Wednesday 22 September 2010

Placing on the market and use of biocidal products ***I

P7_TA(2010)0333

European Parliament legislative resolution of 22 September 2010 on the proposal for a regulation of the European Parliament and of the Council concerning the placing on the market and use of biocidal products (COM(2009)0267 – C7-0036/2009 – 2009/0076(COD))

2012/C 50 E/17

(Ordinary legislative procedure: first reading)

The European Parliament,

having regard to the Commission proposal to Parliament and the Council (COM(2009)0267),

having regard to Article 251(2) and Article 95 of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament (C7-0036/2009),

having regard to the communication from the Commission to the European Parliament and the Council entitled: ‘Consequences of the entry into force of the Treaty of Lisbon for ongoing interinstitutional decision-making procedures’ (COM(2009)0665),

having regard to the opinion of the Committee on Legal Affairs on the proposed legal basis,

having regard to Article 294(3) and Article 114 of the Treaty on the Functioning of the EU,

having regard to the opinion of the European Economic and Social Committee of 17 February 2010 (1) ,

having regard to Rules 55 and 37 of its Rules of Procedure,

having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinions of the Committee on the Internal Market and Consumer Protection and the Committee on Industry, Research and Energy (A7-0239/2010),

Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text;

Instructs its President to forward its position to the Council, the Commission and the national parliaments.

(1) Not yet published in the Official Journal.

Wednesday 22 September 2010

P7_TC1-COD(2009)0076

Position of the European Parliament adopted at first reading on 22 September 2010 with a view to the adoption of Regulation (EU) No …/2010 of the European Parliament and of the Council concerning the placing on the market and use of biocidal products and repealing Directive 98/8/EC

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,

Having regard to the proposal from the European Commission,

Having regard to the opinion of the European Economic and Social Committee (1),

Acting in accordance with the ordinary legislative procedure (2),

Whereas:

(1) Biocidal products are necessary for the control of organisms that are harmful to human or animal health and for the control of organisms that cause damage to natural or manufactured products. However, biocidal products can pose risks to humans, animals and the environment due to their intrinsic properties and associated use patterns.

(2) Biocidal products should not be placed on the market or used unless they comply with the authorisation granted in accordance with this Regulation.

(3) The purpose of this Regulation is to increase the free movement of biocidal products within the Union and to ensure a high level of protection of both human and animal health and the environment . Particular attention should be paid to the protection of vulnerable groups of the population, including pregnant women, infants and children. The provisions of this Regulation should be underpinned by the precautionary principle in order to ensure that substances or products produced or placed on the market do not have any harmful effect on human or animal health or any unacceptable effects on the environment. In order to remove as far as possible obstacles to trade in biocidal products ▐, rules should be laid down for the approval of active substances and the placing on the market and use of biocidal products, including the rules on the mutual recognition of authorisations and on parallel trade.

(4) Rules concerning the placing on the market of biocidal products in the Community were initially adopted in Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (3). It is necessary to adapt that system on the basis of the report from the Commission to the Council and the European Parliament entitled ‘Evaluation of the implementation of Directive 98/8/EC concerning the placing of biocidal products on the market (submitted in accordance with Article 18(5) of the Directive) and progress Report on the work programme referred to in Article 16(2) of the same Directive’ on the first seven years of its implementation, which analyses the problems and weaknesses of that Directive.

(5) Taking into account the main adaptations which are introduced in the existing regulatory system, a Regulation is the appropriate legal instrument to replace Directive 98/8/EC as it imposes clear and detailed rules which do not give room for diverging transposition by Member States. Moreover, a Regulation ensures that legal requirements are implemented at the same time throughout the Union.

(6) A difference should be made between existing active substances which were on the market in biocidal products on 14 May 2000 and new active substances which were not yet on the market in biocidal products by that date. That date was initially set in Directive 98/8/EC as the date by which that Directive had to be transposed into national legislation. A distinction was drawn between substances which were on the market on that date and those which were not. A work programme is being carried out for the review of all existing substances with view to their inclusion in Annex I to Directive 98/8/EC. During that review, biocidal products containing existing substances can continue to be placed on the market in order to prevent a situation where no biocidal products would be available on the market. New active substances should be reviewed before biocidal products containing them can be placed on the market so as to ensure that only safe new products can be placed on the market.

(7) During the work programme, and at most up until the decision on inclusion of the active substance in Annex I to Directive 98/8/EC, Member States may temporarily authorise biocidal products that do not comply with the provisions of this Regulation under certain conditions. Following the decision on inclusion, Member States should grant, cancel or modify authorisations in accordance with this Regulation.

(8) In order to ensure legal certainty, it is necessary to establish a Union list of active substances permitted for use in biocidal products. A procedure should be laid down for assessing whether or not an active substance can be entered in the Union list. The information that interested parties should submit in support of an inclusion of an active substance in the Union list should be specified.

(9) The risks associated with the production, use and disposal of a chemically active substance and materials and articles treated with it are to be assessed and managed in a similar way as they are in Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency (4).

(10) With a view to achieving a high level of environmental and human health protection, active substances with the worst hazard profiles should not be approved for use in biocidal products except in specific situations. These should include situations when the approval is justified because of a negligible exposure of humans to the substance, public health reasons or disproportionate negative impacts of a possible non-inclusion provided no alternatives exist.

(11) In order to prevent the use of active substances with the worst hazard profiles, in particular when their use is not authorised under 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 (5), it is appropriate to restrict their approval to situations when the exposure of humans to the substance is negligible or the substance is necessary for public health reasons.

(12) The active substances in the Union list should be regularly examined to take account of developments in science and technology. Where there are serious indications that an active substance used in biocidal products may pose a higher risk than previously thought, the Commission should be able to review the inclusion of the active substance.

(13) Active substances can, on basis of their intrinsic hazardous properties, be designated as candidates for substitution with other active substances, whenever such substances considered as effective towards the targeted harmful organisms become available in sufficient variety to avoid the development of resistance amongst harmful organisms. In order to allow for a regular examination of substances identified as candidates for substitution, the inclusion period for these substances should not, even in the case of renewal, exceed seven years . Furthermore, the identification of substances which are considered as candidates for substitution should be considered as a first step of a comparative assessment.

(14) In the course of the authorisation or renewal of biocidal product authorisations, it should be possible to compare two or more biocidal products with regard to risks posed by them and benefits accrued through their use. As a result of such a comparative assessment, authorised biocidal products containing active substances indicated as candidates for substitution could be replaced with others that present significantly less risk to health or to the environment and where there are no significant adverse economic or practical impacts. Appropriate phase-out periods should be provided for in such cases.

(15) In order to avoid unnecessary administrative and financial burden for the industry as well as competent authorities, a full in-depth evaluation of an application to renew the inclusion of an active substance in the Union list or the authorisation should be carried out only if the competent authority that was responsible for the initial evaluation decides so on the basis of the available information.

(16) There is a need to ensure effective coordination and management of the technical, scientific and administrative aspects of this Regulation at Union level. The European Chemicals Agency set up under Regulation (EC) No 1907/2006 (hereinafter the ‘Agency’) should carry out specified tasks with regard to the evaluation of active substances as well as the authorisation of certain categories of biocidal products and related tasks in the Union territory. Consequently, a Biocidal Products Committee should be established within the Agency to carry out the tasks attributed to the Agency by this Regulation.

(17) It is recognised that biocidal products intended to be used not only for purposes of this Regulation but also in connection with medical devices, such as disinfectants used for the disinfection of surfaces in hospitals as well as medical devices, may pose risks different from those covered by this Regulation. Therefore, such biocidal products should be required to comply, in addition to the requirements laid down in this Regulation, with the relevant essential requirements of Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (6), Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (7) or Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (8).

(18) As the costs of the application of this Regulation to food or feedingstuffs used for biocidal purposes would be disproportionate to the benefits thereof, food and feedingstuffs used for biocidal purposes should not be covered by this Regulation. Furthermore, the safety of food and feedingstuffs is subject to Union legislation, in particular Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (9).

(19) Processing aids are covered by existing Union legislation, in particular Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorized for use in foodstuffs intended for human consumption (10) and Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (11). Therefore, it is appropriate to exclude them from the scope of this Regulation.

(20) As products used for the preservation of food or feedstocks by the control of harmful organisms, which were previously covered by product type 20, are now covered by Directive 89/107/EEC and Regulation (EC) No 1831/2003, it is not appropriate to maintain this product type.

(21) As the International Convention for the Control and Management of Ships' Ballast Water and Sediments provides for an effective assessment of the risks posed by ballast water management systems, the final approval and subsequent type approval of such systems should be considered equivalent to the product authorisation required under this Regulation.

(22) In order to take account of the specific nature of some biocidal products and the low level of risk associated with their proposed use, and to encourage the development of biocidal products containing new active substances, it is appropriate to provide for a Union authorisation of those products.

(23) In order to ensure that only biocidal products that comply with the relevant provisions of this Regulation are placed on the market, biocidal products should be subject to authorisation either by competent authorities for placing on the market or use in the territory of a Member State, or a part of it, or by the Commission for placing on the market or use in the Union.

(24) In order to facilitate access to the internal market and to avoid the additional costs and time involved in obtaining separate national authorisations in separate Member States, ▐ the scope of the Union authorisation procedure should be extended to all categories of biocidal products with the exception of biocidal products that contain certain active substances .

(25) In order to ensure a harmonised application of the low-risk criteria by competent authorities, it is necessary to specify those criteria in the Regulation as far as possible. The criteria should be based on the hazard characteristics of the biocidal products and the exposure to the product associated with its use. The use of low-risk biocidal products should not lead to a high risk of developing resistance in target organisms. ▐

(26) In view of the provisions on low-risk biocidal products in this Regulation, it seems appropriate to exempt active substances contained in those products from the registration obligations under Regulation (EC) No 1907/2006. This is, in particular, necessary because these substances do not fulfil the conditions in Article 15(2) of that Regulation.

(27) It is necessary to provide common principles for the evaluation and authorisation of biocidal products to ensure a harmonised approach by competent authorities.

(28) In order to evaluate the risks that would arise from the proposed uses of biocidal products, it is appropriate that the applicants submit dossiers which contain the necessary information. Defining a data set for active substances and for biocidal products in which they are contained is necessary so as to assist both the applicants seeking authorisation and competent authorities carrying out the evaluation in deciding on the authorisation.

(29) In the light of the diversity of both the active substances and the biocidal products, the data and test requirements should suit the individual circumstances and allow an overall risk assessment. Therefore, an applicant should be able to request adaptations of the data requirements, as appropriate, including the waiving of data requirements which are unnecessary or impossible to submit in view of the nature or the proposed uses of the product. Applicants should provide the appropriate technical and scientific justification to support their requests.

(30) In order to ensure that the applicant can effectively exercise his right to request an adaptation of the data requirements, the competent authorities should inform the applicant about this possibility and the grounds on which such request could be made. Furthermore, in order to facilitate the preparation of the request, in particular by small- and medium-sized enterprises (SMEs), the competent authority should assist the applicant, where possible, in preparing such a request.

(31) In order to help applicants, and in particular SMEs, to comply with the requirements of this Regulation, Member States should establish national helpdesks. These should be in addition to the operational guidance documents provided by the Agency.

(32) In order to facilitate access to the market of biocidal products belonging to one group of products, it should be possible to authorise such groups of biocidal products with similar uses and allow limited variations with regard to the reference biocidal product provided that those variations do not affect the level of the risk and the efficacy of the products.

(33) When biocidal products are being authorised, it is necessary to ensure that, when properly used for the purpose intended, they are sufficiently effective and have no unacceptable effect on the target organisms such as resistance, and, in the case of vertebrate animals, unnecessary suffering and pain, and have, in the light of current scientific and technical knowledge, no unacceptable effect on the environment and on human or animal health. When deciding whether a biocidal product should be authorised, due consideration should be given to the benefits resulting from its use.

(34) Infestation with harmful organisms should be avoided by means of suitable deterrents to banish or repel such organisms. In addition, other precautionary steps should be taken, such as proper warehousing of goods, compliance with hygiene standards and immediate disposal of waste. Only if such measures have no effect should further steps be taken. Biocidal products that pose lower risks for humans, animals and the environment should always be used in preference to other products where those lower risk products provide an effective remedy in particular situations. Biocidal products that are intended to harm, kill or destroy animals that are capable of experiencing pain and distress should be used as a last resort.

(35) In order to avoid duplication of the evaluation procedures and to ensure free movement of biocidal products, as well as of materials and articles treated with them, within the Union, procedures should be established to ensure that authorisations of products granted in one Member State are recognised in all other Member States.

(36) Specific provisions should lay down procedures to ensure the smooth operation of mutual recognition of authorisations granted by Member States, and in particular the resolution of any disagreements without undue delay.

(37) In order to enable Member States to co-operate in the evaluation of biocidal products and to facilitate the access of biocidal products to the market, it should be possible to launch the process of mutual recognition together with the application for the first authorisation.

(38) There is a need to provide for a dispute settlement mechanism at Union level to ensure the effective functioning of mutual recognition. If a competent authority refuses to mutually recognise an authorisation or proposes to restrict it, the Commission should be empowered to take a decision. In the event of technical or scientific questions, the Commission may consult the Agency before preparing the decision.

(39) While envisaging harmonised provisions for all biocidal product types, including those intended to control vertebrates, the actual use of such product types might give rise to concern. Therefore, Member States should be allowed to derogate from the principle of mutual recognition for biocidal products that fall under certain particular types of biocides when intended to control particular kinds of vertebrates, in so far as such derogations are justified and do not jeopardise the purpose of this Regulation regarding an appropriate level of protection of the internal market.

(40) In order to facilitate the functioning of the authorisation and mutual recognition procedures, it is appropriate to establish a system for the mutual exchange of information, and Member States, the Commission and the Agency should make available to each other on request the particulars and scientific documentation submitted in connection with applications for authorisation of biocidal products.

(41) If the use of a biocidal product is in the interest of a Member State, but there is no applicant interested in the placing on the market of such product in the Member State, pest control bodies and other professional organisations should be allowed to apply for an authorisation. In the event that they are granted an authorisation, they should possess the same rights and obligations as any other authorisation holder.

(42) In order to take account of the scientific and technical developments as well as the needs of the authorisation holders, it should be specified under what conditions authorisations can be cancelled, reviewed or amended. Provisions on the notification and exchange of information which may affect the authorisations should be set out so as to enable the competent authorities and the Commission to take appropriate action.

(43) In the event of an unforeseen danger threatening public health or the environment which cannot be contained by other means, it should be possible for Member States to authorise, for a limited period of time, biocidal products which do not comply with the requirements laid down in this Regulation.

(44) In order to encourage the development of new active substances, the procedure for the evaluation of a newly developed active substance should not prevent Member States or the Union from authorising, for a limited period of time, biocidal products containing that active substance before the active substance is entered in Annex I, provided that a dossier meeting all requirements has been submitted and it is believed that the active substance and the biocidal product satisfy the conditions set for them.

(45) In order to encourage research and development in active substances and biocidal products, it is necessary to establish rules under which unauthorised biocidal products or active substances may be placed on the market for the purposes of research and development.

(46) In view of the benefits for the internal market and for the consumer, it is desirable to establish harmonised rules for parallel trade of ▐ identical biocidal products that are authorised in different Member States.

(47) For the purposes of ensuring the protection of human and animal health and of the environment, and non-discrimination between articles or materials originating in the Union and articles or materials imported from third countries, all treated articles or materials placed on the internal market should contain only authorised biocidal products.

(48) For the purposes of enabling consumers to make informed choices and facilitating the enforcement of this Regulation by competent authorities, articles or materials treated with biocidal products should be appropriately labelled.

(49) Applicants that have invested in supporting the inclusion of an active substance in Annex I or in the authorisation of a biocidal product in accordance with the provisions of this Regulation or in accordance with Directive 98/8/EC should be able to recover part of their investment by receiving equitable compensation whenever use is made of proprietary information that they submitted in support of such inclusions or authorisations for the benefit of subsequent applicants.

(50) With a view to ensuring that all proprietary information submitted in support of the inclusion of an active substance in Annex I or an authorisation of a biocidal product is protected from the moment of its submission, and to prevent situations where some information is without protection, the provision on information protection periods should also apply to information submitted for the purposes of Directive 98/8/EC.

(51) In order to encourage the development of new active substances and biocidal products containing them, it is necessary to provide for a period of protection with respect to the proprietary information submitted in support of the inclusion of active substances or authorisations of products which is longer than the period of protection for information concerning existing active substances and products containing them.

(52) It is essential to minimise the number of tests on animals and to ensure that testing with biocidal products or active substances contained in biocidal products should be made dependent on the purpose and use of a product. Applicants should share, and not duplicate, vertebrate animal studies in exchange for equitable compensation. In the absence of an agreement on sharing vertebrate animal studies between the data owner and the prospective applicant, the Agency should allow the use of the studies by the prospective applicant without prejudice to the decision on the compensation made by national courts. A Union register listing the contact details of the owners of such studies should be established and put at the disposal of all authorities to inform prospective applicants.

(53) The generation of information by alternative means that do not involve tests on animals and that are equivalent to prescribed tests and test methods should also be encouraged. In addition, the adaptation of data requirements should be used to prevent unnecessary costs related to testing.

(54) In order to ensure that the requirements laid down in respect of authorised biocidal products are satisfied when they are placed on the market, the Member States should take measures for appropriate control and inspection arrangements.

(55) It is necessary to provide for the effective communication of information on risks resulting from biocidal products and risk management measures as it forms an essential part of the system established by this Regulation. While facilitating access to information, competent authorities, the Agency and the Commission should respect the principle of confidentiality and avoid any disclosure of information which could be harmful for the commercial interests of the person concerned , except where it is necessary for the protection of human health and the environment .

(56) In order to increase the effectiveness of monitoring and control, and to provide information relevant for addressing the risks of biocidal products, producers, importers and professional users should be required to keep records of the products they produce, place on the market or use. The Commission should adopt implementing rules on data collection, transmission and processing.

(57) In order to facilitate the exchange of information between competent authorities, the Agency and the Commission, a Union Register for Biocidal Products should be established.

(58) It is necessary to specify that provisions concerning the Agency laid down in Regulation (EC) No 1907/2006 should apply accordingly in the context of biocidal active substances and products. Where separate provisions need to be made with respect to the tasks and functioning of the Agency under this Regulation, it should be specified in the provisions of this Regulation.

(59) The costs of the procedures associated with the operation of this Regulation need to be recovered from those who seek to place or do place biocidal products on the market and from those supporting the inclusion of active substances in Annex I. In order to promote the smooth operation of the internal market, the Commission should adopt measures to harmonise the structure of fee systems established by the Member States and the Agency taking into account the special needs of SMEs.

(60) It is necessary to provide for the possibility of an appeal against certain decisions of the Agency. The Board of Appeal set up within the Agency by Regulation (EC) No 1907/2006 should also guarantee the processing of appeals against decisions adopted by the Agency under this Regulation. ▐

(61) There is scientific uncertainty about the safety of nanomaterials for human health and the environment and the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) has identified some specific health hazards as well as toxic effects on environmental organisms for some nanomaterials. SCENIHR has furthermore found a general lack of high-quality exposure data for both humans and the environment, concluding that the knowledge on the methodology for both exposure estimates and hazard identification needs to be further developed, validated and standardised. More and more biocidal products contain nanosilver. The use of nanomaterials in biocidal products may increase with the further development of technology. In order to ensure a high level of consumer protection, free movement of goods and legal certainty for manufacturers, it is necessary to develop a uniform definition for nanomaterials at international level. The Union should endeavour to reach an agreement on a definition in appropriate international fora. Should such an agreement be reached, the definition of nanomaterials in this Regulation should be adapted accordingly. At present, there is inadequate information on the risks associated with nanomaterials. In order to better assess their safety, the Scientific Committee for Consumer Safety (SCCS) should provide guidance in cooperation with relevant bodies on test methodologies which take into account the specific characteristics of nanomaterials. The Commission should regularly review the provisions on nanomaterials in the light of scientific progress.

(62) In view of the environmental impact that anti-fouling products can have in water, the Commission should take steps at international level to ensure that the AFS Convention (International Convention on the Control of Harmful Anti-Fouling Systems on Ships) is ratified worldwide and adapted to this Regulation.

(63) According to Article 291 of the Treaty on the Functioning of the European Union, rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers are to be laid down in advance by a regulation adopted in accordance with the ordinary legislative procedure. Pending the adoption of that new regulation, and given the necessity to adopt as soon as possible this Regulation, Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (12) continues to apply, with the exception of the regulatory procedure with scrutiny, which is not applicable. References to provisions of that Decision should nevertheless be replaced with references to the rules and principles set out in the new regulation as soon as that regulation enters into force.

(64) It is appropriate to provide for a deferred application of this Regulation so as to facilitate the smooth transition to the new system applying to the inclusion of active substances in Annex I and authorisation of biocidal products.

(65) Due to the limited number of new submissions of applications for inclusion of active substances in Annex I, the Agency should take over the co-ordination and facilitation tasks for new submissions as of the date of applicability of this Regulation. However, in view of the high number of historical dossiers and in order to allow some time for the Agency to prepare for the new role, it should take over the tasks related to dossiers submitted under Directive 98/8/EC as of 1 January 2014.

(66) In order to respect the legitimate expectations of companies with respect to the placing on the market and use of low-risk biocidal products covered by Directive 98/8/EC, those companies should be allowed to place such products on the market if they comply with the rules on the registration of low-risk biocidal products under that Directive. However, this Regulation should apply after the expiry of the first registration.

(67) Taking into consideration that some products were not previously covered by the Union legislation in the field of biocidal products, it is appropriate to allow for a transitional period for the companies to be prepared to apply the rules concerning in situ generated active substances and treated articles and materials ▐.

(68) In order to ensure an equal treatment of persons placing on the market biocidal products containing one or more existing active substances, they should be required to hold a dossier or have a letter of access to a dossier, or to each component of the dossier, for each of the active substances contained in the product. Those persons who do not comply with this obligation by 1 January 2014 should no longer be allowed to place their products on the market. Appropriate phase-out periods for disposal, storage and use of existing stocks of biocidal products should be laid down in such cases.

(69) This Regulation should take account, as appropriate, of other work programmes concerned with the review or authorisation of substances and products, or relevant international conventions,

HAVE ADOPTED THIS REGULATION:

CHAPTER I

SCOPE AND DEFINITIONS

Article 1

Subject matter

This Regulation lays down rules for:

(1) the placing on the market and use of biocidal products within the Member States or the Union;

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

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

The purpose of this Regulation is to ensure a high level of protection of both human and animal health and the environment and to improve the functioning of the internal market through the harmonisation of the rules on the placing on the market and use of biocidal products. The provisions of this Regulation are underpinned by the precautionary principle, in order to ensure that active substances or products placed on the market do not have harmful effects on humans, non-target species and the environment. Special attention shall be paid to protecting children, pregnant women and the sick.

Article 2

Scope

1. This Regulation shall apply to biocidal products as defined in point (a) of Article 3(1).

A list of the types of biocidal products covered by this Regulation and their descriptions is set out in Annex V.

2. This Regulation shall not apply to biocidal products that are within the scope of the following instruments:

(a) Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (13);

(b) Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition (14);

(c) Council Directive 88/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production (15);

(d) Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (16);

(e) 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 (17);

(f) Directive 90/385/EEC;

(g) Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (18);

(h) Directive 93/42/EEC;

(i) European Parliament and Council Directive No 95/2/EC of 20 February 1995 on food additives other than colours and sweeteners (19);

(j) Council Directive 96/25/EC of 29 April 1996 on the circulation and use of feed materials (20);

(k) Directive 98/79/EC;

(l) Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (21);

(m) 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 (22);

(n) 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 (23);

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

(p) Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (24);

(q) 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 (25);

(r) Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food (26).

3. Subject to any explicit provision to the contrary, this Regulation shall be without prejudice to the following instruments:

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

(b) Council Directive 79/117/EEC of 21 December 1978 prohibiting the placing on the market and use of plant protection products containing certain active substances (28);

(c) 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 (29);

(d) 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 (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (30);

(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 (31);

(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 (seventh individual directive within the meaning of Article 16(1) of Directive 89/391/EEC) (32);

(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 (33);

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

(i) Directive 2006/114/EC of the European Parliament and of the Council of 12 December 2006 concerning misleading and comparative advertising (34);

(j) 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 (35);

(k) 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 (36);

(l) 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 (37).

4. Article 58 shall not apply to the carriage of biocidal products by rail, road, inland waterway, sea or air.

5. This Regulation shall not apply to food or feedingstuffs that are used for biocidal purposes.

6. This Regulation shall not apply to processing aids that are used for biocidal purposes.

7. Where a biocidal product is intended by its manufacturer to be used for the purpose of exerting a controlling effect on any harmful organism present on medical devices and for other purposes covered by this Regulation, the relevant essential requirements of Directives 90/385/EEC, 93/42/EEC or 98/79/EC shall also be fulfilled.

8. Biocidal products which obtained the final approval under the International Convention for the Control and Management of Ships' Ballast Water and Sediments shall be considered as authorised under Chapter VII of this Regulation. Articles 38 and 57 shall apply accordingly.

Article 3

Definitions

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

(a) ‘biocidal products’ means active substances or mixtures containing one or more active substances, put up in the form in which they are supplied to the user, primarily intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by chemical or biological means. All substances, mixtures and devices placed on the market with the intention to generate active substances shall also be considered biocidal products;

(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 with an action 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 an active substance, which has an inherent capacity to cause an adverse effect , immediately or in the more distant future, on humans, especially children, animals or the environment and is present or is produced in a biocidal product in sufficient concentration to present a risk of causing such an effect. Such a substance would, unless there are other grounds for concern, normally be a substance classified as dangerous according to Directive 67/548/EEC and be present in the biocidal product at a concentration leading to the product being regarded as dangerous within the meaning of Directive 1999/45/EC or Regulation (EC) No 1272/2008;

(g) ‘harmful organism’ means organisms, including pathogenic agents, which have an unwanted presence or a detrimental effect , immediately or in the more distant future, on humans, especially children, human activities or the products they use or produce, or on animals or the environment;

(h) ‘residues’ means substances present in or on plants or products of plant origin, edible animal products, water resources, drinking water or elsewhere in the environment and resulting from the use of a biocidal product, including their metabolites, breakdown or reaction products;

(i) ‘placing on the market’ means the ▐ supply of a biocidal product to third parties , whether in return for payment or free of charge, or the making available of a biocidal product to third parties . Importation shall be deemed to be placing on the market. No supply to third parties is involved when in the course of a commercial activity treated materials or products are individually manufactured and then incorporated by the manufacturer ;

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

(k) ‘treated material or article’ means any substance, mixture, material or article which was treated with or incorporates one or more biocidal products ▐;

(l) ‘external biocidal effect’ means the effect of applications whereby the incorporated biocidal product is intended to be released under normal or reasonably foreseeable conditions of use;

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

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

(o) ‘authorisation’ means national authorisation or Union authorisation;

(p) ‘unique product formulation’ means a biocidal product with no variations as to the percentage of the active substance, the percentage composition of the non-active substances, or the perfumes, dyes or pigments it contains;

(q) ‘frame formulation’ means a group of biocidal products that have similar uses and that present limited variations in their composition with regard to a reference biocidal product belonging to that group which contains the same active substances of the same specifications, where such permitted variations do not adversely affect the level of risk or the efficacy of these products;

(r) ‘letter of access’ means an original document, signed by the owner or owners of information or their authorised representative , which states that the information may be used by the designated competent authority , the Agency, or the Commission for the purpose of evaluating an active substance or granting an authorisation for the benefit of a third party ;

(s) ‘food and feedingstuff’ means food as defined in Article 2 of Regulation (EC) No 178/2002 and feedingstuff as defined in Article 3(4) of that Regulation.

(t) ‘food contact materials’ means any material or article, intended to come into contact with food, that is covered by Regulation (EC) No 1935/2004;

(u) ‘processing aid’ means any substance which: (i) is not consumed as a food or feedingstuff by itself; (ii) is intentionally used in the processing of raw materials, foods or feedingstuff or their ingredients to fulfil a certain technological purpose during treatment or processing; and (iii) may result in the unintentional but technically unavoidable presence in the final product of residues of the substance or its derivatives, provided they do not present any health risk and do not have any technological effect on the final product;

(v) ‘administrative change’ means a modification of an existing authorisation of a purely administrative nature, which does not involve a re-assessment of the risk for public health or the environment or the efficacy of the product;

(w) ‘minor change’ means a modification of an existing authorisation which cannot be deemed to be an administrative change as it involves a limited re-assessment of the risk for public health or the environment or of the efficacy of the product, and does not adversely affect the level of risk for public health or the environment and the efficacy of the product;

(x) ‘major change’ means a modification of an existing authorisation which cannot be deemed to be an administrative change or a minor change;

(y) ‘technical equivalence’ means similarity as regards the chemical composition and hazard profile of a substance produced from a new manufacturing source, compared to the substance of the reference source with respect to which the initial risk assessment was carried out;

(z) ‘nanomaterial’ means any intentionally produced material that has one or more dimensions of the order of 100 nm or less or is composed of discrete functional parts, either internally or at the surface, many of which have one or more dimensions of the order of 100 nm or less, including structures, agglomerates or aggregates, which may have a size above the order of 100 nm but retain properties that are characteristic of the nanoscale. Properties that are characteristic of the nanoscale include: (i) those related to the large specific surface area of the materials considered; and/or (ii) specific physico-chemical properties that are different from those of the non-nanoform of the same material;

(za) ‘manufacturer’ means (i) in the case of an active substance produced within the Union and placed on the market, the manufacturer of that active substance or a person established within the Union designated by the manufacturer as his sole representative for the purposes of this Regulation, (ii) in the case of an active substance produced outside the Union, the person established within the Union and designated by the manufacturer of that active substance as his sole representative for the purposes of this Regulation or, where no such person has been so designated, the importer into the Union of that active substance, (iii) in the case of a biocidal product produced outside the Union, the person established within the Union and designated by the manufacturer of that biocidal product as his sole representative for the purposes of this Regulation or, where no such person has been so designated, the importer into the Union of that biocidal product;

(zb) ‘professional user’ means any natural or legal person who uses biocidal products in the framework of his professional activity;

(zc) ‘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 workers and residents subject to high biocide exposure over the long term;

(zd) ‘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 ( 38 )

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.

CHAPTER II

INCLUSION OF AN ACTIVE SUBSTANCE IN ANNEX I

Article 4

Conditions for inclusion

1. An active substance shall be included in Annex I for an initial period not exceeding 10 years if at least one of the biocidal products containing that active substance fulfils the conditions laid down in point (b) of Article 16(1). An active substance referred to in Article 5 may be included in Annex I only for an initial period of 5 years.

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

3. Active substances, as such or in biocidal products, may be placed on the market in the Union for use in biocidal products only if they have been included in Annex I in accordance with the provisions of this Regulation.

4. Unless otherwise provided in this Regulation, all manufacturers of an active substance, as such or in a biocidal product, shall submit to the Agency an application for inclusion in Annex I.

5. An active substance and the definition of the reference source for the active substance for the purposes of determining technical equivalence shall, where appropriate, be included in Annex I together with conditions relating to any of the following:

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

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

(c) the product type as outlined in Annex V;

(d) manner and area of use;

(e) designation of categories of users;

(f) 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.

6. Where appropriate, maximum residue limits shall be established with respect to active substances included in Annex I in accordance with Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin (39) and Regulation (EC) No 470/2009 of the European Parliament and the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin (40).

Article 5

Exclusion criteria

1. Without prejudice to paragraph 2, the following active substances ▐ shall not be included in Annex I ▐:

(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 assessment of Union or internationally agreed test guidelines or other peer-reviewed scientific data and information, including a review of the scientific literature, reviewed by the Agency, are considered as having endocrine-disrupting properties that may cause adverse effect in humans, or which are identified under Article 57(f) of Regulation (EC) No 1907/2006 as having endocrine-disrupting properties. Not later than 13 December 2013, the Commission shall adopt, by means of delegated acts in accordance with Articles 73 and subject to the conditions of Articles 74 and 75, measures on specific scientific criteria for determining endocrine-disrupting properties. Pending the adoption of those criteria, substances that are, or are to be, classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as carcinogenic category 2 and toxic for reproduction category 2, shall be considered as having endocrine-disrupting properties. In addition, substances such as those that are, or are to be, classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as toxic for reproduction category 2 and which have toxic effects on the endocrine organs, may be considered as having such endocrine-disrupting properties;

(e) active substances that are persistent, bio-accumulative and toxic;

(f) active substances that are very persistent and very bio-accumulative;

(g) persistent organic pollutants (POP) under Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants (41).

2. The ▐ active substances referred to in paragraph 1 may be included in Annex I only if at least one of the following conditions ▐ is met:

(a) the exposure of humans or the environment to the active substance in question in a biocidal product, under normal conditions of use, is negligible, meaning that the product is used in closed systems or under other conditions excluding contact with humans;

(b) it is shown by evidence that the active substance is necessary to prevent or control a serious danger to public or animal health or to the environment, to food and feed safety, or to the public interest and that there are no effective alternative substances or technologies available.

The use of any biocidal product containing active substances included in Annex I pursuant to this paragraph shall be subject to appropriate risk mitigation measures to ensure that exposure of humans and the environment is minimised.

A Member State authorising a biocidal product containing an active substance included in Annex I pursuant to this paragraph shall draw up a substitution plan concerning the control of the serious danger by other means including non-chemical methods that are as effective as the biocidal product concerned, and shall without delay transmit that plan to the Commission. The use of the biocidal product with the active substance concerned shall be restricted to those Member States where the serious danger has to be prevented or, if it occurs, controlled.

Article 6

Data requirements for an application

1. An application to include an active substance in Annex I shall contain at least the following elements:

(a) a dossier , or a letter of access to a dossier, for the active substance satisfying the requirements set out in Annex II;

(b) a dossier , or a letter of access to a dossier, for at least one representative biocidal product that contains the active substance satisfying the requirements set out in Annex III.

The application shall be accompanied by the fees payable under Article 71.

2. Notwithstanding paragraph 1, the applicant need not provide data required under that paragraph if any of the following grounds applies:

(a) the information is not necessary as all relevant exposure can be ruled out under the proposed uses;

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

(c) it is not technically possible to supply the information.

3. An applicant may propose to adapt the data required under 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.

The competent authority shall inform the applicant about the possibility of proposing the adaptation of data requirements, the grounds on which such an adaptation can be requested and, where possible, shall provide assistance in preparing such a proposal.

4. In order to define what constitutes adequate justification to adapt the data required under paragraph 1 on the ground referred to in paragraph 2(a), the Commission shall adapt the criteria by means of delegated acts in accordance with Article 73 and subject to the conditions of Articles 74 and 75 .

Article 7

Submission and validation of applications

1. The applicant shall submit an application for inclusion of an active substance in Annex I, or for subsequent amendments to the conditions of inclusion of an active substance, to the Agency. The Agency shall indicate the name of the competent authority of the Member State that it has chosen to evaluate the application. That competent authority (hereinafter the ‘evaluating competent authority’) shall be responsible for the evaluation of the application.

2. The Agency shall provide a submission number to be used in all correspondence relating to the application until the active substance is included in Annex I, and a submission date, which shall be the date on which the application is received by the Agency.

3. The Agency shall, within one month from the receipt of the application, notify the evaluating competent authority that the application is available in the Agency database.

4. Within three weeks after receipt of an application, the Agency shall validate the application if it complies with the following requirements:

(a) dossiers referred to in points (a) and (b) of Article 6(1) have been submitted;

(b) it is accompanied by the fees payable under Article 71.

The validation shall not include an assessment of the quality or the adequacy of any data or justifications for the adaptation of data requirements submitted.

5. If the Agency considers that the application is incomplete, it shall inform the applicant what additional information is required for the validation of the application and shall set a ▐ time limit of up to two months for the submission of that information.

The Agency shall, within three weeks after receipt of the additional information, determine whether the additional information submitted is sufficient to validate the application.

The Agency shall reject the application if the applicant fails to submit the requested information by the deadline and shall inform the applicant thereof. In such cases a part of the fee paid to the Agency in accordance with Article 71 shall be reimbursed.

Within two months of receiving the application, the Agency shall assign a unique identification code to all the information in the dossier.

6. An appeal may be brought, in accordance with Article 68, against Agency decisions under the third subparagraph of paragraph 5.

7. If the Agency, on the basis of the validation made pursuant to paragraph 4, considers that the application is complete, it shall without delay inform the applicant and the evaluating competent authority thereof.

Article 8

Evaluation of applications

1. The evaluating competent authority shall, within 12 months after the validation, evaluate the dossiers in accordance with Article 4, including, where relevant, any proposal to adapt data requirements submitted in accordance with Article 6(3).

The evaluating competent authority shall provide the applicant with an opportunity to provide written or oral comments on the conclusions of the evaluation within two months. The evaluating competent authority shall take due account of these comments when finalising its evaluation.

The evaluating competent authority shall send the conclusions of the evaluation to the Agency.

2. If, when the dossiers are evaluated, 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 that shall not exceed six months. In exceptional circumstances and following proper justification, the time limit may be extended by up to a further six months. The evaluating competent authority shall inform the Agency about its request to the applicant and the extension of the time limit. Where such additional information includes animal testing, the applicant shall be advised by experts from the Agency or competent authorities regarding suitable alternative methods and testing strategies to replace, reduce or refine the use of vertebrate animals.

The 12-month period referred to in paragraph 1 shall be suspended from the date of issue of the request until the date the information is received.

3. If the evaluating competent authority considers that there are concerns with regard to the cumulative effects from the use of biocidal products containing the same active substance , or different substances with similar or common effects on the same endpoints, whether by the same or different mechanism of action, 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 nine months after receipt of the conclusions of the evaluation, the Agency shall prepare and submit to the Commission an opinion on the inclusion of the active substance in Annex I, having regard to the conclusions of the evaluating competent authority.

5. In order to keep the list of authorised active substances updated, on receipt of the opinion of the Agency, the Commission shall adopt , by means of delegated acts in accordance with Article 73 and subject to the conditions of Articles 74 and 75, a decision ▐ to include the active substance in Annex I. ▐

6. Notwithstanding Article 7(1), the evaluation of the application may be carried out by the competent authority other than the one which has received the copy of the application.

The competent authority that has been notified of the application for the evaluation may submit a duly substantiated request to appoint another evaluating competent authority to the Commission within one month after receipt of the notification referred to in Article 7(3). The Commission shall take the decision in accordance with the procedure referred to in Article 76(2). The 12-month period referred to in paragraph 1 shall commence on the date when this decision is taken.

Article 9

Active substances which are candidates for substitution

1. An active substance that fulfils at least one of the following criteria shall be considered a candidate for substitution in accordance with the procedure referred to in paragraph 2:

(a) its acceptable daily intake, acute reference dose or acceptable operator exposure level is significantly lower than those of the majority of the active substances included in Annex I for the same product type;

(b) it meets two of the criteria to be considered as a persistent, bio-accumulative and toxic substance as set out in Annex XIII of Regulation (EC) No 1907/2006;

(c) there are reasons for concern linked to the nature of the critical effects, in particular developmental neurotoxic or immunotoxic 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;

(d) it is very persistent and very bioaccumulative according to the criteria set out in Annex XIII to Regulation (EC) No 1907/2006;

(e) it is classified or meets the criteria to be classified, in accordance with Regulation (EC) No 1272/2008, as respiratory sensitisers, carcinogen category 1A or 1B, mutagen category 1A or 1B or toxic for reproduction category 1A or 1B;

(f) it is considered to have endocrine-disrupting properties that may cause adverse effect on humans or the environment on the basis of the assessment of Union or internationally agreed test guidelines or other available data.

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

3. Prior to submitting the opinion on the inclusion, or renewal of the inclusion, of an active substance in Annex I to the Commission, the Agency shall make publicly available information on potential candidates for substitution with a reasonable period during which relevant information, including information on available substitutes, may be submitted by interested third parties. The Agency shall take due account of the information received when finalising its opinion.

4. By way of derogation from Articles 4(1) and 10(3), the inclusion of an active substance in Annex I that is considered as a candidate for substitution shall be granted or renewed 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 Annex I.

CHAPTER III

RENEWAL AND REVIEW OF INCLUSION OF AN ACTIVE SUBSTANCE

Article 10

Conditions for renewal

1. The Commission shall renew the inclusion of an active substance in Annex I if the active substance still complies with the requirements referred to in Articles 4 and 5 .

2. Based on new elements examined or adaptations to technical progress, the renewal of the inclusion may be accompanied, as appropriate, by conditions and restrictions.

3. Unless more strictly specified in the decision to renew the inclusion of an active substance in Annex I, the renewal may be renewed for a period not exceeding 10 years .

Article 11

Submission and validation of applications

1. The applicant shall submit the application for renewal of the inclusion of an active substance in Annex I to the Agency at least 18 months before the expiry of the inclusion in Annex I for a given product-type.

The application shall be accompanied by the fees payable under Article 71.

When applying for renewal, the applicant shall submit a list of all data relating to the active substance that have been generated since the inclusion of the active substance in Annex I and a justification as to whether the conclusions of the initial assessment of the active substance are still valid. The evaluating competent authority may require the applicant to submit the data referred to in this list at any time.

2. The Agency shall, within one month after receipt of the application, notify the evaluating competent authority that carried out the initial evaluation of the application for inclusion in Annex I that the application is available in the Agency database.

3. Within two months after receipt of an application, the Agency shall validate the application if it complies with the following requirements:

(a) information referred to paragraph 1 has been submitted;

(b) it is accompanied by the fees payable under Article 71.

The validation shall not include an assessment of the quality or the adequacy of any data or justifications for the adaptation of data requirements submitted.

4. If the Agency considers that the application is incomplete, it shall inform the applicant what additional information is required for the validation of the application and shall set a ▐ time limit of up to two months for the submission of that information.

The Agency shall, within two months after receipt of the additional information, determine whether the additional information submitted is sufficient to validate the application.

The Agency shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant thereof. In such cases a part of the fee paid to the Agency in accordance with Article 71 shall be reimbursed.

5. An appeal may be brought, in accordance with Article 68, against Agency decisions under the third subparagraph of paragraph 4.

6. If the Agency considers, on basis of the validation made pursuant to paragraph 3, that the application is complete, it shall without delay inform the applicant and the evaluating competent authority thereof.

Article 12

Evaluation of applications for renewal

1. On the basis of the available information and the need to review the conclusions of the initial evaluation of the application for inclusion in Annex I, the evaluating competent authority that carried out the initial evaluation shall, within one month after the validation referred to in Article 11, decide whether a full evaluation of the application for renewal is necessary.

If 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 to 4 of Article 8. The decision on the application shall be adopted in accordance with paragraphs 5, 6 and 7 of this Article.

2. If the evaluating competent authority decides that a full evaluation of the application is not necessary, it shall, within six months, prepare and submit to the Agency a recommendation on the renewal of the inclusion of the active substance in Annex I.

Prior to submitting the recommendation to the Agency, the evaluating competent authority shall provide the applicant with an opportunity to provide written or oral comments on the recommendation within one month. The evaluating competent authority shall take due account of these comments when finalising its recommendation.

3. On receipt of the recommendation from the evaluating competent authority, the Agency shall make it available to the Commission, the competent authorities of other Member States and the applicant and allow a period of three months during which they may submit written comments to it.

4. The Commission may ask the Agency for an opinion on scientific or technical matters raised by a competent authority objecting to the recommendation referred to in paragraph 2. The Agency shall issue an opinion within six months from the date on which the matter was referred to it.

5. In order to keep the list of authorised active substances updated, at the end of the period referred to in paragraph 3 or on receipt of the opinion of the Agency, the Commission shall adopt , by means of delegated acts in accordance with Article 73 and subject to the conditions of Articles 74 and 75, a decision concerning the renewal of the inclusion of the active substance in Annex I. ▐

6. Where, for reasons beyond the control of the applicant, the inclusion of the active substance in Annex I is likely to expire before a decision has been taken on its renewal, the Commission shall, in accordance with the procedure referred to in Article 76(2), adopt a decision postponing the expiry date of inclusion for a period sufficient to enable it to examine the application.

7. Where the Commission decides not to renew the inclusion of an active substance in Annex I, it may grant a period of grace for the disposal, storage, placing on the market and use of existing stocks of biocidal products containing that active substance.

The period of grace shall not exceed six months for the placing on the market and an additional maximum of twelve months for the disposal, storage, and use of existing stocks of the biocidal products containing that active substance.

Article 13

Review of inclusion of an active substance in Annex I

1. In order to keep the list of authorised active substances updated, the Commission may review the inclusion of an active substance in Annex I at any time where there are ▐ indications that any of the requirements ▐ in Articles 4 and 5 are no longer complied with. It shall review the inclusion also in cases where there are indications that the objectives of Article 4(1)(a)(iv), Article 4(1)(b)(i) and Article 7(2) and (3) of Directive 2000/60/EC may not be achieved. Where those indications are confirmed, the Commission shall adopt , by means of delegated acts in accordance with Article 73 and subject to the conditions of Articles 74 and 75, a decision amending the entry of an active substance in Annex I or removing it from that Annex.

▐

2. The Commission may consult the Agency on any questions of a scientific or technical nature relating to the review of the inclusion of an active substance in Annex I. The Agency shall, within nine months of the request, prepare an opinion and submit it to the Commission.

3. Where the Commission removes the entry of an active substance from Annex I, it may grant a period of grace for the disposal, storage, placing on the market and use of existing stocks of biocidal products containing that active substance.

The period of grace shall not exceed six months for the placing on the market and an additional maximum of twelve months for the disposal, storage, and use of existing stocks of the biocidal products containing that active substance.

Article 14

Detailed procedures for renewal and review

In order to ensure the smooth functioning of the renewal and review procedures, the Commission may adopt further detailed measures by means of delegated acts in accordance with Article 73 and subject to the conditions of Articles 74 and 75 .

▐

CHAPTER IV

GENERAL PRINCIPLES OF AUTHORISATION OF BIOCIDAL PRODUCTS

Article 15

Placing on the market and use of biocidal products

1. No biocidal product may be placed on the market or used unless an authorisation has been issued for that biocidal product in accordance with this Regulation.

2. Application for authorisation shall be made by, or on behalf of, the person who will be the authorisation holder. The person may be, but is not necessarily, the person responsible for the placing on the market of a biocidal product in a particular Member State or in the Union.

▐

Application for ▐ authorisation shall be submitted to the Agency. When an applicant submits an application for national authorisation, that applicant shall, with the agreement of the Member State concerned on whose territory the national authorisation would be applicable, identify in the application itself, as laid down in Article 22, the competent authority of the Member State of his choice which shall be responsible for the evaluation of, and decision on, the application (hereinafter the ‘receiving competent authority’).

Authorisation holders shall have a permanent office within the Union.

A single application for authorisation may be made by the applicant for a group of products intended to be authorised under a frame formulation.

3. An authorisation may be granted for a unique product formulation or for a frame formulation.

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

5. Biocidal products shall be used properly. Proper use shall include compliance with the conditions for granting an authorisation established in Article 16 and labelling requirements laid down in Article 58.

Proper use shall also 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.

Infestation with harmful organisms shall be avoided by suitable measures of deterrence to banish or repel such organisms. In addition, other precautionary steps shall be taken, such as proper warehousing of goods, compliance with hygiene standards and immediate disposal of waste. Only if those measures show no effect shall further steps be taken. Biocidal products that pose low risks for humans, animals and the environment shall always be used in preference to others. Biocidal products that are intended to harm, kill or destroy animals that are capable of experiencing pain and distress shall be applied only as a last resort.

Mandatory measures shall be established through a framework directive for Union action and thereafter implemented in order to achieve the sustainable professional use of biocidal products including the introduction of National Action Plans, integrated pest management, risk-reduction measures and the promotion of alternatives.

By … (42), the Commission shall submit a proposal for such a framework directive to the European Parliament and the Council.

Article 16

Conditions for granting an authorisation

1. A biocidal product shall be authorised only if the following conditions are met:

(a) the active substances included therein are listed in Annex I and any conditions included in that Annex together with those active substances are complied with;

(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, complies with the following criteria: (i) it is sufficiently effective; (ii) it has no unacceptable effects on the target organisms, in particular unacceptable resistance or cross-resistance or unnecessary suffering and pain for vertebrates; (iii) it has no immediate or delayed harmful effect itself or as a result of its residues on groundwater or on human health, including the health of vulnerable groups , or animal health , directly or through drinking water (taking into account substances resulting from water treatment), food, feed or air, or consequences in the workplace or through other indirect effects, taking into account known cumulative and synergistic effects where the scientific methods accepted by the Agency to assess such effects are available ; (iv) it has no unacceptable effects itself, or as a result of its residues, on the environment, having particular regard to the following considerations: — its fate and distribution 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 ; — its impact on non-target organisms; — its impact on biodiversity and the ecosystem;

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

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

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

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

(a) all normal conditions under which the biocidal product may be used;

(b) how any material or article treated with it or containing it may be used;

(c) the consequences of its use and disposal;

(d) cumulative or synergistic effects.

3. When evaluating whether the criteria in point (b) of paragraph 1 have been fulfilled, information should whenever possible be derived from information already available on the substance of concern contained in the biocidal product, in order to keep tests on animals to a minimum. In particular, the provisions of Directive 1999/45/EC or Regulation (EC) No 1272/2008 should wherever possible be applied for the purpose of ascertaining the adverse effects of the biocidal product and for the subsequent risk assessment.

4. The evaluation of the compliance of the biocidal product with the criteria set out in points (b) and (c) of paragraph 1 shall not take into account a substance contained in the biocidal product if it is present in a preparation at a concentration lower than any of the following:

(a) the applicable concentrations laid down in Article 3(3) of Directive 1999/45/EC;

(b) the concentration limit values laid down in Annex I to Directive 67/548/EEC;

(c) the concentration limit values laid down in Part B of Annex II to Directive 1999/45/EC;

(d) the concentration limit values laid down in Part B of Annex III to Directive 1999/45/EC;

(e) the concentration limit values laid down in an agreed entry in the classification and labelling inventory established under Title V of Regulation (EC) No 1272/2008;

(f) 0,1 % weight by weight (w/w), if the substance meets the criteria in Annex XIII to Regulation (EC) No 1907/2006.

5. An authorisation to place a low-risk biocidal product on the market may be granted only if the active substances are evaluated as low-risk active substances and included in Annex I in accordance with Articles 4 and 5. The authorisation shall be subject to compliance with the requirements of points (a) to (d) of paragraph 1.

6. A biocidal product shall be authorised only for uses for which relevant information has been submitted in accordance with Article 18.

7. A biocidal product shall not be authorised for placing on the market to, or use by, the general public if it fulfils any of the following criteria for classification:

(a) it is toxic, very toxic or a category 1 or 2 carcinogen, or a category 1 or 2 mutagen or toxic for reproduction category 1 or 2 according to Directive 1999/45/EC;

(b) it is toxic, very toxic or a category 1A or 1B carcinogen, or a category 1A or 1B mutagen or toxic for reproduction category 1A or 1B according to Regulation (EC) No 1272/2008;

(c) it is considered to have endocrine-disrupting properties;

(d) it has developmental neurotoxic or immunotoxic effects.

8. In the case of a frame formulation, the following variations in composition with regard to a reference biocidal product are possible:

(a) elimination of an active substance in a reference biocidal product with at least two active substances;

(b) a reduction in the percentage of the active substances;

(c) elimination of one or more non-active substances;

(d) an alteration in percentage composition of one or more non-active substances ;

(e) the replacement of one or more non-active substances by others presenting the same or lower risk.

9. The Commission should, in accordance with the procedure set out in Article 76(2), provide technical and scientific guidance for product authorisation, with particular regard to harmonised data requirements, evaluation procedures and decisions by the Member States.

10. In order to facilitate the harmonisation of authorisation practices throughout the Union and to reduce the administrative burden on companies and competent authorities, the Commission shall adopt, by means of delegated acts in accordance with Article 73 and subject to the conditions of Articles 74 and 75, measures specifying the conditions, criteria and procedures for regulating the authorisation and placing on the market of the same product for the same use, under different trade names and by different companies. The criteria and the procedures for such measures shall be based on, but not limited to, the following principles:

(a) no additional evaluation will be performed as it concerns an already authorised product;

(b) authorisation decisions shall be taken within a short timeframe;

(c) authorisation fees shall be low in accordance with the limited administrative work required.

Article 17

Criteria for low-risk biocidal products

1. A biocidal product shall be considered a low-risk biocidal product if the active substances therein are included in Annex I and if all of the following conditions are fulfilled:

(a) for any given environmental compartment, the ratio of the predicted environmental concentration (PEC) to predicted no-effect concentration (PNEC) may be derived and does not exceed 0.1;

(b) for any effect to human health, the margin of exposure (the ratio of no observed adverse effect level (NOAEL) and exposure concentration) is higher than 1 000;

(c) the cumulative effects of both active substances and non-active substances are taken into consideration and defined as low-risk.

However, a biocidal product shall not be considered a low-risk biocidal product if at least one of the following conditions is met:

(a) it contains one or more ▐ substances which fulfil the criteria for being a persistent organic pollutant under Regulation (EC) No 850/2004, for being persistent, bio-accumulative and toxic (PBT) or very persistent and very bio-accumulative (vPvB) in accordance with Annex XIII of Regulation (EC) No 1907/2006;

(b) it contains one or more active substances qualified as endocrine disrupters;

(c) it contains one or more active substances which have been classified in accordance with Regulation (EC) No 1272/2008 as or which meet the criteria to be classified as one of the following: (i) carcinogenic; (ii) mutagenic; (iii) neurotoxic; (iv) immunotoxic; (v) toxic to reproduction; (vi) sensitising; (vii) corrosive; (viii) very toxic or toxic.

(d) it contains a nanomaterial;

(e) it is explosive;

(f) it contains any substance of concern;

(g) it is highly flammable;

(h) it is self-igniting at application temperature.

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2. For a low-risk biocidal product it shall be demonstrated that the potential for the development of resistance in target organisms due to the use of the biocidal product is low.

3. In addition to the active substances referred to in Article 15(2) of Regulation (EC) No 1907/2006, active substances manufactured or imported for use in low-risk biocidal products that are authorised for placing on the market in accordance with Article 15 shall be regarded as being registered, and the registration as completed, for manufacture or import for use in a low-risk biocidal product, and therefore as fulfilling the requirements of Chapters 1 and 5 of Title II of that Regulation.

Article 18

Data requirements for an application for authorisation

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

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

(b) a proposal for a summary of the biocidal product characteristics that includes the information referred to in points (a), (b) and (e) to (m) of Article 20(2);

(c) for biocidal products other than low-risk biocidal products, a dossier or a letter of access to a dossier satisfying the requirements set out in Annex II for each active substance in the biocidal product;

(d) for low-risk biocidal products, any relevant information in support of the conclusion that the biocidal product is to be considered a low-risk biocidal product;

(e) if the active substance contained in a low-risk biocidal product has been included in Annex I, a letter of access if the appropriate protection period for information according to Article 49 has not expired.

2. The application for authorisation shall be accompanied by the fees payable under Article 71.

3. The Agency may require applications for a national authorisation to be submitted in an official language of the Member State in which the receiving competent authority is situated.

4. If the application concerns a biocidal product that is intended by its manufacturer to be used inter alia for the purposes referred to in Article 2(7), it shall be accompanied by a declaration of conformity regarding the compliance with the relevant essential requirements of Directives 90/385/EEC, 93/42/EEC or 98/79/EC.

5. The Commission shall, in accordance with the procedure referred to in Article 76(2), draw up technical notes for guidance to facilitate the implementation of point (d) of paragraph 1. The Commission shall, in accordance with the procedure set out in Article 76(2), provide technical and scientific guidance and tools, in particular to support applications for authorisation under Articles 18, 19 and 20, above all for SMEs.

The technical notes shall be published in the ‘C’ series of the Official Journal of the European Union.

Article 19

Waiving of data requirements

1. Notwithstanding Article 18, the applicant need not provide data required under that Article if any of the following grounds applies:

(a) the information is not necessary owing to the exposure associated with the proposed uses;

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

(c) it is not technically possible to supply the information.

2. The applicant may propose to adapt the data required under Article 18 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.

The competent authority shall inform the applicant about the possibility of proposing the adaptation of data requirements, the grounds on which such an adaptation can be requested and, where possible, shall provide assistance in preparing such a proposal.

3. In order to define what constitutes adequate justification to adapt the data required under Article 18 on the grounds referred to in point (a) of paragraph 1 , the Commission shall adapt the criteria by means of delegated acts in accordance with Article 73 and subject to the conditions of Articles 74 and 75 .

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Article 20

Content of authorisation

1. An authorisation shall stipulate the terms and the conditions relating to the placing on the market and use of the biocidal product.

2. An authorisation shall include the summary of the biocidal product characteristics listing 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;

(e) where required for proper use of the biocidal product, the qualitative and quantitative composition in terms of the active substances and non-active substances, taking account of the concentration limits in Article 16(4) ;

(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) physical state and nature of the biocidal product;

(i) hazard and precautionary statements;

(j) the product-type in accordance with Annex V and the target harmful organisms;

(k) application doses and instructions for use;

(l) categories of users;

(m) particulars of likely direct or indirect adverse effects and first aid instructions;

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

(o) in the case of a biocidal product that is intended by its manufacturer to be used inter alia for the purposes referred to in Article 2(7), any specific conditions of use and a statement that the biocidal product is in conformity with the relevant essential requirements of Directives 90/385/EEC, 93/42/EEC or 98/79/EC;

(p) for toxicologically and ecotoxicologically relevant components of biocidal products and residues thereof, analytical methods including recovery rates and the limits of determination (LOD).

3. In addition to paragraph 2, in the case of a frame formulation, the authorisation shall indicate, as appropriate, the following information:

(a) the reference biocidal product within the group of products comprising the frame formulation ▐;

(b) the permitted alteration of the composition of this reference biocidal product expressed as a reduction in the percentage of the active substances or as an alteration in the percentage of the non-active substances contained in the biocidal products which are considered to belong to that frame formulation;

(c) the non-active substances that may be substituted in the authorised biocidal products belonging to that frame formulation.

4. In the case of a frame formulation, one single authorisation number shall be provided for all biocidal products which belong to that frame formulation.

Article 21

Comparative assessment of biocidal products

1. The receiving competent authority or, in the case of 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 an authorisation or a renewal of an authorisation of a biocidal product containing an active substance that is a candidate for substitution in accordance with Article 9(1). The comparative assessment shall be carried out in relation to all biocidal products that have the same purpose, when sufficient experience has been gained in their use and they have been in use for at least five years.

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.

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 placing on the market or use of a biocidal product containing an active substance that is a candidate for substitution where the comparative assessment weighing up the risks and benefits in accordance with Annex VI demonstrates that all the following criteria are met:

(a) for the uses specified in the application, other authorised biocidal products already exist which present significantly lower risk for human or animal health or the environment and which prove equally effective and involve no significant increase in the risks for any other parameter ;

(b) the biocidal product or non-chemical control or prevention method referred to in point (a) does not present significant economic or practical disadvantages;

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

4. The Commission shall, on the basis of paragraph 3, adopt measures laying down the procedure necessary for the definition of an application for comparative assessment of biocidal products. Those measures shall define the criteria and algorithms to be used in a comparative assessment to ensure that there is uniform application throughout the Union.

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 its decision in accordance with Article 76(3).

In order to specify the procedures relating to comparative assessments involving questions of Union interest, the Commission shall adapt the criteria by means of delegated acts in accordance with Article 73 and subject to the conditions of Articles 74 and 75 .

6. Notwithstanding Article 15(4), an authorisation for a biocidal product containing an active substance that is a candidate for substitution shall be granted for periods not exceeding five years.

Member States shall establish and implement a substitution plan in order to ensure that the application of the relevant biocidal product is phased out within the authorisation period and that the relevant active substance or product can be replaced with sound chemical or non-chemical alternatives.

7. Where it is decided not to authorise or to restrict the use of a biocidal product pursuant to paragraph 3, that cancellation or modification of the authorisation shall take effect three years after the decision or at the end of the inclusion period of the candidate for substitution, whichever is the earlier.

CHAPTER V

NATIONAL AUTHORISATIONS OF BIOCIDAL PRODUCTS

Article 22

Submission and validation of application

1. The person responsible for the placing of a biocidal product on the market, or his representative, shall submit an application for a national or Union authorisation to the Agency and inform the Agency of the name of the receiving competent authority. The Agency shall, within three weeks after receipt of the application, notify the receiving competent authority or, in the case of an application for a Union authorisation, the evaluating competent authority, that the application is available in the Agency database.

2. Within three weeks after receipt of an application, the Agency shall validate the application if it complies with the following requirements:

(a) the documents referred to in Article 18 have been submitted;

(b) it is accompanied by the fees payable under Article 71.

The validation shall not include an assessment of the quality or the adequacy of any data or justifications for the adaptation of data requirements submitted.

3. If the Agency considers that the application is incomplete , it shall ▐ inform the applicant what additional information is required for the validation of the application and shall set a reasonable time limit for the submission of that information .

The Agency shall, within three weeks after receipt of the additional information, determine whether the additional information submitted is sufficient to validate the application.

The Agency shall reject the application if the applicant does not submit the required additional information on time, and shall notify the applicant and the receiving competent authority of the rejection.

In such cases, part of the fees payable to the Agency under Article 71 shall be reimbursed.

4. An applicant may, in accordance with Article 68, submit an appeal against the decision of the Agency under the third subparagraph of paragraph 3.

5. If the Agency considers, on the basis of the validation made pursuant to paragraph 2, that the application is complete, it shall without delay inform the applicant and the receiving competent authority to that effect.

Article 23

Evaluation of application

1. The receiving competent autho