On January 13, 2026, the European Commission published Regulation (EU) 2026/78, introducing amendments and updates to the requirements for the use of carcinogenic, mutagenic, or reprotoxic (CMR) substances in cosmetics. The regulation modifies Annexes II, III, IV, and V of the EU Cosmetics Regulation (EC) No 1223/2009.
This regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union and will apply in all EU Member States starting from May 1, 2026.
Substance Review and Regulatory Revisions
1.Perboric acid and its salts
Perboric acid and its salts, which have been classified as CMR substances of category 1B, are listed in entries 1397, 1398 and 1399 of Annex II to Regulation (EC) No 1223/2009 and are, therefore, prohibited for use in cosmetic products. However, the substances listed in those entries are all perborate derivatives and are structurally related. They share a common borate core and release hydrogen peroxide upon dissolution in water, which accounts for their similar chemical properties and biological activity. Due to their common mode of action and health risks, it is appropriate from a regulatory perspective to treat perboric acid and its salts as a group rather than individual substances.
For reasons of clarity, legal certainty and simplification, the merging of entries 1397, 1398 and 1399 of Annex II to Regulation (EC) No 1223/2009 would simplify that Regulation and improve clarity for stakeholders. Therefore, entry 1397 should be amended to reflect the content of entries 1398 and 1399, while entries 1398 and 1399 should be deleted.
| Reference number | Substance identification | ||
| Chemical name/INN | CAS number | EC number | |
| a | b | c | d |
| 1397 | Perboric acid (H3BO2(O2)), monosodium salt trihydrate [1] | 13517-20-9 [1] | 239-172-9 [1] |
| Perboric acid, sodium salt, tetrahydrate [2] | 37244-98-7 [2] | 234-390-0 [2] | |
| Perboric acid (HBO(O2)), sodium salt, tetrahydrate [3] | 10486-00-7 [3] | — [3] | |
| Sodium peroxoborate, hexahydrate [4] | — [4] | — [4] | |
| Sodium perborate [5] | 15120-21-5 [5] | 239-172-9 [5] | |
| Sodium peroxometaborate; sodium peroxoborate [6] | 7632-04-4/10332-33-9/10486-00-7 [6] | 231-556-4 [6] | |
| Perboric acid, sodium salt [7] | 11138-47-9 [7] | 234-390-0 [7] | |
| Perboric acid, sodium salt, monohydrate [8] | 12040-72-1 [8] | 234-390-0 [8] | |
| Perboric acid (HBO(O2)), sodium salt, monohydrate [9] | 10332-33-9 [9] | — [9] | |
| Trimethyl borate | 121-43-7 [10] | 204-468-9 [10] | |
2. Silver
The substance silver (CAS No 7440-22-4) has been classified as a CMR substance of category 2 (toxic for reproduction) by Delegated Regulation (EU) 2024/2564, when its particle diameter is equal to or larger than 1 mm (silver massive), when its particle diameter is larger than 100 nm and smaller than 1 mm (silver powder) and when its particle diameter is larger than 1 nm and smaller than or equal to 100 nm (silver nano).
Silver is currently listed in entry 142 of Annex IV to Regulation (EC) No 1223/2009 as an authorised colorant (CI 77820), while its colloidal nanoform (1-100 nm) is prohibited in cosmetic products and listed as entry 1727 in Annex II to that Regulation. The Scientific Committee on Consumer Safety (SCCS) concluded in its opinion of 27 March 2024 that micron-sized particulate silver can be considered safe under specific conditions of use in cosmetic products.
In light of the classification of silver massive, silver powder and silver nano as CMR substances of category 2, the specific exemption request relevant to only the micron-sized silver and the relevant SCCS opinion, entry 1727 of Annex II to Regulation (EC) No 1223/2009 should be amended to include silver massive and silver nano.
| Reference number | Substance identification | ||
| Chemical name/INN | CAS number | EC number | |
| a | b | c | d |
| 1727 |
Silver (nano) [1 nm < particle diameter ≤ 100 nm] Silver (massive) [particle diameter ≥ 1 mm] |
7440-22-4 | 231-131-3 |
Furthermore, entry 142 of Annex IV to Regulation (EC) No 1223/2009 should be amended to allow the use of micron-sized silver (silver powder) as a colorant only at certain conditions considered safe by the SCCS.
| Reference number | Substance identification | Conditions | Wording of conditions of use and warnings | ||||||
| Chemical name | Colour index Number/Name of Common Ingredients Glossary | CAS number | EC number | Color | Product type, Body parts | Maximum concentration in ready for use preparation | Other | ||
| a | b | c | d | e | f | g | h | i | j |
| 142 | Silver (powder) [100 nm < particle diameter < 1 mm] | 77820 | 7440-22-4 | 231-131-3 | White |
(a) Lip products (b) Eye shadow |
For (a) and (b):0.2% | ||
Micron-sized silver should also be added to the list of substances restricted in cosmetic products in Annex III to that Regulation.
| Reference number | Substance identification | Conditions | Wording of conditions of use and warnings | |||||
| Chemical name/INN | Name of Common Ingredients Glossary | CAS number | EC number | Product type, Body parts | Maximum concentration in ready for use preparation | Other | ||
| a | b | c | d | e | f | g | h | i |
| 379 | Silver (powder) [100 nm < particle diameter < 1 mm] | Silver | 7440-22-4 | 231-131-3 |
(a) Toothpaste (b) Mouthwash |
For (a) and (b): 0,05 % | ||
3. Hexyl Salicylate
The substance Hexyl Salicylate(CAS No 6259-76-3) has been classified as a CMR substance of category 2 (toxic for reproduction) by Delegated Regulation (EU) 2024/2564 which is currently not regulated under Regulation (EC) No 1223/2009. The SCCS concluded in its opinion of 25 October 2024 (5) that Hexyl Salicylate can be considered safe under specific conditions of use in cosmetic products.
Hexyl Salicylate is added to the list of substances restricted in cosmetic products in Annex III to Regulation (EC) No 1223/2009.
| Reference number | Substance identification | Conditions | Wording of conditions of use and warnings | |||||
| Chemical name/INN | Name of Common Ingredients Glossary | CAS number | EC number | Product type, Body parts | Maximum concentration in ready for use preparation | Other | ||
| a | b | c | d | e | f | g | h | i |
| 380 | Hexyl 2-hydroxybenzoate | Hexyl Salicylate | 6259-76-3 | 228-408-6 |
(a) Hydroalcoholic-based fragrances (except hydroalcoholic-based fragrances intended for children below 3 years of age) (b) All rinse-off products (except shower gel/bath products, hand wash, hair conditioner and shampoo intended for children below 3 years of age) (c) All leave-on products (except hair conditioner, body lotion, face cream, hand cream, lipstick/lip balm and fragrance products intended for children below 3 years of age) (d) Toothpaste (e) Mouthwash (f) Shower gel/bath products, hand wash, shampoo, hair conditioner, body, face and hand (skin) care products, lipstick/lip balm and fragrance products intended for children below 3 years of age |
(a) 2 % (b) 0,5 % (c) 0,3 % (d) 0,001 % (e) 0,001 % (f) 0,1 % |
Not to be used in preparations for children under 3 years of age, with the exception of (d) Toothpaste and (f). | |
4. o-Phenylphenol
The substance o-Phenylphenol (CAS No 90-43-7), has been classified as a CMR substance of category 2 (carcinogen of category 2), by Delegated Regulation (EU) 2024/2564 which is currently listed in entry 7 of Annex V to Regulation (EC) No 1223/2009 as an allowed preservative in rinse-off and leave-on products with a maximum allowed concentration of 0,2 % and 0,15 % (as phenol), respectively. The SCCS concluded in its opinion of 25 October 2024 that o-Phenylphenol and Sodium o-Phenylphenate can be considered safe under specific conditions of use in cosmetic products.
Based on above assessment, entry 7 of Annex V to Regulation (EC) No 1223/2009 is amended to add the substance Sodium o-Phenylphenate to the list of preservatives allowed in cosmetic products.
| Reference number | Substance identification | Conditions | Wording of conditions of use and warnings | |||||
| Chemical name/INN | Name of Common Ingredients Glossary | CAS number | EC number | Product type, Body parts | Maximum concentration in ready for use preparation | Other | ||
| a | b | c | d | e | f | g | h | i |
| 7 |
Biphenyl-2-ol; 2-phenylphenol; 2-hydroxybiphenyl Sodium 2-biphenylate |
o-Phenylphenol Sodium o-Phenylphenate |
90-43-7 132-27-4 |
201-993-5 205-055-6 |
(a) Rinse-off products (b) Leave-on products |
(a) 0,2 % (as phenol (b) 0,15 % (as phenol) |
When o-Phenylphenol and Sodium o-Phenylphenate are used together, the combined concentration (as phenol) shall not exceed 0,2 % in rinse-off and 0,15 % in leave-on products. 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. |
Avoid contact with eyes |
5. Other Substances
With regard to all substances other than silver, hexyl 2-hydroxybenzoate and biphenyl-2-ol, which were classified as CMR substances by Delegated Regulation (EU) 2024/2564, no request for use in cosmetic products has been submitted. Consequently, the CMR substances that are not already listed in Annex II to Regulation (EC) No 1223/2009 should be added to the list of substances prohibited in cosmetic products in that Annex.
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Further Information:
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202600078
