Activities of Françoise GROSSETÊTE related to 2008/0035(COD)
Plenary speeches (1)
Cosmetic products (recast version) (debate)
Amendments (16)
Amendment 44 #
Proposal for a regulation
Article 2 – paragraph 1 – point l
Article 2 – paragraph 1 – point l
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 51 #
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
2. Compliance with good manufacturing practice shall be presumed where manufacturing is in accordance with the relevant harmonised standards, the references of which have been published in the Official Journal of the European Union, or with other internationally recognised standards.
Amendment 59 #
Proposal for a regulation
Article 8 – paragraph 3 a (new)
Article 8 – paragraph 3 a (new)
3a. The responsible person shall keep the product information file accessible for a period of at least ten years after the last delivery of the cosmetic product.
Amendment 60 #
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. In absence of any applicable Community legislation, compliance with paragraph 1 shall be presumed if the method used is in accordance with the relevant harmonised standards, the references of which have been published in the Official Journal of the European Union, or with other internationally recognised standards.
Amendment 72 #
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 2 – indent 3
Article 12 – paragraph 2 – subparagraph 2 – indent 3
- there are no economically and technically viable suitable alternative substances available, as documented in an analysis of alternatives.
Amendment 74 #
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 6
Article 12 – paragraph 2 – subparagraph 6
The Commission shall mandate the SCCP to re-evaluate one or more of those substances: - if, in accordance with Articles 60 and 61 of Regulation (EC) No 1907/2006, it imposes conditions, refuses or withdraws authorisation for the substance or substances following consideration of the total exposure from other sources; - as soon as safety concerns arise and at the latest every 5 years after their inclusion in Annexes III to VI.
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)
Amendment 89 #
Proposal for a regulation
Article 15 – paragraph 7
Article 15 – paragraph 7
7. The information mentioned in point (g) of paragraph 1 shall be expressed by using the common ingredient name set out in the glossary provided for in Article 28 in accordance with the International Nomenclature of Cosmetic Ingredients (INCI). In the absence of a common ingredient name, a term as contained in a generally accepted nomenclature shall be used.
Amendment 91 #
Proposal for a regulation
Article 16 – paragraph 2 a (new)
Article 16 – paragraph 2 a (new)
Two years after …*, the Commission shall submit a report to the European Parliament and the Council on the claims used for cosmetic products and on the proof provided in accordance with Article 8(2)(d). The Commission shall focus first and foremost on claims as to the natural or organic nature of cosmetic products, on quality labels and on the relevant justification. * Date of entry into force of the Regulation.
Amendment 93 #
Proposal for a regulation
Article 22 - paragraphs 1 and 2
Article 22 - paragraphs 1 and 2
1. Where Article 21 does not apply, and a competent authority ascertains that a cosmetic product placed on the market is liable to present a serious risk for human health, it shall take all appropriate provisional measures in order to ensure that a cosmetic product is withdrawn, recalled or its availability otherwise restricted. Where Article 21 applies and the responsible person does not agree with the competent authority's interpretation regarding compliance or with the remedial measures proposed, the competent authority and the responsible person shall agree that a dispute has arisen, without prejudice to Article 21. 2. The competent authority shall immediately communicate to the Commission and the competent authorities of the other Member States of the measures taken and any supporting data in cases covered by paragraph 1, first subparagraph, or, in cases covered by paragraph 1, second subparagraph, shall forward details of the dispute. For the purposes of the first subparagraph of this paragraph, the information exchange system provided for in Article 12(1) of Directive 2001/95/EC shall be used. Article 12 (2), (3) and (4) of Directive 2001/95/EC shall apply.
Amendment 94 #
Proposal for a regulation
Article 22 a (new)
Article 22 a (new)
Amendment 99 #
Proposal for a regulation
Article 26 a (new)
Article 26 a (new)
Article 26a Assessing the safety of finished cosmetic products Where necessary, in order to ensure safe use of substances in cosmetic products placed on the market, the Commission shall, after consulting the European Chemicals Agency (ECHA), consider the need to adjust and, where appropriate, propose amendments to Regulation (EC) No 1907/2006.
Amendment 100 #
Proposal for a regulation
Article 28
Article 28
The Commission shall compile and update a glossary of common ingredient names in accordance with the International Nomenclature of Cosmetic Ingredients (INCI) and the Chemical Abstract Service (CAS) database. That glossary shall not constitute a list of the substances authorised for use in cosmetic products. The common ingredient name shall be applied for the purpose of labelling cosmetic products placed on the market at the latest twelve montho years after publication of the glossary in the Official Journal of the European Union.
Amendment 118 #
Proposal for a regulation
Annex I – part A – point 10
Annex I – part A – point 10
Other relevant information, e.g. description of existing studies from human volunteers or the duly confirmed and substantiated findings of risk assessments carried out in other relevant areas.