BETA

6 Amendments of Anne LAPERROUZE 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).
2008/10/16
Committee: ENVI
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.
2008/10/16
Committee: ENVI
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.
2008/10/16
Committee: ENVI
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;
2008/10/16
Committee: ENVI
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.
2008/10/16
Committee: ENVI
Amendment 317 #

Annex II - point 3.6.5. a (new)
3.6.5.a. An active substance shall only be approved if: - tests of behaviour of the active substance, its metabolites and degradation and reaction products in response to different drinking water treatment processes have not highlighted the formation of potentially harmful by- products for human health - tests of treatability based on common drinking water treatment processes have demonstrated that drinking water produced from raw waters (ground and surface waters) containing the active substance, its metabolites and degradation and reaction products will comply with the value of 0,1µg/l set in Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption1 and not involve risks for human health. The tests will be carried out according to common protocols established at EU level and recognised by both water suppliers and pesticide manufacturers. 1 OJ L 330, 5.12.1998, p. 32.
2008/10/16
Committee: ENVI