Obligations of manufacturers
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.
Information obligations of suppliers of packaging or packaging materials
1. 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. That information and documentation shall be provided in either paper or electronic form.
2. 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.
Authorised representatives
1. A manufacturer may, by a written mandate, appoint an authorised representative.
2. An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate 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 as follows:
(i)
as regards single-use packaging: for 5 years from the date the packaging was placed on the market; and
(ii)
as regards reusable packaging: for 10 years from the date the packaging was placed on the market;
(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.
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.
Obligations of importers
1. Importers 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, 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).
Where an importer considers or has reason to believe that packaging is not in conformity with the applicable requirements laid down in or pursuant to Articles 5 to 12, the importer shall not place the packaging on the market until it has been brought into conformity.
3. Importers shall indicate on the packaging their name and their 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 it is not possible to indicate that information on the packaging, it shall be provided via standardised, open, digital data carrier as referred to in Article 12 or in a document accompanying the packaged product.
4. Importers shall ensure that information provided in accordance with paragraph 3 is clear, understandable and legible, and does not replace or obscure, nor can be confused with information required by other Union legal acts on the labelling of the packaged product.
5. Importers shall 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 laid down in or pursuant to Articles 5 to 12.
6. Importers who consider or have reason to 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 shall immediately take the corrective measures necessary to bring that packaging into conformity, to withdraw it or to recall it, as appropriate. Importers shall immediately inform the market surveillance authorities of the Member States in which they made the packaging available of the suspected non-compliance and of the corrective measures taken.
7. Importers shall 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, as follows:
(a)
as regards single-use packaging: for 5 years from the date the packaging was placed on the market; and
(b)
as regards reusable packaging: for 10 years from the date the packaging was placed on the market.
8. Importers shall, 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.
9. Importers shall 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.
Obligations of distributors
1. When making packaging available on the market, distributors shall act with due care in relation to the requirements of this Regulation.
2. Before making packaging available on the market, distributors shall verify that:
(a)
the producer that is subject to the obligations on extended producer responsibility for the packaging is registered in the register of producers referred to in Article 44;
(b)
the packaging is labelled in accordance with Article 12; and
(c)
the manufacturer and the importer have complied with the requirements set out in Article 15(5) and (6) and Article 18(3), respectively.
3. Where a distributor, before making packaging available on the market, considers or has reason to believe that the packaging is not in conformity with the requirements laid down in or pursuant to Articles 5 to 12 or that the manufacturer or importer is not complying with the requirements set out in Article 15(5) and (6) and Article 18(3), respectively, the distributor shall not make the packaging available on the market until it has been brought into conformity or until the manufacturer or importer complies.
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.
4. Information disclosed by the producer shall not be used by the distributor for any purpose other than to verify compliance with applicable requirements laid down in or pursuant to Articles 5 to 12. In particular, the misuse of such information by distributors for commercial purposes shall be prohibited.
5. Distributors who consider or have reason to believe that packaging which they have made available on the market with the packaged product is not in conformity with the applicable requirements laid down in or pursuant to Articles 5 to 12 shall make sure that the necessary corrective measures are taken to bring that packaging into conformity, to withdraw it or to recall it, as appropriate.
Distributors shall 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.
6. Distributors shall, upon a reasoned request from a national authority, provide that authority 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 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.
Distributors 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.
Obligations of 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.
Case in which obligations of manufacturers apply to importers and 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.
Identification of economic operators
1. Economic operators shall, upon request, provide information to the market surveillance authorities on the following:
(a)
the identity of any economic operator that has supplied them with packaging or packaged products;
(b)
the identity of any economic operator to which they have supplied packaging or packaged products.
2. Economic operators shall be able to provide the information referred to in paragraph 1, point (a), as follows:
(a)
as regards single use packaging: for 5 years from the date they supplied or were supplied with the packaging;
(b)
as regards reusable packaging: for 10 years from the date they have supplied or been supplied with the reusable packaging.
Information obligations of packaging waste management operators
Packaging waste management operators shall, on an annual basis, provide the competent authorities with the information on packaging waste listed in Table 3 of Annex XII to this Regulation, with the exception of information on packaging made available on the territory of the Member State for the first time, through the electronic registry or registries, in accordance with Article 35(1) of Directive 2008/98/EC.
The packaging waste management operators shall, on an annual basis, provide the producers, in the case of individual fulfilment of extended producer responsibility obligations, or the producer responsibility organisation entrusted with carrying out those obligations, in the case of collective fulfilment of extended producer responsibility obligations, with all the information necessary to comply with the information obligations laid down in Article 44(10).
Member States may, in accordance with national law, provide that, where public authorities are responsible for the organisation of the management of packaging waste, packaging waste management operators shall, on an annual basis, provide such public authorities with all the information necessary to comply with the information obligations laid down in Article 44(10), or with other means to supplement the electronic registry or registries, in accordance with Article 35(1) of Directive 2008/98/EC.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
