A review of the cosmetic regulation is planned for 2025, covering issues such as, among others, regulation for ED (endocrine disruptor) substances, additional changes to labelling regarding the expiry date or a revision of the definition of nanomaterial. The action on the part of the regulatory bodies is a response to the new challenges of the cosmetic industry and the constantly evolving and changing market for cosmetic raw materials. The changes discussed in this article refer mainly to the introduced or planned regulation of ingredients, an extended list of allergens allowed in cosmetic products or directives and regulations affecting the industry directly or indirectly.

The information contained here is current as of October 2024 and is a compendium of knowledge for technologists, safety assessors and anyone introducing or planning to introduce new cosmetic products.

We will first discuss the main changes and terms relating to the regulation of cosmetic ingredients. Each cosmetic ingredient should have a name according to the International Nomenclature of Cosmetic Ingredients (INCI). The INCI system was established in the early 1970s by the Personal Care Products Council (formerly CTFA, Cosmetic, Toiletry, and Fragrance Association) and the list is maintained by the Personal Care Products Council. INCI names are used in the United States, the European Union, China, Japan and many other countries to list ingredients on cosmetic product labels. In the following section, we refer to the regulation of fragrance ingredients, the use of microplastics in cosmetic raw materials or environmental regulations.

Main regulations relating to cosmetic ingredients:

• HOMOSALATE - regulation: facial products except propellant sprays: max. concentration: 7.34 %.
  Time limits for application: marketing ban: 1 January 2025, ban on making available on the market: 1 July 2025

• GENISTEIN - regulation: maximum concentration in finished product: 0.007 %. 
  Time limits for application: marketing ban: 1 February 2025, ban on making available on the market: 1 November 2025
• DAIDZEIN - regulation: maximum concentration in finished product: 0.02 %.
  Time limits for application: marketing ban: 1 February 2025, ban on making available on the market: 1 November 2025

• KOJIC ACID - regulation: maximum concentration in face and hand products: 1 %.
  Time limits for application: marketing ban: 1 February 2025, ban on making available on the market: 1 November 2025

• RETINOL- regulation: body emulsion: maximum concentration: 0.05 % (retinol equivalent); other no-rinse and rinse-off products: maximum concentration: 0.3 % (retinol equivalent).
  Content of the warning required on the label: Contains vitamin A. Consider its daily intake before use.
  Time limits for application: marketing ban: 1 November 2025, ban on making available on the market: 1 May 2027

• RETINYL ACETATE - control: body lotion: maximum concentration: 0.05 % (retinol equivalent); other leave-on, rinse-off products: maximum concentration: 0.3 % (retinol equivalent)
  Content of the warning required on the label: Contains vitamin A. Consider its daily intake before use.
  Time limits for application: marketing ban: 1 November 2025, ban on making available on the market: 1 May 2027

• RETINYL PALMITATE - regulation: body lotion: maximum concentration: 0.05 % (retinol equivalent), other leave-on and rinse-off products: maximum concentration: 0.3 % (retinol equivalent)
  Content of the warning required on the label: Contains vitamin A. Consider its daily intake before use.
  Time limits for application: marketing ban: 1 November 2025, ban on making available on the market: 1 May 2027

• ALPHA-ARBUTIN Regulation: face cream: maximum concentration: 2%; body lotion: maximum concentration: 0.5%. The concentration of hydroquinone should not exceed trace amounts.
  Time limits for application: marketing ban: 1 February 2025, ban on making available on the market: 1 November 2025
• ARBUTIN regulation: face cream: maximum concentration: 7%. The concentration of hydroquinone should not exceed trace amounts.
  Time limits for application: marketing ban: 1 February 2025, ban on making available on the market: 1 November 2025

• TRICLOSAN regulation: toothpastes; hand soaps, body soaps/shower gels, deodorants (non-spray), face powders and concealers; toenail cleaning products prior to application of artificial nails: maximum concentration: 0.3 %. Prohibition of use in toothpastes intended for children under 3 years of age. Mandatory warning for toothpaste: Not to be used for children under 3 years.
  Time limits for application: marketing ban: 31 December 2024, ban on making available on the market: 31 October 2025.

• FORMALDEHYDE DONORS regulation: mandatory labelling: "releases formaldehyde" if the total concentration of formaldehyde released in the finished product exceeds 0.001 % (10 ppm), regardless of whether the finished product contains one or more formaldehyde-releasing substances covered by Annex V.
  Time limits for application: marketing ban: 31 July 2024, prohibition to make available on the market: 31 July 2026

• COLLOIDAL SILVER (nano) regulation: prohibition of use.
  Time limits for application: marketing ban: 1 February 2025, ban on making available on the market: 1 November 2025.

• GOLD/ COLLOIDAL GOLD (nano) regulation: prohibition of use.
  Time limits for application: marketing ban: 1 February 2025, ban on making available on the market: 1 November 2025.

• HYDROXYAPATITE (nano) regulation: toothpastes: maximum concentration: 10%; mouthwashes: maximum concentration: 0.465%. Prohibition of use in products that may lead to exposure by inhalation.
  Time limits for application: marketing ban: 1 February 2025, ban on making available on the market: 1 November 2025.

• CYCLOTETRASILOXANE (D4), CYCLOPENTASILOXANE (D5), CYCLOHEXASILOXANE (D6) - regulation: prohibition to place on the market as: substance, constituent of other substances, in a mixture - in a concentration equal to or greater than 0.1%
  Time limits for application: ban on D4, D5 in non-rinse products and D6 in rinse and non-rinse products: 7 June 2027. D4, D5: rinse-off products: from 1 February 2020.

Changes in fragrance ingredients

Fragrance compositions are special mixtures of natural and synthetic ingredients designed to give fragrance to cosmetic products such as creams, lotions, shampoos or soaps. Some of the ingredients in their composition are suspected of having adverse health effects.

• HELIOTROPINE - in June this year. The RAC adopted an opinion on the harmonised classification of Heliotropine / piperonal; 1,3-benzodioxole-5-carbaldehyde (CAS: 120-57-0) as Repr. 1B reproductive toxicant. This means that Heliotropine classified as Repr. 1B will be banned for use in cosmetic products.
• HYDROXYCITRONELLAL - The European Chemicals Agency (ECHA) has published a proposal from the Netherlands for the harmonised classification and labelling (CLH) of Hydroxycitronellal (Skin Sens. 1B, H317, Repr. 1B, H360D). If the proposed classification of Hydroxycitronellal as CMR Reprotoxic 1B is approved, its use in cosmetic products will be banned throughout the European Union unless a specific exemption is granted for its controlled use. This ban will affect a wide range of products currently containing Hydroxycitronellal, forcing manufacturers to reformulate such products or, in some cases, withdraw them from the market.
• HEXYL SALICYLATE - On 31 May 2024, the Scientific Committee on Consumer Safety (SCCS) issued a new mandate to review the safety of hexyl salicylate in cosmetic products, focusing in particular on the exposure of children, including children under three years of age. This mandate complements and expands on the European Commission's previous proposal, highlighting continued safety concerns about this ingredient. Hexyl salicylate is an ingredient used in perfumes and cosmetic products, known for its sweet and floral aroma. Although not currently restricted by the Cosmetics Regulation (EC) No 1223/2009, ECHA recommended in March 2022 that it be classified as 'reproductive toxicant category 2' and 'skin sensitiser category 1'. On 29 July 2024, the Scientific Committee on Consumer Safety (SCCS) published an addendum to the scientific opinion on hexyl salicylate (SCCS/1658/23), specifically addressing the issue of children's exposure to this chemical present in cosmetic products for children aged 0 to 3 years. This opinion, open for comments until 23 September 2024, re-examines the safety assessment of hexyl salicylate in light of its future classification as a category 2 carcinogen, mutagen or substance toxic for reproduction (CMR cat 2) under Annex VI of Regulation (EC) No 1272/2008. The SCCS provisionally concluded that hexyl salicylate may be considered safe for use in cosmetic products intended for children under 3 years of age, provided that it is used at the maximum concentrations specified in the dossier submitted (see table below). This conclusion takes into account the potential endocrine disrupting properties of the compound.
• TEA TREE OIL (Melaleuca Alternifolia, ext. CAS 85085-48-9, Melaleuca alternifolia, essential oil; tea tree oil CAS 68647-73-4) - In March 2023. ECHA launched ad hoc consultation on harmonised classification and labelling for melaleuca alternifolia (tea tree oil), and in November 2023. The Risk Assessment Committee (RAC) adopted the opinion that tea tree oil is a Category 1B reproductive toxicant. Any substance classified as CMR (carcinogenic, mutagenic and toxic to reproduction) in the EU Classification, Labelling and Packaging (CLP) Regulation, which includes substances classified as category 1B (H360), is banned for use in cosmetics in the EU unless industry obtains a waiver by demonstrating safe use according to specific criteria under Article 15 of the EU Cosmetics Regulation (EC) 1223/2009. At present, there is no certainty that the ingredient will be defended and the likelihood is that tea tree oil will be banned. Industry funded mechanistic research in vitro, which are currently being conducted to demonstrate that tea tree oil has a different mode of action in humans. The feasibility study is expected to be completed by the end of October 2024 and the comparative metabolism study by the end of February 2025. Tea tree oil was provisionally included in the 23rd adaptation to scientific and technical progress (ATP) list of the CLP. However, the industry has requested that this process be suspended pending preliminary test results. The WTO (World Trade Organisation) notification of 25 September 2024 does not include this substance, so the Commission appears to have accepted the request.

Changes in allergen labelling in cosmetic products

Cosmetic Regulation 1223 of 2009 requires the inclusion of 24 allergens from synthetic fragrances, essential oils and extracts in the list of cosmetic ingredients (INCI) if their concentration exceeds 0.01% in a washable cosmetic (e.g. soap, shower gel, shampoo) or 0.001% in a non-washable cosmetic (e.g. cream, lotion, tonic). Commission Regulation EU 2023/1545 of 26 July 2023 amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council introduces changes with regard to the labelling of fragrance allergens in cosmetic products. Until now, 24 allergens listed in items 45 and 67-92 of Annex III of Regulation No 1223/2009 were required to be labelled in the INCI composition on the cosmetic label. The new regulation mandates the labelling of an additional 56 allergens, bringing the total to 80 potential allergens to be labelled in the INCI composition.

Time limits for application: marketing: 31 July 2026, market release: 31 July 2028

Microplastics - Microparticles of Synthetic Polymers 

On 27 September 2023, Commission Regulation (EU) 2023/2055 was published regarding the restriction of synthetic polymer microparticles (microplastics) intentionally added to products obtained by industrial processes, including cosmetics. The amendments affect a great many raw materials used in the cosmetics industry. The ban applies to the placing on the market of synthetic polymer microparticles as substances on their own or, when present to impart a desired property, in mixtures in concentrations equal to or greater than 0.01 % (w/w)

Application dates: prohibited for use as an abrasive (scrubs) - on the date of entry into force of the regulation, i.e. 17.10.2023; prohibited for use: in rinse-off products: 17.10.2027, for encapsulating fragrances: 17.10.2029, in no-rinse products except make-up, lip, nail products: 17.10.2029, in make-up, lip, nail products: 17.10.2035.

Additional changes to cosmetic law:

• Natural Compound Substances - On 30 June 2023. The Council of Europe finalised its position on the proposed CLP Regulation, focusing, inter alia, on the classification of 'substances containing more than one component' (MOCS), including essential oils. The proposed CLP Regulation introduces a definition of multicomponent substances and states that their classification should follow the same principles as mixtures when data on individual components are available, unless there are specific provisions in Annex I of CLP. Therefore, if a single ingredient in a multi-ingredient substance was classified as CMR (carcinogenic, mutagenic or toxic to reproduction) and/or ED (endocrine disruptor), this classification would apply to the multi-ingredient substance as a whole, even if data indicated that the substance had no or less serious properties. For the cosmetic industry, this means banning the use of multiple natural substances in cosmetic formulations. One example is the classification process for p-cymene, which is an ingredient in some 350 natural compounded substances (e.g. thyme oil, eucalyptus oil). The industry is currently fighting to obtain an exemption for the continued use of a natural compounding substance containing an ingredient classified as CMR cat 1.
• Salicylates - an assessment of the combined exposure to salicylic acid from different salicylates used in cosmetic products is planned. This action is consequential. This action follows a 2021 SCCS opinion on homosalate and methyl salicylate, in which the SCCS raised concerns about potential overexposure of consumers to salicylic acid from various salicylates used in cosmetics.
• General Product Safety Regulation - The Regulation ensures a high level of consumer protection and creates a level playing field for businesses, thereby improving the functioning of the European Union (EU) internal market. It repeals the 2001 General Product Safety Directive and establishes a new EU General Product Safety Framework to keep pace with the new challenges of digitalisation and the increasing number of goods and products sold online. It addresses issues such as food imitation products, attractive/childlike products, distance selling, electronic address, among others. The regulation is applicable from 13 December 2024.
• Packaging and Packaging Waste Ordinance Packaging and Packaging Waste Ordinance - aims to establish uniform packaging and packaging waste legislation across the EU. Its publication is expected in Q4 2024.
• Regulation on the Ecodesign of Sustainable Products - Its objectives include reducing the overall carbon and environmental footprint of products throughout their life cycle, ensuring the free movement of products within the single market, providing product information (labelling rules, Digital Product Passport), preventing the destruction of unsold products. The regulation entered into force on 18 July 2024.

• Directive on the Empowerment of Consumers in the Environmental Transformation Process - The provisions of this Directive will enhance consumer rights by amending the Unfair Commercial Practices Directive and the Consumer Rights Directive and aligning these acts with the green transition and the circular economy. It entered into force on 26 March 2024. The adoption and publication of national legislation is due on 27 March 2026 and the application of the legislation by Member States: 27 September 2026.
  The directive prohibits, among other things:

• • advertising benefits that are irrelevant and not derived from any product or company feature;
  • the use of a sustainability label which: is not based on a certification scheme and has not been established by public authorities.
• Directive on the substantiation of explicit environmental claims (GCD): The Directive introduces minimum requirements for substantiating, verifying and communicating explicit environmental claims. The draft will currently undergo further processing at EU level. Once the final act is adopted, Member States will have 18 months to implement the provisions. National rules will apply 24 months after the entry into force of the directive. 
• Urban Waste Water Treatment Directive - It aims to protect the environment from water pollution. The directive would introduce new obligations such as the introduction of quaternary wastewater treatment methods - removal of 'micropollutants'. The cost of their introduction would be paid for by producers in at least 80%. Publication of the directive on Eur-Lex is likely to take place in Q4 2024.

Cosmetic law is changing dynamically and we hope that the information collected here will help you to smoothly register and market cosmetic products. The success of a product is based on many aspects including the most important one: user safety. If you have questions, want to share insights or are looking for a partner in the field of cosmetic law - please contact us