Issuing Body: State Administration of Quality Supervision, Inspection and Quarantine
Issuing Date: March 22, 2012
Effective Date: May 1, 2012
China's General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) has updated the nation's rules governing the registration of overseas producers of imported food, replacing 10-year-old regulations with the Provisions on Administration of the Registration of Overseas Production Enterprises for Imported Food ("2012 Foreign Food Producer Regulations"). Released by AQSIQ in March, the 2012 Foreign Food Producer Regulations went into effect on May 1, 2012, superseding the Provisions on Administration of the Registration of Foreign Production Enterprises for Imported Food ("2002 Foreign Food Producer Regulations"). While the changes effected by the new rules are generally modest, they are worth noting, particularly for companies that export food to China—including companies based in Hong Kong, Taiwan, and Macau. We understand that the 2012 Foreign Food Producer Regulations are intended to expand the scope of the imported food producer registration system, but the new system may not work well in practice until the detailed application catalogue is issued.
China first adopted a foreign food enterprise registration system to supervise the safety of imported food in 2002, when AQSIQ issued the 2002 Foreign Food Producer Regulations. Those rules included a catalogue, known as the "Catalogue of Imported Food of Enterprises Subject to Registration" ("2002 Imported Food Catalogue"), and stipulated that foreign food enterprises producing food listed in the catalogue must register with AQSIQ before the food can be imported into China. However, it only dealt with meat (including meat products, edible byproducts, and internal organs). Other food products were not covered by this registration system.
The 2012 Foreign Food Producer Regulations apply to the registration of overseas food production, processing, and storage enterprises ("Overseas Food Enterprises") that export food into China. The responsible authority for registration management is the Certification and Accreditation Administration ("CNCA"), which is under AQSIQ.
The change from "foreign" in 2002 to "overseas" in 2012 is cosmetic rather than substantive. The 2012 Foreign Food Producer Regulations, like the 2002 rules, apply to all countries and areas outside the borders of China proper, including Hong Kong, Macau, and Taiwan.
The 2012 Catalogue
The 2012 Foreign Food Producer Regulations reference but do not actually include a new catalogue, "Registration Implementing Catalogue for Overseas Production Enterprises of Imported Food" ("2012 Imported Food Catalogue"). CNCA is responsible for drafting and publishing the 2012 catalogue. However, it is not yet available on either CNCA's website or the website of AQSIQ.
As mentioned above, only products listed in the 2002 Imported Food Catalogue were subject to registration, and the 2012 Foreign Food Producer Regulations adhere to this principle as well. In the absence of a 2012 catalogue, however, it is unclear whether the 2002 Imported Food Catalogue is still being enforced after May 1, 2012, when the new regulations took effect and it is currently unknown when a 2012 catalogue will be issued.
The drafting notes of the 2012 Foreign Food Producer Regulations posted on CNCA's website contain a statement that the 2002 Imported Food Catalogue is not changed, but the statement says nothing about its effectiveness after May 1, 2012. We understand that AQSIQ recognizes the merits of registration, and that the process has worked well since its implementation. As a result, we expect that registration for overseas meat producers (covered under the 2002 Imported Food Catalogue) will still be enforced until the 2012 Imported Food Catalogue is released.
We also understand that CNCA is currently working on the 2012 Imported Food Catalogue. We expect the food categories covered by the 2012 catalogue to be expanded, since scandals involving imported food other than meat (including imported infant formula, fruit, wine, and other foods) have occurred in China in the past few years, and registration helps CNCA and AQSIQ track food to its production source and take preventive measures.
Registration Application Documentation
Applications for registration must be filed by the responsible governmental authority where the Overseas Food Enterprise is located. The following documents must be provided:
- The laws and regulations of the home country regarding epidemics involving animals and plants, veterinary health, public health, plant protection, and monitoring of the residue of pesticides and drugs given to animals; written materials documenting the structure of the authority responsible for such laws and regulations, as well as the staff; and those responsible for enforcement of local laws and regulations
- A list of Overseas Food Enterprises for the registration application
- A report issued by the responsible governmental authority of the home country on the actual situation of quarantine and public health involving the Overseas Food Enterprise
- A statement issued by the responsible governmental authority of the home country on compliance with China's laws and regulations governing Overseas Food Enterprises
- Application documents prepared by the Overseas Food Enterprise, including floor plans of factories and warehouses, and refrigerated warehouses and techniques.
In addition, Overseas Food Enterprises must meet the following conditions, and certain certificates must be submitted at the same time as well:
- The home country's veterinary service system, plant protection system, and public health administration system pass evaluation by CNCA.
- Raw materials used for food imported into China must come from areas where there are no epidemics.
- Overseas Food Enterprises must be established with all required approvals and currently be under the supervision of responsible authorities of the home country.
- Sanitation conditions of Overseas Food Enterprises must comply with the relevant laws and regulations of China.
Review and Post-Registration Supervision
CNCA will review the application package when it is submitted and decide whether to allow the Overseas Food Enterprise to undergo registration and thus to import food into China. However, the 2012 Foreign Food Producer Regulations contain no timeframe for review, and in practice it is likely to be at CNCA's sole discretion. Considering the cumbersome application package mentioned above and the unspecified review timeframe, we anticipate that the review process may be time-consuming, and the history of cooperation between China and the home country of the Overseas Food Enterprise (or lack thereof) may also matter. In addition, CNCA may send staff members to conduct on-site inspections of the Overseas Food Enterprise if the agency deems its necessary. The 2012 Foreign Food Producer Regulations require the responsible authority of the home country to offer assistance with on-site inspections.
Registration by an Overseas Food Enterprise will be effective for four years. The enterprise must apply to renew the registration via the responsible governmental authority in its home country one year prior to the expiration date of its registration.
Overseas Food Enterprises that pass CNCA review must affix their registration numbers on the packaging of all food imported into China. Meanwhile, they will remain under ongoing supervision by CNCA, and may be exposed to re-inspections by CNCA if necessary. In addition, CNCA may revoke an enterprise's registration if it is found to be non-compliant with relevant regulations, and severe food problems result.
It is not possible to understand fully the scope of CNCA's supervision of food imports until the 2012 Imported Food Catalogue becomes available, but it seems clear that CNCA will continue to require registration of certain imported food products, since AQSIQ has reiterated CNCA's jurisdiction with issuance of the 2012 Foreign Food Producer Regulations. Overseas Food Enterprises are advised to pay attention to the registration system and to understand the mechanism and effect of the 2012 Foreign Food Producer Regulations on their business in China.