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Recevez une fois par mois les dernières actus réglementaires et conseils d’experts.
Following Brexit, 2,900 UK REACH registrations face revocation due to non-transfer to EU entities, impacting market access for some substances. Companies can register as importers or appoint an Only Representative. A trade deal limits data use for UK REACH.
The General Directorate for Competition Policy, Consumer Affairs and Fraud Control (DGCCRF) is the French organization in charge of controlling institutions' compliance with European chemical regulations such as REACH and CLP. The last reports of the DGCCRF show striking results on the number of industries that are not yet compliant with those chemical regulations. Discover the main results of these reports and the measures taken by the DGCCRF in the following article!
Learn about the risks of non-compliance with the new medical devices regulation in Europe, including financial losses, damage to brand image, and sanctions by Member States. Understand evolving obligations and how to ensure compliance to avoid these risks.
The new Medical Device Regulation expands the scope to cover non-medical devices and changes device classifications. Notified Bodies are now under stricter control, leading to longer time to market. Economic operators have specific roles and obligations. Stricter rules for clinical evaluation and post-marketing monitoring. A unique identification system and EUDAMED database enhance traceability. Regulation 2017/745 aims to improve transparency and safety of medical devices in Europe.
The European Commission released an addendum clarifying banned claims in cosmetics for hand gels. The document provides a negative list of prohibited claims and images. Understanding the difference between cosmetic and biocidal products is crucial for marketing strategies. Consider the advantages of marketing a leave-on cleansing gel versus a hand disinfectant.
The European Commission's REACH Committee has approved the postponement of the authorisation deadlines for ethoxylated 4-(1,1,3,3-tetramethylbutyl)phenol, crucial for Covid-19 related medical products. The new deadlines extend the application and sunset dates by 18 and 36 months, respectively.