Packaging regulation in the pharmaceutical and medical devices sector

What is excluded, and from what

Article 6(11) provides that the article on recyclability does not apply to:

• the primary packaging of medicinal products for human and veterinary use, as defined by Directive 2001/83/EC and Regulation (EU) 2019/6;
• contact-sensitive packaging of medical devices, referred to in Regulation (EU) 2017/745;
• contact-sensitive packaging of in-vitro diagnostic medical devices, referred to in Regulation (EU) 2017/746;
• the outer packaging of medicinal products, where it is necessary to meet specific requirements aimed at preserving the quality of the medicinal product;
• contact-sensitive packaging for infant formula and follow-on formula, processed cereal-based food and other food for infants and young children, and food for special medical purposes referred to in Regulation (EU) No 609/2013;
• packaging used for the transport of dangerous goods under Directive 2008/68/EC.

Article 7(4) repeats a similar list for minimum recycled content, adding compostable plastic packaging.

The Commission reviews these exceptions by 1 January 2035 (Art. 6(12)).

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What remains due

Technical documentation and the EU declaration of conformity, for each type of packaging, under Annexes VII and VIII: the exclusion concerns certain sustainability requirements, not the manufacturer’s obligations under Article 15.

The substance limit: the sum of lead, cadmium, mercury and hexavalent chromium does not exceed 100 mg/kg in the packaging or in one of its components, and conformity is demonstrated in the technical documentation.

The qualification of the role: whoever places goods on the market under its own name or trademark is a manufacturer under Article 21, even when the packaging is bought from third parties.

Traceability under Article 22, for five years in the case of single-use packaging and ten in the case of reusable packaging.

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The point that generates the most errors

The exclusion applies by requirement and by type of packaging, not by sector.

A pharmaceutical undertaking almost always has three levels of packaging: primary packaging, outer packaging and transport packaging. The exclusions under Articles 6 and 7 cover the first, and the second only when necessary to preserve the quality of the medicinal product. Transport packaging remains subject to all requirements, including the empty-space rule under Article 24 and the reuse targets under Article 29.

Products that are not medicinal products but are handled by the same undertaking, such as supplements and cosmetics, follow their own rules: cosmetics packaging, for instance, falls within the contact-sensitive category and is subject to the recycled-content percentages under Article 7.

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References

Regulation (EU) 2025/40 of the European Parliament and of the Council of 19 December 2024 on packaging and packaging waste, in OJ L of 22 January 2025.

• Art. 3 · Definition of contact-sensitive packaging
• Art. 5(4) · Heavy metals
• Art. 6(11) and (12) · Exclusions from recyclability and their review
• Art. 7(4) · Exclusions from recycled content
• Arts. 15, 21 and 22 · Manufacturer obligations, qualification of the role, traceability
• Arts. 24 and 29 · Empty space and reuse targets for transport packaging
• Annexes VII and VIII · Technical documentation and EU declaration of conformity

Official text: http://data.europa.eu/eli/reg/2025/40/oj