FDA updates on efforts to assist U.S. companies with China’s new food facility regulation

FDA announced last week that it, along with other government agencies including the Office of the U.S. Trade Representative (USTR) and the USDA/Foreign Agriculture Service (FAS), are currently engaging General Administration of Customs China (GACC) to obtain further details in their efforts to assist US food companies exporting foods to China.  China will require manufacturers of certain foods to receive a “recommendation from FDA” as a condition of registration.  Any establishment that imports products into China should determine the procedure that must be followed for obtaining the GACC registration.  Those establishments producing food products that do not require an “FDA recommendation” should start registering their facilities on or around November 1, 2021, by using the Chinese website: www.singlewindow.cn.  Those establishments producing foods that require an “FDA recommendation” should monitor the situation closely.  Hopefully China and the US government will develop a solution that will allow for the continued importation of these foods after the first of the year.  If a resolution is not reached, however, it is possible China could block the importation of foods until the registration is in place. 

Background

China recently announced its Regulations on the Registration and Administration of Overseas Producers of Imported Food (“Decree 248”) that, once effective on January 1, 2022, will require all overseas food manufacturers, processors, and storage facilities to be registered with the GACC to import product into China.  The new requirements cover all food products except for food additives and “food-related products,” which are defined by the Food Safety Law of China to include food packaging materials, detergents, disinfectants, and tools and equipment used in food manufacturing.  Also notably, Decree 248 requires the registration number be provided on the inner and outer packaging of the foods exported to China.¹

The new facility registration requirements differ based on the specific types of food products manufactured.  China currently requires facilities importing meat and meat products, aquatic products, dairy products, bird's nest and bird's nest products to be registered.  GACC has clarified these registrations will remain valid.  For establishments that are not currently subject to registration, GACC has established two separate categories:  Group 1 that requires a recommendation from a competent authority (e.g., FDA) as a condition for the registration and Group 2 that can register as of November 1 without the recommendation from a competent authority. 

• Group #1: The following 18 categories of food products must be recommended by the competent authority of the home country (e.g., FDA) as a condition of registration: (1) meat and meat products; (2) sausage casings; (3) aquatic products; (4) dairy products; (5) bird nests and bird nest products; (6) bee products; (7) eggs and egg products; (8) edible oils and fats, oilseeds; (9) stuffed wheaten products; (10) edible grains; (11) milled grain industry products and malt; (12) fresh and dehydrated vegetables and dried beans; (13) condiments; (14) nuts and seeds; (15) dried fruits; (16) unroasted coffee beans and cocoa beans; (17) foods for special dietary purposes; and (18) health foods.
• Group #2: Other foods not covered by the above 18 categories.

FDA Update

FDA disclosed in its update that GACC sent a letter to the U.S. government on September 29, 2021 that provided further instruction on the registration requirements.  We repeat below the information provided by GACC (as translated by FAS).

• Registration of registered overseas production facilities of four categories of products (including meat and meat products, aquatic products, dairy products, bird's nest and bird's nest products) continues to be valid.
• For overseas production facilities that export the four categories of products to China for the first time, GACC shall follow Articles 11 to 17 of the "Administrative Measures on Import and Export Food Safety of the People’s Republic of China" (Decree 249 of the GACC) to conduct assessment and review of the food safety management system and food safety status of the foreign countries (regions) to determine the inspection and quarantine requirements. After GACC has completed the assessment and review, and determined the corresponding inspection and quarantine requirements, the competent authority of your country could recommend the companies for registration in accordance with the relevant requirements of Article 8 of the "Registration Regulations" by December 31, 2021; such companies could also be recommended for registration following the current practice.
• For overseas production enterprises of the remaining 14 categories of products (including casings, bee products, egg and egg products, edible fats and oils, stuffed wheaten products, edible grains, milled grain industry products and malt, fresh and dehydrated vegetables, as well as beans, seasonings, nuts and seeds, fruits, unroasted coffee beans and cocoa beans, special dietary foods, health foods), the competent authorities of your country can complete the "Recommended Registration List of Overseas Production Facilities of Imported Food" (see Annex 2), listing facilities that have exported food products listed in the "Catalogue of Imported Foods with Trade Records" (see Annex 1) to China since January 1, 2017, and complete the Declaration of Conformity of Recommended Registration Facilities (Reference Format)" (see Annex 3). The forms shall be submitted to the Import and Export Food Safety Bureau of GACC by October 31, 2021. GACC will expedite the registration of companies in the list submitted on time. If the list is not submitted on time, starting from November 1, 2021, overseas production facilities of imported foods shall apply for registration in accordance with provisions of Article 8 of the “Registration Regulations”.
•  If your competent authority and GACC have agreed otherwise on the relevant enterprise registration methods and application materials, the agreement between both parties shall prevail.
• If the information and assessment materials of the registered overseas production companies of the above-mentioned 18 food categories are incomplete, competent authority in your country is asked to add the missing information in the "Registration Management of Overseas Production Enterprise of Imported Foods " system (translator’s note: the CIFER system) before June 30, 2023.

Along with other agencies, FDA is actively seeking further details on the implementation of Decree 248.  While FDA did not provide any details of its communication to GACC, certain key details are lacking.  For example, it is unclear from the GACC communication what specific standard or criteria GACC is expecting regulatory agencies such as FDA to take when offering a “recommendation for registration” or whether GACC will provide regulatory agencies with additional time to establish the process of “recommending registration.”  In the past, FDA has maintained a list of US manufacturers/processors that produce aquatic products, dairy products, bird's nest and bird's nest products with interest in exporting to China.² The facilities need to be found by FDA to be “in good regulatory standing with FDA, and have, during the most recent facility inspection, been found to be in substantial compliance with all applicable FDA regulations.”³

In the FDA update, the agency noted that it is currently working with GACC to obtain more details, and FDA will provide further details to help US food exporters, especially those in Group #1.  We have identified the more detailed description of 14 categories of foods under Group #1 from GACC and have summarized them in Appendix 1. Companies are encouraged to take a closer look at these descriptions to assess whether their products fall under Group #1.   For the food facilities exporting to China under Group #2, they can use the Chinese website referenced in the GACC letter directly for registration starting November 1, 2021. FDA also states firms may provide their FDA Establishment Identifier (FEI) as the identification or approval number for registration with China.

FDA has also provided the references, below, in its update.

• Overseas Facilities Registration Regulation – Decree 248
• Administrative Measures on Import and Export Food Safety – Decree 249
• Decrees 248 and 249 Status Update on Facilities Registration and Food Safety Measures
• GACC Issues Explanatory Letter on Decree 248

Next steps   

Importantly, GACC has stated it will give priority review to the registrations received prior to October 31, 2021.  US establishments in Group #1 will be ineligible for this expedited review unless FDA is able to “offer a recommendation” this week.  Hopefully the US government and China will reach a resolution to allow the continued importation of products in Group #1 while FDA establishes the framework to collect data needed for the agency to issue its “recommendation for registration.”  To the extent a resolution is not achieved and GACC fails to issue the registration prior to the effective date of Jan 1, 2022, establishments could be barred from importing foods into China.  If your establishment is exporting to China food products in Group #1, you should monitor the situation carefully.  Those establishments in Group #2 should begin filing their registration as of November 1, 2022.   We can provide assistance in completing the registration process if you would like our assistance in doing so.

We will continue to closely monitor the legal and regulatory developments related to the implementation of China’s Decree 248.  If you have any questions in the meantime, please don’t hesitate to contact us.