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)

CHAPTER I

SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1

Subject matter and scope

This Regulation lays down rules for:

(a) the placing on the market of plastic materials and articles falling within the scope of Article 1(2) of Regulation (EC) No 1935/2004, containing plastic originating from waste or manufactured therefrom;

(b) the development and operation of recycling technologies, processes and installations, to produce recycled plastic for use in those plastic materials and articles;

(c) the use in contact with food of recycled plastic materials and articles and of plastic materials and articles which are intended to be recycled.

Article 2

Definitions

For the purposes of this Regulation, the following definitions also apply:

(1) ‘waste’, ‘municipal waste’, ‘waste management’, ‘collection’, ‘re-use’, ‘recycling’, and ‘non-hazardous waste’, as laid down in Article 3 of Directive 2008/98/EC of the European Parliament and of the Council (¹);

(2) ‘food business’ and ‘food business operator’, as laid down in Article 3 of Regulation (EC) No 178/2002 of the European Parliament and of the Council (²);

(3) ‘competent authorities’, and ‘audit’, as laid down in Article 3 of Regulation (EU) 2017/625.

The following definitions shall also apply for the purpose of this Regulation:

(1) ‘recycling technology’ means a specific combination of physical or chemical concepts, principles, and practices to recycle a waste stream of a certain type and collected in a certain way into recycled plastic materials and articles of a specific type and with a specific intended use, and includes a decontamination technology;

(2) ‘decontamination technology’ means a specific combination of physical or chemical concepts, principles, and practices part of a recycling technology which have as primary purpose to remove contamination or to purify;

(3) ‘recycling process’ means a sequence of unit operations that is intended to manufacture recycled plastic materials and articles through pre-processing, a decontamination process, and post-processing, and which is based on a specific recycling technology;

(4) ‘recycled plastic’ means plastic resulting from the decontamination process of a recycling process and plastic resulting from subsequent post-processing operations and that is not yet transformed into recycled plastic materials and articles;

(5) ‘recycled plastic materials and articles’ means food contact materials and articles in their finished state, and that are made either fully or partly of recycled plastic;

(6) ‘recycled content’ refers to the amount of recycled plastic directly resulting from the decontamination process of a recycling process contained either in further post-processed recycled plastic or recycled plastic materials and articles manufactured therefrom.

(7) ‘pre-processing’ means all waste management operations carried out to sort, shred, wash, mix or otherwise treat plastic waste in order to make it suitable for the decontamination process;

(8) ‘plastic input’ means the plastic materials resulting from pre-processing which are entered into a decontamination process;

(9) ‘decontamination process’ means a specific sequence of unit operations which together have as primary purpose to remove contamination from plastic input in order to make it suitable for contact with food, using a specific decontamination technology;

(10) ‘incidental contamination’ means contamination present in plastic input originating from food, from plastic materials and articles intended and used for contact with food, from their use or misuse for non-food purposes, and from the unintentional presence of other substances, materials and articles due to waste management;

(11) ‘post-processing’ means all unit operations subsequent to the decontamination process by which its output is further polymerised, otherwise treated, and/or converted, resulting in recycled plastic materials and articles in their finished state;

(12) ‘recycling installation’ means the equipment operating at least a part of a recycling process;

(13) ‘decontamination installation’ means specific equipment operating a decontamination process;

(14) ‘recycling facility’ means a location where at least one decontamination installation is located;

(15) ‘recycling scheme’ means an arrangement between legal entities to manage the use, separate collection and recycling of plastic materials and articles with the objective to limit or prevent their contamination in order to facilitate their recycling;

(16) ‘recycler’ means any natural or legal person who applies a decontamination process;

(17) ‘converter’ means any natural or legal person that carries out one or more post-processing unit operations;

(18) ‘unit operation’ means a basic operation that is part of a process, and applies a single transformation to its input, or more transformations if they occur in conjunction;

(19) ‘manufacturing stage’ means one or more sequential unit operations and which are followed by a quality assessment of the material resulting from that stage;

(20) ‘batch’ means a quantity of material of the same quality, and produced using uniform production parameters at a certain manufacturing stage, stored and contained to exclude mixing with other materials, or contamination, and designated as such by a single production number.

Article 3

Suitable recycling technologies

Recycling technologies shall be distinguished based on the following properties:

(a) the type, mode of collection and origin of the input material;

(b) the specific combination of physical and chemical concepts, principles and practices used to decontaminate that input material;

(c) the type and the intended use of the recycled plastic materials and articles;

(d) the need or absence thereof for the evaluation and authorisation of recycling processes applying that technology, and the criteria therefore.

CHAPTER II

PLACING ON THE MARKET OF RECYCLED PLASTIC AND RECYCLED PLASTIC MATERIALS AND ARTICLES

Article 4

Requirements for recycled plastic materials and articles

The recycled plastic materials and articles are manufactured using one of the following:

(a) a suitable recycling technology listed in Annex I; or,

(b) a novel technology as referred to in Article 3(6) and developed in accordance with Chapter IV.

Where the recycled plastic materials and articles are manufactured using a suitable recycling technology, the following requirements are met:

(a) where relevant, the recycling process used to manufacture the recycled plastic materials and articles has been granted an authorisation.

(b) the recycling and use of recycled plastic to manufacture the recycled plastic materials and articles complies with the general requirements laid down in Articles 6, 7 and 8, as supplemented by the specifications and requirements for the technology set out in column 8 of Table 1 of Annex I and those laid down in the authorisation, and subject to the specific derogations specified in column 9 of Table 1 of Annex I, and in the authorisation.

(c) by derogation to point (b), where the suitable recycling technology is to be implemented through a recycling scheme, the recycling and use of the recycled plastic materials and articles comply with the general requirements laid down in Article 9, and, where relevant, with the specific rules for the technology set out in Annex I.

The Union register established in Article 24 includes the following information regarding the manufacture of the recycled plastic:

(a) the decontamination installation where the recycled plastic was manufactured, the address of the recycling facility, and the identity of the recycler operating it;

(b) the applied authorised recycling process, if the applied suitable recycling technology requires the authorisation of recycling processes;

(c) the name of the recycling scheme used, the identity of the entity managing it, and the applied markings, if the applied recycling technology requires the use of a recycling scheme;

(d) the name of the novel technology, if the manufacture of the recycled plastic uses a novel recycling technology.

Article 5

Requirements for documentation, instructions and labelling

Recycled plastic delivered to converters shall bear a label affixed to each container showing the symbol defined in Annex II to Regulation (EC) No 1935/2004, followed by:

(a) the symbol and the registry number of the decontamination installation where the recycled plastic was manufactured in accordance with Article 24,

(b) the symbol followed by the batch number,

(c) the percentage by weight of the recycled content,

(d) the maximum percentage by weight of the recycled content that final recycled plastic materials and articles containing the recycled plastic may contain, if this is less than 100 %, and,

(e) when the declaration referred to in paragraph 2 provides additional instructions, the symbol defined in ISO 7000 with reference number 1641.

The minimum font size on the labels shall be at least 17 points (6 mm) on containers of which the largest dimension is smaller than 75 centimetres, 23 points on containers of which the largest dimension is in between 75 centimetres and 125 centimetres, and 30 points on containers where the largest dimension exceeds 125 centimetres.

CHAPTER III

GENERAL REQUIREMENTS FOR PLASTIC RECYCLING AND THE USE OF RECYCLED PLASTIC

Article 6

Requirements for collection and pre-processing

Waste management operators that participate in the supply chain of plastic input shall ensure that the collected plastic waste meets the following requirements:

(a) the plastic waste originates only from municipal waste, or from food retail or other food businesses if it was only intended and used for contact with food, including waste discarded from a recycling scheme in accordance with Article 9(6);

(b) the plastic waste originates only from plastic materials and articles manufactured in accordance with Regulation (EU) No 10/2011 or recycled plastic materials and articles manufactured in accordance with this Regulation;

(c) the plastic waste is subject to separate collection;

(d) the presence of plastic materials and articles that are different from the plastic for which the decontamination process is intended, including caps, labels and adhesives, other materials and substances, and remaining food is reduced to a level specified in the requirements for the plastic input provided by the recycler and which shall not compromise the achieved level of decontamination.

For the purposes of paragraph 1, point (c), the plastic waste shall be considered as collected separately when one of the following conditions is fulfilled:

(a) it consists only of plastic materials and articles meeting the requirements of paragraph 1, points (a) and (b), and which have been collected separately for recycling from any other waste;

(b) it is collected together with other packaging waste fractions of municipal waste or with other non-packaging plastic, metal, paper or glass fractions of municipal waste collected separately from residual waste for recycling, and the following requirements are met: (i) the collection system collects only non-hazardous waste; (ii) the collection of waste and the subsequent sorting are designed and carried out to minimise contamination of collected plastic waste from any plastic waste not meeting the requirements of paragraph 1, points (a) and (b), or other waste;

The plastic waste shall be controlled throughout collection and pre-processing by means of quality assurance systems. The quality assurance systems shall:

(a) ensure the conditions and requirements set out in paragraph 1 and 2 are met;

(b) ensure traceability of each batch up to the point of the first sorting of collected plastic waste; and,

(c) be certified by an independent third party.

Articles 4, 5, 6 and 7 of Commission Regulation (EC) No 2023/2006 as well as point B of the Annex to that Regulation shall apply mutatis mutandis as regards good manufacturing practice, quality control and assurance systems and the relevant documentation.

Article 7

Requirements for decontamination

The decontamination installation shall meet the following requirements:

(a) it is located at a single recycling facility, which is organised so as to ensure that no new contamination of recycled plastic or recycled plastic materials and articles can occur;

(b) its configuration and operation corresponds to that of the recycling process it applies;

(c) it is operated as described in the compliance monitoring summary sheet established in accordance with Article 26.

Article 8

Post-processing and use of recycled plastic materials and articles

Converters shall comply with the following requirements:

(a) post-process recycled plastic in accordance with the instructions provided by the recycler or the supplying converter in accordance with Article 5(3);

(b) where relevant, provide to subsequent converters instructions in accordance with Article 5, paragraphs (3), (4) and (5); and,

(c) where relevant, provide instructions to the users of the recycled plastic materials and articles in accordance with Article 5(6).

They shall communicate relevant instructions to consumers of food packed in such materials and articles, and/or to other food business operators, where relevant.

Article 9

Requirements for the operation of recycling schemes

At least 15 working days prior to the start of the operation of a recycling scheme the manager of the recycling scheme shall inform the competent authority in the territory where it is established and the Commission for the purpose of its registration in the Union register established in accordance with Article 24.

The manager shall provide its name, address, contact persons, the name of the scheme, a summary of the scheme not exceeding 300 words, the marking referred to in paragraph 5, a list of Member States where business operators participating in the schemes are located, and references to any decontamination installations used by the scheme. Thereafter, the manager shall ensure this information is kept up to date.

A waste collection system shall be part of a recycling scheme and shall be dedicated to the scheme so as to ensure that only materials and articles that were used subject to the scheme are collected.

Any food business operator using materials and articles bearing a marking provided for in paragraph 5 shall ensure that those materials and articles meet the following requirements:

(a) they are labelled, used and cleaned in accordance with instructions obtained from the manager of the recycling scheme;

(b) they are used only for the purpose of distribution, storage, display and sale of the foods which they are intended for;

(c) they are not contaminated with materials or substances other than those permitted by the recycling scheme.

Where any of these requirements is not fulfilled, the materials or articles shall be excluded from the recycling scheme and be discarded.

Business operators and other organisations that participate in a recycling scheme:

(a) shall operate a quality assurance system in accordance with Regulation (EU) No 2023/2006, designed to ensure compliance with the requirements of the scheme; or,

(b) alternatively, small food business operators, may implement the requirements of the scheme as part of their permanent procedures based on the ‘hazard analysis and critical control points’ (HACCP) principles, as referred to in Article 5 of Regulation (EC) No 852/2004 of the European Parliament and of the Council (³), applying these procedures mutatis mutandis to contamination hazards of the plastic.

CHAPTER IV

DEVELOPMENT AND LISTING OF RECYCLING TECHNOLOGIES

Article 10

Requirements for the development of a novel technology

Where business operators or other organisations collaborate on the development of a novel technology, a single legal entity shall represent these operators or organisations, and act as the developer of the novel technology.

For the purpose of the registration of the novel technology in the Union register established in Article 24, the developer shall include in this notification its name, address, contact persons, the name of the novel technology, a summary of the novel technology not exceeding 300 words, an Uniform Resource Locator (‘URL’) locating the reports to be published in accordance with paragraph 4 and Article 13(4), and the names and addresses or numbers of any recycling facilities at which the development of the technology is foreseen to take place.

The notification by the developer shall also provide detailed information concerning the following:

(a) a characterisation of the novel technology based on the properties of recycling technologies set out in Article 3(2);

(b) an explanation of any deviations from the requirements set out in Articles 6, 7 and 8, or whether the novel technology applies a recycling scheme;

(c) extensive reasoning, and scientific evidence and studies, compiled by the developer, demonstrating that the novel technology can manufacture recycled plastic materials and articles that comply with Article 3 of Regulation (EC) No 1935/2004 ensuring also their microbiological safety, including a characterisation of contaminant levels in the plastic input and in the recycled plastic, a determination of the decontamination efficiency, and of the transfer of these contaminants from the recycled plastic materials and articles to the food, and reasoning on why the applied concepts, principles, and practices are sufficient for meeting those requirements;

(d) a description of one or more typical recycling processes using the technology, including a block diagram of the main manufacturing stages, and, if relevant, an explanation of the used recycling scheme and of the rules governing its functioning;

(e) an explanation based on point (a) describing why the technology is to be considered different from existing technologies and is to be considered novel;

(f) a summary proposing evaluation criteria to the Authority for its potential future evaluation of recycling processes that apply the novel technology on which the installation is based as required in Article 20(2);