Industry News

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.

Typical EU RAPEX Notifications on Fluorinated Compounds (PFAS/PFOA/PFCAs)

RAPEX, as the EU's rapid alert system for non-food dangerous products, has issued multiple notification cases for fluorinated compounds such as PFAS, PFOA and PFCAs, covering clothing, textiles, outdoor equipment and other product categories. These notifications reflect the EU's strict regulatory requirements and high-intensity law enforcement for PFAS residues in consumer products, and also bring clear compliance challenges to global manufacturers, exporters and cross-border e-commerce platforms.

NIAS (Non-Intentionally Added Substances) Testing and Risk Assessment Services

Food contact plastics entering the European market are regulated by EU regulation EU 10/2011. EU legislation is based on the "positive list" principle, where substances used to manufacture food contact plastic materials must be selected from the list in Annex I of EU regulation EU 10/2011. Only substances listed can be added as monomers, additives, or production aids in the manufacturing formula. In the actual production process, apart from substances intentionally added during the process, there are also Non-Intentionally Added Substances (NIAS).