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EU
Consumer Goods
Under the EU PPWR, Is Medical Device Packaging Truly Exempt?

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.

Why Choose CIRS Testing for EU PPWR Compliance?

The EU Packaging and Packaging Waste Regulation (PPWR, Regulation (EU) 2025/40), will become mandatorily applicable across the entire EU from August 12, 2026, replacing the 94/62/EC Directive that has been in force for nearly 30 years. PPWR is upgraded into a directly applicable regulation and it imposes full-chain requirements on all packaging placed on the EU marke

Mandatory Enforcement in Less Than 2 Months! Is Your Packaging Ready to Pass the "PPWR Checkpoint"?

On 12 August 2026, the EU Packaging and Packaging Waste Regulation (PPWR, Regulation (EU) 2025/40) will become fully mandatory. This is not a "recommendatory" guidance document. It is a regulation with direct legal force, uniformly applicable to all EU Member States. From that date onwards, packaging that fails to meet requirements – including excessive heavy metals, non-compliant PFAS levels, incomplete EPR registration, or missing mandatory labels – may face product delisting, customs detention, heavy fines, or even exclusion from the EU market.

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.

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.