8 Sept 2017
EU Adopts New Regulations on Cosmetics Aimed at Restricting Use of Fragrance Allergens and a Colorant
On 3 and 4 August 2017, the European Commission published two new regulations, Commission Regulation 2017/1410 and Commission Regulation 2017/1413. Both are aimed at revising Regulation 1223/2009, which is the framework EU law on the safety of cosmetic products.
Pursuant to Regulation 2017/1410, the following substances will have to be phased out entirely in cosmetics placed on the EU market:
- 3- and 4-(4-Hydroxy-4-methylpentyl) cyclohex-3-ene-1-carbaldehyde (HICC);
- 2,6-Dihydroxy-4-methyl-benzaldehyde (atranol); and
- 3-Chloro-2,6-Dihydroxy-4-methyl-benzaldehyde (chloroatranol).
It is noteworthy that provisions of the law concerning the safety of cosmetics take aim at so-called “fragrance allergens”, which refer to substances present in fragrances which may cause a skin or respiratory allergy. Both synthetic chemicals and substances of natural origin may be skin allergens. It is estimated that between 1-3% of the population in Europe has a skin allergy to fragrances. The most frequent symptoms include irritation, swelling and rash, but they may develop into a chronic condition (eczema). An allergic reaction to a substance depends on many factors, including the genetic predisposition, age and intensity of exposure to the substance.
Commission Regulation 2017/1410 was adopted pursuant to the potential health risks HICC, atranol and chloroatranol were found to pose to humans, as concluded by the Scientific Committee on Consumer Safety (SCCS) in its opinion of 26–27 June 2012. The Committee held that these substances should not be used in cosmetic products as they are the fragrance allergens which caused the highest number of contact allergy cases in past years. Consequently their continued use has potential to harm human health; those substances should therefore be prohibited in cosmetic products.
In addition, pursuant to new Commission Regulation 2017/1413, the use of zinc oxide as a colorant, in its uncoated non-nano form, in cosmetic products, will be restricted to those applications which may not lead to exposure of the end-user’s lungs by inhalation.
In its opinion of 18 September 2012, revised on 23 September 2014, the SCCS concluded that the use of zinc oxide should be restricted. The study concluded that use of zinc oxide is safe when used as a colorant in its uncoated non-nano form in cosmetics for dermal application. However, due to lung inflammation induced by zinc oxide particles after inhalation, the use of zinc oxide in cosmetic products that may result in exposure of a consumer’s lungs to zinc oxide by inhalation was of concern.
In light of the SCCS opinion, the use of zinc oxide as a colorant, in its uncoated non-nano form, in cosmetic products, will now be restricted to those applications which may not lead to exposure of the end-user’s lungs by inhalation.
Both regulations conceded that the cosmetics industry should be allowed a reasonable period of time to make the necessary adjustments to product formulations in view of their placing on the market and for withdrawal of non-compliant products. When determining those periods of time, due account was taken of the potential risk of those products to human health.
Manifestations of contact allergies to fragrances are normally confined to skin, and consumers with reactions are often aware that they cannot tolerate scented products on their skin and therefore can avoid them. Therefore with respect to Commission Regulation 2017/1410 in particular, the adaptation time is unusually long given the complex and lengthy procedures for fragrance reformulation and consumers’ concerns over the change of the olfactory properties of fragrances.
In sum, from 23 August 2019 cosmetic products containing any of the substances prohibited by Regulation 2017/1410 (HICC, atranol, and chloroatranol) shall not be placed on the EU market, and, from 23 August 2021 cosmetic products containing any of those substances shall not be made available on the EU market.
For the restrictions on the use of zinc oxide, from 24 February 2018 only cosmetic products which comply with Regulation 2017/1413 shall be placed on the EU market; and, from 24 May 2018 only cosmetic products which comply with the Regulation shall be made available on the EU market.