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Promulgated on July 6, 2007.
Amendment to Article 25 promulgated on September 20, 2007.
Article 1
These Regulations are established in accordance with Paragraph 2, Article 5 of the Agricultural Production and Certification Act (hereinafter referred to as the Act).
Article 2
Terms used in these Regulations are defined as follows:
1.Factory (farm): a domestic premise involved in the production, processing, packaging or distribution of organic agricultural products or organic agricultural processed products.
2.Extensional assessment: an assessment performed by a certification body to determine whether a certified agricultural product operator may extend its certification scope within the valid certification period.
3.Re-assessment: an assessment performed by a certification body to determine whether a certified agricultural product operator may maintain certification by the end of the valid certification period.
4.Surveillance: an inspection performed by a certification body of a certified agricultural product operator to verify that the operator has continued to comply with certification criteria within the valid certification period.
Article 3
These Regulations shall apply to the certification of organic agricultural products and organic agricultural processed products that are produced, processed, packaged or distributed in the Republic of China (Taiwan).
Article 4
As used in these Regulations, a certification body shall refer to an organization, school, juristic person or group that has been accredited and granted an accreditation document on organic agricultural product certification in accordance with the Act.
Article 5
An agricultural product operator applying for organic agricultural product or organic agricultural processed product certification shall possess one of the following qualifications:
1.A farmer;
2.A farm, livestock farm, farmer group or agricultural production and marketing group established or registered in accordance with related regulations; or
3.An operator that has obtained a business registration certificate.
Article 6
An agricultural product operator applying for certification of organic agricultural products or organic agricultural processed products shall make the application to a certification body by filling out an application form and providing the following documents:
1.A document verifying possession of one of the qualifications in the preceding Article;
2.Information on the geographical location of the factory (farm), including its land location labeling and a nearby area map;
3.Descriptions of the production or processes that comply with the certification criteria for organic agricultural products or organic agricultural processed products;
4.Maintenance of records and documents concerning the organic operating system, including records of operation, quality control, raw materials, inventory, product production and marketing, and records of the management of production land, facilities and environment; and
5.Other documents required by the central competent authority.
The certification criteria for organic agricultural products or organic agricultural processed products mentioned in Subparagraph 3 of the preceding Paragraph are specified in Appendix 1.
Article 7
Upon acceptance of an application for certification of organic agricultural products or organic agricultural processed products, the certification body shall proceed to procedures of document review, on-site inspection, product testing and certification decision. The certification body shall notify the applicant in writing of the results of each procedural stage.
The certification body shall determine the processing period of each procedural stage. The sum of the processing periods of all stages may not exceed one year. Nevertheless, the time notified to the applicant to make corrections or improvements shall not be included in these calculations.
Article 8
Under any of the following circumstances, the certification body shall reject an application and clearly state the reasons:
1.Where the production or processing of organic agricultural products or organic agricultural processed products does not comply with the certification criteria, and the nonconformities are critical;
2.Where the percentage of organic raw materials of organic agricultural processed products is less than 95%;
3.Where the on-site inspection cannot be performed within six months after document review due to reasons attributable to the applicant;
4.Where the applicant, without good cause shown, fails to make corrections or improvements within the given time limit upon receipt of notification;
5.Where the results of product testing fail to comply with the provisions of Article 13 of the Act; or
6.Where the application case cannot be closed within a one-year period after the date of application acceptance for reasons attributable to the applicant.
Article 9
When an organic agricultural product or organic agricultural processed product is certified, the certification body shall sign a contract with the applicant and issue an organic agricultural product certificate based on the categories of the organic products.
The organic agricultural product certificate mentioned in the preceding Paragraph shall state the following items:
1.The name and address of the agricultural product operator, and the name of its statutory responsible person;
2.The product category and item;
3.The period of validity;
4.The name of the certification body; and
5.The certificate number.
The format of the organic agricultural product certificate mentioned in Paragraph 1 shall be prescribed by the central competent authority.
The product categories and items mentioned in Subparagraph 2, Paragraph 2 of this Article are specified in Appendix 2.
Article 10
Under any of the following circumstances, an application shall be made for modification of the organic agricultural product certificate with relevant data attached:
1.Where changes are made to the name, address or telephone number of the agricultural product operator or appointment of its principal manager; or
2.Where the certification scope is reduced in terms of the certified premises/locations or certified product items.
After the application in the preceding Paragraph has been reviewed and approved, a replacement certificate with the same period of validity as the original certificate shall be issued.
Article 11
If there are changes in the production, processing or maintenance of organic operating system for the organic agricultural products or organic agricultural processed products, the agricultural product operator shall report the changes to the certification body for review.
If the certification body, following review, determines that the changes would be significantly affect the results of the original certification results, the certification body shall determine whether certification will be granted to the changes by following certification procedures.
Article 12
Under any of the following circumstances, an extensional assessment shall be made with related document attached:
1.An addition of production premises/locations; or
2.An addition of product items.
When the assessment verifies compliance with certification criteria, a replacement certificate with the same period of validity as the original certificate shall be issued.
Article 13
A new application for certification shall be made when the factories (farms) producing organic agricultural products or organic agricultural processed products are relocated or product categories are to be added to the certification scope.
The preceding Paragraph shall not apply when the relocation of a factory (farm) performing the packaging or distribution of organic agricultural products or organic agricultural processed products does not involve any change to the original operation or management procedures. The factory (farm) shall comply with related health and safety regulations after its relocation.
Article 14
An organic agricultural product certificate may not be transferred.
Article 15
Organic agricultural product certificates shall have a three-year period of validity. An agricultural product operator holding a certificate shall submit a renewal application form with attached data within six months of the expiration of the period of validity. Late renewal application shall not be accepted.
Replacement certificates shall be issued after the renewal applications mentioned in the preceding Paragraph have been re-assessed and approved.
Article 16
A certification body shall perform surveillance of agricultural product operators with certified products at regular or unfixed intervals.
The surveillance in the preceding Paragraph shall be conducted at least once each year. The frequency of surveillance may be increased when necessary.
Article 17
The procedures prescribed in Paragraph 1 of Article 7 shall apply mutatis mutandis to the certification in Paragraph 2 of Article 11, the extensional assessment in Paragraph 1 of Article 12, the re-assessment in Paragraph 2 of Article 15, and the surveillance in the preceding Article, or the certification body may implement necessary procedures in view of the situations of the individual case.
Article 18
If a certification body finds, in view of relevant evidence, that a certified organic agricultural product or organic agricultural processed product may not comply with certification criteria, the organization may collect samples from the factory (farm) for testing.
The cost of samples collected in the preceding Paragraph shall be born by the certified organic agricultural operators.
Article 19
A certification body shall notify the competent authority when it terminates the certification of an agricultural product operator in accordance with the regulations established under Paragraph 2, Article 9 of the Act.
An agricultural product operator of which the certification is terminated by the certification body shall not be allowed to make applications for certification within six months of the termination.
Article 20
The statutory responsible person or relevant personnel of the premises under inspection shall accompany the inspection team when a certification body performs certification, extensional assessment, re-assessment, surveillance or product sampling.
A certification body performing the activities mentioned in the preceding Paragraph shall keep records. The statutory responsible person or relevant accompanying personnel of the premises under inspection shall sign or affix their chops to the said records.
Article 21
A certification body shall maintain records and documents in accordance with these Regulations for three years.
Agricultural product operators shall maintain records and documents concerning the operating system of their organic agricultural products or organic agricultural processed products for at least one year. Where the labeling of a certified product indicates an expiration date, the records and documents shall be maintained until at least one year after the expiration date.
Article 22
A certification body shall submit information, including names of certified agricultural product operators, categories and items of certified products, and the periods of validity of certificates to the central competent authority on a quarterly basis for subsequent references.
Article 23
The language used for labeling organic agricultural products and organic agricultural processed products shall be standard Chinese, which may be supplemented by foreign languages or commonly used symbols. However, products exclusively for export shall not be subject to this requirement.
Article 24 The container or packaging of organic agricultural products and organic agricultural processed products shall state the following items at the time of sale:
1.Product name;
2.Names of raw materials;
3.Name, telephone number and address of the agricultural product operator;
4.Place of origin;
5.Name of the certification body;
6.Number of the organic agricultural product certificate; and
7.Other items that are required to be labeled in accordance with other labeling regulations or as announced by the central competent authority.
The names of raw materials mentioned in Subparagraph 2 of the preceding Paragraph is not required when they are completely identical to the product name mentioned in Subparagraph 1.
The product name mentioned in Subparagraph 2, Paragraph 1 shall contain the word "organic."
Article 25
The labeling of raw materials mentioned in Subparagraph 2, Paragraph 1 of the preceding Article shall comply with the following requirements:
1.The names of raw materials shall be stated in descending order based on the percentage of content, when the product consists of two or more mixed or processed raw materials; and
2.Apart from water and salt, the word "organic" or other symbolic notation may be used to indicate organic raw material items.
Article 26
The labeling of place of origin mentioned in Subparagraph 4, Paragraph 1 of Article 24 shall be determined and labeled in accordance with the following requirements:
1.The place of origin shall be that of the raw material accounting for no less than 95% of the product content or of the three raw materials with the highest percentages. However, if the raw materials have been processed in the Republic of China (Taiwan) and are substantially transformed, the place of origin shall be domestic or the county (city) where a domestic operator of the certified products is located;
2.The height and width of characters shall not be less than 6 mm; and
3.The labeling shall be marked in a visible place slightly below the center of the front of the packaging or container.
Article 27
The labeling of the certification body mentioned in Subparagraph 5, Paragraph 1 of Article 24 shall comply with the following requirements:
1.The height and width of characters shall not be less than 6 mm; and
2.The labeling shall be marked in a visible place slightly below the center of the front of the packaging or container.
Article 28
When a business premise possessing a business registration certificate wishes to sell bulk organic agricultural products and organic agricultural processed products, it shall use a sign near the place of display and sale to state the product name and the place of origin, and shall also display a photocopy of the organic agricultural product certificate as specified in Subparagraph 6, Paragraph 1, Article 24.
The requirements of Paragraph 3 of Article 24 and Paragraph 1 of Article 26 shall apply to the labeling of product name and place of origin mentioned in the preceding Paragraph.
The height and width of the characters for marking the place of origin mentioned in Paragraph 1 shall not be less than 3 cm.
Article 29
In addition to the requirements prescribed in Paragraph 3 of Article 24 and Subparagraph 2, of Article 25, the labeling of organic agricultural products and organic agricultural processed products shall not include other labeling, domestic or foreign organic markings, or other marking methods that may be misleading. This requirement shall not be applicable when marks are used as the labeling method.
Article 30
Marks affixed to organic agricultural products or organic agricultural processed products are limited to the followings:
1.An agricultural product mark specified in Paragraph 2, Article 12 of the Act; and
2.The mark of a certification body.
Certified organic agricultural products or organic agricultural processed products shall be affixed with the organic agricultural product marks prescribed in Paragraph 2, Article 12 of the Act, and comply with regulations mentioned in Paragraph 2, Article 12 of the Act.
When an organic agricultural product or organic agricultural processed product is affixed with all marks mentioned in each Subparagraph of Paragraph 1, the printing format shall go from large to small and shall follow the order of the Subparagraphs in Paragraph 1.
Article 31
These Regulations shall come into force on the date of promulgation.
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