To thoroughly implement the amended Food Safety Law which came into effect on October 1, 2015, the China Food and Drug Administration (the “CFDA”) drafted the Implementing Regulations of the Food Safety Law (Revised Draft for Public Comment) (the “Draft”) and published it on December 9, 2015 to solicit public comments.
The Draft has elaborated, supplemented, and refined the current Implementing Regulations of the Food Safety Law (the “Current Regulations”) pursuant to the spirit of the amended Food Safety Law. Although the Draft has kept the framework of the Current Regulations, it has more enriched content, more specific provisions, and stricter supervision. In addition, the length of the text has been extended from over 8,000 words (64 articles in 10 chapters) to over 33,000 words ( 200 articles in 10 chapters).
I. The regulatory scope is more comprehensive
Special foods such as health food and baby and toddler formula products are included in the regulatory scope
The Draft provides explicit requirements regarding the registration/ record filing, manufacturing and sale of health foods, foods for special medical purposes (FSMPs) and baby and toddler formula foods that are administrated through registration (collectively referred to as “Special Foods”) as a separate section.
Pursuant to the Draft, the Special Foods administrated through registration must obtain the registration certificates issued by the CFDA. For Special Foods and food additives, no local food safety standards can be made. The Special Foods must be sold on a special counter or in a special area and must not be mixed with drugs or ordinary food. In addition, the Draft also states that one enterprise must not use one recipe to manufacture different brands of FSMPs and health foods, and that the health food under one registration certificate or filing number must use the same trademark, which means that the OEM production mode will not be practicable any more. If the promulgated Implementing Regulations of the Food Safety Law retains such provisions, the health food industry may face a reshuffle.
As for baby formula and toddler formula, the Draft requires that baby formula and toddler formula manufacturing enterprises must not manufacture or sell baby formula and toddler formula, whose trademarks, names and addresses of the enterprises are only registered overseas, in China. Such enterprises must not use milk or milk products of any animals other than from cows and sheep to manufacture baby formula and toddler formula. The product recipes for the same age range that the enterprise applies for registration must have obvious differences backed by scientific proof. In principle, each enterprise cannot register for more than 3 series and 9 product recipes. No restricted regional sales are allowed for baby formula and toddler formula. Baby formula and toddler formula must not customize produce for retailers. The Draft specifically states that imported baby formula and toddler formula must be registered pursuant to laws and regulations.
Specifying the supervision over online food transactions for the first time
Echoing the new Food Safety Law, the Draft provides more detailed stipulations regarding the supervision over online food transactions. For example, the providers of online food transaction third party platforms (Third Party Platforms), as well as the manufacturers and distributors of food sold online must file information such as their websites and IP addresses with food and drug administrations for record; the manufacturers and distributors of food sold online must also obtain licenses for food manufacturing and distribution and the business scope must be consistent with the permitted scope for offline transactions. The Draft also provides specific requirements for Third Party Platforms regarding their obligations to register the real names of the online food distributors, review licenses, and report to the relevant departments based on the Food Safety Law.
For the first time, the Draft states the requirements and the operational process for the random inspections of food sold online, specifying that food sold online is also subject to periodic random inspections by the food and drug administrations and Third Party Platforms which operate illegally will face strict penalties such as a fine that can be up to RMB 200,000, or the revocation of their license.
Cross-border E-commerce must also comply with the relevant regulations
The Draft, for the first time, specifies that food imported and exported through cross-border E-commerce must also comply with the relevant regulations regarding food importation and exportation in the Food Safety Law and its implementation regulations. In addition, the Draft states that the relevant departments of the State Council will formulate administrative measures on supervising the importation of food, food additives, and food-related products through cross-border E-business, meaning that more detailed administrative measures will come out that regulate cross-border E-commerce.
II. The regulatory methods are more diversified
A more refined food safety inspection system
The Draft specifies the responsibilities of the State Council and the food and drug administrations at the provincial, city, and county levels to refine the mechanisms of the inspections of the food safety system, unannounced inspections, and routine inspections. In addition, the Draft develops a new food safety inspector mechanism.
The new mechanism of food safety judicial authentication
The Draft develops a mechanism of food safety judicial authentication by stating that the relevant departments of the State Council will formulate the administrative measures on food safety judicial authentication to specify the qualifications and conditions as well as decide on the directory of food safety judicial authentication institutions and authentication personnel. To entrust food safety judicial authentication, food safety judicial authentication institutions and authentication personnel must be selected from the directory. Such a mechanism will be beneficial for improving the authority of food safety authentication opinions.
The graded administrative mechanism for food safety incidents
The Draft provides a graded administrative mechanism for handling food safety incidents and classifies food safety incidents into four grades: extraordinarily serious; serious; relatively serious; and ordinary. The Draft clarifies the supervisory departments directly in charge and their responsibilities respectively, including drafting emergency preparedness plans, establishing and planning for an emergency preparedness system, the information monitoring and reporting mechanism, and the process for reporting information regarding incidents after the food safety incident occurs, etc.
(This article was originally written in English, and the Chinese version is a translation)
Editor’s note: This article was first published on Chinalawinght.com