(fra kommisjonsforordningen)

(1) Regulation (EC) No 1272/2008 of the European Parliament and of the Council 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, 1B or 2, depending on the weight of evidence of their CMR properties. 

(2) Article 15 of Regulation (EC) No 1223/2009 provides that the use of 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 in cosmetic products. Those CMR substances can, 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 set out in Annex II to Regulation (EC) No 1223/2009 and, where relevant, deleted from the lists of restricted or allowed substances set out 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) No request for use in cosmetic products by way of exception has been submitted for the substances of categories 1A, 1B or 2 classified as CMR substances by Commission Delegated Regulation (EU) 2025/1222. Consequently, where those CMR substances are not listed in Annex II to Regulation (EC) No 1223/2009, they should be added to the list of substances prohibited in cosmetic products. 

(5) Furthermore, this Regulation concerns certain cosmetic ingredients that have been recently assessed by the Scientific Committee on Consumer Safety (SCCS), namely ‘Benzophenone-1’, ‘Benzophenone-2’, ‘Butylated Hydroxyanisole’, ‘Butylparaben’, ‘Basic Brown 16’, ‘Basic Blue 99’, ‘ethyl tafluprostamide’, ‘methylamido-dihydronoralfaprostal’, ‘isopropyl cloprostenate’, ‘thiomersal’, ‘phenylmercuric salts’, ‘Cannabidiol’ and ‘Hydroxyapatite (nano)’. 

(6) The substance ‘2,4-dihydroxybenzophenone’ (CAS No 131-56-6), which has been assigned the name ‘Benzophenone-1’ under the International Nomenclature of Cosmetic Ingredients (INCI), is not regulated by Regulation (EC) No 1223/2009. However, it is used as a light stabiliser in cosmetic products since it can absorb and disperse ultraviolet (UV) radiation, protecting the product formulation from the damaging effects of UV radiation. 

(7) The substance ‘2,2',4,4'-tetrahydroxybenzophenone’ (CAS No 131-55-5), which has been assigned the INCI name ‘Benzophenone-2’, is not regulated by Regulation (EC) No 1223/2009. However, it is used in cosmetic products as a UV filter, light stabiliser and fragrance, protecting the products from the deterioration effects caused by light, including UV light and enhancing their smell or perfuming the skin. 

(8) The substance ‘tert-butyl-4-methoxyphenol’ (CAS No 25013-16-5), which has been assigned the INCI name ‘Butylated Hydroxyanisole’, is composed of two isomers: 2- tert-butyl-4-methoxyanisole and 3-tert-butyl-4-hydroxyanisole. Butylated Hydroxyanisole is not regulated by Regulation (EC) No 1223/2009. However, it is used as a fragrance ingredient and an antioxidant in cosmetic products to prolong their shelf life. 

(9) The substance ‘butyl 4-hydroxybenzoate’ (CAS No 94-26-8), which has been assigned the INCI name ‘Butylparaben’, is listed in entry 12a of Annex V to Regulation (EC) No 1223/2009. It is therefore allowed for use as a preservative, as an acid, in a concentration of up to 0.14 %, when used on its own or for the sum of its combined use with propylparaben and its salts. 

(10) Considering concerns related to potential endocrine-disrupting properties of Benzophenone-1, Benzophenone-2, Butylated Hydroxyanisole and Butylparaben, the Commission launched a public call for data in 2019 and 2021. The cosmetics industry submitted scientific evidence to demonstrate the safety of those substances when used in cosmetic products. The Commission requested the SCCS to carry out safety assessments of those substances in light of the information provided by the industry.

(11) The SCCS concluded in its opinion of 27 March 2025  that Benzophenone-1 is not safe when used as a light stabiliser in cosmetic products. It can be concluded from the SCCS opinion that there is a potential risk to human health arising from the use of Benzophenone-1 in cosmetic products. That substance should therefore be added to the list of substances prohibited in cosmetic products set out in Annex II to Regulation (EC) No 1223/2009. 

(12) In its corrigendum of 26 March 2026 to its scientific advice of Benzophenone-2 and Benzophenone-5 , the SCCS could not draw any conclusions on the safety of Benzophenone-2 because its genotoxicity potential could not be excluded. Data on the repeated dose toxicity and reproductive toxicity of Benzophenone-2 are also either limited or not available. The available evidence shows that of Benzophenone-2 is an endocrine-active substance by clearly demonstrating oestrogenic activity both in vitro and in vivo. That substance should therefore be added to the list of substances prohibited in cosmetic products set out in Annex II to Regulation (EC) No 1223/2009. 

(13) The SCCS concluded in its scientific advice of 26 March 2026, that Butylated Hydroxyanisole is safe for use in leave-on and rinse-off cosmetic products up to the maximum concentration of 0.07 %. This SCCS scientific advice considered only dermal use and hence is applicable to the use of Butylated Hydroxyanisole only in dermally applied products, and not in oral care products or cosmetic products, which can lead to exposure of the end-user’s lungs by inhalation. 

(14) It can be concluded from the SCCS scientific advice of 26 March 2026 that there is a potential risk to human health arising from the use of Butylated Hydroxyanisole in cosmetic products when the concentration of that substance exceeds certain levels. The use of Butylated Hydroxyanisole in cosmetic products should therefore be restricted to the maximum concentration proposed by the SCCS. 

(15) On 30 April 2025 the SCCS adopted an opinion concluding that Butylparaben can be considered safe for children of all age groups and product types included in the assessment, whether used individually or in combination, provided that the concentration of Butylparaben, as acid, does not exceed 0.14 % in rinse-off products, 0.002 %, as acid, in leave-on products and 0.092 %, as acid, in oral care products. The opinion is not applicable to sprayable products, including mouth sprays, that could lead to exposure of the end user’s lungs by inhalation. 

(16) It can be concluded from the SCCS opinion of 30 April 2025 that there is a potential risk to human health arising from the use of Butylparaben in cosmetic products. The current restrictions on the use of Butylparaben in those products should therefore be revised by creating a separate entry for Butylparaben as entry 12b in Annex V to Regulation (EC) No 1223/2009. At the same time, the existing entry 12a, which currently regulates Butylparaben together with Propylparaben, should be amended in order for it to apply exclusively to Propylparaben.

(17) - (41) utelatt her.