02012R0528 — EN — 25.04.2014 — 002.011

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►B 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 (Text with EEA relevance) (OJ L 167 27.6.2012, p. 1)

Amended by:





Corrected by:









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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

(Text with EEA relevance)







CHAPTER I

SCOPE AND DEFINITIONS

Article 1

Purpose and subject matter

1. The purpose of this Regulation is to improve the functioning of the internal market through the harmonisation of the rules on the making available on the market and the use of biocidal products, whilst ensuring a high level of protection of both human and animal health and the environment. The provisions of this Regulation are underpinned by the precautionary principle, the aim of which is to safeguard the health of humans, the health of animals and the environment. Particular attention shall be paid to the protection of vulnerable groups.

2. This Regulation lays down rules for:

(a) the establishment at Union level of a list of active substances which may be used in biocidal products;

(b) the authorisation of biocidal products;

(c) the mutual recognition of authorisations within the Union;

(d) the making available on the market and the use of biocidal products within one or more Member States or the Union;

(e) the placing on the market of treated articles.

Article 2

Scope

1. This Regulation shall apply to biocidal products and treated articles. A list of the types of biocidal products covered by this Regulation and their descriptions is set out in Annex V.

2. Subject to any explicit provision to the contrary in this Regulation or other Union legislation, this Regulation shall not apply to biocidal products or treated articles that are within the scope of the following instruments:

(a) Council Directive 90/167/EEC of 26 March 1990 laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community ( 1 );

(b) Directive 90/385/EEC, Directive 93/42/EEC and Directive 98/79/EC;

(c) Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products ( 2 ), Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use ( 3 ) and Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency ( 4 );

(d) Regulation (EC) No 1831/2003;

(e) Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs ( 5 ) and Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin ( 6 );

(f) Regulation (EC) No 1333/2008;

(g) Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods ( 7 );

(h) Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed ( 8 );

(i) Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market ( 9 );

(j) Regulation (EC) No 1223/2009;

(k) Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys ( 10 ).

Notwithstanding the first subparagraph, when a biocidal product falls within the scope of one of the abovementioned instruments and is intended to be used for purposes not covered by those instruments, this Regulation shall also apply to that biocidal product insofar as those purposes are not addressed by those instruments.

3. Subject to any explicit provision to the contrary in this Regulation or other Union legislation, this Regulation shall be without prejudice to the following instruments:

(a) Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances ( 11 );

(b) Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work ( 12 );

(c) Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work ( 13 );

(d) Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption ( 14 );

(e) Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations ( 15 );

(f) Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work ( 16 );

(g) 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 ( 17 );

(h) Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work ( 18 );

(i) Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants ( 19 );

(j) Regulation (EC) No 1907/2006;

(k) Directive 2006/114/EC of the European Parliament and of the Council of 12 December 2006 concerning misleading and comparative advertising ( 20 );

(l) Regulation (EC) No 689/2008 of the European Parliament and of the Council of 17 June 2008 concerning the export and import of dangerous chemicals ( 21 );

(m) 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 ( 22 );

(n) Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides ( 23 );

(o) Regulation (EC) No 1005/2009 of the European Parliament and of the Council of 16 September 2009 on substances that deplete the ozone layer ( 24 );

(p) Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes ( 25 );

(q) Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions ( 26 ).

4. Article 69 shall not apply to the carriage of biocidal products by rail, road, inland waterway, sea or air.

5. This Regulation shall not apply to:

(a) food or feed used as repellents or attractants;

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(b) biocidal products when used as processing aids within the meaning of Regulation (EC) No 1831/2003 and Regulation (EC) No 1333/2008.

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6. Biocidal products which obtained final approval under the International Convention for the Control and Management of Ships’ Ballast Water and Sediments shall be considered as authorised under Chapter VIII of this Regulation. Articles 47 and 68 shall apply accordingly.

7. Nothing in this Regulation shall prevent Member States from restricting or banning the use of biocidal products in the public supply of drinking water.

8. Member States may allow for exemptions from this Regulation in specific cases for certain biocidal products, on their own or in a treated article, where necessary in the interests of defence.

9. The disposal of active substances and biocidal products shall be carried out in accordance with the Union and national waste legislation in force.

Article 3

Definitions

1. For the purposes of this Regulation, the following definitions shall apply:

(a) ‘biocidal product’ means

— any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action,

— any substance or mixture, generated from substances or mixtures which do not themselves fall under the first indent, to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.

A treated article that has a primary biocidal function shall be considered a biocidal product.

(b) ‘micro-organism’ means any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material, including lower fungi, viruses, bacteria, yeasts, moulds, algae, protozoa and microscopic parasitic helminths;

(c) ‘active substance’ means a substance or a micro-organism that has an action on or against harmful organisms;

(d) ‘existing active substance’ means a substance which was on the market on 14 May 2000 as an active substance of a biocidal product for purposes other than scientific or product and process-orientated research and development;

(e) ‘new active substance’ means a substance which was not on the market on 14 May 2000 as an active substance of a biocidal product for purposes other than scientific or product and process-orientated research and development;

(f) ‘substance of concern’ means any substance, other than the active substance, which has an inherent capacity to cause an adverse effect, immediately or in the more distant future, on humans, in particular vulnerable groups, animals or the environment and is present or is produced in a biocidal product in sufficient concentration to present risks of such an effect.

Such a substance would, unless there are other grounds for concern, normally be:

— a substance classified as dangerous or that meets the criteria to be classified as dangerous according to Directive 67/548/EEC, and that is present in the biocidal product at a concentration leading the product to be regarded as dangerous within the meaning of Articles 5, 6 and 7 of Directive 1999/45/EC, or

— a substance classified as hazardous or that meets the criteria for classification as hazardous according to Regulation (EC) No 1272/2008, and that is present in the biocidal product at a concentration leading the product to be regarded as hazardous within the meaning of that Regulation,

— a substance which meets the criteria for being a persistent organic pollutant (POP) under Regulation (EC) No 850/2004, or which meets the criteria for being persistent, bio-accumulative and toxic (PBT) or very persistent and very bio-accumulative (vPvB) in accordance with Annex XIII to Regulation (EC) No 1907/2006;

(g) ‘harmful organism’ means an organism, including pathogenic agents, which has an unwanted presence or a detrimental effect on humans, their activities or the products they use or produce, on animals or the environment;

(h) ‘residue’ means a substance present in or on products of plant or animal origin, water resources, drinking water, food, feed or elsewhere in the environment and resulting from the use of a biocidal product, including such a substance’s metabolites, breakdown or reaction products;

(i) ‘making available on the market’ means any supply of a biocidal product or of a treated article for distribution or use in the course of a commercial activity, whether in return for payment or free of charge;

(j) ‘placing on the market’ means the first making available on the market of a biocidal product or of a treated article;

(k) ‘use’ means all operations carried out with a biocidal product, including storage, handling, mixing and application, except any such operation carried out with a view to exporting the biocidal product or the treated article outside the Union;

(l) ‘treated article’ means any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products;

(m) ‘national authorisation’ means an administrative act by which the competent authority of a Member State authorises the making available on the market and the use of a biocidal product or a biocidal product family in its territory or in a part thereof;

(n) ‘Union authorisation’ means an administrative act by which the Commission authorises the making available on the market and the use of a biocidal product or a biocidal product family in the territory of the Union or in a part thereof;

(o) ‘authorisation’ means national authorisation, Union authorisation or authorisation in accordance with Article 26;

(p) ‘authorisation holder’ means the person established within the Union who is responsible for the placing on the market of a biocidal product in a particular Member State or in the Union and specified in the authorisation;

(q) ‘product-type’ means one of the product-types specified in Annex V;

(r) ‘single biocidal product’ means a biocidal product with no intended variations as to the percentage of the active or non-active substances it contains;

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(s) ‘biocidal product family’ means a group of biocidal products having:

(i) similar uses;

(ii) the same active substances;

(iii) similar composition with specified variations; and

(iv) similar levels of risk and efficacy;

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(t) ‘letter of access’ means an original document, signed by the data owner or its representative, which states that the data may be used for the benefit of a third party by competent authorities, the Agency, or the Commission for the purposes of this Regulation;

(u) ‘food’ and ‘feed’ mean food as defined in Article 2 of Regulation (EC) No 178/2002 and feed as defined in Article 3(4) of that Regulation;

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(w) ‘technical equivalence’ means similarity, as regards the chemical composition and hazard profile, of a substance produced either from a source different to the reference source, or from the reference source but following a change to the manufacturing process and/or manufacturing location, compared to the substance of the reference source in respect of which the initial risk assessment was carried out, as established in Article 54;

(x) ‘Agency’ means the European Chemicals Agency established by Regulation (EC) No 1907/2006;

(y) ‘advertisement’ means a means of promoting the sale or use of biocidal products by printed, electronic or other media;

(z) ‘nanomaterial’ means a natural or manufactured active substance or non-active substance containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100 nm.

Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm shall be considered as nanomaterials.

For the purposes of the definition of nanomaterial, ‘particle’, ‘agglomerate’ and ‘aggregate’ are defined as follows:

— ‘particle’ means a minute piece of matter with defined physical boundaries,

— ‘agglomerate’ means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components,

— ‘aggregate’ means a particle comprising strongly bound or fused particles;

(aa) ‘administrative change’ means an amendment of an existing authorisation of a purely administrative nature involving no change to the properties or efficacy of the biocidal product or biocidal product family;

(ab) ‘minor change’ means an amendment of an existing authorisation that is not of a purely administrative nature and requires only a limited re-assessment of the properties or efficacy of the biocidal product or biocidal product family;

(ac) ‘major change’ means an amendment of an existing authorisation which is neither an administrative change nor a minor change;

(ad) ‘vulnerable groups’ means persons needing specific consideration when assessing the acute and chronic health effects of biocidal products. These include pregnant and nursing women, the unborn, infants and children, the elderly and, when subject to high exposure to biocidal products over the long term, workers and residents;

(ae) ‘small and medium-sized enterprises’ or ‘SMEs’ means small and medium-sized enterprises as defined in Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises ( 27 ).

2. For the purposes of this Regulation, the definitions laid down in Article 3 of Regulation (EC) No 1907/2006 shall apply for the following terms:

(a) ‘substance’;

(b) ‘mixture’;

(c) ‘article’;

(d) ‘product and process-orientated research and development’;

(e) ‘scientific research and development’.

3. The Commission may, at the request of a Member State, decide, by means of implementing acts, whether a substance is a nanomaterial, having regard in particular to Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of nanomaterial ( 28 ), and whether a specific product or group of products is a biocidal product or a treated article or neither. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 82(3).

4. The Commission shall be empowered to adopt delegated acts in accordance with Article 83 in order to adapt the definition of nanomaterial set out in point (z) of paragraph 1 of this Article in view of technical and scientific progress and taking into account the Recommendation 2011/696/EU.







CHAPTER II

APPROVAL OF ACTIVE SUBSTANCES

Article 4

Conditions for approval

1. An active substance shall be approved for an initial period not exceeding 10 years if at least one biocidal product containing that active substance may be expected to meet the criteria laid down in point (b) of Article 19(1) taking into account the factors set out in Article 19(2) and (5). An active substance that falls under Article 5 may only be approved for an initial period not exceeding five years.

2. The approval of an active substance shall be restricted to those product-types for which relevant data have been submitted in accordance with Article 6.

3. The approval shall specify the following conditions, as appropriate:

(a) the minimum degree of purity of the active substance;

(b) the nature and maximum content of certain impurities;

(c) the product-type;

(d) manner and area of use including, where relevant, use in treated articles;

(e) designation of categories of users;

(f) where relevant, characterisation of the chemical identity with regard to stereoisomers;

(g) other particular conditions based on the evaluation of the information related to that active substance;

(h) the date of approval and the expiry date of the approval of the active substance.

4. The approval of an active substance shall not cover nanomaterials except where explicitly mentioned.

Article 5

Exclusion criteria

1. Subject to paragraph 2, the following active substances shall not be approved:

(a) active substances which have been classified in accordance with Regulation (EC) No 1272/2008 as, or which meet the criteria to be classified as, carcinogen category 1A or 1B;

(b) active substances which have been classified in accordance with Regulation (EC) No 1272/2008 as, or which meet the criteria to be classified as, mutagen category 1A or 1B;

(c) active substances which have been classified in accordance with Regulation (EC) No 1272/2008 as, or which meet the criteria to be classified as, toxic for reproduction category 1A or 1B;

(d) active substances which, on the basis of the criteria specified pursuant to the first subparagraph of paragraph 3 or, pending the adoption of those criteria, on the basis of the second and third subparagraphs of paragraph 3, are considered as having endocrine-disrupting properties that may cause adverse effects in humans or which are identified in accordance with Articles 57(f) and 59(1) of Regulation (EC) No 1907/2006 as having endocrine disrupting properties;

(e) active substances which meet the criteria for being PBT or vPvB according to Annex XIII to Regulation (EC) No 1907/2006.

2. Without prejudice to Article 4(1), active substances referred to in paragraph 1 of this Article may be approved if it is shown that at least one of the following conditions is met:

(a) the risk to humans, animals or the environment from exposure to the active substance in a biocidal product, under realistic worst case conditions of use, is negligible, in particular where the product is used in closed systems or under other conditions which aim at excluding contact with humans and release into the environment;

(b) it is shown by evidence that the active substance is essential to prevent or control a serious danger to human health, animal health or the environment; or

(c) not approving the active substance would have a disproportionate negative impact on society when compared with the risk to human health, animal health or the environment arising from the use of the substance.

When deciding whether an active substance may be approved in accordance with the first subparagraph, the availability of suitable and sufficient alternative substances or technologies shall be a key consideration.

The use of a biocidal product containing active substances approved in accordance with this paragraph shall be subject to appropriate risk-mitigation measures to ensure that exposure of humans, animals and the environment to those active substances is minimised. The use of the biocidal product with the active substances concerned shall be restricted to Member States in which at least one of the conditions set out in this paragraph is met.

3. No later than 13 December 2013, the Commission shall adopt delegated acts in accordance with Article 83 specifying scientific criteria for the determination of endocrine-disrupting properties.

Pending the adoption of those criteria, active substances that are classified in accordance with Regulation (EC) No 1272/2008 as, or meet the criteria to be classified as, carcinogen category 2 and toxic for reproduction category 2, shall be considered as having endocrine-disrupting properties.

Substances such as those that are classified in accordance with Regulation (EC) No 1272/2008 as, or that meet the criteria to be classified as, toxic for reproduction category 2 and that have toxic effects on the endocrine organs, may be considered as having endocrine-disrupting properties.

Article 6

Data requirements for an application

1. An application for approval of an active substance shall contain at least the following elements:

(a) a dossier for the active substance satisfying the requirements set out in Annex II;

(b) a dossier satisfying the requirements set out in Annex III for at least one representative biocidal product that contains the active substance; and

(c) if the active substance meets at least one of the exclusion criteria listed in Article 5(1), evidence that Article 5(2) is applicable.

2. Notwithstanding paragraph 1, the applicant need not provide data as part of the dossiers required under points (a) and (b) of paragraph 1 where any of the following applies:

(a) the data are not necessary owing to the exposure associated with the proposed uses;

(b) it is not scientifically necessary to supply the data; or

(c) it is not technically possible to generate the data.

However, sufficient data shall be provided in order to make it possible to determine whether an active substance meets the criteria referred to in Article 5(1) or Article 10(1), if required by the evaluating competent authority under Article 8(2).

3. An applicant may propose to adapt the data as part of the dossiers required under points (a) and (b) of paragraph 1 in accordance with Annex IV. The justification for the proposed adaptations to the data requirements shall be clearly stated in the application with a reference to the specific rules in Annex IV.

4. The Commission shall be empowered to adopt delegated acts in accordance with Article 83 specifying criteria for determining what constitutes adequate justification to adapt the data requirements under paragraph 1 of this Article on the grounds referred to in point (a) of paragraph 2 of this Article.

Article 7

Submission and validation of applications

1. The applicant shall submit an application for approval of an active substance, or for making subsequent amendments to the conditions of approval of an active substance, to the Agency, informing it of the name of the competent authority of the Member State that it proposes should evaluate the application and providing written confirmation that that competent authority agrees to do so. That competent authority shall be the evaluating competent authority.

2. The Agency shall inform the applicant of the fees payable under Article 80(1) and shall reject the application if the applicant fails to pay the fees within 30 days. It shall inform the applicant and the evaluating competent authority accordingly.

Upon receipt of the fees payable under Article 80(1), the Agency shall accept the application and inform the applicant and the evaluating competent authority accordingly, indicating the date of the acceptance of the application and its unique identification code.

3. Within 30 days of the Agency accepting an application, the evaluating competent authority shall validate the application if the data required in accordance with points (a) and (b) and, where relevant, point (c) of Article 6(1), and any justifications for the adaptation of data requirements, have been submitted.

In the context of the validation referred to in the first subparagraph, the evaluating competent authority shall not make an assessment of the quality or the adequacy of the data or justifications submitted.

The evaluating competent authority shall, as soon as possible after the Agency has accepted an application, inform the applicant of the fees payable under Article 80(2) and shall reject the application if the applicant fails to pay the fees within 30 days. It shall inform the applicant accordingly.

4. Where the evaluating competent authority considers that the application is incomplete, it shall inform the applicant as to what additional information is required for the validation of the application and shall set a reasonable time limit for the submission of that information. That time limit shall not normally exceed 90 days.

The evaluating competent authority shall, within 30 days of receipt of the additional information, validate the application if it determines that the additional information submitted is sufficient to comply with the requirement laid down in paragraph 3.

The evaluating competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant and the Agency accordingly. In such cases, part of the fees paid in accordance with Article 80(1) and (2) shall be reimbursed.

5. On validating an application in accordance with paragraph 3 or 4, the evaluating competent authority shall without delay inform the applicant, the Agency and other competent authorities accordingly, indicating the date of the validation.

6. An appeal may be brought, in accordance with Article 77, against decisions of the Agency under paragraph 2 of this Article.

Article 8

Evaluation of applications

1. The evaluating competent authority shall, within 365 days of the validation of an application, evaluate it in accordance with Articles 4 and 5, including, where relevant, any proposal to adapt data requirements submitted in accordance with Article 6(3), and send an assessment report and the conclusions of its evaluation to the Agency.

Prior to submitting its conclusions to the Agency, the evaluating competent authority shall give the applicant the opportunity to provide written comments on the assessment report and on the conclusions of the evaluation within 30 days. The evaluating competent authority shall take due account of those comments when finalising its evaluation.

2. Where it appears that additional information is necessary to carry out the evaluation, the evaluating competent authority shall ask the applicant to submit such information within a specified time limit, and shall inform the Agency accordingly. As specified in the second subparagraph of Article 6(2), the evaluating competent authority may, as appropriate, require the applicant to provide sufficient data to permit a determination of whether an active substance meets the criteria referred to in Article 5(1) or Article 10(1). The 365-day period referred to in paragraph 1 of this Article shall be suspended from the date of issue of the request until the date the information is received. The suspension shall not exceed 180 days in total unless it is justified by the nature of the data requested or by exceptional circumstances.

3. Where the evaluating competent authority considers that there are concerns for human health, animal health or the environment as a result of the cumulative effects from the use of biocidal products containing the same or different active substances, it shall document its concerns in accordance with the requirements of the relevant parts of Section II.3 of Annex XV to Regulation (EC) No 1907/2006 and include this as part of its conclusions.

4. Within 270 days of receipt of the conclusions of the evaluation, the Agency shall prepare and submit to the Commission an opinion on the approval of the active substance having regard to the conclusions of the evaluating competent authority.

Article 9

Approval of an active substance

1. The Commission shall, on receipt of the opinion of the Agency referred to in Article 8(4), either:

(a) adopt an implementing Regulation providing that an active substance is approved, and under which conditions, including the dates of approval and of expiry of the approval; or

(b) in cases where the conditions laid down in Article 4(1) or, where applicable, the conditions set out in Article 5(2), are not satisfied or where the requisite information and data have not been submitted within the prescribed period, adopt an implementing decision that an active substance is not approved.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 82(3).

2. Approved active substances shall be included in a Union list of approved active substances. The Commission shall keep the list up to date and make it electronically available to the public.

Article 10

Active substances which are candidates for substitution

1. An active substance shall be considered a candidate for substitution if any of the following conditions are met:

(a) it meets at least one of the exclusion criteria listed in Article 5(1) but may be approved in accordance with Article 5(2);

(b) it meets the criteria to be classified, in accordance with Regulation (EC) No 1272/2008, as a respiratory sensitiser;

(c) its acceptable daily intake, acute reference dose or acceptable operator exposure level, as appropriate, is significantly lower than those of the majority of approved active substances for the same product-type and use scenario;

(d) it meets two of the criteria for being PBT in accordance with Annex XIII to Regulation (EC) No 1907/2006;

(e) there are reasons for concern linked to the nature of the critical effects which, in combination with the use patterns, amount to use that could still cause concern, such as high potential of risk to groundwater, even with very restrictive risk management measures;

(f) it contains a significant proportion of non-active isomers or impurities.

2. When preparing its opinion on the approval or renewal of the approval of an active substance, the Agency shall examine whether the active substance fulfils any of the criteria listed in paragraph 1 and address the matter in its opinion.

3. Prior to submitting its opinion on the approval or renewal of the approval of an active substance to the Commission, the Agency shall make publicly available, without prejudice to Articles 66 and 67, information on potential candidates for substitution during a period of no more than 60 days, during which time interested third parties may submit relevant information, including information on available substitutes. The Agency shall take due account of the information received when finalising its opinion.

4. By way of derogation from Article 4(1) and Article 12(3), the approval of an active substance that is considered as a candidate for substitution and each renewal shall be for a period not exceeding seven years.

5. Active substances that are considered as candidates for substitution in accordance with paragraph 1 shall be identified as such in the relevant Regulation adopted in accordance with Article 9.

Article 11

Technical guidance notes

The Commission shall draw up technical guidance notes to facilitate the implementation of this Chapter, in particular Article 5(2) and Article 10(1).







CHAPTER III

RENEWAL AND REVIEW OF APPROVAL OF AN ACTIVE SUBSTANCE

Article 12

Conditions for renewal

1. The Commission shall renew the approval of an active substance if the active substance still meets the conditions laid down in Article 4(1) or, where applicable, the conditions set out in Article 5(2).

2. In the light of scientific and technical progress, the Commission shall review and, where appropriate, amend the conditions specified for the active substance referred to in Article 4(3).

3. The renewal of an approval of an active substance shall be for 15 years for all product-types to which the approval applies, unless a shorter period is specified in the implementing regulation adopted in accordance with point (a) of Article 14(4) renewing such an approval.

Article 13

Submission and acceptance of applications

1. Applicants wishing to seek renewal of the approval of an active substance for one or more product-types shall submit an application to the Agency at least 550 days before the expiry of the approval. Where there are different expiry dates for different product-types, the application shall be submitted at least 550 days before the earliest expiry date.

2. When applying for the renewal of the approval of the active substance, the applicant shall submit:

(a) without prejudice to Article 21(1), all relevant data required under Article 20 that it has generated since the initial approval or, as appropriate, previous renewal; and

(b) its assessment of whether the conclusions of the initial or previous assessment of the active substance remain valid and any supporting information.

3. The applicant shall also submit the name of the competent authority of the Member State that it proposes should evaluate the application for renewal and provide written confirmation that that competent authority agrees to do so. That competent authority shall be the evaluating competent authority.

The Agency shall inform the applicant of the fees payable under Article 80(1) and shall reject the application if the applicant fails to pay the fees within 30 days. It shall inform the applicant and the evaluating competent authority accordingly.

Upon receipt of the fees payable under Article 80(1), the Agency shall accept the application and inform the applicant and the evaluating competent authority accordingly, indicating the date of the acceptance.

4. An appeal may be brought, in accordance with Article 77, against decisions of the Agency under paragraph 3 of this Article.

Article 14

Evaluation of applications for renewal

1. On the basis of an assessment of the available information and the need to review the conclusions of the initial evaluation of the application for approval or, as appropriate, the previous renewal, the evaluating competent authority shall, within 90 days of the Agency accepting an application in accordance with Article 13(3), decide whether, in the light of current scientific knowledge, a full evaluation of the application for renewal is necessary taking account of all product-types for which renewal is requested.

2. Where the evaluating competent authority decides that a full evaluation of the application is necessary, the evaluation shall be carried out in accordance with paragraphs 1, 2 and 3 of Article 8.

Where the evaluating competent authority decides that a full evaluation of the application is not necessary, it shall, within 180 days of the Agency accepting the application in accordance with Article 13(3), prepare and submit to the Agency a recommendation on the renewal of the approval of the active substance. It shall provide the applicant with a copy of its recommendation.

The evaluating competent authority shall, as soon as possible after the Agency has accepted an application, notify the applicant of the fees payable under Article 80(2). The evaluating competent authority shall reject the application if the applicant fails to pay the fees within 30 days of the notification and shall inform the applicant accordingly.

3. Within 270 days of receipt of a recommendation from the evaluating competent authority, if it has carried out a full evaluation of the application, or 90 days otherwise, the Agency shall prepare and submit to the Commission an opinion on renewal of the approval of the active substance.

4. The Commission shall, on receipt of the opinion of the Agency, adopt:

(a) an implementing regulation providing that the approval of an active substance is renewed for one or more product-types, and under which conditions; or

(b) an implementing decision that the approval of an active substance is not renewed.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 82(3).

Article 9(2) shall apply.

5. Where, for reasons beyond the control of the applicant, the approval of the active substance is likely to expire before a decision has been taken on its renewal, the Commission shall, by means of implementing acts, adopt a decision postponing the expiry date of approval for a period sufficient to enable it to examine the application. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 82(2).

6. Where the Commission decides not to renew or decides to amend the approval of an active substance for one or more product-types, the Member States or, in the case of a Union authorisation, the Commission shall cancel or, where appropriate, amend the authorisations of biocidal products of the product-type(s) concerned containing that active substance. Articles 48 and 52 shall apply accordingly.

Article 15

Review of approval of an active substance

1. The Commission may review the approval of an active substance for one or more product-types at any time where there are significant indications that the conditions laid down in Article 4(1) or, where applicable, the conditions set out in Article 5(2) are no longer met. The Commission may also review the approval of an active substance for one or more product-types at the request of a Member State if there are indications that the use of the active substance in biocidal products or treated articles raises significant concerns about the safety of such biocidal products or treated articles. The Commission shall make publicly available the information that it is carrying out a review and shall provide an opportunity for applicant to submit comments. The Commission shall take due account of those comments in its review.

Where those indications are confirmed, the Commission shall adopt an implementing Regulation amending the conditions of approval of an active substance or cancelling its approval. That implementing Regulation shall be adopted in accordance with the examination procedure referred to in Article 82(3). Article 9(2) shall apply. The Commission shall inform the initial applicants for the approval accordingly.

On duly justified imperative grounds of urgency the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 82(4).

2. The Commission may consult the Agency on any questions of a scientific or technical nature related to the review of approval of an active substance. The Agency shall, within 270 days of the request, prepare an opinion and submit it to the Commission.

3. Where the Commission decides to cancel or amend the approval of an active substance for one or more product-types, the Member States or, in the case of a Union authorisation, the Commission shall cancel or, where appropriate, amend the authorisations of biocidal products of the product-type(s) concerned containing that active substance. Articles 48 and 52 shall apply accordingly.

Article 16

Implementing measures

The Commission may adopt, by means of implementing acts, detailed measures for the implementation of Articles 12 to 15, further specifying the procedures for the renewal and review of the approval of an active substance. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 82(3).







CHAPTER IV

GENERAL PRINCIPLES CONCERNING THE AUTHORISATION OF BIOCIDAL PRODUCTS

Article 17

Making available on the market and use of biocidal products

1. Biocidal products shall not be made available on the market or used unless authorised in accordance with this Regulation.

2. Applications for authorisation shall be made by, or on behalf of, the prospective authorisation holder.

Applications for national authorisation in a Member State shall be submitted to the competent authority of that Member State (‘the receiving competent authority’).

Applications for Union authorisation shall be submitted to the Agency.

3. An authorisation may be granted for a single biocidal product or a biocidal product family.

4. An authorisation shall be granted for a maximum period of 10 years.

5. Biocidal products shall be used in compliance with the terms and conditions of the authorisation stipulated in accordance with Article 22(1) and the labelling and packaging requirements laid down in Article 69.

Proper use shall involve the rational application of a combination of physical, biological, chemical or other measures as appropriate, whereby the use of biocidal products is limited to the minimum necessary and appropriate precautionary steps are taken.

Member States shall take necessary measures to provide the public with appropriate information about the benefits and risks associated with biocidal products and ways of minimising their use.

6. The authorisation holder shall notify each competent authority that has granted a national authorisation for a biocidal product family of each product within the biocidal product family at least 30 days before placing it on the market, except where a particular product is explicitly identified in the authorisation or the variation in composition concerns only pigments, perfumes and dyes within the permitted variations. The notification shall indicate the exact composition, trade name and suffix to the authorisation number. In the case of a Union authorisation, the authorisation holder shall notify the Agency and the Commission.

7. The Commission shall, by means of an implementing act, specify procedures for the authorisation of the same biocidal products by the same or different enterprises under the same terms and conditions. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 82(3).

Article 18

Measures geared to the sustainable use of biocidal products

By 18 July 2015 the Commission shall, on the basis of experience gained with the application of this Regulation, submit to the European Parliament and the Council a report on how this Regulation is contributing to the sustainable use of biocidal products, including on the need to introduce additional measures, in particular for professional users, to reduce the risks posed to human health, animal health and the environment by biocidal products. That report shall, inter alia, examine:

(a) the promotion of best practices as a means of reducing the use of biocidal products to a minimum;

(b) the most effective approaches for monitoring the use of biocidal products;

(c) the development and application of integrated pest management principles with respect to the use of biocidal products;

(d) the risks posed by the use of biocidal products in specific areas such as schools, workplaces, kindergartens, public spaces, geriatric care centres or in the vicinity of surface water or groundwater and whether additional measures are needed to address those risks;

(e) the role that improved performance of the equipment used for applying biocidal products could play in sustainable use.

On basis of that report, the Commission shall, if appropriate, submit a proposal for adoption in accordance with the ordinary legislative procedure.

Article 19

Conditions for granting an authorisation

1. A biocidal product other than those eligible for the simplified authorisation procedure in accordance with Article 25 shall be authorised provided the following conditions are met:

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(a) the active substances are included in Annex I or approved for the relevant product-type and any conditions specified for those active substances are met;

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(b) it is established, according to the common principles for the evaluation of dossiers for biocidal products laid down in Annex VI, that the biocidal product, when used as authorised and having regard to the factors referred to in paragraph 2 of this Article, fulfils the following criteria:

(i) the biocidal product is sufficiently effective;

(ii) the biocidal product has no unacceptable effects on the target organisms, in particular unacceptable resistance or cross-resistance or unnecessary suffering and pain for vertebrates;

(iii) the biocidal product has no immediate or delayed unacceptable effects itself, or as a result of its residues, on the health of humans, including that of vulnerable groups, or animals, directly or through drinking water, food, feed, air, or through other indirect effects;

(iv) the biocidal product has no unacceptable effects itself, or as a result of its residues, on the environment, having particular regard to the following considerations:

— the fate and distribution of the biocidal product in the environment,

— contamination of surface waters (including estuarial and seawater), groundwater and drinking water, air and soil, taking into account locations distant from its use following long-range environmental transportation,

— the impact of the biocidal product on non-target organisms,

— the impact of the biocidal product on biodiversity and the ecosystem;

(c) the chemical identity, quantity and technical equivalence of active substances in the biocidal product and, where appropriate, any toxicologically or ecotoxicologically significant and relevant impurities and non-active substances, and its residues of toxicological or environmental significance, which result from uses to be authorised, can be determined according to the relevant requirements in Annexes II and III;

(d) the physical and chemical properties of the biocidal product have been determined and deemed acceptable for the purposes of the appropriate use and transport of the product;

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(e) where appropriate, maximum residue limits for food and feed have been established with respect to active substances contained in a biocidal product in accordance with Council Regulation (EEC) No 315/93 ( 29 ), Regulation (EC) No 396/2005 of the European Parliament and of the Council ( 30 ), Regulation (EC) No 470/2009 of the European Parliament and of the Council ( 31 ) or Directive 2002/32/EC of the European Parliament and of the Council ( 32 ), or specific migration limits or limits for the residual content in food contact materials have been established with respect to such active substances in accordance with Regulation (EC) No 1935/2004 of the European Parliament and of the Council ( 33 );

▼B

(f) where nanomaterials are used in that product, the risk to human health, animal health and the environment has been assessed separately.

2. The evaluation of whether a biocidal product fulfils the criteria set out in point (b) of paragraph 1 shall take into account the following factors:

(a) realistic worst case conditions under which the biocidal product may be used;

(b) the way in which treated articles treated with the biocidal product or containing the biocidal product may be used;

(c) the consequences of use and disposal of the biocidal product;

(d) cumulative effects;

(e) synergistic effects.

3. A biocidal product shall only be authorised for uses for which relevant information has been submitted in accordance with Article 20.

4. A biocidal product shall not be authorised for making available on the market for use by the general public where:

(a) it meets the criteria according to Directive 1999/45/EC for classification as:

— toxic or very toxic,

— a category 1 or 2 carcinogen,

— a category 1 or 2 mutagen, or

— toxic for reproduction category 1 or 2;

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(b) it meets the criteria according to Regulation (EC) No 1272/2008 for classification as:

— acute oral toxicity category 1, 2 or 3,

— acute dermal toxicity category 1, 2 or 3,

— acute inhalation toxicity (gases and dust/mist) category 1, 2 or 3,

— acute inhalation toxicity (vapours) category 1 or 2,

— specific target organ toxicity by single or repeated exposure category 1,

— a category 1A or 1B carcinogen,

— a category 1A or 1B mutagen, or

— toxic for reproduction category 1A or 1B;

(c) it consists of, contains or generates, a substance that meets the criteria for being PBT or vPvB in accordance with Annex XIII to Regulation (EC) No 1907/2006;

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(d) it has endocrine-disrupting properties; or

(e) it has developmental neurotoxic or immunotoxic effects.

5. Notwithstanding paragraphs 1 and 4, a biocidal product may be authorised when the conditions laid down in paragraph 1(b)(iii) and (iv) are not fully met, or may be authorised for making available on the market for use by the general public when the criteria referred to in paragraph 4(c) are met, where not authorising the biocidal product would result in disproportionate negative impacts for society when compared to the risks to human health, animal health or the environment arising from the use of the biocidal product under the conditions laid down in the authorisation.

The use of a biocidal product authorised pursuant to this paragraph shall be subject to appropriate risk mitigation measures to ensure that exposure of humans and the environment to that biocidal product is minimised. The use of a biocidal product authorised pursuant to this paragraph shall be restricted to Member States in which the condition of the first subparagraph is met.

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6. The assessment of the biocidal product family conducted according to the common principles set out in Annex VI shall consider the maximum risks to human health, animal health and the environment and the minimum level of efficacy over the whole potential range of products within the biocidal product family.

A biocidal product family shall be authorised only if:

(a) the application explicitly identifies the maximum risks to human health, animal health and the environment, and the minimum level of efficacy, on which the assessment is based, as well as the permitted variations in composition and uses referred to in point (s) of Article 3(1) together with their respective classification, hazard and precautionary statements and any appropriate risk mitigation measures; and

(b) it can be established based on the assessment referred to in the first subparagraph of this paragraph that all the biocidal products within the family comply with the conditions set out in paragraph 1.

7. Where appropriate, the prospective authorisation holder or its representative shall apply for the establishment of maximum residue limits with respect to active substances contained in a biocidal product in accordance with Regulation (EEC) No 315/93, Regulation (EC) No 396/2005, Regulation (EC) No 470/2009 or Directive 2002/32/EC, or for the establishment of specific migration limits or limits for the residual content in food contact materials with respect to such substances in accordance with Regulation (EC) No 1935/2004.

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8. Where, for active substances covered by Article 10(1)(a) of Regulation (EC) No 470/2009, no maximum residue limit has been established in accordance with Article 9 of that Regulation at the time of the approval of the active substance, or where a limit established in accordance with Article 9 of that Regulation needs to be amended, the maximum residue limit shall be established or amended in accordance with the procedure referred to in Article 10(1)(b) of that Regulation.

9. Where a biocidal product is intended for direct application to the external parts of the human body (epidermis, hair system, nails, lips and external genital organs), or to the teeth and the mucous membranes of the oral cavity, it shall not contain any non-active substance that may not be included in a cosmetic product pursuant to Regulation (EC) No 1223/2009.

Article 20

Requirements for applications for authorisation

1. The applicant for an authorisation shall submit the following documents together with the application:

(a) for biocidal products other than biocidal products meeting the conditions laid down in Article 25:

(i) a dossier or letter of access for the biocidal product satisfying the requirements set out in Annex III;

(ii) a summary of the biocidal product characteristics including the information referred to in points (a), (b) and (e) to (q) of Article 22(2), as applicable;

(iii) a dossier or a letter of access for the biocidal product satisfying the requirements set out in Annex II for each active substance in the biocidal product;

(b) for biocidal products that the applicant considers meet the conditions laid down in Article 25:

(i) a summary of the biocidal product characteristics as referred to in point (a)(ii) of this paragraph;

(ii) efficacy data; and

(iii) any other relevant information in support of the conclusion that the biocidal product meets the conditions laid down in Article 25.

2. The receiving competent authority may require that applications for national authorisation be submitted in one or more of the official languages of the Member State where that competent authority is situated.

3. For applications for Union authorisations submitted under Article 43, the applicant shall submit the summary of the biocidal product characteristics referred to in point (ii) of paragraph (1)(a) of this Article in one of the official languages of the Union accepted by the evaluating competent authority at the time of application and in all official languages of the Union before the authorisation of the biocidal product.

Article 21

Waiving of data requirements

1. By way of derogation from Article 20, the applicant need not provide data required under that Article where any of the following applies:

(a) the data are not necessary owing to the exposure associated with the proposed uses;

(b) it is not scientifically necessary to supply the data; or

(c) it is not technically possible to generate the data.

2. The applicant may propose to adapt the data requirements of Article 20 in accordance with Annex IV. The justification for the proposed adaptations to the data requirements shall be clearly stated in the application with reference to the specific rules in Annex IV.

3. In order to ensure the harmonised application of paragraph 1(a) of this Article, the Commission shall be empowered to adopt delegated acts in accordance with Article 83 specifying criteria for defining when the exposure associated with the proposed uses would justify adapting the data requirements of Article 20.

Article 22

Content of authorisation

1. An authorisation shall stipulate the terms and conditions relating to the making available on the market and use of the single biocidal product or the biocidal product family and include a summary of the biocidal product characteristics.

2. Without prejudice to Articles 66 and 67, the summary of the biocidal product characteristics for a single biocidal product or, in the case of a biocidal product family, the biocidal products within that biocidal product family, shall include the following information:

(a) trade name of the biocidal product;

(b) name and address of the authorisation holder;

(c) date of the authorisation and its date of expiry;

(d) authorisation number of the biocidal product, together with, in the case of a biocidal product family, the suffixes to apply to individual biocidal products within the biocidal product family;

(e) qualitative and quantitative composition in terms of the active substances and non-active substances, knowledge of which is essential for proper use of biocidal products; and in the case of a biocidal product family, the quantitative composition shall indicate a minimum and maximum percentage for each active and non-active substance, where the minimum percentage indicated for certain substances may be 0 %;

(f) manufacturers of the biocidal product (names and addresses including location of manufacturing sites);

(g) manufacturers of the active substances (names and addresses including location of manufacturing sites);

(h) type of formulation of the biocidal product;

(i) hazard and precautionary statements;

(j) product-type and, where relevant, an exact description of the authorised use;

(k) target harmful organisms;

(l) application doses and instructions for use;

(m) categories of users;

(n) particulars of likely direct or indirect adverse effects and first aid instructions and emergency measures to protect the environment;

(o) instructions for safe disposal of the product and its packaging;

(p) conditions of storage and shelf-life of the biocidal product under normal conditions of storage;

(q) where relevant, other information about the biocidal product.

Article 23

Comparative assessment of biocidal products

1. The receiving competent authority or, in the case of an evaluation of an application for a Union authorisation, the evaluating competent authority, shall perform a comparative assessment as part of the evaluation of an application for authorisation or for renewal of authorisation of a biocidal product containing an active substance that is a candidate for substitution in accordance with Article 10(1).

2. The results of the comparative assessment shall be forwarded, without delay, to the competent authorities of other Member States and the Agency and, in the case of evaluation of an application for a Union authorisation, also to the Commission.

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3. The receiving competent authority or, in the case of a decision on an application for a Union authorisation, the Commission, shall prohibit or restrict the making available on the market or the use of a biocidal product containing an active substance that is a candidate for substitution where a comparative assessment, performed in accordance with the technical guidance notes referred to in Article 24, demonstrates that both of the following criteria are met:

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(a) for the uses specified in the application, another authorised biocidal product or a non-chemical control or prevention method already exists which presents a significantly lower overall risk for human health, animal health and the environment, is sufficiently effective and presents no other significant economic or practical disadvantages;

(b) the chemical diversity of the active substances is adequate to minimise the occurrence of resistance in the target harmful organism.

4. By way of derogation from paragraph 1, a biocidal product containing an active substance that is a candidate for substitution may be authorised for a period of up to four years without comparative assessment in exceptional cases where it is necessary to acquire experience first through using that product in practice.

5. Where the comparative assessment involves a question which, by reason of its scale or consequences, would be better addressed at Union level, in particular where it is relevant to two or more competent authorities, the receiving competent authority may refer the question to the Commission for a decision. The Commission shall adopt that decision by means of implementing acts in accordance with the examination procedure referred to in Article 82(3).

The Commission shall be empowered to adopt delegated acts in accordance with Article 83 specifying the criteria for determining when comparative assessments involve questions better addressed at Union level and the procedures for such comparative assessments.

6. Notwithstanding Article 17(4), and without prejudice to paragraph 4 of this Article, an authorisation for a biocidal product containing an active substance that is a candidate for substitution shall be granted for a period not exceeding five years and renewed for a period not exceeding five years.

7. Where it is decided not to authorise or to restrict the use of a biocidal product pursuant to paragraph 3, that cancellation or amendment of the authorisation shall take effect four years after that decision. However, where the approval of the active substance which is a candidate for substitution expires on an earlier date, the cancellation of the authorisation shall take effect on that earlier date.

Article 24

Technical guidance notes

The Commission shall draw up technical guidance notes to facilitate the implementation of this Chapter and, in particular, Article 22(2) and Article 23(3).







CHAPTER V

SIMPLIFIED AUTHORISATION PROCEDURE

Article 25

Eligibility for the simplified authorisation procedure

For eligible biocidal products, an application for authorisation may be made under a simplified authorisation procedure. A biocidal product shall be eligible if all the following conditions are met:

(a) all the active substances contained in the biocidal product appear in Annex I and satisfy any restriction specified in that Annex;

(b) the biocidal product does not contain any substance of concern;

(c) the biocidal product does not contain any nanomaterials;

(d) the biocidal product is sufficiently effective; and

(e) the handling of the biocidal product and its intended use do not require personal protective equipment.

Article 26

Applicable procedure

1. Applicants seeking the authorisation of a biocidal product meeting the conditions of Article 25 shall submit an application to the Agency, informing it of the name of the competent authority of the Member State that it proposes should evaluate the application and providing written confirmation that that competent authority agrees to do so. That competent authority shall be the evaluating competent authority.

2. The evaluating competent authority shall inform the applicant of the fees payable under Article 80(2) and shall reject the application if the applicant fails to pay the fees within 30 days. It shall inform the applicant accordingly.

Upon receipt of the fees payable under Article 80(2), the evaluating competent authority shall accept the application and inform the applicant accordingly, indicating the date of the acceptance.

3. Within 90 days of accepting an application, the evaluating competent authority shall authorise the biocidal product if satisfied that the product meets the conditions laid down in Article 25.

4. Where the evaluating competent authority considers that the application is incomplete, it shall inform the applicant as to what additional information is required and shall set a reasonable time limit for the submission of that information. That time limit shall not normally exceed 90 days.

The evaluating competent authority shall, within 90 days of receipt of the additional information, authorise the biocidal product if satisfied, on the basis of the additional information submitted, that the product meets the conditions laid down in Article 25.

The evaluating competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant accordingly. In such cases, where fees have been paid, part of the fees paid in accordance with Article 80(2) shall be reimbursed.

Article 27

Making available on the market of biocidal products authorised in accordance with the simplified authorisation procedure

1. A biocidal product authorised in accordance with Article 26 may be made available on the market in all Member States without the need for mutual recognition. However, the authorisation holder shall notify each Member State no later than 30 days before placing the biocidal product on the market within the territory of that Member State and shall use the official language or languages of that Member State in the product’s labelling, unless that Member State provides otherwise.

2. Where a Member State other than that of the evaluating competent authority considers that a biocidal product authorised in accordance with Article 26 has not been notified or labelled in accordance with paragraph 1 of this Article or does not meet the requirements of Article 25, it may refer that matter to the coordination group established in accordance with Article 35(1). Article 35(3) and Article 36 shall apply mutatis mutandis.

Where a Member State has valid reasons to consider that a biocidal product authorised in accordance with Article 26 does not meet the criteria laid down in Article 25 and a decision pursuant to Articles 35 and 36 has not yet been taken, that Member State may provisionally restrict or prohibit making available on the market or use of that product on its territory.

Article 28

Amendment of Annex I

1. The Commission shall be empowered to adopt delegated acts in accordance with Article 83 amending Annex I, after receiving the opinion of the Agency, in order to include active substances provided that there is evidence that they do not give rise to concern according to paragraph 2 of this Article.

2. Active substances give rise to concern where:

(a) they meet the criteria for classification according to Regulation (EC) No 1272/2008 as:

— explosive/highly flammable,

— organic peroxide,

— acutely toxic of category 1, 2 or 3,

— corrosive of category 1A, 1B or 1C,

— respiratory sensitiser,

— skin sensitiser,

— germ cell mutagen of category 1 or 2;

— carcinogen of category 1 or 2,

— human reproductive toxicant of category 1 or 2 or with effects on or via lactation,

— specific target organ toxicant by single or repeated exposure, or

— toxic to aquatic life of acute category 1;

(b) they fulfil any of the substitution criteria set out in Article 10(1); or

(c) they have neurotoxic or immunotoxic properties.

Active substances also give rise to concern, even if none of the specific criteria in points (a) to (c) are met, where a level of concern equivalent to that arising from points (a) to (c) can be reasonably demonstrated based on reliable information.

3. The Commission shall also be empowered to adopt delegated acts in accordance with Article 83 amending Annex I, after receiving the opinion of the Agency, in order to restrict or to remove the entry for an active substance if there is evidence that biocidal products containing that substance do not, in certain circumstances, satisfy the conditions set out in paragraph 1 of this Article or in Article 25. Where imperative grounds of urgency so require, the procedure provided for in Article 84 shall apply to delegated acts adopted pursuant to this paragraph.

4. The Commission shall apply paragraph 1 or 3 at its own initiative or at the request of an economic operator or a Member State providing the necessary evidence as referred to in those paragraphs.

Whenever the Commission amends Annex I it shall adopt a separate delegated act in respect of each substance.

5. The Commission may adopt implementing acts further specifying the procedures to be followed with respect to an amendment of Annex I. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 82(3).







CHAPTER VI

NATIONAL AUTHORISATIONS OF BIOCIDAL PRODUCTS

Article 29

Submission and validation of applications

1. Applicants wishing to apply for a national authorisation in accordance with Article 17 shall submit an application to the receiving competent authority. The receiving competent authority shall inform the applicant of the fees payable under Article 80(2), and shall reject the application if the applicant fails to pay the fees within 30 days. It shall inform the applicant accordingly. Upon receipt of the fees payable under Article 80(2), the receiving competent authority shall accept the application and inform the applicant accordingly, indicating the date of the acceptance.

2. Within 30 days of acceptance, the receiving competent authority shall validate the application if it complies with the following requirements:

(a) the relevant information referred to in Article 20 has been submitted; and

(b) the applicant states that it has not applied to any other competent authority for a national authorisation for the same biocidal product for the same use(s).

In the context of the validation referred to in the first subparagraph, the receiving competent authority shall not make an assessment of the quality or the adequacy of the data or justifications submitted.

3. Where the receiving competent authority considers that the application is incomplete, it shall inform the applicant as to what additional information is required for the validation of the application and shall set a reasonable time limit for the submission of that information. That time limit shall not normally exceed 90 days.

The receiving competent authority shall, within 30 days of receipt of the additional information, validate the application if it determines that the additional information submitted is sufficient to comply with the requirements laid down in paragraph 2.

The receiving competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant accordingly.

4. Where the Register for Biocidal Products referred to in Article 71 shows that a competent authority other than the receiving competent authority is examining an application relating to the same biocidal product or has already authorised the same biocidal product, the receiving competent authority shall decline to evaluate the application. In that event, the receiving competent authority shall inform the applicant of the possibility of seeking mutual recognition in accordance with Article 33 or 34.

5. If paragraph 3 does not apply and the receiving competent authority considers that the application is complete, it shall validate the application and without delay inform the applicant accordingly, indicating the date of the validation.

Article 30

Evaluation of applications

1. The receiving competent authority shall, within 365 days of the validation of an application in accordance with Article 29, decide whether to grant an authorisation in accordance with Article 19. It shall take into account the results of the comparative assessment carried out in accordance with Article 23, if applicable.

2. Where it appears that additional information is necessary to carry out the evaluation, the receiving competent authority shall ask the applicant to submit such information within a specified time limit. The 365-day period referred to in paragraph 1 shall be suspended from the date of issue of the request until the date the information is received. The suspension shall not exceed 180 days in total unless it is justified by the nature of the data requested or by exceptional circumstances.

The receiving competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant accordingly.

3. Within the 365-day period referred to in paragraph 1, the receiving competent authority shall:

(a) draft a report summarising the conclusions of its assessment and the reasons for authorising the biocidal product or for refusing to grant an authorisation (the ‘assessment report’);

(b) send an electronic copy of the draft assessment report to the applicant and provide it with the opportunity to submit comments within 30 days; and

(c) take due account of those comments when finalising its assessment.

Article 31

Renewal of a national authorisation

1. An application by or on behalf of an authorisation holder wishing to seek the renewal of a national authorisation for one or more product-types shall be submitted to the receiving competent authority at least 550 days before the expiry date of the authorisation. Where renewal is sought for more than one product-type, the application shall be submitted at least 550 days before the earliest expiry date.

2. The receiving competent authority shall renew the national authorisation, provided that the conditions set out in Article 19 are still satisfied. It shall take into account the results of the comparative assessment carried out in accordance with Article 23, if applicable.

3. When applying for renewal, the applicant shall submit:

(a) without prejudice to Article 21(1), all relevant data required under Article 20 that it has generated since the initial authorisation or, as appropriate, previous renewal; and

(b) its assessment of whether the conclusions of the initial or previous assessment of the biocidal product remain valid and any supporting information.

4. The receiving competent authority shall inform the applicant of the fees payable under Article 80(2) and shall reject the application if the applicant fails to pay the fees within 30 days. It shall inform the applicant accordingly.

Upon receipt of the fees payable under Article 80(2), the receiving competent authority shall accept the application and inform the applicant accordingly, indicating the date of the acceptance.

5. On the basis of an assessment of the available information and the need to review the conclusions of the initial evaluation of the application for authorisation or, as appropriate, the previous renewal, the receiving competent authority shall, within 90 days of accepting an application in accordance with paragraph 4, decide whether, in the light of current scientific knowledge, a full evaluation of the application for renewal is necessary taking account of all product-types for which renewal is requested.

6. Where the receiving competent authority decides that a full evaluation of the application is necessary, it shall decide on the renewal of the authorisation after carrying out an evaluation of the application in accordance with paragraphs 1, 2 and 3 of Article 30.

Where the receiving competent authority decides that a full evaluation of the application is not necessary, it shall decide on the renewal of the authorisation within 180 days of accepting the application in accordance with paragraph 4 of this Article.

7. Where, for reasons beyond the control of the holder of a national authorisation, no decision is taken on the renewal of that authorisation before its expiry, the receiving competent authority shall grant a renewal for the period necessary to complete the evaluation.







CHAPTER VII

MUTUAL RECOGNITION PROCEDURES

Article 32

Authorisation through mutual recognition

1. Applications for mutual recognition of a national authorisation shall be made in accordance with the procedures set out in Article 33 (mutual recognition in sequence) or Article 34 (mutual recognition in parallel).

2. Without prejudice to Article 37, all Member States receiving applications for mutual recognition of a national authorisation for a biocidal product shall, in accordance with and subject to the procedures set out in this Chapter, authorise the biocidal product under the same terms and conditions.

Article 33

Mutual recognition in sequence

1. Applicants wishing to seek the mutual recognition in sequence, in one or more Member States (‘the Member States concerned’), of the national authorisation of a biocidal product already granted in another Member State in accordance with Article 17 (‘the reference Member State’) shall submit an application to each of the competent authorities of the Member States concerned containing, in each case, a translation of the national authorisation granted by the reference Member State into such official languages of the Member State concerned as it may require.

The competent authorities of the Member States concerned shall inform the applicant of the fees payable under Article 80 and shall reject the application if the applicant fails to pay the fees within 30 days. They shall inform the applicant and the other competent authorities accordingly. Upon receipt of the fees payable under Article 80, the competent authorities of the Member States concerned shall accept the application and inform the applicant indicating the date of acceptance.

2. Within 30 days of acceptance referred to in paragraph 1, the Member States concerned shall validate the application and inform the applicant accordingly, indicating the date of the validation.

Within 90 days of validating the application, and subject to Articles 35, 36 and 37, the Member States concerned shall agree on the summary of biocidal product characteristics referred to in Article 22(2) and shall record their agreement in the Register for Biocidal Products.

3. Within 30 days of reaching agreement, each of the Member States concerned shall authorise the biocidal product in conformity with the agreed summary of biocidal product characteristics.

4. Without prejudice to Articles 35, 36, and 37, if no agreement is reached within the 90-day period referred to in the second subparagraph of paragraph 2, each Member State that agrees to the summary of biocidal product characteristics referred to in paragraph 2, may authorise the product accordingly.

Article 34

Mutual recognition in parallel

1. Applicants wishing to seek the mutual recognition in parallel of a biocidal product which has not yet been authorised in accordance with Article 17 in any Member State shall submit to the competent authority of the Member State of its choice (‘the reference Member State’) an application containing:

(a) the information referred to in Article 20;

(b) a list of all other Member States where a national authorisation is sought (‘the Member States concerned’).

The reference Member State shall be responsible for the evaluation of the application.

2. The applicant shall, at the same time as submitting the application to the reference Member State in accordance with paragraph 1, submit to the competent authorities of each of the Member States concerned an application for mutual recognition of the authorisation for which it has applied to the reference Member State. This application shall contain:

(a) the names of the reference Member State and of the Member States concerned;

(b) the summary of biocidal product characteristics referred to in Article 20(1)(a)(ii) in such official languages of the Member States concerned as they may require.

3. The competent authorities of the reference Member State and of the Member States concerned shall inform the applicant of the fees payable in accordance with Article 80 and shall reject the application if the applicant fails to pay the fees within 30 days. They shall inform the applicant and the other competent authorities accordingly. Upon receipt of the fees payable under Article 80, the competent authorities of the reference Member State and of the Member States concerned shall accept the application and inform the applicant indicating the date of acceptance.

4. The reference Member State shall validate the application in accordance with Article 29(2) and (3) and inform the applicant and the Member States concerned accordingly.

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Within 365 days of validating an application, the reference Member State shall evaluate the application and draft an assessment report in accordance with Article 30 and shall send its assessment report and the summary of biocidal product characteristics to the Member States concerned and to the applicant.

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5. Within 90 days of receipt of the documents referred to in paragraph 4, and subject to Articles 35, 36 and 37, the Member States concerned shall agree on the summary of biocidal product characteristics, and shall record their agreement in the Register for Biocidal Products. The reference Member State shall enter the agreed summary of biocidal product characteristics and the final assessment report in the Register for Biocidal Products, together with any agreed terms or conditions imposed on the making available on the market or use of the biocidal product.

6. Within 30 days of reaching agreement, the reference Member State and each of the Member States concerned shall authorise the biocidal product in conformity with the agreed summary of biocidal product characteristics.

7. Without prejudice to Articles 35, 36, and 37, if no agreement is reached within the 90-day period referred to in paragraph 5, each Member State that agrees to the summary of biocidal product characteristics referred to in paragraph 5 may authorise the product accordingly.

Article 35

Referral of objections to the coordination group

1. A coordination group shall be set up to examine any question, other than matters referred to in Article 37, relating to whether a biocidal product for which an application for mutual recognition has been made in accordance with Article 33 or 34 meets the conditions for granting an authorisation laid down in Article 19.

All Member States and the Commission shall be entitled to participate in the work of the coordination group. The Agency shall provide the secretariat of the coordination group.

The coordination group shall establish its rules of procedure.

2. If any of the Member States concerned considers that a biocidal product assessed by the reference Member State does not meet the conditions laid down in Article 19, it shall send a detailed explanation of the points of disagreement and the reasons for its position to the reference Member State, the other Member States concerned, the applicant, and, where applicable, to the authorisation holder. The points of disagreement shall be referred without delay to the coordination group.

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3. Within the coordination group, all Member States referred to in paragraph 2 of this Article shall use their best endeavours to reach agreement on the action to be taken. They shall allow the applicant the opportunity to make its point of view known. Where they reach agreement within 60 days of the referral of the points of disagreement referred to in paragraph 2 of this Article, the reference Member State shall record the agreement in the Register for Biocidal Products. The procedure shall then be considered to be closed and the reference Member State and each of the Member States concerned shall authorise the biocidal product in accordance with Article 33(3) or 34(6) as appropriate.

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Article 36

Referral of unresolved objections to the Commission

1. If the Member States referred to in Article 35(2) fail to reach agreement within the 60-day period laid down in Article 35(3), the reference Member State shall immediately inform the Commission, and provide it with a detailed statement of the matters on which Member States have been unable to reach agreement and the reasons for their disagreement. A copy of that statement shall be forwarded to the Member States concerned, the applicant and, where applicable, the authorisation holder.

2. The Commission may ask the Agency for an opinion on scientific or technical questions raised by Member States. Where the Commission does not ask the Agency for an opinion it shall provide the applicant and, where applicable, the authorisation holder with the opportunity to provide written comments within 30 days.

3. The Commission shall adopt, by means of implementing acts, a decision on the matter referred to it. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 82(3).

4. The decision referred to in paragraph 3 shall be addressed to all Member States and reported for information to the applicant and, where applicable, the authorisation holder. The Member States concerned and the reference Member State shall, within 30 days of notification of the decision, either grant, refuse to grant or cancel the authorisation, or vary its terms and conditions as necessary to comply with the decision.

Article 37

Derogations from mutual recognition

1. By way of derogation from Article 32(2), any of the Member States concerned may propose to refuse to grant an authorisation or to adjust the terms and conditions of the authorisation to be granted, provided that such a measure can be justified on grounds of:

(a) the protection of the environment;

(b) public policy or public security;

(c) the protection of health and life of humans, particularly of vulnerable groups, or of animals or plants;

(d) the protection of national treasures possessing artistic, historic or archaeological value; or

(e) the target organisms not being present in harmful quantities.

Any of the Member States concerned may, in particular, propose in accordance with the first subparagraph to refuse to grant an authorisation or to adjust the terms and conditions of the authorisation to be granted for a biocidal product containing an active substance to which Article 5(2) or Article 10(1) applies.

2. The Member State concerned shall communicate to the applicant a detailed statement of the grounds for seeking a derogation pursuant to paragraph 1 and shall seek to reach an agreement with the applicant on the proposed derogation.

If the Member State concerned is unable to reach agreement with the applicant or receives no reply from the applicant within 60 days of that communication it shall inform the Commission. In that case, the Commission:

(a) may ask the Agency for an opinion on scientific or technical questions raised by the applicant or the Member State concerned;

(b) shall adopt a decision on the derogation in accordance with the examination procedure referred to in Article 82(3).

The Commission’s decision shall be addressed to the Member State concerned and the Commission shall inform the applicant thereof.

The Member State concerned shall take necessary measures to comply with the Commission’s decision within 30 days of its notification.

3. If the Commission has not adopted a decision pursuant to paragraph 2 within 90 days of being informed in accordance with the second subparagraph of paragraph 2, the Member State concerned may implement the derogation proposed pursuant to paragraph 1.

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‘While the procedure under this Article is ongoing, the Member States’ obligation to authorise a biocidal product within three years of the date of approval, referred to in the first subparagraph of Article 89(3), shall be temporarily suspended.

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4. By way of derogation from Article 32(2), a Member State may refuse to grant authorisations for product-types 15, 17 and 20 on grounds of animal welfare. Member States shall without delay inform other Member States and the Commission of any decision taken in this respect and its justification.

Article 38

Opinion of the Agency

1. If so requested by the Commission pursuant to Article 36(2) or Article 37(2), the Agency shall issue an opinion within 120 days from the date on which the matter in question was referred to it.

2. Before issuing its opinion, the Agency shall provide the applicant and, where applicable, the authorisation holder with an opportunity to provide written comments within a specified time limit not exceeding 30 days.

The Agency may suspend the time limit referred to in paragraph 1 to allow the applicant or the authorisation holder to prepare the comments.

Article 39

Application for mutual recognition by official or scientific bodies

1. Where no application for a national authorisation has been submitted in a Member State for a biocidal product that is already authorised in another Member State, official or scientific bodies involved in pest control activities or the protection of public health may apply, under the mutual recognition procedure provided for in Article 33 and with the consent of the authorisation holder in that other Member State, for a national authorisation for the same biocidal product, with the same use and the same conditions for use as in that Member State.

The applicant shall demonstrate that the use of such a biocidal product is of general interest for that Member State.

The application shall be accompanied by the fees payable under Article 80.

2. Where the competent authority of the Member State concerned considers that the biocidal product fulfils the conditions referred to in Article 19 and the conditions under this Article are met, the competent authority shall authorise the making available on the market and use of the biocidal product. In that case, the body that made the application shall have the same rights and obligations as other authorisation holders.

Article 40

Supplementary rules and technical guidance notes

The Commission shall be empowered to adopt delegated acts in accordance with Article 83 laying down supplementary rules for the renewal of authorisations subject to mutual recognition.

The Commission shall also draw up technical guidance notes to facilitate the implementation of this Chapter and, in particular, Articles 37 and 39.







CHAPTER VIII

UNION AUTHORISATIONS OF BIOCIDAL PRODUCTS







SECTION 1

Granting of Union authorisations

Article 41

Union authorisation

A Union authorisation issued by the Commission in accordance with this Section shall be valid throughout the Union unless otherwise specified. It shall confer the same rights and obligations in each Member State as a national authorisation. For those categories of biocidal products referred to in Article 42(1), the applicant may apply for Union authorisation as an alternative to applying for a national authorisation and mutual recognition.

Article 42

Biocidal products for which Union authorisation may be granted

1. Applicants may apply for Union authorisation for biocidal products which have similar conditions of use across the Union with the exception of biocidal products that contain active substances that fall under Article 5 and those of product-types 14, 15, 17, 20 and 21. The Union authorisation may be granted:

(a) from 1 September 2013, to biocidal products containing one or more new active substances and biocidal products of product-types 1, 3, 4, 5, 18 and 19;

(b) from 1 January 2017, to biocidal products of product-types 2, 6 and 13; and

(c) from 1 January 2020, to biocidal products of all remaining product-types.

2. The Commission shall by 1 September 2013 draw up guidance documents on the definition of ‘similar conditions of use across the Union’.

3. The Commission shall submit a report to the European Parliament and the Council on the application of this Article by 31 December 2017. That report shall contain an assessment of the exclusion of product-types 14, 15, 17, 20 and 21 from the Union authorisation.

The report shall, if appropriate, be accompanied by relevant proposals for adoption in accordance with the ordinary legislative procedure.

Article 43

Submission and validation of applications

1. Applicants wishing to apply for Union authorisation in accordance with Article 42(1) shall submit an application to the Agency, including a confirmation that the biocidal product would have similar conditions of use across the Union, informing the Agency of the name of the competent authority of the Member State that they propose should evaluate the application and providing written confirmation that that competent authority agrees to do so. That competent authority shall be the evaluating competent authority.

2. The Agency shall inform the applicant of the fees payable under Article 80(1), and shall reject the application if the applicant fails to pay the fees within 30 days. It shall inform the applicant and the evaluating competent authority accordingly.

Upon receipt of the fees payable under Article 80(1), the Agency shall accept the application and inform the applicant and the evaluating competent authority accordingly, indicating the date of acceptance.

3. Within 30 days of the Agency accepting an application, the evaluating competent authority shall validate the application if the relevant information referred to in Article 20 has been submitted.

In the context of the validation referred to in the first subparagraph, the evaluating competent authority shall not make an assessment of the quality or the adequacy of the data or justifications submitted.

The evaluating competent authority shall, as soon as possible after the Agency has accepted an application, inform the applicant of the fees payable under Article 80(2) and shall reject the application if the applicant fails to pay the fees within 30 days. It shall inform the applicant accordingly.

4. Where the evaluating competent authority considers that the application is incomplete, it shall inform the applicant what additional information is required for the evaluation of the application and shall set a reasonable time limit for the submission of that information. That time limit shall not normally exceed 90 days.

The evaluating competent authority shall, within 30 days of receipt of the additional information, validate the application if it determines that the additional information submitted is sufficient to comply with the requirement laid down in paragraph 3.

The evaluating competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant accordingly. In such cases, part of the fees paid in accordance with Article 80(1) and (2) shall be reimbursed.

5. On validating the application in accordance with paragraph 3 or 4, the evaluating competent authority shall, without delay, inform the applicant, the Agency and other competent authorities accordingly, indicating the date of the validation.

6. An appeal may be brought, in accordance with Article 77, against decisions of the Agency under paragraph 2 of this Article.

Article 44

Evaluation of applications

1. The evaluating competent authority shall, within 365 days of the validation of an application, evaluate it in accordance with Article 19, including, where relevant, any proposal to adapt data requirements submitted in accordance with Article 21(2), and send an assessment report and the conclusions of its evaluation to the Agency.

Prior to submitting its conclusions to the Agency, the evaluating competent authority shall provide the applicant with the opportunity to provide written comments on the conclusions of the evaluation within 30 days. The evaluating competent authority shall take due account of those comments when finalising its evaluation.

2. Where it appears that additional information is necessary to carry out the evaluation, the evaluating competent authority shall ask the applicant to submit such information within a specified time limit, and shall inform the Agency accordingly. The 365-day period referred to in paragraph 1 shall be suspended from the date of issue of the request until the date the information is received. However, the suspension shall not exceed 180 days in total other than in exceptional cases and where justified by the nature of the information requested.

3. Within 180 days of receipt of the conclusions of the evaluation, the Agency shall prepare and submit to the Commission an opinion on the authorisation of the biocidal product.

If the Agency recommends the authorisation of the biocidal product, the opinion shall contain at least the following elements:

(a) a statement on whether the conditions laid down in Article 19(1) are fulfilled, and a draft summary of biocidal product characteristics, as referred to in Article 22(2);

(b) where relevant, details of any terms or conditions which should be imposed on the making available on the market or use of the biocidal product;

(c) the final assessment report on the biocidal product.

4. Within 30 days of submitting its opinion to the Commission, the Agency shall transmit to the Commission, in all the official languages of the Union, the draft summary of the biocidal product characteristics, as referred to in Article 22(2), where applicable.

5. On receipt of the opinion of the Agency, the Commission shall adopt either an implementing regulation granting the Union authorisation to the biocidal product or an implementing decision stating that the Union authorisation of the biocidal product has not been granted. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 82(3).

The Commission shall, at the request of a Member State, decide to adjust certain conditions of a Union authorisation specifically for the territory of that Member State or decide that a Union authorisation shall not apply in the territory of that Member State, provided that such a request can be justified on one or more of the grounds referred to in Article 37(1).







SECTION 2

Renewal of Union authorisations

Article 45

Submission and acceptance of applications

1. An application by or on behalf of an authorisation holder wishing to seek the renewal of a Union authorisation shall be submitted to the Agency at least 550 days before the expiry date of the authorisation.

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2. When applying for renewal, the applicant shall submit:

(a) without prejudice to Article 21(1), all relevant data required under Article 20 that it has generated since the initial authorisation or, as appropriate, previous renewal; and

(b) its assessment of whether the conclusions of the initial or previous assessment of the biocidal product remain valid and any supporting information.

3. The applicant shall also submit the name of the competent authority of the Member State that it proposes should evaluate the application for renewal and provide written confirmation that that competent au