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Regulation (EU) 2025/40 CHAPTER VII — CONFORMITY OF PACKAGING

Article 35–Article 39 · 5 articles

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Test, measurement and calculation methods

Article 35

For the purposes of compliance and verification of compliance of packaging with the requirements laid down in or pursuant to Articles 5 to 12, 24 and 26, tests, measurements and calculations shall be made using reliable, accurate and reproducible methods which take into account the generally recognised state-of-the art methods and whose results are considered to be of low uncertainty.

Presumption of conformity

Article 36

1.   Test, measurement or calculation methods referred to in Article 35 which are in conformity with harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union , shall be presumed to be in conformity with the requirements covered by those standards or parts thereof set out in that Article. 2.   Where test, measurement or calculation methods as referred to in paragraph 1 of this Article are performed by conformity assessment bodies under accreditation in accordance with Regulation (EC) No 765/2008 of the European Parliament and of the Council  ( 72 ) , they shall be presumed to be in conformity with the requirements under paragraph 1 of this Article. 3.   Packaging which is in conformity with harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union , shall be presumed to be in conformity with the requirements laid down in or pursuant to Articles 5 to 12, 24 and 26 covered by those standards or parts thereof.

Common specifications

Article 37

1.   Packaging which is in conformity with common specifications referred to in paragraph 2 of this Article, or parts thereof, shall be presumed to be in conformity with the requirements laid down in or pursuant to Articles 5 to 12, 24 and 26 to the extent that those requirements are covered by those common specifications or parts thereof. 2.   The Commission may, by means of implementing acts, establish common specifications for the requirements laid down in or pursuant to Articles 5 to 12, 24 and 26 where the following conditions are fulfilled: (a) either: (i) no reference to harmonised standards covering the relevant requirements laid down in or pursuant to Articles 5 to 12, 24 and 26 of this Regulation has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable period; or (ii) the existing standard does not satisfy the requirements the request aims to cover; and (b) the Commission has requested, pursuant to Article 10(1) of Regulation (EU) No 1025/2012, one or more European standardisation organisations to draft or to revise a harmonised standard for the requirements laid down in or pursuant to Articles 5 to 12, 24 and 26 of this Regulation and either: (i) the request has not been accepted by any of the European standardisation organisations to which the request was addressed; or (ii) the request has been accepted by at least one of the European standardisation organisations to which the request was addressed, but the requested harmonised standards: — are not adopted within the deadline set in the request, — do not comply with the request, or — are not fully in line with the requirements they aim to cover. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 65(2). 3.   Before preparing a draft implementing act as referred to in paragraph 2 of this Article, the Commission shall inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers that the conditions set out in paragraph 2 of this Article have been fulfilled. 4.   Where a European standardisation organisation adopts a harmonised standard and proposes the harmonised standard to the Commission for the publication of its reference in the Official Journal of the European Union , the Commission shall assess the harmonised standard in accordance with Regulation (EU) No 1025/2012. When such a reference to a harmonised standard is published in the Official Journal of the European Union , the Commission shall repeal the implementing acts referred to in paragraph 2 of this Article, or parts thereof, which cover the same requirements laid down in or pursuant to Articles 5 to 12, 24 and 26. 5.   Where a Member State or the European Parliament considers that a common specification does not entirely satisfy the requirements laid down in or pursuant to Articles 5 to 12, 24 and 26, it shall inform the Commission thereof by submitting a detailed explanation. The Commission shall assess that detailed explanation and may, if appropriate, amend the implementing act establishing the common specification in question.

Conformity assessment procedure

Article 38

Conformity assessment of packaging as regards the requirements laid down in or pursuant to Articles 5 to 12 shall be carried out in accordance with the procedure set out in Annex VII.

EU declaration of conformity

Article 39

1.   The EU declaration of conformity shall state that the fulfilment of the requirements laid down in or pursuant to Articles 5 to 12 has been demonstrated. 2.   The EU declaration of conformity shall have the model structure set out in Annex VIII, contain the elements specified in the module set out in Annex VII and be continuously updated. It shall be drawn up in, or translated into, one or more languages required by the Member State in which the packaging is placed on the market or made available on the market. 3.   Where packaging or the packaged product are subject to more than one Union act requiring an EU declaration of conformity, a single EU declaration of conformity shall, where appropriate, be drawn up in respect of all such Union acts. That declaration shall state the Union acts concerned and their publication references. The declaration may consist of a dossier made up of relevant individual EU declarations of conformity. 4.   By drawing up the EU declaration of conformity, the manufacturer assumes responsibility for the compliance of the packaging with the requirements laid down in this Regulation. 5.   Competent authorities shall endeavour to control the accuracy of at least part of the declarations of conformity per year, assessed on a risk-based approach and shall take the necessary measures to address non-compliance, such as the withdrawal of non-compliant products from the market.

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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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