Proposal for a Regulation of the European Parliament and of the Council concerning the placing of plant protection products on the market

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Tekst

Delegations will find hereafter a modified version of the Presidency's compromise, taking into

account the discussion held in COREPER on 11 June 2008.

· Legal basis: Articles [ 37(2), 95 and 152(4)(b)];

· Recital (9): The following text is inserted at the end of this recital:

"... on the basis of harmonised criteria. These criteria should be applied for the first approval of an active substance under this Regulation. For already approved active substances, they should be applied at the time of renewal or review of their approval."

· Article 4: A new paragraph 7 is added which reads as follows:

"7. By way of derogation from paragraph 1, where on the basis of documented evidence an active substance is necessary to control a serious danger to plant health which cannot be contained by other available means, such active substance may be approved for a time limited period not exceeding five years even if it does not satisfy the criteria set out in points [...] 3.6.3, 3.6.4, 3.6.5 or 3.8.2 of Annex II, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005.

This derogation does not apply to active substances which are or have to be classified in accordance with the provisions of Directive 67/548/EEC, as carcinogenic category 1 or toxic for reproduction category 1."

· Article 14(2): a new sentence is added which reads as follows:

"The renewal of approval of active substances covered by Article 4(7) shall be for a period

not exceeding five years."

· Article 40(2): a new subparagraph d) is added:

"d) it contains a substance approved in accordance with Article 4(7)".

· Article 56(1): The second sentence of the last subparagraph would read as follows:

"The period for data protection shall be 2 years and 6 months." · Point 3.6.3 of Annex II would read as follows:

"3.6.3. An active substance, safener or synergist shall only be approved, if, on the basis of

assessment of carcinogenicity testing carried out in accordance with the data requirements for the active substances, safener or synergist and other available data and information, including a review of the scientific literature, reviewed by the Authority, it is not or has not to be classified, in accordance with the provisions of Directive 67/548/EEC, as carcinogen category 1 or 2 unless the exposure of humans to that active substance, safener or synergist in a plant protection product, under realistic proposed conditions of use is negligible, i.e. the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance, safener or synergist concerned on food and feed do not exceed the default value set in accordance with Article 18(1) (b) of Regulation (EC) No 396/2005."

· Point 3.6.4 of Annex II would read as follows:

"3.6.4. An active substance, safener or synergist shall only be approved, if, on the basis of

assessment of reproductive toxicity testing carried out in accordance with the data requirements for the active substances, safeners or synergists and other available data and information, including a review of the scientific literature, reviewed by the Authority, it is not or has not to be classified, in accordance with the provisions of Directive 67/548/EEC, as toxic for reproduction category 1 or 2 unless the exposure of humans to that active substance, safener or synergist in a plant protection product, under realistic proposed conditions of use is negligible,. i.e. the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance, safener or synergist concerned on food and feed do not exceed the default value set in accordance with Article 18(1) (b) of Regulation (EC) No 396/2005."

· Point 3.6.5 of Annex II would read as follows:

"3.6.5. An active substance, safener or synergist shall only be approved, if, on the basis of

the assessment of Community or internationally agreed test guidelines or other available data and information including a review of the scientific literature, reviewed by the Authority, it is not considered to have endocrine disrupting properties that may cause adverse effect in humans unless the exposure of humans to that active substance, safener or synergist in a plant protection product, under realistic proposed conditions of use, is negligible, i.e. the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance, safener or synergist concerned on food and feed do not exceed the default value set in accordance with Article 18(1) (b) of Regulation (EC) No 396/2005."

· Point 4 of Annex II, 5th and 6th indents: The words "category 2" would be replaced by

"category 1 or 2".

AD MEMORIAM: it will be added that HU reserve the right to return to the question of the

division into three zones at the Regulation's second reading.

2.

Originele weergave

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