12 Amendments of Lambert van NISTELROOIJ related to 2008/0035(COD)
Amendment 30 #
Proposal for a regulation
Recital 12
Recital 12
(12) Cosmetic products should be safe under normal or reasonably foreseeable conditions of use. In particular, a risk- benefit reasoning should not justify a riskn unacceptable risk likely to result in adverse effects to human health.
Amendment 34 #
Proposal for a regulation
Recital 31
Recital 31
(31) The safety of finished cosmetic products can already be ensured on the basis of knowledge of the safety of the ingredients that they contain. Provisions prohibiting animal testing of finished cosmetic products should therefore be provided. The application, in particular by small and medium-sized enterprises, of methodsboth test methods and assessment procedures for relevant available data, including the use of read-across and weight-of-evidence approaches, which do not involve the use of animals for assessing the safety of finished cosmetic products could be facilitated by Commission guidelines.
Amendment 35 #
Proposal for a regulation
Recital 53 a (new)
Recital 53 a (new)
(53a) In carrying out a safety assessment and preparing the product information file the responsible person can be expected to use, amongst others, available information on substances stemming from Regulation (EC) No 1907/2006. When necessary to ensuring the safe use of substances in cosmetic products the Commission should consider the need for necessary amendments to Regulation (EC) No 1907/2006.
Amendment 42 #
Proposal for a regulation
Article 2 – paragraph 1 – point k
Article 2 – paragraph 1 – point k
(k) ‘undesirable effect’ means a harmfuln adverse reaction for human health attributable to the normal or reasonably foreseeable use of a specific cosmetic product;
Amendment 45 #
Proposal for a regulation
Article 2 – paragraph 1 – point l
Article 2 – paragraph 1 – point l
(l) ’serious undesirable effect’ means an undesirable effect which results in temporary or permanent functional incapacity, disability, hospital care or prolonged hospitalisation, congenital anomaliesy or an immediate vital riskbirth defect, a life threatening situation or death;
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 52 #
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)
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 119 #
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 account taken of the substantiated and justified results of risk assessments that have been carried out in other relevant areas.