The European Commission has announced new cosmetics compliance deadlines affecting Retinol, Triclosan, and several nanomaterials. From late 2025, products containing these ingredients must meet stricter safety limits or be withdrawn from the EU market. Learn what these changes mean for your formulations and labelling.
Since 2024, the European Commission has been conducting a targeted evaluation of the EU Medical Devices Regulations (MDR and IVDR). The Parliament as well as many Member States have called for a simplification of the regulations, together with business associations from the medical device sector.
Manufacturers of Class D IVDs must sign an agreement with a notified body by 26 September 2025 to benefit from IVDR transitional periods. Learn about the deadlines, requirements, and how Obelis supports the process.
In 2025, the EU introduced Omnibus Acts VII and VIII, banning and restricting several substances in cosmetics due to CMR classifications. These changes require immediate compliance. Learn how Obelis can help ensure your products meet the latest regulations.
KORAVIE LIMITED, a UK-based start-up, partnered with Obelis Group to navigate the complexities of UK medical device registration. With expert guidance and hands-on support, they transformed regulatory uncertainty into a successful market launch—laying the groundwork for EU expansion.
From 1 July 2025, the EU will enforce new limits on Homosalate in cosmetics, allowing a max of 7.34% in face products. Reformulation may be required to ensure compliance.
Understand who qualifies as the data controller in clinical investigations under the EU MDR and GDPR. Learn the roles of sponsors and investigators, the implications of joint controllership, and the legal responsibilities tied to personal data processing in clinical trials.
HELLO CHAKRA LLC, a U.S.-based wellness brand, set out to expand into the EU and UK with a new product line under the General Product Safety Regulation (GPSR). With expert guidance from Obelis Group they successfully navigated product classification, documentation, and compliance—ensuring a confident and well-prepared market entry.
In June 2022, Quebec passed Bill 96, An Act respecting French, the official and common language of Québec, which amended the Charter of the French Language. These amendments significantly affect labelling and advertising requirements for businesses, including those in the cosmetics industry.
TrailHeads, a U.S. outdoor brand, partnered with Obelis Group to navigate GPSR compliance and launch successfully in the EU, overcoming Amazon-related challenges and accelerating their market entry.