Feed control act

Link to law: http://law.moj.gov.tw/ENG/LawClass/LawAll.aspx?PCode=M0060001

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Chapter I. GENERAL PROVISIONS

Article 1

This Act is established to maintain the quality of feeds and promote the development of the animal husbandry and the aquaculture industry so as to maintain the public health. Matters that are not provided herein shall be governed by other applicable laws.

Article 2

For the purposes of this Act, the term "competent authority" shall denote the Council of Agriculture, Executive Yuan at the central government level; the municipal government at the municipality level; and the county/city government at the county or city level.

Article 3

3.1 The term “feed” in this Act refers to foodstuffs that provide nutrition to, or promote healthy growth of, livestock, poultry and aquatic animals. Feed can be grouped into:
3.1.1 plant-based feed: plants, plant products, or processed results thereof;
3.1.2 animal-based feed: animal, animal products, or processed results thereof;
3.1.3 feed supplement: minerals, vitamins, amino acids, or process results thereof;
3.1.4 formulated feed: formulated mixture or compound of two or more of the above.
3.2 The central competent authority shall proclaim a detailed list describing the [types of] feeds that are subject to mandatory testing for possible changes in biosafety or quality level after manufacturing, processing, packing or importation.

Article 3-1

3-1.1 The term “feed additive” in this Act refers to the non-drug non-nutrient substances proclaimed by the central competent authority to be added into feedstuffs to improve feed efficacy, maintain feed quality, facilitate growth of livestock, poultry and aquatic animals, and keep them healthy.
3-1.2 A detailed list shall be proclaimed by the central competent authority describing the [type of] feed additives (defined in Section 3-1.1) that are subject to mandatory testing for possible changes in biosafety or quality level after manufacturing, processing, packing or importation.
3-1.3 The central competent authority shall prescribe the guidelines for end users intended, allowable amounts, usages and other matters concerning feed additives.

Article 4

4.1 The term “contents” in this Act refers to:
4.1.1 feed contents: the amounts of crude protein, crude fat, crude ash, crude fiber, phosphate, calcium and other active ingredients, restrictive ingredients, and hazardous substances in the feed.
4.1.2 feed additive contents: the amount of active ingredients, restrictive ingredients, and hazardous substances in the feed additive.
4.2 National standards shall govern the contents of feed and feed additives. In the absence of a national standard, one will be established by the central competent authority in collaboration with relevant agencies at the time of new item registration/license.

Article 5

5.1 The term “animal feed makers” in this Act refers to entities engaged in manufacturing, processing and packing of animal feed or feed additives.
5.2 Animal feed and feed additives must not be used to manufacture or process food (for human consumption), be stored or sold along with food. Animal feed makers must not manufacture, process, pack or store food in the same factory for feed or feed additives.

Article 6

For the purposes of this Act, the term "feed vendor" shall denote a business concern that deals in feeds or feed additives as a wholesaler, retailer, importer and exporter; provided that a feed manufacturer shall not be required to apply to be registered as a feed vendor if the feed manufacturer sells its products by wholesale.

Article 7

For the purposes of this Act, the term "labelling" shall mean any legend, logo or symbol appearing on containers or packages of feeds or feed additives.

Article 8

The central competent authority shall, in concert with the competent authority, work out plans with respect to the production, manufacture, transportation and marketing as well as the exportation and importation of feeds so as to avoid disrupting the demand and supply of feeds or creating abnormal prices.

Article 8-1

8-1.1 The central competent authority shall compile information about (1) manufacture & import licenses of feeds/additives; (2) certifications and sales permits of genetically modified feeds/additives and setting up a Feedstuffs Flow databank allowing public access to track the flow of feeds/additives. The central competent authority shall also enforce the announced deadline before which animal feed makers and vendors are to switch to electronic invoicing.
8-1.2 Animal feed makers and vendors shall (1) keep records of incoming and outgoing flows of feed/additives, (2) preserve hardcopy documents and proofs for five years, and (3) transmit such data to the Feedstuffs Flow databank for public access regarding the types of feed/additives and quantity proclaimed by the central competent authority.
8-1.3 The central compete authority is to prescribe details about the creation of the Feedstuffs Flow databank, public access, the deadline to start electronic invoicing of Section 8-1.1, and about keeping records of feedstuffs flow, preserving hardcopy documents and proofs, transmitting data and related tasks in Section 8-1.2.

Chapter II. MANUFACTURE, EXPORTATION AND IMPORTATION OF FEEDS

Article 9

9.1 A feed or feed additive factory shall be established in conformity with the feed or feed additive factory establishment standard; in addition, factory registration shall be obtained in accordance with law.
9.2 The above mentioned factory establishment standard shall be prescribed by the central competent authority in concert with the central competent industrial development authority and the central health authority.
9.3 Feed or feed additive factory permits shall be issued by the competent industrial development authority in concert with the competent agricultural authority.

Article 10

10.1 Feed makers are required to have a license for making, processing and packing each feed/additive proclaimed by the central competent authority. Feed makers shall apply with the central competent authority for such certificates and not engage in manufacturing, processing or packing until after a license is obtained for each feed/additive passing the test.
10.2 The central competent authority shall prescribe eligibility, procedure, and documents to be presented for license application, the certificate of origin, lab test protocols, review criteria, as well as the issuance, renewal and replacement of licenses and related instructions.
10.3 The following entities are waived from having a license described in Section 10.1:
10.3.1 A make-for-self-use feedstuffs user: after getting a made-for-self-use license from the local municipal competent authority, such an entity may make feeds for its own livestock, poultry or aquatic animals.
10.3.2 A testing/research laboratory that makes, processes feed/additives specifically for testing purposes.
10.4 The make-for-self-use feedstuffs user in Section 10.3.1 shall comply with the quantity guidelines set by the central competent authority in terms of contents and quantity; and record the source and usage of feed additives.
10.5 The central competent authority shall prescribe eligibility for the entity in Section 10.3.1, procedure, and documents to be presented for license application, review criteria, as well as the issuance, renewal and replacement of licenses, keeping records of sources and usage of additives described in Section 10.4 and related instructions.
10.6 The central competent authority may delegate to a local municipal competent authority the tasks of accepting applications, conducting lab tests, and issuance of manufacture licenses described in Section 10.1.

Article 11

11.1 Importers shall need licenses to import the types of feed/additives proclaimed by the central competent authority. They must not do so until after such import licenses are issued by the central competent authority for feed/additives passing the test. Entities with manufacture licenses for feed supplements or formulated feed are waived if imported feed is only for its own use to make pre-specified food supplements or formulated feed.
11.2 Entities granted import licenses described in Section 11.1 may delegate importation tasks to other feed vendors.
11.3 The central competent authority shall prescribe the qualification, procedure, documents to be presented for license application, test protocols, review criteria, and issuance, renewal, replacement of import licenses described in Section 11.1, and conditions for delegated importation described in Section11.2, and other tasks.
11.4 The central competent authority may delegate the tasks of accepting applications, conducting lab tests, and issuance of import licenses described in Section 11.1 to its own subordinate agencies, municipal competent authorities, or other organizations.

Article 11-1

11-1.1 Genetically modified feed/additives of foreign origin may not be imported, offered for sale, or used until after the developer applies for and obtains the GMO certificate issued by the central competent authority after passing the verification tests (including biosafety check).
11-1.2 Genetically modified organisms (GMO; animals, plants or microbes) of domestic origin that have completed field tests and relevant reviews may be used for feedstuffs. The developer shall apply with the central competent authority for GMO certificate for feedstuffs usage. Only after such a certificate is issued after passing verification tests (including biosafety check) can the GMO be exported, made into feed/additives, or used as feed/additives.
11-1.3 The GMO certificate described in Sections 11-1.1 and 11-1.2 is valid for no more than five years. The developer may apply for renewal with the central competent authority during the 60-day-period starting on the day with three-month validity remaining. Validity of each renewed certificate shall be no more than five years. The developer shall apply for a new certificate if it fails to renew an existing one.
11-1.4 The central competent authority shall prescribe the procedure, documents to be presented for license application, biosafety evaluation, verification test protocols, review period and criteria, as well as issuance, renewal and replacement of GMO certificates described in Sections 11-1.1, 11-1.2 and 11-1.3, and other instructions.
11-1.5 Regarding the GMO verification tests in Sections 11-1.1 and 11-1.2, the central competent authority may delegate the tasks to its own subordinate agencies or public/private organizations.
11-1.6 Those GMO feed/additives without GMO certificates as of January 23, 2015 – the day this latest revision becomes effective – shall obtain the certificates in compliance with Section 11-1.1 within two years from this effective date.

Article 12

12.1 The registration certificate of the production or import of fodder or fodder additives is valid for four years. Those who continue to produce or import them after their certificates expire need to apply to the competent authority in advance for an extension only that each extension must not exceed four years.
12.2 If the registration certificate of the production or import of fodder or fodder additives is lost or damaged, the person concerned needs to state the reasons clearly, pay for the certificate fee and apply to the original authority which had issued the certificate for a duplicate or replacement. Those who lose their certificates need to revoke the original ones while those who have their certificates damaged need to submit and revoke the original ones.

Article 13

Change in any of the material facts, such as category, item, compositions and potential users of a feed/feed additive, which are specified in a feed/feed additive manufacture/import registration license, shall not be permissible. With respect to change in any material facts other than those enumerated above, approval shall be sought from the competent authority.

Article 14

Chinese language and universal symbols shall be used on the package or container prior to the sales of feed/additives to indicate:
14.1 name and address of the manufacturer or vendor,
14.2 category, description and commercial name,
14.3 contents,
14.4 GMO ingredients used,
14.5 primary ingredients and their suppliers,
14.6 intended use, method and instructions,
14.7 net weight,
14.8 the number of manufacture or import license,
14.9 production year, month, day of manufacturing, processing or packing
14.10 other designated items proclaimed by the central competent authority.

Article 15

Fodder or fodder additives which are to be exported, meet the demands of the foreign buyer, and go in accordance with the regulation of the importing country are exempt from the regulation as prescribed in Article 4 Item 2 concerning the component criterion after the central or municipal competent authority where the factory is located grants the producer the registration certificate of production.

Chapter III. VENDING

Article 16

Those who run the business of trading fodder need to apply to the municipal or prefecture (city) competent authority for registration. They can start their business only after the registration certificates of sale are issued.
The formalities concerning registration in the foregoing item are prescribed by the central competent authority.
The municipal or prefecture (city) competent authority which issues the registration certificate of the sale of fodder may charge the applicant the certificate fees; the charge rate is set by the central competent authority.

Article 17

Within 15 days of the suspension of its business or the change in its business name, address and the name or address of its representative, a feed vendor shall file a report on such suspension or change with the competent authority of the municipal/county/city in which the vendor is located.

Article 18

Whoever is doing business concurrently as a feed vendor shall cause any and all feeds/feed additives being offered for sale to be displayed and stored independently of any goods hazardous to health.

Article 19

Complimentary or samples of feeds/feed additives imported with approval, feeds/feed additives manufactured for own use, or those manufactured, processed or repacked on a consignment basis for experiment purposes shall not be offered for sale.

Chapter IV. SUPERVISION, INSPECTION AND CRACKDOWN

Article 20

Unless for research-purpose manufacturing or processing described in Section10.3.2, feed/additives in any of the following situations must not be used for manufacture, processing, packing, exportation or importation, regardless for self-use or general use:
20.1 Containing hazardous substance exceeding allowable amount, indirectly endangering human health, or containing substances prohibited for use in feed/additives in regulations promulgated by the government,
20.2 Failure to obtain the license or certificate required in Sections 10.1, 11.1, 11-1.1 and 11-1.2.
20.3 Misrepresenting products replaced or adulterated with questionable substances as from legitimate sources of manufacturing, processing, packing or importation.
20.4 Containing expired, spoiled, decomposed, non-feed or non-additive substances or those likely to impact the health of livestock, poultry and aquatic animals.
20.5 Non-compliant with Section 3-1.3 in the use of feed additives.
20.6 Non-consistent with the “allowed contents” described in the license; this clause does not govern feedstuffs prepared by a made-for-self-use entity.
20.7 Non-compliance with Article 14, namely flawed, unclear or incomplete labeling. This clause does govern feedstuffs prepared by a made-for-self-use entity.

Article 21

No feed manufacturer or vendor shall place any false promotional advertisement containing any facts other than those contained in the registration about the feeds/feed additives manufactured or being offered for sale.

Article 22

The competent authority may, in concert with the authority concerned, inspect the feeds/feed additives, equipment, storage facilities and other relevant information of the manufacturer or vendor. If it is necessary, the inspector may also take for inspection and analysis purposes a sample of feeds/feed additives at any end-user thereof.
The samples taken for the inspection and analysis referred to in the preceding paragraph shall be only in an amount sufficient to serve the inspection and analysis purposes.
In performing his duties, an inspector shall show his identification card.
No feed manufacturer/vendor or feed/feed additive end-user shall reject a requested inspection or taking of samples for analysis purposes under the first paragraph of this Article.

Article 22-1

22-1.1 The competent authority shall keep confidential the identify of, may offer reward to, an informant who provides information leading to the discovery of feedstuffs or feed additives in violation of this Act.
22-1.2 The central competent authority shall prescribe the reward program mentioned in 22-1.1.

Article 22-2

22-2.1 Importation of feed/additives proclaimed by the central competent authority shall be released from the customs only after passing the inspection by the central competent authority.
22-2.2 Regarding the feed/additives failing the inspection described in Section 22-2.1, the central competent authority may demand part or all of the feed/additives be returned, destroyed or confiscated. Returned goods must not be included in future applications for importation.
22-2.3 Regarding the importation of feed/additives described in Section 22-2.1 and Section 22-2.2, the central competent authority shall prescribe the customs declaration, the inspection protocol (procedure, check items, methods, and quantity), return and destruction of goods, documents to be presented, and other instructions.
22-2.4 The central competent authority may delegate the inspection tasks described in Section 22-2.1 to its subordinate agencies or other organizations.

Article 23

Where taking of samples of any feed or feed additive is required to determine whether any of the situations under Article 20 hereof exists as alleged, the feed or feed additive shall be sealed and then held in trust by the specific manufacturer, vendor or end-user issue in accordance with an undertaking issued by the latter.
The samples taken in accordance with the preceding paragraph shall be delivered to the competent authority for analysis and appraisal. The period for the competent authority to take official actions with respect to the feeds/feed additives at issue shall not exceed 15 days from the date the analysis and assessment have been completed.

Article 24

The competent agency deal with defective feed/additives in the following manner:
24.1 For non-compliance of Section 5.2, or any of Sections 20.1 to 20.6: demanding the feedstuffs be returned, recalled/recycled, re-processed, destroyed, discarded, or confiscated before a designated deadline.
24.2 For non-compliance of Section 20.7 about labeling: demanding corrective actions be taken before a deadline.

Article 25

25.1 Besides measures against non-compliant feedstuffs, parties involved in violation of Section 5.2 or any section from 20.1 to 20.7 are also subject to penalties:
25.1.1 Related licenses shall be revoked for the party violating Section 5.2 or making, processing, packing or importing feed/additives against any section from 20.1 to 20.5.
25.1.2 Related licenses shall be revoked for the party making, processing, packing and importing feed/additives in violation of Section 20.6 or Section 20.7 more than twice and in an aggravated manner.
25.1.3 Related licenses shall be revoked for the party selling, exporting, displaying or storing (with intent to sell) feed/additives violating any section in Article 20.
25.1.4 The competent authority may disclose the offending party’s name, company or commercial name, sales venue, person in charge, names of the defective merchandize and details of the offense.
25.2 Feed or additives for which licenses have been revoked according to any clause in Section 25.1 are no longer eligible for application of manufacturing license, import license or sales license.

Chapter V. PENAL PROVISIONS

Article 26

26.1 A jail term or penal servitude under five years, in conjunction with a fine under NT$20,000,000 will be imposed for violation of any clause from Sections 20.1 to Section 20.3
26.2 Penal servitude and a fine of under NT$100,000 will be imposed for a violation described in Section 26.1 that is out of negligence.
26.3 A penalty will be imposed for attempted violation of any section from Section 20.1 to Section 20.3.

Article 27

27.1 A jail term of under two years and a fine of under NT$1,000,000 shall be imposed on the party selling, exporting, displaying or storing (with intent to sell) feed/additives violating any section from Section 20.1 to Section 20.3.
27.2 A fine of under NT$60,000 will be imposed for a violation described in Section 27.1 that is out of negligence.

Article 28

(Deleted)

Article 29

A fine of over NT$30,000 and under NT$3,000,000 will be imposed for any of the following:
29.1 Violation of Section 5.2, namely (1) using feed/additives to manufacture or process (human) food, (2) storing or selling feedstuffs along with food, or (3) manufacturing, processing, packing or storing food in the same factory for feedstuffs.
29.2 Using feed/additives described in Sections 20.1, 20.2, 20.4 and 20.5.
29.3 Manufacturing, processing , packing, importing feed/additives described in clauses from Section 20.4 to Section 20.7.
29.4 Importation of feed/additives not inspected, or having failed the inspection, or application for importation of feed/additives previously ordered to be returned by the Central competent authority.

Article 30

A fine of over NT$30,000 and under NT$500,000 will be imposed for selling, exporting , or display/storage with intents to sell, of animal feeds/additives described in Sections 20.4-20.7 [20.1.4-20.1.7].

Article 31

A fine of over NT$30,00 and under NT$300,000 will be imposed for any of the following:
31.1.1 Failure to comply with Section 8-1.2 or regulations prescribed according to 8-1.3, namely failure to record, transmit (to authority) or disclose the source and destination of foodstuffs; failure to preserve certificates or evidence; or failure to issue electronic invoices; or record, transmit to authority or disclose false information.
31.1.2 Violation of Article 9, namely failure to set up a factory according to this Act.
31.1.3 A make-for-self-use entity’s failure to make feedstuffs meeting the quantity limits set by the central competent authority; failure to apply for a self-use license according to Section 10.3.1; or failure to keep records of sources, use of feed additives, according to Sections 10.4 and 10.5, or the records are flawed.
31.1.4 Violation of Article 13, namely engaging in tasks [operation] not listed on the license, or make changes to the license without prior official approval.
31.1.5 Violation of Article 16, namely engaged in business operation without a sales license.
31.1.6 Violation of Articles 19 and 21, and Section 22.4.
31.1.7 violation of Section 24.1 and 24.2, namely failure to recall, re-process, fix the label, destroy or discard.
31.2 The local competent authority may – besides imposing the fine stipulated in Section 31.1 – order [demand] the made-for-self-use feed user to begin to (1) truthfully keep the records, (2) re-process, discard or destroy the feeds or additives by one’s own means, or discontinue the use. If the feed user fails to comply by a prescribed deadline, the self-use license may be revoked.

Article 32

A written warning will be issued for violation of Article 17 or Article 18. A repeated offense will result in a fine of over NT$15000 and under NT$100,000.

Article 32-1

For violation of a statute from Articles 29 to 32, if the illegal gain exceeds the highest prescribed amount of fine, the penalty imposed may/could be up to ten times of the total sales revenue during the period of violation.

Article 33

If the representative of a legal entity, or the agent, employee or any other professional of any legal entity or natural person is guilty of the offenses under Article 26 or 27 hereof in performing their duties, not only the wrongdoer shall be punishable in accordance with Article 26 or 27, but also the legal entity or natural person shall be imposed the fines provided under any of the applicable Articles.

Article 34

(Deleted)

Article 35

A case in which the fine imposed in pursuance hereof is not paid within the prescribed time limit shall be referred to the court for compulsory execution.

Article 36

(Deleted)

Article 37

The competent authority at each level shall be the authority with powers to impose sanctions and fine in accordance with this Act.

Chapter VI. SUPPLEMENTARY PROVISIONS

Article 38

Any and all feed manufacturers which were established prior to the amendment of this Act and which do not satisfy the requirements of Article 5 of this Act shall apply to be registered as feed vendors in accordance with this Act within one year of the effectiveness of this amended Act.

Article 39

The enforcement rules of this Act shall be established by the central competent authority.

Article 39-1

Animal feeds or feed additives manufactured, processed, packed, imported, exported, sold, displayed (offered for sale), stored or used before January 23, 2015 -- the date this revision of this Act becomes effective – AND without the issues listed in Article 20 [before the revision?] will be deemed as [the type of] feeds or additives proclaimed by the central competent authority according to Section 3.1 and Section 3-1.1.

Article 40

This Act shall become effective as of the date of its being promulgated.