November 30, 2020
On November 12, 2020, three new amendments to the Cosmetics Regulation (EC) 1223/2009 were published. (EU) 2020/1682 amending Annex III to the Regulation, (EU) 2020/1683 amending Annexes II and III to the Regulation, and (EU) 2020/1684 amending Annex VI to the Regulation.
(EU) 2020/1682 amending Annex III to the Regulation
The Swedish Medical Products Agency, the competent authority for purposes of Regulation (EC) 1223/2009 in Sweden, informed the Commission as required, that substances 2-Hydroxyethyl methacrylate (HEMA) and 11,14-Dioxa-2,9-diazaheptadec-16-enoic acid, 4,4,6,16- tetramethyl-10,15-dioxo, 2-[(2-methyl-1-oxo-2-propenyl)oxy]ethyl ester (Di-HEMA Trimethylhexyl Dicarbamate or Di-HEMA TMHDC), were reported to cause a high number of undesirable effects. These substances have been used without restriction or prohibition in artificial nail modeling. Based on the data, the Scientific Committee on Consumer Safety (SCCS) concluded that, when applied properly to the nail plate avoiding contact to adjacent skin, these substances are not likely to cause sensitization. However, HEMA and Di-HEMA TMHDC are considered to be moderate sensitizers, and may therefore pose a risk from unintentional contamination to the adjacent skin under normal conditions of use. This observation was also reported by other Member States and led the SCCS to the decision that HEMA and Di-HEMA TMHDC would be safer for the consumer if were applied only by professionals. The (EU) 2020/1682 amendment of November 12, 2020 reflects that, by adding these substances to Annex III of (EC) 1223/2009 with the warning ‘for professional use only’ and to draw the attention to professionals, the warning ‘can cause allergic reaction’. The implementation timeframe is from June 3, 2021 for new products and September 3, 2021 for existing products.
(EU) 2020/1683 amending Annexes II and III to the Regulation
After a 2001 scientific study on ‘Use of permanent hair dyes and bladder cancer risk’ was published, the Scientific Committee on Consumer Products (SCCP) concluded that the potential health risk of hair dyes was of concern and should be addressed. Upon agreement of the Commission with Member States and stakeholders on the regulation of substances used in hair dye products, the industry was required to submit information containing updated data on the safety of hair dye substances for further risk assessment. Based on the data provided by the industry, the SCCS assessed the safety of individual hair dye substances.
The conclusion of the risk assessment showed that it was necessary to prohibit the use of three hair dye substances: 1,2,4-Trihydroxybenzene, 2-[(4-Amino-2- nitrophenyl)-amino]-benzoic acid, and 4-Amino-3-hydroxytoluene. These are now added to Annex II of the Regulation. The dye substances are also explicitly prohibited for use on eyelashes. Additionally, based on the final opinion of SCCS, six further hair dye substances, Dimethylpiperazinium Aminopyrazolopyridine HCl, Methylimidazoliumpropyl p-phenylenediamine HCl, HC Orange No 6, Acid Orange 7, Tetrabromophenol Blue and Indigofera Tinctoria should be used with restrictions and are added to Annex III of the Regulation. For the prohibited dye substances, the implementation timeframe is from September 3, 2021 for new products and June 3, 2022 for existing products. For the dye substances added to Annex III to the Regulation, there are varied implementation timeframes.
(EU) 2020/1684 amending Annex VI to the Regulation
On December 13, 2019, the SCCS concluded that the substance Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate is safe for use as a UV filter in cosmetic products at a maximum concentration of 3% except in spray products which can lead to lung exposure. In addition, the substance being a secondary amine, is prone to formation to nitrosamine and therefore should not be combined with nitrosating substances.
UL’s LOLI database is being updated to reflect the Amendments and will be available for the January 2021 (2021-1) release.