The EU Commission published Commission Regulation (EU) 2021/850 amending Annexes II, III, IV and VI to Regulation (EC) No 1223/2009.
This Regulation will apply from 1 October 2021.
By Commission Delegated Regulation (EU) 2020/217 certain substances have been classified as CMR substances in accordance with Regulation (EC) No 1272/2008. Based on Article 15 of the Cosmetics regulation 1223/2009, CMR substances of category 1A, 1B or 2 are prohibited for use in cosmetic products. However, a CMR substance may be used in cosmetic products if the conditions laid down in the second sentence of Article 15 (1) or in the second subparagraph of Article 15 (2) of the cosmetics regulation 1223/2009 are fulfilled.
Titanium dioxide in powder form containing 1% or more particles withing aerodynamic diameter of ≤ 10 μm was classified as Carcinogen Category 2 (inhalation) by Delegated Regulation (EU) 2020/217. Following this classification, the SCCS has evaluated the safety of titanium dioxide. The opinion covered titanium dioxide (inhalable) in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 μm and it was concluded that the substance is safe for general consumers in face products in loose powder form when used up to a maximum concentration of 25% and in hair products in aerosol spray form up to a maximum concentration of 1.4%. For professional use products, a max conc. of 1.1% was considered safe when used in hair products in aerosol spray form.
The SCCS pointed out that the opinion is applicable only to pigmentary type of titanium dioxide and it could not be established whether those conclusions would be also applicable to the cosmetic applications containing other types of titanium dioxide.
In light of the SCCS conclusions, the regulation will be amended as follows:
Annex III will include the following entry:
- Titanium dioxide in powder form containing 1% or more particles withing aerodynamic diameter of ≤ 10 μm:
- Face products in loose powder form in up to 25% (only pigmentary form)
- Hair aerosol spray products in up to 1.4% for general consumers and up to 1% for professional use (only pigmentary form)
- Other products: Not to be used in applications that may lead to end user’s lungs by inhalation
The same restrictions will apply also for titanium dioxide when used as a colorant and UV filter.
In order to align the entry 98 of Annex III with the conclusion of the SCCS opinion on the use of salicylic acid in cosmetic products, the entry will be updated to include the following:
- Rinse off hair products up to 3%
- Other products except body lotion, eye shadow, mascara, eyeliner, lipstick, roll-on deodorant up to 2%
- Body lotion, eye shadow, mascara, eyeliner, lipstick, roll-on deodorant up to 0.5%
The following restrictions and warnings apply to all uses:
Not to be used in preparations for children under 3 years of age. Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation. Not to be used in oral products. For purposes other than inhibiting the development of microorganisms in the product. This purpose has to be apparent from the presentation of the product. These levels are inclusive of any use of salicylic acid.
The regulation will also amend annex II to include CMR substances, for which no request for use in cosmetic products by way of exception has been submitted.
This concerns cobalt, metaldehyde (ISO), methylmercuric chloride, benzo[rst] pentaphene, dibenzo[b,def]chrysene; dibenzo[a,h]pyrene, ethanol, 2,2′-iminobis-,N-(C13-15-branched and linear alkyl) derivs, cyflumetofen (ISO), diisohexyl phthalate, halosulfuron-methyl (ISO), 2-methylimidazole, metaflumizone (ISO), dibutylbis(pentane-2,4-dionato-O,O’)tin, nickel bis(sulfamidate), 2-Benzyl-2-dimethylamino4′- morpholinobutyrophenone and ethylene oxide.