OTO No. 670 Classification MHLW-12
Date of Acceptance September 8, 2004 Ministry/Agency Receiving Complaint Cabinet Office
Responsible Ministries Ministry of Health, Labour and Welfare Related Laws Food Sanitation Law
Complainant Foreign firm Exporting Countries Republic of Korea
Subject Lifting of import suspension of gelatin and other products using raw cowhide of U.S. origin
Description of Complaint 1. The Ministry of Health, Labour and Welfare does not permit import of cow-derived products, excluding milk and dairy products, from countries where an outbreak of BSE has been confirmed.
2. As BSE broke out in the United States at the end of December 2003, it is now prohibited to export to Japan gelatin, which was made from raw cowhide of U.S. origin, and hard capsules using such gelatin.
3. However, the Ministry of Health, Labour and Welfare stated in the Shoku-An-Kan No. 0331006 "Handling of Cowhide-Derived Gelatin" dated March 31, 2004 that there would be no problem with using gelatin, which was made from raw cowhide of U.S. origin within Japan, for food if hide from the head is removed before salting.
4. Products that the complainant wants to import this time satisfy the above-mentioned condition in the production process.
5. Therefore, the Ministry of Health, Labour and Welfare should lift import suspension of gelatin and other products, which were made from raw cowhide of U.S. origin, if it can be certified that hide from the head was removed before salting.

(An opinion on October 14, 2004)
1. The Ministry of Health, Labour and Welfare stated in the reply dated October 12, 2004 "with respect to the skin used for producing edible gelatin, it is necessary to establish a system to certify the removal of hide from the head before salting. It is permitted to import gelatin or other products for which the removal of hide from the head was certified by a government organization, after consultation with the governments of related exporting countries."
2. On the other hand, in the Shoku-An-Kan No. 0331006 "Handling of Cowhide-Derived Gelatin" dated March 31, 2004, the ministry stated that there would be no problem with using gelatin, which was made from raw cowhide of U.S. origin within Japan, for food if hide from the head was removed before salting. The complainant wants the ministry to inform him of the certification, which domestic firms obtain from a U.S. government organization when importing raw cowhide of U.S. origin. (The complainant wants to see a copy of certificate if there are any.)

(An opinion on November 17, 2004)
The Ministry of Health, Labour and Welfare stated that there would be no problem with using gelatin, which was made from raw cowhide of U.S. origin within Japan, for food if hide from the head was removed before salting, while saying that the ministry "does not know" about the certification of "removal of hide from the head before salting." On the other hand, the ministry requires obtaining a certification from a (U.S.) government organization after establishment of a system to certify the "removal of hide from the head before salting" with respect to import of edible gelatin, which was made from raw cowhide of U.S. origin in other countries. The complainant wants to know the reason for this difference in treatment.

(An opinion on March 16, 2005)
Although the Ministry of Health, Labour and Welfare stated over and over that it is necessary to establish a system to confirm the removal of hide from the head, after consultation with the governments of related exporting countries, the complainant could achieve a certification of "nonuse of hide from the head" from a public organization.
Therefore, the ministry should allow the import of products in question.

Details of Measures (A reply on October 12, 2004)
As shown in the notice, since there is concern that cow hide from the head is contaminated by brain or other parts in the course of livestock processing, with respect to the skin used for producing edible gelatin, it is necessary to establish a system to certify the removal of hide from the head before salting. It is permitted to import gelatin or other products for which the removal of hide from the head was certified by a government organization, after consultation with the governments of related exporting countries.

(A reply on November 9, 2004)
Raw cowhide is not imported as food, and it thus does not go through procedures at the quarantine stations of the Ministry of Health, Labour and Welfare. Therefore, the ministry does not know about the certification obtained.

(A reply on November 30, 2004)
The OIE (World Organization for Animal Health) standards require the removal of hide from the head from food materials since hide from the head may be contaminated by brain, which is a specified risk material, during livestock processing.
Since the removal of hide from the head is not required at the stage of processing raw cowhide in the United States, the ministry considers it necessary to establish a system to confirm that hide from the head is not used for edible gelatin made from raw cowhide of U.S. origin, which is exported to Japan.
Incidentally, raw cowhide of U.S. origin imported into Japan does not go through import procedures under the Food Sanitation Law at the stage of import since there is no classification between materials for food gelatin and those for nonfood gelatin. However, no special procedures are required since it is possible to confirm the removal of hide from the head at the production stage of domestic edible gelatin within Japan.

(A reply on June 6, 2005)
For the certificate of sanitation that the complainant submitted on March 16, 2005, the ministry is now confirming regulations, monitoring system, issuance procedures and other related matters in the Republic of Korea with the Government of the Republic of Korea. Based on the result, the ministry will consider the propriety of importing the relevant products.
Classification of Processing Pending Directions IV
Remarks A written reply was made on October 12, 2004.
A written reply was made on November 9, 2004.
A written reply was made on November 30, 2004.
A written reply was made on June 6, 2005.

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