Regulation and Policy 

Provisional Regulations Of The Ministry Of Agriculture Of The People’s Republic of China For The Registration Of Imported Feed Additives

Issued on June 25, 1988

Article 1 The following regulations are formulated with a view of exercising more effective control over the feed additives imported from abroad and to ensure safe production of domestic animals, poultry and fishes.

Article 2 All imported feed additives used in the production of animals, poultry and fishes within the boundaries of the People’s Republic of China are governed by these provisional regulations.

Article 3 Foreing manufacturing enterprises, companies and their agents with the intention to sell their feed additives to China shall apply for registration from the Ministry Of Agriculture of the People’s Republic of China. Products without registration shall not be imported.

Article 4 Feed additives produced and marketed in China under foreign trademarks should be registered in accordance with the regulations.

Article 5 Feed additives predicted and marketed should be in conformity with the principle of safety and effectiveness. Feed additives no longer in use in the producing countries shall not be registered.

Article 6 The Ministry of Agriculture shall delegate authority to the Feed Products Quality Monitoring Center of the Ministry of Agriculture to re-examine the quality of the imported feed additives, arrange feeding trials, quality evaluations and submit the results to the Ministry of Agriculture for approval. After approval, license or the product registration shall be issued by the Ministry of Agriculture.

Article 7 The following information (two copies) and products samples shall be submitted to the Ministry of Agriculture by foreign manufacturing enterprises, companies or their agents:

1 Information

(1)   Name, principal ingredients and physical and chemical properties of the product;

(2)   The approval documents for the production and sale of the product in the manufacturing country;

(3)   Quality specifications, analytical methods, range of use and application method, trademark, label and user’s manual, package, storage and date of expiration, precautions etc.;

(4)   Data on acute, sub acute and chronic toxicological test and if necessary, also date on carcinogen city, teratology, mutagenicity and their reports;

(5)   Residue trail report on degradation kinetics of the feed additive in animal, poultry and fish tissue and its analytical method;

(6)   Feeding trials application;

(7)   Registration of the product in other countries.

2 Samples

(1)   Providing 2-5 grams of the standard material of chemical reference material of the relevant product when necessary;

(2)   Sample quantity: Each sample shall be taken from 3 lot numbers and the quantity of each sample shall be 3-5 times that of the quantity needed for test.

Article 8 If feed additives with no registration in the manufacturing country need to be registered in China, feeding trials, reproduction trials and tests on toxicity, carcinogen city, teratology, mutagenicity, residue and environmental toxicity shall be carried out. The procedure and scale of test shall be determined by the two parties through consultation. Any expenses incurred for the tests shall be borne by the foreign companies concerned.

The number of animals required for the feeding trials of new feed additives is as follows:

Large domestic animals                                    100 head

Medium domestic animals                                    200 head

Small domestic animals or poultry                 500 or more

Fish or shrimps                                                  500-1000 or more

If foreign manufacturing enterprises and companies could submit trial reports approved by the government of the manufacturing country, then only re-examination trials shall be conducted and the number of animals for the trials could be reduced to 50% of the numbers as stipulated herein before.

Article 9 When feed additives already registered and marketed in the producing country need to be registered in China, the necessity of feeding trials shall be determined according to the specific conditions.

Article 10 If feed additives already registered and in use in China have been proved to be harmful to human being, animals, poultry, fishes and environment, its use shall be limited and the registration be revoked. All the economic losses shall be borne by the foreign manufacturing enterprises and companies.

Article 11 for feed additive registration, fees for test and registration shall be paid. The relevant registration forms shall be filled in Chinese and in English. All payment shall be made in US dollars.

Fees are charged as follows:

1 Registration fee: US$1,000 for each variety of the product; 50% of the original fee shall be charged for the renewal of the registration license.

2 Test fee: US$1,000 for each variety of the product; US$200 for every new preparation or form of the product; US$1000 for a compound product within 6 composition and US$100 for each new composition added.

Article 12 Persons involved in testing and registration shall be responsible to keep confidential the technical information and samples provided by the applying enterprises and companies.

Article 13 the terns of validity of the fed additive registration license shall be 5 years, upon expiration, the license shall be renewed within 6 months of the expiring date if the sale of the product should continue. The change of product form and range of application shall require a new registration.

Article 14 Feed additives without registration shall not be advertised on the Chinese publicity medium such as newspapers, magazines, radio and television and others.

Article 15 the registration of feed additives shall be ratified within one year counting from the date on which all the information and samples are submitted.

Article 16 without approvals from the Ministry of Agriculture, no one is allowed to accept requests from foreign manufacturing enterprises, companies and agents for the production and sale of feed additives in China. In the event of an offence, a fine of 1-3 times of the actual value shall be imposed in addition to the detention of all the products for disposal. A fine of 1,000 to 5,000 Yuan shall be imposed on persons who are directly responsible.

Article 17 when the imported feed additives with registration license arrive at the port of entry, the feed control agencies authorized by the Ministry of Agriculture, together with the Customs, shall hold the products for test and inspection. Permission for sale and use shall be granted after the products are proved to be qualified.

Article 18 The “Provisional Regulations” comes into force on the date of issue. Medicated feed additives shall be governed by the Animal Drug Administration Regulations of the People’s Republic of China.

Article 19 Ancillary Provisions

1 Large domestic animals refer to cattle, horses, mules, donkeys, camels; medium domestic animals refer to pig, sheep and goats, dogs; small domestic animals and poultry refer’ to rabbits, chickens, ducks, geese and other animals of economic and ornamental value.

2 Registration shall be completed within one year that includes the following two instances;

(1)   Within 3 months when no feeding trials is required.

(2)   Within one year when feeding trials are required.

3 Feed additives already in production or on sale in China before the issuance of the regulations, but not registered, should be registered within 6 months starting from the date of issue of the regulations, Sales in China shall not be permitted beyond this time limit.