Chapter IV, Article 14 · Commission Regulation (EU) 2022/1616

Contents

Article 14Assessment of novel technologies#

1.When the Commission considers there is sufficient data available on a novel technology, it may on its own initiative request the Authority to assess that technology, and include other novel technologies in that request, provided these technologies are substantially similar or the same.

2.A developer may request the Commission to initiate the assessment referred to in paragraph 1 once it published at least four consecutive reports in accordance with Article 13(4) concerning a decontamination installation.In case the developer requests the assessment of the novel technology, the Commission may delay the request to the Authority by up to 2 years in case it considers that the available knowledge on the novel technology is still insufficient, or when other operators are developing the same or similar novel technologies.

3.The Authority shall assess the suitability of the decontamination technology that the novel technology applies taking into account the recycling technology as a whole.The suitability assessment shall include the efficiency of the employed chemical and/or physical principles to decontaminate a specified plastic input so that the plastic materials and articles manufactured from recycled plastic obtained from the novel technology comply with Article 3 of Regulation (EC) No 1935/2004. It shall also include the microbiological safety.

4.Within 1 year after receiving the request for assessing the novel technology, the Authority shall give an opinion concerning the outcome of its assessment. That opinion shall contain:

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

(b)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;

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

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

(e)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).

5.Where the Authority considers that it needs to involve new experts to assess a novel technology, it may extend the period provided for in paragraph 4 by up to 1 year.

6.Where needed for completing its assessment, the Authority may request the developers of the novel technologies under assessment to supplement the information available to it with information compiled in accordance with Article 10(3), (4), and (5) and Article 12, as well as with other information or explanations that it deems necessary for that purpose, and within time limits it specifies, which shall not exceed 1 year in total. Where the Authority requests such supplementary information, the time limit laid down in paragraph 4 is suspended until the requested information is received, from one, several, or all developers as appropriate for the purposes of the assessment.

7.The Commission may decide to adjust the time limits referred to in paragraph 4, 5 and 6 for the assessment of a specific novel technology, after consultation of the Authority and of the developers of that technology.

8.Articles 39 to 39e of Regulation (EC) No 178/2002 and Article 20 of Regulation (EC) No 1935/2004 shall apply mutatis mutandis to the supplementary information requested in accordance with paragraph 6; for this purpose, the developer or developers of the novel technologies in the scope of the assessment shall be regarded as the applicant.For the purpose of assessing technologies, the Authority shall provide confidential treatment to supplementary information it requests on aspects specific to individual recycling processes and installations used by a recycler. Information referred to in Article 12(1)(a) and (c), and Article 12(3) shall not be treated as confidential.Information considered confidential in accordance with this paragraph shall not be shared with or between other developers, recyclers, or third parties without the consent of the owner of that information.

9.When developers of other novel technologies not included in the scope of the assessment publish new information relevant for the assessment, the Authority may take this information into account.

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;