P-Cymene may soon be banned from cosmetics
Ingredient: P-CYMENE
Date of publication: 10/1/2025
P-cymene may be banned from cosmetics as its proposed classification as Reprotoxic 1B is under review and is expected to be approved.
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
SCCS issues preliminary opinion on children’s exposure to Salicylic Acid
Ingredient: SALICYLIC ACID
Date of publication: 13/1/2025
On January 13 2025, the Scientific Committee on Consumer Safety (SCCS) assessed the safety of Salicylic Acid for children's between 3 and 10 years old. The deadline for comments is set to March 10, 2025.
SCCS issues preliminary opinion on children’s exposure to Butylparaben
Ingredient: BUTYLPARABEN
Date of publication: 10/1/2025
On January 10 2025, the Scientific Committee on Consumer Safety (SCCS) established new limits to Butylparaben when considering children's exposure. The deadline for comments is set to March 10, 2025.
SCCS Scientific Advice on HC Red No. 18 (Colipa No. B124) – Submission II
Ingredient: HC RED NO. 18
Date of publication: 6/12/2024
On December 6 2024, the Scientific Committee on Consumer Safety (SCCS) assessed the safety of hair dyeing agent HC Red No. 18 (Colipa No. B124). The deadline for comments is set to January 13, 2025.
SCCS Preliminary Opinion on Benzophenone-1 (BP-1)
Ingredient: BENZOPHENONE-1
Date of publication: 25/10/2024
On October 25 2024, the Scientific Committee on Consumer Safety (SCCS) could not conclude on the safety of UV absorber Benzophenone-1 (BP-1) due to insufficient data. The deadline for comments is set to January 13, 2025.
Regulation (EU) 2023/988 on General Product Safety (GPSR) comes into force in the European Union
Date of publication: 13/12/2024
Since December 13, 2024, the new Regulation (EU) 2023/988 on General Product Safety (GPSR) has been applicable in all EU Member States.
UK – OPSS Releases Statuatory Instrument on CMR Substances and Kojic Acid
Ingredients: CMR SUBSTANCES AND KOJIC ACID
Date of publication: 17/12/2024
On December 17, 2024, UK's Office for Product Safety and Standards (OPSS) published the Cosmetic Products (Restriction of Chemical Substances) (No.2) Regulations 2024' adding 64 substances classified as Carcinogenic, Mutagenic, or Reprotoxic (CMR) to Annex II of the UK Cosmetics Regulation (UKCR) and Kojic Acid to Annex III of the UKCR.
SCCS Preliminary Opinion on Ethylhexyl Methoxycinnamate (EHMC)
Ingredient: ETHYLHEXYL METHOXYCINNAMATE (EHMC)
Date of publication: 25/10/2024
On October 25 2024, the Scientific Committee on Consumer Safety (SCCS) could not conclude on the safety of UV-filter Ethylhexyl Methocycinnamate (EHMC) due to insufficient data. The deadline for comments is set to January 17, 2025.
SCCS reviews its opinion on children’s exposure to Methyl Salicylate
Ingredient: METHYL SALICYLATE
Date of publication: 20/1/2025
On January 20 2025, the Scientific Committee on Consumer Safety (SCCS) re-assessed children's exposure to Methyl Salicylate. The deadline for comments is set to February 17, 2025.
UK SAG-CS Opinion on Octocrylene
Ingredients: OCTOCRYLENE
Date of publication: 24/10/2024
On October 24 2024, the Scientific Advisory Group on Chemical Safety in Consumer Products (SAG-CS) published its opinion on the safety of Octocrylene and the conclusions differ from the opinions of the European Scientific Commitee on Consumer Safety (SCCS) and/or the regulations in force in the EU.
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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