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EU Calls for Safety Assessment Data on 10 Ingredients
On February 15, 2021, the EU released a notice calling for safety assessment data on 10 ingredients with potential endocrine-disrupting properties used in cosmetic products:
Butylparaben
Methylparaben
Ethylhexyl methoxycinnamate (EHMC)/Octylmethoxycinnamate (OMC)/Octinoxate
Benzophenone-1 (BP-1)
Benzophenone-2 (BP-2)
Benzophenone-4 (BP-4)
Benzophenone-5 (BP-5)
BHA/Butylated Hydroxyanisole/Tert-butylhydroxyanisole
Triphenyl phosphate
Salicylic acid
Upon receipt of sufficient data, the Commission will mandate the SCCS to evaluate the substances as soon as possible. If needed, the Commission will then take appropriate action to prohibit or restrict the use of these substances in cosmetics. [Reference Link]
EU Restricts the Use of Two Substances
In 2020, the EU released the amendments to the Regulation (EC) No 1223/2009, of which two substances were added with use restrictions:
HEMA (Chemical name: 2-Hydroxyethyl Methacrylate)
DI-HEMA TRIMETHYLHEXYL DICARBAMATE (Chemical name: 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)
It is regulated that the two ingredients can be added to nail products and for professional use only. Products containing the two substances and not complying with the conditions specified, shall not be placed on the Union market from 3 June 2021 and not be made available on the Union market from 3 September 2021. [Reference Link]
EU to Ban the Use of Three Substances in Hair and Eyelash Dye Products
In 2020, the EU released the amendments to the Regulation (EC) No 1223/2009, of which three substances will be prohibited for use in hair and eyelash dye products:
1,2,4-Trihydroxybenzene
4-Amino-3-hydroxytoluene
2-[(4-Amino-2-nitrophenyl)-amino]-benzoic acid
The timeline for the ban is as follows:
From 3 September 2021, hair and eyelash dye products containing the three substances shall not be placed on the Union market.
From 3 June 2022, hair and eyelash dye products containing the three substances shall not be made available on the Union market.
EU Amends Annexes of Regulation (EC) No 1223/2009 on Cosmetic Products
The EU released the amendments to the annexes of Regulation (EC) No 1223/2009 on May 26, 2021 and will implement the amendments on Oct. 1, 2021. The amendments are as follows:
1. Add 12 ingredients to the Annex II List of Substances Prohibited in Cosmetic Products
Chemical name/INN | CAS number | EC number |
Cobalt | 7440-48-4 | 231-158-0 |
Metaldehyde (ISO); 2,4,6,8-tetramethyl- 1,3,5,7-tetraoxacyclooctane | 108-62-3 | 203-600-2 |
Methylmercuric chloride | 115-09-3 | 204-064-2 |
Benzo[rst]pentaphene | 189-55-9 | 205-877-5 |
Dibenzo[b,def]chrysene; dibenzo[a,h]pyrene | 189-64-0 | 205-878-0 |
Ethanol, 2,2'-iminobis-, N- (C13-15-branched and linear alkyl) derivs | 97925-95-6 | 308-208-6 |
Cyflumetofen (ISO); 2-methoxyethyl (RS)-2- (4-tert-butylphenyl)-2-cyano-3-oxo-3-(α,α,α-trifluoroo-tolyl)propionate | 400882-07-7 | |
Diisohexyl phthalate | 71850-09-4 | 276-090-2 |
halosulfuron-methyl (ISO); methyl 3-chloro-5-{[(4,6- dimethoxypyrimidin-2-yl) carbamoyl] sulfamoyl}-1- methyl-1H-pyrazole-4- carboxylate | 100784-20-1 | |
2-methylimidazole | 693-98-1 | 211-765-7 |
Metaflumizone (ISO); (EZ)-2'-[2-(4-cyanophenyl)-1-(α,α,α -trifluoro-m- tolyl)ethylidene]-[4-(trifluoromethoxy)phenyl] carbanilohydrazide [E-isomer ≥ 90 %, Z-isomer ≤ 10 % relative content]; [1] (E)-2'-[2-(4-cyanophenyl)- 1-(α,α,α -trifluoro-m-tolyl) ethylidene]-[4-(trifluoromethoxy)phenyl] carbanilohydrazide [2] | 139968-49-3 [1] 852403-68-0 [2] | |
Dibutylbis(pentane-2,4- dionato-O,O’)tin | 22673-19-4 | 245-152-0 |
2. Amend one ingredient and add one ingredient to the Annex III List of Substances Which Cosmetic Products Must Not Contain Except Subject to the Restrictions Laid Down
Type | Name of Common Ingredients Glossary | CAS number | Product type, body parts | Maximum concentration in ready for use preparation | Other |
Revision | Salicylic acid | 69-72-7 | (a) Rinse-off hair products (b) Other products except body lotion, eye shadow, mascara, eyeliner, lipstick, roll-on deodorant (c) Body lotion, eye shadow, mascara, eyeliner, lipstick, roll-on deodorant | (a) 3,0 % (b) 2,0 % (c) 0,5 % | a) (b) (c) 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. |
Addition | Titanium Dioxide | 13463-67-7/ 1317-70-0/ 1317-80-2 | (a) face products in loose powder form (b) hair aerosol spray products (c) other products | (a) 25%; (b) 1,4% for general consumers, and 1.1% for professional use. | (a) (b) Only in the pigmentary form (c) Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation |
3. Amend one ingredient in the Annex IV List of Colorants Allowed in Cosmetic Products
Chemical Name | Color Index Number /Name of Common Ingredients Glossary | Color | Other |
Titanium dioxide | 77891 | White | — Purity criteria as set out in Commission Directive 95/45/E (E 171) — Titanium dioxide in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 μm, to be used in compliance with Annex III, No [321] |
4. Amend one ingredient in Annex VI List of UV Filters Allowed in Cosmetic Products
Chemical Name | CAS number | Maximum concentration in ready for use preparation | Other |
Titanium dioxide | 13463-67-7/ 1317-70-0/ 1317-80-2 | 25% | Titanium dioxide in powder form containing 1% or more of particles with aerodynamic diameter≤10 μm, to be used in compliance with Annex III, No [321]. For the product types under letter (c) of column (f) in Annex III, No [321], the maximum concentration in ready for use preparation provided in column (g) of this entry applies. |
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