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.

India Eliminates Mandatory BIS Certification for Six Key Chemicals

On November 20, 2025, the Department of Chemicals and Petrochemicals (DCPC) under the Ministry of Chemicals and Fertilizers of India issued multiple notifications announcing the withdrawal of six previously issued Quality Control Orders. This decision was made by the DCPC based on public interest considerations and in consultation with the Bureau of Indian Standards, in accordance with Section 16 of the Bureau of Indian Standards Act, 2016. The withdrawal took effect immediately upon announcement. Compliance actions already completed or initiated prior to the withdrawal remain unaffected.

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.