Last year, China passed several high-impact regulatory reforms that significantly affected market access requirements for international stakeholders. ChemLinked picked our ten most important updates in 2019, listed below in chronological order:
1. Labeling Filing for Imported Prepackaged Food Cancelled From October 1, 2019
As revealed by a GAC announcement issued on April 22, 2019, label filing for imported prepackaged food was no longer required starting from Oct.1, 2019. Instead, labeling inspection will become a regular sampling inspection item during the customs release, and importers may be required to provide relevant documents as needed. Post-market supervision will also be an important stage of label inspection; any compliance violations discovered during market circulation will be subject to severe punishment. (Read more)
ChemLinked Interpretation:The government is trying to foster industry self-regulation, which means enterprises shall bear more responsibilities and be held to a higher level of accountability.
2. China Consults on Infant Formula Recipe Registration Measures
On June 26, SAMR opened the revision of Administrative Measures for Registration of Infant and Young Children Milk Powder Formula Recipes (2016) to public comment. The update mainly strengthens the supervision of infant formula registration (e.g., specifying seven conditions when the registration application will be rejected). The new draft version better encapsulates China’s overriding goal to "streamline administration, delegate powers, and improve regulation and services". (Read more)
ChemLinked Interpretation:
Stricter registration requirements were raised in this draft. It is predicted China will slow down the approval rate of infant formula recipes in an attempt to increase the quality of products. One confusing article in the new draft is the stipulation that “applicants must possess competent R&D, production or testing capacity for target recipe production." Can infant formula manufacturers who co-manufacturer or outsource their product testing or R&D, still apply for product registration? The answer is yes, but the applicants must clarify the production/R&D/testing capacities of all 3rd parties clearly in the application and shall also be responsible for the manufacturing capacities and conditions of all 3rd parties.
3. SAMR Issues Health Food Disclaimer and Labeling Guidelines
On August 20, SAMR released Health Food Labelling Warning Language Guide, which stipulated that the disclaimer 'health foods are not medicines and cannot replace medicine to treat diseases' shall be marked in an obvious area on health food labels. This guideline came into effect on January 1, 2020. (Read more)
ChemLinked Interpretation:
Although this document is called "guideline," it is a mandatory requirement. Hence, products shall all be marked with the disclaimer mentioned in the document. Our advice to stakeholders that trade through crossborder e-commerce is to also provide this disclaimer in mandarin Chineses on the purchasing interface available to consumers.
4. Companies can Propose the Addition of New Health Food Ingredients and Functional Claims
On August 20, 2019, China State Administration for Market Regulation (SAMR) released decree No.13, publicizing Administrative Measures on Directory of Health Food Raw Materials and Directory of Health Functions and announcing its effective date (October 1, 2019). The measures specify basic requirements for health food raw materials and function claims, prohibitions, procedures of expanding the lists, application documentation, and so forth. (Read more)
ChemLinked Interpretation:
Under the old regulatory framework, SAMR would designate qualified agencies to conduct studies on certain raw materials or functional claims before approving or rejecting the claim or the ingredient. Under the new system, companies and individuals will be able to propose the addition of new ingredients to the health food raw materials directory and also expand the permitted functional claims.
5. Updated GB Standards for Pesticides and Veterinary Drug MRLs in Food
On August 15, 2019, China NHC, MOARA, and SAMR jointly released GB 2763-2019 Maximum Residue Limits for Pesticides in Food, which specifies 7107 maximum residue limits (MRL) for 483 pesticides in 356 food categories. This updated standard will come into effect on February 28, 2020. (Read more)
On October 8, 2019, GB 31650-2019 National Food Safety Standard Maximum Residue Limits of Veterinary Drugs in Food was issued. It stipulated restrictions on 2,191 items of 267 kinds of veterinary drugs in livestock, poultry products, aquatic products, and other foods, which will enter into effect on April 1, 2020. (Read more)
ChemLinked Interpretation:
China MOARA aims to set up over 10 thousand items for pesticide MRLs and corresponding testing method standards by 2020. One of MOARA's main goals is to stipulate MRLs for almost all permitted veterinary drugs and edible animal/issues applicable in the next 3 to 5 years.
6. Promulgation of Implementation Rules of Food Safety Law 2019
As revealed by the State Council Notice No. 721 on October 31, China released the new Implementation Rules of the Food Safety Law to satisfy the updated food supervision requirements. It put forward stricter food safety supervision requirements, optimized risk monitoring mechanism, and further detailed entity's responsibilities and penalties. (Read more)
ChemLinked Interpretation:
Compared to the 2016 version, the 2019 version mainly bolstered the parts related to punitive measures, helping the rules earn the title “the strictest implementation rules in history." In addition to enterprises being held accountable, legal representatives, principal persons in charge, directors, and other responsible persons will also face punishments. They may face a fine of between 1 to 10x the amount of their income from the previous year.
7. Affixing Labels to Imported Food after Importation May be Prohibited
On November 21, 2019, China SAMR opened the draft version of “Food Labeling Supervision Administrative Measures” to public feedback. The draft stipulates that imported food shall have Chinese labels, which should be directly affixed, printed, or indicated on the minimum sales unit package during production, before cargo arrives in China. Also, it is not permitted to use statements on labels which include terminology such as "exclusive for…" or wording that indicates a food product is more suitable for specific groups such as infant and young children, children, the elderly, or pregnant women. The use of such labeling claims is limited to products covered by specific national standards or regulations which are specific to certain groups (food for pregnant/lactating women, infant formula). (Read more)
ChemLinked Interpretation:
This draft goes with GAC's broad goal that China’s trade partners and overseas enterprises should bear more responsibility when they are exporting food to China. If this requirement is implemented in the future, foreign manufacturers are likely to incur higher costs during importation. Importers will also need to plan their regulatory compliance strategy more carefully as their products will be subject to heightened scrutiny during customs clearance.
8. Proposed Overseas Manufacturer Registration for All Imported Foods
On November 26, 2019, GAC released a consultation draft on the Administrative Provisions on Registration of Overseas Manufacturers of Imported Foods. The draft stipulates that overseas manufacturers of foods exported to China shall register with GAC and obtain approval before shipment of consignments to Chinese ports. In order to fulfill this requirement, long-distance video inspection will serve as one new method of inspection, making facility registration easier for overseas factories. In line with new manufacturer registration requirements, imported foods shall be labeled with the manufacturer name, address, and registration number on the packaging of the minimum sales unit.
ChemLinked Interpretation:
Currently, overseas manufacturer registration is only applicable to aquatic products, dairy products, meat, and birds nest.
9. More CBEC Pilot Cities, CBEC +List Expanded with 100+ Products
On December 24, 2019, the State Council of China authorized the establishment of CBEC comprehensive pilot zones in 24 cities, which are expected to be the next batch of CBEC pilot cities. (Read more)
On December 27, 2019, China promulgated the List of Cross-border E-commerce Retail Imported Commodities (2019 Edition) and increased the approved commodities from 1321 items to 1413 items, including the addition of aquatic products, liquor products as well as prepackaged pet food. The new positive list came into force on January 1, 2020. (Read more)
ChemLinked Interpretation:
The expected expansion in the number of CBEC pilot cities will afford international stakeholders greater access to lower-tier cities. The CBEC positive list is expected to keep expanding. CBEC will become a more and more important channel for overseas enterprises entering China’s market.
10. NHC Consults on New Labeling Standard, Maximum Limits of Mycotoxins, Contaminants and Pathogenic Bacteria in Foods
On December 31, 2019, China NHC opened 13 national food safety standards for public feedback, including:
National Food Safety Standard Maximum Residue Limit of Contaminant in Food
National Food Safety Standard Maximum Residue Limit of Mycotoxin in Food
National Food Safety Standard Maximum Residue Limit of Pathogens in Food
National Food Safety Standard General Standard for the Labeling of Prepackaged Foods, etc. (Read more)
Any feedback shall be sent back before February 28, 2020.
ChemLinked Interpretation:
Compared to its predecessor GB 7718-2011, the new GB 7718 includes a chapter stipulating the labeling requirements of imported prepackaged food, including character requirements, ingredient list requirements, production date, shelf life, origin countries/regions, etc. Furthermore, allergen labeling will become a mandatory labeling requirement for all prepackaged food products sold in China. Click here to view more about the comparison of other standards.
For a deeper dive into the regulatory reforms that affected China's food sector in 2019, be sure to check out our annual report, which will be released soon!
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