The EU Packaging and Packaging Waste Regulation (EU) 2025/40 (PPWR) has applied in full since 12 August 2026. All four categories of export packaging — food, pharmaceutical, medical device and tobacco — fall within its scope, but each is primarily governed by a different piece of legislation, and each has a different set of exemptions.
With exactly six weeks remaining, China’s revised national toy safety standards GB 6675.1-2025 to GB 6675.4-2025 will take effect on 1 November 2026. From that date, all toys newly manufactured in, or imported into, China must comply with the 2025 revision.
Between July and September 2026, new EU regulations significantly reshaped compliance for food contact materials (FCM). Key changes include a full ban on bisphenol A in single-use FCM, PPWR restrictions limiting PFAS in food packaging, updated purity rules for plastic FCM, and formal PET bottle recycled-content calculation guidelines including chemical recycling. Exporters must now back every shipment with updated Declarations of Conformity, mandatory BPA test reports (1 µg/kg detection limit), and documented PFAS screenings. Furthermore, recent RASFF data highlights bisphenol S, mineral oil, formaldehyde, and primary aromatic amine migrations as top compliance risks requiring routine testing.
China’s mandatory national food safety standards GB 4806.10-2025 (coatings and coated layers) and GB 4806.16-2025 (silicone rubber) took effect on September 2, 2026. The new standards introduce strict requirements, including limits on primary aromatic amines and volatile substances, requiring affected companies to immediately ensure full regulatory compliance.
Recently, the European Union's Rapid Alert System for non-food consumer products (Safety Gate) has reported multiple cases of non-compliance with the EU RoHS Directive, mainly involving restriction requirements for lead (Pb), cadmium (Cd), bis(2-ethylhexyl) phthalate (DEHP) and short-chain chlorinated paraffins (SCCPs). The non-compliant products listed below have been notified and subject to enforcement measures. CIRS Testing advises relevant manufacturers, exporters and supply-chain stakeholders to strengthen quality control in order to mitigate trade risks.
On 27 August 2026, the UK Health and Safety Executive (HSE) issued a notice announcing significant updates to the chemicals list under the GB Prior Informed Consent (PIC) Regulation. The new rules officially took effect on 28 August 2026.
Under the EU Packaging and Packaging Waste Regulation (PPWR), "Producer" is an Extended Producer Responsibility (EPR) role assigned to manufacturers, importers, or distributors who first place packaging on a Member State’s market. Producers face strict registration, fee, and reporting obligations. Non-EU sellers must appoint an Authorized Representative, while platforms like Amazon verify compliance.
Key Takeaways: On August 11, 2026, the European Commission proposed amending Annex II of the Toy Safety Directive (2009/48/EC), banning Lilial and lowering migration limits for Bisphenol A, Phenol, and BIT. Following public consultation ending October 10, 2026, the directive is expected to take effect in late 2026.
A four-week public consultation has now officially opened, with a deadline of August 5, 2026.
PPWR imposes on all companies placing packaging on the EU market a full chain of obligations spanning substances, design, and recyclability. Medical device companies are no bystanders — although, given the special nature of their products, the primary packaging in direct contact with the product enjoys certain relaxations with regard to "recyclability" and "recycled content," core responsibilities such as minimization, hazardous substances, labeling, EPR, and the Declaration of Conformity apply in full. There is therefore no such thing as a complete exemption for medical device packaging under the PPWR framework.
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