Parallel to the ongoing debate and vote on the revision of the European Novel Foods Regulation, the European Parliament is scheduled to decide about the regulation of nanomaterials in cosmetics on the 24 and 25 March 2009. In the course of the European Cosmetics Directive (Cosmetics Directive 76/768/EEC) recast, an increasing number of references to ‘nanomaterials’ have been drafted into the ongoing amendments.
This current report from the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI), which will be debated and voted on next week, focuses on the establishment of a definition of nanomaterials, the notification of the application of nanomaterials in cosmetics and the labelling of nanomaterials ingredients.
References to ‘nanomaterials’ in the current ENVI Report include:
- (25a) The use of nanomaterials in cosmetic products may increase with the further development of technology. In order to ensure a high level of consumer protection, free movement of goods and legal certainty for manufacturers, it is necessary to develop a uniform definition for nanomaterials at international level. The Community should endeavour to reach an agreement on a definition in appropriate international forums. Should such an agreement be reached, the definition of nanomaterials in this Regulation should be adapted accordingly (Amendment 1, Proposal for a regulation, Recital 25 a (new))
- (25c) The Commission should regularly review the provisions on nanomaterials, regardless of their persistence and solubility, in the light of scientific progress (Amendment 3, Proposal for a regulation, Recital 25 c (new))
- (ia) 'nanomaterial' means an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm (Amendment 12; Proposal for a regulation Article 2 - paragraph 1 - point i 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 shall adapt, no later than 18 months after the entry into force of this Regulation, the definition in paragraph 1(ia) to ensure that it is in keeping with scientific and technological progress and with definitions subsequently agreed at international level (Amendment 17; Proposal for a regulation Article 2 – paragraph 2 a (new))
Article 10: Notification: 1. The responsible person shall submit, prior to placing the cosmetic product on the market, the following information to the Commission:
(e) the presence of substances in the form of nanomaterials, regardless of their persistence and solubility (Amendment 26; Proposal for a regulation Article 10 - paragraph 1 - point e)
[NOTE: this wording amends the changes initially proposed by the European Commission (5 February 2008): (e) the presence of substances in the form of micronised particles other than substances listed in Annexe III to VI to this Regulation]
1. For every product that contains nanomaterials as defined in Article 2, a high level of consumer protection and the protection of human health shall be ensured.
2. At the latest 12 months before the date of application of this Regulation, the responsible person shall notify the Commission of all existing cosmetic products that contain nanomaterials, identifying the category of each product and the specific nature of the nanomaterials as used in it, as well as the specific exposure conditions.
At the latest six months before the date of application of this Regulation, the Commission shall publish an initial Status Report on all nanomaterials already used in cosmetic products as well as on the exposure conditions linked to these cosmetic products. In the event that the Commission has concerns regarding the safety of the nanomaterials as used, the Commission shall request the SCCP to give its opinion on the safety of these nanomaterials for these categories of products and the specific exposure conditions...
3. 18 months before the date of application of this Regulation, every new product that contains nanomaterials not included in the Status Report or placed on the market before the publication of the initial Status Report referred to in paragraph 2, or nanomaterials used in a new product category or under new exposure conditions, shall be notified by the responsible person to the Commission in accordance with Article 10(1)(e) six months prior to the placing on the market. The responsible person shall also submit, upon the Commission's request, the safety assessment of the product related to the specific nature of the nanomaterials as used in the product category and the exposure conditions. The Commission may request the SCCP to give its opinion on the safety of these nanomaterials for these categories of products and the specific exposure conditions. The SCCP shall give its opinion within six months of the submission of all relevant safety data and transmit it to the Commission (Amendment 30; Proposal for a regulation; Article 12 a (new))
- All ingredients present in the form of nanomaterials shall be clearly indicated in the list of ingredients. The names of such ingredients shall be preceded by the word 'nano' (Amendment 32; Proposal for a regulation; Article 15 – paragraph 1 – point g – subparagraph 3 a (new))