21 Amendments of Liam AYLWARD related to 2006/0136(COD)
Amendment 215 #
Recital 6
(6) Plant production has a very important place in the Community. One of the most important ways of protecting plants and plant products against harmful organisms, including weeds, and of improving agricultural production is the use of plant protection products. It should be ensured that a complete impact assessment, including the impact of any cut-off system on agricultural activity, has been undertaken.
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 241 #
Article 4 – paragraph 7
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 3.6.2, 3.6.3, 3.6.4, 3.6.5, 3.7.2, 3.7.3 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 shall not apply to active substances which are or have to be classified in accordance with Directive 67/548/EEC, as mutagenic category 1, carcinogenic category 1 or toxic for reproduction category 1.
Amendment 243 #
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 253 #
Article 30 – paragraph 1 - subparagraph 1 a ( new)
If no decision concerning the active substance has been made before the provisional period of authorisation for the plant protection product has expired, the Member State may extend this authorisation upon application up to the date when a decision is made on the authorisation of the active substance.
Amendment 258 #
Article 30 – paragraph 2
2. In such cases the Member State may start its evaluation regarding a provisional authorisation as soon as there is evidence that the deadlines for the substance authorisation will not be met and shall immediately inform the other Member States and the Commission of its assessment of the dossier and of the terms of the authorisation, giving at least the information provided for in Article 57 (1).
Amendment 261 #
Article 30 – paragraph 3 a (new)
Amendment 276 #
Article 50 – paragraph 2
Amendment 280 #
Article 52 – paragraph 3 – point (c)
(c) they are either the same or equivalent in the co-formulants present and the packaging size, material or form, in terms of the potential adverse impact on the safety of the product with regard to human or animal health or the environment.
Amendment 281 #
Article 52 – paragraph 3 – point (c) a (new)
(ca) they have not been repackaged and their packaging is the same as or equivalent to that of the reference products in terms of size, material and form.
Amendment 283 #
Article 52 – paragraph 4 – point (h)
(h) a sample of the product and packaging which is intended to be introduced if it is considered as necessary by the competent authority of the Member State of introduction;
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 302 #
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 306 #
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 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 312 #
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 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 point (b) of Article 18(1) of Regulation (EC) No 396/2005.
Amendment 313 #
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 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.
Amendment 322 #
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.