 g/mol is less than 1 %.</p></td></tr></tbody></table>
Since most substances used in lubricants are quite hydrophobic the bioconcentration factor (BCF) value should be based on the lipid weight content and care must be shown to ensure a sufficient exposure time. The BCF shall be assessed according to Part C.13 of the Annex to Regulation (EC) No 440/2008 or equivalent test methods.
The log octanol/water partition coefficient (log K ow ) shall be assessed according to Part A.8 of the Annex to Regulation (EC) No 440/2008 or OECD 123 or equivalent test methods. In case of an organic substance other than a surfactant where no experimental value is available, a calculation method can be used. The following calculation methods are allowed: CLOGP, LOGKOW, (KOWWIN) and SPARC. Estimated log K ow values obtained by any of these calculation methods < 3 or > 7 indicate that the substance is not expected to bioaccumulate.
Log K ow values are applicable to organic chemicals only. To assess the bioaccumulation potential of non-organic compounds, surfactants, and some organo-metallic compounds, BCF measurements shall be carried out.
CRITERION 4 — RENEWABLE INGREDIENTS REQUIREMENTS
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>In the specific case of renewable ingredients from palm oil or palm kernel oil, or derived from palm oil or palm kernel oil, 100 % w/w of the renewable ingredients used shall meet the requirements for sustainable production of a certification scheme that is a multi-stakeholder organisation with a broad membership, including NGOs, industry and government and that addresses environmental impacts on soil, biodiversity, organic carbon stocks and conservation of natural resources.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>If the term ‘bio-based’ or ‘bio-lubricant’ is used, the minimum bio-based carbon content in the final product shall be 25 % in accordance with EN 16807.</p></td></tr></tbody></table>
Assessment and verification
To demonstrate compliance with criterion 4(a) evidence through third-party chain of custody certificates that the input materials used in the manufacturing originate from sustainably managed plantations shall be provided. Roundtable for Sustainable Palm Oil (RSPO) certificates or certificates of any equivalent or stricter sustainable production scheme demonstrating compliance to any of the following models: identity preserved, segregated, mass balance shall be accepted. For palm oil and palm kernel oil derivatives, the amounts of RSPO credits purchased and claimed in the RSPO PalmTrace system model during the most recent annual trading period shall be provided to demonstrate compliance to the Book and Claim supply chain model.
To demonstrate compliance with criterion 4(b) the applicant shall enclose the final product test report in accordance with EN 16807, ASTM D 6866, DIN CEN/TS 16137 (SPEC 91236), EN 16640 or EN 16785-1.
CRITERION 5 — PACKAGING/CONTAINER REQUIREMENTS
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>Recycled content (applicable only in the case of lubricants sold in plastic packaging/container): plastic packaging/container shall be made of a minimum of 25 % of post-consumer plastic.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>Design (applicable only in the case of lubricants designed to be sold to private end-consumers): the packaging/container should have an appropriate system (e.g. prolongation systems or narrow apertures) in order to avoid spillage during use.</p></td></tr></tbody></table>
Assessment and verification
The applicant shall provide the following evidence as applicable:
The composition of the plastic packaging/container and the shares of recycled and virgin material. If necessary, a declaration of compliance from the plastic packaging/container supplier shall be included.
Post-consumer plastic means plastic generated by households or by commercial, industrial and institutional facilities in their role as end-users of the product which can no longer be used for its intended purpose. This includes returns of plastic from the distribution chain.
Post-consumer plastic content shall be calculated as shown below. As there are no methods available for directly measuring the recycled content in a product or packaging, the mass of plastic obtained from the recycling process, after accounting for losses and other diversions, shall be used.
X(%) = A/P × 100
Where:
<table><col/><col/><tbody><tr><td><p> </p></td><td><p>X is the (post-consumer) recycled content</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p> </p></td><td><p>A is the mass of the recycled (post-consumer) plastic</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p> </p></td><td><p>P is the mass of the packaging/container</p></td></tr></tbody></table>
A description of the design of the packaging/container, along with photos or technical drawings, shall also be provided.
CRITERION 6 — MINIMUM TECHNICAL PERFORMANCE
The lubricant product shall comply with the corresponding minimum technical performance requirements as specified in Table 5.
Table 5
Minimum technical performance for lubricant products
<table><col/><col/><tbody><tr><td><p>Lubricant category</p></td><td><p>Minimum technical performance</p></td></tr><tr><td><p>Chainsaw oils</p></td><td><p>KWF test version 2017 test or equivalent</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Wire rope lubricants</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Concrete release agents</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Other total loss lubricants</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Stern tube oils</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Metalworking fluids</p></td></tr></tbody></table></td><td><p>‘Fit for purpose’ demonstrated by at least one ‘applicant's clients' approval’</p></td></tr><tr><td><p>Gear oils</p></td><td><p>gear oils (closed gears): ISO 12925-1 or DIN 51517 (Section I, II or III)</p><p>gear oils (open gears): ‘Fit for purpose’ demonstrated by at least one ‘applicant's clients' approval’.</p></td></tr><tr><td><p>Two-stroke oils</p></td><td><p>two-stroke marine: NMMA TC-W3</p><p>two-stroke terrestrial: ISO 13738 (EGD)</p></td></tr><tr><td><p>Hydraulic systems</p></td><td><p>ISO 15380 (Tables 2 to 5)</p><p>Fire resistant hydraulic fluids: ISO 15380 (Tables 2 to 5) + ISO 12922 (Table 1 to 3) or Factory Mutual Approval</p></td></tr><tr><td><p>Temporary protection against corrosion</p></td><td><p>ISO/TS 12928 or ‘Fit for purpose’ demonstrated by at least one ‘applicant's clients' approval’.</p></td></tr><tr><td><p>Lubricating greases</p></td><td><p>Greases for temporary protection against corrosion: ISO/TS 12928 or ‘Fit for purpose’ demonstrated by at least one ‘applicant's clients' approval’.</p><p>Greases for closed gear: DIN 51826</p><p>Greases for roller bearings, plain bearings and sliding surfaces: DIN 51825</p><p>All other greases: ISO 12924 or ‘Fit for purpose’ demonstrated by at least one ‘applicant's clients' approval’</p></td></tr></tbody></table>
Note: Multipurpose greases that include any of the above specified applications among their potential uses shall be tested according to the corresponding specific test of the relevant specified application.
Assessment and verification
The applicant shall provide a declaration of compliance with this criterion supported by testing results, where appropriate.
For hydraulic systems, it shall be indicated on the product information sheet which elastomers have been tested.
Applicant's clients' approval means a letter/document/statements issued by clients for a specific product, assuring that the product met their specifications and works correctly in its intended application.
CRITERION 7 — CONSUMER INFORMATION REGARDING USE AND DISPOSAL
In the case of lubricants designed to be sold to private end-consumers, the following information (in text form or pictograms) shall be present on the packaging/container (comparable text formulations are permitted):
<table><col/><col/><tbody><tr><td><p> </p></td><td><p>‘Avoid any spillage of unused product to the environment’,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p> </p></td><td><p>‘Product residue and package/container should be disposed of in dedicated collection points’.</p></td></tr></tbody></table>
Assessment and verification
The applicant shall provide a sample of the product container/packaging or its artwork where the above information appears.
CRITERION 8 — INFORMATION APPEARING ON THE EU ECOLABEL
The optional label with text box may contain the following text:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>‘Less hazardous substances ending up in the environment’;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>‘Verified performance’;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>‘X % of certified renewable ingredients used’ (where relevant) <a>(<span>8</span>)</a>,</p></td></tr></tbody></table>
The guidelines for the use of the optional label with text box can be found in the ‘Guidelines for the use of the EU Ecolabel logo’ on the website:
http://ec.europa.eu/environment/ecolabel/documents/logo_guidelines.pdf
Assessment and verification
The applicant shall provide a sample of the label. If statement c) is used, the applicant shall provide the relevant certificate(s) related to the percentage of certified renewable ingredient(s) used.
<note>
( 1 ) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 ( OJ L 218, 13.8.2008, p. 30 ).
( 2 ) http://ec.europa.eu/environment/ecolabel/
( 3 ) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC ( OJ L 396, 30.12.2006, p. 1 ).
( 4 ) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 ( OJ L 353, 31.12.2008, p. 1 ).
( 5 ) Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy ( OJ L 327, 22.12.2000, p. 1 ).
( 6 ) Decision No 2455/2001/EC of the European Parliament and of the Council of 20 November 2001 establishing the list of priority substances in the field of water policy and amending Directive 2000/60/EC ( OJ L 331, 15.12.2001, p. 1 ).
( *1 ) M-factors for highly toxic components of mixtures shall be applied in accordance with Article 10 of Regulation (EC) No 1272/2008 as described in Section 4.1.3.5.5.5 of Annex I to that Regulation.
( 7 ) Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) ( OJ L 142, 31.5.2008, p. 1 ).
( 8 ) If certified renewable ingredients are used, regardless of the type of biomass (e.g. rapeseed, sunflower, palm, soy, etc.), total content of certified ingredients can be indicated.
</note> | ENG | 32018D1702 |
<table><col/><col/><col/><col/><tbody><tr><td><p>14.3.2018   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 71/1</p></td></tr></tbody></table>
COMMISSION REGULATION (EU) 2018/394
of 13 March 2018
amending Regulation (EU) No 965/2012 as regards the deletion of air operations requirements for balloons
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 216/2008 of the European Parliament and of the Council of 20 February 2008 on common rules in the field of civil aviation and establishing a European Aviation Safety Agency, and repealing Council Directive 91/670/EEC, Regulation (EC) No 1592/2002 and Directive 2004/36/EC ( 1 ) , and in particular Article 8(5) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Commission Regulation (EU) No 965/2012<a> (<span>2</span>)</a> establishes the conditions for the safety of several types of air operations with different categories of aircraft, including balloon operations.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Commission Regulation (EU) 2018/395<a> (<span>3</span>)</a> establishes specific rules for the operation of balloons. From the date of application of that Regulation, such operations should no longer be subject to the general rules for air operations laid down in Regulation (EU) No 965/2012. However, the rules in respect of oversight of air operations by the competent authorities of the Member States, set out in Article 3 of Regulation (EU) No 965/2012 and Annex II thereof, should continue to apply with respect to air operations with balloons, as those requirements are not specific to any particular air operation activity but apply horizontally in respect of all such activities.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Regulation (EU) No 965/2012 should therefore be amended accordingly, so as to take account of the new rules applicable to balloon operations and to clarify the affected provisions of that Regulation where appropriate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>Considering the close link between them, the date of application of the amendments to Regulation (EU) No 965/2012 set out in this Regulation should be aligned with the date of application of Regulation (EU) 2018/395.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>The Agency prepared draft implementing rules and submitted them as an opinion<a> (<span>4</span>)</a> to the Commission in accordance with point (b) of Article 17(2) and Article 19(1) of Regulation (EC) No 216/2008.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 65 of Regulation (EC) No 216/2008,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
Regulation (EU) No 965/2012 is amended as follows:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Article 1 is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>paragraphs 1, 2 and 3 are replaced by the following:</p><p>‘1.   This Regulation lays down detailed rules for air operations with aeroplanes, helicopters and sailplanes, including ramp inspections of aircraft of operators under the safety oversight of another State when landed at aerodromes located in the territory subject to the provisions of the Treaties.</p><p>2.   This Regulation also lays down detailed rules on the conditions for issuing, maintaining, amending, limiting, suspending or revoking the certificates of operators of aircraft referred to in points (b) and (c) of Article 4(1) of Regulation (EC) No 216/2008, except for balloons, engaged in commercial air transport operation, the privileges and responsibilities of the holders of certificates as well as conditions under which operations shall be prohibited, limited or subject to certain conditions in the interest of safety.</p><p>3.   This Regulation also lays down detailed rules on the conditions and procedures for the declaration by operators engaged in commercial specialised operations of aeroplanes, helicopters and sailplanes or in non-commercial operation of complex motor-powered aircraft, including non-commercial specialised operations of complex motor-powered aircraft, of their capability and the availability of the means to discharge the responsibilities associated with the operation of aircraft, and for the oversight of such operators.’;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>paragraph 6 is replaced by the following:</p><p>‘6.   This Regulation shall not apply to air operations with airships.’;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the following paragraph 7 is added:</p><p>‘7.   This Regulation shall not apply to air operations with balloons. However, in respect of such air operations with balloons, other than tethered gas balloons, the requirements in respect of oversight of Article 3 shall apply.’</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>In Article 2 the following points (1a) and (1b) are inserted:</p><table><col/><col/><tbody><tr><td><p>‘(1a)</p></td><td><p>“balloon” means a manned lighter-than-air aircraft which is not power driven and sustains flight through the use of either a lighter-than-air gas or an airborne heater, including gas balloons, hot-air balloons, mixed balloons and, although power driven, hot-air airships;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(1b)</p></td><td><p>“tethered gas balloon” means a gas balloon with a tether system that continuously anchors the balloon to a fixed point during operation;’.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>In Article 3(1), the following second subparagraph is inserted:</p><p>‘The administration and management systems of the competent authorities of the Member States and of the Agency shall comply with the requirements specified in Annex II.’</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>Article 5 is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>paragraph 1 is replaced by the following:</p><p>‘1.   Operators shall only operate an aeroplane, a helicopter or a sailplane for the purpose of commercial air transport (hereinafter “CAT”) operations in accordance with the requirements specified in Annexes III and IV.’;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>in paragraph 2, point (b) is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘(b)</p></td><td><p>aeroplanes, helicopters and sailplanes used for the transport of dangerous goods (DG);’;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>paragraph 4 is replaced by the following:</p><p>‘4.   Operators of other-than complex motor-powered aeroplanes and helicopters, and of sailplanes, involved in non-commercial operations, including non-commercial specialised operations, shall only operate the aircraft in accordance with the requirements specified in Annex VII.’;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>in paragraph 5, point (b) is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘(b)</p></td><td><p>other aeroplanes and helicopters, as well as sailplanes, in accordance with the provisions specified in Annex VII.’;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>paragraph 6 is replaced by the following:</p><p>‘6.   Operators shall only operate an aeroplane, a helicopter or a sailplane for the purpose of commercial specialised operations in accordance with the requirements specified in Annexes III and VIII.’.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>Article 6 is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>paragraph 3 is replaced by the following:</p><p>‘3.   By way of derogation from Article 5 of this Regulation, and without prejudice to point (a) of Article 5(4) of Regulation (EC) No 216/2008 and to Subpart P of Annex I to Commission Regulation (EU) No 748/2012<a> (<span>*1</span>)</a> concerning the permit to fly, the following flights shall continue to be operated under the requirements specified in the national law of the Member State in which the operator has its principal place of business, or, where the operator has no principal place of business, the place where the operator is established or resides.</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>flights related to the introduction or modification of aeroplane, helicopter or sailplane types conducted by design or production organisations within the scope of their privileges;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>flights carrying no passengers or cargo where the aeroplane, helicopter or sailplane is ferried for refurbishment, repair, maintenance checks, inspections, delivery, export or similar purposes.</p></td></tr></tbody></table><p><a>(<span>*1</span>)</a>  Commission Regulation (EU) No 748/2012 of 3 August 2012 laying down implementing rules for the airworthiness and environmental certification of aircraft and related products, parts and appliances, as well as for the certification of design and production organisations (<a>OJ L 224, 21.8.2012, p. 1</a>).’;"</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>in paragraph 4a, the introductory wording is replaced by the following:</p><p>‘By way of derogation from Article 5(1) and (6), the following operations with other-than complex motor-powered aeroplanes and helicopters, and with sailplanes may be conducted in accordance with Annex VII:’.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>Article 8 is replaced by the following:</p><p>‘Article 8</p><p>Flight time limitations</p><p>1.   CAT operations shall be subject to the requirements of Subpart FTL of Annex III.</p><p>2.   By way of derogation from paragraph 1, air taxi, emergency medical service and single pilot CAT operations by aeroplanes shall be subject to the requirements specified in the national law referred to in Article 8(4) of Regulation (EEC) No 3922/91 and in Subpart Q of Annex III to that Regulation.</p><p>3.   By way of derogation from paragraph 1, CAT operations with helicopters and CAT operations with sailplanes shall comply with the requirements specified in the national law of the Member State in which the operator has its principal place of business.</p><p>4.   Non-commercial operations, including non-commercial specialised operations, with complex motor-powered aeroplanes and helicopters, as well as commercial specialised operations with aeroplanes, helicopters and sailplanes shall comply as regards flight time limitations, with the requirements specified in the national law of the Member State in which the operator has its principal place of business, or, where the operator has no principal place of business, the place where the operator is established or resides.’</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>Article 10 is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>paragraphs 2 and 3 are replaced by the following:</p><p>‘2.   The requirements of Annexes II and VII shall apply to non-commercial operations with sailplanes from 25 August 2013. However, Member States that have decided in accordance with Union law before 8 April 2019 that some or all of those requirements do not apply to such operations in their territory, shall make those decisions publicly available. If any such decision is still in force by 8 April 2020, it shall cease to apply from that date.</p><p>3.   The requirements of Annexes II, III, VII and VIII shall apply to specialised operations with sailplanes from 1 July 2014. However, Member States that have decided in accordance with Union law before 8 April 2019 that some or all of those requirements do not apply to such operations in their territory, shall make those decisions publicly available. If any such decision is still in force by 8 April 2020, it shall cease to apply from that date.’;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>in paragraph 5, point (b) is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘(b)</p></td><td><p>CAT operations with sailplanes from 1 July 2014. However, Member States that have decided in accordance with Union law before 8 April 2019 that some or all of those requirements do not apply to such operations in their territory, shall make those decisions publicly available. If any such decision is still in force by 8 April 2020, it shall cease to apply from that date.’</p></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>Annexes I, II, III, IV, VII and VIII are amended in accordance with the Annex to this Regulation.</p></td></tr></tbody></table>
Article 2
Entry into force and application
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
It shall apply from 8 April 2019.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 13 March 2018.
For the Commission
The President
Jean-Claude JUNCKER
( 1 ) OJ L 79, 19.3.2008, p. 1 .
( 2 ) Commission Regulation (EU) No 965/2012 of 5 October 2012 laying down technical requirements and administrative procedures related to air operations pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council ( OJ L 296, 25.10.2012, p. 1 ).
( 3 ) Commission Regulation (EU) 2018/395 of 13 March 2018 laying down detailed rules for the operation of balloons pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council (see page 10 of this Official Journal).
( 4 ) Opinion No 01/2016 of the European Aviation Safety Agency of 6 January 2016 for a Commission Regulation on the revision of the European operational rules for balloons.
ANNEX
Annexes I, II, III, IV, VII and VIII of Regulation (EU) No 965/2012 are amended as follows:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>In Annex I, point (120) is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘(120)</p></td><td><p>“traffic load” means the total mass of passengers, baggage, cargo and carry-on specialist equipment and including any ballast;’;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Annex II is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>in point ARO.GEN.345, point (a) is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘(a)</p></td><td><p>Upon receiving a declaration from an organisation carrying out or intending to carry out activities for which a declaration is required, the competent authority shall verify that the declaration contains all the information required pursuant to point ORO.DEC.100 of Annex III (Part-ORO) to this Regulation, or for balloons operators all the information required pursuant to point BOP.ADD.100 of Annex II (Part-BOP) to Commission Regulation (EU) 2018/395<a> (<span>*1</span>)</a>, and shall acknowledge receipt of the declaration to the organisation.</p></td></tr></tbody></table><p><a>(<span>*1</span>)</a>  Commission Regulation (EU) 2018/395 of 13 March 2018 laying down detailed rules for the operation of balloons pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council (<a>OJ L 71, 14.3.2018, p. 10</a>)’;"</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>in point ARO.GEN.350(b), point (1) is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘(1)</p></td><td><p>failure to give the competent authority access to the facilities of the organisation in accordance with point ORO.GEN.140 of Annex III (Part-ORO) to this Regulation, or for balloons operators in accordance with points BOP.ADD.015 and BOP.ADD.035 of Annex II (Part-BOP) to Regulation (EU) 2018/395, during normal operating hours and after two written requests;’;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the heading of point ARO.OPS.110 is replaced by the following:</p><p><span>‘ARO.OPS.110</span>   <span>Lease agreements for aeroplanes and helicopters’;</span></p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Annex III is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>in point ORO.GEN.110, point (k) is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘(k)</p></td><td><p>Notwithstanding point (j), operators conducting commercial operations with either of the following aircraft shall ensure that the flight crew has received an appropriate dangerous goods training or briefing, so as to enable them to recognise undeclared dangerous goods brought on board by passengers or as cargo:</p><table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>a sailplane;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>a single-engined propeller-driven aeroplane having a maximum certified take-off mass of 5 700 kg or less and a MOPSC of 5 or less, operated in a flight taking off and landing at the same aerodrome or operating site, under VFR by day;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>an other-than complex motor-powered helicopter, single-engined, with a MOPSC of 5 or less, operated in a flight taking off and landing at the same aerodrome or operating site, under VFR by day.’;</p></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>in point ORO.MLR.101, the introductory wording is replaced by the following:</p><p>‘Except for operations with single-engined propeller-driven aeroplanes with a MOPSC of 5 or less or with single-engined non-complex helicopters with a MOPSC of 5 or less, taking off and landing at the same aerodrome or operating site, under VFR by day, and for operations with sailplanes, the main structure of the OM shall be as follows:’;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>in point ORO.FC.005(b), point (1) is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘(1)</p></td><td><p>commercial air transport operations of sailplanes; or’;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>in point ORO.CC.100, point (a) is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘(a)</p></td><td><p>The number and composition of cabin crew shall be determined in accordance with point 7.a of Annex IV to Regulation (EC) No 216/2008, taking into account operational factors or circumstances of the particular flight to be operated. At least one cabin crew member shall be assigned for the operation of aircraft with an MOPSC of more than 19 when carrying one or more passenger(s).’;</p></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>Annex IV is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>point CAT.GEN.105 is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>the heading is replaced by the following:</p><p><span>‘CAT.GEN.105</span>   <span>Touring motor gliders and powered sailplanes’;</span></p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>point (d) is deleted;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>point CAT.GEN.NMPA.100 is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>in point (a), point (2) is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘(2)</p></td><td><p>be responsible for the operation and safety of the sailplane from the moment the launch procedure is started until the sailplane comes to a rest at the end of the flight;’;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>point (d) is deleted;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>point CAT.GEN.NMPA.105 is deleted;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>in point CAT.GEN.NMPA.140(a), point (19) is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘(19)</p></td><td><p>mass and balance documentation;’;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>point CAT.OP.NMPA.105 is replaced by the following:</p><p><span>‘CAT.OP.NMPA.105</span>   <span>Noise abatement procedures — powered sailplanes</span></p><p>The commander shall take into account the effect of aircraft noise, while ensuring however that safety has priority over noise abatement.’;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>point CAT.OP.NMPA.110 is deleted;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>point CAT.OP.NMPA.135 is deleted;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(h)</p></td><td><p>point CAT.OP.NMPA.140 is replaced by the following:</p><p><span>‘CAT.OP.NMPA.140</span>   <span>Smoking on board</span></p><p>No person shall be allowed to smoke on board a sailplane.’;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>point CAT.OP.NMPA.165 is deleted;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(j)</p></td><td><p>point CAT.OP.NMPA.180 is deleted;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(k)</p></td><td><p>in Subpart C, Section 5 is deleted;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(l)</p></td><td><p>in Subpart D, Section 4 is deleted;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>Annex VII (Part-NCO) is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>point NCO.GEN.102 is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>the heading is replaced by the following:</p><p><span>‘NCO.GEN.102</span>   <span>Touring motor gliders and powered sailplanes’;</span></p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>point (d) is deleted;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>in point NCO.GEN.103, point (a) is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘(a)</p></td><td><p>start and end at the same aerodrome or operating site, except for sailplanes;’;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>point NCO.GEN.105 is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>in point (a)(4), points (iii) and (iv) are replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘(iii)</p></td><td><p>instruments and equipment required for the execution of that flight are installed in the aircraft and are operative, unless operation with inoperative equipment is permitted by the minimum equipment list (MEL) or equivalent document, if applicable, as provided for in points NCO.IDE.A.105, NCO.IDE.H.105 or NCO.IDE.S.105;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iv)</p></td><td><p>the mass of the aircraft and the centre of gravity location are such that the flight can be conducted within limits prescribed in the airworthiness documentation;’;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>in point (f), point (1) is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘(1)</p></td><td><p>keep his/her safety belt fastened while at his/her station; and’;</p></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>point NCO.GEN.106 is deleted;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>in point NCO.GEN.135, point (c) is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘(c)</p></td><td><p>Notwithstanding point (a), on flights with sailplanes, excluding touring motor gliders (TMGs), the documents and information referred to in points (a)(2) to (a)(8) and points (a)(11), (a)(12) and (a)(13) may be carried in the retrieve vehicle.’;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>point NCO.OP.121 is deleted;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>point NCO.OP.127 is deleted;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(h)</p></td><td><p>point NCO.OP.150 is replaced by the following:</p><p><span>‘NCO.OP.150</span>   <span>Carriage of passengers</span></p><p>The pilot-in-command shall ensure that, prior to and during taxiing, take-off and landing, and whenever deemed necessary in the interest of safety, each passenger on board occupies a seat or berth and has his/her safety belt or restraint device properly secured.’;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>point NCO.OP.156 is replaced by the following:</p><p><span>‘NCO.OP.156</span>   <span>Smoking on board — sailplanes</span></p><p>No person shall be allowed to smoke on board a sailplane.’;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(j)</p></td><td><p>point NCO.OP.176 is deleted;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(k)</p></td><td><p>point NCO.OP.185 is replaced by the following:</p><p><span>‘NCO.OP.185</span>   <span>In-flight fuel management</span></p><p>The pilot-in-command shall check at regular intervals that the amount of usable fuel remaining in flight is not less than the fuel required to proceed to a weather-permissible aerodrome or operating site and the planned reserve fuel as required by points NCO.OP.125 or NCO.OP.126.’;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(l)</p></td><td><p>point NCO.OP.215 is deleted;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(m)</p></td><td><p>in point NCO.POL.100, point (a) is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘(a)</p></td><td><p>During any phase of operation, the loading, the mass and the centre of gravity (CG) position of the aircraft shall comply with any limitation specified in the AFM or equivalent document.’;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(n)</p></td><td><p>point NCO.POL.105 is replaced by the following:</p><p><span>‘NCO.POL.105</span>   <span>Weighing</span></p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>The operator shall ensure that the mass and the CG of the aircraft have been established by actual weighing prior to the initial entry into service of the aircraft. The accumulated effects of modifications and repairs on the mass and balance shall be accounted for and properly documented. Such information shall be made available to the pilot-in-command. The aircraft shall be reweighed if the effect of modifications on the mass and balance is not accurately known.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>The weighing shall be accomplished:</p><table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>for aeroplanes and helicopters, by the manufacturer of the aircraft or by an approved maintenance organisation; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>for sailplanes, by the manufacturer of the aircraft or in accordance with Annex I to Regulation (EU) No 1321/2014.’;</p></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(o)</p></td><td><p>in Subpart D, Section 4 is deleted;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(p)</p></td><td><p>in point NCO.SPEC.115, point (b) is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘(b)</p></td><td><p>During critical phases of the flight or whenever deemed necessary by the pilot-in-command in the interest of safety, the crew member shall be restrained at his/her assigned station, unless otherwise specified in the checklist.’;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(q)</p></td><td><p>in NCO.SPEC.120, point (b) is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘(b)</p></td><td><p>During critical phases of the flight or whenever deemed necessary by the pilot-in-command in the interest of safety, the task specialist shall be restrained at his/her assigned station, unless otherwise specified in the checklist.’;</p></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>Annex VIII is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>point SPO.GEN.102 is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>the heading is replaced by the following:</p><p><span>‘SPO.GEN.102</span>   <span>Touring motor gliders and powered sailplanes’;</span></p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>point (d) is deleted;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>in point SPO.GEN.105, point (b) is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘(b)</p></td><td><p>During critical phases of the flight or whenever deemed necessary by the pilot-in-command in the interest of safety, the crew member shall be restrained at his/her assigned station, unless otherwise specified in the SOP.’;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>in point SPO.GEN.106, point (b) is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘(b)</p></td><td><p>During critical phases of the flight or whenever deemed necessary by the pilot-in-command in the interest of safety, the task specialist shall be restrained at his/her assigned station, unless otherwise specified in the SOP.’;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>in point SPO.GEN.107(a)(4), points (iii) and (iv) are replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘(iii)</p></td><td><p>instruments and equipment required for the execution of that flight are installed in the aircraft and are operative, unless operation with inoperative equipment is permitted by the minimum equipment list (MEL) or equivalent document, if applicable, as required in points SPO.IDE.A.105, SPO.IDE.H.105 or SPO.IDE.S.105;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iv)</p></td><td><p>the mass of the aircraft and the centre of gravity location are such that the flight can be conducted within the limits prescribed in the airworthiness documentation;’;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>point SPO.GEN.108 is deleted;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>in point SPO.GEN.140, point (c) is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘(c)</p></td><td><p>Notwithstanding point (a), on flights with sailplanes, excluding touring motor gliders (TMGs), the documents and information in points (a)(1) to (a)(10) and points (a)(13) to (a)(19) may be carried in the retrieve vehicle.’;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>point SPO.OP.121 is deleted;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(h)</p></td><td><p>point SPO.OP.132 is deleted;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>point SPO.OP.160 is replaced by the following:</p><p><span>‘SPO.OP.160</span>   <span>Use of headset</span></p><p>Each flight crew member required to be on duty in the flight crew compartment shall wear a headset with boom microphone or equivalent and use it as the primary device to communicate with ATS, other crew members and task specialists.’;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(j)</p></td><td><p>point SPO.OP.181 is deleted;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(k)</p></td><td><p>point SPO.OP.225 is deleted;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(l)</p></td><td><p>in point SPO.POL.100, point (a) is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘(a)</p></td><td><p>During any phase of operation, the loading, the mass and the centre of gravity (CG) position of the aircraft shall comply with any limitation specified in the appropriate manual.’;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(m)</p></td><td><p>point SPO.POL.105 is replaced by the following:</p><p><span>‘SPO.POL.105</span>   <span>Mass and balance</span></p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>The operator shall ensure that the mass and the CG of the aircraft have been established by actual weighing prior to the initial entry into service of the aircraft. The accumulated effects of modifications and repairs on the mass and balance shall be accounted for and properly documented. Such information shall be made available to the pilot-in-command. The aircraft shall be reweighed if the effect of modifications on the mass and balance is not accurately known.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>The weighing shall be accomplished:</p><table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>for aeroplanes and helicopters, by the manufacturer of the aircraft or by an approved maintenance organisation; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>for sailplanes, by the manufacturer of the aircraft or in accordance with Annex I to Regulation (EU) No 1321/2014.’;</p></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(n)</p></td><td><p>in Subpart D, Section 4 is deleted;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(o)</p></td><td><p>point SPO.SPEC.PAR.120 is deleted.</p></td></tr></tbody></table></td></tr></tbody></table> | ENG | 32018R0394 |
<table><col/><col/><col/><col/><tbody><tr><td><p>23.6.2015   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 157/96</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING DECISION (EU) 2015/975
of 19 June 2015
on a measure taken by Spain in accordance with Directive 2006/42/EC of the European Parliament and of the Council to prohibit the placing on the market of an impact drill imported to Spain by Hidalgo's Group, Spain
(notified under document C(2015) 4086)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC ( 1 ) , and in particular Article 11(3) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Spain informed the Commission of a measure to prohibit the placing on the market of the impact drill, type Dayron/70000, imported to Spain by Hidalgo's Group, Spain.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The impact drill bore CE marking, according to Directive 2006/42/EC.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>The reason for taking the measure was the non-conformity of the impact drill with the essential health and safety requirements set out in Annex I to Directive 2006/42/EC, points 1.3.2 — Risk of break up during operation, 1.7.3 — Marking of machinery and 1.7.4.2 — Contents of instructions, on the grounds that the machine did not pass the resistance test, breaking the framework, with the consequent risk of cut and/or the possibility of accessing to the active parts.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>Spain informed the distributor and importer about the deficiencies. The importer voluntarily took the necessary measures to remove non-compliant products from the market.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>The documentation available, the comments expressed and the action taken by the parties concerned demonstrate that the impact drill, type Dayron/70000, fails to satisfy the essential health and safety requirements of Directive 2006/42/EC. It is therefore appropriate to consider the measure taken by Spain as justified,</p></td></tr></tbody></table>
HAS ADOPTED THIS DECISION:
Article 1
The measure taken by Spain to prohibit the placing on the market of the impact drill, type Dayron/70000, imported to Spain by Hidalgo's Group, Spain, is justified.
Article 2
This Decision is addressed to the Member States.
Done at Brussels, 19 June 2015.
For the Commission
Elżbieta BIEŃKOWSKA
Member of the Commission
<note>
( 1 ) OJ L 157, 9.6.2006, p. 24 .
</note> | ENG | 32015D0975 |
<table><col/><col/><col/><col/><tbody><tr><td><p>18.10.2018   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 261/6</p></td></tr></tbody></table>
COMMISSION REGULATION (EU) 2018/1556
of 17 October 2018
refusing to authorise certain health claims made on foods, other than those referring to the reduction of disease risk and to children's development and health
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods ( 1 ) , and in particular Article 18(5) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Pursuant to Regulation (EC) No 1924/2006 health claims made on foods are prohibited unless they are authorised by the Commission in accordance with that Regulation and included in a list of permitted claims.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Regulation (EC) No 1924/2006 also provides that applications for authorisations of health claims may be submitted by food business operators to the national competent authority of a Member State. The national competent authority is to forward valid applications to the European Food Safety Authority (EFSA), hereinafter referred to as ‘the Authority’, for a scientific assessment, as well as to the Commission and the Member States for information.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>The Authority is to deliver an opinion on the health claim concerned.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>The Commission is to decide on the authorisation of health claims taking into account the opinion delivered by the Authority.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>Following an application from Laboratoires Nutrition et Cardiométabolisme, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to Stablor®, a drink preparation with defined macro- and micronutrient composition and specific proportion of amino acids (tryptophan to neutral amino acids ratio) and decrease in visceral fat while preserving lean mass (Question No EFSA- Q-2016-00319 <a>(<span>2</span>)</a>). The claim proposed by the applicant was worded as follows: ‘In the context of a well-balanced diet and a mild caloric restriction, the addition of Stablor® contributes to decrease visceral fat while preserving lean mass in overweight or obese subjects with abdominal fat and cardiometabolic risk factors’.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>On 28 February 2017, the Commission and the Member States received the scientific opinion from the Authority, which concluded that, on the basis of the data presented, a cause and effect relationship has not been established between the consumption of Stablor® and reduction of visceral fat while maintaining lean body mass in the context of an energy restricted diet. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>Following an application from Suomen Terveysravinto Oy, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to curcumin and normal functioning of joints (Question No EFSA- Q-2016-00856 <a>(<span>3</span>)</a>). The claim proposed by the applicant was worded as follows: ‘Curcumin contributes to the normal functioning of joints’.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>On 8 May 2017, the Commission and the Member States received the scientific opinion from the Authority, which concluded that, on the basis of the data presented, a cause and effect relationship has not been established between the consumption of curcumin and the maintenance of joint function. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>Following an application from Marks and Spencer PLC, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to a carbohydrate:protein (CHO:P) ratio ≤ 1.8 on an energy basis in the context of an energy-restricted diet and body weight (Question No EFSA-Q-2016-00436 <a>(<span>4</span>)</a>). The claim proposed by the applicant was worded as follows: ‘Helps to achieve a reduction in body weight and body fat when consumed as part of an energy restricted diet (< 8,368 kJ/2,000 kcal/day) for a minimum of 12 weeks’.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>On 13 June 2017, the Commission and the Member States received the scientific opinion from the Authority, which concluded that, on the basis of the data presented, a cause and effect relationship has not been established between the consumption of a CHO:P ratio ≤ 1.8 on an energy basis consumed in the context of an energy-restricted diet and the reduction of body weight. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>Following an application from Loc Troi group, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to Vibigaba (germinated brown rice) and reduction of body weight in the context of an energy-restricted diet (Question No EFSA- Q-2017-00032 <a>(<span>5</span>)</a>). The claim proposed by the applicant was worded as follows: ‘In the context of an energy-restricted diet contributes to weight loss’.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(12)</p></td><td><p>On 21 July 2017, the Commission and the Member States received the scientific opinion from the Authority, which concluded that, on the basis of the data presented, a cause and effect relationship has not been established between the consumption of Vibigaba (germinated brown rice) and the reduction of body weight in the context of an energy-restricted diet. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(13)</p></td><td><p>Following an application from Loc Troi group, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to Vibigaba (germinated brown rice) and maintenance of long-term normal blood glucose concentration (Question No EFSA- Q-2017-00033 <a>(<span>6</span>)</a>). The claim proposed by the applicant was worded as follows: ‘Contributes to the maintenance of normal blood glucose levels’.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(14)</p></td><td><p>On 21 July 2017, the Commission and the Member States received the scientific opinion from the Authority, which concluded that, on the basis of the data presented, a cause and effect relationship has not been established between the consumption of Vibigaba (germinated brown rice) and the maintenance of long-term normal blood glucose concentration. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(15)</p></td><td><p>Following an application from Loc Troi group, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to Vibigaba (germinated brown rice) and contribution to the maintenance of normal blood pressure (Question No EFSA- Q-2017-00031 <a>(<span>7</span>)</a>). The claim proposed by the applicant was worded as follows: ‘Contributes to the maintenance of normal blood pressure’.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(16)</p></td><td><p>On 21 July 2017, the Commission and the Member States received the scientific opinion from the Authority, which concluded that, on the basis of the data presented, a cause and effect relationship has not been established between the consumption of Vibigaba (germinated brown rice) and the maintenance of normal BP. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(17)</p></td><td><p>Following an application from Loc Troi group, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to Vibigaba (germinated brown rice) and contribution to the maintenance of normal blood cholesterol concentration (Question No EFSA- Q-2017-00030 <a>(<span>8</span>)</a>). The claim proposed by the applicant was worded as follows: ‘Contributes to the maintenance of normal blood cholesterol levels’.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(18)</p></td><td><p>On 21 July 2017, the Commission and the Member States received the scientific opinion from the Authority, which concluded that, on the basis of the data presented, a cause and effect relationship has not been established between the consumption of Vibigaba (germinated brown rice) and maintenance of normal blood cholesterol concentration. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(19)</p></td><td><p>The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
The health claims listed in the Annex to this Regulation shall not be included in the Union list of permitted claims as provided for in Article 13(3) of Regulation (EC) No 1924/2006.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 17 October 2018.
For the Commission
The President
Jean-Claude JUNCKER
( 1 ) OJ L 404, 30.12.2006, p. 9 .
( 2 ) EFSA Journal 2017;15(2):4723.
( 3 ) EFSA Journal 2017;15(5):4774.
( 4 ) EFSA Journal 2017;15(6):4839.
( 5 ) EFSA Journal 2017;15(7):4915.
( 6 ) EFSA Journal 2017;15(7):4916.
( 7 ) EFSA Journal 2017;15(7):4914.
( 8 ) EFSA Journal 2017;15(7):4913.
ANNEX
Rejected health claim
<table><col/><col/><col/><col/><tbody><tr><td><p>Application — Relevant provisions of Regulation (EC) No 1924/2006</p></td><td><p>Nutrient, substance, food or food category</p></td><td><p>Claim</p></td><td><p>EFSA opinion reference</p></td></tr><tr><td><p>Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data</p></td><td><p>Stablor®, a drink preparation with defined macro- and micronutrient composition and specific proportion of amino acids (tryptophan to neutral amino acids ratio)</p></td><td><p>In the context of a well-balanced diet and a mild caloric restriction, the addition of Stablor® contributes to decrease visceral fat while preserving lean mass in overweight or obese subjects with abdominal fat and cardiometabolic risk factors.</p></td><td><p>Q-2016-00319</p></td></tr><tr><td><p>Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data</p></td><td><p>Curcumin</p></td><td><p>Curcumin contributes to the normal functioning of joints.</p></td><td><p>Q-2016-00856</p></td></tr><tr><td><p>Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data</p></td><td><p>A carbohydrate:protein (CHO:P) ratio ≤ 1.8 on an energy basis in the context of an energy-restricted diet and body weight</p></td><td><p>Helps to achieve a reduction in body weight and body fat when consumed as part of an energy restricted diet (< 8 368  kJ/2 000 kcal/day) for a minimum of 12 weeks.</p></td><td><p>Q-2016-00436</p></td></tr><tr><td><p>Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data</p></td><td><p>Vibigaba (germinated brown rice)</p></td><td><p>In the context of an energy-restricted diet contributes to weight loss.</p></td><td><p>Q-2017-00032</p></td></tr><tr><td><p>Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data</p></td><td><p>Vibigaba (germinated brown rice)</p></td><td><p>Contributes to the maintenance of normal blood glucose levels.</p></td><td><p>Q-2017-00033</p></td></tr><tr><td><p>Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data</p></td><td><p>Vibigaba (germinated brown rice)</p></td><td><p>Contributes to the maintenance of normal blood pressure.</p></td><td><p>Q-2017-00031</p></td></tr><tr><td><p>Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data</p></td><td><p>Vibigaba (germinated brown rice)</p></td><td><p>Contributes to the maintenance of normal blood cholesterol levels.</p></td><td><p>Q-2017-00030</p></td></tr></tbody></table> | ENG | 32018R1556 |
<table><col/><col/><col/><col/><tbody><tr><td><p>31.7.2023   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>C 270/1</p></td></tr></tbody></table>
Statement of revenue and expenditure for the 2023 financial year – European Training Foundation (ETF) – amending budget No 1
(2023/C 270/01)
REVENUE
<table><col/><col/><col/><col/><col/><tbody><tr><td><p>Title</p><p>Chapter</p></td><td><p>Heading</p></td><td><p>2023 estimate</p></td><td><p>Amending budget No 1/2023</p></td><td><p>New amount</p></td></tr><tr><td><p><span>1</span></p></td><td><p><span>EUROPEAN UNION SUBSIDY</span></p></td></tr><tr><td><p>1 2</p></td><td><p>EUROPEAN TRAINING FOUNDATION (ARTICLE 04 03 14 OF THE GENERAL BUDGET)</p></td><td><p>22 534 092</p></td><td><p> </p></td><td><p>22 534 092</p></td></tr><tr><td><p>1 3</p></td><td><p>UNION CONTRIBUTION FROM RECOVERY OF SURPLUS FROM PREVIOUS YEARS</p></td><td><p>93 864</p></td><td><p> </p></td><td><p>93 864</p></td></tr><tr><td><p> </p></td><td><p><span>Title 1 — Total</span></p></td><td><p><span>22 627 956</span></p></td><td><p> </p></td><td><p><span>22 627 956</span></p></td></tr><tr><td><p><span>4</span></p></td><td><p><span>REVENUE FROM OTHER SOURCES</span></p></td></tr><tr><td><p>4 2</p></td><td><p>COOPERATION WITH OTHER EUROPEAN INSTITUTIONS AND BODIES</p></td><td><p>2 060 000</p></td><td><p>3 175 000</p></td><td><p>5 235 000</p></td></tr><tr><td><p>4 3</p></td><td><p>COOPERATION WITH ITALIAN INSTITUTIONS</p></td><td><p>p.m.</p></td><td><p> </p></td><td><p>p.m.</p></td></tr><tr><td><p>4 9</p></td><td><p>COOPERATION WITH ITALIAN INSTITUTIONS — FINANCING OF EARLIER YEARS</p></td><td><p>p.m.</p></td><td><p> </p></td><td><p>p.m.</p></td></tr><tr><td><p> </p></td><td><p><span>Title 4 — Total</span></p></td><td><p><span>2 060 000</span></p></td><td><p><span>3 175 000</span></p></td><td><p><span>5 235 000</span></p></td></tr><tr><td><p><span>8</span></p></td><td><p><span>EUROPEAN UNION CONTRIBUTION IN KIND</span></p></td></tr><tr><td><p>8 0</p></td><td><p>EUROPEAN UNION CONTRIBUTION IN KIND</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p><span>Title 8 — Total</span></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p><span>9</span></p></td><td><p><span>MISCELLANEOUS REVENUE</span></p></td></tr><tr><td><p>9 0</p></td><td><p>MISCELLANEOUS REVENUE</p></td><td><p>p.m.</p></td><td><p> </p></td><td><p>p.m.</p></td></tr><tr><td><p> </p></td><td><p><span>Title 9 — Total</span></p></td><td><p><span>p.m.</span></p></td><td><p> </p></td><td><p><span>p.m.</span></p></td></tr><tr><td><p><span>10</span></p></td><td><p><span>RESULTS OF EARLIER YEARS</span></p></td></tr><tr><td><p>10 1</p></td><td><p>RESULTS OF EARLIER YEARS</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p><span>Title 10 — Total</span></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr/><tr/><tr><td><p> </p></td><td><p><span>GRAND TOTAL</span></p></td><td><p><span>24 687 956</span></p></td><td><p><span>3 175 000</span></p></td><td><p><span>27 862 956</span></p></td></tr></tbody></table>
EXPENDITURE
<table><col/><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Title</p><p>Chapter</p></td><td><p>Heading</p></td><td><p>2023 appropriations</p></td><td><p>Amending budget No 1/2023</p></td><td><p>New amount</p></td></tr><tr><td><p>Commitments</p></td><td><p>Payments</p></td><td><p>Commitments</p></td><td><p>Payments</p></td><td><p>Commitments</p></td><td><p>Payments</p></td></tr><tr><td><p><span>1</span></p></td><td><p><span>EXPENDITURE RELATED TO PERSONS WORKING WITH THE FOUNDATION</span></p></td></tr><tr><td><p>1 1</p></td><td><p>STAFF IN ACTIVE EMPLOYMENT</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p>Non-differentiated appropriations</p></td><td><p>15 620 850</p></td><td><p>15 620 850</p></td><td><p>–15 000</p></td><td><p>–15 000</p></td><td><p>15 605 850</p></td><td><p>15 605 850</p></td></tr><tr><td><p>1 3</p></td><td><p>MISSIONS AND DUTY TRAVELS</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p>Non-differentiated appropriations</p></td><td><p>50 000</p></td><td><p>50 000</p></td><td><p>30 000</p></td><td><p>30 000</p></td><td><p>80 000</p></td><td><p>80 000</p></td></tr><tr><td><p>1 4</p></td><td><p>SOCIOMEDICAL INFRASTRUCTURE</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p>Non-differentiated appropriations</p></td><td><p>334 500</p></td><td><p>334 500</p></td><td><p> </p></td><td><p> </p></td><td><p>334 500</p></td><td><p>334 500</p></td></tr><tr><td><p>1 5</p></td><td><p>STAFF EXCHANGES BETWEEN THE FOUNDATION AND THE PUBLIC SECTOR</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p>Non-differentiated appropriations</p></td><td><p>p.m.</p></td><td><p>p.m.</p></td><td><p> </p></td><td><p> </p></td><td><p>p.m.</p></td><td><p>p.m.</p></td></tr><tr><td><p>1 7</p></td><td><p>ENTERTAINMENT AND REPRESENTATION EXPENSES</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p>Non-differentiated appropriations</p></td><td><p>4 000</p></td><td><p>4 000</p></td><td><p> </p></td><td><p> </p></td><td><p>4 000</p></td><td><p>4 000</p></td></tr><tr><td><p> </p></td><td><p><span>Title 1 — Total</span></p></td><td><p><span>16 009 350</span></p></td><td><p><span>16 009 350</span></p></td><td><p><span>15 000</span></p></td><td><p><span>15 000</span></p></td><td><p><span>16 024 350</span></p></td><td><p><span>16 024 350</span></p></td></tr><tr><td><p><span>2</span></p></td><td><p><span>BUILDING, EQUIPMENT AND MISCELLANEOUS OPERATING EXPENDITURE</span></p></td></tr><tr><td><p>2 0</p></td><td><p>INVESTMENTS IN IMMOVABLE PROPERTY, RENTAL OF BUILDINGS AND ASSOCIATED COSTS</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p>Non-differentiated appropriations</p></td><td><p>875 075</p></td><td><p>875 075</p></td><td><p>–15 000</p></td><td><p>–15 000</p></td><td><p>860 075</p></td><td><p>860 075</p></td></tr><tr><td><p>2 1</p></td><td><p>INFORMATION AND COMMUNICATION TECHNOLOGIES</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p>Non-differentiated appropriations</p></td><td><p>1 307 000</p></td><td><p>1 307 000</p></td><td><p> </p></td><td><p> </p></td><td><p>1 307 000</p></td><td><p>1 307 000</p></td></tr><tr><td><p>2 2</p></td><td><p>MOVABLE PROPERTY AND ASSOCIATED COSTS</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p>Non-differentiated appropriations</p></td><td><p>10 000</p></td><td><p>10 000</p></td><td><p> </p></td><td><p> </p></td><td><p>10 000</p></td><td><p>10 000</p></td></tr><tr><td><p>2 3</p></td><td><p>CURRENT ADMINISTRATIVE EXPENDITURE</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p>Non-differentiated appropriations</p></td><td><p>48 100</p></td><td><p>48 100</p></td><td><p> </p></td><td><p> </p></td><td><p>48 100</p></td><td><p>48 100</p></td></tr><tr><td><p>2 4</p></td><td><p>POST AND TELECOMMUNICATIONS</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p>Non-differentiated appropriations</p></td><td><p>5 000</p></td><td><p>5 000</p></td><td><p> </p></td><td><p> </p></td><td><p>5 000</p></td><td><p>5 000</p></td></tr><tr><td><p>2 5</p></td><td><p>MEETINGS AND ASSOCIATED COSTS</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p>Non-differentiated appropriations</p></td><td><p>100 000</p></td><td><p>100 000</p></td><td><p> </p></td><td><p> </p></td><td><p>100 000</p></td><td><p>100 000</p></td></tr><tr><td><p> </p></td><td><p><span>Title 2 — Total</span></p></td><td><p><span>2 345 175</span></p></td><td><p><span>2 345 175</span></p></td><td><p><span>–15 000</span></p></td><td><p><span>–15 000</span></p></td><td><p><span>2 330 175</span></p></td><td><p><span>2 330 175</span></p></td></tr><tr><td><p><span>3</span></p></td><td><p><span>EXPENSES RELATED TO PERFORMANCE OF SPECIFIC MISSIONS</span></p></td></tr><tr><td><p>3 0</p></td><td><p>OPERATIONAL EXPENSES</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p>Differentiated appropriations</p></td><td><p>375 000</p></td><td><p>375 000</p></td><td><p> </p></td><td><p> </p></td><td><p>375 000</p></td><td><p>375 000</p></td></tr><tr><td><p>3 1</p></td><td><p>PRIORITY ACTIONS: WORK PROGRAMME ACTIVITIES</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p>Differentiated appropriations</p></td><td><p>3 558 431</p></td><td><p>3 558 431</p></td><td><p> </p></td><td><p> </p></td><td><p>3 558 431</p></td><td><p>3 558 431</p></td></tr><tr><td><p>3 2</p></td><td><p>OPERATIONAL MISSIONS</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p>Differentiated appropriations</p></td><td><p>400 000</p></td><td><p>400 000</p></td><td><p> </p></td><td><p> </p></td><td><p>400 000</p></td><td><p>400 000</p></td></tr><tr><td><p> </p></td><td><p><span>Title 3 — Total</span></p></td><td><p><span>4 333 431</span></p></td><td><p><span>4 333 431</span></p></td><td><p> </p></td><td><p> </p></td><td><p><span>4 333 431</span></p></td><td><p><span>4 333 431</span></p></td></tr><tr><td><p><span>4</span></p></td><td><p><span>EARMARKED EXPENDITURE</span></p></td></tr><tr><td><p>4 2</p></td><td><p>COOPERATION WITH OTHER EUROPEAN INSTITUTIONS AND BODIES</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p>Differentiated appropriations</p></td><td><p>2 000 000</p></td><td><p>2 000 000</p></td><td><p>3 175 000</p></td><td><p>3 175 000</p></td><td><p>5 175 000</p></td><td><p>5 175 000</p></td></tr><tr><td><p>4 3</p></td><td><p>COOPERATION WITH NATIONAL INSTITUTIONS</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p>Differentiated appropriations</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p><span>Title 4 — Total</span></p></td><td><p><span>2 000 000</span></p></td><td><p><span>2 000 000</span></p></td><td><p><span>3 175 000</span></p></td><td><p><span>3 175 000</span></p></td><td><p><span>5 175 000</span></p></td><td><p><span>5 175 000</span></p></td></tr><tr><td><p><span>8</span></p></td><td><p><span>EUROPEAN UNION CONTRIBUTION IN KIND</span></p></td></tr><tr><td><p>8 0</p></td><td><p>EUROPEAN UNION CONTRIBUTION IN KIND</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p>Differentiated appropriations</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p><span>Title 8 — Total</span></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p><span>9</span></p></td><td><p><span>EXPENSES NOT SPECIFICALLY PROVIDED FOR</span></p></td></tr><tr><td><p>9 9</p></td><td><p>EXPENSES NOT SPECIFICALLY PROVIDED FOR</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p>Differentiated appropriations</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p><span>Title 9 — Total</span></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p><span>10</span></p></td><td><p><span>RESULTS OF EARLIER YEARS</span></p></td></tr><tr><td><p>10 1</p></td><td><p>RESULTS OF EARLIER YEARS</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p>Differentiated appropriations</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p> </p></td><td><p><span>Title 10 — Total</span></p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr/><tr/><tr><td><p> </p></td><td><p><span>GRAND TOTAL</span></p></td><td><p><span>24 687 956</span></p></td><td><p><span>24 687 956</span></p></td><td><p><span>3 175 000</span></p></td><td><p><span>3 175 000</span></p></td><td><p><span>27 862 956</span></p></td><td><p><span>27 862 956</span></p></td></tr></tbody></table>
Remarks
The likely schedule of payments vis-à-vis commitments is as follows:
<table><col/><col/><col/><col/><tbody><tr><td><p> </p></td><td><p> </p></td><td><p>Payments</p></td></tr><tr/><tr/><tr><td><p>Commitments</p></td><td><p> </p></td><td><p>2023</p></td><td><p>2024</p></td></tr><tr><td><p>Pre-2023 Commitments still outstanding</p></td><td><p>150 000</p></td><td><p>150 000</p></td><td><p>—</p></td></tr><tr><td><p>Appropriations 2023</p></td><td><p><span>375 000</span></p></td><td><p>225 000</p></td><td><p>150 000</p></td></tr><tr><td><p>Total</p></td><td><p>525 000</p></td><td><p><span>375 000</span></p></td><td><p>150 000</p></td></tr></tbody></table>
Remarks
The likely schedule of payments vis-à-vis commitments is as follows:
<table><col/><col/><col/><col/><tbody><tr><td><p> </p></td><td><p> </p></td><td><p>Payments</p></td></tr><tr/><tr/><tr><td><p>Commitments</p></td><td><p> </p></td><td><p>2023</p></td><td><p>2024</p></td></tr><tr><td><p>Pre-2023 Commitments still outstanding</p></td><td><p>1 700 000</p></td><td><p>1 700 000</p></td><td><p>—</p></td></tr><tr><td><p>Appropriations 2023</p></td><td><p><span>3 558 431</span></p></td><td><p>1 858 431</p></td><td><p>1 700 000</p></td></tr><tr><td><p>Total</p></td><td><p>5 258 431</p></td><td><p><span>3 558 431</span></p></td><td><p>1 700 000</p></td></tr></tbody></table>
Remarks
The likely schedule of payments vis-à-vis commitments is as follows:
<table><col/><col/><col/><col/><tbody><tr><td><p> </p></td><td><p> </p></td><td><p>Payments</p></td></tr><tr/><tr/><tr><td><p>Commitments</p></td><td><p> </p></td><td><p>2023</p></td><td><p>2024</p></td></tr><tr><td><p>Pre-2023 Commitments still outstanding</p></td><td><p>40 000</p></td><td><p>40 000</p></td><td><p>—</p></td></tr><tr><td><p>Appropriations 2023</p></td><td><p><span>400 000</span></p></td><td><p>360 000</p></td><td><p>40 000</p></td></tr><tr><td><p>Total</p></td><td><p>440 000</p></td><td><p><span>400 000</span></p></td><td><p>40 000</p></td></tr></tbody></table>
Establishment plan
<table><col/><col/><col/><col/><col/><tbody><tr><td><p>Function group and grade</p></td><td><p>European Training Foundation (ETF)</p></td></tr><tr><td><p>2023</p></td><td><p>2022</p></td></tr><tr><td><p>Authorized under the Union budget</p></td><td><p>Authorized under the Union budget</p></td></tr><tr><td><p>Permanent posts</p></td><td><p>Temporary posts</p></td><td><p>Permanent posts</p></td><td><p>Temporary posts</p></td></tr><tr/><tr/><tr><td><p>AD 16</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>AD 15</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>AD 14</p></td><td><p>—</p></td><td><p>1</p></td><td><p>—</p></td><td><p>1</p></td></tr><tr><td><p>AD 13</p></td><td><p>—</p></td><td><p>5</p></td><td><p>—</p></td><td><p>5</p></td></tr><tr><td><p>AD 12</p></td><td><p>—</p></td><td><p>11</p></td><td><p>—</p></td><td><p>11</p></td></tr><tr><td><p>AD 11</p></td><td><p>—</p></td><td><p>10</p></td><td><p>—</p></td><td><p>10</p></td></tr><tr><td><p>AD 10</p></td><td><p>—</p></td><td><p>10</p></td><td><p>—</p></td><td><p>10</p></td></tr><tr><td><p>AD 9</p></td><td><p>—</p></td><td><p>12</p></td><td><p>—</p></td><td><p>12</p></td></tr><tr><td><p>AD 8</p></td><td><p>—</p></td><td><p>5</p></td><td><p>—</p></td><td><p>5</p></td></tr><tr><td><p>AD 7</p></td><td><p>—</p></td><td><p>4</p></td><td><p>—</p></td><td><p>4</p></td></tr><tr><td><p>AD 6</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>AD 5</p></td><td><p>—</p></td><td><p>1</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>Subtotal AD</p></td><td><p>—</p></td><td><p>59</p></td><td><p>—</p></td><td><p>58</p></td></tr><tr><td><p>AST 11</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>AST 10</p></td><td><p>—</p></td><td><p>2</p></td><td><p>—</p></td><td><p>3</p></td></tr><tr><td><p>AST 9</p></td><td><p>—</p></td><td><p>13</p></td><td><p>—</p></td><td><p>13</p></td></tr><tr><td><p>AST 8</p></td><td><p>—</p></td><td><p>6</p></td><td><p>—</p></td><td><p>6</p></td></tr><tr><td><p>AST 7</p></td><td><p>—</p></td><td><p>4</p></td><td><p>—</p></td><td><p>4</p></td></tr><tr><td><p>AST 6</p></td><td><p>—</p></td><td><p>2</p></td><td><p>—</p></td><td><p>2</p></td></tr><tr><td><p>AST 5</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>AST 4</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>AST 3</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>AST 2</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>AST 1</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>Subtotal AST</p></td><td><p>—</p></td><td><p>27</p></td><td><p>—</p></td><td><p>28</p></td></tr><tr><td><p>AST/SC 6</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>AST/SC 5</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>AST/SC 4</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>AST/SC 3</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>AST/SC 2</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>AST/SC 1</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p>Subtotal AST/SC</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td><td><p>—</p></td></tr><tr><td><p><span>Total</span></p></td><td><p><span>—</span></p></td><td><p><span>86</span></p></td><td><p><span>—</span></p></td><td><p><span>86</span></p></td></tr><tr><td><p><span>Grand Total</span></p></td><td><p><span>86</span></p></td><td><p><span>86</span></p></td></tr></tbody></table> | ENG | 32023B0731(01) |
<table><col/><col/><col/><col/><tbody><tr><td><p>27.2.2016   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 52/27</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2016/279
of 26 February 2016
establishing the standard import values for determining the entry price of certain fruit and vegetables
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 ( 1 ) ,
Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors ( 2 ) , and in particular Article 136(1) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the<span>Official Journal of the European Union</span>,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
The standard import values referred to in Article 136 of Implementing Regulation (EU) No 543/2011 are fixed in the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 26 February 2016.
For the Commission,
On behalf of the President,
Jerzy PLEWA
Director-General for Agriculture and Rural Development
( 1 ) OJ L 347, 20.12.2013, p. 671 .
( 2 ) OJ L 157, 15.6.2011, p. 1 .
ANNEX
Standard import values for determining the entry price of certain fruit and vegetables
<table><col/><col/><col/><tbody><tr><td><p>(EUR/100 kg)</p></td></tr><tr><td><p>CN code</p></td><td><p>Third country code<a> (<span>1</span>)</a></p></td><td><p>Standard import value</p></td></tr><tr><td><p>0702 00 00</p></td><td><p>IL</p></td><td><p>236,2</p></td></tr><tr><td><p>MA</p></td><td><p>83,8</p></td></tr><tr><td><p>SN</p></td><td><p>149,8</p></td></tr><tr><td><p>TN</p></td><td><p>116,3</p></td></tr><tr><td><p>TR</p></td><td><p>109,4</p></td></tr><tr><td><p>ZZ</p></td><td><p>139,1</p></td></tr><tr><td><p>0707 00 05</p></td><td><p>JO</p></td><td><p>206,0</p></td></tr><tr><td><p>MA</p></td><td><p>83,5</p></td></tr><tr><td><p>TR</p></td><td><p>171,2</p></td></tr><tr><td><p>ZZ</p></td><td><p>153,6</p></td></tr><tr><td><p>0709 91 00</p></td><td><p>TN</p></td><td><p>173,6</p></td></tr><tr><td><p>ZZ</p></td><td><p>173,6</p></td></tr><tr><td><p>0709 93 10</p></td><td><p>MA</p></td><td><p>42,6</p></td></tr><tr><td><p>TR</p></td><td><p>105,5</p></td></tr><tr><td><p>ZZ</p></td><td><p>74,1</p></td></tr><tr><td><p>0805 10 20</p></td><td><p>EG</p></td><td><p>47,0</p></td></tr><tr><td><p>IL</p></td><td><p>78,2</p></td></tr><tr><td><p>MA</p></td><td><p>56,1</p></td></tr><tr><td><p>TN</p></td><td><p>56,9</p></td></tr><tr><td><p>TR</p></td><td><p>63,4</p></td></tr><tr><td><p>ZZ</p></td><td><p>60,3</p></td></tr><tr><td><p>0805 20 10</p></td><td><p>IL</p></td><td><p>112,1</p></td></tr><tr><td><p>MA</p></td><td><p>84,8</p></td></tr><tr><td><p>TR</p></td><td><p>84,6</p></td></tr><tr><td><p>ZZ</p></td><td><p>93,8</p></td></tr><tr><td><p>0805 20 30, 0805 20 50, 0805 20 70, 0805 20 90</p></td><td><p>IL</p></td><td><p>136,2</p></td></tr><tr><td><p>JM</p></td><td><p>161,2</p></td></tr><tr><td><p>MA</p></td><td><p>110,7</p></td></tr><tr><td><p>TR</p></td><td><p>68,2</p></td></tr><tr><td><p>US</p></td><td><p>146,9</p></td></tr><tr><td><p>ZZ</p></td><td><p>124,6</p></td></tr><tr><td><p>0805 50 10</p></td><td><p>EG</p></td><td><p>90,7</p></td></tr><tr><td><p>MA</p></td><td><p>85,9</p></td></tr><tr><td><p>TR</p></td><td><p>96,6</p></td></tr><tr><td><p>ZZ</p></td><td><p>91,1</p></td></tr><tr><td><p>0808 10 80</p></td><td><p>CL</p></td><td><p>93,2</p></td></tr><tr><td><p>US</p></td><td><p>128,0</p></td></tr><tr><td><p>ZZ</p></td><td><p>110,6</p></td></tr><tr><td><p>0808 30 90</p></td><td><p>CL</p></td><td><p>132,6</p></td></tr><tr><td><p>CN</p></td><td><p>90,6</p></td></tr><tr><td><p>TR</p></td><td><p>156,1</p></td></tr><tr><td><p>ZA</p></td><td><p>102,7</p></td></tr><tr><td><p>ZZ</p></td><td><p>120,5</p></td></tr></tbody></table>
<note>
( 1 ) Nomenclature of countries laid down by Commission Regulation (EU) No 1106/2012 of 27 November 2012 implementing Regulation (EC) No 471/2009 of the European Parliament and of the Council on Community statistics relating to external trade with non-member countries, as regards the update of the nomenclature of countries and territories ( OJ L 328, 28.11.2012, p. 7 ). Code ‘ZZ’ stands for ‘of other origin’.
</note> | ENG | 32016R0279 |
<table><col/><col/><col/><col/><tbody><tr><td><p>13.5.2020   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 150/1</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2020/639
of 12 May 2020
amending Implementing Regulation (EU) 2019/947 as regards standard scenarios for operations executed in or beyond the visual line of sight
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 216/2008 and (EC) No 552/2004 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 ( 1 ) , and in particular Article 57 thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Pursuant to Commission Implementing Regulation (EU) 2019/947 <a>(<span>2</span>)</a>, an unmanned aircraft system (‘UAS’) must comply with operational limitations set out in operational authorisations or in a standard scenario, established by that Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>On the basis of the experience of Member States, the European Union Aviation Safety Agency (EASA) developed two standard scenarios for the operations.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Standard scenario 1 (‘STS-01’) covers operations executed in visual line of sight (‘VLOS’), at a maximum height of 120 m over a controlled ground area in a populated environment using a CE class C5 UAS.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>Standard scenario 2 (‘STS-02’) covers operations that could be conducted beyond visual line of sight (‘BVLOS’), with the unmanned aircraft at a distance of not more than 2 km from the remote pilot with the presence of airspace observers, at a maximum height of 120 m over a controlled ground area in a sparsely populated environment, and using a CE class C6 UAS.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>Implementing Regulation (EU) 2019/947 should therefore be amended to include those standard scenarios.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>Where the probability of encountering manned aircraft is not low, Member States may establish geographical zones in such areas to prevent UAS operators from conducting operations under standard scenarios.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>A requirement for a minimum overall mark attesting that remote pilots have successfully completed the theoretical knowledge examination should be introduced.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>In order to improve the conspicuity of the unmanned aircraft flown at night, and in particular, to allow a person on the ground to easily distinguish the unmanned aircraft from a manned aircraft, a green flashing light should be activated on the unmanned aircraft.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>Well defined rules should apply to practical skill training and assessment of remote pilots operating under a standard scenario. That training and assessment should be provided by an entity recognised by the competent authority or by an UAS operator in compliance with requirements laid down in this Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>In case of cross-border operations or operations outside the Member State of registration by a holder of a light UAS operator certificate (LUC), the Member State of operation should receive information regarding the location or locations of the intended operation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>EASA prepared draft implementing rules and submitted them with Opinion No 05/2019 <a>(<span>3</span>)</a> pursuant to points (b) and (c) of Article 75(2) and with Article 76(1) of Regulation (EU) 2018/1139.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(12)</p></td><td><p>The measures provided for in this Regulation are in accordance with the opinion of the committee established in accordance with Article 127 of Regulation (EU) 2018/1139,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
Amendments to Implementing Regulation (EU) 2019/947
Implementing Regulation (EU) 2019/947 is amended as follows:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>in Article 2, the following points (24) to (34) are added:</p><table><col/><col/><tbody><tr><td><p>‘(24)</p></td><td><p>“unmanned aircraft observer” means a person, positioned alongside the remote pilot, who, by unaided visual observation of the unmanned aircraft, assists the remote pilot in keeping the unmanned aircraft in VLOS and safely conducting the flight;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(25)</p></td><td><p>“airspace observer” means a person who assists the remote pilot by performing unaided visual scanning of the airspace in which the unmanned aircraft is operating for any potential hazard in the air;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(26)</p></td><td><p>“command unit” (“CU”) means the equipment or system of equipment to control unmanned aircraft remotely as defined in point 32 of Article 3 of Regulation (EU) 2018/1139 which supports the control or the monitoring of the unmanned aircraft during any phase of flight, with the exception of any infrastructure supporting the command and control (C2) link service;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(27)</p></td><td><p>“C2 link service” means a communication service supplied by a third party, providing command and control between the unmanned aircraft and the CU;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(28)</p></td><td><p>“flight geography” means the volume(s) of airspace defined spatially and temporally in which the UAS operator plans to conduct the operation under normal procedures described in point (6)(c) of Appendix 5 to the Annex;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(29)</p></td><td><p>“flight geography area” means the projection of the flight geography on the surface of the earth;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(30)</p></td><td><p>“contingency volume” means the volume of airspace outside the flight geography where contingency procedures described in point (6)(d) of Appendix 5 to the Annex are applied;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(31)</p></td><td><p>“contingency area” means the projection of the contingency volume on the surface of the earth;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(32)</p></td><td><p>“operational volume” is the combination of the flight geography and the contingency volume;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(33)</p></td><td><p>“ground risk buffer” is an area over the surface of the earth, which surrounds the operational volume and that is specified in order to minimise the risk to third parties on the surface in the event of the unmanned aircraft leaving the operational volume;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(34)</p></td><td><p>“night” means the hours between the end of evening civil twilight and the beginning of morning civil twilight as defined in Implementing Regulation (EU) No 923/2012<a> (<span>*1</span>)</a>.</p></td></tr></tbody></table><p><a>(<span>*1</span>)</a>  Commission Implementing Regulation (EU) No 923/2012 of 26 September 2012 laying down the common rules of the air and operational provisions regarding services and procedures in air navigation and amending Implementing Regulation (EU) No 1035/2011 and Regulations (EC) No 1265/2007, (EC) No 1794/2006, (EC) No 730/2006, (EC) No 1033/2006 and (EU) No 255/2010 (<a>OJ L 281, 13.10.2012, p. 1</a>).’;"</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>paragraph 5 of Article 5 is replaced by the following:</p><div><p>‘5.   Where the UAS operator submits a declaration to the competent authority of the Member State of registration in accordance with point UAS.SPEC.020 laid down in Part B of the Annex for an operation complying with a standard scenario set out in Appendix 1 to that Annex, the UAS operator shall not be required to obtain an operational authorisation in accordance with paragraphs 1 to 4 of this Article and the procedure laid down in paragraph 5 of Article 12 shall apply. The UAS operator shall use the declaration referred to in Appendix 2 to that Annex.’;</p></div></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>in Article 13 a new paragraph 4 is added:</p><div><p>‘4.   Where a UAS operator holding an LUC with privileges in accordance with point UAS.LUC.060 of the Annex intends to conduct an operation in the “specific category” taking place partially or entirely in the airspace of a Member State other than the Member State of registration, the UAS operator shall provide the competent authority of the Member State of intended operation with the following information:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>a copy of the term of approval received in accordance with point UAS.LUC.050 of the Annex; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the location or locations of the intended operation in accordance with paragraph 1(b) of this Article.’;</p></td></tr></tbody></table></div></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>in Article 14, the following paragraph 9 is added:</p><div><p>‘9.   In addition to the data defined in point (2) Member States may collect additional identity information from the UAS operators.’;</p></div></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>in Article 15, point (a) of paragraph 1 is replaced by the following:</p><table><col/><col/><tbody><tr><td><p>‘(a)</p></td><td><p>prohibit certain or all UAS operations, request particular conditions for certain or all UAS operations or require a prior flight authorisation for certain or all UAS operations;’;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>Article 22 is replaced by the following:</p><div><p>‘Article 22</p><p>Without prejudice to Article 20, the use of UAS in the “open” category which do not comply with the requirements of Parts 1 to 5 of the Annex to Commission Delegated Regulation (EU) 2019/945<a> (<span>*2</span>)</a> shall be allowed for a transitional period of two years starting one year after the date of entry into force of this Regulation, subject to the following conditions:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>unmanned aircraft with a take-off mass of less than 500 g are operated within the operational requirements set out in points UAS.OPEN.020(1) of Part A of the Annex by a remote pilot having competency level defined by the Member State concerned;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>unmanned aircraft with a take-off mass of less than 2 kg is operated by keeping a minimum horizontal distance of 50 meters from people and the remote pilots have a competency level at least equivalent to the one set out in point UAS.OPEN.030(2) of Part A of the Annex;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>unmanned aircraft with a take-off mass of less than 25 kg is operated within the operational requirements set out in point UAS.OPEN.040(1) and (2) and the remote pilots have a competency level at least equivalent to the one set out in point UAS.OPEN.020(4)(b) of Part A of the Annex.</p></td></tr></tbody></table></div><p><a>(<span>*2</span>)</a>  Commission Delegated Regulation (EU) 2019/945 of 12 March 2019 on unmanned aircraft systems and on third-country operators of unmanned aircraft systems (<a>OJ L 152, 11.6.2019, p. 1</a>).’;"</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>Article 23 is replaced by the following:</p><div><p>‘Article 23</p><div><p>1.   This Regulation shall enter into force on the twentieth day following that of its publication in the<span>Official Journal of the European Union</span>.</p><p>It shall apply from 1 July 2020.</p></div><div><p>2.   Paragraph 5 of Article 5 and point (1)(l) of point UAS.SPEC.050 shall apply from 2 December 2021;</p></div><div><p>3.   Point (2)(g) of point UAS.OPEN.060 shall apply from 1 July 2022.</p></div><div><p>4.   Without prejudice to paragraph 1 of Article 21, until 2 December 2021 Member States may accept declarations made by UAS operators in accordance with paragraph 5 of Article 5, based on national standard scenarios or equivalent, if those national scenarios meet the requirements of point UAS.SPEC.020 of the Annex.</p><p>Such declarations shall cease to be valid from 2 December 2023.</p></div><div><p>5.   Paragraph 3 of Article 15 shall apply from 1 July 2021.’;</p></div></div></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>the Annex is replaced by the Annex to this Regulation.</p></td></tr></tbody></table>
Article 2
Entry into force and application
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 12 May 2020.
For the Commission
The President
Ursula VON DER LEYEN
( 1 ) OJ L 212, 22.8.2018, p. 1 .
( 2 ) Commission Implementing Regulation (EU) 2019/947 of 24 May 2019 on the rules and procedures for the operation of unmanned aircraft ( OJ L 152, 11.6.2019, p. 45 ).
( 3 ) https://www.easa.europa.eu/document-library/opinions
ANNEX
UAS OPERATIONS IN THE ‘OPEN’ AND ‘SPECIFIC’ CATEGORIES
PART A
UAS OPERATIONS IN THE ‘OPEN’ CATEGORY
UAS.OPEN.010 General provisions
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>The category of UAS ‘open’ operations is divided into three subcategories A1, A2 and A3, on the basis of operational limitations, requirements for the remote pilot and technical requirements for UAS.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>Where the UAS operation involves the flight of the unmanned aircraft starting from a natural elevation in the terrain or over terrain with natural elevations, the unmanned aircraft shall be maintained within 120 metres from the closest point of the surface of the earth. The measurement of distances shall be adapted accordingly to the geographical characteristics of the terrain, such as plains, hills, mountains.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>When flying an unmanned aircraft within a horizontal distance of 50 metres from an artificial obstacle taller than 105 metres, the maximum height of the UAS operation may be increased up to 15 metres above the height of the obstacle at the request of the entity responsible for the obstacle.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>By way of derogation from point (2), unmanned sailplanes with a MTOM, including payload, of less than 10 kg, may be flown at a distance in excess of 120 metres from the closest point of the surface of the earth, provided that the unmanned sailplane is not flown at a height greater than 120 metres above the remote pilot at any time.</span></td></tr></tbody></table>
UAS.OPEN.020 UAS operations in subcategory A1
UAS operations in subcategory A1 shall comply with all of the following conditions:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>for unmanned aircraft referred to in point (5)(d), be conducted in such a way that a remote pilot of the unmanned aircraft does not overfly assemblies of people and reasonably expects that no uninvolved person will be overflown. In the event of unexpected overflight of uninvolved persons, the remote pilot shall reduce as much as possible the time during which the unmanned aircraft overflies those persons;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>in the case of an unmanned aircraft referred to in points (5)(a), (5)(b) and (5)(c), be conducted in such a way that the remote pilot of the unmanned aircraft may overfly uninvolved persons, but shall never overfly assemblies of people;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>by way of derogation from point (d) of paragraph 1 of Article 4, be conducted, when the follow-me mode is active, up to a distance of 50 metres from the remote pilot;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>be performed by a remote pilot who:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>is familiar with manufacturer’s instructions provided by the manufacturer of the UAS;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>in the case of an unmanned aircraft class C1, as defined in Part 2 of the Annex to Delegated Regulation (EU) 2019/945, has completed an online training course followed by completing successfully an online theoretical knowledge examination provided by the competent authority or by an entity designated by the competent authority of a Member State achieving at least 75% of the overall marks. The examination shall comprise 40 multiple-choice questions distributed appropriately across the following subjects:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>air safety;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>airspace restrictions;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>aviation regulation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iv)</p></td><td><p>human performance limitations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(v)</p></td><td><p>operational procedures;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(vi)</p></td><td><p>UAS general knowledge;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(vii)</p></td><td><p>privacy and data protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(viii)</p></td><td><p>insurance;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ix)</p></td><td><p>security.</p></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>be performed with an unmanned aircraft that:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>has an MTOM, including payload, of less than 250 g and a maximum operating speed of less than 19 m/s, in the case of a privately built UAS; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>meets the requirements defined in point (a) of Article 20;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>is marked as class C0 and complies with the requirements of that class, as defined in Part 1 of the Annex to Delegated Regulation (EU) 2019/945; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>is marked as class C1 and complies with the requirements of that class, as defined in Part 2 of the Annex to Delegated Regulation (EU) 2019/945 and is operated with active and updated direct remote identification system and geo-awareness function.</p></td></tr></tbody></table></td></tr></tbody></table>
UAS.OPEN.030 UAS operations in subcategory A2
UAS operations in subcategory A2 shall comply with all of the following conditions:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>be conducted in such a way that the unmanned aircraft does not overfly uninvolved persons and the UAS operations take place at a safe horizontal distance of at least 30 metres from them; the remote pilot may reduce the horizontal safety distance down to a minimum of 5 metres from an uninvolved person when operating an unmanned aircraft with an active low speed mode function and after evaluation of the situation regarding:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>weather conditions,</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>performance of the unmanned aircraft,</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>segregation of the overflown area.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>be performed by a remote pilot who is familiar with manufacturer’s instructions provided by the manufacturer of the UAS and holds a certificate of remote pilot competency issued by the competent authority or by an entity designated by the competent authority of a Member State. This certificate shall be obtained after complying with all of the following conditions and in the order indicated:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>completing an online training course and passed the online theoretical knowledge examination as referred to in point (4)(b) of point UAS.OPEN.020;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>completing a self-practical training in the operating conditions of the subcategory A3 set out in points (1) and (2) of point UAS.OPEN.040;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>declaring the completion of the self-practical training defined in point (b) and passing an additional theoretical knowledge examination provided by the competent authority or at an entity designated by the competent authority of a Member State achieving at least 75% of the overall marks. The examination shall comprise at least 30 multiple-choice questions aimed at assessing the remote pilot’s knowledge of the technical and operational mitigations for ground risk, distributed appropriately across the following subjects:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>meteorology;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>UAS flight performance;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>technical and operational mitigations for ground risk.</p></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>be performed with an unmanned aircraft which is marked as class C2 and complies with the requirements of that class, as defined in Part 3 of the Annex to Delegated Regulation (EU) 2019/945, and is operated with active and updated direct remote identification system and geo-awareness function.</p></td></tr></tbody></table>
UAS.OPEN.040 UAS operations in subcategory A3
UAS operations in subcategory A3 shall comply with all of the following conditions:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>be conducted in an area where the remote pilot reasonably expects that no uninvolved person will be endangered within the range where the unmanned aircraft is flown during the entire time of the UAS operation;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>be conducted at a safe horizontal distance of at least 150 metres from residential, commercial, industrial or recreational areas;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>be performed by a remote pilot who is familiar with manufacturer’s instructions provided by the manufacturer of the UAS and who has completed an online training course and passed an online theoretical knowledge examination as defined in point (4)(b) of point UAS.OPEN.020;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>be performed with an unmanned aircraft that:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>has an MTOM, including payload, of less than 25 kg, in the case of a privately built UAS, or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>meets the requirements defined in point (b) of Article 20;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>is marked as class C2 and complies with the requirements of that class, as defined in Part 3 of the Annex to Delegated Regulation (EU) 2019/945 and is operated with active and updated direct remote identification system and geo-awareness function or;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>is marked as class C3 and complies with the requirements of that class, as defined in Part 4 of the Annex to Delegated Regulation (EU) 2019/945 and is operated with active and updated direct remote identification system and geo-awareness function; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>is marked as class C4 and complies with the requirements of that class, as defined in Part 5 of the Annex to Delegated Regulation (EU) 2019/945.</p></td></tr></tbody></table></td></tr></tbody></table>
UAS.OPEN.050 Responsibilities of the UAS operator
The UAS operator shall comply with all of the following:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>develop operational procedures adapted to the type of operation and the risk involved;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>ensure that all operations effectively use and support the efficient use of radio spectrum in order to avoid harmful interference;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>designate a remote pilot for each flight;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>ensure that remote pilots and all other personnel performing a task in support of the operations are familiar with manufacturer’s instructions provided by the manufacturer of the UAS, and:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>have appropriate competency in the subcategory of the intended UAS operations in accordance with points UAS.OPEN.020, UAS.OPEN.030 or UAS.OPEN.040 to perform their tasks or, for personnel other than the remote pilot, have completed an on-the-job-training course developed by the operator;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>are fully familiar with the UAS operator’s procedures;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>are provided with the information relevant to the intended UAS operation concerning any geographical zones published by the Member State of operation in accordance with Article 15;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>update the information into the geo-awareness system when applicable according to the intended location of operation;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>in the case of an operation with an unmanned aircraft of one of the classes defined in Parts 1 to 5 of the Annex of Delegated Regulation (EU) 2019/945, ensure that the UAS is:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>accompanied by the corresponding EU declaration of conformity, including the reference to the appropriate class; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the related class identification label is affixed to the unmanned aircraft.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>Ensure in the case of an UAS operation in subcategory A2 or A3, that all involved persons present in the area of the operation have been informed of the risks and have explicitly agreed to participate.</p></td></tr></tbody></table>
UAS.OPEN.060 Responsibilities of the remote pilot
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Before starting an UAS operation, the remote pilot shall:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>have the appropriate competency in the subcategory of the intended UAS operations in accordance with points UAS.OPEN.020, UAS.OPEN.030 or UAS.OPEN.040 to perform its task and carry a proof of competency while operating the UAS, except when operating an unmanned aircraft referred to in points (5)(a), (5)(b) or (5)(c) of point UAS.OPEN.020;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>obtain updated information relevant to the intended UAS operation about any geographical zone published by the Member State of operation in accordance with Article 15;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>observe the operating environment, check the presence of obstacles and, unless operating in subcategory A1 with an unmanned aircraft referred to in points (5)(a), (5)(b) or (5)(c) of point UAS.OPEN.020, check the presence of any uninvolved person;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>ensure that the UAS is in a condition to safely complete the intended flight, and if applicable, check if the direct remote identification is active and up-to-date;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>if the UAS is fitted with an additional payload, verify that its mass does not exceed neither the MTOM defined by the manufacturer or the MTOM limit of its class.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>During the flight, the remote pilot shall:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>not perform duties under the influence of psychoactive substances or alcohol or when it is unfit to perform its tasks due to injury, fatigue, medication, sickness or other causes;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>keep the unmanned aircraft in VLOS and maintain a thorough visual scan of the airspace surrounding the unmanned aircraft in order to avoid any risk of collision with any manned aircraft. The remote pilot shall discontinue the flight if the operation poses a risk to other aircraft, people, animals, environment or property;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>comply with the operational limitations in geographical zones defined in accordance with Article 15;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>have the ability to maintain control of the unmanned aircraft, except in the case of a lost link or when operating a free-flight unmanned aircraft;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>operate the UAS in accordance with manufacturer’s instructions provided by the manufacturer, including any applicable limitations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>comply with the operator’s procedures when available;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>when operating at night, ensure that a green flashing light on the unmanned aircraft is activated.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>During the flight, remote pilots and UAS operators shall not fly close to or inside areas where an emergency response effort is ongoing unless they have permission to do so from the responsible emergency response services.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>For the purposes of point (2)(b), remote pilots may be assisted by an unmanned aircraft observer. In such case, clear and effective communication shall be established between the remote pilot and the unmanned aircraft observer.</p></td></tr></tbody></table>
UAS.OPEN.070 Duration and validity of the remote pilot online theoretical competency and certificates of remote pilot competency
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>The remote pilot online theoretical competency, required by points (4)(b) of point UAS.OPEN.020 and point (3) of point UAS.OPEN.040, and the certificate of remote pilot competency, required by point (2) of point UAS.OPEN.030, shall be valid for five years.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The revalidation of the remote pilot online theoretical competency and of the certificate of remote pilot competency is, within its validity period, subject to:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>a demonstration of competencies respectively in accordance with point (4)(b) of point UAS.OPEN.020 or point (2) of point UAS.OPEN.030; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the completion of a refresher training addressing respectively the theoretical knowledge subjects as defined in point (4)(b) of point UAS.OPEN.020 or point (2) of point UAS.OPEN.030 provided by the competent authority or by an entity designated by the competent authority.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>In order to revalidate the remote pilot online theoretical competency or the certificate of remote pilot competency upon its expiration, the remote pilot shall comply with point (2)(a).</p></td></tr></tbody></table>
PART B
UAS OPERATIONS IN THE ‘SPECIFIC’ CATEGORY
UAS.SPEC.010 General provisions
The UAS operator shall provide the competent authority with an operational risk assessment for the intended operation in accordance with Article 11, or submit a declaration when point UAS.SPEC.020 is applicable, unless the operator holds a light UAS operator certificate (LUC) with the appropriate privileges, in accordance with Part C of this Annex. The UAS operator shall regularly evaluate the adequacy of the mitigation measures taken and update them where necessary.
UAS.SPEC.020 Operational declaration
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>In accordance with Article 5, the UAS operator may submit an operational declaration of compliance with a standard scenario as defined in Appendix 1 to this Annex to the competent authority of the Member State of registration as an alternative to points UAS.SPEC.30 and UAS.SPEC.40 in relation to operations:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>of unmanned aircraft with:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>maximum characteristic dimension up to 3 metres in VLOS over controlled ground area except over assemblies of people,</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>maximum characteristic dimension up to 1 metre in VLOS except over assemblies of people;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>maximum characteristic dimension up to 1 metre in BVLOS over sparsely populated areas;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iv)</p></td><td><p>maximum characteristic dimension up to 3 metres in BVLOS over controlled ground area.</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>performed below 120 metres from the closest point of the surface of the earth, and:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>in uncontrolled airspace (class F or G) unless different limitations are provided by Member States through UAS geographical zones in areas where the probability of encountering manned aircraft is not low; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>in controlled airspace, in accordance with published procedures for the area of operation, so that a low probability of encountering manned aircraft is ensured.</p></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>A declaration of UAS operators shall contain:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>administrative information about the UAS operator;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>a statement that the operation satisfies the operational requirement set out in point (1) and a standard scenario as defined in Appendix 1 to the Annex;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the commitment of the UAS operator to comply with the relevant mitigation measures required for the safety of the operation, including the associated instructions for the operation, for the design of the unmanned aircraft and the competency of involved personnel.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>confirmation by the UAS operator that an appropriate insurance cover will be in place for every flight made under the declaration, if required by Union or national law.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Upon receipt of the declaration, the competent authority shall verify that the declaration contains all the elements listed in point (2) and shall provide the UAS operator with a confirmation of receipt and completeness without undue delay.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>After receiving the confirmation of receipt and completeness, the UAS operator is entitled to start the operation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>UAS operators shall notify, without any delay, the competent authority of any change to the information contained in the operational declaration that they submitted.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>UAS operators holding an LUC with appropriate privileges, in accordance with Part C of this Annex, are not required to submit the declaration.</p></td></tr></tbody></table>
UAS.SPEC.030 Application for an operational authorisation
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Before starting an UAS operation in the ‘specific’ category the UAS operator shall obtain an operational authorisation from the national competent authority of the Member State of registration, except:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>when point UAS.SPEC.020 is applicable; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the UAS operator holds an LUC with the appropriate privileges, in accordance with Part C of this Annex.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The UAS operator shall submit an application for an updated operational authorisation if there are any significant changes to the operation or to the mitigation measures listed in the operational authorisation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>The application for an operational authorisation shall be based on the risk assessment referred to in Article 11 and shall include in addition the following information:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the registration number of the UAS operator;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the name of the accountable manager or the name of the UAS operator in the case of a natural person;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the operational risk assessment;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>the list of mitigation measures proposed by the UAS operator, with sufficient information for the competent authority to assess the adequacy of the mitigation means to address the risks;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>an operations manual when required by the risk and complexity of the operation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>a confirmation that an appropriate insurance cover will be in place at the start of the UAS operations, if required by Union or national law.</p></td></tr></tbody></table></td></tr></tbody></table>
UAS.SPEC.040 Issuing of an operational authorisation
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>When receiving an application in accordance with point UAS.SPEC.030, the competent authority shall issue, without undue delay, an operational authorisation in accordance with Article 12 when it concludes that the operation meets the following conditions:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>all information in accordance with point (3) of point UAS.SPEC.030 is provided;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>a procedure is in place for coordination with the relevant service provider for the airspace if the entire operation, or part of it, is to be conducted in controlled airspace.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The competent authority shall specify in the operational authorisation the exact scope of the authorisation in accordance with Article 12.</p></td></tr></tbody></table>
UAS.SPEC.050 Responsibilities of the UAS operator
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>The UAS operator shall comply with all of the following:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>establish procedures and limitations adapted to the type of the intended operation and the risk involved, including:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>operational procedures to ensure the safety of the operations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>procedures to ensure that security requirements applicable to the area of operations are complied with in the intended operation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>measures to protect against unlawful interference and unauthorised access;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iv)</p></td><td><p>procedures to ensure that all operations are in respect of Regulation (EU) 2016/679 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data. In particular it shall carry out a data protection impact assessment, when required by the National Authority for data protection in application of Article 35 of Regulation (EU) 2016/679;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(v)</p></td><td><p>guidelines for its remote pilots to plan UAS operations in a manner that minimises nuisances, including noise and other emissions-related nuisances, to people and animals.</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>designate a remote pilot for each flight or, in the case of autonomous operations, ensure that during all phases of the flight, responsibilities and tasks especially those defined in points (2) and (3) of point UAS.SPEC.060 are properly allocated in accordance with the procedures established pursuant to point (a);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>ensure that all operations effectively use and support the efficient use of radio spectrum in order to avoid harmful interference;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>ensure that before conducting operations, remote pilots comply with all of the following conditions:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>have the competency to perform their tasks in line with the applicable training identified by the operational authorisation or, if point UAS.SPEC.020 applies, by the conditions and limitations defined in the appropriate standard scenario listed in Appendix 1 or as defined by the LUC;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>follow remote pilot training which shall be competency based and include the competencies set out in paragraph 2 of Article 8:</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>follow remote pilot training, as defined in the operational authorisation, for operations requiring such authorisation, it shall be conducted in cooperation with an entity designated by the competent authority;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iv)</p></td><td><p>follow remote pilot training for operations under declaration that shall be conducted in accordance with the mitigation measures defined by the standard scenario;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(v)</p></td><td><p>have been informed about the UAS operator’s operations manual, if required by the risk assessment and procedures established in accordance with point (a);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(vi)</p></td><td><p>obtain updated information relevant to the intended operation about any geographical zones defined in accordance with Article 15;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>ensure that personnel in charge of duties essential to the UAS operation, other than the remote pilot itself, comply with all of the following conditions:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>have completed the on-the-job-training developed by the operator;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>have been informed about the UAS operator’s operations manual, if required by the risk assessment, and about the procedures established in accordance with point (a);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>have obtained updated information relevant to the intended operation about any geographical zones defined in accordance with Article 15;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>carry out each operation within the limitations, conditions, and mitigation measures defined in the declaration or specified in the operational authorisation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>keep and maintain an up-to-date record of:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>all the relevant qualifications and training courses completed by the remote pilot and the other personnel in charge of duties essential to the UAS operation and by the maintenance staff, for at least 3 years after those persons have ceased employment with the organisation or have changed their position in the organisation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>the maintenance activities conducted on the UAS for a minimum of 3 years;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>the information on UAS operations, including any unusual technical or operational occurrences and other data as required by the declaration or by the operational authorisation for a minimum of 3 years;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(h)</p></td><td><p>use UAS which, as a minimum, are designed in such a manner that a possible failure will not lead the UAS to fly outside the operation volume or to cause a fatality. In addition, Man Machine interfaces shall be such to minimise the risk of pilot error and shall not cause unreasonable fatigue;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>maintain the UAS in a suitable condition for safe operation by:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>as a minimum, defining maintenance instructions and employing an adequately trained and qualified maintenance staff; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>complying with point UAS.SPEC.100, if required;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>using an unmanned aircraft which is designed to minimise noise and other emissions, taking into account the type of the intended operations and geographical areas where the aircraft noise and other emissions are of concern.</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(j)</p></td><td><p>establish and keep an up-to-date list of the designated remote pilots for each flight;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(k)</p></td><td><p>establish and keep an up-to-date list of the maintenance staff employed by the operator to carry out maintenance activities; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(l)</p></td><td><p>ensure that each individual unmanned aircraft is installed with:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>at least one green flashing light for the purpose of visibility of the unmanned aircraft at night, and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>an active and up-to-date remote identification system.</p></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table>
UAS.SPEC.060 Responsibilities of the remote pilot
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>The remote pilot shall:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>not perform duties under the influence of psychoactive substances or alcohol or when it is unfit to perform its tasks due to injury, fatigue, medication, sickness or other causes;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>have the appropriate remote pilot competency as defined in the operational authorisation, in the standard scenario defined in Appendix 1 or as defined by the LUC and carry a proof of competency while operating the UAS.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>be familiar with manufacturer’s instructions provided by the manufacturer of the UAS.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Before starting an UAS operation, the remote pilot shall comply with all of the following:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>obtain updated information relevant to the intended operation about any geographical zones defined in accordance with Article 15;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>ensure that the operating environment is compatible with the authorised or declared limitations and conditions;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>ensure that the UAS is in a safe condition to complete the intended flight safely, and if applicable, check if the direct remote identification is active and up-to-date;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>ensure that the information about the operation has been made available to the relevant air traffic service (ATS) unit, other airspace users and relevant stakeholders, as required by the operational authorisation or by the conditions published by the Member State for the geographical zone of operation in accordance with Article 15.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>During the flight, the remote pilot shall:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>comply with the authorised or declared limitations and conditions;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>avoid any risk of collision with any manned aircraft and discontinue a flight when continuing it may pose a risk to other aircraft, people, animals, environment or property;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>comply with the operational limitations in geographical zones defined in accordance with Article 15;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>comply with the operator’s procedures;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>not fly close to or inside areas where an emergency response effort is ongoing unless they have permission to do so from the responsible emergency response services.</p></td></tr></tbody></table></td></tr></tbody></table>
UAS.SPEC.070 Transferability of an operational authorisation
An operational authorisation is not transferable.
UAS.SPEC.080 Duration and validity of an operational authorisation
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>The competent authority shall specify the duration of the operational authorisation in the authorisation itself.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>Notwithstanding point (1), the operational authorisation remains valid as long as the UAS operator remains compliant with the relevant requirements of this Regulation and with the conditions defined in the operational authorisation.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>Upon revocation or surrender of the operational authorisation the UAS operator shall provide an acknowledgment in digital format that must be returned to the competent authority without delay.</span></td></tr></tbody></table>
UAS.SPEC.085 Duration and validity of an operational declaration:
The operational declaration shall have a limited duration of 2 years. The declaration shall no longer be considered as complete within the meaning of point (4) of point UAS.SPEC.020 if:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>during the oversight of the UAS operator, the competent authority has found that the UAS operation is not conducted in accordance with the operational declaration;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>the conditions of the UAS operation have changed to the extent that the operational declaration no longer complies with the applicable requirements of this Regulation;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>the competent authority is not granted access in accordance with point UAS.SPEC.090.</p></td></tr></tbody></table>
UAS.SPEC.090 Access
For the purpose of demonstrating compliance with this Regulation, an UAS operator shall grant to any person, that is duly authorised by the competent authority, an access to any facility, UAS, document, records, data, procedures or to any other material relevant to its activity, which is subject to operational authorisation or operational declaration, regardless of whether or not its activity is contracted or subcontracted to another organisation.
UAS.SPEC.100 Use of certified equipment and certified unmanned aircraft
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>If the UAS operation is using an unmanned aircraft for which a certificate of airworthiness or a restricted certificate of airworthiness have been issued, or using certified equipment, the UAS operator shall record the operation or service time in accordance either with the instructions and procedures applicable to the certified equipment, or with the organisational approval or authorisation.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>The UAS operator shall follow the instructions referred to in the unmanned aircraft certificate or equipment certificate, and also comply with any airworthiness or operational directives issued by the Agency.</span></td></tr></tbody></table>
PART C
LIGHT UAS OPERATOR CERTIFICATE (LUC)
UAS.LUC.010 General requirements for an LUC
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>A legal person is eligible to apply for an LUC under this Part.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>An application for an LUC or for an amendment to an existing LUC shall be submitted to the competent authority and shall contain all of the following information:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>a description of the UAS operator’s management system, including its organisational structure and safety management system;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the name(s) of the responsible UAS operator’s personnel, including the person responsible for authorising operations with UASs;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>a statement that all the documentation submitted to the competent authority has been verified by the applicant and found to comply with the applicable requirements.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>If the requirements of this Part are met, an LUC holder may be granted the privileges, in accordance with point UAS.LUC.060.</span></td></tr></tbody></table>
UAS.LUC.020 Responsibilities of the LUC holder
The LUC holder shall:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>comply with the requirements of points UAS.SPEC.050 and UAS.SPEC.060;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>comply with the scope and privileges defined in the terms of approval;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>establish and maintain a system for exercising operational control over any operation conducted under the terms of its LUC;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>carry out an operational risk assessment of the intended operation in accordance with Article 11 unless conducting an operation for which an operational declaration is sufficient according to point UAS.SPEC.020,</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>keep records of the following items in a manner that ensures protection from damage, alteration and theft for a period at least 3 years for operations conducted using the privileges specified under point UAS.LUC.060:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the operational risk assessment, when required according to point (4), and its supporting documentation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>mitigation measures taken; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the qualifications and experience of personnel involved in the UAS operation, compliance monitoring and safety management;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>keep personnel records referred to in point (5)(c) as long as the person works for the organisation and shall be retained until 3 years after the person has left the organisation.</p></td></tr></tbody></table>
UAS.LUC.030 Safety management system
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>An UAS operator who applies for an LUC shall establish, implement and maintain a safety management system corresponding to the size of the organisation, to the nature and complexity of its activities, taking into account the hazards and associated risks inherent in these activities.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>The UAS operator shall comply with all of the following:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>nominate an accountable manager with authority for ensuring that within the organisation all activities are performed in accordance with the applicable standards and that the organisation is continuously in compliance with the requirements of the management system and the procedures identified in the LUC manual referred to in point UAS.LUC.040;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>define clear lines of responsibility and accountability throughout the organisation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>establish and maintain a safety policy and related corresponding safety objectives;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>appoint key safety personnel to execute the safety policy;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>establish and maintain a safety risk management process including the identification of safety hazards associated with the activities of the UAS operator, as well as their evaluation and the management of associated risks, including taking action to mitigate those risks and verify the effectiveness of the action;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>promote safety in the organisation through:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>training and education;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>communication;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>document all safety management system key processes for making personnel aware of their responsibilities and of the procedure for amending this documentation; key processes include:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>safety reporting and internal investigations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>operational control;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>communication on safety;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iv)</p></td><td><p>training and safety promotion;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(v)</p></td><td><p>compliance monitoring;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(vi)</p></td><td><p>safety risk management;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(vii)</p></td><td><p>management of change;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(viii)</p></td><td><p>interface between organisations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ix)</p></td><td><p>use of sub-contractors and partners;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(h)</p></td><td><p>include an independent function to monitor the compliance and adequacy of the fulfilment of the relevant requirements of this Regulation, including a system to provide feedback of findings to the accountable manager to ensure effective implementation of corrective measures as necessary;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>include a function to ensure that safety risks inherent to a service or product delivered through subcontractors are assessed and mitigated under the operator’s safety management system.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>If the organisation holds other organisation certificates within the scope of Regulation (EU) 2018/1139, the safety management system of the UAS operator may be integrated with the safety management system that is required by any of those additional certificate(s).</span></td></tr></tbody></table>
UAS.LUC.040 LUC manual
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>An LUC holder shall provide the competent authority with an LUC manual describing directly or by cross reference its organisation, the relevant procedures and the activities carried out.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>The manual shall contain a statement signed by the accountable manager that confirms that the organisation will at all times work in accordance with this Regulation and with the approved LUC manual. When the accountable Manager is not the Chief Executive Officer of the organisation, the chief executive officer shall countersign the statement.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>If any activity is carried out by partner organisations or subcontractors, the UAS operator shall include in the LUC manual procedures on how the LUC holder shall manage the relationship with those partner organisations or subcontractors.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>The LUC manual shall be amended as necessary to retain an up-to-date description of the LUC holder’s organisation, and copies of amendments shall be provided to the competent authority.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(5)</p></td><td><span>The UAS operator shall distribute the relevant parts of the LUC manual to all its personnel in accordance with their functions and duties.</span></td></tr></tbody></table>
UAS.LUC.050 Terms of approval of the LUC holder
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>The competent authority shall issue an LUC after it is satisfied that the UAS operator complies with points UAS.LUC.020, UAS.LUC.030 and UAS.LUC.040.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>The LUC shall include:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the UAS operator identification;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the UAS operator’s privileges;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>authorised type(s) of operation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>the authorised area, zone or class of airspace for operations, if applicable;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>any special limitations or conditions, if applicable;</p></td></tr></tbody></table></td></tr></tbody></table>
UAS.LUC.060 Privileges of the LUC holder
When satisfied with the documentation provided, the competent authority:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>shall specify the terms and conditions of the privilege granted to the UAS operator in the LUC; and</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>may, within the terms of approval, grant to an LUC holder the privilege to authorise its own operations without:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>submitting an operational declaration;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>applying for an operational authorisation.</p></td></tr></tbody></table></td></tr></tbody></table>
UAS.LUC.070 Changes in the LUC management system
After an LUC is issued, the following changes require prior approval by the competent authority:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>any change in the terms of approval of the UAS operator;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>any significant change to the elements of the LUC holder’s safety management system as required by point UAS.LUC.030.</p></td></tr></tbody></table>
UAS.LUC.075 Transferability of an LUC
Except for the change to the ownership of the organisation, approved by the competent authority in accordance with point UAS.LUC.070, an LUC is not transferable.
UAS.LUC.080 Duration and validity of an LUC
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>An LUC shall be issued for an unlimited duration. It shall remain valid subject to:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the LUC holder’s continuous compliance with the relevant requirements of this Regulation and of the Member State that issued the certificate; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>it not being surrendered or revoked.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>Upon revocation or surrender of an LUC, the LUC holder shall provide an acknowledgment in digital format that must be returned to the competent authority without delay.</span></td></tr></tbody></table>
UAS.LUC.090 Access
For the purpose of demonstrating compliance with this Regulation, the LUC holder shall grant any person, that is duly authorised by the competent authority, an access to any facility, UAS, document, records, data, procedures or to any other material relevant to its activity, which is subject to certification, operational authorisation or operational declaration, regardless of whether or not its activity is contracted or subcontracted to another organisation.
Appendix 1
for standard scenarios supporting a declaration
CHAPTER I
STS-01 – VLOS over a controlled ground area in a populated environment
UAS.STS-01.010 General provisions
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>During flight, the unmanned aircraft shall be maintained within 120 m from the closest point of the surface of the earth. The measurement of distances shall be adapted accordingly to the geographical characteristics of the terrain, such as plains, hills, mountains.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>When flying an unmanned aircraft within a horizontal distance of 50 m from an artificial obstacle taller than 105 metres, the maximum height of the UAS operation may be increased up to 15 m above the height of the obstacle at the request of the entity responsible for the obstacle.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>The maximum height of the operational volume shall not exceed 30 m above the maximum height allowed in points (1) and (2).</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>During flight, the unmanned aircraft shall not carry dangerous goods.</span></td></tr></tbody></table>
UAS.STS-01.020 UAS operations in STS-01
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>UAS operations in STS-01 shall meet all of the following conditions:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>be conducted with the unmanned aircraft kept in VLOS at all times;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>be conducted in accordance with the operations manual referred to in point (1) of point UAS.STS-01.030;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>be conducted over a controlled ground area comprising:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>for the operation of an untethered unmanned aircraft:</p><table><col/><col/><tbody><tr><td><p>(A)</p></td><td><p>the flight geography area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(B)</p></td><td><p>the contingency area, with its external limit(s) at least 10 m beyond the limit(s) of the flight geography area; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(C)</p></td><td><p>the ground risk buffer, which shall cover a distance beyond the external limit(s) of the contingency area that meets at least the following parameters:</p><table><col/><col/><col/><tbody><tr><td><p> </p></td><td><p>Minimum distance to be covered by the ground risk buffer for untethered unmanned aircraft</p></td></tr><tr><td><p>Maximum height above ground</p></td><td><p>with an MTOM up to 10 kg</p></td><td><p>with an MTOM above 10 kg</p></td></tr><tr><td><p>30 m</p></td><td><p>10 m</p></td><td><p>20 m</p></td></tr><tr><td><p>60 m</p></td><td><p>15 m</p></td><td><p>30 m</p></td></tr><tr><td><p>90 m</p></td><td><p>20 m</p></td><td><p>45 m</p></td></tr><tr><td><p>120 m</p></td><td><p>25 m</p></td><td><p>60 m</p></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>for operation of a tethered unmanned aircraft, a radius equal to the tether length plus 5 m and centred on the point where the tether is fixed over the surface of the earth.</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>be conducted at a ground speed of less than 5 m/s in the case of untethered unmanned aircraft;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>be conducted by a remote pilot who:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>holds a certificate of remote pilot theoretical knowledge in accordance with Attachment A to this Chapter for operations in the standard scenarios issued by the competent authority or by an entity designated by the competent authority of a Member State;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>holds an accreditation of completion of the STS-01 practical skill training, in accordance with Attachment A to this Chapter and issued by:</p><table><col/><col/><tbody><tr><td><p>(A)</p></td><td><p>an entity that has declared compliance with the requirements in Appendix 3 and is recognised by the competent authority of a Member State; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(B)</p></td><td><p>an UAS operator that has declared to the competent authority of the Member State of registration, compliance with STS-01 and that has declared compliance with the requirements in Appendix 3; and</p></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>be conducted with an unmanned aircraft which is marked as class C5 and complies with the requirements of that class, as defined in Part 16 of the Annex to Delegated Regulation (EU) 2019/945, and is operated with active and updated direct remote identification system.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>The remote pilot shall obtain the certificate of theoretical knowledge for operations in the standard scenarios after:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>having completed an online training course and passed the online theoretical knowledge examination as referred to in point (4)(b) of point UAS.OPEN.020; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>having passed an additional theoretical knowledge examination provided by the competent authority or by an entity designated by the competent authority of a Member State in accordance with Attachment A to this Chapter.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>This certificate shall be valid for five years. The revalidation, within its validity period is subject to any of the following:</span><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the demonstration of competencies in accordance with point (2);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the completion of a refresher training addressing the theoretical knowledge subjects as defined in point (2) provided by the competent authority or by an entity designated by the competent authority.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>In order to revalidate the certificate upon its expiration, the remote pilot shall comply with point (2).</span></td></tr></tbody></table>
UAS.STS-01.030 Responsibilities of the UAS operator
In addition to the responsibilities defined in UAS.SPEC.050, the UAS operator shall:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>develop an operations manual including the elements defined in Appendix 5;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>define the operational volume and ground risk buffer for the intended operations, including the controlled ground area covering the projections on the surface of the earth within both the volume and the buffer;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>ensure the adequacy of the contingency and emergency procedures through any of the following:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>dedicated flight tests;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>simulations, provided that the representativeness of the simulation means is appropriate for the intended purpose;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>develop an effective emergency response plan (ERP) suitable for the operation that includes at least:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the plan to limit any escalating effects of the emergency situation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the conditions to alert the relevant authorities and organisations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the criteria to identify an emergency situation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>clear delineation of the duties of the remote pilot(s) and any other personnel in charge of duties essential to the UAS operation;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>ensure that the level of performance for any externally provided service necessary for the safety of the flight is adequate for the intended operation;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>define the allocation of the roles and responsibilities between the operator and the external service provider(s), if applicable;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>upload updated information into the geo-awareness, if the function is installed on the UAS, when required by the UAS geographical zone for the intended location of operation;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>ensure that, before starting the operation, the controlled ground area is in place, effective and compliant with the minimum distance defined in point UAS.STS-01.020(1)(C)(i)(C) and, when required, coordination with the appropriate authorities has been conducted;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>ensure that, before starting the operation, all persons present in the controlled ground area:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>have been informed of the risks of the operation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>have been briefed or trained, as appropriate, on the safety precautions and measures established by the UAS operator for their protection; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>have explicitly agreed to participate in the operation;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>ensure that:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the UAS is accompanied by the corresponding EU declaration(s) of conformity, including the reference to class C5 or reference to class C3 and to the accessories kit; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the class C5 identification label is affixed to the unmanned aircraft or to the accessories kit.</p></td></tr></tbody></table></td></tr></tbody></table>
UAS.STS-01.040 Responsibilities of the remote pilot
In addition to the responsibilities defined in UAS.SPEC.060, the remote pilot:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>before starting an UAS operation, shall verify that the means to terminate the flight of the unmanned aircraft are operational and check if the direct remote identification is active and up-to-date;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>during the flight:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>shall keep the unmanned aircraft in VLOS and maintain a thorough airspace scan of the airspace surrounding the unmanned aircraft in order to avoid any risk of a collision with any manned aircraft. The remote pilot shall discontinue the flight if the operation poses a risk to other aircraft, people, animals, environment or property;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>for the purposes of point (a), may be assisted by an unmanned aircraft observer. In such case, clear and effective communication shall be established between the remote pilot and the unmanned aircraft observer;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>shall have the ability to maintain control of the unmanned aircraft, except in the case of a lost command and control (C2) link;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>shall operate only one unmanned aircraft at a time;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>shall not operate the unmanned aircraft from a moving vehicle;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>shall not hand over the control of the unmanned aircraft to another command unit;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>shall perform the contingency procedures defined by the UAS operator for abnormal situations, including when the remote pilot has an indication that the unmanned aircraft may exceed the limits of the flight geography; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(h)</p></td><td><p>shall perform the emergency procedures defined by the UAS operator for emergency situations, including triggering the means to terminate the flight when the remote pilot has an indication that the unmanned aircraft may exceed the limits of the operational volume.</p></td></tr></tbody></table></td></tr></tbody></table>
ATTACHMENT A: REMOTE PILOT THEORETICAL KNOWLEDGE AND PRACTICAL SKILL EXAMINATION FOR STS-01
(1) Theoretical knowledge examination
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>The examination referred in point (2)(b) of point UAS.STS-01.020 shall comprise at least 40 multiple-choice questions aimed at assessing the remote pilot’s knowledge of the technical and operational mitigations, distributed appropriately across the following subjects:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>aviation regulations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>human performance limitations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>operational procedures;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iv)</p></td><td><p>technical and operational mitigations for ground risk;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(v)</p></td><td><p>UAS general knowledge;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(vi)</p></td><td><p>meteorology;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(vii)</p></td><td><p>the flight performance of the UAS; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(viii)</p></td><td><p>technical and operational mitigations for air risks.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>If the student remote pilot already holds a certificate of remote pilot competency as referred to in point (2) of point UAS.OPEN.030, the examination shall comprise at least 30 multiple-choice questions distributed appropriately across the subjects in points (1)(a)(i) to (1)(a)(v).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>To pass the theoretical knowledge examination, the remote pilot student shall achieve at least 75 % of the overall marks.</p></td></tr></tbody></table>
(2) Practical skill training and assessment
The training and assessment of the practical skill for operations under any standard scenario shall cover at least the subjects and areas identified in Table 1:
Table 1
Subjects and areas to be covered for practical skill training and assessment
<table><col/><col/><tbody><tr><td><p>Subject</p></td><td><p>Areas to be covered</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>Pre-flight actions</p></td></tr></tbody></table></td><td><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>Operation planning, airspace considerations and site risk assessment. The following points are to be included:</p><table><col/><col/><tbody><tr><td><p>(A)</p></td><td><p>identify the objectives of the intended operation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(B)</p></td><td><p>make sure that the defined operational volume and relevant buffers (e.g. ground risk buffer) are suitable for the intended operation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(C)</p></td><td><p>spot the obstacles in the operational volume that could hinder the intended operation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(D)</p></td><td><p>identify whether the wind speed and/or direction may be affected by topography or by obstacles in the operational volume;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(E)</p></td><td><p>select relevant data on airspace information (including on UAS geographical zones) that can have an impact on the intended operation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(F)</p></td><td><p>make sure the UAS is suitable for the intended operation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(G)</p></td><td><p>make sure that the selected payload is compatible with the UAS used for the operation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(H)</p></td><td><p>implement the necessary measures to comply with the limitations and conditions applicable to the operational volume and ground risk buffer for the intended operation in accordance with the operations manual procedures for the relevant scenario;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(I)</p></td><td><p>implement the necessary procedures to operate in controlled airspace, including a protocol to communicate with ATC and obtain clearance and instructions, if necessary;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(J)</p></td><td><p>confirm that all the necessary documents for the intended operation are on site; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(K)</p></td><td><p>brief all participants about the planned operation.</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>UAS pre-flight inspection and set-up (including flight modes and power-source hazards). The following points are to be included:</p><table><col/><col/><tbody><tr><td><p>(A)</p></td><td><p>assess the general condition of the UAS;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(B)</p></td><td><p>ensure that all the removable components of the UAS are properly secured;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(C)</p></td><td><p>make sure that the UAS software configurations are compatible;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(D)</p></td><td><p>calibrate the instruments in the UAS;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(E)</p></td><td><p>identify any flaw that may jeopardise the intended operation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(F)</p></td><td><p>make sure that the energy level of the battery is sufficient for the intended operation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(G)</p></td><td><p>make sure that the flight termination system of the UAS and its triggering system are operational;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(H)</p></td><td><p>check the correct functioning of the command and control link;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(I)</p></td><td><p>activate the geo-awareness function and upload the information to it (if geo-awareness function is available); and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(J)</p></td><td><p>set the height and speed limitation systems (if available).</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>Knowledge of the basic actions to be taken in the event of an emergency situation, including issues with the UAS, or if a mid-air collision hazard arises during the flight.</p></td></tr></tbody></table></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>In-flight procedures</p></td></tr></tbody></table></td><td><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>Maintain an effective look-out and keep the unmanned aircraft within visual line of sight (VLOS) at all times to include: situational awareness of the location in relation to the operational volume and other airspace users, obstacles, terrain and persons who are not involved at all times.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>Perform accurate and controlled flight manoeuvres at different heights and distances representative of the corresponding STS (including flight in manual/non-GNSS assisted mode or the equivalent, where fitted). At least the following manoeuvres shall be performed:</p><table><col/><col/><tbody><tr><td><p>(A)</p></td><td><p>hover in position (only for rotorcraft);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(B)</p></td><td><p>transition from hover into forward flight (only for rotorcraft);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(C)</p></td><td><p>climb and descent from level flight;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(D)</p></td><td><p>turns in level flight;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(E)</p></td><td><p>speed control in level flight;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(F)</p></td><td><p>actions after a failure of a motor/ propulsion system; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(G)</p></td><td><p>evasive action (manoeuvres) to avoid collisions</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>Real-time monitoring of the UAS status and endurance limitations.</p><p>Flight under abnormal conditions:</p><table><col/><col/><tbody><tr><td><p>(A)</p></td><td><p>manage a partial or complete power shortage of the unmanned aircraft propulsion system while ensuring the safety of third parties on the ground;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(B)</p></td><td><p>manage the path of the unmanned aircraft in abnormal situations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(C)</p></td><td><p>manage a situation in which the unmanned aircraft positioning equipment is impaired;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(D)</p></td><td><p>manage a situation of an incursion by a person not involved into the operational volume or the controlled ground area, and take appropriate measures to maintain safety;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(E)</p></td><td><p>react to, and take the appropriate corrective actions for a situations where the unmanned aircraft is likely to exceed the limit of the flight geography (contingency procedures) and from the operational volume (emergency procedures) as defined during the flight preparation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(F)</p></td><td><p>manage the situation when an aircraft approaches the operational volume; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(G)</p></td><td><p>demonstrate the recovery method following a deliberate (simulated) loss of the command and control link.</p></td></tr></tbody></table></td></tr></tbody></table></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>Post-flight actions</p></td></tr></tbody></table></td><td><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>Shut down and secure the UAS.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>Post-flight inspection and recording of any relevant data relating to the general condition of the UAS (its systems, components and power sources) and crew fatigue.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>Conduct a debriefing about the operation.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iv)</p></td><td><p>Identify situations when an occurrence report was necessary and complete the required occurrence report.</p></td></tr></tbody></table></td></tr></tbody></table>
CHAPTER II
STS-02 – BVLOS with Airspace Observers over a controlled ground area in a sparsely populated environment
UAS.STS-02.010 General provisions
<table><col/><col/><col/><tbody><tr><td/><td><p>(1)</p></td><td><span>During flight, the unmanned aircraft shall be maintained within 120 m from the closest point of the surface of the earth. The measurement of distances shall be adapted according to the geographical characteristics of the terrain, such as plains, hills, mountains.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(2)</p></td><td><span>When flying an unmanned aircraft within a horizontal distance of 50 m from an artificial obstacle taller than 105 m, the maximum height of the UAS operation may be increased up to 15 m above the height of the obstacle at the request of the entity responsible for the obstacle.</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(3)</p></td><td><span>The maximum height of the operational volume shall not exceed 30 m above the maximum height allowed in points (1) and (2).</span></td></tr></tbody></table>
<table><col/><col/><col/><tbody><tr><td/><td><p>(4)</p></td><td><span>During flight, the unmanned aircraft shall not carry dangerous goods.</span></td></tr></tbody></table>
UAS.STS-02.020 UAS operations in STS-02
UAS operations in STS-02 shall be conducted:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>in accordance with the operations manual referred to in point (1) of point UAS.STS-02.030;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>over a controlled ground area entirely located in a sparsely populated environment including:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the flight geography area,</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the contingency, which its external limit(s) shall be located at least 10 m beyond the limit(s) of the flight geography area,</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>a ground risk buffer covering a distance that is at least equal to the distance most likely to be travelled by the UA after activation of the means to terminate the flight specified by the UAS manufacturer in manufacturer’s instructions, considering the operational conditions within the limitations specified by the UAS manufacturer;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>in an area where the minimum flight visibility is more than 5 km;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>with the unmanned aircraft in sight of the remote pilot during the launch and recovery of the unmanned aircraft, unless the latter is the result of an emergency flight termination;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>if no airspace observer is used in the operation, with the unmanned aircraft flying no further than 1 km from the remote pilot, with the unmanned aircraft following a pre-programmed trajectory when the unmanned aircraft is not in VLOS of the remote pilot;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>if one or more airspace observers are used in the operation, it shall comply with all of the following conditions:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the airspace observer(s) are positioned in a manner allowing for an adequate coverage of the operational volume and the surrounding airspace with the minimum flight visibility indicated in point (3);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the unmanned aircraft is operated no further than 2 km from the remote pilot;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the unmanned aircraft is operated no further than 1 km from the airspace observer who is nearest to the unmanned aircraft;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>the distance between any airspace observer and the remote pilot is not more than 1 km;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>robust and effective communication means are available for the communication between the remote pilot and the airspace observer(s);</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>by a remote pilot who holds:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>a certificate of remote pilot theoretical knowledge for operations in standard scenarios, issued by the competent authority or by an entity designated by the competent authority of a Member State;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>an accreditation of completion of the STS-02 practical skill training, in accordance with Attachment A to this Chapter and issued by:</p><table><col/><col/><tbody><tr><td><p>(A)</p></td><td><p>an entity that has declared compliance with the requirements in Appendix 3 and is recognised by the competent authority of a Member State; or</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(B)</p></td><td><p>by an UAS operator that has declared to the competent authority of the Member State of registration, compliance with STS-02 and that has declared compliance with the requirements in Appendix 3;</p></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>with an unmanned aircraft which complies with all of the following conditions:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>is marked as class C6 and complies with the requirements of that class, as defined in Part 17 of the Annex to Delegated Regulation (EU) 2019/945;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>is operated with an active system to prevent the unmanned aircraft from breaching the flight geography;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>is operated with active and updated direct remote identification system.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>The remote pilot shall obtain the certificate of theoretical knowledge for operations in the standard scenarios after:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>having completed an online training course and passed the online theoretical knowledge examination as referred to in point (4)(b) of point UAS.OPEN.020; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>having passed an additional theoretical knowledge examination provided by the competent authority or by an entity designated by the competent authority of a Member State in accordance with Attachment A to this Chapter.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>This certificate shall be valid for five years. The revalidation, within its validity period is subject to any of the following:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the demonstration of competencies in accordance with point (9);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the completion of a refresher training addressing the theoretical knowledge subjects as defined in point (9) provided by the competent authority or by an entity designated by the competent authority;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>In order to revalidate the certificate upon its expiration, the remote pilot shall comply with point (9).</p></td></tr></tbody></table>
UAS.STS-02.030 Responsibilities of the UAS operator
In addition to the responsibilities defined in UAS.SPEC.050, the UAS operator shall:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>develop an operations manual including the elements defined in Appendix 5;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>define the operational volume and ground risk buffer for the intended operations, including the controlled ground area covering the projections on the surface of the earth of both the volume and the buffer;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>ensure the adequacy of the contingency and emergency procedures through any of the following:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>dedicated flight tests;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>simulations, provided that the representativeness of the simulation means is appropriate for the intended purpose;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>develop an effective emergency response plan (ERP) suitable for the operation that includes at least:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the plan to limit the escalating effects of the emergency situation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the conditions to alert the relevant authorities and organisations;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the criteria to identify an emergency situation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>clear delineation of the duties of the remote pilot(s) and any other personnel in charge of duties essential to the UAS operation;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>ensure that the level of performance for any externally provided service necessary for the safety of the flight is adequate for the intended operation;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>define the allocation of the roles and responsibilities between the operator and the external service provider(s), if applicable;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>upload updated information into the geo-awareness, if the function is installed on the UAS, when required by the UAS geographical zone for the intended location of the operation;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>ensure that, before starting the operation, all appropriate measures to reduce the risk of intrusion of uninvolved persons in the controlled ground area compliant with the minimum distance defined in point UAS.STS-02.020(2) have been taken and, when required, coordination with the appropriate authorities has been conducted;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>ensure that, before starting the operation, all persons present in the controlled ground area:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>have been informed of the risks of the operation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>have been briefed and, if applicable, trained on the safety precautions and measures established by the UAS operator for their protection; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>have explicitly agreed to participate in the operation;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>before starting the operation, if airspace observers are used:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>ensure the correct placement and number of airspace observers along the intended flight path;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>verify:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>that the visibility and the planned distance of the airspace observer are within acceptable limits as defined in the operations manual;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>the absence of potential terrain obstructions for each airspace observer;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>that there are no gaps between the zones covered by each of the airspace observers;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iv)</p></td><td><p>that the communication with each airspace observer is established and effective;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(v)</p></td><td><p>that if means are used by the airspace observers to determine the position of the unmanned aircraft, those means are functioning and effective;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>ensure that the airspace observers have been briefed on the intended path of the unmanned aircraft and the associated timing;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>ensure that:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the UAS is accompanied by the corresponding EU declaration of conformity, including the reference to class C6;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the class C6 identification label is affixed to the unmanned aircraft.</p></td></tr></tbody></table></td></tr></tbody></table>
UAS.STS-02.040 Responsibilities of the remote pilot
In addition to the responsibilities defined in UAS.SPEC.060, the remote pilot shall:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>before starting an UAS operation:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>set the programmable flight volume of the unmanned aircraft to keep it within the flight geography;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>verify that the means to terminate the flight and the programmable operational volume functionality of the unmanned aircraft are operational; and, check if the direct remote identification is active and up-to-date.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>during flight:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>unless supported by airspace observers, maintain a thorough airspace scan of the airspace surrounding the unmanned aircraft in order to avoid any risk of a collision with any manned aircraft. The remote pilot shall discontinue the flight if the operation poses a risk to other aircraft, people, animals, environment or property;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>have the ability to maintain control of the unmanned aircraft, except in the case of a lost command and control (C2) link;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>operate only one unmanned aircraft at a time;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>not operate the unmanned aircraft from a moving vehicle;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>not hand over the control of the unmanned aircraft to another command unit;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>inform the airspace observer(s), when employed, in a timely manner of any deviations of the unmanned aircraft from the intended path, and the associated timing;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>perform the contingency procedures defined by the UAS operator for abnormal situations, including when the remote pilot has indication that the unmanned aircraft may exceed the limits of the flight geography;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(h)</p></td><td><p>perform the emergency procedures defined by the UAS operator for emergency situations, including triggering the means to terminate the flight when the remote pilot has an indication that the unmanned aircraft may exceed the limits of the operational volume.</p></td></tr></tbody></table></td></tr></tbody></table>
UAS.STS-02.050 Responsibilities of the airspace observer
An airspace observer shall:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>maintain a thorough airspace scan of the airspace surrounding the unmanned aircraft in order to identify any risk of a collision with any manned aircraft;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>maintain awareness of the position of the unmanned aircraft through direct airspace observation or through assistance provided by electronic means;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>alert the remote pilot when a hazard is detected and assist in avoiding or minimising the potential negative effects.</p></td></tr></tbody></table>
ATTACHMENT A: REMOTE PILOT THEORETICAL KNOWLEDGE AND PRACTICAL SKILL FOR STS-02
1. Theoretical knowledge examination
The examination shall be defined in accordance with point 1 of Attachment A to Chapter I.
2. Practical skill training and assessment
In addition to the areas defined in point A.2 of Attachment A to Chapter I, the following areas shall be covered:
Table 1
Additional subjects and areas to be covered for practical skill training and assessment for STS-02
<table><col/><col/><tbody><tr><td><p>Subject</p></td><td><p>Areas to be covered</p></td></tr><tr><td><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>BVLOS operations conducted under STS-02</p></td></tr></tbody></table></td><td><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>Pre-flight actions — operation planning, airspace considerations and site risk-assessment. The following points are to be included:</p><table><col/><col/><tbody><tr><td><p>(A)</p></td><td><p>airspace scanning;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(B)</p></td><td><p>operations with airspace observers (AOs): adequate placement of AOs, and a deconfliction scheme that includes phraseology, coordination and communications means;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>The in-flight procedures, defined in point 2.(b)(ii) of Attachment A to Chapter I, shall be performed in both VLOS and BVLOS.</p></td></tr></tbody></table></td></tr></tbody></table>
Appendix 2
Operational declaration
<table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p><img/></p></td><td><p><span>Operational declaration</span></p></td></tr><tr><td><p><span>Data protection:</span> Personal data included in this declaration is processed by the competent authority pursuant to Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation). It will be processed for the purposes of the performance, management and follow up of the oversight activities according to Commission Implementing Regulation (EU) 2019/947.</p><p>If you require further information concerning the processing of your personal data or you wish to exercise your rights (e.g. to access or rectify any inaccurate or incomplete data), please refer to the contact point of the competent authority.</p><p>The applicant has the right to make a complaint regarding the processing of the personal data at any time to the national Data Protection Supervisory Authority.</p></td></tr><tr><td><p>UAS operator registration number</p></td><td><p> </p></td></tr><tr><td><p>UAS operator name</p></td><td><p> </p></td></tr><tr><td><p>UAS manufacturer</p></td><td><p> </p></td></tr><tr><td><p>UAS model</p></td><td><p> </p></td></tr><tr><td><p>UAS Serial number</p></td><td><p> </p></td></tr><tr><td><p><span>I hereby declare that:</span></p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p><span>I comply with all the applicable provisions of Implementing Regulation (EU) 2019/947 and with STS.x; and</span></p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p><span>appropriate insurance cover will be in place for every flight made under the declaration, if required by Union or national law.</span></p></td></tr></tbody></table></td></tr><tr><td><p><span>Date</span></p></td><td><p> </p></td><td><p><span>Signature or other verification</span></p></td><td><p> </p></td></tr></tbody></table>
Appendix 3
Additional requirements for entities recognised by the competent authority and UAS operators that conduct practical skill training and assessment of remote pilots for operations covered by STS
An entity that intends to be recognised by the competent authority for conducting practical skill training and assessment of remote pilots for an STS, shall declare to the competent authority compliance with the following requirements using the declaration form in Appendix 6.
An UAS operator that intends to conduct practical skill training and assessment of remote pilots for an STS, in addition to submitting the operational declaration for that STS, shall declare to the competent authority compliance with the following requirements using the declaration form in Appendix 4.
If the competent authority or the UAS operator intends to conduct practical skill training and assessment of remote pilots for an STS in a Member State other than the Member State of registration, a copy of the declaration form in Appendix 4 shall be submitted to the competent authority of the Member State where the training is conducted.
If an entity recognised by the competent authority intends to conduct practical skill training and assessment of remote pilots for an STS in a Member State other than the Member State of recognition, a proof of the recognition shall be submitted to the competent authority of the Member State where the training is conducted.
(1) The entity recognised by the competent authority or the UAS operator shall ensure a clear separation between the training activities and any other operational activity to guarantee the independence of the evaluation.
(2) The entity recognised by the competent authority or the UAS operator shall have the capability to adequately perform the technical and administrative activities linked with the entire task process, including the adequacy of personnel and the use of facilities and equipment appropriate to the task.
(3) The entity recognised by the competent authority or the UAS operator shall have an accountable manager, with the responsibility for ensuring that all tasks are performed in compliance with the information and procedures identified in point (8).
(4) The personnel responsible for the practical skill training and practical skill assessment tasks shall:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>have the competence to conduct these tasks;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>be impartial and shall not participate in assessments if they feel that their objectivity may be affected;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>have a sound theoretical knowledge and practical skill training experience, and satisfactory knowledge of the requirements for the practical skill assessment tasks they carry out as well as adequate experience of such processes;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>have the ability to administer the declarations, records and reports that demonstrate that the relevant practical skill assessments have been carried out and to draw the conclusions of those practical skill assessments; and</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>not disclose any information supplied by the operator or remote pilot to any person other than the competent authority upon their request.</p></td></tr></tbody></table>
(5) The training and assessment shall cover the practical skills corresponding to the STS for which the declaration is made, included in Attachment A to the relevant Chapter.
(6) The practical skill training and assessment location(s) shall be conducted in an environment representative of the conditions of the STS.
(7) The practical skill assessment shall consist of a continuous evaluation of the student remote pilot.
(8) The entity recognised by the competent authority or the UAS operator shall produce an assessment report after completing the practical skill assessment, which shall:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>include at least:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>the student remote pilot’s identification details;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>the identity of the person responsible for the practical skill assessment;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>the identification of the STS for which the practical skill assessment has been performed;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iv)</p></td><td><p>performance marks for each action performed by the student remote pilot;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(v)</p></td><td><p>an overall practical skill assessment of the student remote pilot’s competencies; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(vi)</p></td><td><p>practical skill assessment feedback providing guidance on areas for improvement where applicable;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>be appropriately signed and dated by the person responsible for the practical skill assessment once complete; and</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>be recorded and made available for inspection by the competent authority upon request.</p></td></tr></tbody></table>
(9) An accreditation of completion of the practical skill training for the STS shall be delivered to the student remote pilot by entity recognised by the competent authority or the UAS operator if the assessment report concludes that the student remote pilot has achieved a satisfactory level of practical skill.
(10) The issuance of the accreditation of completion of point (9) shall be notified to the competent authority of the Member State where the practical skill training and assessment are conducted including the student remote pilot’s identification details, the STS covered, the date of issuance and the identification details of the entity recognised by the competent authority of a Member State or the UAS operator issuing it.
(11) The entity recognised by the competent authority or the UAS operator shall include in the operations manual, developed in accordance with Appendix 5, a separate section covering the training elements, including the following:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the nominated personnel conducting practical skill training and assessment, including:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>descriptions of the respective personnel’s competence;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>the personnel’s duties and responsibilities; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>a chart of the organisation showing the associated chains of responsibility;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the procedures and processes used for practical skill training and assessment, including the training syllabus covering the practical skill corresponding to the STS for which the declaration is made, defined in Attachment A to the relevant Chapter;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>a description of the UAS and any other equipment, tools and environment used for the practical skill training and assessment; and</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>a template for the assessment report.</p></td></tr></tbody></table>
Appendix 4
Declaration of UAS operators that intend to provide practical skill training and assessment of remote pilots in STS-x
<table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p><img/></p></td><td><p><span>STS-x</span></p></td></tr><tr><td><p><span>Declaration of UAS operators that intend to provide practical skill training and assessment of remote pilots</span></p></td></tr><tr><td><p><span>Data protection:</span> Personal data included in this declaration is processed by the competent authority pursuant to Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation). It will be processed for the purposes of the performance, management and follow up of the oversight activities according to Commission Regulation (EU) 2019/947.</p><p>If you require further information concerning the processing of your personal data or you wish to exercise your rights (e.g. to access or rectify any inaccurate or incomplete data), please refer to the contact point of the competent authority.</p><p>The applicant has the right to make a complaint regarding the processing of the personal data at any time to the national Data Protection Supervisory Authority.</p></td></tr><tr><td><p>UAS operator registration number</p></td><td><p> </p></td></tr><tr><td><p>UAS operator name</p></td><td><p> </p></td></tr><tr><td><p><span>I hereby declare that:</span></p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p><span>I have submitted the operational declaration for STS-x;</span></p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p><span>I comply with the requirements defined in Appendix 3 to the Annex to Implementing Regulation (EU) 2019/947; and</span></p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p><span>when operating an UAS in the context of training activities for STS.x, I comply with all the applicable provisions of Implementing Regulation (EU) 2019/947, including requirements for operations under STS.x</span></p></td></tr></tbody></table></td></tr><tr><td><p><span>Date</span></p></td><td><p> </p></td><td><p><span>Signature or other verification</span></p></td><td><p> </p></td></tr></tbody></table>
Appendix 5
Operations manual for Standard Scenario
The operations manual for STS defined in Appendix 1 shall contain at least the following:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>a statement that the operations manual complies with the relevant requirements of this Regulation and with the declaration, and contains instructions that are to be complied with by the personnel involved in flight operations;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>an approval signature by the accountable manager or the UAS operator in the case of a natural person;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>an overall description of the UAS operator’s organisation;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>a description of the concept of the operation, including at least:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the nature and description of the activities performed in the UAS operations, and the identified associated risks;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the operational environment and geographical area for the intended operations, including:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>the characteristics of the area to be overflown in terms of the population density, topography, obstacles, etc.;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>the characteristics of the airspace to be used;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>the environmental conditions including at least the weather and the electromagnetic environment;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iv)</p></td><td><p>the definition of the operational volume and risk buffers to address the ground and air risks;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>the technical means used and their main characteristics, performance and limitations, including the UAS, external systems supporting the UAS operation, facilities, etc.;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>the required personnel for conducting operations, including the composition of the team, their roles and responsibilities, selection criteria, initial training and recent experience requirements and/or recurrent training;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>the maintenance instructions required to keep the UAS in a safe condition, covering the UAS manufacturer’s maintenance instructions and requirements, if applicable;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>operational procedures, which shall be based on manufacturer’s instructions provided by the UAS manufacturer, and shall include:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>consideration of the following to minimise human errors:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>a clear distribution and assignment of tasks; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>an internal checklist to check that staff are performing their assigned tasks adequately;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>consideration of the deterioration of external systems supporting the UAS operation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>normal procedures, including at least:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>pre-flight preparations and checklists, covering:</p><table><col/><col/><tbody><tr><td><p>(A)</p></td><td><p>the assessment of the operational volume and related buffers (the ground risk buffer, and air risk buffer when applicable), including the terrain and potential obstacles and obstructions that may reduce the ability to keep the unmanned aircraft in visual line of sight or to scan the airspace, the potential overflight of persons who are not involved and potential overflight of critical infrastructure;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(B)</p></td><td><p>the assessment of the surrounding environment and airspace, including the proximity of UAS geographical zones and potential activities by other airspace users;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(C)</p></td><td><p>the environmental conditions suitable for conducting the UAS operation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(D)</p></td><td><p>the minimum number of personnel in charge of duties essential to the UAS operation who are required to perform the operation, and their responsibilities;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(E)</p></td><td><p>the required communication procedures between the remote pilot(s) and any other personnel in charge of duties essential to the UAS operation and with any external parties, when needed;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(F)</p></td><td><p>compliance with any specific requirements from the relevant authorities in the intended area of operations, including those related to security, privacy, data and environmental protection, and the use of the RF spectrum;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(G)</p></td><td><p>the required risk mitigations in place to ensure the safe conduct of the operation; in particular, for the controlled ground area:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>determination of the controlled ground area; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>securing the controlled ground area to prevent third parties from entering the area during the operation, and ensuring coordination with the local authorities, when needed;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(H)</p></td><td><p>the procedures to verify that the UAS is in a suitable condition to safely conduct the intended operation;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>launch and recovery procedures;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>in-flight procedures, including those to ensure that the unmanned aircraft remains within the flight geography;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iv)</p></td><td><p>post-flight procedures, including the inspections to verify the condition of the UAS;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(v)</p></td><td><p>procedures for the detection of potentially conflicting aircraft by the remote pilot and, when required by the UAS operator, by airspace observer(s) or unmanned aircraft observer(s), as applicable;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>contingency procedures, including at least:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>procedures to cope with the unmanned aircraft leaving the designated ‘flight geography’;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>procedures to cope with persons who are not involved entering the controlled ground area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>procedures to cope with adverse operating conditions;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iv)</p></td><td><p>procedures to cope with the deterioration of external systems supporting the operation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(v)</p></td><td><p>if airspace observers are employed, the phraseology to be used;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(vi)</p></td><td><p>Conflict avoidance procedures with other airspace users;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>emergency procedures to cope with emergency situations, including at least:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>procedures to avoid, or at least minimise, harm to third parties in the air or on the ground;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>procedures to cope with the unmanned aircraft leaving the ‘operational’ volume;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>procedures for the emergency recovery of the unmanned aircraft;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>security procedures as referred to in point (1)(a)(ii) and (iii) of point UAS.SPEC.050;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(g)</p></td><td><p>the procedures for the protection of personal data referred to in point (1)(a)(iv) of point UAS.SPEC.050;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(h)</p></td><td><p>the guidelines to minimise nuisance and environmental impact referred to in point (1)(a)(v) of point UAS.SPEC.050;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>occurrence reporting procedures;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(j)</p></td><td><p>record-keeping procedures; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(k)</p></td><td><p>the policy defining how the remote pilot(s) and any other personnel in charge of duties essential to the UAS operation can declare themselves fit to operate before conducting any operation.</p></td></tr></tbody></table></td></tr></tbody></table>
Appendix 6
Declaration of the entity intending to be recognised by the competent authority to provide practical skill training and assessment of remote pilots in STS-x
<table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p><img/></p></td><td><p><span>STS-x</span></p></td></tr><tr><td><p><span>Declaration of the entity intending to be recognised by the competent authority to provide practical skill training and assessment of remote pilots</span></p></td></tr><tr><td><p><span>Data protection:</span> Personal data included in this declaration is processed by the competent authority pursuant to Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation). It will be processed for the purposes of the performance, management and follow up of the oversight activities according to Regulation (EU) 2019/947.</p><p>If you require further information concerning the processing of your personal data or you wish to exercise your rights (e.g. to access or rectify any inaccurate or incomplete data), please refer to the contact point of the competent authority.</p><p>The applicant has the right to make a complaint regarding the processing of the personal data at any time to the national Data Protection Supervisory Authority.</p></td></tr><tr><td><p>Identification of the entity</p></td><td><p> </p></td></tr><tr><td><p>First and last name, telephone number and email address of the responsible person</p></td><td><p> </p></td></tr><tr><td><p><span>I hereby declare that:</span></p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p><span>I comply with the requirements defined in Appendix 3 to the Annex to Regulation (EU) 2019/947; and</span></p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p><span>when operating an UAS in the context of training activities for STS.x, I comply with all the applicable provisions of Regulation (EU) 2019/947, including requirements for operations under STS.x</span></p></td></tr></tbody></table></td></tr><tr><td><p><span>Date</span></p></td><td><p> </p></td><td><p><span>Signature or other verification</span></p></td><td><p> </p></td></tr></tbody></table> | ENG | 32020R0639 |
<table><col/><col/><col/><col/><tbody><tr><td><p>3.10.2017   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 255/1</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2017/1781
of 28 September 2017
on the derogations from the product-specific rules of origin laid down in the Comprehensive Economic and Trade Agreement between Canada of the one part, and the European Union and its Member States, of the other part, that apply within the limits of annual quotas for certain products from Canada
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code ( 1 ) , and in particular Article 58(1) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>By Council Decision (EU) 2017/38<a> (<span>2</span>)</a>, the Council authorised the provisional application of the Comprehensive Economic and Trade Agreement between Canada, of the one part, and the European Union and its Member States, of the other part (‘the Agreement’)<a> (<span>3</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Annex 5 to the Protocol on rules of origin and origin procedures attached to the Agreement (‘the Origin Protocol’) lays down product-specific rules of origin. For a number of products, Annex 5-A to the Origin Protocol provides for derogations to the product-specific rules of origin that apply within the limits of annual quotas.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>The quotas set out in Annex 5-A to the Origin Protocol should be managed on a ‘first-come, first-served’ basis in accordance with Commission Implementing Regulation (EU) 2015/2447<a> (<span>4</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>For certain products, the volumes of the quotas are to be increased if the conditions laid down in Annex 5-A to the Origin Protocol are fulfilled.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>In accordance with the publication in the<span>Official Journal of the European Union</span>, the Agreement is to be applied provisionally from 21 September 2017<a> (<span>5</span>)</a>. In order to ensure the effective application and management of the origin quotas granted under the Agreement that the Commission is to manage on a ‘first-come, first-served’, this Regulation should apply from 21 September 2017.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>The measures provided for in this Regulation are in accordance with the opinion of the Customs Code Committee,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
The derogations from the product-specific rules of origin set out in Annex 5-A to the Protocol on rules of origin and origin procedures attached to the Comprehensive Economic and Trade Agreement between Canada, of the one part, and the European Union and its Member States, of the other part (‘the Origin Protocol’), shall apply to the products listed in the Annex to this Regulation within the quotas set out in that Annex.
Article 2
The quotas set out in the Annex to this Regulation shall be managed in accordance with Articles 49 to 54 of Implementing Regulation (EU) 2015/2447.
Article 3
1. For the products listed in section B of the Annex, the volumes of the quotas shall be increased, from 1 January of the year in question, by 10 % of the volumes assigned in the previous calendar year, if more than 80 % of the corresponding quota is used up in that year. This paragraph shall apply for the first time on 1 January 2019 and for the last time on 1 January 2022.
2. For the products listed in section C of the Annex, the volumes of the quotas shall be increased, from 1 January of the year in question, by 3 % of the volumes assigned in the previous calendar year, if more than 80 % of the corresponding quota is used up in that year. This growth provision shall apply for the first time on 1 January 2019 and for the last time on 1 January 2028.
Article 4
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union .
It shall apply from 21 September 2017.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 28 September 2017.
For the Commission
The President
Jean-Claude JUNCKER
( 1 ) OJ L 269, 10.10.2013, p. 1 .
( 2 ) Council Decision (EU) 2017/38 of 28 October 2016 on the provisional application of the Comprehensive Economic and Trade Agreement (CETA) between Canada, of the one part, and the European Union and its Member States, of the other part ( OJ L 11, 14.1.2017, p. 1080 ).
( 3 ) OJ L 11, 14.1.2017, p. 23 .
( 4 ) Commission Implementing Regulation (EU) 2015/2447 of 24 November 2015 laying down detailed rules for implementing certain provisions of Regulation (EU) No 952/2013 of the European Parliament and of the Council laying down the Union Customs Code ( OJ L 343, 29.12.2015, p. 558 ).
( 5 ) Notice concerning the provisional application of the Comprehensive Economic and Trade Agreement (CETA) between Canada, of the one part, and the European Union and its Member States, of the other part ( OJ L 238, 16.9.2017, p. 9 ).
ANNEX
Notwithstanding the rules for the interpretation of the Combined Nomenclature, the scope of the preferential scheme shall be determined, within the context of this Annex, by the CN codes as they exist at the time of adoption of this Regulation, in accordance with Annex I to Council Regulation (EEC) No 2658/87, as amended by Commission Implementing Regulation (EU) 2016/1821 . Where an ‘ex’ CN code is indicated, the scope of the preferential scheme shall be determined by the CN code as it exists at the time of adoption of this Regulation, in accordance with Annex I to Council Regulation (EEC) No 2658/87, as amended by Commission Implementing Regulation (EU) 2016/1821, and the description of the product in the tables of this Annex taken together.
SECTION A: AGRICULTURAL PRODUCTS
<table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Order No</p></td><td><p>CN code</p></td><td><p>TARIC subdivision</p></td><td><p>Description of products</p></td><td><p>Quota period</p></td><td><p>Quota volume (in tonnes net weight unless otherwise specified)</p></td></tr><tr><td><p>09.8300<a> (<span>1</span>)</a></p></td><td><p>ex 1302 20 10</p><p>ex 1302 20 90</p></td><td><p>61 , 69</p><p>61 , 69</p></td><td><p>Pectic substances, pectinates and pectates, containing 65 % or more by net weight of added cane or beet sugar of subheadings 1701 91 to 1701 99<a> (<span>2</span>)</a></p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>8 384</p></td></tr><tr><td><p>1806 10 30</p><p>1806 10 90</p></td><td><p> </p></td><td><p>Cocoa powder, containing 65 % or more by weight of sucrose (including invert sugar expressed as sucrose) or isoglucose expressed as sucrose<a> (<span>3</span>)</a></p></td><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>30 000</p></td></tr><tr><td><p>ex 1806 20 10</p><p>ex 1806 20 30</p><p>ex 1806 20 50</p><p>ex 1806 20 70</p><p>ex 1806 20 80</p><p>ex 1806 20 95</p></td><td><p>20</p><p>20</p><p>20</p><p>20</p><p>12 , 92</p><p>12 , 92</p></td><td><p>Other preparations in blocks, slabs or bars weighing more than 2 kg or in liquid, paste, powder, granular or other bulk form in containers or immediate packings of a content exceeding 2 kg, containing 65 % or more by net weight of added cane or beet sugar of subheadings 1701 91 to 1701 99<a> (<span>4</span>)</a>, for the preparation of chocolate beverages</p></td></tr><tr><td><p>ex 2101 12 92</p><p>ex 2101 12 98</p></td><td><p>92</p><p>92 , 94</p></td><td><p>Preparations with a basis of extracts, essences or concentrates of coffee or with a basis of coffee, containing 65 % or more by net weight of added cane or beet sugar of subheadings 1701 91 to 1701 99<a> (<span>5</span>)</a></p></td></tr><tr><td><p>ex 2101 20 92</p><p>ex 2101 20 98</p></td><td><p>82</p><p>85 , 87</p></td><td><p>Preparations with a basis of extracts, essences or concentrates of tea or maté or with a basis of tea or maté, containing 65 % or more by net weight of added cane or beet sugar of subheadings 1701 91 to 1701 99<a> (<span>6</span>)</a></p></td></tr><tr><td><p>ex 2106 90 20</p><p>ex 2106 90 30</p><p>ex 2106 90 51</p><p>ex 2106 90 55</p><p>ex 2106 90 59</p><p>ex 2106 90 98</p></td><td><p>10</p><p>10</p><p>10</p><p>10</p><p>10 , 92</p><p>26 , 32 , 33 , 34 , 37 , 38 , 42 , 53 ,</p><p>55</p></td><td><p>Other food preparations not elsewhere specified or included, containing 65 % or more by net weight of added cane or beet sugar of subheadings 1701 91 to 1701 99<a> (<span>7</span>)</a></p></td></tr><tr><td><p>09.8301<a> (<span>8</span>)</a></p></td><td><p>1704</p></td><td><p> </p></td><td><p>Sugar confectionery (including white chocolate), not containing cocoa</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>2 795</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>10 000</p></td></tr><tr><td><p>1806 31</p></td><td><p> </p></td><td><p>Chocolate and other food preparations containing cocoa, in blocks, slabs or bars, filled, weighing no more than 2 kilograms</p></td></tr><tr><td><p>1806 32</p></td><td><p> </p></td><td><p>Chocolate and other food preparations containing cocoa, in blocks, slabs or bars, not filled, weighing no more than 2 kilograms</p></td></tr><tr><td><p>1806 90</p></td><td><p> </p></td><td><p>Chocolate and other food preparations containing cocoa other than those of subheading 1806 10 to 1806 32</p></td></tr><tr><td><p>09.8302<a> (<span>9</span>)</a></p></td><td><p>1901</p></td><td><p> </p></td><td><p>Malt extract; food preparations of flour, groats, meal, starch or malt extract, not containing cocoa or containing less than 40 % by weight of cocoa calculated on a totally defatted basis, not elsewhere specified or included; food preparations of goods of headings 0401 to 0404 , not containing cocoa or containing less than 5 % by weight of cocoa calculated on a totally defatted basis, not elsewhere specified or included</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>9 781</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>35 000</p></td></tr><tr><td><p>ex 1902 11 00</p></td><td><p>20</p></td><td><p>Uncooked pasta, not stuffed or otherwise prepared, containing eggs and rice</p></td></tr><tr><td><p>ex 1902 19 10</p><p>ex 1902 19 90</p></td><td><p>20</p><p>20</p></td><td><p>Uncooked pasta, not stuffed or otherwise prepared, other, containing rice</p></td></tr><tr><td><p>ex 1902 20 10</p><p>ex 1902 20 30</p><p>ex 1902 20 91</p><p>ex 1902 20 99</p></td><td><p>20</p><p>20</p><p>20</p><p>20</p></td><td><p>Stuffed pasta, whether or not cooked or otherwise prepared, containing rice</p></td></tr><tr><td><p>ex 1902 30 10</p><p>ex 1902 30 90</p></td><td><p>20</p><p>20</p></td><td><p>Other pasta, containing rice</p></td></tr><tr><td><p>1904 10</p></td><td><p> </p></td><td><p>Prepared foods obtained by the swelling or roasting of cereals or cereal products</p></td></tr><tr><td><p>1904 20</p></td><td><p> </p></td><td><p>Prepared foods obtained from unroasted cereal flakes or from mixtures of unroasted cereal flakes and roasted cereal flakes or swelled cereals</p></td></tr><tr><td><p>1904 90</p></td><td><p> </p></td><td><p>Prepared foods other than those of subheading 1904 10 to 1904 30</p></td></tr><tr><td><p>1905</p></td><td><p> </p></td><td><p>Bread, pastry, cakes, biscuits and other bakers' wares, whether or not containing cocoa; communion wafers, empty cachets of a kind suitable for pharmaceutical use, sealing wafers, rice paper and similar products</p></td></tr><tr><td><p>2009 81</p></td><td><p> </p></td><td><p>Cranberry (<span>Vaccinium macrocarpon</span>,<span>Vaccinium oxycoccos</span>,<span>Vaccinium vitis-idaea</span>) juice</p></td></tr><tr><td><p>ex 2009 89 35</p></td><td><p>41 , 45 ,</p><p>47 , 49</p></td><td><p>Blueberry juice</p></td></tr><tr><td><p>ex 2009 89 38</p></td><td><p>21 , 29</p></td></tr><tr><td><p>ex 2009 89 79</p></td><td><p>41 , 49</p></td></tr><tr><td><p>ex 2009 89 86</p></td><td><p>21 , 29</p></td></tr><tr><td><p>ex 2009 89 89</p></td><td><p>21 , 29</p></td></tr><tr><td><p>ex 2009 89 99</p></td><td><p>17 , 94</p></td></tr><tr><td><p>2103 90</p></td><td><p> </p></td><td><p>Other sauces and preparations therefor, other mixed condiments and mixed seasonings</p></td></tr><tr><td><p>2106 10 20</p></td><td><p> </p></td><td><p>Protein concentrates and textured protein substances, not containing added cane or beet sugar of subheading 1701 91 to 1701 99 or containing less than 65 % by net weight of added cane or beet sugar of subheading 1701 91 to 1701 99</p></td></tr><tr><td><p>ex 2106 10 80</p></td><td><p>31 , 70</p></td></tr><tr><td><p>ex 2106 90 20</p><p>2106 90 92</p></td><td><p>10</p></td><td><p>Other food preparations not elsewhere specified or included, not containing added cane or beet sugar of subheadings 1701 91 to 1701 99 or containing less than 65 % by net weight of added cane or beet sugar of subheadings 1701 91 to 1701 99</p></td></tr><tr><td><p>ex 2106 90 98</p></td><td><p>30 , 36 ,</p><p>43 , 45 ,</p><p>49</p></td></tr><tr><td><p>09.8303<a> (<span>10</span>)</a></p></td><td><p>2309 10</p></td><td><p> </p></td><td><p>Dog or cat food, put up for retail sale</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>16 768</p></td></tr><tr><td><p>ex 2309 90 10</p></td><td><p>31 , 91</p></td><td><p>Dog or cat food, not put up for retail sale</p></td><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>60 000</p></td></tr><tr><td><p>ex 2309 90 20</p></td><td><p>10</p></td></tr><tr><td><p>ex 2309 90 31</p></td><td><p>11 , 17 ,</p><p>81</p></td></tr><tr><td><p>ex 2309 90 33</p></td><td><p>10</p></td></tr><tr><td><p>ex 2309 90 35</p></td><td><p>10</p></td></tr><tr><td><p>ex 2309 90 39</p></td><td><p>10</p></td></tr><tr><td><p>ex 2309 90 41</p></td><td><p>41 , 51 ,</p><p>81</p></td></tr><tr><td><p>ex 2309 90 43</p></td><td><p>10</p></td></tr><tr><td><p>ex 2309 90 49</p></td><td><p>10</p></td></tr><tr><td><p>ex 2309 90 51</p></td><td><p>10</p></td></tr><tr><td><p>ex 2309 90 53</p></td><td><p>10</p></td></tr><tr><td><p>ex 2309 90 59</p></td><td><p>10</p></td></tr><tr><td><p>ex 2309 90 70</p></td><td><p>10</p></td></tr><tr><td><p>ex 2309 90 91</p></td><td><p>10</p></td></tr><tr><td><p>ex 2309 90 96</p></td><td><p>31 , 91</p></td></tr></tbody></table>
SECTION B: FISH AND SEAFOOD
<table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Order No</p></td><td><p>CN code</p></td><td><p>TARIC subdivision</p></td><td><p>Description of products</p></td><td><p>Quota period</p></td><td><p>Quota volume (in tonnes net weight)<a> (<span>11</span>)</a></p></td></tr><tr><td><p>09.8304</p></td><td><p>ex 0304 83 90</p></td><td><p>19</p></td><td><p>Frozen fillets of halibut, other than<span>Reinhardtius hippoglossoides</span></p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>2,795</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>10</p></td></tr><tr><td><p>09.8305</p></td><td><p>ex 0306 12 10</p><p>ex 0306 12 90</p></td><td><p>10 , 91</p><p>10 , 91</p></td><td><p>Cooked and frozen lobster, in shell</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>559</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>2 000</p></td></tr><tr><td><p>09.8306</p></td><td><p>1604 11</p></td><td><p> </p></td><td><p>Prepared or preserved salmon, whole or in pieces but not minced</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>839</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>3 000</p></td></tr><tr><td><p>09.8307</p></td><td><p>1604 12</p></td><td><p> </p></td><td><p>Prepared or preserved herring, whole or in pieces but not minced</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>13,972</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>50</p></td></tr><tr><td><p>09.8308</p></td><td><p>ex 1604 13 11</p><p>ex 1604 13 19</p><p>1604 13 90</p></td><td><p>90</p><p>90</p></td><td><p>Prepared or preserved sardines, sardinella and brisling or sprats, whole or in pieces but not minced, excluding<span>Sardina pilchardus</span></p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>55,891</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>200</p></td></tr><tr><td><p>09.8309</p></td><td><p>ex 1605 10 00</p></td><td><p>19 , 99</p></td><td><p>Prepared or preserved crab, other than<span>Cancer pagurus</span></p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>12,296</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>44</p></td></tr><tr><td><p>09.8310</p></td><td><p>1605 21 10</p><p>1605 21 90</p><p>1605 29 00</p></td><td><p> </p></td><td><p>Prepared or preserved shrimps and prawns</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>1 398</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>5 000</p></td></tr><tr><td><p>09.8311</p></td><td><p>1605 30</p></td><td><p> </p></td><td><p>Prepared or preserved lobster</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>67,069</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>240</p></td></tr></tbody></table>
SECTION C: TEXTILES AND APPAREL
Table C 1 — Textiles
<table><col/><col/><col/><col/><col/><tbody><tr><td><p>Order No</p></td><td><p>CN code</p></td><td><p>Description of products</p></td><td><p>Quota period</p></td><td><p>Quota volume (in kilograms net weight unless otherwise specified)<a> (<span>12</span>)</a></p></td></tr><tr><td><p>09.8312</p></td><td><p>5107 20</p></td><td><p>Yarn of combed wool, not put up for retail sale, containing less than 85 % by weight of wool</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>53 655</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>192 000</p></td></tr><tr><td><p>09.8313</p></td><td><p>5205 12 00</p></td><td><p>Cotton yarn (other than sewing thread), 85 % or more by weight of cotton, not put up for retail sale, single yarn of uncombed fibres, measuring less than 714,29 decitex but not less than 232,56 decitex (exceeding 14 metric number but not exceeding 43 metric number)</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>328 636</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>1 176 000</p></td></tr><tr><td><p>09.8314</p></td><td><p>5208 59</p></td><td><p>Other woven fabrics of cotton, containing 85 % or more by weight of cotton, printed, other than plain weave, not elsewhere specified or included, weighing not more than 200 g/m<span>2</span></p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>16 768  m<span>2</span></p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>60 000  m<span>2</span></p></td></tr><tr><td><p>09.8315</p></td><td><p>5209 59 00</p></td><td><p>Other woven fabrics of cotton, containing 85 % or more by weight of cotton, printed, other than plain weave, not elsewhere specified or included, weighing more than 200 g/m<span>2</span></p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>22 077  m<span>2</span></p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>79 000  m<span>2</span></p></td></tr><tr><td><p>09.8316</p></td><td><p>5402</p></td><td><p>Synthetic filament yarn (other than sewing thread), not put up for retail sale, including synthetic monofilaments of less than 67 decitex</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>1 118 368</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>4 002 000</p></td></tr><tr><td><p>09.8317</p></td><td><p>5404 19 00</p></td><td><p>Other synthetic monofilament of 67 decitex or more and of which no cross-sectional dimension exceeds 1 mm, not elsewhere specified or included</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>5 869</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>21 000</p></td></tr><tr><td><p>09.8318</p></td><td><p>5407</p></td><td><p>Woven fabrics of synthetic filament yarn, including woven fabrics obtained from materials of heading 5404</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>1 351 990  m<span>2</span></p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>4 838 000  m<span>2</span></p></td></tr><tr><td><p>09.8319</p></td><td><p>5505 10</p></td><td><p>Waste (including noils, yarn waste and garnetted stock), of synthetic fibres</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>286 441</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>1 025 000</p></td></tr><tr><td><p>09.8320</p></td><td><p>5513 11</p></td><td><p>Woven fabrics of polyester staple fibres, containing less than 85 % by weight of such fibres, unbleached or bleached, plain weave, mixed mainly or solely with cotton, of a weight not exceeding 170 g/m<span>2</span></p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>1 749 091 m<span>2</span></p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>6 259 000 m<span>2</span></p></td></tr><tr><td><p>09.8321</p></td><td><p>5602</p></td><td><p>Felt, whether or not impregnated, coated, covered or laminated</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>162 921</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>583 000</p></td></tr><tr><td><p>09.8322</p></td><td><p>5603</p></td><td><p>Nonwovens, whether or not impregnated, coated, covered or laminated</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>173 540</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>621 000</p></td></tr><tr><td><p>09.8323</p></td><td><p>5703</p></td><td><p>Carpets and other textile floor coverings, tufted, whether or not made-up</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>54 773  m<span>2</span></p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>196 000  m<span>2</span></p></td></tr><tr><td><p>09.8324</p></td><td><p>5806</p></td><td><p>Narrow woven fabrics, other than goods of heading 5807 ; narrow fabrics consisting of warp without weft assembled by means of an adhesive (bolducs)</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>47 228</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>169 000</p></td></tr><tr><td><p>09.8325</p></td><td><p>5811 00 00</p></td><td><p>Quilted textile products in the piece, composed of one or more layers of textile materials assembled with padding by stitching or otherwise, other than embroidery of heading 5810</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>3 354  m<span>2</span></p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>12 000  m<span>2</span></p></td></tr><tr><td><p>09.8326</p></td><td><p>5903</p></td><td><p>Textile fabrics impregnated, coated, covered or laminated with plastics, other than those of heading 5902</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>490 159  m<span>2</span></p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>1 754 000  m<span>2</span></p></td></tr><tr><td><p>09.8327</p></td><td><p>5904 90 00</p></td><td><p>Floor coverings, consisting of a coating or covering applied on a textile backing, whether or not cut to shape, excluding linoleum</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>6 707  m<span>2</span></p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>24 000  m<span>2</span></p></td></tr><tr><td><p>09.8328</p></td><td><p>5906</p></td><td><p>Rubberized textile fabrics, other than those of heading 5902</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>125 754</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>450 000</p></td></tr><tr><td><p>09.8329</p></td><td><p>5907 00</p></td><td><p>Textile fabrics otherwise impregnated, coated or covered; painted canvas being theatrical scenery, studio back-cloths or the like</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>829 694  m<span>2</span></p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>2 969 000  m<span>2</span></p></td></tr><tr><td><p>09.8330</p></td><td><p>5911</p></td><td><p>Textile products and articles for specified technical uses</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>48 346</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>173 000</p></td></tr><tr><td><p>09.8331</p></td><td><p>6004</p></td><td><p>Knitted or crocheted fabrics of a width exceeding 30 cm, containing by weight 5 % or more elastomeric yarn or rubber thread, other than those of heading 6001</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>6 987</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>25 000</p></td></tr><tr><td><p>09.8332</p></td><td><p>6005</p></td><td><p>Warp knit fabrics (including those made on galloon knitting machines), other than those of headings 6001 to 6004</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>4 472</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>16 000</p></td></tr><tr><td><p>09.8333</p></td><td><p>6006</p></td><td><p>Knitted or crocheted fabrics, not elsewhere specified or included</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>6 707</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>24 000</p></td></tr><tr><td><p>09.8334</p></td><td><p>6306</p></td><td><p>Tarpaulins, awnings and sunblinds; tents; sails for boats, sailboards or landcraft; camping goods</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>34 653</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>124 000</p></td></tr><tr><td><p>09.8335</p></td><td><p>6307</p></td><td><p>Other made-up articles, including dress patterns</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>140 565</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>503 000</p></td></tr></tbody></table>
Table C 2 — Apparel
<table><col/><col/><col/><col/><col/><tbody><tr><td><p>Order No</p></td><td><p>CN code</p></td><td><p>Description of products</p></td><td><p>Quota period</p></td><td><p>Quota volume (in number of items unless otherwise specified)<a> (<span>13</span>)</a></p></td></tr><tr><td><p>09.8336</p></td><td><p>6101 30</p></td><td><p>Men's or boys' overcoats, car coats, capes, cloaks, anoraks (including ski jackets), windcheaters, wind-jackets and similar articles of man-made fibres, knitted or crocheted</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>2 795</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>10 000</p></td></tr><tr><td><p>09.8337<a> (<span>14</span>)</a></p></td><td><p>6102 30</p></td><td><p>Women's or girls' overcoats, car coats, capes, cloaks, anoraks (including ski jackets), windcheaters, wind-jackets and similar articles of man-made fibres, knitted or crocheted</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>4 751</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>17 000</p></td></tr><tr><td><p>09.8338<a> (<span>15</span>)</a></p></td><td><p>6104</p></td><td><p>Women's or girls' suits, ensembles, jackets, blazers, dresses, skirts, divided skirts, trousers, bib and brace overalls, breeches and shorts (other than swimwear), knitted or crocheted</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>149 507</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>535 000</p></td></tr><tr><td><p>09.8339</p></td><td><p>6106 20 00</p></td><td><p>Women's or girls' blouses, shirts and shirt-blouses of man-made fibres, knitted or crocheted</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>12 296</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>44 000</p></td></tr><tr><td><p>09.8340</p></td><td><p>6108 22 00</p></td><td><p>Women's or girls' briefs and panties of man-made fibres, knitted or crocheted</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>36 050</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>129 000</p></td></tr><tr><td><p>09.8341<a> (<span>16</span>)</a></p></td><td><p>6108 92 00</p></td><td><p>Women's or girls' negligees, bathrobes, dressing gowns and similar articles of man-made fibres, knitted or crocheted</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>10 899</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>39 000</p></td></tr><tr><td><p>09.8342</p></td><td><p>6109 10 00</p></td><td><p>T-shirts, singlets and other vests, of cotton, knitted or crocheted</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>95 573</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>342 000</p></td></tr><tr><td><p>09.8343</p></td><td><p>6109 90</p></td><td><p>T-shirts, singlets and other vests, of other textile materials, knitted or crocheted</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>50 581</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>181 000</p></td></tr><tr><td><p>09.8344</p></td><td><p>6110</p></td><td><p>Jerseys, pullovers, cardigans, waistcoats and similar articles, knitted or crocheted</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>133 579</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>478 000</p></td></tr><tr><td><p>09.8345</p></td><td><p>6112 41</p></td><td><p>Women's or girls' swimwear of synthetic fibres, knitted or crocheted</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>20 400</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>73 000</p></td></tr><tr><td><p>09.8346<a> (<span>17</span>)</a></p></td><td><p>6114</p></td><td><p>Garments not elsewhere specified or included, knitted or crocheted</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>25 151  kilograms</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>90 000  kilograms</p></td></tr><tr><td><p>09.8347</p></td><td><p>6115</p></td><td><p>Pantyhose, tights, stockings, socks and other hosiery, including graduated compression hosiery (for example stockings for varicose veins) and footwear without applied soles, knitted or crocheted</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>27 387  kilograms</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>98 000  kilograms</p></td></tr><tr><td><p>09.8348<a> (<span>18</span>)</a></p></td><td><p>6201</p></td><td><p>Men's or boys' overcoats, car coats, capes, cloaks, anoraks (including ski jackets), windcheaters, wind-jackets and similar articles, not knitted or crocheted, other than those of heading 6203</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>26 828</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>96 000</p></td></tr><tr><td><p>09.8349</p></td><td><p>6202</p></td><td><p>Women's or girls' overcoats, car coats, capes, cloaks, anoraks (including ski jackets), windcheaters, wind-jackets and similar articles, not knitted or crocheted, other than those of heading 6204</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>27 666</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>99 000</p></td></tr><tr><td><p>09.8350</p></td><td><p>6203</p></td><td><p>Men's or boys' suits, ensembles, jackets, blazers, trousers, bib and brace overalls, breeches and shorts (other than swimwear), not knitted or crocheted</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>26 548</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>95 000</p></td></tr><tr><td><p>09.8351</p></td><td><p>6204</p></td><td><p>Women's or girls' suits, ensembles, jackets, blazers, dresses, skirts, divided skirts, trousers, bib and brace overalls, breeches and shorts (other than swimwear), not knitted or crocheted</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>141 403</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>506 000</p></td></tr><tr><td><p>09.8352<a> (<span>19</span>)</a></p></td><td><p>6205</p></td><td><p>Men's or boys' shirts, not knitted or crocheted</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>4 192</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>15 000</p></td></tr><tr><td><p>09.8353</p></td><td><p>6206</p></td><td><p>Women's or girls' blouses, shirts and shirt-blouses, not knitted or crocheted</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>17 885</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>64 000</p></td></tr><tr><td><p>09.8354</p></td><td><p>6210 40 00</p></td><td><p>Men's or boys' garments, made up of fabrics of heading 59.03 , 59.06 or 59.07 , not elsewhere specified or included, not knitted or crocheted</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>19 003  kilograms</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>68 000  kilograms</p></td></tr><tr><td><p>09.8355</p></td><td><p>6210 50 00</p></td><td><p>Women's or girls' garments, made up of fabrics of heading 59.03 , 59.06 or 59.07 , not elsewhere specified or included, not knitted or crocheted</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>8 384  kilograms</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>30 000  kilograms</p></td></tr><tr><td><p>09.8356</p></td><td><p>6211</p></td><td><p>Track suits, ski-suits and swimwear; other garments, not knitted or crocheted</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>14 532  kilograms</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>52 000  kilograms</p></td></tr><tr><td><p>09.8357</p></td><td><p>6212 10</p></td><td><p>Brassieres, whether or not knitted or crocheted</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>82 998</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>297 000</p></td></tr><tr><td><p>09.8358</p></td><td><p>6212 20 00</p></td><td><p>Girdles and panty girdles, whether or not knitted or crocheted</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>8 943</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>32 000</p></td></tr><tr><td><p>09.8359</p></td><td><p>6212 30 00</p></td><td><p>Corselettes, whether or not knitted or crocheted</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>11 179</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>40 000</p></td></tr><tr><td><p>09.8360</p></td><td><p>6212 90 00</p></td><td><p>Braces, suspenders, garters and similar articles and parts thereof, whether or not knitted or crocheted</p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>4 472  kilograms</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>16 000  kilograms</p></td></tr></tbody></table>
SECTION D: VEHICLES
<table><col/><col/><col/><col/><col/><tbody><tr><td><p>Order No</p></td><td><p>CN code</p></td><td><p>Description of products</p></td><td><p>Quota period</p></td><td><p>Quota volume (in number of items)</p></td></tr><tr><td><p>09.8361<a> (<span>20</span>)</a></p></td><td><p>8703 21</p></td><td><p>Other vehicles, with spark-ignition internal combustion reciprocating piston engine, of a cylinder capacity not exceeding 1 000  cm<span>3</span></p></td><td><p>From 21.9.2017 to 31.12.2017</p></td><td><p>27 946</p></td></tr><tr><td><p>From 1.1 to 31.12.2018 and for each period thereafter from 1.1 to 31.12</p></td><td><p>100 000</p></td></tr><tr><td><p>8703 22</p></td><td><p>Other vehicles, with spark-ignition internal combustion reciprocating piston engine, of a cylinder capacity exceeding 1 000  cm<span>3</span> but not exceeding 1 500  cm<span>3</span></p></td></tr><tr><td><p>8703 23</p></td><td><p>Other vehicles, with spark-ignition internal combustion reciprocating piston engine, of a cylinder capacity exceeding 1 500  cm<span>3</span> but not exceeding 3 000  cm<span>3</span></p></td></tr><tr><td><p>8703 24</p></td><td><p>Other vehicles, with spark-ignition internal combustion reciprocating piston engine, of a cylinder capacity exceeding 3 000  cm<span>3</span></p></td></tr><tr><td><p>8703 31</p></td><td><p>Other vehicles, with compression-ignition internal combustion piston engine (diesel or semi-diesel), of a cylinder capacity not exceeding 1 500  cm<span>3</span></p></td></tr><tr><td><p>8703 32</p></td><td><p>Other vehicles, with compression-ignition internal combustion piston engine (diesel or semi-diesel), of a cylinder capacity exceeding 1 500  cm<span>3</span> but not exceeding 2 500  cm<span>3</span></p></td></tr><tr><td><p>8703 33</p></td><td><p>Other vehicles, with compression-ignition internal combustion piston engine (diesel or semi-diesel), of a cylinder capacity exceeding 2 500  cm<span>3</span></p></td></tr><tr><td><p>8703 40</p><p>8703 60</p></td><td><p>Other vehicles, with both spark-ignition internal combustion reciprocating piston engine and electric motor as motors for propulsion</p></td></tr><tr><td><p>8703 50</p><p>8703 70</p></td><td><p>Other vehicles, with both compression-ignition internal combustion piston engine (diesel or semi-diesel) and electric motor as motors for propulsion</p></td></tr><tr><td><p>8703 90</p></td><td><p>Other</p></td></tr></tbody></table>
<note>
( 1 ) The benefit of this tariff quota is submitted to the presentation of an export permit issued by Canada under the Export and Import Permits Act
( 2 ) The cane and the beet sugar must have been refined in Canada
( 3 ) The cane and the beet sugar must have been refined in Canada
( 4 ) The cane and the beet sugar must have been refined in Canada
( 5 ) The cane and the beet sugar must have been refined in Canada
( 6 ) The cane and the beet sugar must have been refined in Canada
( 7 ) The cane and the beet sugar must have been refined in Canada
( 8 ) The benefit of this tariff quota is submitted to the presentation of an export permit issued by Canada under the Export and Import Permits Act
( 9 ) The benefit of this tariff quota is submitted to the presentation of an export permit issued by Canada under the Export and Import Permits Act
( 10 ) The benefit of this tariff quota is submitted to the presentation of an export permit issued by Canada under the Export and Import Permits Act
( 11 ) Article 3(1) applies.
( 12 ) Article 3(2) applies.
( 13 ) Article 3(2) applies.
( 14 ) The benefit of this tariff quota is submitted to the presentation of an export permit issued by Canada under the Export and Import Permits Act
( 15 ) The benefit of this tariff quota is submitted to the presentation of an export permit issued by Canada under the Export and Import Permits Act
( 16 ) The benefit of this tariff quota is submitted to the presentation of an export permit issued by Canada under the Export and Import Permits Act
( 17 ) The benefit of this tariff quota is submitted to the presentation of an export permit issued by Canada under the Export and Import Permits Act
( 18 ) The benefit of this tariff quota is submitted to the presentation of an export permit issued by Canada under the Export and Import Permits Act
( 19 ) The benefit of this tariff quota is submitted to the presentation of an export permit issued by Canada under the Export and Import Permits Act
( 20 ) The benefit of this tariff quota is submitted to the presentation of an export permit issued by Canada under the Export and Import Permits Act
</note> | ENG | 32017R1781 |
<table><col/><col/><col/><col/><tbody><tr><td><p>18.8.2016   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>C 299/69</p></td></tr></tbody></table>
COUNCIL RECOMMENDATION
of 12 July 2016
on the 2016 National Reform Programme of Lithuania and delivering a Council opinion on the 2016 Stability Programme of Lithuania
(2016/C 299/17)
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 121(2) and 148(4) thereof,
Having regard to Council Regulation (EC) No 1466/97 of 7 July 1997 on the strengthening of the surveillance of budgetary positions and the surveillance and coordination of economic policies ( 1 ) , and in particular Article 5(2) thereof,
Having regard to the recommendation of the European Commission,
Having regard to the resolutions of the European Parliament,
Having regard to the conclusions of the European Council,
Having regard to the opinion of the Employment Committee,
Having regard to the opinion of the Economic and Financial Committee,
Having regard to the opinion of the Social Protection Committee,
Having regard to the opinion of the Economic Policy Committee,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>On 26 November 2015, the Commission adopted the Annual Growth Survey, marking the start of the 2016 European Semester for economic policy coordination. The priorities of the Annual Growth Survey were endorsed by the European Council on 17-18 March 2016. On 26 November 2015, on the basis of Regulation (EU) No 1176/2011 of the European Parliament and of the Council<a> (<span>2</span>)</a>, the Commission adopted the Alert Mechanism Report, in which it did not identify Lithuania as one of the Member States for which an in-depth review would be carried out. On the same day, the Commission also adopted a recommendation for a Council Recommendation on the economic policy of the euro area. That Recommendation was endorsed by the European Council on 18-19 February 2016 and adopted by the Council on 8 March 2016<a> (<span>3</span>)</a>. As a country whose currency is the euro and in view of the close interlinkages between the economies in the economic and monetary union, Lithuania should ensure the full and timely implementation of the Recommendation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The country report for Lithuania was published on 26 February 2016. The report assessed Lithuania's progress in addressing the country-specific recommendations adopted on 14 July 2015 and Lithuania's progress towards its national Europe 2020 targets.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>On 29 April 2016, Lithuania submitted its 2016 National Reform Programme and its 2016 Stability Programme. In order to take account of their interlinkages, the two programmes have been assessed at the same time.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>Relevant country-specific recommendations have been addressed in the programming of the European Structural and Investment Funds for the 2014-2020 period. As foreseen in Article 23 of Regulation (EU) No 1303/2013 of the European Parliament and of the Council<a> (<span>4</span>)</a>, where it is necessary to support the implementation of relevant Council recommendations, the Commission may request a Member State to review and propose amendments to its Partnership Agreement and relevant programmes. The Commission has provided further details on how it would make use of this provision in guidelines on the application of the measures linking the effectiveness of the European Structural and Investment Funds to sound economic governance.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>In its 2016 Stability Programme, Lithuania has requested a temporary deviation of 0,6 % of GDP from the required adjustment path towards the medium-term objective in 2017, to take account of major structural reforms with a positive impact on the long-term sustainability of public finances. However, pending a final agreement, uncertainty on the set of reform measures as well as their implementation remains. Thus, while Lithuania has sufficient fiscal space to benefit from a temporary deviation, it does not appear to fulfil the eligibility criterion related to the implementation of the reform to avail itself of the structural reform clause. Moreover, it is currently not possible to assess the plausibility of the impact of the reform estimated by the Government. Therefore, the impact of these reforms has not yet been reflected in the required adjustment towards the medium-term budgetary objective for 2017.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>Lithuania is currently under the preventive arm of the Stability and Growth Pact. In its 2016 stability programme, the government plans an improvement of the headline balance from a deficit of 0,8 % of GDP in 2016 to a surplus of 0,9 % of GDP in 2019. The (recalculated<a> (<span>5</span>)</a>) structural balance is set to stay above the medium-term budgetary objective — a deficit of 1 % of GDP in structural terms — in 2016 and thereafter. The adjustment path incorporates the systemic pension reform in 2016 but does not reflect the planned structural reform in 2017. According to the Stability Programme, the government debt-to-GDP ratio is expected to fall from 39,9 % of GDP in 2016 to 35,7 % in 2019. The macroeconomic scenario underpinning these budgetary projections is plausible. The measures needed to support the planned deficit targets from 2018 onwards have not been sufficiently specified yet. Based on the Commission 2016 spring forecast, the structural balance is forecast to be at – 1,2 % of GDP in 2016, which can be considered as close to the medium-term budgetary objective, and at – 0,8 % of GDP in 2017, above the medium-term budgetary objective. Based on its assessment of the Stability Programme and taking into account the Commission 2016 spring forecast Lithuania is expected to comply with the provisions of the Stability and Growth Pact.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>A fall in the working age population, caused by ageing, poor health outcomes and significant net emigration may harm Lithuania's growth potential and ultimately its future convergence path, while putting at risk the sustainability of its pension and long-term care systems. A cumulative loss of 35 % of the working age population is estimated by 2030. If that trend is not reversed, it will jeopardise the availability of suitable labour resources, the sustainability of long-term economic growth and social security systems, in particular the pension system.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>Ongoing demographic trends underscore the need for a comprehensive pension reform in Lithuania that addresses the medium-term sustainability and adequacy risks of the current pension system. The level of poverty among the elderly in Lithuania is among the highest in the Union. However, at present there is no indexation mechanism in place for publicly provided pensions and spending on social insurance pensions is relatively low. The Parliament has not yet adopted the draft law proposed by the Government to introduce an indexation mechanism, link the retirement age to changes in life expectancy after 2026 and improve the way the basic part of the social insurance pension is financed.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>In Lithuania, health outcomes are among the poorest in the European Union. In particular, the mortality rate of the population aged between 20 to 64 years of age is the highest in the Union, having an important impact on the potential available workforce and labour productivity. Weaknesses in the health system include too much reliance on in-patient care and low expenditure on prevention and public health. There is a need to address the negative demographic trend.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>It is important that Lithuania strengthens investment in human capital to counteract some of the negative effects of its shrinking working age population and support Lithuania's transition towards a higher value-added economy. Although educational attainment has increased, the proportion of pupils with insufficient basic skills is high. Efforts should be pursued to ensure high quality teaching, which is crucial to tackling underachievement and educational shortcomings. Furthermore, there are weaknesses in the quality of teaching in higher education and its ability to foster innovation. The persistently low level of participation in adult learning is undermining efforts to improve the quality of human capital and increase productivity. There are signs of emerging skills shortages in certain sectors of the economy. Those skills shortages are expected to become more acute in the future. Strong wage growth and a slowdown in productivity growth may weaken cost-competitiveness. It is therefore important to improve the labour market relevance of education, streamline the structure and funding of the educational system, develop life-long learning and improve the targeting and effectiveness of active labour market policies. Lithuania has taken steps to improve its active labour market measures and other services to support job seekers, but there is still scope to improve targeting for specific groups, in particular the very long-term unemployed and those lacking necessary skills. Spending on effective labour market policy measures remains limited and social safety nets in Lithuania are weak. Around 27 % of Lithuania's population is at risk of poverty or social exclusion and income inequality is among the highest in the Union. The Government plans to improve the coverage and adequacy of unemployment and social assistance benefits, but the relevant legislation has still not been adopted.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>A comprehensive revision of the Labour Code and the social model is under discussion in the Parliament. The intention is to increase the flexibility of labour market relations and provide more security, but the relevant legislation still needs to be adopted. The involvement of social partners in the implementation of the reform and more extensive social dialogue are important.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(12)</p></td><td><p>Investment has recovered slowly since the onset of the economic crisis and will be supported by EU structural and investment funds in the coming years. Nevertheless, the adoption and absorption of new technology has not spread across the economy and innovation is low, hampering productivity growth. Private investment in research and innovation has also been low, perhaps due to the insufficiency of incentives for business research and innovation and public-private cooperation. Strengthening private investment could mitigate the risks relating to the dependency of Lithuania's public investment in research and innovation on EU structural and investment funds. The tertiary education system shows weaknesses in quality and innovation outcomes, with limited levels of cooperation with foreign universities and research centres. The research and innovation system is fragmented and characterised by overlaps and duplication. This prevents Lithuania from reaching the critical mass of research and development capacity needed to increase innovative knowledge. Incentives for innovation and cooperation between academia and business need to be increased, inter alia, by developing and investing in human capital, which could increase the level of technology transfers to the real economy. Improving the limited capacity of Lithuanian companies to absorb external knowledge and apply it to commercial ends would raise the level of innovation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(13)</p></td><td><p>In the context of the European Semester, the Commission has carried out a comprehensive analysis of Lithuania's economic policy and published it in the 2016 country report. It has also assessed the Stability Programme and the National Reform Programme and the follow-up given to the recommendations addressed to Lithuania in previous years. It has taken into account not only their relevance for sustainable fiscal and socioeconomic policy in Lithuania but also their compliance with EU rules and guidance, given the need to strengthen the the EU's overall economic governance by providing EU level input into future national decisions. The recommendations under the European Semester are reflected in recommendations (1) to (3) below.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(14)</p></td><td><p>In the light of this assessment, the Council has examined the Stability Programme and its opinion<a> (<span>6</span>)</a> is reflected in particular in recommendation (1) below,</p></td></tr></tbody></table>
HEREBY RECOMMENDS that Lithuania take action in 2016 and 2017 to:
<table><col/><col/><tbody><tr><td><p>1.</p></td><td><p>Ensure that the deviation from the medium-term budgetary objective is limited to the allowance linked to the systemic pension reform in 2016 and in 2017. Reduce the tax burden on low-income earners by shifting the tax burden to other sources less detrimental to growth and improve tax compliance, in particular in the area of VAT.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>2.</p></td><td><p>Strengthen investment in human capital and address skills shortages, by improving the labour market relevance of education, raising the quality of teaching and adult learning. Reinforce the coverage and effectiveness of active labour market policies. Strengthen the role of social dialogue mechanisms. Improve the performance of the healthcare system by strengthening outpatient care, disease prevention and health promotion. Improve the coverage and adequacy of unemployment benefits and social assistance.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>3.</p></td><td><p>Take measures to strengthen productivity and improve the adoption and absorption of new technology across the economy. Improve the coordination of innovation policies and encourage private investment, inter alia, by developing alternative means of financing.</p></td></tr></tbody></table>
Done at Brussels, 12 July 2016.
For the Council
The President
P. KAŽIMÍR
<note>
( 1 ) OJ L 209, 2.8.1997, p. 1 .
( 2 ) Regulation (EU) No 1176/2011 of the European Parliament and of the Council of 16 November 2011 on the prevention and correction of macroeconomic imbalances ( OJ L 306, 23.11.2011, p. 25 ).
( 3 ) OJ C 96, 11.3.2016, p. 1 .
( 4 ) Regulation (EU) No 1303/2013 of the European Parliament and of the Council of 17 December 2013 laying down common provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund, the European Agricultural Fund for Rural Development and the European Maritime and Fisheries Fund and laying down general provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund and the European Maritime and Fisheries Fund and repealing Council Regulation (EC) No 1083/2006 ( OJ L 347, 20.12.2013, p. 320 ).
( 5 ) The structural balance as recalculated by the Commission based on the information in the stability programme, following the commonly agreed methodology.
( 6 ) Under Article 5(2) of Regulation (EC) No 1466/97.
</note> | ENG | 32016H0818(17) |
<table><col/><col/><col/><col/><tbody><tr><td><p>26.10.2021   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 378/15</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING DECISION (EU) 2021/1877
of 22 October 2021
on the framework of inclusion measures of the Erasmus+ and European Solidarity Corps Programmes 2021-2027
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 165(4) and 166(4) thereof,
Having regard to Regulation (EU) 2021/817 of the European Parliament and of the Council of 20 May 2021 establishing Erasmus+: the Union Programme for education and training, youth and sport and repealing Regulation (EU) No 1288/2013 ( 1 ) , and in particular Article 15 thereof,
Having regard to Regulation (EU) 2021/888 of the European Parliament and of the Council of 20 May 2021 establishing the European Solidarity Corps Programme and repealing Regulations (EU) 2018/1475 and (EU) No 375/2014 ( 2 ) , and in particular Article 16(2) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>The need to strengthen and extend the Erasmus+ Programme was expressed by the European Council on several occasions. Furthermore, in the consultations on the mid-term evaluation of the Erasmus+ Programme (2014-2020) established by Regulation (EU) No 1288/2013 of the European Parliament and of the Council <a>(<span>3</span>)</a>, and on the programme which would replace that programme <a>(<span>4</span>)</a>, the need for continuity in the Erasmus+ Programme’s scope, architecture and delivery mechanisms was established. At the same time a need for a number of improvements was identified, such as making the Erasmus+ Programme more inclusive, simpler and more manageable for beneficiaries.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Both the Erasmus+ Regulation and the Solidarity Corps Regulation foresee that the Commission shall develop a framework of inclusion measures for people with fewer opportunities <a>(<span>5</span>)</a>. Taking into consideration the similarities of the Erasmus+ and the European Solidarity Corps Programmes as regards some of the target groups addressed (people with fewer opportunities in the Erasmus+ Programme and young people with fewer opportunities in the European Solidarity Corps Programme), the shared nature of the implementing structures of the two Programmes, and the similarities in the funding structure, a joint framework of inclusion measures should be established.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>The framework of inclusion measures should take into account areas of intervention for global challenges as set out in Annex III, point 4, of Regulation (EU) 2021/947 of the European Parliament and of the Council <a>(<span>6</span>)</a>, as well as the European Union Work Plan for Sport 2021-2024. Organisations such as the entities receiving grants under the Programmes have a key role in making inclusion a reality, particularly in terms of organisational development, acquiring and building more capacity in handling inclusion projects and accessibility requirements, promoting inclusion across the organisation, and outreach and support to participants before, during and after the project.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>In some cases, people with fewer opportunities are less likely to participate in the Programmes for financial reasons, whether because of their economic situation or because of the higher participation costs that their specific situation generates, as is often the case for people with disabilities. In such cases, their participation could be facilitated with targeted financial support.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>Lack of awareness about the availability of dedicated measures for people with fewer opportunities can result in less participation of these target groups. Greater effort is needed to raise awareness and increase their levels of information and awareness about the opportunities in place and how to access them.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>Organisations are invited to address inclusion and diversity in line with their needs and those of their community. Staff dealing specifically with issues of inclusion and diversity and with participants with fewer opportunities in their organisations can benefit from working together with peers from other organisations to support people with fewer opportunities. Different forms of support, such as training sessions, peer learning experiences and job shadowing opportunities, can be arranged with a view to helping to increase their capacity in this respect.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>A strong supportive approach to participants with fewer opportunities is key to help removing the obstacles to their full participation in the Programmes.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>Inclusion and diversity are part of the criteria to select applications for funding and to allocate financial support. Quality projects that actively address inclusion and diversity and that involve participants with fewer opportunities may be given priority in the grant awarding process.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>People with fewer opportunities should be reached out to in their respective personal environments by tailoring the approach to their specific information and accessibility needs. An important success factor for providing information to under-represented groups is the cooperation with stakeholders working with these target groups and the involvement of users at local and regional level.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>Dedicated monitoring activities, using a set of specific indicators, should provide qualitative and quantitative data to gradually support an even more strategic and targeted use of the available budget under the Programmes.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>Inclusion measures may already be in place in the national context. Complementarity and synergies with the measures put in place by this framework may contribute to achieving a greater impact in reaching out to and supporting participants with fewer opportunities.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(12)</p></td><td><p>This Decision and the ensuing inclusion action plans should respect the fundamental rights and observe the principles recognised by the Charter of Fundamental Rights of the European Union. <a>(<span>7</span>)</a> They should also ensure full respect for the right to non-discrimination and to promote the application of Article 21 of the Charter.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(13)</p></td><td><p>The actors involved in the process of making the Erasmus+ and the European Solidarity Corps Programmes more inclusive and diverse are heterogeneous and contribute to the development of ideas and new or improved mechanisms, as well as act as key multipliers of the inclusion and diversity efforts,</p></td></tr></tbody></table>
HAS ADOPTED THIS DECISION:
CHAPTER I
GENERAL PROVISIONS
Article 1
Subject matter
1. This Decision establishes a framework of inclusion measures for the Erasmus+ and European Solidarity Corps Programmes for the period of the 2021-2027 Multiannual Financial Framework.
2. It lays down the objectives of the framework and the actions and mechanisms to be implemented.
Article 2
Objectives of the framework of inclusion measures
1. The general objective of the framework of inclusion measures is to facilitate the access to the Erasmus+ and European Solidarity Corps Programmes for people with fewer opportunities, to ensure the putting in place of measures to remove the obstacles that may prevent such access, and to serve as a basis for further implementation guidance as set out in the Annex. Based on the principle that the Programmes have to be accessible for all, regardless of the barriers people may face, the aim is to leave no one behind and contribute to more inclusive societies.
2. The framework of inclusion measures has four specific objectives:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>mainstreaming inclusion and diversity as a cross-cutting priority and guiding principle;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>ensuring the offer of inclusive features and mechanisms within the design of the Programmes and the budget allocated to its actions, and that the focus on inclusion and diversity is taken into account at all stages of the Programmes’ management;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>establishing a common understanding of those who may be considered people with fewer opportunities and fostering a positive approach to diversity;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>supporting beneficiary organisations in establishing more high quality projects that address inclusion and diversity, and in designing and implementing projects in a more inclusive and diverse manner.</p></td></tr></tbody></table>
3. The Annex to this Decision provides a non-exhaustive list of the actions which the Commission has taken and will take in order to provide guidance on the implementation of inclusion measures in the Erasmus+ and European Solidarity Corps Programmes.
CHAPTER II
INCLUSION MEASURES
Article 3
Learning formats
The Programmes shall offer flexible and accessible learning formats to enable reaching out to large target groups, thus increasing the integration of people with fewer opportunities in education and training, youth, sport and solidarity activities.
Article 4
Support to participants with fewer opportunities
Mechanisms to adequately prepare and support participants with fewer opportunities before, during and after their participation within the Programmes, such as preparatory visits, linguistic support, reinforced mentorship and coaching, shall be available and duly financed.
Article 5
Support to organisations
Mechanisms shall be put in place to:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>support organisations in making inclusion a reality, particularly in terms of organisational development, accessibility and the interaction with participants with fewer opportunities before, during and after the project. This can take the form of support activities for staff dealing specifically with inclusion and diversity in organisations, such as training and thematic networking opportunities, to work together to support people with fewer opportunities and to ensure inclusive selection procedures;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>support organisations in their key role to reach out and raise awareness among potential participants with fewer opportunities on the various opportunities and support mechanisms that the Programmes offer them.</p></td></tr></tbody></table>
Article 6
Financial support
1. The Programmes shall provide adequate levels of financial support to participants with fewer opportunities, contributing to removing the barriers that prevent them to participate in Programme’s activities on equal footing to their peers. This includes taking into consideration the most appropriate mechanisms for granting such support.
2. The Programmes shall make available reinforced financial support for organisations working with participants with fewer opportunities, recognising the additional efforts put in place to effectively involve these target groups in their project activities.
Article 7
Selection process
Priority may be given in the grant awarding process to quality projects that actively address the inclusion and involvement of participants with fewer opportunities.
Article 8
User-friendliness of programme’s documents
The Programmes shall ensure that the application and reference documents are user-friendly and accessible and available in different languages. Those documents shall have a clear structure and use simple language in order to support the needs of people with fewer opportunities.
Article 9
Training activities
Funding may be provided under the Programmes to offer training activities aimed at inclusion of people with fewer opportunities for, inter alia, experts, practitioners, staff of the organisations and participants. These training activities shall be aimed at creating opportunities for the exchange of best practices, building competences and for encouraging innovative ideas regarding inclusion measures.
Article 10
Supportive approach
The Programmes shall provide qualitative support for inclusion measures through the Erasmus+ and European Solidarity Corps national agencies and the European Education and Culture Executive Agency (EACEA), as well as through structures such as Support, Advanced Learning and Training Opportunities (SALTO) Inclusion and Diversity.
Article 11
Communication activities
Information and awareness-raising about the opportunities offered by the Programmes and the inclusion support mechanisms may have to be conveyed and adapted to their national and sector-specific context for each category of participants with fewer opportunities. To achieve this, implementing organisations are encouraged to provide suitable and accessible information material, establish different outreach and information channels, share best practices, and proactively target and contact organisations active in the fields of inclusion and diversity. These tasks shall be carried out in particular by the Erasmus+ and European Solidarity Corps national agencies. To support the implementation of these tasks, inclusion and diversity officers shall be appointed in the national agencies.
CHAPTER III
MONITORING AND REPORTING
Article 12
Monitoring activities
1. Relevant data shall be collected, in particular by the Commission and by Erasmus+ and European Solidarity Corps national agencies and the EACEA, during the lifespan of the Programmes through a mix of sources, such as the IT tools supporting the implementation of the Programmes or the participant surveys.
2. Monitoring tasks will be carried out by the Commission with the help of the Erasmus+ and European Solidarity Corps national agencies and the EACEA, and through ad-hoc analysis, while respecting the applicable data protection rules and procedures for processing sensitive personal data.
Article 13
Inclusion action plans
1. As an integral part of their work programmes, the Erasmus+ and European Solidarity Corps national agencies shall develop inclusion action plans, based on this framework of inclusion measures, and with particular attention to the specific challenges to access the Programmes within the national contexts. They shall report on a regular basis to the Commission on the progress made in the implementation of their inclusion action plan.
2. The Commission shall monitor the implementation of those inclusion action plans on a regular basis.
3. Where necessary, the Commission shall provide recommendations and observations to the national agencies in relation to their inclusion action plans, with a view to improve the design, implementation and follow-up of the content of these action plans.
Article 14
Reporting
The Commission shall publish reports on a regular basis on the progress made in the implementation of the inclusion measures, in particular through the mid-term evaluation of the Programmes and annual reporting activities.
Article 15
Complementarity and synergies
1. In the implementation of the inclusion measures, national agencies may ensure complementarity with other existing national measures for inclusion, in order to maximise the impact of these efforts for participants with fewer opportunities.
2. Synergies with other Union funds and national funds shall be sought, to allow for a greater impact and reinforced support to people with fewer opportunities.
CHAPTER IV
FINAL PROVISIONS
Article 16
Co-creation
1. The implementation of these measures to make the Programmes more inclusive and diverse shall be carried out based on a co-creation spirit, in constant dialogue with relevant stakeholders, in particular international and national organisations and networks active in the field of inclusion and diversity, experts, practitioners and participants themselves, the Erasmus+ and European Solidarity Corps national agencies, the EACEA, the SALTO Resource Centres, the Erasmus+ Committee, and representatives of other Union institutions.
2. This dialogue may take place in a wide range of settings, ranging from European events to ad hoc working groups, targeted consultations and training and networking opportunities – either taking place physically, online or in a hybrid mode.
Article 17
Entry into force
This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
Done at Brussels, 22 October 2021.
For the Commission
The President
Ursula VON DER LEYEN
( 1 ) OJ L 189, 28.5.2021, p. 1 . Hereinafter “the Erasmus+ Regulation”.
( 2 ) OJ L 202, 8.6.2021, p. 32 . Hereinafter “the European Solidarity Corps Regulation.” The Erasmus+ and European Solidarity Corps Programme will also be jointly referred to hereinafter as “the Programmes”.
( 3 ) Regulation (EU) No 1288/2013 of the European Parliament and of the Council of 11 December 2013 establishing “Erasmus+”: the Union programme for education, training, youth and sport and repealing Decisions No 1719/2006/EC, No 1720/2006/EC and No 1298/2008/EC ( OJ L 347, 20.12.2013, p. 50 ).
( 4 ) Regulation (EU) 2021/817 of the European Parliament and of the Council of 20 May 2021 establishing Erasmus+: the Union Programme for education and training, youth and sport and repealing Regulation (EU) No 1288/2013 ( OJ L 189, 28.5.2021, p. 1 ).
( 5 ) The Erasmus+ Regulation defines “people with fewer opportunities” in Article 2(25), and the European Solidarity Corps Regulation defines “young people with fewer opportunities” in Article 2(4), in a largely identical manner. In this Decision, they will also be referred to as “participants with fewer opportunities”.
( 6 ) Regulation (EU) 2021/947 of the European Parliament and of the Council of 9 June 2021 establishing the Neighbourhood, Development and International Cooperation Instrument – Global Europe, amending and repealing Decision No 466/2014/EU and repealing Regulation (EU) 2017/1601 and Council Regulation (EC, Euratom) No 480/2009 ( OJ L 209, 14.6.2021, p. 1 ).
( 7 ) Hereinafter referred to as “the Charter”.
ANNEX
Guidance for implementation of the inclusion measures for the Erasmus+ and European Solidarity Corps Programmes
The Commission, in consultation with stakeholders, may further develop the details for implementation of the inclusion measures set out in this Decision in implementation guidelines, to be elaborated and updated throughout the lifespan of the Erasmus+ and European Solidarity Corps Programmes 2021-2027.
The following guidance may be developed and progressively fine-tuned, as part of the regular programme lifecycle:
<table><col/><col/><tbody><tr><td><p>1.</p></td><td><p><span>Reference documents of the programme</span>: the Commission may provide guidance to stakeholders regarding the implementation modalities of inclusion and diversity measures in documents such as the call for proposals and programme guides, in the guidance for experts evaluating project proposals, as well as in application forms, and other technical documents, such as the Inclusion and Diversity Strategy <a>(<span>1</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>2.</p></td><td><p><span>Activities in the framework of the management of Erasmus+ and European Solidarity Corps national agencies</span>: as part of their periodic assessment process, national agencies shall provide information regarding the impact of their national plans in the area of inclusion and diversity and how they contribute to the overall inclusion and diversity objectives of the Programmes at Union level.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>3.</p></td><td><p><span>Communication materials and strategic guidelines</span>: In addition to the programme reference documents, the Commission may develop further guidance documents with useful recommendations, success stories and good practices addressed to Erasmus+ and European Solidarity Corps national agencies and the European Education and Culture Executive Agency (EACEA), beneficiary organisations and potential participants with fewer opportunities to qualitatively support the implementation of inclusion and diversity measures, as well as to raise awareness about the different opportunities on offer. These materials and guidelines shall be developed in co-creation with relevant stakeholders in the field.</p></td></tr></tbody></table>
Where relevant, the Commission, with the support of the relevant implementing structures, shall ensure a wide reach of the materials referred to in point 3 of the second subparagraph. This shall be done through the dedicated websites, social media channels and other forms of communication, in the spirit of ensuring visibility and awareness among potential beneficiaries and participants with fewer opportunities, as well as to promote the active engagement of those potential beneficiaries and participants with fewer opportunities in the co-creation process of more inclusive and diverse Erasmus+ and European Solidarity Corps programmes.
<note>
( 1 ) https://ec.europa.eu/programmes/erasmus-plus/resources/implementation-guidelines-erasmus-and-european-solidarity-corps-inclusion-and-diversity_en
</note> | ENG | 32021D1877 |
<table><col/><col/><col/><col/><tbody><tr><td><p>25.4.2019   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>LI 110/1</p></td></tr></tbody></table>
COUNCIL DECISION (EU) 2019/642
of 13 April 2019
amending Decision (EU) 2019/274 on the signing, on behalf of the European Union and of the European Atomic Energy Community, of the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community
(Text with EEA relevance)
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on European Union, and in particular Article 50 thereof,
Having regard to the proposal from the European Commission,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>On 29 March 2017, the United Kingdom notified the European Council of its intention to withdraw from the European Union and the European Atomic Energy Community (‘Euratom’) in accordance with Article 50 of the Treaty on European Union (‘TEU’), which applies to Euratom by virtue of Article 106a of the Treaty establishing the European Atomic Energy Community.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>In accordance with Article 50 TEU, the European Union negotiated with the United Kingdom an agreement setting out the arrangements for its withdrawal, taking account of the framework for its future relationship with the Union (‘Withdrawal Agreement’).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>On 11 January 2019, the Council adopted Decision (EU) 2019/274 <a>(<span>1</span>)</a> on the signing of the Withdrawal Agreement <a>(<span>2</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>On 21 March 2019, the European Council approved the Instrument relating to the Withdrawal Agreement and the Joint Statement supplementing the Political Declaration, agreed between Prime Minister May and the President of the European Commission Juncker on 11 March 2019.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>By Decision (EU) 2019/476 <a>(<span>3</span>)</a>, the European Council, in agreement with the United Kingdom, decided to extend the period under Article 50(3) TEU until 22 May 2019 in the event that the House of Commons approved the Withdrawal Agreement by 29 March 2019, or, if that were not to be the case, until 12 April 2019. The House of Commons did not approve the Withdrawal Agreement by 29 March 2019.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>On 5 April 2019, the United Kingdom submitted another request to the European Council for an extension of the period provided for in Article 50(3) TEU. On 11 April 2019, by Decision (EU) 2019/584 <a>(<span>4</span>)</a> the European Council, in agreement with the United Kingdom, decided to further extend that period until 31 October 2019. The European Council recalled that, under Article 50(3) TEU, the Withdrawal Agreement may enter into force on an earlier date, should the Parties complete their respective ratification procedures before 31 October 2019. Consequently, the withdrawal should take place on the first day of the month following the completion of the ratification procedures or on 1 November 2019, whichever is the earliest. Furthermore, as indicated in the second paragraph of Article 2 of that Decision, that Decision will cease to apply on 31 May 2019 in the event that the United Kingdom has not held elections to the European Parliament in accordance with applicable Union law and has not ratified the Withdrawal Agreement by 22 May 2019.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>As a consequence, the date of entry into force of the Withdrawal Agreement had to be adapted to reflect the period provided for in Article 50(3) TEU, as extended by the European Council in agreement with the United Kingdom.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>On 11 April 2019, in agreement with the United Kingdom, the Withdrawal Agreement was adapted in three instances as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>in the last recital, the words ‘after 29 March 2019’ were replaced by ‘from the date of entry into force of this Agreement’;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>in Article 185, the first paragraph was replaced by:</p><div><p>‘This Agreement shall enter into force on one of the following dates, whichever is the earliest:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the day following the end of the period provided for in Article 50(3) TEU, as extended by the European Council in agreement with the United Kingdom, provided that, prior to that date, the depositary of this Agreement has received the written notifications by the Union and the United Kingdom regarding the completion of the necessary internal procedures;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the first day of the month following the receipt by the depositary of this Agreement of the last of the written notifications referred to in point (a).</p></td></tr></tbody></table><p>In the event that, prior to the end of the period provided for in Article 50(3) TEU, as extended by the European Council in agreement with the United Kingdom, the depositary of this Agreement has not received the written notifications referred to in point (a), this Agreement shall not enter into force.’;</p></div></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>in Article 2 of the Protocol on Gibraltar, the date of 30 March 2019 was replaced by ‘the date of entry into force of the Withdrawal Agreement’.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>Decision (EU) 2019/274 should therefore be amended accordingly.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>As provided for in Article 50(4) TEU, the United Kingdom has not taken part in the discussions of the Council concerning this decision nor in its adoption,</p></td></tr></tbody></table>
HAS ADOPTED THIS DECISION:
Article 1
Article 1 of Decision (EU) 2019/274 is replaced by the following:
‘Article 1
The signing, on behalf of the Union and the European Atomic Energy Community, of the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, as adapted, is hereby authorised, subject to the conclusion of the said Agreement.
The text of the Agreement, as adapted, is attached to this Decision ( *1 ) .
Article 2
The text of the Agreement attached to Decision (EU) 2019/274 is replaced by the text of the adapted Agreement attached to this Decision ( 5 ) .
Article 3
This Decision shall enter into force on the date of its adoption.
Done at Brussels, 13 April 2019.
For the Council
The President
G. CIAMBA
<note>
( 1 ) Council Decision (EU) 2019/274 of 11 January 2019 on the signing, on behalf of the European Union and of the European Atomic Energy Community, of the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community ( OJ L 47 I, 19.2.2019, p. 1 ).
( 2 ) The text of the Withdrawal Agreement attached to Decision (EU) 2019/274 was published in OJ C 66 I, 19.2.2019, p. 1.
( 3 ) European Council Decision (EU) 2019/476 taken in agreement with the United Kingdom of 22 March 2019 extending the period under Article 50(3) TEU ( OJ L 80 I, 22.3.2019, p. 1 ).
( 4 ) European Council Decision (EU) 2019/584 taken in agreement with the United Kingdom of 11 April 2019 extending the period under Article 50(3) TEU ( OJ L 101, 11.4.2019, p. 1 ).
( 5 ) OJ C 144 I, 25.4.2019, p. 1.
</note> | ENG | 32019D0642 |
<table><col/><col/><col/><col/><tbody><tr><td><p>31.8.2022   </p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 226/1</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2022/1434
of 22 July 2022
granting a Union authorisation for the biocidal product family ‘CMIT-MIT Aqueous 1.5-15’
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products ( 1 ) , and in particular the first subparagraph of Article 44(5) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>On 21 June 2017, Nutrition & Biosciences Netherlands B.V. submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘CMIT-MIT Aqueous 1.5-15’ of product-types 2, 4, 6, 11, 12 and 13, as described in Annex V to that Regulation, providing written confirmation that the competent authority of France had agreed to evaluate the application. The application was recorded under case number BC-CY032700-28 in the Register for Biocidal Products.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>‘CMIT-MIT Aqueous 1.5-15’ contains a mixture of CMIT/MIT, as the active substance, which is included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>On 31 March 2020, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, the assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>On 18 December 2020, the Agency submitted to the Commission an opinion <a>(<span>2</span>)</a>, the draft summary of the biocidal product characteristics (‘SPC’) of ‘CMIT-MIT Aqueous 1.5-15’ and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>The opinion concludes that ‘CMIT-MIT Aqueous 1.5-15’ is a ‘biocidal product family’ within the meaning of Article 3(1), point (s), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>On 15 January 2021, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘CMIT-MIT Aqueous 1.5-15’.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
A Union authorisation with authorisation number EU-0025449-0000 is granted to Nutrition & Biosciences Netherlands B.V. for the making available on the market and use of the biocidal product family ‘CMIT-MIT Aqueous 1.5-15’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 20 September 2022 until 31 August 2032.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 22 July 2022.
For the Commission
The President
Ursula VON DER LEYEN
( 1 ) OJ L 167, 27.6.2012, p. 1 .
( 2 ) ECHA opinion of 3 December 2020 on the Union authorisation of ‘CMIT-MIT Aqueous 1.5-15’ (ECHA/BPC/273/2020), https://echa.europa.eu/bpc-opinions-on-union-authorisation.
ANNEX
Summary of product characteristics for a biocidal product family
CMIT-MIT Aqueous 1.5-15
Product type 2 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Product type 4 - Food and feed area (Disinfectants)
Product type 6 - Preservatives for products during storage (Preservatives)
Product type 11 - Preservatives for liquid-cooling and processing systems (Preservatives)
Product type 12 - Slimicides (Preservatives)
Product type 13 - Working or cutting fluid preservatives (Preservatives)
Authorisation number: EU-0025449-0000
R4BP asset number: EU-0025449-0000
PART I
FIRST INFORMATION LEVEL
1. ADMINISTRATIVE INFORMATION
1.1. Family name
<table><col/><col/><tbody><tr><td><p>Name</p></td><td><p>CMIT-MIT Aqueous 1.5-15</p></td></tr></tbody></table>
1.2. Product type(s)
<table><col/><col/><tbody><tr><td><p>Product type(s)</p></td><td><p>PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)</p><p>PT04 - Food and feed area (Disinfectants)</p><p>PT06 - Preservatives for products during storage (Preservatives)</p><p>PT11 - Preservatives for liquid-cooling and processing systems (Preservatives)</p><p>PT12 - Slimicides (Preservatives)</p><p>PT13 - Working or cutting fluid preservatives (Preservatives)</p></td></tr></tbody></table>
1.3. Authorisation holder
<table><col/><col/><col/><tbody><tr><td><p>Name and address of the authorisation holder</p></td><td><p>Name</p></td><td><p>MC (Netherlands) 1 B.V.</p></td></tr><tr><td><p>Address</p></td><td><p>Willem Einthovenstraat 4, 2342BH Oegstgeest Netherlands</p></td></tr><tr><td><p>Authorisation number</p></td><td><p>EU-0025449-0000</p></td></tr><tr><td><p><span>R4BP asset number</span></p></td><td><p>EU-0025449-0000</p></td></tr><tr><td><p>Date of the authorisation</p></td><td><p>20 September 2022</p></td></tr><tr><td><p>Expiry date of the authorisation</p></td><td><p>31 August 2032</p></td></tr></tbody></table>
1.4. Manufacturer(s) of the biocidal products
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>AD Productions BV</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>Markweg Zuid 27, 4794 SN Heijningen, Netherlands</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>Markweg Zuid 27, 4794 SN Heijningen, Netherlands</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>Jiangsu FOPIA Chemicals Co., Ltd</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>Touzeng Village, 224555 Binhuai Town, Binhai County, Yancheng City, Jiangsu, China</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>Touzeng Village, 224555 Binhuai Town, Binhai County, Yancheng City, Jiangsu, China</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>Acquaflex S.R.L</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>Vigano di Gaggiano, 20083 Milan, Italy</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>Vigano di Gaggiano, 20083 Milan, Italy</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>LABORATORIOS MIRET, S.A.</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>Hercules, 18, 08228 Terrassa, Barcelona, Spain</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>Hercules, 18, 08228 Terrassa, Barcelona, Spain</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>HYDRACHIM</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>Route de Saint Poix, 35370 LE PERTRE, France</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>Route de Saint Poix, 35370 LE PERTRE, France</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>DAXEL srl.</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>via Pietro Nenni 8, 42048 Rubiera RE, Italy</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>via Pietro Nenni 8, 42048 Rubiera RE, Italy</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>Aquatreat Chemical Products Ltd</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>Unit 7, Abbey Industrial Estate, 24 Willow Lane, CR4 4NA Mitcham, United Kingdom</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>Unit 7, Abbey Industrial Estate, 24 Willow Lane, CR4 4NA Mitcham, United Kingdom</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>Flexfill s.r.o.</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>Siřejovická 1213, 410 02 Lovosice, Czech Republic</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>Siřejovická 1213, 410 02 Lovosice, Czech Republic</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>Sopura SA</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>199 rue de trazegnies, 6180 Courcelles, Belgium</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>199 rue de trazegnies, 6180 Courcelles, Belgium</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>Stenco Industrial</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>C/ Gran Vial, 50817 Montornès del Vallès, Barcelona, Spain</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>C/ Gran Vial, 50817 Montornès del Vallès, Barcelona, Spain</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>SUEZ WTS France S.A.S.</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>44, Rue Paul Sabatier Z.I. Nord, 71530 Crissey, France</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>44, Rue Paul Sabatier Z.I. Nord, 71530 Crissey, France</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>QUIPROCALT S.L.</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>Calle Lleida, 2 (Pol Ind Empalme), 43712 Llorenç del Penedès. Tarragona, Spain</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>Calle Lleida, 2 (Pol Ind Empalme), 43712 Llorenç del Penedès. Tarragona, Spain</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>nv Buckman Laboratories</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>Wondelgemkaai 159, 9000 Gent, Belgium</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>Wondelgemkaai 159, 9000 Gent, Belgium</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>N.C.R. Biochemical S.p.A.</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>Via dei Carpentieri n.8, 40050 Castello d’Argile, Italy</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>Via dei Carpentieri n.8, 40050 Castello d’Argile, Italy</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>Alliance Production</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>4 BOULEVARD DEODAT DE SEVERAC, 31770 COLOMIERS, France</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>4 BOULEVARD DEODAT DE SEVERAC, 31770 COLOMIERS, France</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>URQUIMIA S.L.</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>POL. IND. DE ARASO C/ERREGEOIANA 2G, 20305 Irún, Guipúzcoa, Spain</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>POL. IND. DE ARASO C/ERREGEOIANA 2G, 20305 Irún, Guipúzcoa, Spain</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>Kalon Mantenimiento Industrial S.A.</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>Avenida de la Industria 4, 28823 Coslada, Madrid, Spain</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>Avenida de la Industria 4, 28823 Coslada, Madrid, Spain</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>Filtrotech Sarl</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>Route des Jeunes 5D, 1227 Les Acacias / Genève, Switzerland</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>Route des Jeunes 5D, 1227 Les Acacias / Genève, Switzerland</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>Helamin France Sarl</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>Le Technoparc, 135 rue Thomas-Edison, 01630 Saint Genis Pouilly, France</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>Le Technoparc, 135 rue Thomas-Edison, 01630 Saint Genis Pouilly, France</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>Odyssée Environnement</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>Z.A de la Belle Croix, 72510 Requeil, France</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>Z.A de la Belle Croix, 72510 Requeil, France</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>MSGA SERVIVAP</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>50 Rue Jean Zay Bâtiment D1, 69800 ST PRIEST, France</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>50 Rue Jean Zay Bâtiment D1, 69800 ST PRIEST, France</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>TECNA ACONDICIONAMIENTOS DE AGUA S.A</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>Letxumborro Hiribidea, 52, 20305 Irun, Guipúzcoa, Spain</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>Letxumborro Hiribidea, 52, 20305 Irun, Guipúzcoa, Spain</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>h2o facilities sa</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>av. des Grandes-Communes 8, CH-1213 Petit-Lancy, France</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>av. des Grandes-Communes 8, CH-1213 Petit-Lancy, France</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>FUPINAX S.L.</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>Polígono Industrial El Saladar I, C/ Molina, Nave 4, 30564 Lorquí, Spain</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>Polígono Industrial El Saladar I, C/ Molina, Nave 4, 30564 Lorquí, Spain</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>Tresch/ chassieu</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>3 Rue Blaise Pascal, 69680 Chassieu, France</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>3 Rue Blaise Pascal, 69680 Chassieu, France</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>DUPUY</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>42 Rue Saint Martin, 08400 Quatre Champs, France</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>42 Rue Saint Martin, 08400 Quatre Champs, France</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>SUEZ Water Technologies and Solutions Belgium BVBA</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>Toekomstlaan 54, Industriepark Wolfstee, 2200 HERENTALS, Belgium</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>Toekomstlaan 54, Industriepark Wolfstee, 2200 HERENTALS, Belgium</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>Buckman Laboratories (Pty)Ltd</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>1 Buckman Boulevard, 3700 Hammarsdale, South Africa</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>1 Buckman Boulevard, 3700 Hammarsdale, South Africa</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>EAUTEX</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>28 RUE KELLERMANN, 59100 ROUBAIX, France</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>28 RUE KELLERMANN, 59100 ROUBAIX, France</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>Hydrogel-Chemie Wasseraufbereitungs-Gesellschaft mbH</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>Zur Mersch 19, 59457 Werl, Germany</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>Zur Mersch 19, 59457 Werl, Germany</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>sceo</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>ZA PECHNAUQUIE SUD, 31340 VILLEMR SUR TARN, France</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>ZA PECHNAUQUIE SUD, 31340 VILLEMR SUR TARN, France</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>Nutrition & Biosciences (Switzerland) GmbH</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>Wolleraustrasse 15-17, CH-8807 Freienbach, Switzerland</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>Haven 1931 Geslecht, 9130 Kallo, Belgium</p><p>Madoerastraat 10, 3199 KR Maasvlakte Rotterdam, Netherlands</p></td></tr></tbody></table>
1.5. Manufacturer(s) of the active substance(s)
<table><col/><col/><tbody><tr><td><p>Active substance</p></td><td><p>Mixture of 5-chloro-2-methyl-2H- isothiazol-3-one (EINECS 247-500-7) and 2-methyl-2H-isothiazol-3-one (EINECS 220-239-6) (Mixture of CMIT/MIT)</p></td></tr><tr><td><p>Name of manufacturer</p></td><td><p>Jiangsu FOPIA Chemicals Co., Ltd</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>Touzeng Village, 224555 Binhuai Town, Binhai County, Yancheng City, Jiangsu, China</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>Touzeng Village, 224555 Binhuai Town, Binhai County, Yancheng City, Jiangsu, China</p></td></tr></tbody></table>
2. PRODUCT FAMILY COMPOSITION AND FORMULATION
2.1. Qualitative and quantitative information on the composition of the family
<table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Min</p></td><td><p>Max</p></td></tr><tr><td><p>Mixture of 5-chloro-2-methyl-2H- isothiazol-3-one (EINECS 247-500-7) and 2-methyl-2H-isothiazol-3-one (EINECS 220-239-6) (Mixture of CMIT/MIT)</p></td><td><p> </p></td><td><p>Active Substance</p></td><td><p>55965-84-9</p></td><td><p> </p></td><td><p>2,2</p></td><td><p>20,9</p></td></tr></tbody></table>
2.2. Type(s) of formulation
<table><col/><col/><tbody><tr><td><p>Formulation(s)</p></td><td><p>AL - Any other liquid</p></td></tr></tbody></table>
PART II
SECOND INFORMATION LEVEL - META SPC(S)
META SPC 1
1. META SPC 1 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 1 identifier
<table><col/><col/><tbody><tr><td><p>Identifier</p></td><td><p>meta-SPC 1 KATHON 13-15 Mg</p></td></tr></tbody></table>
1.2. Suffix to the authorisation number
<table><col/><col/><tbody><tr><td><p>Number</p></td><td><p>1-1</p></td></tr></tbody></table>
1.3. Product type(s)
<table><col/><col/><tbody><tr><td><p>Product type(s)</p></td><td><p>PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)</p><p>PT04 - Food and feed area (Disinfectants)</p><p>PT06 - Preservatives for products during storage (Preservatives)</p><p>PT11 - Preservatives for liquid-cooling and processing systems (Preservatives)</p><p>PT12 - Slimicides (Preservatives)</p><p>PT13 - Working or cutting fluid preservatives (Preservatives)</p></td></tr></tbody></table>
2. META SPC 1 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 1
<table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Min</p></td><td><p>Max</p></td></tr><tr><td><p>Mixture of 5-chloro-2-methyl-2H- isothiazol-3-one (EINECS 247-500-7) and 2-methyl-2H-isothiazol-3-one (EINECS 220-239-6) (Mixture of CMIT/MIT)</p></td><td><p> </p></td><td><p>Active Substance</p></td><td><p>55965-84-9</p></td><td><p> </p></td><td><p>18,8</p></td><td><p>20,9</p></td></tr></tbody></table>
2.2. Type(s) of formulation of the meta SPC 1
<table><col/><col/><tbody><tr><td><p>Formulation(s)</p></td><td><p>AL - Any other liquid</p></td></tr></tbody></table>
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
<table><col/><col/><tbody><tr><td><p>Hazard statements</p></td><td><p>Harmful if swallowed. Harmful if inhaled.</p><p>Toxic in contact with skin.</p><p>Causes severe skin burns and eye damage.</p><p>May cause an allergic skin reaction.</p><p>Very toxic to aquatic life with long lasting effects.</p><p>Corrosive to the respiratory tract.</p><p>May be corrosive to metals.</p></td></tr><tr><td><p>Precautionary statements</p></td><td><p>Do not breathe fume.</p><p>Wash skin thoroughly after handling.</p><p>Do not eat, drink or smoke when using this product.</p><p>Use only outdoors or in a well-ventilated area.</p><p>Contaminated work clothing should not be allowed out of the workplace.</p><p>Avoid release to the environment.</p><p>Wear protective gloves/ protective clothing/ eye protection/ face protection/ hearing protection.</p><p>Rinse mouth.</p><p>IF ON SKIN: Wash with plenty of water.</p><p>Take off contaminated clothing. And wash it before reuse.</p><p>IF SWALLOWED: Call a Poison Center or doctor if you feel unwell.</p><p>If skin irritation or rash occurs: Get medical advice.</p><p>IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.</p><p>IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.</p><p>IF INHALED: Remove person to fresh air and keep comfortable for breathing.</p><p>Immediately call a Poison Center / doctor.</p><p>IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.</p><p>Collect spillage.</p><p>Store locked up.</p><p>Keep only in original packaging.</p><p>Absorb spillage to prevent material damage.</p><p>Store in a corrosion-resistant container with a resistant inner liner.</p></td></tr></tbody></table>
4. AUTHORISED USE(S) OF THE META SPC 1
4.1. Use description
Table 1
Use # 1 – Preservation of sump water in air conditioning and air washer systems
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria (including L. pneumophila)</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p><p>Common name: Fungi</p><p>Development stage:</p><p>Common name: Algae</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Outdoor</p><p>Preservation of sump water in air conditioning and air washer systems.</p><p>Air conditioning systems and in air washer systems to preserve the sump water. Air washer systems are used extensively in textile factories and in the tobacco industry to scrub or clean the air and for fine control of temperature and humidity.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: -</p><p>Detailed description:</p><p>Automatic and Manual Dosing</p><p>The biocidal product is typically added in a central chilled water sump which supplies several air washers. The loading process may be conducted either manually or by automation. In the automated process, the biocide is metered directly into the sump from a holding tank or other type of bulk container by a dosimeter (pump). The feeding pipe must dose the biocidal product below the water level in order to limit its evaporation.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Curative application: Bacteria, yeasts and fungi. When the system is noticeably fouled, apply 5 to 14,9 mg C(M)IT/MIT (3:1) per Litre of water to be treated, as post treatment after a shock dose of minimum 0,3 ppm of free chlorine. Preventive application: algae When control is obtained, add a continuous or semi continuous feed of 3 to 5 mg C(M)IT/MIT (3:1) per L of water to be treated</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>Curative application: Bacteria, yeasts and fungi</p><p>When the system is noticeably fouled, apply 5 to 14,9 mg C(M)IT/MIT (3:1) per Litre of water to be treated, as post treatment after a shock dose of minimum 0,3 ppm of free chlorine.</p><p>Contact time of 1 hour.</p><p>Preventive application: algae</p><p>When control is obtained, add a continuous or semi continuous feed of 3 to 5 mg C(M)IT/MIT (3:1) per L of water to be treated.</p><p>Regardless of the manner of treatment, the total concentration of the active ingredient C(M)IT/MIT (3:1) in the system should not exceed 14,9 mg/L in the sump water.</p><p>Preliminary steps prior to addition:</p><p>The biocidal product is automatically dosed to the system. Manual handling is necessary for the loading of the biocidal product into the dosing systems.</p><p>Application Frequency:</p><p>Nominally every 2 to 3 days or as needed to obtain control. Repeat until fouling is reduced to an acceptable level for controlling the microbial growth.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>High Density Poly Ethylene (HDPE) flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Intermediate bulk container (IBC): 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.1.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Respect the conditions of use of the product (concentration, contact time, temperature, pH, etc.).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The CMIT/MIT biocidal products are used after a shock dose of free chlorine in this application as standard industry practice.</p></td></tr></tbody></table>
4.1.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During mixing and loading and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of personal protective equipment (PPE) and application of technical and organisational risk mitigation measures (RMM):</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.2. Use description
Table 2
Use # 2 – Preservation of fluids in conveyor belts and pasteurisers
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT04 - Food and feed area (Disinfectants)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p><p>Common name: Fungi</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of fluids in conveyor belts and pasteurisers</p><p>The biocidal product is used for the preservation of process fluids in pasteurisers and conveyor belts used in food industry. The biocidal product is used in these systems to either control or kill bacteria and fungi.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Automated dosing</p><p>The biocidal product is dosed automatically in the heat transfer fluid, in a place of good mixing (e.g. collecting sump below the conveyor belt).</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Curative application: Bacteria, yeasts and fungi When the system is noticeably fouled, apply 10 to 14,9 g C(M)IT/MIT (3:1) per m<span>3</span> of water to be treated as post treatment after a shock dose of minimum 0,3 ppm of free chlorine Preventive application: Bacteria: When control is obtained, add a continuous or semi continuous feed of 2,5 to 5 g C(M)IT/MIT (3:1) per m<span>3</span> of water to be treated.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>Curative application: Bacteria, yeasts and fungi</p><p>When the system is noticeably fouled, apply 10 to 14,9 g C(M)IT/MIT (3:1) per m<span>3</span> of water to be treated as post treatment after a shock dose of minimum 0,3 ppm of free chlorine.</p><p>Contact time of 1 hour.</p><p>Preventive application: Bacteria:</p><p>When control is obtained, add a continuous or semi continuous feed of 2,5 to 5 g C(M)IT/MIT (3:1) per m<span>3</span> of water to be treated.</p><p>Preliminary steps prior to addition:</p><p>The biocidal product is automatically dosed to system. Manual handling is necessary for the loading of containers containing the biocidal product into the dosing systems.</p><p>Application Frequency:</p><p>Nominally every 2 to 3 days or as needed to obtain control. Repeat until fouling is reduced to an acceptable level for controlling the microbial growth.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.2.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Respect the conditions of use of the product (concentration, contact time, temperature, pH, etc.).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The CMIT/MIT biocidal products are used after a shock dose of free chlorine in this application as standard industry practice.</p></td></tr></tbody></table>
4.2.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During mixing and loading and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.3. Use description
Table 3
Use # 3 – Long term offline preservation of reverse osmosis membranes used in potable water
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT04 - Food and feed area (Disinfectants)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Long term offline preservation of reverse osmosis membranes used in potable water</p><p>The C(M)IT/MIT (3:1) biocidal product is recommended for controlling biological growth in off-line trains reverse osmosis membranes producing potable water for extended periods of time.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated dosing.</p><p>It is recommended that fouled membranes be cleaned prior to shut-down and preservation. Please refer to RO /NF supplier manual for membrane cleaning and system shutdown procedures.</p><p>The biocidal product should be dispensed as a tankside additive into the circulating use-dilution of the fluid, using a metering pump or by manual pouring, at a point to assure adequate mixing throughout the system. After complete filling of the trains RO/NF systems with the biocide solution, pumps are stopped (Off line treatment) for extended periods of time.</p><p>Typically C(M)IT/MIT (3:1) solutions are prepared in the CIP (cleaning in place) tank and added via the dosing system. Dilution with the permeate water or high quality water is recommended for the preparation of the biocide solution.</p><p>Membranes should be soaked in the biocide solution during the shut-down period.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: 7,5 -20 g of C(M)IT/MIT (3:1)/ m<span>3</span> of water</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>7,5 -20 g of C(M)IT/MIT (3:1)/ m<span>3</span> of water</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.3.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Respect the conditions of use of the product (concentration, contact time, temperature, pH, etc.).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Prior to taking the membranes back on-line, flush carefully the elements with permeate water in order to eliminate all the residual biocidal product.</p></td></tr></tbody></table>
4.3.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During mixing and loading and cleaning of the whole system, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.4. Use description
Table 4
Use # 4 – Preservation of paints and coatings
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Outdoor</p><p>Preservation of paints and coatings</p><p>(including electrodeposition)</p><p>The biocidal product is recommended to control the growth of bacteria and yeasts in coatings applied by an electrodeposition process and associated rinse systems and in water-based paints and coatings in storage containers before use.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated dosing.</p><p>The biocidal product should be dispensed as a tankside additive into the fluid, using a metering pump or by manual pouring, at a point to assure adequate mixing throughout the system.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products; Professional paints and general public paints: 7,5-14,9 mg/kg C(M)IT/MIT (3:1) in final product.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>The biocidal product is added at the time of manufacture, storage or shipment.</p><p>Industrial uses:</p><p>1,5 - 14,5 % C(M)IT/MIT in the biocidal products.</p><p>Professional paints and general public paints:</p><p>7,5-14,9 mg/kg C(M)IT/MIT (3:1) in final product.</p><p>For the biocidal product as supplied: for industrial use only.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.4.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product shall be used for treatment of products (articles/mixtures) distributed to professional users and to the general public.</p></td></tr></tbody></table>
4.4.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases of products from Meta SPC 1, 2, 3 and 4 (Mixing and Loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The maximal concentration of products from Meta SPC 1, 2, 3 and 4 to be added in paints used must be below the threshold value of 15 ppm.</p></td></tr></tbody></table>
4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.5. Use description
Table 5
Use # 5 – Preservation of detergents and household products
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p><p>Common name: Fungi</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of detergents (washing and cleaning fluids) and household products.</p><p>The biocidal product is recommended for the control of bacteria, yeast and fungi in detergents and cleaning fluids (i.e. hard surface cleaners (all-purpose cleaners), hand dish washing products, fabric softeners, laundry detergents), products used for car care, floor care, waxes, hard surface cleaners, pre-moistened sponges or mops, and the surfactants used in these types of products.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated application.</p><p>The biocidal product should be dispensed to the end use fluid at a point to ensure adequate mixing using preferably automated metering pump or by manual addition.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products; Professional and general public uses: 6-14,9 mg/kg C(M)IT/MIT (3:1) in final product.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>The biocidal product is added at single dose at the time of manufacturing, storage or shipment.</p><p>To ensure uniform distribution, slowly disperse using automated metering or manual addition, into product with agitation. Mix thoroughly until evenly dispersed throughout the product.</p><p>Institutional and Household products:</p><p>(detergents, cleaners, softeners, etc.)</p><p>Industrial uses:</p><p>1,5 - 14,5 % C(M)IT/MIT in the biocidal products.</p><p>Professional and general public uses:</p><p>6-14,9 mg/kg C(M)IT/MIT (3:1) in final product.</p><p>For the biocidal product as supplied: for industrial use only.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.5.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product shall be used for treatment of products (articles/mixtures) distributed to professional users and to the general public.</p></td></tr></tbody></table>
4.5.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases of products from Meta SPC 1 and 3 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The maximal concentration of products from Meta SPC 1 and 3 to be added in detergents and household products used must be below the threshold value of 15 ppm.</p></td></tr></tbody></table>
4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.6. Use description
Table 6
Use # 6 – Preservation of fluids used in paper, textile and leather production - Curative treatment
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of fluids used in paper, textile and leather production -</p><p>The biocidal product is used to reduce contamination by bacteria in textile additives (woven and non-woven, natural and synthetic including silicone emulsions) processing chemicals, all chemicals used in the leather process industry and paper additives (e.g. water pigment pastes, starch, natural gums, synthetic and natural latexes, sizing agents, coating binders, retention aids, dyes, fluorescent whitening agents, wet-strength resins) used in paper mills. The biocidal product inhibits the growth microorganisms, which would otherwise lead to odours formation, viscosity alteration, discolouration of product and premature product failure.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated dosing.</p><p>The biocidal product should be dispensed to the end use fluid at a point to ensure adequate mixing using preferably automated metering pump or by manual addition.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products; Professional uses: 16 to 30 mg/kg of C(M)IT/MIT (3:1) in final product</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>The biocidal product is added at single dose at time of manufacturing, storage or shipment.</p><p>Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products.</p><p>Professional uses:</p><p>Curative treatment:</p><p>16 to 30 mg/kg of C(M)IT/MIT (3:1) in final product</p><p>Contact time: 24 hours</p><p>For the biocidal product as supplied: for industrial use only.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.6.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product shall be used for treatment of products (articles/mixtures) distributed only to professional users.</p></td></tr></tbody></table>
4.6.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases of products from Meta SPC 1, 2, 3 and 4 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The maximal products concentration used for the preservation of fluids used in paper, textile and leather production being above the threshold value of 15 ppm, exposure has to be limited by use of PPE protecting skin and mucous membranes potentially exposed and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.7. Use description
Table 7
Use # 7 – Preservation of glues and adhesives
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of glues and adhesives</p><p>The biocidal product is recommended to control the growth of bacteria and yeasts in water-soluble and water-dispersed synthetic and natural adhesives and tackifiers in storage containers before use</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated application.</p><p>The biocidal product should be dispensed to the end use fluid at a point to ensure adequate mixing using preferably automated metering pump or by manual addition.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products; Professional uses: 8-30 mg/kg C(M)IT/MIT (3:1) in final product. General public uses: 8-14,9 mg/kg C(M)IT/MIT (3:1) in final product.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>The biocidal product is added at single dose at the time of manufacture, storage or shipment.</p><p>To ensure uniform distribution, slowly disperse using automated metering or manual addition, into product with agitation. Mix thoroughly until evenly dispersed throughout the product.</p><p>Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products.</p><p>Professional uses:</p><p>8-30 mg/kg C(M)IT/MIT (3:1) in final product.</p><p>General public uses:</p><p>8-14,9 mg/kg C(M)IT/MIT (3:1) in final product.</p><p>For the biocidal product as supplied: for industrial use only.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.7.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product shall be used for treatment of products (articles/mixtures) distributed to professional users and to the general public. For products distributed to the general public the maximal concentration used must be below the threshold value of 15 ppm.</p></td></tr></tbody></table>
4.7.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases of products from Meta SPC 1, 2, 3 and 4 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>For professional users, the maximal products concentration used for the preservation of glues and adhesives being above the threshold value of 15 ppm, exposure has to be limited by use of PPE, protecting skin and mucous membranes potentially exposed, and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.8. Use description
Table 8
Use # 8 – Preservation of polymer lattices
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p><p>Common name: Fungi</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of polymer latexes</p><p>The biocidal product is recommended for the control of bacteria, yeast and fungi in the manufacture, storage, and transport of latexes, synthetic polymers including Hydrolysed Poly Acryl Amide (HPAM) and biopolymers (e.g. xanthan, dextran.) natural latexes.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated application.</p><p>The biocidal product should be dispensed to the end use fluid at a point to ensure adequate mixing using preferably automated metering pump or by manual addition.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products; Professional uses: 14,9 - 50 mg /kg of C(M)IT/MIT (3:1) in final product.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>The biocidal product is added at single dose at the time of manufacture, storage or shipment.</p><p>To ensure uniform distribution, slowly disperse using automated metering or manual addition, into product with agitation. Mix thoroughly until evenly dispersed throughout the product.</p><p>Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products.</p><p>Professional uses</p><p>14,9 - 50 mg /kg of C(M)IT/MIT (3:1) in final product.</p><p>For the biocidal product as supplied: for industrial use only.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.8.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product shall be used for treatment of products (articles/mixtures) distributed only to professional users.</p></td></tr></tbody></table>
4.8.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases of products from Meta SPC 1, 2, 3 and 4 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The maximal products concentration used for the preservation of polymer lattices being above the threshold value of 15 ppm, exposure has to be limited by use of PPE, protecting skin and mucous membranes potentially exposed, and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.9. Use description
Table 9
Use # 9 – Preservation of biocides and fertilizers
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Outdoor</p><p>Preservation of biocides and fertilizers</p><p>The biocidal product is recommended to control the growth of bacteria and yeasts in fertilizers and biocidal products.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: -</p><p>Detailed description:</p><p>Manual and automated application.</p><p>The biocidal product should be dispensed to the end use fluid at a point to ensure adequate mixing using preferably automated metering pump or by manual addition.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products; Professional uses: 10- 30 mg/kg of C(M)IT/MIT (3:1) in final product.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>The biocidal product is added at single dose at the time of manufacture, storage or shipment.</p><p>Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products.</p><p>Professional uses:</p><p>10- 30 mg/kg of C(M)IT/MIT (3:1) in final product.</p><p>For the biocidal product as supplied: for industrial use only.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.9.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product shall be used for treatment of products (articles/mixtures) distributed only to professional users.</p></td></tr></tbody></table>
4.9.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases of products from Meta SPC 1 and 3 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>For professional users, the maximal products concentration used for the preservation of biocides and fertilizers being above the threshold value of 15 ppm, exposure has to be limited by use of PPE, protecting skin and mucous membranes potentially exposed, and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.9.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.10. Use description
Table 10
Use # 10 – Preservation of mineral slurries
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of mineral slurries</p><p>The biocidal product is recommended to control the growth of bacteria in aqueous-based inorganic/mineral slurries and inorganic pigments which are formulated into paints, coatings and paper.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated application.</p><p>The biocidal product should be dispensed as a tankside additive into the circulating use-dilution of the fluid, using a metering pump or by manual pouring, at a point to assure adequate mixing throughout the system.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products; Professional uses: 10- 30 mg/kg of C(M)IT/MIT (3:1) in final product.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>The biocidal product is added at single dose at the time of manufacture, storage or shipment.</p><p>Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products.</p><p>Professional uses:</p><p>10- 30 mg/kg of C(M)IT/MIT (3:1) in final product.</p><p>For the biocidal product as supplied: for industrial use only.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.10.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product shall be used for treatment of products (articles/mixtures) distributed only to professional users.</p></td></tr></tbody></table>
4.10.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases of products from Meta SPC 1, 2, 3 and 4 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The maximal products concentration used for the preservation of mineral slurries being above the threshold value of 15 ppm, exposure has to be limited by use of PPE, protecting skin and mucous membranes potentially exposed, and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.11. Use description
Table 11
Use # 11 – Preservation of building products applied indoor only
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of building (construction) products (including sealants, caulks, plasters etc.)</p><p>The biocidal product is recommended to control the growth of bacteria in building (construction) products (sealants, caulks, biopolymers, plasters, fillers, admixtures concrete additives, joints compounds,.).</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: -</p><p>Detailed description:</p><p>Manual and automated dosing.</p><p>The biocidal product should be dispensed to the end use fluid at a point to ensure adequate mixing using preferably automated metering pump or by manual addition.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products; Professional uses: Add at typical use rate between 16,2-30 mg C(M)IT/MIT (3:1) per Kg final product to be treated.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>The biocidal product is added at single dose at the time of manufacture, storage or shipment.</p><p>Slowly dispense using automated metering or manually. Mix thoroughly until the biocidal product is evenly dispersed.</p><p>Industrial uses:</p><p>1,5 - 14,5 % C(M)IT/MIT in the biocidal products.</p><p>Professional uses:</p><p>Add at typical use rate between 16,2-30 mg C(M)IT/MIT (3:1) per Kg final product to be treated.</p><p>For the biocidal product as supplied: for industrial use only.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.11.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product shall be used for treatment of products (articles/mixtures) distributed only to professional users.</p></td></tr></tbody></table>
4.11.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>This use is restricted to the preservation of building material applied indoor only.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases for products from Meta SPC 1, 3 and 4 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>For professional users, the maximal products concentration used for the preservation of building products being above the threshold value of 15 ppm, exposure has to be limited by use of PPE, protecting skin and mucous membranes potentially exposed, and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
4.11.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.11.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.11.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.12. Use description
Table 12
Use # 12 – Preservation of electronic chemicals – Curative treatment
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p><p>Common name: Fungi</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of electronic chemicals</p><p>The biocidal product is used to reduce contamination by bacteria, yeasts and fungi in electronic chemicals as Chemical Mechanical Polishing (CMP) silica slurries.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated application.</p><p>The biocidal product should be dispensed to the end use fluid at a point to ensure adequate mixing using preferably automated metering pump or by manual addition.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products; Professional uses: Add at typical use rate between 10-30 mg C(M)IT/MIT (3:1) per L final product to be treated.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>The biocidal product is added at single dose at the time of manufacture, storage or shipment.</p><p>Slowly dispense using automated metering or manually. Mix thoroughly until the biocidal product is evenly dispersed.</p><p>Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products.</p><p>Professional uses</p><p>Curative treatment:</p><p>10-30 mg C(M)IT/MIT (3:1) per kg final product to be treated.</p><p>Contact time: 7 days</p><p>For the biocidal product as supplied: for industrial use only.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.12.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product shall be used for treatment of products (articles/mixtures) distributed only to professional users.</p></td></tr></tbody></table>
4.12.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases for products from Meta SPC 3 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The maximal products concentration used for the preservation of electronic chemicals being above the threshold value of 15 ppm, exposure has to be limited by use of PPE, protecting skin and mucous membranes potentially exposed, and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
4.12.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.12.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.12.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.13. Use description
Table 13
Use # 13 – Preservation of inks
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of inks</p><p>The biocidal product is recommended to control the growth of bacteria and yeasts in inks and ink components (printing inks lithographic, photographic, ink-jet fluids, water based dampening or fountain solutions inks used for textile printing). The biocidal product inhibits the growth of microorganisms, which would otherwise lead to odour formation, viscosity alteration, product discolouration and premature product failure.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated dosing.</p><p>The biocidal product should be dispensed to the end use fluid at a point to ensure adequate mixing using preferably automated metering pump or by manual addition.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products. Professional uses: 6-30 mg C(M)IT/MIT (3:1) /kg final product. General public uses: 6-14,9 mg C(M)IT/MIT (3:1) /kg final product.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>The biocidal product is added at single dose at time of manufacturing, storage or shipment.</p><p>Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products.</p><p>Professional uses:</p><p>6-30 mg C(M)IT/MIT (3:1) /kg final product.</p><p>General public uses:</p><p>6-14,9 mg C(M)IT/MIT (3:1) /kg final product.</p><p>For the biocidal product as supplied: for industrial use only.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.13.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product shall be used for treatment of products (articles/mixtures) distributed to professional users and to the general public. For products distributed to the general public the maximal concentration used must be below the threshold value of 15 ppm.</p></td></tr></tbody></table>
4.13.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases of products from Meta SPC 1, 2, 3 and 4 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>For professional users, the maximal products concentration used for the preservation of inks being above the threshold value of 15 ppm, exposure has to be limited by use of PPE, protecting skin and mucous membranes potentially exposed, and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
4.13.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.13.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.13.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.14. Use description
Table 14
Use # 14 – Preservation of functional fluids (hydraulic fluids, antifreeze, corrosion inhibitors, etc. - excluding fuel additives)
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of functional fluids (hydraulic fluids, antifreeze, corrosion inhibitors, etc. - excluding fuel additives)</p><p>The biocidal product is recommended to control the growth of bacteria in functional fluids such as brake and hydraulic fluids, antifreeze additives, corrosion inhibitors, spinning fluids. The biocidal product inhibits the growth microorganisms, which would otherwise lead to odours formation, viscosity alteration, discolouration of product and premature product failure.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated dosing.</p><p>The biocidal product should be dispensed to the end use fluid at a point to ensure adequate mixing using preferably automated metering pump or by manual addition.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products. Professional uses: Add at a typical use rate between 6 to 30 mg C(M)IT/MIT (3:1) per kg final product to be treated.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>The biocidal product is added at single dose at time of manufacturing, storage or shipment.</p><p>Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products.</p><p>Professional uses:</p><p>Add at a typical use rate between 6 to 30 mg C(M)IT/MIT (3:1) per kg final product to be treated</p><p>For the biocidal product as supplied: for industrial use only.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.14.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product shall be used for treatment of products (articles/mixtures) distributed only to professional users.</p></td></tr></tbody></table>
4.14.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases of products from Meta SPC 1, 2, 3 and 4 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The maximal products concentration used for the preservation of functional fluids (hydraulic fluids, antifreeze, corrosion inhibitors, etc…) being above the threshold value of 15 ppm, exposure has to be limited by use of PPE, protecting skin and mucous membranes potentially exposed, and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
4.14.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.14.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.14.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.15. Use description
Table 15
Use # 15 – Preservation of laboratory reagents
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of laboratory reagents .</p><p>The biocidal product is recommended to control the growth of bacteria and yeasts in laboratory reagents.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated dosing.</p><p>The biocidal product should be dispensed to the end use fluid at a point to ensure adequate mixing using preferably automated metering pump or by manual addition.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products. Professional use: Add at typical use rate of 15,2 mg C(M)IT/MIT (3:1) per kg final product to be treated.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>The biocidal product is added at single dose at the time of manufacture, storage or shipment.</p><p>Slowly dispense using automated metering or manually. Mix thoroughly until the biocidal product is evenly dispersed.</p><p>Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products.</p><p>Professional use: Add at typical use rate of 15,2 mg C(M)IT/MIT (3:1) per kg final product to be treated.</p><p>For the biocidal product as supplied: for industrial use only.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 1 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.15.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product shall be used for treatment of products (articles/mixtures) distributed only to professional users.</p></td></tr></tbody></table>
4.15.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases for products from Meta SPC 1, 3 and 4 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>For professional users, the maximal products concentration used for the preservation of laboratory reagents being above the threshold value of 15 ppm, exposure has to be limited by use of PPE, protecting skin and mucous membranes potentially exposed, and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
4.15.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.15.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.15.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.16. Use description
Table 16
Use # 16 – Offline preservation of industrial reverse osmosis membranes
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Offline preservation of industrial reverse osmosis membranes</p><p>The biocidal product is recommended to control the growth of bacteria of reverse osmosis and nanofiltration membranes producing industrial water for extended periods of time.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated dosing.</p><p>The biocidal product should be dispensed as a tankside additive into the circulating use-dilution of the fluid, using a metering pump or by manual pouring, at a point to ensure adequate mixing throughout the system. After complete filling of the trains RO/NF systems with the biocide solution, pumps are stopped (Off line treatment) for extended periods of time.</p><p>Typically C(M)IT/MIT (3:1) solutions are prepared in the CIP (cleaning in place) tank and added via the dosing system. Dilution with permeate water or high quality water is recommended for the preparation of the biocide solution. Membranes should be soaked in the biocide solution during the shut-down period.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: 7,5–20 g/m<span>3</span> (ppm w/v) of C(M)IT/MIT (3:1).</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>7,5–20 g/m<span>3</span> (ppm w/v) of C(M)IT/MIT (3:1).</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.16.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
4.16.2. Use-specific risk mitigation measures
Rinse the system with water prior to perform the maintenance of the system.
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases for products from Meta SPC 1, 3 and 4 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
4.16.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.16.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.16.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.17. Use description
Table 17
Use # 17 – Preservation of liquids used in closed recirculating cooling systems
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT11 - Preservatives for liquid-cooling and processing systems (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria (including Legionella pneumophila)</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p><p>Common name: Fungi</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Outdoor</p><p>Preservation of liquids used in closed recirculating cooling systems (Closed re-circulating cooling water systems comprise compressor cooling, air conditioning chilled water, boilers, engine jacket cooling, power supply cooling, and other industrial processes).</p><p>The biocidal product is used to control the growth of aerobes and anaerobes bacteria, yeast, fungi, and biofilm in the circulating water of closed systems</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated dosing.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Curative efficacy:- against bacteria (including L. pneumophila) at 5 - 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water. Contact time: 24 hours - against biofilm: 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water. Contact time: 24 hours.- against fungi and yeasts at 1 – 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water. Contact time: 48 hours. Preventive efficacy:- against bacteria (including L. pneumophila) at 3 – 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water. - against biofilm (including L. pneumophila): 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>Curative efficacy:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against bacteria (including L. pneumophila) at 5 - 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p><p>Contact time: 24 hours</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against biofilm: 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p><p>Contact time: 24 hours</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against fungi and yeasts at 1 – 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p><p>Contact time: 48 hours</p></td></tr></tbody></table><p>Preventive efficacy:</p><p>against bacteria (including L. pneumophila) at 3 – 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p><p>against biofilm (including L. pneumophila): 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.17.1. Use-specific instructions for use
Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
4.17.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
4.17.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.17.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.17.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.18. Use description
Table 18
Use # 18 – Preservation of liquids used in small open recirculating cooling systems
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT11 - Preservatives for liquid-cooling and processing systems (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria (including Legionella pneumophila)</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p><p>Common name: Fungi</p><p>Development stage:</p><p>Common name: Algae (green algae and cyanobacteria)</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Outdoor</p><p>Preservation of liquids used in small open recirculating cooling systems (blowdown and recirculating flow rates, as well as total volume of water limited to 2 m<span>3</span>/h, and 100 m<span>3</span>/h and 300 m<span>3</span> respectively)</p><p>Process and cooling water: Used to control the growth of bacteria, algae, fungi and biofilm</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Open system</p><p>Detailed description:</p><p>Manual and automated dosing.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Curative treatment Against bacteria (including L. pneumophila) at 5 – 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water, - against biofilm (including L. pneumophila) at 1,5 to 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water, - against fungi (including yeast) at 1 – 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water. Preventive treatment: - against bacteria, green algae and cyanobacteria at 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water, - against biofilm (including L. pneumophila) at 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>Curative treatment:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Against bacteria (including L. pneumophila) at 5 – 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water</p><p>Contact time: 24 hours</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against biofilm (including L. pneumophila) at 1,5 - 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water</p><p>Contact time: 48 hours.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against fungi and yeast at 1 – 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water</p><p>Contact time: 48 hours.</p></td></tr></tbody></table><p>Preventive treatment:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against bacteria, green algae and cyanobacteria at 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against biofilm (including L. pneumophila) at 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p></td></tr></tbody></table></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.18.1. Use-specific instructions for use
Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
4.18.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Cooling fluid must not enter surface water directly. Use product only in premises that are connected to a STP.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The product can only be used when the cooling towers are equipped with drift eliminators that reduce the drift at least by 99 %.</p></td></tr></tbody></table>
4.18.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.18.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.18.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.19. Use description
Table 19
Use # 19 – Preservation of liquids used in pasteurizers, conveyor belts and air washers
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT11 - Preservatives for liquid-cooling and processing systems (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria (including Legionella pneumophila)</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p><p>Common name: Fungi</p><p>Development stage:</p><p>Common name: Algae (green algae and cyanobacteria)</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Outdoor</p><p>Preservation of liquids used in non-food pasteurizers and conveyor belts, air washers.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: -</p><p>Detailed description:</p><p>The biocidal product is dosed automatically in the heat transfer fluid, in a place of good mixing (e.g. collecting sump below the conveyor belt). The feeding pipe is used to dose the biocidal product below the water level in order to limit its evaporation.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Curative treatment: -against bacteria (including L. pneumophila): 5 - 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water - against biofilm (including L. pneumophila) at 1,5 - 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water - against fungi and yeast at 1 – 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water. Preventive treatment: Against bacteria, green algae and cyanobacteria at 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water, against biofilm (including L. pneumophila) at 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>Curative treatment:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against bacteria (including L. pneumophila): 5 - 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p><p>Contact time: 24 hours</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against biofilm (including L. pneumophila) at 1,5 - 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water</p><p>Contact time: 48 hours.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against fungi and yeast at 1 – 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water</p><p>Contact time: 48 hours.</p></td></tr></tbody></table><p>Preventive treatment:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Against bacteria, green algae and cyanobacteria at 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against biofilm (including L. pneumophila) at 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p></td></tr></tbody></table></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.19.1. Use-specific instructions for use
Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
Air washers: For use only in industrial air-washer systems that maintain effective mist eliminating components.
4.19.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
4.19.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.19.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.19.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.20. Use description
Table 20
Use # 20 – Preservation of wood treatment solutions
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT11 - Preservatives for liquid-cooling and processing systems (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Scientific name: fungi</p><p>Common name: other</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Outdoor</p><p>Preservation of wood treatment solutions for application on wood of classes 1, 2 and 3 only. The biocidal product is used as a preservative for aqueous wood preservative treatment solution during the wet-state process used in timber treatment solutions.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: -</p><p>Detailed description:</p><p>—</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Preventive treatment: against fungi: 15 - 50 g C(M)IT/MIT (3:1) / m<span>3</span> of in use wood preservation solution</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>Preventive treatment: against fungi: 15 - 50 g C(M)IT/MIT (3:1) / m<span>3</span> of in use wood preservation solution</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.20.1. Use-specific instructions for use
Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product is not intended to function as a wood preservative against wood destroying fungus relative to product type 8.</p></td></tr></tbody></table>
4.20.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases (mixing and loading) and cleaning phases, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The product shall not be used in a wood treatment solution to be applied to wood which may come in direct contact with food, feeding stuff and livestock animals</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The product can be used to preserve wood treatment solutions for the treatment of wood in use classes 1, 2 and 3 only.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The product can be used in a wood treatment solution where the industrial application processes of wood treatment can be carried out within a contained area situated on impermeable hard standing with bunding to prevent run-off and a recovery system in place (e.g. sump).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The product can be used in wood treatment solutions for the preservation of freshly treated timber, which after treatment is stored under shelter or on impermeable hard standing, or both, to prevent direct losses to soil, sewer or water. Any losses of wood treatment solution shall be collected for reuse or disposal.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The product can be used only in wood treatment solutions for industrial application if these cannot be released to soil, ground- and surface water or any kind of sewer and the wood treatment solutions and/or the product are collected and reused or disposed of as hazardous waste.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product can be used only in wood treatment solutions used for the treatment of objects or materials which are stored until completely dried on impermeable ground and under roof, to avoid leakage into the soil.</p></td></tr></tbody></table>
4.20.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.20.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.20.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.21. Use description
Table 21
Use # 21 – Preservation of recirculating fluids used in textile and fiber processing, leather processing, photo-processing and fountain solution systems
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT11 - Preservatives for liquid-cooling and processing systems (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of recirculating fluids used in textile, fiber processing, leather processing, photo-processing and fountain solution systems</p><p>C(M)IT/MIT (3:1) biocidal products are used for the preservation of textile and spinning fluids, photo processing solutions, leather process (e.g. washing and soaking treatment stages) and printing fountain solutions to control the integrity of recirculating fluid by reducing microbial contamination in the bulk solution.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: -</p><p>Detailed description:</p><p>Manual and automated dosing.</p><p>The preservation of all end-products is performed in most cases highly automated by industrial users</p><p>The biocidal product is added to the central sump, basin or recirculating lines in an area with adequate mixing.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Curative treatment: Against bacteria at 16-30 mg C(M)IT/MIT (3:1) per L of fluid</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>Curative treatment: Against bacteria at 16-30 mg C(M)IT/MIT (3:1) per L of fluid</p><p>Contact time 5 days</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.21.1. Use-specific instructions for use
Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
4.21.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Liquids used in textile and fiber processing fluids must not enter surface water directly. Use product only in premises that are connected to a STP.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Recirculating liquids in photoprocessing systems and fountain solution systems must not enter surface water directly. Use product only in premises that are connected to a STP.</p></td></tr></tbody></table>
4.21.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.21.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.21.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.22. Use description
Table 22
Use # 22 – Preservation of re-circulating liquids used in paint spray booths and electrodeposition coating systems
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT11 - Preservatives for liquid-cooling and processing systems (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of re-circulating liquids used in paint spray booths and electrodeposition coating systems.</p><p>The biocidal product is used for preservation of fluids in pre- treatment processes (Cleaning treatment for grease removal and soil, degreasing Phosphating process, Rinse off tanks) paint spray booths and electrodeposition coating systems (e.g. cataphoretic baths) applied in Car Refinishing and Original equipment Car Manufacturing to control the integrity of recirculating fluid by reducing microbial contamination from bacteria and fungi in the bulk solution.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: -</p><p>Detailed description:</p><p>—</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Preventive treatment: 7,5 to 30 mg C(M)IT/MIT (3:1) per Kg final product.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>Preventive treatment: 7,5 to 30 mg C(M)IT/MIT (3:1) per Kg final product.</p><p>The biocidal product is added at the time of manufacture, storage or shipment.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.22.1. Use-specific instructions for use
Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
4.22.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
4.22.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.22.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.22.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.23. Use description
Table 23
Use # 23 – Preservation of liquids used in closed recirculating heating systems and associated pipework
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT11 - Preservatives for liquid-cooling and processing systems (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria (anaerobes and aerobes (including Legionella pneumophila)</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p><p>Common name: Fungi</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Outdoor</p><p>Preservation of liquids used in closed recirculating heating systems and associated pipework. Pre-commission biocide flushing of new or existing pipework systems (heating and chilling pipework) includes used or new structural pipework built on industrial building projects.</p><p>Closed recirculating heating systems: pre-commission biocidal product flushing of new or existing pipework systems (heating and chilling pipework) includes used or new structural pipework built on industrial building projects. The biocidal product is used to control the growth of aerobic and anaerobic bacteria, fungi and biofilm in the circulating water of closed systems. Closed systems are less susceptible to corrosion, scaling and biological fouling than open systems. However microbial problems can occur, if the system is left filled and untreated. This is due to the presence of nitrite and glycols used as nutrients by microbes.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated dosing.</p><p>The biocidal product is dosed automatically in the heat transfer fluid, in a place of good mixing. The feeding pipe must dose the biocidal product below the water level in order to limit the evaporation of the biocidal product.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Curative treatment - against bacteria at 5 g C(M)IT/MIT (3:1) / m<span>3</span> of water (including L. pneumophila) - against biofilm at 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water - against fungi and yeast at 1 g C(M)IT/MIT / m<span>3</span> of water Preventive treatment - against bacteria (including L. pneumophila) at 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water - against biofilm at 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>Curative treatment:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against bacteria at 5 g C(M)IT/MIT (3:1) / m<span>3</span> of water (including L. pneumophila)</p><p>Contact time: 24 hours</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against biofilm at 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water</p><p>Contact time: 24 hours</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against fungi and yeast at 1 g C(M)IT/MIT / m<span>3</span> of water</p><p>Contact time: 48 hours</p></td></tr></tbody></table><p>Preventive treatment</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against bacteria (including L. pneumophila) at 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water and against biofilm at 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p></td></tr></tbody></table></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.23.1. Use-specific instructions for use
Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
4.23.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
4.23.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.23.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.23.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.24. Use description
Table 24
Use # 24 – Preservation of polymers used in oilfield processes (e.g. enhanced oil recovery, drilling muds, etc.)
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT11 - Preservatives for liquid-cooling and processing systems (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Outdoor</p><p>Preservation of polymers used in oilfield processes (e.g. enhanced oil recovery, drilling muds, etc.)</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: -</p><p>Detailed description:</p><p>—</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Preventive treatment of polymers used in the injection water: Xanthan polymer: 30 -50 g C(M)IT/MIT/m<span>3</span> solution. HPAM polymer: 30 - 50 g C(M)IT/MIT/m<span>3</span> solution. Preventive treatment of polymers used in the drilling muds: Xanthan polymer: 30 g C(M)IT/MIT/m<span>3</span> solution. HPAM polymer: 30 g C(M)IT/MIT/m<span>3</span> solution.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>Preventive treatment of polymers used in the injection water:</p><p>Xanthan polymer: 30 -50 g C(M)IT/MIT/m<span>3</span> solution.</p><p>HPAM polymer: 30 - 50 g C(M)IT/MIT/m<span>3</span> solution.</p><p>Preventive treatment of polymers used in the drilling muds:</p><p>Xanthan polymer: 30 g C(M)IT/MIT/m<span>3</span> solution.</p><p>HPAM polymer: 30 g C(M)IT/MIT/m<span>3</span> solution.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.24.1. Use-specific instructions for use
Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
4.24.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
4.24.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.24.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.24.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.25. Use description
Table 25
Use # 25 – Slimicide treatment in the de-inking process of the pulp and paper
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT12 - Slimicides (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p><p>Common name: Fungi</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Slimicide treatment in the de-inking process of the pulp and paper. Recycling paper /deinking paper mills. Deinking process is a manufacturing paper process of removing printing inks from waste paper-fibers to produce deinked pulp.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated dosing.</p><p>The biocidal product is automatically dosed by pump and fixed pipes into the circuit, usually in the pulper below the water level.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Curative treatment: 10 to 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water to be treated. Preventive treatment: 5 g C(M)IT/MIT (3:1) / m<span>3</span> of water to be treated.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>Curative treatment: 10 to 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water to be treated</p><p>Contact time: 24 hours</p><p>Preventive treatment: 5 g C(M)IT/MIT (3:1) / m<span>3</span> of water to be treated.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.25.1. Use-specific instructions for use
Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
4.25.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
4.25.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.25.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.25.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.26. Use description
Table 26
Use # 26 – Slimicide treatment in the wet-end stage of paper manufacturing process
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT12 - Slimicides (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p><p>Common name: Fungi</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Slimicide treatment in the wet-end stage of the paper manufacturing process (paper mills, wet-end stage (water circuits), and paper mills process system).</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated dosing.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Curative treatment: 10 to 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water to be treated. Preventive treatment: 5 g C(M)IT/MIT (3:1) / m<span>3</span> of water to be treated.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>Curative treatment: 10 to 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water to be treated</p><p>Contact time: 24 hours</p><p>Preventive treatment: 5 g C(M)IT/MIT (3:1) / m<span>3</span> of water to be treated.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.26.1. Use-specific instructions for use
Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
4.26.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The use of C(M)IT/MIT (3:1) containing products for the slimicide treatment in the wet-end stage of the paper manufacturing process is restricted to</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>curative treatments in plants connected to a slimicide-free water from a pulp mill and only for the treatment of the short circulation of the paper mill; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>preventive treatments,</p></td></tr></tbody></table><p>and, for both cases, only if the factory’s waste water is purified in an on-site (full) industrial sewage treatment plant with a minimal capacity of 5 000 m<span>3</span> per day as described in the Industrial Emission Directive 2010/75/EU (Best Available Techniques for the production of pulp, paper and board) and if a dilution of at least 200 times in surface water is achieved after the industrial sewage treatment plant.</p></td></tr></tbody></table>
4.26.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.26.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.26.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.27. Use description
Table 27
Use # 27 – Preventive treatment (biofouling control) online and after cleaning in place for industrial RO/NF membranes
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT12 - Slimicides (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preventive treatment (biofouling control) online and after cleaning in place for industrial RO/NF membranes</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated dosing.</p><p>Biocidal product application on a routine basis will prevent biofilm growth on Reverse Osmosis or Nano Filtration membrane surfaces, feed spacer, filter media and pipework. The biocidal product should be dispensed to the feed water at a point to assure adequate mixing throughout the system.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Preventive treatment: 5 g C(M)IT/MIT (3:1) per m<span>3</span> of fluid</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>Preventive treatment: 5 g C(M)IT/MIT (3:1) per m<span>3</span> of fluid</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.27.1. Use-specific instructions for use
Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
4.27.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use product only in premises that are connected to a STP.</p></td></tr></tbody></table>
4.27.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.27.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.27.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.28. Use description
Table 28
Use # 28 – Products to control microbial deterioration in fluids used for working or cutting metal, glass or other materials
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT13 - Working or cutting fluid preservatives (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p><p>Common name: Fungi</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Products to control microbial deterioration in fluids used for working or cutting metal, glass or other materials</p><p>The biocidal product is recommended to control the growth of bacteria and fungi in fluids used for metalworking fluids (cutting, grinding, rolling, drawing, etc.) metal surface treatment (aqueous multipurpose and de-watering rust cleaner fluids, etc.) and cutting fluids for glass or other materials.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: -</p><p>Detailed description:</p><p>The biocidal product should be dispensed as a tankside additive into the circulating use-dilution of the fluid, using a metering pump or by manual pouring, at a point to assure adequate mixing throughout the system.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Curative treatment: When the system is noticeably fouled, apply 14,9 g C(M)IT/MIT (3:1) per m<span>3</span> of fluid to be treated. Preventive treatment: When control is obtained, adding 10 g C(M)IT/MIT (3:1) per m<span>3</span> of fluid to be treated.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>Curative treatment:</p><p>When the system is noticeably fouled, apply 14,9 g C(M)IT/MIT (3:1) per m<span>3</span> of fluid to be treated.</p><p>Contact time: 24 h</p><p>Preventive treatment:</p><p>When control is obtained, adding 10 g C(M)IT/MIT (3:1) per m<span>3</span> of fluid to be treated.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.28.1. Use-specific instructions for use
Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
4.28.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
4.28.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.28.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.28.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
5. GENERAL DIRECTIONS FOR USE ( 1 ) OF THE META SPC 1
5.1. Instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration of the effect is dependent on the performance requirements of the customer for their preserved material and on the specific ingredients composition and pH of the preserved product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Always read the label or leaflet before use and follow all the instructions provided.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Respect the conditions of use of the product (concentration, contact time, temperature, pH, etc.)</p></td></tr></tbody></table>
PRECAUTIONARY MEASURES DURING STORAGE AND TRANSPORT:
Keep in a well-ventilated place. The product as supplied may evolve gas (largely carbon dioxide) slowly. To prevent the buildup of pressure the product is packaged in specially vented containers, where necessary. Keep this product in the original container when not in use. Container must be stored and transported in an upright position to prevent spilling the contents through the vent, where fitted.
5.2. Risk mitigation measures
— 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Skin contact: Remove contaminated clothing and shoes. Wash contaminated skin with water. Contact poison treatment specialist if symptoms occur.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye contact: Immediately flush with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses if easy to do. Continue to rinse with tepid water for at least 30 minutes. Call 112/ambulance for medical assistance.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Ingestion: Wash out mouth with water. Contact poison treatment specialist. Seek medical advice immediately if symptoms occur and/or large quantities have been ingested. Do not give fluids or induce vomiting.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Inhalation (of spray mist): Remove victim to fresh air and keep at rest in a position comfortable for breathing. Seek medical advice immediately if symptoms occur and/or large quantities have been inhaled.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In case of impaired consciousness place in recovery position and seek medical advice immediately.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Keep the container or label available.</p></td></tr></tbody></table>
5.4. Instructions for safe disposal of the product and its packaging
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Do not discharge unused product on the ground, into water courses, into pipes (e.g. sink, toilets) nor down the drains.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Dispose of unused product, its packaging and all other waste, in accordance with local regulations.</p></td></tr></tbody></table>
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Conditions for safe storage, including any incompatibilities: Keep in a dry, cool and well-ventilated place, in the original container.
Protect from frost
Shelf-life: 24 months
Protect from sunlight.
Recommendation: If a metal packaging is used, a varnish layer should be applied.
6. OTHER INFORMATION
— 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1
7.1. Trade name(s), authorisation number and specific composition of each individual product
<table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Trade name(s)</p></td><td><p>KATHON™ WT BIOCIDE</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>KATHON™ WT</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>KATHON™LX BIOCIDE</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>KATHON™ LX</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>KATHON™ LX Microbicide</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>KATHON™886MW BIOCIDE</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>KATHON™ 886 F BIOCIDE</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Bansan 160</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Biocide KT1400WT</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Biocide KT1400LX</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Biocide KT1400MW</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>KT1400MW</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>KT1400WT</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Hydrex™ 7320</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>MIRECIDE-KW/650</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>obbio211</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>AQUACIDE C 140</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>AQUACIDE C 15</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>AQUACIDE C 21</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>AQUACIDE C 30</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>BAC 416</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>BIOSTOP 140</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>BIOSTOP 15</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>BIOSTOP 21</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>BIOSTOP 30</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>CAT 3693</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>GWC 3363</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>GWC 3630</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>GWE 3693</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>IWC BACTERICIDE 416</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Isocil® 14</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>France Algue 232</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>KT1400LX</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Authorisation number</p></td><td><p>EU-0025449-0001 1-1</p></td></tr><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Mixture of 5-chloro-2-methyl-2H- isothiazol-3-one (EINECS 247-500-7) and 2-methyl-2H-isothiazol-3-one (EINECS 220-239-6) (Mixture of CMIT/MIT)</p></td><td><p> </p></td><td><p>Active Substance</p></td><td><p>55965-84-9</p></td><td><p> </p></td><td><p>20,3</p></td></tr></tbody></table>
7.2. Trade name(s), authorisation number and specific composition of each individual product
<table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Trade name(s)</p></td><td><p>KATHON™ CF 1400 BIOCIDE</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Biocide KT1400</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>KT1400</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>‘hygel’ KW 60 B ATESTEO</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Isocil® Ultra 14</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>MK3201</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>FINEAMIN</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Authorisation number</p></td><td><p>EU-0025449-0002 1-1</p></td></tr><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Mixture of 5-chloro-2-methyl-2H- isothiazol-3-one (EINECS 247-500-7) and 2-methyl-2H-isothiazol-3-one (EINECS 220-239-6) (Mixture of CMIT/MIT)</p></td><td><p> </p></td><td><p>Active Substance</p></td><td><p>55965-84-9</p></td><td><p> </p></td><td><p>20,5</p></td></tr></tbody></table>
META SPC 2
1. META SPC 2 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 2 identifier
<table><col/><col/><tbody><tr><td><p>Identifier</p></td><td><p>meta-SPC 2 KATHON 13-15 Na</p></td></tr></tbody></table>
1.2. Suffix to the authorisation number
<table><col/><col/><tbody><tr><td><p>Number</p></td><td><p>1-2</p></td></tr></tbody></table>
1.3. Product type(s)
<table><col/><col/><tbody><tr><td><p>Product type(s)</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr></tbody></table>
2. META SPC 2 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 2
<table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Min</p></td><td><p>Max</p></td></tr><tr><td><p>Mixture of 5-chloro-2-methyl-2H- isothiazol-3-one (EINECS 247-500-7) and 2-methyl-2H-isothiazol-3-one (EINECS 220-239-6) (Mixture of CMIT/MIT)</p></td><td><p> </p></td><td><p>Active Substance</p></td><td><p>55965-84-9</p></td><td><p> </p></td><td><p>18,8</p></td><td><p>20,9</p></td></tr></tbody></table>
2.2. Type(s) of formulation of the meta SPC 2
<table><col/><col/><tbody><tr><td><p>Formulation(s)</p></td><td><p>AL - Any other liquid</p></td></tr></tbody></table>
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
<table><col/><col/><tbody><tr><td><p>Hazard statements</p></td><td><p>May be corrosive to metals.</p><p>Harmful if swallowed. Harmful if inhaled.</p><p>Toxic in contact with skin.</p><p>Causes severe skin burns and eye damage.</p><p>May cause an allergic skin reaction.</p><p>Very toxic to aquatic life with long lasting effects.</p><p>Corrosive to the respiratory tract.</p></td></tr><tr><td><p>Precautionary statements</p></td><td><p>Do not breathe fume.</p><p>Wash skin thoroughly after handling.</p><p>Do not eat, drink or smoke when using this product.</p><p>Use only outdoors or in a well-ventilated area.</p><p>Contaminated work clothing should not be allowed out of the workplace.</p><p>Avoid release to the environment.</p><p>Wear protective gloves/ protective clothing/ eye protection/ face protection/ hearing protection.</p><p>Rinse mouth.</p><p>IF ON SKIN: Wash with plenty of water.</p><p>Take off contaminated clothing. And wash it before reuse.</p><p>IF SWALLOWED: Call a POISON CENTER or doctor if you feel unwell.</p><p>If skin irritation or rash occurs: Get medical advice.</p><p>IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.</p><p>IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.</p><p>IF INHALED: Remove person to fresh air and keep comfortable for breathing.</p><p>Immediately call a POISON CENTER/ doctor.</p><p>IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.</p><p>Collect spillage.</p><p>Store locked up.</p><p>Keep only in original packaging.</p><p>Absorb spillage to prevent material damage.</p><p>Store in a corrosion-resistant container with a resistant inner liner.</p></td></tr></tbody></table>
4. AUTHORISED USE(S) OF THE META SPC 2
4.1. Use description
Table 29
Use # 1 – Preservation of paints and coatings
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Outdoor</p><p>Preservation of paints and coatings</p><p>(including electrodeposition)</p><p>The biocidal product is recommended to control the growth of bacteria and yeasts in coatings applied by an electrodeposition process and associated rinse systems and in water-based paints and coatings in storage containers before use.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated dosing.</p><p>The biocidal product should be dispensed as a tankside additive into the fluid, using a metering pump or by manual pouring, at a point to assure adequate mixing throughout the system.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products; Professional paints and general public paints: 7,5-14,9 mg/kg C(M)IT/MIT (3:1) in final product.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>The biocidal product is added at the time of manufacture, storage or shipment.</p><p>Industrial uses:</p><p>1,5 - 14,5 % C(M)IT/MIT in the biocidal products.</p><p>Professional paints and general public paints:</p><p>7,5-14,9 mg/kg C(M)IT/MIT (3:1) in final product.</p><p>For the biocidal product as supplied: for industrial use only.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.1.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product shall be used for treatment of products (articles/mixtures) distributed to professional users and to the general public.</p></td></tr></tbody></table>
4.1.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases of products from Meta SPC 1, 2, 3 and 4 (Mixing and Loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The maximal concentration of products from Meta SPC 1, 2, 3 and 4 to be added in paints used must be below the threshold value of 15 ppm.</p></td></tr></tbody></table>
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.2. Use description
Table 30
Use # 2 – Preservation of fluids used in paper, textile and leather production - Curative treatment
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of fluids used in paper, textile and leather production -</p><p>The biocidal product is used to reduce contamination by bacteria in textile additives (woven and non-woven, natural and synthetic including silicone emulsions) processing chemicals, all chemicals used in the leather process industry and paper additives (e.g. water pigment pastes, starch, natural gums, synthetic and natural latexes, sizing agents, coating binders, retention aids, dyes, fluorescent whitening agents, wet-strength resins) used in paper mills. The biocidal product inhibits the growth microorganisms, which would otherwise lead to odours formation, viscosity alteration, discolouration of product and premature product failure.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated dosing.</p><p>The biocidal product should be dispensed to the end use fluid at a point to ensure adequate mixing using preferably automated metering pump or by manual addition.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products; Professional uses: 16 to 30 mg/kg of C(M)IT/MIT (3:1) in final product</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>The biocidal product is added at single dose at time of manufacturing, storage or shipment.</p><p>Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products.</p><p>Professional uses:</p><p>Curative treatment:</p><p>16 to 30 mg/kg of C(M)IT/MIT (3:1) in final product</p><p>Contact time: 24 hours</p><p>For the biocidal product as supplied: for industrial use only.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.2.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product shall be used for treatment of products (articles/mixtures) distributed only to professional users.</p></td></tr></tbody></table>
4.2.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases of products from Meta SPC 1, 2, 3 and 4 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The maximal products concentration used for the preservation of fluids used in paper, textile and leather production being above the threshold value of 15 ppm, exposure has to be limited by use of PPE protecting skin and mucous membranes potentially exposed and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.3. Use description
Table 31
Use # 3 – Preservation of glues and adhesives
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of glues and adhesives</p><p>The biocidal product is recommended to control the growth of bacteria and yeasts in water-soluble and water-dispersed synthetic and natural adhesives and tackifiers in storage containers before use</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated application.</p><p>The biocidal product should be dispensed to the end use fluid at a point to ensure adequate mixing using preferably automated metering pump or by manual addition.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products; Professional uses: 8-30 mg/kg C(M)IT/MIT (3:1) in final product. General public uses: 8-14,9 mg/kg C(M)IT/MIT (3:1) in final product.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>The biocidal product is added at single dose at the time of manufacture, storage or shipment.</p><p>To ensure uniform distribution, slowly disperse using automated metering or manual addition, into product with agitation. Mix thoroughly until evenly dispersed throughout the product.</p><p>Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products.</p><p>Professional uses:</p><p>8-30 mg/kg C(M)IT/MIT (3:1) in final product.</p><p>General public uses:</p><p>8-14,9 mg/kg C(M)IT/MIT (3:1) in final product.</p><p>For the biocidal product as supplied: for industrial use only.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.3.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product shall be used for treatment of products (articles/mixtures) distributed to professional users and to the general public. For products distributed to the general public the maximal concentration used must be below the threshold value of 15 ppm.</p></td></tr></tbody></table>
4.3.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases of products from Meta SPC 1, 2, 3 and 4 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>For professional users, the maximal products concentration used for the preservation of glues and adhesives being above the threshold value of 15 ppm, exposure has to be limited by use of PPE, protecting skin and mucous membranes potentially exposed, and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.4. Use description
Table 32
Use # 4 – Preservation of polymer lattices
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p><p>Common name: Fungi</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of polymer latexes</p><p>The biocidal product is recommended for the control of bacteria, yeast and fungi in the manufacture, storage, and transport of latexes, synthetic polymers including Hydrolysed Poly Acryl Amide (HPAM) and biopolymers (e.g. xanthan, dextran.) natural latexes.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated application.</p><p>The biocidal product should be dispensed to the end use fluid at a point to ensure adequate mixing using preferably automated metering pump or by manual addition.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products; Professional uses: 14,9 - 50 mg /kg of C(M)IT/MIT (3:1) in final product.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>The biocidal product is added at single dose at the time of manufacture, storage or shipment.</p><p>To ensure uniform distribution, slowly disperse using automated metering or manual addition, into product with agitation. Mix thoroughly until evenly dispersed throughout the product.</p><p>Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products.</p><p>Professional uses</p><p>14,9 - 50 mg /kg of C(M)IT/MIT (3:1) in final product.</p><p>For the biocidal product as supplied: for industrial use only.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.4.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product shall be used for treatment of products (articles/mixtures) distributed only to professional users.</p></td></tr></tbody></table>
4.4.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases of products from Meta SPC 1, 2, 3 and 4 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The maximal products concentration used for the preservation of polymer lattices being above the threshold value of 15 ppm, exposure has to be limited by use of PPE, protecting skin and mucous membranes potentially exposed, and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.5. Use description
Table 33
Use # 5 – Preservation of mineral slurries
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of mineral slurries</p><p>The biocidal product is recommended to control the growth of bacteria in aqueous-based inorganic/mineral slurries and inorganic pigments which are formulated into paints, coatings and paper.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated application.</p><p>The biocidal product should be dispensed as a tankside additive into the circulating use-dilution of the fluid, using a metering pump or by manual pouring, at a point to assure adequate mixing throughout the system.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products; Professional uses: 10- 30 mg/kg of C(M)IT/MIT (3:1) in final product.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>The biocidal product is added at single dose at the time of manufacture, storage or shipment.</p><p>Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products.</p><p>Professional uses:</p><p>10- 30 mg/kg of C(M)IT/MIT (3:1) in final product.</p><p>For the biocidal product as supplied: for industrial use only.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.5.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product shall be used for treatment of products (articles/mixtures) distributed only to professional users.</p></td></tr></tbody></table>
4.5.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases of products from Meta SPC 1, 2, 3 and 4 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The maximal products concentration used for the preservation of mineral slurries being above the threshold value of 15 ppm, exposure has to be limited by use of PPE, protecting skin and mucous membranes potentially exposed, and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.6. Use description
Table 34
Use # 6 – Preservation of building products applied indoor only
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of building (construction) products (including sealants, caulks, plasters etc.)</p><p>The biocidal product is recommended to control the growth of bacteria in building (construction) products (sealants, caulks, biopolymers, plasters, fillers, admixtures concrete additives, joints compounds,.).</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: -</p><p>Detailed description:</p><p>Manual and automated dosing.</p><p>The biocidal product should be dispensed to the end use fluid at a point to ensure adequate mixing using preferably automated metering pump or by manual addition.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products; Professional uses: Add at typical use rate between 16,2-30 mg C(M)IT/MIT (3:1) per Kg final product to be treated.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>The biocidal product is added at single dose at the time of manufacture, storage or shipment.</p><p>Slowly dispense using automated metering or manually. Mix thoroughly until the biocidal product is evenly dispersed.</p><p>Industrial uses:</p><p>1,5 - 14,5 % C(M)IT/MIT in the biocidal products.</p><p>Professional uses:</p><p>Add at typical use rate between 16,2-30 mg C(M)IT/MIT (3:1) per Kg final product to be treated.</p><p>For the biocidal product as supplied: for industrial use only.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.6.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product shall be used for treatment of products (articles/mixtures) distributed only to professional users.</p></td></tr></tbody></table>
4.6.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>This use is restricted to the preservation of building material applied indoor only.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases for products from Meta SPC 1, 3 and 4 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>For professional users, the maximal products concentration used for the preservation of building products being above the threshold value of 15 ppm, exposure has to be limited by use of PPE, protecting skin and mucous membranes potentially exposed, and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.7. Use description
Table 35
Use # 7 – Preservation of inks
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of inks</p><p>The biocidal product is recommended to control the growth of bacteria and yeasts in inks and ink components (printing inks lithographic, photographic, ink-jet fluids, water based dampening or fountain solutions inks used for textile printing). The biocidal product inhibits the growth of microorganisms, which would otherwise lead to odour formation, viscosity alteration, product discolouration and premature product failure.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated dosing.</p><p>The biocidal product should be dispensed to the end use fluid at a point to ensure adequate mixing using preferably automated metering pump or by manual addition.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products. Professional uses: 6-30 mg C(M)IT/MIT (3:1) /kg final product. General public uses: 6-14,9 mg C(M)IT/MIT (3:1) /kg final product.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>The biocidal product is added at single dose at time of manufacturing, storage or shipment.</p><p>Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products.</p><p>Professional uses:</p><p>6-30 mg C(M)IT/MIT (3:1) /kg final product.</p><p>General public uses:</p><p>6-14,9 mg C(M)IT/MIT (3:1) /kg final product.</p><p>For the biocidal product as supplied: for industrial use only.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:- HDPE flask: 5 L (nominal)- HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)- Box with HDPE liner: 20 L</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L- HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.7.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product shall be used for treatment of products (articles/mixtures) distributed to professional users and to the general public. For products distributed to the general public the maximal concentration used must be below the threshold value of 15 ppm.</p></td></tr></tbody></table>
4.7.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases of products from Meta SPC 1, 2, 3 and 4 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>For professional users, the maximal products concentration used for the preservation of inks being above the threshold value of 15 ppm, exposure has to be limited by use of PPE, protecting skin and mucous membranes potentially exposed, and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.8. Use description
Table 36
Use # 8 – Preservation of functional fluids (hydraulic fluids, antifreeze, corrosion inhibitors, etc. - excluding fuel additives)
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of functional fluids (hydraulic fluids, antifreeze, corrosion inhibitors, etc. - excluding fuel additives)</p><p>The biocidal product is recommended to control the growth of bacteria in functional fluids such as brake and hydraulic fluids, antifreeze additives, corrosion inhibitors, spinning fluids. The biocidal product inhibits the growth microorganisms, which would otherwise lead to odours formation, viscosity alteration, discolouration of product and premature product failure.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated dosing.</p><p>The biocidal product should be dispensed to the end use fluid at a point to ensure adequate mixing using preferably automated metering pump or by manual addition.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products. Professional uses: Add at a typical use rate between 6 to 30 mg C(M)IT/MIT (3:1) per kg final product to be treated.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>The biocidal product is added at single dose at time of manufacturing, storage or shipment.</p><p>Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products.</p><p>Professional uses:</p><p>Add at a typical use rate between 6 to 30 mg C(M)IT/MIT (3:1) per kg final product to be treated</p><p>For the biocidal product as supplied: for industrial use only.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.8.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product shall be used for treatment of products (articles/mixtures) distributed only to professional users.</p></td></tr></tbody></table>
4.8.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases of products from Meta SPC 1, 2, 3 and 4 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The maximal products concentration used for the preservation of functional fluids (hydraulic fluids, antifreeze, corrosion inhibitors, etc…) being above the threshold value of 15 ppm, exposure has to be limited by use of PPE, protecting skin and mucous membranes potentially exposed, and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
5. GENERAL DIRECTIONS FOR USE ( 2 ) OF THE META SPC 2
5.1. Instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration of the effect is dependent on the performance requirements of the customer for their preserved material and on the specific ingredients composition and pH of the preserved product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Always read the label or leaflet before use and follow all the instructions provided.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Respect the conditions of use of the product (concentration, contact time, temperature, pH, etc.)</p></td></tr></tbody></table>
PRECAUTIONARY MEASURES DURING STORAGE AND TRANSPORT:
Keep in a well-ventilated place. The product as supplied may evolve gas (largely carbon dioxide) slowly. To prevent the buildup of pressure the product is packaged in specially vented containers, where necessary. Keep this product in the original container when not in use. Container must be stored and transported in an upright position to prevent spilling the contents through the vent, where fitted.
5.2. Risk mitigation measures
— 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Skin contact: Remove contaminated clothing and shoes. Wash contaminated skin with water. Contact poison treatment specialist if symptoms occur.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye contact: Immediately flush with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses if easy to do. Continue to rinse with tepid water for at least 30 minutes. Call 112/ambulance for medical assistance.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Ingestion: Wash out mouth with water. Contact poison treatment specialist. Seek medical advice immediately if symptoms occur and/or large quantities have been ingested. Do not give fluids or induce vomiting.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Inhalation (of spray mist): Remove victim to fresh air and keep at rest in a position comfortable for breathing. Seek medical advice immediately if symptoms occur and/or large quantities have been inhaled.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In case of impaired consciousness place in recovery position and seek medical advice immediately.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Keep the container or label available.</p></td></tr></tbody></table>
5.4. Instructions for safe disposal of the product and its packaging
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Do not discharge unused product on the ground, into water courses, into pipes (e.g. sink, toilets) nor down the drains.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Dispose of unused product, its packaging and all other waste, in accordance with local regulations.</p></td></tr></tbody></table>
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Conditions for safe storage, including any incompatibilities: Keep in a dry, cool and well-ventilated place, in the original container.
Protect from frost
Shelf-life: 6 months
Protect from sunlight.
Recommendation: If a metal packaging is used, a varnish layer should be applied.
6. OTHER INFORMATION
— 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2
7.1. Trade name(s), authorisation number and specific composition of each individual product
<table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Trade name(s)</p></td><td><p>KATHON™ LX 1400 Biocide</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>KATHON™ LX 1400</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>AQUACIDE C 15 P</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>AQUACIDE C 21 P</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>AQUACIDE C 30 P</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>AQUACIDE C 140 P</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>BAC 416 P</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>BIOSTOP 140 P</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>BIOSTOP 15 P</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>BIOSTOP 21 P</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>BIOSTOP 30 P</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>CAT 3693 P</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>GWC 3363 P</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>GWC 3630 P</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>GWE 3693 P</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>IWC BACTERICIDE 416 P</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Authorisation number</p></td><td><p>EU-0025449-0003 1-2</p></td></tr><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Mixture of 5-chloro-2-methyl-2H- isothiazol-3-one (EINECS 247-500-7) and 2-methyl-2H-isothiazol-3-one (EINECS 220-239-6) (Mixture of CMIT/MIT)</p></td><td><p> </p></td><td><p>Active Substance</p></td><td><p>55965-84-9</p></td><td><p> </p></td><td><p>20,5</p></td></tr></tbody></table>
META SPC 3
1. META SPC 3 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 3 identifier
<table><col/><col/><tbody><tr><td><p>Identifier</p></td><td><p>meta-SPC 3 KATHON 1.5-4.5 Mg</p></td></tr></tbody></table>
1.2. Suffix to the authorisation number
<table><col/><col/><tbody><tr><td><p>Number</p></td><td><p>1-3</p></td></tr></tbody></table>
1.3. Product type(s)
<table><col/><col/><tbody><tr><td><p>Product type(s)</p></td><td><p>PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)</p><p>PT04 - Food and feed area (Disinfectants)</p><p>PT06 - Preservatives for products during storage (Preservatives)</p><p>PT11 - Preservatives for liquid-cooling and processing systems (Preservatives)</p><p>PT12 - Slimicides (Preservatives)</p><p>PT13 - Working or cutting fluid preservatives (Preservatives)</p></td></tr></tbody></table>
2. META SPC 3 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 3
<table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Min</p></td><td><p>Max</p></td></tr><tr><td><p>Mixture of 5-chloro-2-methyl-2H- isothiazol-3-one (EINECS 247-500-7) and 2-methyl-2H-isothiazol-3-one (EINECS 220-239-6) (Mixture of CMIT/MIT)</p></td><td><p> </p></td><td><p>Active Substance</p></td><td><p>55965-84-9</p></td><td><p> </p></td><td><p>2,2</p></td><td><p>6,5</p></td></tr></tbody></table>
2.2. Type(s) of formulation of the meta SPC 3
<table><col/><col/><tbody><tr><td><p>Formulation(s)</p></td><td><p>AL - Any other liquid</p></td></tr></tbody></table>
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3
<table><col/><col/><tbody><tr><td><p>Hazard statements</p></td><td><p>Harmful if inhaled.</p><p>Causes severe skin burns and eye damage.</p><p>May cause an allergic skin reaction.</p><p>Very toxic to aquatic life with long lasting effects.</p><p>Corrosive to the respiratory tract.</p><p>May be corrosive to metals.</p><p>Harmful if swallowed.</p></td></tr><tr><td><p>Precautionary statements</p></td><td><p>Do not breathe fume.</p><p>Wash skin thoroughly after handling.</p><p>Do not eat, drink or smoke when using this product.</p><p>Contaminated work clothing should not be allowed out of the workplace.</p><p>Avoid release to the environment.</p><p>Wear protective gloves/ protective clothing/ eye protection/ face protection/ hearing protection.</p><p>Take off contaminated clothing. And wash it before reuse.</p><p>If skin irritation or rash occurs: Get medical advice.</p><p>IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.</p><p>IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.</p><p>IF INHALED: Remove person to fresh air and keep comfortable for breathing.</p><p>Immediately call a POISON CENTER/ doctor.</p><p>IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.</p><p>Collect spillage.</p><p>Store locked up.</p><p>Keep only in original packaging.</p><p>IF SWALLOWED: Call a POISON CENTER/ doctor if you feel unwell.</p><p>Store in a corrosion-resistant container with a resistant inner liner.</p><p>Absorb spillage to prevent material damage.</p></td></tr></tbody></table>
4. AUTHORISED USE(S) OF THE META SPC 3
4.1. Use description
Table 37
Use # 1 – Preservation of sump water in air conditioning and air washer systems
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria (including Legionella pneumophila)</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p><p>Common name: Fungi</p><p>Development stage:</p><p>Common name: Algae</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Outdoor</p><p>Preservation of sump water in air conditioning and air washer systems.</p><p>Air conditioning systems and in air washer systems to preserve the sump water. Air washer systems are used extensively in textile factories and in the tobacco industry to scrub or clean the air and for fine control of temperature and humidity.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Open and closed Systems</p><p>Detailed description:</p><p>Automatic and Manual Dosing</p><p>The biocidal product is typically added in a central chilled water sump which supplies several air washers. The loading process may be conducted either manually or by automation. In the automated process, the biocide is metered directly into the sump from a holding tank or other type of bulk container by a dosimeter (pump). The feeding pipe must dose the biocidal product below the water level in order to limit its evaporation.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Curative application: Bacteria, yeasts and fungi. When the system is noticeably fouled, apply 5 to 14,9 mg C(M)IT/MIT (3:1) per Litre of water to be treated, as post treatment after a shock dose of minimum 0,3 ppm of free chlorine. Preventive application: algae When control is obtained, add a continuous or semi continuous feed of 3 to 5 mg C(M)IT/MIT (3:1) per L of water to be treated</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>Curative application: Bacteria, yeasts and fungi</p><p>When the system is noticeably fouled, apply 5 to 14,9 mg C(M)IT/MIT (3:1) per Litre of water to be treated, as post treatment after a shock dose of minimum 0,3 ppm of free chlorine.</p><p>Contact time of 1 hour.</p><p>Preventive application: algae</p><p>When control is obtained, add a continuous or semi continuous feed of 3 to 5 mg C(M)IT/MIT (3:1) per L of water to be treated.</p><p>Regardless of the manner of treatment, the total concentration of the active ingredient C(M)IT/MIT (3:1) in the system should not exceed 14,9 mg/L in the sump water.</p><p>Preliminary steps prior to addition:</p><p>The biocidal product is automatically dosed to the system. Manual handling is necessary for the loading of the biocidal product into the dosing systems.</p><p>Application Frequency:</p><p>Nominally every 2 to 3 days or as needed to obtain control. Repeat until fouling is reduced to an acceptable level for controlling the microbial growth.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.1.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Respect the conditions of use of the product (concentration, contact time, temperature, pH, etc.).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The CMIT/MIT biocidal products are used after a shock dose of free chlorine in this application as standard industry practice.</p></td></tr></tbody></table>
4.1.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During mixing and loading and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.2. Use description
Table 38
Use # 2 – Preservation of fluids in conveyor belts and pasteurisers
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT04 - Food and feed area (Disinfectants)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p><p>Common name: Fungi</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of fluids in conveyor belts and pasteurisers</p><p>The biocidal product is used for the preservation of process fluids in pasteurisers and conveyor belts used in food industry. The biocidal product is used in these systems to either control or kill bacteria and fungi.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Automated dosing</p><p>The biocidal product is dosed automatically in the heat transfer fluid, in a place of good mixing (e.g. collecting sump below the conveyor belt).</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Curative application: Bacteria, yeasts and fungi When the system is noticeably fouled, apply 10 to 14,9 g C(M)IT/MIT (3:1) per m<span>3</span> of water to be treated as post treatment after a shock dose of minimum 0,3 ppm of free chlorine Preventive application: Bacteria: When control is obtained, add a continuous or semi continuous feed of 2,5 to 5 g C(M)IT/MIT (3:1) per m<span>3</span> of water to be treated.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>Curative application: Bacteria, yeasts and fungi</p><p>When the system is noticeably fouled, apply 10 to 14,9 g C(M)IT/MIT (3:1) per m<span>3</span> of water to be treated as post treatment after a shock dose of minimum 0,3 ppm of free chlorine.</p><p>Contact time of 1 hour.</p><p>Preventive application: Bacteria:</p><p>When control is obtained, add a continuous or semi continuous feed of 2,5 to 5 g C(M)IT/MIT (3:1) per m<span>3</span> of water to be treated.</p><p>Preliminary steps prior to addition:</p><p>The biocidal product is automatically dosed to system. Manual handling is necessary for the loading of containers containing the biocidal product into the dosing systems.</p><p>Application Frequency:</p><p>Nominally every 2 to 3 days or as needed to obtain control. Repeat until fouling is reduced to an acceptable level for controlling the microbial growth.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.2.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Respect the conditions of use of the product (concentration, contact time, temperature, pH, etc.).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The CMIT/MIT biocidal products are used after a shock dose of free chlorine in this application as standard industry practice.</p></td></tr></tbody></table>
4.2.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During mixing and loading and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.3. Use description
Table 39
Use # 3 – Long term offline preservation of reverse osmosis membranes used in potable water
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT04 - Food and feed area (Disinfectants)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Long term offline preservation of reverse osmosis membranes used in potable water</p><p>The C(M)IT/MIT (3:1) biocidal product is recommended for controlling biological growth in off-line trains reverse osmosis membranes producing potable water for extended periods of time.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated dosing.</p><p>It is recommended that fouled membranes be cleaned prior to shut-down and preservation. Please refer to RO /NF supplier manual for membrane cleaning and system shutdown procedures.</p><p>The biocidal product should be dispensed as a tankside additive into the circulating use-dilution of the fluid, using a metering pump or by manual pouring, at a point to assure adequate mixing throughout the system. After complete filling of the trains RO/NF systems with the biocide solution, pumps are stopped (Off line treatment) for extended periods of time.</p><p>Typically C(M)IT/MIT (3:1) solutions are prepared in the CIP (cleaning in place) tank and added via the dosing system. Dilution with the permeate water or high quality water is recommended for the preparation of the biocide solution.</p><p>Membranes should be soaked in the biocide solution during the shut-down period.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: 7,5 -20 g of C(M)IT/MIT (3:1)/ m<span>3</span> of water</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>7,5 -20 g of C(M)IT/MIT (3:1)/ m<span>3</span> of water</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.3.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Respect the conditions of use of the product (concentration, contact time, temperature, pH, etc.).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Prior to taking the membranes back on-line, flush carefully the elements with permeate water in order to eliminate all the residual biocidal product.</p></td></tr></tbody></table>
4.3.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During mixing and loading and cleaning of the whole system, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.4. Use description
Table 40
Use # 4 – Preservation of paints and coatings
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Outdoor</p><p>Preservation of paints and coatings</p><p>(including electrodeposition)</p><p>The biocidal product is recommended to control the growth of bacteria and yeasts in coatings applied by an electrodeposition process and associated rinse systems and in water-based paints and coatings in storage containers before use.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated dosing.</p><p>The biocidal product should be dispensed as a tankside additive into the fluid, using a metering pump or by manual pouring, at a point to assure adequate mixing throughout the system.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products; Professional paints and general public paints: 7,5-14,9 mg/kg C(M)IT/MIT (3:1) in final product.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>The biocidal product is added at the time of manufacture, storage or shipment.</p><p>Industrial uses:</p><p>1,5 - 14,5 % C(M)IT/MIT in the biocidal products.</p><p>Professional paints and general public paints:</p><p>7,5-14,9 mg/kg C(M)IT/MIT (3:1) in final product.</p><p>For the biocidal product as supplied: for industrial use only.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.4.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product shall be used for treatment of products (articles/mixtures) distributed to professional users and to the general public.</p></td></tr></tbody></table>
4.4.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases of products from Meta SPC 1, 2, 3 and 4 (Mixing and Loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The maximal concentration of products from Meta SPC 1, 2, 3 and 4 to be added in paints used must be below the threshold value of 15 ppm.</p></td></tr></tbody></table>
4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.5. Use description
Table 41
Use # 5 – Preservation of detergents and household products
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p><p>Common name: Fungi</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of detergents (washing and cleaning fluids) and household products.</p><p>The biocidal product is recommended for the control of bacteria, yeast and fungi in detergents and cleaning fluids (i.e. hard surface cleaners (all-purpose cleaners), hand dish washing products, fabric softeners, laundry detergents), products used for car care, floor care, waxes, hard surface cleaners, pre-moistened sponges or mops, and the surfactants used in these types of products.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated application.</p><p>The biocidal product should be dispensed to the end use fluid at a point to ensure adequate mixing using preferably automated metering pump or by manual addition.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products; Professional and general public uses: 6-14,9 mg/kg C(M)IT/MIT (3:1) in final product.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>The biocidal product is added at single dose at the time of manufacturing, storage or shipment.</p><p>To ensure uniform distribution, slowly disperse using automated metering or manual addition, into product with agitation. Mix thoroughly until evenly dispersed throughout the product.</p><p>Institutional and Household products:</p><p>(detergents, cleaners, softeners, etc.)</p><p>Industrial uses:</p><p>1,5 - 14,5 % C(M)IT/MIT in the biocidal products.</p><p>Professional and general public uses:</p><p>6-14,9 mg/kg C(M)IT/MIT (3:1) in final product.</p><p>For the biocidal product as supplied: for industrial use only.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.5.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product shall be used for treatment of products (articles/mixtures) distributed to professional users and to the general public.</p></td></tr></tbody></table>
4.5.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases of products from Meta SPC 1 and 3 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The maximal concentration of products from Meta SPC 1 and 3 to be added in detergents and household products used must be below the threshold value of 15 ppm.</p></td></tr></tbody></table>
4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.6. Use description
Table 42
Use # 6 – Preservation of fluids used in paper, textile and leather production - Curative treatment
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of fluids used in paper, textile and leather production -</p><p>The biocidal product is used to reduce contamination by bacteria in textile additives (woven and non-woven, natural and synthetic including silicone emulsions) processing chemicals, all chemicals used in the leather process industry and paper additives (e.g. water pigment pastes, starch, natural gums, synthetic and natural latexes, sizing agents, coating binders, retention aids, dyes, fluorescent whitening agents, wet-strength resins) used in paper mills. The biocidal product inhibits the growth microorganisms, which would otherwise lead to odours formation, viscosity alteration, discolouration of product and premature product failure.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated dosing.</p><p>The biocidal product should be dispensed to the end use fluid at a point to ensure adequate mixing using preferably automated metering pump or by manual addition.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products; Professional uses: 16 to 30 mg/kg of C(M)IT/MIT (3:1) in final product</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>The biocidal product is added at single dose at time of manufacturing, storage or shipment.</p><p>Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products.</p><p>Professional uses:</p><p>Curative treatment:</p><p>16 to 30 mg/kg of C(M)IT/MIT (3:1) in final product</p><p>Contact time: 24 hours</p><p>For the biocidal product as supplied: for industrial use only.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.6.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product shall be used for treatment of products (articles/mixtures) distributed only to professional users.</p></td></tr></tbody></table>
4.6.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases of products from Meta SPC 1, 2, 3 and 4 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The maximal products concentration used for the preservation of fluids used in paper, textile and leather production being above the threshold value of 15 ppm, exposure has to be limited by use of PPE protecting skin and mucous membranes potentially exposed and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.7. Use description
Table 43
Use # 7 – Preservation of glues and adhesives
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of glues and adhesives</p><p>The biocidal product is recommended to control the growth of bacteria and yeasts in water-soluble and water-dispersed synthetic and natural adhesives and tackifiers in storage containers before use</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated application.</p><p>The biocidal product should be dispensed to the end use fluid at a point to ensure adequate mixing using preferably automated metering pump or by manual addition.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products; Professional uses: 8-30 mg/kg C(M)IT/MIT (3:1) in final product. General public uses: 8-14,9 mg/kg C(M)IT/MIT (3:1) in final product.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>The biocidal product is added at single dose at the time of manufacture, storage or shipment.</p><p>To ensure uniform distribution, slowly disperse using automated metering or manual addition, into product with agitation. Mix thoroughly until evenly dispersed throughout the product.</p><p>Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products.</p><p>Professional uses:</p><p>8-30 mg/kg C(M)IT/MIT (3:1) in final product.</p><p>General public uses:</p><p>8-14,9 mg/kg C(M)IT/MIT (3:1) in final product.</p><p>For the biocidal product as supplied: for industrial use only.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.7.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product shall be used for treatment of products (articles/mixtures) distributed to professional users and to the general public. For products distributed to the general public the maximal concentration used must be below the threshold value of 15 ppm.</p></td></tr></tbody></table>
4.7.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases of products from Meta SPC 1, 2, 3 and 4 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>For professional users, the maximal products concentration used for the preservation of glues and adhesives being above the threshold value of 15 ppm, exposure has to be limited by use of PPE, protecting skin and mucous membranes potentially exposed, and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.8. Use description
Table 44
Use # 8 – Preservation of polymer lattices
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p><p>Common name: Fungi</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of polymer latexes</p><p>The biocidal product is recommended for the control of bacteria, yeast and fungi in the manufacture, storage, and transport of latexes, synthetic polymers including Hydrolysed Poly Acryl Amide (HPAM) and biopolymers (e.g. xanthan, dextran.) natural latexes.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated application.</p><p>The biocidal product should be dispensed to the end use fluid at a point to ensure adequate mixing using preferably automated metering pump or by manual addition.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products; Professional uses: 14,9 - 50 mg /kg of C(M)IT/MIT (3:1) in final product.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>The biocidal product is added at single dose at the time of manufacture, storage or shipment.</p><p>To ensure uniform distribution, slowly disperse using automated metering or manual addition, into product with agitation. Mix thoroughly until evenly dispersed throughout the product.</p><p>Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products.</p><p>Professional uses</p><p>14,9 - 50 mg /kg of C(M)IT/MIT (3:1) in final product.</p><p>For the biocidal product as supplied: for industrial use only.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.8.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product shall be used for treatment of products (articles/mixtures) distributed only to professional users.</p></td></tr></tbody></table>
4.8.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases of products from Meta SPC 1, 2, 3 and 4 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The maximal products concentration used for the preservation of polymer lattices being above the threshold value of 15 ppm, exposure has to be limited by use of PPE, protecting skin and mucous membranes potentially exposed, and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.9. Use description
Table 45
Use # 9 – Preservation of biocides and fertilizers
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Outdoor</p><p>Preservation of biocides and fertilizers</p><p>The biocidal product is recommended to control the growth of bacteria and yeasts in fertilizers and biocidal products.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: -</p><p>Detailed description:</p><p>Manual and automated application.</p><p>The biocidal product should be dispensed to the end use fluid at a point to ensure adequate mixing using preferably automated metering pump or by manual addition.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products; Professional uses: 10- 30 mg/kg of C(M)IT/MIT (3:1) in final product.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>The biocidal product is added at single dose at the time of manufacture, storage or shipment.</p><p>Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products.</p><p>Professional uses:</p><p>10- 30 mg/kg of C(M)IT/MIT (3:1) in final product.</p><p>For the biocidal product as supplied: for industrial use only.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.9.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product shall be used for treatment of products (articles/mixtures) distributed only to professional users.</p></td></tr></tbody></table>
4.9.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases of products from Meta SPC 1 and 3 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>For professional users, the maximal products concentration used for the preservation of biocides and fertilizers being above the threshold value of 15 ppm, exposure has to be limited by use of PPE, protecting skin and mucous membranes potentially exposed, and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.9.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.10. Use description
Table 46
Use # 10 – Preservation of mineral slurries
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of mineral slurries</p><p>The biocidal product is recommended to control the growth of bacteria in aqueous-based inorganic/mineral slurries and inorganic pigments which are formulated into paints, coatings and paper.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated application.</p><p>The biocidal product should be dispensed as a tankside additive into the circulating use-dilution of the fluid, using a metering pump or by manual pouring, at a point to assure adequate mixing throughout the system.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products; Professional uses: 10- 30 mg/kg of C(M)IT/MIT (3:1) in final product.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>The biocidal product is added at single dose at the time of manufacture, storage or shipment.</p><p>Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products.</p><p>Professional uses:</p><p>10- 30 mg/kg of C(M)IT/MIT (3:1) in final product.</p><p>For the biocidal product as supplied: for industrial use only.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.10.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product shall be used for treatment of products (articles/mixtures) distributed only to professional users.</p></td></tr></tbody></table>
4.10.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases of products from Meta SPC 1, 2, 3 and 4 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The maximal products concentration used for the preservation of mineral slurries being above the threshold value of 15 ppm, exposure has to be limited by use of PPE, protecting skin and mucous membranes potentially exposed, and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.11. Use description
Table 47
Use # 11 – Preservation of building products applied indoor only
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of building (construction) products (including sealants, caulks, plasters etc.)</p><p>The biocidal product is recommended to control the growth of bacteria in building (construction) products (sealants, caulks, biopolymers, plasters, fillers, admixtures concrete additives, joints compounds,.).</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: -</p><p>Detailed description:</p><p>Manual and automated dosing.</p><p>The biocidal product should be dispensed to the end use fluid at a point to ensure adequate mixing using preferably automated metering pump or by manual addition.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products; Professional uses: Add at typical use rate between 16,2-30 mg C(M)IT/MIT (3:1) per Kg final product to be treated.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>The biocidal product is added at single dose at the time of manufacture, storage or shipment.</p><p>Slowly dispense using automated metering or manually. Mix thoroughly until the biocidal product is evenly dispersed.</p><p>Industrial uses:</p><p>1,5 - 14,5 % C(M)IT/MIT in the biocidal products.</p><p>Professional uses:</p><p>Add at typical use rate between 16,2-30 mg C(M)IT/MIT (3:1) per Kg final product to be treated.</p><p>For the biocidal product as supplied: for industrial use only.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.11.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product shall be used for treatment of products (articles/mixtures) distributed only to professional users.</p></td></tr></tbody></table>
4.11.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>This use is restricted to the preservation of building material applied indoor only.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases for products from Meta SPC 1, 3 and 4 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>For professional users, the maximal products concentration used for the preservation of building products being above the threshold value of 15 ppm, exposure has to be limited by use of PPE, protecting skin and mucous membranes potentially exposed, and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
4.11.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.11.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.11.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.12. Use description
Table 48
Use # 12 – Preservation of electronic chemicals – Curative treatment
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p><p>Common name: Fungi</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of electronic chemicals</p><p>The biocidal product is used to reduce contamination by bacteria, yeasts and fungi in electronic chemicals as Chemical Mechanical Polishing (CMP) silica slurries.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated application.</p><p>The biocidal product should be dispensed to the end use fluid at a point to ensure adequate mixing using preferably automated metering pump or by manual addition.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products; Professional uses: Add at typical use rate between 10-30 mg C(M)IT/MIT (3:1) per L final product to be treated.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>The biocidal product is added at single dose at the time of manufacture, storage or shipment.</p><p>Slowly dispense using automated metering or manually. Mix thoroughly until the biocidal product is evenly dispersed.</p><p>Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products.</p><p>Professional uses</p><p>Curative treatment:</p><p>10-30 mg C(M)IT/MIT (3:1) per kg final product to be treated.</p><p>Contact time: 7 days</p><p>For the biocidal product as supplied: for industrial use only.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.12.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product shall be used for treatment of products (articles/mixtures) distributed only to professional users.</p></td></tr></tbody></table>
4.12.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases for products from Meta SPC 3 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The maximal products concentration used for the preservation of electronic chemicals being above the threshold value of 15 ppm, exposure has to be limited by use of PPE, protecting skin and mucous membranes potentially exposed, and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
4.12.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.12.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.12.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.13. Use description
Table 49
Use # 13 – Preservation of inks
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of inks</p><p>The biocidal product is recommended to control the growth of bacteria and yeasts in inks and ink components (printing inks lithographic, photographic, ink-jet fluids, water based dampening or fountain solutions inks used for textile printing). The biocidal product inhibits the growth of microorganisms, which would otherwise lead to odour formation, viscosity alteration, product discolouration and premature product failure.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated dosing.</p><p>The biocidal product should be dispensed to the end use fluid at a point to ensure adequate mixing using preferably automated metering pump or by manual addition.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products. Professional uses: 6-30 mg C(M)IT/MIT (3:1) /kg final product. General public uses: 6-14,9 mg C(M)IT/MIT (3:1) /kg final product.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>The biocidal product is added at single dose at time of manufacturing, storage or shipment.</p><p>Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products.</p><p>Professional uses:</p><p>6-30 mg C(M)IT/MIT (3:1) /kg final product.</p><p>General public uses:</p><p>6-14,9 mg C(M)IT/MIT (3:1) /kg final product.</p><p>For the biocidal product as supplied: for industrial use only.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:- HDPE flask: 5 L (nominal)- HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)- Box with HDPE liner: 20 L</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L- HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.13.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product shall be used for treatment of products (articles/mixtures) distributed to professional users and to the general public. For products distributed to the general public the maximal concentration used must be below the threshold value of 15 ppm.</p></td></tr></tbody></table>
4.13.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases of products from Meta SPC 1, 2, 3 and 4 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>For professional users, the maximal products concentration used for the preservation of inks being above the threshold value of 15 ppm, exposure has to be limited by use of PPE, protecting skin and mucous membranes potentially exposed, and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
4.13.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.13.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.13.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.14. Use description
Table 50
Use # 14 – Preservation of functional fluids (hydraulic fluids, antifreeze, corrosion inhibitors, etc. - excluding fuel additives)
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of functional fluids (hydraulic fluids, antifreeze, corrosion inhibitors, etc. - excluding fuel additives)</p><p>The biocidal product is recommended to control the growth of bacteria in functional fluids such as brake and hydraulic fluids, antifreeze additives, corrosion inhibitors, spinning fluids. The biocidal product inhibits the growth microorganisms, which would otherwise lead to odours formation, viscosity alteration, discolouration of product and premature product failure.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated dosing.</p><p>The biocidal product should be dispensed to the end use fluid at a point to ensure adequate mixing using preferably automated metering pump or by manual addition.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products. Professional uses: Add at a typical use rate between 6 to 30 mg C(M)IT/MIT (3:1) per kg final product to be treated.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>The biocidal product is added at single dose at time of manufacturing, storage or shipment.</p><p>Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products.</p><p>Professional uses:</p><p>Add at a typical use rate between 6 to 30 mg C(M)IT/MIT (3:1) per kg final product to be treated</p><p>For the biocidal product as supplied: for industrial use only.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.14.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product shall be used for treatment of products (articles/mixtures) distributed only to professional users.</p></td></tr></tbody></table>
4.14.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases of products from Meta SPC 1, 2, 3 and 4 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The maximal products concentration used for the preservation of functional fluids (hydraulic fluids, antifreeze, corrosion inhibitors, etc…) being above the threshold value of 15 ppm, exposure has to be limited by use of PPE, protecting skin and mucous membranes potentially exposed, and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
4.14.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.14.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.14.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.15. Use description
Table 51
Use # 15 – Preservation of laboratory reagents
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of laboratory reagents .</p><p>The biocidal product is recommended to control the growth of bacteria and yeasts in laboratory reagents.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated dosing.</p><p>The biocidal product should be dispensed to the end use fluid at a point to ensure adequate mixing using preferably automated metering pump or by manual addition.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products. Professional use: Add at typical use rate of 15,2 mg C(M)IT/MIT (3:1) per kg final product to be treated.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>The biocidal product is added at single dose at the time of manufacture, storage or shipment.</p><p>Slowly dispense using automated metering or manually. Mix thoroughly until the biocidal product is evenly dispersed.</p><p>Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products.</p><p>Professional use: Add at typical use rate of 15,2 mg C(M)IT/MIT (3:1) per kg final product to be treated.</p><p>For the biocidal product as supplied: for industrial use only.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 1 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.15.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product shall be used for treatment of products (articles/mixtures) distributed only to professional users.</p></td></tr></tbody></table>
4.15.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases for products from Meta SPC 1, 3 and 4 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>For professional users, the maximal products concentration used for the preservation of laboratory reagents being above the threshold value of 15 ppm, exposure has to be limited by use of PPE, protecting skin and mucous membranes potentially exposed, and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
4.15.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.15.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.15.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.16. Use description
Table 52
Use # 16 – Offline preservation of industrial reverse osmosis membranes
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Offline preservation of industrial reverse osmosis membranes</p><p>The biocidal product is recommended to control the growth of bacteria of reverse osmosis and nanofiltration membranes producing industrial water for extended periods of time.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated dosing.</p><p>The biocidal product should be dispensed as a tankside additive into the circulating use-dilution of the fluid, using a metering pump or by manual pouring, at a point to ensure adequate mixing throughout the system. After complete filling of the trains RO/NF systems with the biocide solution, pumps are stopped (Off line treatment) for extended periods of time.</p><p>Typically C(M)IT/MIT (3:1) solutions are prepared in the CIP (cleaning in place) tank and added via the dosing system. Dilution with permeate water or high quality water is recommended for the preparation of the biocide solution. Membranes should be soaked in the biocide solution during the shut-down period.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: 7,5–20 g/m<span>3</span> (ppm w/v) of C(M)IT/MIT (3:1).</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>7,5–20 g/m<span>3</span> (ppm w/v) of C(M)IT/MIT (3:1).</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.16.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
4.16.2. Use-specific risk mitigation measures
Rinse the system with water prior to perform the maintenance of the system.
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases for products from Meta SPC 1, 3 and 4 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
4.16.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.16.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.16.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.17. Use description
Table 53
Use # 17 – Preservation of liquids used in closed recirculating cooling systems
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT11 - Preservatives for liquid-cooling and processing systems (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria (including Legionella pneumophila)</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p><p>Common name: Fungi</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Outdoor</p><p>Preservation of liquids used in closed recirculating cooling systems (Closed re-circulating cooling water systems comprise compressor cooling, air conditioning chilled water, boilers, engine jacket cooling, power supply cooling, and other industrial processes).</p><p>The biocidal product is used to control the growth of aerobes and anaerobes bacteria, yeast, fungi, and biofilm in the circulating water of closed systems</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated dosing.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Curative efficacy:- against bacteria (including L. pneumophila) at 5 - 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water. Contact time: 24 hours - against biofilm: 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water. Contact time: 24 hours.- against fungi and yeasts at 1 – 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water. Contact time: 48 hours. Preventive efficacy:- against bacteria (including L. pneumophila) at 3 – 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water. - against biofilm (including L. pneumophila): 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>Curative efficacy:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against bacteria (including L. pneumophila) at 5 - 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p><p>Contact time: 24 hours</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against biofilm: 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p><p>Contact time: 24 hours</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against fungi and yeasts at 1 – 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p><p>Contact time: 48 hours</p></td></tr></tbody></table><p>Preventive efficacy:</p><p>against bacteria (including L. pneumophila) at 3 – 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p><p>against biofilm (including L. pneumophila): 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.17.1. Use-specific instructions for use
Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
4.17.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
4.17.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.17.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.17.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.18. Use description
Table 54
Use # 18 – Preservation of liquids used in small open recirculating cooling systems
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT11 - Preservatives for liquid-cooling and processing systems (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria (including Legionella pneumophila)</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p><p>Common name: Fungi</p><p>Development stage:</p><p>Common name: Algae (green algae and cyanobacteria)</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Outdoor</p><p>Preservation of liquids used in small open recirculating cooling systems (blowdown and recirculating flow rates, as well as total volume of water limited to 2 m<span>3</span>/h, and 100 m<span>3</span>/h and 300 m<span>3</span> respectively)</p><p>Process and cooling water: Used to control the growth of bacteria, algae, fungi and biofilm</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Open system</p><p>Detailed description:</p><p>Manual and automated dosing.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Curative treatment Against bacteria (including L. pneumophila) at 5 – 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water, - against biofilm (including L. pneumophila) at 1,5 to 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water, - against fungi (including yeast) at 1 – 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water. Preventive treatment: - against bacteria, green algae and cyanobacteria at 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water, - against biofilm (including L. pneumophila) at 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>Curative treatment:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Against bacteria (including L. pneumophila) at 5 – 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water</p><p>Contact time: 24 hours</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against biofilm (including L. pneumophila) at 1,5 - 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water</p><p>Contact time: 48 hours.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against fungi and yeast at 1 – 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water</p><p>Contact time: 48 hours.</p></td></tr></tbody></table><p>Preventive treatment:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against bacteria, green algae and cyanobacteria at 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against biofilm (including L. pneumophila) at 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p></td></tr></tbody></table></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.18.1. Use-specific instructions for use
Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
4.18.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Cooling fluid must not enter surface water directly. Use product only in premises that are connected to a STP.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The product can only be used when the cooling towers are equipped with drift eliminators that reduce the drift at least by 99 %.</p></td></tr></tbody></table>
4.18.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.18.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.18.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.19. Use description
Table 55
Use # 19 – Preservation of liquids used in pasteurizers, conveyor belts and air washers
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT11 - Preservatives for liquid-cooling and processing systems (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria (including Legionella pneumophila)</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p><p>Common name: Fungi</p><p>Development stage:</p><p>Common name: Algae (green algae and cyanobacteria)</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Outdoor</p><p>Preservation of liquids used in non-food pasteurizers and conveyor belts, air washers.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: -</p><p>Detailed description:</p><p>The biocidal product is dosed automatically in the heat transfer fluid, in a place of good mixing (e.g. collecting sump below the conveyor belt). The feeding pipe is used to dose the biocidal product below the water level in order to limit its evaporation.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Curative treatment: -against bacteria (including L. pneumophila): 5 - 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water - against biofilm (including L. pneumophila) at 1,5 - 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water - against fungi and yeast at 1 – 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water. Preventive treatment: Against bacteria, green algae and cyanobacteria at 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water, against biofilm (including L. pneumophila) at 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>Curative treatment:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against bacteria (including L. pneumophila): 5 - 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p><p>Contact time: 24 hours</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against biofilm (including L. pneumophila) at 1,5 - 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water</p><p>Contact time: 48 hours.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against fungi and yeast at 1 – 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water</p><p>Contact time: 48 hours.</p></td></tr></tbody></table><p>Preventive treatment:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Against bacteria, green algae and cyanobacteria at 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against biofilm (including L. pneumophila) at 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p></td></tr></tbody></table></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.19.1. Use-specific instructions for use
Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
Air washers: For use only in industrial air-washer systems that maintain effective mist eliminating components.
4.19.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
4.19.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.19.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.19.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.20. Use description
Table 56
Use # 20 – Preservation of wood treatment solutions
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT11 - Preservatives for liquid-cooling and processing systems (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Scientific name: fungi</p><p>Common name: other</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Outdoor</p><p>Preservation of wood treatment solutions for application on wood of classes 1, 2 and 3 only. The biocidal product is used as a preservative for aqueous wood preservative treatment solution during the wet-state process used in timber treatment solutions.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: -</p><p>Detailed description:</p><p>—</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Preventive treatment: against fungi: 15 - 50 g C(M)IT/MIT (3:1) / m<span>3</span> of in use wood preservation solution</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>Preventive treatment: against fungi: 15 - 50 g C(M)IT/MIT (3:1) / m<span>3</span> of in use wood preservation solution</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.20.1. Use-specific instructions for use
Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product is not intended to function as a wood preservative against wood destroying fungus relative to product type 8.</p></td></tr></tbody></table>
4.20.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases (mixing and loading) and cleaning phases, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The product shall not be used in a wood treatment solution to be applied to wood which may come in direct contact with food, feeding stuff and livestock animals</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The product can be used to preserve wood treatment solutions for the treatment of wood in use classes 1, 2 and 3 only.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The product can be used in a wood treatment solution where the industrial application processes of wood treatment can be carried out within a contained area situated on impermeable hard standing with bunding to prevent run-off and a recovery system in place (e.g. sump).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The product can be used in wood treatment solutions for the preservation of freshly treated timber, which after treatment is stored under shelter or on impermeable hard standing, or both, to prevent direct losses to soil, sewer or water. Any losses of wood treatment solution shall be collected for reuse or disposal.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The product can be used only in wood treatment solutions for industrial application if these cannot be released to soil, ground- and surface water or any kind of sewer and the wood treatment solutions and/or the product are collected and reused or disposed of as hazardous waste.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product can be used only in wood treatment solutions used for the treatment of objects or materials which are stored until completely dried on impermeable ground and under roof, to avoid leakage into the soil.</p></td></tr></tbody></table>
4.20.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.20.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.20.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.21. Use description
Table 57
Use # 21 – Preservation of recirculating fluids used in textile and fiber processing, leather processing, photo-processing and fountain solution systems
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT11 - Preservatives for liquid-cooling and processing systems (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of recirculating fluids used in textile, fiber processing, leather processing, photo-processing and fountain solution systems</p><p>C(M)IT/MIT (3:1) biocidal products are used for the preservation of textile and spinning fluids, photo processing solutions, leather process (e.g. washing and soaking treatment stages) and printing fountain solutions to control the integrity of recirculating fluid by reducing microbial contamination in the bulk solution.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: -</p><p>Detailed description:</p><p>Manual and automated dosing.</p><p>The preservation of all end-products is performed in most cases highly automated by industrial users</p><p>The biocidal product is added to the central sump, basin or recirculating lines in an area with adequate mixing.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Curative treatment: Against bacteria at 16-30 mg C(M)IT/MIT (3:1) per L of fluid</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>Curative treatment: Against bacteria at 16-30 mg C(M)IT/MIT (3:1) per L of fluid</p><p>Contact time 5 days</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.21.1. Use-specific instructions for use
Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
4.21.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Liquids used in textile and fiber processing fluids must not enter surface water directly. Use product only in premises that are connected to a STP.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Recirculating liquids in photoprocessing systems and fountain solution systems must not enter surface water directly. Use product only in premises that are connected to a STP.</p></td></tr></tbody></table>
4.21.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.21.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.21.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.22. Use description
Table 58
Use # 22 – Preservation of re-circulating liquids used in paint spray booths and electrodeposition coating systems
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT11 - Preservatives for liquid-cooling and processing systems (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of re-circulating liquids used in paint spray booths and electrodeposition coating systems.</p><p>The biocidal product is used for preservation of fluids in pre- treatment processes (Cleaning treatment for grease removal and soil, degreasing Phosphating process, Rinse off tanks) paint spray booths and electrodeposition coating systems (e.g. cataphoretic baths) applied in Car Refinishing and Original equipment Car Manufacturing to control the integrity of recirculating fluid by reducing microbial contamination from bacteria and fungi in the bulk solution.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: -</p><p>Detailed description:</p><p>—</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Preventive treatment: 7,5 to 30 mg C(M)IT/MIT (3:1) per Kg final product.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>Preventive treatment: 7,5 to 30 mg C(M)IT/MIT (3:1) per Kg final product.</p><p>The biocidal product is added at the time of manufacture, storage or shipment.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.22.1. Use-specific instructions for use
Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
4.22.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
4.22.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.22.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.22.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.23. Use description
Table 59
Use # 23 – Preservation of liquids used in closed recirculating heating systems and associated pipework
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT11 - Preservatives for liquid-cooling and processing systems (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria (anaerobes and aerobes (including Legionella pneumophila)</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p><p>Common name: Fungi</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Outdoor</p><p>Preservation of liquids used in closed recirculating heating systems and associated pipework. Pre-commission biocide flushing of new or existing pipework systems (heating and chilling pipework) includes used or new structural pipework built on industrial building projects.</p><p>Closed recirculating heating systems: pre-commission biocidal product flushing of new or existing pipework systems (heating and chilling pipework) includes used or new structural pipework built on industrial building projects. The biocidal product is used to control the growth of aerobic and anaerobic bacteria, fungi and biofilm in the circulating water of closed systems. Closed systems are less susceptible to corrosion, scaling and biological fouling than open systems. However microbial problems can occur, if the system is left filled and untreated. This is due to the presence of nitrite and glycols used as nutrients by microbes.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated dosing.</p><p>The biocidal product is dosed automatically in the heat transfer fluid, in a place of good mixing. The feeding pipe must dose the biocidal product below the water level in order to limit the evaporation of the biocidal product.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Curative treatment - against bacteria at 5 g C(M)IT/MIT (3:1) / m<span>3</span> of water (including L. pneumophila) - against biofilm at 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water - against fungi and yeast at 1 g C(M)IT/MIT / m<span>3</span> of water Preventive treatment - against bacteria (including L. pneumophila) at 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water - against biofilm at 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>Curative treatment:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against bacteria at 5 g C(M)IT/MIT (3:1) / m<span>3</span> of water (including L. pneumophila)</p><p>Contact time: 24 hours</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against biofilm at 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water</p><p>Contact time: 24 hours</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against fungi and yeast at 1 g C(M)IT/MIT / m<span>3</span> of water Contact time: 48 hours</p></td></tr></tbody></table><p>Preventive treatment</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against bacteria (including L. pneumophila) at 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water and against biofilm at 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p></td></tr></tbody></table></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.23.1. Use-specific instructions for use
Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
4.23.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
4.23.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.23.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.23.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.24. Use description
Table 60
Use # 24 – Preservation of polymers used in oilfield processes (e.g. enhanced oil recovery, drilling muds, etc.)
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT11 - Preservatives for liquid-cooling and processing systems (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Outdoor</p><p>Preservation of polymers used in oilfield processes (e.g. enhanced oil recovery, drilling muds, etc.)</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: -</p><p>Detailed description:</p><p>—</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Preventive treatment of polymers used in the injection water: Xanthan polymer: 30 -50 g C(M)IT/MIT/m<span>3</span> solution. HPAM polymer: 30 - 50 g C(M)IT/MIT/m<span>3</span> solution. Preventive treatment of polymers used in the drilling muds: Xanthan polymer: 30 g C(M)IT/MIT/m<span>3</span> solution. HPAM polymer: 30 g C(M)IT/MIT/m<span>3</span> solution.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>Preventive treatment of polymers used in the injection water:</p><p>Xanthan polymer: 30 -50 g C(M)IT/MIT/m<span>3</span> solution.</p><p>HPAM polymer: 30 - 50 g C(M)IT/MIT/m<span>3</span> solution.</p><p>Preventive treatment of polymers used in the drilling muds:</p><p>Xanthan polymer: 30 g C(M)IT/MIT/m<span>3</span> solution.</p><p>HPAM polymer: 30 g C(M)IT/MIT/m<span>3</span> solution.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.24.1. Use-specific instructions for use
Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
4.24.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
4.24.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.24.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.24.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.25. Use description
Table 61
Use # 25 – Slimicide treatment in the de-inking process of the pulp and paper
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT12 - Slimicides (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p><p>Common name: Fungi</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Slimicide treatment in the de-inking process of the pulp and paper. Recycling paper /deinking paper mills. Deinking process is a manufacturing paper process of removing printing inks from waste paper-fibers to produce deinked pulp.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated dosing.</p><p>The biocidal product is automatically dosed by pump and fixed pipes into the circuit, usually in the pulper below the water level.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Curative treatment: 10 to 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water to be treated. Preventive treatment: 5 g C(M)IT/MIT (3:1) / m<span>3</span> of water to be treated.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>Curative treatment: 10 to 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water to be treated</p><p>Contact time: 24 hours</p><p>Preventive treatment: 5 g C(M)IT/MIT (3:1) / m<span>3</span> of water to be treated.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.25.1. Use-specific instructions for use
Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
4.25.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
4.25.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.25.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.25.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.26. Use description
Table 62
Use # 26 – Slimicide treatment in the wet-end stage of paper manufacturing process
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT12 - Slimicides (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p><p>Common name: Fungi</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Slimicide treatment in the wet-end stage of the paper manufacturing process (paper mills, wet-end stage (water circuits), and paper mills process system).</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated dosing.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Curative treatment: 10 to 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water to be treated. Preventive treatment: 5 g C(M)IT/MIT (3:1) / m<span>3</span> of water to be treated.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>Curative treatment: 10 to 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water to be treated</p><p>Contact time: 24 hours</p><p>Preventive treatment: 5 g C(M)IT/MIT (3:1) / m<span>3</span> of water to be treated.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.26.1. Use-specific instructions for use
Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
4.26.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The use of C(M)IT/MIT (3:1) containing products for the slimicide treatment in the wet-end stage of the paper manufacturing process is restricted to</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>curative treatments in plants connected to a slimicide-free water from a pulp mill and only for the treatment of the short circulation of the paper mill; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>preventive treatments,</p></td></tr></tbody></table><p>and, for both cases, only if the factory’s waste water is purified in an on-site (full) industrial sewage treatment plant with a minimal capacity of 5 000 m<span>3</span> per day as described in the Industrial Emission Directive 2010/75/EU (Best Available Techniques for the production of pulp, paper and board) and if a dilution of at least 200 times in surface water is achieved after the industrial sewage treatment plant.</p></td></tr></tbody></table>
4.26.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.26.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.26.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.27. Use description
Table 63
Use # 27 – Preventive treatment (biofouling control) online and after cleaning in place for industrial RO/NF membranes
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT12 - Slimicides (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preventive treatment (biofouling control) online and after cleaning in place for industrial RO/NF membranes</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated dosing.</p><p>Biocidal product application on a routine basis will prevent biofilm growth on Reverse Osmosis or Nano Filtration membrane surfaces, feed spacer, filter media and pipework. The biocidal product should be dispensed to the feed water at a point to assure adequate mixing throughout the system.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Preventive treatment: 5 g C(M)IT/MIT (3:1) per m<span>3</span> of fluid</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>Preventive treatment: 5 g C(M)IT/MIT (3:1) per m<span>3</span> of fluid</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.27.1. Use-specific instructions for use
Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
4.27.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use product only in premises that are connected to a STP.</p></td></tr></tbody></table>
4.27.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.27.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.27.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.28. Use description
Table 64
Use # 28 – Products to control microbial deterioration in fluids used for working or cutting metal, glass or other materials
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT13 - Working or cutting fluid preservatives (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p><p>Common name: Fungi</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Products to control microbial deterioration in fluids used for working or cutting metal, glass or other materials</p><p>The biocidal product is recommended to control the growth of bacteria and fungi in fluids used for metalworking fluids (cutting, grinding, rolling, drawing, etc.) metal surface treatment (aqueous multipurpose and de-watering rust cleaner fluids, etc.) and cutting fluids for glass or other materials.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: -</p><p>Detailed description:</p><p>The biocidal product should be dispensed as a tankside additive into the circulating use-dilution of the fluid, using a metering pump or by manual pouring, at a point to assure adequate mixing throughout the system.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Curative treatment: When the system is noticeably fouled, apply 14,9 g C(M)IT/MIT (3:1) per m<span>3</span> of fluid to be treated. Preventive treatment: When control is obtained, adding 10 g C(M)IT/MIT (3:1) per m<span>3</span> of fluid to be treated.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>Curative treatment:</p><p>When the system is noticeably fouled, apply 14,9 g C(M)IT/MIT (3:1) per m<span>3</span> of fluid to be treated.</p><p>Contact time: 24 h</p><p>Preventive treatment:</p><p>When control is obtained, adding 10 g C(M)IT/MIT (3:1) per m<span>3</span> of fluid to be treated.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.28.1. Use-specific instructions for use
Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
4.28.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
4.28.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.28.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.28.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
5. GENERAL DIRECTIONS FOR USE ( 3 ) OF THE META SPC 3
5.1. Instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration of the effect is dependent on the performance requirements of the customer for their preserved material and on the specific ingredients composition and pH of the preserved product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Always read the label or leaflet before use and follow all the instructions provided.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Respect the conditions of use of the product (concentration, contact time, temperature, pH, etc.)</p></td></tr></tbody></table>
PRECAUTIONARY MEASURES DURING STORAGE AND TRANSPORT:
Keep in a well-ventilated place. The product as supplied may evolve gas (largely carbon dioxide) slowly. To prevent the buildup of pressure the product is packaged in specially vented containers, where necessary. Keep this product in the original container when not in use. Container must be stored and transported in an upright position to prevent spilling the contents through the vent, where fitted.
5.2. Risk mitigation measures
— 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Skin contact: Remove contaminated clothing and shoes. Wash contaminated skin with water. Contact poison treatment specialist if symptoms occur.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye contact: Immediately flush with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses if easy to do. Continue to rinse with tepid water for at least 30 minutes. Call 112/ambulance for medical assistance.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Ingestion: Wash out mouth with water. Contact poison treatment specialist. Seek medical advice immediately if symptoms occur and/or large quantities have been ingested. Do not give fluids or induce vomiting.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Inhalation (of spray mist): Remove victim to fresh air and keep at rest in a position comfortable for breathing. Seek medical advice immediately if symptoms occur and/or large quantities have been inhaled.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In case of impaired consciousness place in recovery position and seek medical advice immediately.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Keep the container or label available.</p></td></tr></tbody></table>
5.4. Instructions for safe disposal of the product and its packaging
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Do not discharge unused product on the ground, into water courses, into pipes (e.g. sink, toilets) nor down the drains.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Dispose of unused product, its packaging and all other waste, in accordance with local regulations.</p></td></tr></tbody></table>
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Conditions for safe storage, including any incompatibilities: Keep in a dry, cool and well-ventilated place, in the original container.
Shelf-life: 12 months
Protect from sunlight.
Recommendation: If a metal packaging is used, a varnish layer should be applied.
6. OTHER INFORMATION
— 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3
7.1. Trade name(s), authorisation number and specific composition of each individual product
<table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Trade name(s)</p></td><td><p>KATHON™ CF 400 Biocide</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Dab 4228</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>BAL 400BI</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Biocide 400</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Biotech 400</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Biocide KT400</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>BioCheck KT400</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>KT400</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>C 412 TT</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Dab 4228</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Deep Bio® 400</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Ecosafe Bio 400</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Filtralga ME</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Filtralga 9550</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>PH-SB400</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Helamin BZ9550</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Isotreat 400</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>OS Isobio4</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Odysside B 330</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Relvamine BIOC</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Sayvol Bio LP400</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Authorisation number</p></td><td><p>EU-0025449-0004 1-3</p></td></tr><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Mixture of 5-chloro-2-methyl-2H- isothiazol-3-one (EINECS 247-500-7) and 2-methyl-2H-isothiazol-3-one (EINECS 220-239-6) (Mixture of CMIT/MIT)</p></td><td><p> </p></td><td><p>Active Substance</p></td><td><p>55965-84-9</p></td><td><p> </p></td><td><p>5,9</p></td></tr></tbody></table>
7.2. Trade name(s), authorisation number and specific composition of each individual product
<table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Trade name(s)</p></td><td><p>KATHON™CF 210 BIOCIDE</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>BAL 210BI</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>BioCheck KT210</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Biocide KT210</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Biocide 210</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Biotech 210</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>B203-210</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Deep Bio® 210</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Ecosafe Bio 210</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Filtralga ME-15</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>KT210</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Isotreat 210</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>MIRECIDE-M/86</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>MK3203</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>MK3094</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>MK3394</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>OS Isobio 210</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Odysside B 330M</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>PH-SB210</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>STENCO B-85</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Sayvol Bio LP210</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>TECNA 520</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Authorisation number</p></td><td><p>EU-0025449-0005 1-3</p></td></tr><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Mixture of 5-chloro-2-methyl-2H- isothiazol-3-one (EINECS 247-500-7) and 2-methyl-2H-isothiazol-3-one (EINECS 220-239-6) (Mixture of CMIT/MIT)</p></td><td><p> </p></td><td><p>Active Substance</p></td><td><p>55965-84-9</p></td><td><p> </p></td><td><p>3,2</p></td></tr></tbody></table>
7.3. Trade name(s), authorisation number and specific composition of each individual product
<table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Trade name(s)</p></td><td><p>KATHON™WT 210 BIOCIDE</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>A-CID SA</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>ADUR 166</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>ALG 200</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Biocide BALK 20</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Biocide KT210WT</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>France Algue 242</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>KL60 TA21</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>KT210WT</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>MK3094</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>MK3394</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>MK3203</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>B203-210WT</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Biocide 210WT</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Biotech 210WT</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Deep Bio® 210WT</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Ecosafe Bio 210WT</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>OS Isobio 210WT</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>PH-SB210WT</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Sayvol Bio LP210WT</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Authorisation number</p></td><td><p>EU-0025449-0006 1-3</p></td></tr><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Mixture of 5-chloro-2-methyl-2H- isothiazol-3-one (EINECS 247-500-7) and 2-methyl-2H-isothiazol-3-one (EINECS 220-239-6) (Mixture of CMIT/MIT)</p></td><td><p> </p></td><td><p>Active Substance</p></td><td><p>55965-84-9</p></td><td><p> </p></td><td><p>3,2</p></td></tr></tbody></table>
7.4. Trade name(s), authorisation number and specific composition of each individual product
<table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Trade name(s)</p></td><td><p>KATHON™ WTE BIOCIDE</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>KATHON™ WTE</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>KATHON™ LXE BIOCIDE</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>KATHON™ LXE</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>KATHON™ MWE BIOCIDE</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Bansan 150</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Biocide KT200LX</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Biocide KT200WT</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Biocide KT200MW</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Biocide 515WTE</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Biocide 515 MW</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Biotech 103WTE</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>BioCheck WTE</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>BioCheck KT MW</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Biocheck WB</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Biocheck 3103</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Biotech 103MW</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>BIOMATE SAN9363</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>BIO 417</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>B203WTE</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>B203MW</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>C 412 TTE</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Deep Bio® 20MW</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Deep Bio® 20WTE</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Ecosafe Bio WTE</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Ecosafe Bio MW</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Hydrex™ 7310</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Isotreat WTE</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>KT200LX</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>KT200WT</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>KT200MW</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>MIRECIDE-M/87</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Novocide 10 C</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>OBBIO210</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>OS Isobio 1.5WTE</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Pastosept K</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>PH-SB102WTE</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>PH-SB102MW</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>PS 2175</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>SAN ADDITIVE</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>SANY POOL</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Sayvol Bio WTE</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Sayvol Bio LP MW</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Wacozid 3150</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>OS Isobio 1.5MW</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>BAC-S</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Biocide BAL GX</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Biocide BAL P10</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Biocide BALK 10</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>biocil-I</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>BIOMATE MBC781</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>France Algue 222</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>GEWA B 352</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>HCT-B-71</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>O'RIZON 415</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>rascal-B-71</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>WANSON W23L</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>watERTreat BIO253 B</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Authorisation number</p></td><td><p>EU-0025449-0007 1-3</p></td></tr><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Mixture of 5-chloro-2-methyl-2H- isothiazol-3-one (EINECS 247-500-7) and 2-methyl-2H-isothiazol-3-one (EINECS 220-239-6) (Mixture of CMIT/MIT)</p></td><td><p> </p></td><td><p>Active Substance</p></td><td><p>55965-84-9</p></td><td><p> </p></td><td><p>2,3</p></td></tr></tbody></table>
7.5. Trade name(s), authorisation number and specific composition of each individual product
<table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Trade name(s)</p></td><td><p>KATHON™ CF 150 Biocide</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>KATHON™ CF-150 Biocide</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>KATHON™ CF-150</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>AAHS BI</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>ACN Green Line 802</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>AQ 616</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>AQF 415</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>AQUATREAT 415</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>ATN JB48</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>BAL 200BI</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Bewacid B 728</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Biocheck WB CF</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Biocheck 3103 CF</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Biocide 515</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Biocide KT200</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>BioCheck KT</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>BIOCONTROL 5</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>BIOMATE MBC781E</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>BiopleX TZ 150</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Bio-Safe KT200</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Biotech 103</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>B203</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>BW 415</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>BS4005A</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Busan 1078</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Butrol 1078</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Bulab 8862</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Bulab 6057</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Carillion ITA</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Certi-KT200</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>CH32</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>ComChem Bio ITA</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Dab 448</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Deep Bio® 20</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>DIABICIDE 90 A</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>DIPOLIQUE 156</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Ecoral 1015</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Ecosafe Bio WT</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Ekobio-5</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>ES515</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>FINEALGUA ME</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>GE32</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Hydrex™ 7943</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>HCS B32</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>In-Boi</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Isocil® Ultra 1.5</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Isotreat</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>IWT KT200</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>KT200</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Lubron BD 100</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Lubron BD 110</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Lubron BD 120</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>MB 215</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Mikrobizid M 24</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>MIRECIDE-KW/600</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>MIRECIDE-KW/600.X</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Novocide 10</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Novo Cide 10</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>NW515</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>OS Isobio 1.5</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>PA32</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>PH-SB102</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>PS 2176</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>QUIPROISO LG</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>RAL200</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Relcide 310</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Sayvol Bio LP</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>ST202</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Starcide Ultra 1.5</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Swiftclean BI</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>UPINZOL -10</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Wacozid 3150</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Wacozid 3150 CF</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Watercare WHM KT200</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>‘hygel’ KW 60 B</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>BioCheck KT200</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Authorisation number</p></td><td><p>EU-0025449-0008 1-3</p></td></tr><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Mixture of 5-chloro-2-methyl-2H- isothiazol-3-one (EINECS 247-500-7) and 2-methyl-2H-isothiazol-3-one (EINECS 220-239-6) (Mixture of CMIT/MIT)</p></td><td><p> </p></td><td><p>Active Substance</p></td><td><p>55965-84-9</p></td><td><p> </p></td><td><p>2,3</p></td></tr></tbody></table>
7.6. Trade name(s), authorisation number and specific composition of each individual product
<table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Trade name(s)</p></td><td><p>KATHON™ CG/ICP Biocide</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>KATHON™ CG-ICP</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>KATHON™ CG/ICP Preservative</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>KATHON™ MK Biocide</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Biocide KT200ICP</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Biogat CG ICP</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Isocil® HP 1.5</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>MIRECIDE-KW/24</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Authorisation number</p></td><td><p>EU-0025449-0009 1-3</p></td></tr><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Mixture of 5-chloro-2-methyl-2H- isothiazol-3-one (EINECS 247-500-7) and 2-methyl-2H-isothiazol-3-one (EINECS 220-239-6) (Mixture of CMIT/MIT)</p></td><td><p> </p></td><td><p>Active Substance</p></td><td><p>55965-84-9</p></td><td><p> </p></td><td><p>2,2</p></td></tr></tbody></table>
7.7. Trade name(s), authorisation number and specific composition of each individual product
<table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Trade name(s)</p></td><td><p>KATHON™ CG/ICPII Biocide</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Authorisation number</p></td><td><p>EU-0025449-0010 1-3</p></td></tr><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Mixture of 5-chloro-2-methyl-2H- isothiazol-3-one (EINECS 247-500-7) and 2-methyl-2H-isothiazol-3-one (EINECS 220-239-6) (Mixture of CMIT/MIT)</p></td><td><p> </p></td><td><p>Active Substance</p></td><td><p>55965-84-9</p></td><td><p> </p></td><td><p>2,2</p></td></tr></tbody></table>
7.8. Trade name(s), authorisation number and specific composition of each individual product
<table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Trade name(s)</p></td><td><p>KATHON™ CL 150 Biocide</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>SPECTRUS NX1164</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Authorisation number</p></td><td><p>EU-0025449-0011 1-3</p></td></tr><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Mixture of 5-chloro-2-methyl-2H- isothiazol-3-one (EINECS 247-500-7) and 2-methyl-2H-isothiazol-3-one (EINECS 220-239-6) (Mixture of CMIT/MIT)</p></td><td><p> </p></td><td><p>Active Substance</p></td><td><p>55965-84-9</p></td><td><p> </p></td><td><p>2,2</p></td></tr></tbody></table>
META SPC 4
1. META SPC 4 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 4 identifier
<table><col/><col/><tbody><tr><td><p>Identifier</p></td><td><p>meta-SPC 4 KATHON 1.5-3.5 Na</p></td></tr></tbody></table>
1.2. Suffix to the authorisation number
<table><col/><col/><tbody><tr><td><p>Number</p></td><td><p>1-4</p></td></tr></tbody></table>
1.3. Product type(s)
<table><col/><col/><tbody><tr><td><p>Product type(s)</p></td><td><p>PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)</p><p>PT04 - Food and feed area (Disinfectants)</p><p>PT06 - Preservatives for products during storage (Preservatives)</p><p>PT11 - Preservatives for liquid-cooling and processing systems (Preservatives)</p><p>PT12 - Slimicides (Preservatives)</p></td></tr></tbody></table>
2. META SPC 4 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 4
<table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Min</p></td><td><p>Max</p></td></tr><tr><td><p>Mixture of 5-chloro-2-methyl-2H- isothiazol-3-one (EINECS 247-500-7) and 2-methyl-2H-isothiazol-3-one (EINECS 220-239-6) (Mixture of CMIT/MIT)</p></td><td><p> </p></td><td><p>Active Substance</p></td><td><p>55965-84-9</p></td><td><p> </p></td><td><p>2,2</p></td><td><p>5,1</p></td></tr></tbody></table>
2.2. Type(s) of formulation of the meta SPC 4
<table><col/><col/><tbody><tr><td><p>Formulation(s)</p></td><td><p>AL - Any other liquid</p></td></tr></tbody></table>
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4
<table><col/><col/><tbody><tr><td><p>Hazard statements</p></td><td><p>Harmful if inhaled.</p><p>Causes severe skin burns and eye damage.</p><p>May cause an allergic skin reaction.</p><p>Very toxic to aquatic life with long lasting effects.</p><p>Corrosive to the respiratory tract.</p><p>Harmful if swallowed.</p></td></tr><tr><td><p>Precautionary statements</p></td><td><p>Do not breathe fume.</p><p>Wash skin thoroughly after handling.</p><p>Do not eat, drink or smoke when using this product.</p><p>Contaminated work clothing should not be allowed out of the workplace.</p><p>Avoid release to the environment.</p><p>Wear protective gloves/ protective clothing/ eye protection/ face protection/ hearing protection.</p><p>Take off contaminated clothing. And wash it before reuse.</p><p>If skin irritation or rash occurs: Get medical advice.</p><p>IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.</p><p>IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.</p><p>IF INHALED: Remove person to fresh air and keep comfortable for breathing.</p><p>Immediately call a POISON CENTER/ doctor.</p><p>IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.</p><p>Collect spillage.</p><p>Store locked up.</p><p>IF SWALLOWED: Call a POISON CENTER/ doctor if you feel unwell.</p></td></tr></tbody></table>
4. AUTHORISED USE(S) OF THE META SPC 4
4.1. Use description
Table 65
Use # 1 – Preservation of sump water in air conditioning and air washer systems
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria (including Legionella pneumophila)</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p><p>Common name: Fungi</p><p>Development stage:</p><p>Common name: Algae</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Outdoor</p><p>Preservation of sump water in air conditioning and air washer systems.</p><p>Air conditioning systems and in air washer systems to preserve the sump water. Air washer systems are used extensively in textile factories and in the tobacco industry to scrub or clean the air and for fine control of temperature and humidity.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Open and closed Systems</p><p>Detailed description:</p><p>Automatic and Manual Dosing</p><p>The biocidal product is typically added in a central chilled water sump which supplies several air washers. The loading process may be conducted either manually or by automation. In the automated process, the biocide is metered directly into the sump from a holding tank or other type of bulk container by a dosimeter (pump). The feeding pipe must dose the biocidal product below the water level in order to limit its evaporation.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Curative application: Bacteria, yeasts and fungi. When the system is noticeably fouled, apply 5 to 14,9 mg C(M)IT/MIT (3:1) per Litre of water to be treated, as post treatment after a shock dose of minimum 0,3 ppm of free chlorine. Preventive application: algae When control is obtained, add a continuous or semi continuous feed of 3 to 5 mg C(M)IT/MIT (3:1) per L of water to be treated</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>Curative application: Bacteria, yeasts and fungi</p><p>When the system is noticeably fouled, apply 5 to 14,9 mg C(M)IT/MIT (3:1) per Litre of water to be treated, as post treatment after a shock dose of minimum 0,3 ppm of free chlorine.</p><p>Contact time of 1 hour.</p><p>Preventive application: algae</p><p>When control is obtained, add a continuous or semi continuous feed of 3 to 5 mg C(M)IT/MIT (3:1) per L of water to be treated.</p><p>Regardless of the manner of treatment, the total concentration of the active ingredient C(M)IT/MIT (3:1) in the system should not exceed 14,9 mg/L in the sump water.</p><p>Preliminary steps prior to addition:</p><p>The biocidal product is automatically dosed to the system. Manual handling is necessary for the loading of the biocidal product into the dosing systems.</p><p>Application Frequency:</p><p>Nominally every 2 to 3 days or as needed to obtain control. Repeat until fouling is reduced to an acceptable level for controlling the microbial growth.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.1.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Respect the conditions of use of the product (concentration, contact time, temperature, pH, etc.).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The CMIT/MIT biocidal products are used after a shock dose of free chlorine in this application as standard industry practice.</p></td></tr></tbody></table>
4.1.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During mixing and loading and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.2. Use description
Table 66
Use # 2 – Preservation of fluids in conveyor belts and pasteurisers
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT04 - Food and feed area (Disinfectants)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p><p>Common name: Fungi</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of fluids in conveyor belts and pasteurisers</p><p>The biocidal product is used for the preservation of process fluids in pasteurisers and conveyor belts used in food industry. The biocidal product is used in these systems to either control or kill bacteria and fungi.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Automated dosing</p><p>The biocidal product is dosed automatically in the heat transfer fluid, in a place of good mixing (e.g. collecting sump below the conveyor belt).</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Curative application: Bacteria, yeasts and fungi When the system is noticeably fouled, apply 10 to 14,9 g C(M)IT/MIT (3:1) per m<span>3</span> of water to be treated as post treatment after a shock dose of minimum 0,3 ppm of free chlorine Preventive application: Bacteria: When control is obtained, add a continuous or semi continuous feed of 2,5 to 5 g C(M)IT/MIT (3:1) per m<span>3</span> of water to be treated.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>Curative application: Bacteria, yeasts and fungi</p><p>When the system is noticeably fouled, apply 10 to 14,9 g C(M)IT/MIT (3:1) per m<span>3</span> of water to be treated as post treatment after a shock dose of minimum 0,3 ppm of free chlorine.</p><p>Contact time of 1 hour.</p><p>Preventive application: Bacteria:</p><p>When control is obtained, add a continuous or semi continuous feed of 2,5 to 5 g C(M)IT/MIT (3:1) per m<span>3</span> of water to be treated.</p><p>Preliminary steps prior to addition:</p><p>The biocidal product is automatically dosed to system. Manual handling is necessary for the loading of containers containing the biocidal product into the dosing systems.</p><p>Application Frequency:</p><p>Nominally every 2 to 3 days or as needed to obtain control. Repeat until fouling is reduced to an acceptable level for controlling the microbial growth.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.2.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Respect the conditions of use of the product (concentration, contact time, temperature, pH, etc.).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The CMIT/MIT biocidal products are used after a shock dose of free chlorine in this application as standard industry practice.</p></td></tr></tbody></table>
4.2.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During mixing and loading and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.3. Use description
Table 67
Use # 3 – Long term offline preservation of reverse osmosis membranes used in potable water
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT04 - Food and feed area (Disinfectants)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Long term offline preservation of reverse osmosis membranes used in potable water</p><p>The C(M)IT/MIT (3:1) biocidal product is recommended for controlling biological growth in off-line trains reverse osmosis membranes producing potable water for extended periods of time.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated dosing.</p><p>It is recommended that fouled membranes be cleaned prior to shut-down and preservation. Please refer to RO /NF supplier manual for membrane cleaning and system shutdown procedures.</p><p>The biocidal product should be dispensed as a tankside additive into the circulating use-dilution of the fluid, using a metering pump or by manual pouring, at a point to assure adequate mixing throughout the system. After complete filling of the trains RO/NF systems with the biocide solution, pumps are stopped (Off line treatment) for extended periods of time.</p><p>Typically C(M)IT/MIT (3:1) solutions are prepared in the CIP (cleaning in place) tank and added via the dosing system. Dilution with the permeate water or high quality water is recommended for the preparation of the biocide solution.</p><p>Membranes should be soaked in the biocide solution during the shut-down period.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: 7,5 -20 g of C(M)IT/MIT (3:1)/ m<span>3</span> of water</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>7,5 -20 g of C(M)IT/MIT (3:1)/ m<span>3</span> of water</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.3.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Respect the conditions of use of the product (concentration, contact time, temperature, pH, etc.).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Prior to taking the membranes back on-line, flush carefully the elements with permeate water in order to eliminate all the residual biocidal product.</p></td></tr></tbody></table>
4.3.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During mixing and loading and cleaning of the whole system, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.4. Use description
Table 68
Use # 4 – Preservation of paints and coatings
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Outdoor</p><p>Preservation of paints and coatings</p><p>(including electrodeposition)</p><p>The biocidal product is recommended to control the growth of bacteria and yeasts in coatings applied by an electrodeposition process and associated rinse systems and in water-based paints and coatings in storage containers before use.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated dosing.</p><p>The biocidal product should be dispensed as a tankside additive into the fluid, using a metering pump or by manual pouring, at a point to assure adequate mixing throughout the system.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products; Professional paints and general public paints: 7,5-14,9 mg/kg C(M)IT/MIT (3:1) in final product.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>The biocidal product is added at the time of manufacture, storage or shipment.</p><p>Industrial uses:</p><p>1,5 - 14,5 % C(M)IT/MIT in the biocidal products.</p><p>Professional paints and general public paints:</p><p>7,5-14,9 mg/kg C(M)IT/MIT (3:1) in final product.</p><p>For the biocidal product as supplied: for industrial use only.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.4.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product shall be used for treatment of products (articles/mixtures) distributed to professional users and to the general public.</p></td></tr></tbody></table>
4.4.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases of products from Meta SPC 1, 2, 3 and 4 (Mixing and Loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The maximal concentration of products from Meta SPC 1, 2, 3 and 4 to be added in paints used must be below the threshold value of 15 ppm.</p></td></tr></tbody></table>
4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.5. Use description
Table 69
Use # 5 – Preservation of fluids used in paper, textile and leather production - Curative treatment
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of fluids used in paper, textile and leather production -</p><p>The biocidal product is used to reduce contamination by bacteria in textile additives (woven and non-woven, natural and synthetic including silicone emulsions) processing chemicals, all chemicals used in the leather process industry and paper additives (e.g. water pigment pastes, starch, natural gums, synthetic and natural latexes, sizing agents, coating binders, retention aids, dyes, fluorescent whitening agents, wet-strength resins) used in paper mills. The biocidal product inhibits the growth microorganisms, which would otherwise lead to odours formation, viscosity alteration, discolouration of product and premature product failure.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated dosing.</p><p>The biocidal product should be dispensed to the end use fluid at a point to ensure adequate mixing using preferably automated metering pump or by manual addition.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products; Professional uses: 16 to 30 mg/kg of C(M)IT/MIT (3:1) in final product</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>The biocidal product is added at single dose at time of manufacturing, storage or shipment.</p><p>Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products.</p><p>Professional uses:</p><p>Curative treatment:</p><p>16 to 30 mg/kg of C(M)IT/MIT (3:1) in final product</p><p>Contact time: 24 hours</p><p>For the biocidal product as supplied: for industrial use only.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.5.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product shall be used for treatment of products (articles/mixtures) distributed only to professional users.</p></td></tr></tbody></table>
4.5.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases of products from Meta SPC 1, 2, 3 and 4 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The maximal products concentration used for the preservation of fluids used in paper, textile and leather production being above the threshold value of 15 ppm, exposure has to be limited by use of PPE protecting skin and mucous membranes potentially exposed and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.6. Use description
Table 70
Use # 6 – Preservation of glues and adhesives
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of glues and adhesives</p><p>The biocidal product is recommended to control the growth of bacteria and yeasts in water-soluble and water-dispersed synthetic and natural adhesives and tackifiers in storage containers before use</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated application.</p><p>The biocidal product should be dispensed to the end use fluid at a point to ensure adequate mixing using preferably automated metering pump or by manual addition.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products; Professional uses: 8-30 mg/kg C(M)IT/MIT (3:1) in final product. General public uses: 8-14,9 mg/kg C(M)IT/MIT (3:1) in final product.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>The biocidal product is added at single dose at the time of manufacture, storage or shipment.</p><p>To ensure uniform distribution, slowly disperse using automated metering or manual addition, into product with agitation. Mix thoroughly until evenly dispersed throughout the product.</p><p>Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products.</p><p>Professional uses:</p><p>8-30 mg/kg C(M)IT/MIT (3:1) in final product.</p><p>General public uses:</p><p>8-14,9 mg/kg C(M)IT/MIT (3:1) in final product.</p><p>For the biocidal product as supplied: for industrial use only.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.6.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product shall be used for treatment of products (articles/mixtures) distributed to professional users and to the general public. For products distributed to the general public the maximal concentration used must be below the threshold value of 15 ppm.</p></td></tr></tbody></table>
4.6.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases of products from Meta SPC 1, 2, 3 and 4 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>For professional users, the maximal products concentration used for the preservation of glues and adhesives being above the threshold value of 15 ppm, exposure has to be limited by use of PPE, protecting skin and mucous membranes potentially exposed, and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.7. Use description
Table 71
Use # 7 – Preservation of polymer lattices
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p><p>Common name: Fungi</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of polymer latexes</p><p>The biocidal product is recommended for the control of bacteria, yeast and fungi in the manufacture, storage, and transport of latexes, synthetic polymers including Hydrolysed Poly Acryl Amide (HPAM) and biopolymers (e.g. xanthan, dextran.) natural latexes.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated application.</p><p>The biocidal product should be dispensed to the end use fluid at a point to ensure adequate mixing using preferably automated metering pump or by manual addition.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products; Professional uses: 14,9 - 50 mg /kg of C(M)IT/MIT (3:1) in final product.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>The biocidal product is added at single dose at the time of manufacture, storage or shipment.</p><p>To ensure uniform distribution, slowly disperse using automated metering or manual addition, into product with agitation. Mix thoroughly until evenly dispersed throughout the product.</p><p>Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products.</p><p>Professional uses</p><p>14,9 - 50 mg /kg of C(M)IT/MIT (3:1) in final product.</p><p>For the biocidal product as supplied: for industrial use only.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.7.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product shall be used for treatment of products (articles/mixtures) distributed only to professional users.</p></td></tr></tbody></table>
4.7.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases of products from Meta SPC 1, 2, 3 and 4 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The maximal products concentration used for the preservation of polymer lattices being above the threshold value of 15 ppm, exposure has to be limited by use of PPE, protecting skin and mucous membranes potentially exposed, and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.8. Use description
Table 72
Use # 8 – Preservation of mineral slurries
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of mineral slurries</p><p>The biocidal product is recommended to control the growth of bacteria in aqueous-based inorganic/mineral slurries and inorganic pigments which are formulated into paints, coatings and paper.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated application.</p><p>The biocidal product should be dispensed as a tankside additive into the circulating use-dilution of the fluid, using a metering pump or by manual pouring, at a point to assure adequate mixing throughout the system.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products; Professional uses: 10- 30 mg/kg of C(M)IT/MIT (3:1) in final product.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>The biocidal product is added at single dose at the time of manufacture, storage or shipment.</p><p>Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products.</p><p>Professional uses:</p><p>10- 30 mg/kg of C(M)IT/MIT (3:1) in final product.</p><p>For the biocidal product as supplied: for industrial use only.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.8.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product shall be used for treatment of products (articles/mixtures) distributed only to professional users.</p></td></tr></tbody></table>
4.8.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases of products from Meta SPC 1, 2, 3 and 4 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The maximal products concentration used for the preservation of mineral slurries being above the threshold value of 15 ppm, exposure has to be limited by use of PPE, protecting skin and mucous membranes potentially exposed, and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.9. Use description
Table 73
Use # 9 – Preservation of building products applied indoor only
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of building (construction) products (including sealants, caulks, plasters etc.)</p><p>The biocidal product is recommended to control the growth of bacteria in building (construction) products (sealants, caulks, biopolymers, plasters, fillers, admixtures concrete additives, joints compounds,.).</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: -</p><p>Detailed description:</p><p>Manual and automated dosing.</p><p>The biocidal product should be dispensed to the end use fluid at a point to ensure adequate mixing using preferably automated metering pump or by manual addition.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products; Professional uses: Add at typical use rate between 16,2-30 mg C(M)IT/MIT (3:1) per Kg final product to be treated.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>The biocidal product is added at single dose at the time of manufacture, storage or shipment.</p><p>Slowly dispense using automated metering or manually. Mix thoroughly until the biocidal product is evenly dispersed.</p><p>Industrial uses:</p><p>1,5 - 14,5 % C(M)IT/MIT in the biocidal products.</p><p>Professional uses:</p><p>Add at typical use rate between 16,2-30 mg C(M)IT/MIT (3:1) per Kg final product to be treated.</p><p>For the biocidal product as supplied: for industrial use only.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.9.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product shall be used for treatment of products (articles/mixtures) distributed only to professional users.</p></td></tr></tbody></table>
4.9.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>This use is restricted to the preservation of building material applied indoor only.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases for products from Meta SPC 1, 3 and 4 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>For professional users, the maximal products concentration used for the preservation of building products being above the threshold value of 15 ppm, exposure has to be limited by use of PPE, protecting skin and mucous membranes potentially exposed, and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.9.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.10. Use description
Table 74
Use # 10 – Preservation of inks
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of inks</p><p>The biocidal product is recommended to control the growth of bacteria and yeasts in inks and ink components (printing inks lithographic, photographic, ink-jet fluids, water based dampening or fountain solutions inks used for textile printing). The biocidal product inhibits the growth of microorganisms, which would otherwise lead to odour formation, viscosity alteration, product discolouration and premature product failure.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated dosing.</p><p>The biocidal product should be dispensed to the end use fluid at a point to ensure adequate mixing using preferably automated metering pump or by manual addition.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products. Professional uses: 6-30 mg C(M)IT/MIT (3:1) /kg final product. General public uses: 6-14,9 mg C(M)IT/MIT (3:1) /kg final product.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>The biocidal product is added at single dose at time of manufacturing, storage or shipment.</p><p>Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products.</p><p>Professional uses:</p><p>6-30 mg C(M)IT/MIT (3:1) /kg final product.</p><p>General public uses:</p><p>6-14,9 mg C(M)IT/MIT (3:1) /kg final product.</p><p>For the biocidal product as supplied: for industrial use only.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:- HDPE flask: 5 L (nominal)- HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)- Box with HDPE liner: 20 L</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L- HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.10.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product shall be used for treatment of products (articles/mixtures) distributed to professional users and to the general public. For products distributed to the general public the maximal concentration used must be below the threshold value of 15 ppm.</p></td></tr></tbody></table>
4.10.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases of products from Meta SPC 1, 2, 3 and 4 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>For professional users, the maximal products concentration used for the preservation of inks being above the threshold value of 15 ppm, exposure has to be limited by use of PPE, protecting skin and mucous membranes potentially exposed, and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.11. Use description
Table 75
Use # 11 – Preservation of functional fluids (hydraulic fluids, antifreeze, corrosion inhibitors, etc. - excluding fuel additives)
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of functional fluids (hydraulic fluids, antifreeze, corrosion inhibitors, etc. - excluding fuel additives)</p><p>The biocidal product is recommended to control the growth of bacteria in functional fluids such as brake and hydraulic fluids, antifreeze additives, corrosion inhibitors, spinning fluids. The biocidal product inhibits the growth microorganisms, which would otherwise lead to odours formation, viscosity alteration, discolouration of product and premature product failure.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated dosing.</p><p>The biocidal product should be dispensed to the end use fluid at a point to ensure adequate mixing using preferably automated metering pump or by manual addition.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products. Professional uses: Add at a typical use rate between 6 to 30 mg C(M)IT/MIT (3:1) per kg final product to be treated.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>The biocidal product is added at single dose at time of manufacturing, storage or shipment.</p><p>Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products.</p><p>Professional uses:</p><p>Add at a typical use rate between 6 to 30 mg C(M)IT/MIT (3:1) per kg final product to be treated</p><p>For the biocidal product as supplied: for industrial use only.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.11.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product shall be used for treatment of products (articles/mixtures) distributed only to professional users.</p></td></tr></tbody></table>
4.11.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases of products from Meta SPC 1, 2, 3 and 4 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The maximal products concentration used for the preservation of functional fluids (hydraulic fluids, antifreeze, corrosion inhibitors, etc…) being above the threshold value of 15 ppm, exposure has to be limited by use of PPE, protecting skin and mucous membranes potentially exposed, and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
4.11.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.11.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.11.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.12. Use description
Table 76
Use # 12 – Preservation of laboratory reagents
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of laboratory reagents .</p><p>The biocidal product is recommended to control the growth of bacteria and yeasts in laboratory reagents.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated dosing.</p><p>The biocidal product should be dispensed to the end use fluid at a point to ensure adequate mixing using preferably automated metering pump or by manual addition.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products. Professional use: Add at typical use rate of 15,2 mg C(M)IT/MIT (3:1) per kg final product to be treated.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>The biocidal product is added at single dose at the time of manufacture, storage or shipment.</p><p>Slowly dispense using automated metering or manually. Mix thoroughly until the biocidal product is evenly dispersed.</p><p>Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products.</p><p>Professional use: Add at typical use rate of 15,2 mg C(M)IT/MIT (3:1) per kg final product to be treated.</p><p>For the biocidal product as supplied: for industrial use only.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 1 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.12.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product shall be used for treatment of products (articles/mixtures) distributed only to professional users.</p></td></tr></tbody></table>
4.12.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases for products from Meta SPC 1, 3 and 4 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>For professional users, the maximal products concentration used for the preservation of laboratory reagents being above the threshold value of 15 ppm, exposure has to be limited by use of PPE, protecting skin and mucous membranes potentially exposed, and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
4.12.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.12.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.12.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.13. Use description
Table 77
Use # 13 – Offline preservation of industrial reverse osmosis membranes
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT06 - Preservatives for products during storage (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Offline preservation of industrial reverse osmosis membranes</p><p>The biocidal product is recommended to control the growth of bacteria of reverse osmosis and nanofiltration membranes producing industrial water for extended periods of time.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated dosing.</p><p>The biocidal product should be dispensed as a tankside additive into the circulating use-dilution of the fluid, using a metering pump or by manual pouring, at a point to ensure adequate mixing throughout the system. After complete filling of the trains RO/NF systems with the biocide solution, pumps are stopped (Off line treatment) for extended periods of time.</p><p>Typically C(M)IT/MIT (3:1) solutions are prepared in the CIP (cleaning in place) tank and added via the dosing system. Dilution with permeate water or high quality water is recommended for the preparation of the biocide solution. Membranes should be soaked in the biocide solution during the shut-down period.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: 7,5–20 g/m<span>3</span> (ppm w/v) of C(M)IT/MIT (3:1).</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>7,5–20 g/m<span>3</span> (ppm w/v) of C(M)IT/MIT (3:1).</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.13.1. Use-specific instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The preservative can be added at any stage of the production of the product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Earliest possible addition is recommended for optimal protection.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Consult the manufacturer to determine the optimal dosage for the various products to be preserved.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.</p></td></tr></tbody></table>
4.13.2. Use-specific risk mitigation measures
Rinse the system with water prior to perform the maintenance of the system.
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases for products from Meta SPC 1, 3 and 4 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
4.13.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.13.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.13.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.14. Use description
Table 78
Use # 14 – Preservation of liquids used in closed recirculating cooling systems
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT11 - Preservatives for liquid-cooling and processing systems (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria (including Legionella pneumophila)</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p><p>Common name: Fungi</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Outdoor</p><p>Preservation of liquids used in closed recirculating cooling systems (Closed re-circulating cooling water systems comprise compressor cooling, air conditioning chilled water, boilers, engine jacket cooling, power supply cooling, and other industrial processes).</p><p>The biocidal product is used to control the growth of aerobes and anaerobes bacteria, yeast, fungi, and biofilm in the circulating water of closed systems</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated dosing.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Curative efficacy:- against bacteria (including L. pneumophila) at 5 - 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water. Contact time: 24 hours - against biofilm: 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water. Contact time: 24 hours.- against fungi and yeasts at 1 – 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water. Contact time: 48 hours. Preventive efficacy:- against bacteria (including L. pneumophila) at 3 – 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water. - against biofilm (including L. pneumophila): 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>Curative efficacy:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against bacteria (including L. pneumophila) at 5 - 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p><p>Contact time: 24 hours</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against biofilm: 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p><p>Contact time: 24 hours</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against fungi and yeasts at 1 – 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p><p>Contact time: 48 hours</p></td></tr></tbody></table><p>Preventive efficacy:</p><p>against bacteria (including L. pneumophila) at 3 – 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p><p>against biofilm (including L. pneumophila): 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.14.1. Use-specific instructions for use
Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
4.14.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
4.14.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.14.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.14.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.15. Use description
Table 79
Use # 15 – Preservation of liquids used in small open recirculating cooling systems
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT11 - Preservatives for liquid-cooling and processing systems (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria (including Legionella pneumophila)</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p><p>Common name: Fungi</p><p>Development stage:</p><p>Common name: Algae (green algae and cyanobacteria)</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Outdoor</p><p>Preservation of liquids used in small open recirculating cooling systems (blowdown and recirculating flow rates, as well as total volume of water limited to 2 m<span>3</span>/h, and 100 m<span>3</span>/h and 300 m<span>3</span> respectively)</p><p>Process and cooling water: Used to control the growth of bacteria, algae, fungi and biofilm</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Open system</p><p>Detailed description:</p><p>Manual and automated dosing.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Curative treatment Against bacteria (including L. pneumophila) at 5 – 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water, - against biofilm (including L. pneumophila) at 1,5 to 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water, - against fungi (including yeast) at 1 – 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water. Preventive treatment: - against bacteria, green algae and cyanobacteria at 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water, - against biofilm (including L. pneumophila) at 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>Curative treatment:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Against bacteria (including L. pneumophila) at 5 – 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water</p><p>Contact time: 24 hours</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against biofilm (including L. pneumophila) at 1,5 - 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water</p><p>Contact time: 48 hours.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against fungi and yeast at 1 – 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water</p><p>Contact time: 48 hours.</p></td></tr></tbody></table><p>Preventive treatment:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against bacteria, green algae and cyanobacteria at 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against biofilm (including L. pneumophila) at 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p></td></tr></tbody></table></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.15.1. Use-specific instructions for use
Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
4.15.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Cooling fluid must not enter surface water directly. Use product only in premises that are connected to a STP.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The product can only be used when the cooling towers are equipped with drift eliminators that reduce the drift at least by 99 %.</p></td></tr></tbody></table>
4.15.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.15.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.15.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.16. Use description
Table 80
Use # 16 – Preservation of liquids used in pasteurizers, conveyor belts and air washers
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT11 - Preservatives for liquid-cooling and processing systems (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria (including Legionella pneumophila)</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p><p>Common name: Fungi</p><p>Development stage:</p><p>Common name: Algae (green algae and cyanobacteria)</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Outdoor</p><p>Preservation of liquids used in non-food pasteurizers and conveyor belts, air washers.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: -</p><p>Detailed description:</p><p>The biocidal product is dosed automatically in the heat transfer fluid, in a place of good mixing (e.g. collecting sump below the conveyor belt). The feeding pipe is used to dose the biocidal product below the water level in order to limit its evaporation.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Curative treatment: -against bacteria (including L. pneumophila): 5 - 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water - against biofilm (including L. pneumophila) at 1,5 - 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water - against fungi and yeast at 1 – 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water. Preventive treatment: against bacteria, green algae and cyanobacteria at 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water, against biofilm (including L. pneumophila) at 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>Curative treatment:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against bacteria (including L. pneumophila): 5 - 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p><p>Contact time: 24 hours</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against biofilm (including L. pneumophila) at 1,5 - 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water</p><p>Contact time: 48 hours.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against fungi and yeast at 1 – 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water</p><p>Contact time: 48 hours.</p></td></tr></tbody></table><p>Preventive treatment:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Against bacteria, green algae and cyanobacteria at 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against biofilm (including L. pneumophila) at 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p></td></tr></tbody></table></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.16.1. Use-specific instructions for use
Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
Air washers: For use only in industrial air-washer systems that maintain effective mist eliminating components.
4.16.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
4.16.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.16.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.16.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.17. Use description
Table 81
Use # 17 – Preservation of wood treatment solutions
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT11 - Preservatives for liquid-cooling and processing systems (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Scientific name: fungi</p><p>Common name: other</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Outdoor</p><p>Preservation of wood treatment solutions for application on wood of classes 1, 2 and 3 only. The biocidal product is used as a preservative for aqueous wood preservative treatment solution during the wet-state process used in timber treatment solutions.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: -</p><p>Detailed description:</p><p>—</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Preventive treatment: against fungi: 15 - 50 g C(M)IT/MIT (3:1) / m<span>3</span> of in use wood preservation solution</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>Preventive treatment: against fungi: 15 - 50 g C(M)IT/MIT (3:1) / m<span>3</span> of in use wood preservation solution</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.17.1. Use-specific instructions for use
Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product is not intended to function as a wood preservative against wood destroying fungus relative to product type 8.</p></td></tr></tbody></table>
4.17.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases (mixing and loading) and cleaning phases, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The product shall not be used in a wood treatment solution to be applied to wood which may come in direct contact with food, feeding stuff and livestock animals</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The product can be used to preserve wood treatment solutions for the treatment of wood in use classes 1, 2 and 3 only.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The product can be used in a wood treatment solution where the industrial application processes of wood treatment can be carried out within a contained area situated on impermeable hard standing with bunding to prevent run-off and a recovery system in place (e.g. sump).</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The product can be used in wood treatment solutions for the preservation of freshly treated timber, which after treatment is stored under shelter or on impermeable hard standing, or both, to prevent direct losses to soil, sewer or water. Any losses of wood treatment solution shall be collected for reuse or disposal.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The product can be used only in wood treatment solutions for industrial application if these cannot be released to soil, ground- and surface water or any kind of sewer and the wood treatment solutions and/or the product are collected and reused or disposed of as hazardous waste.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The biocidal product can be used only in wood treatment solutions used for the treatment of objects or materials which are stored until completely dried on impermeable ground and under roof, to avoid leakage into the soil.</p></td></tr></tbody></table>
4.17.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.17.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.17.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.18. Use description
Table 82
Use # 18 – Preservation of recirculating fluids used in textile and fiber processing, leather processing, photo-processing and fountain solution systems
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT11 - Preservatives for liquid-cooling and processing systems (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of recirculating fluids used in textile, fiber processing, leather processing, photo-processing and fountain solution systems</p><p>C(M)IT/MIT (3:1) biocidal products are used for the preservation of textile and spinning fluids, photo processing solutions, leather process (e.g. washing and soaking treatment stages) and printing fountain solutions to control the integrity of recirculating fluid by reducing microbial contamination in the bulk solution.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: -</p><p>Detailed description:</p><p>Manual and automated dosing.</p><p>The preservation of all end-products is performed in most cases highly automated by industrial users</p><p>The biocidal product is added to the central sump, basin or recirculating lines in an area with adequate mixing.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Curative treatment: Against bacteria at 16-30 mg C(M)IT/MIT (3:1) per L of fluid</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>Curative treatment: Against bacteria at 16-30 mg C(M)IT/MIT (3:1) per L of fluid</p><p>Contact time 5 days</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.18.1. Use-specific instructions for use
Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
4.18.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Liquids used in textile and fiber processing fluids must not enter surface water directly. Use product only in premises that are connected to a STP.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Recirculating liquids in photoprocessing systems and fountain solution systems must not enter surface water directly. Use product only in premises that are connected to a STP.</p></td></tr></tbody></table>
4.18.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.18.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.18.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.19. Use description
Table 83
Use # 19 – Preservation of re-circulating liquids used in paint spray booths and electrodeposition coating systems
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT11 - Preservatives for liquid-cooling and processing systems (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preservation of re-circulating liquids used in paint spray booths and electrodeposition coating systems.</p><p>The biocidal product is used for preservation of fluids in pre- treatment processes (Cleaning treatment for grease removal and soil, degreasing Phosphating process, Rinse off tanks) paint spray booths and electrodeposition coating systems (e.g. cataphoretic baths) applied in Car Refinishing and Original equipment Car Manufacturing to control the integrity of recirculating fluid by reducing microbial contamination from bacteria and fungi in the bulk solution.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: -</p><p>Detailed description:</p><p>—</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Preventive treatment: 7,5 to 30 mg C(M)IT/MIT (3:1) per Kg final product.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>Preventive treatment: 7,5 to 30 mg C(M)IT/MIT (3:1) per Kg final product.</p><p>The biocidal product is added at the time of manufacture, storage or shipment.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.19.1. Use-specific instructions for use
Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
4.19.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
4.19.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.19.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.19.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.20. Use description
Table 84
Use # 20 – Preservation of liquids used in closed recirculating heating systems and associated pipework
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT11 - Preservatives for liquid-cooling and processing systems (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria (anaerobes and aerobes (including Legionella pneumophila)</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p><p>Common name: Fungi</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Outdoor</p><p>Preservation of liquids used in closed recirculating heating systems and associated pipework. Pre-commission biocide flushing of new or existing pipework systems (heating and chilling pipework) includes used or new structural pipework built on industrial building projects.</p><p>Closed recirculating heating systems: pre-commission biocidal product flushing of new or existing pipework systems (heating and chilling pipework) includes used or new structural pipework built on industrial building projects. The biocidal product is used to control the growth of aerobic and anaerobic bacteria, fungi and biofilm in the circulating water of closed systems. Closed systems are less susceptible to corrosion, scaling and biological fouling than open systems. However microbial problems can occur, if the system is left filled and untreated. This is due to the presence of nitrite and glycols used as nutrients by microbes.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated dosing.</p><p>The biocidal product is dosed automatically in the heat transfer fluid, in a place of good mixing. The feeding pipe must dose the biocidal product below the water level in order to limit the evaporation of the biocidal product.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Curative treatment - against bacteria at 5 g C(M)IT/MIT (3:1) / m<span>3</span> of water (including L. pneumophila) - against biofilm at 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water - against fungi and yeast at 1 g C(M)IT/MIT / m<span>3</span> of water Preventive treatment - against bacteria (including L. pneumophila) at 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water - against biofilm at 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>Curative treatment:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against bacteria at 5 g C(M)IT/MIT (3:1) / m<span>3</span> of water (including L. pneumophila)</p><p>Contact time: 24 hours</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against biofilm at 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water</p><p>Contact time: 24 hours</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against fungi and yeast at 1 g C(M)IT/MIT / m<span>3</span> of water Contact time: 48 hours</p></td></tr></tbody></table><p>Preventive treatment</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>against bacteria (including L. pneumophila) at 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water and against biofilm at 3 g C(M)IT/MIT (3:1) / m<span>3</span> of water.</p></td></tr></tbody></table></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.20.1. Use-specific instructions for use
Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
4.20.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
4.20.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.20.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.20.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.21. Use description
Table 85
Use # 21 – Preservation of polymers used in oilfield processes (e.g. enhanced oil recovery, drilling muds, etc.)
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT11 - Preservatives for liquid-cooling and processing systems (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Outdoor</p><p>Preservation of polymers used in oilfield processes (e.g. enhanced oil recovery, drilling muds, etc.)</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: -</p><p>Detailed description:</p><p>—</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Preventive treatment of polymers used in the injection water: Xanthan polymer: 30 -50 g C(M)IT/MIT/m<span>3</span> solution. HPAM polymer: 30 - 50 g C(M)IT/MIT/m<span>3</span> solution. Preventive treatment of polymers used in the drilling muds: Xanthan polymer: 30 g C(M)IT/MIT/m<span>3</span> solution. HPAM polymer: 30 g C(M)IT/MIT/m<span>3</span> solution.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>Preventive treatment of polymers used in the injection water:</p><p>Xanthan polymer: 30 -50 g C(M)IT/MIT/m<span>3</span> solution.</p><p>HPAM polymer: 30 - 50 g C(M)IT/MIT/m<span>3</span> solution.</p><p>Preventive treatment of polymers used in the drilling muds:</p><p>Xanthan polymer: 30 g C(M)IT/MIT/m<span>3</span> solution.</p><p>HPAM polymer: 30 g C(M)IT/MIT/m<span>3</span> solution.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.21.1. Use-specific instructions for use
Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
4.21.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
4.21.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.21.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.21.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.22. Use description
Table 86
Use # 22 – Slimicide treatment in the de-inking process of the pulp and paper
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT12 - Slimicides (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p><p>Common name: Fungi</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Slimicide treatment in the de-inking process of the pulp and paper. Recycling paper /deinking paper mills. Deinking process is a manufacturing paper process of removing printing inks from waste paper-fibers to produce deinked pulp.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated dosing.</p><p>The biocidal product is automatically dosed by pump and fixed pipes into the circuit, usually in the pulper below the water level.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Curative treatment: 10 to 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water to be treated. Preventive treatment: 5 g C(M)IT/MIT (3:1) / m<span>3</span> of water to be treated.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>Curative treatment: 10 to 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water to be treated</p><p>Contact time: 24 hours</p><p>Preventive treatment: 5 g C(M)IT/MIT (3:1) / m<span>3</span> of water to be treated.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.22.1. Use-specific instructions for use
Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
4.22.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
4.22.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.22.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.22.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.23. Use description
Table 87
Use # 23 – Slimicide treatment in the wet-end stage of paper manufacturing process
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT12 - Slimicides (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p><p>Common name: Yeasts</p><p>Development stage:</p><p>Common name: Fungi</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Slimicide treatment in the wet-end stage of the paper manufacturing process (paper mills, wet-end stage (water circuits), and paper mills process system).</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated dosing.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Curative treatment: 10 to 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water to be treated. Preventive treatment: 5 g C(M)IT/MIT (3:1) / m<span>3</span> of water to be treated.</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>Curative treatment: 10 to 14,9 g C(M)IT/MIT (3:1) / m<span>3</span> of water to be treated</p><p>Contact time: 24 hours</p><p>Preventive treatment: 5 g C(M)IT/MIT (3:1) / m<span>3</span> of water to be treated.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.23.1. Use-specific instructions for use
Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
4.23.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The use of C(M)IT/MIT (3:1) containing products for the slimicide treatment in the wet-end stage of the paper manufacturing process is restricted to</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>curative treatments in plants connected to a slimicide-free water from a pulp mill and only for the treatment of the short circulation of the paper mill; and</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>preventive treatments,</p></td></tr></tbody></table><p>and, for both cases, only if the factory’s waste water is purified in an on-site (full) industrial sewage treatment plant with a minimal capacity of 5 000 m<span>3</span> per day as described in the Industrial Emission Directive 2010/75/EU (Best Available Techniques for the production of pulp, paper and board) and if a dilution of at least 200 times in surface water is achieved after the industrial sewage treatment plant.</p></td></tr></tbody></table>
4.23.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.23.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.23.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.24. Use description
Table 88
Use # 24 – Preventive treatment (biofouling control) online and after cleaning in place for industrial RO/NF membranes
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT12 - Slimicides (Preservatives)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>—</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Common name: Bacteria</p><p>Development stage:</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Preventive treatment (biofouling control) online and after cleaning in place for industrial RO/NF membranes</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Method: Closed system</p><p>Detailed description:</p><p>Manual and automated dosing.</p><p>Biocidal product application on a routine basis will prevent biofilm growth on Reverse Osmosis or Nano Filtration membrane surfaces, feed spacer, filter media and pipework. The biocidal product should be dispensed to the feed water at a point to assure adequate mixing throughout the system.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Application Rate: Preventive treatment: 5 g C(M)IT/MIT (3:1) per m<span>3</span> of fluid</p><p>Dilution (%): -</p><p>Number and timing of application:</p><p>Preventive treatment: 5 g C(M)IT/MIT (3:1) per m<span>3</span> of fluid</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Industrial</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>For industrial and professional users:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE flask: 5 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Pail / Jerrycan: 10 L, 20 L, 25 L, 30 L (nominal)</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Box with HDPE liner: 20 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE Drum: 110 L, 120 L, 200 L, 260 L</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>HDPE IBC: 650 L, 800 L, 1 000 L, 1 250 L</p></td></tr></tbody></table><p>All products should be transport and stored in a vented room.</p></td></tr></tbody></table>
4.24.1. Use-specific instructions for use
Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
4.24.2. Use-specific risk mitigation measures
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Minimisation of manual phases (process automation);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use of a dosing device;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Regular cleaning of equipment and work area;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Avoidance of contact with contaminated tools and objects;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Good standard of general ventilation;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Training and management of staff on good practice.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>PPE is as follows:</p><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye protection;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Substance/task appropriate respirator if ventilation is inadequate.</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Use product only in premises that are connected to a STP.</p></td></tr></tbody></table>
4.24.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.24.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.24.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
5. GENERAL DIRECTIONS FOR USE ( 4 ) OF THE META SPC 4
5.1. Instructions for use
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>The duration of the effect is dependent on the performance requirements of the customer for their preserved material and on the specific ingredients composition and pH of the preserved product.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Always read the label or leaflet before use and follow all the instructions provided.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Respect the conditions of use of the product (concentration, contact time, temperature, pH, etc.)</p></td></tr></tbody></table>
PRECAUTIONARY MEASURES DURING STORAGE AND TRANSPORT:
Keep in a well-ventilated place. The product as supplied may evolve gas (largely carbon dioxide) slowly. To prevent the buildup of pressure the product is packaged in specially vented containers, where necessary. Keep this product in the original container when not in use. Container must be stored and transported in an upright position to prevent spilling the contents through the vent, where fitted.
5.2. Risk mitigation measures
— 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Skin contact: Remove contaminated clothing and shoes. Wash contaminated skin with water. Contact poison treatment specialist if symptoms occur.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Eye contact: Immediately flush with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses if easy to do. Continue to rinse with tepid water for at least 30 minutes. Call 112/ambulance for medical assistance.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Ingestion: Wash out mouth with water. Contact poison treatment specialist. Seek medical advice immediately if symptoms occur and/or large quantities have been ingested. Do not give fluids or induce vomiting.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Inhalation (of spray mist): Remove victim to fresh air and keep at rest in a position comfortable for breathing. Seek medical advice immediately if symptoms occur and/or large quantities have been inhaled.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>In case of impaired consciousness place in recovery position and seek medical advice immediately.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Keep the container or label available.</p></td></tr></tbody></table>
5.4. Instructions for safe disposal of the product and its packaging
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Do not discharge unused product on the ground, into water courses, into pipes (e.g. sink, toilets) nor down the drains.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>—</p></td><td><p>Dispose of unused product, its packaging and all other waste, in accordance with local regulations.</p></td></tr></tbody></table>
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Conditions for safe storage, including any incompatibilities: Keep in a dry, cool and well-ventilated place, in the original container.
Shelf-life: 24 months
Protect from sunlight.
Recommendation: If a metal packaging is used, a varnish layer should be applied.
6. OTHER INFORMATION
— 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4
7.1. Trade name(s), authorisation number and specific composition of each individual product
<table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Trade name(s)</p></td><td><p>KATHON™ LX 300 BIOCIDE</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>KATHON™ WT 300 Biocide</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>ACQ 819</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Biocide KT300WT</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>KT300WT</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>KT300LX</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>SANITER 454</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>OS Isobio3</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Authorisation number</p></td><td><p>EU-0025449-0012 1-4</p></td></tr><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Mixture of 5-chloro-2-methyl-2H- isothiazol-3-one (EINECS 247-500-7) and 2-methyl-2H-isothiazol-3-one (EINECS 220-239-6) (Mixture of CMIT/MIT)</p></td><td><p> </p></td><td><p>Active Substance</p></td><td><p>55965-84-9</p></td><td><p> </p></td><td><p>4,6</p></td></tr></tbody></table>
7.2. Trade name(s), authorisation number and specific composition of each individual product
<table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Trade name(s)</p></td><td><p>KATHON™ WT 150 Biocide</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>KATHON™ LX 150 BIOCIDE</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>BIO 419</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>SANITER 420</p></td><td><p>Market area: EU</p></td></tr><tr><td><p>Authorisation number</p></td><td><p>EU-0025449-0013 1-4</p></td></tr><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Mixture of 5-chloro-2-methyl-2H- isothiazol-3-one (EINECS 247-500-7) and 2-methyl-2H-isothiazol-3-one (EINECS 220-239-6) (Mixture of CMIT/MIT)</p></td><td><p> </p></td><td><p>Active Substance</p></td><td><p>55965-84-9</p></td><td><p> </p></td><td><p>2,3</p></td></tr></tbody></table>
<note>
( 1 ) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1.
( 2 ) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 2.
( 3 ) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 3.
( 4 ) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 4.
</note> | ENG | 32022R1434 |