Leyes y regulaciones relacionadas de la agricultura orgánica

Fecha de lanzamiento：2018-08-15

Acta

Organic Agriculture Promotion Act

Organic Agriculture Promotion Act

Promulgation Date: 30th May 2018

Chapter 1 General Principles

Article 1

The Act has been established for maintaining water and soil resources, ecological environment, biodiversity, animal welfare and consumer interests, and promoting agricultural operation that is eco-friendly and sustainable use of resources.

Article 2

The term "competent authority" used in this Act is the Council of Agriculture of the Executive Yuan at the central level; the municipal/county/city governments at the local level.

Article 3

The terms used in this Act shall be defined as the following:

1. Agricultural product: Any product which is produced or processed as food by utilizing natural resources, agricultural materials and technology, including cultivation, forestry, aquaculture, and animal husbandry or any product promulgated by the Central Competent Authority.

2. Operator: Any individual or legal entity who engages in the production, processing, packaging, importing, distribution or sale of agricultural products.

3. Organic agriculture: Any farming practice including cultivation, forestry, aquaculture, and animal husbandry without using chemical fertilizer, chemical pesticide, genetically modified organism (GMO), and related products, based on the principle of ecological balance and nutrient recycling.

4. Organic agricultural product: Any agricultural product that is produced, processed, packaged and distributed in accordance with the certification standard established by the Central Competent Authority and certified under this Act, or any imported agricultural product approved in accordance with Article 17 paragraph 1 of this Act.

5. In-conversion agricultural product: Any agricultural product that is undergoing conversion to organic, during which the product is required to be produced, processed, packaged and distributed in accordance with the certification standard established by the Central Competent Authority and certified under this Act.

6. Organic mark: The mark used to indicate the agricultural product to be organic.

7. Labeling: Words, graphics, symbols or additional instruction affixed to agricultural products, the containers or packaging of agricultural products when displayed or for sale.

8. Accreditation body: An institution or legal entity who is reviewed and permitted by the Central Competent Authority and with the qualification to conduct accreditation activities prescribed by this Act.

9. Accreditation: The process in which the accreditation body evaluates whether an institution, school or legal entity is qualified to provide certification services prescribed by this Act under a contract.

10. Certification body: An institution, school or legal entity who is accredited by the accreditation body to provide certification services.

11. Certification: The process in which the certification body verifies whether the production, processing, packaging or distribution of a specific agricultural product is in compliance with this Act under a contract with the respective operator.

Chapter 2 Promotion of Organic Agriculture

Article 4

The competent authority shall promote the agricultural production management system which adopts the approach of agronomical, biological, and machinery operation and uses natural resources, excluding synthetic chemicals and GMOs, in order to fulfill the eco-friendly requirement of organic agriculture.

The above organic agriculture that competent authority shall promote includes eco-friendly farming, despite it not certified as mentioned in subparagraph 11 of Article 3.

The competent authority shall uphold the principle of balancing supply and demand in promotion of organic agriculture by proceeding with the development and implementation of new technology prudently and reasonably, improving production techniques and product quality of the operator, making the organic agricultural products accessible to consumers, enlarging the understanding, and gaining consumer trusts. All these efforts are for the purpose of making farmers willing to engage in organic agriculture.

Article 5

To promote the sustainable development of agriculture, the Central Competent Authority shall set up the consultant board, consult related authorities (institutions) and organizations on its path toward a country with full organic adoption. Every four years Organic Agriculture Promotion Program shall be revised and implemented after approved by the Executive Yuan.

Contents of the Organic Agriculture Promotion Program are as

follow:

1. The target organic agricultural production area, its proportion of total arable land, and the annual budget allocation.

2. Forward-looking development plan and status survey for organic agriculture.

3. Counseling for organic agricultural production, marketing, and product certification.

4. Incentives and subsidies for conversion to organic agriculture and environment preservation.

5. Improvement of agricultural practices, research and development of agricultural technologies, and personnel training for organic agriculture and organic agricultural products.

6. Promotion of organic agricultural products and organic food and farming education for authorities (institutions) at all levels, schools, and consumers.

7. Counseling relevant civil groups for the promotion of organic agriculture.

8. Other tasks that facilitate the development of organic agriculture.

In promotion of organic agriculture, the competent authority shall allocate ample budget, which will be raised every four years on a roll planning basis, for conducting tasks mentioned in the previous paragraph, in pursuance of full organic adoption.

The Central Competent Authority shall establish the standard on the principle of proportionality for issuing incentives and subsidies mentioned in subparagraph 4 of paragraph 2.

Article 6

The Local Competent Authorities shall review the districts of their jurisdiction annually and locate suitable areas to establish organic agricultural promotion zones while encouraging civil production cooperatives or collaborative marketing organizations to participate in the establishment.

Public land or lands of state-owned enterprises suitable for agricultural production shall be prioritized for the establishment of organic agricultural promotion zones. The competent authority shall prioritize in providing assistance or subsidies on public infrastructure and marketing facilities (equipment) in organic agricultural promotion zones.

The Local Competent Authorities may provide assistance to farmers in organic agricultural promotion zones established under paragraph 1 who have not yet adopted organic agricultural production and require them to take necessary measures to avoid the impediment of organic agricultural production at neighboring lands.

Article 7

The competent authority may provide proper assistance to operators on the certification fees, the technology upgrade, marketing channel expansion, production-marketing facilities (equipment), materials, fund loan and other organic agriculture related matters in accordance with this Act as well as incentives for seed reserving, breeding activities, and seedling production of organic agriculture; the operators in organic agricultural promotion zones of the previous paragraph may be prioritized in receiving assistance and incentives.

The operator who rents public lands or lands of state-owned enterprises for organic agricultural production shall be provided with a rental discount.

For the operator who rents public lands or lands of state- owned enterprises under the previous paragraph for organic agricultural production and has been certified according to subparagraph 11 of Article 3, the land lease shall be guaranteed for a period from 10 years up to 20 years and free from the restriction of the lease period stipulated in Article 43 of National Property Act.

The regulations governing the rental discount mentioned in paragraph 2, guaranteed land lease period in the previous paragraph, and matters concerning lease management shall be established by the Central Competent Authority after it consult with the management authority of public lands or state-owned enterprises lands and relevant departments.

Article 8

The competent authority shall establish online platforms to integrate certification data from certification bodies and information about organic farming, marketing, materials permitted for organic production, seedlings, qualified organic imports, and else for public query.

Article 9

The competent authority shall encourage relevant authorities (institution), organizations or enterprises for preferential use of local organic agricultural products.

The competent authority shall counsel authorities (institution), organizations or enterprises to establish farmers’ market to provide the channels for selling organic agricultural products.

The competent authority may assist operators in establishing online platforms to provide consumers with direct channels to purchase from producers.

Article 10

The competent authority shall devote to organic agriculture technology research and the provision of information and personnel training.

The competent authority shall encourage its personnel to participate in organic agriculture related training.

The Central Competent Authority shall participate in international organizations and international cooperation affairs to carry out the exchange of information, technology and personnel related to organic agriculture.

Chapter 3 Management of Accreditation Body and Certification

Body

Article 11

Any institution or legal entity shall not engage the following accreditation activities until submitting the documents to apply for and obtaining the permission from the Central Competent Authority and any amendments thereto.

The validity of the certificate of the aforementioned permission shall not exceed 5 years and shall be renewed by the Central Competent Authority one year prior to expiration. The validity of renewed certificate shall not exceed 5 years.

The accreditation tasks conducted by accreditation bodies are

the following:

1. Accepting and reviewing accreditation applications.

2. Signing accreditation contracts with those who are qualified.

3. Issuing accreditation certificates to the certification bodies in the qualified scope.

4. Assessing the accredited certification bodies through examining their certification activities.

5. Other tasks related to accreditation activities.

Accreditation bodies shall be subject to supervision by the

Central Competent Authority and shall not evade from, impede, or

refuse such supervision or provide false data. The accreditation

bodies shall comply with the following :

1. Accepting accreditation applications from the countries or areas approved by the Central Competent Authority.

2. Establishing and submitting accreditation standards to the Central Competent Authority for approval. The amendments or abolishment of which are included.

3. Reviewing accreditation application and assessing the certification bodies in accordance with accreditation standards approved by the Central Competent Authority.

4. Retaining records related to accreditation tasks for at least 5 years and notifying the Central Competent Authority for the record.

5. Assisting and coordinating with the Central Competent Authority on examining accredited certification bodies.

6. For certification bodies unable to provide certification services, the accreditation bodies shall coordinate among certification bodies for their certification business to be taken over.

The Central Competent Authority shall establish regulations to stipulate the eligibility, procedure, required documents, and criteria for the application of permission and its amendment specified in paragraph 1; required documents for renewal application specified in paragraph 2; the items that shall be described in the certificates specified in subparagraph 3 of paragraph 3; the procedures and methods for supervising, managing, examining the accreditation bodies, the required coverage of accreditation standards, the required items related to the accreditation tasks to be recorded, and the notification documents specified in the above paragraph; and other relevant requirements.

Article 12

Any institution, school, or legal entity shall not engage in the certification activities until being accredited by an accreditation body and receiving the accreditation certificate in the qualified scope.

The certification activities of certification bodies are the

following:

1. Signing contracts with operators to certify their agricultural products in accordance with the certification standards.

2. Issuing certificates of organic agricultural products and in- conversion agricultural products and controlling the organic marks used by the certified operators.

3. Inspecting agricultural products according to the contracts.

4. Other certification related activities promulgated by the Central Competent Authority.

The Central Competent Authority shall establish the certification standards, categories, and items of agricultural products mentioned in subparagraph 1 of the above paragraph.

The certification bodies engaging in the aforementioned certification activities shall retain the data and records according to the items, methods and periods promulgated by the Central Competent Authority. The certification bodies shall provide those data and records when requested by the Central Competent Authority. The certification bodies shall not evade, impede, or refuse the examination or provide false data or records.

Article 13

The certification bodies may sign agreements with operators to determine the scope of certification in production, processing, packaging, or distribution of agricultural products.

The Central Competent Authority may promulgate the upper limit for certification service fee.

When a certification body is unable to provide certification services due to withdrawal of accreditation, termination of accreditation contract, dismissal, or any other causes, the contracted operator shall sign a new contract with another certification body within the period specified by the Central Competent Authority. The status of organic agricultural products or in-conversion agricultural products remains certified during the above specified period.

Article 14

The Central Competent Authority may promulgate mandatory or prohibitory items in the contracts between the accreditation bodies and certification bodies as well as between the certification bodies and operators.

Provisions of the contract that violate the above items are null and void. Other parts of the contract that stand without the above null and void parts may still be effective. But, if the contract is unconscionable to one of the parties, then the entire contract shall be rendered null and void.

Provisions promulgated by the Central Competent Authority but not specified in contracts shall still constitute a part of the contract.

Chapter 4 Management of Organic Agricultural Products

Article 15

The Central Competent Authority shall promulgate the substances allowed to be used in production, processing, packaging, distribution and sale of organic agricultural products and in- conversion agricultural products.

Except for the aforementioned substances, operators shall not use prohibited substances such as GMO derived products, chemical pesticides, chemical fertilizers, animal drugs, and other synthetic chemical substances.

Operators shall ensure the organic agricultural products and in-conversion agricultural products they produced, processed, packaged, distributed, and sold contain no prohibited substances as stated in the previous paragraph.

Article 16

Agricultural products shall be certified to be organic throughout their production, processing, packaging, and distribution before they can be sold, labelled, displayed or advertised as organic.

Agricultural products shall be certified to be in conversion throughout their production, processing, packaging, and distribution before they can be sold, labelled, displayed or advertised as in-conversion agricultural products.

The day after the anniversary date of the implementation of this Act, any non-natural operator, such as a legal entity, business, farm, unincorporated body, and ranch shall not use the term “organic”, as a whole or a part of its name, unless all agricultural products sold are certified or reviewed qualified according to subparagraph 2 of paragraph 1 of Article 17.

Article 17

Imported agricultural products shall meet one of the following conditions before they can be sold, labelled or advertised as organic :

1. Certified by a domestic or foreign certification body accredited by ROC, given that the certification activities are performed within the territory prescribed on the accreditation certificate.

2. Certified by a certification body accredited by a country or member of World Trade Organization that is in organic equivalence with ROC, given that the certification activities are performed within the territory of the accrediting country or WTO member, reviewed qualified by the Central Competent Authority at the request of the importer, and issued with an approval document.

Countries or members of WTO with organic equivalence defined in paragraph 2 shall sign the mutual organic equivalence recognition treaty, agreement, or other official documents with ROC. After signing, the countries or members shall be promulgated by the Central Competent Authority.

The Central Competent Authority shall establish the regulations to stipulate the application requirement, the review procedures, the data to retain, the labeling, the management, and other relevant items, as described in subparagraph 2 of paragraph 1.

Article 18

The container or packaging of organic agricultural products and in-conversion agricultural products shall be notably indicated in Chinese and common symbols with the following items:

1. Product name. For organic agricultural products, the term “organic” shall be indicated; for in-conversion agricultural products, the term “in-conversion agricultural products” shall be indicated.

2. Ingredients. Those containing more than one ingredient shall be accordingly indicated in a descending order of proportion; in the case of a product containing single ingredient represented by the product name, the product is exempted from ingredient indication.

3. The name, address, and telephone number of the operator. In the case of organic products being imported, the name, address, and telephone number of the importer shall be indicated instead.

4. Origin (country). However, those with the address of the manufacturing plant or certification site that can represent the origin indicated are exempted.

5. Name of the certification body.

6. Certificate number. Organic agricultural products imported in accordance with subparagraph 2 of paragraph 1 of Article 17 shall be indicated with the number of approval document.

7. Other items required to be indicated promulgated by the Central Competent Authority.

In case of difficulty to label the items mentioned in the previous paragraph due to the limited package surface area, material, or other conditions, the Central Competent Authority may promulgate conditions for exemption or alternative indication methods.

For any changes to the subject matter being indicated according to the paragraph 1, the label shall be updated within three months of the occurrence of the changes.

Article 19

Operators selling organic agricultural products and in- conversion agricultural products in bulk package shall display the name, the origin (country) of the products on site with billboards, with a duplicate copy of the certificate of organic certification or in-conversion presented. Those selling organic agricultural products imported under subparagraph 2 of paragraph 1 of Article 17 shall present a duplicate copy of the approval document.

The aforementioned disclosure of product name and origin (country) is subject to provisions in subparagraph 1 and 4 of paragraph 1 of the pervious article.

The Central Competent Authority shall establish the regulations governing the items, methods, and other requirements regarding indication and display specified in the above 2 subparagraphs and the previous article.

Article 20

Only agricultural products certified as organic under this Act are allowed to be labeled with organic mark.

The Central Competent Authority shall establish regulations to stipulate the specification, design, use condition, and other requirements regarding the above organic mark.

Article 21

Those entrusted to disseminate advertisement about organic agricultural products or in-conversion agricultural products shall retain the following records for 6 months from the date of the first broadcast: the entruster’s name , personal identification number or business registration number, residence, the address of the residence or office, the telephone number, and the content of dissemination. When requested for provision by the competent authority, the entrustee shall not evade, impede, refuse, or provide false data.

Article 22

The competent authority may assign staffs with proof of identity to enter the premise concerning production, processing, packaging, storing, selling, and other operations as well as transporting vehicles related to organic agricultural products or in-conversion agricultural products to examine, sample for test, or acquire data or record from operators. Any subject shall not evade, impede, refuse, or provide false data or record.

Article 23

For testing of organic agricultural products and in-conversion agricultural products, the Central Competent Authority shall refer to the test methods established in Act Governing Food Safety and Sanitation by the Central Competent Authority of Health and Welfare. For the test methods not been established by the Central Competent Authority of Health and Welfare, other international recognized test methods can be referred to.

The Central Competent Authority may appoint its affiliated testing body (institution) or entrust other bodies (institutions), schools, or organizations for the above testing.

Article 24

Dissident for the result of testing, the operator may apply for a retest to the original sampling authority and pay the retest fees within 15 days on receiving the notice, and is limited to once.

Upon accepting the retest application, the sampling authority shall notify the original testing body to conduct a retest of the original specimen within 7 days. The authority may refuse the retest application if the specimen has deteriorated or could not be preserved properly.

Article 25

When the organic agricultural products and in-conversion agricultural products tested contain the prohibited substances specified in paragraph 2 of Article 15 or any other matters violating the provision of this Act, the competent authorities may prohibit the operator or owner from transporting the agricultural products and order them to withdraw or recall the product from the market, or take other appropriate measures.

Article 26

The competent authority shall keep the identification of those reporting a potential violation of this Act confidential, and those enable the identification of such violation shall be rewarded.

The Central Competent Authority shall establish regulations governing the reporting, rewarding and other relevant matters prescribed in the previous paragraph.

Chapter 5 Penalties

Article 27

In one of the following situations, a subject is fined from NTD600,000 up to NTD60,000,000:

1. Violation of paragraph 1 of Article 11, engaging in accreditation activities without the permission of the Central Competent Authority or engaging in accreditation activities without the renewal permission of the Central Competent Authority in accordance with paragraph 2 of Article 11.

2. Violation of the suspension of accepting new accreditation applications imposed on accreditation bodies by the Central Competent Authority under paragraph 1 of Article 33.

Article 28

Violating paragraph 1 of Article 12 by engaging in certification activities without accredited by an accreditation body and obtaining a corresponding certificate is fined from NTD300,000 up to NTD30,000,000.

Article 29

Under any of the following circumstances, a fine from NTD200,000 up to NTD2,000,000 is applicable to each individual violation:

1. Violation of paragraph 1 of Article 20, labeling organic mark on uncertified products.

2. Violating the suspension of the usage of organic mark imposed by the Central Competent Authority under paragraph 2 of Article 32.

Article 30

Under any of the following circumstance, a fined from NTD100,000 up to NTD1,000,000 is applicable to each individual violation:

1. Violation of paragraph 4 of Article 12, evading, impeding, or refusing the examination by the competent authority, or providing false data and records, or failing to retain relevant data and records in accordance with the items, methods, and time periods promulgated by the Central Competent Authority.

2. Violation of Article 21, failing to retain data, evading, impeding, or refusing to provide data or providing false data.

3. Violation of Article 22, evading, impeding or refusing the staffs of the competent authority entering the premise or transporting vehicles for the purpose of conducting examination, or sampling specimen for testing, or failing to provide relevant data or records, or providing false data or records.

4. Failing to comply with the proceedings by the Central Competent Authority under Article 34.

Article 31

Under any one of the following circumstances, an operator is subject to a fine from NTD60,000 up to NTD600,000 for each individual violation:

1. Violation of paragraph 2 of Article 15, using the prohibited substances.

2. Violation of paragraph 3 of Article 15, the organic agricultural products and in-conversion agricultural products containing the prohibited substances; however, operators validating that they have taken necessary precautionary measures, and their fields are identified by the competent authority to be contaminated by adjacent farms, are exempted from penalties.

3. Violation of paragraph 1 and 2 of Article 16 or paragraph 1 of Article 17, agricultural products not certified or imports not reviewed qualified being sold, labeled, displayed, or advertised as organic or in a misleading way.

4. Violation of paragraph 3 of article 16, non-natural person operator using the term “organic” as whole or a part of its name without having all its product certified or reviewed qualified under subparagraph 2 of paragraph 1 of Article 17.

5. Violating the suspension of selling, labeling, displaying, or advertising products as organic imposed by the Central Competent Authority under paragraph 2 of Article 32.

Operators in the above situations in production, processing, packaging, or distribution under the instruction of an entruster or client shall inflict penalties on the entruster or client instead.

Article 32

Under any of the following circumstances, operators shall be order to correct within a specified period; a fine from NTD30,000 up to NTD300,000 is applicable to those unable to comply in time and to each individual violation.

1. Not labeling in accordance with paragraph 1 of Article 18, making false labeling, or not updating the label within 3 months of the date when a change to the subject matter indicated occurs in accordance with paragraph 3 of Article 18.

2. Violation of paragraph 1 of Article 19, not displaying the product name, origin, a duplicate copy of the certificate of organic certification or in-conversion certification, or a duplicate copy of the approval document; violation of paragraph 2 of Article 19, which directly refers to subparagraph 1 and 4 of paragraph 1 of Article 18, not displaying the product name or origin (country).

3. Violation of paragraph 3 of Article 19 regarding the items and methods of labeling and displaying.

4. Violation of paragraph 2 of Article 20 regarding the specification, design, and usage of organic marks.

For any one of the above situations, the competent authority shall suspend the operators’ usage of organic mark, selling, labeling, displaying, and advertising products as organic for a period from 3 months up to 1 year.

Article 33

For any one of the following situations, the Central Competent Authority shall warn the accreditation bodies according to the severity, or impose a penalty of suspending the accreditation bodies to accept new accreditation applications for a period from 2 months up to 2 years:

1. Violation of paragraph 4 of Article 11, accreditation bodies evading, impeding, or refusing the supervision by the Central Competent Authority, or providing false data.

2. Violation of subparagraph 1 of paragraph 4 of Article 11, accreditation bodies accepting accreditation applications from countries or areas not permitted by the Central Competent Authority.

3. Violation of subparagraph 2 of paragraph 4 of Article 11, accreditation bodies failing to report the formulation, amendment or abolishment of accreditation standards to the Central Competent Authority.

4. Violation of subparagraph 3 of paragraph 4 of Article 11, accreditation bodies failing to review accreditation applications or assess certification activities performed by the certification body in accordance with standards approved by the Central Competent Authority.

5. Violation of subparagraph 4 of paragraph 4 of Article 11, failing to retain records related to accreditation task for at least 5 years, keeping false records, or failing to notify the Central Competent Authority for the record.

6. Violation of subparagraph 5 of paragraph 4 of Article 11, accreditation bodies failing to comply with the Central Competent Authority on examining the certification bodies they accredited.

7. Violation of subparagraph 6 of paragraph 4 of Article 11, accreditation bodies failing to entrust other accreditation bodies with their accreditation tasks when they are unable to fulfill those obligations.

8. Violation of paragraph 5 of Article 11, regarding the supervision and management of accreditation bodies, the required items related to the accreditation tasks to be recorded, and the notification documents specified in the above paragraph.

If an accreditation body has been suspended from accepting new applications by the Central Competent Authority under the above paragraph twice in the previous 3 years, another violation specified in the previous paragraph shall result in Central Competent Authority abolishing the permission and prohibit accreditation body to apply for permission under paragraph 1 of Article 11 for a period from 2 years up to 5 years.

For accreditation body repealed under the above paragraph, the Central Competent Authority shall assume the accreditation body’s contracts signed with the certification bodies; those certification bodies shall enter into an accreditation contract with other accreditation bodies within the period designated by the Central Competent Authority, and the accreditation contracts with the Central Competent Authority will thereby be terminated at the same time.

Article 34

For agricultural products appearing in advertisements and meeting conditions specified in Article 31 or Article 32, aside from penalties prescribed by this Act, the following proceedings also apply:

1. Enforcing the advertiser to order the broadcast of corrective advertising on the same page or timeslots of the original broadcast that shall extend apology and corrective message.

2. Enforcing the broadcaster to suspend the broadcast and withdraw advertising materials.

Article 35

For situations specified between Article 29 and 32, asidefrom imposing penalties under the relevant regulations, the administrator may announce the details of violations, the product name, the name and address of operators, the name of its affiliated legal entities, organizations, firm offices, or business premise, the name of its manager or representative, and the site and date the agricultural product sampled.

Article 36

The penalties established by this Act, except those targeting accreditation bodies and certification bodies, which are imposed by the Central Competent Authority, are carried out by the municipality or county (city) government.

Chapter 6 Supplementary Provisions

Article 37

For countries promulgated by the Central Competent Authority as organic equivalent under paragraph 1 of Article 6 of Agricultural Production and Certification Act prior to the implementation of this Act, if they fail to reach mutual organic equivalence with ROC by signing a bilateral treaty, agreement, or official document within one year of the implementation of this Act, the Central Competent Authority shall abolish the equivalence recognition.

For certification bodies of a country with equivalence recognition abolished under the previous paragraph, agricultural products certified by them and reviewed qualified by the Central Competent Authority prior to the abolishment are allowed to be sold, labeled, displayed, or advertised as organic, even after the abolishment enters into effect.

Article 38

Prior to the implementation of this Act, the certification bodies that have been accredited to conduct certification activities under the Agricultural Production and Certification Act and other relevant regulations shall retain their accredited status for 18 months after the implementation of this Act. During which the certification bodies may conduct certification activities under Agricultural Production and Certification Act.

Prior to the implementation of this Act, the organic agricultural products that have been certified under the Agricultural Production and Certification Act shall be deemed certified under this Act for up to 18 months after the implementation of this Act, given that the certificate of organic certification is within its valid period.

Article 39

In the absence of domestic institutions or legal entities serving as accreditation bodies, the Central Competent Authority may promulgate itself other designated institutions or legal entities as the accreditation body for a limited period.

In the absence of domestic institutions, schools or legal entities serving as certification bodies, the Central Competent Authority may promulgate institutions, schools, or legal entities as the certification body for a limited period.

Article 40

Unless otherwise stipulated in this Act, the provisions of Agricultural Production and Certification Act relating to organic agricultural production no longer apply from the implementation date of this Act.

Article 41

Enforcement rules for this Act shall be established by the Central Competent Authority.

Article 42

This Act shall enter into force one year after the date of promulgation.

Enforcement Rules for Organic Agriculture Promotion Act

Legislative history

Full text of 13 articles was promulgated by the Council of Agriculture on May 9, 2019 per Order Nung-Liang-Tze 1081069050A, and was set to be effective on May 30, 2019.

Article 1

These enforcement rules have been established in accordance with Article 41 of Organic Agriculture Promotion Act (hereinafter referred to as the Act).

Article 2

Organic agricultural products and in-conversion agricultural products which meet any of the following conditions in distribute procedure shall be certified in accordance with the Act:

1. The original packages or labels of the organic agricultural products or in-conversion agricultural products are changed, and thereby the organic integrity of agricultural products is affected.

2. Organic agricultural products or in-conversion agricultural products are entrusted to another operator in production, processing, packaging or distribution procedure, and the entruster or client is labelled as the operator in accordance with subparagraph 3 of paragraph 1 of Article 18 of the Act.

Article 3

The organic ingredients content in processed organic agricultural products defined in subparagraph 4 of Article 3 of the Act shall be no less than 95%, except for water and salt.

The sum of organic and in-conversion ingredients content in processed in-conversion agricultural products defined in subparagraph 5 of Article 3 of the Act shall be no less than 95%, except for water and salt.

Article 4

For those who engage in eco-friendly farming defined in paragraph 2 of Article 4 of the Act, their farm practices shall be recognized as complying with subparagraph 3 of Article 3 of the Act by legal entities and organizations that are approved by the Central Competent Authority, and they shall be registered at the information system designated by the Central Competent Authority.

Article 5

Promotion of organic agriculture defined in paragraph 3 of Article 5 includes review and assessment in paragraph 1 of Article 9 for promulgating countries or members of World Trade Organization (WTO) in organic equivalence defined in paragraph 2 of Article 17 of the Act as well as participation in international organizations and international cooperation affairs and other related work specified in and paragraph 3 of Article 10 of the Act.

Article 6

The personnel sent by the Central Competent Authority to conduct examination prescribed in paragraph 4 of Article 11 and paragraph 4 of Article 12 of the Act shall present proof documents concerning the performance of their duties.

Article 7

The competent authority shall ensure that any secrets of the inspected party that are known or obtained shall be kept confidential when conducting supervision, examination, review, and sampling for test and acquiring data or record from operators stipulated in the Act.

When the competent authority conducts specimen sampling for testing stipulated in Article 22 of the Act, the competent authority may acquire an appropriate amount of samples without compensation and shall exercise the custodial duty.

Article 8

When an imported agricultural product is to be sold, labelled, displayed or advertised as organic in accordance with subparagraph 1 of paragraph 1 of Article 17 of the Act, the importer shall prepare the document demonstrating that the imported agricultural product has been granted as organic for the purpose of examination of the competent authority.

The certificate document stated in the previous paragraph shall be issued by a domestic or foreign certification body accredited by the ROC and include the following items:

1.The name and address of the foreign operator;

2.The name and batch number of the product;

3.The weight or volume of the product;

4.The name of the importer or buyer;

5.The name and address of the certification body;

6.The date of issuance; and

7.Other items required by the Central Competent Authority.

When handling records and documents relevant to import and sale of organic agricultural products in accordance with subparagraph 1 of paragraph 1 of Article 17 of the Act and the demonstrating documents specified in paragraph 1, the importers shall keep them for at least five years.

Article 9

Prior to promulgating countries or members of the WTO as being in organic equivalence with the ROC in paragraph 2 of Article 17 of the Act, the Central Competent Authority may first conduct review. When it is necessary, personnel may be sent abroad to assess the process.

The Central Competent Authority may invite representatives from relevant government authorities, experts and scholars, industrial or institutions and organizations which have interests involved to take part in the review meetings and go abroad to assist the assessment in order to perform the review and assessment specified in the previous paragraph.

Article 10

The containers or packaging of organic agricultural products and in-conversion agricultural products defined in paragraph 1 of Article 18 of the Act is referred to as the containers or packaging of per sold unit.

Article 11

The relevant term “data or record” used in paragraph 22 of the Act is the source of ingredients, quantity of ingredients, certificate of origin, certified document, basis of operating production, relevant record of manufacturing process, buyer, amount of money, or other relevant data necessary for enforcing the Act.

Article 12

Operators who produce, process, package, or distribute organic agricultural products and in-conversion agricultural products under the instruction of an entruster or client shall be certified qualified under the Act.

Article 13

The Enforcement Rules shall enter into force on May 30, 2019.

Regulaciones y Estándares

Acreditación y Certificación

Regulations for Approving and Supervising Organic Accreditation Bodies

Legislative history

1. Full text of 17 articles was promulgated by the Council of Agriculture on May 8, 2019 per Order Nung-Liang-Tze 1081069113A, and was set to be effective on May 30, 2019.

Article 1

These Regulations have been established in accordance with paragraph 5 of Article 11 of the Organic Agriculture Promotion Act (hereinafter referred to as the Act).

Article 2

Any institution or legal entity engaging in accreditation activities shall have the following qualifications:

1. Have a system of conformity assessment of certification bodies set up and implemented in accordance with ISO/ IEC 17011 and a Mutual Recognition Arrangement for the accreditation scope of product certification bodies signed.

2. Be a member of International Accreditation Forum (IAF).

Article 3

Any institution or legal entity that engages in accreditation activities shall submit the following documents to the Central Competent Authority to apply for permission:

1. Copies of supporting documents regarding the establishment or registration of the institution or legal entity.

2. Copies of the arrangement in subparagraph 1 of the previous article.

3. Relevant documents for conducting accreditation activities.

4. Other documents required by the Central Competent Authority. The documents in subparagraph 3 of the previous paragraph are as the following:

1. Quality manual.

2. Scope of accreditation.

3. Areas and countries where the accreditation is to be performed.

4. Accreditation standards: the standards for evaluating the qualifications to provide certification services; the required items are shown in the Appendix.

5. Assessment procedures: including initial assessment procedures, surveillance procedures, renewal assessment procedures, and extensional assessment procedures.

6. Assessment personnel: including internal regulations regarding selecting, training, dispatching, and appraisal of personnel, and requirements that eligible assessment personnel shall receive the training held by the Central Competent Authority or its designated body (institution) or legal entities at least once every two years and obtain the certificate of completion.

7. Rules for assessment operation.

8. Accreditation contract template.

9. Pricing standard.

Article 4

For institutions or legal entities that have passed the permission review after applying according to the previous article, the Central Competent Authority shall issue the accreditation body permission, which shall include the following

items:

1. Name and address of the accreditation body.

2. Scope of accreditation.

3. Areas and countries where the accreditation may be performed.

4. Valid period. The scope of accreditation stipulated in subparagraph 2 of the previous paragraph is as the following:

1. Organic crops.

2. Organic livestock products.

3. Organic aquatic products.

4. Non-edible organic forest products.

5. Organic processing, packaging, and distribution.The validity in subparagraph 4 of paragraph 1 is five years;one year prior to expiration, the accreditation body may submit copies of the arrangement in paragraph 1 of Article 2 to the Central Competent Authority to apply for permission renewal. The validity of the renewed permission shall not exceed 5 years.

Article 5

In case of any amendment to the permissions stipulated in subparagraphs 1 to 3 of paragraph 1 of the previous article, the accreditation body shall submit relevant documents to the Central Competent Authority to apply for such amendment permission.

Accreditation body shall apply for the amendment permission of subparagraph 1 of paragraph 1 of the previous article from the Central Competent Authority within 30 days after occurrence of the event.

Article 6

Upon the accreditation body’s amendment to or abolishment of the documents stipulated in paragraph 2 of Article 3, the accreditation standards stipulated in subparagraph 4, paragraph 2 of Article 3 shall be submitted to the Central Competent Authority for approval, and other documents shall be kept record with the Central Competent Authority.

Article 7

Upon accepting the accreditation application from an institution, school or legal entity, the accreditation body shall sign the accreditation contract with the applicant who is reviewed eligible according to the accreditation standards in initial assessment procedures to provide certification

service, and shall issue the accreditation certificate to the certification body. The accreditation certificate in the above paragraph shall include the following items:

1. Name and address of the certification body.

2. Name of accreditation standards.

3. Scope of accreditation and certification type.

4. Areas and countries where the certification activity is allowed to be performed.

5. Accreditation certificate number.

6. Name of accreditation body.

7. Issuing date and valid period.

Article 8

The certification type in subparagraph 3 of paragraph 2 of the previous article refers to individual certification and group certification. Non-natural person operators who meet the following conditions can apply for group certification:

1. The management center is established to be responsible for business planning and implementing.

2. Group members adopt the quality management system established by the management center, continuously operate under the supervision of the management center, and meet the requirements and rules thereof.

3. The produced organic agricultural products and in-conversion agricultural products are labeled and sold in the name of the group.

Article 9

For the accredited certification body, the accreditation body shall conduct surveillance at least once a year to ensure that the certification body constantly meets the accreditation standards in the valid period of the accreditation certificate.

Article 10

The valid period of the accreditation certificate of the certification body is three years. Six months prior to expiration, the certification body may apply for renewal assessment; in case of an overdue application, re-application

for accreditation is required. For the certification body that applys for renewal assessment and is found eligible through renewal assessment procedures, the accreditation body shall approve the renewal and issue the

accreditation certificate, provided that each renewal period shall not exceed three years.

Article 11

The certification body may apply to the accreditation body for an extensional assessment regarding the scope of accreditation, and the area and country in which the accreditation activities are performed. For the application stipulated in the previous paragraph, if the applicant is found eligible through extensional assessment procedures, the accreditation body shall update the accreditation certificate.

Article 12

If the certification body can no longer engage in its scope of certification or certain certification activities in the area and country, the certification body shall immediately notify the accreditation body in writing. After receiving the aforementioned notice, the accreditation body shall reduce the incapacitated part of that certification body and update the accreditation certificate.

Article 13

If the certification body is under any of the following circumstances, the accreditation body may terminate its certification qualification or certain scope of certification activity:

1. Lacking the ability required for all certification activities within the scope of the accreditation according to accreditation standards.

2. Lacking the ability required for some certification activities within the scope of accreditation according to accreditation standards and failure to notify the accreditation body as required in paragraph 1 of the previous article.

3. Organizational functioning and perspective fail to maintain impartiality and independence stipulated in accreditation standards.

4. Failing to conduct certification activities in accordance with the relevant provisions of the accredited scope in a serious manner.

5. Its certified operator fails to meet certification standards stipulated in paragraph 3 of Article 12 of the Act in a serious manner and failure to subsequently handle it effectively.

6. Failing to manage its certified operator regarding the use of the organic mark as stipulated in paragraph 2 of Article 20 of the Act in a serious manner.

7. Engages in certification activities beyond the scope of accreditation.

8. Provides false certification records or relevant documents in a serious manner.

9. Other serious inconformity to accreditation standards according to the assessment results of the accreditation body.

Article 14

Accreditation contracts signed with the certification body and following records of the accreditation body’s engagement in accreditation activities shall be retained for at least five years:

1. Records of formulation, amendment, and abolishment of the documents in paragraph 2 of Article 3.

2. Assessment records of the certification body according to assessment process.

3. Records of the accreditation decision according to assessment results.

4. Records regarding selecting, training, dispatching, and appraisal of assessment personnel.

5. Other records required by the Central Competent Authority.

Article 15

Based on the engaged accreditation activities, the accreditation body shall submit a written performance report of the previous year to the Central Competent Authority by March 31 every year. The Central Competent Authority may form an examination team to conduct examination of the accreditation body and its accredited certification body.

Article 16

The accreditation body shall disclose the name, address, contact number, scope of accreditation, area and country of accreditation, valid accreditation period, and information about its disposals of its accredited certification body on the accreditation body’s website.

Article 17

These Regulations shall enter into force on May 30, 2019. Appendix Required Items for the Accreditation Standards of Accreditation Bodies

1. Certification body

1.1 With the accreditation qualifications stipulated in the Accreditation Requirements for Product Certification Bodies (ISO/IEC 17065).

1.2 Conduct audit according to the Guidelines for Auditing Management Systems (ISO 19011).

1.3 Testing required for certification shall be conducted by a test laboratory accredited according to the General Requirements for the Competence of Testing and Calibration Laboratories (ISO/IEC 17025). However, for specific test items, when a laboratory cannot completely meet the requirements and no other laboratories have such capacity, the accreditation body may witness how the certification body confirms laboratory capabilities through witness assessment.

1.4 Organizational functioning and perspective maintain impartiality and independence.

1.5 Capable of managing the use of the organic mark by its certified operators.

1.6 Capable of handling businesses and issues between and among the Central Competent Authority, the accreditation body, the certification applicant, its certified operator, and consumers.

1.7 Capable of training and appraising its personnel to meet basic personnel requirements.

1.8 Starting from the date of the accreditation application, the accreditation qualifications have not been terminated by the accreditation body within the last three years.

1.9 Contents of the certification contract shall meet the Items Required to be Stated in the Contract between Organic Certification Bodies and Agricultural Operators stipulated by Central Competent Authority.

2. Basic personnel requirements

2.1 Certification auditor

2.1.1 Shall meet one of the following qualifications:

2.1.1.1 Passed the relevant national occupational test.

2.1.1.2 With work experience in the production, processing, research, development, technology, transportation and sale, test, and quality management of agricultural products (crops, livestock products, aquatic products, forest products, processed products), or in the formulation (establishment), amendment, or review of relevant standards or regulations.

2.1.1.2.1 If graduated from an agriculture and food-related department: one year.

2.1.1.2.2 If not graduated from an agriculture and food-related department: two years.

2.1.2 Shall obtain a certificate of qualifying conformity assessment training for auditors and have experience participating in at least five on-site audits according to the category of agricultural products (crops, livestock products, aquatic products, forest products, processed products), which shall be accomplished within two years before obtaining auditor qualifications.

2.1.3 Shall undergo the following training and obtain the corresponding certificates:

2.1.3.1 At least eight hours of training on the applicable laws of organic agricultural products and domestic and foreign certification systems.

2.1.3.2 At least 16 hours of training on knowledge related to the processes and technologies for the production, storage and distribution of agricultural products.

2.1.3.3 At least 16 hours of training on audit skills, methods and case analysis.

2.1.4 The training participation stipulated in 2.1.3 shall be limited to the following:

2.1.4.1 Training held by the Central Competent Authority and its affiliated body.

2.1.4.2 Training held by an institution entrusted by the Central Competent Authority.

2.1.4.3 Training held by institutions of college.

2.1.4.4 Training held by a professional institution approved by the Central Competent Authority.

2.1.5 If not graduated from an agriculture and food-related department, the hours of training received according to 2.1.3 shall be no less than 60 hours.

2.1.6 An eligible auditor shall receive at least 20 hours of advanced training every two years, whose contents are the same as those stipulated in 2.1.3, and at least 10 on-site audits shall be conducted to maintain qualification.

2.1.7 For the number of on-site audit stipulated in 2.1.2 and 2.1.6, if the number of on-site audit on the specific category of agricultural products cannot be accomplished due to special circumstances, the number thereof may be reduced with the Central Competent Authority’s consent. 2.2 Certification decision maker

2.2.1 Knowledgeable about regulations related to organic agriculture.

2.2.2 Knowledgeable about certification body operating procedures and scopes of certification activity.

2.2.3 Knowledgeable about audit principles and techniques.

2.2.4 With more than three years of cumulative experience in fields related to organic agriculture, the production or certification of organic agricultural products, or assessment of accreditation body.

3. Basic certification criteria

3.1 Certification procedure and operation period

3.1.1 Upon accepting an application for the certification of organic agricultural products and in-conversion agricultural products, the certification body shall carry out the procedures of the document review, on-site audit, product sampling for testing and certification decision, and the applicant shall be notified of the results in writing. However, if according to risk assessment or no products are available for testing due to the factor of force majeure, the certification body may test the plant-tree thereof.

3.1.2 The certification body shall determine the operation period of each procedural stage stipulated in 3.1.1, and the duration of the operation periods of all stages shall not exceed six months. However, this period shall not include the time period to make corrections or improvements notified to the applicant.

3.2 Group certification

3.2.1 For a group certification application case, prior to on- site audit, the certification body shall first evaluate whether the operation of its management center meets the requirements of its own regulations and operating procedures; if the results indicate that sampling may be applicable for the following on-site audit, the number of members sampled shall be no less than the square root of the total number of members.

3.2.2 If sampling is adopted for on-site audit of group members according to 3.2.1, the certification body shall audit all lands of the sampled members that applied for certification.

3.2.3 When the certification body conducts product sampling for testing in a group certification case, the number of sampling for testing thereof shall be no less than the square root of the total number of members.

3.3 For the sampling carried out by the certification body, the procedure and quantity thereof shall give consideration to the objectivity, representativeness, and purpose of risk management and be capable of avoiding contamination.

3.4 Certification certificate

3.4.1 For those who apply for organic agricultural products and in-conversion agricultural products certification and are found eligible through certification, the certification body will issue the certification certificate for organic

agricultural products and in-conversion agricultural

products according to the relevant product categories.

3.4.2 The certification certificate shall include the following

items:

3.4.2.1 The name and address of the operator, and the name of

its statutory responsible person.

3.4.2.2 Address or land number of the certification site.

3.4.2.3 Category and item of agricultural products and

certification type thereof.

3.4.2.4 Valid period.

3.4.2.5 Name and address of the certification body.

3.4.2.6 Certificate number.

3.4.3 The validity period of a certification certificate for organic agricultural products and in-conversion agricultural products shall be no more than three years; three months prior to expiration of the valid period, the certification body shall ask the operator to fill in the application form to apply to the certification body for renewal; overdue renewal applications shall not be accepted.

3.4.4 After the renewal application according to 3.4.3 has been reviewed and approved, the certification certificate will be renewed.

3.5 Amendment to certification certificate

3.5.1 If an operator has any of the following circumstances, the certification body shall ask it to submit relevant materials to apply for the amendment to the certificate of organic certification or in-conversion certification:

3.5.1.1 Change of the name or address of the operator, or the name of its statutory responsible person.

3.5.1.2 The certification scope is reduced in terms of the certified site or certified product items.

3.5.1.3 Reduction of group certification members.

3.5.2 After the application according to 3.5.1 has been reviewed and approved, a replacement certificate with the same period of validity as the original certificate shall be issued.

3.6 Report to the certification body for review

3.6.1 If changes are made to the production and processing of

organic agricultural products and in-conversion agricultural

products, or in the operating system maintaining organic

integrity, the operator shall take the initiative to report

such changes to the certification body for review.

3.6.2 If the certification body reviews the change and determines that it is likely to affect the results of the original certification, the certification shall be granted to the change by the certification body.

3.7 Application for extensional audit

3.7.1 Under any of the following circumstances, the certification body shall ask the operator to submit relevant materials to apply for extensional audit:

3.7.1.1 An extension of the certification site.

3.7.1.2 An extension of the agricultural product items to be

certified.

3.7.1.3 An extension of group certification members.

3.7.2 After the extensional audit according to 3.7.1 has been reviewed and approved, a replacement certificate with the same period of validity as the original certificate shall be issued.

3.8 Surveillance

3.8.1 The certification body shall perform surveillance on all of its operators with the certified products at least once a year. However, the frequency of surveillance may be increased as necessary.

3.8.2 For the surveillance conducted by the certification body according to 3.8.1, the proportion of surveillance without notice or by serving notice within 24 hours before surveillance shall account for at least five percent of the total number of its certified operators.

3.9 The procedures prescribed in 3.1.1 shall apply mutatis mutandis to the renewal audit stipulated in 3.4.3, the review and certification stipulated in 3.6, the extensional audit stipulated in 3.7.1 and the surveillance audit stipulated in 3.8.1, the certification body shall refer to procedures, or the certification body may implement necessary procedures in view of the certification risk of the individual case.

3.10 The certification body shall conduct sample testing of its certified agricultural products in the market every year, and the number thereof shall account for at least three percent of the total number of its certified operators.

3.11 The certification body shall publish relevant information of its certified operators, such as the name, address, contact number, categories and items of certified agricultural products, valid period and disposals in the information system designated by the Central Competent Authority within 10 days after making a certification decision or reviewing, as well as quarterly publish the relevant information on issuing organic marks in the same system.

Operating Records Required to Be Kept by Organic Certification Bodies and Their Methods and Periods

This Table was promulgated on Jun. 5, 2019 per Order Nung-Liang-Tze 1081069323A.

No.	Item	Description of contents	Retention period	Retention method
1	Quality Manual	Commitment of top management to the development of its quality system and ensuring its effective operation, including quality objectives, strategies, and operating procedures.	Six years after the version is no longer applicable	In paper document or electronic file
2	Certification Operating Procedures	Operating procedures such as initial audit, surveillance, renewal audit and extensional audit and relevant documents	Six years after the version is no longer applicable
3	Records of Certification Activities	Records related to the application, audit, sampling for testing, review or certification decisions, etc. of each certification case	Six years
4	Personnel Qualification Documents,Training and Appraisal Records	Qualification documents, training and appraisal records of the personnel conducting audit, sampling for testing, reviews, and certification decisions related to certification activities	Six years starting from the date of departure from the organization; kept updated until the departure
5	Internal Audit Records	Checklists, non-conformance reports, corrective actions, and their review records	Six years
6	Documents Related to Selection and Evaluation of Outsourced Service Institutions and Their Execution Records	Qualification and selection criteria for institutions that provide the outsourced service Evaluation records of the outsourced services Records related to the outsourced service.	Six years

Items Required to be Stated in the Contract between Organic Certification Bodies and Agricultural Operators

Legislative history
1. Full text of 4 items was promulgated by the Council of Agriculture on June 5, 2019 per Order Nung-Liang-Tzu-Tze 1081069322A.

1 Definitions of terms used in this Contract:

1.1 Production place: premises involved in the production, processing, packaging, or distribution of organic agricultural products or in-conversion agricultural products.
1.2 Surveillance: an audit performed by the certification body to verify that the certified operator keep complying with the certification standards within the valid certification period.
1.3 Renewal audit: an audit conducted by a certification body before the valid certification period ends to determine whether a certified operator may maintain its certified status.
1.4 Extensional audit: an audit conducted by a certification body to determine whether a certified operator may extend its certification scope within the valid certification period.
1.5 Certification standards, categories, and items of agricultural products: the certification standards, categories, and items of agricultural products established by the Central Competent Authority in accordance with paragraph 3 of Article 12 of Organic Agriculture Promotion Act (hereinafter referred to as the Act).
1.6 Operator: a natural person; a farm, ranch, aquafarm, organization, agricultural production and marketing group incorporated or registered pursuant to law; a legal entity obtaining a company license or business registration certificate; an authority (institution), school, or legal entity.
1.7 Group certification: the group certification stipulated in Regulations for Approving and Supervising Organic Accreditation Bodies.

2 Certification application stage

2.1

2.1.1 The documents below shall be submitted by the operator applying for the certification:

2.1.1.1 Documents to prove that the Applicant is a qualified operator.
2.1.1.2 Information about the geographical location of the production place.
2.1.1.3 Production plan or process description subject to the certification standards. The operators subcontracting others to produce, process, package, distribute, or sell products shall submit the subcontracting production plan or process description.
2.1.1.4 Records and documents related to the maintenance of its organic operation system.
2.1.1.5 Other documents required by the Central Competent Authority or certification body.

2.1.2 Records and documents related to the maintenance of the organic operation system as stipulated in 2.1.1.4 include:

2.1.2.1 Operation records.
2.1.2.2 Ingredient and material procurement and inventory records.
2.1.2.3 Product production and sale records.
2.1.2.4 Management records of production land, facility, and environment.
2.1.2.5 Certification history.
2.1.2.6 Customer complaint records.
2.1.2.7 An operator applying to multiple certification bodies for certification shall also submit the self-management mechanism and relevant records.

2.1.3 Operators applying for group certification shall also submit the following documents to the certification body for application:

2.1.3.1 Supporting documents regarding the contractual or other legal relations between and among all members and the management center.
2.1.3.2 Quality management system documents, relevant operating procedures, and execution records of the management center.
2.1.3.3 Records of at least one round of self-audit on the management center.
2.1.3.4 Records of at least one internal inspection conducted by the management center on all members.

2.2 Certification procedure and operation period of each procedural stage carried out by certification body shall include:

2.2.1 Certification procedures shall include documents review, on-site audit, product sampling for testing, and certification decision, and the applicant shall be notified of the results in writing. However, if according to risk assessment, or no products are available for testing due to the factor of force majeure, the certification body may test other part of the plant thereof. If considered necessary, the certification body may sample a proper quantity of materials or substances used by the operators for testing purposes.
2.2.2 The certification body shall determine the operation period of each procedural stage, and the total duration of the operations shall not exceed six months. However, this period shall not include the time period to make corrections or improvements notified to the applicant.
2.2.3 The way to handle the issues caused by exceeding the time limit of the aforesaid operation period due to reasons attributable to the certification body.
2.2.4 The certification body is exempted from paying for the products, materials or substances sampled for testing, and shall conduct sampling for testing according to the accreditation standards approved by the Central Competent Authority pursuant to subparagraph 2 of paragraph 4 of Article 11 of the Act.

2.3 The reasons for rejecting application for certification shall include the following items:

2.3.1 The production, processing, packaging, or distribution process of the agricultural products applying certification does not comply with the certification standards, and such non-compliances are critical.
2.3.2 Where the percentage of organic and in-conversion ingredients of the respective agricultural products applying for certification accounts for less than 95 %.
2.3.3 Where the on-site audit cannot be conducted within six months after the document review due to reasons attributable to the applicant.
2.3.4 Where the applicant, without good cause shown, fails to make corrections or improvements within the given time limit notified by the certification body;
2.3.5 Where the test result indicates the product contains prohibited substances.
2.3.6 False documents or information is provided that can result in serious consequences.
2.3.7 Where the certification procedure cannot be completed within a one-year period after the date of accepting the application for reasons attributable to the applicant.
2.3.8 Within one year after the certified status is terminated by the certification body due to the violation of the Act.

3 Post-certification stage:

3.1

3.1.1 Circumstances under which an operator shall take the initiative to apply to the certification body for an amendment to the certificate of organic certification or in-conversion certification include the following:

3.1.1.1 Change of the name or address of the operator, or the name of its statutory person responsible.
3.1.1.2 The certification scope is reduced in terms of the certified site or certified product item.
3.1.1.3 Reduction of group certification members.

3.1.2 After the relevant materials have been submitted and the application in the previous paragraph has been reviewed and approved, the certification body shall issue a replacement certificate with the same period of validity as the original certificate.

3.2

3.2.1 Circumstances under which operators shall take the initiative to apply to the certification body for review include changes in the production process of organic agricultural products and in-conversion agricultural products, or changes in the operating system maintaining organic integrity as well as the subcontracting production process.

3.2.2 If the certification body reviews the change and determines that it is likely to affect the results of the original certification, the certification shall be conducted on the change by the certification body.

3.3

3.3.1 Circumstances under which an operator shall take the initiative to apply to the certification body for an extensional audit include the following:

3.3.1.1 An extension of certification site.
3.3.1.2 An extension of agricultural product items to be certified.
3.3.1.3 An extension of group certification members.

3.3.2 When an operator submits relevant materials to apply for and has passed the extensional audit stipulated in the previous paragraph, the certification body shall issue a replacement certificate with the same period of validity as the original certificate.

3.4 Regarding the use of certificate for organic agricultural products and in-conversion agricultural products, it shall include being non-transferable to others; however, when a duplicate copy needs to be provided, it shall include all contents of the certificate.

3.5

3.5.1 For first-time applicant, the validity period of certification certificate for organic agricultural products and in-conversion agricultural products shall be no more than three years from application date. Three months prior to the expiration of validity period, the operator may fill in an application form to apply to the certification body for renewal audit; overdue renewal applications shall not be accepted.

3.5.2 After the renewal application according to the previous paragraph has been reviewed and approved, the certification body will issue a replacement certificate. The validity period shall be counted from the day after the expiration of the original valid period and be no more than three years.

3.6

3.6.1 The frequency of the surveillance on operators by the certification body shall be no less than once a year and may be increased if necessary.

3.6.2 The surveillance conducted by the certification body according to the previous paragraph may be conducted without notice or by serving notice to the operator within twenty-four hours before surveillance, and the operator shall not refuse without good cause.

3.7 The periods that operators must retain relevant operational records and documents regarding the maintenance of product’s organic integrity are as follows:

3.7.1 One year for fresh agricultural products.
3.7.2 If the product’s label indicates an expiration date, one year after the expiration date.
3.7.3 Five years for other products.

3.8 Reasons for the termination of certification by the certification body shall include the following:

3.8.1 The operator fails to keep conforming to the relevant provisions of the certification standards or certification contract in a serious manner, or fails to make correction within the time limit required by the certification body.
3.8.2 The operator refuses, evades, or impedes the surveillance by the certification body.
3.8.3 The operator provides false documents or information that has serious consequences.
3.8.4 The contents of an advertisement published by the operator are inconsistent with the certified contents in a serious manner.

4 Others

4.1 Operators shall cooperate with relevant matters when the certification body is conducting the initial audit, surveillance, renewal audit, extensional audit or product sampling; the statutory person responsible or relevant personnel of the place being audited shall accompany the audit and shall sign or stamp on the record made by the certification body after work is completed.

4.2 The certification procedures in 2.2 shall apply mutatis mutandis to the procedures of reviewing and certification stated in 3.2.2, the extensional audit stated in 3.3.1, the renewal audit stated in 3.5.1 and the surveillance stated in 3.6.1. The certification body shall thereby implement necessary procedures after assessing the certification risk of an individual case.

4.3 The labeling, usage, suspension of usage and relevant management of organic marks.

4.4 Calculation of compensation for damages to the operator certified by the certification body due to the termination of its accreditation qualification in whole or in part by the accreditation body.

4.5 Calculation of compensation for the leak of operator’s confidential technical production information or trade secrets that the certification body learns through certification activities.

Certification Standard for Organic Agricultural Products and In-conversion Agricultural Products and Allowable Substances in their Production, Processing, Packaging, Distribution, and Sale

Certification Standard for Organic Agricultural Products and In-conversion Agricultural Products and Allowable Substances in their Production, Processing, Packaging, Distribution, and Sale

These Standards were promulgated on Jun. 5, 2019 per Order Nung-Liang-Tze 1081069457A.

Chapter 1 Certification standards

Part I Common standards

1. Packaging

(1) Packaging methods shall be based on a principle of simplicity to avoid over-packaging, and the products shall be irreplaceable without the seal opened or destroyed.

(2) Packaging materials shall be biodegradable, recyclable or reusable. However, ordinary packaging materials may be used if the foregoing packaging materials are not available or not applicable.

(3) Packaging materials containing germicides, preservatives, fumigants, pesticides, migrating fluorescent agents, prohibited substances and other contaminating material materials are prohibited.

(4) Carbon dioxide and nitrogen used as packaging fillers and vacuum packaging are allowed.

(5) Printing inks and adhesives that are harmless to human health shall be used whenever available.

(6) The storage of packaging materials shall be kept sanitary and clean to avoid contamination.

2. Storage

(1) Organic agricultural products and in-conversion agricultural products (both hereinafter referred to as organic products) shall be kept free from contaminations during storage. Storeroom shall be clean, sanitary, bright, capable of preventing the intrusion of hazardous pest and has no residue of harmful substances.

(2) Besides room temperature storage, the use of environment control like regulating the air, temperature and humidity in storage is allowed.

(3) When organic products and non-organic products are stored in the same storeroom, they shall be distinctively labeled and well separated to avoid commingling. Inventories shall be arranged in a way that is easily traceable and recognizable.

3. Transportation and delivery

(1) The transportation vehicles shall be thoroughly washed and kept clean before loaded with organic products and during the transportation to avoid contamination.

(2) Labels and relevant instructions on the outer packaging of organic products shall stay intact during transportation and delivery.

(3) When organic products and non-organic products are transported or delivered together, the products shall be appropriately packaged and readily marked to avoid commingling products.

4. Records

(1) Relevant operation records, receipts and vouchers that are sufficient to prove the organic integrity of the products are required.

(2) Records of cleaning and management of the facilities, equipment and site shall be kept.

(3) When organic products and non-organic agricultural products are produced in the same production unit or are certified by more than one certification body, the operator shall implement autonomous management and keep the records of quantities produced, marks used and sales by organic status and certification bodies and accept the joint audit of different certification bodies.

5. Principles for using substances during production, processing, packaging, distribution and sale of organic products:

(1) Natural substances, except those prohibited in Chapter 2, are allowed.

(2) Synthetic chemicals, except those stipulated in Chapter 2, are prohibited.

Part II Processing, packaging and distribution

1. Scope

(1) Processing: Production procedures such as heating, drying, smoking, mixing, grinding, tableting, stirring, separation, distillation, extraction, fermentation, pickling, dehydration, shelling, milling, or freezing of organic raw materials, or other processes sufficient to change the physical or chemical characteristics or capable of substantially transforming the original product.

(2) Packaging: Selection, washing, cutting, or packaging of organic raw materials that do not change the physical or chemical characteristics of the original product.

(3) Distribution:

a. Original packages or labels of an organic agricultural product and in-conversion agricultural product changed in a way that affects the organic integrity of that agricultural product.

b. Organic agricultural products or in-conversion agricultural products entrusted to another operator in production, processing, packaging or distribution procedure by an entruster or a client who is labeled as the operator in accordance with subparagraph 3 of paragraph 1 of Article 18 of Organic Agriculture Promotion Act.

2. Requirements for the staff: At least one process manager shall be designated to train for at least four hours per year or 12 hours every three years on the operation related to organic products. The manager shall be in charge of overseeing a majority of the production process and shall accompany the certification auditor throughout the audit process.

3. Environmental conditions

(1) There are no harmful gases, radioactive matter, sources of diffuse pollution, trash dumps, or environment for the potential propagation of harmful organisms near the factory (farm).

(2) The factory (farm) shall have sanitation and waste management plans in order to maintain the cleanliness of facilities, equipment and sites.

4. Harmful organism control

(1) The following preventive measures shall be taken with priority:

a. Elimination of habitats, food sources and breeding areas of harmful organisms.

b. Measures preventing harmful organisms from entering processing facilities and equipment.

c. Control of environmental conditions. For instance, control of temperature, humidity, illumination and ventilation to prevent the propagation of harmful organisms.

(2) Adoption of biological, physical, or mechanical control measures. For instance, the use of sex pheromones, insect trap, paper stickers, or solar disinfection.

(3) In case the above-mentioned measures to prevent or control harmful organisms are ineffective, substances in Item 1 (1) and 1 (2) of Chapter 2 may be used, or preventive plans of harmful organisms may be submitted to the certification body for the confirmation of regulatory compliance and shall not be implemented until approved. However, the use of radiation, fumigant treatment, or preparations and substances containing genetically modified organisms (GMO) shall not be part of the plan. And the preparations and substances used shall not directly contact the organic raw materials and final products.

5. Production process

(1) The operator shall take necessary measures to prevent the mixing of organic and non-organic products, and shall avoid organic products in direct contact with the prohibited substances.

(2) Organic products are preferably produced at dedicated sites. If a production site must be used for producing non-organic products, its facilities, equipment, and areas shall be thoroughly cleaned before each treatment of organic products following the treatment of non-organic products. Organic products and non-organic products shall be produced separately in a sequence with adequate separation in-between.

(3) Biological, physical, or mechanical methods may be used to produce organic products. The selection of methods shall be based on its ability to preserve the natural ingredients and nutritional value.

(4) Radiation treatment, fumigants, or filtration equipment that may contain or produce hazardous substances may not be used in the production process.

(5) Any waste produced in the production process shall not have a negative impact on the ecological environment.

(6) The use of raw materials, food additives and other substances shall comply with the following clauses:

a. The same raw material shall not be simultaneously used in a mix of organic, conversion and non-organic source.

b. The substances listed in Item 1 (3) and 1 (4) of Chapter 2 are allowed but shall be used in a minimum quantity required for production and in accordance with relevant regulations.

c. The use of water and salt during the production process shall comply with drinking water quality standards and relevant sanitation standards.

d. Except the substances allowed in Item 1 (3) and (4) of Chapter 2, required by laws or seriously lacking in the product’s nutrient content and allowed to be used by the certification body, the use of minerals (including trace minerals), vitamin, amino acid and pure substances isolated from plant and animal is prohibited.

e. The use of raw materials, food additives, or other substances containing GMO is prohibited.

f. When organic raw materials are available, non-organic raw materials shall not be used. If a particular organic raw material is not available, other organic raw materials with the same function shall be used. Non-organic natural raw materials can only be used when the organic raw materials with the same function are not available. As for the availability of organic raw materials, it shall be determined by the certification body based on the formula and website information provided by the operators. Non-organic natural raw materials can only be used after the certification body has confirmed their compliance with the regulations.

6. The following methods are used to calculate the organic raw material content:

(1) Solid products: Divide the total weight of the organic raw materials in the product (excluding water and salt) by the total weight of the raw materials (excluding water and salt).

(2) Liquid products: Divide the total volume of the organic raw materials in the product (excluding water and salt) by the total volume of the raw materials (excluding water and salt). If the product consists of a reconstituted liquid concentrate, the organic raw material content shall be calculated considering the concentration of organic content in the liquid concentrate.

(3) Products consisting of solid-liquid-gas mixtures: Divide the total weight of the organic raw materials in the product (excluding water and salt) by the total weight of the raw materials (excluding water and salt).

(4) Expressions shall be rounded to the nearest integer.

Part III Crops

1. Conditions for the production environment:

(1) Operators shall hold the ownership of the production land or the right to manage and also conform to the following conditions in their production:

a. Production land: An adequate contamination prevention measure like fencing or buffer zone shall be in place to prevent organic cultivation from being contaminated.

b. Mushroom farm: A farm shall take necessary measures to prevent the drifting or influx of prohibited substances.

c. For wild plants and their parts that grow naturally in natural territories, forests and agricultural zones, gathering them is deemed as an organic way of production, given that such gathering activities would not impact the stability of natural habitats or preservation of local species.

(2) Operators shall properly manage the production materials used to maintain or improve the composition in organic matters of soil. All production materials and application methods that could lead crops, soil, or water sources to be contaminated by heavy metals or prohibited substances shall be avoided.

(3) Proper measures of soil management and water-and-soil conservation shall be implemented on the production land to maintain water-and-soil resources, ecological environment and biodiversity, and ensure the sustainable utilization of resources.

(4) For perennial plants, it is preferable that cover crops are planted in the surrounding area or the habitat of natural enemies of pests be kept. This prevents soil from being exposed and increases local bio-diversity.

(5) This Chapter only applies to crops that are cultivated in a soil-based environmental system. Plants rooting in mineral solutions or inert medium like perlite, gravel and mineral cotton filled with mineral nutrient solutions are categorized as hydroponic cultivation and thus not eligible for organic certification application.

(6) Sprouts or sprouting vegetables that are cultivated in pure water, with no substances added, are not categorized as hydroponic cultivation and thus eligible for organic certification application.

2. Farming area of short-term crops requires a two-year conversion period before it can be certified organic. Long-term crops (like perennial fruit trees or tea trees) and gathering operation require a three-year conversion period. During the conversion period, organic cultivation and gathering shall be performed in accordance with this Chapter. Conversion periods are subject to extension at the discretion of the certification body. In case the operator submits the supporting data (including work record, material record, harvest record, product test report and other description documents) of implementing organic cultivation as per regulations of this Chapter or the proof of eco-friendly farming, the certification body may shorten the conversion period on the basis of its observation.

3. Parallel production: When organic and non-organic crop are cultivated at the same time, the organic crops, production materials and products shall be entirely separated from non-organic ones. A proper identification and signifying system shall be implemented, with production records of both segments kept separately and made available to certification bodies for review.

4. Crops, varieties and propagative materials

(1) Under the principle of biological and genetic diversity, breeding preference shall be given to the crop varieties with strong environmental suitability and pest resistance in the way of organic cultivation.

(2) Genetic modification on seeds, seedlings or the whole or partial plant (hereinafter referred to as propagative material) that can be used for propagating is prohibited.

(3) Organic propagative materials that have been produced for at least one generation as per the regulation of this Chapter or at least for two years in the case of perennial crops may be used. In case there is no organic propagative material, those not treated by synthetic chemicals as well as botanical extracts or mineral material harmless to human health (hereinafter referred to as untreated) can be used. However, this doesn’t apply to those allow to be treated by synthetic chemical as per the regulations of this Chapter. If organic propagative materials or those untreated cannot be obtained in the aforementioned circumstances, the use plan shall be submitted to the certification body, and then general commercial propagative materials can be used only after if the unavailability is confirmed by the certification body.

(4) For the production of sprouts and seedlings, only organic seeds can be used.

5. Weed, plant disease and pest management

(1) Weed control

a. Preventative control: Reducing the amount of weed seeds in mixture with seeds for cultivation and the contamination of agri-machinery and irrigation water to inhibit the spread of weed in fields.

b. Cultural control: Rotating between wet and dry cultivation, different crops, or different planting intervals.

c. Weed population control: Applying high-density plantation, sowing, transplanting or plant selected autogenic weeds or other grass varieties and green manure crops to maintain the grassland condition of the land.

d. Mulches and cover crops:

(a) Using cut weeds (unflowered or without seed sprouted), remainders of crops, or various allowable biological materials as mulches.

(b) Using polyethylene, polypropylene and other polycarbonate-based plastic mulches.

(c) Planting green manure crops during fallow periods or conducting sod cultivation; propagating Azolla in wet paddy fields.

(d) Those who adopt this method shall not use crop residues and bio-materials containing pesticides, radioactive substances, or excessive heavy metals as well as polyvinyl chloride. Those who use plastic mulches shall clean and move out the used plastic mulches, and burning on site is prohibited.

e. Weeding: Manual weeding, mechanical plough, drying, flooding, etc.

f. Grazing poultry and livestock: Grazing poultry and livestock on the field for weed control.

g. Allelopathy: The use of any direct or indirect chemical effect of secondary metabolites released by non-GMO plants to suppress the germination, growth or development of themselves or neighboring plants.

h. Microbial herbicide: Application of non-GMO bio-organism or materials based on pathogenic microorganisms (e.g. fungus) of weeds.

(2) Plant disease and pest control

a. Plowing control:

(a) Crop rotation or intercropping of non-host crops.

(b) Mix-cropping with synergetic crops.

(c) Repellent plants.

(d) Fence plants.

(e) Using pest-resistant cultivars that are non-GMO.

(f) Using predatory animals (such as chicken and duck).

b. Physical control:

(a) Using high-temperature or solar energy for soil sterilization, but stubble burning in the field is not allowed.

(b) Using materials containing no synthetic chemical like paper bag, plastic cloth and non-woven fabric bag as protection.

(c) Wrapping the stem bottom of fruit trees with gunny bag, straw to prevent long-horned beetle.

(d) Setting up ditches or physical traps.

(e) Using colored paper stickers and moth-attracting lamp.

(f) Selecting seeds by water (such as salt solution and warm water) or treatment with high or low temperature.

c. Biological control:

(a) Releasing parasitic or predatory natural enemies of the pest insects.

(b) Non-GMO formulation of microorganism.

(3) The resources inside the farm shall be given preference for cyclic utilization. The plant protection material obtained outside the farm or commercialized one shall be reviewed and approved by the certification body, and the commercialized material shall obtain the agro-pesticide permit pursuant to Agro-pesticides Management Act and the relevant regulations or shall be promulgated as non-controlled agro-pesticides.

(4) The food material of natural substances stipulated in Item 5 (1) of Part I in this Chapter may be used as management substances of diseases, insects and weeds, and other substances shall conform to the stipulation in Item 2 (1) in Chapter 2.

(5) To safeguard the public interest, if there is any synthetic chemical which is not included in Items 2 (1) in Chapter 2 but has to be used for the overall epidemic prevention and control work required by the government, the operator shall report the area, drugs and method of implementation to the certification body, who will define the controlled area and period, during which the controlled products shall not be sold as organic.

6. Soil and fertility management:

(1) Analysis of soil samples may be timely conducted to understand the physical and chemical properties of soil and fertilization condition to serve as a basis for fertility management and rationalization fertilizing. The measures used shall be capable of preventing the loss of nutrients and avoiding the accumulation of heavy metal and pollutants.

(2) Proper crop rotation, intercropping, timely fallowing, mulching with plant residues and in-situ tillage shall be adopted to maintain the regional biodiversity and keep the soil fertility.

(3) The resources inside the farm shall be given preference for cyclic utilization, the material or commercialized fertilizer obtained outside the farm shall be reviewed and approved by the certification body, and the commercialized fertilizer shall obtain the fertilizer registration certificate pursuant to the Fertilizer Management Act.

(4) The direct use of the urine or feces of human, poultry or livestock is prohibited. If those of poultry or livestock must be used, they shall be fully composted with fermentation.

(5) The use of chemical fertilizers (including trace elements) and microorganism or composite fertilizers containing chemical fertilizers are prohibited. However, the trace elements conforming to the stipulation of Item 2 (2) in Chapter 2 can be used when the soil or plant that has been diagnosed as lacking trace elements and a use plan has been submitted to and approved by the certification body.

(6) The soil fertility management material shall conform to the stipulation of Items 2 (2) in Chapter 2.

7. Growth regulation, harvest, preparation, storage and packaging:

(1) Expose to irradiation and fumigants is prohibited during crop cultivation, harvest and postharvest handlings.

(2) To ensure the organic products are free from any contaminants from non-organic products, harvesting and postharvest handlings, preparation, storage and packaging shall be separated from conventional agricultural products.

(3) Operators that use self-produced organic products as processing raw material may apply for the certification of self-produced processed agricultural products. Harmful organism control, production process and the method of calculation of organic raw materials content thereof are require to be in accordance with the Item 4 to 6 of Part II in this Chapter.

(4) Growth regulation techniques including and not limited to trimming, pruning, grafting, girdling and root pruning are allowed.

(5) Preparation and storage techniques including and not limited to temperature are allowed.

(6) Growth regulation, harvesting, preparation, storage and packaging materials shall comply with the stipulation of Item 2 (3) in Chapter 2.

Part IV livestock Products

1. General Principles

(1) Organic livestock production shall comply with related rules in this Chapter.

(2) Livestock production shall proceed without affecting natural ecological balance, and shall contribute to the organic agriculture system in the following aspects:

a. To improve and maintain soil fertility;

b. To protect plant communities and ecology with adequate pasturage;

c. To maintain biodiversity and promote plant-animal and animal-soil interdependence;

d. To increase the diversity of the agricultural production system.

(3) Organic livestock production shall follow the natural behavior of animals and provide necessary production conditions such as access to land, sunlight and fresh air.

(4) Livestock shall be provided with enough organic corps and feeds.

(5) The number of livestock shall consider the following factors: feeds production, adaptability of livestock to the local environment and impact on the environment, nutrition balance, as well as livestock health.

(6) The management of organic livestock shall base on the following principles:

a. Reproduction by natural breeding and artificial insemination;

b. Protection of animal health and welfare;

c. Reduction of stress;

d. Paying attention to biosecurity;

e. Prohibition of use of chemically synthesized allopathic animal drugs and antibiotics unless authorized by a veterinarian.

2. Definitions

(1) Crop land: land that grows crops used for livestock feeds.

(2) Pasture land: land for pasture to grow or land for livestock to pasture.

(3) Outdoor access area: open space, other than animal housing, for animal daily activities and exercises.

(4) Animal replacement: to bring in livestock from outside of the farm because of sales, natural selection, natural disaster, serious illness, etc.

(5) Organic feeds: including crops, processed products, by-products, matching feeds, animal source feeds, etc. The feeds shall comply with related requirements in this Chapter or in Regulations for Managing and Reviewing Imported Organic Agricultural Products.

(6) Phytotherapeutic: therapeutic methods using plant extracts and essences.

(7) Homeopathic: therapeutic methods using diluted remedies to induce autoimmune in patients to cure disease. The remedies used shall not be chemically synthetic medicines or antibiotics.

(8) Allopathic: therapeutic methods using substances that may cause problems, such as drug resistance, chemical derivatives, or drug residual, to directly eliminate symptoms of a disease.

3. Conversion

(1) The conversion period for the land intended for feeding crops or pasture shall be at least two years.

(2) The conversion period for pasture, open-air runs and exercise areas used by non-herbivore species shall be at least one year.

(3) Once the land has reached organic status and livestock from a nonorganic source is introduced, and if the products are to be sold as organic, such livestock shall be reared according to the following compliance periods:

a. Livestock for milk production: six months;

b. Livestock for meat production:

(a) Not less than six months for calf, goats and pigs;

(b) Not less than 12 months for beef cattle;

(c) Not less than 10 weeks for poultry.

c. Six weeks for layer;

d. Others: over three quarters of their production life cycle.

(4) The conversion of the land intended for feeding crops may occur simultaneously with that of the existing livestock fed mainly with products from the unit.

4. Parallel production

(1) Where operations include both organic and conventional livestock production on the same farm, organic crops, livestock, materials and production shall be separated from the non-organic production area, and proper distinguishing and marking system shall be established.

(2) Production records for organic and non-organic production shall be maintained separately.

(3) If organic-prohibited materials contaminate the land or livestock of organic operation, the farmer shall report to the certification body, and the land or livestock shall return to conversion period.

5. Origin of animals

(1) Livestock shall be managed in accordance with this Chapter from the date of birth, and organic livestock reared shall be from the organically-managed female livestock.

(2) Breeding female livestock from conventional farms may be allowed with a yearly maximum of 10% of the same species of breeding female livestock on the farm.

(3) Under any of the following situations with approval by certification bodies, the maximum quantity of breeding livestock from conventional farms may increase to 40%:

a. Serious natural disasters or accidents causing more than 25% loss of livestock;

b. More than 30% of expansion on the farm;

c. Change of species of reared livestock on the farm.

(4) Breeding male livestock can be brought from non-organic farms, and may be included in the organic production immediately.

(5) Livestock farms during conversion period may, when organic livestock is not available, purchase the following livestock from non-organic farms:

a. Less than two days old chick for meat production;

b. Less than 12 weeks old pullets or ducks for the egg production;

c. Less than two weeks old for other poultry;

d. Weaning livestock that meets animal health requirements.

(6) Replacement or expansion of livestock other than breeding livestock shall be approved by certification bodies. If the livestock is brought from non-organic farm, it cannot be sold as organic products unless it complies with Item 3 (3) and 5 (5) of Part IV in this Chapter. The total number of animals on the farm after replacement or expansion shall not exceed the maximum capacity of the farm.

6. Livestock management

(1) Feeds and nutrition

a. Organic feeds and feed additives shall be used for animal nutritional needs.

b. The use of organic feeds and feed additives shall be approved by certification bodies, and the processing of these feeds shall be clearly separated from that of non-organic feeds.

c. Feed materials from animal origin shall be approved by certification bodies, and can only be used if they comply with the stipulation of Item 3 (2) in Chapter 2.

d. The following alternative materials for forage quality improvement could be used after they are approved by certification bodies:

(a) Probiotics and enzyme;

(b) By-products of food industry;

(c) Derivative plant products through fermentation;

(d) Non-GMO material for forage quality improvement.

e. Ruminants shall be fed at least 50% of the dry matter in daily rations in the form of roughage, forage or silage.

f. The ratio of organic feeds for ruminants and non-ruminants shall be over 85% and 80%, respectively. The feeds from the conversion land are permitted with a maximum of 30% of the dried matter. If the feeds from the conversion land are owned by the same farmers, these feeds are permitted with a maximum of 60% of the dried matter. The above ratio does not apply to the livestock reared prior to the conversion of pasture land and simultaneously converted with the land. However, the organic feeds in daily ration shall be over 75% of the dried matter, and shall be non-GMO products.

g. Livestock cannot be sold as organic products, if the ratio of organic feeds does not comply with Item 6 (1) f. of Part IV in this Chapter.

(2) Management

a. Based on the natural behavior of animals, the earliest weaning time is 90 days for calves, 60 days for sheep and goats, and 42 days for piglets.

b. The young mammal species shall be fed with organic milk from the same species. Under special situations with approval by certification bodies, non-organic milk without containing antibiotics, chemically synthesized compounds or milk-based substitute can be used.

c. During organic livestock production, the following biotechnologies are prohibited:

(a) Embryo transfer technique;

(b) Hormones to synchronize estrous cycles for breeding, with the exception of therapeutic use for reproduction interference of individual livestock under veterinary prescription;

(c) Use of genetically modified breed or strain of animals.

d. Temporary indoor holding space shall be provided under the following situations:

(a) Serious weather conditions;

(b) Reproduction period:

Calf and lamb: from birth born to the seventh day after weaning;

Cow and ewe: from the last one fifth of pregnancy period to parturition;

Piglet: from birth to weaning;

Sow: from three months in pregnancy to weaning of the piglets.

(c) Last part of the fattening period: three months before marketing or one fifth of life cycle, whichever is less;

(d) Potential damage to health, safety and welfare of livestock;

(e) Soil or water being polluted.

e. Photoperiods of laying hens shall not exceed 16 hours per day.

f. Physical alteration of organic livestock to promote their welfare and safety is allowed but shall be performed at the stage of young animal by the experienced staffs in a manner that minimizes pain and stress. The following procedures for physical alteration shall be conducted under the permission of certification body:

(a) Tooth clipping (not exceeding the one third of the top) and tail docking for pigs;

(b) Beak trimming for young poultry before 10-day-old, not exceeding the one third of the tip;

(c) Castration and dehorning for young livestock.

(3) Living conditions

a. All animals shall be cage-free, and shall have access to outdoor exercise areas. Adequate space shall be provided to maintain living conditions that accommodate the health and natural behavior of the animals.

b. A pasture land or an outdoor exercise area shall be provided for herbivores.

c. Livestock with social recognition abilities shall not be confined individually, except in conditions that are approved by certification bodies, such as sickness, parturition, breeding male or young animals.

d. The living conditions shall be adequate for animal growth or production in terms of providing shade, cover, shelter, exercise areas, fresh air, sunlight and specific pathogenic free environment.

e. Animal growth or production area shall have proper protection from outside predators to ensure safety of animals.
f. The facilities of outdoor production area shall comply with the following principles:

(a) To prevent contamination of the prohibited materials from the surrounding area by applying necessary protection;

(b) To provide proper cover or shelter to prevent animals from serious weather conditions, if animal housing could not provide free access to indoor;

(c) To have suitable water sources in the outdoor production area for waterfowls;
(d) To prevent damage to vegetation and soil due to overgrazing by rotating grazing or reducing stocking density. The requirements of minimum outdoor production area for each animal are listed below:

Animal	Outdoor living area
Dairy cow	4 m2/head
Beef cattle	a. Less than 100 kg: 1.5 m2/head b. From 100 kg to less than 200 kg: 2.5 m2/head c. From 200 kg to less than 350 kg: 4.0 m2/head d. 350 kg and above: 5.0 m2/head
Bull for breeding	20 m2/head
Sheep or goat	a. Less than 20 kg: 0.5 m2/head b. 20 kg and above: 2.5 m2/head
Farrowing sow and piglet within 42-day-old	2.5 m2/nest
Pig	a. Less than 30 kg after weaning: 0.6 m2/head b. From 30 kg to less than 60 kg: 0.6 m2/head c. From 60 kg to less than 100 kg: 0.8 m2/head d. 100 kg and above: 1.0 m2/head
Boar for breeding	8 m2/head
Sow for breeding	1.9 m2/head
Laying hen (during the laying period)	4 birds/m2
Broiler (over 28 days)	10 birds/m2
Turkey	2 birds/m2
Duck	3 birds/m2
Goose	3 birds/m2

g.The housing of livestock shall provide a clean, comfortable and sufficient space that animals can lay down or rest; and fulfill the following requirements:

(a)Livestock have free access to clean water and feed;

(b)The housing structure shall provide proper insulation, ventilation and natural light;

(c)The housing shall, based on species and group sizes, have proper resting space and sufficient access to outdoor space for livestock, and shall have perches for land fowls;

(d)The housing and equipment shall be routinely cleaned and sanitized only using materials complied with Item 3 (1) in Chapter 2. Excrements and uneaten feeds shall be routinely removed to ensure environmental hygiene;

(e)The materials used for cleaning and/or sanitation of housing and equipment shall not be hazardous to animals and human;

(f)The bedding and ground for animal resting shall be kept dry. If there is a possibility that livestock may eat the bedding materials, the bedding material shall comply with rules in this Chapter;
(g)The stocking density shall depend on animal types, breeds and age, and consider their comfort and welfare. The minimum requirements of housing areas for each animal are listed below:

Animal	Housing space
Dairy cow	4 m2/head
Beef cattle	a. Less than 100 kg: 1.5 m2/head b. From 100 kg to less than 200 kg: 2.5 m2/head c. From 200 kg to less than 350 kg: 4.0 m2/head d. 350 kg and above: 5.0 m2/head
Bull for breeding	10 m2/head
Sheep or goat	a. Less than 20 kg: 0.35 m2/head b. 20 kg and above: 1.5 m2/head
Farrowing sow and piglet within 42-day-old	7.5 m2/nest
Pig	a. Less than 30 kg after weaning: 0.6 m2/head b. From 30 kg to less than 60 kg: 0.8 m2/head c. From 60 kg to less than 100 kg: 1.1 m2/head d. 100 kg and above: 1.3 m2/head
Boar for breeding	6 m2/head
Sow for breeding	2.5 m2/head
Laying hen (during the laying period)	6 birds/m2
Broiler (over 28 days)	10 birds/m2
Turkey	2 birds/m2
Duck	10 birds/m2
Goose	5 birds/m2

h. The pasture management for grazing shall comply with Part III in this Chapter.

(4) Health care

a. Selection of organic livestock shall be those breeds or strains that are adapted to local conditions and resistant to diseases and parasites.

b. Housing and pasture land shall conform to anti-epidemic conditions so as to prevent an outbreak and spread of diseases. In addition, there shall be adequate space.

c. Legal and necessary vaccines are permitted.

d. The producer of an organic livestock operation shall be subject to the following requirements:

(a) Animal drugs shall not be used in the absence of illness, except vaccine;

(b) Chemically synthetic parasiticides shall not be used on livestock for meat products, or routinely used on other livestock;

(c) Injured or sick animals shall be treated immediately to prevent suffering. If necessary, the animal shall be isolated in a suitable housing.

e. In organic farms, the use of animal drugs to treat animals shall comply with the following principles:

(a) Effective phytotherapy, homeotherapy, vitamins and trace minerals shall be used preferentially;

(b) If the use of the above treatments is not effective in reducing suffering or stress to the animal, chemically synthesized allopathic animal drugs or antibiotics may be used under the prescription of a veterinarian;

(c) The use of chemically synthesized allopathic animal drugs or antibiotics for preventive treatments is prohibited.

f. If organic livestock is treated with chemically synthesized allopathic animal drugs, the following rules shall apply:

(a) The withdrawal period of such medical products shall be twice the legal withdrawal period and no less than 48 hours;

(b) If the productive lifecycle of animal is more than one year, the treatment shall not be more than two courses within one year;

(c) If the productive lifecycle of animal is less than one year, the treatment shall not be more than one course;

(d) Livestock for meat products shall not have any chemically synthesized allopathic treatment.

Livestock not complying with the above rules shall not be sold as organic products. However, animals undergoing conversion period and approved by certification bodies are not included.

7. Pest control and animal manure management

(1) Pest control shall adopt preventive approaches, such as biological control or proper pasture rotating plan. If the preventive apporaches are not effective, non-chemical methods shall be in preference of using. Only when the above approaches fail to prove effective control, techniques and materials complying with this Chapter can be permitted to be used.

(2) Organic farms shall have animal manure management plan, which includes manure collection, processing and usage.

(3) The collection, processing and usage of animal manure shall comply with the following rules:

a. Not to pollute crops, soil, water and environment;

b. Not to adversely affect the growth of crops;

c. Not to pose risks of weed spread, pest outbreak or jeopardizing environment hygiene;

d. Not to apply burning or any techniques prohibited in this Chapter;

e. Composting process shall follow all standards related to composting and use only the materials allowed in this Chapter.

8. Transportation, slaughter, collection and packing of livestock products

(1) The transportation and slaughter of livestock as well as collection of livestock products shall comply with the animal welfare.

(2) Before or during transportation, use of any synthesized tranquilizer or electrical goads is prohibited.

(3) To ensure that organic livestock products are not mixed with or contaminated by non-organic products, the collection, processing, storage and packaging of organic livestock products shall be separated from non-organic livestock products.

(4) Packaging, storage, transportation and delivery of livestock products shall comply with related rules in this Chapter.

9. Materials permitted to be used in production of organic livestock products shall comply with the requirements stated in Item 3 (1) in Chapter 2.

10. Production records and related documents

Organic livestock producers shall fill up detailed and accurate records based on practical operation, and keep all related trade documents. The records shall be clear, accurate and traceable, and shall include the following items:

(1) Basic information, including the name and address of farm, name, address and telephone number of producer, certified area and registration number, certified livestock products and name of the certified bodies;

(2) Facility map indicating the sites of livestock production, crop production and storage shall include the following items and be routinely updated:

a. Production area, location, farm address and land number;

b. Roads, storehouses, buildings, surrounding vegetation and major topographical marks and surface features to be used to identify the farm;

c. Types of livestock and feed crops;

d. Rivers, wells, trenches and other water sources within the surrounding;

e. Pollution blocking facilities and buffering zone;

f. Description of crop types in neighboring areas.

(3) Organic livestock production plan:

a. Details of all organic livestock, including species, origin, quantity and dates of introduction;

b. Records of animal drugs usage, including systems of livestock identification, quantity, diagnosis, date and types of drugs used, methods of management and date of sale;

(4) Sources, characteristics, quantities, usage and proof of purchase of raw materials, which include:

a. Materials for livestock production;

b. Materials for crop production (including seeds and seedlings);

c. Feeds;

d. Animal drugs;

e. Materials for pest control;

f. Other treatment materials.

(5) Sale records of livestock products, including:

a. Types, quantities, slaughter weight or age, destination and identification of livestock products;

b. Name of buyer and sale receipts.

(6) Other processing records, which include those of slaughtering, cutting, packaging, labeling, storage and transportation of products;

(7) Cleaning records of slaughtering, cutting, processing, storage and transportation equipment as well as prevention records of harmful pests in slaughterhouses, cutting and packaging plants;
(8) Records of customers or consumers complaints about organic products;
(9) Other records related to traceability of product organic integrity.

Part V Aquatic Plants

1. Conditions for the production environment

(1) The cultivation or harvest areas shall have adequate fencing or buffering zones to prevent pollution from outside thus avoiding the aquatic plants of organic cultivation from being contaminated.
(2) The cultivation water quality shall meet the requirements set forth by the Environmental Protection Administration, Executive Yuan, in the Surface Water Classifications and Water Quality Standards as first-class aquatic production use water.
(3) The heavy metal contents in the cultivation bottom soil shall be lower than the standard of soil pollution control. For the cultivation soil with heavy metal contents exceeding the monitoring standard, the certification organization shall periodically track it while conducting renewal audit.
(4) The cultivation or harvesting activities shall not damage the environmental resources to ensure sustainable use of resources.

2. Outdoor areas for the production of aquatic plants require a two-year conversion period before it can acquire organic certification. During the conversion period, organic cultivation needs to be implemented in accordance with this Chapter.

3. Seedlings

(1) The use of any genetically modified seedlings is prohibited.

(2) During the seeding cultivation process, nonsynthetic chemical shall be used.

(3) Conventional seedlings can be used only when certified seedlings cannot be obtained.

(4) The use of synthetic chemicals for sterilization at the site of seedling facilities is prohibited, except the synthetic substances permitted in this Chapter.

4. Weeds control

(1) Weeds shall be adequately controlled by physical or biological prevention methods while no synthetic chemical is permitted to be used.

(2) The use of any GMO’s preparations or materials is prohibited.

5. Fertility management

(1) Analysis of water samples shall be timely conducted to understand the fertilization condition to serve as a basis for fertility management.

(2) The use of chemical fertilizers (including microelements) and of microorganism preparation materials and compound fertilizers which are blended with chemical fertilizers or containing pesticides are prohibited.

(3) Mineral fertilizer shall be used in its natural composition, and there shall be no chemical processing to increase its solubility or effectiveness.

(4) The use of any GMO’s preparations or materials is prohibited.

6. Pest control

(1) The use of synthetic chemicals or plant extract harmful to human health or mineral materials is prohibited, except the synthetic substances permitted in this Chapter.

(2) The use of any GMO’s preparations or materials is prohibited.

7. Cropping, preparation, storage and packaging

(1) After cropping, the use of additives or synthetic chemicals is not allowed for the processing, nor is radiation processing allowed.

(2) To ensure the organic aquatic plants are free from any mixing or contamination by the non-organic aquatic plants, the cropping process and preparation, storage and packaging after the cropping shall be separated from the handling of general aquatic plants.

(3) The aquatic products business operators that use their self-produced organic aquatic products as raw materials for primary processing may have their processing procedure certified at the same time, of which the harmful biology prevention, processing procedure and the calculation method for organic matter contents shall be in accordance with Item 4 to Item 6 of Part II in this Chapter.

8. The substances used for aquatic plant production shall conform to the stipulation of Item 2 in Chapter 2.

Part VI Aquatic Animals

1. General Principles

Organic aquaculture production shall proceed without affecting natural ecological balance, and shall comply with the animal welfare and shall adopt the basic production principle on the healthy and well-managed environment.

2. Definitions

(1) Life cycle: the sequence of life stages that an animal undergoes from birth to the desired market size.

(2) Organic feeds: including crops, processed products, by-products, formula feed, animal feed sources origin.

(3) Phytotherapeutic: therapeutic methods using plant extracts and essences for improving animal health.

(4) Homeopathic: therapeutic methods using diluted remedies to induce autoimmune of animals to cure disease.

(5) Allopathic: therapeutic methods using substance or antibiotics to directly eliminate symptoms of diseases.

3. Organic conversion period

(1) The conversion period of the organic production unit from non-organic aquaculture shall be at least one life cycle of the organism or 12 months from the date operator/producer apply for organic certification to its certification bodies. However, provided the operators/producers had adopted organic aquaculture production before applying for organic certification and with relevant supporting documents, they may apply to the certification bodies to shorten the conversion period.

(2) During a conversion period, the production process for organic aquaculture cannot be converted to non-organic aquaculture.

(3) When the organic producers want to discontinue organic aquaculture certification during the conversion period, they shall inform the certification bodies to withdraw certification procedures.

4. Parallel production

(1) The organic aquaculture production units shall be obviously separated from non-organic production areas.

(2) Production records for organic and non-organic production shall be maintained separately.

5. Origin of the aquatic animals

(1) Organic aquatic animals shall be raised and managed in accordance with this Chapter from birth, and the seedlings shall come from organic production of broodstock or wild populations.

(2) Prohibited genetic resources are as follows:

a. GMO;

b. Polyploid;

c. Hybridization;

d. All-female aquaculture.

(3) Non-organic seedlings can be used before 1 January 2023, but those which are over two thirds of the life span shall conform to the production management stipulated in this Chapter.

(4) Broodstock breeding

a. Broodstock breeding is subject to at least one complete cycle of organic production, and shall ensure the organic management practices in accordance with this Chapter at least 12 months before the hatching.

b. The management plan for broodstock breeding shall be established and includes the following:

(a) Production unit (batch) management plan;

(b) Conversion timetable and management practices.

c. The requirements for organic fry (eggs): a clear separation to prevent cross-contamination or mixed with other substances.

6. Organic Aquatic Animal Management

(1) Feeds

a. The use of organic feeds and feed additives shall comply with this Chapter, and imported organic feed shall comply with Regulations for Managing and Reviewing Imported Organic Agricultural Products.

b. When producers cannot get commercially organic feed and feed additives the certification bodies may certify a viable alternative program of homemade organic feed production, the raw material origins of the feed and feed additives required for the program shall be provided by producers and the production processing shall be obviously separated with non-organic feed ingredients.

c. Feed for aquatic animals shall meet the following requirements:

(a) The sources are restricted from a sustainable supply of marine organisms or by-products of organic farming;

(b) The fishmeal in animal feed shall not exceed 20%.

d. The following substances are prohibited in the diet for organic aquaculture:

(a) Synthetic growth-promoting hormone, hormones or attractant;

(b) Synthetic antioxidants or preservatives;

(c) Synthetic amino acids;

(d) Artificial, synthetic or similarly natural pigments;

(e) Non-protein nitrogen;

(f) Animal excrement;

(g) GMO or its products and raw materials;

(h) Livestock and their wastes.

(2) Disease prevention

a. Selection of organic species shall be those breeds or strains that are adapted to local conditions and resistant to diseases and parasites.

b. The following materials shall be used to disinfect water bodies and pond bottom in order to prevent the occurrence of aquatic animal diseases:

(a) Quicklime (calcium oxide);

(b) Zeolite powder;

(c) Hydrogen peroxide;

(d) Sodium hypochlorite (antiformin);

(e) Acetic acid;

(f) Citric acid;

(g) Ethanol;

(h) Probiotics;

(i) Tea-seed cake;

(j) Tobacco (nicotiana).

c. Legal and necessary vaccines are permitted.

d. The producers of the organic aquaculture operation shall comply with the following requirements:

(a) Not to use animal drugs, except vaccine, in the absence of illness;

(b) For an aquatic animal that is injured or sick, to have it be treated immediately, if necessary put in isolation with a suitable living unit.

e. In organic farms, the use of animal drugs to treat aquatic animals shall comply with the following principles:

(a) Therapeutic effective phytotherapeutic and homeopathic products shall be used preferentially;

(b) The use of chemically synthesized allopathic animal drugs or antibiotics for preventive treatments is prohibited.

(c) If the use of above products is not effective in combating illness or injury, chemically synthesized allopathic animal drugs or antibiotics may be used under the responsibility of a veterinarian; and the following rules shall apply:

i. The withdrawal period of such medical products shall be twice the legal withdrawal period.

ii. When processing drug treatment, the organically sick aquatic animals shall be isolated.

(3) Living environment

a. The farm location shall consider the vicinity environment to maintain its ecological balance and biodiversity.

b. Organic farming areas shall be distinctly separated from non-organic farming areas. More than two meters buffer zone shall be retained in the land-based aquaculture; where the buffer zone in marine cages shall be kept more than 80 meters with the conventional farms. However the surrounding of the farms are subject to the certification bodies to adjust the buffer distance for the purpose of isolation.

c. The drainage water from the farm cannot affect the ecological environment and the water quality shall comply with the relevant regulations of the waste water.

d. The material used in the construction and management is not allowed to jeopardize the living organisms or environmental substances.

(4) Aquaculture management

a. Operators shall take adequate measures to prevent escapes of aquatic animals as not lead to locally adverse environmental impacts, and simultaneously prevent other animals getting into the organic aquaculture farms or prey on organically aquatic animals, and shall prevent cultivated species from entering natural water bodies.

b. Polyculture of aquatic organisms is highly recommended to maintain biodiversity.

(5) Production records and related documents: Organic aquaculture producers shall fill up detailed and accurate records based on practical operation, and keep all related trade documents. The records shall be clear, accurate and traceable, and shall include the following items:

a. Basic information, including the name and address of farm, name, address and telephone number of the producer, certified area and registration number, certified aquaculture products and name of the certified bodies, etc.

b. The management record of organic aquaculture animal production:

(a) The production records of all certified organic aquatic animals including the species, source, quantity and entry date, water quality monitoring information, etc.;
(b) Records of the drug administration for organic aquatic animals including drugs identification, quantity, diagnosis, date and types of medicine used;
(c) Methods of management and date of sale for aquaculture products.

c. Location diagram of organic aquaculture production, feeds variety and storage shall include the following items and routinely updated:

(a) Farm information and site registration number (fishing rights information);
(b) Roads, storehouses, buildings, surrounding vegetation and major topographical marks and surface features, or offshore/onshore markers to be used to identify the farm;
(c) Species of aquatic animals or types of feed;
(d) Rivers, wells, trenches and other water sources;
(e) Pollution blocking facilities and buffering zone;
(f) Conditions and types of crops in neighboring areas.

d. The records for sources, characteristics, quantities, usage and proof of purchase of raw materials from all the following items as feeds, veterinary medical products, materials for pest control and other processing materials shall be preserved.

7. Harvest, transportation and slaughter of aquatic animals

(1) When processing harvest, the operator shall take measures as peaceful as possible to reduce the stress and adverse effect on organic aquatic animals.

(2) The use of any synthesized tranquilizer/sedatives is prohibited either prior to or during transport.

(3) There shall be someone responsible for the health of organic aquatic animals during transportation.

(4) The water and stocking density shall be consistent with the needs of aquatic animals during transportation.

(5) The transportation distance and frequency shall be reduced to a minimum.

(6) When slaughtering, humane methods or appropriate applications of physical anesthesia such as the percussion and electric shock shall be used to lead aquatic animals to a coma immediately.

(7) Avoid organically aquatic live animals having direct or indirect contact with the dead or slaughtered ones.

(8) To ensure organic aquatic animals/products not mixed with or contaminated by non-organic animals/products, the collection, processing, storage and packaging of organic animals/products shall be separated from non-organic aquatic animals/products.

Chapter 2 Substances allowed to be used in production, processing, packaging, distribution and sale

1. Processing, packaging, distribution and sale

(1) Substances allowed to be used in harmful organism control

Substances	Conditions
Plant infusions or extracts by natural processes (1)Neem (2)Lemon grass (3)Marigold
Boric acid	Limited to be used in container
Diatomaceous earth	Limited to be used in controlling pests and diseases in protective facilities
Lime, Lime and sulphur mixture
Non-GMO microbial pesticides which consist of bacteria (e.g. Bt, Bs, Ba), entomopathogenic fungi and viruses	Forbidding exotoxin
Pyrethrum extract
Sodium bicarbonate

(2)Substances allowed to be used in cleaning and disinfectin

Substances	Conditions
1 Alcohols (1)Ethanol (2)Isopropanol	Limited to the use as cleaning agent as per regulations
2 Chlorine materials (1)Calcium hypochlorite (2)Chlorine dioxide (3)Sodium hypochlorite (4)Hypochlorous acid solution	Limited to the use as cleaning agent as per regulations
3 Fungicide-free soap
4 Phosphoric acid	Limited to the use as cleaning agent as per regulations
5 Sodium hydroxide (alkali liquor, caustic flakes, caustic soda)	Limited to the use as cleaning agent as per regulations
6 Peracetic acid, peroxyacetic acid	Limited to the use as cleaning agent as per regulations

(3)Food additives allowed to be use

Substances	Conditions
1 (1) Alginic acid (2) Calcium alginate (3) Potassium alginate (4) Sodium alginate
2 (1) Ammonium carbonate (2) Ammonium bicarbonate (3) Sodium bicarbonate	Limited to the use as leavening agent
3 Bentonite
4 Carnauba wax
5 (1) Potassium carbonate (2) Calcium carbonate (3) Magnesium carbonate (4) Sodium carbonate (5) Sodium carbonate, anhydrous	Limited to the use for cereal products
6 (1) Magnesium chloride (2) Salt brine; bittern (3) Calcium chloride (4) Potassium chloride	Limited to the use of those extracted from sea water and to be used as coagulator for soy products
7 (1) Citric acid (2) Calcium citrate (3) Potassium citrate (4) Sodium citrate	Limited to the use of those extracted from fruit or fermented by natural raw material like carbohydrate
8 Sulphuric acid	Limited to the use for production of sugar and gelatin
9 (1) Calcium sulphate (2) Magnesium sulphate	Limited to the use of those from natural sources
10 Sulphite	Limited to the use for grape wine and fruit wine under the precondition that the residual quantity of SO₂is less than 100 ppm
11 (1) Calcium phosphate， dibasic (2) Calcium phosphate, monobasic (3) Calcium phosphates, tribasic
12 Carrageenan
13 Casein	Limited to the use for liquor and meat processing
14 Diatomaceous earth	Limited to the use for adsorption or filtering of food manufacturing
15 DL-malic acid (Hydroxysuccinic acid)
16 DL-α-Tocopherol (Vitamin E)
17 Enzyme	1. Limited to the use of those from edible non-poisonous plants, nonpathogenic microorganisms or healthy animals 2. Limited to the use of those not treated by organic solvent
18 (1) Fumaric acid (2) Monosodium fumarate
19 Glucono-δ-Lactone
20 Glycerol	Limited to the use of those made by lipid hydrolysis
21 Hydrogen peroxide	Limited to the use as sanitizing agents
22 (1) L-Ascorbic acid (Vitamin C) (2) Sodium L-Ascorbate
23 Lactic acid
24 Calcium lactate
25 Perlite
26 Polygalloyl-Glucose, Tannic acid
27 (1) Tartaric acid (2) Monopotassium tartrate (3) D&DL-Sodium tartrate
28 (1) Potassium hydroxide (2) Sodium hydroxide (3) Calcium hydroxide	1. Limited to the use as pH adjustment for processing sugar or cereal products 2. Not to be used for alkali peeling of vegetables and fruits
29 Silicon dioxide
30 Talc
31 Xanthan gum
32 Hydroxypropyl methyl cellulose	Limited to the use as capsule material

(4)Other substances allowed to be use

Substances	Conditions
Gum Arabic	Conform to Specifications Standard for Gum Arabic as Food Raw Material
Calcium carbide
Activated carbon
Agar	Limited to be unbleached
Beeswax	Limited to the use as releasing agents
Carbon dioxide
Charcoal ash
Corn starch (native)
Ethanol
Ethylene	Used in the form of processing aid
Gelatin
Guar gum
Kaolin
Lecithin	When in liquid form, it shall be obtained without organic solvents.
Carob bean gum	When used in processed animal products, it is only for dairy and meat product processing.
Natural colors
Natural flavors
Natural yeast
Nitrogen	Only from non-petroleum sources or oil-free grade
Oxygen	Only from oil-free grade
Ozone	Only for cleaning and infection purpose
Pectins	Limited to the use of those from non-amidation

2. Crop production

(1) Substances allowed to be used for weed, plant disease and pest control

a. The use of synthetic chemicals, including those natural substances which are treated with synthetic chemicals or by a chemical process to change their original physicochemical properties, shall not be used unless listed below and shall be subject to the following conditions.

Substances	Conditions
Chitosan Synthetic vinegars Chlorine materials: hypochlorites, chlorates and chlorine dioxide Copper materials: copper sulphate, copper hydroxide, cuprous oxide, copper oxychloride and tribasic copper sulphate Bordeaux mixture (copper sulphate + lime) Neutralized phosphorous acid (Phosphorous acid + Potassium hydroxide) Potassium bicarbonate, sodium bicarbonate (baking soda) Calcium carbonate Lime, sulphur, lime and sulphur mixture Potassium hydroxide Siliceous substances: silicates, silicon dioxide Mineral oil Insect attractant or repellent (pheromone, methyl eugenol, protein hydrolysate, cuelure and etc.) Fungicide-free salts of fatty acids (soap) Borax, boric acid Methyl eugenol with insecticide	While using chlorine materials or copper materials, decrease the accumulated chlorine or copper as possible While using pheromone, insect attractant, borax or boric acid, the direct contact with crop is prohibited While using methyl eugenol with insecticide, it shall be placed in trap and avoid directly contacting with plant and soil. Before using it, the applying plan shall be submitted to the certification body and it can only be used according to the applying plan permitted by certification body.

Substances

Conditions

Chitosan
Synthetic vinegars
Chlorine materials: hypochlorites, chlorates and chlorine dioxide
Copper materials: copper sulphate, copper hydroxide, cuprous oxide, copper oxychloride and tribasic copper sulphate
Bordeaux mixture (copper sulphate + lime)
Neutralized phosphorous acid (Phosphorous acid + Potassium hydroxide)
Potassium bicarbonate, sodium bicarbonate (baking soda)
Calcium carbonate
Lime, sulphur, lime and sulphur mixture
Potassium hydroxide
Siliceous substances: silicates, silicon dioxide
Mineral oil
Insect attractant or repellent (pheromone, methyl eugenol, protein hydrolysate, cuelure and etc.)
Fungicide-free salts of fatty acids (soap)
Borax, boric acid
Methyl eugenol with insecticide

While using chlorine materials or copper materials, decrease the accumulated chlorine or copper as possible
While using pheromone, insect attractant, borax or boric acid, the direct contact with crop is prohibited
While using methyl eugenol with insecticide, it shall be placed in trap and avoid directly contacting with plant and soil. Before using it, the applying plan shall be submitted to the certification body and it can only be used according to the applying plan permitted by certification body.

b.Except those stipulated below, all the natural substances can be used:

Substances	Conditions
Derris trifoliata Lour. Plant extracts and mineral materials which are harmful to human body

(2) Substances allowed to be used for soil fertility management

Substances	Conditions
The residues of brewery (waste wine lees, distillers’ grains or distillers’ wort).
The waste of plant residue during process procedure without addition of spice by food and beverage manufacturer (such as tea residues, coffee residues, bean residues, fruit and vegetable residues).	Waste residues shall not contain the slug from waste water process.
Flavored or formulated milk powders
Basic slag	The usage of silicate slag shall not exceed four tons/hectare/year.
The meals produced after the oil had been extracted from plant seeds (such as soybeans, peanuts, linseed, sesame, rapeseed, castor bean, coconut meals and etc.).	The meals produced from seed oil extraction treated with an adequate amount of potassium hydroxide can be used, but the weight of potassium oxide in the product shall not exceed 3%, the humus shall not be below 1% and the ratio of humus and potassium oxide shall be at least 3 (W/W).
The chitin or the chitosan obtained from shells of shrimps and crabs processed by adequate amount of hydrochloric acid and potassium hydroxide.	While using the chitin or the chitosan obtained from shells of shrimps and crabs processed by adequate amount of hydrochloric acid and potassium hydroxide, the weights of potassium oxide and chlorine of the products shall not exceed 3% and 2%, respectively.
Products (sugar) and by-products (bagasse, molasses and sugar filter mud) of sugar industry
Amino acid
Seaweed hydrolysate, fish hydrolysate

b.Except those stipulated below, all the natural substances can be used:

Substances	Conditions
Ashes and dusts from industrial process
Chile saltpeter
Lime obtained from industrial by-products

(3) Substances allowed to be used for growth regulation, harvest, preparation, storage and packaging The use of synthetic chemicals, including those natural substances which are treated with synthetic chemicals or by a chemical process to change their original physicochemical properties, shall not be used unless listed below and shall be subject to the following conditions:

Substances	Condition
Ethylene Calcium carbide Carbon dioxide Nitrogen Ethanol (Alcohol)	Industrial alcohol is prohibited.

3. Livestock products

(1) Synthetic substances allowed to be used for livestock production

Substances	Use conditions
Synthetic substances used for disinfecting, cleaning and medical treatment:
(1)Alcohol
i.Ethanol	For use only as disinfectant; and cleaning agent and strictly prohibited to use as supplementary feed
ii.Isopropyl alcohol	For use only as disinfectant
(2)Chlorine materials
i.Calcium hypochlorite.	For use only as sterilization or cleaning of utensils and equipment. The residual of chlorine shall not exceed the threshold value of drinking water.
ii.Chlorine dioxide
iii.Sodium hypochlorite
(3)Chlorhexidine	Veterinarian may use this during surgery. When all germicides fail to cure mastitis, it may be used to soak the breast teat.
(4)Electrolyte without antibiotics
(5)Glucose
(6)Glycerol	For use only in soaking teats of livestock. Its source shall be from hydrolysis of fat or oil.
(7)Iodide
(8)Hydrogen peroxide
(9)Phosphoric acid	For use only in cleaning equipment. It shall not contaminate the livestock living area or make physical contact with organic livestock
(10)Vaccine
(11)Aspirin	For use only to reduce inflammation
(12)Sodium hydroxide	For use only in cleaning equipment. It shall not contaminate the livestock living area or make physical contact with organic livestock.
(13)Organic acid	Limited to be used in cleaning equipment
i.Acetic acid
ii.Lactic acid
iii.Citric acid
(14)Sodium carbonate	Limited to be used in cleaning equipment
(15)Fungicide-free soaps	Limited to be used in cleaning equipment
2 Synthetic substances used for local treatment, elimination of ectoparasite or local anesthesia
(1)Iodide
(2)Calcium hydroxide
(3)Mineral oil	For use only in local application or for lubricant use
(4)Copper sulphate
(5)Diatomite	For use to disinfect ectoparasite
(6)Vegetable oil	For use to disinfect ectoparasite
3 Supplementary feed
(1)Trace minerals	For use only as nutrient enhancement. The varieties and dosage shall meet related national standards.
(2)Vitamins	For use only as nutrient enhancement
(3)Methionine	For use only for poultry
4 Substances allowed to be used in the drinking water: none.

(2)Prohibited natural substances:

Substances
By-products of livestock slaughter Excrements of livestock Radiation processed or genetically modified organisms and products thereof Industrial waste cultured algae and their products Plants containing Strychnine Invertebrates (such as earthworms, but those bred and raised by the organic farm are excluded.) Egg and egg products

Categories and Items of Organic Agricultural Products and In-conversion Agricultural Products

Legislative history
1. This table was promulgated by the Council of Agriculture on June 5, 2019 per Order Nung-Liang-Tzu-Tze 1081069460A.

**Categories and Items of Organic Agricultural Products and In-conversion Agricultural Products**
Category	Item	Scope of Product (or description)
Crops	Rice	Paddy
	Cereals and Pulses	Barley, wheat, oat, sorghum, sweet potato, soy bean, field corn, peanut, mung bean, Adzuki bean, buckwheat, millet, red quinoa, black soy bean, hyacinth bean, millet, sesame, pine nut, sunflower seed, pumpkin seed, linseed, chickpea, rice bean, pinto bean, triticale, etc.
	Brassica Vegetables excluding Leafy and Flowering Vegetables	Cabbage, Chinese cabbage, head lettuce, cos lettuce, butterhead lettuce, head mustard, etc.
	Short-term Vegetables	Chinese mustard (bok choy, rape, pak choi, etc.), Chinese kale, Chinese celery, water spinach, spinach, lettuce, crown daisy, chard, green garlic, green onion, leek, bud chive, cabbage sprout, sweet potato leave, amaranth, leafy radish, chicory, common white basella, Taiwan velvet plant, Gynura, purslane, Chinese parsley, chayot leaf, rocket leaf, mountain celery, celery, vegetable fern, basil, perilla, pea shoot, etc.
	Stem, Stalk, Root and Tuber Vegetables	Radish, carrot, ginger, onion, potato, bamboo shoot, asparagus, water bamboo, taro, lappa, water chestnut, lotus root, Chinese yam, kohlrabi (sprout), big stem mustard (stem mustard), stem lettuce, cherry belle radish, beetroot, garlic bulb, etc.
	Flowering Vegetables	Cauliflower, broccoli, daylily, etc.
	Edible Fungi	Shiitake, button mushroom, straw mushroom, winter mushroom, Jew’s ear (wood ear), king oyster mushroom, etc.
	Fruiting Vegetables	Tomato, eggplant, bell pepper (including green pepper), chili, edible corn, okra (lady’s finger), etc.
	Cucurbit Vegetables	Cucumber, bitter melon, loofah, Chinese wax gourd, pumpkin, chayote, bottle gourd, etc.
	Legume Vegetables	Pea, young soybean, Hyacinth Bean, cowpea, Kentucky wonder pole beans, lima bean (duffin bean), kidney bean, etc.
	Edible Sprouts	Seed sprouts that are produced by sprouting of plant seed in dark and used as edible vegetables, such as mung bean sprout and soy bean sprout. Seed sprouts that are produced in water throughout the growing period by sprouting of plant seeds and greening treatment, such as cabbage sprout, pea sprout and radish sprout.
	Melon Fruits	Water melon, melon, muskmelon, honeydew melon, etc.
	Large Berries	Banana, papaya, pineapple, kiwi fruit, custard apple, avocado (Persea Americana), dragon fruit, passion fruit, abiu (caimito), fig, etc.
	Small Berries	Grape, strawberry, star fruit, wax apple, guava, etc.
	Stone Fruits	Mango, longan, lichee, loquat, waxberry, date, red jujube, etc.
	Pome Fruits	Apple, pear, peach, plum, prune, cherry, jujube, persimmon, etc.
	Citrus Fruits	Tangerine, lemon, pomelo, grape fruit, orange, lime, etc.
	Tea	Fresh tea leaves
	Coffee	Fresh coffee fruit
	Sugar Canes	Edible cane, sugarcane, etc.
	Tree Nuts	Coconut, almond, pecan, chestnut, walnut, cashew nut, hazel nut, etc.
	Seeds (Seedlings)	Seed, seedling, ramet, etc.
	Forage Crops	Pangolagrass, napiergrass, forage corn, etc.
	Self-produced Agricultural Processed Products	Products produced by simple processing farmers’ self-produced organic agricultural ingredient in ways such as drying, sun dry, air dry, blanching, roasting, milling, grinding, shelling or simple cutting, with no additives added. Such as dried vegetable, dried mushroom, dried daylily, dried Jew’s ear (dried wood ear), and Chinese wax gourd cut.
	Others	Jewel orchid, houseleek, Asia mugwort, Acathopanax root, Formosan Fig Tree, bread fruit, Oldham Elaeagnus, pig thigh, Formosan beauty-berry, moringa tree, Goji berry, guava leaf, alfalfa, Indian mulberry, roselle, Brazilian fireweed, edible flower, jelly fig and others that cannot be categorized to the aforementioned items
	Non-edible Crops	Australian Tea Tree and cotton, etc.
Livestock products	Meats	Pork, beef, mutton, chicken, duck, and other meats
Livestock products	Eggs	Chicken egg, duck egg, quail egg, and other eggs
Aquatic products	Algae	Spirulina (blue algae), green algae, brown algae and other algae products
Aquatic products	Aquatic Animals	Tilapia, cobia, grouper, bass, milkfish, hard clam, freshwater clam, white shrimp, ayu
Processed products	Processed Grain Products	Processed products produced from rice, wheat and food grain: 1. Flour, starch, coarse powder, dry raw strip, and flask, etc. made from rice, wheat, pulse or tuber; instant cereal products; or varieties of raw noodle, cooked noodle and short noodle made from fine powder of cereal. Such as wheat flour, soybean flour, barley flour, oatmeal, cornstarch, cornmeal, sweet potato starch, tapioca starch, wholemeal flour, potato flour, wheat seedling powder, rice noodle, short noodle, noodle, refined rice cereal powder, rice paste, rice porridge, and refined oat cereal powder. 2. Dehulled cereal, fine grinding, roasting and mixed products, such as dehulled pea, pea kernel, rye kernel, cornflake, corn crisp, barley flake, oatmeal flake, bread, confectionery, and potato chip.
	Dried Vegetable and Fruit Products	Processed vegetable and fruit products by drying processing (such as freeze drying and vacuum drying) with associated equipment
	Canned Food	Processed agricultural products sealed in metal, glass, sterilized bag, plastics, multilayer structure airtight container or other containers conforming to aforementioned condition. These products are sterilized before or after sealing and can be preserved under room temperature for a long period of time. Such as canned corn kernel, vegetable and fruit puree, puree for baby or infant, vegetable bouillon cube, vegetable chowder, broth and stock.
	Chilled or Frozen Food	1. Chilled food: agricultural processed products cooled rapidly and stored above freezing point and under 7℃. Such as cut and peeled aloe vera, peeled sugar cane, sliced winter gourd, diced Chinese yam, diced tomato, tofu, bamboo for cold dish. 2. Frozen food: agricultural processed products frozen rapidly and stored under -18℃. Such as frozen pea kernel, vegetable dumpling, and hash brown.
	Pickled Food	Fruit and vegetable are used according to variety of finished products. Salt, organic acid or (and) sugar are employed to marinate, store or flavor directly, ferment, and ripen food, such as raisin, dried berry, dried apricot, dried apricot, fruit jam, dried tomato, dried raspberry, pickles, fermented soybean curd, soy sauce pickles, and vinegar pickles.
	Plant Powdery Processed Products	Ground and smashed agricultural products, excluding cereals. Such as cocoa powder, peanut powder, cactus powder, coconut powder, and Indian mulberry powder.
	Tea	Semi-made tea, made tea, tea bag, tea powder, etc.
	Coffee	Coffee green bean (peeled, dried), coffee bean (baked), coffee powder (ground), etc.
	Natural Plant Tea	Tea or tea bag made from edible flower, fruit, herbal, fennel, cinnamon and other natural plants, etc.
	Sugar and Its Derived Products	1. Granulated sugar and other sugar products produced from sugar cane, beetroot, starch, other ingredients or raw sugar. Granulated sugar, sucrose, white sugar crystal, brown sugar crystal, brown sugar, molasses, beetroot molasses, maple syrup, etc. 2. Varieties of eastern and western candies, as well as chocolate produced from sucrose, fructose, maltose, cereal, dried fruit, spice, and edible pigment.
	Herbs and Spice Plants and Their Derived Flavorings	1. Herb and spice plant and their parts after drying and grinding, such as rosemary, parsley, thyme leaf, basil leaf, oregano leaf, bay, vanilla, spice, curry powder, granulated pepper, black and white pepper, coriander seed powder, garlic powder and cinnamon powder. 2. Or, formulated flavorings containing herbs or spice plants as ingredients, such as table salt, table sauce product, vegetable salad (dressing) and flavored vinegar.
	Refined or Dried Plants	Refined treatment (water treatment, fire treatment, water and fire treatment or other treatment) or dried plant products, such as ginseng fibrous root, aniseed, lilac, Chuanchiong, root of herbaceous peony, Bai chu, Poriacocos, cinnamon, Chinese caterpillar fungus, tuber of multiflower knotweed, Goji berry, Eucommia Bark, Cassia Seed, red jujube, Corydalis Tuber, plantain seed, psyllium, Radix Rehmanniae Preparata, Alisma Orientalis, root of Pilose Asiabell, curcuma, astragalus, root of Chinese angelica, and lotus seed
	Drink	Soy bean drink (milk), vegetable and fruit juice, mix juice for baby and infant, wine, tea, non-alcohol drink, fruit vinegar, etc.
	Oil	Plant oil, like olive oil, peanut oil, salad oil, sunflower oil, grape seed oil and cocoa butter.
	Fermented Food	Products are produced through fermentation of microorganism, such as miso, soy sauce, fermentation liquid, and edible vinegar.
	Dairy Products	Fresh milk, milk powder, yogurt, butter, cheese, and other dairy products
	Meat Products	Sausage, cured meat, bacon, ham, fried pork fiber, dried pork fiber, dried sliced meat and other meat products
	Egg Products	Shell egg product, liquid egg, egg powder, and other egg products
	Alga Products	Alga powder, alga tablet, and other alga products
	Processed Products of Aquatic Animal	The primary raw materials of aquatic processed products from tilapia, cobia, grouper, bass, milkfish, hard clam, freshwater clam, white shrimp and ayu
	Others	Processed products that cannot be categorized into the aforementioned items

Gestión e inspección de productos

Regulations for Managing the Labeling and Marks of Organic Agricultural Products and In-conversion Agricultural Products

Legislative history
1. Full text of 12 articles was promulgated by the Council of Agriculture on May 9, 2019 per Order Nung-Liang-Tze 1081069053A, and was set to be effective on May 30, 2019.

Article 1
These Regulations are established in accordance with paragraph 3 of Article 17, paragraph 3 of Article 19 and paragraph 2 of Article 20 of the Organic Agriculture Promotion Act (hereinafter referred to as the Act).

Article 2
The container or packaging of organic agricultural products and in-conversion agricultural products shall be labelled in accordance with Article 18 of the Act and these Regulations. Organic agricultural products and in-conversion agricultural products in bulk package shall be displayed in accordance with Article 19 of the Act and these Regulations.

Article 3
The container or packaging of organic agricultural products and in-conversion agricultural products labelled with the name of ingredients may use the term organic or in-conversion or other symbolic notation to indicate organic or in-conversion ingredients items, except for water and salt.

Article 4
The labeling of origin (country) of organic agricultural products and in-conversion agricultural products shall comply with the following requirements:

1. Those certified in the ROC shall be labelled with the origin (country) of the ingredient accounting for no less than 95% of the product content or of the three ingredients with the highest percentages. However, if the ingredients have been processed domestically and are substantially transformed, other than the labeling with the wording which would symbolize as the local products, after the terms of the three ingredients with the highest percentages, the actual origin (country) shall be labelled with parentheses;
2. The origin (country) of imported organic agricultural products shall be determined in accordance with Regulations Governing the Determination of Country of Origin of an Import Goods.
The height and width of the characters for marking the origin (country) of bulk package of organic agricultural products and in-conversion agricultural products shall not be less than 3 cm.

Article 5
Organic agricultural products and in-conversion agricultural products with the containers or packaging shall be labelled with organic mark on each sold unit. However, a product which meets any of the following conditions is not allowed to be labelled with organic mark:

1. Imported organic agricultural products;
2. Imported organic agricultural products which have been packaged and certified domestically;
3. Organic processed agricultural products of which the imported organic ingredients account for over 50% and which have not been substantially transformed through processing domestically.
The specification and design of the organic mark are provided in the Appendix.
In-conversion agricultural products are not allowed to be labelled with organic mark.

Article 6
Organic agricultural products and in-conversion agricultural products may use the certification body mark. Upon organic agricultural products, the sizes of the certification body mark shall not be larger than the organic mark.
Organic agricultural products and in-conversion agricultural products with containers or packaging can be labelled with certification body mark instead of the name of the certification body, according to subparagraph 5 of paragraph 1 of Article 18 of the Act.

Article 7
The duration of using organic mark is in length equivalent to the validity duration of organic agricultural products certification.
The certification body shall be responsible for management over the use of organic mark by the operators that are certified by the certification body. The agreements executed by and between the certification body and the agricultural product operators in accordance with subparagraph

1 of paragraph 2 of Article 12 of the Act shall expressly bear the specifications governing labeling, usage, suspension of the usage, and relevant management with the organic mark.

Article 8
The dimensions of organic mark may be duly adjusted based on the sizes of the products, the dimensions of their packaging or containers and shall not be smaller than 1.7 cm in diameter. In case of a restriction in packaging or containers as agreed upon by the certification body, nevertheless, the dimensions are free of the restriction of 1.7 cm diameter minimum.

Article 9
Where an organic mark comes in the form of gluey stickers, the certification body shall print it onto non-reusable labels when providing for the use of operators.
Where an organic mark is printed onto the packaging or containers of products, the operators shall have their own designs for packaging or containers approved by the certification body before printing. This same process shall be required in case of any change.

Article 10
Where the municipal/county/city competent authority or certification body suspends the operator’s usage of organic mark according to paragraph 2 of Article 32 of the Act or the contracts stipulated in subparagraph 1 of paragraph 2 of Article 12 of the Act, the operator shall stop using organic mark immediately. That municipal/county/city competent authority or certification body shall register relevant information at the information system designated by Council of Agriculture within 10 days.

Article 11
Those comply with paragraph 2 of Article 3 of Regulations Governing Management over Agricultural Product Marks prior to the implementation of these regulations may continue to use the former mark under the requirements of that paragraph.

Article 12
These Regulations shall enter into force on May 30, 2019.

Regulations for Managing and Reviewing Imported OrganicAgricultural Products

Regulations for Managing and Reviewing Imported Organic Agricultural Products

Legislative history
1. Full text of 12 articles was promulgated by the Council of Agriculture on May 9, 2019 per Order Nung-Liang-Tze 1081069052A, and was set to be effective on May 30, 2019.

Article 1
These Regulations are established in accordance with paragraph 3 of Article 17 of the Organic Agriculture Promotion Act (hereinafter referred to as the Act).

Article 2
These regulations are applicable to imported organic agricultural products certified by a certification body accredited by the country or member of World Trade Organization (WTO) in organic equivalence with the ROC announced by the Central Competent Authority in accordance with paragraph 2 of Article 17 of the Act, given that the certification activities are performed within the territory of that country or WTO member.

Article 3
When applying for the imported organic agricultural product review for the first time, the importer shall complete an importer registration application form and submit a copy of identity document for a natural person or a copy of establishment or business registration document for a legal entity or business to apply to the Central Competent Authority for importer registration number issuance.
The Central Competent Authority shall notify the importer mentioned in the previous paragraph of the importer registration number upon issuance.

Article 4
Before agricultural products are to be sold, labelled, displayed or advertised as organic, the importer shall apply for the imported organic agricultural product review by completing an application form; paying the review fee and attaching photocopies of the following documents stamped with seals of the importer and applying to the Central Competent Authority for issuance of the approval document:

1. Natural person’s identity document, or establishment registration document of business or legal entity or business registration document;
2. A document demonstrating that the agricultural products have been certified as organic;
3. A document demonstrating that the foreign certification body that issues the aforementioned document is accredited by a country or WTO member promulgated by the Central Competent Authority as organic equivalent with the ROC, except those foreign certification bodies that are registered with the Central Competent Authority;
4. The declaration with its import and export permit blank filled with the pre-generated number of the approval document, or the slip of import declaration;
5. A certificate of quarantine inspection or a document of quarantine compliance issued by the animal or plant quarantine authority, except for those items that are exempted from the quarantine requirement;
6. The ingredient ratio table of processed product, except for those certificates that extend the ratio content of organic ingredients in subparagraph 2;
7. Other documents required by the Central Competent Authority.
Where the documents in the previous paragraph are not in the language of Chinese, a Chinese translation stamped with seals of the importer and noted that the translation is equivalent to the original shall be provided.

Article 5
The certificate mentioned in subparagraph 2 of paragraph 1 of the previous article shall include the following items:

1. The name and address of the foreign operator;
2. The name and batch number of the product;
3. The weight or volume of the product;
4. The name of the importer or buyer;
5. The name and address of the certification body;
6. The date of issuance; and
7. Other items required by the Central Competent Authority.

Article 6
When an application for imported organic agricultural product review meets one of the following conditions, the Central Competent Authority shall reject the application and the review fee shall not be refunded.

1. The organic ingredients content of the imported organic agricultural products is less than 95%;
2. The imported agricultural products do not comply with the certification standard of paragraph 3 of Article 12 of the Act (hereinafter referred to as certification standard) due to quarantine treatment.
3. The application documents are incomplete or need to be corrected, and the applicant who has been notified by the Central Competent Authority fails to correct within a specified period or make incomplete corrections.
The requirements of certification standard shall apply to the calculation of organic ingredients content mentioned in subparagraph 1 of the previous paragraph.

Article 7
The Central Competent Authority shall issue an approval document to the applicant when the applicant passes the imported organic agricultural product review.
The approval document mentioned in the previous paragraph shall state the following items:

1. The name and address of the importer;
2. The name of the foreign operator;
3. The name, batch number and package specification of the products;
4. The weight or volume of the products;
5. The name of the certification body; and
6. The number of the approval document.

Article 8
Importers shall preserve records and documents pertaining to the import and sale of organic agricultural products for at least five years.

Article 9
The importer may issue a letter of authorization, appointing an agent to act on his/her behalf for applying the issuance of importer registration number according to paragraph 1 of Article 3 and the approval document according to paragraph 1 of Article 4.

Article 10
The Central Competent Authority may appoint its affiliated institution to conduct the tasks stipulated in Article 3, 4, 6 and 7.

Article 11
The labelling of imported organic agricultural products shall comply with Regulations for Managing the Labeling and Marks of Organic Agricultural Products and In-conversion Agricultural Products.

Article 12
These Regulations shall enter into force on May 30, 2019.

Operation Directions for the Inspection of Organic Agricultural Products and In-conversion Agricultural Products and the Handling of its Results

Operation Directions for the Inspection of Organic Agricultural Products and In-conversion Agricultural Products and the Handling of its Results

These Directions were promulgated on Jun. 13, 2019 per Order Nung-Liang-Tze 1081069430A.

1. These Directions are established by the Council of Agriculture, Executive Yuan (hereinafter referred to as the COA) to facilitate the competent authority in managing organic agricultural products and in-conversion agricultural products in a consistent manner in accordance with the Organic Agriculture Promotion Act (hereinafter referred to as the Act) and enhancing management efficiency and credibility.

2. The terms used in these Directions shall be defined as follows:

(1) Inspection: Any examination, sampling for test, or request for data or record from operators by the competent authority in accordance with Article 22 of the Act
(2) Testing body: Any affiliated testing body (institution) appointed or any other body (institution), school or organization entrusted by the central competent authority in accordance with paragraph 2 of Article 23 of the Act
(3) Organic product: Any organic agricultural product or in-conversion agricultural product defined in Article 3 of the Act

3. Matters that the competent authority shall inspect in accordance with the Act are provided as follows:

(1) No use of such prohibited substances as stipulated in paragraph 2 of Article 15 of the Act, and assurance that organic products do not contain prohibited substance as stipulated in paragraph 3 of Article 15 of the Act;
(2) Matters concerning sale, labeling, display or advertisement of organic products in paragraphs 1 and 2 of Article 16 of the Act;
(3) Matters concerning naming of the non-natural operator in paragraph 3 of Article 16 of the Act;
(4) Matters concerning sale, labeling, display, or advertisement of imported agricultural products as organic in paragraph 1 of Article 17 of the Act;
(5) Matters concerning labeling and display of organic products in Articles 18 and 19 of the Act;
(6) Matters concerning the use of organic marks in accordance with Article 20 of the Act;
(7) Matters concerning advertisement about agricultural products in Article 21 of the Act;
(8) Matters concerning agricultural products prohibited from being transported, withdrawn, recalled from the market or other measures in Article 25 of the Act; and
(9) Other matters to be inspected in accordance with the Act.

4. Inspections conducted by the competent authority shall be recorded. The operator or its representative or designee shall cooperate with inspections and sign or stamp on inspection records. However, in case the operator refuses to sign or stamp on the records, the staff assigned by the competent authority shall indicate the refusal and the time and place of inspection on the records.

5. The competent authority shall take samples for test in accordance with Article 22 of the Act in such sampling method and quantity for organic products (specified in the Appendix). The quantity of samples may be properly adjusted as practically needed for each tested item, providing that the samples shall be sufficient for test.
The samples taken in accordance with the preceding paragraph shall be sealed by the competent authority with the endorsement of the operator or its representative or designee by signing on the seal. If the operator or its representative or designee refuses to sign, the competent authority shall indicate the refusal on the aforementioned records. The competent authority shall take photos of the samples before and after being sealed.
The competent authority shall issue a receipt of samples to the inspected party when conducting the inspection of samples and keep a copy of the receipt for its record. However, the competent authority does not have to issue a receipt of samples to the inspected party if it obtains the samples by paying for them.
The samples taken by the competent authority in accordance with the first paragraph shall be delivered to the testing body for testing within 3 days after the date of sampling.

6. The testing body, after receiving the samples delivered by the competent authority in accordance with the fourth paragraph of the previous article, shall complete the testing and submit a test report to the competent authority conducting the inspection within 20 days, and it shall also inform the Central Competent Authority.
The competent authority, after receiving the test report mentioned in the preceding paragraph, shall inform the domestically certified operator or importer of any non-compliance with the Act within 10 days in writing.
Test results showing that the products are required to be destroyed by the regulations of the central health and welfare authority shall be notified to the operator in a written notice.

7. If the organic products, as shown by inspection results, do not meet the requirements provided in the Act and are therefore withdrawn or recalled from the market pursuant to the order of the competent authority, the operator or the owner of the agricultural products shall withdraw all the non-compliant products within one day after receiving the notice of inspection results from the competent authority, finish the recall of them within 10 days, and file the recall report in writing to the competent authority of the local municipality or county (city) government within 15 days. The report shall indicate clearly the names of relevant entities that have be informed and the results of the recall that has been conducted, including the name, weight or volume, batch number and quantity of each recalled product and other relevant information.

8. After receiving the notice of destruction from the competent authority, the operator shall inform the competent authority in its municipal/county/city government to jointly undertake the destruction five days before the scheduled date of destruction, or within five days before the scheduled date in case of emergency.

9. Competent authorities in municipal/county/city governments shall also inform the Central Competent Authority of the inspections specified in these Directions.

10. Results of the inspections conducted by the competent authority in accordance with these Directions shall be announced periodically. However, when an operator applies for a retest of organic products in accordance with paragraph 1 of Article 24 of the Act, the result shall be announced after the retest is completed.

Appendix

Requirements for Sampling Methods and Quantities of Organic Product Samples Taken

I. Crop Products

Item

Sampling Methods and Quantities of Samples Taken

Cereals, Rice Products, Fruits, Vegetables, and Crops for Specific Purposes

1. Cereals, Pluses and Rice

(1) Sampling of pre-market products: 1,000 g, with homogeneous mixture, shall be sampled at random.

(2) Sampling of post-market products:

a. In a bag: Products fully packaged shall be sampled at random. The volume of the samples shall be more than 1,000 g.

b. In bulk: Samples of more than 1,000 g shall be taken at random.

2. Fruits, Vegetables and Crops for Specific Purposes

(1) Sampling of pre-market products

A proper quantity of samples shall be taken at random, with homogeneous mixture. Requirements are set forth as follows:

a. The quantity of samples taken shall comply with the minimum quantity of samples or the minimum weight of samples. In case no minimum quantity of samples is provided, the quantity of samples shall satisfy the minimum weight of samples:

Size of Sample	Minimum Quantity of Samples	Minimum Weight of Samples
More than 1 kg	2 to 4 pieces	2 kg
More than 300 g and less than 1,000 g	4 to 6 pieces	1 kg
More than 30 g and less than 300 g	10 to 15 pieces	1 kg
Less than 30 g	4 to 6 bunches 50 to 100 pieces	1 kg

Edible flowers and herbs without regular shape		600 g
Products with high unit price		100 g

b. Tea leaves (dried), processed foods after being dried once (dried mushrooms, dried daylilies, dried eatable flowers, dried herbs) shall be sampled at random to get a sample of 300 g, with homogeneous mixture.

(2) Sampling of post-market products

A proper quantity of samples shall be taken at random, with homogeneous mixture. Requirements are set forth as follows:

a. For those in a unit package with the net weight of less than 200 g, six units shall be taken. Tea leaves (dried) shall be sampled to get 300 g.

b. For those in a unit package with the net weight of more than 200 g and less than 500 g, four units shall be taken as samples.

c. For those in a unit package with the net weight of more than 500 g, two units shall be taken as samples.

d. For those in bulk, a sample of more than 1,000 g shall be taken at random.

e. For products with high unit price, a sample of 100 g shall be taken.

Processed Foods

1. Solid or Powdered Agricultural Processed Foods: One sample is obtained from those of the same type in the same batch.

(1) For those in a unit package with the net weight of less than 200 g, three cans (bottles, bags, boxes, packs, etc.) shall be taken as samples.

(2) For those in a unit package with the net weight of more than 200 g and less than 500 g, two cans (bottles, bags, boxes, packs, etc.) shall be taken as samples.

(3) For those in a unit package with the net weight of more than 500 g, one can (bottle, bag, box, pack, etc.) shall be taken as the sample.

(4) For those in bulk, a sample of more than 500 g shall be taken.

2. Liquid Agricultural Processed Foods: One sample is obtained from those of the same type in the same batch.

(1) Soy bean sauce, vinegar and other sauces: For those with the unit package volume of more than 300 ml, two bottles (cans, bags or packs, etc.) shall be taken as samples. For those with the unit package volume of less than 300 ml, three bottles (cans, bags or packs, etc.) shall be taken as samples.

(2) Liquor: Bottled products shall be first taken as samples. In case of no bottled products in the factory (plant), unpacked products in a bucket shall be taken.

a. Bottled: For those in the bottle volume of more than 300 ml, three bottles shall be taken as samples. For those in the bottle volume of less than 300 ml, four bottles shall be taken.

b. Unpacked: Liquor is poured to a sample bottle. Three bottles shall be taken and there shall be at least 300 ml for each bottle.

(3) Other liquid agricultural processed foods: The sampling rules for solid agricultural processed foods shall apply, mutatis mutandis, when the unit of measurement “g” is amended to “ml”.

II.Livestock Products

Item	Sampling Methods and Quantities of Samples Taken
Livestock or Poultry Meat	1. Sampling Methods (1) Both pre-market products (in stocks) or post-market products can be sampled. (2) Only one sample is required from the same product of the same batch number. 2. Quantities of Samples Taken (1) Chilled meat: Randomly select two packs as samples. Each pack shall be more than 300 g. If one pack is less than 300 g, it requires to meet the 300 g sample size. (2) Frozen meat: Randomly select three packs as samples. Each pack shall be more than 300 g. If one pack is less than 300 g, it requires to meet the 300 g sample size. (3) Fresh slaughter meat without cooling: Randomly sample 600 g.
Processed Meat Products	1. Sampling Methods (1) Both pre-market products (in stocks) or post-market products can be sampled. (2) Only one sample is required from the same product of the same batch number. 2. Quantities of Samples Taken (1) If each pack (cans, bottles, bags, boxes, packs, etc.) less than 200 g, randomly select three packages. (2) If each pack (cans, bottles, bags, boxes, packs, etc.) more than 200 g and less than 500 g, randomly select two packages. (3) If each pack (cans, bottles, bags, boxes, packs, etc.) more than 500 g, randomly select one packages. (4) For unpacked products, 500 g of randomly selected sample is required.
Eggs	1. Sampling Methods (1) Both pre-market products (in stocks) or post-market products can be sampled. (2) Only one sample is required from the same product of the same batch number. 2. Quantities of Samples Taken (1) Shell egg: Randomly select 10 eggs as samples. (2) Liquid egg: More than 500 g of randomly selected sample is required.
Dairy Products	1. Sampling Methods (1) Both pre-market products (in stocks) or post-market products can be sampled. (2) Only one sample is required from the same product of the same batch number. 2. Quantities of Samples Taken: (1) If each pack (cans, bottles, bags, boxes, packs, etc.) less than 200 g, randomly select three packages. (2) If each pack (cans, bottles, bags, boxes, packs, etc.) more than 200 g and less than 500 g, randomly select two packages. (3) If each pack (cans, bottles, bags, boxes, packs, etc.) more than 500 g, randomly select one packages. (4) For unpacked products, 500 g of randomly selected sample is required.

III. Aquatic Products

1. Sampling Methods and Quantity

(1) For pre-market products or post-market products, a sample shall be obtained from those of the same type in the same batch.
(2) The quantity of samples for each type of products is listed below by the size of each sample. Such quantity shall comply with the minimum quantity of samples or the minimum weight of samples. In case no minimum quantity of samples is provided, the minimum weight of samples shall be satisfied.

Type	Item	Size of Sample	Minimum Quantity of Samples	Minimum Weight of Samples
Aquatic Animals	Fish	More than 1 kg	1	1 kg
		More than 500 g and less than 1,000 g	1	600 g
		More than 100 g and less than 500 g	3	600 g
		Less than 100 g		600 g
	Shellfish	More than 60 pieces / kg	60	1 kg
		Less than 60 pieces / kg (Note)		1 kg
		Oyster		1 kg
	Crustaceans (Shrimps)	Less than 50 pieces / kg	30	600 g
		More than 66 and less than 50 pieces / kg	40	600 g
		More than 66 pieces / kg		600 g
	Crustaceans (Crabs)	More than 250 g	4	1 kg
		More than 110 g and less than 250 g	10	1 kg
		Less than 110 g		1 kg
Aquatic Plants	Algae	More than 1 kg		600 g

Note: Less than 60 pieces / kg mean that there are 70, 80, 90 ……pieces in a kg.

(3) Aquatic food products
a. Solid aquatic processed foods: For those in a unit package with the net weight of less than 200 g, four packs (cans, bottles, bags, boxes, etc.) shall be sampled. For those in a unit package with the net weight of more than 200 g and less than 500 g, three packs (cans, bottles, bags, boxes, etc.) shall be sampled. For those in a unit package with the net weight of more than 500 g, two packs (cans, bottles, bags, boxes, etc.) shall be sampled. For those in bulk, 1,000 g shall be sampled.

b. Liquid aquatic processed foods: For those in a unit package with the volume of more than 300 ml, two bottles (cans, bags, packs, etc.) shall be sampled. For those in a unit package with the volume of less than 300 ml, three bottles (cans, bags, packs, etc.) shall be sampled.

(4) The quantity of samples to be taken from post-market products is as follows:

a. Packed: Products with package fully intact shall be sampled at random. The volume of the samples shall be at least 600 g.
b. In bulk: A sample shall be taken at random and shall be at least 600 g.

2. Packing of Samples and Delivery Methods

(1) Packing: Product samples shall be contained in a container that cannot be replaced easily. Name of sample, time and place of sampling and sampling person shall be expressly labeled, and the container shall be sealed.
(2) Delivery: The temperature required for storage of the products shall be the temperature required for transportation.

Otros

Regulations Governing Awards to Informants Reporting Violations against the Organic Agriculture Promotion Act

Regulations Governing Awards to Informants Reporting Violations against the Organic Agriculture Promotion Act

Legislative history
1. Full text of 10 articles was promulgated by the Council of Agriculture on May 9, 2019 per Order Nung-Liang-Tze 1081069051A, and was set to be effective on May 30, 2019.

Article 1
These Regulations are established in accordance with paragraph 2 of Article 26 of Organic Agriculture Promotion Act (hereinafter referred to as the Act).

Article 2
Once the violation report of the Act proves to be true after an investigation by the competent authority and the administrative disposition or fines of the violation report is imposed, the informants shall be rewarded according to these regulations.
The reward described in the previous paragraph may be medal, prize, certificate or money. And the rewarding money may only be granted if the reported violation is determined to be fined in accordance with Article 27 to 29 of the Act.

Article 3
The competent authority shall set up the Act violations report email, private telephone line, fax, or website of the authority to accept violation report.

Article 4
An informant may report the Act violations to the competent authority by means of written communications, oral communications, telephone number, fax number, email or other available media. The report shall include the following information:

1. The informant’s name and contact means.
2. The violator’s name, the name of the business and address.
3. The specifics of the violation, including the acts of violation, location, relevant information.
The government agency that receives a violation report through oral communication shall produce a written record.

Article 5
According to paragraph 2 of Article 2, the reward given by the competent authority to the informant shall not be less than 20 percent of the amount of the fine that the violator is subject to.
When rewarding the informant, the competent authority shall require the informant to provide relevant documents that can provide proof of the identification.

Article 6
When two or more people jointly file individual reports for the same violation, the rewarding money is to be equally distributed to all informants; when two or more people file individual reports for the same violation, the informant who files first receives the reward.
When it is impossible to identify the chronological order of the reports, the reward is to be equally distributed to all informants.

Article 7
No reward will be granted for the following reports:

1. The report is made anonymously or a forged name by the informant.
2. The report does not contain specifics of a violation or does not reflect the specifics of a violation.
3. The competent authorities or the certification body are already aware of or have processed the violation before the filing of the report.

Article 8
The competent authority shall be strictly confidential to information of informants and appropriately store the relevant document.
The competent authority may, ex officio or upon an application filed by an informant, ask the police authorities for the protection of the informant when deeming it as necessary.

Article 9
The competent authority shall take reference of the amount of fine on violations of the Act from the previous year to allocate annual budget to pay out the rewarding money.

Article 10
These Regulations shall enter into force on May 30, 2019.

Operation Rules for Review and Assessment of World Trade Organization Members or Countries in Organic Equivalence

Operation Rules for Review and Assessment of World Trade Organization Members or Countries in Organic Equivalence

Legislative history
1. Full text of 9 rules was promulgated by the Council of Agriculture on June 6, 2019 per Order Nung-Liang-Tzu-Tze 1081069451A.

1. These Rules have been established by the Council of Agriculture, Executive Yuan (hereinafter referred to as the COA) to review and assess countries or members of World Trade Organization (WTO) in organic equivalence in accordance with Article 9 of the Enforcement Rules for Organic Agriculture Promotion Act.

2. Any country or WTO member who applies for review of organic equivalence (hereinafter collectively referred to as the Applicant) shall file applications with the following documents, to the COA:

(1) A letter of application, specifying the scope of the products applied for review and the information of contact persons;
(2) A comparison of the laws and regulations for management of organic agriculture between the Applicant and the ROC;
(3) Status of organic agriculture, which shall include the amount of certification bodies, the amount of certified farmlands and processing factories and the area of cultivation certified organic; and
(4) Management framework and measures for organic products, which shall include product testing, examination of labeling and disposal of violation cases, among other matters.

3. To conduct the review indicated in the previous article, the COA may invite relevant government authorities, experts, scholars, industries or institutions and organizations which have interests involved on a case-by-case basis to form the organic equivalence review team (hereinafter referred to as the Review Team), which shall participate in the review. The COA may require the Applicant to cooperate for on-site assessment, if necessary.

4. For conducting the on-site assessment in the previous article, except for competent staff designated by the COA, the COA may also appoint at least one person respectively from accreditation bodies, the Review Team and the experts or scholars in the field of relevant technologies, to form the assessment team, which shall participate in on-site assessment operation.

5. Targets to be assessed on-site by the assessment team are listed below and may be expanded if necessary.

(1) Accreditation bodies, or conformity assessment institutions with equivalent functions;
(2) Certification bodies: Preferably, two certification bodies shall be assessed (headquarters assessment). The number of certification bodies to be assessed may be increased or reduced, if necessary.
(3) Operators: Two of the operators that have been certified by the certification body shall be assessed (witness assessment). The number of operators to be assessed may be increased, if necessary.

6. An on-site assessment schedule for the assessment team shall be prepared and submitted by the Applicant to the COA and shall be followed only with the consent of the COA. Local transportation and translation expenses incurred during the assessment period shall be borne by the Applicant. Expenses of flight tickets to/from the applying country or area, meals, accommodations and relevant matters shall be borne by the COA.

7. From the arrival of the assessment team members at the airport in the territory of the Applicant, the Applicant shall arrange staff to provide pick-up and drop-off services and shall also designate a person or persons to accompany the assessment team all the way throughout the assessment so as to ensure the successful completion of the assessment schedule and the safety of the assessment personnel.

8. Preferably, the assessment team shall conduct on-site assessment in Chinese. In a non-Chinese speaking country, the Applicant shall arrange a person who is proficient in the local language and Chinese to interpret for the assessment team.

9. The assessment team shall submit an assessment report in Chinese to the COA after returning to the ROC. The COA shall have it translated into English and then deliver an English copy to the Applicant in writing.

Criteria for Determining the Penalties for Violating Organic Agriculture Promotion Act

Criteria for Determining the Penalties for Violating Organic Agriculture Promotion Act

Legislative history

This Criteria was promulgated on Jun. 13, 2019 per Order Nung-Liang-Tze 1081069433A.

1. This Criteria is established by the Council of Agriculture, Executive Yuan (hereinafter referred to as the COA) to address all incidents concerning violations of the Organic Agriculture Promotion Act (hereinafter referred to as the Act) and establish clear and consistent guidelines to enhance law enforcement efficiency and credibility.

2. The competent authority shall refer to the Table of the Criteria for Determining the Penalties for Violating Organic Agriculture Promotion Act (attached as the Appendix) to impose penalties on those who violate the Act.

The number of violations provided in the Table indicated in the previous paragraph shall be calculated backward to a year from the date of latest violation.

3. When the domestic production, processing, distribution or importing of agricultural products is found in violation of the Act, the operator who assumes the final responsibility for such products shall be punished.

4. When imported agricultural products are found in violation of the Act, the importer shall be held liable to take the legal punishment.

5. The number of violations shall be decided as follows:

(1) If different types of agricultural products from an operator are found in violation of the same provisions of the Act, such violations shall be deemed as different acts of violation.

(2) If different batches of the same type of agricultural products of an operator are found in violation of the same provision of the Act (e.g. date of expiration, date of manufacturing, date of production, and batch number), such violations shall be deemed as different acts of violation.

(3) If the agricultural products on which a fine has been imposed for violation of the Act or which have been ordered to be corrected, withdrawn or recalled from the market within a given period are found in violation of the same provisions of the Act after the payment of the fine or the expiration of the period, such violations shall be deemed as different acts of violation, which will be counted toward the number of violations.

6. All penalties, except those on accreditation bodies or certification bodies, shall be imposed by the municipal/county/city governments where the household address of the violator or the address of the violating incorporation or group is registered.

Unit: NTD

**Appendix: Table of the Criteria for Determining the Penalties for Violating Organic Agriculture Promotion Act**
Violated Article	Content of the Article	Violation Description	Legal Grounds for Punishment	Violation Recurrence	Penalty or Fine Imposed	Applicable Subject
Paragraph 1 of Article 11	The entity that engages in accreditation activities shall apply for and obtain the permission from the Central Competent Authority.	Engaging in accreditation activities without the permission issued by the Central Competent Authority	Subparagraph 1 of Article 27	For the first time	NTD600,000	Entity engaging in accreditation activities
				For the second time	NTD12,000,000
				For the third time	NTD24,000,000
				For the fourth time	NTD36,000,000
				For the fifth time	NTD48,000,000
Paragraph 2 of Article 11	Upon expiration of the certificate of permission, the accreditation entity shall apply for renewal with the Central Competent Authority.	Engaging in accreditation activities before obtaining the renewal approved by the Central Competent Authority		For more than six times	NTD60,000,000
Paragraph 1 of Article 12	The entity that engages in certification activities shall be accredited by an accreditation body and receive the accreditation certificate.	Engaging in certification activities before accredited by an accreditation body and obtaining the accreditation certificate.	Article 28	For the first time	NTD300,000	Entity engaging in certification activities
				For the second time	NTD6,000,000
				For the third time	NTD12,000,000
				For the fourth time	NTD18,000,000
				For the fifth time	NTD24,000,000
				For more than six times	NTD30,000,000
Paragraph 4 of Article 12	The certification body shall coordinate with the competent authority for its examination and provide data and records and shall retain relevant data and records in accordance with the regulations provided for by the Central Competent Authority.	The certification body evades, impedes or refuses the examination conducted by the competent authority, provides false data or records, or fails to retain relevant data and records in accordance with the regulations provided for by the Central Competent Authority.	Subparagraph 1 of Article 30	For the first time	NTD100,000	Certification body
				For the second time	NTD200,000
				For the third time	NTD400,000
				For the fourth time	NTD600,000
				For the fifth time	NTD800,000
				For more than six times	NTD1,000,000
Paragraph 2 of Article 15	The operator shall not use prohibited substances.	The operator uses prohibited substances.	Subparagraph 1 of paragraph 1 of Article 31	For the first time	NTD60,000	Operator
				For the second time	NTD120,000
				For the third time	NTD240,000
				For the fourth time	NTD360,000
				For the fifth time	NTD480,000
				For more than six times	NTD600,000
Paragraph 3 of Article 15	The operator shall ensure the organic agricultural products and in-conversion agricultural products contain no prohibited substances.	The organic agricultural products or in-conversion agricultural products contain prohibited substances.	Subparagraph 2 of paragraph 1 of Article 31	For the first time	NTD60,000	Operator
				For the second time	NTD120,000
				For the third time	NTD240,000
				For the fourth time	NTD360,000
				For the fifth time	NTD480,000
				For more than six times	NTD600,000
Paragraph 1 and 2 of Article 16	Agricultural products shall be certified qualified before they can be sold, labeled, displayed or advertised as organic or in-conversion agricultural products.	Agricultural products are sold, labeled, displayed or advertised as organic or in-conversion agricultural products before being certified qualified, or in a manner that people might think they are organic.	Subparagraph 3 of paragraph 1 of Article 31	For the first time	NTD60,000	Operator
				For the second time	NTD120,000
				For the third time	NTD240,000
				For the fourth time	NTD360,000
				For the fifth time	NTD480,000
				For more than six times	NTD600,000
Paragraph 3 of Article 16	All agricultural products sold by a non-natural operator that uses the term “organic” as a whole or a part of its name shall be certified qualified or reviewed qualified upon importation.	Any of the agricultural products sold by a non-natural operator that uses the term “organic” as a whole or a part of its name is not certified qualified or reviewed qualified upon importation.	Subparagraph 4 of paragraph 1 of Article 31	For the first time	NTD60,000	Non-natural operator
				For the second time	NTD120,000
				For the third time	NTD240,000
				For the fourth time	NTD360,000
				For the fifth time	NTD480,000
				For more than six times	NTD600,000
Paragraph 1 of Article 17	Imported agricultural products shall be certified or reviewed qualified before being sold, labeled, displayed or advertised as organic.	Imported agricultural products not being certified or reviewed qualified are sold, labeled, displayed or advertised as organic or in a manner that people might think they are organic.	Subparagraph 3 of paragraph 1 of Article 31	For the first time	NTD60,000	Importer
				For the second time	NTD120,000
				For the third time	NTD240,000
				For the fourth time	NTD360,000
				For the fifth time	NTD480,000
				For more than six times	NTD600,000
Paragraph 1 of Article 18	The container or packaging of organic agricultural products and in-conversion agricultural products shall be indicated with required items.	The container or packaging of organic agricultural products and in-conversion agricultural products is not indicated as required or is indicated falsely.	Subparagraph 1 of paragraph 1 of Article 32	For the first time	Notice to correct within a specified period	Operator
				For the second time	NTD30,000
				For the third time	NTD60,000
				For the fourth time	NTD120,000
				For the fifth time	NTD180,000
				For the sixth times	NTD240,000
				For more than seven times	NTD300,000
Paragraph 3 of Article 18	For any change to the subject matter being indicated on the container or packaging of organic agricultural products and in-conversion agricultural products, the label shall be updated within the period provided.	For any change to the subject matter being indicated on the container or packaging of organic agricultural products and in-conversion agricultural products, the label is not updated within the period provided.	Subparagraph 1 of paragraph 1 of Article 32	For the first time	Notice to correct within a specified period	Operator
				For the second time	NTD30,000
				For the third time	NTD60,000
				For the fourth time	NTD120,000
				For the fifth time	NTD180,000
				For the sixth times	NTD240,000
				For more than seven times	NTD300,000
Paragraph 1 and 2 of Article 19	The operator selling organic agricultural products and in-conversion agricultural products in bulk package shall display relevant matters required.	The operator selling organic agricultural products and in-conversion agricultural products in bulk package does not display relevant matters required.	Subparagraph 2 of paragraph 1 of Article 32	For the first time	Notice to correct within a specified period	Operator
				For the second time	NTD30,000
				For the third time	NTD60,000
				For the fourth time	NTD120,000
				For the fifth time	NTD180,000
				For the sixth times	NTD240,000
				For more than seven times	NTD300,000
Paragraph 3 of Article 19	The regulations governing the items, methods, and other requirements regarding indication and display required shall be complied with.	The operator selling organic agricultural products and in-conversion agricultural products violates the regulations governing the items, methods, and other requirements regarding indication and display required.	Subparagraph 3 of paragraph 1 of Article 32	For the first time	Notice to correct within a specified period	Operator
				For the second time	NTD30,000
				For the third time	NTD60,000
				For the fourth time	NTD120,000
				For the fifth time	NTD180,000
				For the sixth times	NTD240,000
				For more than seven times	NTD300,000
Paragraph 1 of Article 20	Only agricultural products certified as organic under the Act are allowed to be labeled with organic mark.	The agricultural products that have not been certified as organic are labeled with organic mark.	Subparagraph 1 of Article 29	For the first time	NTD200,000	Operator
				For the second time	NTD400,000
				For the third time	NTD800,000
				For the fourth time	NTD1,200,000
				For the fifth time	NTD1,600,000
				For more than six times	NTD2,000,000
Paragraph 2 of Article 20	Regulations stipulating the use condition and other requirements regarding the organic mark shall be complied with.	The operator fails to comply with the regulations stipulating the use condition and other requirements regarding the organic mark.	Subparagraph 4 of paragraph 1 of Article 32	For the first time	Notice to correct within a specified period	Operator
				For the second time	NTD30,000
				For the third time	NTD60,000
				For the fourth time	NTD120,000
				For the fifth time	NTD180,000
				For more than six times	NTD240,000
					NTD300,000
Article 21	Those entrusted to disseminate advertisement about agricultural products shall retain the information concerning the entruster and provide the information required.	Those entrusted to disseminate advertisement about agricultural products fail to retain the information concerning the entruster, fail to provide the information required, or provide false information.	Subparagraph 2 of Article 30	For the first time	NTD100,000	Those entrusted to disseminate advertisement about agricultural products
				For the second time	NTD200,000
				For the third time	NTD400,000
				For the fourth time	NTD600,000
				For the fifth time	NTD800,000
				For more than six times	NTD1,000,000
Article 22	The operator shall cooperate with the competent authority for inspection and sampling for test and provide relevant data and records.	The operator evades, hinders or refuses the inspection or sampling for test conducted by the competent authority, or fails to provide relevant data and records or provides false data and records.	Subparagraph 3 of Article 30	For the first time	NTD100,000	Operator
				For the second time	NTD200,000
				For the third time	NTD400,000
				For the fourth time	NTD600,000
				For the fifth time	NTD800,000
				For more than six times	NTD1,000,000
Paragraph 2 of Article 32	The operator shall stop using organic marks when the competent authority orders it to do so.	The operator still uses organic marks when the competent authority orders it to stop using the organic marks.	Subparagraph 2 of Article 29	For the first time	NTD200,000	Operator
				For the second time	NTD400,000
				For the third time	NTD800,000
				For the fourth time	NTD1,200,000
				For the fifth time	NTD1,600,000
				For more than six times	NTD2,000,000
Paragraph 2 of Article 32	The operator shall stop selling, labeling, displaying or advertising its agricultural products as organic when the competent authority orders it to do so.	The operator still sells, labels, displays or advertises its agricultural products as organic when the competent authority orders it to stop such sale, labeling, display or advertisement.	Subparagraph 5 of paragraph 1 of Article 31	For the first time	NTD60,000	Operator
				For the second time	NTD120,000
				For the third time	NTD240,000
				For the fourth time	NTD360,000
				For the fifth time	NTD480,000
				For more than six times	NTD600,000
Paragraph 1 of Article 33	The accreditation body shall stop accepting new accreditation applications when the competent authority orders it to do so.	The accreditation body still accepts new accreditation applications when the competent authority orders it to stop accepting new accreditation applications.	Subparagraph 2 of Article 27	For the first time	NTD600,000	Accreditation body
				For the second time	NTD12,000,000
				For the third time	NTD24,000,000
				For the fourth time	NTD36,000,000
				For the fifth time	NTD48,000,000
				For more than six times	NTD60,000,000
Article 34	When the operator is punished pursuant to Article 31 or 32, the broadcaster entrusted to advertise the agricultural products shall cooperate to deal with the matters required.	The broadcaster entrusted to advertise the agricultural products violates the decision provided by the competent authority in accordance with Article 34.	Subparagraph 4 of Article 30	For the first time	NTD100,000	Those entrusted to disseminate advertisement about agricultural products
				For the second time	NTD200,000
				For the third time	NTD400,000
				For the fourth time	NTD600,000
				For the fifth time	NTD800,000
				For more than six times	NTD1,000,000

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Centro de Promoción de Agricultura Orgánica ｜ +886-4-22840145 ｜ 145 XingdaRd. , South Dist., Taichung City 40227, Taiwán (R.O.C) ｜ info@oapc.org.tw