17 Amendments of Anja WEISGERBER related to 2006/0136(COD)
Amendment 227 #
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 Annex 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 236 #
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 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 244 #
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 255 #
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 257 #
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 268 #
Article 36 – paragraph 2
2. The Member States concerned shall grant or refuse authorisations within 180 days of receiving an application accordingly on the basis of the conclusions of the assessment of the Member State examining the application as provided for in Articles 31 and 32.
Amendment 270 #
Article 36 – paragraph 3
3. By way of derogation from paragraph 2 and subject to Community law, appropriate conditions may be imposed with respect to the requirements referred to in points (a) and (b) of Article 31(3) and other risk mitigation measures deriving from specific conditions of use. W taking into account non-comparable agricultural, plant health or environmental conditions. In very exceptional cases, where the concerns of a Member State related to human or animal health or the environmenthealth cannot be controlled by the establishment of national risk mitigation measures referred to in the first subparagraph, a Member State may as a last resort refuse authorisation of the plant protection product in its territory if, due to its very specific environmental or agricultural circumstances, it has substantiated reasons to consider that the product in question poses a serious risk to human or animal health or the environmenthealth. It shall immediately inform the applicant and the Commission of its decision and provide a technical or scientific justification therefore. The Commission shall within 90 days present a report with a conclusion concerning the decision of the Member State to refuse authorisation of the plant protection product in its territory. Member States shall provide for a possibility to challenge a decision refusing the authorisation of such product before the national courts or other instances of appeal.
Amendment 273 #
Article 41 – paragraph 1
1. The Member State to which an application under Article 40 is submitted shall authorise the plant protection product concerned under the same conditions as the Member State examining the application excep. Where the agricultural, plant where Article 36(3)alth or environmental conditions are non- comparable, Article 36(2) and (3) shall appliesy.
Amendment 275 #
Article 46
Where a Member State withdraws or amends an authorisation or does not renew it, it may grant a grace period for the disposal, storage, placing on the market and use of existing stocks. in line with Article 20(2). Where the reasons for withdrawal, amendment or not renewing the authorisation permit it, the grace period shall be limited and not exceed six monthsone year for the placing on the market and ain addition al maximum of one year for the disposal, storage, and use of existing stocks of the plant protection products concerned. If the authorisation is withdrawn or not renewed because of immediate concerns for human or animal health or the environment, the plant protection products concerned shall be withdrawn from the market immediately.
Amendment 277 #
Article 50 – paragraph 2
Amendment 284 #
Article 52 – paragraph 10 a (new)
10a. Without prejudice to Article 63, Member State authorities shall make publicly available information about parallel trade permits..
Amendment 287 #
Article 58
Amendment 290 #
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 301 #
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 304 #
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 308 #
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 320 #
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.