With the New Year now underway, the Cosmetic RP Service team is pleased to share a series of EU and UK Regulation updates that we believe you will find valuable.
To start, we would like to outline a key RP Service requirement:
Cosmetic Responsible Person Service – UK and EU
As your Responsible Person, it is essential that we ensure that all your product registrations and Product Information Files remain fully up to date. Through our vigilance activities, we have noted instances where clients or manufacturers experience ingredient or raw material issues, leading to changes in suppliers, formulations and/or packaging. Such updates can affect the accuracy of the information held within the Product Information File/s (PIFs).
Please contact us of any changes to your registered product(s) so we can gather the required data, documentation and information to maintain compliance with the Cosmetic Regulations. This requirement forms part of the standard terms outlined in your signed Mandate Agreements.
Regulatory News
EU Cosmetic Regulations
In January 2026, the European Commission published Regulation (EU) 2026/78, introducing amendments and updates to the requirements for the use of carcinogenic, mutagenic, or reprotoxic (CMR) substances in cosmetics. The Regulation modifies Annexes II, III, IV, and V of the EU Cosmetics Regulation (EC) No 1223/2009.
View Link for the Regulation: https://eur-lex.europa.eu/eli/reg/2026/78/oj/eng
Substance Review and Regulatory Revisions
Perboric Acid and its Salts [5 & 6]
Perboric Acid and its Salts, which have been classified as CMR substances of category 1B, are listed in entries 1397, 1398 and 1399 of Annex II to Regulation (EC) No 1223/2009 and are, therefore, prohibited for use in cosmetic products. However, the substances listed in those entries are all perborate derivatives and are structurally related. They share a common borate core and release hydrogen peroxide upon dissolution in water, which accounts for their similar chemical properties and biological activity. Due to their common mode of action and health risks, it is appropriate from a regulatory perspective to treat Perboric Acid and its Salts as a group rather than individual substances.
Silver [7, 8, 9 & 11]
The substance silver (CAS No 7440-22-4) has been classified as a CMR substance of category 2 (toxic for reproduction) by Delegated Regulation (EU) 2024/2564, when its particle diameter is equal to or larger than 1 mm (silver massive), when its particle diameter is larger than 100 nm and smaller than 1 mm (silver powder) and when its particle diameter is larger than 1 nm and smaller than or equal to 100 nm (silver nano).
Silver is currently listed in entry 142 of Annex IV to Regulation (EC) No 1223/2009 as an authorised colorant (CI 77820), while its colloidal nanoform (1-100 nm) is prohibited in cosmetic products and listed as entry 1727 in Annex II to that Regulation. The Scientific Committee on Consumer Safety (SCCS) concluded in its opinion of 27 March 2024 that micron-sized particulate silver can be considered safe under specific conditions of use in cosmetic products.
In light of the classification of silver massive, silver powder, and silver nano as CMR substances of category 2, the specific exemption request relevant to only the micron-sized silver and the relevant SCCS opinion, entry 1727 of Annex II to Regulation (EC) No 1223/2009 should be amended to include silver massive and silver nano.
Furthermore, entry 142 of Annex IV to Regulation (EC) No 1223/2009 should be amended to allow the use of micron-sized silver (silver powder) as a colorant only under certain conditions considered safe by the SCCS. Micron-sized silver should also be added to the list of substances restricted in cosmetic products in Annex III to that Regulation.
Hexyl Salicylate [12, 13, 14 & 16]
The substance Hexyl Salicylate (CAS No 6259-76-3) has been classified as a CMR substance of category 2 (toxic for reproduction) by Delegated Regulation (EU) 2024/2564, which is currently not regulated under Regulation (EC) No 1223/2009. The SCCS concluded in its opinion of October 25, 2024 (5) that Hexyl Salicylate can be considered safe under specific conditions of use in cosmetic products.
Hexyl Salicylate is added to the list of substances restricted in cosmetic products in Annex III to Regulation (EC) No 1223/2009.
o-Phenyl phenol [17, 18, 20 & 21]
The substance o-Phenyl phenol (CAS No 90-43-7), has been classified as a CMR substance of category 2 (carcinogen of category 2), by Delegated Regulation (EU) 2024/2564 which is currently listed in entry 7 of Annex V to Regulation (EC) No 1223/2009 as an allowed preservative in rinse-off and leave-on products with a maximum allowed concentration of 0.2% and 0.15% (as phenol), respectively. The SCCS concluded in its opinion of October 25 2024, that o-Phenyl phenol and Sodium o-Phenyl phenate can be considered safe under specific conditions of use in cosmetic products.
The above assessment, entry 7 of Annex V to Regulation (EC) No 1223/2009 is amended to add the substance Sodium o-Phenyl phenate the list of preservatives allowed in cosmetic products.
Other Substances [22]
All substances other than silver, hexyl 2-hydroxybenzoate and biphenyl-2-ol, which were classified as CMR substances by Delegated Regulation (EU) 2024/2564, no request for use in cosmetic products has been submitted. Consequently, the CMR substances that are not already listed in Annex II to Regulation (EC) No 1223/2009 should be added to the list of substances prohibited in cosmetic products in that Annex.
Under Article 1 – Annexes II, III, IV and V to Regulation (EC) NO 1223/2009 are amended in accordance with the Annex to this Regulation.
Under Article 2 – This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
It shall apply from 1st May 2026
Continued Awareness
Fragrance Allergens (EU)
On 26th July 2023, the European Union (EU) adopted Regulation (EU) 2023/1545 to update labelling of fragrance allergens under Annex III to Regulation (EC) 1223/2009 on cosmetic products.
This Regulation came into force on 16th August 2023.
A long transition period of 3 or 5 years is given to the industry to adapt the new requirements in response to Regulation (EU) 2023/1545.
Expansion of Allergen List – this amendment contains several important changes:
- Replaces 17 entries
- Deletes 10 entries
- Adds 45 entries
Transition Timeline
For new cosmetic products to be placed onto the EU market, they shall comply with the new requirement by 31st Jul 2026 (within 3 years).
For existing cosmetic products already on the EU market, they shall comply with the new requirement by 31st July 2028 (within 5 years).
EU Deforestation Regulation (EUDR)
Amendments to the EU Deforestation Regulation (EUDR) have been adopted and published in the Official Journal of the European Commission.
The amending Regulation (EU/2025/2650) is available via this link:
Regulation – EU – 2025/2650 – EN – EUR-Lex
As a result of the Regulation, the implementation of the EUDR has been postponed to 30th December 2026 for large operators and traders, and 30th June 2027 for small operators.
UK Cosmetic Regulations
Amendments to the Annexes of the UKCR are published.
On the 15th January 2026, the Office for Product Safety and Standards (OPSS) published a Statutory Instrument (SI 2026 No. 23 – Consumer Protection) amending the Annexes to the UK Cosmetics Regulation. Link: https://www.legislation.gov.uk/uksi/2026/23/introduction/made
Annex II Amendments:
- Addition of UV filter 4-methylbenzylidene camphor (4-MBC) and is therefore banned for use in cosmetic products. The ‘placing on the market deadline’ is 15 July 2026; the ‘making available on the market’ (off shelf) deadline is 14 January 2027.
- Addition of a list of 16 CMR substances is added to Annex II of the UKCR and are therefore banned for use in cosmetic products. Of these, one has an INCI name and is used in cosmetic products: trimethyl benzoyl diphenyl phosphine oxide (TPO – CAS 75980-60-8). The ‘placing on the market’ deadline is 15 August 2026; the ‘making available on the market’ (off shelf) deadline is 14 February 2027.
Annex V Amendments:
- The Annex V (list of permitted preservatives) is amended regarding the labelling requirements for formaldehyde-releasing preservatives:
“All finished products containing substances in this Annex and which release formaldehyde must be labelled with the warning ‘releases formaldehyde’ where the concentration of formaldehyde in the finished product exceeds 0.001%”.
The ‘placing on the market’ deadline is 15th July 2026; the ‘making available on the market’ (off shelf) deadline is 14th January 2027.
Substance Review and Regulatory Revisions
In November 2024, the EU scientific bodies recommended to classifying talc as a category 1B carcinogen, with a potential cosmetic ban anticipated for 2027.
Last month, the UK Health and Safety Executive (HSE) recently completed its own review of the same scientific evidence and found it insufficient to support this classification.
Meanwhile, advisers to The European Chemicals Agency (ECHA) have maintained their recommendation to classify talc as a category 1B carcinogen, citing ovarian cancer signals and animal tumour data.
In the UK, the use of talc contaminated with asbestos continues to be strictly prohibited due to long-standing safety concerns.
Plastic wet wipes ban
This ban comes into force on the 19th May 2027 in England.
All UK nations are introducing this ban, with different start dates:
For Wales – into force 18th December 2026
For Scotland – into force 11th August 2027
For Northern Ireland – into force 18th May 2027
This will affect product types like:
- Baby Wipes
- Face and Makeup Removal Wipes
- Cosmetic Face Sheet Masks
- Personal hygiene and deodorant wipes
There are exemptions which are plastic-free biodegradable wipes, limited exist for medical and industrial and business to business use. In addition, Pharmacies may still sell plastic containing wipes for medical use only however will not be permitted to display them.
If more information is required for any of the above article items, please contact the Cosmetic RP Team via our new Cos RP email address: Cos-RP@advenamedical.com
