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1. Manufacturers shall only place on the market packaging which is in conformity with the requirements laid down in or pursuant to Articles 5 to 12.

2. Before placing packaging on the market, manufacturers shall carry out the conformity assessment procedure referred to in Article 38 or have it carried out on their behalf, and shall draw up the technical documentation referred to in Annex VII. Where compliance of packaging with the applicable requirements has been demonstrated by the conformity assessment procedure referred to in Article 38, manufacturers shall draw up an EU declaration of conformity in accordance with Article 39.

3. Manufacturers shall keep the technical documentation referred to in Annex VII and the EU declaration of conformity as follows:

(a) in the case of single-use packaging: for 5 years from the date the packaging was placed on the market;

(b) in the case of reusable packaging: for 10 years from the date the packaging was placed on the market.

4. Manufacturers shall ensure that procedures are in place for series production of packaging to remain in conformity with this Regulation. Manufacturers shall adequately take into account changes in packaging design or in characteristics, as well as changes in harmonised standards, common technical specifications or other technical specifications by reference to which conformity is declared or by application of which its conformity is verified. Where the manufacturers find that the packaging’s conformity could be affected, they shall carry out a re-assessment in accordance with the conformity assessment procedure referred to in Article 38, or have it carried out on their behalf.

5. Manufacturers shall ensure that the packaging bears a type, batch or serial number or other element allowing its identification or, where the size or nature of the packaging does not so allow, that the required information is provided in a document accompanying the packaged product.

6. Manufacturers shall indicate on the packaging or on a QR code or another data carrier their name, registered trade name or registered trademark as well as the postal address at which and, where available, the electronic means of communication by which they can be contacted. Where that is not possible, the required information shall be provided as part of the information through the QR code or other type of standardised, open, digital data carrier as referred to in Article 12(1), (2), (4) or (5) or in a document accompanying the packaged product. The postal address shall indicate a single point at which the manufacturer can be contacted.

7. Manufacturers shall ensure that information provided in accordance with paragraphs 5 and 6 is clear, understandable and legible, and that it does not replace, or obscure nor can be confused with information required by other Union legal acts on the labelling of the packaged product.

8. Manufacturers who consider or have reason to believe that packaging which they have placed on the market from the date of entry into force of this Regulation is not in conformity with one or more of the applicable requirements laid down in or pursuant to Articles 5 to 12 shall immediately take the corrective measures necessary to bring that packaging into conformity, to withdraw it or to recall it, as appropriate. Manufacturers shall immediately inform the market surveillance authority of the Member State in which they made the packaging available of the suspected non-compliance and of the corrective measures taken.

9. By way of derogation from paragraph 8 of this Article, the obligation to bring into conformity, withdraw or recall packaging which is believed not to be in conformity with the requirements laid down in or pursuant to Articles 5 to 12 shall not apply to reusable packaging placed on the market before 11 February 2025.

10. Manufacturers shall, upon a reasoned request from a national authority, provide all the information and documentation necessary to demonstrate the conformity of the packaging with the requirements laid down in or pursuant to Articles 5 to 12, including the technical documentation, in one or more languages which can be easily understood by that authority. That information and documentation shall be provided in electronic form and, on request, in paper form. The relevant documents shall be made available within 10 days of receipt of the request from the national authority. Manufacturers shall cooperate with the national authority on any action taken to remedy any case of non-compliance with the requirements laid down in or pursuant to Articles 5 to 12.

11. Paragraphs 2 and 3 shall not apply to custom-made transport packaging for configurable medical devices and medical systems that are to be used in industrial and healthcare environments.

12. Where the natural or legal person that has the packaging designed or manufactured under its own name or trademark falls within the definition of micro-enterprise set out in Recommendation 2003/361/EC as applicable on 11 February 2025, and the natural or legal person that supplies the packaging to the natural or legal person that has the packaging designed or manufactured under its own name or trademark is located in the Union, the natural or legal person that supplies the packaging shall be considered to be the manufacturer for the purposes of this Article.