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Regulations Governing Traceability of Foods and Relevant Products
1.中華民國一百零二年十一月十九日衛生福利部部授食字第 1021351000 號令訂定發布全文 10 條；並自發布日施行 2.中華民國一百零五年六月八日衛生福利部部授食字第 1051300426 號令 修正發布第 1、4～6、8 條條文 3.中華民國一百零七年十月三日衛生福利部衛授食字第 1071302442 號令 修正發布全文 10 條；除第 4 條第 1 項第 4 款第 8 目及第 5 款、第 5 條第 1 項第 3 款第 8 目及第 4 款、第 6 條第 1 項第 3 款第 8 目及第 4 款規定自一百零八年一月一日施行外，其 餘條文自發布日施行
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This regulation is prescribed in accordance with the provision of Paragraph 5 of Article 9 of the Act Governing Food Safety and Sanitation (hereinafter referred to as “this Act”).
“Foods and relevant products” referred to in this regulation shall mean foods, special dietary foods, food additives, food utensils, food containers or packaging, and food cleansers prescribed under Subparagraphs 1 to 6, Paragraphs 1, Article 3 of this Act.
“Traceability” referred to in this regulation shall mean food businesses established the information and management to trace the source and track the flow of foods and relevant products at all stage of supply chain.
1Food businesses that engage in the manufacture, processing, preparation of the foods and relevant products shall establish traceability system including at least the following management items:
21. Raw material source information:
3(1) name, food business registration number, address, contact person and contact telephone number of raw material supplier;
4(2) raw material name;
5(3) net weight, volume, quantity or measurement;
6(4) lot/batch number;
7(5) expiry date, manufacture date or other recognizable date or information about the source of the raw material;
8(6) receiving date; and
9(7) country of origin of raw material.
102. Product information:
1Food businesses that engage in the import of the foods and relevant products shall establish traceability system including at least the following management items s:
21. Product Information:
3(1) Chinese and English (foreign) product name;
4(2) main and minor raw materials;
5(3) food additives;
6(4) packaging containers;
7(5) storage conditions;
8(6) employer identification number and food business registration number;
9(7) name or factory code,address, contact person and contact phone number of the exporter and manufacturer (slaughter or responsible company of the export country) ;
10(8) net weight, volume, quantity or measurement;
1Food businesses that engage in the sale and export of the foods and relevant products shall establish traceability system including at least the following management items:
21. Product Information:
3(1) name, food business registration number, address, contact person and contact telephone number of product supplier;
4(2) product name;
5(3) net weight, volume, quantity or measurement;
6(4) lot/batch number;
7(5) expiry date or manufacture date or other recognizable date or information about the source of the raw material;
8(6) receiving date; and
9(7) country of origin of raw material.
102. Identification: including any unique mark, lot/batch number, text or picture that is identifiable on products.
1Food businesses that engage in the packaging of the foods and relevant products shall comply with the provisions of Article 4. If the original packaging has not been changed after combining the various raw
2materials, the provisions of the previous articles shall be complied with.
1Food businesses shall record detailed information of management items referred to Articles 4 to 6.
2Food businesses shall retain records such as complete proof and shall also keep documents regarding food traceability in written or electronic form for at least 5 years.
The municipal or county/city competent authority may enter the place of food businesses to perform on-site examination and ensure that food businesses are in compliance with the provisions of food traceability relevant documents, and businesses shall not evade, impede or refuse.
Unless otherwise specified, these regulation shall take effect as of the date of promulgation.
11(1)product manufacturer;
12(2)name, food business registration number, address, contact person and contact phone number of the product responsible domestic company;
13(3) product name;
14(4) main and minor raw materials;
15(5) food additives;
16(6) packaging containers;
17(7) storage conditions;
18(8) net weight, volume, quantity or measurement; and
19(9) expiry date and manufacture date.
203. Identification: including any unique mark, lot/batch number, text or picture that is identifiable on raw materials, semi- products or end products.
214. Product flow information
22(1)name, food business registration number, address, contact person and contact telephone number of the product transporting distributor;
23(2) name, address, contact person and contact telephone number of the product recipient besides natural person; in the case of that is food business, the food business registration number shall be included;
24(3) product name;
25(4) net weight, volume, quantity or measurement;
26(5) lot/batch number;
27(6) expiry date or manufacture date;
28(7) delivery date; and
29(8)name, total weight or total capacity, reason and follow-up measure of recall products, sales returned products and inferior products ; name and address of product-returning businesses.
305. Name, total weight or total capacity of inventory materials and products.
316. Name, total weight or total capacity, follow-up measure and the cause of materials and products that discard (including passed their expiry date).
327. Other necessary information or record for internal traceability system management with effective connection for tracing the source and tracking the flow.
33The information of food business registration number mentioned in the Item 1 of Subparagraph 1, Item 2 of Subparagraph 2, and Item 1 and 2 of Subparagraph 4 of the preceding paragraph, shall mean that the food business registration number information for those food businesses designated by the central competent authority in a public announcement shall be retained.
34The information of country of origin of raw material mentioned in the Item 7 of Subparagraph 1 of the Paragraph 1 shall mean that the country of origin information for those raw materials required to be labeled designated by the central competent authority in a public announcement shall be retained.
35If the manufacturer and the responsible domestic company in the Item 6 and 7 of Subparagraph 2 of the Paragraph 1 are the same, either of them may be chosen to be recorded.
36Item 8 of Subparagraph 4 of Paragraph 1 and Subparagraph 5 shall be implemented on 1 January 2019.
12(10) expiry date, manufacture date or other recognizable date or
13information about the source of the product;
14(11) date of customs release;
15(12) application number for import food and relevant products inspection; and
16(13)country of origin of raw material.
172. Identification: including any unique mark, lot/batch number, text or picture that is identifiable on products
183. Product flow information:
19(1) name, food business registration number, address, contact person and contact telephone number of the product transporting distributor;
20(2) name, address, contact person and contact telephone number of the product recipient besides natural person; in the case of that is food business, the food business registration number shall be included;
21(3) product name;
22(4) net weight, volume, quantity or measurement;
23(5) lot/batch number;
24(6) expiry date or manufacture date or other recognizable date or information about the source of the raw materials;
25(7) delivery date; and
26(8) name, total weight or total capacity, reason and follow-up measure of recall products, sales returned products and inferior products ; name and address of product-returning businesses.
274. Name, total weight or total capacity of inventory products.
285. Name, total weight or total capacity, follow-up measure and the cause of materials and products that discard (including passed their expiry date).
296. Other necessary information or record for internal traceability system management with effective connection for tracing the source and tracking the flow.
30The information of food business registration number mentioned in the Item 6 of Subparagraph 1, Item 1 and 2 of Subparagraph 3 of the
31preceding paragraph, shall mean that the food business registration number information for those food businesses designated by the central competent authority in a public announcement shall be retained.
32The information of country of origin of raw material mentioned in the Item 13 of Subparagraph 1 of the Paragraph 1 shall mean that the country of origin information for those raw materials in food products required to be labeled designated by the central competent authority in a public announcement shall be retained.
33Item 8 of Subparagraph 3 of Paragraph 1 and Subparagraph 4 shall be implemented on 1 January 2019.
113. Product flow information:
12(1) name, food business registration number, address, contact person and contact telephone number of the product transporting distributor;
13(2) name, address, contact person and contact telephone number of the product recipient besides natural person; in the case of that is food business, the food business registration number shall be included;
14(3) product name;
15(4) net weight, volume, quantity or measurement;
16(5) lot/batch number;
17(6) expiry date or manufacture date or other recognizable date or information about the source of the raw material;
18(7) delivery date; and
19(8) name, total weight or total capacity, reason and follow-up measure of recall products, sales returned products and inferior products ; name and address of product-returning businesses.
204. Name, total weight or total capacity of inventory products.
215. Name, total weight or total capacity, follow-up measure and the cause of materials and products that discard (including passed their expiry date).
226. Other necessary information or record for internal traceability system management with effective connection for tracing the source and tracking the flow.
23The information of food business registration number mentioned in the Item 1 of Subparagraph 1, Item 1 and 2 of Subparagraph 3 of the preceding paragraph, shall mean that the food business registration number information for those food businesses designated by the central competent authority in a public announcement shall be retained.
24The information of country of origin of raw material information mentioned in the Item 7 of Subparagraph 1 of the Paragraph 1 shall mean that the country of origin information for those raw materials in food products required to be labeled designated by the central competent authority in a public announcement shall be retained.
25Item 8 of Subparagraph 3 of Paragraph 1 and Subparagraph 4 shall be implemented on 1 January 2019.