
Article 1 

1. This Regulation shall apply to the plastic materials and articles and parts thereof intended to come into contact with foodstuffs as referred to in Article 1 of Directive 2002/72/EC which contain recycled plastic (hereafter ‘recycled plastic materials and articles’).
2. This Regulation shall not apply to the following recycled plastic materials and articles, provided that they have been manufactured according to good manufacturing practice, as laid down in Regulation (EC) No 2023/2006:
(a) recycled plastic materials and articles made with monomers and starting substances, derived from chemical depolymerization of plastic materials and articles;
(b) recycled plastic materials and articles made from unused plastic production offcuts and/or process scraps in compliance with Directive 2002/72/EC, that are recycled within the manufacturing site or are used at another site;
(c) recycled plastic materials and articles in which the recycled plastic is used behind a plastic functional barrier, as specified in Directive 2002/72/EC.
3. The plastic materials and articles that fall within the scope of this Regulation remain subject to Directive 2002/72/EC.
Article 2 

1. For the purposes of this Regulation, the definitions laid down in Regulation (EC) No 1935/2004 and Directive 2002/72/EC shall apply.
2. The following definitions shall also apply:
(a) ‘recycling process’ means a process in which plastic waste is recycled pursuant to the definition of recycling in point 7 of Article 3 of Directive 94/62/EC on packaging and packaging waste; for the purpose of this Regulation, this term is limited to processes, in which a recycled plastic is produced;
(b) ‘plastic input’ means collected and sorted post-use plastic materials and articles used as input into a recycling process;
(c) ‘product loops which are in a closed and controlled chain’ means manufacture and distribution cycles in which products circulate with a controlled reuse and distribution system, and in which the recycled material originates only from these entities in the chain, so that the unintentional introduction of external material is just the minimum technically feasible;
(d) ‘challenge test’ means a demonstration of the effectiveness of a recycling process to remove chemical contamination from plastic materials or articles;
(e) ‘converter’ means the natural or legal person responsible for ensuring that the requirements of this Regulation, as regards the recycled plastic materials and articles are met within the business under their control;
(f) ‘recycler’ means the natural or legal person responsible for ensuring that the requirements of this Regulation, as regards the recycling process are met within the business under their control.
Article 3 

1. Recycled plastic materials and articles shall only be placed on the market if they contain recycled plastic obtained only from a recycling process, authorised in accordance with this Regulation.
2. The authorised recycling process, referred to in paragraph 1 of this Article, shall be managed by an appropriate quality assurance system that ensures that the recycled plastic complies with the requirements set out in the authorisation.That quality assurance system shall comply with the detailed rules laid down in the Annex to Regulation (EC) No 2023/2006.
Article 4 
In order to be authorised, a recycling process shall comply with the following conditions:

((a)) the quality of plastic input must be characterised and controlled in accordance with pre-established criteria that ensure compliance of the final recycled plastic material and article with Article 3 of Regulation (EC) No 1935/2004;
((b)) the plastic input must originate from plastic materials and articles that have been manufactured in accordance with legislation on plastic food contact materials and articles, in particular, Council Directive 78/142/EEC of 30 January 1978 on the approximation of laws of the Member States relating to materials and articles which contain vinyl chloride monomer and are intended to come into contact with foodstuffs and Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with foodstuffs;
((c)) 
((i)) either the plastic input must originate from a product loop which is in a closed and controlled chain ensuring that only materials and articles which have been intended for food contact are used and any contamination can be ruled out; or
((ii)) it must be demonstrated in a challenge test, or by other appropriate scientific evidence that the process is able to reduce any contamination of the plastic input to a concentration that does not pose a risk to human health;
((d)) the quality of the recycled plastic must be characterised and controlled in accordance with pre-established criteria that ensure compliance of the final recycled plastic material and article with Article 3 of Regulation (EC) No 1935/2004;
((e)) there must be established conditions of use of the recycled plastic whereby it can be ensured that the recycled plastic materials and articles comply with Article 3 of Regulation (EC) No 1935/2004.
Article 5 

1. The procedure for authorisation laid down in Articles 9 and 10 of Regulation No (EC) 1935/2004 shall apply mutatis mutandis for the authorisation of recycling processes, subject to the specific provisions laid down in paragraphs 2 to 4 of this Article.
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3. The  Food Safety Authority  shall give an opinion within six months of receipt of a valid application as to whether or not the recycling process complies with the conditions laid down in Article 4.
4. In the event of an opinion in favour of authorising the evaluated recycling process, the opinion of the Authority shall include the following:
(a) a short description of the recycling process;
(b) where appropriate, any recommendations on conditions or restrictions concerning the plastic input;
(c) where appropriate, any recommendations on conditions or restrictions concerning the recycling process;
(d) where appropriate, any criteria to characterise the recycled plastic;
(e) where appropriate, any recommendations concerning conditions in the field of application of the recycled plastic;
(f) where appropriate, any recommendations concerning monitoring compliance of the recycling process with the conditions of the authorisation.
Article 6 

1. The authorisation of a recycling process must be prescribed by the appropriate authority and must contain—
(a) the name of the recycling process;
(b) the name and address of the authorisation holder;
(c) a short description of the recycling process;
(d) any conditions or restrictions concerning the plastic input;
(e) any conditions or restrictions concerning the recycling process;
(f) any characterisation of the recycled plastic;
(g) any conditions in the field of application of the recycled plastic that has been manufactured by the recycling process;
(h) any requirements concerning monitoring of the compliance of the recycling process with the conditions of the authorisation;
(i) the date from which the authorisation is effective.
2. Any converter using recycled plastic from the authorised recycling process or any business operator using materials or articles containing recycled plastic from the authorised recycling process must comply with any condition or restriction attached to such authorisation.
3. The applicant or any business operator using the recycling process must immediately inform the Food Safety Authority of any new scientific or technical information, which might affect the safety assessment of the recycling process in relation to human health. If necessary, the Food Safety Authority must review the assessment.
Article 6A 

(1.) Any power to make regulations under this Regulation—
(a) so far as exercisable by a Minister of the Crown, is exercisable by statutory instrument;
(b) so far as exercisable by the Welsh Ministers, is exercisable by statutory instrument;
(2.) For regulations made under this Regulation by the Scottish Ministers, see also section 27 of the Interpretation and Legislative Reform (Scotland) Act 2010 (Scottish statutory instruments).
(3.) Any power to make regulations under this Regulation includes power—
(a) to make different provision in relation to different cases or classes of case (including different provision for different areas or different classes of business); and
(b) to provide for such exceptions, limitations and conditions, and to make such supplementary, incidental, consequential or transitional provisions, as the appropriate authority considers necessary or expedient.
(4.) 
                      Any statutory instrument or Scottish statutory instrument  containing regulations made under this Regulation is subject to annulment in pursuance of a resolution—
(a) in the case of England, of either House of Parliament;
(b) in the case of Wales, of  Senedd Cymru;
(c) in the case of Scotland, of the Scottish Parliament;
(5.) In this Regulation, any power—
(a) of the Secretary of State to make regulations is limited to regulations which apply in relation to England only;
(b) of the Welsh Ministers to make regulations is limited to regulations which apply in relation to Wales only;
(c) of the Scottish Ministers to make regulations is limited to regulations which apply in relation to Scotland only;
Article 7 
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Article 8 

1. The applicant or any business operator using the recycling process may apply for modification of the existing authorisation in accordance with the procedure laid down in Article 5(1).
2. The application must be accompanied by the following:
(a) a reference to the original application;
(b) a technical dossier containing the new information;
(c) a new complete summary of the technical dossier in a standardised form.
3. The Food Safety Authority must evaluate whether the opinion or the authorisation is still in accordance with this Regulation. The Food Safety Authority may, where necessary, consult the applicant.
4. The appropriate authority must examine the opinion of the Food Safety Authority without delay and may prescribe amendments to the authorisation, including without limitation changes in the conditions of use and changes the restrictions attached to that authorisation.
Article 9 

1. The Food Safety Authority must establish and maintain a register of authorised recycling processes. The register must be made available to the public. Each entry in the register must include details of the restrictions or conditions prescribed in relation to the authorised recycling process.
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3. Each entry in the register shall include the information referred to in Article  6(1).
Article 10 

1. The official control of a recycling plant and converter must be performed in accordance with the rules laid down in Regulation (EC) No 882/2004 and must include in particular audits as control technique as specified in Article 10 of Regulation (EC) No 882/2004.
2. The official control must verify that the recycling process corresponds to the authorised process and that an effective quality assurance system in accordance with Regulation (EC) No 2023/2006 is in place.
3. The authorisation holder must notify the Food Safety Authority about the recycling or manufacturing site in which the authorised recycling process is being applied.
Article 11 
Voluntary self-declaration of the recycled content in recycled plastic materials and articles shall follow the rules laid down in ISO 14021:1999 or equivalent.
Article 12 

1. In addition to the requirements of Article 9 of Directive 2002/72/EC, the declaration of compliance of recycled plastic materials and articles shall contain the information laid down in Part A of Annex I to this Regulation.
2. In addition to the requirements of Article 9 of Directive 2002/72/EC, the declaration of compliance of recycled plastic shall contain the information laid down in Part B of Annex I to this Regulation.
Article 13 

1. For the initial authorisation phase of recycling processes, the procedure provided for in Articles 5, 6 and 7 shall apply subject to paragraphs 2 to 6 of this Article.
2. During the 18 months following the publication of the guidelines for the safety assessment of a recycling process of the Authority as provided for in Article 5(2), business operators seeking authorisation shall submit an application in accordance with Article 5.
3. The Commission shall make available to the public a register of recycling processes for which a valid application has been submitted in accordance with paragraph 2.
4. The Authority shall issue an opinion on each recycling process for which a valid application has been submitted during the period referred to in paragraph 2 of this Article. The deadline of six months for issuing the opinion, as referred to in Article 5(3), shall not apply.
5. Applications for which the Authority could not issue an opinion owing to the applicant’s failure to comply with the time limits specified for submission of supplementary information in accordance with Article 10(2) of Regulation (EC) No 1935/2004 shall be excluded from consideration for the initial authorisation.
6. Within six months of receiving all the opinions referred to in paragraph 4, the Commission shall submit for opinion to the Standing Committee on the Food Chain and Animal Health draft decisions granting or refusing authorisation of the recycling processes referred to in paragraph 1.
Article 14 

1. Trade in and use of recycled plastic from a recycling process already in place on the date of entry into force of this Regulation, for which authorisation is refused or for which no valid application has been submitted in accordance with Article 13 shall be permitted until six months after the date of adoption of the Decisions referred to in Article 13(6).
2. Trade in and use of recycled plastic materials and articles containing recycled plastic from a recycling process already in place on the date of entry into force of this Regulation, for which authorisation is refused or for which no valid application has been submitted in accordance with Article 13 shall be permitted until exhaustion of stocks.
Article 15 
The Annex to Regulation (EC) No 2023/2006 is amended in accordance with Annex II to this Regulation.
Article 16 
This Regulation shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.
However, Articles 3, 9, 10 and 12 shall apply from the date of the adoption of the Decisions referred to in Article 13(6). Until that date, national provisions in force concerning recycled plastic materials and articles and recycled plastic shall continue to apply in the Member States.
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ANNEX I
PART A
The written declaration referred to in Article 12(1) shall contain the following additional information:

A declaration that only recycled plastic from an authorised recycling process has been used listing the  register  number of the authorised recycling process.

PART B
The written declaration referred to in Article 12(2) shall contain the following additional information:


1.. The declaration that the recycling process has been authorised listing the register number of the authorised recycling process;
2.. The declaration that the plastic input, the recycling process and the recycled plastic meet the specifications for which the authorisation has been granted;
3.. The declaration that a quality assurance system according to Section B of Annex to Regulation (EC) No 2023/2006 is in place.

ANNEX II

The Annex to Regulation (EC) No 2023/2006 is amended as follows:

((1)) The following section title is inserted after the title:
'
A. '
((2)) The following section is added:
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B.  1. The quality assurance system implemented by the recycler must give adequate confidence in the capability of the recycling process to ensure the recycled plastic meets the requirements in the authorisation.
 2. 
That quality system documentation must permit uniform interpretation of the quality policy and procedures, such as quality programmes, plans, manuals, records and measures taken to ensure traceability.

It must include, in particular:


((a)) a quality policy manual, containing a clear definition of the recycler’s quality objectives, the organisation of the business and in particular the organisational structures, the responsibilities of the managerial staff and their organisational authority where manufacture of the recycled plastic is concerned;
((b)) the quality control plans, including those for input and recycled plastic characterisation, suppliers’ qualification, sorting processes, washing processes, deep cleansing processes, heating processes, or any other part of the process relevant for the quality of the recycled plastic including the choice of points which are critical for the quality control of the recycled plastics;
((c)) the managing and operative procedures implemented to monitor and control the whole recycling process, including the inspection and quality assurance techniques at all the manufacturing stages, especially the establishment of critical limits at the points which are critical for the quality of the recycled plastics;
((d)) the methods of monitoring the efficient operation of the quality system and in particular its ability to achieve the desired recycled plastic quality, including control of products which fail to conform;
((e)) the tests and analytical protocols or any other scientific evidence applied before, during and after recycled plastic production, the frequency with which they will take place, and the test equipment used; it must be adequately possible to trace back the calibration of the test equipment;
((f)) the recording documents adopted.
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