Advanced Materials in Europe: a need for regulatory clarity
Differences between Advanced Materials and Nanomaterials Advanced materials (AdMat) are materials designed to offer superior properties to conventional materials. They are defined by their performance and functionality and are distinguished by: Their specific...
Medicines and the environment: the EMA’s new framework
The 2024 revision of the EMA guideline on the environmental risk assessment (ERA) of human medicinal products (EMA, 2024)[1] replaces practice-based approaches with a clear, harmonised methodology. It retains the tiered approach introduced in 2006, clarifies how it...
When a Micro-Story Illustrates Macro-Regulatory Challenges: A Look Back at the Chromium Trioxide Case
Exactly one year ago, the Paris 2024 Olympic Games came to a close, symbolised by the medals awarded to athletes. Yet by January 2025, more than a hundred bronze medals were already showing visible signs of deterioration(1). The reason: a failure in surface treatment....
Biodegradability of Coating Agents and Water Retainers for Fertiliser Use: Prepare for the 2028 Requirements
Biodegradability of Coating Agents and Water Retainers for Fertiliser Use: Prepare for the 2028 Requirements At a time when the European Commission has just published its guidance on the restriction of microplastics (Regulation (EU) 2023/2055), the polymers used in EU...
Biological safety assessment of MD will get a makeover!
In September 2023, the standard on toxicological risk assessment of medical device components (ISO 10993-17) was revised. One year later, ISO 10993-1 is being revised, redefining the requirements and general principles for the assessment of biological safety as part...
Poison centre notifications for hazardous mixtures: only 3 months to go before the end of the transitional period!
The CLP regulation (Reg. (EC) 1272/2008, article 45 and Annex VIII) requires information on mixtures classified as hazardous. This applies in particular to mixtures with physical or health hazards. Notifications must be sent to the poison centres of European Member...
(R)EVOLUTION IN THE APPLICATION AND MANAGEMENT OF SAME BIOCIDAL PRODUCTS
The 104th meeting of the Competent Authorities (CA) took place on June 19 and 20, 2024. During this meeting, the European Commission presented its intention to review Regulation (EU) 414/2013 concerning the procedure for the authorization of SAME biocidal products. In...
Poison Centre Notification: the end of the transitional period for mixtures for industrial use!
Article 45 and Annex VIII of the Regulation (EC) 1272/2008 (CLP) require the transmission of information on mixtures classified as hazardous based on their physical or health effects to the poison control centres in the EU Member State(s) where they are placed on the...
