Article 1
Annexes II, III, IV and V to Regulation (EC) No 1223/2009 are amended in accordance with the Annex to this Regulation.
Commission Regulation (EU) 2026/78 of 12 January 2026 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 for reproduction
Commission Regulation (EU) 2026/78 of 12 January 2026 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 for reproduction
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union . It shall apply from 1 May 2026.
Supplementary provisions
ANNEXSupplementary provisions
ANNEX Annexes II, III, IV and V to Regulation (EC) No 1223/2009 are amended as follows: (1) Annex II is amended as follows: (a) entry 1397 is replaced by the following: Reference number Substance identification Chemical name/INN CAS number EC number a b c d ‘1397 Perboric acid (H 3 BO 2 (O 2 )), 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(O 2 )), 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(O 2 )), sodium salt, monohydrate [9] 10332-33-9 [9] — [9] Trimethyl borate 121-43-7 [10] 204-468-9 [10]’ (b) entries 1398 and 1399 are deleted; (c) entry 1727 is replaced by the following: 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’ (d) the following entries are added: Reference number Substance identification Chemical name/INN CAS number EC number a b c d ‘1752 Multi-walled Carbon Tubes (synthetic graphite in tubular shape) with a geometric tube diameter range ≥ 30 nm to < 3 μm and a length ≥ 5 μm and aspect ratio > 3:1, including Multi-Walled Carbon Nanotubes, MWC(N)T — — 1753 reaction mass of 1,3-dioxan-5-ol and 1,3-dioxolan-4-ylmethanol — — 1754 Acetone oxime 127-06-0 204-820-1 1755 2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl)phenyl]butan-1-one 119344-86-4 438-340-0 1756 2,3-epoxypropyl neodecanoate 26761-45-5 247-979-2 1757 Benthiavalicarb-isopropyl (ISO); isopropyl [( S )-1-{[( R )-1-(6-fluoro-1,3-benzothiazol-2-yl)ethyl]carbamoyl}-2-methylpropyl]carbamate 177406-68-7 — 1758 7-oxabicyclo[4.1.0]hept-3-ylmethyl 7-oxabicyclo[4.1.0]heptane-3-carboxylate 2386-87-0 219-207-4 1759 Sodium 3-(allyloxy)-2-hydroxypropanesulphonate 52556-42-0 258-004-5 1760 1,4-dichloro-2-nitrobenzene 89-61-2 201-923-3 1761 Fenpropidin (ISO); ( R , S )-1-[3-(4-tert-butylphenyl)-2-methylpropyl]piperidine 67306-00-7 — 1762 N,N’ -methylenediacrylamide 110-26-9 203-750-9 1763 tert -butyl 2-ethylperoxyhexanoate 3006-82-4 221-110-7 1764 Trimethyl borate 121-43-7 204-468-9 1765 S -metolachlor (ISO); 2-chloro- N -(2-ethyl-6-methylphenyl)- N -[(2 S )-1-methoxypropan-2-yl]acetamide; ( R a S a )-2-chloro- N -(6-ethyl- o -tolyl)- N -[(1 S )-2-methoxy-1-methylethyl]acetamide [contains 80-100 % 2-chloro- N -(2-ethyl-6-methylphenyl)- N -[(2 S )-1-methoxypropan-2-yl]acetamide and 0-20 % 2-chloro- N -(2-ethyl-6-methylphenyl)- N -[(2 R )-1-methoxypropan-2-yl]acetamide] 87392-12-9 — 1766 Pyraclostrobin (ISO); methyl N -(2-{[1-(4-chlorophenyl)-1 H -pyrazol-3-yl]oxymethyl}phenyl) N -methoxy carbamate 175013-18-0 —’ (2) in Annex III, the following entries are added: Reference number Substance identification Restrictions 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 % 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).’ (3) in Annex IV, entry 142 is replaced by the following: 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 Colour 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 %’ (4) in Annex V, entry 7 is replaced by the following: 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’
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
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