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.)
Modified by
Commission Regulation (EC) No 1048/2005of 13 June 2005amending Regulation (EC) No 2032/2003 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(Text with EEA relevance)
Corrigendum to Commission Regulation (EC) No 1048/2005 of 13 June 2005 amending Regulation (EC) No 2032/2003 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(Official Journal of the European Union L 178 of 9 July 2005), 32005R104832005R1048R(01), July 9, 2005
Commission Regulation (EC) No 1849/2006of 14 December 2006amending Regulation (EC) No 2032/2003 concerning 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(Text with EEA relevance), 32006R1849, December 15, 2006
Commission Regulation (EC) No 1451/2007of 4 December 2007on 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(Text with EEA relevance), 32007R1451, December 11, 2007
Corrected by
Corrigendum to 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, 32003R2032R(01), March 23, 2006
Corrigendum to Commission Regulation (EC) No 1048/2005 of 13 June 2005 amending Regulation (EC) No 2032/2003 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, 32005R1048R(01), March 23, 2006
Commission Regulation (EC) No 2032/2003of 4 November 2003on 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 marketOJ L 123, 24.4.1998, p. 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 productsOJ L 228, 8.9.2000, p. 6..(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 1896/2000OJ L 258, 26.9.2002, p. 15.. 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 preparationsOJ L 262, 27.9.1976, p. 201., as last amended by Directive 2003/53/EC of the European Parliament and of the CouncilOJ L 178, 17.7.2003, p. 24..(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: