2 SRMs should be removed during the slaughtering process when producing collagen and gelatin by using bones of cattle from a country with reported cas

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1 MAFRA Notice No Under Article 34.2 of the Act on the Prevention of Contagious Animal Disease, Ministry of Agriculture, Food and Rural Affairs (MAFRA) enacts the Import Health Requirements for Collagen and Gelatin as follows. Import Health Requirements for Collagen and Gelatin (Draft) Month Day, 2017 Minister of Agriculture, Food and Rural Affairs Article 1 (Objective) The objective of this notice is to stipulate necessary conditions such as quarantine and animal disease-free situation in the exporting country with regard to collagen and gelatin that are exported to the Republic of Korea in accordance with Article 34.2 of Act on the Prevention of Contagious Animal Diseases. Article 2 (Definitions) The terms used in this notice shall be defined as follows. 1. Collagen means protein collected from connective tissues of raw hide, skin or bones of animals. 2. Gelatin means partially hydrolysis product made by protein which had been collected from connective tissues of raw hide, skin or bones of animals. 3. Specified Risk Material (SRM) means brain, eyes, spinal cord, skull, and spinal column of cattle aged 30 months or older, and tonsils and distal ileum from cattle of any age. 4. The veterinary officer of the exporting country means the person who belongs to the government of the exporting country and who is granted the authority to carry out inspection or quarantine for livestock products. Article 3 (Conditions for collagen and gelatin) 1 Collagen and gelatin must be produced from animals that are deemed healthy based on the ante-mortem and post-mortem inspections conducted by the government of the exporting country.

2 2 SRMs should be removed during the slaughtering process when producing collagen and gelatin by using bones of cattle from a country with reported case of BSE. Collagen and gelatin should be collected, transported, and handled in a manner that prevents cross contamination with SRMs during the manufacturing process of collagen and gelatin. 3 When collagen and gelatin are produced by using bones of cattle from a country with reported case of BSE, they shall be produced through processes including degreasing, acid demineralization, acid or alkali treatment, filtration and sterilization (for a minimum of four seconds at 138 ). Article 4 (Conditions for manufacturing facility) 1 Manufacturing facility shall be dedicated to collagen and gelatin exclusively and be registered in accordance with relevant regulations of the exporting country and be inspected by the government of the exporting country. 2 Manufacturing facility producing collagen and gelatin by using bones of cattle from a country with reported case of BSE must have been notified from the government of the exporting country to that of the Republic of Korea and must have been approved by the Korean government through an on-site audit or other means. 3 When the manufacturing facility producing collagen and gelatin by using bones of cattle from a country with reported case of BSE suspends production of goods for export due to bankruptcy or closure, etc. the government of the exporting country must cancel the registration of the given manufacturing facility and immediately notify the government of the Republic of Korea. 4 The government of the Republic of Korea may cancel the approval of the manufacturing facility if there is no record of export of collagen and gelatin to the Republic of Korea for 3 years or more from the date it is approved as a manufacturing facility to produce collagen and gelatin by using bones of cattle from a country with reported case of BSE or from the date of the last export. The government of the Republic of Korea must notify this to the government of exporting country and hold consultations before making a decision to cancel the approval. Article 5 (Information to be provided in the quarantine certificate) 1 The veterinary officer

3 of the exporting country must issue a quarantine certificate that has been consulted with the government of the Republic of Korea before the shipment of collagen and gelatin. 2 The government of the exporting country should consult the quarantine certificate of collagen and gelatin in accordance with the quarantine certificate (draft) of the Appendix with the government of the Republic of Korea. Article 6 (Review deadline) The Minister of Agriculture, Food and Rural Affairs must take actions on this notice such as making improvements by reviewing the validity at the time marking an interval of three years starting July 1, 2017 (meaning until June 30 in the third year). Addendum <MAFRA Notice , Month, Date, 2017> Article 1 (Effective date) This notice shall be enacted on the day marking three months from the day of announcement of this notice. Article 2 (Interim measures) 1 Collagen and gelatin imported in accordance with Quarantine method and standard of designated quarantine (Animal and Plant Quarantine Agency Notice ) prior to the enact of this notice shall be considered to have been imported according to this notice. 2 The Health Certificate for collagen or gelatin that has been used before the enact of this notice shall be deemed effective up to three years from the effective date of this notice.

4 [ 별표 ] 콜라겐및젤라틴검역증명서서식 ( 안 ) [Appendix] Draft of Quarantine Certificate for Collagen and Gelatin Ⅰ. 제품정보 Product information 품명 Product : 축종 Species : 포장형태 Type of packaging : 포장수량 Number of packaging : 총중량 Gross weight : 순중량 Net weight : 제조시설의명칭및주소 Name and address of the manufacturing plant(s) 승인제조시설의승인번호 ( 소해면상뇌증 (BSE) 발생국산소뼈유래콜라겐과젤라틴에한함 ) Approval number of the approved manufacturing plant(s) (only for collagen and gelatin derived from bones of cattle from countries with reported case of bovine spongiform encephalopathy(bse)) 수출자의주소와성명 ( 업체명 ) Name and address of consignor : 수입자의주소와성명 ( 업체명 ) Name and address of consignee : 선적일자 Date of shipment : 선적지 Place of shipment : 선박명또는항공기명 Name of means of transport : 컨테이너번호 Container No. : 봉인번호 Seal No. : Ⅱ. 위생증명사항 Health information

5 수출국정부검역관은다음사항을증명한다. The undersigned quarantine official of the exporting country certifies the following : BSE 발생국산소뼈유래콜라겐및젤라틴 For collagen and gelatin derived from bones of cattle from countries with reported case of BSE 1) (Delete as appropriate) 1. 콜라겐과젤라틴을생산하기위한소는수출국정부에서실시한생체및해 체검사결과이상이없다. The cattle from which collagen and gelatin had been derived were subject to ante-mortem and post-mortem inspections conducted by the government of exporting country, and were found to be healthy. 2. BSE 발생국산소의뼈유래콜라겐과젤라틴을생산하기위한소는도축과정에서특정위험물질 2) 이제거되었다. 콜라겐과젤라틴제조과정중에이러한특정위험물질과교차오염이이루어지지않도록수집, 운반, 처리되었다. Specified risk materials (SRMs) have been removed during the slaughter of cattle from which collagen and gelatin were derived. Collagen and gelatin were collected, transported, and handled in such a manner as to prevent cross-contamination with SRMs. 3. BSE 발생국산소의뼈에서유래된콜라겐과젤라틴의제조공정은다음과같다. 다음을포함한다. The collagen and gelatin derived from bones of cattle have been processed by the following manufacture method. ( 제조공정예, example of manufacture method) I) 탈지 degreasing

6 ii) 산성탈염 acid deminerlaisation iii) 산또는알칼리처리 acid or alkaline treatment iv) 여과 filtration, v) 살균 ((138 에서최소 4초간 ) sterilisation at 138 for a minimum of 4 seconds 4. 제조시설은콜라겐과젤라틴만전용으로취급하는곳이어야하며, 수출국의관련규정에의거하여등록된곳으로수출국정부에서점검을실시하여야한다. The manufacturing plant should be dedicated to handling collagen and gelatin only, and registered according to related regulations of the exporting country, and inspected by the government of exporting country. 상기항목에해당되지않은모든동물유래콜라겐및젤라틴 For collagen and gelatin other than those derived from bones of cattle from countries with reported case of BSE (Delete as appropriate) 1. 콜라겐과젤라틴을생산하기위한동물은수출국정부에서실시한생체및해 체검사결과이상이없었다. The animal from which collagen and gelatin had been derived was subject to ante-mortem and post-mortem inspections conducted by the government of exporting country, and was found to be healthy. 2. 제조시설은콜라겐과젤라틴만전용으로취급하는곳이어야하며, 수출국의관련규정에의거하여등록된곳으로수출국정부에서점검을실시하여야한다. The manufacturing plant should be dedicated to handling collagen and gelatin only, and registered according to related regulations of the exporting country, and inspected by the government of exporting country.

7 3. 콜라겐및젤라틴제조공정 ( 수출국선택사항 ) 발급장소 Place : 발급일자 Date : 수출국정부검역관의소속및직책 Competent authorities and qualification of the issuer : 수출국정부검역관성명 Name of the quarantine officer : 수출국정부검역관서명 Signature of the quarantine officer : 수출검역도장 Official Stamp

Microsoft Word - template for the written confirmation for active substances exported to the EU

Microsoft Word - template for the written confirmation for active substances exported to the EU Brussels, 10/07/2012 SANCO/SF/sl/ddg1.d.6(2012)997444 Template for the 'written confirmation' for active substances exported to the European Union for medicinal products for human use, in accordance with