FDA Provides Important Update on the China Requirement that All Facilities Importing Food into China Must Be Registered By January 1, 2022 (“Decree 248”)

On By Xin Tao

On October 22, 2021, the U.S. Food and Drug Administration (FDA) published an update on its efforts to assist US companies on China’s implementation of a new registration requirement for all food facilities importing foods into China that is set to become effective January 1, 2022.  Food facilities may be prohibited from importing products into China unless they are registered.  Different requirements are established for the registration depending upon the type of food being imported.  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 #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).

(1) 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.

(2) 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.

(3) 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”.

(4) 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.

(5) 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.

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.  

[1]/            There might be other applicable food labeling requirements; this update is not intended as a complete summary of all applicable food labeling requirements under the Chinese law.

[2]/           FDA,  Establishing and Maintaining a List of U.S. Milk and Milk Product, Seafood, Infant Formula, and Formula for Young Children Manufacturers/Processors with Interest in Exporting to China: Guidance for Industry (November 2018).

[3]/           See id.

Appendix 1 [1]/

1.Casings (“sausage casings”) : It refers to animal tissues that are salted or dried on the retained parts by using organs such as small intestine, large intestine and bladder of healthy livestock, after special processing such as scraping and de-oiling, and is the casing for sausage.
2.Bee products: Natural sweet substances made from nectar, secretions or honeydew of plants collected by honeys and mixed with their own secretions, as well as edible substances formed naturally or made by special techniques during reproduction and reproduction, including royal jelly, royal jelly powder, honey pollen, royal jelly freeze-dried powder, etc.
3.Egg and Egg products: Egg products include: 
(1)liquid egg products: egg products made from fresh eggs after shelling and processing, such as whole egg liquid, egg yolk liquid and protein liquid;
(2)Dried egg products: egg products made from fresh eggs by shelling, processing, desugaring, drying and other processes, such as whole egg powder, egg yolk powder and protein powder;
(3)Frozen egg products: egg products made from fresh eggs by shelling, processing and freezing, such as frozen whole eggs, frozen egg yolk, ice protein, etc;
(4)Remanufactured egg: egg products processed by different processes such as salt, alkali, distiller’s grains and brine with or without auxiliary materials, such as preserved egg, salted egg, salted egg yolk and etc.
4.Edible fats and oils: edible fat refers to the vegetable oil ade from edible vegetable oil for processing or consumption, and single products or mixtures of vegetable fat processed by one or more methods of refining and fractionation. Edible oil refers to the seeds of oil plants used for extracting edible vegetable oil, mainly including peanut and sesame for oil.
5.Stuffed pastry products (“stuffed wheaten products”): refers to cooked or uncooked frozen products made with various raw materials as fillings and wheat flour as skins, such as steamed stuffed buns, jiaozi or pies.
6.Edible grains: refers to the seeds, roots and tuber products of cultivated plants such as cereals and potatoes, mainly including edible products of gramineous herbaceous seeds after rough processing, such as rice, oats and sorghum.
7.Milled Grain Industry Products and Malt: refer to fine powdery products in which seeds, roots and tubers of cultivated plants such as cereals, potatoes, fruits and nuts are ground and screened for edible powder, or malt products formed after hydrolysis processing.
8.Fresh and dehydrated vegetables and dried beans: refer to fresh vegetables or dried vegetable products processed by fresh-keeping, dehydration, drying and other drying processes  and dried beans.
9.Unroasted coffee beans and cocoa beans
10.Condiments: refer to natural plant products such as plant fruits, seeds, flowers, roots, stems, leaves, skins or whole plants, which can be used directly with the functions of fragrant, flavoring and seasoning.
11.Nuts and seeds: nuts refer to the seeds of woody plants with hard shells, including walnuts, chestnuts, apricot kernels, almond kernels, pecans, pistachios, torreya grandis, Hawaiian fruits and pine seeds. Seeds refer to the seeds of melons, fruits, vegetables and other plants, including watermelon seeds and pumpkin seeds.
12.Dried fruits: refer to the dried fruit products made from fresh fruits by sun drying, drying and other dehydration processes
13.Food for Special Dietary purpose:
(1)Soybased infant formula:refers to soy and soy protein products as the main raw material, adding the right amount of vitamins, minerals and / or other ingredients, using only physical methods of production and processing made suitable for normal infants and young children to eat liquid or powder products.
(2)Special medical use formula, in order to meet the eating restrictions, digestive and absorption disorders, metabolic disorders or specific disease states of people with special needs for nutrients or diet, specially processed and formulated formula. Such products must be under the guidance of a doctor or clinical nutritionist, eaten alone or in conjunction with other foods.
(3)Infant and toddler complementary foods, including infant and toddler canned complementary foods and infant and toddler cereal complementary foods. Infant and toddler filling supplements are food materials processed, filling, sealing, sterilization or aseptic filling to commercial sterility, can be stored at room temperature for infants and toddlers over 6 months of age; infant and toddler cereal supplements are one or more cereals as the main raw material, and cereals account for more than 25% of the dry matter composition, add the appropriate amount of nutritional fortification and (or) other auxiliary ingredients, made by processing The supplementary food suitable for infants and toddlers above 6 months of age.
(4)Others (supplemental nutritional supplements, sports nutrition food, etc.) other to meet the special physical or physiological conditions and (or) to meet the special dietary needs of disease, disorders and other states, specially processed or formulated food.
14.Functional food (“health food”) : claim and have a specific health function or to supplement vitamins, minerals for the purpose of food. That is, suitable for consumption by a specific group of people, has the function of regulating the body, not for the purpose of treating disease, and does not produce any acute, subacute or chronic harm to the human body food.

[1]/            Please note given the differences in English translations by FAS and China’s GACC, some of these terms may differ when referring to the same food category.  Appendix 1 is based on information provided by GACC, and to avoid any confusion caused by English translation, when appropriate we also insert the terms used by FAS to refer to the same category of food in parenthesis. 

 

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