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.
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.
Ingredients: BENZOPHENONE-3
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 Benzophenone-3 and the conclusions are similar to the opinions of the European Scientific Commitee on Consumer Safety (SCCS) and/or the regulations in force in the EU.
Topic: UK PROPOSES AMENDMENTS TO THE INGREDIENT LISTS IN UK REGULATION: 52 PROHIBITED AND 1 RESTRICTED INGREDIENTS ADDED
Date of publication: 10/04/2024
On April 10, 2024, UK notified the World Trade Organization (WTO) of a draft regulation, proposing amendments to the ingredient lists in UK Regulation. The draft is open for comments until June 9, 2024, and expected to be adopted on June 25, 2024.
Ingredients: HC YELLOW 16
Date of publication: 01/08/2024
On august 1 2024, the Scientific Committee on Consumer Safety (SCCS) published a preliminary opinion on the safety of HC Yellow No. 16 in hair dye formulations. The draft is open for comments until September 27, 2024.
Topic: SCOTLAND BANS WET WIPES CONTAINING PLASTIC
Date of publication: 23/07/2024
On July 23, 2024, Scotland announced a draft Statutory Instrument aimed at environmental protection, which proposes a ban on the supply and sale of wipes containing plastic. This ban will take effect from April 30, 2026.
Topic: TALC RECLASSIFIED AS "PROBABLY CARCINOGENIC TO HUMANS"
Date of publication: 05/07/2024
On July 5, 2024, the International Agency for Research on Cancer (IARC), reclassified talc from "possibly" to "probably" carcinogenic to humans.
Ingredients: SALICYLIC ACID
Date of publication: 01/07/2024
On July 1 2024, the European Commission launched a call for data to assess the aggregate exposure to Salicylic Acid from various salicylic esters used in cosmetic products in the framework of the Cosmetic Product Regulation (EC) 1223/2009.
Topic: DEADLINE FOR LABEL WARNING ABOUT FORMALDEHYDE RELEASERS
Date of publication: 31/07/2024
Since 31 July 2024, the warning "releases formaldehyde" is mandatory for products placed on the market, where the total concentration of formaldehyde released in the finished product exceeds 0,001 % (10 ppm).
Topic: POSTPONEMENT OF FRANCE'S INTENTION TO RESTRICT THE UV FILTER OCTOCRYLENE
Date of publication: 29/01/2024
On October 11, 2023, the European Chemicals Agency (ECHA) announced that France plans to propose restrictions on the marketing of mixtures containing Octocrylene under the REACH Regulation. The restriction dossier was due to be submitted on 4 October 2024. This date has just been postponed to 10 January 2025.
Topic: PUBLICATION OF FORM TEMPLATE TO BE USED FOR PRODUCT RECALLS
Date of publication: 23/07/2024
On May 27 2024, the European Commission published the Implementing Regulation (EU) 2024/1435, establishing a template for product recall notice. On July 23, 2024, the European Commission published a corrigendum adding an additional "whereas" and adapting the recall model accordingly. This regulation will be effective from December 13, 2024, aligning with the GPSR.
Ingredients: DIMETHYLTOLYLAMINE, TRIMETHYLBENZOYL DIPHENYLPHOSPHINE OXIDE
Date of publication: 24/06/2024
On June 24, 2024, the European Commission (EC) notified to the World Trade Organization (WTO) the “Omnibus VII” regulation. The adoption is expected to take place after the September 1st, 2025.
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.
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.
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).
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.
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.
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.
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.
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.
One email when an area publishes, in the language you choose. Nothing else.
