Commission Regulation (EU) 2016/1198 of 22 July 2016 amending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance)
Commission Regulation (EU) 2016/1198of 22 July 2016amending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products(Text with EEA relevance) THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic productsOJ L 342, 22.12.2009, p. 59., and in particular Article 31(1) thereof,Whereas:(1)Methylisothiazolinone is authorised as a preservative in cosmetic products at concentrations up to 0,01 % weight/weight (100 ppm) through entry 57 of Annex V to Regulation (EC) No 1223/2009.(2)The Scientific Committee on Consumer Safety (SCCS) adopted an opinion on the safety of methylisothiazolinone (sensitisation only) on 12 December 2013SCCS/1521/13 Revision of 27 March 2014..(3)The SCCS concluded that current clinical data indicate that the concentration of 100 ppm of methylisothiazolinone in cosmetic products is not safe for the consumer. For leave-on cosmetic products (including "wet wipes"), no safe concentrations of methylisothiazolinone for induction of contact allergy or elicitation have been adequately demonstrated.(4)In light of the SCCS opinion mentioned above, it is important to address the increased incidence of allergies induced by methylisothiazolinone and this substance should therefore be banned in leave-on products.(5)Regulation (EC) No 1223/2009 should therefore be amended accordingly.(6)The application of the above-mentioned ban should be deferred to allow the industry to make the necessary adjustments to product formulations. In particular, undertakings should be granted six 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.(7)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Cosmetic Products,HAS ADOPTED THIS REGULATION:
Article 1Annex V to Regulation (EC) No 1223/2009 is amended in accordance with the Annex to this Regulation.
Article 2From 12 February 2017 only cosmetic products which comply with this Regulation shall be placed and made available on the Union market.
Article 3This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 22 July 2016.For the CommissionThe PresidentJean-Claude JunckerANNEXIn Annex V to Regulation (EC) No 1223/2009, entry 57 is replaced by the following:
Methylisothiazolinone is also regulated in entry 39 of Annex V in a mixture with methylchloroisothiazolinone. The two entries are mutually exclusive: the use of the mixture of Methylchloroisothiazolinone (and) Methylisothiazolinone is incompatible with the use of Methylisothiazolinone alone in the same product."
Reference numberSubstance IdentificationConditionsWording of conditions of use and warnings
Chemical name/INNName of Common Ingredients GlossaryCAS numberEC numberProduct type, Body partsMaximum concentration in ready for use preparationOther
abcdefghi
"572-Methyl-2H-isothiazol-3-oneMethylisothiazolinone2682-20-4220-239-6Rinse-off products0,01 %
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Methylisothiazolinone is also regulated in entry 39 of Annex V in a mixture with methylchloroisothiazolinone. The two entries are mutually exclusive: the use of the mixture of Methylchloroisothiazolinone (and) Methylisothiazolinone is incompatible with the use of Methylisothiazolinone alone in the same product."