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Attention: EU Proposes to List TBPH in Annex A of the Stockholm Convention

On 30 April 2026, the Official Journal of the European Union published Decision (EU) 2026/878. The decision clearly states that the European Union, on behalf of its Member States, will submit a proposal to the Secretariat of the Stockholm Convention on Persistent Organic Pollutants (hereinafter referred to as "the Convention") to recommend the listing of bis(2-ethylhexyl) tetrabromophthalate (abbreviated as TBPH) in Annex A (Elimination) of the Convention.

PFAS Regulatory Wave: Compliance Challenges & Solutions for Medical Devices

Per- and Polyfluoroalkyl Substances (PFAS), commonly known as "forever chemicals", feature extremely stable carbon-fluorine bonds, high bioaccumulation potential and suspected endocrine disrupting properties, leading to stringent regulatory restrictions worldwide. According to OECD statistics, the PFAS family comprises over 10,000 substances. Fluoropolymers including Polytetrafluoroethylene (PTFE), FEP, PFA, PVDF and PCTFE are widely applied in cardiovascular catheters, implant coatings, pacemaker wire insulation, as well as sterile high-barrier packaging for medical devices.

EU Updates RoHS Directive with Revised Lead Exemption Clauses

On November 21, 2025, the Official Journal of the European Union published three Commission Delegated Directives, introducing centralized revisions to multiple lead-related exemptions under the Restriction of Hazardous Substances (RoHS 2) Directive (2011/65/EU). These amendments focus on lead applications in alloys, glass/ceramics, and high melting temperature solders.

EU Proposes to Include Three Persistent Pollutants under POPs Regulation

On November 21, 2025, the European Commission released three draft proposals to upgrade and integrate three categories of Persistent Organic Pollutants (POPs)—chlorpyrifos, medium-chain chlorinated paraffins (MCCPs), and long-chain perfluorocarboxylic acids (C9-21 PFCAs)—into Part A of Annex I to the EU POPs Regulation (EU) 2019/1021. The move aims to comprehensively prohibit their production, circulation, and use within the EU, with only minimal transitional exemptions granted to a very limited number of industries.

ECHA Proposes Adding TPO, Melamine, and Two Other Substances to REACH Authorisation List

On November 18, 2025, the European Chemicals Agency (ECHA) published its 12th recommendation for authorization, proposing for the first time to include four Substances of Very High Concern (SVHCs), including melamine, into the REACH Authorisation List. If adopted by the European Commission, companies will need to submit applications and pass reviews to continue using these substances in the future.

ECHA Releases PFAS Draft Use Mapping

On November 5, 2025, the European Chemicals Agency (ECHA) published mapping of PFAS uses, serving as an industry support document for the upcoming public consultation on PFAS restrictions. The mapping systematically outlines PFAS applications across 14 major industrial, professional, and consumer sectors, including battery manufacturing, textiles, electronics, and PFAS production.