Outlook about China's Supervision Policy for Recycled Plastics in Food Contact Materials

As countries worldwide are grappling with severe plastic pollution, strategic goals and policy systems for plastic pollution governance have been introduced across the world, primarily focusing on reducing plastic use and increasing recycling rates. Given the widespread and massive use of plastic products in the food industry, if recycled plastics are to be utilized in food contact materials, ensuring food safety is paramount. Up until now, many countries and regions, such as the United States (US), the European Union (EU), Japan, and South Korea, have developed legislative measures to address the safety issues associated with the application of recycled plastic in food contact materials (FCMs). In assessing whether recycled plastics can be used in FCMs, these countries generally focus on the performance of recycling process, pollutant removal test results, and the condition of final products.

In China, the State Administration for Market Regulation (SAMR) abolished the "Detailed Rules for Examination of Production License of Plastic Packaging, Containers, Utensils and Other Products for Food Use" in 2018, which was previously promulgated by the former Ministry of Health in 2006. Ever since then, no laws and regulations have been established for the application of recycled plastics in FCMs.¹ However, against the backdrop of environmental protection, circular economy, and green consumption strategies, the utilization of recycled plastics in FCMs should become a key component in achieving China’s sustainable development goals. Presently, China National Center for Food Safety Risk Assessment (CFSA) of the National Health Commission (NHC) is leading the investigation and technical research on recycled plastics for food contact applications. If the study progresses smoothly, the management framework for recycled plastics FCMs tailored to China's national conditions may be enacted in 2024.

Among all the countries and regions that have already established legislative measures for recycled plastics FCMs, the US and the EU have developed the most comprehensive supervision frameworks. China, in its efforts to address this issue, is likely to draw upon the advanced experiences of these countries. Based on REACH24H’s compliance experience in the US and EU, we conjecture the future policy for recycled plastics in FCMs that China may adopt as the following. This article aims to facilitate industry communication, while acknowledging that the final management requirements should follow the regulations issued by the Chinese authorities.

I. Types of Recycled Plastics Approved for Use

The US does not restrain the types of recycled plastics. Applicants are allowed to apply for the No Objection Letter (NOL) from the Food and Drug Administration (FDA) for all types of recycled plastics. The most common applications are for polyethylene terephthalate (PET), as well as polyolefins, which includes polypropylene (PP), high-density polyethylene (HDPE), linear low-density polyethylene (LLDPE), and low-density polyethylene (LDPE). Other plastic categories involved in the applications are polystyrene (PS), polylactic acid (PLA), polycarbonate (PC), etc.

In the EU, PET is the only recycled plastic permitted to be used in FCMs through physical recycling. However, with the adoption of closed-loop recycling technology, other types of recycled plastics can also be utilized in FCMs.

With respect to China's circumstances, the primary types of waste plastics in China's recycling market are PET, PE, and PP, as indicated in the Report on the Development Trend of China's Plastic Recycling Market and Future Investment Forecast (2022-2029)² published by the Guanyan Report Network. Among them, waste PET holds the largest share, with a recycling volume of 5.5 million tons, accounting for 29%. Following that, waste PE and waste PP contribute with recycling volumes of 4 million tons and 3.8 million tons in 2021, accounting for 21% and 20%, respectively. Correspondingly, the top three recycled pellets in China are rPET, rPE, and rPP.

Therefore, based on the urgency of addressing the current plastic pollution issue in China and the actual industrial situation, these three types of materials need to be covered in the management system for the long run. However, considering the more comprehensive research on rPET and the fact that rPET itself is easier to achieve cleanliness, REACH24H speculates that if China introduces a regulation on recycled plastics for food contact applications this year, a rPET-related standards may come first.

II. Applicable Plastic Recycling Processes

According to US FDA's guidance document Guidance for Industry: Use of Recycled Plastics in Food Packaging (Chemistry Considerations)³, in the US, plastic recycling processes can be categorized into three types: primary recycling, secondary recycling (physical recycling), and tertiary recycling (chemical recycling).

• Primary recycling is the recycling of pre-consumer industrial scrap produced during the manufacture of FCMs. Following the good manufacturing practices, such industrial scrap can be recycled and used into food packaging.

• Secondary recycling, also known as physical recycling, involves a series of mechanical processes such as grinding, washing, melting, and extrusion of the recycled materials, with the purpose of removing contaminants. The polymer composition and structure of plastic pellets and sheets remain unchanged after the process.

• Tertiary recycling, also known as chemical recycling, refers to the process of regenerating purified monomers or oligomers, which are obtained through depolymerizing the used packaging material with subsequent processes like distillation and purification, where contaminants will be removed.

In the EU, the utilization of recycled plastic FCMs is governed by Commission Regulation (EU) 2022/1616 on Recycled Plastic Materials and Articles Intended to Come into Contact with Foods⁴. As per the regulation, only plastics containing recycled plastic manufactured through a suitable technology or novel technology can be placed on the market. Suitable recycling technologies, as specified in this regulation, include a) post-consumer mechanical PET recycling, which requires authorization of individual processes, and b) close-loop recycling. Any other recycling process is considered a novel technology, which requires a longer application process that can span several years.

Regarding the circumstances in China, there is a considerable presence of plastic recycling companies. However, when it comes to producing recycled plastic materials for FCMs, the number of capable enterprises is limited. This is primarily due to the stringent requirements for the decontamination and cleaning of plastics during the production of food-grade recycled plastics. Currently, there are several companies in China that possess the capability to produce recycled plastic FCMs and have obtained the authorization or recognition from regulatory bodies such as the US FDA or European Food Safety Authority (EFSA). These companies include Guolong Recyclable Resource Development, Kingfa Sci.&Tech., Ceville Materials, BoReTech, and Shanghai Re-poly, etc. Notably, their authorized recycling processes are primarily physical recycling technologies. In the field of chemical recycling, ensuring the purity and yield of recycled products requires advanced recycling processes. Chemical recycling on a large scale faces some difficulties, but leading domestic companies are actively advancing in this field, including Sinopec, Wanhua Chemical, COMY, Beijing Aerospace Petrochemical, etc.

For China’s future policy on recycling process, CFSA revealed that China may be more inclined to follow the EU’s approach, i.e., evaluating the pollution levels of different types of plastics individually and approving the applicable recycling processes stage by stage. Currently, CFSA’s final evaluation of physically recycled PET is nearing completion, with a batch of pilot companies having passed the challenging tests. However, the evaluation procedures for PE and PP are still ongoing. Therefore, it can be expected that closed-loop recycling and physical recycling processes will certainly be accepted in China. As for chemical recycling, whether China will adopt a cautious approach similar to the EU, i.e., imposing additional requirements and limitations, remains to be seen.

III. Approval Method

In the US, FDA is the competent authority supervising the use of recycled plastics in food packaging. Major legislative framework consists of federal regulations, namely, Food, Drug, and Cosmetic Act (FD&C Act)⁵ and Code of Federal Regulations - Title 21 - Food and Drugs⁶, as well as the specific guidance Guidance for Industry: Use of Recycled Plastics in Food Packaging (Chemistry Considerations)³. The primary regulatory oversight method employed by the FDA is the issuance of a No Objection Letter (NOL), as mentioned above. FDA NOL serves as an official statement provided to a specific entity or organization, signifying that the FDA does not raise any objections or opposition to a particular operation, plan, or the submitted document of that entity or organization. Obtaining an NOL is voluntary instead of mandatory for companies under the US regulations. However, many enterprises still choose to apply for an NOL, as the NOL represents the FDA's positive evaluation of the company's recycling process, making it highly valued by the upstream and downstream sectors of the recycled plastics industry.

In the EU, the compliance obligations for manufacturers of recycled plastic FCMs include the registration of recycling installation, notification of closed-loop recycling schemes, authorization applications for mechanical PET recycling processes, and authorization applications for novel technologies. The authorization for a mechanical PET recycling process requires the administrative review and risk assessment conducted by EFSA. After obtaining a positive Scientific Opinion Letter (SOL) from EFSA, corresponding recycling process can be considered officially recognized by EFSA.

China has not issued regulations regarding food contact recycled plastics. In terms of supervision, multiple departments are involved but an overall management approach has not yet been formed. However, stakeholders can refer to the declaration and approval process of food-related products by the NHC to gain insights. Taking the approval of new FCM varieties as an example, the approval process consists of the following steps:

• First, the applicant submits complete dossier to the NHC;

• Then, the NHC will organize experts from the CFSA to conduct a technical review;

• Once the dossier passed the review, CFSA will issue announcement to solicit public opinions;

• Finally, the NHC will decide whether to approve the substance based on the technical review and suggestions, and issue a final announcement.

Substances that receive approval through these announcements are permitted for use by all companies, provided they are in line with the specified conditions outlined in the announcements. Furthermore, these substances will be included in the positive list in the corresponding standard in the upcoming amendment.

REACH24H conjectures that the approval process for recycled plastic FCMs will follow a similar administrative management approach with food related products. This would involve the submission of necessary dossiers, followed by a technical review process and then announcements of approved enterprises and specific recycling processes. However, considering substantial variations in technical routes and equipment employed by different enterprises, it is highly possible that the application for recycling processes will be evaluated on a case-by-case basis. In other words, each recycling enterprise would need to obtain individual approval for each of their recycling process. This approach is the same with the officially recognized practices in the US and EU.

IV. Application Dossier

In the US and EU, the content of and requirement for registration dossiers are quite similar, mainly including:

• Description of feedstock. Applicant needs to provide a detailed description of the source of the recycled plastic feedstock, an explanation of the contamination level of the feedstock, how the consistency of the plastic type is controlled, as well as the explanation of some basic physicochemical characterizations of the feedstock, such as melting point, density, and spectrogram.

• Description of the recycling process. A process flow diagram for the recycling process shall be submitted, including detailed parameters for each step. The EU additionally requires the submission of a piping and instrumentation diagram. The effectiveness of the decontamination process shall be evaluated through challenge tests. The recycling process will be considered qualified if the level of residual contaminants does not exceed the safety threshold.

• Product compliance test results. Recycled pellets used in the production need to pass the tests for residues, migration, and other tests required by the regulations to ensure the product compliance.

• Declaration of the specific intended use scenarios. This involves providing information on the intended use temperature, types of food which it is intended to be put in contact with, contact time, and whether it is single-use or repeated use. Such information needs to be communicated to downstream users. The EU additionally requires a declaration of conformity for FCM products.

REACH24H conjectures that China's dossier requirements for recycled plastic FCMs will be similar to those of the US and EU. Applicants need to provide information on the source of feedstock, a description of the recycling process, test results showing that the recycled pellets comply with the GB 4806.7 National Food Safety Standard — Food Contact Plastic Materials and Articles⁷, as well as a declaration regarding the intended use scenarios for the recycled material.

V. Testing Requirements

Surrogate contaminant testing, or challenge test in the EU, is a common method used to evaluate the effectiveness of recycling processes in removing potential contaminants/residues from plastic materials.

In the US, during the test, plastics are soaked to the surrogate solution of four different organic substances to simulate the potential environmental contaminants and contamination process. The four organic substances are: a) volatile polar organic substance, b) volatile non-polar organic substance, c) non-volatile polar organic substance, and d) non-volatile non-polar organic substance. Afterwards, subsequent analysis is conducted to evaluate the efficacy of the recycling process and ensure the quality and safety of the recycled plastics.

The general procedure for surrogate contaminant testing in the US is as follows:

• Step 1: Select one surrogate per category below and mix them by using hexane or heptane as the solvent, to obtain the surrogate solution.

• Step 2: Expose the virgin plastics of the declared recycled plastic type in the surrogate solution and soak for 2 weeks at 40°C. Then measure the sorption values of surrogate contaminants in the virgin plastic.

• Step 3: Conduct a complete or simulated decontamination process for the contaminated plastic and test if the residual levels meet the requirements. Different polymers have different residual migration limits. The table below shows the migration limits for four common polymers (PET, PS, PVC, and PP).

• Step 4: If the measured residual level is below the limit value, the surrogate contaminant testing is considered to be successful. Otherwise, additional migration testing and/or additional calculation by the migration model need to be considered.

Surrogate contaminant testing is more commonly known as “challenge test” in the EU. When conducting the challenge test for PET materials in EU, the materials will be contaminated with a large quantity of chemical simulants, then go through the recycling processes. After undergoing the entire recycling process, the regenerated plastics shall be sampled and analyzed for the residual levels of chemical contaminants. By comparing the initial residual concentration in the plastics with the residual concentration after the recycling process, the decontamination efficiency of the recycling process can be determined through the following formula: residual contamination level after regeneration process = 3 mg/kg* x (100% - decontamination efficiency%). [*Note: EFSA assumed that PET flakes for recycling are contaminated with 3 mg/Kg⁸ of PCR substances]

As a common testing requirement, surrogate contaminant testing/challenge test will undoubtedly be regarded as an important evaluation approach in China as well to assess the efficacy of recycling processes. During the 28th China Plastics Recycling Conference & Exhibition (ChinaReplas2023), Dr. Zhong Huaining, a researcher from the National Key Laboratory for Food Contact Materials Testing (Guangdong), mentioned the contamination level in China in his speech "Research Progress of Recycled Materials Used in Food Contact Materials in China". According to Dr. Zhong, a preliminary investigation into the contamination levels of PET products in China has revealed that the surrogate contaminants used in the US and EU cannot fully encompass the contaminants detected in China. Therefore, the PET assessment panel at CFSA will establish an initial concentration level of contaminants for PET products based on the Chinese context. Additionally, the contaminants recommended to be considered in China may differ from those in the US and EU due to variations of contamination environments. Therefore, companies are suggested to await the release of official regulatory documents to obtain precise details regarding testing parameters and contaminant types. Overall, it is believed that this testing requirement will align with the Chinese context and be feasible for enterprises to meet.

REACH24H Solutions

The FCM team of REACH24H Consulting Group, the founder of ChemLinked, is professional in 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, 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, and China/EU New Food Contact Substance Application. For any assistance, please feel free to contact chengzhenyu@reach24h.com.

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