Commission regulation (EC) No 2032/2003
of 4 November 2003
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, and amending Regulation (EC) No 1896/2000
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to 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(1), and in particular Article 16(2) thereof,
Whereas:
(1) Pursuant to Directive 98/8/EC a programme of work is to be carried out for the review of all active substances in biocidal products already on the market on 14 May 2000, hereinafter "existing active substances". The initial phase of the programme was laid down in Commission Regulation (EC) No 1896/2000 of 7 September 2000 on the first phase of the programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council on biocidal products(2).
(2) Under Regulation (EC) No 1896/2000 existing active substances for use in biocidal products had to be identified and those to be evaluated with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC in one or more product types had to be notified no later than 28 March 2002. An additional period for the submission of notifications for existing active substances that had been identified only or had been notified only in respect of certain product types was granted by Commission Regulation (EC) No 1687/2002 of 25 September 2002 on an additional period for notification of certain active substances already on the market for biocidal use as established in Article 4(1) of Regulation (EC) No 1896/2000(3). That period expired on 31 January 2003.
(3) It is necessary to establish an exhaustive list of existing active substances that have been identified in accordance with Article 3(1) or Article 5(2) of Regulation (EC) No 1896/2000 or in respect of which equivalent information has been submitted in a notification in accordance with Article 4(1) of that Regulation.
(4) It is also necessary to establish an exhaustive list of existing active substances in respect of which at least one notification has been accepted in accordance with Article 4(2) of Regulation (EC) No 1896/2000 or in which a Member State has expressed an interest in accordance with Article 5(3) of that Regulation. That list should specify the product types concerned.
(5) Since existing active substances that have been identified only will not be evaluated within the framework of the review programme, they should not be included in Annex I, IA or IB to Directive 98/8/EC. The same should apply to any existing active substance/product type combination, notification of which has not been accepted.
(6) It is necessary to specify the date from which, in view of that non-inclusion decision, the Member States must comply with their obligations under Article 16(3) of Directive 98/8/EC.
(7) After the exhaustive list of existing substances has been established, no further phase-out period should be allowed for active substances not identified within the time-limits laid down in Regulation (EC) No 1896/2000, or for biocidal products containing those substances.
(8) For the second phase of the review programme, priorities for the evaluation of existing active substances should be established. The lists of prioritised substances and the dates for submission of complete dossiers should be specified The task of evaluation should be distributed among the competent authorities of the various Member States. In order to enable new Member States to participate in the review programme after their accession, it is appropriate, for the time being, to designate Rapporteur Member States only in respect of certain product types. A Member State which has indicated an interest in seeking review of a particular active substance should not be designated Rapporteur Member State for that substance.
(9) In order to avoid duplication of work, and in particular to reduce testing involving vertebrate animals, the requirements concerning preparation and submission of the complete dossier should be such as to encourage those whose notifications have been accepted, hereinafter "participants", to act collectively, in particular by submitting collective dossiers. It should be possible for the Rapporteur Member State to make available the reference to any test involving vertebrate animals that has been carried out in respect of a notified existing active substance unless that reference is confidential under Article 19 of Directive 98/8/EC. Also, in order to gain experience on the appropriateness of data requirements and to ensure that the review of active substances is carried out in a cost-effective way, participants should be encouraged to provide information on the costs of compiling a dossier and on the need to carry out tests on vertebrate animals.
(10) In order to avoid delays, participants should start discussions as early as possible with Rapporteur Member States in order to resolve uncertainties in relation to data requirements. Applicants, other than participants, who wish to apply in accordance with Article 11 of Directive 98/8/EC for inclusion in Annex I, IA or IB thereto of an active substance/product type combination being evaluated under the review programme should submit complete dossiers for that combination no earlier than participants so as not to disturb the smooth functioning of the review programme.
(11) The requirements concerning the content and format of dossiers and the number of dossiers to be submitted should be defined.
(12) Provision should be made for cases in which a participant is joined by a producer, formulator or association and in which a participant withdraws from the review programme.
(13) Producers, formulators or associations should within certain time-limits have the opportunity of taking over the role of participant for an existing active substance/product type combination in respect of which all participants have withdrawn or none of the dossiers meets requirements. Subject to the same time-limits, it should also be possible in certain circumstances for Member States to indicate an interest in the inclusion in Annex I, IA or IB to Directive 98/8/EC of such a combination. A Member State which has indicated such an interest should be deemed to act as participant.
(14) All information required for a proper evaluation of, and decision on, the active substance concerned in the light of the criteria set out in Articles 10 and 11 of Directive 98/8/EC should be submitted in the complete dossier. If only limited information is submitted, in particular for the purposes of risk assessment regarding exposure of humans or the environment, the conditions for inclusion of the active substance in Annex I, IA or IB to Directive 98/8/EC should, where appropriate, be made more stringent.
(15) Time-limits should be specified within which the Rapporteur Member States must verify the completeness of the dossiers. It should be possible, in exceptional circumstances, for the Rapporteur Member States to establish a new deadline for the submission of parts of a dossier, in particular where the participant has demonstrated that it was impossible to submit information in due time or in order to resolve uncertainties regarding data requirements that remain despite earlier discussions between the participant and the Rapporteur Member State.
(16) For each existing active substance, the Rapporteur Member State should examine and evaluate the dossier and present the results to the Commission and the other Member States in the form of a competent authority report and a recommendation as to the decision to be taken with regard to the active substance concerned. In order not to prolong decision-making unnecessarily, the Rapporteur Member State should at the same time consider carefully the need for additional studies. For the same reason, Rapporteur Member States should be obliged to take into consideration information submitted after acceptance of the dossier only under specified conditions.
(17) The competent authority reports should be examined by the other Member States within a programme co-ordinated by the Commission before they are submitted to the Standing Committee on Biocidal Products.
(18) Where, despite a recommendation for inclusion of an active substance in Annex I, IA or IB to Directive 98/8/EC, concerns as referred to in Article 10(5) of that Directive remain, it should be possible for the Commission to take into account, but without prejudice to Article 12 of that Directive, the finalisation of the evaluation on other existing active substances applied for the same use. Provision should be made for Rapporteur Member States to update competent authority reports where necessary.
(19) Rules should be laid down regarding access to the information in the final competent authority reports.
(20) It should be possible to suspend the procedures provided for in this Regulation in the light of the application of other Community acts, in particular as regards Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations(4), as last amended by Directive 2003/53/EC of the European Parliament and of the Council(5).
(21) In requiring notifiers to submit the complete dossier to the Commission rather than to the Rapporteur Member State, Article 4(3) and the first subparagraph of Article 8(2) of Regulation (EC) No 1896/2000 are incompatible with Articles 8 and 11 of Directive 98/8/EC. Also, since it was urgent that the evaluation of active substances in relation to product types 8 and 14 commence without delay, provisions concerning those substances were laid down in Regulation (EC) No 1896/2000. For reasons of clarity and coherence, however, it is appropriate to lay down in a single instrument the provisions concerning all product types referred to in Directive 98/8/EC.
(22) Regulation (EC) No 1896/2000 should therefore be amended accordingly.
(23) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,
HAS ADOPTED THIS REGULATION:
Article 1
Subject matter
This Regulation lays down detailed rules for the implementation of the second phase of the programme of work for the systematic examination of all active substances already on the market on 14 May 2000 as active substances of biocidal products, hereinafter "the review programme", referred to in Article 16(2) of Directive 98/8/EC.
Article 2
Definitions
For the purposes of this Regulation the definitions in Article 2 of Directive 98/8/EC and Article 2 of Regulation (EC) No 1896/2000 shall apply.
In addition, "participant" means a producer, formulator or association which has submitted a notification that has been accepted by the Commission in accordance with Article 4(2) of Regulation (EC) No 1896/2000 or a Member State which has indicated an interest in accordance with Article 5(3) of that Regulation.
Article 3
Identified and notified existing active substances
1. Annex I contains the exhaustive list of existing active substances which have been identified in accordance with the requirements of Article 3(1) or 5(2) of Regulation (EC) No 1896/2000 or in respect of which equivalent information has been provided in a notification submitted in accordance with Article 4(1) of that Regulation.
2. Annex II contains the exhaustive list of existing active substances in respect of which:
(a) at least one notification has been accepted by the Commission in accordance with Article 4(2) of Regulation (EC) No 1896/2000, or
(b) a Member State has indicated an interest in accordance with Article 5(3) of Regulation (EC) No 1896/2000.
That list specifies, for each notified existing active substance included, the product type(s) in respect of which notification has been accepted or a Member State has expressed an interest.
3. Annex III contains the list of existing active substances that have been identified but in respect of which there has been neither an accepted notification nor an expression of interest by a Member State.
Article 4
Non-inclusion
1. Active substances listed in Annex III shall not be included in Annex I, IA or IB to Directive 98/8/EC within the framework of the review programme.
An active substance listed in Annex II shall not be included in Annex I, IA or IB to Directive 98/8/EC within the framework of the review programme in relation to any product type not specified in Annex II in conjunction with that substance.
2. Without prejudice to Article 8 of Directive 98/8/EC, the date with effect from which Member States shall, in accordance with Article 16(3) of Directive 98/8/EC, cancel existing authorisations or registrations for biocidal products containing the active substances listed in Annex III, and ensure that such biocidal products are not placed on the market in their territory, shall be 1 September 2006.
In the case of an active substance listed in Annex II, the first subparagraph shall also apply to that substance in relation to any product type for which no notification has been accepted.
3. From the date of entry into force of this Regulation, any active substance not listed in Annex I shall be deemed not to have been placed on the market for biocidal purposes before 14 May 2000.
Article 5
Review of notified existing active substances
1. The review of an active substance listed in Annex II, in respect of the product type(s) specified, shall be undertaken by the Rapporteur Member State designated for that purpose on the basis of the complete dossier for that substance and product type, provided that:
(a) the dossier complies with the requirements set out in Annex IV;
(b) the complete dossier is submitted within the time period specified in Annex V to this Regulation for the product type concerned, together with the summary dossier referred to in Article 11(1)(b) of Directive 98/8/EC and defined in Annex IV to this Regulation.
Without prejudice to Article 8 of this Regulation, an active substance listed in Annex II shall be reviewed exclusively in relation to the product type(s) in respect of which notification has been accepted.
2. The Rapporteur Member States designated to review active substances listed in Annex II in respect of product types 8 and 14 are specified in Part A of Annex V.
The Rapporteur Member States designated to review active substances listed in Annex II in respect of product types 16, 18, 19 and 21 are specified in Part B of Annex V.
A Member State which has indicated an interest in an existing active substance pursuant to Article 5(3) of Regulation (EC) No 1896/2000 shall not be designated as Rapporteur Member State in respect of that substance.
3. Without prejudice to Article 8 of this Regulation, an applicant who is not a participant and who wishes to apply, in accordance with Article 11 of Directive 98/8/EC, for the inclusion in Annex I, IA or IB thereto of an existing active substance which has been notified, or in which a Member State has indicated an interest, in relation to a product type specified in Annex V to this Regulation shall submit a complete dossier within the time period specified in that Annex for that substance/product type combination.
4. The relevant competent authorities as of 1 July 2003 are listed in Annex VI.
Article 6
Preparation of the complete dossier
1. In the preparation of the complete dossier, all reasonable efforts shall be made, inter alia, to avoid duplication of testing on vertebrate animals and, where appropriate, to establish a collective complete dossier.
2. Before commencing compilation of the complete dossier, a participant shall:
(a) inform the Rapporteur Member State of any testing on vertebrate animals that it has already carried out;
(b) contact the Rapporteur Member State for advice as to the acceptability of justifications for waiving certain studies;
(c) inform the Rapporteur Member State of any intention to carry out further testing on vertebrate animals for the purposes of the complete dossier;
(d) when informed by the Rapporteur Member State that another participant has notified plans to carry out the same tests, make all reasonable efforts to cooperate with that participant in the performance of common testing.
Advice given by Rapporteur Member States in accordance with point (b) of the first subparagraph shall not predetermine the outcome of the completeness check under Article 9(1).
3. A Rapporteur Member State may make available the reference to any test carried out on vertebrate animals in respect of an active substance listed in Annex II to this Regulation, save where that reference is to be treated as confidential in accordance with Article 19 of Directive 98/8/EC. Such reference may include the name of the active substance concerned, the end points of the tests, and the contact address of the data owner.
4. Where a Rapporteur Member State is aware that more than one participant is seeking review of a particular active substance, it shall inform those participants accordingly.
5. Participants seeking review of the same active substance for the same product type(s) shall undertake all reasonable efforts to submit a collective complete dossier, while fully respecting the Community rules on competition.
Where, in those circumstances, a collective dossier is not submitted, each individual dossier shall detail the efforts made to secure co-operation and the reasons for non-participation.
6. Details shall be given in the complete dossier and in the summary dossier of the efforts made to avoid duplication of testing on vertebrate animals.
7. In order to provide information on the costs entailed in applying for review and on the need for animal testing for the purposes of compiling the complete dossier, participants may submit to the Rapporteur Member State together with the complete dossiers a breakdown of the costs of the respective actions and studies carried out.
The Rapporteur Member State shall communicate that information to the Commission when submitting the competent authority report in accordance with Article 10(5).
8. The Commission shall include in the report referred to in Article 18(5) of Directive 98/8/EC information on the costs entailed in compiling the complete dossier and on the animal testing carried out for that purpose, together with any appropriate recommendations concerning modifications of data requirements in order to reduce to a minimum the need for testing on vertebrate animals, and to ensure cost-effectiveness and proportionality.
Article 7
Submission of the complete dossier
A participant shall submit to the Rapporteur Member State at least one paper copy of the complete dossier and one copy in electronic format. The Rapporteur Member State may require additional copies on paper or in electronic format.
The participant shall also, in accordance with Article 9(3), submit one paper copy of the summary dossier and one copy in electronic format to the Commission and to each of the other Member States.
Article 8
Joining, replacing or withdrawal of participants
1. If, by mutual agreement, a producer, formulator or association joins or replaces a participant in the submission of the complete dossier, all parties to the agreement shall jointly inform the Commission and the Rapporteur Member State accordingly, attaching any relevant letter of access.
The Commission shall inform accordingly any other participant seeking review of the same active substance in relation to the same product type(s).
2. If a participant intends to discontinue participation in the review programme, it shall inform the relevant Rapporteur Member State and the Commission accordingly, in writing and without delay, stating the reasons.
The Commission shall inform accordingly the other Member States and any other participant seeking review of the same active substance in relation to the same product type(s).
3. The Commission shall inform the Member States if a situation arises where, as regards a particular existing active substance/product type combination, all the participants have withdrawn. That information shall also be made public by electronic means.
4. Within three months of the publication of the information referred to in paragraph 3, a producer, formulator, association or other person wishing to take over the role of participant as regards the existing active substance/product type combination shall inform the Commission accordingly.
Within the time period referred to in the first subparagraph, a Member State also may indicate to the Commission an interest in the inclusion in Annex I, IA or IB to Directive 98/8/EC of the existing active substance/product type combination, where there are uses which the Member State considers essential, in particular for the protection of human health, animal health or the environment. By indicating such an interest that Member State shall be deemed to have taken over the role of participant.
In the cases envisaged in the first and second subparagraphs, the relevant time period specified in Annex V may, where appropriate, be prolonged and a different Rapporteur Member State may be designated.
5. Where the Commission receives no response pursuant to paragraph 4, a decision shall be taken not to include the existing active substance in Annex I, IA or IB to Directive 98/8/EC within the framework of the review programme for the product type(s) concerned.
Article 9
Completeness check of dossiers
1. Within three months of receiving the dossier for an existing active substance/product type combination and no later than three months after the end of the time period specified in Annex V to this Regulation, the Rapporteur Member State shall verify whether the dossier is to be accepted as complete in accordance with Article 11(1)(b) of Directive 98/8/EC.
Where the Rapporteur Member State has initiated consultations with other Member States and the Commission in relation to the acceptability of a dossier, the period may be prolonged until consultations have been finalised, up to a maximum of six months from receipt of the dossier.
2. A Rapporteur Member State may require, as a condition for considering a dossier to be complete advance payment, in full or in part, of the charges payable under Article 25 of Directive 98/8/EC and proof of payment to be provided in the dossier.
3. Where a dossier is considered to be complete, the Rapporteur Member State shall confirm acceptance of the dossier to the participant and agree to the participant forwarding the summary dossier to the Commission and the other Member States within one month of receiving the confirmation.
4. In exceptional circumstances, the Rapporteur Member State may establish a new deadline for the submission of information which, for reasons duly substantiated, the participant was unable to submit in due time.
The participant shall, within three months of being informed of the new deadline, provide evidence to the Rapporteur Member State that work to provide the missing information has been commissioned.
If the Rapporteur Member State considers that it has received sufficient evidence, it shall carry out its evaluation in accordance with Article 10 as if the dossier were complete. Otherwise, the evaluation shall not commence until the missing information is submitted.
5. If a complete dossier is not received within the time period specified in Annex V or, where relevant, by a new deadline established in accordance with paragraph 4, the Rapporteur Member State shall inform the Commission, giving the reasons put forward by the participant by way of justification.
The Rapporteur Member State shall also inform the Commission in cases where a participant fails to provide the evidence required in accordance with the second subparagraph of paragraph 4.
In the cases referred to in the first and second subparagraphs and if no other dossier concerns the same existing active substance/product type combination, the procedure referred to in Article 8(3), (4) and (5) shall apply mutatis mutandis.
6. If a Member State in receipt of a summary dossier in accordance with paragraph 3 has legitimate reason to believe that the dossier is incomplete, it shall without delay communicate its concerns to the Rapporteur Member State, the Commission and the other Member States.
The Rapporteur Member State shall immediately take up consultations with that Member State and the Commission in order to discuss the concern expressed and resolve divergent opinions.
Article 10
Evaluation of dossiers by the Rapporteur Member State
1. The Rapporteur Member State shall, in the case of a dossier which it considers to be complete, carry out the evaluation in accordance with Article 11(2) of Directive 98/8/EC and shall prepare a report on that evaluation, hereinafter "the competent authority report".
Without prejudice to Article 12 of Directive 98/8/EC, the Rapporteur Member State may take into consideration other relevant technical or scientific information regarding the properties of the active substance, metabolites or residues.
2. A participant may require the Rapporteur Member State to take into consideration additional information relating to an active substance for which the dossier has been accepted as complete only if, at the time when the dossier was submitted, the participant informed the Rapporteur Member State that preparation of the information was under way, and if:
(a) the information is submitted no later than nine months after acceptance of the dossier in accordance with Article 9(3);
(b) by comparison with the data originally submitted, the information is equally or more reliable owing to the application of the same or higher quality standards;
(c) by comparison with the data originally submitted, the information supports a different conclusion concerning the active substance for the purposes of the recommendation under paragraph 7.
The Rapporteur Member State shall take into account additional information submitted by persons other than the participant only if that information satisfies the conditions set out in points (a), (b) and (c) of the first subparagraph.
3. Where relevant in the application of paragraph 1, in particular when additional information has been requested by a deadline established by the Rapporteur Member State, the latter may request that the participant submit updated summary dossiers to the Commission and the other Member States when the additional information is received.
Article 8(3), (4) and (5) shall apply mutatis mutandis if:
(a) the additional information is not received by the deadline;
(b) the participant fails to provide adequate justification for further postponing the deadline;
(c) no other dossier concerns the same existing active substance/product type combination.
4. The Commission shall organise, when necessary, meetings with experts from the Member States to discuss specific issues arising in the context of ongoing evaluations.
A Rapporteur Member State may request that the Commission include certain specific problems on the agenda of those meetings, in which case it shall provide the necessary documentation for distribution through the Commission.
5. The Rapporteur Member State shall, without undue delay, send a copy of the competent authority report to the Commission, the other Member States and to the participant.
6. A Rapporteur Member State may decide to withhold the competent authority report if the charges payable under Article 25 of Directive 98/8/EC have not been paid in full, in which case it shall inform the participant and the Commission accordingly.
Article 8(3), (4) and (5) shall apply mutatis mutandis if:
(a) full payment is not received within three months of the date of receipt of that information;
(b) no other dossier concerns the same existing active substance/product type combination.
7. The competent authority report shall be presented in a format to be recommended by the Commission and shall include one of the following:
(a) a recommendation to include the existing active substance in Annex I, IA or IB to Directive 98/8/EC, stating, where appropriate, conditions for inclusion;
(b) a recommendation not to include the existing active substance in Annex I, IA or IB to Directive 98/8/EC, stating the reasons.
Article 11
Commission procedures
1. When the Commission receives a competent authority report pursuant to Article 10(5) of this Regulation it shall, without undue delay, prepare a draft decision in accordance with Article 27 of Directive 98/8/EC.
2. Before preparing the draft decision referred to in paragraph 1, the Commission shall, when necessary in the light of the comments received on the competent authority report, organise meetings with experts from the Member States to discuss any problems remaining unresolved. Where necessary and upon a request from the Commission, the Rapporteur Member State shall prepare an updated competent authority report.
3. In the case of an existing active substance which, despite a recommendation for inclusion pursuant to Article 10(7) of this Regulation, still gives rise to concern, as referred to in Article 10(5) of Directive 98/8/EC, the Commission may, without prejudice to Article 12 of that Directive, take into account the finalisation of the evaluation on other existing active substances applied for the same use.
Article 12
Access to information
When a Rapporteur Member State has submitted the competent authority report in accordance with Article 10(5) of this Regulation, the report shall be made publicly available by electronic means, except for information that is to be treated as confidential in accordance with Article 19 of Directive 98/8/EC.
Article 13
Suspension of procedures
Where, in respect of an active substance listed in Annex II to this Regulation, the Commission presents a proposal to the European Parliament and to the Council, pursuant to Directive 76/769/EEC, for the prohibition of its placing on the market or its use, including use for biocidal purposes, in certain or all product types, the procedures provided for in this Regulation concerning that substance for use in the product type(s) concerned may be suspended pending a decision on that proposal.
Article 14
Amendments to Regulation (EC) No 1896/2000
Regulation (EC) No 1896/2000 is amended as follows:
(1) In Article 4, paragraph 3 is replaced by the following:"3. If a notification is accepted by the Commission, the notifier shall provide to the competent authority of the designated Rapporteur Member State all data and information necessary for the evaluation of the existing active substance with a view to its possible inclusion in Annex I or Annex IA to Directive 98/8/EC during the second phase of the review programme. The designation shall be carried out by the Commission when the list referred to in Article 6(1)(b) of this Regulation is established".
(2) In Article 4(4), the first three subparagraphs are deleted.
(3) Article 7 is deleted.
(4) In Article 8(2), the first subparagraph is replaced by the following:"If a notification is accepted by the Commission, the notifier shall provide to the competent authority of the designated Rapporteur Member State all data and information necessary for the evaluation of the existing active substance with a view to its possible inclusion in Annex IB to Directive 98/8/EC during the second phase of the review programme. The designation shall be carried out by the Commission when the list referred to in Article 6(1)(b) of this Regulation is established".
Article 15
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 4 November 2003
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