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.
