Application for the authorisation of individual recycling processes
1. To obtain authorisation of an individual recycling process, the natural person or legal entity that developed the decontamination process of the recycling process, either exclusively for its own purposes as a recycler or for the sale or licensing of recycling or decontamination installations to recyclers, ‘the applicant’, shall submit an application in accordance with paragraph 2.
2. The applicant shall submit the application to the competent authority of a Member State accompanied by the following:
(a)
the name and address of the applicant;
(b)
a technical dossier containing the information specified in paragraph 5;
(c)
a summary of the technical dossier.
3. The competent authority referred to in paragraph (2) shall:
(a)
acknowledge receipt of the application in writing to the applicant within 14 days of its receipt, stating the date of the receipt ;
(b)
inform the Authority without delay;
(c)
make the application and any supplementary information supplied by the applicant available to the Authority.
4. The Authority shall without delay:
(a)
inform the Commission and the other Member States of the application and make the application and any supplementary information supplied by the applicant available to them;
(b)
make public the application, relevant supporting information and any supplementary information supplied by the applicant, in accordance with Articles 19 and 20 of Regulation (EC) No 1935/2004, unless otherwise provided for in paragraph 6 of this Article.
5. The technical dossier shall contain the following information:
(a)
any information required in the detailed guidance published by the Authority in accordance with Article 20(2);
(b)
a description of the pre-processing carried out to produce plastic input suitable for being entered into the decontamination process and of the specific quality control procedures applied during collection and pre-processing, including a detailed specification of the pre-processed plastic input;
(c)
a description of any required post-processing of the recycled plastic and of the intended use of the resulting plastic materials and articles and of uses for which it would not be suitable, including relevant instructions and labelling to be provided to convertors and to end-users of the recycled plastic materials and articles;
(d)
a simple block diagram of all unit operations used in the decontamination process, that provides a reference to the input, output and quality control procedures applied by each operation;
(e)
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;
(f)
a description of the quality control procedures applied at each unit operation of the decontamination process, including:
(i)
the values of monitored parameters such as operating temperatures, pressures, flowrates and concentrations, and acceptable ranges thereof;
(ii)
laboratory analysis and its frequency; if any,
(iii)
correction and record keeping procedures; and
(iv)
any other information the applicant deems relevant to fully describe its quality control procedures.
6. Information provided in accordance with paragraph 5, points (e) and (f), and equivalent information submitted in accordance with paragraph 5, point (a), may be kept confidential pursuant to Article 20(2) of Regulation (EC) No 1935/2004.
Opinion of the Authority
1. The Authority shall publish an opinion within a time limit of 6 months from the receipt of a valid application as to whether the recycling process is capable of applying the suitable recycling technology it uses so that plastic materials and articles manufactured with it meet Article 3 of Regulation (EC) No 1935/2004 and are microbiologically safe.
The Authority may extend the time limit provided for in the first subparagraph by a maximum period of a further 6 months. In such a case, it shall provide an explanation for the extension to the applicant, the Commission and the Member States.
2. The Authority may, where appropriate, request the applicant to supplement the particulars accompanying the application within a specified time, whether in writing or by oral explanation. Where the Authority requests supplementary information, the time limit laid down in paragraph 1 is suspended until that information has been provided.
3. The Authority shall:
(a)
verify that the information and documents submitted by the applicant are in accordance with Article 17(5), in which case the application shall be regarded as valid;
(b)
inform the applicant, the Commission and the Member States if the application is not valid.
4. The opinion of the Authority shall include the following information:
(a)
the identification and address of the applicant;
(b)
the number assigned in table 1 of Annex I of the suitable recycling technology the process uses;
(c)
a short description of the recycling process including a short description of the required pre-processing and post-processing stages, a characterisation of the plastic input, and conditions and limitations of use of the output;
(d)
a process flow diagram of the decontamination process that discerns the order of the distinct unit operations that the Authority has evaluated together with a description of each of these operations and how any parameters critical to their operation are controlled;
(e)
a scientific evaluation of the decontamination efficiency in accordance with the guidance set out in Article 20(2);
(f)
a discussion and conclusion on whether the recycling process can manufacture recycled plastic materials and articles that comply with Article 3 of Regulation (EC) No 1935/2004 and are microbiologically safe, including a reasoning justifying restrictions and specifications that should in the opinion of the Authority apply to the plastic input, the configuration and operation of the decontamination process and the use of the recycled plastic and recycled plastic materials and articles;
(g)
where appropriate, any recommendations concerning monitoring of the compliance of the recycling process with the conditions of the authorisation.
Authorisation of an individual recycling process
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 consider whether the individual recycling process complies with the conditions of use of the suitable recycling technology it applies and produces recycled plastic materials and articles that comply with Article 3 of Regulation (EC) No 1935/2004 and are microbiologically safe.
The Commission shall prepare a draft decision to be addressed to the applicant granting or refusing the authorisation of the recycling process. Article 23(1) of Regulation (EC) No 1935/2004 and Article 5 of Regulation (EU) No 182/2011 of the European Parliament and of the Council ( 12 ) shall apply.
Where the draft decision is not in accordance with the opinion of the Authority, the Commission shall explain the reasons for its decision.
2. A decision granting the authorisation shall include the following:
(a)
a recycling process authorisation number (‘RAN’);
(b)
the name of the recycling process;
(c)
the recycling technology, as listed in Annex I, for which the process is authorised;
(d)
the name and address of the authorisation holder;
(e)
a reference to the opinion of the Authority on which the decision is based;
(f)
any specific requirements for the operation of the decontamination process, pre-processing and post-processing complementing or derogating from the general requirements set out in Articles 6, 7 and 8, or Article 9;
(g)
any specific requirements concerning monitoring and verification of the compliance of the recycling process with the conditions of the authorisation;
(h)
any conditions, specifications, and specific labelling requirements concerning the use of recycled plastic originating from the process.
Guidance published by the Authority
1. The Authority shall publish detailed guidance, following the agreement with the Commission, concerning the preparation and the submission of the application, taking into account standard data formats, where they exist in accordance with Article 39f of Regulation (EC) No 178/2002, which shall apply mutatis mutandis .
2. For each suitable recycling technology for which the authorisation of individual recycling processes is required, the Authority shall publish scientific guidance describing the evaluation criteria and the scientific evaluation approach it will use to evaluate the decontamination capability of those recycling processes. The guidance shall specify the information required to be included in an application dossier for the authorisation of a recycling process applying that specific technology.
General obligations arising from the authorisation of a recycling process
1. The granting of an authorisation of a recycling process shall not affect the civil and criminal liability of any business operator in respect of the authorised recycling process, a recycling installation applying the process, recycled plastic and recycled plastic materials and articles obtained with the recycling process, and the food that is in contact with such material or article.
2. The authorisation holder or any recycler shall immediately inform the Commission of any new scientific or technical information which might affect the evaluation on which the authorisation is based.
3. An authorisation holder may permit third parties to operate a decontamination installation under its licence as recyclers. The authorisation holder shall ensure that those recyclers receive all necessary information, instructions and support required to ensure that the operation of the installation and the resulting recycled plastic complies with this Regulation.
4. The authorisation holder shall communicate without delay to the competent authority in the territory where it is established and to the Commission, any changes to its points of contact, its trade and company names, or to other information included in the register established in accordance with Article 24, and other information relevant to the authorisation of a recycling process.
5. The authorisation holder shall immediately inform the competent authority in the territory where it is established and the Commission of a situation under which it can or will no longer assume its responsibilities as authorisation holder in accordance with this Article. The authorisation holder shall provide all necessary information to allow the Commission to determine whether the authorisation of a recycling process should be modified or revoked.
Request for the modification of an authorisation by the authorisation holder
1. The authorisation holder may apply for a modification of the authorisation of a recycling process.
2. The modification referred to in paragraph 1 shall be subject to the procedure laid down in Articles 17 to 20, unless otherwise provided for in this Article.
3. The application referred to in paragraph 1 shall be accompanied by the following:
(a)
the reference to the original application;
(b)
a technical dossier containing the information required in Article 17(5), including the information of the technical dossier already submitted during the original application in accordance with Article 17(5) and Article 18(2), updated with the modifications. All modifications (deletions and additions) shall be clearly marked and visible in the technical dossier;
(c)
a new complete summary of the technical dossier in a standardised form;
(d)
at least one complete compliance monitoring summary sheet related to a decontamination installation operating the authorised process as submitted to a competent authority in accordance with Article 26, and an updated version which includes all changes, if any, expected to be forthcoming from the requested change.
4. In case the modification concerns a transfer of the authorisation of a recycling process to a third party, the authorisation holder shall notify the Commission before the transfer, indicating the name, address and contact information of that third party. At the time of the transfer, it shall provide the notified authorisation, the technical dossier and all documents included therein to the third party. That third party shall contact the Commission without delay by a registered letter, stating that it accepts the transfer, has received all documents and accepts to meet all the obligations arising from this Regulation and the authorisation.
Modification, suspension and revocation of the authorisation of a recycling process on the initiative of the competent authorities, the Authority or the Commission
1. On its own initiative or following a request from a Member State or the Commission, the Authority shall evaluate whether the opinion, authorisation of a recycling process ran/or the recycling process is still in accordance with this Regulation, in accordance with the procedure laid down in Article 18, which shall apply mutatis mutandis . The Authority may, where necessary, consult the authorisation holder.
2. Prior to submitting a request in accordance with paragraph 1, the Commission or a Member State shall consult the Authority on whether a new evaluation of the authorised process is necessary based on the particulars of the request. The Authority shall provide the Commission and, where appropriate, the requesting Member State with its views within a period of 20 working days. Where the Authority considers that an evaluation is not necessary, it shall provide a written explanation to the Commission and, if applicable, to the requesting Member State.
3. Based on the opinion of the Authority published in accordance with Article 18(1), the Commission may decide to amend or revoke the authorisation. Where needed, the recycling process or the operation of specific decontamination installations may be suspended until these amendments are implemented in the recycling installations based on the process. The status of the registration in the Union register shall change accordingly.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
