UK SAG-CS publishes final opinion on Kojic Acid
Ingredients: Kojic Acid
The UK's Scientific Advisory Group on Chemical Safety in Consumer Products (SAG-CS) published its final opinion on Kojic Acid as used in cosmetic products.
Briefings
What is changing in the rules, what it means for your product, your municipality or your project, and who here handles it. In English and Portuguese.
Monitoring reports, cosmetic products
Our monitoring reports record the changes to cosmetics rules in a given period, and we publish one each month. Each one is a dated publication: it reflects the rules on the date it was published and is not updated afterwards. For what applies today, read the latest briefings or ask us.
Results
UK SAG-CS publishes final opinion on Butylated Hydroxytoluene (BHT)
Ingredients: BHT
The UK's Scientific Advisory Group on Chemical Safety in Consumer Products (SAG-CS) published its final opinion on BHT as used in cosmetic products.
SCCS publishes Final Opinion on children’s exposure to Methyl Salicylate
Ingredients: METHYL SALICYLATE
Date of publication: 14/09/2023
On 14 September, 2023, the Scientific Committee on Consumer Safety (SCCS) published its Final Opinion on the safety of Methyl Salicylate as used in cosmetic products intended to children.
EU updates the requirements on fragrance allergen labelling in cosmetic products
The European Commission published Regulation 2023/1545, amending The EU Cosmetics Regulation by adding new allergens to be declared on the ingredient list of the label of cosmetic products. The new amendment will add 56 new substances to the allergens list, and these substances must be declared when present at certain concentrations in cosmetic products.
European Commission publishes Omnibus Act VI
On 20 July 2023, the European Commission published the CMR Omnibus VI Regulation (EU) 2023/1490. This regulation prohibits the substances classified as Carcinogenic, Mutagenic and Toxic to Reproduction (CMR) 1A, 1B, or 2 by the 18th Adaptation to Technical Progress (ATP) to the EU Classification Labelling and Packaging (CLP) Regulation. The regulation enters into force on the 1st of December 2023.
UK OPSS calls for data on the safety of cosmetic ingredients
On 15 August 2023, the Office for Product Safety and Standards (OPSS – the UK regulator for cosmetic products) issued calls for data on the safety of cosmetic ingredients to investigate any suspected endocrine disrupting properties and safety whe used as nanomaterials.
Update on EU Ecolabel Decision
Update of Commission Decision (EU) 2021/1870 which establishes EU Ecolabel criteria and related assessment and verifications requirements for cosmetic products.
French ANSES calls for a ban on the UV filter Octocrylene in sunscreens
The French National Agency for Food, Environmental and Occupational Health Safety (ANSES) has sent the French government a request to ban the use of the UV filter Octocrylene in sunscreen products.
Ban on CMR substances in cosmetic products applicable from 1 December 2023
Ingredients: BENZOPHENONE, TEOPHYLLINE, PENTETIC ACID, PENTASODIUM PENTETATE
Date of publication: 08/06/2023
On 8 June 2023, the European Commission published an amendment of Annex XVII to the Regulation (EC) 1907/2006 (REACH) regarding substances recently classified as Carcinogenic, Mutagenic, or Reprotoxic (CMR). The ban is applicable from 1 december 2023.
Updates to the UK Cosmetics Regulation – Methyl-N-methylanthranilate, HAA299 and HAA299 (nano)
Ingredients: METHYL-N-METHYLANTHRANILATE, HAA299 and HAA299 (nano)
Date of publication: 06/07/2023
On July 6, 2023, the United Kigndom aligned its regulation with the European Union, applying new restrictions on the ingredients Methyl-N-methylanthranilate, HAA299 and HAA299 (nano).
Cosmetic Products
European Commission requests SCCS Opinion on the safety of Cyclamen Aldehyde
Ingredient: CYCLAMEN ALDEHYDE
Date of publication: 8 June 2026
The Scientific Committee on Consumer Safety (SCCS) has accepted a mandate to assess the safety of Cyclamen Aldehyde, following potential classification as a reproductive toxicant under the CLP Regulation.
European Union will ban and restrict new substances in cosmetics – Omnibus Act IX
Topic: OMNIBUS ACT IX - COSMETICS REGULATION
Date of publication: 28 July 2026
The European Commission notified the WTO about the draft Omnibus Act IX, proposing amendments to Annexes II, III, and V of the EU Cosmetics Regulation.
European Cosmetics Regulation – Updates on Cosmetic Ingredients
Topic: NEW RESTRICTIONS ON COSMETIC INGREDIENTS
Date of publication: 13 January 2026
The European Commission published Commission Regulation (EU) 2026/78, which brings new restrictions on several cosmetic ingredients that were classified as Carcinogenic, Mutagenic or Toxic for Reproduction (CMR).
United Kingdom publishes Technical Report on the Classification and Labelling of Talc
Ingredient: TALC
Date of publication: January 2026
The United Kingdom (UK) Health and Safety Executive (HSE) has published a technical report concluding that Talc does not warrant carcinogenicity classification, diverging from ECHA's Risk Assessment Committee (RAC) opinion supporting Category 1B classification.
Medical Devices
What is EUDAMED? Modules, actor registration and the 27 November 2026 deadline
Four EUDAMED modules have been mandatory since 28 May 2026. Devices already on the market have until 27 November 2026. Who registers what, and what changed in Portugal.
What does Regulation (EU) 2026/977 change for notified bodies?
From 25 February 2027, notified bodies under the MDR and IVDR must quote on defined information, keep to maximum timelines and publish their performance. What it changes for manufacturers.
Is your software a medical device? SaMD qualification under MDCG 2019-11
Whether software is a medical device depends on what you say it is for, not on the code. The qualification test under the MDR and IVDR, updated for 2025 guidance.
How to demonstrate equivalence under the MDR
Clinical data from an equivalent device can support your clinical evaluation, but the MDR sets a higher bar than the Directives did. The three characteristics, data access, and documentation.
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