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European Union (EU) promulgated its new regulation, Commission Regulation (EU) 2022/16161, on food contact recycled plastics/recycled plastic FCMs on September 20, 2022. This new Regulation will enter into effect on October 10, 2022. At that time, the current regulation, Commission Regulation (EC) No 282/20082, will be repealed.
Compared with the current regulation, this newly released Regulation sets up a totally different supervision system in the following aspects.
A. Explanation on suitable recycling technologies
As per the new Regulation, from July 10, 2023, only recycled plastic materials manufactured with a suitable recycling technology or novel technology following Chapter IV can be placed on the market.
The new Regulation presently lays down two suitable recycling technologies in Annex I:
Post-consumer mechanical PET recycling, which requires authorization of individual processes as per Articles 17 to 19;
Recycling from product loops that are in a closed and controlled chain, which does not require authorization for individual processes but needs submission of a recycling scheme.
B. New rules regarding novel recycling technologies
Recyclers using a technology that is not presently considered suitable (as listed in Annex I) should consider the procedure applicable to novel recycling technologies. Different from the current regulation, all plastic FCMs containing plastic originating from waste or manufactured therefrom are subject to the new Regulation, including when they are produced by a chemical recycling technology.
Enterprises that want to use novel recycling technologies to produce plastic FCMs shall apply to EU. When the Commission considers there is sufficient data available on a novel technology, it may request the European Food Safety Authority (EFSA) to assess that technology. EFSA will then provide an opinion on whether a novel recycling technology is suitable to be used as a basis for recycling processes. Finally, the European Commission will decide whether the novel technology is a new suitable recycling technology. The whole procedure may last for several years.
C. Detailed recycling process and stricter requirements on inputs
This new Regulation details the recycling process for plastics into three stages, namely, pre-processing, decontamination processing, and post-processing. Each stage is stipulated with elaborate requirements. It’s worth mentioning that this Regulation raises stricter requirements for the collection and pre-processing of plastic inputs. It is said a quality assurance system shall be built to control the plastic waste throughout collection and pre-processing; and such a system shall be certified by an independent third party from October 10, 2024.
D. Enhanced transparency
The new Regulation sets up a Union register, which will provide a comprehensive overview of all operators that recycle plastic FCMs, covering recyclers, recycling processes, recycling installations (refers to equipment), the facilities where these installations are located, recycling schemes, and novel technologies. This register will be launched in the coming months on this website.
Moreover, recyclers shall notify the European Commission and the competent authority in the territory following information at least 30 working days before the start date of production:
The installation and either the address of the facility or the facility number;
Recycler’s registration number if it is registered;
The recycling authorization number if it applies to an authorized process;
The number of the suitable or novel technology, as applicable;
Recycler’s company name, contact persons, and the address of its head office.
Following the notification mentioned above, the installation shall be registered in the Union register. Besides, they shall prepare the compliance monitoring summary sheet using the template provided in Annex II and submit this sheet to the competent authority in the territory within 1 month from the start date of the production of the recycled plastic.
Others
After the new Regulation comes into effect, applications submitted for the authorization of recycling processes shall be deemed terminated when the recycling technology is not regarded as a suitable recycling technology. However, these recycled plastics can still be placed on the market until July 10, 2023. If manufacturers still want to use such a recycling process based on the recycling technology that is not considered suitable, they can consider the procedure applicable to novel recycling technologies.
EFSA has been evaluating the safety of recycling processes since 2010, particularly PET recycling processes. For PET recycling processing that have gotten EFSA’s opinion before, the Commission is in the process of preparing authorizations. These authorizations will be notified to the recyclers in the months following the implementation of the new Regulation and include restrictions and specifications on the use of authorized processes.
Apart from the new Regulation, recycled plastic FCMs must also comply with Regulation (EU) No 10/20113.
More answers to frequently asked questions about this new Regulation can be read in this website: Plastic Recycling4.
Our Services
Our FCM team of REACH24H Consulting Group, the founder of ChemLinked, can provide regulatory compliance services in the U.S., EU, China, Canada, MERCOSUR, Switzerland, etc. With successful experience, we have helped numerous customers solve their food contact material compliance problems in the above-mentioned countries and areas, including but not limited to ESFA/FDA Post-Consumer Recycled (PCR) Plastic for FCMs Registration Service, Declaration of Compliance (DoC) Editing/Checking, U.S. FCN Application, China/EU New Food Contact Substance Application. Feel free to contact [email protected] if you need any help.
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