Recital 38

(38) In order to ensure a high level of protection of human and animal health in accordance with Union law, and to avoid any risk to the security of supply or to the safety of medicinal products and medical devices, certain types of plastic packaging should be excluded from the obligation of having a minimum recycled content. Those types of plastic packaging are immediate packaging as defined in Directive 2001/83/EC and in Regulation (EU) 2019/6, contact-sensitive plastic packaging for medical devices covered by Regulation (EU) 2017/745, contact-sensitive packaging for in vitro diagnostic medical devices covered by Regulation (EU) 2017/746, contact-sensitive plastic packaging for food intended only for infants and young children and contact-sensitive plastic packaging for food for special medical purposes covered by Regulation (EU) No 609/2013. That exclusion should also apply to outer packaging for human and veterinary medicinal products as defined in Regulation (EU) 2019/6 and Directive 2001/83/EC in cases where the packaging has to comply with specific requirements to preserve the quality of the medicinal product.

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Source: EUR-Lex CELLAR · retrieved 2026-08-26 · Text as adopted (Official Journal); later amendments are not incorporated in this text.