5 May 2017
EU Cosmetics Law Revised Regarding Certain Substances in Hair Dyes and Sunscreen Products
Hong Kong traders exporting hair dye products and sunscreen products to the EU should be informed that the European Commission has adopted two new regulations amending framework Regulation 1223/2009 on cosmetic products (the Cosmetics Regulation) which affect the marketability of these two types of products.
In the European Union, cosmetic products’ ingredients, such as preservatives, colorants, hair colours, UV-filters, fragrances and nanomaterials, are specifically controlled under the Cosmetics Regulation. To this end, the Scientific Committee on Consumer Safety (the SCCS) advises the Commission on the safety of cosmetic ingredients in order to support regulatory decisions on whether or not a chemical ingredient should be allowed in cosmetic products, and under which conditions.
The safety assessment carried out by the SCCS is intended to be very thorough and to analyse detailed information relating to the physical and chemical properties of an ingredient, its potential to cause harmful effects, and the consumer exposure to such products. The safety assessment is intended to make sure that a chemical ingredient is sufficiently pure and does not contain unacceptable impurities that could be harmful to consumers’ health. In particular, the assessment aims to exclude any safety risk from hazardous chemicals that may be a carcinogen, mutagen, or reproductive toxin (CMR).
The SCCS will only give a positive opinion when experts have sufficient evidence on safety to exclude a risk to consumers’ health under foreseeable conditions of the relevant product’s use. For instance, the European Commission has permitted 100 hair dyes to be introduced on the market and has banned another 180, based on the SCCS’ advice or due to a lack of required evidence on safety.
Against this background, the Commission has adopted Commission Regulation 2017/237 amending Annex III to Regulation 1223/2009 on cosmetic products, setting maximum concentrations for a range of substances used in hair dye products. For the exact number and names of substances covered, traders are advised to check the annex to the new Commission Regulation.
Moreover, the Regulation stipulates that it is appropriate to provide for reasonable periods of time in order for the industry to adapt to the new requirements and to phase out products concerned which do not comply with those requirements. Relevant dates are also provided in the annex to the new Commission Regulation.
Regulation 2017/237 follows a recommendation of the SCCS to conduct an overall safety assessment strategy for hair dye substances including the requirement for testing substances in hair dye products for their potential genotoxicity or carcinogenicity.
Following the opinions of the SCCS, the Commission agreed with Member States and stakeholders on a strategy to regulate substances used in hair dye products according to which the industry was required to submit files containing updated scientific data on the safety of hair dye substances.
In addition, the SCCS gave an opinion on oxidative hair dye substances and hydrogen peroxide, used in products to colour eyelashes, which concluded that oxidative hair dye substances can be safely used in products intended for colouring eyelashes. However, Hong Kong cosmetics sellers may wish to know that the Commission has specified in Regulation 2017/237 that products intended for colouring eyelashes should be allowed for professional use only, in order to avoid any risk connected with the self-application of products. Finally, Regulation 2017/237 provides for appropriate warnings on labels of products intended for colouring eyelashes so as to inform consumers about possible adverse effects.
The second regulation adopted by the European Commission, Commission Regulation 2017/238 amending Annex VI to Regulation 1223/2009 on cosmetic products, seeks to regulate the use of Benzophenone-3 as a UV filter in sunscreen products. It does this by decreasing the substance’s maximum permitted concentration in ready-for-use preparations from 10% to 6% following an opinion of the SCCS.
Regulation 2017/238 will begin to apply on 3 September 2017.