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;

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

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

‘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 );

‘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 );

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

‘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;

‘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;

‘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;

‘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;

‘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;

‘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.

‘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;

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

‘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;

‘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;

‘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;

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

‘decontamination installation’ means specific equipment operating a decontamination process;

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

‘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;

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

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

‘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;

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

‘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.

the type, mode of collection and origin of the input material;

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

the type and the intended use of the recycled plastic materials and articles;

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

a suitable recycling technology listed in Annex I; or,

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

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

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.

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

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

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;

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

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

the symbol followed by the batch number,

the percentage by weight of the recycled content,

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,

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

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);

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;

the plastic waste is subject to separate collection;

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.

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;

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:

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

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

be certified by an independent third party.

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;

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

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

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

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

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

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

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

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

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,

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.

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

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;

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;

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;

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

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);

an estimate of the expected number of decontamination installations that will be operated to develop the novel technology, and the foreseen addresses of the recycling facilities where they will be located.

For the purposes of point (c), the data used to determine the decontamination efficiency shall be obtained either by the operation of a pilot installation, or originate from commercial production of recycled plastics not intended for contact with food. Where needed to fully establish the safety of the plastic materials and articles, the data shall be complemented by tests designed to assess the concepts, principles, and practices specific to the technology. Where the plastic input may contain plastics not produced in compliance with Regulation (EU) No 10/2011, the evidence required shall demonstrate that the technology removes substances that were used in the manufacture of those plastics to the extent necessary to ensure the requirement in Article 4(2) is met.

The information referred to in the first and second subparagraph shall be available to the Member States, and to the Authority. The developer shall also provide it to all recyclers using the novel technology. It shall be updated without delay on the basis of new information forthcoming from development activities. The information shall be considered of commercial relevance to the developer, and shall not be made public prior to a request of the Commission to the Authority to assess the recycling technology in accordance with Article 14.

a summary of the novel technology not exceeding 250 words;

a summary describing the complete recycling installation and the process it applies, not exceeding 1 500 words. This summary shall demonstrate the safety of the recycled plastic manufactured with the installation, and shall be based on the information provided by the developer in accordance with Article 10(3), as well as the evaluation criteria referred to in point (f) of Article 10(3);

a detailed block diagram showing the sequence of the main manufacturing stages of the recycling installation, including all individual unit operations operated at the recycling facility;

a piping and instrumentation diagram of the decontamination process in accordance with section 4.4 of ISO 10628-1:2014, showing only the instrumentation relevant for decontamination; .

information on the level of incidental contamination present in the plastic input, and information on other kinds of contamination and the levels thereof, in particular where on the basis of Article 11(3) the plastic input does not meet one or more of the requirements set out in Article 6;

information on the amount or percentage of the contamination that the decontamination process can remove (‘the decontamination efficiency’);

information on estimated residual contamination present in the output of the decontamination process taking the decontamination efficiency into account, including that of potentially remaining genotoxic and endocrine disrupting substances and substances referred to in Article 13(4)(a) of Regulation (EU) No 10/2011, even if their occurrence is below the limit of their detection of the applied analytical techniques;

information on the fate of contaminants removed in the decontamination process;

information on the migration to food of the residual contamination present in the recycled plastic material or article, post-processed in accordance with the requirements of the recycling process, and taking into account the conditions of use defined for the concerned materials and articles;

an overall reasoning, discussion and conclusion on the safety of the recycled plastic materials and articles based on the information set out in points (a) to (e).

The information referred to in this paragraph shall be kept up to date and be based on the latest information relevant to these elements, including information provided by the suppliers of the plastic input and the users of the recycled plastic, and information forthcoming from the monitoring in accordance with Article 13 and the dialogue referred to in Article 10(7).

a brief description of the novel technology on the basis of the information referred to in Article 10(3), including the information required under points (a), (b), (d) and (f) thereof;

a summary of the reasoning on the capability of the novel technology and the recycling process(es) to manufacture recycled plastic materials and articles that comply with Article 3 of Regulation (EC) No 1935/2004 and that are microbiologically safe on the basis of the information included in points (a) to (f) of Article 10(3), and taking into account the information received in accordance with paragraph 3;

a list of all substances with a molecular weight below 1 000 Dalton found in the plastic inputs to each of the decontamination installations and in the recycled plastic output thereof, sorted in descending order by their relative occurrence and of which at least the first 20 detected incidental contaminants in the input have been identified, and their amounts specified as weight fraction of the input and output;

a list of contaminating materials regularly present in the plastic input, including polymer types that differ from that in the intended plastic input, plastics not intended for contact with food, and other materials that are found in the inputs and outputs referred to in point (c), and their amounts specified as weight fraction of the input and output;

an analysis of the most likely origin of the identified contaminants referred to in points (c) and (d), and of whether those origins could give rise to the simultaneous presence of other substances of concern that are either undetected or unidentified with the applied analytical techniques;

a measurement or estimation of the migration levels to food of contaminants present in the recycled plastic materials and articles;

a detailed description of the applied sampling strategy;

a detailed description of the analytical procedures and methods used, including sampling procedures and limits of detection and quantification, as well as validation data and reasoning on their suitability;

an analysis and explanation of any discrepancies observed between contaminant levels expected in the input plastic and in the output of the installation and its decontamination efficiency based on the reasoning provided under point (b) and the actual results under point (c).

a discussion of the differences with previous reports published in accordance with this paragraph, if any.

a characterisation of the recycling technology based on the properties defined in Article 3(2);

a discussion and conclusion on its assessment of the capacity of the novel technology to recycle plastic waste in accordance with paragraph 3, including specific observations or concerns the Authority has on the technology, and on processes and installations using it, and a definition and justification of any restrictions and specifications deemed necessary;

a conclusion on whether individual recycling processes applying that recycling technology require further individual evaluation in accordance with Articles 17 to 20;

if the Authority concludes that individual evaluation of the recycling processes is necessary, specific guidance as referred to in Article 20(2);

in case that the Authority concludes that individual evaluation of the recycling processes is not necessary, information equivalent to the information required in Article 18(4), points (c) to (g).

lay down restrictions and specifications regarding the technology, as necessary;

consider the recycling technology as unsuitable.

the name and address of the applicant;

a technical dossier containing the information specified in paragraph 5;

a summary of the technical dossier.

acknowledge receipt of the application in writing to the applicant within 14 days of its receipt, stating the date of the receipt ;

inform the Authority without delay;

make the application and any supplementary information supplied by the applicant available to the Authority.

inform the Commission and the other Member States of the application and make the application and any supplementary information supplied by the applicant available to them;

make public the application, relevant supporting information and any supplementary information supplied by the applicant, in accordance with Articles 19 and 20 of Regulation (EC) No 1935/2004, unless otherwise provided for in paragraph 6 of this Article.

any information required in the detailed guidance published by the Authority in accordance with Article 20(2);

a description of the pre-processing carried out to produce plastic input suitable for being entered into the decontamination process and of the specific quality control procedures applied during collection and pre-processing, including a detailed specification of the pre-processed plastic input;

a description of any required post-processing of the recycled plastic and of the intended use of the resulting plastic materials and articles and of uses for which it would not be suitable, including relevant instructions and labelling to be provided to convertors and to end-users of the recycled plastic materials and articles;

a simple block diagram of all unit operations used in the decontamination process, that provides a reference to the input, output and quality control procedures applied by each operation;

a piping and instrumentation diagram of the decontamination process in accordance with section 4.4 of ISO 10628-1:2014, showing only the instrumentation relevant for decontamination;

a description of the quality control procedures applied at each unit operation of the decontamination process, including:

verify that the information and documents submitted by the applicant are in accordance with Article 17(5), in which case the application shall be regarded as valid;

inform the applicant, the Commission and the Member States if the application is not valid.

the identification and address of the applicant;

the number assigned in table 1 of Annex I of the suitable recycling technology the process uses;

a short description of the recycling process including a short description of the required pre-processing and post-processing stages, a characterisation of the plastic input, and conditions and limitations of use of the output;

a process flow diagram of the decontamination process that discerns the order of the distinct unit operations that the Authority has evaluated together with a description of each of these operations and how any parameters critical to their operation are controlled;

a scientific evaluation of the decontamination efficiency in accordance with the guidance set out in Article 20(2);

a discussion and conclusion on whether the recycling process can manufacture recycled plastic materials and articles that comply with Article 3 of Regulation (EC) No 1935/2004 and are microbiologically safe, including a reasoning justifying restrictions and specifications that should in the opinion of the Authority apply to the plastic input, the configuration and operation of the decontamination process and the use of the recycled plastic and recycled plastic materials and articles;

where appropriate, any recommendations concerning monitoring of the compliance of the recycling process with the conditions of the authorisation.

a recycling process authorisation number (‘RAN’);

the name of the recycling process;

the recycling technology, as listed in Annex I, for which the process is authorised;

the name and address of the authorisation holder;

a reference to the opinion of the Authority on which the decision is based;

any specific requirements for the operation of the decontamination process, pre-processing and post-processing complementing or derogating from the general requirements set out in Articles 6, 7 and 8, or Article 9;

any specific requirements concerning monitoring and verification of the compliance of the recycling process with the conditions of the authorisation;

any conditions, specifications, and specific labelling requirements concerning the use of recycled plastic originating from the process.

the reference to the original application;

a technical dossier containing the information required in Article 17(5), including the information of the technical dossier already submitted during the original application in accordance with Article 17(5) and Article 18(2), updated with the modifications. All modifications (deletions and additions) shall be clearly marked and visible in the technical dossier;

a new complete summary of the technical dossier in a standardised form;

at least one complete compliance monitoring summary sheet related to a decontamination installation operating the authorised process as submitted to a competent authority in accordance with Article 26, and an updated version which includes all changes, if any, expected to be forthcoming from the requested change.

the names of novel technologies and the names and addresses of the developers, and the URL referred to in Article 10(2);

the names of authorised recycling processes and the names and addresses of the authorisation holders, and on which technology each process is based;

the authorisation status of each registered recycling process, including whether its authorisation is suspended, revoked, or subject to transitional provisions, and the latest date of change of the authorisation status;

the company name and the address of the head office of recyclers operating a decontamination installation;

the addresses of recycling facilities;

decontamination installations, the technology they use, the facility at which they are located, and the authorised process they apply, if any;

the registration status of decontamination installations, including whether the status is newly registered, being established, active or suspended, and the latest date of change of that status;

names of recycling schemes, and names and addresses of the entity managing the scheme;

the markings required in accordance with Article 9(5);

where relevant, the information required in accordance with Article 19(2);

cross-references between technologies, processes, schemes, recyclers, and installations and schemes;

at least 30 working days prior to the start date of the production of recycled plastic in a decontamination installation, the recycler shall notify the installation and either the address of the facility where it is located or the facility number to the Commission and to the competent authority in the territory where the installation is located, as well as its own registration number if the recycler is already registered, the recycling authorisation number if it applies an authorised process, and the number of the suitable or novel technology, as applicable;

upon notification of its first decontamination installation in accordance with point (a), the recycler shall notify its company name, contact persons, and the address of its head office to the Commission and to the competent authority in the territory where the head office is located;

the recycler shall have a completed compliance monitoring summary sheet in accordance with Annex II available at the recycling installation and have submitted it to the competent authority in accordance with Article 26;

a recycler has placed it on the market without appropriate documentation or labelling;

a recycler cannot demonstrate on the basis of its records and other documentation that it was manufactured in accordance with this Regulation;

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.

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,

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,

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.

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,

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.