Pre-market Authorization of Food Ingredients and Products in Chinese Food Law: Legal Systematic Analysis of the Pre-Market Authorization Requirements of Food Ingredients and Products in the People’s Republic of China

Abstract

The basic principle of food safety regulation in the People’s Republic of China is that foods are not subject to explicit permission but that food businesses will be held responsible when the food they produce or distribute violates food safety norms. However, certain categories of food materials and end-products do require explicit permission before they can be produced and subsequently distributed. In other words: they are subject to a form of pre-market authorization. This applies to food ingredients that are newly introduced to the market as well as to special foods. The categories of materials to which such authorization requirement apply are i) new food additives, ii) novel food materials and iii) functional ingredients. Materials that fall into those categories must undergo pre-market authorization because of their novelty. The category of end-products that requires pre-market authorization is special foods, which includes i) health foods, ii) foods for special medical purposes and iii) infant formulas. The authorization of functional ingredients and of health foods directly relate to each other. Authorization takes place on application from a food business. The business has to provide evidence that the product is safe and meets other specified requirements regarding its functionality. Pre-market authorization procedures are an important part of food law in the People’s Republic of China, especially when it comes to special foods. The purpose of this paper is to clarify to which food materials and end-products authorization requirements apply and to set out the applicable procedures.

Keywords: Pre-Market Authorization, Registration, New Food Additives, Novel food Materials, Special Foods, Health Foods, Foods for Special Medical Purposes, FSMP, Infant Formula

JEL Classification: K20, K23, K30, K32, Q18