China’s new Food Safety Law became effective on 1 Oct 2015. A supporting regulation, the new “Administrative Measures of Food Production Licensing” went into effect on the same day. This article, presented in a Q&A format, summarizes new changes and requirements for food production licensing upon the implementation of these measures.
Q1: What are the major changes in the new version compared to the old food production licensing system?
A1: The administrative system has been made more efficient and supervision of licensing has become stricter. In addition several modifications have been made which could be summed up as 5 cancelations, 4 adjustments and 4 reinforcements:
5 Cancelations:
Simplification of documents required for pre-approval
Product testing no longer needs to be conducted in a designated agency, instead the applicant could either conduct independent testing or entrust a qualified food testing agency.
The charges for the food production licensing process have been removed.
The record filing requirement for subcontracting has been removed. Both parties are merely required to appropriately mark the name, address and contact information as well as the information of the food production license of the processor.
The requirement of annual inspection and annual report is annulled. The modification is made in response to the provision in the new Food Safety Law that a self-inspection system should be established by food manufacturers and operators.
4 Adjustments:
One manufacturer one license. That is to say, only one license should be issued to a manufacturer approved for the production of food of various categories while the specific categories should be noted in the copy of the license.
The validity period of a license has been extended from 3 years to 5 years.
The scope of field inspection has been adjusted. Holders of food production license could be exempted from field inspection when:
increasing food production varieties under the licensed categories
applying licensing for health food, formula food for special medical purpose and infant formula during the product registration for which a field inspection has already been conducted.
With the exception of infant formula, food for special medical purpose and health food, the production licensing can be carried out by cities and county authorities.
4 Reinforcements:
License filing: Food production licensing records should be well documented by FDAs.
Post-licensing supervision: a supervisory plan should be made by FDAs so that daily inspection of manufacturer can be increased.
Management of inspection staffs.
Information construction: It is expected that a system for online application, acceptance, examination and approval will be developed and an e-license will be introduced in the near future.
Q2: Will the current subordinate rules remain effective upon the implementation of the Measure?
A2: CFDA is currently drafting general rules and detailed rules for food, food additives and health food production licensing which are anticipated to be released in the near future. In the meantime the old rules remain in force. However, if any conflicts occur between the old rules and the new meaures, the latter should prevail.
Q3: How should the food classification number be understood under the new measure?
A3: The number is present in three digits. Assume that “ABC” represents a food classification number, in which:
A - the identification code between food and food additive. 1=food, 2=food additive
BC – the classification number of food and food additive.
The classification number for food should be arranged in sequence to article 11 of the new measure. For food additive classification number, 01=food additive, 02= food flavor, 03=compounded food additive.
Q4: Should the production of food additives be subject to this measure?
A4: Yes. The production permit of food additives have been integrated into the new measures.
Q5: Will current licenses be still valid after the implementation of the new measure?
A5: The production licenses issued before the implementation of the new measure will continue to be valid. Holders of old licenses could apply for recertification in advance as well.
Q6: How to replace an old license?
A6: Holders of an old product license can file an application for renewal if the license has expired, and a new version will be issued to qualified applicants. To be specific, there are two modes for the renewal of a product license:
In line with the principle of “one manufacturer one license”, the manufacturer could complete the application for the new license to replace the old licenses.
Upon the expiration of one license under the old system, the manufacturer could apply for a new license. The replacement of the remaining old licenses should be noted on the new license thereafter.
Q7: Will the QS mark be retained after the implementation of the Measure?
A7: The mark should be removed.
Q8: How should stock packages be handled after the implementation of the new measure?
A8: For manufacturers with a newly issued license certificate, the new food production license number should be present on the food package or the label instead of the QS mark. A grace period not exceeding 3 years has been given to manufacturers meaning that the old package, label and the QS mark should not be applied to food products manufactured from 1 Oct 2018 onwards.
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