8 May 2019
New Cosmetics Laws Regulate Use of Certain Substances in Sunscreens, Other Cosmetic Products
On 2 May 2019, two new Regulations were published in the Official Journal of the European Union, amending the EU’s framework legislation, Regulation 1223/2009 on cosmetic products, pursuant to new opinions presented by the EU’s expert committee, the Scientific Committee on Consumer Safety. Regulation 1223/2009 is the primary regulatory framework for finished cosmetic products which are placed on the EU market. The European Commission adopts changes to this framework as and when the need arises, in light of scientific and technical progress.
Hong Kong sellers of cosmetics may know that under EU law, a ‘cosmetic product’ means any substance or mixture intended to be placed in contact with the external parts of the human body, e.g., the skin, hair, nails, lips and external genital organs, or with the teeth, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours. Cosmetic products may include lotions, gels and oils for the skin and hair, make-up, soaps, deodorant, perfumes, and sunbathing products.
Commission Regulation 2019/680, which was published on 2 May 2019, amends Annex VI of the framework Regulation on cosmetic products. Annex VI is a list of “UV filters allowed in cosmetic products” throughout the EU. The new Commission Regulation thus concerns a particular UV filter, known as Phenylene Bis-Diphenyltriazine.
The new Regulation notes that the EU’s Scientific Committee on Consumer Safety (SCCS) concluded in its opinion of 30 July 2018 that Phenylene Bis-Diphenyltriazine is safe for use as a UV filter in sunscreen products and other cosmetic products, but only at a maximum concentration of 5%. Moreover, the SCCS opines that its use was found to be safe only in dermally applied products and not in products that may lead to inhalation exposure.
In light of the SCCS opinion and in order to take into account technical and scientific progress, the use of Phenylene Bis-Diphenyltriazine as a UV filter in cosmetic products will be authorised at a maximum concentration of 5%, except in applications that may lead to exposure of the end user's lungs by inhalation.
Annex VI to framework Regulation 1223/2009 has therefore been amended, i.e., by adding the aforementioned requirement with regard to Phenylene Bis-Diphenyltriazine. It is thus noteworthy that, henceforth, not only will the 5% limit be strictly applied uniformly for cosmetics placed on the EU market, but also, as now noted in Annex VI, the chemical must “not be used in applications that may lead to exposure of the end-user’s lungs by inhalation.”
Hong Kong sellers of UV filter-containing products such as sunscreens should also take heed that new Commission Regulation 2019/680 will enter into force 20 days from the date of its publication.
Commission Regulation 2019/681 was also published on 2 May 2019. It amends Annex II of framework Regulation 1223/2009. Annex II sets out a “List of substances prohibited in cosmetic products” throughout the EU. The new Regulation notes that the substance 2-Chloro-p-Phenylenediamine, including its sulfate and dihydrochloride salts, is used in formulations for colouring eyebrows and eyelashes in a maximum concentration of 4.6%.
However, the SCCS stated in its opinion of 19 September 2013 that no sufficient margin of safety may be deduced for the use of 2-Chloro-p-Phenylenediamine in oxidative hair dye formulations for eyebrows and eyelashes in a concentration of maximum 4.6%. The SCCS further stated that it was not possible to give a conclusion on the genotoxic potential of 2-Chloro-p-Phenylenediamine based on the available data and the lack of a proper in vivo test for gene mutation induction.
Therefore, the SCCS does not consider the use of 2-Chloro-p-Phenylenediamine safe for the consumer. The SCCS has, in addition, subsequently clarified that it is of the opinion that sulfate and dihydrochloride salts of 2-Chloro-p-Phenylenediamine should be handled with the same caution as 2-Chloro-p-Phenylenediamine until proven to be safe, because they have the same core structure, including genotoxic potential, as 2-Chloro-p-Phenylenediamine. Moreover, the SCCS has clarified that the scope of the SCCS opinion and its conclusion can be extended to the hair on the head. With regard to products for colouring the hair on the head, the exposure to the substance is felt to be even higher, since those products are applied to a larger surface of the body.
In consequence, 2-Chloro-p-Phenylenediamine, its sulfate and dihydrochloride salts are added to the list of prohibited substances in Annex II to Regulation 1223/2009. They will be prohibited in hair dye products, including eyebrow dye products, and in eyelash dye products.
Helpfully for sellers of such products that currently use these chemicals, the new Regulation affords a grace period, during which the industry can adapt to the new EU-wide prohibition. Thus, the prohibition enters into force only by the following deadlines:
- From 22 November 2019, hair dye products, including eyebrow dye products, and eyelash dye products containing the substances prohibited by the Regulation shall not be placed on the Union market.
- From 22 February 2020, hair dye products, including eyebrow dye products, and eyelash dye products containing the substances prohibited by the Regulation shall not be made available on the Union market.
Framework Regulation 1223/2009 for cosmetic products is amended accordingly.