History of the NFR

Novel food is nothing new. Since the 1960s and 70s scientists have focused on plants and microorganisms instead of traditional crops as alternative sources of protein for human beings to counter the worldwide food shortage problem,^[539] while in the 1990s, the improvement of food production through biotech­nology became the new pet of scientists.

These advanced developments, whether involving the appearance or attrib­utes of foods brought about by technological achievements, exceeded the cov­erage of contemporary food-related safety-assessing measures of the EU and resulted in a vacuum in management.^[543] What made the situation complicated was that the different policies adopted by varied Member States^[544] threatened the practical operation of the EU single market. This situation prompted the institutions of the EU to address these challenges with generalized and unified administrative governance through legitimate instruments.

Throughout the legislating process, in line with the principle of “substan­tial equivalence” that “new technologies will not cause food to be inherently less safe than those produced by traditional methods,”^[545] which has been the core logic of the global regulatory framework for a long time, the European Union’s food control authorities began to evaluate and develop new regulation based on the characteristics of so-called “novelty” food.

In July 1992, the EU proposed the first NFR.^[546] Historically, the lengthy pro­cess of discussion, deliberation, and negotiation was known as the most difficult and time-consuming of the EU’s food-related laws at the time. Among the

Revisiting Novel Food Regulation 149 reasons that complicated the situation, the innermost epistemological problem encountered was how to define whether a food is “novel.”^[547]

According to the promulgated texts in Regulation 258/97, novel foods are defined as those foods and ingredients which have not been circulated in the market, that is, commercialized, at a significant scale for human consumption in any of the EU Member States prior to May 15, 1997. Based on this, the relevant EU administrative agencies, initially both the EU institutions and the governments of various Member States, have the right to determine whether a food meets the two conditions listed subsequently and should be regarded as “novel” in the EU “market.”

First, under the EU’s governance, the NFR stipulated the legitimized time and space conditions of novelty. On the one hand, it took May 15, 1997, the day the NFR was enforced, as an arbitrary boundary, while, on the other, it drew on the right to review food that “is not obviously consumed by the people in the EU or not.” The administrations of the Member States and the EU are empowered to judge the condition of “inside vs. outside” the govern­ing territory. These two elements provide a subjective basis for determining whether any food, under the governance of the EU, meets “novel” status.

Under the EU’s jurisdiction, when an “exotic food” is first introduced into the EU “territory,” once it is judged novel, the importer must file an application to the government of the member country where the food is intended to be sold first with relevant scientific safety certifications before it is marketed; cor­respondingly, the relevant authority of the Member State will conduct a pre­liminary evaluation of the food and decide whether it can be legally introduced into the market or further evaluation is needed. The European Commission or any Member State can express reasonable objections to the application, while in the latter case, or when further evaluation by the European Food Safety Authority (EFSA) is required, the relevant EU administrative agencies, includ­ing experts from member States, will be consulted. In other words, under the NFR, novel foods can only be commercialized and marketed through the companies that enjoy the approval issued by the Executive Committee. As for certain products that can be proven “substantially equivalent” to existing foods in the EU market, in accordance with article 5 of the NFR, they are detoured through simplified procedures and can be marketed more efficiently.

However, as mentioned, it is essentially an administrative consideration other than a scientific one to determine which items should be included. For exam­ple, since the very beginning, the European Parliament has expressed objections

to juxtaposing GMOs with other novel foods^[548] under the NFR. Besides, for meat produced from cloned animals, although its identity of “novel” makes it a potential candidate, the design of the regulatory provisions that allowed these products to be sold without clear labeling is deemed totally against the EU citi­zens’ moral values and violated the consumers’ “right to know” in choosing.^[549] Some people argued that the simplified prior notification procedure is too rough to provide any protection for the consumers.

Therefore, in response to these concerns, the EU agencies revised the orig­inal proposal that did not mention consumer protection but only included it in the second legislative reason of the NFR and adopted more stringent texts on procedures and labeling.^[550] As for the controversial GMF, it was finally removed from the regulated subjects in 2003 and placed under the manage­ment of another deliberately formulated regulation, Regulation 1829/2003. The issue of meat produced from cloned animals, for which is difficult to define its “novel” identity, has a pending status and is still attracting the spot­light as a hot topic.

However, after its promulgation in 1997, the NFR encountered challenges that were never touched on in the initial negotiation, namely the continuous changing of the territory of the EU, on which the original time and geograph­ical delineation of the “novel” identity are based. On the other hand, countries outsides the EU that are eager to export traditional domestic crops, such as Peru,^[551] protested that the formulation and implementation of the NFR create a needless obstacle to international trade, especially the lengthy and compli­cated license application process, and interfere with the international flow of goods and economic development under globalization^[552] because traditional food in their country is regarded by the EU as “novel” and treated unfairly.

III.