Update on substances classified as CMR substances in Commission Regulation (EU) 2023/1490 of 19 July 2023
On 19 July 2023, the European Commission adopted Regulation (EU) 2023/1490, which amends Regulation (EC) No 1223/2009 of the European Parliament and of the Council on the use of substances classified as carcinogenic, mutagenic or toxic for reproduction (Cmr) in cosmetic products.
Update by the Court of Justice of the European Union on the classification of the substance “Titanium dioxide”
The Court of Justice of the EU has annulled the European Commission’s delegated regulation of 2019, which labelled titanium dioxide (tio2) as carcinogenic by inhalation in certain dust forms. The danger of carcinogenicity, the EU Court notes, “is linked only to some” respirable particles of titanium dioxide present in a certain physical state, a certain shape, size and quantity, “occurs only in conditions of pulmonary overload and corresponds to particles.
Update of the New Regulation 2020/878, New safety data sheets from 1st January 2023
Published in the Official Journal of the European Union on 26 June 2020, Commission Regulation EEC/EU 18 June 2020 n.878, contains an update to the requirements for the compilation of Safety Data Sheets (SDS) of the chemical substances contained in Annex II of the previous Regulation (EC) No 1907/2006 (REACH). Regulation 2020/878, came into force on 16 July 2020 and will be applied throughout Europe, from 1 January 2021. SDS that no longer comply with the new Regulation may continue to be provided by way of derogation until 31 December 2022.
Update of Regulation (EU) 2022/1531 of 15 September 2022 on the prohibition of the marketing of products containing the substance “Methyl salicylate”
With the entry into force of the EU Regulation NR. Commission Regulation 2022/1531 of 15/09/2022 amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use in cosmetic products of certain substances classified as carcinogenic, mutagenic or toxic to reproduction and rectifying the same regulation, the use of methyl 2-hydroxybenzoate (Methyl salicylate) in preparations intended for children under the age of 6 years excluding toothpaste is prohibited. The regulation will take effect from 17/12/2022.
Update of Regulation (EU) 2021/1902 on the prohibition of the marketing of cosmetics containing Lilial
Commission Regulation (EU) 2021/1902 of 29/10/2021 amending Annexes II, III and V to Reg. (EC) 1223/2009 as regards the use in cosmetics of certain substances classified as carcinogenic, mutagenic or toxic to reproduction (CMR) PROHIBITS from 1 March 2022 the marketing of cosmetics containing the substance 2-(4-tert-butylbenzyl) propionaldehyde, INCI name: Butylphenyl methylpropional (Lilial).
Regulation (EC) 1272/2008 on the classification and labelling of substances (CLP) updated on 19.5.2020 has led to the amendment of Annex II to Regulation 1223/2009 (list of substances not allowed in cosmetics) – (European Journal L 387/3.11.2021).
The substance in question is a synthetic molecule widely used as an odorous component – fragrance in cosmetic products in particular perfumes, shampoos, soaps, body creams, cleansing milks but also in some household hygiene products such as detergents.
Structurally it is an aldehyde with a floral smell reminiscent of the fragrant notes of lilac, lily of the valley and cyclamen that is present in the list of perfume allergens along with several other substances.
The Scientific Committee for Consumer Safety of the European Commission (SCCS) has re-evaluated this substance and in its opinion of 14.12.2017 it considered that its genotoxicity cannot be excluded. The Regulation (EU) 2021/1902, in a nutshell, in the light of the studies conducted prohibits the use of BMHCA – Butylphenyl methylpropional in cosmetic products.
In the light of the above, it is therefore necessary to withdraw from the market all cosmetic products containing this substance, which will no longer be allowed to be marketed from 1 March 2022. It is therefore necessary to ask its suppliers whether such substances are present in the purchased products and it is still necessary to check the IBCs of the cosmetic products held in order to verify the presence of BMHCA through its INCI name.
In the case of the presence of BMHCA, the cosmetic products must be stored and sealed in a container with the words “Products not saleable or transferable – to be returned to the supplier” and returned to the supplier in the appropriate manner. Trace of the entire operation should be maintained in case of checks by health authorities.
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