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On 19th October, the State Council released the revised draft of Implementation Rules of Food Safety Law (hereafter called Implementation Rules) for public consultation. The consultation deadline is the 19th of November, 2016.
The revised Implementation Rules is the major implementation regulation for China’s Food safety law. The implementation rules contain 10 chapters and an additional 54 articles compared to the first draft, bringing the total number of articles to 208. The final version could be implemented as early as 2017 after being passed by the national people’s congress. Influence on food enterprises are summarized in this article.
Highlights:
Labelling of allergic ingredients is mandatory for the first time.
Standards of food additives used in food catering industry will be established.
Manufacturers producing premix and extracts used in health food should obtain a health food production license as well.
Each enterprise can only register or file an individual product formula once. “Special foods” (infant formula, FSMP, health foods) with different recipes formula should use different names.
Stringent inspection on all imported infant formulas against all relevant national standards will be conducted.
Food Safety Standards
China has hundreds of food standards ranging from national standards, local standards, industrial standards and enterprises standards. Too many standards overlap and some are even in conflict with each other. The authority started to streamline the standard system in 2012. Normally, local standards are drafted by enterprises and local research institutions. In the future, local standards will be mainly applicable to local agri-food. For high risk food categories such as infant formulas, foods for special medical purpose (FSMP), food additives, food related products and food safety testing methods, the Implementation Rules stipulates that those foods or food related products should only comply with national standards.
Regarding enterprise standards, previously, enterprises standards should all be filed with provincial health departments, however the new administrative measures of health food registration, infant formula recipe registration and FSMP registration have standards with detailed requirements on corresponding food quality and processing. Enterprises standards for these food categories do not require filing and approval by authorities but should be open to the public for reference.
Another obvious change is that the establishment of food additive standards used in catering will be prioritized. National food safety standards on permitted food additive types, application scope and permitted concentrations will be developed.
Food Production and Operation
The new Food Safety Law reforms the management of food operation and production licenses. In addition to health food manufacturer registration, the Implementation Rules also requires upstream suppliers of premix and extracts used in health food to obtain a health food production license.
Application for novel food material, new food additive or food related products, should include relevant documentation/evidence on product necessity supported by relevant industrial organizations, and safety assessment and research on standards from professional institutions.
Traceability was a hot topic in 2015 and 2016. Several announcements relating to food traceability were released in 2016 (see CL news on 12 Jan., 18 Jan., 8 Jun., 14 Sep.). The new Implementation Rules emphasizes that food producers and operators should keep purchasing and sales record for traceability purposes.For high risk food types like special food, meat, dairy, edible plant oil and alcohol products an electronic traceability system should be established as a priority task. Currently, there are mainly two types of traceability systems promoted by the governments. The first is an internal traceability system within the enterprise which can record purchase and sales activities. The other is external traceability, which can connect the stakeholders along the supply chain, including suppliers, manufacturers, distributors and customer. Guangdong Government has attempted to implement e-traceability already (see CL news on 14 Sep.) although overall the development of traceability systems in China is still on trial. There is no universal e-traceability platform to cover all food categories across the country. Independent enterprise traceability platform, industrial traceability platform (such as meat, agri-food, infant formulas etc.), provincial traceability platform, and third-party traceability platforms co-exist in the market, which is sometimes confusing for customers and those who plan to use traceability for their products. Consequently, the Implementation Rules further stipulates that competent authorities (CFDA, MOA and AQSIQ) should clarify traceability requirements and build food safety data collection systems, transformation formats, data interface standards and coding rules to facilitate data exchange. Traceability is a developing trend of food safety in China, the government plans to have more than 95% of high risk food categories traceable by 2020. Food imported via CBEC has also been earmarked for prioritized implementation of traceability.
In addition, operators of food trade sites are required to shoulder more responsibilities and manage food traders and trade activities on their site, particularly, operators of online food platform and agri-food wholesale markets. The popularity of online-to-offline food platforms have grown in recent years, following increasing concern associated with food safety. Measures for the Investigation and Punishment of Illegal Acts concerning Online Food Safety (see CL news on Jul. 19) have been released which details the investigation methods and punishments associated with violations. Under the Implementation Rules, accountability is designated and all illegal trading activities should be stopped immediately once uncovered by the operator and the competent authority notified immediately. While, operators of agri-food wholesale market should check documents of trader qualification.
Label and Advertisement
Allergen labelling is mandatory for the first time. Foods that are produced from GMO raw materials should comply with relevant regulations, such as the “Regulation on the Administration of Safety of Agricultural Genetically Modified Organisms”. In addition, misleading labelling information should be prohibited. Negative content claims are forbidden such as mentioning a lack of prohibited ingredients or usage of wording such as “not containing”, “not added with” or “non-GMO”. Except for health food, other foods shall not express or imply functional claims.
Special Food
Health foods are commonly placed with medicines in pharmaceutical stores, which often mislead consumers on the efficacy and function of such foods. In future, health food, FSMP and infant formula should be sold on independent counters in designated areas with clear food category labels. Inspection of special food circulating in the market will be conducted by authorized institutions and the qualified institutions list will be released later. To streamline OEM trade, one enterprise cannot register or file one formulation for more than one brand/product line at the same time, and products with different formulations should not use the same product name. The Implementation Rules also prohibits products that are manufactured for regional distribution only, which is very common practice in China’s infant formula industry.
Registration measures and corresponding supplementary documents of Health food have not been finalized yet. The raw material list and permitted function list will be a dynamic system that changes with the release of research outcomes etc. Advertisement of FSMP products will be regulated strictly. Advertisement of specific nutritionally complete food should get prior advertisement approval, while advertisement of other FSMP types will be the same as Over-the-counter medicines.
Food Import and Export
According to the Implementation Rules, CFDA will organize on-site audition of quality management systems and GMP on overseas food manufacturers. Inspection of imported food will be strengthened in the future especially for high risk products. Inspection on all infant formulas should be conducted batch by batch against all relevant national safety standards. As for importation of raw materials designated for use only in health food production, the usage in health food production should be clearly declared, or the authority may reject the importation.
Supervision and Management
The inspection responsibilities shouldered by China’s food safety authorities are extremely burdensome. CFDA will build a food production and operation credit management system to encourage self-compliance. The credit assessment result will impact industry market access, financing and security. A credit system for importers, overseas exporters and overseas food manufacturers has already been developed. AQSIQ publishes a monthly import food blacklist to the public and implements more stringent inspections on low credit enterprises.
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