The Evolution of Rules Concerning “Novel Food” in China

The basic law regulating food safety regulation in general, and “novel food” regulation in particular, from 1983 to May 31, 2009, was the Food Hygiene Law. From June 1, 2009, the Food Safety Law has provided the legal founda­tion for regulating novel food/material.

Although the Measures on Hygiene of Novel Sources for Food was estab­lished in 1987 as one of the implementing acts for the Food Hygiene Law of 1983, the definition of novelty had not been clarified until the arrival of the Measures on Hygiene of Food from Novel Sources in 1990. According to this rule, four categories of new sources for food had been clarified, includ­ing newly invented sources, newly discovered sources, newly imported sources without history of consumption in China, and existing sources in China with history of consumption only in certain local places. Then, novel food meant the food produced from these novel sources, including food material as well as the final product. It was in line with this definition that genetically modified (GM) food was regarded as novel food.

food from the scope of novel food. As a result, the regulation of GM food has been placed under a separate regulatory framework of GM organisms operated by the agriculture department, such as the Regulations on Administration of Agricultural Genetically Modified Organism Safety. For this reason, it is said that there are legislative gaps regarding the regulation of GM food, while the existing regulation or rules rather than law are at relatively lower levels of legal hierarchy. Thus, the attitude of the government in the regulation of GM food is quite ambiguous.^[523]

With the establishment of the Food Safety Law to replace the Food Hygiene Law in 2009, the new basic law has employed the terms of novel food material instead of food from novel sources and confirmed the requirement concerning pre-market approval. Therefore, the updated Measures on the Safety Review of Novel Food Material in 2013 has further simplified the definition of its target, namely what can be regarded as novel food material. Accordingly, the first gen­eral requirement is the lack of traditional consumption habits in China. A tradi­tional habit of consumption means that a certain type of food has been produced or traded as standard-packaged food or non-standard-packaged food in a prov­ince for over 30 years and has not been listed in the Pharmacopoeia of the Peo­ple’s Republic of China.

In a nutshell, there are three stages with regard to what is focused on by the so-called “novel food regulation.” They are stage I for novel sources, stage II for novel food, and stage III for novel food material. The evolution is first closely linked to the modernization of food safety regulation as a back­ground. As mentioned, the progress of the Food Safety Law replacing the Food Hygiene Law has re-structured the safety guarantee in the interest of public health. As far as the legal framework is concerned, vertical legisla­tion has been completed on the basis of the Food Safety Law to cover dif­ferent food or food-related categories like health food and food additives. This is why the initial scope of novel sources has been narrowed down to exclude products like food additives. Second, experience has indicated that the material-focused rules rather than product-focused ones can reduce the administrative workload and promote the application of novel food material because once a kind of food material is classified as safe raw material, food operators can use it in a variety of food products as long as they respect the requirements regarding the usage quantity and labeling.^[524] That is to say, a food product produced with approved novel food material is regarded as

The Regulation of “Novel Food” in China 139 conventional food rather than novel food. Third, taking the latest definition of novel food material as reference, on the one hand, the final catch-all clause in the form of all other newly developed food raw materials provides flexibil­ity to allow applying for a material resulting from newly advanced science and technology in food production.^[525] On the other hand, the precision of what can be perceived as traditional consumption habits is measured by 30 years at the provincial level. Notably, while novel food from the perspective of tradi­tional food refers to exotic food outside the EU under the European novel food regulation, the different opinion on this aspect in China also includes local food with no history of consumption at the national level. Actually, as a country of diversity in food and food material, such a provision will provide chances to exploit local traditional food and ethnic food while taking account of modernized safety requirements. In this aspect, local food safety standards can be further established if national food safety standards are lacking, which are the mandatory measures to make sure that food entering into the market will not cause hazards to public health.

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