8 Amendments of Christa KLASS related to 2006/0136(COD)
Amendment 229 #
Article 4 – paragraph 1 – subparagraph 2
The assessment of the active substance shall first establish whether the approval criteria set out in points 3.6.2 to 3.6.4 and 3.7 of Annex II are satisfied. If these criteria are satisfied the assessment shall continue to establish whether the other approval criteria set out in points 2 and 3 of Aannex II are satisfied, including points 3.6.5 and 3.8.2 once specific scientific criteria have been adopted for these annex points in accordance with Article 78(2).
Amendment 237 #
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 availablppropriate 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.
Amendment 239 #
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, including the development of resistance, 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.
Amendment 242 #
Article 4 – paragraph 7 – subparagraph 1 a (new)
If a Member State applies for a derogation under this paragraph the Commission shall, within two months, put forward the measures as proposed in this application to the Standing Committee for opinion and take a decision in accordance with the regulatory procedure referred to in Art. 79 (3). The derogation may in some cases be limited to only that Member State making the application.
Amendment 277 #
Article 50 – paragraph 2
Amendment 288 #
Article 59 – paragraph 1 – subparagraph 7
A study shall also be protected if it was necessary for the renewal or review of an authorisation. The period for data protection shall be 2 years and 6 months. The first to fourth subparagraphs shall apply with due changesubmitted for the renewal or review of an authorisation shall not be protected except where required for the purposes of legislative changes or updates to scientific and technical knowledge, in which case the time period of protection shall be equivalent to that set out in the fourth subparagraph.
Amendment 307 #
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, on the basis of specific scientific criteria once they are adopted in accordance with Article 78(2), 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.
Amendment 321 #
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, on the basis of specific scientific criteria once they are adopted in accordance with Article 78(2), 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 under realistic proposed conditions of use is negligible.