2004D0247 — EN — 01.05.2004 — 001.001 — 1
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►B COMMISSION DECISION
of 10 March 2004
concerning the non-inclusion of simazine in Annex I to Council Directive 91/414/EEC and the
withdrawal of authorisations for plant protection products containing this active substance
(notified under document number C(2004) 727)
(Text with EEA relevance)
(2004/247/EC)
(OJ L 78, 16.3.2004, p. 50)
Amended by:
Official Journal
No page date
►M1 Commission Regulation (EC) No 835/2004 of 28 April 2004 L 127 43 29.4.2004
▼B
COMMISSION DECISION
of 10 March 2004
concerning the non-inclusion of simazine in Annex I to Council
Directive 91/414/EEC and the withdrawal of authorisations for
plant protection products containing this active substance
(notified under document number C(2004) 727)
(Text with EEA relevance)
(2004/247/EC)
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 2003/119/EC (2), and in
particular the third and the fourth subparagraph of Article 8(2) thereof,
Having regard to Commission Regulation (EEC) No 3600/92 of 11
December 1992 laying down the detailed rules for the implementation
of the first stage of the program of work referred to in Article 8(2) of
Council Directive 91/414/EEC concerning the placing of plant protec-tion products on the market (
3), as last amended by Regulation (EC) No
2266/2000 (4), and in particular Article 7(3A)(b) thereof,
Whereas:
(1) Article 8(2) of Directive 91/414/EEC provided for the Commis-
sion to carry out a programme of work for the examination ofthe active substances used in plant protection products whichwere already on the market on 25 July 1993. Detailed rules for
the carrying out of this programme were established in Regula-
tion (EEC) No 3600/92.
(2) Commission Regulation (EC) No 933/94 of 27 April 1994 layingdown the active substances of plant protection products anddesignating the rapporteur Member States for the implementationof Commission Regulation (EEC) No 3600/92 (
5), as last
amended by Regulation (EC) No 2230/95 (6), designated the
active substances which should be assessed in the framework ofRegulation (EEC) No 3600/92, designated a Member State to actas rapporteur in respect of the assessment of each substance andidentified the producers of each active substance who submitted
a notification in due time.
(3) Simazine is one of the 89 active substances designated in Regu-
lation (EC) No 933/94.
(4) In accordance with Article 7(1)(c) of Regulation (EEC) No3600/92, the United Kingdom, being the designated rapporteurMember State, submitted on 20 December 1996 to the Commis-
sion the report of its assessment of the information submitted by
the notifiers in accordance with Article 6(1) of that Regulation.
(5) On receipt of the report of the rapporteur Member State, theCommission undertook consultations with experts of the MemberStates as well as with the main notifier Syngenta as provided forin Article 7(3) of Regulation (EEC) No 3600/92.
(6) The Commission organised a tripartite meeting with the maindata submitter and the rapporteur Member State for this activesubstance on 6 June 2003.2004D0247 — EN — 01.05.2004 — 001.001 — 2
(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 325, 12.12.2003, p. 41.
(3) OJ L 366, 15.12.1992, p. 10.
(4) OJ L 259, 13.10.2000, p. 27.
(5) OJ L 107, 28.4.1994, p. 8.
(6) OJ L 225, 22.9.1995, p. 1.
▼B
(7) The assessment report prepared by the United Kingdom has been
reviewed by the Member States and the Commission within the
Standing Committee on the Food Chain and Animal Health. Thisreview was finalised on 3 October 2003 in the format of theCommission review report for simazine.
(8) The dossier and the information from the review were also
submitted to the Scientific Committee for Plants. The Committee
was asked to comment on the aspects of possible contaminationof groundwater by simazine. In its opinion (
1), the Scientific
Committee on Plants did not accept the reported calculations ofthe environmental concentrations in groundwater. The
Committee is also of the opinion that available monitoring data
does not demonstrate that concentrations of simazine or itsbreakdown products will not exceed 0,1 µg/l in groundwater.
(9) Assessments made on the basis of the information submitted
have not demonstrated that it may be expected that, under the
proposed conditions of use, plant protection products containingsimazine satisfy in general the requirements laid down in Article5(1)(a) and (b) of Directive 91/414/EEC. In particular availablemonitoring data were insufficient to demonstrate that in largeareas concentrations of the active substance and its breakdown
products will not exceed 0,1 µg/l in groundwater. Moreover it
cannot be assured that continued use in other areas will permita satisfactory recovery of groundwater quality where concentra-tions already exceed 0,1 µg/l in groundwater. These levels of the
active substance exceed the limits in Annex VI to Directive 91/
414/EEC and would have an unacceptable effect on ground-
water.
(10) Simazine should therefore not be included in Annex I to Direc-tive 91/414/EEC.
(11) Measures should be taken to ensure that existing authorisationsfor plant protection products containing simazine are withdrawnwithin a prescribed period and are not renewed and that no newauthorisations for such products are granted.
(12) In the light of the information submitted to the Commission itappears that, in the absence of efficient alternatives for certainlimited uses in certain Member States, there is a need for furtheruse of the active substance so as to enable the development ofalternatives. It is therefore justified in the present circumstances
to prescribe under strict conditions aimed at minimising risk a
longer period for the withdrawal of existing authorisations forthe limited uses considered as essential for which no efficientalternatives appear currently to be available for the control ofharmful organisms.
(13) Any period of grace for disposal, storage, placing on the marketand use of existing stocks of plant protection products containingsimazine allowed by Member States, should be limited to aperiod no longer than 12 months to allow existing stocks to beused in no more than one further growing season.
(14) This Decision does not prejudice any action the Commissionmay undertake at a later stage for this active substance withinthe framework of Council Directive 79/117/EEC of 21December 1978 prohibiting the placing on the market and use
of plant protection products containing certain active
substances (
2), as last amended by Regulation (EC) No 807/
2003 (3)2004D0247 — EN — 01.05.2004 — 001.001 — 3
(1) Opinion of the Scientific Committee on Plants on specific questions from
the Commission concerning the evaluation of simazine in the context of
Council Directive 91/414/EEC — SCP/SIMAZINE/002-Final — adopted
on 30 January 2003.
(2) OJ L 33, 8.2.1979, p. 36.
(3) OJ L 122, 16.5.2003, p. 36.
▼B
(15) The measures provided for in this Decision are in accordance
with the opinion of the Standing Committee on the Food Chain
and Animal Health,
HAS ADOPTED THIS DECISION:
Article 1
Simazine shall not be included as active substance in Annex I to Direc-
tive 91/414/EEC.
Article 2
Member States shall ensure that:1. authorisations for plant protection products containing simazine are
withdrawn by 10 September 2004;
2. from 16 March 2004 no authorisations for plant protection products
containing simazine are granted or renewed under the derogation
provided for in Article 8(2) of Directive 91/414/EEC;
3. in relation to the uses listed in column B of the Annex, a Member
State specified in column A may maintain in force authorisations forplant protection products containing simazine until 30 June 2007
provided that it:
(a) ensures that such plant protection products remaining on the
market are relabelled in order to match the restricted use condi-tions;
(b) imposes all appropriate risk mitigation measures to reduce any
possible risks in order to ensure the protection of human and
animal health and the environment; and
(c) ensures that alternative products or methods for such uses are
being seriously sought, in particular, by means of action plans.
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 (c) and
provide on a yearly basis estimates of the amounts of simazine usedfor essential uses pursuant to this Article.
Article 3
Any period of grace granted by Member States in accordance with the
provisions of Article 4(6) of Directive 91/414/EEC, shall be as short aspossible and:
(a) for the uses for which the authorisation is to be withdrawn on 10
September 2004, shall expire not later than 10 September 2005;
(b) for the uses for which the authorisation is to be withdrawn by 30
June 2007, shall expire not later than 31 December 2007.
Article 4
This Decision is addressed to the Member States.2004D0247 — EN — 01.05.2004 — 001.001 — 4
▼B
ANNEX
List of authorisations referred to in Article 2(3)
Column A Column B
Member State Use
Greece Olives
United Kingdom Beans, asparagus, rhubarb, hardy
ornamental nursery stock
The Netherlands StrawberryIreland Potatoes, field beans, rhubarb, aspar-
agus, soft fruit, tree fruit, ornamen-
tals/amenity
Belgium Scorsonera, asparagus, ornamentals,
rhubarb
Spain Pome fruit, citrus, hazelnut and vine-
yard
Poland Asparagus, rhubarb, fruit (apple, pear,
apricot, peach, plum, cherry, walnut,
currant, gooseberry, raspberry, grape,
strawberry)2004D0247 — EN — 01.05.2004 — 001.001 — 5
▼M1