The European Parliament approved the amended recast of the EU Cosmetics Directive, introducing the mention of ‘nanomaterials’ into an EU legislation. The text adopted during the first reading (24 March 2009) contains a number of references to nanomaterials, including the following: '(29) 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 fora. Should such an agreement be reached, the definition of nanomaterials in this Regulation should be adapted accordingly
Article 2 - Definitions:
1. For the purposes of this Regulation, the following definitions shall apply:
(k) "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
3. 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 adjust and adapt point (k) of paragraph 1 to technical and scientific progress and with definitions subsequently agreed at international level. That measure, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 32(3).
Article 5 - Obligations of the responsible person:
1. The responsible person shall ensure compliance with Articles 3 (safety), 8 (GMP), 10 (safety assessment), 11 (product information file), 12 (sampling and analysis), 13 (notification), 14 (restrictions for substances listed in Annexes), 15 (CMR), 16 (nanomaterials), 17 (traces), 18 (animal testing), 19(1),(2) and (5) (labelling), 20 (claims), 21 (information to the public), 23 (communication of SUE) and 24 (information on substances).
Article 13 - Notification:
1. Prior to placing the cosmetic product on the market the responsible person shall submit, through electronic means , the following information to the Commission:...
(f) the presence of substances in the form of nanomaterials and:
i) their identification including the chemical name (IUPAC) and other descriptors as specified in paragraph 2 of the Preamble to Annexes II to VI
ii) the reasonably foreseeable exposure conditions
Article 16 - Nanomaterials:...
3. In addition to the notification in Article 13, cosmetic products containing nanomaterials shall be notified by the responsible person to the Commission through electronic means six months prior to the placing on the market, except when they have already been placed on the market by the same responsible person before (36 months after the date of entry into force of this Regulation). In this latter case, cosmetic products containing nanomaterials placed on the market shall be notified by the responsible person to the Commission between (36 months after the date of entry into force of this Regulation) and (42 months after the date of entry into force of this Regulation)through electronic means, in addition to the notification in Article 13...
The information notified to the Commission shall contain at least the following:
(a) the identification of the nanomaterial including its chemical name (IUPAC) and other descriptors as specified in paragraph 2 of the Preamble to Annexes II to VI
(b) the specification of the nanomaterial including size of particles, physical and chemical properties
(c) an estimate of the quantity intended to be placed on the market per year
(d) the toxicological profile of the nanomaterial
(e) its safety data related to the category of cosmetic product as used in it
(f) the reasonably foreseeable exposure conditions.
The responsible person may designate another legal or natural person by written mandate for the notification of nanomaterials and shall inform the Commission thereof. The Commission shall provide a reference number to the submission for the toxicological profile which may replace point (d) above.
4. In case the Commission has concerns regarding the safety of the nanomaterial, the Commission shall, without delay, request the SCCS to give its opinion on the safety of these nanomaterials for the relevant categories of cosmetic products and the reasonably foreseeable exposure conditions. The Commission shall make this information public. The SCCS shall give its opinion within six months of the Commission request. If any missing data are defined by the SCCS, the Commission shall require the responsible person to provide them within one explicitly stated reasonable time, which shall not be extended. The SCCS shall give its final opinion within six months of submission of additional data. The opinion of the SCCS shall be made publicly available.
10. The following information shall be made available by the Commission:
(a) By (48 months after the date of entry into force of this Regulation), the Commission shall make available a catalogue of all nanomaterials used in cosmetic products, including those used as colorants, UV-filters and preservatives in a separate section, placed on the market, indicating the categories of cosmetic products and the reasonably foreseeable exposure conditions. This catalogue shall be regularly updated thereafter and be made publicly available
(b) The Commission shall submit to the European Parliament and the Council an annual status report, which will give information on developments in the use of nanomaterials in cosmetic products within the Community, including those used as colorants, UV-filters and preservatives in a separate section. The first report will be presented before the (Fifty-four months after date of entry into force of this Regulation). The report update shall summarise, in particular, the new nanomaterials in new categories of cosmetic products, the number of notifications, the progress made in developing nano-specific assessment methods and safety assessment guides, and information on international cooperation programmes.
11. The Commission shall regularly review the provisions of this Regulation concerning nanomaterials in the light of scientific progress and, where necessary, shall propose suitable amendments to those provisions
The first review shall be provided at the latest by (Five years after the date of application of this Regulation).
Article 19 - Labelling:
1....All ingredients present in the form of nanomaterials shall be clearly indicated in the list of ingredients. The names of such ingredients shall be followed by the word "nano" in brackets .
8. Toxicological profile of the substances. Particular consideration shall be given to any possible impacts on the toxicological profile due to:
- particle sizes, including nanomaterials
- impurities of the substances and raw material used
- interaction of substances
Follow these links to find out more about the Cosmetics Directive recast, to access the procedure file, or to view the adopted text.