Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast) (Text with EEA relevance)

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, and

• — interaction of substances.

Any read-across shall be duly substantiated and justified.

The source of information shall be clearly identified.

9. Undesirable effects and serious undesirable effects

All available data on the undesirable effects and serious undesirable effects to the cosmetic product or, where relevant, other cosmetic products. This includes statistical data.

10. Information on the cosmetic product

Other relevant information, e.g. existing studies from human volunteers or the duly confirmed and substantiated findings of risk assessments carried out in other relevant areas.

PART B –   Cosmetic product safety assessment

1. Assessment conclusion

Statement on the safety of the cosmetic product in relation to Article 3.

2. Labelled warnings and instructions of use

Statement on the need to label any particular warnings and instructions of use in accordance with Article 19(1)(d).

3. Reasoning

Explanation of the scientific reasoning leading to the assessment conclusion set out under Section 1 and the statement set out under Section 2. This explanation shall be based on the descriptions set out under Part A. Where relevant, margins of safety shall be assessed and discussed.

There shall be inter alia a specific assessment for cosmetic products intended for use on children under the age of three and for cosmetic products intended exclusively for use in external intimate hygiene.

Possible interactions of the substances contained in the cosmetic product shall be assessed.

The consideration and non-consideration of the different toxicological profiles shall be duly justified.

Impacts of the stability on the safety of the cosmetic product shall be duly considered.

4. Assessor's credentials and approval of part B

Name and address of the safety assessor.

Proof of qualification of safety assessor.

Date and signature of safety assessor.

Preamble to Annexes II to VI

• (1) For the purposes of the Annexes II to VI:
• (a) ‘Rinse-off product’ means a cosmetic product which is intended to be removed after application on the skin, the hair or the mucous membranes;
• (b) ‘Leave-on product’ means a cosmetic product which is intended to stay in prolonged contact with the skin, the hair or the mucous membranes;
• (c) ‘Hair product’ means a cosmetic product which is intended to be applied on the hair of head or face, except eye lashes;
• (d) ‘Skin product’ means a cosmetic product which is intended to be applied on the skin;
• (e) ‘Lip product’ means a cosmetic product which is intended to be applied on the lips;
• (f) ‘Face product’ means a cosmetic product which is intended to be applied on the skin of the face;
• (g) ‘Nail product’ means a cosmetic product which is intended to be applied on nails;
• (h) ‘Oral product’ means a cosmetic product which is intended to be applied on teeth or the mucous membranes of the oral cavity;
• (i) ‘Product applied on mucous membranes’ means a cosmetic product which is intended to be applied on the mucous membranes
• — of the oral cavity,
• — on the rim of the eyes,
• — or of the external genital organs;
• (j) ‘Eye product’ means a cosmetic product which is intended to be applied in the vicinity of the eyes;
• (k) ‘Professional use’ means the application and use of cosmetic products by persons in the exercise of their professional activity.

• (2) In order to facilitate substance identification, the following descriptors are used:
• — The Non-proprietary Names (INN) for pharmaceutical products, WHO, Geneva, August 1975;
• — The Chemical Abstracts Service numbers (CAS);
• — The EC number which correspond to either the European Inventory of Existing Commercial chemical Substances (EINECS) numbers or the European List of Notified Chemical Substances (ELINCS) numbers or the registration number given under Regulation (EC) No 1907/2006;
• — The XAN which is the name approved by specific country (X), e.g. USAN which correspond to the United State approved name;
• — The name in the glossary of common ingredient names referred to in Article 33 of this Regulation.

• (3) Substances listed in Annexes III to VI do not cover nanomaterials, except where specifically mentioned.

ANNEX II

LIST OF SUBSTANCES PROHIBITED IN COSMETIC PRODUCTS