Regulation (EU) 2025/40 of the European Parliament and of the Council of 19 December 2024 on packaging and packaging waste, amending Regulation (EU) 2019/1020 and Directive (EU) 2019/904, and repealing Directive 94/62/EC (Text with EEA relevance)

Type Regulation
Publication 2024-12-19
Last updated 2026-04-15
State In force
Department Council of the European Union, European Parliament
Source EUR-Lex
articles 71
Reform history JSON API
2.

Measures to be taken by Member States to meet the target set out in paragraph 1 shall take into consideration the environmental impact of lightweight plastic carrier bags when they are manufactured, recycled or disposed of, and their composting properties, durability or specific intended use. Such measures may, by way of derogation from Article 4, include marketing restrictions, provided that they are proportionate and non-discriminatory.

3.

In addition to the measures under paragraphs 1 and 2 of this Article, Member States may take measures, such as economic instruments and national reduction targets, as regards any kind of plastic carrier bags, regardless of their wall thickness, in accordance with the obligations arising from the TFEU.

4.

Member States may exclude from the obligations set out in paragraph 1 very lightweight plastic carrier bags which are required for hygiene purposes or provided as sales packaging for loose food to prevent food wastage.

5.

By 12 February 2032, the Commission shall prepare a report on packaging materials, other than those referred to in paragraphs 1 and 2, which are likely to have a more detrimental impact on the environment than lightweight plastic carrier bags and, where appropriate, present a legislative proposal setting out reduction targets and measures to achieve those targets.

CHAPTER VII

CONFORMITY OF PACKAGING

Article 35
Test, measurement and calculation methods

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.

Article 36
Presumption of conformity
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.

Article 37
Common specifications
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:

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.

Article 38
Conformity assessment procedure

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.

Article 39
EU declaration of conformity
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.

CHAPTER VIII

MANAGEMENT OF PACKAGING AND OF PACKAGING WASTE

Section 1

General provisions

Article 40
Competent authority
1.

Member States shall designate one or more competent authorities to be responsible for implementation and enforcement of the obligations set out in this Chapter and in Article 6(10), Article 29(1) to (7) and (9) and Articles 30 to34.

2.

Member States shall lay down the details of the organisation and operation of the competent authority or competent authorities, including administrative and procedural rules governing:

(a) the registration of producers in accordance with Article 44;

(b) the organisation and monitoring of reporting requirements under Article 44(7) and (8);

(c) the oversight of the implementation of the extended producer responsibility obligations in accordance with Article 45;

(d) the authorisation on fulfilment of extended producer responsibility in accordance with Article 47;

(e) the making available of information in accordance with Article 56.

3.

By 12 July 2025, Member States shall notify the Commission of the names and addresses of the competent authorities designated pursuant to paragraph 1. Member States shall inform the Commission without undue delay of any changes to the names or addresses of those competent authorities.

Article 41
Early warning report
1.

The Commission shall, in cooperation with the European Environment Agency, draw up reports on the progress made towards the achievement of the targets laid down in Articles 43 and 52 at the latest 3 years before each of the deadlines laid down in those Articles.

2.

The reports referred to in paragraph 1 shall include the following:

(a) an estimation of the achievement of the targets by each Member State;

(b) a list of Member States at risk of not achieving the targets by the respective deadlines, accompanied by appropriate recommendations for the Member States concerned;

(c) examples of best practices throughout the Union which could provide guidance for progressing towards achievement of the targets.

Article 42
Waste management plans and waste prevention programmes
1.

Member States shall include in the waste management plans required pursuant to Article 28 of Directive 2008/98/EC a dedicated chapter on the management of packaging and packaging waste, including measures taken pursuant to Articles 48, 50 and 52 of this Regulation.

2.

Member States shall include in the waste prevention programmes required pursuant to Article 29 of Directive 2008/98/EC a dedicated chapter on the prevention of packaging, packaging waste and packaging discarded as litter, including measures taken pursuant to Articles 43 and 51 of this Regulation.

Section 2

Waste prevention

Article 43
Prevention of packaging waste
1.

Each Member State shall reduce the packaging waste generated per capita, as compared to the packaging waste generated per capita in 2018 as reported to the Commission in accordance with Decision 2005/270/EC, by at least:

(a) 5 % by 2030;

(b) 10 % by 2035;

(c) 15 % by 2040.

2.

In order to support Member States achieve the packaging waste prevention targets set out in paragraph 1 of this Article, by 12 February 2027, the Commission shall establish a correction factor to account for the increase or decrease in tourism in relation to the base year 2018 by means of implementing acts adopted pursuant to Article 56(7), point (c). That correction factor shall be based on the rate of packaging waste generation per tourist and the variation in the number of tourists relative to the base year 2018 and take the packaging waste reduction potential in tourism into account.

3.

Without prejudice to paragraphs 1 and 4, Member States that have already established separate systems for the management of household packaging waste, on the one hand, and for industrial and commercial packaging waste, on the other, may retain those systems.

4.

In achieving the targets set out in paragraph 1, each Member State shall endeavour to reduce the quantity of plastic packaging waste generated.

5.

In addition to the measures provided for by this Regulation, Member States shall, in line with the overall objectives of the Union’s waste policy and in order to reach the targets set out in this Article, implement measures that aim to prevent the generation of packaging waste and to minimise the environmental impact of packaging. Such measures may include the use of economic instruments and other measures to provide incentives for the application of the waste hierarchy, such as the measures referred to in Annexes IV and IVa to Directive 2008/98/EC, or other appropriate instruments and measures, including incentives provided through extended producer responsibility schemes, and obligations on producers or producer responsibility organisations to adopt waste prevention plans. The measures shall be proportionate and non-discriminatory and be designed so as to avoid barriers to trade or distortions of competition. Such measures shall not lead to a shift to lighter packaging material being used to fulfil the goal of packaging waste reduction.

6.

For the purpose of paragraph 5 of this Article and without prejudice to Article 16(2) of Directive (EU) 2020/2184 of the European Parliament and of the Council (73), Member States shall incentivise restaurants, canteens, bars, cafés and catering services to serve their customers tap water, where available, free of charge or for a low service fee, in a reusable or refillable format.

7.

For the purpose of paragraph 5, Member States may introduce packaging waste prevention measures that exceed the minimum targets set out in paragraph 1, while acting in accordance with this Regulation.

8.

By way of derogation from paragraph 1, Member States may, by 31 December 2025, request the Commission to use a base year other than 2018 for the calculations of the targets set out in paragraph 1. If a Member State makes such request, the Commission may, without prejudice to paragraphs 5 and 7, allow the Member State to use such other base year for the purpose of calculating the targets set out in paragraph 1 on condition that the Member State provide substantiated evidence:

(a) of a significant increase in packaging waste during the year that it requests to use as a base year for the purpose of calculating the targets set out in paragraph 1;

(b) that the significant increase in packaging waste demonstrated under point (a) is due to changes in the reporting procedures only;

(c) that the significant increase in packaging waste demonstrated under point (a) is not due to an increased consumption; and

(d) of better comparability of data between the Member States.

9.

By 12 February 2032, the Commission shall review the targets laid down in paragraph 1 and assess the need to include specific targets for certain packaging materials. To that end, the Commission shall submit a report to the European Parliament and to the Council, accompanied, if the Commission finds it appropriate, by a legislative proposal.

Section 3

Register of producers and extended producer responsibility

Article 44
Register of producers
1.

Each Member State shall, within 18 months of the date of entry into force of first implementing act adopted pursuant to paragraph 14, establish a national register which shall serve to monitor compliance of producers with the requirements set out in this Chapter.

Each national register shall provide links to other national registers of producers’ websites to facilitate, in all Member States, registration of producers or authorised representatives for the extended producer responsibility.

2.

Producers shall be obliged to register in the register referred to in paragraph 1 of this Article in each Member State where they make packaging or packaged products available on the territory of the Member State for the first time or where they unpack packaged products without being end users, by submitting an application for registration to the competent authority responsible for the register of each such Member State. Where a producer has entrusted a producer responsibility organisation with carrying out the extended producer responsibility obligations on its behalf pursuant to Article 46(1), the obligations set out in this Article shall be met by that organisation, unless otherwise specified by the Member State in which the register is established.

3.

Member States may provide that the obligations set out in this Article may, on the basis of a written mandate, be met on behalf of producers by an authorised representative for the extended producer responsibility.

4.

Producers shall not make available packaging or packaged products on the territory of a Member State for the first time, or unpack packaged products without being end users, if they or, where applicable, in accordance with Article 45, their authorised representatives for the extended producer responsibility are not registered in that Member State.

5.

The application for registration shall include the information to be provided in accordance with Part A of Annex IX. A Member State may request producers to provide additional information or documents if such information or documents are necessary to monitor and ensure compliance with this Regulation and with the rules adopted by that Member State pursuant to Article 40(2).

6.

Where an authorised representative for the extended producer responsibility represents more than one producer, it shall, in addition to the information to be provided pursuant to paragraph 5, provide the name and the contact details of each one of the producers which it represents, separately.

7.

The producer or, where applicable, the producer’s authorised representative for the extended producer responsibility or the producer responsibility organisation, as stipulated by national law in accordance with paragraphs 2 and 3 of this Article, shall submit the information set out in Part B, point 1, of Annex IX to the competent authority responsible for the register, by 1 June for each full preceding calendar year.

Member States may require the information provided pursuant to this paragraph to be audited and certified by independent auditors under the supervision of the competent authorities referred to in Article 40(1), on the basis of national standards, if any.

8.

Where a producer has made available for the first time on the territory of the Member State a quantity of packaging, including packaging of packaged products, of less than 10 tonnes during one calendar year, or where a producer as defined in Article 3(1), point (15)(e), unpacks a quantity of packaging of less than 10 tonnes during one calendar year, the producer or, where applicable, the producer’s authorised representative for the extended producer responsibility or the producer responsibility organisation, as stipulated by national law in accordance with paragraphs 2 and 3 of this Article, shall submit the information set out in Part B, point 2, of Annex IX to the competent authority responsible for the register, by 1 June for each full preceding calendar year.

By way of derogation from the first subparagraph, a Member State may, for a specific calendar year, set a lower maximum threshold than that referred to in the first subparagraph if the Member State would otherwise have insufficient accurate data in order to:

(a) comply with the reporting obligations under Article 56(1) and (2) in that calendar year; and

(b) ensure that the database under Article 57 is complete and provide the data under Article 56(2), point (a).

9.

If it is necessary for budgetary reasons, a Member State may require the producer to submit the information set out in Part B, points 1 and 2, of Annex IX to the competent authority responsible for the register on a quarterly basis.

10.

Producers, in the case of individual fulfilment of extended producer responsibility obligations, the producer responsibility organisation entrusted with carrying out those obligations, in the case of collective fulfilment of extended producer responsibility obligations, or the re-use system operators, in the case where re-use systems are fulfilling the extended producer responsibility obligations, shall submit the information set out in Part B, point 3, of Annex IX to the competent authority for each preceding calendar year on an annual basis.

Where under national law public authorities are responsible for the organisation of the management of packaging waste, Member States may provide that those authorities shall submit the information set out in Part B, point 3, of Annex IX.

11.

The competent authority responsible for the register:

(a) shall receive applications for registration as referred to in paragraph 2 via an electronic data-processing system, the details of which shall be made available on the competent authority’s website;

(b) shall grant registrations and provide a registration number within a maximum period of twelve weeks from the moment that all the information required under paragraphs 5 and 6 is provided;

(c) may lay down modalities with respect to the requirements and process of registration without adding substantive requirements to those laid down in paragraphs 5 and 6;

(d) may charge producers cost-based and proportionate fees for the processing of applications for registration as referred to in paragraph 2;

(e) shall receive and monitor the information submitted pursuant to paragraphs 7 and 8.

12.

The producer, or, where applicable, the producer’s authorised representative for the extended producer responsibility or the producer responsibility organisation shall, without undue delay, notify the competent authority of any changes to the information contained in the registration and of any permanent cessation of the making available for the first time on the territory of the Member State of the packaging or packaged product referred to in the registration. A producer shall be removed from the register 3 years from the end of the calendar year in which the producer’s registration ends if the producer has ceased to exist as a producer.

13.

Member States shall ensure that the list of registered producers is easily accessible, publicly available and free of charge, without prejudice to the preservation of the confidentiality of commercially sensitive information in conformity with the relevant Union and national law. The list of registered producers shall be machine readable, sortable and searchable, and shall respect open standards for third-party use.

14.

The Commission shall, by 12 February 2026, adopt implementing acts establishing the format for registration in, and reporting to, the register and specifying the granularity of data to be provided and the packaging types and material categories to be covered by the information submitted.

The format for the submission of information pursuant to this Article shall be interoperable, shall be based on open standards and machine-readable data, and shall be transferable through an interoperable data exchange network without vendor lock-in.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 65(2).

Article 45
Extended producer responsibility
1.

Producers shall have extended producer responsibility under the schemes established in accordance with Articles 8 and 8a of Directive 2008/98/EC and with this Section for the packaging, including packaging of packaged products, that they make available for the first time on the territory of a Member State or that they unpack without being end users.

2.

In addition to the costs referred to in Article 8a(4), point (a), of Directive 2008/98/EC, the financial contributions paid by the producer shall cover the following costs:

(a) costs of labelling waste receptacles for the collection of packaging waste as referred to in Article 13 of this Regulation; and

(b) costs of carrying out compositional surveys of collected mixed municipal waste under Commission Implementing Regulation (EU) 2023/595 (74) and under the implementing acts to be adopted pursuant to Article 56(7), point (a), of this Regulation where those implementing acts provide for an obligation to carry out such surveys.

The costs to be covered shall be established in a transparent, proportional, non-discriminatory and efficient way.

3.

A producer referred to in Article 3(1), point (15)(c) and (d), shall appoint, by written mandate, an authorised representative for the extended producer responsibility in each Member State where the producer makes packaging or packaged products available for the first time, other than the Member State where the producer is established. Member States may provide that producers established in third countries shall appoint, by written mandate, an authorised representative for the extended producer responsibility when making packaging or packaged products available on their territory for the first time.

4.

For the purposes of compliance with Article 30(1), points (d) and (e), of Regulation (EU) 2022/2065, providers of online platforms that fall within the scope of Section 4 of Chapter III of that Regulation and that allow consumers to conclude distance contracts with producers shall obtain the following information from producers that offer packaging or packaged products to consumers located in the Union prior to allowing those producers to use their services:

(a) information on the registration of the producers referred to in Article 44 of this Regulation in the Member State where the consumer is located and the registration number(s) of the producer in that register;

(b) a self-certification by the producer confirming that it only offers packaging with regard to which the extended producer responsibility requirements referred to in paragraphs 1, 2 and3 of this Article are complied with in the Member State where the consumer is located.

Where a producer sells its products via an online marketplace, the obligations set out in paragraph 2 of this Article may, on the basis of written mandate, be met by the provider of the online platform, on behalf of the producer.

5.

Member States may provide that, where automated data reconciliation with the national register is provided for in that Member State, it shall be applicable for verification of the information referred to in paragraph 4, points (a) and (b).

6.

Upon receiving the information referred to in paragraph 4 and prior to allowing producers to use its services, the provider of the online platform shall make best efforts to assess whether the information received is complete and reliable.

7.

Producers offering packaging or packaged products to consumers located in the Union shall provide fulfilment service providers with the information referred to in paragraph 4, points (a) and (b), of this Article at the moment of the conclusion of the contract between the fulfilment service provider and the producer for any of the services referred to in Article 3, point (11), of Regulation (EU) 2019/1020.

8.

Upon receiving the information referred to in paragraph 7of this Article and at the moment of the conclusion of the contract between the fulfilment service provider and the producer for any of the services referred to in Article 3, point (11), of Regulation (EU) 2019/1020, the fulfilment service provider shall, through the use of any freely accessible official online database or online interface made available by a Member State or the Union or by means of the publicly available registration list under Article 44(13) of this Regulation or requests to the producer to provide supporting documents from reliable sources, make best efforts to assess whether the information referred to in paragraph 7 of this Article is reliable and complete. For the purposes of this Regulation, producers shall be responsible for the accuracy of the information provided.

Where the fulfilment service provider obtains sufficient indications or has reason to believe that any item of information referred to in paragraph 7 obtained from the producer concerned is inaccurate, incomplete or not up-to-date, that fulfilment service provider shall request that the producer remedies that situation without delay or within the period set by Union or national law, as applicable.

Where the producer fails to correct or complete that information, the fulfilment service provider shall swiftly suspend the provision of its service to that producer in relation to the offering of packaging or packaged products to consumers located in the Union until the request has been fully complied with. The fulfilment service provider shall provide the producer with the reasons for the suspension.

9.

Without prejudice to Article 4 of Regulation (EU) 2019/1150 of the European Parliament and of the Council (75), in the event that a fulfilment service provider suspends the provision of its services pursuant to paragraph 8 of this Article, the producer concerned shall have the right to challenge the decision of the fulfilment service provider before a court in a Member State in which the fulfilment service provider is established.

Article 46
Producer responsibility organisation
1.

Producers may entrust a producer responsibility organisation authorised in accordance with Article 47 with carrying out the extended producer responsibility obligations on their behalf. Member States may adopt measures to make entrusting the extended producer responsibility obligations to a producer responsibility organisation mandatory.

2.

Where, on the territory of a Member State, one or multiple producer responsibility organisations are authorised to fulfil extended producer responsibility obligations on behalf of producers, the Member State shall ensure that the producer responsibility organisation or organisations and producers that have not entrusted the carrying out of the extended producer responsibility obligations to a producer responsibility organisation, when taken together, cover the whole territory of the Member State as regards the activities in accordance with Article 47(3) and Articles 48 and 50. Member States shall appoint an independent third party to oversee the carrying out of the extended producer responsibility obligations by the producer responsibility organisations in a coordinated manner or shall entrust such oversight to the competent authority.

3.

Producer responsibility organisations shall ensure the confidentiality of the data in their possession as regards proprietary information or information directly attributable to individual producers or their authorised representatives.

4.

In addition to the information referred to in Article 8a(3), point (e), of Directive 2008/98/EC, producer responsibility organisations shall publish on their websites, at least once a year, information on the quantity of packaging, including packaging of packaged products, made available for the first time on the territory of a Member State, or unpacked by a producer without being an end user, and on the levels of recovered and recycled materials in relation to the quantity of packaging for which they have been performing producer responsibility obligations.

Member States may provide that public authorities that are responsible for the organisation of the management of packaging waste shall publish on their websites, at least once a year, information on the levels of recovered and recycled materials in relation to the quantity of packaging waste generated on their territory.

5.

Producer responsibility organisations shall ensure equal treatment of producers regardless of their origin or size, without placing a disproportionate burden on producers of small quantities of packaging, including packaging of packaged products, including small and medium-sized enterprises.

Article 47
Authorisation on fulfilment of extended producer responsibility
1.

The producer, 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, shall apply for an authorisation on fulfilment of extended producer responsibility from the competent authority.

2.

When adopting measures laying down the administrative and procedural rules referred to in Article 40(2), Member States shall establish the requirements and details of the authorisation procedure. Those requirements and details may differ for individual and collective fulfilment of the extended producer responsibility obligations. Member States shall also establish the modalities for verifying compliance, including the information to be provided by producers or producer responsibility organisations to that end. The authorisation procedure shall include requirements on the verification of the arrangements put in place to ensure compliance with the requirements laid down in paragraph 3 of this Article, and timeframes for that verification, which shall not exceed 18 weeks from the submission of a complete application dossier. That verification shall be carried out by a competent authority or an independent expert who shall issue a verification report on its result. The independent expert shall be independent of the competent authority and of the producer responsibility organisations or the producers authorised for individual fulfilment.

3.

The measures to be established by Member States in accordance with paragraph 2 shall include measures ensuring that:

(a) the requirements laid down in Article 8a(3), points (a) to (d), of Directive 2008/98/EC are complied with;

(b) the measures put in place or paid for by the producer or producer responsibility organisation are sufficient to allow for the return and waste management of all packaging waste in accordance with Article 48(1) and (5) and Article 50, free of charge for consumers, with a frequency proportionate to the area and volume of packaging waste covered with regard to the quantity and types of packaging, including packaging of packaged products, made available for the first time on the territory of a Member State by that producer or producers on whose behalf the producer responsibility organisation acts, or packaging unpacked by such producer or producers without being end users;

(c) the necessary arrangements, including preliminary arrangements, to that end are in place with distributors, public authorities or third parties carrying out waste management on their behalf;

(d) the necessary sorting and recycling capacity is available to ensure that packaging waste collected is subsequently subject to preliminary treatment and high-quality recycling;

(e) the requirement laid down in paragraph 6 of this Article is complied with.

4.

The producer or the producer responsibility organisation shall notify the competent authority without undue delay of any changes to the information contained in the application for an authorisation, of any changes that concern the terms of the authorisation, or of the permanent cessation of operations. On the basis of some or all of such notified changes, the competent authority may decide to amend the authorisation.

5.

The competent authority may decide to revoke the authorisation, in particular if the producer or producer responsibility organisation no longer fulfils the requirements on the organisation of the treatment of packaging waste or fails to fulfil other extended producer responsibility obligations under the schemes established in accordance with Articles 8 and 8a of Directive 2008/98/EC or under this Section, such as obligations to report to the competent authority, or obligations to notify any changes to the terms of the authorisation or if the producer has permanently ceased operations.

6.

The producer, 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, shall provide an adequate guarantee intended to cover the costs related to waste management operations owed by the producer or the producer responsibility organisation, in the event of non-compliance with the extended producer responsibility obligations, including in the permanent cessation of its operations, or insolvency. Member States may specify additional requirements for the guarantee. The guarantee may take the form of a public fund that is financed by producers’ fees and for which a Member State is jointly and severally liable.

Section 4

Return, collection, deposit and return systems

Article 48
Return and collection systems
1.

Member States shall ensure that systems and infrastructures are set up to provide for the return and separate collection of all packaging waste from the end users, in order to ensure that it is treated in accordance with Articles 4, 10 and 13 of Directive 2008/98/EC, and to facilitate its preparation for re-use and high-quality recycling.

Packaging that complies with design for recycling criteria as established in delegated acts adopted pursuant to Article 6(4) of this Regulation shall be collected for recycling. Incineration and landfill of such packaging shall be prohibited, with the exception of waste resulting from subsequent treatment operations of separately collected packaging waste for which recycling is not feasible or does not deliver the best environmental outcome.

2.

In order to facilitate high-quality recycling, Member States shall ensure that systems and infrastructures for comprehensive collection and sorting are in place to facilitate recycling and to ensure that plastic feedstock is available for recycling. Such systems and infrastructures may provide priority access to recycled materials for use in applications where the distinct quality of the recycled material is preserved or recovered in such a way that it can be recycled further and used in the same way and for a similar application with minimal loss of quantity, quality or function.

3.

Member States may derogate from the return and separate waste collection obligation in paragraph 1 of this Article for certain formats of waste, provided that collecting fractions of packaging waste together, or collecting packaging waste or fractions of such packaging waste together with other waste does not affect the capacity of such packaging or fractions of packaging waste to undergo preparing for re-use, recycling or other recovery operations in accordance with Articles 4 and 13 of Directive 2008/98/EC and generates output from those operations which is of comparable quality to that achieved through separate collection.

4.

Member States may ensure that packaging waste that is not collected separately is sorted prior to disposal or energy recovery operations to remove packaging designed for recycling.

5.

The systems and infrastructures referred to in paragraph 1 shall:

(a) be open to the participation of the economic operators of the sectors concerned, the competent public authorities and third parties carrying out waste management on their behalf;

(b) cover the whole territory of the Member State and all packaging waste from all types of packaging and activities, and take into account population size, expected volume and composition of packaging waste, as well as accessibility and proximity to end users; they shall include the separate collection in public spaces, business premises and residential areas, and shall be of sufficient capacity;

(c) be open to imported products under non-discriminatory conditions, in particular with regard to the detailed arrangements and any tariffs imposed for access, and be designed so as to avoid barriers to trade or distortions of competition.

6.

Member States may provide for public waste management systems to participate in the organisation of the systems referred to in paragraph 1.

7.

Member States shall take measures to promote recycling of packaging waste which meets the quality standards for the use of recycled materials in relevant sectors.

Article 49
Mandatory collection

By 1 January 2029, Member States shall set mandatory collection objectives and take the necessary measures to ensure that the collection of the materials listed in Article 52 is consistent with the recycling targets set out in that Article and with the mandatory recycled content targets set out in Article 7.

Article 50
Deposit and return systems
1.

By 1 January 2029, Member States shall take the necessary measures to ensure the separate collection of at least 90 % per year by weight of the following packaging formats made available on the market for the first time in that Member State in a given calendar year:

(a) single-use plastic beverage bottles with a capacity of up to three litres; and

(b) single-use metal beverage containers with a capacity of up to three litres.

Member States may use the quantity of packaging waste generated from packaging placed on the market to calculate, in accordance with the implementing acts adopted pursuant to Article 56(7), point (a), the targets set out in the first subparagraph, points (a) and (b), of this paragraph.

2.

In order to achieve the targets set out in paragraph 1, Member States shall take the necessary measures to ensure that deposit and return systems are set up for the relevant packaging formats referred to in paragraph 1 and that a deposit is charged at the point of sale.

3.

By way of derogation from paragraph 2, Member States may exempt economic operators in the HORECA sector from charging a deposit where the following conditions are fulfilled:

(a) the deposit bearing packaging is opened on the premises;

(b) the product is consumed on the premises; and

(c) the empty deposit bearing packaging is returned at the premises.

4.

Paragraph 2 shall not apply to packaging for:

(a) categories of grapevine products listed in points 1, 3, 8, 9, 11, 12, 15, 16 and 17, Part II of Annex VII to Regulation (EU) No 1308/2013 or for aromatised wine products as defined in Regulation (EU) No 251/2014;

(b) products that are similar to wine products and aromatised wine products and that are obtained from fruit other than grapes and from vegetables, and other fermented beverages falling within CN code 2206 00;

(c) alcohol-based spirituous beverages corresponding to CN heading 2208; and

(d) milk and milk products listed in Part XVI of Annex I to Regulation (EU) No 1308/2013.

By way of derogation from paragraph 2, Member States may exempt single-use plastic beverage bottles and single use metal beverage containers with capacities lower than 0,1 litres from participation in the deposit and return systems, where such participation is not technically feasible.

5.

Member States may be exempt from the obligation under paragraph 2 under the following conditions:

(a) the rate of separate collection as required under Article 48 of the relevant packaging format as submitted to the Commission under Article 56(1), point (c), is 80 % or more by weight of such packaging made available on the territory of that Member State for the first time in the calendar year 2026; and

(b) by 1 January 2028, the Member State notifies the Commission of its request for exemption and submits an implementation plan showing a strategy with concrete measures, including their timeline, that ensure achievement of the 90 % separate collection rate by weight of the packaging referred to in paragraph 1.

For the purposes of point (a), where the information on the rate of separate collection of the relevant packaging format has not yet been submitted to the Commission, the Member State shall provide a reasoned explanation as to how the conditions for the exemption set out in this paragraph are otherwise fulfilled. The reasoned explanation shall be based on validated national data and include a description of the measures implemented.

6.

Within 3 months of receipt of the implementation plan submitted pursuant to paragraph 5, point (b), the Commission may request the Member State to revise the plan if it considers that the plan does not comply with the requirements set out in paragraph 5, point (b). The Member State shall submit a revised implementation plan within 3 months of receipt of the Commission’s request.

7.

If the separate collection rate of the packaging referred to in paragraph 1 in a Member State decreases and remains below 90 % by weight of a given packaging format placed on the market for three consecutive calendar years, the Commission shall notify that Member State that the exemption no longer applies. A deposit and return system shall be established by 1 January of the second calendar year following the year in which the Commission notified the Member State concerned that the exemption no longer applies.

8.

Member States shall endeavour to establish and maintain deposit and return systems in particular for single-use glass beverage bottles and beverage cartons. Member States shall endeavour to ensure that deposit and return systems for single-use packaging formats, in particular for single-use glass beverage bottles, are equally available for reusable packaging where technically and economically feasible.

9.

A Member State may, while observing the general rules laid down in the TFEU and acting in accordance with this Regulation, adopt provisions which go beyond the minimum requirements set out in this Article, such as the possibility to include packaging listed in paragraph 4, and packaging for other products or made of other materials.

10.

Member States shall ensure that return points and opportunities for reusable packaging with a similar purpose and format to those established under paragraph 1 are as convenient for end users as return points and opportunities are to return single-use packaging to a deposit and return system.

11.

By 1 January 2029, Member States shall ensure that at least the deposit and return systems established under paragraph 2 of this Article following the entry into force of this Regulation meet the minimum requirements listed in Annex X.

The minimum requirements listed in Annex X shall not apply to deposit and return systems established before the entry into force of this Regulation which achieve the 90 % target set out in paragraph 1 of this Article by 1 January 2029. Member States shall endeavour to ensure that existing single-use deposit and return systems comply with the minimum requirements in Annex X when they are first reviewed. If the 90 % target is not achieved by 1 January 2029, existing single-use deposit and return systems shall comply with the minimum requirements in Annex X at the latest by 1 January 2035.

By 1 January 2038, the Commission, in collaboration with the Member States, shall assess the implementation of this Article and identify how to maximise the interoperability of deposit and return systems.

12.

The minimum requirements listed in Annex X to this Regulation shall not apply in outermost regions as recognised in Article 349, third paragraph, TFEU, taking into account their local specificities.

Section 5

Re-use and refill

Article 51
Re-use and refill
1.

Member States shall take measures to encourage the establishment of re-use systems for packaging with sufficient incentives for return and of refill systems in an environmentally sound manner. Those systems shall comply with the requirements laid down in Articles 27 and 28 and Annex VI and shall not compromise food hygiene or the safety of consumers.

2.

The measures referred to in paragraph 1 may include:

(a) the use of deposit and return systems compliant with minimum requirements in Annex X for reusable packaging and for packaging formats other than those referred to in Article 50(1);

(b) the use of economic incentives, including obligations on final distributors to charge for the use of single-use packaging and to inform consumers about the cost of such packaging at the point of sale;

(c) obligations on manufacturers or final distributors to make available in reusable packaging within a re-use system or through refill a certain percentage of products other than those covered by the re-use targets laid down in Article 29, on condition that that does not lead to distortions on the internal market or trade barriers for products from other Member States.

3.

Member States shall ensure that extended producer responsibility schemes and deposit and return systems allocate a minimum share of their budget to financing reduction and prevention actions.

Section 6

Recycling targets and promotion of recycling

Article 52
Recycling targets and promotion of recycling
1.

Member States shall take the necessary measures to achieve the following recycling targets covering the whole of their territory:

(a) by 31 December 2025, a minimum of 65 % by weight of all packaging waste generated;

(c) by 31 December 2030, a minimum of 70 % by weight of all packaging waste generated;

2.

Without prejudice to paragraph 1, points (a) and (c), a Member State may postpone the deadlines set out in paragraph 1, points (b) and (d), by up to 5 years under the following conditions:

(a) the derogation from the targets in the period of postponement is limited to a maximum of 15 percentage points from a single target or divided between two targets;

(b) as a result of the derogation from the targets in the period of postponement, the recycling rate for a single target is not reduced below 30 %;

(c) as a result of the derogation from the targets in the period of postponement, the recycling rate for a single target set out in paragraph 1, points (b)(v) and (vi), is not reduced below 60 %, and the recycling rate for a single target set out in paragraph 1, points (d)(v) and (vi), is not reduced below 70 %; and

(d) at the latest 24 months before the respective deadline laid down in paragraph 1, points (b) and (d), of this Article, the Member State notifies the Commission of its intention to postpone the deadline and submits to the Commission an implementation plan in accordance with Annex XI to this Regulation, which may be combined with an implementation plan submitted pursuant to Article 11(3), point (b), of Directive 2008/98/EC.

3.

Where a Member State requests to postpone the deadline laid down in paragraph 1, point (d), of this Article the Commission may, within 3 months of receipt of the implementation plan submitted pursuant to paragraph 2, point (d), of this Article request the Member State to revise the plan if the Commission considers that the plan does not comply with the requirements set out in Annex XI. The Member State shall submit a revised implementation plan within 3 months of receipt of the Commission’s request. If the Commission considers that the revised implementation plan does not comply with the requirements set out in Annex XI and that it is unlikely that the Member State will be able to meet the targets within the period of postponement pursuant to paragraph 2 of this Article, the Commission shall reject the implementation plan and the Member State shall be obliged to comply with the targets within the deadlines set in paragraph 1, point (d), of this Article.

4.

By 12 February 2032, the Commission shall review the targets laid down in paragraph 1, points (c) and (d), with a view to increasing them or setting further targets. To that end, the Commission shall submit a report to the European Parliament and to the Council, accompanied, if the Commission finds it appropriate, by a legislative proposal.

5.

Member States shall, where appropriate, encourage the use of materials obtained from recycled packaging waste for the manufacturing of packaging and other products by:

(a) improving market conditions for such materials;

(b) reviewing existing rules that prevent the use of such materials.

6.

A Member State may, while observing the general rules laid down in the TFEU and acting in accordance with this Regulation, adopt provisions which go beyond the minimum targets set out in this Article.

Article 53
Rules on the calculation of the achievement of the recycling targets
1.

The calculation to determine whether the targets laid down in Article 52(1) have been achieved shall be carried out in accordance with the rules laid down in this Article.

2.

Member States shall calculate the weight of packaging waste generated in a given calendar year. The calculation of packaging waste generated in a Member State shall be exhaustive.

The methodology to calculate the packaging waste generated shall be based on the following approaches:

(a) the packaging made available on the territory of a Member State, or unpacked by a producer without being an end user, in that specific year; or

(b) the quantity of packaging waste generated in the same year in that Member State.

Calculations performed pursuant to this paragraph shall be adjusted to ensure the comparability, reliability and exhaustiveness of the results in accordance with the requirements and verifications to be established by the implementing act adopted pursuant to Article 56(7), point (a).

3.

Member States shall calculate the weight of packaging waste recycled in a given calendar year. The weight of packaging waste recycled shall be calculated as the weight of packaging that has become waste which, having undergone all necessary checking, sorting and other preliminary operations to remove waste materials that are not targeted by the subsequent reprocessing and to ensure high-quality recycling, enters the recycling operation whereby waste materials are actually reprocessed into products, materials or substances.

4.

Composite packaging and other packaging composed of more than one material shall be calculated and reported per material contained in the packaging. Member States may derogate from this requirement where a given material constitutes an insignificant part of the packaging unit, and in no case more than 5 % of the total mass of the packaging unit.

5.

For the purposes of paragraph 3, the weight of packaging waste recycled shall be measured when the waste enters the recycling operation.

By way of derogation from the first subparagraph of this paragraph, the weight of the packaging waste recycled may be measured at the output of any sorting operation provided that:

(a) such output waste is subsequently recycled;

(b) the weight of materials or substances that are removed by further operations preceding the recycling operation and are not subsequently recycled is not included in the weight of waste reported as recycled.

6.

Member States shall establish an effective system of quality control and traceability of the packaging waste to ensure that the conditions laid down in paragraphs 2 to 5 of this Article are met. That system may consist of electronic registries set up pursuant to Article 35(4) of Directive 2008/98/EC or technical specifications for the quality requirements of sorted waste. It may also consist of average loss rates for sorted waste for various waste types and waste management practices, respectively, provided that reliable data cannot be otherwise obtained. Average loss rates shall be calculated on the basis of the calculation rules established in the delegated act adopted pursuant to Article 11a(10) of Directive 2008/98/EC.

7.

The quantity of biodegradable packaging waste that enters aerobic or anaerobic treatment may be counted as recycled where that treatment generates compost, digestate, or other output with a similar quantity of recycled content in relation to input, which is to be used as a recycled product, material or substance. Where the output is used on land, Member States may count it as recycled provided that this use results in benefits to agriculture or ecological improvement.

8.

The quantity of packaging waste materials that have ceased to be waste as a result of a preparatory operation before being reprocessed may be counted as recycled provided that such materials are destined for subsequent reprocessing into products, materials or substances to be used for the original or other purposes. However, end-of-waste materials to be used as fuels or other means to generate energy, or to be incinerated, backfilled or landfilled, shall not be counted as recycled.

9.

Member States may take into account the recycling of metals separated after incineration of waste in proportion to the share of the packaging waste incinerated provided that the recycled metals meet the quality criteria laid down in Decision (EU) 2019/1004.

10.

Where packaging waste is sent to another Member State for the purposes of recycling in that other Member State, only the Member State in which that packaging waste was collected may count it as recycled.

11.

Packaging waste exported from the Union shall be counted as recycled by the Member State in which it was collected only if the requirements set out in paragraph 3 are met and if, in accordance with Regulation (EC) No 1013/2006 or Regulation (EU) 2024/1157, as applicable, the exporter provides documentary evidence that the shipment of waste complies with the requirements of that Regulation, including that the treatment of packaging waste in a third country took place under conditions that are equivalent to the requirements of the relevant Union environmental law.

Article 54
Rules on the calculation of the achievement of the recycling targets by including re-use
1.

A Member State may decide to achieve an adjusted level of the targets set out in Article 52(1) for a given year by taking into account the average share, in the preceding 3 years, of reusable sales packaging placed on the market for the first time and re-used within a re-use system.

The adjusted level shall be calculated by subtracting:

(a) from the targets laid down in Article 52(1), points (a) and (c), the share of the reusable sales packaging referred to in the first subparagraph of this paragraph in all sales packaging placed on the market; and

(b) from the targets laid down in Article 52(1), points (b) and (d), the share of the reusable sales packaging referred to in the first subparagraph of this paragraph, composed of the respective packaging material, in all sales packaging composed of that material placed on the market.

No more than five percentage points of the average share of reusable sales packaging shall be taken into account for the calculation of the adjusted target level.

2.

A Member State may take into account the quantity of wooden packaging that is repaired for re-use in the calculation of the targets laid down in Article 52(1), point (a), Article 52(1), point (b)(ii), Article 52(1), point (c), and Article 52(1), point (d)(ii).

Section 7

Information and reporting

Article 55
Information on prevention and management of packaging waste
1.

In addition to the information referred to in Article 8a(2) of Directive 2008/98/EC and in Article 12 of this Regulation, producers or, where entrusted with carrying out extended producer responsibility obligations in accordance with Article 46(1) of this Regulation, producer responsibility organisations, or public authorities appointed by Member States when applying Article 8a(2) of Directive 2008/98/EC, shall make available to end users, in particular consumers, the following information regarding the prevention and management of packaging waste with respect to the packaging that the producers supply on the territory of a Member State:

(a) the role of end users in contributing to waste prevention, including any best practices;

(b) re-use arrangements available for packaging;

(c) the role of end users in contributing to the separate collection of packaging waste materials, including handling of packaging containing hazardous products or waste;

(d) the meaning of the labels and symbols affixed, printed or engraved on packaging in accordance with Article 12 of this Regulation or present in the documents accompanying the packaged product;

(e) the impact of inappropriate discarding of packaging waste, for example as litter or in mixed municipal waste, on the environment and on human health or the safety of persons and the adverse environmental impact of single-use packaging, in particular plastic carrier bags;

(f) the composting properties and appropriate waste management options for compostable packaging in accordance with Article 9(2) of this Regulation; consumers shall be informed that compostable packaging is not suitable for home composting and that compostable packaging is not to be discarded in nature.

Obligations under the first subparagraph, point (d) of this paragraph shall apply from 12 August 2028 or from the date of application of the relevant provision of Article 12, whichever is the latest.

2.

The information referred to in paragraph 1 shall be up to date and provided by means of:

(a) a website or other means of electronic communication;

(b) public information;

(c) education programmes and campaigns;

(d) signposting in one or more languages which can be easily understood by end users and consumers.

3.

Where information is provided publicly, the confidentiality of commercially sensitive information in accordance with the relevant Union and national law shall be preserved.

Article 56
Reporting to the Commission
1.

Member States shall submit the following data to the Commission for each calendar year:

(a) data on the implementation of Article 52(1), points (a) to (d), and data pursuant to Table 2 of Annex XII on reusable packaging;

(b) the annual consumption of very lightweight plastic carrier bags, lightweight plastic carrier bags, thick plastic carrier bags and very thick plastic carrier bags per capita, separately for each category as listed in Table 4 of Annex XII;

(c) the separate collection rate of packaging as listed in Table 5 of Annex XII covered by the obligation to establish deposit and return systems set out in Article 50(2).

Member States may also provide data on the annual consumption of carrier bags of other materials.

2.

Member States shall submit the following data to the Commission for each calendar year:

(a) the quantity of packaging made available for the first time on the territory of that Member State, or unpacked by a producer without being an end user, for each packaging category as listed in Table 3 of Annex XII;

(b) the quantity of collected packaging waste for each packaging material as referred to in Article 52;

(c) the quantity of recycled packaging waste and recycling rates for each packaging category as listed in Table 3 of Annex XII.

3.

The first reporting year shall concern:

(a) with respect to the obligations laid down in paragraph 1, points (a) and (b), and paragraph 2, the second full calendar year after the entry into force of the implementing act that establishes the format for reporting to the Commission, in accordance with paragraph 7;

(b) with respect to the obligation laid down in paragraph 1, point (c), the calendar year 2028.

4.

Member States shall submit the data referred to in paragraphs 1 and 2 electronically within 19 months of the end of the reporting year for which the data are collected in the format established by the Commission in accordance with paragraph 7.

5.

The data submitted by Member States in accordance with this Article shall be accompanied by a quality check report. That quality check report shall be presented in the format established by the Commission in accordance with paragraph 7.

6.

The data submitted by Member States in accordance with this Article shall be accompanied by a report on the application of Article 53(7) and (11), and shall include detailed information about the average loss rates where applicable.

7.

The Commission shall, by 12 February 2027, adopt implementing acts establishing:

(a) rules for the calculation, verification and submission of data in accordance with paragraph 1, points (a) and (c), and paragraph 2, including the methodology for determining the quantity of packaging waste generated, and the format for the submission of those data;

(b) the methodology for the calculation of the annual consumption of lightweight plastic carrier bags per capita referred to in paragraph 1, point (b), and the format for the submission of those data;

(c) the correction factor referred to in Article 43(2) to account for the increase or decrease in tourism in relation to the base year.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 65(2).

8.

Member States shall require that system operators of re-use systems and all economic operators making packaging available in the Member States provide competent authorities with accurate and reliable data allowing Member States to fulfil their reporting obligations under this Article, taking into account, where relevant, particular problems faced by small and medium-sized enterprises with regard to the provision of detailed data.

Article 57
Packaging databases
1.

By 12 months from the date of adoption of the implementing acts referred to in Article 56(7), Member States shall take the necessary measures to ensure that databases on packaging and packaging waste are established, where not already in place, on a harmonised basis, for the purpose of fulfilling their reporting obligations laid down in Article 56.

2.

The databases referred to in paragraph 1 shall include the following:

(a) information on the magnitude, characteristics and evolution of the packaging and packaging waste flows at the level of individual Member States;

(b) the data listed in Annex XII.

3.

The packaging databases shall be accessible to the wider public in a machine-readable format that allows access to up-to-date data regarding reporting and cost of packaging waste management and that ensures interoperability and the re-use of data. They shall be provided in the official language or languages of the Member State concerned by means of:

(a) a website or other means of electronic communication; or

(b) public reports.

The requirements referred to in the first subparagraph shall be without prejudice to commercially sensitive information or data protection laws.

CHAPTER IX

SAFEGUARD PROCEDURES

Article 58
Procedure for dealing with packaging presenting a risk at national level
1.

Without prejudice to Article 19 of Regulation (EU) 2019/1020, where the market surveillance authorities of a Member State have sufficient reason to believe that packaging covered by this Regulation presents a risk to the environment or human health, they shall, without undue delay, carry out an evaluation in relation to the packaging concerned covering all requirements laid down in this Regulation that are relevant to that risk. The relevant economic operators shall cooperate as necessary with the market surveillance authorities.

For the purposes of the first subparagraph, the authorities responsible for the enforcement of this Regulation shall follow up on complaints or reports related to alleged non-compliance of packaging with this Regulation, and verify that the appropriate corrective action has been taken.

Where, in the course of the evaluation carried out pursuant to the first subparagraph, the market surveillance authorities find that the packaging does not comply with the requirements laid down in this Regulation, they shall, without delay, require the relevant economic operator to take appropriate and proportionate corrective measures, within a period prescribed by the market surveillance authorities which is reasonable and commensurate with the nature and, where relevant, the degree of the non-compliance, to bring the packaging into compliance with those requirements.

2.

By way of derogation from paragraph 1, where there is a risk to human health relating to contact-sensitive packaging that is subject to a specific law aimed at protecting human health and that risk is transferred to the packaged content of the packaging material, the market surveillance authorities shall not carry out an evaluation in relation to the risk to human or animal health originating from the packaging material. Instead, they shall alert the authorities competent for evaluating such risks, namely the competent authorities referred to in Regulations (EU) 2017/625, (EU) 2017/745, (EU) 2017/746 or (EU) 2019/6 or Directive 2001/83/EC.

3.

Where the market surveillance authorities consider that non-compliance is not restricted to their territory, they shall inform the Commission and the other Member States of the results of the evaluation and of the actions which they have required the economic operator to take.

4.

The economic operator shall ensure that all appropriate corrective measures are taken in respect of all the non-compliant packaging that the economic operator has made available on the market throughout the Union.

5.

Where the economic operator does not take adequate corrective measures within the period referred to in paragraph 1, third subparagraph, or the non-compliance persists, the market surveillance authorities shall take all appropriate provisional measures to prohibit the making available of the packaging on their territory, to withdraw it or to recall it.

The market surveillance authorities shall inform the Commission and the other Member States of those measures without delay.

6.

The information to be sent to the Commission and the other Member States pursuant to paragraph 5 of this Article shall be communicated through the information and communication system referred to in Article 34 of Regulation (EU) 2019/1020 and shall include all available details, in particular the data necessary for the identification of the non-compliant packaging, the origin of the packaging, the nature of the alleged non-compliance and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the economic operator and, where applicable, the information referred to in Article 61(1) of this Regulation. The market surveillance authorities shall also indicate whether the non-compliance is due to either of the following:

(a) failure of the packaging to meet the sustainability requirements laid down in or pursuant to this Regulation;

(b) shortcomings in the harmonised standards or common specifications referred to in Articles 36 and 37 of this Regulation.

7.

Member States other than the Member State taking the measures pursuant to paragraph 5 shall, without delay, inform the Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the packaging concerned, and, in the event that Member States object to the measures taken pursuant to paragraph 5, of their objections.

8.

Where, within 3months of receipt of the information referred to in paragraph 5 or 7 no objection has been raised either by a Member State or the Commission in respect of provisional measures taken by a Member State, those measures shall be considered justified.

Member States may provide for a longer or shorter period of application for provisional measures than 3months in order to take account of the specificities of the requirements concerned.

9.

Member States shall ensure that the packaging is withdrawn from their market or that other appropriate restrictive measures are taken without delay in respect of the packaging or the manufacturer concerned.

Article 59
Union safeguard procedure
1.

Where, on completion of the procedure set out in Article 58(5) and (6), objections are raised against a measure taken by a Member State pursuant to Article 58, or where the Commission considers a national measure to be contrary to Union law, the Commission shall, without delay, enter into consultation with the Member States and the relevant economic operator and shall evaluate the national measure. On the basis of the results of that evaluation, the Commission shall adopt an implementing act determining whether the national measure is justified.

That implementing act shall be adopted in accordance with the examination procedure referred to in Article 65(2).

2.

The Commission shall address the implementing act referred to in paragraph 1 to all Member States and shall communicate it to them and the relevant economic operator without delay.

If the national measure is considered justified, all Member States shall take the necessary measures to ensure that the non-compliant packaging is withdrawn from their market, and shall inform the Commission accordingly.

If the national measure is considered unjustified, the Member State concerned shall withdraw that measure.

3.

Where the national measure is considered justified and the non-compliance of the packaging is attributed to shortcomings in the harmonised standards referred to in Article 36 of this Regulation, the Commission shall apply the procedure provided for in Article 11 of Regulation (EU) No 1025/2012.

4.

Where the national measure is considered justified and the non-compliance of the packaging is attributed to shortcomings in the common technical specifications referred to in Article 37, the Commission shall, without delay, amend or repeal the common technical specifications concerned.

Article 60
Compliant packaging which presents a risk
1.

Where, having carried out an evaluation under Article 58, a Member State finds that although packaging is in compliance with the applicable requirements laid down in or pursuant to Articles 5 to 12, it nevertheless presents a risk to the environment or human health, it shall, without delay, require the relevant economic operator to:

(a) take all appropriate measures, within a reasonable period prescribed by the market surveillance authorities and commensurate with the nature and, where relevant, the degree of risk, to ensure that the packaging concerned, when placed on the market, no longer presents that risk;

(b) bring the packaging into conformity;

(c) withdraw the packaging from the market; or

(d) recall the packaging.

2.

By way of derogation from paragraph 1, where there is a risk to human health relating to contact-sensitive packaging that is subject to a specific law aimed at protecting human health and that risk is transferred to the packaged content of the packaging material, the surveillance authorities shall not carry out an evaluation in relation to the risk to human or animal health originating from the packaging material. Instead, they shall alert the authorities competent for controlling such risks, namely the competent authorities referred to in Regulations (EU) 2017/625, (EU) 2017/745, (EU) 2017/746 or (EU) 2019/6 or Directive 2001/83/EC.

3.

The economic operator shall ensure that corrective measures are taken in respect of all the non-compliant packaging that the economic operator has made available on the market throughout the Union.

4.

The Member State shall immediately inform the Commission and the other Member States of its findings and subsequent actions pursuant to paragraph 1. That information shall include all available details, in particular the data necessary for the identification of the non-compliant packaging, the origin and the supply chain of the packaging, the nature of the risk involved and the nature and duration of the national measures taken.

5.

The Commission shall, without delay, enter into consultation with the Member State and the relevant economic operator and shall evaluate the national measures taken. On the basis of the results of that evaluation, the Commission shall adopt an implementing act determining whether the national measure is justified and, where necessary, propose appropriate measures.

That implementing act shall be adopted in accordance with the examination procedure referred to in Article 65(2).

On duly justified imperative grounds of urgency relating to the protection of the environment or human health, the Commission shall adopt an immediately applicable implementing act in accordance with the procedure referred to in Article 65(3).

The Commission shall address the implementing act referred to in this paragraph to all Member States and shall immediately communicate it to them and the relevant economic operator.

Article 61
Controls on packaging entering the Union market
1.

Market surveillance authorities shall, without delay, communicate to the authorities designated pursuant to Article 25(1) of Regulation (EU) 2019/1020 the measures referred to in Article 58(5) of this Regulation where the non-compliance is not restricted to their territory. That communication shall include all relevant information, in particular the details necessary for the identification of the non-compliant packaging to which the measures apply and, in the case of a packaged product, the product itself.

2.

The authorities designated pursuant to Article 25(1) of Regulation (EU) 2019/1020 shall use the information communicated pursuant to paragraph 1 of this Article for carrying out their risk analysis under Article 25(3) of Regulation (EU) 2019/1020.

3.

The communication of information referred to in paragraph 1 shall take place through entering the information in the relevant customs risk management environment.

4.

The Commission shall develop an interconnection to automate the communication referred to in paragraph 1 of this Article from the information and communication system referred to in Article 58(6) to the environment referred to in paragraph 3 of this Article. That interconnection shall start operating no later than 24 months from the date of the adoption of the implementing act referred to in paragraph 5 of this Article.

5.

The Commission is empowered to adopt implementing acts specifying the procedural rules and the details of the implementation arrangements for paragraph 4 including the functionalities, data elements and data processing, as well as the rules on the processing of personal data, confidentiality and controllership for the interconnection referred to in paragraph 4.

Those implementing acts shall be adopted in accordance with the examination procedure pursuant to Article 65(2).

Article 62
Formal non-compliance
1.

Where a Member State becomes aware of any of the following circumstances, it shall require the relevant economic operator to put an end to the non-compliance concerned:

(a) the EU declaration of conformity has not been drawn up;

(b) the EU declaration of conformity has not been drawn up correctly;

(c) the QR code or data carrier referred to in Article 12 do not provide access to the information required in accordance with that Article;

(d) the technical documentation referred to in Annex VII is not available, is not complete or contains errors;

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