Chapter IV, Article 12 · Commission Regulation (EU) 2022/1616

Contents

Article 12Supplementary information requirements on recycling installations using novel technology#

1.A recycler shall keep available at the decontamination installation the following supplementary information:

(a)a summary of the novel technology not exceeding 250 words;

(b)a summary describing the complete recycling installation and the process it applies, not exceeding 1500 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);

(c)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;

(d)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; .

2.The supplementary information in paragraph 1 shall be updated without delay as a result of on-going dialogue between the developer and the recyclers, when new information becomes available either as a result of the operation and development of the installation, or of the monitoring in accordance with Article 13, or where the developer changes the technology or collects new measurements on the performance or functioning of the novel technology. The recycler shall then provide the developer with the updated information and supporting documentation.

3.For the purpose of paragraph 1, point (b), the supplementary information shall include at least the following elements:

(a)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;

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

(c)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;

(d)information on the fate of contaminants removed in the decontamination process;

(e)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;

(f)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).

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;