This article reviews and summarizes the latest international cosmetic regulatory developments in the first half of 2025, with a focus on the European and American markets. It covers key updates from the EU, the UK, the US, Canada, and other relevant countries and regions. The aim is to help enterprises stay informed of regulatory changes, ensure compliant product launches, and enhance global market competitiveness.
European Union (EU)
SCCS Issued Preliminary Opinion on Butylparaben - Children Exposure
On 13 January, 2025, the Scientific Committee on Consumer Safety (SCCS) of the European Union issued preliminary opinion (SCCS/1674/25) on Butylparaben (CAS No. 94-26-8). The deadline for comments is set for March 10, 2025.
The SCCS is of the opinion that the use of Butylparaben as preservative at a maximum concentration of 0.14 % (as acid) in all cosmetic products included in this exposure assessment is not safe for children between 0.5-1 years, 1-3 years, 3-6 years and 6-10 years when used in combination. With the exception of body lotion, it is safe in single dermal and oral product categories, when used only in the respective product category. Also, to be safe for all the childrens’ age groups that were considered, the maximum concentration of Butylparaben in final products should not exceed 0.028% (as acid).
https://health.ec.europa.eu/document/download/453366da-0b79-48f6-963e-648f8c176000_en?filename=sccs_o_296.pdf
SCCS Issued Scientific Advice on the Safety of Diethylamino Hydroxybenzoyl Hexyl Benzoate
On February 17, 2025, the Scientific Committee on Consumer Safety (SCCS) of the European Union issued scientific advice (SCCS/1678/25) on Diethylamino Hydroxybenzoyl Hexyl Benzoate (DHHB) (CAS No. 302776-68-7). The deadline for comments is set for April 25, 2025.
The SCCS calculated a maximum level of 0.026% (260 ppm) for this contaminant in the UV filter DHHB. This applies when DHHB is used up to 10% in cosmetic products and only if DnHexP is an unavoidable impurity. Also, the trace level (1 ppm) should be the target for the maximal level of DnHexP as an unavoidable trace impurity in DHHB.
The EU Plans to Update the Glossary of Common Ingredient Names in Cosmetics to Standardize the Ingredients Labeling
On March 13, 2025, the European Union announced a cosmetic related notification (G/TBT/N/EU/1116), proposing to update the glossary of common ingredient names in cosmetics in the EU Regulation (EC) No 1223/2009, while abolishing the current Commission Implementing Decision (EU) 2022/6772 to standardize ingredients labeling and improve ingredient identification. The draft is expected to be approved in the second quarter of 2025 and will officially come into effect 20 days after its publication in the Official Journal of the EU.
https://technical-barriers-trade.ec.europa.eu/en/notification/36211
SCCS Issued Final Opinion on Benzophenone - 1
On 1 April, 2025, the Scientific Committee on Consumer Safety (SCCS) of the European Union issued final opinion (SCCS/1672/24) on Benzophenone -1 (CAS No. 131-56-6). The preliminary opinion on Benzophenone -1 was issued on 7 November, 2024.
The SCCS considers Benzophenone-1 not safe when used as a light stabiliser in cosmetic products for the following reasons:
- The available data indicate genotoxicity potential of Benzophenone-1.
- The evidence assessed by the SCCS also shows that Benzophenone-1 is an endocrine-active substance due to clear demonstration of estrogenic activity and weak anti-androgenic activity both in vitro and in vivo, and potential activity against thyroid modality in vitro.
SCCS Issued Preliminary Opinion on Hydroxyapatite (nano)
On 3 April, 2025, the Scientific Committee on Consumer Safety (SCCS) of the European Union issued preliminary opinion (SCCS/1677/25) on Hydroxyapatite (nano) (CAS No. 1306-06-5). The deadline for comments is set for 30 May, 2025.
The SCCS considers hydroxyapatite (nano) safe when used at concentrations up to 29.5% in toothpaste, and up to 10% in mouthwash. This safety evaluation only applies to the hydroxyapatite (nano) that have the following characteristics:
- composed of rod-shaped particles of which at least 87% (in particle number) have aspect ratios equal to or less than 3, and the remaining 13% have aspect ratios not exceeding 9;
- the HAP particles are not coated or surface modified.
Major Reform of EU REACH Regulation Impacts the Cosmetics Industry
On April 3, 2025, at the CARACAL-54 meeting of the joint advisory body REACH-CLP, the European Commission officially released the final proposal for the reform of the REACH Regulation. The European Chemical Industry Council (Cefic) pointed out that the digital transformation is expected to increase costs for SMEs by 40%, and that the 10-year review cycle and complex mixed assessment models may slow down the development of innovative pharmaceuticals.
SCCS Issued Preliminary Opinion on Benzophenone-2 and Benzophenone-5
On 22 April, 2025, the Scientific Committee on Consumer Safety (SCCS) of the European Union issued preliminary opinion (SCCS/1679/25) on Benzophenone-2 (BP-2) (CAS No. 131-55-5) and Benzophenone-5 (BP-5) (CAS No. 6628-37-1). The deadline for comments is set for June 17, 2025.
Benzophenone-2 (BP-2): the SCCS cannot conclude on the safety of Benzophenone-2 because genotoxicity potential cannot be excluded. The data on repeated dose toxicity and reproductive toxicity of Benzophenone-2 are also either limited or not available. The available evidence shows that BP-2 is an endocrine-active substance, due to a clear demonstration of estrogenic activity both in vitro and in vivo. Benzophenone-5 (BP-5): the SCCS has considered that data from a close analogue BP-4 can be used for read-across for the safety assessment of BP-5.
SCCS Issued Final Opinion on Butylparaben - Children Exposure
On 2 May, 2025, the Scientific Committee on Consumer Safety (SCCS) of the European Union issued final opinion (SCCS/1674/25) on Butylparaben (CAS No. 94-26-8). The preliminary opinion was issued on 13 January, 2025.
The SCCS is of the opinion that the use of Butylparaben as preservative at a maximum concentration of 0.14% (as acid) in all cosmetic products included in this exposure assessment is not safe for children between 0.5-1 years, 1-3 years, 3-6 years and 6-10 years when used in combination. With the exception of body lotion, it is safe in single dermal and oral product categories, when used only in the respective product category. Also, Butylparaben could be considered safe for children of all age groups that were evaluated, provided that the maximum concentration of Butylparaben is reduced in some product types so that the aggregate exposure does not exceed 245 µg/kg bw/day.
SCCS Issued Final Opinion on Salicylic Acid - Children Exposure
On 2 May, 2025, the Scientific Committee on Consumer Safety (SCCS) of the European Union issued final opinion (SCCS/1675/25) on Salicylic Acid (CAS No. 69-72-7). The preliminary opinion was issued on 13 January, 2025.
Based on the safety assessment carried out in consideration of all available information, including the potential endocrine effects:
- The SCCS is of the opinion that Salicylic Acid (CAS 69-72-7) is not safe when used as preservative at a concentration of 0.5% in all cosmetic products listed under conclusion (b).
- This Opinion is not applicable to any sprayable product (including mouth spray) that may lead to exposure of end-user’s lungs by inhalation.
- The provided information shows that Salicylic Acid is an eye irritant with the potential to cause serious damage to the eye.
The use of Salicylic Acid as a restricted ingredient for purposes other than inhibiting the development of micro-organisms is not safe at the following concentrations when aggregate exposure is considered:
- up to 3.0% for the cosmetic rinse-off hair products used by children (shampoo, conditioner),
- up to 2.0% for selected other dermally applied products used by children (face moisturizer, hand cream, liquid soap, shower gel), and
- up to 0.5% for body lotion.
- With the exception of body lotion, it is safe in single dermal and oral product categories, when used only in the respective product category.
SCCS Issued Scientific Advice on Methyl Salicylate - Children’s Exposure (Revision of SCCS/1654/23)
On 2 May, 2025, the Scientific Committee on Consumer Safety (SCCS) of the European Union issued scientific advice (SCCS/1675/25) on Methyl Salicylate (CAS No. 119-36-8) which is the revision of the scientific advice been issued on 22 September, 2023 (SCCS/1654/23) . The SCCS is of the view that, to be considered safe, the concentration of Methyl Salicylate should not exceed 0.4% in toothpaste and 0.02% in other products when used in products intended for children of age 0-3 years.
The SCCS is of the view that, to be considered safe when used in products intended for children of age 0-3 , the concentration of Methyl Salicylate should not exceed 0.4% in toothpaste and 0.02% in other products when used in products intended for children of age 0-3 years.
EU Amends Cosmetics Regulation: 21 CMR Substances Added to the List of Prohibited Substances
On May 12, 2025, the European Commission published Regulation (EU) 2025/877, amending the EU Cosmetics Regulation (EC) No 1223/2009. This amendment incorporates a new group of substances classified as carcinogenic, mutagenic, or toxic to reproduction (CMR substances)-as identified under the Classification, Labelling and Packaging (CLP) Regulation- into Annex II, the List of Substances Prohibited in Cosmetic Products. Additionally, Entry 311 of Annex III has been deleted and its content transferred to Entry 1730 of Annex II. This regulation will enter into force on September 1, 2025.
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32025R0877
EU Proposes Cosmetics Regulation Amendment: 15 CMR Substances to Be Banned; Annexes III-V to Be Revised
On 21 May 2025, the European Union submitted notification G/TBT/N/EU/1140 to the World Trade Organization (WTO), proposing an amendment to the EU Cosmetics Regulation (EC) No 1223/2009. This proposed amendment aims to add 15 substances classified as CMR (carcinogenic, mutagenic, or toxic for reproduction) to Annex II (List of Prohibited Substances). At the same time, updates will be made to Annex III (List of Restricted Substances), Annex IV (List of Permitted Colorants), and Annex V (List of Permitted Preservatives). The regulation will enter into force on the 20th day following its publication in the Official Journal of the European Union and will apply from 1 May 2026.
https://members.wto.org/crnattachments/2025/tbt/EEC/25_03493_00_e.pdf
https://members.wto.org/crnattachments/2025/tbt/EEC/25_03493_01_e.pdf
SCCS Issued Scientific Opinion on Prostaglandin Analogues
On 6 June, 2025, the Scientific Committee on Consumer Safety (SCCS) of the European Union issued preliminary opinion (SCCS/1680/25) on Prostaglandin Analogues: Methylamido-Dihydro-Noralfaprostal (MDN) (CAS No. 155206-01-2), Isopropyl Cloprostenate (IPCP) (CAS No. 157283-66-4) and Dechloro Dihydroxy Difluoro Ethylcloprostenolamide (DDDE) (CAS No. 1185851-52-8). The deadline for comments is set for 18 August 2025.
The SCCS is of the opinion that none of them can be considered safe for use in cosmetic products intended for promoting the growth of eyelashes and eyebrows.
SCCS Issued Scientific Opinion on Tea Tree Oil
On 6 June, 2025, the Scientific Committee on Consumer Safety (SCCS) of the European Union issued scientific opinion(SCCS/1681/25) on Tea Tree Oil (CAS/EC No. 68647-73-4 /285-377-1). The deadline for comments is set for 18 August 2025.
The SCCS considers the use of Tea Tree Oil (TTO) as an anti-seborrheic and anti-microbial agent safe up to the maximum concentration of 2.0% in shampoo, 1.0% in shower gel, 1.0% in face wash and 0.1% in face cream.
SCCS Issued Opinion on Ethylhexyl Methoxycinnamate (EHMC)
On 30 June, 2025, the Scientific Committee on Consumer Safety (SCCS) of the European Union issued scientific opinion(SCCS/1671/24) on Ethylhexyl Methoxycinnamate (EHMC) (CAS No. 5466-77-3/83834-59-7, EC No. 226-775-7/629-661-9).
The SCCS is of the opinion that EHMC is safe when used as a UV filter up to a maximum concentration of 10% in sunscreen lotion, face and hand cream, lipstick, sunscreen propellant spray and pump spray, when used separately or in combination. Based on these reduced concentrations, Butylparaben is considered safe for children of all age groups and product types included in the assessment, whether used individually or in combination.
SCCS Issued Scientific Advice on the safety of Diethylamino Hydroxybenzoyl Hexyl Benzoate
On 6 June, 2025, the Scientific Committee on Consumer Safety (SCCS) of the European Union issued scientific opinion(SCCS/1678/25) on Diethylamino Hydroxybenzoyl Hexyl Benzoate (DHHB) (CAS/EC No. 302776-68-7/443-860-6).
Considering the health concerns associated with DnHexP, the SCCS calculated a maximum safe level of 0.026% (260 ppm) for this impurity in the UV filter DHHB. This applies when DHHB is used up to 10% in cosmetic products and only if DnHexP is an unavoidable impurity. Considering the existence of such alternative manufacturing process for DHHB, the SCCS is of the opinion that a trace level of 1 ppm should be the target for the maximal level of DnHexP as an impurity in DHHB.
SCCS Issued Final Scientific Advice on Benzophenone-2 (BP-2) and Benzophenone-5 (BP-5)
On 30 June, 2025, the Scientific Committee on Consumer Safety (SCCS) of the European Union issued scientific opinion(SCCS/1679/25) on Benzophenone-2 (BP-2)(CAS No. 131-55-5, EC No. 205-028-9) and Benzophenone-5 (BP-5) (CAS No. 6628-37-1, EC No. 613-918-7).
The SCCS cannot conclude on the safety of Benzophenone-2 because genotoxicity potential cannot be excluded. Also, the SCCS is of the opinion that BP-5 is safe when used as a UV filter up to a maximum concentration of 5% in sunscreen, face and hand cream, lipstick, sunscreen propellant spray and pump spray, when used separately or in combination (based on deterministic aggregated exposure of BP-4).
UK
UK to Restrict the Use of Methyl Salicylate in Cosmetics
On January 16, 2025, the UK notified the World Trade Organization (WTO) of the draft Cosmetic Products (Restriction of Chemical Substances) Regulations 2025, proposing amendments to Annex III of Regulation (EC) No. 1223/2009 on cosmetic products to restrict the use of Methyl Salicylate in certain cosmetic formulations. The regulation is scheduled to be adopted on April 30, 2025, and will officially come into effect on September 30, 2025.
https://members.wto.org/crnattachments/2025/TBT/GBR/25_00683_00_e.pdf
SAG-CS Issued Opinion on Formaldehyde Releasing Substances
On May, 2025, Scientific Advisory Group of Chemical Safety of Non-food and Non-medicinal Consumer Products (SAG-CS) issued opinion on formaldehyde releasing substances (Opinion 16). Members agreed that a threshold of labelling of formaldehyde releasing preservatives of 10 mg/kg (10 ppm) or 0.001% would be appropriate to protectconsumers based on current scientific evidence when using leave-on or rinse-off products.
SAG-CS Issued Opinion on Homosalate in Cosmetics
On May, 2025, Scientific Advisory Group of Chemical Safety of Non-food and Non-medicinal Consumer Products (SAG-CS) issued opinion on Homosalate in Cosmetics (Opinion 17). Members concluded that homosalate is safe at a maximum concentration of 10% in sunscreen products. An adequate analytical method appears to be available for homosalate.
SAG-GS Issued Opinion on 4-MBC as a UV Filter in Cosmetic Product
On May, 2025, Scientific Advisory Group of Chemical Safety of Non-food and Non-medicinal Consumer Products (SAG-GS) issued opinion on 4-Methylbenzylidene Camphor (4-MBC) as a UV Filter in Cosmetic Product (Opinion 18). Given the limited data package available for review, and potential concerns for genotoxicity and endocrine disruption, the SAG-CS could not conclude that 4-MBC is safe for use in sunscreen products and other cosmetic products.
North America
U. S. to Ban the Sale of Cosmetics Containing Formaldehyde and Formaldehyde Releasers
On February 11, 2025, the United States notified a cosmetic-related measure (G/TBT/N/USA/2187) restricting the intentional addition of formaldehyde and formaldehyde releasers in cosmetics. The deadline for public comments is April 11, 2025. If approved, the restriction will take effect on January 1, 2027.
https://members.wto.org/crnattachments/2025/TBT/USA/25_01289_00_e.pdf
Health Canada Revised the Cosmetic Ingredient Hotlist
In February 2025, Health Canada revised the Cosmetic Ingredient Hotlist, which outlines prohibited and restricted ingredients in cosmetics.
Canada Updates the Guide for Cosmetic Notifications
On March 18, 2025, Health Canada issued an update to the Guide for Cosmetic Notification. The update mainly clarifies the address requirements in the notification details and reinforces the labeling requirements for fragrance allergens.
South America
MERCOSUR Revises List of Prohibited Substances in Cosmetics
On June 12, 2025, the MERCOSUR Secretariat issued Directive No. 07/25, revising the list of substances prohibited in cosmetic products, effective on the date of publication. The main updates include: the addition of 18 boron-containing compounds such as boron trioxide, boron oxide, and boric acid; eight other chemical substances including Polyurethane-18; modifications to the names of certain substances already listed as prohibited, etc.
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