16 REGULATIONS
kept up to date in view of additional relevant information generated subsequent to placing the product on the market”. Therefore, any undesirable effects reported once the product is on the market, including those that cannot be considered serious and those deriving from a misuse of the product, must be listed in order to update the CPSR. Statistical data, notifications of serious undesirable effects to the national Competent Authorities9
and
handling of these cases by the Responsible Person, including preventive and corrective measures, must be included. The safety assessor may re-assess the safety of the product in light of all reported (serious) undesirable effects. Finally, any other available data on the
product or similar formulations may be used to support or assess its safety as, for instance, existing studies on human volunteers or risk assessments carried out in other areas.
The Cosmetic Product Safety Report (CPSR) – Part B Part B of the CPSR must firstly state the safety assessment conclusion for the product, which may be considered safe, safe with restrictions or not safe for human health under normal or reasonably foreseeable conditions of use. Importantly, a product that is not considered safe must not be placed on the market. Secondly, the safety assessor will state the need to label any particular warnings and instructions of use, including any mandatory wording required by the Regulation if certain ingredients are present.
Both statements must be based on the available information compiled in Part A of the CPSR. A specific section of Part B (Reasoning) must summarise the assessment and discussion of these data. As these can come from all sources (raw material suppliers, scientific literature, clinical studies, comparison with similar products, etc.), an appropriate weight-of- evidence approach shall be used (as stated in Article 10 of the Regulation); the relevance of the data in relation to the product must be considered. The safety assessment must be reviewed if new toxicological data are made available, if there are changes in the formula, the raw materials or the conditions of use or if a rising trend can be established regarding undesirable effects.
Assessor’s credentials According to Article 10 of the Regulation: “the cosmetic product safety assessment shall be carried out by a person in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical
PERSONAL CARE EUROPE
E. coli culture.
study in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent by a Member State”. The name, address, proof of qualification and signature of the safety assessor must be stated on the CPSR, as well as the date of completion of the assessment.
Conclusion
By establishing specific rules for the safety assessment of cosmetic products, the Cosmetics Regulation aims to protect consumer health. Any cosmetic product made available on the EU market must fulfil specific composition and labelling requirements and must have a Cosmetic Product Safety Report. The safety assessor, who must have specific qualifications, must consider all available data before concluding on product safety, and this assessment must be regularly updated in the light of additional relevant information emerging after the product has been placed on the market.
Note 1: Raw materials are substances or mixtures of substances used in the manufacture of a cosmetic product. According to the Regulation, a substance is: “a chemical element and its compounds in the natural state or obtained by any manufacturing process including any additive necessary to preserve its stability and any impurity deriving from the process used but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition”. The words “substance” and “ingredient” are used interchangeably in this article. Note 2: According to the Regulation, an undesirable effect is an: “adverse reaction for human health attributable to the normal
or reasonably foreseeable use of a cosmetic product”. A serious undesirable effect is “an undesirable effect which results in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies or an immediate vital risk or death”.
PC
References 1. Regulation (EC) No 1223/2009 of the European
Parliament and of the Council of 30 November 2009 on cosmetic products.
2. 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.
3. The SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation 9th revision. SCCS/1564/15, revised version of 25 April 2016.
4. ISO 17516:2014. Cosmetics – Microbiology – Microbiological limits.
5. ISO 29621:2017. Cosmetics – Microbiology – Guidelines for the risk assessment and identification of microbiologically low-risk products.
6. Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC.
7. Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food.
8. SCCP/1171/08. Opinion on use of the Threshold of Toxicological Concern (TTC) approach for human safety assessment of chemical substances with focus on cosmetics and consumer products.
9. European Commission. SUE Reporting Guidelines. Ref. Ares(2015)4460770 – 21/10/15. Version: July 2013.
April 2018
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