Closely tied to food safety, food-related products have received widespread attention. It is likely for some hazardous substances to migrate from food packaging and containers to food products and pose potential risks to human health. China is no stranger to food contact contamination scandals. Ensuring the safety of food contact materials (FCM) plays a key part in China’s efforts on achieving a food-safety society.
China has been making efforts on constantly optimizing the regulatory environment. On March 1, 2022, China National Health Commission (NHC) officially approved 19 food-related products. (Check the news.) Among them, a new variety of FCM additive is successfully granted the approval, which is submitted by a corporate with professional support from Reach24H, the founder of ChemLinked. With the approval, Reach24H has assisted the corporate and the whole industry taking a significant step in exploring a wider market.
Q1: What are food-related products?
FCM Team from Reach24H: As per Food Safety Law, food-related products conclude:
1. Food packaging materials, containers, as well as tools and equipment for food production and operation. They are commonly called food contact materials and articles.
2. Detergents and disinfectors
Q2: What is the legal basis for new food-related product registration?
FCM Team from Reach24H: Since there is always uncertainty on the safety during the use of new food contact materials, so it is particularly important to evaluate the safety before putting them on the market.
According to Article 37 of Food Safety Law, for the use of new food-related products, applicants shall submit the safety assessment materials relative to the product to NHC. Specific scope, material requirements and registration procedures are stipulated in Provisions on Application and Acceptance of New Varieties of Food-related Products and Provisions on Administration of Administrative Licensing for New Varieties of Food-related Products.
Q3: What kinds of food-related products need to complete new substance application?
FCM Team from Reach24H: In China, the following materials are subject to new substance application.
Food packaging materials, containers and additives that have not been listed in the national food safety standards or NHC Announcements;
Food packaging materials, containers and additives that intend to be used with expanded application scope and usage;
New materials and new additives in food production and operation tools or equipment that directly contact food;
New raw materials not listed in the list of raw materials of disinfectants and detergents for food.
Q4: How about the overall performance of new substance application? How likely for the application to be granted approval?
FCM Team from Reach24H: Please see the below chart of accepted applications and approved applications over the past five years. In conclusion, with professional support and compliance guidance, it is very likely to get the application approved.
Q5: What are the required materials for new substance application?
FCM Team from Reach24H: The required materials are listed in the table below.
NO. | Materials | New Substance | Use or usage scope expansion |
1 | Application form | √ | √ |
2 | Physicochemical property | √ | |
3 | Technical necessity, purpose and use conditions | √ | √ |
4 | Manufacturing Technique | √ | |
5 | Quality specification requirements, test methods and test reports | √ | |
6 | Toxicological safety assessment data | √ | √ |
7 | Migration and/ or residue, estimated dietary exposure and its assessment method | √ | √ |
8 | Materials or supporting documents of permitted usage at home and abroad (the substance shall be allowed in at least 2 foreign countries) | √ | |
9 | Other information that may assist in the evaluation | √ | |
10 | Scope of use and usage | Only for new additives | √ |
Q6: What is the workflow of new substance application?
FCM Team from Reach24H: The workflow can be summarized as the chart below.
As revealed by the flow chart, during new substance application, challenges such as complex procedures and relatively long evaluation period do exist. That's why professional team and reliable service really matter.
With rich experience and expertise, as well as strong communication ability with applicants and competent authorities, Reach24H together with ChemLinked have overcome a great number of difficulties during the application, and paved a way for our corporate clients and the whole industry to move forward. If you have any FCM-related query or demand, don't hesitate to contact us.
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