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

Contents

Article 10Requirements for the development of a novel technology#

1.Several developers may independently develop novel technologies at the same time, even if these technologies may be regarded as similar or the same.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.

2.At least 6 months prior to the start of the operation of the first decontamination installation operated on the basis of Article 4(3)(b), the developer shall notify the competent authority in the territory where the developer is established and the Commission 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.

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.

4.At the time of the notification, the developer shall also publish a detailed initial report on its website using the URL provided in accordance with paragraph 2, concerning the safety of the manufactured plastic based on the information provided in paragraph 3. That report may omit details of recycling processes and installations that use the novel technology as far as these details are justifiably of commercial relevance, and shall provide a robust summary containing all information necessary to make an independent assessment of the technology without the need to consult the information contained in more detailed reports and studies;

5.The developer shall adapt the template of the compliance monitoring summary sheet provided for in Annex II to the extent necessary to reflect the particularities of the novel technology. It shall provide this adapted template to compliance monitoring summary sheet to all recyclers using the novel technology.

6.Where a technology applies a recycling scheme the developer shall act as the manager of the recycling scheme referred to in Article 9(1). Articles 6, 7 and 8, and Article 9(2) shall not apply.

7.The developer shall ensure an on-going dialogue with all recyclers using the novel technology to exchange knowledge about its functioning and capacity to decontaminate the plastic input. It shall keep records thereof, setting out the matters discussed and conclusions on the functioning and decontamination capacity of the technology, which shall be made available upon request to any competent authority in a territory where the developer and/or recyclers are located.

8.A competent authority that was notified in accordance with paragraph 2 shall verify within 5 months from the notification whether the requirements set out in paragraphs 1 to 6 are met and verify the requirements forthcoming from paragraph 7 regularly thereafter.In case the competent authority considers these requirements are not met, it shall notify its concerns to the developer, and it may instruct the developer to delay the start of the operation of the first decontamination installation in accordance with paragraph 2 until the developer addressed those concerns.The developer shall inform the competent authority of the way it addressed the concerns or clarify why it considers that no action is necessary.In case the competent authority has serious concerns over the safety of the recycled plastic materials and articles, the competent authority shall notify the Commission.