Recital 34

(34) In order to protect human and animal health and safety, due to the nature of the packaged products and the related requirements, the recyclability requirements should not be mandatory for immediate packaging in accordance with Directive 2001/83/EC of the European Parliament and of the Council (15) and with Regulation (EU) 2019/6 of the European Parliament and of the Council (16), which is in direct contact with the medicinal product, as well as outer packaging as defined in those legislative acts in cases where such packaging is necessary to comply with specific requirements to preserve the quality of the medicinal product. In addition, the recyclability requirements should not be mandatory for contact-sensitive plastic packaging for medical devices covered by Regulation (EU) 2017/745 of the European Parliament and of the Council (17), contact-sensitive plastic packaging for in vitro diagnostics medical devices covered by Regulation (EU) 2017/746 of the European Parliament and of the Council (18), contact-sensitive plastic packaging for foods intended for infants and young children and food for special medical purposes covered by Regulation (EU) No 609/2013 of the European Parliament and of the Council (19) or for packaging used for the transport of dangerous goods in accordance with Directive 2008/68/EC of the European Parliament and of the Council (20). Sales packaging made from lightweight wood, cork, textile, rubber, ceramic or porcelain should also be exempted, since those materials are placed on the market in very small quantities, i.e. each category amounts to less than 1 % of the weight of the packaging placed on the Union market. The obligation to pay financial contributions in accordance with the extended producer responsibility should not be covered by that exemption.

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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.