EU Cosmetics Regulation Updated: Involving Annexes II, III and V

On July 8 2026, the European Union submitted notification G/TBT/N/EU/1219 to the World Trade Organization (WTO), planning to amend the EU Cosmetics Regulation, involving Annex II (list of prohibited substances), Annex III (list of restricted substances) and Annex V (list of allowed preservatives). The public comment period for this notification closes on 6 September 2026; the Regulation is expected to be adopted in Q4 2026, and will officially enter into force on the 20th day following its publication in the Official Journal of the European Union.

CIRS Group has summarized the core points of this amendment and provided interpretation of the restricted ingredients involved, for cosmetic companies' compliance reference.

Background to the Amendment

To ensure the uniform application of the ban on carcinogenic, mutagenic and reprotoxic (CMR) substances within the EU internal market, to provide economic operators and national competent authorities with a clear legal basis, and to protect human health, all CMR substances should be included in the list of substances prohibited in cosmetic products (Annex II); where they have previously been listed in the lists of restricted or authorised substances in Annexes III to VI of the Regulation, they should be deleted therefrom; however, where the relevant conditions of Article 15 of Regulation (EC) No 1223/2009 are met, the lists of restricted and authorized substances in Annexes III to VI should be amended accordingly.

Recently, the EU Scientific Committee on Consumer Safety (SCCS) has conducted safety assessments on a number of cosmetic ingredients, and based on the assessment conclusions, the use requirements for the relevant substances need to be adjusted.

Ingredient Interpretation and Regulatory Amendments

Annex II-List of Prohibited Substances

1. Mercury and its compounds

【Interpretation】Council Directive 76/768/EEC has already prohibited the use of mercury and its compounds; pursuant to entry 221 of Annex II to the EU Cosmetics Regulation, mercury and its compounds remain prohibited substances to this day.

Thiomersal and phenylmercuric salts (including phenylmercuric borate) are mercury-containing compounds listed in entries 16 and 17 of Annex V, and may be used as preservatives in cosmetic products under specific conditions. Given the severe health risks associated with mercury, the SCCS conducted a scientific safety assessment on mercury-containing preservatives and mercury compounds. In its scientific advice of 2 February 2026 (SCCS/1686/25), the SCCS concluded that, considering that the margin of safety (MoS) calculated using renal toxicity as the most sensitive endpoint is below 100, and that the genotoxicity evidence remains unclear, the use of thiomersal and phenylmercuric salts (including phenylmercuric borate) is not safe at the currently permitted concentration levels.

Accordingly, the use of mercury compounds in cosmetic products poses a potential risk to human health. Therefore, entries 16 and 17 of Annex V should be deleted; at the same time, the generic entry 221 governing mercury and its compounds in Annex II should be amended by removing the exemption from the ban for the special cases previously provided for under Annex V.

【Amendment】 Entry 221 of Annex II is updated as follows:

2. 16 newly added substances

【Interpretation of selected substances】Benzophenone-1 (CAS No. 131-56-6) is currently not regulated by Regulation (EC) No 1223/2009. It can absorb and disperse ultraviolet (UV) radiation, protecting the formulation from UV damage, and is therefore commonly used as a light stabiliser in cosmetic products. Benzophenone-2 (CAS No. 131-55-5) is likewise not regulated by Regulation (EC) No 1223/2009. It can act as a UV filter, light stabilizer and fragrance ingredient in cosmetic products, preventing product deterioration caused by light (including UV light) on the one hand, and enhancing the fragrance or perfuming the skin on the other.

In view of concerns related to the potential endocrine-disrupting properties of Benzophenone-1 and Benzophenone-2, the European Commission launched calls for data in 2019 and 2021 respectively. The cosmetics industry submitted scientific evidence to demonstrate the safety of these substances when used in cosmetic products. Based on the information submitted by the industry, the SCCS completed safety assessments of the two substances. In its opinion of 27 March 2025 (SCCS/1672/24), the SCCS concluded that Benzophenone-1 is not safe when used as a light stabilizer in cosmetic products. Accordingly, the use of Benzophenone-1 in cosmetic products poses a potential risk to human health, and it should therefore be added to the list of prohibited substances in Annex II.

In the corrigendum (SCCS/1679/25) of 26 March 2026 to its scientific advice, the SCCS indicated that the genotoxicity potential of Benzophenone-2 cannot be excluded, and it was unable to draw a conclusion on its safety. Moreover, data on the repeated-dose toxicity and reproductive toxicity of Benzophenone-2 are limited or unavailable. The available evidence shows that the substance exhibits oestrogenic activity both in vitro and in vivo, and is an endocrine-active substance. Benzophenone-2 should therefore be added to the list of prohibited substances in Annex II.

Basic Brown 16 (C009) (CAS No. 26381-41-9) and Basic Blue 99 (C059) (CAS No. 68123-13-7) are currently not regulated by Regulation (EC) No 1223/2009.

In its scientific advice of 2 February 2026 (SCCS/1684/25), the SCCS concluded that the use of Basic Brown 16 (C009) is not safe when used in non-oxidative hair dye formulations, as the weight of evidence indicates its potential for mutagenicity; the use of Basic Blue 99 (C059) in non-oxidative hair dyes is likewise not safe, as the evidence indicates a potential for genotoxicity. Accordingly, the use of Basic Brown 16 (C009) and Basic Blue 99 (C059) in cosmetic products poses a potential risk to human health, and these substances should be added to the list of prohibited substances in Annex II.

Prostaglandins and their analogues (PGAs) are commonly added to cosmetic products to promote eyelash growth. They are not regulated by Regulation (EC) No 1223/2009, and their use in cosmetic products is currently not restricted.

Given that eyelash-growth cosmetic products containing prostaglandin analogues may cause various adverse health effects, the European Commission launched a public call for data in 2020. In its final opinion of 2 February 2026 (SCCS/1680/25), the SCCS concluded that prostaglandins and their analogues used in cosmetic products raise safety concerns: these substances are pharmacologically active and may cause serious undesirable effects even at very low concentrations, particularly affecting ocular health. In addition, there is insufficient evidence to rule out potential adverse effects related to reproductive and developmental toxicity. Given that users of cosmetic products containing these substances are most likely women of child-bearing age, their safety assessment is of particular importance. Therefore, the use of prostaglandins and their analogues in cosmetic products should be prohibited, and they should be added to the list of prohibited substances in Annex II.

【Amendment】The following entries are added:

(*) From 12 months following the entry into force of this Regulation, products containing that substance shall not be placed on the Union market. From 24 months following the entry into force of this Regulation, cosmetic products containing that substance shall not be made available on the Union market.

Annex III-List of Restricted Substances

1. Hydroxyapatite (nano)

【Interpretation】 Hydroxyapatite (nano) (CAS No. 1306-06-5, 12167-74-7) is currently listed in entry 372 of Annex III to the EU Cosmetics Regulation, and may be used in cosmetic products as an abrasive, bulking agent, oral care ingredient and skin conditioning agent. In its opinion of 26 June 2025, the SCCS concluded that Hydroxyapatite (nano) is safe at maximum concentrations of 29.5% in toothpaste and 10% in mouthwash. This safety assessment applies only to Hydroxyapatite (nano) with the following characteristics: composed of rod-shaped particles of which at least 87% (in particle number) have aspect ratios ≤ 3, and the remaining 13% have aspect ratios not exceeding 9; the particles are not coated or surface-modified; and the maximum particle length is 122±43 nm. Accordingly, entry 372 of Annex III should be amended.

【Amendment】 Entry 372 is replaced by the following:

2. Cannabidiol (CBD) and Butylated Hydroxyanisole (BHA)

【Interpretation】 Cannabidiol (CBD) (CAS No. 13956-29-1) is used in cosmetic products as a skin conditioning, skin protecting, antioxidant and anti-sebum ingredient. The EU Cosmetics Regulation does not yet specifically regulate Cannabidiol; however, entry 306 of Annex II to the Regulation prohibits the use in cosmetic products of "Narcotics, natural and synthetic: All substances listed in Tables I and II of the Single Convention on Narcotic Drugs signed in New York on 30 March 1961".

In its opinion of 26 March 2026 (SCCS/1685/25), the SCCS concluded that Cannabidiol is safe when used at concentrations of up to 0.19% in dermal and oral cosmetic products, whether used alone or in combination; it also concluded that the presence of Delta-9-tetrahydrocannabinol (THC, CAS No. 1972-08-3) as an impurity is safe at concentrations not exceeding 0.00025% (2.5 ppm) in dermal and oral cosmetic products. Accordingly, when the concentration of Cannabidiol exceeds the specified limit, its use in cosmetic products poses a potential risk to human health. A provision should therefore be added to Annex III to control the use limit of this ingredient.

Butylated Hydroxyanisole (BHA) (CAS No. 25013-16-5) is currently not regulated by Regulation (EC) No 1223/2009, but may be added to cosmetic products as a fragrance ingredient and antioxidant.

In its scientific advice of 26 March 2026 (SCCS/1682/25), the SCCS concluded that BHA is safe for use in leave-on and rinse-off cosmetic products at a maximum concentration of 0.07%. This assessment considered only dermal use, and therefore BHA may only be used in dermally applied products, and not in oral care products or in cosmetic products that may lead to exposure of the end-user's lungs by inhalation. Accordingly, when the concentration of BHA exceeds the specified range, it poses a potential risk to human health. The use limit of this substance in cosmetic products should be set at the maximum concentration proposed by the SCCS.

【Amendment】 The following entries are added:

(**) From 12 months following the entry into force of this Regulation, cosmetic products containing these substances and not complying with the restrictions shall not be placed on the Union market. From 24 months following the entry into force of this Regulation, cosmetic products containing these substances and not complying with the restrictions shall not be made available on the Union market.

Annex V- List of Allowed Preservatives

1. Butylparaben

【Interpretation】 Butylparaben (CAS No. 94-26-8) is currently listed in entry 12a of Annex V and may be used as a preservative, as acid, at a maximum concentration of 0.14% when used on its own or for the sum of its combined use with propylparaben and its salts.

In its opinion of 30 April 2025 (SCCS/1674/25), the SCCS concluded that Butylparaben can be considered safe for all age groups and product types covered by 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% in leave-on products and 0.092% in oral care products. This opinion is not applicable to sprayable products (including mouth sprays), which may lead to exposure of the end-user's lungs by inhalation.

Therefore, the use of Butylparaben in cosmetic products poses a potential health risk, and the current restrictions on Butylparaben should be revised by creating a separate entry 12b in Annex V specifically for Butylparaben; the existing entry 12a should be amended at the same time.

【Amendment】 Entry 12a is updated as follows:

【Amendment】 Entry 12b is added as follows:

2.【Amendment】 Entries 16 and 17 — which allow the use of Thiomersal and Phenylmercuric salts in Annex V — are deleted **

(**) From 12 months following the entry into force of this Regulation, cosmetic products containing these substances and not complying with the restrictions shall not be placed on the Union market. From 24 months following the entry into force of this Regulation, cosmetic products containing these substances and not complying with the restrictions shall not be made available on the Union market.

Date of Application

• CMR substances: Amendments relating to substances classified as CMR under Delegated Regulation (EU) 2025/1222 shall apply from 1 February 2027.
• Other substances: For amendments not linked to CMR classification under Delegated Regulation (EU) 2025/1222, the cosmetics industry shall be granted reasonable transitional periods to achieve compliance. The transitional periods should allow companies to complete the necessary reformulation of products so that only compliant products are placed on the Union market; economic operators should also be allowed a reasonable period to withdraw non-compliant cosmetic products from the market.

CIRS Reminder

Cosmetic companies are advised to closely follow the latest amendments to the EU Cosmetics Regulation, benchmark against the latest versions of Annexes II, III and V, and fully implement the requirements for managing prohibited and restricted substances; companies should also make full use of the regulatory transitional periods and carry out product formulation optimisation in advance. Should you have any needs regarding EU cosmetic compliance, cosmetic notification, formulation optimisation, PIF preparation, etc., please feel free to contact us at any time!

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