21.7.2015   

EN

Official Journal of the European Union

L 193/115

(1)

Following the 2001 scientific study entitled ‘Use of permanent hair dyes and bladder cancer risk’, the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers, subsequently replaced by the Scientific Committee on Consumer Products (SCCP), pursuant to Commission Decision 2004/210/EC (2), concluded that the potential risks of the use of hair dyes were of concern. The SCCP, in its opinions, recommended that the Commission takes further steps to control the use of hair dye substances.

(2)

The SCCP further recommended an overall safety assessment strategy for hair dye substances including the requirements for testing substances used in hair dye products for their potential genotoxicity or carcinogenicity.

(3)

Following the opinions of the SCCP, the Commission agreed with Member States and stakeholders on an overall 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, for a risk assessment by the SCCP.

(4)

The SCCP, subsequently replaced by the Scientific Committee on Consumer Safety (SCCS) pursuant to Commission Decision 2008/721/EC (3), assessed the safety of individual substances for which updated files had been submitted by the industry.

(5)

Taking into account the final opinions given by the SCCS on the safety of individual substances, it is appropriate to limit the maximum concentrations of nine assessed hair dye substances and to list them in Annex III to Regulation (EC) No 1223/2009.

(6)

As regards the evaluation of possible consumer health risks by reaction products formed by oxidative hair dye substances during the hair-dyeing process, based on the data yet available, the SCCS, in its opinion of 21 September 2010, did not raise any major concern regarding genotoxicity and carcinogenicity of hair dyes and their reaction products currently used in the Union.

(7)

The sensitising potential of individual hair dye substances has been addressed in their risk assessments by the SCCS. In order to better inform the consumer about possible adverse effects of hair dye use and to lower the risk of sensitisation to hair dye products among consumers, appropriate warnings should be printed on the label of oxidative hair dye products and of non-oxidative hair dye products containing hair dye substances with an extreme or strong sensitising potential.

(8)

The definition of a hair product in Regulation (EC) No 1223/2009 excluded its application on eyelashes. That exclusion was motivated by the fact that the level of risk is different when cosmetic products are applied on the hair on the head and on eyelashes. A specific safety assessment was therefore needed for the application of thioglycolic acid and its salts on eyelashes.

(9)

The SCCS, in its opinion on thioglycolic acid and its salts of 11 November 2013, concluded that the general use (personal use by consumers at home) of products intended for eyelash-waving containing thioglycolic acid and its salts is not recommended because of the risk of eye irritation during self-application. However, the concentration of thioglycolic acid and its salts in those products is safe up to 11 % when applied on eyelashes by a professional which reduces the risk of a direct contact with the eyes. In addition, the SCCS concluded that the use of thioglycolic acid and its salts up to 5 % is safe for use as a depilatory when used as intended. The safety of these types of cosmetic products highly depends on responsible risk management including warnings and extensive guidance for use.

(10)

On the basis of the scientific assessment of thioglycolic acid and its salts their use should be allowed in products intended for eyelash waving and for use as depilatories. However, in order to avoid any risk connected with the self-application of products intended for eyelash-waving by consumers, they should be allowed for professional use only. 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 should be printed on their labels.

(11)

Annex III to Regulation (EC) No 1223/2009 should therefore be amended accordingly.

(12)

The application of the restrictions relating to hair dye substances should be deferred to allow the industry to comply with the requirements for hair dye products. In particular, undertakings should be granted 12 months to place on the market compliant products and to withdraw from the market non-compliant products after the entry into force of this Regulation.

(13)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Cosmetic Products,