"Substantial equivalence" is an important concept in the food safety assessment process. It was first proposed by the Organization for Economic Cooperation and Development (OECD) in 1993 in the food industry to evaluate the safety of new foods or food ingredients (including genetically modified food). The core idea is to determine whether new foods are similar in terms of safety to traditional ones by comparing them. If there are no significant differences in key characteristics between new food and traditional food, they can be regarded as "substantially equivalent", thereby simplifying the safety assessment process.

The domestic food industry clearly stipulated and applied the relevant requirements of "substantial equivalence" in the review process of novel food ingredients, which is a situation where the review conclusion of novel food ingredients is "termination of review". The relevant regulations on the review of novel food ingredients clarified the definition of "substantial equivalence", review principles (including comparison objects and comparison contents), the implementing entity of review, the public announcement of the review results, etc.

PART.1 Definition

The Measures for the Administration of the Safety Review of Novel Food Ingredients (Order No. 1 of the National Health and Family Planning Commission) clarified the definition of "substantial equivalence", that is, if a newly declared food ingredient is the same as a food or a novel food ingredient announced in terms of species, source, biological characteristics, main components, edible parts, usage, scope of use, target population, etc., and the adopted processes and quality requirements are basically the same, it can be regarded as equal safety and substantial equivalence.

PART.2 Scope of application, review principles

1) Scope of application: It can be seen from the definition of "substantial equivalence" that it is applicable to the safety review of novel food ingredients.

2) Objects of comparison: According to the Measures for the Administration of the Safety Review of Novel Food Ingredients, in the process of determining whether it is "substantially equivalent", the declared novel food ingredient is compared with a food or a novel food ingredient announced. The Regulations for Safety Review of Novel Food Ingredients provides further explanations on the objects of comparison, namely, general food and the novel food ingredient announced. According to the review results made public by the National Health Commission, it is mostly determined that the novel food ingredients are substantially equivalent to those already announced.

3) Comparison content: Include species, source, biological characteristics, main components, edible parts, usage, scope of use and target population, production process, quality requirements, etc. Among them, where the production process and quality requirements are basically the same, and the requirements for other comparison content are the same, it can be determined as "substantial equivalence".

PART.3 The implementing entity of review and the public announcement of the review result

The review is conducted by the China National Center for Food Safety Risk Assessment (CFSA) under the National Health Commission. Applicants should submit their application materials to the government service hall of the National Health Commission in accordance with the Regulations on the Application and Acceptance of Novel Food Ingredients. After the government service hall accepts the application, it will transfer the materials to the CFSA, which will organize experts to conduct a technical review. After the review determines that the novel food ingredient applied for is "substantially equivalent" to the approved food or the approved novel food ingredient, the novel food ingredient will be included in the Catalogue of Novel Food Ingredients for Termination Review and will be publicly displayed on the official website of the National Health Commission. From the perspective of the application cycle, for novel food ingredients determined as "substantially equivalent", the period from submitting materials to approval and public announcement is much shorter than that of other novel food ingredients, as there is no need to go through the procedures of soliciting external opinions and subsequent review.

Source: Antion

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