BETA

4 Amendments of Erna HENNICOT-SCHOEPGES related to 2008/0035(COD)

Amendment 47 #
Proposal for a regulation
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).
2008/09/22
Committee: ENVI
Amendment 53 #
Proposal for a regulation
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.
2008/09/22
Committee: ENVI
Amendment 78 #
Proposal for a regulation
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.
2008/09/22
Committee: ENVI
Amendment 79 #
Proposal for a regulation
Article 12 b (new)
Article 12b Nanomaterials After …*, existing cosmetic products containing nanomaterials may continue to be placed on the market provided that: (a) - the responsible person notifies the Commission, within a period of three months, of the relevant product's category and the specific nature of the nanomaterials used in the product: - an SCCP assessment does not conclude that the use of nanomaterials in the relevant product category is unsafe. At least six months prior to the placing on the market of - any category of cosmetic product containing new nanomaterials, or - a category of cosmetic product containing existing nanomaterials not previously used in that category, the responsible person shall submit the information referred to in Article 10 to the Commission and, at the same time, forward to it a risk assessment taking due account of the specific nature of the nanomaterials and the use for which the cosmetic product is intended. The product may be made available on the market provided that an SCCP assessment does not conclude that the use of nanomaterials in the relevant product category is unsafe. * OJ: insert the date of entry into force of the Regulation.
2008/09/22
Committee: ENVI