In brief
- In January 2026, the European Commission introduced amendments to EU cosmetics regulations, focusing on substances classified as CMRs (carcinogenic, mutagenic, or toxic for reproduction). These will be fully applicable from 1 May 2026, resulting in certain substances being either prohibited outright or subject to restricted use in cosmetic products.
- In the UK, the Government has introduced equivalent, albeit not identical, legislation, which sets slightly different deadlines for implementation of the new regulations.
- Beauty and cosmetics companies should carefully review these amendments and ensure compliance by auditing their product formulations and confirming that none of the substances present in their products, including those present as impurities, are prohibited or fail to meet the applicable concentration restrictions under the new regulations.
Overview: Cosmetics Regulations in the EU and the UK
In the EU, any cosmetic product made available on the market must comply with Regulation (EC) No 1223/2009 (the EU Cosmetics Regulation), which aims to ensure both the functioning of the internal market and a high level of protection for human health.
Regulation (EC) No 1272/2008 (the EU CLP Regulation) provides uniform requirements for the classification, labelling and packaging of chemical substances, in particular those which are carcinogenic, mutagenic or toxic for reproduction (CMR). Substances are classified in different categories of CMR substances depending on the weight of evidence of their CMR properties. Strict limitations apply to the use of certain harmful substances - they may either be prohibited or restricted in use.
Following Brexit, the EU's regulatory framework was largely retained in the UK, with the law as at 1 January 2021 mirroring the EU Cosmetics Regulation. However, since then, the UK has been developing its own independent process for implementing changes, and amendments made to the EU framework no longer apply automatically in the UK.
The principal regulation governing cosmetic products available to members of the public in the UK is Regulation (EC) No 1223/2009, as amended by the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (the UK Cosmetics Regulation). The UK Cosmetics Regulation sets out the requirements that must be met before cosmetic products can be placed on the UK market. Like the EU Cosmetics Regulation, the UK Cosmetics Regulation has two aims: to ensure the functioning of the UK market and to ensure a high level of protection for human health.
Both in the EU and the UK, the use of CMR substances in cosmetic products is banned. As a general rule, once a substance is classified as a CMR, it is prohibited from use in cosmetic products regardless of any prior regulatory restrictions or conditions, and regardless of whether it is currently being used in cosmetics. However, a company may apply for an exemption, supported by evidence sufficient to demonstrate the safety of the substance for cosmetic use.
Changes to the EU Cosmetics Regulations from May 2026
Commission Regulation (EU) 2026/78, adopted on 12 January 2026 (the EU Amending Instrument), amended the EU Cosmetics Regulation with respect to the use of CMRs in cosmetic products.
The amendments update Annexes II, III, IV and V to the EU Cosmetics Regulation, which set out restrictions on the ingredients that may be used in cosmetic products placed on the EU market. The changes result in certain substances being either prohibited outright or made subject to restricted use conditions, as detailed below.
The changes will apply from 1 May 2026.
New prohibitions (Annex II - list of prohibited substances)
Approximately 15 substances newly classified as CMR have been added to the list of banned substances. These substances will not be permitted for use as ingredients in cosmetic products.
The list of new CMR substances is in section (d) of the Annex to the EU Amending Instrument. It includes, amongst others, acetone oxime (often used to help synthesise scent compounds), 2,3-epoxypropyl neodecanoate (often used as a diluent, reducing viscosity and allowing for easier application and as a stabiliser improving the durability of the product) and 1,4-dichloro-2-nitrobenzene (often used in production of pigments and UV absorbents).
Products containing these substances must be withdrawn from the EU market by 1 May 2026.
In addition, perboric acid (which is often used as an oxidising or bleaching agent) and its salts, which were listed separately in Annex II, have been consolidated and will be treated as a substance group rather than individual substances.
New restrictions (Annex III, IV & V - lists of restricted or allowed substances)
Following submission of exemption applications, the Scientific Committee on Consumer Safety (SCCS) assessed three substances: Silver, Hexyl Salicylate, and O-Phenylphenol. The SCCS concluded that each could be safely used in cosmetics, subject to specific restrictions introduced through updates to Annexes III, IV and V of the EU Cosmetics Regulation. Those restrictions are as follows:
- Silver - permitted only in powder form at a maximum concentration of between 0.05% and 0.2%, depending on particle size and product type.
- Hexyl Salicylate - permitted at a maximum concentration of between 0.001% and 2%, depending on product type, with additional restrictions for products intended for use by children under the age of three years.
- O-Phenylphenol - permitted at a maximum concentration of between 0.15% and 0.2% depending on product type, with additional requirements for warnings regarding the avoidance of eye contact.
Forthcoming changes to the UK Cosmetics Regulation
As noted above, following Brexit, the UK regulatory framework does not automatically incorporate amendments made to parallel EU Regulations. In the UK, decisions on the safe use of chemicals in cosmetic products are informed by independent scientific assessment of the available safety data and other scientific evidence on those chemicals when used in cosmetics. In addition to scientific advice, the Government also considers the impact on the UK internal market before making changes to the UK Cosmetics Regulation.
Following the EU Amending Instrument, the UK Government issued the Cosmetics Products Regulation (EC) No 1223/2009 (Restriction of Chemical Substances) (Amendment and Transitional Provisions) Regulations 2026 (SI 2026/23) (the UK Amending Instrument), which introduces equivalent changes to UK legislation concerning most of the substances included in the EU Amending Instrument.
The main changes in the UK introduced by the UK Amending Instrument are:
- Substances listed in the Schedule to the UK Amending Instrument, such as acetone oxime listed above will no longer be permitted in cosmetic products placed on the UK market. This amendment applies from 15 August 2026.
- Prohibition of 3-(4’-methylbenzylidene)-camphor - added to Annex II (list of substances prohibited in cosmetic products). The substance will also be removed from Annex VI at the same time, meaning it will no longer be permitted as a UV filter. These amendments apply from 15 July 2026.
- Amendments made to the Preamble to Annex IV (list of preservatives allowed in cosmetic products) to the UK Cosmetics Regulation to reduce the threshold for warning labelling requirements for formaldehyde releasing preservatives used in cosmetic products. The wording is changed from products that 'contain' formaldehyde to those that 'release' formaldehyde, and the threshold triggering warning labelling is lowered from 0.05% to 0.001%. These amendments apply from 15 July 2026.
The UK Amending Instrument also sets out the transitional arrangements for cosmetic products containing these substances:
- Cosmetic products placed on the market before 15 July 2026 that contain 3-(4-methylbenzylidene)-camphor and are labelled in accordance with the previous Annex V requirements may continue to be made available until 14 January 2027.
- Cosmetic products placed on the market before 15 August 2026 that contain any of the newly prohibited CMR substances may continue to be made available until 14 February 2027.
Application to Northern Ireland
The EU Cosmetics Regulation continues to apply in Northern Ireland so the changes introduced by the EU Amending Instrument will also apply to cosmetic products placed on the Northern Ireland market.
However, the EU Cosmetics Regulation does not apply to products placed on the UK market; cosmetic products placed on the Northern Ireland market in compliance with the applicable EU rules may continue to be sold in the UK through the provisions for Northern Ireland's unfettered access to the rest of the UK (albeit there are some exceptions where, amongst other things, UK authorities have to be notified about certain cosmetics as per the UK Government's guidance on this issue).
How Mishcon de Reya can help
The EU and UK Amending Instruments have significant practical implications for businesses operating in the beauty and cosmetics sector. Any product not meeting the new CMR standards must be withdrawn from the EU market by 1 May 2026, with different deadlines applying under the equivalent UK Amending Instrument. Cosmetics businesses, particularly those operating across multiple markets, should audit their product formulations and labelling arrangements promptly to ensure compliance ahead of the relevant deadlines.
If you have any questions in relation to the above or any other life sciences regulations, please contact the Life Sciences team at Mishcon de Reya.