Commission Regulation (EC) No 2076/2002 of 20 November 2002 extending the time period referred to in Article 8(2) of Council Directive 91/414/EEC and concerning the non-inclusion of certain active substances in Annex I to that Directive and the withdrawal of authorisations for plant protection products containing these substances (Text with EEA relevance)
OJ L 319, 23.11.2002, p. 3–11 (ES, DA, DE, EL, EN, FR, IT, NL, PT, FI, SV)
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Commission Regulation (EC) No 2076/2002
of 20 November 2002
extending the time period referred to in Article 8(2) of Council Directive 91/414/EEC and concerning the non-inclusion of certain active substances in Annex I to that Directive and the withdrawal of authorisations for plant protection products containing these substances
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(1), as last amended by Commission Directive 2002/81/EC(2), and in particular Article 8(2) thereof,
Having regard to Commission Regulation (EC) No 451/2000 of 28 February 2000 laying down the detailed rules for the implementation of the second and third stages of the work programme referred to in Article 8(2) of Directive 91/414/EEC(3), as last amended by Regulation (EC) No 1490/2002(4), and in particular Article 6(7) and Article 11(2) thereof,
(1) Article 8(2) of Directive 91/414/EEC provides that a Member State may, during a period of 12 years following the notification of that Directive, authorise the placing on the market of plant protection products containing active substances not listed in Annex I that are already on the market two years after the date of notification, except where a decision has been taken not to include a substance in Annex I.
(2) Commission Regulation (EEC) No 3600/92(5), as last amended by Regulation (EC) No 2266/2000(6), Regulation (EC) No 451/2000 and Regulation (EC) No 1490/2002 lay down the detailed rules for the implementation of the first, second and third stages of the programme of work referred to in Article 8(2) of Directive 91/414/EEC. This programme is ongoing and it has not been possible yet to complete decision making on a number of active substances. The notification procedure for the active substances covered by Regulation (EC) No 1112/2002(7) has not yet been finalised either and therefore for certain of these active substances the time period will also need to be extended.
(3) The Commission presented its progress report on 26 July 2001(8). It concluded that progress has not been as good as was originally anticipated and therefore the deadline should be extended for those substances still under review or for which industry has notified a commitment to further prepare the necessary dossiers within the time limits.
(4) For the active substances covered by the first stage the Commission will ensure that as many decisions as possible are taken before July 2003, acknowledging however that for a number of active substances a decision can not be taken before 2005. Additional time is needed to evaluate the further data required by the Commission before it can be decided whether these active substances satisfy the safety requirements of Directive 91/414/EEC and the Commission will ensure that the extension of the time period will be as short as possible.
(5) Active substances for which a commitment to further prepare the necessary dossier has not been notified, should not be included in Annex I to Directive 91/414/EEC and Member States should withdraw all authorisations for plant protection products containing such active substances.
(6) For uses for which additional technical evidence has been provided demonstrating the essential need for further use of the active substance and the absence of an efficient alternative, temporary measures should be provided to enable the development of alternatives. For a number of uses such information has been presented and evaluated by the Commission with Member State experts. Derogations should be given only for cases, which appear justified and as not giving rise to concern, and should be restricted to the control of harmful organisms, for which no efficient alternatives exist.
(7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS REGULATION:
The time period of 12 years referred to in Article 8(2) of Directive 91/414/EEC is extended until 31 December 2005 for the active substances which are assessed in the framework of Regulations (EEC) No 3600/92 and the second stage under Regulation (EC) No 451/2000, and until 31 December 2008 for the active substances which are assessed in the framework of Regulation (EC) No 1490/2002, unless a decision has been taken or is taken before that date to include or not include the active substance in Annex I to Directive 91/414/EEC. During these periods the Member States may continue to authorise or authorise again the placing on the market of plant protection products containing the above mentioned active substances, in accordance with the provisions of Article 8(2) of Directive 91/414/EEC.
1. The active substances listed in Annex I to this Regulation are not included as active substance in Annex I to Directive 91/414/EEC.
2. Member States shall ensure that authorisations for plant protection products containing the active substances listed in Annex I to this Regulation are withdrawn by 25 July 2003 except as provided in paragraph 3.
3. In relation to a substance specified in column A of Annex II, any Member State specified in column B of that Annex in relation to the substance may maintain in force authorisations for plant protection products containing that substance for the uses listed in column C until 30 June 2007 provided that it:
(a) ensures that the continued use is only accepted as far it does not have any harmful effect on human or animal health and no unacceptable influence on the environment;
(b) ensures that such plant protection products remaining on the market after 31 December 2003 are relabelled in order to match the restricted use conditions;
(c) imposes all appropriate risk mitigation measures to reduce any possible risks;
(d) ensures that alternatives for such uses are being seriously sought.
The Member State concerned shall inform the Commission on 31 December 2004 at the latest on the application of this paragraph and in particular on the actions taken pursuant to points (a) to (d).
Any period of grace granted by Member States in accordance with Article 4(6) of Directive 91/414/EEC shall be as short as possible and:
(a) for the uses for which the authorisation is to be withdrawn by 25 July 2003, shall expire not later than 31 December 2003, except for the limited number of essential uses referred to in Annex II, for which the authorisation can still be maintained in specified Member States in accordance with the provisions of Article 2(3);
(b) for the uses for which the authorisation is to be withdrawn by 30 June 2007, shall expire not later than 31 December 2007.
This Regulation shall enter into force on the seventh day following its publication in the Official Journal of the European Communities.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 20 November 2002.
For the Commission
Member of the Commission
(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 276, 12.10.2002, p. 28.
(3) OJ L 55, 29.2.2000, p. 25.
(4) OJ L 224, 21.8.2002, p. 23.
(5) OJ L 366, 15.12.1992, p. 10.
(6) OJ L 259, 13.10.2000, p. 27.
(7) OJ L 168, 27.6.2002, p. 14.
(8) COM(2001) 444 final.
List of active substances which are not included as active substance in Annex I to Directive 91/414/EEC
2-Aminobutane (aka sec-butylamine)
4-CPA (4-chlorophenoxyaceticacid = PCPA)
Alkyltrimethyl ammonium chloride
Alkyltrimethylbenzyl ammonium chloride
Calcium carbonate (aka chalk)
Calcium hydroxide (aka slake lime)
Calcium oxide (quick lime)
Chinomethionat (aka quinomethionate)
Chlorfenson (aka chlorfenizon)
delta-endotoxin of Bacillus thuringiensis
Diphenamid (aka difenamide)
Disodium octaborate tetrahydrate
EPTC (ethyl dipropylthiocarbamate)
Ethidimuron (aka sulfodiazol)
Ethion (aka diethion)
Fenson (aka fenizon)
Halfenprox (aka brofenprox)
Merphos (aka tributylphosphorotrithioite)
MAA (methyl arsonic acid)
Naphtylacetic acid hydrazide
Nonylphenol ether polyoxyethyleneglycol
Seconal (aka 5-allyl-5-(1'-methylbutyl) barbituric acid)
Sodium dioctyl sulfosuccinate
Sodium silver thiosulphate
Tebutam (aka butam)
List of authorisations referred to in Article 2(3)