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REACH24H Consulting Group, the parent company of ChemLinked, joined the "Technology Symposium on the Safety of Recycled Plastic Food Contact Materials" last week. The symposium is jointly held by the Key Laboratory of China National Center for Food Safety Risk Assessment (CFSA) and Shanghai JS Life Sciences Institute. Experts from CFSA, industries associations and large companies have shared the latest supervision of recycled plastic food contact materials (hereinafter, recycled plastic FCMs) worldwide, the application of recycled plastics in practice, etc.
In this article, ChemLinked summarizes and supplements the worldwide supervision situation regarding recycled plastic FCMs based on experts’ speeches.
US
In the US, there are no specialized regulations for recycled plastic FCMs. The regulatory requirements for food-contact recycled plastics are the same as those for virgin food-contact plastics, i.e., recycled plastics need to abide by the Federal Food, Drug, and Cosmetic Act and Title 21 of the Code of Federal Regulations (21CFR) requirements. Different from the supervision in the EU, it is voluntary for US enterprises to submit applications for the use of recycled plastic FCMs to FDA, following an FDA guidance document named Guidance for Industry: Use of Recycled Plastics in Food Packaging1. After submitting the technical dossier, FDA will start to evaluate the entire recycling process. If FDA concludes that the recycled plastic products produced by this recycling process are safe, the authority will issue a No Objection Letter (NOL) to the applicant confirming that the recycling process in producing relevant recycled plastics is suitable for food-contact applications. Up until December 2022, US FDA released 286 NOLs, among which 67.8% were related to PET. Read more at ChemLinked article: Regulatory Compliance of U.S. Post-Consumer Recycled (PCR) Plastics for Food-Contact Articles2.
EU
In the EU, the safety of recycled plastic FCMs is managed by three parties, European Commission, European Food Safety Authority (EFSA), and member countries. Enterprises that want to use recycled plastics shall submit applications to the supervisory authority of the member countries first, then member countries will refer the applications to EFSA for evaluation3. At last, European Commission will make decision based on the risk evaluation result. As for the corresponding regulatory framework, recycled plastic FCMs and products thereof shall meet Regulation (EC) No 1935/20044 on food contact materials and articles, Commission Regulation (EC) No 2023/20065 on good manufacturing practice for materials and articles intended to come into contact with food, Regulation (EU) No 10/20116 on plastic FCMs, and also the new regulation released last year—Commission Regulation (EU) 2022/16167 on recycled plastic FCMs.
At the symposium, Zhu Lei, Director of Food Safety Standard Division I, CFSA, shared her analysis of this new regulation Commission Regulation (EU) 2022/1616. According to her, the new version has four key changes.
The application scope of the new regulation is expanded to more materials while the scope of the exemption is narrowed down.
The authorized processes are divided into two types, suitable recycling technologies, and novel recycling technologies. Subjects that can be applicants and the information needed to be publicized are also defined.
The requirements for recycling technologies are more stringent and specified, e.g. the requirements for each stage in the recycling process, and the quality requirements for input and output.
Definitions, document requirements, instructions, labels, and GMP are detailed. It is worth mentioning that GMP requirements are quite challenging for enterprises in practice.
Read more about this new regulation at ChemLinked news: How EU’s Supervision on Food Contact Recycled Plastic Changed in Its New Regulation?8
Japan
In Japan, the Ministry of Health, Labour, and Welfare (MHLW) is the competent authority taking charge of recycled plastic FCMs. In 2012, Japan issued a specialized document Guidelines for the Use of Recycled Plastic Materials in Food Equipment, Containers, and Packaging9, specifying the evaluation requirements for safety.
South Korea
In South Korea, recycled plastic FCMs are managed by the Ministry of Food and Drug Safety (MFDS) and the Ministry of Environment. The supervision progress is improving fast in South Korea.
In 202010, MFDS amended Standards and Specifications for Utensils, Containers, and Packages, allowing the use of chemically recycled PET and PEN in food contact materials.
In 202111, MFDS revised the aforementioned regulation and permitted physically recycled PET materials to be used as the raw materials of synthetic resin for manufacturing food utensils, containers, and packages.
In February 2022, the Ministry of Environment issued the Standards of Recycled Materials for Food Packages12.
In December 2022, MFDS updated the Enforcement Rule of Food Sanitation Act13, adding the authorization procedure for using recycled materials in utensils, containers, and packages.
On January 17, 2023, MFDS approved the first physically recycled PET materials14 for manufacturing food packaging.
India
In January 2022, the Food Safety and Standards Authority of India (FSSAI) released a direction regarding the use of recycled plastics15, detailing the guidelines for recycling post-consumer PET for food contact applications and the acceptance criteria for recycled PET resin for food contact applications.
Indonesia
In July 2019, the National Agency of Drug and Food Control in Indonesia (also named BPOM) issued a new Regulation 20/2019 on Food Packaging16. The new regulation permits the use of recycled PET and specifies the permitted and prohibited materials in food packaging.
Thailand
In June 2022, Thailand issued Notification No. 435 B.E. 2022 regarding the Qualities or Standards of Containers Made from Plastic17 and permitted the use of recycled PET.
Taiwan, China
In May 2022, Taiwan released the application process for using recycled pet chips and flakes in food containers and packaging manufacturing. As per the document, Taiwan only accepts the application of physically recycled PET chips and flakes in food packaging manufacturing. For imported recycled PET chips and flakes, the party responsible for inspection declaration shall be the applicant. Read more at ChemLinked News: Taiwan Releases the Application Process for Using Recycled PET Chips and Flakes in Food Container and Packaging Manufacturing18.
Chinese Mainland
There’s no specialized regulation for recycled materials for food contact use in China. China is at its investigation, research, and safety evaluation stage, among which the investigation stage is almost finished. At present, the evaluation is still focusing on physically recycled PET and PE.
ChemLinked Solutions
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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