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Official Journal EN
of the European Union L series
2026/78 13.1.2026
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
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on
cosmetic products(1), and in particular Article 15(1), third sentence, and Article 15(2), fourth subparagraph, thereof,
Whereas:
(1) Regulation (EC) No 1272/2008 of the European Parliament and of the Council(2) provides for a harmonised
classification of substances as carcinogenic, mutagenic or toxic for reproduction (CMR) based on a scientific
assessment by the Committee for Risk Assessment of the European Chemicals Agency. The substances are classified
as CMR substances of category 1A, category 1B or category 2 depending on the weight of evidence of their CMR
properties.
(2) Article 15 of Regulation (EC) No 1223/2009 provides that substances which have been classified as CMR substances
of category 1A, 1B or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 are to be prohibited from use in
cosmetic products. Those CMR substances may however be used in cosmetic products where the conditions laid
down in Article 15(1), second sentence, or Article 15(2), second subparagraph, of Regulation (EC) No 1223/2009
are fulfilled.
(3) In order to uniformly implement the prohibition of CMR substances within the internal market, to ensure legal
certainty in particular for economic operators and national competent authorities, and to ensure a high level of
protection of human health, all CMR substances should be included in the list of prohibited substances in Annex II
to Regulation (EC) No 1223/2009 and, where relevant, deleted from the lists of restricted or allowed substances in
Annexes III to VI to that Regulation. However, where the conditions laid down in Article 15(1), second sentence, or
Article 15(2), second subparagraph, of Regulation (EC) No 1223/2009 are fulfilled, the lists of restricted or allowed
substances in Annexes III to VI to that Regulation should be amended accordingly.
(4) This Regulation concerns substances classified as CMR substances of categories 1A, 1B or 2 by Commission
Delegated Regulation (EU) 2024/2564(3).
(5) 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.
(1) OJ L 342, 22.12.2009, p. 59, ELI: http://data.europa.eu/eli/reg/2009/1223/oj.
(2) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and
packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation
(EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1, ELI: http://data.europa.eu/eli/reg/2008/1272/oj).
(3) Commission Delegated Regulation (EU) 2024/2564 of 19 June 2024 amending Regulation (EC) No 1272/2008 of the European
Parliament and of the Council as regards the harmonised classification and labelling of certain substances (OJ L, 2024/2564,
30.9.2024, ELI: http://data.europa.eu/eli/reg_del/2024/2564/oj).
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(6) 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.
(7) 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).
(8) 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.
(9) In May 2023, a request for the application of Article 15(1), second sentence, of Regulation (EC) No 1223/2009 was
submitted concerning only the use of micron-sized particulate silver in cosmetic products.
(10) The Scientific Committee on Consumer Safety (SCCS) concluded in its opinion of 27 March 2024(4) that micron-
sized particulate silver can be considered safe under specific conditions of use in cosmetic products.
(11) 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.
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, while
micron-sized silver should also be added to the list of substances restricted in cosmetic products in Annex III to that
Regulation.
(12) The substance ‘hexyl 2-hydroxybenzoate’ (CAS No 6259-76-3) has been classified as a CMR substance of category 2
(toxic for reproduction) by Delegated Regulation (EU) 2024/2564.
(13) Hexyl 2-hydroxybenzoate, with INCI name ‘Hexyl Salicylate’, is currently not regulated under Regulation (EC)
No 1223/2009.
(14) In December 2022, a request for the application of Article 15(1), second sentence, of Regulation (EC) No 1223/2009
was submitted concerning the use of Hexyl Salicylate in cosmetic products.
(15) 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.
(16) In light of the classification of Hexyl Salicylate as a CMR substance of category 2 and the final opinion of SCCS, Hexyl
Salicylate should be added to the list of substances restricted in cosmetic products in Annex III to Regulation (EC)
No 1223/2009.
(17) The substance ‘biphenyl-2-ol’ (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.
(18) Biphenyl-2-ol, with INCI name ‘o-Phenylphenol’, 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.
(4) SCCS (Scientific Committee on Consumer Safety), Opinion on the safety of Silver (CAS/EC No 7440-22-4/231-131-3) used in
cosmetic products, preliminary version of 27 March 2024, final version of 20 June, SCCS/1665/24.
(5) SCCS (Scientific Committee on Consumer Safety), Addendum to the Scientific Opinion on Hexyl Salicylate SCCS/1658/23 (CAS/EC
No 6259-76-3/228-408-6) – children exposure 0-3 y.o., SCCS/1668/24, preliminary version of 26 July 2024, final version of
25 October 2024, corrigendum of 18 December 2024.
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(19) In December 2023, a request for the application of Article 15(1), second sentence, of Regulation (EC) No 1223/2009
was submitted concerning the use of o-Phenylphenol as a preservative in cosmetic products. In addition, the request
included the safety of ‘Sodium o-Phenylphenate’ (CAS No 132-27-4), which is the sodium salt of o-Phenylphenol and
which is currently not listed in the Annexes to Regulation (EC) No 1223/2009.
(20) The SCCS concluded in its opinion of 25 October 2024(6)that o-Phenylphenol and Sodium o-Phenylphenate can be
considered safe under specific conditions of use in cosmetic products.
(21) In light of the classification of o-Phenylphenol as a CMR substance of category 2 and the final SCCS opinion on both
o-Phenylphenol and Sodium o-Phenylphenate, entry 7 of Annex V to Regulation (EC) No 1223/2009 should be
amended to add the substance Sodium o-Phenylphenate to the list of preservatives allowed in cosmetic products.
(22) 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.
(23) Regulation (EC) No 1223/2009 should therefore be amended accordingly.
(24) The amendments to Regulation (EC) No 1223/2009 that are based on the classifications of the relevant substances as
CMR substances by Delegated Regulation (EU) 2024/2564 should apply from the same date as those classifications.
(25) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
Cosmetic Products,
HAS ADOPTED THIS REGULATION:
Article 1
Annexes II, III, IV and V to Regulation (EC) No 1223/2009 are amended in accordance with the Annex to this Regulation.
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 12 January 2026.
For the Commission
The President
Ursula VON DER LEYEN
(6) SCCS (Scientific Committee on Consumer Safety), Opinion on the safety of ‘Biphenyl-2-ol’ and ‘Sodium 2-biphenylolate’ (CAS/EC
No 90-43-7/201-993-5 and 132-27-4/205-055-6) used in cosmetic products, preliminary version of 31 July 2024, final version of
25 October 2024, SCCS/1669/24.
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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:
Substance identification
Reference
number
Chemical name/INN CAS number EC number
a b c d
‘1397 Perboric acid (H BO (O )), monosodium salt 13517-20-9 [1] 239-172-9 [1]
3 2 2
trihydrate [1]
Perboric acid, sodium salt, tetrahydrate [2] 37244-98-7 [2] 234-390-0 [2]
Perboric acid (HBO(O )), sodium salt, tetrahydrate [3] 10486-00-7 [3] — [3]
2
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/ 231-556-4 [6]
10332-33-9/
10486-00-7 [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 )), sodium salt, monohydrate 10332-33-9 [9] — [9]
2
[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:
Substance identification
Reference
number
Chemical name/INN CAS number EC number
a b c d
‘1727 Silver (nano) [1 nm < particle diameter ≤ 100 nm] 7440-22-4 231-131-3’
Silver (massive) [particle diameter ≥ 1 mm]
(d) the following entries are added:
Substance identification
Reference
number
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
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Substance identification
Reference
number
Chemical name/INN CAS number EC number
a b c d
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]- 119344-86-4 438-340-0
1-[4-(morpholin-4-yl)phenyl]butan-1-one
1756 2,3-epoxypropyl neodecanoate 26761-45-5 247-979-2
1757 Benthiavalicarb-isopropyl (ISO); isopropyl [(S)- 177406-68-7 —
1-{[(R)-1-(6-fluoro-1,3-benzothiazol-2-yl)ethyl]
carbamoyl}-2-methylpropyl]carbamate
1758 7-oxabicyclo[4.1.0]hept-3-ylmethyl 2386-87-0 219-207-4
7-oxabicyclo[4.1.0]heptane-3-carboxylate
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)- 67306-00-7 —
2-methylpropyl]piperidine
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- 87392-12-9 —
6-methylphenyl)-N-[(2S)-1-methoxypropan-2-yl]
acetamide; (RS)-2-chloro-N-(6-ethyl-o-
a a
tolyl)-N-[(1S)-2-methoxy-1-methylethyl]acetamide
[contains 80-100 % 2-chloro-N-(2-ethyl-
6-methylphenyl)-N-[(2S)-1-methoxypropan-2-yl]
acetamide and 0-20 % 2-chloro-N-(2-ethyl-
6-methylphenyl)-N-[(2R)-1-methoxypropan-2-yl]
acetamide]
1766 Pyraclostrobin (ISO); methyl 175013-18-0 —’
N-(2-{[1-(4-chlorophenyl)-1H-pyrazol-3-yl]
oxymethyl}phenyl) N-methoxy carbamate
ELI: http://data.europa.eu/eli/reg/2026/78/oj 5/7(2) in Annex III, the following entries are added:
Substance identification Restrictions
Wording of
Reference Name of Maximum
conditions of use
number Common concentration in
Chemical Name/INN CAS number EC number Product type, Body parts Other and warnings
Ingredients ready for use
Glossary preparation
a b c d e f g h i
‘379 Silver (powder) Silver 7440-22-4 231-131-3 (a) Toothpaste For (a) and (b):
[100 nm < particle 0,05 %
(b) Mouthwash
diameter < 1 mm]
380 Hexyl Hexyl 6259-76-3 228-408-6 (a) Hydroalcoholic-based (a) 2 % Not to be used
2-hydroxybenzoate Salicylate fragrances (except in preparations
(b) 0,5 %
hydroalcoholic-based for children
fragrances intended for (c) 0,3 % under 3 years of
children below 3 years of age) age, with the
(d) 0,001 %
exception of (d)
(b) All rinse-off products (except
(e) 0,001 % “Toothpaste”
shower gel/bath products,
and (f).’
hand wash, hair conditioner (f) 0,1 %
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
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13.1.2026(3) in Annex IV, entry 142 is replaced by the following:
Substance identification Conditions
Colour index
Wording of
Reference Num Maximum
conditions of use
number ber/Name of Product type, Body concentration in
Chemical name CAS number EC number Colour Other and warnings
Common parts ready for use
Ingredients preparation
Glossary
a b c d e f g h i j
‘142 Silver (powder) 77820 7440-22-4 231-131-3 White (a) Lip products For (a) and (b):
[100 nm < particle 0,2 %’
(b) Eye shadow
diameter < 1 mm]
(4) in Annex V, entry 7 is replaced by the following:
Substance identification Conditions
Wording of
Reference Name of Maximum
conditions of use
number Common Product type, Body concentration in
Chemical name/INN CAS number EC number Other and warnings
Ingredients parts ready for use
Glossary preparation
a b c d e f g h i
‘7 Biphenyl-2-ol; o-Phenylphenol 90-43-7 201-993-5 (a) Rinse-off (a) 0,2 % (as When Avoid contact
2-phenylphenol; products phenol o-Phenylphenol and with eyes’
2-hydroxybiphenyl Sodium
o-Phenylphenate are
Sodium Sodium 132-27-4 205-055-6 (b) Leave-on (b) 0,15 % (as
used together, the
2-biphenylate o-Phenylphe products phenol)
combined
nate
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.
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