Current Safety Assessment and Administrative Approval

The introduction of the risk assessment principle and substantial equivalence principle by Measures on Food from New Sources of 2007 was a turning point in the transition from hygiene assessment to safety assessment.

As far as the substantial equivalence principle is concerned, if a certain new food raw material regarding which an application has been filed and a food or a new food raw material that has been approved are equivalent in terms of spe­cies, source, biological property, main ingredients, edible parts, usage quantity, scope of use, potential consumers, and other aspects, and they adopt basically the same techniques and quality requirements, they may be deemed equally

safe and substantively equivalent. With this provision, it is the responsibility of the experts, who are selected from an expert database consisting of professionals from the domain of food, nutrition, and medicine, to carry out the review. If the reviewer finds that the applied novel food material is substantively equiva­lent to conventional food or announced novel food material during the review, he or she can close the review.

Following the expert opinion, pre-marketing approval issued by the respon­sible health department constitutes the basic legal mechanism for using novel material in food production. Along with the evolution of legal requirements, there are the following changes regarding the approval procedures. First, before 2007, the approved new sources could be used in production and marketing only within a given location for a trial period of two years. During this period, the composition and production method would not be allowed to change and the involved technique could not be transferred to others, either. Second, the catalogue of approved novel food and food material has been established since 2007 and announced to the public. Accordingly, food operators can directly use the listed food materials as long as they respect the requirements provided in the announcement, such as the usage quantity and labeling. Notably, the health department also has the power to exclude an approved food material from the catalogue in two situations. One case is when the concerned food material is deemed as safe as conventional material on the ground of a period of safe use, and the other case is that the food material at issue is not safe anymore given new scientific opinion issued from a re-review. Third, with the develop­ment of administrative law, the rule of law in the approval procedure for novel food material has also been strengthened. As accompanying rule to the Meas­ures on the Safety Review of Novel Food Material, the Rule on Application and Review of Novel Food Material has reinforced the competent authorities’ responsibility in paperwork like in-time notification in receiving the applica­tion, demanding additional documents, or refusing an application.

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