21 Aug 2015
New Additions and Restrictions in Relation to Hair-Dye Products and Eyelash Applications Published; and Substance Ban Introduced for Sunscreen Products
On 20 July and 28 July 2015, two new laws related to cosmetics were published in the EU’s Official Journal. These are, respectively, Commission Regulation 2015/1190 and Commission Regulation 2015/1298, relating to various aspects of safety. Both new laws amend Regulation 1223/2009 of the European Parliament and the Council, also known as the Cosmetics Regulation, which is the principal EU law on cosmetic products. It strengthens the safety of cosmetic products and streamlines the framework for all operators in the sector.
Hong Kong and mainland Chinese producers of cosmetics will already be familiar with the definition of “cosmetics”. The term covers any substance or preparation which could come into contact with the human body, including the skin, hair, nails and genital organs, or with the oral cavity, for the main purpose of cleaning, perfuming, or altering their appearance. Cosmetic products include creams, lotions, gels, oils, soaps, shampoos, deodorants, perfumes, hair-dyes and sprays, make-up, shaving products and sunscreen/tanning products.
Commission Regulation 2015/1190: The amendment brought by this new Regulation was made in light of the conclusions reached by the Scientific Committee on Consumer Products (SCCP) that the potential risks of the use of hair dyes were of concern. The Commission, along with Member States and stakeholders, therefore came to a conclusion on an overall strategy to regulate substances used in hair dye products. This strategy required the SCCP to assess the safety of hair dye substances.
The SCCP’s assessment has prompted the Commission to limit the maximum concentrations of nine assessed hair dye substances, as shown in point (2) of the Annex to new Commission Regulation 2015/1190. These entries amend, in turn, Annex III to Regulation 1223/2009. Annex III of the latter Regulation contains a list of substances which cosmetic products must not contain except subject to the restrictions laid down in the Annex’s table.
Additionally, the sensitising potential of individual hair dye substances was addressed in their risk assessments by the SCCS. In consequence, the Commission has expressed that appropriate warnings should be placed on the labels of oxidative and non-oxidative hair dye products containing hair dye substances with an extreme or strong sensitising potential. This would ensure that consumers are informed about the potential adverse effects of hair dye use and it would lower the risk of sensitisation to hair dye products among consumers. Hong Kong producers should, therefore, examine the last column of the table in point (2) of the Annex to new Commission Regulation 2015/1190 in order to familiarise themselves with the appropriate warnings to be placed on labelling.
The Regulation’s definition of hair product does not include those for application on eyelashes because the risk level is different. A separate safety assessment was required for the application of thioglycolic acid and its salts on eyelashes.
In its opinion of 11 November 2013, the SCCS concluded that the general use of products intended for eyelash-waving containing thioglycolic acid and its salts, is not recommended due to risk of irritation. However, the concentration of thioglycolic acid and its salts in these products is safe up to 11% when applied to eyelashes by a professional. Application by a professional reduces the risk of direct contact with eyes. The SCCS also concluded that the use of thioglycolic acid and its salts up to 5% is safe for use as a depilatory. In order to allow professionals to inform consumers about possible adverse effects of the application of products containing thioglycolic acid and its salts on eyelashes and to lower the risk of skin sensitisation to those products, appropriate warnings have to be printed on their labels. Hong Kong producers will see all these aforementioned requirements reflected in section (1) of the Annex to new Commission Regulation 2015/1190. These are also introduced as an amendment to Annex III of the Cosmetics Regulation 1223/2009.
The provisions of new Commission Regulation 2015/1190 began applying as from 10 August 2015, except for the provisions in point (2) of the Annex, which will apply as from 10 August 2016.
Commission Regulation 2015/1298: On 28 July 2015, the European Commission published Commission Regulation 2015/1298 amending Annexes II and VI to Regulation 1223/2009 on cosmetic products. Annex II lists the substances that are prohibited in cosmetic products. Annex VI lists the UV filters that are allowed in cosmetic products.
These amendments have been made in response to an opinion published on 18 June 2013. In that opinion, the Scientific Committee on Consumer Safety (SCCS) concluded that the use of 3-Benzylidene Camphor as a UV filter in cosmetic products in a concentration of up to 2.0% is considered unsafe.
3-Benzylidene Camphor has been and is currently used in cosmetic products as a UV filter in a concentration of up to a maximum of 2.0%. This compound is listed under reference number 19 of Annex VI to Regulation 1223/2009.
Based on the SCCS’s report, it is felt necessary to remove 3-Benzylidene Camphor from the list of UV filters allowed in cosmetic products as laid down in Annex VI to Regulation 1223/2009, in order to ensure the safety of sunscreen products for human health. Given that 3-Benzylidene Camphor also serves as a UV absorber, it should be banned in cosmetic products across the board. These prohibitions are laid down in the Annex to new Commission Regulation 2015/1298, which, in turn, amend the respective annexes of the Cosmetics Regulation.
The application of the restriction is being deferred for six months so as to allow the industry to make the necessary adjustments to product formulations. Therefore, from 18 February 2016, only cosmetic products which comply with the new Regulation may be placed and made available on the EU market.