On July 20, 2015 the European Commission adopted Regulation (EU) 2015/1190 thereby amending the Annex III to Regulation (EC) No 1223/2009. The new Regulation, binding in its entirety and directly applicable to all Member States, restricts the use of hair dye substances and was put forward by the Scientific Committee on Consumer Safety.
The Annex III to the Cosmetics Regulation contains a list of cosmetic ingredients that are only allowed in Europe if they comply with the restrictions imposed by the Annex. The new restrictions are the result of further efforts by the European Commission to control the potential health risks of hair dye ingredients in beauty products.
The scientific background behind the decision
The first change regards the use of the ingredient Thioglycolic acid and its salt in products that are intended for eyelash-waving. According to the SCCS Opinion, which was adopted on November 11, 2013, the use of this ingredient is not recommended because of the risk of eye-irritation during self-application of the cosmetic product. However, the SCCS concluded that the use of the ingredient is safe up to 11% of the time when applied on eyelashes by professionals as this reduces the risk of direct contact with the eyes. It also stated that the product is safe up to 5% of the time when used as a depilatory. In addition, the safety of the products will depend on the warnings and extensive guidance for use that must appear on cosmetic product labelling.
The second change regards 9 hair dye ingredients whose safety was evaluated by following different steps. In 2001, the Scientific Committee on Consumer Safety recommended further steps to control the use of hair dye substances following the scientific study entitled “Use of permanent hair dyes and bladder cancer risk.” Based on the data submitted by the beauty product industry, the SCCS assessed the safety of nine hair dye substances and considered whether or not it was appropriate to limit their maximum concentration. Nevertheless, taking into account the data that was available from the Opinion that was adopted on September, 21 2010, the SCCS did not raise any major concerns on the hair dyes´ genotoxicity and carcinogenicity. The SCCS underscored the importance of informing the consumer of possible adverse effects by printing appropriate safety warnings d on the labels of oxidative and non-oxidative cosmetic products containing substances with an extreme or strong sensitising potential.
The changes to the Annex III to Regulation (EC) 1223/2009
The entry # 2a that concerns Thioglycolic acid (CAS 68-11-1) has been changed regarding the percentages that can be used in products intended for eyelash waving.
The change will come into effect on August 10, 2015.
The entries # 288 to # 296 have been added, establishing limits to the maximum percentages as well as introducing mandatory warnings on the labels of the following colorants:
- HC Blue No 17 (CAS 16517-75-2)
- HC Blue No 15 (CAS 74578-10-2)
- Acid Green 25 (CAS 4403-90-1)
- Acid Violet 43 (CAS 4430-18-6)
- 2-Methoxymethyl-p-Phenylenediamine (CAS 337906-36-2)
- 2-Methoxymethyl-p-Phenylenediamine Sulfate (CAS 337906-37-3)
- Hydroxyanthraquinone-aminopropyl Methyl Morpholinium Methosulfate (CAS 38866-20-5)
- Disperse Red 17 (CAS 3179-89-3)
- Acid Black 1 (CAS 1064-48-8)
- Pigment Red 57 (CAS 5858-81-1)
The changes will come into force on August 10, 2016.
The application of the new restriction for the use of hair dyes has been deferred in order to allow the cosmetics industry to complete the necessary steps to comply with the new Regulation. The cosmetics manufacturers and their designated EU Responsible Person have 12 months to place beauty products on the European market that comply with the new rules and to withdraw non-compliant products after the entry into force of the new Regulation.
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