Regulation (EC) No 1223/2009 of the European Parliament and of the CouncilShow full title

CHAPTER IV RESTRICTIONS FOR CERTAIN SUBSTANCES

Article 14 Restrictions for substances listed in the Annexes

1. Without prejudice to Article 3, cosmetic products shall not contain any of the following:

(a) prohibited substances

• (a) prohibited substances listed in Annex II;

(b) restricted substances

• (b) restricted substances which are not used in accordance with the restrictions laid down in Annex III;

(c) colorants

(i)

colorants other than those listed in Annex IV and colorants which are listed there but not used in accordance with the conditions laid down in that Annex, except for hair colouring products referred to in paragraph 2;

(ii)

without prejudice to points (b), (d)(i) and (e)(i), substances which are listed in Annex IV but which are not intended to be used as colorants, and which are not used in accordance with the conditions laid down in that Annex;

(d) preservatives

(i)

preservatives other than those listed in Annex V and preservatives which are listed there but not used in accordance with the conditions laid down in that Annex;

(ii)

without prejudice to points (b), (c)(i) and (e)(i), substances listed in Annex V but which are not intended to be used as preservatives, and which are not used in accordance with the conditions laid down in that Annex;

(e) UV-filters

(i)

UV-filters other than those listed in Annex VI and UV-filters which are listed there but not used in accordance with the conditions laid down in that Annex;

(ii)

without prejudice to points (b), (c)(i) and (d)(i), substances listed in Annex VI but which are not intended to be used as UV-filters and which are not used in accordance with the conditions laid down in that Annex.

2. Subject to a decision of the Commission to extend the scope of Annex IV to hair colouring products, such 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 listed there but not used in accordance with the conditions laid down in that Annex.

The decision of the Commission referred to in the first subparagraph, 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 15 Substances classified as CMR substances

1. The use in cosmetic products of substances classified as CMR substances, of category 2, under Part 3 of Annex VI to Regulation (EC) No 1272/2008 shall be prohibited. However, a substance classified in category 2 may be used in cosmetic products where the substance has been evaluated by the SCCS and found safe for use in cosmetic products. To these ends the Commission shall adopt the necessary measures in accordance with the regulatory procedure with scrutiny referred to in Article 32(3) of this Regulation.

2. The use in cosmetic products of substances classified as CMR substances, of category 1A or 1B under Part 3 of Annex VI to Regulation (EC) No 1272/2008 shall be prohibited.

However, such substances may be used in cosmetic products by way of exception where, subsequent to their classification as CMR substances of category 1A or 1B under Part 3 of Annex VI to Regulation (EC) No 1272/2008, all of the following conditions are fulfilled:

(a) they comply with the food safety requirements as defined in Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety(1);

(b) there are no suitable alternative substances available, as documented in an analysis of alternatives;

(c) the application is made for a particular use of the product category with a known exposure; and

(d) they have been evaluated and found safe by the SCCS for use in cosmetic products, in particular in view of exposure to these products and taking into consideration the overall exposure from other sources, taking particular account of vulnerable population groups.

Specific labelling in order to avoid misuse of the cosmetic product shall be provided in accordance with Article 3 of this Regulation, taking into account possible risks linked to the presence of hazardous substances and the routes of exposure.

In order to implement this paragraph, the Commission shall amend the Annexes to this Regulation in accordance with the regulatory procedure with scrutiny referred to in Article 32(3) of this Regulation within 15 months of the inclusion of the substances concerned in Part 3 of Annex VI to Regulation (EC) No 1272/2008.

On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 32(4) of this Regulation.

The Commission shall mandate the SCCS to re-evaluate those substances as soon as safety concerns arise, and at the latest five years after their inclusion in Annexes III to VI to this Regulation, and at least every subsequent five years.

3. By 11 January 2012, the Commission shall ensure that appropriate guidance is developed with the aim of enabling a harmonised approach to the development and use of overall exposure estimates in assessing the safe use of CMR substances. This guidance shall be developed in consultation with the SCCS, the ECHA, the EFSA and other relevant stakeholders, drawing, as appropriate, on relevant best practice.

4. When Community or internationally agreed criteria for identifying substances with endocrine-disrupting properties are available, or at the latest on 11 January 2015, the Commission shall review this Regulation with regard to substances with endocrine-disrupting properties.

Article 16 Nanomaterials

1. For every cosmetic product that contains nanomaterials, a high level of protection of human health shall be ensured.

2. The provisions of this Article do not apply to nanomaterials used as colorants, UV-filters or preservatives regulated under Article 14, unless expressly specified.

3. In addition to the notification under Article 13, cosmetic products containing nanomaterials shall be notified to the Commission by the responsible person by electronic means six months prior to being placed on the market, except where they have already been placed on the market by the same responsible person before 11 January 2013.

In the latter case, cosmetic products containing nanomaterials placed on the market shall be notified to the Commission by the responsible person between 11 January 2013 and 11 July 2013 by electronic means, in addition to the notification in Article 13.

The first and the second subparagraphs shall not apply to cosmetic products containing nanomaterials that are in conformity with the requirements set out in Annex III.

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 point 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 of nanomaterial contained in cosmetic products intended to be placed on the market per year;

(d) the toxicological profile of the nanomaterial;

(e) the safety data of the nanomaterial relating to the category of cosmetic product, as used in such products;

(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 for the submission of the toxicological profile, which may substitute the information to be notified under point (d).

4. In the event that the Commission has concerns regarding the safety of a nanomaterial, the Commission shall, without delay, request the SCCS to give its opinion on the safety of such nanomaterial for use in the relevant categories of cosmetic products and on the reasonably foreseeable exposure conditions. The Commission shall make this information public. The SCCS shall deliver its opinion within six months of the Commission's request. Where the SCCS finds that any necessary data is lacking, the Commission shall request the responsible person to provide such data within an explicitly stated reasonable time, which shall not be extended. The SCCS shall deliver its final opinion within six months of submission of additional data. The opinion of the SCCS shall be made publicly available.

5. The Commission may, at any time, invoke the procedure in paragraph 4 where it has any safety concerns, for example due to new information supplied by a third party.

6. Taking into account the opinion of the SCCS, and where there is a potential risk to human health, including when there is insufficient data, the Commission may amend Annexes II and III.

7. The Commission may, taking into account technical and scientific progress, amend paragraph 3 by adding requirements.

8. The measures, referred to in paragraphs 6 and 7, 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).

9. On imperative grounds of urgency the Commission may use the procedure referred to in Article 32(4).

10. The following information shall be made available by the Commission:

(a) By 11 January 2014, the Commission shall make available a catalogue of all nanomaterials used in cosmetic products placed on the market, including those used as colorants, UV-filters and preservatives in a separate section, 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 shall be presented by 11 July 2014 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 shall, where necessary, propose suitable amendments to those provisions.

The first review shall be undertaken by 11 July 2018.

Article 17 Traces of prohibited substances

The non-intended presence of a small quantity of a prohibited substance, stemming from impurities of natural or synthetic ingredients, the manufacturing process, storage, migration from packaging, which is technically unavoidable in good manufacturing practice, shall be permitted provided that such presence is in conformity with Article 3.

(1)

OJ L 31, 1.2.2002, p. 1.