Requirements 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 recycler 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 7 are met, and verify the requirements forthcoming from paragraph 8 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.
Conditions on the operation of recycling installations applying novel technologies
1. A recycling installation applying a novel recycling technology shall be based on a novel technology notified in accordance with Article 10(2).
2. The recycler shall comply with the administrative requirements set out in Article 25.
3. A recycling installation used to develop a novel technology may be operated in a way that deviates from one or more of the specific requirements set out in Article 6, 7 and 8, or use a recycling scheme in accordance with Article 9, provided each deviation or the use of that scheme is justified by the explanation provided in accordance with Article 10(3)(b).
4. The recycler shall have documented supplementary information available in accordance with Article 12 demonstrating that the recycled plastic produced with the recycling installation meets the requirements of Article 3 of Regulation (EC) No 1935/2004 and is microbiologically safe.
5. The recycler shall have a completed compliance monitoring summary sheet on the basis of the template provided by the developer in accordance with Article 10(5).
6. The supplementary information referred to in paragraph 3 including any supporting documentation, and the compliance monitoring summary sheet referred to in paragraph 4 shall be provided to the developer and to the competent authorities on their request.
Supplementary 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 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);
(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 supporting documentation 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).
Monitoring and reporting of contamination levels
1. A recycler operating a decontamination installation in accordance with Article 11 shall monitor the average contamination level on the basis of a robust sampling strategy which samples the plastic input batches and the corresponding decontaminated output batches. The sampling strategy shall take account of all factors potentially affecting the composition of the plastic input, and particularly address variations in the origin thereof, whether geographic or otherwise.
The sampling shall initially include all input batches and corresponding output batches, but the sampling frequency may be reduced once stable averages are obtained. The sampling frequency shall in any case be maintained at a suitable level to detect trends and/or other changes in the contamination levels of the input batches, and to identify whether the presence of contaminants is reoccurring.
Where determining the sampling frequency based on plastic input batches is impractical due to the particularities of the recycling process, the frequency shall be determined on the basis of batches used at the closest pre-processing operation for which such determination is practical.
Residual contaminant levels in the output shall be determined before any dilution of the output material by addition of other material. Where contaminant levels in the output are below the level of quantification of the applied analytical methods for monitoring, the monitoring of the output may be replaced with one or more studies that determine the residual contaminant level in a limited number of output batches with analytical methods with a limit of quantification sufficiently low for determining the real decontamination efficiency obtained in the decontamination installation. In case residual contamination in the output is so low that quantification thereof is not possible, the level of detection of those methods shall be sufficiently low to support reasoning on whether the decontamination efficiency is sufficient to ensure that recycled plastic materials and articles comply with Article 3 of Regulation (EC) No 1935/2004.
2. For the analyses and tests required to determine the contamination level in accordance with paragraph 1, laboratories performing these activities shall take part regularly and with satisfactory performance in proficiency tests appropriate for this purpose. The first time a laboratory participates in such a proficiency test shall be before the start of the operation of the recycling facility.
3. Recyclers shall provide the developer at least every 6 months with the data forthcoming from the monitoring and their updated reasoning in accordance with Article 12 (3)(f) if that has changed on the basis of the data.
4. The developer shall publish every 6 months a report on its website, based on the latest information from all installations using the novel technology received in accordance with paragraph 3.
5. The report shall contain at least:
(a)
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;
(b)
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;
(c)
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;
(d)
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;
(e)
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;
(f)
a measurement or estimation of the migration levels to food of contaminants present in the recycled plastic materials and articles;
(g)
a detailed description of the applied sampling strategy;
(h)
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;
(i)
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).
(j)
a discussion of the differences with previous reports published in accordance with this paragraph, if any.
Assessment 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 publish 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 3 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 Articles 10 and 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 3, 4 and 5 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)(b) and (e), 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.
Decision on the suitability of a novel technology
1. Taking into account the opinion of the Authority, relevant provisions of Union law and other legitimate factors relevant to the matter under consideration, the Commission shall decide whether the novel technology is a new suitable recycling technology in accordance with Article 3(1) or whether it shall be included in an existing suitable recycling technology.
Where the Commission considers a novel technology is a suitable recycling technology, it shall set out, as necessary, the specific requirements applicable to that technology and decide whether recycling processes applying it shall be subject to authorisation and whether it shall include the use of a recycling scheme.
2. Where the Commission considers that recycling processes applying a technology shall be subject to authorisation, it shall set out provisions concerning the operation of recycling installations notified in accordance with Article 10(2).
3. A technology that was not considered suitable in accordance with paragraph 1 shall no longer be considered a novel technology. Developers may use that technology as a basis to start the development of another novel technology, provided it is substantially changed so as to address the concerns of the Authority and/or the Commission.
Safeguard clause concerning the placing on the market of recycled plastic materials and articles manufactured with a novel or suitable recycling technology
1. On the request of a Member State or on its own initiative the Commission may analyse whether there are grounds to change the conditions of the placing on the market of recycled plastic materials and articles manufactured with a specific recycling technology, or fully prevent their placing on the market, even if that technology has been considered suitable.
2. For the purpose of the analysis referred to in paragraph 1, the developer of the technology, developers, manufacturers or providers of recycling processes or installations using the technology such as those referred to in Article 17(1), recyclers, converters and Member States shall provide the Commission with all the information they have obtained on the recycling technology. Where necessary, the Commission may consult the Authority.
3. The Commission may call upon the actors referred to in paragraph 2 to carry out a specific monitoring programme or migration testing. The Commission may specify deadlines before which those actors shall provide the required information or reports.
4. On basis of the outcome of its analysis, the Commission may:
(a)
lay down restrictions and specifications regarding the technology, as necessary;
(b)
consider the recycling technology as unsuitable.
5. Where the Commission decides that a recycling technology is unsuitable, Article 15(3) shall apply.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
