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Article 15 |
Manufacturers*
* Please note that, under the conditions detailed in Article 15(12) PPWR, the natural or legal person that supplies the packaging shall be considered to be the manufacturer. | 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, manufacturers shall draw up an EU Declaration of Conformity in accordance with Article 39. They shall only place on the market packaging which is in conformity with the requirements laid down in or pursuant to Articles 5 to 12. It should be noted that such obligations do not apply to custom-made transport packaging for configurable medical devices and medical systems that are to be used in industrial and healthcare environments. Please also note PPWR Recitals 76 and 111. | Manufacturers shall: - keep the technical documentation referred to in Annex VII and the EU declaration of conformity (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. - ensure that procedures are in place for series production of packaging to remain in conformity with this Regulation. Where manufacturers find that the packaging’s conformity could be affected (e.g. by changes in packaging design, harmonised standards or used technical specification), 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.
- 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.
- 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 digital data carrier. The postal address shall indicate a single point at which the manufacturer can be contacted.
- ensure that information provided on the packaging is clear, understandable and legible.
- upon request from a national authority, provide all the information and documentation necessary to demonstrate the conformity of packaging, including the technical documentation, in one or more languages which can be easily understood by that authority. 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.
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Article 16 |
Suppliers of packaging or packaging materials | Suppliers shall provide the manufacturer with all the information and documentation necessary for the manufacturer to demonstrate the conformity of the packaging and the packaging materials with this Regulation, including the technical documentation referred to in Annex VII and required under or pursuant to Articles 5 to 11, in one or more languages which can be easily understood by the manufacturer. Please also note PPWR Recitals 77 and 174. | The information and documentation shall be provided in either paper or electronic form. Where appropriate, the documentation and information required under Union legal acts applicable to contact-sensitive packaging shall be part of the information and documentation to be provided to the manufacturer pursuant to paragraph 1. |
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Article 17 |
Authorised representative | Authorised representatives (if appointed by the manufacturer) may undertake specific manufacturer’s duties on behalf of the manufacturer, while the manufacturer remains ultimately responsible under Article 15. The mandate given to the Authorised representatives shall allow the authorised representative to do at least the following: (a) keep the EU declaration of conformity and the technical documentation at the disposal of the national market surveillance authorities;
(b) cooperate with the competent national authorities, at their request, on any measures taken with regard to cases of non-compliance of the packaging covered by the authorised representative’s mandate;
(c) upon a reasoned request from a competent national authority, provide that authority with all the information and technical documentation necessary to demonstrate the conformity of packaging in one or more languages which can be easily understood by that authority;
(d) upon a request from a competent national authority, make available relevant documents within 10 days of the receipt of such a request;
(e) terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation It should be noted that the obligations laid down in Article 15(1) and the obligation to draw up the technical documentation referred to in Annex VII and required under or pursuant to Articles 5 to 11 shall not form part of the authorised representative’s mandate. | In cases where the Authorised representative is entrusted to keep the EU declaration of conformity and the technical documentation, it shall do so: (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. |
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Article 18 |
Importers | Before placing packaging on the market, importers shall ensure that: (a) the conformity assessment procedure referred to in Article 38 has been carried out by the manufacturer and that the manufacturer has drawn up the technical documentation referred to in Annex VII and required under or pursuant to Articles 5 to 11;
(b) the packaging is labelled in accordance with Article 12;
(c) the packaging is accompanied by the required documents; and
(d) the manufacturer has complied with the requirements set out in Article 15(5) and (6). Importers shall only place on the market packaging which is in conformity with the requirements of Articles 5 to 12. Where it considers that packaging is not in conformity, it shall not place the packaging on the market until it has been brought into conformity. Please also note PPWR Recital 78. | Importers shall: - indicate on the packaging their name and their registered trade name or trademark, as well as the postal address at which and, where available, the electronic means of communication by which they can be contacted. Where it is not possible to indicate that information on the packaging, it shall be provided via digital data carrier as referred to in Article 12 or in a document accompanying the packaged product.
- ensure that information provided in accordance with paragraph 3 is clear, understandable and legible.
- ensure that, while the packaging is under their responsibility, whether empty or with a product, storage or transport conditions do not jeopardise its compliance with the applicable requirements.
- take the corrective measures necessary to bring that packaging into conformity, to withdraw it or to recall it, as appropriate, should they consider or believe that packaging which they have placed on the market is not in conformity with the applicable requirements laid down in or pursuant to Articles 5 to 12.
- keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation referred to in Annex VII and required under or pursuant to Articles 5 to 11 can be made available to those authorities, upon request for a period of 5 and 10 years respectively, from the date the packaging was placed on the market, for single use and reusable packaging.
- upon a reasoned request from a national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of packaging, including technical documentation, with the applicable requirements laid down in or pursuant to Articles 5 to 12, 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.
- cooperate with the competent 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.
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Article 19 |
Distributors | Distributors shall act with due care and, before making packaging available on the market, must verify that: a) the relevant producer is registered in the EPR register;
b) that packaging is properly labelled, and that
c) the manufacturer and the importer have complied with their obligations under PPWR, Chapter IV. If they believe packaging is non-compliant, they must not make it available until conformity is restored. They must cooperate with enforcement authorities and provide relevant information on request. | Distributors shall: - ensure that, while the packaging, whether empty or with a product, is under their responsibility, the storage or transport conditions do not jeopardise its conformity with the requirements laid down in or pursuant to Articles 5 to 12.
- not use the information disclosed by the producer for any purpose other than verifying compliance.
- immediately inform the market surveillance authorities of the Member States in which they made the packaging available of the suspected non-conformity and of the corrective measures taken.
- provide authorities, upon request, with all the information and documentation to which they have access and that is relevant for demonstrating the conformity of the packaging with the applicable requirements, in one or more languages which can be easily understood by that authority.
- ensure that information and documentation is provided in electronic form and, on request, in paper form.
- 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.
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Article 20 |
Fulfilment service providers | Fulfilment service providers shall ensure that for packaging, whether empty or with a product, that they handle, the conditions during warehousing, handling and packing, addressing or dispatching do not jeopardise the packaging’s compliance with the requirements laid down in or pursuant to Articles 5 to 12. | |
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Article 21 |
Cases where manufacturer obligations apply to importers & distributors | Where an importer or a distributor places packaging on the market under its own name or trademark or modifies packaging already placed on the market in a way that could affect compliance with the relevant requirements of this Regulation, that importer or distributor shall be considered to be a manufacturer for the purposes of this Regulation and shall be subject to the obligations of the manufacturer under Article 15. Where an importer or a distributor as referred to in the first subparagraph 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 importer or distributor 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 Article 15 | |
