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Top 10 Food Regulatory Updates in China of 2021

2021 was a year of significant events and progress in the food industry in China. As we are stepping into 2022, ChemLinked brings you the top 10 news in China to look back on 2021 and kick start the new year. 

1. GACC Decree 248: Provisions for Overseas Food Manufacturer Registration 

On Apr. 13, 2021, General Administration of Customs of China (GACC) unveiled the long-awaited Regulations of the People’s Republic of China on the Registration and Administration of Overseas Manufacturers of Imported Food (Decree 248), which has been effective since Jan. 1, 2022. Later, GACC released the corresponding interpretation, implementation measures, the official registration system and the enquiry platform.

Decree 248 expanded the application scope of overseas manufacturer registration from the former four food categories to all. However, food additives and food-related products are exempted. Overseas manufacturers producing the 18 food categories with relatively higher risk should be recommended by their local competent authorities to complete the registration; others should register with GACC by themselves via the registration system. Applicants can check the approved Chinese registration number on the enquiry platform and use it for import declaration. (Read more)

ChemLinked's Interpretation:

The release of Decree 248 is definitely the most vital regulatory event in 2021. It greatly effects all overseas food manufacturers who intend to trade with China, except for those already registered manufacturers producing the former four food categories. It also sets new labeling requirements for imported food. For now, the registration of manufacturers is proceeding quickly and well. 

2. GACC Decree 249: Administrative Measures on Safety of Import and Export Food 

On Apr. 13, 2021, GACC released the Measures of the People's Republic of China for the Administration of Import and Export Food Safety (Decree 249), which has taken effect on Jan. 1, 2022. Later, GACC published the interpretation as the supporting document.

Decree 249 applies to the production and operation activities of import and export foods, excluding food additives and food-related products. It specifies new labeling requirements for imported health food, food for special dietary uses, frozen and fresh meat, and aquatic products. Besides, it details the conformity assessment of imported food and demands importers to bear more responsibilities of food safety. (Read more)

ChemLinked's Interpretation:

Among the regulatory changes brought by Decree 249, the new labeling requirements for several food categories is of outstanding importance. Given the fact that the labeling of imported food has always been a black spot, it can never be overstated that stakeholders should be more attentive on the new labeling provisions stipulated in Decree 248 and 249.

3. New GB Standards for Infant Formula 

On Mar. 18, 2021, China National Health Commission (NHC) released the new national food safety standards for infant formula (GB 10765-2021), older infant formula (GB 10766-2021), and young children formula (GB 10767-2021). These three standards replace GB 10765-2010 and GB 10767-2010, and will be effective on Feb. 22, 2023 with a two-year grace period. Later, SAMR released the following-up notice and Q&A guidance regarding the infant formula recipe registration under the new GB standards and during the grace period.

Notably, the new standard GB 10766-2021 is newly set and exclusive for stage 2 infant formula. Choline becomes the essential ingredient in both stage 1 and 2 formula. Nutrients and protein level are also adjusted to ensure efficacy and safety. (Read more)

ChemLinked's Interpretation:

As we all know, recipe registration is a tricky problem and usually takes a lot of time and efforts, especially for overseas enterprises. Despite the grace period, it is still recommended to comply with the new GB standards as soon as possible, e.g, adjusting the product recipe, since the new requirements will become mandatory after the new GB standards come into effect.

4. New Ingredients and Dosage Forms for Health Food Filing 

On Feb. 1, 2021, SAMR released a notice which specified the dosage forms, auxiliary materials and technical requirements allowed for filing health food using the five ingredients, namely, coenzyme Q10, reishi shell-broken spore powder, spirulina, fish oil and melatonin. However, only Chinese domestic health food products that uses the five ingredients are subject to filing. (Read more)

Later on Feb. 20, 2021, SAMR published the Dosage Forms and Technical Requirements for Health Food Filing (2021 Edition) and the List of Auxiliary Materials for Health Food Filing and Terms of Use (2021 Edition). Both came into effect on Jun. 1, 2021. According to the two regulations, gelatinized confection and powder are added as the allowed dosage forms for health food filing; the updated auxiliary material list for health food filing includes 197 items. (Read more)

Recently, SAMR opened the drafts of Health Food Raw Materials Directory - Nutrient Supplement (2022) and Health Function Catalogue Allowed for Health Food Claims - Nutrient Supplement (2022), as well as Health Food Raw Material Directory - Protein for public comments. Once these drafts get approved, six new ingredients will be listed in health food raw materials directories. As a result, imported nutrient supplement using DHA can bear the claim to supplement n-3 polyunsaturated fatty acids and enter the Chinese market by filing. (Read more)

ChemLinked's Interpretation:

China has been active on the regulatory revisions regarding health food, so as to boost the industry. More new ingredients and dosage forms allowed for health food filing provide more freedom and convenience for overseas manufacturers in terms of health food production and market access. Despite that first-imported health food using the five ingredients including coenzyme Q10 are still required to register, industrial insiders revealed that SAMR might consider a facilitation for the registration of such imported products.

5. Updated GB Standard for MRLs of Pesticides 

In Mar. 2021, Ministry of Agriculture and Rural Affairs (MOARA) unveiled the new GB standard for the maximum residue limits (MRLs) of pesticides in food (GB 2763-2021), which implemented on Sept. 3, 2021.

It specifies the MRLs of 564 pesticides in 376 types of food, amounting to 10,092 items, which are almost twice as the number of items stipulated in Codex Alimentarius Commission. Notably, in order to strengthen the supervision of imported agricultural products, the MRLs of 87 unregistered pesticides are stipulated. (Read more)

ChemLinked's Interpretation:

The new standard outnumbers the previous version by a large margin in terms of the covered pesticides and MRL items, especially for imported agricultural products. In addition, the high stringency revealed by the provisions is also a highlight of this revision.

6. Updated GB Standards for Contaminants 

In Mar. 2021, China NHC issued the Amendment No. 1 of GB 2762 Maximum Levels of Contaminants in Foods with immediate effect, adding the maximum limit of cadmium in grain complementary foods for infant and young children as 0.06 mg/kg. (Read more)

Later in Sept. 2021, NHC unveiled GB 29921-2021 Pathogen Limit in Prepackaged Foods and GB 31607-2021 Pathogen Limit in Bulk Ready-to-eat Foods to replace GB 29921-2013. The new GB 29921-2021 came into force on Nov. 22, 2021. Major changes include the addition of the maximum level of pathogens in dairy products and special dietary food, the addition of Annex A—Description of Food Category (Name) for product classification and the revision of test items for five major food categories. (Read more)

ChemLinked's Interpretation:

Playing a critical role in risk management, the control over pathogen limit in food shall never be underestimated. Food enterprises need to check the food ingredients they use, to ensure there's no violation of pathogen limit in food ingredients. Particularly, for dairy and special dietary food, in addition to their corresponding product standards, they shall also meet the pathogen limit specified in GB 29921-2021.

7. Updated GB Standard for Cheese 

On Mar. 18, 2021, China NHC released the long-anticipated GB 5420-2021 Cheese with effect from Nov. 22, 2021, whose previous version has been used for 12 years since 2010. The biggest highlight of the revision was the deletion of yeast and mold limits. In addition, the limit of pathogenic bacteria specified in the 2010 version were deleted. Other changes mainly include the revision of definitions, the addition of the requirements and conditions for claiming hardness and fat content, etc. (Read more)

ChemLinked's Interpretation:

As a promising sector in the dairy market, the import volume and value of cheese has been climbing steadily. In spite of the general recession caused by covid pandemic, the import volume of cheese gained a striking 37% growth. Industrial insiders point out that the implementation of the new cheese standard will make the types of imported cheese more diversified and will enrich the market supply.

8. The Second Draft of GB Standard for the Use of Food Additives 

On Mar. 31, 2021, China NHC opened the second draft of GB 2760-2014 Standard for the Use of Food Additives for public feedback. The draft incorporates the food additives approved by 18 previous notifications issued by NHC and removes some rarely-used food additives. The usage requirements of some food additives are also revised, which involve the application scope, dosage, and functions. As for the processing aid, the use of hydrogen peroxide is subject to more stringent requirement as it has specific functions and limited application scopes. (Read more)

ChemLinked's Interpretation:

The correct use of food additives is strongly correlated with food production and labeling, and a crucial factor of the market access. The current GB 2760-2014 was implemented in May 2015. In 2017, China released the first consultation draft, then in March of 2021, it was under consultation for the second time. The second draft improves the coverage of approved food additives, revises the use requirements for some additives, and optimizes the search mechanism. It is regarded as a move to make the standard more practical and user-friendly.

9. The Third Draft of GB Standard for Nutritional Labeling of Prepackaged Foods 

On Sept. 26, 2021, China NHC opened the third draft of GB 28050 General Rules for Nutrition Labeling of Prepackaged Foods for public feedback. Compared to the current version, this draft expands the application scope. For prepackaged food that is not provided to consumers directly as well as food packages for storage and transportation, if the corresponding nutrition labeling for prepackaged food is required, it should comply with this draft. The content of saturated fat (or saturated fatty acid) and sugar is listed as compulsory labeling items in this draft. Moreover, the maximum of the largest surface area for food exempted from nutrition labeling is changed to 40 cm2. (Read more)

ChemLinked's Interpretation:

This draft amends some requirements for nutrition labeling, and promotes the healthy lifestyle by adjusting the labeling of nutrients, so as to help the implementation of the Healthy China 2030 Plan. Compared with the previous version, the content of this draft has been adjusted according to the industry feedback. Stakeholders can keep an eye on the subsequent changes and prepare early.

10. FCM Regulatory Updates 

On Sept. 16, 2021, China NHC unveiled the new version of GB 31604.8-2021 Food Contact Materials and Articles Determination of Overall Migration with effect from Mar. 7, 2022. The new version extends the application scope of overall migration determination to olive oil, demands for higher precision, and introduces two methods to check the water sensitivity of the sample. (Read more)

In 2021, China also consulted on several FCM regulations, such as the drafts of GB 4806.10-2016 Paints and Coatings in Contact with Foodstuffs, GB 4806.11-2016 Rubber Materials and Articles in Contact with Foodstuffs and GB 4806.7-2016 Plastic Materials and Articles in Contact with Foodstuffs.

ChemLinked's Interpretation:

The new GB 31604.8-2021 was a significant update with many critical changes. As China increasingly intensify the supervision on food safety, more FCM regulatory revisions and improvements can be anticipated.

Of course, it is impossible to wrap up the whole 2021 with this top 10 list. For more regulatory events happened in China and the rest of Asia Pacific region over the past year, stay tuned with ChemLinked for our limited-time free webinar: A Look back at 2021 with ChemLinked Food Regulation Updates

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