Interpreting China’s Food Safety Law Implementation Rules (2017 Draft)

On 14^th August 2017, CFDA notified the WTO on the release of the draft version of China’s Revised Food Safety Law Implementation Rules (See ChemLinked previous News). The public consultation period will end on 13^th October. Compared to the 2016 version the 2017 version encompasses major amendments including a drastic reduction in the number of articles which have dropped from 208 to 98.

Comparison between the 2 versions
Many of the more controversial articles included in the 2016 version have been removed including certain industrial standards regulating special foods companies. Most of the deleted content is included in other pieces of legislation, regulation or national standards. This chart will give you an idea of the changes made and after that we will describe them in a more detailed way.

Chapter	2017 number of entries	2016 number of entries	Important revised content
First Chapter: General Provisions	7	7	“Food safety commitment to territorial management responsibility in People’s government above county level to administrative areas” was amended to “Local people's governments above the county level implementation of food safety supervision and management by administrative heads of responsibility system"
Second Chapter Food Safety inspection and Supervision	5	14	Deleted the specific division of labor in the authorities competent for Food Safety Risk monitoring and assessment, while retaining the basic duties of the various departments
Third Chapter Food Safety Standards	4	7	1. Clarified the sentence “Food Production Enterprises should manage their administrative department filing according to national food safety standards or local, provincial, autonomous region and municipality enterprise standards”. 2. Deleted the sentence “Product standards for Health Food, Food for Special Medical Use, Infant Formula has been incorporated into product formulation, production technology and other technical requirements and can avoid Enterprise Standard Filing factory Standards”. 3. Deleted some of the procedural requirements for the development of food safety standards
Fourth Chapter Food Production & Operation	28	69	1． Simplified and deleted a number of articles already specified in other provisions. 2． Clarified the sentence “The food production license is valid for 5 years and the food sales and catering service license is valid for 3 years, and the sale of edible agricultural products does not require permission.”
Fifth Chapter Food Inspections	4	12	1. Deleted “Concrete implementation requirements for food inspections” while keeping “Duties and Obligations for regulatory authorities, food production operators and testing agencies and during food inspection”. 2. Added the sentence “No company or individual shall issue food inspection information issued by a food inspection agency that has not obtained legal endowment in accordance with the law.
Sixth Chapter Food Import and Export	10	12	1. Deleted “Publication of Inspection and Quarantine Certificate, Customs Clearance Certificate and other requirements”. 2. Clarified the sentence“Health Food, FSMP and Infant Formula handling import registration should also provide the Certificate of Registration issued by CFDA.”. 3. Clarified the sentence“Food with no national food safety standard refers to food produced by foreign companies for which there is no corresponding national food safety standard, not including food already covered by equivalent national food safety standard”.
Seventh Chapter Food Safety Risk Management	6	11	Kept “Food Safety Accident Emergency Plan and Food Safety Accident handling basic procedures and requirements.
Eighth Chapter Inspection Management	12	41	Deleted the “Administrative duties of related government departments at all levels” and simplified “Regulations on supervision and checkup and illegal cases of inspection”
Ninth Chapter Legal Responsibility	20	30	Deleted many penalties but added individual penalties.
Tenth Chapter Annexes	2	5	Deleted the explanation of the meaning of the words used in the regulations, keeping the requirement for special foods to pay registration fees.

Foods for Special Dietary Requirements
FSMP, Health Food, infant formula and other new foods are not classed as local products and therefore don’t need to comply with local standards. Manufacturers should provide free public consultation on their own standards. If their standards are higher than city, county, province and national level ones, they should be filed anyway. This contrasts with the 2016 version, containing the following provision: “All Health food, FSMP and infant formula companies whose internal standard incorporates national formulation and production standard don’t need to undergo filing”. Normally, internal formulation and production standard are proprietary information which enterprise do not share. The same can’t be said of product quality and safety standard that can generally be disclosed. For this reason that section was deleted.

Validity Period of Food Operation License Permit
The current “Measures for the Administration of Food Business Licensing” set the validity of the Food Operation License Permit as 5 years but the 17^th article of the 2017 version states that the product sale and the catering service permit last for 3 years. We can notice that there is a new subdivision of food operations in sale and catering services and that CFDA wants to cut down validity periods.

Food Label
In the 37^th article of 2017 version, food companies are forbidden from using negative content claims on substances not permitted by food safety standards. In the past companies have used this approach to differentiate products from competitors and create an illusion of superiority. This kind of behavior has been now clearly defined as illegal. However, GB 7718 national standard regarding general labeling rules is being revised, and so there might be other additional provisions.

Special Foods
The 2017 version of the 44^th article states that CFDA should publish on its website product labels and manuals of all filed and registered health food, FSMP and Infant Formula and that special food shouldn’t be sold together with normal food and medicines.

This raises two problems:
-First of all, the publication of product labels and manuals is for sure an advantage for consumers but it is damaging to enterprise IP. It also presents opportunities for food criminals to download the published pictures and create fake product packaging, like what happened in 2016 in Shanghai with counterfeit infant formula. Most infant formula companies only use a lot number to identify their products, and it’s not workable for them to have an id for every item. Therefore, if a criminal succeeds in copying that product, it will be very difficult for manufacturers and supervisors to distinguish it from the fake one.

-Secondly, differentiating sales channels for Health Food and normal Food might influence the sale of products like Red Bull and Ichimore. This kind of product has always been mixed with normal food both in supermarkets and small shops but if this draft passes, such products will only be permitted to be sold in special health food corners. In addition, the 97^th article states that special food is subject to registration tax. This might raise problems with products that have already been registered and raises questions about who should pay.

Food Inspection
At the moment, many websites, traditional media and third parties conduct product testing, both within legally accredited laboratories or their own facilities. The 48^th article of 2017 version states that no individual or company should publish test results obtained from structures without legal endowment. Testing results can’t be used to mislead consumers. This means that from now on this kind of test can be performed only by authorized laboratories. Results from unauthorized labs can’t be made public. Sanctions are implemented to enforce these provisions

CBEC
The 2017 version deleted the article on CBEC and the Food Safety Law also doesn’t contain any provisions on this. In future there will be a specially designed set of rules to regulate CBEC. At the moment and until 31th December 2017, CBEC is regulated both by AQSIQ’s “Basic Requirements for CBEC” and the “Eight April New Provisions” by ministry of Finance but a new Law on E-commerce will be implemented after next spring’s Thirteen National People’s Congress and go into force by the second half of the year. In regards to special food entering through CBEC and registration requirements, before the end of this year the relevant government bodies will issue an interpretation or a set of rules better defining the administration measures for such products.

Imported food without National Food Safety Standard
In the 52^nd article of 2017 version, foreign products on the market with a corresponding Chinese standard are not included in the category of product with no relevant food safety national standard. Corresponding standard include GB 2760, GB 2761, GB 2762, GB 2763, GB 14880 and GB 29921. At the moment, the only product approved this way is Mexican tequila, complying with GB 2757 and bearing a geographical recognition status.

Personal Penal Responsibility
Personal Penal Responsibility was increased as follows: “Damages equal or greater than the offender’s last year annual income will be subject to a fine of no more than five times that amount. Damages greater than 30% of the offender’s last year annual income will be subject to fines not exceeding that amount. Damages greater than 20% of the offender’s last year annual income will be subject to fines no more than 50% of that amount. Damages greater than 2000 Yuan will be subject to fines no more than 20000 Yuan or no more than 10000 Yuan depending on the crime. Damages greater than 20000 Yuan will be subject to fines no more than 100000 Yuan or 50000 depending on the crime.

Conclusion
Compared to 2015 and 2016 versions, the 2017 Revised Draft of Food Safety Law Implementation Regulations is more compact and refined. Responsibilities have been clarified, duplicate content deleted and issues treated extensively in other laws have been removed.