Chapter IV, Article 10, Paragraph 3. · Commission Regulation (EU) 2022/1616

Contents

3.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);

(g)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.

Source: EUR-Lex, © European Union, 1998-2026. Reuse authorised under Decision 2011/833/EU.

Key facts

Type

Regulation · Commission Regulation (EU) 2022/1616 · EEA relevant

Adopted

15 Sept 2022

In force

10 Oct 2022

Applies from

10 Oct 2024

Text current to

3 Dec 2025

Made by

Directorate-General for Health and Food Safety, European Commission

Official

EUR-Lex 32022R1616 · ELI

Defined terms · 24

Show every defined term

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.
converter
means any natural or legal person that carries out one or more post-processing unit operations;
decontamination installation
means specific equipment operating 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;
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;
food-grade
means plastic that was as primary material compliant with Regulation (EU) No 10/2011;
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;
manufacturing stage
means one or more sequential unit operations and which are followed by a quality assessment of the material resulting from that stage;
Non-food %
(% w/w) means the maximum amount of non-food PCW present in the input;
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;
plastic input
means the plastic materials resulting from pre-processing which are entered into a decontamination process;
post-consumer waste
means plastic waste collected in accordance with Article 6;
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;
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;
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.
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;
recycler
means any natural or legal person who applies a decontamination process;
recycling facility
means a location where at least one decontamination installation is located;
recycling installation
means the equipment operating at least a part of a recycling process;
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;
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;
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;
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;