5 Amendments of Marianne THYSSEN related to 2006/0136(COD)
Amendment 235 #
Article 4 – paragraph 7 – subparagraph 1
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, 3.7.2, 3.7.3, 3.8.1 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.
Amendment 303 #
Annex II - point 3.6.3.
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 withmargin of safety for humans aund where residues of the active substance, safener or synergist concerned on food and feed do not exceed the default value alistic proposed conditions of all usets in accordance with point (b) of Article 18(1) of Regulation (EC) No 396/s higher than 2005.
Amendment 305 #
Annex II - point 3.6.4.
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 withmargin of safety for humans aund where residues of the active substance, safener or synergist concerned on food and feed do not exceed the default value alistic proposed conditions of all usets in accordance with point (b) of Article 18(1) of Regulation (EC) No 396/s higher than 2005.
Amendment 314 #
Annex II - point 3.6.5.
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 withmargin of safety for humans aund where residues of the active substance, safener or synergist concerned on food and feed do not exceed the default value alistic proposed conditions of all usets in accordance with point (b) of Article 18(1) of Regulation (EC) No 396/s higher than 2005.
Amendment 323 #
Annex II - point 3.8.2.
3.8.2. An active substance, safener or synergist shall only be approved if, on the basis of the assessment of Community or internationally agreed test guidelines, it is not considered to have endocrine disrupting properties that may cause adverse effects on non-target organisms unless the exposure of non-target organisms to that active substance in a plant protection product is negligible, i.e. under realistic proposed conditions of use is negligiblethe product does not lead to unacceptable negative effects in the environment.