As put by P.B. Hutt, the history of progress in food and drug regulation over the past century is largely the history of the development of science, not the enactment of statutory provisions.1

Indeed, the development of science not only changes the way food is produced and consumed but also the regulatory response, especially the application of risk assessment to reinforce a science-based risk regulation in a preventive way.

Taking the cultured meat that is currently highly relevant as an example, developments in the business of cultured meat go fast, and both American and European regulators have reacted to deal with this novel food in line with their own exiting legislative arrangements.² Among the others, the system in the EU is specifically designed to handle food developed from newly emerged science and technology, namely novel food regulation. Historically speaking, the European regulation of novel foods³ emerged as a reaction to the application of new technologies in the food domain, in particular the use of genetic modification in food.⁴ Accordingly, foods and food ingredients are considered novel if they have not been used for human consumption to a significant degree prior to May 15, 1997, within the EU. This concept of novel foods not only includes tech-foods, as mentioned previously, but also exotic foods, which may be traditional food with a long history of use outside the EU.⁵ However, six years after the implementation of the so-called Novel Foods Regulation, the regulation of GM foods has been separated and transferred to a series of specific

* This chapter is an update of a previous paper; see “The Regulation of ‘Novel Food' in China: The Tendency of Deregulation” (2015) 10(6) European Food and Feed Law Review 442, 442—448.

1 R. I. Field, Health Care Regulation in America: Complexity, Confrontation, and Compromise (Oxford, OUP 2007), at 114.

2 K. Verzijden & J. Buijs, “Meat 3.0—How Cultured Meat Is Making Its Way to the Market” (2020) 15(2) European Food and Feed Law Review 96.

3 Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients, 1997 OJ L 43, 1.

4 C. Ballke, “The New Novel Food Regulation” (2014) 5 European Food and Feed Law Review 285.

5 M. Hermann, “The Impact of the European Novel Food Regulation on Trade and Food Innovation Based on Traditional Plant Foods from Developing Countries” (2009) 34 Food Policy 500.

DOI: 10.4324/9781003271918-12

The Regulation of “Novel Food” in China 135 regulations, which address requirements for authorization,^[512] traceability, and labeling.^[513] Now, revised regulation on novel food^[514] has introduced a centralized assessment and authorization process that makes the overall process more efficient.

Comparatively, the regulation of “novel food” in China resembles the EU model. For example, cultured meat also became a hot topic for the representatives at the two sessions^[515] this year. To facilitate business development and protect public health, a representative from the Chinese People’s Political Consultative Conference (CPPCC) has proposed regulating cultured meat like the EU, since the Measures on the Safety Review of Novel Food Material in China is like the Novel Food Regulation in the EU.^[516] Yet such regulation in China can be traced back in 1990. Generally speaking, the specific rule targeting “novel food” was Measures on the Hygiene of Food from Novel Sources, implemented in 1990. Accordingly, hygiene assessment and pre-market approval were required if the food were legally classified as novel, such as newly invented food or newly imported food without a history of use in China. As a new invented food from biotechnology, GM food should be subject to the requirements provided by this general rule. What is more, to reinforce the regulation of GM food and protect consumers’ health and right to know, a specific rule, the Measures on Hygiene of Genetically Modified Food, was established in 2002.

In addition to safety assessment and pre-market approval, this rule also required the food producer to keep records and perform labeling.^[517]

In comparison to the EU, the specifics of regulating “novel food” in China can be outlined and illustrated as follows. First, while the so-called Novel Foods Regulation targets food and food ingredients in the EU, the regulated targets in China have evolved from novel sources towards novel food and finally focused on novel material (as shown in Table 9.1). That is to say,

Table 9.1 Successful authorization of domestic produced or imported novel food/material

Figure 9.1 The evolution of rules concerning “novel food” in China

currently, “novel food material regulation” is a more precise label for the approach in China. Second, while the safety assessment constitutes a prerequisite administrative approval, the procedure has been streamlined to provide deregulation to a certain degree, in particular by introduction of a substantial equivalence principle. Third, the traditional custom that the same raw materials such as plants can be used for both food and medicine because of their beneficial health effects is taken into consideration.^[518] As a result, traditional materials like herbals can be further exploited as novel food material to promote health food.^[519] In view of this, not only the definition of food in the Chinese Food Safety Law but also the regulation of novel food material has taken into account such Chinese characteristics. Last but not least, there is the relation to patent law. Food safety is a highly sensitive issue. The competent authority responsible for granting patents has been blamed in the case of “poisonous gelatin” made from leather due to their failure to guarantee safety by granting a patent to such artificial gelatin.^[520] Consequently, while investment in the development of novel materials can be encouraged by patent protection, the competent authority is under pressure to consider safety during the review of applications.

The Regulation of “Novel Food” in China 137

<< | >>

↑

Source: Ni Kuei-Jung, Lin Ching-Fu (eds.). Food Safety and Technology Governance. Routledge,2022. — 252 p.. 2022

As put by P.B. Hutt, the history of progress in food and drug regulation over the past century is largely the history of the development of science, not the enactment of statutory provisions.1

More on the topic As put by P.B. Hutt, the history of progress in food and drug regulation over the past century is largely the history of the development of science, not the enactment of statutory provisions.1: