25 Amendments of Margrete AUKEN related to 2008/0035(COD)
Amendment 32 #
Proposal for a regulation
Recital 25 a (new)
Recital 25 a (new)
(25a) Before placing on the market any cosmetic product containing nanomaterials not yet included in Annex VIa, the nanomaterial contained should be evaluated by the SCCP on the basis of an adequate nano-specific safety assessment. In order to have the nanomaterial included in Annex VIa, the responsible person should submit a request together with a risk assessment to the Commission. The risk assessment should take into account the specific nature of the nanomaterial used and the intended use of the cosmetic product in question. The cosmetic product containing nanomaterials should not be placed on the market unless the Commission considers that, having due regard to the opinion of the SCCP, the use of the nanomaterial in that product is safe.
Amendment 41 #
Proposal for a regulation
Article 2 – paragraph 1 – point i a (new)
Article 2 – paragraph 1 – point i a (new)
(ia)'nanomaterial' means an intentionally manufactured material with one or more external dimensions, or an internal structure, of the order of 100 nm or less, which could exhibit novel characteristics compared to the same material without nanoscale features.
Amendment 64 #
Proposal for a regulation
Article 10 – paragraph 1 – point e
Article 10 – paragraph 1 – point e
(e) the presence of substances in the form of micronised particles other than substances listed in Annexe III to VI to this Regulationr nanomaterials;
Amendment 66 #
Proposal for a regulation
Article 11 – paragraph 1 – point h a (new)
Article 11 – paragraph 1 – point h a (new)
(ha) substances produced in the form of nanomaterials other than those listed in Annex VIa and substances produced in the form of nanomaterials which are not used in accordance with the conditions laid down in this Annex.
Amendment 69 #
Proposal for a regulation
Article 11 – paragraph 2 – subparagraph 1
Article 11 – paragraph 2 – subparagraph 1
2. Subject to a Commission Decision to extend the scope of Annex IV to hair colouring productsBy 31 December 2009 at the latest, these products shall not contain colorants intended to colour the hair, other than those listed in Annex IV and colorants intended to colour the hair, which are not used in accordance with the conditions laid down in that Annex.
Amendment 70 #
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 2 – introductory part and indent 1
Article 12 – paragraph 2 – subparagraph 2 – introductory part and indent 1
However, such substances may exceptionally be used in specific cosmetic products if, subsequent to their classification as carcinogenic, mutagenic or toxic for reproduction of category 1 or 2 under Directive 67/548/EEC after entry into force of this Regulation, all of the following conditions are fulfilled: - they have been evaluated and found safe for use by the SCCP in specific cosmetic products in particular in view of exposurethe global exposure from other significant sources as well as taking particular account of vulnerable population groups;
Amendment 87 #
Proposal for a regulation
Article 15 – paragraph 1 – point g – subparagraph 3 a (new)
Article 15 – paragraph 1 – point g – subparagraph 3 a (new)
Nanomaterials shall be referred to by using the prefix 'nano'.
Amendment 102 #
Proposal for a regulation
Article 34 – paragraph 2 a (new)
Article 34 – paragraph 2 a (new)
2a. Article 26(2) shall not apply to cosmetic products which contain nanomaterials not yet listed in Annex VIa if they have been placed on the market before the date referred to in paragraph 1 of this Article. These products may remain on the market for two years after the date referred to in paragraph 2. After that date Article 11(h) and Article 26(2) shall apply.
Amendment 105 #
Proposal for a regulation
Annex I – part A – point 1
Annex I – part A – point 1
Amendment 106 #
Proposal for a regulation
Annex I – part A – point 2 – subparagraph 1 and 2
Annex I – part A – point 2 – subparagraph 1 and 2
Amendment 107 #
Proposal for a regulation
Annex I – part A – point 3 – subparagraph 1
Annex I – part A – point 3 – subparagraph 1
Amendment 108 #
Proposal for a regulation
Annex I – part A – point 4 – subparagraph 1
Annex I – part A – point 4 – subparagraph 1
Amendment 109 #
Proposal for a regulation
Annex I – part A – point 4 – subparagraph 3
Annex I – part A – point 4 – subparagraph 3
Amendment 110 #
Proposal for a regulation
Annex I – part A – point 5
Annex I – part A – point 5
Amendment 111 #
Proposal for a regulation
Annex I – part A – point 6 – introduction
Annex I – part A – point 6 – introduction
Description ofata on and assessment of the exposure to cosmetic product taking into consideration the findings under Section 5 in relation to
Amendment 112 #
Proposal for a regulation
Annex I – part A – point 7
Annex I – part A – point 7
Descriptionata on and assessment of the exposure to the substances contained in the cosmetic product for the relevant toxicological endpoints taking into account the information under Section 6.
Amendment 113 #
Proposal for a regulation
Annex I – part A – point 8 – subparagraph 1
Annex I – part A – point 8 – subparagraph 1
Without prejudice to Article 14, descriptionan assessment of the toxicological profile of all relevant toxicological endpoints. A particular focus on local toxicity evaluation (skin and eye irritation), skin sensitisation, and in the case of UV absorption photo- induced toxicity shall be made.
Amendment 115 #
Proposal for a regulation
Annex I – part A – point 8 – subparagraph 3 – indent 3
Annex I – part A – point 8 – subparagraph 3 – indent 3
- interaction of substances (cumulative and synergistic effects)
Amendment 116 #
Proposal for a regulation
Annex I – part A – point 9
Annex I – part A – point 9
Amendment 117 #
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.
Amendment 121 #
Proposal for a regulation
Annex III – introduction (new)
Annex III – introduction (new)
This list of substances does not apply to substances in the form of nanomaterials.
Amendment 122 #
Proposal for a regulation
Annex IV – introduction (new)
Annex IV – introduction (new)
This list of substances does not apply to substances in the form of nanomaterials.
Amendment 123 #
Proposal for a regulation
Annex V – introduction (new)
Annex V – introduction (new)
This list of substances does not apply to substances in the form of nanomaterials.
Amendment 124 #
Proposal for a regulation
Annex VI – introduction (new)
Annex VI – introduction (new)
This list of substances does not apply to substances in the form of nanomaterials.
Amendment 125 #
Proposal for a regulation
Annex VI a (new)
Annex VI a (new)
Annex VIa List of permitted nanomaterials