Commission Regulation (EU) 2022/1616 of 15 September 2022 on recycled plastic materials and articles intended to come into contact with foods, and repealing Regulation (EC) No 282/2008 (Text with EEA relevance)

Type Regulation
Publication 2022-09-20
Last updated 2025-12-03
State In force
Department European Commission, SANTE
Source EUR-Lex
articles 34
Reform history JSON API

Article 27

Official controls of recycling installations

Official controls of recycling installations and recyclers shall include in particular audits in accordance with Article 14, point (i), of Regulation (EU) 2017/625.

These audits shall be complemented by:

  • (a) an assessment of procedures on good manufacturing practices in accordance with Article 14, point (d), of Regulation (EU) 2017/625;
  • (b) an examination in accordance with Article 14, points (a) and (e), of Regulation (EU) 2017/625, of the compliance monitoring summary sheet established in accordance with Article 26, and, on the basis of that summary sheet, of the controls that operators have put in place and of documents and records referred to in that summary sheet.

Article 28

Non-compliance of recycled plastic
1.

A competent authority shall establish that a batch of recycled plastic is non-compliant if it finds during official controls that:

  • (a) a recycler has placed it on the market without appropriate documentation or labelling;
  • (b) a recycler cannot demonstrate on the basis of its records and other documentation that it was manufactured in accordance with this Regulation;
  • (c) the batch was manufactured at a recycling installation that was not operated in accordance with this Regulation during a period established in accordance with paragraph 3.
2.

When one or more batches are established as non-compliant, the competent authority shall take appropriate action in accordance with Article 138 of Regulation (EU) 2017/625.

3.

The operation of a recycling installation shall be considered not in accordance with this Regulation when the competent authority establishes that:

  • (a) at least two batches are non-compliant on the basis of paragraph 1, point (b), due to deficiencies in the operation of the recycling installation, and that these deficiencies due to their nature are likely to affect other batches,
  • (b) the manufacturing of recycled plastic at the recycling installation is not in accordance with the general requirements laid down in this Regulation and, where relevant, the specific requirements applicable to the suitable recycling technology applied and the recycling process used, or with the requirements applicable to the novel technology applied, or,
  • (c) where relevant, it could not verify the compliance monitoring summary sheet in accordance with Article 24(3) within 1 year from the start date of the production of recycled plastic in the decontamination installation.

When the competent authority establishes that the operation of a recycling installation is not in accordance with this Regulation, the competent authority shall establish the period during which it was the case, taking account of any available evidence or the lack thereof. In case of the first subparagraph, point (c), this shall be the entire period of operation of the recycling installation.

4.

In case the competent authority considers changes are necessary to the recycling installation, the use of a decontamination installation part thereof may be suspended. If this suspension is expected to be longer than 2 months, the suspension shall be indicated in the Union Register in accordance with Article 24(2)(g).

CHAPTER VIII COMPLIANCE DOCUMENTATION

Article 29

Specific requirements for declarations of compliance for recyclers and converters
1.

Recyclers shall provide a declaration of compliance in accordance with the description and template set out in Part A of Annex III.

2.

The declaration of compliance shall include instructions to converters that are sufficient for ensuring that converters can further process the recycled plastic into recycled plastic materials and articles that are in compliance with Article 3 of Regulation (EC) 1935/2004. These instructions shall be based on the specifications, requirements or restrictions set out for the recycling technology applied and, where applicable, the recycling process used.

3.

Converters shall provide a declaration of compliance in accordance with the description and the template set out in Part B of Annex III;

CHAPTER IX FINAL PROVISIONS

Article 30

Repeal

Regulation (EC) No 282/2008 is repealed.

Article 31

Transitional provisions
1.

Recycled plastic materials and articles obtained by means of a recycling process based on a suitable recycling technology for which this Regulation requires the individual authorisation of recycling processes and for which a valid application has been submitted to the competent authority in accordance with Article 5 of Regulation (EC) No 282/2008, or for which an application is submitted in accordance with Articles 17(1) or 22(1) of this Regulation at the latest on 10 July 2023 may be placed on the market until the applicant withdraws its application, or until the Commission adopts a decision granting or refusing authorisation of the recycling process pursuant to Article 19(1).

2.

Applications submitted in accordance with Regulation (EC) No 282/2008 for the authorisation of recycling processes based on a recycling technology that is not included as a suitable recycling technology in Annex I at the time of entry into force of this Regulation and for product loops which are in a closed and controlled chain shall be deemed terminated.

3.

Recycled plastic materials and articles obtained by means of recycling processes based on a recycling technology that is not considered suitable by this Regulation may continue to be placed on the market only until 10 July 2023, unless manufactured with a recycling installation that is operated for the purpose of development of a novel technology in accordance with Chapter IV.

4.

For the purposes of this Regulation, the start date of a decontamination installation that was used to produce recycled plastic before 10 October 2022 shall be 10 December 2022 for a decontamination installation which is based on a suitable recycling technology, or 10 June 2023 for a decontamination installation that is operated for the purpose of development of a novel technology in accordance with Chapter IV.

5.

By derogation to the time limit specified in Article 10(2), developers of technologies already in use to manufacture recycled plastic materials and articles before 10 October 2022 shall provide the information required in accordance with Article 10(3) and publish the report required in accordance with Article 10(4) before 10 April 2023. The time limit of 5 months referred to in the first subparagraph of Article 10(8) shall apply from the date on which the competent authority receives the information in accordance with Article 10(3). The possibility for a competent authority to delay the start of the operation of the first decontamination installation set out in the second sub-paragraph of Article 10(8) shall not apply.

6.

Food business operators may use recycled plastic materials and articles legally placed on the market to pack food and place that on the market until exhaustion of stocks.

Article 32

Specific transitional provisions applicable to the manufacture of materials and articles in which the recycled plastic is used behind a functional barrier
1.

The following additional requirements shall apply to the operation of recycling installations that already manufactured recycled plastic materials and articles in which the recycled plastic is used behind a plastic functional barrier before 10 October 2022:

  • (i) the decontamination installation manufacturing the recycled plastic as well as any post-processing installation adding the functional barrier is included in a list of installations submitted by a developer notifying the specific recycling technology applied by all the installations on the list in accordance with Article 10(2); and,
  • (ii) results from migration tests, challenge tests, and/or migration modelling, as appropriate and applicable to the notified recycling technology and to the specifics of the process that the recycling installation applies, unequivocally show that the functional barrier is capable, taking into account the contamination level of the recycled plastic, of acting as a functional barrier in accordance with Regulation (EU) No 10/2011 during the foreseeable shelf-life of the manufactured recycled plastic materials and articles, which comprises the time from their manufacture onwards, and the maximum shelf-life of the packaged food, if any.

The developer shall communicate the list referred to in point (i) and a study report incorporating the test results required under point (ii) to the competent authority and to the Commission before 10 April 2023. A robust summary of the study shall be part of the initial report published in accordance with Article 10(4).

2.

Individual recyclers, converters or other operators participating in the manufacture of the materials referred to in paragraph 1 shall not act as developer in accordance with point (i) thereof. In case the developer of a specific technology is the individual recycler, converter or other operator using the installation or part thereof, or may not be identified, does no longer exist or is not willing to assume the obligations laid down in this Regulation, at least one of the operators using the installation shall join a consortium or association that can act as developer on its behalf, or ask an independent third party to act as developer. Where a consortium, association or third party receives multiple requests from such operators, it shall group these requests on the basis of the technical equivalence of the applied recycling installations and processes with the purpose to minimise the number of technologies it notifies.

3.

By derogation to Article 13(1), recyclers operating decontamination installations notified by the same developer may agree to monitor the contamination levels in only a third of the installations included in the list provided in accordance with point (i) of paragraph 1, provided that the installations where the monitoring is carried out are designated on that list, monitoring is carried out at all recycling facilities, and the robustness of the overall sampling strategy is not reduced.

Article 33

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Article 6 (3)(c) and 13(2) shall apply from 10 October 2024.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEX I

Suitable Recycling technologies as referred to in Article 3

Table 1 contains the following information:

  • Column 1: number assigned to the recycling technology;
  • Column 2: name of the recycling technology;
  • Column 3: types of polymer that the recycling technology allow to recycle;
  • Column 4: short description of the recycling technology and reference to a detailed description in Table 3;
  • Column 5: the type of input that the recycling technology can decontaminate, where
  • — PCW: ‘post-consumer waste’ means plastic waste collected in accordance with Article 6;
  • — FG: ‘food-grade’ means plastic that was as primary material compliant with Regulation (EU) No 10/2011;
  • — ‘Non-food PCW’ means packaging that was not used to package food and may not have been manufactured in full compliance with Regulation (EU) No 10/2011 and other post-consumer plastic materials which were not intended for contact with food;
  • — ‘Non-food %’ (% w/w) means the maximum amount of non-food PCW present in the input;
  • Column 6: the type of output manufactured with the recycling technology;
  • Column 7: if ‘yes’ is indicated in column 7, individual recycling processes shall be authorised in accordance with Articles 17 to 19;
  • Column 8: reference to Table 4 on specifications and requirements applicable to the use of the technology in accordance with Article 4(4)(b), supplementing the requirements in Article 6 to 8;
  • Column 9: derogations from Articles 6 to 8 in accordance with Article 4(4)(b), and derogations from Article 9(8);
  • Column 10: if ‘yes’ is indicated in column 10, the recycling technology shall only be used as part of a recycling scheme in accordance with Article 9 Table 1 List of suitable recycling technologies (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) Recycling technology number Technology name Polymer type (detailed specification in Table 2) Short description of the recycling technology (detailed specification in Table 3) Specification of plastic input Specification of output Subject to the authorisation of individual processes Specifications and requirements (reference to Table 4) Derogations (reference to Table 5) Recycling scheme applies 1 Post-consumer mechanical PET recycling PET (2.1) Mechanical recycling (3.1) Only PET PCW containing maximum 5 % of materials and articles that were used in contact with non-food materials or substances. Decontaminated PET, final materials and articles not to be used in microwave and conventional ovens; additional specifications may apply to output from individual processes Yes - - No 2 Recycling from product loops which are in a closed and controlled chain All polymers manufactured as primary materials in compliance with Regulation (EU) No 10/2011 Basic cleaning and microbiological decontamination during remoulding (3.2) Chemically uncontaminated plastic materials and articles produced from a single polymer or from compatible polymers which were used or intended for use under the same conditions of use and solely obtained from a product loop which is in a closed and controlled chain, and excludes collection from consumers Remoulded materials and articles intended to be used for the same purpose and under the same conditions of use as the materials and articles circulated in the recycling scheme from which the plastic input was obtained. No 4.1 - Yes Table 2 Detailed specification of polymers Reference number Acronym Resin number and/or Recycling symbol, if any [^E0005] Detailed specification for the purposes of this Regulation 2.1 PET 1 polyethylene terephthalate polymer made by the polycondensation of the comonomers ethylene glycol and terephthalic acid or dimethyl terephthalate, of which the polymeric backbone contains up to 10 % w/w other comonomers listed in Table 1 of Annex I to Regulation (EU) No 10/2011, such as isophthalic acid and diethyleneglycol (1) As defined in Decision 97/129/EC, ASTM D7611 or GB/T 16288-2008. Table 3 Detailed description of the decontamination technology Reference number Name Detailed description 3.1 Mechanical recycling This recycling technology recovers collected plastics via mechanical and physical processes, typically sorting, grinding, washing, separating materials, drying, and re-crystallisation to produce plastic input which retains the chemical identity of the collected plastic. The critical stage of this recycling technology is the decontamination during which the plastic input is subjected for at least a minimum time to heat, and a vacuum or flowing gas, in order to remove incidental contamination down to a level that is without health concern. This stage may be followed by further recycling and conversion stages, such as filtration, re-granulation, compounding, extrusion and moulding stages. The use of this recycling technology retains the polymeric chains that constitute the plastic, and may increase their molecular weight. A small unintentional decrease in molecular weight may also occur. 3.2 Recycling from product loops which are in a closed and controlled chain A recycling technology that recycles plastic input only originating from entities participating in closed cycles consisting of manufacturing, distribution or catering stages, and which participate in a recycling scheme in accordance with Article 9. Plastic input originates only from materials and articles that are intended and used for food contact, and any contamination other than surface residues from food and labelling, can be ruled out. The plastic input may contain shredded materials and articles, as well as off-cuts and scraps from the production of plastic materials and articles. The scheme excludes the collection of materials and articles as plastic input if these have been provided to consumers for use outside of the premises and/or control of the entities participating in the recycling scheme. The decontamination technology applied as part of this recycling technology provides for microbiological decontamination by high temperature during remoulding preceded by basic surface cleaning by washing or other means suitable for preparing the material for remoulding. In addition it may add new plastic to prevent quality loss of the recycled plastic that would make it unsuitable for the use that it was intended for. The recycled plastic is used only for manufacturing plastic materials and articles for contact with the same foods and under the same conditions as the collected materials and articles were intended for, and for which compliance to Regulation (EU) No 10/2011 was initially verified. Table 4 Specifications and requirements applicable to the use of the technology in accordance with Article 4(4) Reference number Specifications/requirements 4.1 (a) the technology and its operation shall fully correspond with the description provided in point 3.2 of Table 3; (b) where materials are subject to re-use within the distribution chain, without recycling operations, they shall be cleaned regularly and sufficiently to prevent the build-up of residues originating from food, usage and labelling; (c) the use, re-use, cleaning in accordance with point (b), and recycling shall be implemented in a way designed to prevent incidental contamination of the plastic input that cannot be removed with surface cleaning; (d) the use of any labelling or printing on the plastic materials and articles which cannot be fully removed with the cleaning applied before remoulding shall be excluded; (e) the document provided in accordance with article 9(3) shall provide explicit instructions and procedures to food business operators participating in the recycling scheme to prevent the introduction of external material and incidental contamination; (f) the plastic input and the recycled plastic shall at all times fully comply with Regulation (EU) No 10/2011; accumulation of constituents of the plastic material, present due to repeated recycling, such as residues of additives, or degeneration products, shall be considered non-intentionally added substances in accordance with Article 6(4)(a) of Regulation (EU) No 10/2011. Their presence shall not exceed a level that is regarded as unsafe in a risk assessment in accordance with article 19 of that Regulation. Where needed to ensure the quality of the recycled plastic materials and articles, new plastic manufactured in accordance with that Regulation shall be added; (g) there is documented scientific evidence demonstrating that the plastic materials and articles recycled as part of the scheme do not pose a risk to human health due to: — accumulation of constituents of the plastic material, such as residues of additives, or degeneration products resulting from repeated recycling; or — the presence of common residues from other sources such as food, detergents and labelling Table 5 Derogations applicable to the use of the technology in accordance with Article 4(5) Reference number Specifications/requirements

ANNEX II

Template for the Compliance Monitoring Summary Sheet in accordance with Article 26 of Regulation (EU) 2022/1616

The template shall be completed taking account of the definitions set out in Regulation (EC) No 2023/2006 on good manufacturing practices, and Annex B thereto.

Abbreviations used in this document in accordance with Regulation (EC) No 2023/2006:

QA : Quality Assessment
--- --- ---
SOP : Standard Operating Procedure
--- --- ---
SOP code : a SOP code is comprised of two numbers, the number of the SOP and the number of the document in which it is described in the format SOPNr – DocNr; the document number shall correspond to the document number listed in Section 2.3, the SOP number to the numbering system of the recycler.

1. SECTION 1: IDENTIFICATION

The numbers (RIN, RFN, RON, RAN, NTN) referred to in this section shall correspond to the numbers in the Union Register laid down in accordance with Article 24 of Regulation (EU) 2022/1616.

1.1   Identification of the recycling installation
Installation name
Applied recycling technology in accordance with Annex I
EU Register number (recycling installation number, ‘RIN’)
Facility Address
Recycling Facility Number (‘RFN’)
Contact details
Position/Role of contact persons
Relevant national register numbers, if any
Notification date (Article 25(1)(a))
1.2.   Identification of the recycler
Company Name
EU Register number (Recycler Operator Number, ‘RON’)
Address of the head office
Contact details
Position/Role of main contact person
Relevant national register numbers, if any
Authorisation holder? (Yes/No/Not applicable)
1.3.   Recycling process authorisation Decision or novel technology
A: identification of the authorisation Decision or novel technology used by the process that the installation applies:
EU Register number, i.e. Recycling Process Authorisation Number (‘RAN’), Novel Technology Number (‘NTN’)
B: authorisation holder or novel technology developer
Name of authorisation holder [^E0006]/ of the technology developer [^E0007] as applicable
Address
Contact details
Position/Role

The name of the authorisation holder and its address must be the same as on the authorisation Decision.

The technology developer that notified the novel technology used by the process which the installation applies, in accordance with Article 10(2).

1.4.   Document references used by the European Food Safety Authority (‘EFSA’)
EFSA Question number
EFSA Publication date of the opinion
EFSA Publication number (output number)
Confidentiality Decision number
Confidentiality Decision date
1.5.   Additional responsible person(s) for the operation of the recycling installation
Name Position/Role Contact details

2. SECTION 2: OPERATION OF THE RECYCLING INSTALLATION

2.1.   Written Statements

A maximum of 3 000 characters including spaces shall apply both to Sections 2.1.1 and 2.1.2

2.1.1   Recyclers’ statement explaining the production and quality of the recycled plastic
2.1.2.   Recycler’s statement explaining correspondence to the authorised process

This section is applicable only to authorised processes.

2.2   Recycling operations at the recycling facility

The following information shall be provided in this section:

  • — A diagram of the main manufacturing stages that are part of the recycling process and which are carried out at the recycling facility (‘site diagram’);
  • — A table describing those manufacturing stages and the material streams connecting them carried out at the recycling facility and corresponding to that diagram.
2.2.1.   Diagram of the main manufacturing stages carried out at the recycling facility (site diagram)
2.2.2.   Description of the main manufacturing stages carried out at the recycling facility and the streams connecting them
Stage Number Name Description Average Processed Tonnage per year
Stream Number Name Description Average Stream size
2.3.   Internal Documents

Provide a comprehensive list of documents relevant to the operation of the process and quality management and other administrative procedures related thereto, as well as documents related to the authorisation. The documents shall be numbered and these numbers shall be used in Section 3 to refer to these documents. The recycler may apply its own numbering system.

Document type Document Number Related production stage Title Description Date, version, author
2.4.   Batch definitions

The following batches shall be defined in accordance with the table below:

  • — Entry Batch: the unprocessed plastic entering the recycling facility from suppliers;
  • — Input Batch: input plastic processed at the facility entered at the decontamination stage;
  • — Output Batch: the recycled plastic resulting from the decontamination stage; and,
  • — Exit Batch: the recycled plastic (or recycled plastic materials and articles) leaving the facility for further processing or use.
  • — Any other intermediate batches corresponding to a QA check.

Where either the entry or input batch is the same because no further QA checks take place, only the input batch shall be defined. The same approach shall be used for the output and exit batches. Where there are different types of entry and or exit batches, these shall be defined separately, and be given a meaningful name.

The QA shall be numbered in the same way as in the site diagram (Section 2.2.1)

Batch type Internal Batch name Stream/QA No Definition/Description Typical size range Traceability rule
2.5.   Process diagram of the decontamination installation

Add a piping and instrumentation diagram in accordance with Section 4.4 of ISO 10628-1:2014, taking account of ISO 10628-2.

2.6.   Control of critical decontamination operations

The table below shall include a reference to steps, stages, or operations that EFSA identified as critical, a control criterion for each critical parameter, the involved control instruments, and the description of corrective actions in case the control criterion fails. Further information of the evaluation of complex control rules shall be added if relevant.

Critical operation (and ref to EFSA opinion) Control criterion Measuring or Control Instrument (reference to 2.5) Short description of corrective actions if control rule is not met SOP code (SOPNr – DocNr)
2.6.1.   Further information on complex control rules, where relevant
2.7.   Relevant standard operating procedure for Operation

The table below shall provide a reference to each SOP used for the operation of the installation, provide a short description thereof, and indicate the location where it is carried out.

SOP code Short description Location)

3. SECTION 3: QUALITY ASSESSMENT

3.1.   List of quality assessment stages

Each QA stage shall be described using the table below:

QA stage and number Assessment name Definition/Description Criterion Records SOP Code (SOPNr – DocNr)

There shall be at least four stages (unless there is no difference between entry and input or output and exit – see Section 2.4):

  • — entry stage (the first QA stage where the material enters the facility),
  • — input stage (where the plastic input enters the decontamination process)
  • — output stage (where the material leaves the decontamination process)
  • — exit stage (where the recycled plastic or the recycled plastic materials and articles leave the facility)

Additional intermediate stages shall be added where relevant for the quality of the material in other stages. Those intermediate stages shall be given a meaningful name.

3.2.   Relevant standard operating procedures applied at QA stages

The table below shall provide a reference to each standard operating procedure used at QA stages, provide a short description thereof, and indicate the location where it is carried out.

Quality Assessment (QA) No (ref 3.1) SOP code (SOPNr – DocNr) Short description Location (of QA)

4. SECTION 4: RECORD REPOSITORY

4.1   Quality assessment recording systems
Quality Assessment No (ref 3.1) Name Definition/Description Location Backup SOP Code (SOPNr – DocNr) Modification prevention
4.2.   List of standard operating procedures codes for recording system
Quality Assessment No (ref 3.1) SOP code (SOPNr – DocNr) Short description Location (of entry into recording system)
4.3.   Other relevant records/systems
Procedure Description/Documentation

ANNEX III

Templates for declaration of compliance

PART A

Declaration of compliance to be used by recyclers

RECYCLERS DECLARATION of COMPLIANCE with REGULATION (EU) 2022/1616 RECYCLERS DECLARATION of COMPLIANCE with REGULATION (EU) 2022/1616 RECYCLERS DECLARATION of COMPLIANCE with REGULATION (EU) 2022/1616 RECYCLERS DECLARATION of COMPLIANCE with REGULATION (EU) 2022/1616 RECYCLERS DECLARATION of COMPLIANCE with REGULATION (EU) 2022/1616 RECYCLERS DECLARATION of COMPLIANCE with REGULATION (EU) 2022/1616
I, the undersigned, declare in name of [ADD NAME OF RECYCLER] as identified in Section 1.1, that the recycled plastic material identified in Section 1.2 was produced in accordance with Regulation (EU) 2022/1616. The recycled material to which this declaration applies is suitable for use in contact with food, provided it is used in accordance with the restrictions set out Section 3 of this declaration, and with the instructions in this declaration and with the labelling on the product. Hereby I declare that the contents of this declaration is correct to the best of my knowledge and in compliance with Regulation (EU) 2022/1616. I, the undersigned, declare in name of [ADD NAME OF RECYCLER] as identified in Section 1.1, that the recycled plastic material identified in Section 1.2 was produced in accordance with Regulation (EU) 2022/1616. The recycled material to which this declaration applies is suitable for use in contact with food, provided it is used in accordance with the restrictions set out Section 3 of this declaration, and with the instructions in this declaration and with the labelling on the product. Hereby I declare that the contents of this declaration is correct to the best of my knowledge and in compliance with Regulation (EU) 2022/1616. I, the undersigned, declare in name of [ADD NAME OF RECYCLER] as identified in Section 1.1, that the recycled plastic material identified in Section 1.2 was produced in accordance with Regulation (EU) 2022/1616. The recycled material to which this declaration applies is suitable for use in contact with food, provided it is used in accordance with the restrictions set out Section 3 of this declaration, and with the instructions in this declaration and with the labelling on the product. Hereby I declare that the contents of this declaration is correct to the best of my knowledge and in compliance with Regulation (EU) 2022/1616. I, the undersigned, declare in name of [ADD NAME OF RECYCLER] as identified in Section 1.1, that the recycled plastic material identified in Section 1.2 was produced in accordance with Regulation (EU) 2022/1616. The recycled material to which this declaration applies is suitable for use in contact with food, provided it is used in accordance with the restrictions set out Section 3 of this declaration, and with the instructions in this declaration and with the labelling on the product. Hereby I declare that the contents of this declaration is correct to the best of my knowledge and in compliance with Regulation (EU) 2022/1616. I, the undersigned, declare in name of [ADD NAME OF RECYCLER] as identified in Section 1.1, that the recycled plastic material identified in Section 1.2 was produced in accordance with Regulation (EU) 2022/1616. The recycled material to which this declaration applies is suitable for use in contact with food, provided it is used in accordance with the restrictions set out Section 3 of this declaration, and with the instructions in this declaration and with the labelling on the product. Hereby I declare that the contents of this declaration is correct to the best of my knowledge and in compliance with Regulation (EU) 2022/1616. I, the undersigned, declare in name of [ADD NAME OF RECYCLER] as identified in Section 1.1, that the recycled plastic material identified in Section 1.2 was produced in accordance with Regulation (EU) 2022/1616. The recycled material to which this declaration applies is suitable for use in contact with food, provided it is used in accordance with the restrictions set out Section 3 of this declaration, and with the instructions in this declaration and with the labelling on the product. Hereby I declare that the contents of this declaration is correct to the best of my knowledge and in compliance with Regulation (EU) 2022/1616.
Section 1: Identification Section 1: Identification Section 1: Identification Section 1: Identification Section 1: Identification Section 1: Identification
1.1  Recycler 1.1  Recycler 1.2  Recycled product 1.2  Recycled product 1.3  Competent authority 1.3  Competent authority
1.1.1  Name 1.2.1  Tradename / designation 1.3.1  Name
1.1.2  FCM-RON [^E0008] 1.2.2  Batch No 1.3.2  Address
1.1.3  Country 1.2.3  FCM-RIN [^E0008] 1.3.3  Country/region
1.1.4  FCM-RFN [^E0008] 1.2.4  Other information 1.3.4  assigned Registration Number
Section 2: Compliance Section 2: Compliance Section 2: Compliance Section 2: Compliance Section 2: Compliance Section 2: Compliance
2.1  Basis for authorisation or permission to operate (tick one box only) 2.1  Basis for authorisation or permission to operate (tick one box only) 2.1  Basis for authorisation or permission to operate (tick one box only) 2.1  Basis for authorisation or permission to operate (tick one box only) 2.1  Basis for authorisation or permission to operate (tick one box only) 2.1  Basis for authorisation or permission to operate (tick one box only)
2.1.1 □ Authorisation Decision RAN [^E0008] RAN [^E0008]
2.1.2 □ Recycling scheme RSN [^E0008] RSN [^E0008]
2.1.3 □ No authorisation or recycling scheme required
2.1.4 □ Novel technology NTN [^E0008] NTN [^E0008]
2.2  Results of compliance assessment as listed in the compulsory quality assessment stages in Table 3.1 of Annex II; compulsory only if 2.1.1 ticked Important: Fields 2.2.2 to 2.2.4 may be left blank, provided field 2.2.5 is ticked 2.2  Results of compliance assessment as listed in the compulsory quality assessment stages in Table 3.1 of Annex II; compulsory only if 2.1.1 ticked Important: Fields 2.2.2 to 2.2.4 may be left blank, provided field 2.2.5 is ticked 2.2  Results of compliance assessment as listed in the compulsory quality assessment stages in Table 3.1 of Annex II; compulsory only if 2.1.1 ticked Important: Fields 2.2.2 to 2.2.4 may be left blank, provided field 2.2.5 is ticked 2.2  Results of compliance assessment as listed in the compulsory quality assessment stages in Table 3.1 of Annex II; compulsory only if 2.1.1 ticked Important: Fields 2.2.2 to 2.2.4 may be left blank, provided field 2.2.5 is ticked 2.2  Results of compliance assessment as listed in the compulsory quality assessment stages in Table 3.1 of Annex II; compulsory only if 2.1.1 ticked Important: Fields 2.2.2 to 2.2.4 may be left blank, provided field 2.2.5 is ticked 2.2  Results of compliance assessment as listed in the compulsory quality assessment stages in Table 3.1 of Annex II; compulsory only if 2.1.1 ticked Important: Fields 2.2.2 to 2.2.4 may be left blank, provided field 2.2.5 is ticked
Stage [^E0009] Decision criteria and outcome(s) Decision criteria and outcome(s) Decision criteria and outcome(s) Batch Number(s) Batch Number(s)
2.2.1  Exit
2.2.2  Entry
2.2.3  Input
2.2.4  Output
2.2.5  The undersigned confirms that the information required in fields 2.2.2 to 2.2.4 will be made available to competent authority upon its request, within 3 working days 2.2.5  The undersigned confirms that the information required in fields 2.2.2 to 2.2.4 will be made available to competent authority upon its request, within 3 working days 2.2.5  The undersigned confirms that the information required in fields 2.2.2 to 2.2.4 will be made available to competent authority upon its request, within 3 working days 2.2.5  The undersigned confirms that the information required in fields 2.2.2 to 2.2.4 will be made available to competent authority upon its request, within 3 working days □ □
Section 3: Instructions and information to users of the product Section 3: Instructions and information to users of the product Section 3: Instructions and information to users of the product Section 3: Instructions and information to users of the product Section 3: Instructions and information to users of the product Section 3: Instructions and information to users of the product
3.1 Instructions to converters Instructions to converters Instructions to converters Instructions to converters Instructions to converters
3.1.1 Maximum recycled content (w/w %) %
3.1.2 Present recycled content (w/w %) %
3.1.3 Restrictions of use [^E0010]
3.1.4 Other instructions
3.2 Instructions to users further down the supply chain, including end users Instructions to users further down the supply chain, including end users Instructions to users further down the supply chain, including end users Instructions to users further down the supply chain, including end users Instructions to users further down the supply chain, including end users
3.2.1 Restrictions of use [^E0010]
3.2.2 Summary of labelling
3.2.3 Other instructions
Section 4: Signature Section 4: Signature Section 4: Signature Section 4: Signature Section 4: Signature Section 4: Signature
4.1  Signature and company stamp 4.1  Signature and company stamp
4.2  Name of person signing 4.2  Name of person signing
4.3  Role/position of person signing 4.3  Role/position of person signing
4.4  Date and place 4.4  Date and place

RAN – recycling authorisation number; RON – recycling operator number (recyclers); RIN – recycling installation number; RSN – recycling scheme number; NTN – novel technology number; RFN – Recycling facility number.

Filling out the fields for the exit stage (the batch that is placed on the market and which is accompanied by this declaration) is compulsory. The completion of the other fields is voluntary, but in case this information is not provided by means of this declaration, it shall be made available to a competent authority, upon its request, within 3 working days.

Restrictions of use shall correspond to any applicable conditions in the field of application of the recycled plastic, in accordance with Annex I for the applied technology, Article 7, 8, or 9, the Authorisation of the recycling process, if any, or any other restriction the recycler deems necessary.

PART B

Declaration of compliance to be used by converters if the converted plastic material contains recycled plastic

CONVERTERS DECLARATION of COMPLIANCE with REGULATION (EU) 2022/1616 CONVERTERS DECLARATION of COMPLIANCE with REGULATION (EU) 2022/1616 CONVERTERS DECLARATION of COMPLIANCE with REGULATION (EU) 2022/1616 CONVERTERS DECLARATION of COMPLIANCE with REGULATION (EU) 2022/1616 CONVERTERS DECLARATION of COMPLIANCE with REGULATION (EU) 2022/1616 CONVERTERS DECLARATION of COMPLIANCE with REGULATION (EU) 2022/1616
I, the undersigned, declare in name of [ADD NAME OF CONVERTER] as identified in Section 1.1, that the recycled plastic material identified in Section 1.2 was produced in accordance with Regulation (EU) 2022/1616. The recycled material to which this declaration applies is suitable for use in contact with food, provided it is used in accordance with the restrictions set out Section 3 of this declaration, and with the instructions in this declaration and with the labelling on the product. Hereby I declare that the contents of this declaration is correct to the best of my knowledge and in compliance with Regulation (EU) 2022/1616. I, the undersigned, declare in name of [ADD NAME OF CONVERTER] as identified in Section 1.1, that the recycled plastic material identified in Section 1.2 was produced in accordance with Regulation (EU) 2022/1616. The recycled material to which this declaration applies is suitable for use in contact with food, provided it is used in accordance with the restrictions set out Section 3 of this declaration, and with the instructions in this declaration and with the labelling on the product. Hereby I declare that the contents of this declaration is correct to the best of my knowledge and in compliance with Regulation (EU) 2022/1616. I, the undersigned, declare in name of [ADD NAME OF CONVERTER] as identified in Section 1.1, that the recycled plastic material identified in Section 1.2 was produced in accordance with Regulation (EU) 2022/1616. The recycled material to which this declaration applies is suitable for use in contact with food, provided it is used in accordance with the restrictions set out Section 3 of this declaration, and with the instructions in this declaration and with the labelling on the product. Hereby I declare that the contents of this declaration is correct to the best of my knowledge and in compliance with Regulation (EU) 2022/1616. I, the undersigned, declare in name of [ADD NAME OF CONVERTER] as identified in Section 1.1, that the recycled plastic material identified in Section 1.2 was produced in accordance with Regulation (EU) 2022/1616. The recycled material to which this declaration applies is suitable for use in contact with food, provided it is used in accordance with the restrictions set out Section 3 of this declaration, and with the instructions in this declaration and with the labelling on the product. Hereby I declare that the contents of this declaration is correct to the best of my knowledge and in compliance with Regulation (EU) 2022/1616. I, the undersigned, declare in name of [ADD NAME OF CONVERTER] as identified in Section 1.1, that the recycled plastic material identified in Section 1.2 was produced in accordance with Regulation (EU) 2022/1616. The recycled material to which this declaration applies is suitable for use in contact with food, provided it is used in accordance with the restrictions set out Section 3 of this declaration, and with the instructions in this declaration and with the labelling on the product. Hereby I declare that the contents of this declaration is correct to the best of my knowledge and in compliance with Regulation (EU) 2022/1616. I, the undersigned, declare in name of [ADD NAME OF CONVERTER] as identified in Section 1.1, that the recycled plastic material identified in Section 1.2 was produced in accordance with Regulation (EU) 2022/1616. The recycled material to which this declaration applies is suitable for use in contact with food, provided it is used in accordance with the restrictions set out Section 3 of this declaration, and with the instructions in this declaration and with the labelling on the product. Hereby I declare that the contents of this declaration is correct to the best of my knowledge and in compliance with Regulation (EU) 2022/1616.
Section 1: Identification Section 1: Identification Section 1: Identification Section 1: Identification Section 1: Identification Section 1: Identification
1.1  Converter 1.1  Converter 1.2  Product with recycled plastic 1.2  Product with recycled plastic 1.3  Competent authority 1.3  Competent authority
1.1.1  Name 1.2.1  Tradename/designation 1.3.1  Name
1.1.2  Address 1.2.2  Batch No 1.3.2  Address
1.1.3  Country 1.2.4  Other info 1.3.3  Country/region
1.3.4  Reg. number
Section 2: Compliance Section 2: Compliance Section 2: Compliance Section 2: Compliance Section 2: Compliance Section 2: Compliance
2.1 2.1 2.1 2.1 2.1 2.1
2.1.1 Origin of recycled plastic; RIN numbers Origin of recycled plastic; RIN numbers Origin of recycled plastic; RIN numbers Origin of recycled plastic; RIN numbers
2.1.2 Batch numbers recycled plastic from decontamination installation Batch numbers recycled plastic from decontamination installation Batch numbers recycled plastic from decontamination installation Batch numbers recycled plastic from decontamination installation
2.1.3 Maximum recycled content indicated by recycler (Part A, 3.1.1) Maximum recycled content indicated by recycler (Part A, 3.1.1) Maximum recycled content indicated by recycler (Part A, 3.1.1) Maximum recycled content indicated by recycler (Part A, 3.1.1) % w/w
2.1.4 Actual recycled content of this product Actual recycled content of this product Actual recycled content of this product Actual recycled content of this product % w/w
2.1.5 Restrictions provided in the Declaration of compliance received from the recycler are met Restrictions provided in the Declaration of compliance received from the recycler are met Restrictions provided in the Declaration of compliance received from the recycler are met Restrictions provided in the Declaration of compliance received from the recycler are met □
2.1.6 Addition of additives or starting substances Addition of additives or starting substances □  □Added additives or starting substances comply with Regulation (EU) No 10/2011 □  □Added additives or starting substances comply with Regulation (EU) No 10/2011 □  □No additions
Section 3: Instructions and information to users of the product Section 3: Instructions and information to users of the product Section 3: Instructions and information to users of the product Section 3: Instructions and information to users of the product Section 3: Instructions and information to users of the product Section 3: Instructions and information to users of the product
3.2 Instructions to users further down the supply chain, including end users Instructions to users further down the supply chain, including end users Instructions to users further down the supply chain, including end users Instructions to users further down the supply chain, including end users Instructions to users further down the supply chain, including end users
3.2.1 The product identified in Section 1.2 is a: (tick as applicable; both may apply) The product identified in Section 1.2 is a: (tick as applicable; both may apply) (A) a recycled plastic for further conversion stages (A) a recycled plastic for further conversion stages □
3.2.1 The product identified in Section 1.2 is a: (tick as applicable; both may apply) The product identified in Section 1.2 is a: (tick as applicable; both may apply) (B) a final plastic material or article suitable for contact with food without further processing. (B) a final plastic material or article suitable for contact with food without further processing. □
3.2.2 Type or types of food with which it is intended to be put in contact Type or types of food with which it is intended to be put in contact
3.2.3 Time and temperature of treatment and storage in contact with the food Time and temperature of treatment and storage in contact with the food
3.2.4 The highest food contact surface area to volume ratio for which compliance has been verified The highest food contact surface area to volume ratio for which compliance has been verified
3.2.5 List of added substances with migration limits; add rows as required. (note: FCM Number and specific migration limit (‘SML’) may not exist for certain substances) List of added substances with migration limits; add rows as required. (note: FCM Number and specific migration limit (‘SML’) may not exist for certain substances) FCM No* Other designation (CAS No, chemical name) SML* (mg/kg food)
3.2.5 List of added substances with migration limits; add rows as required. (note: FCM Number and specific migration limit (‘SML’) may not exist for certain substances) List of added substances with migration limits; add rows as required. (note: FCM Number and specific migration limit (‘SML’) may not exist for certain substances)
3.2.5 List of added substances with migration limits; add rows as required. (note: FCM Number and specific migration limit (‘SML’) may not exist for certain substances) List of added substances with migration limits; add rows as required. (note: FCM Number and specific migration limit (‘SML’) may not exist for certain substances)
3.2.6 Other relevant information and instructions, including in accordance with points 7 and 9 of Annex IV to Commission Regulation (EU) No 10/2011 [^E0011] Other relevant information and instructions, including in accordance with points 7 and 9 of Annex IV to Commission Regulation (EU) No 10/2011 [^E0011]
3.2.7 The recycled plastic to which this declaration applies is contained in a layer in a multi-layer material or article subject respectively to Articles 13 or 14 of Regulation (EU) No 10/2011 that contains plastic manufactured in accordance with that Regulation in another layer or layers. A separate declaration of compliance in accordance with Article 15 of that Regulation regarding that layer or those layers is available and must be taken into account. The recycled plastic to which this declaration applies is contained in a layer in a multi-layer material or article subject respectively to Articles 13 or 14 of Regulation (EU) No 10/2011 that contains plastic manufactured in accordance with that Regulation in another layer or layers. A separate declaration of compliance in accordance with Article 15 of that Regulation regarding that layer or those layers is available and must be taken into account. The recycled plastic to which this declaration applies is contained in a layer in a multi-layer material or article subject respectively to Articles 13 or 14 of Regulation (EU) No 10/2011 that contains plastic manufactured in accordance with that Regulation in another layer or layers. A separate declaration of compliance in accordance with Article 15 of that Regulation regarding that layer or those layers is available and must be taken into account. The recycled plastic to which this declaration applies is contained in a layer in a multi-layer material or article subject respectively to Articles 13 or 14 of Regulation (EU) No 10/2011 that contains plastic manufactured in accordance with that Regulation in another layer or layers. A separate declaration of compliance in accordance with Article 15 of that Regulation regarding that layer or those layers is available and must be taken into account. □
Section 4: Signature Section 4: Signature Section 4: Signature Section 4: Signature Section 4: Signature Section 4: Signature
4.1  Signature and company stamp 4.1  Signature and company stamp 4.1  Signature and company stamp
4.2  Name of person signing 4.2  Name of person signing 4.2  Name of person signing
4.3  Role/position of person signing 4.3  Role/position of person signing 4.3  Role/position of person signing
4.4  Date and place 4.4  Date and place 4.4  Date and place

Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food Text with EEA relevance (OJ L 12, 15.1.2011, p. 1).

[^E0001]: Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3).

[^E0002]: Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).

[^E0003]: Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004, p. 1).

[^E0004]: Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).

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