2013/674/EU: Commission Implementing Decision of 25 November 2013 on Guidelines o... (32013D0674)
2013/674/EU: Commission Implementing Decision of 25 November 2013 on Guidelines on Annex I to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products Text with EEA relevance
- COMMISSION IMPLEMENTING DECISION
- of 25 November 2013
- on Guidelines on Annex I to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products
- (Text with EEA relevance)
- (2013/674/EU)
- Article 1
- Article 2
- ANNEX
- GUIDELINES ON ANNEX I TO REGULATION (EC) No 1223/2009 ON THE COSMETIC PRODUCT SAFETY REPORT
- 1. INTRODUCTION
- 2. ANNEX I TO REGULATION (EC) No 1223/2009 — COSMETIC PRODUCT SAFETY REPORT
- 3. PART A — COSMETIC PRODUCT SAFETY INFORMATION
- 3.1.
- Quantitative and qualitative composition of the cosmetic product
- 3.2.
- Physical/chemical characteristics and stability of the cosmetic product
- 3.2.1.
- Physical/chemical characteristics of substances or mixtures
- 3.2.2.
- Physical/chemical characteristics of the finished cosmetic product
- 3.2.3.
- Stability of the cosmetic product
- 3.3.
- Microbiological quality
- 3.3.1.
- Microbiological quality of substances and mixtures
- 3.3.2.
- Microbiological quality of the finished cosmetic product
- 3.4.
- Impurities, traces, information about the packaging material
- 3.4.1.
- Purity of substances and mixtures
- 3.4.2.
- Evidence of the technical unavoidability of traces of prohibited substances
- 3.4.3.
- The relevant characteristics of packaging material
- 3.5.
- Normal and reasonably foreseeable use
- 3.6.
- Exposure to the cosmetic product
- 3.7.
- Exposure to the substances
- 3.8.
- Toxicological profile of the substances
- 3.8.1.
- General considerations concerning the toxicological profile as part of the safety assessment
- 3.8.2.
- Toxicological profile of substances for all the relevant toxicological endpoints
- 3.8.3.
- Consideration of all the significant routes of absorption
- (a) Absorption after dermal exposure
- (b) Absorption after oral exposure
- (c) Absorption after inhalation
- 3.8.4.
- Consideration of systemic effects and calculation of the margin of safety
- 3.8.5.
- Impact on the toxicological profile of certain characteristics of the substances or the product
- (a) Particle size
- (b) Impurities in the substances and raw materials
- 3.8.6.
- Use of read-across should be substantiated and justified
- 3.8.7.
- Identification of the sources of information
- 3.9.
- Undesirable effects and serious undesirable effects
- 3.10.
- Information on the cosmetic product
- 4. PART B OF ANNEX I TO REGULATION (EC) No 1223/2009 — COSMETIC PRODUCT SAFETY ASSESSMENT
- 4.1.
- Assessment conclusion
- 4.2.
- Labelled warnings and instructions of use
- 4.3.
- Reasoning
- 4.3.1.
- Safety Evaluation of Substances and/or Mixtures
- 4.3.2.
- Safety Evaluation of the Cosmetic Product
- 4.4.
- Assessor’s credentials and approval of Part B
- References
- Appendix
- Known Databases Containing Toxicological Data on Substances Used in Cosmetics
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