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
Date: 2026-01-12
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: carcinogenic substance, chemical product, consumer information, cosmetic product, health control, health risk, preservative, product safety, silver, toxic substance








L_202600078EN.000101.fmx.xml












Official Journal of the European Union


EN
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.












(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.












(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
            





(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).

(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.

(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.




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 (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]’














(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-[(2S)-1-methoxypropan-2-yl]acetamide; (R
a
S
a)-2-chloro-N-(6-ethyl-o-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]


87392-12-9


—




1766


Pyraclostrobin (ISO); methyl N-(2-{[1-(4-chlorophenyl)-1H-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’











ELI: http://data.europa.eu/eli/reg/2026/78/oj
ISSN 1977-0677 (electronic edition)