5 Amendments of Cristina GUTIÉRREZ-CORTINES related to 2009/0076(COD)
Amendment 125 #
Council position
Article 3 – paragraph 1 – point aa
Article 3 – paragraph 1 – point aa
(aa) ‘nanomaterial’ means nanomaterial as defined in Commission Recommendation 20../…/EC of … … … concerning the definition of nanomaterials; The Commission shall regularly review and update the definition in light of latest advances in technical and scientific development.
Amendment 155 #
Council position
Article 10 – paragraph 3
Article 10 – paragraph 3
3. Prior to submitting its opinion on the approval or renewal of the approval of an active substance to the Commission, the Agency shall make publicly available, without prejudice to Articles 65 and 66, information on potential candidates for substitution during a period of no more than 690 days, during which time interested third parties may submit relevant information, including information on available substitutes. The Agency shall take due account of the information received when finalising its opinion.
Amendment 310 #
Council position
Article 88 – paragraph 3 – subparagraph 2
Article 88 – paragraph 3 – subparagraph 2
To that effect, those wishing to apply for the authorisation or mutual recognition in parallel of biocidal products of that product-type containing no active substances other than approved existing active substances shall submit applications for authorisation or mutual recognition in parallel to Member States' competent authorities no later than the date of approval of the active substance(s). In the case of biocidal products containing more than one active substance, applications for authorisation shall be submitted no later than the date of approval of the last active substance for that product-type.
Amendment 311 #
Council position
Article 88 – paragraph 3 – subparagraph 3 – point a
Article 88 – paragraph 3 – subparagraph 3 – point a
(a) the biocidal product shall no longer be made available on the market with effect from 180 days after the date of approval of the active substance(s); and
Amendment 351 #
Council position
Annex VI – Introduction – point 2
Annex VI – Introduction – point 2
2. The principles set out in this Annex can be applied in their entirety to the evaluation of biocidal products comprised of chemical substances. For biocidal products containing micro-organisms, these principles should be further developed in technical guidance taking into account practical experience gained, and be applied taking into account the nature of the product and the latest scientific information. In the case of biocidal products containing nanomaterials the principles set out in this Annex will also need to be adapted and elaborated in technical guidance to take account of the latest scientific information. The guidance, for substances falling under Recommendation 20../.../EC of ... with regard to specific requirements under this Regulation relating to their nature as nanomaterials shall not apply where these substances contain: -less than 10 w-% of nano-objects as defined by ISO, or -have not been intentionally manufactured at the nanoscale in order to take advantage of their specific nano qualities.