EN

Brussels, 12.6.2009

COM(2009) 267 final

2009/0076 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

concerning the placing on the market and use of biocidal products

(Text with EEA relevance)

{SEC(2009) 773}

{SEC(2009) 774}

EXPLANATORY MEMORANDUM

1. Context of the proposal

1.1. Grounds for and objectives of the proposal

Directive 98/8/EC of the European Parliament and the Council of 16 February 1998 concerning the placing of biocidal products on the market (hereinafter 'the Directive') establishes a harmonised regulatory framework for the authorisation and the placing on the market of biocidal products, the mutual recognition of these authorisations within the Community and the establishment at Community level of a positive list of active substances that may be used in biocidal products. In its Article 18(5), the Directive requires the Commission to draw up a report seven years after its entry into force and to submit the report to the Council. The report shall address the implementation of the Directive and the functioning up to that date of the simplified procedures (frame formulations, low-risk biocidal products and commodity substances). In accordance with the same provision, the Commission may accompany its report, if necessary, by proposals for amendment of the Directive.

The Commission submitted the report on 8 October 2008 (COM(2008)620) and proposed at this occasion to extend the review programme, the transitional period, and certain provisions on data protection that accompany this period for an additional three years.

Further to the proposal already presented, and based on the conclusions of the ‘seven years’ report, the present proposal for revision of Directive 98/8/EC aims to tackle the identified weaknesses of the regulatory framework during the first eight years of its implementation, to improve and update certain elements of the system and to avoid problems anticipated in the future.

1.2. General context

The review of the implementation of the Directive has indicated that for the evaluation of active substances, the simplified procedures provided for in the Directive, notably for low-risk products (Annex IA to the Directive), have no real effect, and that in addition the data requirements and data waiving provisions may be unclear or inconsistently applied or lead to a disproportionate burden in some circumstances.

In addition, although product authorisation has not yet started, simplification of the procedures concerning the authorisation of biocidal products in the Member States may be beneficial in reducing costs and administrative burden for companies and public authorities alike. The proposal is seeking to improve the existing regulatory framework, without reducing the high level of protection for the environment and human and animal health.

The proposal also intends to simplify the data protection rules, to avoid duplicating vertebrate animal studies through mandatory data-sharing, increase harmonisation of fees systems in the Member States, establish rules for parallel trade of biocidal products, and cover articles or materials treated with biocidal products.

1.3. 130Existing provisions in the area of the proposal

The current regulatory framework for biocidal products is established by Directive 98/8/EC of the European Parliament and the Council of 16 February 1998 concerning the placing of biocidal products on the market and a number of implementing Commission Regulations, in particular Commission Regulation (EC) No 1451/2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market. .

1.4. 140Consistency with the other policies and objectives of the Union

The proposal to revise the Directive takes into consideration the recent revision of EU legislation on Chemicals with the adoption of Regulation (EC) No 1907/2006 (REACH) as well as Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006.

Due note is also taken of changes in horizontal legislation that affect the biocides regulatory framework, such as those related to the procedures for the exercise of implementing powers conferred on the Commission (recent amendment of Decision 1999/468/EC). Furthermore, it also takes into consideration the general rules and the obligations for Member States under Regulation (EC) No 765/2008 organising the market surveillance relating to the marketing of products.

2. Consultation of interested parties and impact assessment

2.1. Consultation of interested parties

2.1.1. 211Consultation methods, main sectors targeted and general profile of respondents

1. A first consultation workshop was held on 21-22 January 2008 in Ljubljana under the auspices of the Slovenian Presidency of the EU. The objective of this workshop was to allow a first informal exchange of views between Member States and Commission representatives on issues to be addressed in the revision of the Directive. An outline of these issues is available at: http://ec.europa.eu/environment/biocides/workshop.htm

2. An additional discussion was organised in Bonn on 7-8 April 2008 gathering more than 140 representatives of industry, NGOs and competent authorities. Participants debated about the need to streamline the scope of the Directive, among others by clarifying border cases and product-types definition, about the product authorisation (e.g. frame formulation, central versus mutual recognition), about data protection rules, as well as simplified or more flexible data requirements approach.

3. A wider consultation of stakeholders was organised through a conference hosted by the Commission in Brussels on 23 May 2008 with the participation of representatives from different sectors of the biocides industry, individual companies, consultants and national governments. After the participants were informed about the key issues for the revision (presentations given by Commission officers) they had the opportunity to comment and debate specific issues of interest.

4. A targeted stakeholder consultation was also carried out in the framework of a study in preparation of the impact assessment for the revision of the Directive. The consultation involved interviews with representatives of the industry (including small and medium-sized enterprises), national administrations/controlling bodies, environmental protection and consumers' associations and others, based on questionnaires that were previously sent to these stakeholders to prepare the discussions.

2.1.2. 212Summary of responses and how they have been taken into account

1. The consultation conference in Ljubljana (Commission & Member States) and the succeeding conference in Bonn (Member States & Industry) focused on numerous topics of interest for the revision, the most prominent of those being:

– the revision of the data protection provisions and (mandatory) data-sharing;

– the scope of the regulatory framework (to include or not the use phase; to add provisions about in-situ generated substances and active substance precursors; the relationship with other pieces of Community legislation; reduction or not of the number of product-types; definition of a biocidal product and definition of placing on the market; how to regulate articles/materials containing biocides);

– the lack of harmonised provisions in the current Directive regarding product authorisation or the procedure to follow after the inclusion of an active substance in the Community positive list;

– the possibility to have a single Community authorisation for biocidal products; the role of a centralised Agency for biocides; effectiveness of implementation and enforcement at Member State level;

– how to facilitate the (future) mutual recognition procedure;

– the harmonisation and proportionality of fees charged by Member States, and ways to alleviate the financial burden of compliance for SMEs;

– the performance so far of the Directive's simplified procedures (Annex IA; Annex IB; prospects for frame formulation concept);

– the need to clarify the possibility for waiving data requirements; the use in the new instrument of data-waiving provisions from the REACH Regulation; the establishment of a tiered system of data requirements (as was the original idea when the Directive was adopted);

– specific rules for low-volume or 'niche' market biocides;

– the need to develop harmonised efficacy requirements.

Finally, the appropriateness of adopting specific provisions on parallel trade; and the pros and cons of turning the Directive into a Regulation were also discussed. The Commission has taken into consideration all the - sometimes conflicting - opinions expressed by the Member States in the development of its proposal, while trying to identify the best elements amongst them that would contribute to a coherent and workable regulatory framework.

2. During the consultation event in May 2008 in Brussels (participation of various stakeholders, mostly industry and enterprises' representatives), the participants had a chance to express their opinions on simplified procedures; data requirements; data protection and data-sharing; the procedure for biocidal product authorisation; the fees applied by Member States and articles or materials containing biocides.

In general (although many varying opinions were voiced), the simplified procedures of Annex IA and Annex IB were considered a failure; the frame formulation procedure has not been tried yet but there seems to be some confusion as to how it would work and different expectations as to what it would offer; the data requirements are seen as particularly strict and in some cases as non-proportionate or inflexible; the data protection system could be further clarified and simplified, and certain elements of it should be amended; the industry seems to have come to terms with introducing mandatory sharing of vertebrate animal studies; providing for harmonised authorisation procedures is seen as a plus by the industry, and even better if a centralised procedure were adopted; the fees or at least the fee systems will need to be harmonised; and a solution should be found for articles or materials that are containing biocidal products, in particular those articles or materials imported from third countries. All these concerns were taken into consideration and are reflected in the proposal.

3. The targeted consultation served mostly the purpose of obtaining the necessary quantitative/qualitative information for preparing the impact assessment report presented in support to this proposal. It covered all the issues discussed with the Member States in Ljubljana, in Bonn and with the stakeholders in Brussels and the responses were mostly the same with those expressed in the three consultation events.

An open consultation was conducted over the internet from 15/11/2006 to 15/01/2007. The Commission received 250 response(s). The results of the open internet consultation were incorporated in the Commission report on the impacts of the implementation of Directive 98/8/EC available at: http://ec.europa.eu/environment/biocides/study.htm .

2.2. Collection and use of expertise

To support this proposal, several studies were carried out by external contractors:

– a study to assess the impact of the revision of Directive 98/8/EC concerning the placing of biocidal products on the market;

– a study on impacts of possible measures to manage articles or materials treated with biocides, in particular when imported;

– a study on the impacts of the implementation of Directive 98/8/EC on biocidal products; and

– a study on the assessment of different options to address risks from the use phase of biocides.

These studies were evaluated by the Commission and taken into consideration while preparing the current proposal. In particular, the study to assess the impact of the revision of Directive 98/8/EC concerning the placing of biocidal products on the market evaluated the economic, social and environmental impacts of the different policy options. The conclusions of this study are directly reflected in the impact assessment described in the following section.

More information on the studies is available at: http://ec.europa.eu/environment/biocides/study.htm and http://ec.europa.eu/environment/biocides/revision.htm.

2.3. 230Impact assessment

The Impact Assessment addresses five policy issues that require action:

POLICY ISSUE 1: SCOPE

– Unchanged policy;

– Extend scope to cover processing aids and food contact materials;

– Extend scope to cover treated materials containing biocides.

The assessment concluded that including materials containing biocides in the scope of the Directive would significantly increase the costs to industry. However, although the equal treatment of industry, and environmental and human health benefits are difficult to quantify, they are likely to be significant. Including, in particular food processing aids in the scope of the Directive is likely to result in a complicated process of authorisation under two legal frameworks which may lead to some duplication of efforts. The related costs are likely to outweigh the limited benefits resulting from better control of environmental impacts and greater regulatory certainty.

POLICY ISSUE 2: PRODUCT AUTHORISATION

– Unchanged policy;

– Strengthening of mutual recognition;

– Single Member State authorisation;

– Community authorisation.

The assessment concluded that a Community authorisation or a single Member State authorisation would be the most efficient systems and would provide incentives for innovation of products based on new active substances/low-risk products. However, as the Member States have expressed significant concerns about a full centralisation of the product authorisation or a single Member State authorisation due to reduced role for the other Member States, a combination of the Community authorisation for certain products with the strengthening of the mutual recognition process for other products appears to be the most acceptable solution.

POLICY ISSUE 3: DATA-SHARING

– Unchanged policy;

– Mandatory sharing of vertebrate animal test data for product authorisation;

– Mandatory sharing of vertebrate animal test data for active substance approval and for product authorisation.

The assessment concluded that mandatory data-sharing for active substance approval and for product authorisation implies the highest total cost savings to applicants, possibly the highest number of safer products remaining on the market and the highest number of animals saved.

POLICY ISSUE 4: DATA REQUIREMENTS

– Unchanged policy;

– Rewording provisions concerning data waiving and the use of existing information;

– Reformulating the system for low-risk substances/products.

The policy options address two types of problems: high data requirements and low attractiveness of the simplified procedures, in particular for low-risk and basic substances. The assessment concluded that all the options have significant potential to reduce costs for industry and that the last two options would also significantly reduce the numbers of vertebrate animal tests. In order to meet the objectives of the revision, the best option seems to be a combination of data waiving with the use of existing information and a new approach to low-risk biocidal products.

POLICY ISSUE 5: FEES CHARGED BY MEMBER STATES FOR CARRYING OUT THE PROCEDURES OF THE DIRECTIVE

– Unchanged policy;

– Partially harmonised fee structure;

– Centralised fee system;

– Specific provisions for SMEs.

The assessment concluded that a partially harmonised fee structure may encourage the development of more new active substances and the retention of more existing active substances. It should also reduce the costs for the approval of active substances for several product types. The last option will make the procedure less costly for SMEs, which should help them to stay on the market. A fully centralised fee system would raise questions concerning the subsidiarity principle as it would transfer the competences over setting the levels of fees from the Member States to the Community.

The Commission carried out an impact assessment which is attached to this proposal.

3. Legal elements of the proposal

3.1. 305Summary of the proposed action

The revision of the Biocides Directive intends to remedy a number of weaknesses that were identified during the first eight years of its implementation, to anticipate problems with the upcoming authorisation and mutual recognition procedure, and to update and adapt the instrument to recent policy developments.

First, the Directive is turned into a Regulation. As a result, there will be no need for a transposition period or for national transposition measures, which is also expected to ensure more harmonised implementation of the regulatory framework in the Member States.

Among the proposed amendments of the scope, particularly relevant are the extension of the scope to biocides in materials that might come into contact with food and the new provisions on articles or materials containing biocidal products.

In particular with regard to the latter, under the current situation, if an article is treated in the EU then only a biocidal product that is authorised for that purpose may be used. However, if the article is treated with a biocidal product outside the EU and then imported, there is no control over the substance it may incorporate. This could represent risks for human health or for the environment if active substances that are not assessed or even banned in the EU are incorporated in such goods which are then imported into the EU. In addition, this situation is discriminatory to the EU industry, and could lead to the production of treated articles or materials being moved out of the EU in order to circumvent restrictions on certain substances. As part of the revision of the Biocides Directive, it is proposed that all articles or materials must be treated only with biocidal products authorised for that purpose in at least one Member State.

Labelling requirements are accompanying the provision on articles or materials treated with biocides. These have two objectives: to inform consumers that the article was treated with a biocidal product; and to alert competent and/or customs authorities in the Member States and trigger any existing inspection provisions aimed at ensuring compliance. The labelling provisions apply equally to EU and non EU manufacturers.

The proposed Regulation provides also for harmonised procedures for the authorisation of biocidal products, an element that is significantly underdeveloped in the current Directive. The provisions regarding mutual recognition of authorisations are reworked and clarified, in particular the resolution of disputes between Member States, or between Member States and applicants. This is expected to contribute to a smooth functioning of the upcoming authorisations of biocidal products.

Apart from the case of authorisations granted by the Member States, a centralised authorisation system is proposed. This will be available for products identified as low-risk - without having to go through a separate evaluation of the active substance first- and for products containing new active substances. The latter is expected to promote research and innovation in the biocides field.

The technical and scientific tasks relevant to this centralised system will be carried out by the European Chemicals Agency (ECHA). To this end, the proposal incorporates the necessary provisions governing the procedural and organisational details. In addition, ECHA will undertake the coordination of organisational and technical tasks for the evaluation of all applications for inclusion of active substances in Annex I (the Community positive list for active substances) which were until now attributed to the Commission Joint Research Centre.

The simplified procedures involving the current Annex IA and IB are repealed, as very little or no use of them has been made so far. The simplified procedure involving frame formulations - which has not yet been put into practice - is modified so as to allow, within a group of products belonging to the same frame formulation, the replacement of any non-active ingredient by other non-active ingredients. Currently, this is restricted to pigments, dyes, and perfumes. The Regulation will also incorporate rules governing the modalities and conditions to apply for modifications to authorisations that are already granted.

The rules on comparative assessment are also modified, as the current system does not seem sufficiently clear - for instance, it is rather problematic to apply comparative assessment during the review programme, where all existing substances are being evaluated. The proposed system comprises a first stage where active substances that even though overall acceptable still give rise to concern are listed in Annex I, but are also flagged for substitution. Biocidal products containing these active substances may be compared with others that are available on the market for the same or similar use pattern, and if they present significantly higher risk than those, their authorisations are refused or cancelled at Member State level.

In line with recent policy developments in REACH and the draft Regulation on the placing of plant protection products on the market, sharing of vertebrate animal studies in exchange for equitable compensation becomes mandatory. This is expected to save costs and animal lives by prohibiting the duplication of these studies.

The data protection system is significantly simplified, without cutting back on any acquired rights under the current system. It also grants protection to data submitted after the inclusion of the active substance in Annex I (mainly during product authorisation): these studies are not protected by the current legislation. The proposed data protection system also covers the case of newly generated studies that, contrary to the legislator's intention, do not benefit from data protection because certain Member States required their submission for the purposes of national authorisation during the transitional period (only data submitted for the first time in support of the first inclusion of the active substance are protected by the current system).

The data requirements of the Directive are modified. First, the principle of proposing and accepting adaptations to the data requirements is formalised and Member States have to inform and if possible assist the applicants with their adaptation requests. Second, the grounds for data waiving provided for in REACH will apply also for the proposed Regulation. Third, the core data requirements are modified and certain long-term animal studies are only required when necessary - these happen to be the most costly data requirements, in terms of lives of test animals and in terms of money.

The confidentiality provisions are slightly modified and aligned with those of REACH. This is to facilitate their application by ECHA, which would otherwise have to apply two different sets of confidentiality rules in its everyday operations.

For the purpose of facilitating the movement of biocidal products in the EU territory, the proposal provides for specific parallel trade rules: authorised biocidal products that have the same use, contain the same active substance and have essentially identical composition to products authorised in another Member State may be placed on the market of that other Member State via a simplified administrative procedure.

Finally, the proposal provides for a number of transitional measures to facilitate the transition from the system of the Directive to that of the draft Regulation, to introduce ECHA into the biocides regulatory framework, and to safeguard any acquired rights under the current system.

3.2. 310Legal basis

Article 95 of TEC.

3.3. 329Subsidiarity principle

The purpose of this Regulation is to facilitate the free movement of biocidal products within the Community. In order to ensure the functioning of the internal market with biocidal products, it is necessary to harmonise the conditions of their placing on the market at the level of the Community.

Individual measures of Member States stemming from the different levels of protection could result in obstacles to trade in biocidal products. This could compromise the achievement of objectives related to the internal market. The Community is, therefore, better placed to take action with regards to the conditions of placing on the market and use of biocidal products.

The subsidiarity principle was also closely considered when deciding on the distribution of tasks between the competent authorities of Member States, the Agency and the Commission, in particular with respect to the authorisation of biocidal products.

3.4. Proportionality principle

The proposal complies with the proportionality principle for the following reason(s).

The proposed Regulation aims to harmonise the conditions for placing biocidal products on the market but with respect to the majority of biocidal products it leaves it to the Member States to authorise these products in accordance with these conditions. The centralised procedure in which the Commission grants a Community authorisation will be restricted to two categories of biocidal products: products based on new active substances and low-risk biocidal products. For these categories of biocidal products centralisation is justified because of its positive impact on innovation and instant access to the entire Community market.

The proportionality principle was also respected with respect to the fees. The Commission will adopt another Regulation setting out a harmonised structure for fees but the decision on the amount of the fees will remain within the competence of the Member States.

Furthermore, the proposed Regulation does not go further than what is necessary with respect to its scope and the administrative burden on the industry as well as the competent authorities. In fact, the administrative and financial burden on the industry and the competent authorities will be reduced compared to Directive 98/8/EC because of the following reasons:

– the provision of strict deadlines for each procedural step will increase the predictability and facilitate the access of biocidal products to the market;

– the centralised authorisation will save time and costs for both the industry and competent authorities;

– the possibility of a mutual recognition in parallel will provide for a closer cooperation among the Member States concerning the evaluation of a biocidal product while saving financial and human resources;

– the mandatory data sharing with respect to vertebrate animal data will save the costs for the industry and avoid repeated evaluating of the same data by the competent authorities.

3.5. Choice of instruments

Proposed instruments: Regulation.

Other means would not be adequate for the following reason(s).

The current regulatory framework for the placing on the market of biocidal products is Directive 98/8/EC. The Commission - in line with recent proposals concerning the plant protection products legislation and general chemicals legislation (the REACH Regulation and the Regulation on classification, labelling and packaging of substances and mixtures) - is proposing to replace that Directive with a Regulation. This will eliminate the need for a transitional period and will advance the implementation of urgently needed provisions by approximately two years. A Regulation will also ensure the uniform application of the new instrument throughout the EU, in particular the procedures and deadlines for authorisation of biocidal products and mutual recognition of those authorisations. Differences in the transposition of measures and/or the implementation would have very serious consequences for the functioning of the internal market in biocidal products.

The choice of the legal instrument will also reduce the administrative burden and ensure the clarity for the industry.

4. Budgetary implication

The proposal will have budgetary implications as there is a need to support the European Chemicals Agency (the Agency) in taking up the additional tasks related to the assessment and inclusion of active substances used in biocidal products in Annex I of the Regulation and the centralised authorisation of certain biocidal products. The Agency will receive specific fees from applicants for certain of these activities as well as an annual fee on products centrally authorised by the Community. The revenue from the fees will have to be supplemented by a subsidy from the Community. It is, however, expected that this support from the Community will be limited in time as the activities of the Agency should be self-funding through fee revenues after a number of years. Detailed rules on the budget of the Agency and its implementation are already laid down in REACH Regulation (EC) No. 1907/2006. These rules shall apply accordingly in the context of this Regulation.

5. Additional information

5.1. 510Simplification

The proposal provides for simplification of legislation, simplification of administrative procedures for public authorities (EU or national), and for private parties.

Apart from the obvious economy of dispensing with transposition measures, transposition periods and transposition conformity controls that is achieved by replacing the current Directive with a Regulation, the proposal clarifies in much greater detail than in the present text the procedures to be followed for granting authorisations by the Member States and the procedures for mutual recognition of those authorisations.

In particular, the acceptable grounds for opposing mutual recognition are made clear and procedural steps are provided for the resolution of disputes.

In addition, the grounds for waiving data requirements are set out in more detail, enhancing legal certainty for the applicants. In the current system, while the principle of waiving data requirements is recognised, little is provided as conditions for implementing the principle. As a result, Member States are sometimes reluctant to allow that certain studies listed in the core data set need not be submitted by the applicant as the safety of a substance is sufficiently established by other available information.

The data protection provisions are simplified and better aligned with the objectives of the Community policy (recovery of costs - protection for newly generated data).

Lastly, the establishment of a centralised system for the authorisation of certain products is an obvious simplification as the products concerned will not need individual authorisation in all or some of the 27 Member States.

The Member States competent authorities will have a more harmonised framework for granting authorisations (e.g. harmonised content of an authorisation document). They will also have specific deadlines and procedures for all the tasks related to authorisation and mutual recognition.

With the handling of the procedure for the evaluation of active substances by ECHA there will be greater transparency, co-ordination and efficiency of the process compared to the current system. This will among others avoid the same active substance being evaluated in parallel by two different Member States.

The proposal foresees that Member States will have a common structure on the basis of which they can rationally develop their fees' systems.

Enterprises supporting the placing on the market of a low-risk product or a product containing a new active substance will be able to obtain only one (Community) authorisation valid for the whole EU territory. Consequently, the Member States will not need to carry out an evaluation as those products will be approved via centralised authorisations. There will also be no need for mutual recognition or multiple provisional authorisation procedures for these products, as those will be handled at Community level by ECHA.

Enterprises will now have to consult only one legal text that applies in the EU instead of 27 national transposition instruments.

Authorisation and mutual recognition procedures are better defined and predictable and specific deadlines are added.

The legal certainty is increased with regard to the protection afforded to studies submitted in support of an application.

The proposal is included in the Commission's rolling programme for up-date and simplification of the acquis communautaire and its Work and Legislative Programme under the reference COM(2007) 640.

5.2. 520Repeal of existing legislation

The adoption of the proposal will lead to the repeal of existing legislation, in particular Directive 98/8/EC.

5.3. Review/revision/sunset clause

The proposal includes a review clause.

5.4. 540Recasting

The proposal does not involve recasting.

5.5. 560European Economic Area

The proposed act concerns an EEA matter and should therefore extend to the European Economic Area.

2009/0076 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

concerning the placing on the market and use of biocidal products

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission [1],

Having regard to the opinion of the European Economic and Social Committee [2],

Having regard to the opinion of the Committee of the Regions [3],

Acting in accordance with the procedure laid down in Article 251 of the Treaty [4],

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 Community. In order to remove as far as possible obstacles to trade in biocidal products stemming from the different levels of protection in the Member States, harmonised 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 [5]. It is necessary to adapt that system on the basis of a report on the first seven years of its implementation submitted by the Commission to the European Parliament and the Council [6], which analyses 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 Community.

(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 this 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. That date made a difference between substances which were on the market on that date and those which were not. A work programme is 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 being 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 could be placed on the market so as to ensure that only safe new products could 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 not complying 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 Community 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 Community list. The information that interested parties should submit in support of an inclusion of an active substance in the Community 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, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC [7].

(10) With 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 XXX/2009 of the European Parliament and of the Council of ..... 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC [8], 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 Community 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 higher risk than previously thought, the Commission should be able to review an 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 efficient towards the targeted harmful organisms become available in sufficient variety to avoid the development of resistances 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 ten 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 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 foreseen 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 Community list or the authorisation should only be carried out if the competent authority that was responsible for the initial evaluation decides so on 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 Community level. The European Chemicals Agency set up under Regulation (EC) No 1907/2006 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 Community territory. Consequently, a Biocidal Products Committee should be established within the Agency to carry out the tasks attributed to the European Chemicals 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, it should be required that such biocidal products 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 [9], Council Directive 93/42/EEC of 14 June 1993 concerning medical devices [10] or Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices [11].

(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 Community 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 [12].

(19) Processing aids are covered by existing Community 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 [13] 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 [14]. 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, previously covered by product type 20, are covered by Council Directive 89/107/EEC and Regulation (EC) No 1831/2003 of the European Parliament and of the Council, 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) 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 Community 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 a territory of a Member State, or a part of it, or by the Commission for placing on the market or use in the Community.

(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 Commission, taking into account the experience with the provisions on Community authorisations, may decide to extend the scope of the Community authorisation procedure to other biocidal products.

(25) 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 order to encourage the use of low-risk biocidal products with more favourable environmental or human health profile compared to other biocidal products, it should be allowed to authorise low-risk biocidal products without prior approval of the active substances contained therein.

(27) 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) 1907/2006. This is, in particular, necessary because these substances do not fulfil the conditions in Article 15(2) of that Regulation.

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

(29) 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 to decide on the authorisation.

(30) 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 not necessary 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.

(31) 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.

(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 for limited variations with regard to the reference biocidal product provided that those changes 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 from its use.

(34) 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 Community, procedures should be established to ensure that authorisations of products granted in one Member States are recognised in all other Member States.

(35) 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.

(36) 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 the mutual recognition together with the application for the first authorisation.

(37) There is a need to provide for a dispute settlement mechanism at Community level to ensure an 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 case of technical or scientific questions, the Commission may consult the Agency before preparing the decision.

(38) 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 falling 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.

(39) 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.

(40) If the use of a biocidal product is in the interest of a Member State, but there is no applicant interested in the placing of 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 case they are granted an authorisation, they should possess the same rights and obligations as any other authorisation holder.

(41) 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 which 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.

(42) 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.

(43) 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 Community from authorising, for a limited period of time, biocidal products containing that active substance before the latter 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.

(44) In order to encourage the 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.

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

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

(47) For the purpose 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.

(48) 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 should be able to recover part of their investment by receiving equitable compensation whenever use of proprietary information which they submitted in support of such inclusions or authorisations is made for the benefit of subsequent applicants.

(49) In view of ensuring that all proprietary information submitted in support of an inclusion of an active substance 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.

(50) 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.

(51) It is essential to minimise the number of tests on animals and to ensure that testing 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 absence of an agreement on sharing of 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 Community 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.

(52) The generation of information by alternative means not involving tests on animals which 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.

(53) 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.

(54) 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.

(55) In order to increase the efficiency 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.

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

(57) 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.

(58) The costs of the procedures associated with the operation of this Regulation need to be recovered from those seeking to place or placing biocidal products on the market and from those supporting the entries 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.

(59) 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 processing of appeals against decisions adopted by the Agency under this Regulation.

(60) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [15].

(61) In particular, the Commission should be empowered to adopt measures to decide on the application to include the active substance in Annex I or to renew or review the inclusion, to specify the procedures related to the renewal and review of an inclusion of an active substance in Annex I, to extend the provisions on Community authorisations to other categories of biocidal products, to specify the criteria and procedures related to a cancellation of an authorisation or amendments of the terms and conditions of an authorisation, including a dispute settlement mechanism, to specify the overall applicable maximum quantities of active substances or biocidal products that may be released during experiments and the minimum data to be submitted, to establish a harmonised structure of fees and other rules concerning the payment of fees and charges to the competent authorities and the Agency, to adapt the Annexes to scientific and technical progress, to carry out the work programme and to specify the related rights and obligations of the competent authorities and the participants in the programme and to extend the duration of the work programme for a determined period. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, inter alia, by supplementing this Regulation with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

(62) When, on imperative grounds of urgency, the normal time limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to apply the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of decisions to amend the inclusion of an active substance in Annex I or to remove it from that Annex on basis of Article 13.

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

(64) 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.

(65) 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 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.

(66) Taking into consideration that some products were not previously covered by the Community 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, treated articles and materials and food contact materials.

(67) 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 will 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 foreseen in such cases.

(68) 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 Community;

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

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

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 [16];

(b) Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition [17];

(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 [18];

(d) Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives [19];

(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 [20];

(f) 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 [21];

(g) Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market [22];

(h) Council Directive 93/42/EEC of 14 June 1993 concerning medical devices [23];

(i) European Parliament and Council Directive No 95/2/EC of 20 February 1995 on food additives other than colours and sweeteners [24];

(j) Council Directive 96/25/EC of 29 April 1996 on the circulation and use of feed materials, amending Directives 70/524/EEC, 74/63/EEC, 82/471/EEC and 93/74/EEC and repealing Directive 77/101/EEC [25];

(k) Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices [26];

(l) 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 [27];

(m) 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 [28];

(n) Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition [29];

(o) Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs [30];

(p) 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 [31].

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 [32];

(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 [33];

(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 [34];

(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) [35];

(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 [36];

(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 [37];

(g) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC [38];

(h) Directive 2006/114/EC of 12 December 2006 of the European Parliament and of the Council concerning misleading and comparative advertising [39];

(i) 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 [40];

(j) [proposal for a Directive of the European Parliament and of the Council establishing a framework for Community action to achieve the sustainable use of pesticides];

(k) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 [41].

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, 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 having 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 the active substance, which has an inherent capacity to cause an adverse effect on humans, animals or the environment and is present or is produced in a biocidal product in sufficient concentration to present risks of such an effect;

(g) 'harmful organism' means

organisms, including pathogenic agents, which have an unwanted presence or a detrimental effect on humans, their 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, 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 first supply of a biocidal product for distribution or for use on the Community market in the course of a commercial activity, whether in return for payment or free of charge;

(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 export of the biocidal product outside the Community;

(k) 'treated material or article' means

any substance, mixture, material or article which was treated with or incorporates one or more biocidal products with the intention to protect the substance, mixture, material or article from deterioration caused by harmful organisms;

(l) '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;

(m) 'Community 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 Community or in a part thereof;

(n) 'authorisation' means

national authorisation or Community authorisation;

(o) '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;

(p) 'frame formulation' means

a group of biocidal products having similar uses and presenting 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;

(q) 'letter of access' means

an original document, signed by the owner or owners of information, which states that the information may be used by the competent authorities, the European Chemicals Agency, or the Commission for the purpose of evaluating an active substance or granting an authorisation;

(r) 'food and feedingstuff' means

food as defined in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council [42] and feedingstuff as defined in Article 3(4) of that Regulation.

(s) 'food contact materials' means

any material and article intended to come into contact with food which are covered by Regulation (EC) No 1935/2004 [43];

(t) '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;.

(u) '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.

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 the biocidal products containing that active substance fulfil the conditions laid down in point (b) of Article 16(1).

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. An active substance shall, where appropriate, be included in Annex I together with any of the following conditions:

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

4. 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 [44] [and Council Regulation (EEC) No 2377/90].

Article 5

Exclusion criteria

1. Notwithstanding Article 4(1), active substances referred to in paragraph 2 shall be included in Annex I only if at least one of the following conditions is met:

(a) the exposure of humans to that active substance in a biocidal product, under normal conditions of use, is negligible, in particular where the product is used in closed systems or strictly controlled conditions;

(b) it is shown that the active substance is necessary to control a serious danger to public health;

(c) it is shown that not including the active substance in Annex I would cause disproportionate negative impacts when compared with the risk to human health or the environment arising from the use of the substance and that there are no suitable alternative substances or technologies.

Point (c) shall not apply to active substances for product types 4 and 14 to 19.

2. The following active substances shall be included in Annex I where at least one of the conditions set out in paragraph 1 is met:

(a) active substances which have been classified in accordance with Regulation (EC) No 1272/2008 as, or which meets 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 identified under Article 57(f) of Regulation (EC) No 1907/2006 as having endocrine disrupting properties.

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 for the active substance satisfying the requirements set out in Annex II;

(b) 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 70.

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 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.

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. The Commission shall adopt the measures designed to set the criteria defining what constitutes adequate justification to adapt the data required under paragraph 1 on the ground referred to in paragraph 2(a).

Those measures designed to amend non-essential elements of this Regulation by supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 72(4).

Article 7

Submission and validation of applications

1. The applicant shall submit an application to include an active substance in Annex I, or to make subsequent amendments to the conditions of inclusion of an active substance, to the European Chemicals Agency (hereinafter referred to as 'the Agency') and inform it of the name of the competent authority of the Member State that he chooses to evaluate his application. That competent authority (hereinafter referred to as 'the evaluating competent authority') shall be responsible for the evaluation of the application.

2. 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.

3. Within two months after the 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 70.

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 as to what additional information is required for the validation of the application and shall set a reasonable time limit for the submission of that information.

The Agency shall, within two months after the 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 70 shall be reimbursed.

5. An appeal may be brought, in accordance with Article 67, against Agency decisions under the third subparagraph of paragraph 4.

6. If the Agency, on the basis of the validation made pursuant to paragraph 3, 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, and shall inform the Agency thereof.

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, 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 the 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.

5. On receipt of the opinion of the Agency, the Commission shall adopt a decision on the application to include the active substance in Annex I. That decision, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 72(4).

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 the receipt of the notification referred to in Article 7(2). The Commission shall take the decision in accordance with the procedure referred to in Article 72(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 fulfilling 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, even with very restrictive risk management measures;

(d) it contains a significant proportion of non-active isomers;

(e) it is classified or meets the criteria to be classified, in accordance with Regulation (EC) No 1272/2008, as 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 on the basis of the assessment of Community 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 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 Article 10(3), the inclusion of an active substance in Annex I that is considered as a candidate for substitution shall be renewed for a period not exceeding ten 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 an active substance inclusion

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 Article 4.

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 otherwise specified in the decision to renew the inclusion of an active substance in Annex I, the renewal shall be for an unlimited period of time.

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 70.

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 the 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 the 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 70.

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 as to what additional information is required for the validation of the application and shall set a reasonable time limit for the submission of that information.

The Agency shall, within two months after the 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 70 shall be reimbursed.

5. An appeal may be brought, in accordance with Article 67, against Agency decisions under the third subparagraph of paragraph 4.

6. If the Agency, on basis of the validation made pursuant to paragraph 3, considers 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 a 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 the 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. At the end of the period referred to in paragraph 3 or on receipt of the opinion of the Agency, the Commission shall adopt a decision concerning a renewal of the inclusion of the active substance in Annex I. That decision, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 72(4).

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 72(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. The Commission may review the inclusion of an active substance in Annex I at any time where there are serious indications that the requirements referred to in Article 4 are no longer complied with. Where those indications are confirmed, the Commission shall adopt a decision amending the inclusion of an active substance in Annex I or removing it from that Annex.

That decision, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 72(4). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 72(5).

2. The Commission may consult the Agency on any questions of a scientific or technical nature related to the review of inclusion of an active substance in Annex I. The Agency shall, within nine months from 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

Implementing measures

The Commission may adopt detailed measures for the implementation of Articles 10 to 13 of this Regulation specifying the procedures related to the renewal and review of an inclusion of an active substance in Annex I.

Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 72(4).

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 shall be responsible for the placing on the market of a biocidal product in a particular Member State or in the Community.

Application for national authorisation in a Member State shall be submitted to the competent authority of that Member State (hereinafter referred to as 'the receiving competent authority').

Application for Community authorisation shall be submitted to the Agency.

A holder of an authorisation shall have a permanent office within the Community.

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 by 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.

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 unacceptable effects itself or as a result of its residues, directly or indirectly, on human or animal health;

(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;

- its impact on non-target organisms;

- its impact on biodiversity and the ecosystem;

(c) the nature, 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 residues of toxicological or environmental significance, which result from uses to be authorised, can be determined according to the relevant requirements in Annexes II and III;

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

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