16 REGULATION
Cosmetics regulatory update for the EU
Dr Martin Perry – Advanced Development & Safety Laboratories (ASDL), UK
This article looks at recent changes to the European Cosmetics Regulation (EC) No. 1223/2009. It follows on from the article that appeared in the June 2020 edition of Personal Care Europe. It looks at notifications the European Commission (EC) has made to the World Trade Organisation (WTO) for future changes to the regulation, then concludes by looking at the opinions of the Scientific Committee on Consumer Safety (SCCS) on nanomaterials.
New EU Regulations Commission Regulation (EU) 2020/1682 adopts the SCCS opinion for HEMA and di- HEMA trimethylhexyl dicarbamate. The SCCS concluded that they are not likely to pose a risk of sensitisation, provided that their use is restricted to the nail plate area, and avoids contact with the surrounding skin. Taking into consideration the requirement
to avoid the skin around the nail area, the EC concluded that it would be safer for consumers if they were restricted to professional use only. The Regulation therefore added them to Annex III (Entries 313 and 314) of Regulation 1223/2009. No maximum permitted concentration is specified but products must be labelled with the warning ‘For professional use only. Can cause an allergic reaction’. Commission Regulation (EU) 2020/1683
regulates the use of a number of hair dye substances. It prohibits the use of 1,2,4-trihydroxybenzene, 4-amino-3- hydroxytoluene and 2-[(4-amino-2- nitrophenyl)-amino]-benzoic acid to colouring the hair and eyelashes by adding them to Annex II (Entries 1642, 1643 and 1644). It also amends the entry for 2-methoxymethyl-p- phenylenediamine and 2-methoxymethyl-p- phenylenediamine sulfate (annex III entry 292) so that they can be used to colour the eyelashes (by professionals only) as well as the hair. The Regulation further permits the use of
dimethylpiperazinium aminopyrazolopyridine HCl and methylimidazoliumpropyl p-phenylenediamine HCl as oxidative hair dyes by adding them to Annex III (Entries 313 and 314). It also permits the use of HC orange no. 6 and 7 (Entries 316 and 317) and indigofera tinctoria leaf, indigofera tinctoria leaf powder, indigofera tinctoria leaf extract and indigofera tinctoria extract (Entry 318) as non–oxidative hair dyes. Tetrabromophenol blue (Entry 317) is permitted to be used as a substance in
PERSONAL CARE November 2021
oxidative. A number of hair dye substances have been subject to new rules and non–oxidative hair dye products. Maximum concentrations and the wording for conditions of use and warnings are specified in the regulation. Commission Regulation (EU)
2020/1684 amends Annex VI of Regulation 1223/2009 to permit the use of the UV filter methoxypropylamino cyclohexenylidene ethoxyethylcyanoacetate. This is restricted to a maximum concentration of 3%. It is not to be used in applications that could result in the product being inhaled into the lungs. As it is a secondary amine,
methoxypropylamino cyclohexenylidene ethoxyethylcyanoacetate should not be used in formulations containing nitrosating substances
O OH OH
because it can form nitrosamines. It should be kept in nitrite-free containers and not contain more than 50 µg/kg of nitrosamine. Commission Delegated Regulation (EU)
2020/217, which applies from 1 October 2021, has classified a number of substances as carcinogenic, mutagenic or toxic to reproduction (CMR) in accordance with Regulation (EC) No 1272/2008. Commission Regulation (EU) 2021/850 prohibits the use of these substances in cosmetic products unless the requirements for CMR substances stated in Article 15 of Regulation 1223/2009 are met. Regulation 2021/850 also prohibits the use of 12 substances and adds them to Annex II of Regulation 1223/2009. Regulation 2020/217 further classifies TiO2
as ‘carcinogen category 2 (inhalation)’ when in powder form containing 1% or more of particles with aerodynamic diameter of ≤10µm. Its use in this form is permitted at up to 25% in face products in loose powder form, 1.4% in hair aerosol spray products for general consumer use and 1.1% in hair aerosol spray products for professional use. For other products, it must not be used in applications that may lead to it being inhaled into the lungs. The entry for use as a colorant in annex IV
(entry 143) has been updated to include the use of TiO2
in powder form containing 1% or more of
particles with aerodynamic diameter of ≤10µm. It will be permitted to be used as a colorant in compliance with Annex III Entry 321. TiO2
in
Salicyclic acid is limited to concentrations of 0.5% in uses other than as a preservative
powder form containing 1% or more particles with aerodynamic diameters of ≤ 10µm has also been included as a UV filter in annex VI (Entry 27).
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