Legislative: |
1.Thirty-nine articles were enacted and promulgated by the president on January 12, 1973per presidential order referenced 1973-Tai-Tung (I) Yi-Tze 182 2.All forty articles after amendment were promulgated by the president on December 5, 1986 per presidential order referenced 1986-Hua-Tsong (I) Yi-Tze 6106 3.Articles 2, 10, 11, 15 were amended and promulgated by the president on May 17, 2000 per presidential order referenced 2000-Hua-Tsong (I) Yi-Tze 8900118430 4.Articles 10~12, 15, 16 and 25 were amended and promulgated by the president on January 30, 2002 per presidential order referenced 2002-Hua-Tsong (I) Yi-Tze 09100017010 5.Articles 3~5, 10, 11, 14, 20, 24~27, 29~32 and the title of chapter four were amended; Articles 8-1, 11-1, 22-1, 22-2, 32-1 and 39-1 were added; Article 36 was deleted. The entire revision was promulgated by the president on February 4, 2015 per presidential order referenced 2015-Hua-Tsong (I) Yi-Tze 10400014919 The announcement was made on July 27, 2023 by the Executive Yuan Order tai-gui-zi No. 1125014346. The relevant matters set out in Article 2, Article 3, Article 3-1, Paragraph 2 of Article 4, Article 8, Article 8-1, Paragraph 2,3 of Article 9, Paragraph 1,2,4,5,6 of Article 10, Paragraph 1,3,4 of Article 11, Paragraph 1,2,3,4,5 of Article 11-1, Article 12, Article 13, Subparagraph 10 of Paragraph 1 of Article 14, Article 15, Paragraph 2,3 of Article 16, Subparagraph 1 of Paragraph 1 of Article 20, Paragraph 1 of Article 22, Article 22-1, Article 22-2, Paragraph 2 of Article 23, Article 24, Subparagraph 4 of Paragraph 1 of Article 25, Subparagraph 4 of Paragraph 1 of Article 29, Subparagraph 3 of Paragraph 1 of Article 31, Article 37, Article 39, Article 39-1 pertaining to “ the Council of Agriculture of the Executive Yuan” shall be handled by “Ministry of Agriculture” as governing body, effective August 1, 2023. |
Content: |
Chapter I. GENERAL PROVISIONS
Article 1
To maintain the quality of feeds; to promote the development of
the livestock and aquaculture industries; and to thereby
maintain the public health, this Act is hereby established. Matters not regulated herein shall be governed by other
applicable laws.
Article 2
The term “competent authority” in this Act shall mean the
Ministry of Agriculture at the central government level; the
municipal government at the directly-controlled municipality
level; and the county/city level in counties/cities.
Article 3
The term “feed” in this Act refers to foodstuffs, as announced
by the central competent authority, as being able to provide
nutrition to, or promote healthy growth of, livestock, poultry,
and animals used in aquaculture. Feed is classified as follows:
1. Plant-based feed: Plants, plant products, and the processed
results thereof.
2. Animal-based feed: Animals, animal products, and the
processed results thereof.
3. Feed supplement: Minerals, vitamins, amino acids, and the
processed results thereof.
4. Formulated feed: Formulated mixtures and compounds of two or
more of the above.
Regarding the specific list of feeds/supplements in the previous
paragraph for which safety or quality levels may vary as a
result of manufacturing, processing, packaging, or importing,
and for which testing is therefore mandatory, the central
competent authority shall announce such list.
Article 3-1
The term “feed additive” in this Act refers to non-medicinal,
non-nutrient substances, as announced by the central competent
authority, that may be added to feed to improve feed efficacy,
maintain feed quality, facilitate growth of livestock/poultry/
animals used in aquaculture, keep such animals healthy, or for
other purposes.
Regarding the specific list of feed additives in the previous
paragraph for which safety or quality levels may vary as a
result of manufacturing, processing, packaging, or importing,
and for which testing is therefore mandatory, the central
competent authority shall announce such list.
Animals with which feed additives may be used, amounts,
purposes, and other principles that shall be complied with shall
be established by the central competent authority.
Article 4
The term “components” in this Act refers to:
1.Feed components: The content of crude protein, crude fat,
crude ash, crude fiber, phosphorus, calcium, and other active
ingredients, restricted ingredients, and hazardous substances
in the feed.
2.Feed additive components: The amount of active ingredients,
restricted ingredients, and hazardous substances in the feed
additive.
The standards for the components of feed and feed additives
shall be in accordance with the provisions National Standards of
the Republic of China (CNS) regulations. In the absence of a
National Standard, one shall be established by the central
competent authority in collaboration with other relevant
agencies at the time of new item license.
Article 5
The term “feed manufacturer” in this Act refers to an entity
engaged in manufacturing, processing, or packaging of feed or
feed additives.
Feed and feed additives shall not be used in manufacturing or
processing food for human consumption, nor stored nor sold along
with food for human consumption. Feed manufacturers shall not
manufacture, process, package or store food for human
consumption in the same factory as feed or feed additives.
Article 6
The term “feed vendor” in this Act refers to a business
concern that deals in feeds or feed additives as a wholesaler,
retailer, importer, or exporter. However, feed manufacturers who
sells their products by wholesale shall be exempt from the
registration as feed venders.
Article 7
The term “labelling” in this Act refers to 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 relevant
competent authorities, make plans regarding production,
anufacture, transportation, marketing, exportation, and
importing of feeds, so as to avoid an imbalance in supply and
demand for feeds and to avoid abnormal prices.
Article 8-1
The central competent authority shall compile the following
information: feed/feed additive Manufacturing licenses;
feed/feed additive Import licenses; genetically modified
feed/feed additive certifications of having passed inspection;
genetically modified feed/feed additive sales licenses; and the
results of genetically modified feed/feed additive inspections.
The central competent authority shall also establish a
tracing/tracking system and database for the origins and flows
of feeds/feed additives, and shall make such system and database
public. The central competent authority shall also announce the
staged deadlines by which feed manufacturers and vendors shall
use electronic uniform invoices.
Feed manufacturers and vendors shall keep records of supply
sources and outflows for feed/feed additives, and shall retain
certification or proof thereof for five years. Where feed/feed
additives that are manufactured, imported, or sold meet
quantities and categories announced by the central competent
authority, the feed manufacturer/vendor shall upload the supply
sources and flows to the database in the previous paragraph and
make such information public.
The central competent authority shall prescribe, from paragraph
1, details about the establishment of the tracing/tracking
system and database; information disclosure for such; and the
deadlines by which electronic uniform invoices shall be used.
The central competent authority shall also prescribe, from
paragraph 2, the rules regarding records and uploading for
information about supply sources and outflows; information
disclosure for such; methods of retaining certification or
proof; and other matters for compliance.
Chapter II. MANUFACTURING, IMPORTING, AND EXPORTING
Article 9
The establishment of a feed or feed additive factory shall
comply with the feed or feed additive factory establishment
standards; in addition, factory registration shall be obtained
in accordance with the law.
The factory establishment standards shall be prescribed by the
central competent authority, in concert with the central
competent authority for industry and the central competent
authority for health.
Permits for establishing a feed or feed additive factory shall
be issued by the competent authority for industry in concert with the central competent authority for agriculture.
Article 10
For manufacturing, processing, or packaging any feed/feed additive announced by the central competent authority as requiring a permit to do so, the entity engaging in such activity shall apply to the central competent authority for such a permit. Only after
the feed/feed additive passes inspection, and only after the Manufacturing license is issued, may the manufacturing, processing, or packaging occur.
The central competent authority shall prescribe, from the previous paragraph, the application criteria, procedures, documents to be attached, proof of origin, testing protocols, permit criteria, Manufacturing license issuance/renewal/replacement, and other
matters for compliance.
The following entities are exempt from needing to apply for and
obtain a Manufacturing license as described in paragraph 1:
1.A self-manufactured, own-use feed user who has applied to a
competent authority at the directly-controlled municipal
government or county/city-levels, for a permit; who has been
issued a self-manufactured, own-use license; and who
manufactures such feed for use with the entity’s own
livestock, poultry or aquatic animals.
2.A research institution that manufactures or processes
feed/feed additives specifically for testing purposes.
In terms of components and quantities, self-manufactured, own-
use feed in subsection 1 of the previous paragraph shall comply
with the quantity limits set by the central competent authority.
Where feed additives are used, the sources and uses of feed
additives shall be recorded.
The central competent authority shall prescribe, from paragraph
3, subsection 1, the application criteria, procedures, documents
to be attached, permit criteria, and license
issuance/renewal/replacement. The central competent authority
shall also prescribe, from the previous paragraph, recording for
sources and uses of feed additives, other matters for
compliance, and quantity limits.
The central competent authority may delegate matters in
paragraph 1 regarding handling applications, inspections,
issuance of Manufacturing licenses, etc. to competent
authorities at the directly-controlled municipal government or
county/city-levels.
Article 11
Importers shall apply for licenses to import feed/feed additives
announced as requiring such by the central competent authority.
Only after the feed/feed additive passes inspection, and only
after an Import license is issued, may the importing occur.
However, if an entity is permitted to manufacture feed
supplements or formulated feed and obtains a Manufacturing
license for such, and then imports feed only for its own factory
in manufacturing said food supplements or formulated feed, this
restriction shall not apply.
Entities granted Import licenses described in the previous
paragraph may authorize other feed vendors to handle importing
tasks on their behalf.
The central competent authority shall prescribe, from the
previous two paragraphs, the application criteria, procedures,
documents to be attached, testing protocols, permit criteria,
Import license issuance/renewal/replacement, authorized
importing, and other matters for compliance.
The central competent authority may delegate the tasks of
accepting applications, conducting lab tests, and issuance of
Import licenses described in paragraph 1 to its own subordinate
agencies/organizations, to competent authorities at the
directly-controlled municipal government or county/city-levels,
or to other organizations.
Article 11-1
Genetically modified feed/feed additives of foreign origin may
not be imported, offered for sale, or used until after such
feed/feed additives pass inspections (including biosafety
check), and until after the developer applies for and obtains a
permit issued by the central competent authority.
Genetically modified organisms (GMO; animals, plants or
microbes) of domestic origin that have completed legally-
required field tests and reviews may only be exported, made into
feed/feed additives, or used as feed/feed additives after the
developer applies with the central competent authority for a GMO
certificate for feed usage; after such a certificate is issued;
and after inspections (including biosafety check) are passed.
The GMO certificate described in the previous two paragraphs
shall be 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 on which three months of
validity remain. Validity of each renewed certificate shall be
no more than five years. If a developer fails to renew a
certificate, the developer shall be required to apply for a new
certificate.
The central competent authority shall prescribe, from the
previous three paragraphs, the certificate application
procedure, documents to be attached, biosafety evaluation,
testing protocols, inspection protocols, review periods, permit
criteria, certificate issuance/renewal/replacement, and other
matters for compliance.
The central competent authority may delegate the inspection
protocols in paragraphs 1 and 2 to its own subordinate
agencies/organizations, or commission other
agencies/organizations/groups to do such inspection.
Before the January 23, 2015 amendment to this Act becomes
effective, those GMO feed/feed additives for which GMO
certificates have not been obtained in accordance with paragraph
1 shall obtain such certificates within two years from the date
this amendment takes effect.
Article 12
A feed/feed additive Manufacturing license or Import license
shall be valid for four years. Where manufacturing or importing
is to continue after said certificates expire, the
manufacturer/importer shall first apply to the competent
authority in advance for an extension. Such an extension shall
not exceed four years each time.
If a feed/feed additive Manufacturing license or Import license
is lost or damaged, the person concerned shall state the reasons
clearly, pay a registration fee, and apply to the original
issuing authority for replacement or renewal. Where the original
certificate is lost, the person concerned shall apply to have
the original canceled; where the original certificate is
damaged, the person concerned shall submit the original for it
to be canceled.
Article 13
Material facts of a license, such as category, item, components,
and animals with which a feed/feed additive is to be used, shall
not be changed. For other matters to be changed, approval must
be applied for and permission obtained from the competent
authority before the changes may be made.
Article 14
For feed/feed additives, before they can be sold, Chinese
language or universal symbols shall be placed on the package or
container to indicate:
1.Name and address of the manufacturer or vendor;
2.Category, description and commercial name;
3.components;
4.GMO ingredients used;
5.Primary ingredients and their suppliers;
6.Intended use, usage method, and precautions for use;
7.Net weight;
8.Manufacturing license number/Import license number;
9.Year, month, and day on which the product was manufactured,
processed, or packaged; and
10.Other matters specified in central competent authority
announcements.
Article 15
For feed/feed additives that are to be exported to meet the
requirements of a foreign buyer, and which comply with the
regulations of the importing country, if the central competent
authority or the competent authority at the directly-controlled
municipal government where the enterprise is located grants the
enterprise Manufacturing license, such exporting shall not be
subject to the component standards specified in Article 4,
paragraph 2.
Chapter III. SALES
Article 16
Enterprises operating as feed vendors shall apply to the
competent authorities at the directly-controlled municipal
government or county/city-levels for registration. Sales may
only begin after the sales license is issued.
The license procedures in the previous paragraph shall be are
prescribed by the central competent authority.
Competent authorities at the directly-controlled municipal
government or county/city-levels that issue sales licenses may
charge applicants license registration fees; the fee rates shall
be set by the central competent authority.
Article 17
Within 15 days of suspending business, a change in name, change
in address, or a change in the name or address of its legal
representative, a feed vendor shall report on such suspension or
change with the competent authority at the directly-controlled
municipal government or county/city-level in which the vendor is
located.
Article 18
Any enterprise concurrently doing business as a feed vendor
shall cause any and all feeds/feed additives being offered for
sale to be displayed and stored separately from any goods
hazardous to health.
Article 19
Samples and complimentary gifts of feeds/feed additives approved
for import; self-manufactured, own-use feeds/feed additives; and
feeds/feed additives that are commissioned for manufacturing,
processing, or packaging for experimental purposes shall not be
offered for sale.
Chapter IV. MONITORING AND INSPECTION
Article 20
Unless for manufacturing or processing feed/feed additives
specifically for testing purposes as described in Article 10,
paragraph 3, subsection 2, feed/feed additives to which any of
the following situations apply shall not be used for
manufacturing, processing, packaging, sales, exporting,
importing, self-use, or use by others:
1.Hazardous substance content exceeds the standard, indirectly
endangers human health, or contains substances otherwise
prohibited for use in feed/feed additives in law or as
announced by the central competent authority;
2.Requires a license in accordance with Article 10, paragraph 1
Article 11, paragraph 1, or Article 11-1, paragraphs 1 or 2,
but has not obtained such a license.
3.Switched or adulterated with products legitimately
manufactured, processed, packaged, or imported by others.
4.Contains expired, spoiled, or decomposed non-feed or non-
additive substances, or substances likely to impact the health
of livestock, poultry or aquatic animals.
5.Feed additives used do not comply with Article 3-1, paragraph
3.
6.Components do not comply with the allowed components listed in
the license. However, with self-manufactured, own-use feed
made by a self-manufactured, own-use user, this restriction
shall not apply.
7.Labeling does not comply that specified in Article 14, or is
unclear or incomplete. However, with self-manufactured, own-
use feed made by a self-manufactured, own-use user, this
restriction shall not apply.
Article 21
No feed manufacturer or vendor shall place any false promotional
advertisement containing facts other than those contained in the
license registration regarding the feeds/feed additives
manufactured or offered for sale.
Article 22
The competent authority may, in concert with related competent
authorities, inspect manufacturers’ and vendors’ feeds/feed
additives, as well as their equipment, storage facilities, and
relevant information, and may take samples for inspection. When
necessary, said authorities may also take for inspection and
analysis purposes samples of feeds/feed additives at any end-
user thereof.
Quantities of samples taken for the inspection and analysis
referred to in the preceding paragraph shall limited to that
which is sufficient to serve the inspection and analysis
purposes.
When performing their duties, inspectors shall display their
identification documents.
Regarding inspection and samples mentioned in paragraph 1, no
feed manufacturer, vendor, or feed/feed additive end-user shall
refuse inspection/sampling.
Article 22-1
When a person blows the whistle on and leads to the discovery of
feed/feed additives that violate this Act, the competent
authority may offer a reward to such person, and shall keep said
person’s identity strictly confidential.
The award rules mentioned in the previous paragraph shall be
prescribed by the central competent authority.
Article 22-2
Importing of feed/feed additives announced by the central
competent authority shall only be released from customs after
they have passed inspection by the central competent authority.
Regarding feed/feed additives that fail inspection described the
previous paragraph, the central competent authority may demand
that part or all of the feed/feed additives be returned,
destroyed, or confiscated. Returned goods shall not be included in future applications for importing.
Regarding the feed/feed additives described in the previous two
paragraphs, the central competent authority shall prescribe the
customs declaration, inspection protocols (procedures, check
items, methods, and quantities), return/destruction of goods,
documents to be presented, and other matters for compliance.
The central competent authority may delegate the inspection
protocols in paragraph 1 to its own subordinate
agencies/organizations, or commission other
agencies/organizations/groups to do such inspection.
Article 23
Where taking samples of any feed or feed additive is required to
determine whether any of the situations under Article 20,
paragraph 1, any subsection exists as alleged, the feed/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.
Samples taken in accordance with the preceding paragraph shall
be delivered for analysis and appraisal as soon as possible. The
period for the competent authority to take official action with
respect to such feeds/feed additives shall not exceed 15 days
from the date the analysis and assessment are completed.
Article 24
For feed/feed additives to which the following circumstances
apply, the competent agency shall deal with them in the
following manner:
1.For non-compliance with Article 5, paragraph 2, or any of the
circumstances in Article 20, paragraph 1, subsections 1 to 6:
Order that the product in question be returned, recycled, re-
processed, destroyed, discarded, scrapped, or confiscated
before a designated deadline.
2.For non-compliance with Article 20, paragraph 7: Order that
corrective action be taken before a deadline.
Article 25
Any feed/feed additive violation discovered to be in violation
of Article 5, paragraph 2, or Article 20, paragraph 1, any
subsection, shall in addition to being handled in accordance
with this Act, be subject to the following penalties:
1.or a party violating Article 5, paragraph 2, or manufacturing,
processing, packaging, or importing feed/feed additives to
which Article 20, paragraph 1, subsections 1 to 5 apply, such
party’s related licenses shall be revoked.
2.For a party manufacturing, processing, packaging, or importing
feed/feed additives to which Article 20, paragraph 1,
subsections 6 or 7 apply, where punishment has been rendered
two or more times and the circumstances are severe, such
party’s related licenses shall be revoked.
3.For a party selling, exporting, intending to sell, and
displaying or storing feed/feed additives to which Article 20,
paragraph 1, any subsection applies, where punishment has been
rendered two or more times or a guilty verdict has been
affirmed, such party’s related licenses shall be revoked.
4.The competent authority may disclose such an offending
party’s name, company or commercial name, sales venue, full
name of the person in charge, names of the defective products,
and details of the offense.
With feed/feed additives for which licenses have been revoked in
accordance with the previous paragraph, any subsection, no
further application may be made for a Manufacturing license,
Import license, or sales license.
Chapter V. PENAL PROVISIONS
Article 26
For any person manufacturing, processing, packaging, or
importing feed/feed additives listed in Article 20, paragraph 1,
subsections 1 to 3, a jail term or penal servitude of no more
than five years, in conjunction with a fine of no more than NT
$20,000,000, shall be imposed.
For a violation in the previous paragraph where the crime was
non-intentional, penal servitude and a fine of no more than NT
$100,000 shall be imposed.
An attempt to commit any act mentioned in paragraph 1 shall also
be punishable.
Article 27
For a party selling, exporting, intending to sell, and
displaying or storing feed/feed additives to which Article 20,
paragraph 1, subsections 1 to 3 apply, a jail term of no more
than two years and a fine of no more than NT$10,000,000 shall be
imposed.
For a violation in the previous paragraph where the crime was
non-intentional, a fine of no more than NT$60,000 shall be
imposed.
Article 28
(Deleted)
Article 29
Where any of the following circumstances apply, a fine of no
less than NT$30,000 and no more than NT$3,000,000 shall be
imposed:
1.Violation of Article 5, paragraph 2, namely, using feed/feed
additives in manufacturing or processing food for human
consumption, or storing or selling such along with food for
human consumption, or manufacturing, processing, packaging, or
storing food for human consumption in the same factory as
feed/feed additives.
2.Using feed/feed additives described in Article 20, paragraph
1, subsections 1, 2, 4, or 5.
3.Manufacturing, processing , packaging, or importing feed/feed
additives described Article 20, paragraph 1, subsections 4 to
7.
4.Importing of feed/feed additives not inspected by or which
have failed inspection by the central competent authority, or
applying for importing of feed/feed additives previously
ordered to be returned by the central competent authority.
Article 30
For a party selling, exporting, intending to sell, and
displaying or storing feed/feed additives to which Article 20,
paragraph 1, subsections 4 to 7 apply, a fine of no less than NT
$30,000 and no more than NT$500,000 shall be imposed.
Article 31
A fine of no less than NT$30,00 and no more than NT$300,000
shall be imposed for any of the following:
1.Failure to comply with Article 8-1, paragraphs 2 and 3,
namely, failure to keep records of supply sources and outflows
for feed/feed additives, and retain certification or proof
thereof for five years; failure to use electronic uniform
invoices; or falsely keeping, uploading, or disclosing such
records.
2.Violation of Article 9, namely, failure to establish a factory
in accordance with this Act.
3.With self-manufactured, own-use feed made by a self-
manufactured, own-use user, there is a failure to comply with
the quantity limits set by the central competent authority; or
a failure to apply for a self-manufactured, own-use license in
accordance with Article 10, paragraph 3, subsection 1; or a
failure to keep records of feed additives’ sources or uses,
in accordance with Article 10, paragraphs 4 and 5, or the
records are flawed.
4.Violation of Article 13, namely, changing matters that require
prior approval without obtaining such prior approval.
5.Violation of Article 16, namely, engaging in business
operation without a sales license.
6.Violation of Article 19, Article 21, or Article 22, paragraph
4.
7.Violation of Article 24, paragraphs 1 or 2, namely, failure to
recall, re-process, correct, destroy, or discard within a
specified time limit.
Where the circumstances in the previous paragraph, subsection 3
apply, the competent authority at the directly-controlled
municipal government or county/city-level may, in addition to
imposing a fine stipulated in the previous paragraph, order the
self-manufactured, own-use feed user to truthfully keep records;
re-process, discard, or destroy the feed/feed additives via such
user’s own means; or order that use of such feed/feed additives
be discontinued. The competent authority may also revoke the
self-manufactured, own-use license.
Article 32
A written warning shall be issued for violation of Article 17 or
Article 18. A repeated offense shall result in a fine of no less
than NT$15,000 and no more than NT$100,000.
Article 32-1
For violation of Articles 29 to 32, if the illegal gain exceeds
the highest prescribed amount of fine, the penalty imposed may
be up to ten times 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 shall the wrongdoer be
punishable in accordance with such Article, but fines shall also
be imposed on the legal entity or natural person under any of
the applicable Articles.
Article 34
(Deleted)
Article 35
A case in which a fine imposed in accordance with this Act is
not paid within the prescribed time limit shall be referred to
the court for compulsory enforcement.
Article 36
(Deleted)
Article 37
The competent authority at the specific 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 that were established prior to
the amendment of this Act and which do not satisfy the
requirements of Article 5 of this Act shall, within one year of
this amended Act taking effect, apply to be registered as feed
vendors in accordance with this Act.
Article 39
The enforcement rules of this Act shall be established by the
central competent authority.
Article 39-1
Feeds/feed additives manufactured, processed, packaged,
imported, exported, sold, displayed, stored, or used before
January 23, 2015 (the date on which the amendment to this Act
takes effect), and without the issues listed in the pre-amended
Article 20, paragraph 1, any subsection, shall be deemed as
feeds/feed additives designated by the central competent
authority in accordance with Article 3, paragraph 1 or Article
3-1, paragraph 1.
Article 40
This Act shall take effect upon the date on which it is
promulgated. |