tags

CIRS Testing provides a complete medical device chemical testing service, built around the chemical-substance requirements of the EU MDR, REACH, RoHS, the POPs Regulation, China NMPA/GB, and US FDA / ISO 10993 frameworks.

On June 30, 2026, the European Commission adopted a draft regulation to include Chlorpyrifos in Part A of Annex I to the POPs Regulation. The official regulation will be published in the EU Official Journal in due course, bringing Chlorpyrifos under formal regulatory control.

On June 3, 2026, ECHA released a briefing on the SEAC consultation for the PFAS restriction proposal, receiving 3,511 comments within a 60-day period.

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.

In June 2026, ECHA released the operation report on REACH and CLP regulations, summarizing the five-year effectiveness of EU chemicals legislation.

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.

Here are five compelling reasons why PCN notification can become your "compliance accelerator."

On December 15, 2025, the European Chemicals Agency (ECHA) Member State Committee (MSC) unanimously agreed to list n-hexane as a Substance of Very High Concern (SVHC). Additionally, 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol (BPAF) and its salts have been added to the SVHC candidate list without committee discussion.

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.

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.