Interpretation of the hottest American food regist

Interpretation of the U.S. food registration and notification system to ensure the smooth export of relevant products

on October 10, the U.S. Food and Drug Administration (FDA) announced two final regulations, namely, the food agency registration regulations and the imported food advance notification regulations. According to the requirements of these two regulations, domestic and foreign institutions that produce/process, package and store food for human or animal consumption in the United States need to register with FDA before December 12, 2003. At the same time, from December 12 this year, food imported into the United States must be pre declared to FDA. Once the registration notification system was introduced, it immediately became the focus of attention of many enterprises. At present, most domestic food enterprises do not understand this system or have been misled by some intermediaries. If enterprises cannot grasp how to register and declare in time, their export business will be seriously affected. CNCA, AQSIQ and the Ministry of Commerce recently jointly issued the notice on actively doing a good job in responding to the regulations of "food enterprise registration" and "advance notification of imported food" in the United States, reminding relevant units to respond actively to ensure the smooth export of our relevant products to the United States

in order to help domestic food enterprises understand this regulation, we specially invite Sha Yihang, director of the comprehensive business department of the China Chamber of Commerce for the import and export of food, native produce and livestock, to interpret these two regulations for relevant enterprises

Q: what products are the new regulations introduced by the United States mainly limited to

answer: this new regulation is only applicable to the institutions that produce/process, package and store food for consumption in the United States as stipulated in the regulations. Examples of "food" include: food additives and food ingredients, baby milk powder, beverages (including alcoholic beverages and bottled water), fruits and vegetables, fish and aquatic products, dairy products and shelled eggs, agricultural raw materials for food or food ingredients, canned and frozen foods, baked foods, snack foods and candy (including chewing gum), live edible animals, animal feed and pet food

food contact substances and pesticides do not belong to the "food" category of this transitional regulation. Therefore, enterprises engaged in the production/processing, packaging or storage of food contact substances and pesticides do not need to register with the food and drug administration

Q: which enterprises in China must register with FDA

answer: the owners, operators or agents of domestic and foreign enterprises that produce/process, package or store food for human or animal consumption in the United States, or individuals authorized by them, must register with the food and drug administration before December 12, 2003. Foreign enterprises must appoint an American agent. For example, the measurement Law of the institution clearly stipulates that the standard gb/t14730 (2) 000 of anchorages stipulates exporters or sellers. Due to the need of registration, this agent must reside or have a business place in the United States, and must be in the United States

Q: do all foreign institutions that produce/process, package or store food for U.S. consumption need to be registered

answer: No. If a foreign institution producing/processing, packaging or warehousing food sends the food to another foreign institution for further production/processing or packaging before exporting to the United States, only the second foreign institution needs to be registered. However, if the second foreign institution only performs micro processing, such as labeling, then both institutions require registration. At the same time, all foreign institutions that pack or store food after the last foreign producer/processor must be registered

ask: do enterprises need to register every time they export

answer: a food agency only requires registration once. However, if the necessary registration information changes, it must be updated in time. But every time food is exported to the United States, it must be declared in advance

ask: does obtaining the registration number after the enterprise is registered mean that the food can be exported smoothly

A: it only means that the owner of the agency has fulfilled this regulation by registering with the food and drug administration. This regulation does not conflict with all other regulations previously issued by FDA. Obtaining the registration number does not mean that FDA Approves or approves the agency or its products

ask: do you need to pay for registration? How should enterprises register

answer: registration and registration updates are free. Registration or registration update must use form 3537. Institutions can register through Internet. It was opened on October 16, 2003, and operates 24 hours a day, 7 days a week. The website can be accessed from all over the world, including libraries, fast printing centers, schools and bars. In addition to creating gaps between various devices, a. gov/furls can get help, registrants can also get help from the registration help desk through:

* call in the United States or

* call outside the United States

* fax questions to

* email questions to furls

from October 16, 2003, these will be answered by a specially assigned person, The time is from 7 a.m. to 11 p.m. Eastern time from Monday to Friday

if the agency cannot access the Internet, it can request the printed form from the food and drug administration by dialing -fda-3882 () or mailing the request letter to:

odanddrugadministration

hfs-681

5600fisherslane

rockville md20857

usa

when the form is complete and clear, it should be sent to the above address or faxed to (301). At the same time, relevant agencies can submit CDs to the food and Drug Administration for registration

Q: when must the pre declaration be submitted when exporting food to the United States

answer: FDA will receive and confirm the pre declaration information electronically within 5 days before the arrival of imported food and before the time specified by the transportation mode mentioned below:

1 Transported by road, 2 hours before arrival

2. 4 hours before arrival by air or land railway

3. By water, 8 hours before arrival

Q: do trading companies need to register with FDA

answer: according to the regulations published by FDA, food enterprises at home and abroad engaged in production, processing, packaging and storage for Americans and animals must register with FD a. Trading companies do not need to register if they are not involved in production, processing, packaging and warehousing

ask: if the food exported by the enterprise to the United States is packaged in large packages and repacked after arriving in the United States, do you need to register

answer: Yes. The handling, storage and packaging of all foods produced and processed in China need to be registered

ask: if a trading company has its own trademark, does it need to be registered

answer: it should be registered, and the supplier of products should also be registered with FDA

Q: does a processing enterprise that has obtained the FDA registration of low acid cans still need to register

answer: the registration requirement this time is based on the anti bioterrorism law. There is no conflict with the previous FDA management of imported food, and there is no substitution relationship. Enterprises that have obtained the registration of FDA low acid cans still need to register with FDA this time. This FDA registration only means that the owner of the enterprise agrees to comply with its regulations, and the assigned registration number does not mean that FDA Approves or approves the facility and its products

Q: according to FDA regulations, meat, poultry and egg products under the jurisdiction of the United States Department of agriculture are exempted from registration. Do poultry processing enterprises need to register with FDA for exporting meat products to the United States

A: according to FDA regulations, meat, poultry and egg products under the exclusive jurisdiction of the U.S. Department of agriculture are exempt from registration. However, cooked chicken products that China can export to the United States also belong to FDA

managed goods, which need to be registered with FDA

ask: if the production enterprise supplies goods to the foreign trade enterprise, can the foreign trade enterprise register on behalf of the production enterprise? Because the production enterprise does not necessarily have manpower to handle the registration matters, or the enterprise is too small to register by itself or is not familiar with the registration procedures and requirements

answer: if authorized by the manufacturer, the foreign trade company can register as the agent of the manufacturer

ask: does the enterprise providing ingredients or additives need to be registered

answer: if ingredients or additives are directly exported to the United States, registration is required. If ingredients or additives are provided for processing outside the United States, registration is not required

ask: does an enterprise have to have an "American agent"

answer: Yes. FDA regulations require registered enterprises to have an "American agent"

ask: "American agent" refers to a registered agent or a trade agent? What role does "American agency" play

answer: the only U.S. agent required for FDA registration does not exclude that enterprises can have multiple agents in other businesses. Companies do not need to register designated U.S. agents to engage in business activities in the United States. Therefore, the "U.S. agent" here is not a trade agent. An enterprise can register with FDA through its designated U.S. agent or by itself. It does not have to register through its designated U.S. agent, so it is not a registered agent. "U.S. agent" is only a person who must be designated by a registered enterprise, lives or has a business place in the United States, and actually lives in the United States. The role of "American agency" is to assist FDA in contacting and communicating with foreign enterprises, so that the information FDA needs to convey to foreign enterprises can be obtained by foreign enterprises in a timely manner

ask: how to find a "qualified American agent" and what conditions does an "American agent" need

answer: there is no "qualified American agent". The "American agent" is just a person who must be designated by a registered enterprise, who lives or has a business place in the United States, and actually lives in the United States. He can play the role of contact between FDA and registered enterprises

Q: the United States requires that food imported after December 12 must be notified in advance. Does December 12 refer to the date of arrival or the date of shipment

answer: this date refers to the arrival date

Q: some media say that registration with FDA must be through an agent company, and importers cannot register as agents. Is there any basis for this statement

plastic is one of the non-metallic materials often used in passenger cars. A: this statement is completely groundless, and importers can register as agents in the United States. For looking for agents, Chinese enterprises are divided into three different situations:

1 Enterprises with branches or offices in the United States. The local post of such enterprises can act as the U.S. agent

2. Enterprises with fixed importers or trading partners in the United States. Trading partners of such enterprises can also act as agents

3. Small scale enterprises. If such enterprises have relatives and friends in the United States, then relatives and friends can also act as agents

Q: how should I submit the pre declaration

answer: the pre declaration must be submitted electronically. FDA expects that more than 80% of the pre declaration of imported food can be transmitted through ABI/ACS. International mailed food and other trade types that cannot be submitted through ABI/ACS or rejected according to 801 (m) of the federal food, drug and cosmetic act must be submitted through the PN system interface of FDA. From December 12, 2003, the technical services for submitting pre declaration:

in the United States: or

countries and regions outside the United States:

Fax:

provide technology from 7:00 to 23:00 every working day in the United States Eastern time