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
(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)
Article 4 of Commission Regulation (EC) No 2032/2003 (2) lays down that, from the date of entry into force, any existing active substance not listed in Annex I to that Regulation is to be considered as not having been placed on the market for biocidal purposes before 14 May 2000. As a consequence biocidal products containing active substances not listed in Annex I may no longer be placed on the market, unless inclusion into Annex I or IA to Directive 98/8/EC is applied for in accordance with Article 11 of that Directive, and provisional authorisation has been received in accordance with Article 15(2) of that Directive. However, a limited number of active substances have been detected by the Member States which were not identified or notified before the time limit laid down in Commission Regulations (EC) No 1896/2000 (3) and (EC) No 1687/2002 (4) although there is evidence they were contained in biocidal products placed on the market before 14 May 2000. Some of these active substances are important from a socioeconomic perspective or for protection of public health. It is therefore appropriate to draw up a further list of active substances that should be allowed to remain on the market until 1 September 2006.
(2)
Certain substances not included in Annex II to Regulation (EC) No 2032/2003 are applied in uses for which Member States claim that there is evidence demonstrating the essential need for reasons of health, safety, and protection of cultural heritage, or the use is critical for the functioning of society in the absence of technically and economically feasible alternatives or substitutes that are acceptable from the standpoint of environment or health. It is therefore appropriate to introduce a system for applying for an extension of the period for marketing of biocidal products containing those substances. Such extensions should only be granted for the requesting Member States if the requests are justified, continued use does not give rise to concerns for human health and the environment, and, where appropriate, alternatives are being developed. The extension should only be allowed until 14 May 2010 at the latest.
(3)
In accordance with Article 4(2) of Regulation (EC) No 2032/2003, placing on the market of biocidal products containing active substances not notified, or not notified for the appropriate product types, has to stop on 1 September 2006 at the latest. For certain substances or substance/product type combinations that have so far not been notified, there is now an interest by economic operators to prepare complete dossiers in view of their inclusion into Annex I or IA to Directive 98/8/EC. It is therefore appropriate, to introduce the possibility to prolong the marketing deadline for biocidal products containing such substances, in the product type concerned, provided interested operators submit complete dossiers well before 1 September 2006. If these dossiers are accepted, an extension of the period for placing those products on the market in the product types concerned should be allowed until the end of the evaluation of the complete dossiers, which should take place in parallel with the evaluation of the notified substances for the product types concerned.
(4)
The task of evaluation should be distributed among the competent authorities of all Member States. Annex V to Regulation (EC) No 2032/2003 so far only designates the Rapporteur Member States for certain active substance/product type combinations. It is therefore necessary to designate the Rapporteur Member States for the remaining product types, taking into account also the accession of the new Member States on 1 May 2004. The list of competent authorities should also be adapted accordingly.
(5)
Economic operators have expressed an interest in taking over the role of participants following the publication by the Commission of those cases where for a given active substance/product type combination, all participants have withdrawn or have failed to comply with their obligations. This has happened for three substances and it is therefore appropriate to list those substances, together with the designated Rapporteur Member States and the new deadlines for submission of the complete dossiers in a separate Annex.
(6)
For a number of notified existing active substances/product type combinations - in particular those notified for product types 8 and 14 - all participants have withdrawn or not complied with their obligations, and no other economic operator or Member State has expressed an interest to take over the role of participants within the given deadlines. Furthermore, following the recent classification by the competent authorities and the Commission of certain milk hygiene products as biocidal products in product type 3 as defined in Annex V to Directive 98/8/EC, it is appropriate to include into Annex II certain substances used in those milk hygiene products where producers, formulators or associations believing that these were not concerned by Directive 98/8/EC did not submit notifications before the deadlines established by Regulations (EC) No 1896/2000 and (EC) No 1687/2002, but have done so before the adoption of this Regulation. Annexes II and III to Regulation (EC) No 2032/2003 should therefore be amended accordingly. Annex V, Parts A, B, C, and D, and Annex VI should also be amended in the light of the provisions contained in this Regulation.
(7)
For one substance listed in Annexes I and II to Regulation (EC) No 2032/2003 an incorrect CAS number and for another one an erroneous common name are indicated. Four substances are not listed in Annexes I and III, although they were identified within the deadlines set by Regulation (EC) No 1896/2000. This should be rectified.
(8)
Regulation (EC) No 2032/2003 should therefore be amended accordingly.
(9)
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
Regulation (EC) No 2032/2003 is amended as follows:
1.
The title of Article 3 is replaced by the following:
‘Existing Active Substances’.
2.
In Article 3 the following paragraph 4 is added:
‘4. Annex VII contains the list of active substances which were not identified or notified within the time limits laid down in Regulation (EC) No 1896/2000 and Regulation (EC) No 1687/2002 although there is evidence that they were on the market as active substances in biocidal products before 14 May 2000.’
3.
Article 4 is amended as follows:
(a)
In paragraph 1 the first subparagraph is replaced by the following:
‘Active substances listed in Annex III and Annex VII shall not be included in Annex I, IA or IB to Directive 98/8/EC within the framework of the review programme.’
(b)
In paragraph 2 the first subparagraph is replaced by the following:
‘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 Annex VII, and ensure that such biocidal products are not placed on the market in their territory, shall be 1 September 2006.’
(c)
Paragraph 3 is replaced by the following:
‘From the date of entry into force of this Regulation, any active substance not listed in Annex I or Annex VII shall be deemed not to have been placed on the market for biocidal purposes before 14 May 2000.’
4.
The following Articles 4a and 4b are inserted:
‘Article 4a
Essential use
1. Member States may apply to the Commission for an extension of the period laid down in Article 4(2) where they consider that an active substance listed in Annex III or VII is essential for them for reasons of health, safety, protection of cultural heritage or is critical for the functioning of society, and where there are no available technically and economically feasible alternatives or substitutes that are acceptable from the standpoint of environment and health.
Applications shall be accompanied by a document stating the reasons and justifications.
2. The applications referred to in paragraph 1 shall be forwarded by the Commission to the other Member States and be made publicly available by electronic means.
Member States or any person may for a period of 60 days following reception of an application submit comments in writing to the Commission.
3. Taking account of the comments received, the Commission may in accordance with Article 16(2) of Directive 98/8/EC grant an extension of the period laid down in Article 4(2) of this Regulation for placing the substance on the market of the requesting Member States until 14 May 2010 at the latest, provided that the Member States:
(a)
ensure that continued use is only possible under the conditions that products containing the substance are approved for the intended essential use;
(b)
conclude that, taking into account all available information, it is reasonable to assume that continued use does not have any unacceptable effect on human or animal health or on the environment;
(c)
impose all appropriate risk reduction measures when granting approval;
(d)
ensure that such approved biocidal products remaining on the market after 1 September 2006 are relabelled in order to match the use conditions laid down by the Member States in accordance with this paragraph; and
(e)
ensure that, where appropriate, alternatives for such uses are being sought by the holders of the approvals or the Member States concerned, or a dossier is being prepared for submission in accordance with the procedure laid down in Article 11 of Directive 98/8/EC by 14 May 2008 at the latest.
4. The Member States concerned shall annually inform the Commission on the application of paragraph 3 and in particular on the actions taken pursuant to point (e).
5. Member States may at any time review the approvals of biocidal products for which the period of placing on the market has been extended in accordance with paragraph 3. Whenever there is reason to believe that any of the conditions set in points (a) to (e) of that paragraph are no longer satisfied, the Member States concerned shall without undue delay take steps to remedy the situation or if that is not possible, withdraw the approvals of the biocidal products concerned.
Article 4b
Extension of deadline for placing on the market
1. Producers, formulators, associations or other persons may apply for an extension of the period laid down in Article 4(2) for the marketing of biocidal products containing active substances referred to in that paragraph by submitting a complete dossier for each active substance and product type combination concerned that complies with the requirements of Annex IV to the competent authority in one of the Member States by 1 March 2006 at the latest.
2. The receiving Member State shall verify whether the dossier referred to in paragraph 1 is to be accepted as complete in accordance with Article 9(1) to (4).
If the dossier is accepted as complete the active substance/product type combinations shall be included into Annex II and Annex V and, where appropriate, be removed from Annex III or VII.
3. For product types other than 8 and 14, the evaluation of the dossiers shall commence at the same time as the evaluation of dossiers for other active substances in the same product type(s) as specified in Annex V.’
5.
Article 5 is amended as follows:
(a)
In paragraph 2, the following is inserted as third and fourth subparagraphs:
‘The Rapporteur Member States designated to review existing active substances listed in Annex II in respect of product types 1 to 6 and 13 are specified in part C of Annex V.
The Rapporteur Member States designated to review existing active substances listed in Annex II in respect of product types 7, 9 to 12, 15, 17, 20, 22 and 23 are specified in part D of Annex V.’
(b)
In paragraph 4, ‘1 July 2003’ is replaced by ‘1 March 2005’.
6.
In Article 7, the following third paragraph is added:
‘However, any Member State wishing to receive copies only in electronic format or different numbers of copies shall inform the Commission, which shall make that information publicly available by electronic means. If the Member State subsequently decides otherwise, it shall inform the Commission without undue delay, whereupon the Commission shall update accordingly the information made publicly available.’
7.
In Article 8(4) the following fourth subparagraph is added:
‘The active substances concerned, the Rapporteur Member States and the new time periods shall be listed in Annex VIII. Annex V shall be updated accordingly.’
8.
Annex I is amended in accordance with Annex I to this Regulation.
9.
Annex II is replaced by the text set out in Annex II to this Regulation.
10.
Annex III is amended in accordance with Annex III to this Regulation.
11.
Annex V is amended in accordance with Annex IV to this Regulation.
12.
Annex VI is replaced by the text set out in Annex V to this Regulation.
13.
The text set out in Annex VI to this Regulation shall be added as Annex VII.
14.
The text set out in Annex VII to this Regulation shall be added as Annex VIII.
Article 2
Entry into force
This Regulation shall enter into force on the twentieth day following 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, 13 June 2005.