4 Amendments of Erna HENNICOT-SCHOEPGES related to 2008/0035(COD)
Amendment 47 #
Proposal for a regulation
Article 2 – paragraph 2 a (new)
Article 2 – paragraph 2 a (new)
2a. In view of the various definitions of nanomaterials published by different bodies and the constant technical and scientific developments in the field of nanotechnologies, the Commission should: a) propose a definition to be accepted at European Community and, if possible, international level, by the competent international fora, no later than 18 months after the adoption of this regulation. Once such an agreement has been reached, paragraph 1(a) shall be adapted; b) adjust and adapt the definition in paragraph 1(a) to ensure that it is in keeping with scientific and technological progress and with definitions subsequently agreed at international level. The measures referred to in points (a) and (b) amending the non-essential elements of this regulation, including by complementing them, shall be adopted in compliance with the regulatory procedure with scrutiny referred to in Article 27(3).
Amendment 53 #
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 2
Article 7 – paragraph 1 – subparagraph 2
The responsible person shall ensure that: (a) the intended use of the cosmetic product and the anticipated systemic exposure to individual ingredients in a final formulation is taken into account in the safety assessment; (b) an appropriate weight-of-evidence approach is used in the safety assessment for reviewing relevant data from several sources, including data from in-vitro, in- silico, existing GLP or non-GLP in-vivo and human studies; c) the cosmetic product safety report is kept up-to-date in view of additional relevant information generated subsequent to placing the product on the market.
Amendment 78 #
Proposal for a regulation
Article 12 a (new)
Article 12 a (new)
Article 12a Nanomaterials The Commission shall review the provisions of this Regulation concerning nanomaterials at least once every five years in the light of scientific progress and, where necessary, shall propose suitable amendments to those provisions. The Commission shall submit to the Council and to Parliament an annual report on developments in the use of nanomaterials in cosmetic products within the Community. The report shall summarise, in particular, the types of use notified and the number of notifications, and the progress made in developing characterisation methods and safety assessment guides and with public information measures and international cooperation programmes.
Amendment 79 #
Proposal for a regulation
Article 12 b (new)
Article 12 b (new)