6 June, 2017
On March 28, 2017, the China Food and Drug Administration (the "CFDA") released the Several Provisions in Respect of the Establishment of Food Safety Tracing Systems by Food Production and Operation Enterprises (the "Provisions").
I.Background
On April 24, 2015, the circulation of the Food Safety Law of the People's Republic of China marked the official establishment of food safety tracing systems in China. Subsequently, the State Council and the CFDA successively issued the Opinion on Accelerating the Construction of Important Product Tracing Systems ([2015] No. 95 Document issued by the General Office of the State Council) and the Opinion on Promoting the Improvement of Food Tracing Systems by Food and Drug Manufacturers and Operators ([2016] No. 122 Document issued by the CFDA), putting forward the general guidance on the implementation of food safety tracing systems.
II.Overview
1.Scope of application
The Provisions apply to food (exclusive of special food1) production and operation enterprises, with the latter including food (inclusive of edible agricultural products) sales, transportation, storage enterprises and catering enterprises. It is further clarified under the Provisions that homemade products sold by food sales (including edible agricultural products) enterprises and the non-prepackaged food sold by catering enterprises shall be excluded although such food production or operation entities may adopt a food tracing system by reference to the Provisions.
2.Tracing information content
The Provision stipulates in detail the specific scopes of the information required to be recorded by food production and operation enterprises for each process during the entire course of food production and circulation (inclusive of production, sales, catering, transportation, storage and transfer, and so on), establishing a systematic standard for food production or operation enterprises to trace and record information. Taking the process for food production as an example, under the Provisions, a production enterprise shall record information on, among other areas, products, raw and auxiliary materials, production, sales, equipment, facility, personnel, recall, destruction and complaints.
3.Requirements for information recording, preservation and connection
In order to ensure the effective operation of tracing systems, the Provisions provides detailed requirements for information recording, preservation and connection, among which include that a food production or operation enterprise shall take actions such as preserving original records and requiring that all records be jointly signed by the personnel who record the information and who are responsible for reviewing the information so as to ensure that the information recorded is true and valid; and the retention period for records and vouchers shall not be less than six months after the expiration of the shelf life of products; or shall not be less than two years for products without a clear shelf life.
4.General principles and objectives for pilots
The Provisions point out that the food and drug regulatory departments at the provincial level shall, by taking into account multiple factors, including the characteristics for the production and operation of food in different categories, the actual business and operation situation of the specific enterprises, and the cost of such tracing systems for manufacturers and operators, carry out pilots in selected representative enterprises of one or several certain types of food (especially high-risk food) and make progress in a steady manner, with the aim of the basic realization of the traceability of food safety of rice, wheat flour, infant formula milk powder, edible vegetable oil, liquor and other food in key areas as early as practical.
III.Implications
The Provisions are the first systematic guidance in respect of the establishment of tracing systems by food production and operation enterprises, setting out clear requirements of the tracing systems for the food production or operation enterprises to follow. It is worth paying close attention to how the local Food and Drug Administration will conduct pilots in practice accordingly.
1、Pursuant to the Food Safety Law, special food includes health food, formula food for special medical purposes, and formula food for infants.
For further information, please contact:
Yang Fan, Partner, Jun He
yangfan@junhe.com
