STC Number - 31

Rules on "specified risk materials" in products of animal origin

Maintained by: European Union
Raised by: United States of America
Supported by: Argentina; Australia; Brazil; Canada; Chile; Colombia; Czech Republic; Mexico; New Zealand; Switzerland; Uruguay
First date raised: October 1997 G/SPS/R/9/Rev.1, paras. 10-14
Dates subsequently raised: March 1998 (G/SPS/R/10, paras. 13-19)
June 1998 (G/SPS/R/11, paras. 34-38)
July 2001 (G/SPS/R/22, para. 127)
Number of times subsequently raised: 3
Relevant documents: G/SPS/GEN/36, G/SPS/GEN/45, G/SPS/GEN/67, G/SPS/GEN/265
Products covered: 30 Pharmaceutical products; 0511 Animal products not elsewhere specified or included; dead animals of Chapter 1 or 3, unfit for human consumption.; 1516 Animal or vegetable fats and oils and their fractions, partly or wholly hydrogenated, inter-esterified, re-esterified or elaidinized, whether or not refined, but not further prepared.
Primary subject keyword: Animal Health
Keywords: Animal health; Human health; International Standards / Harmonization; Zoonoses
Status: Not reported
Date reported as resolved:

Extracts from SPS Committee meeting summary reports

In October 1997, the United States raised concerns with Decision 97/534 EC banning the use of certain specified risk materials, which might cause international shortages of needed medical products and have a major restrictive impact on trade in tallow and derivatives, gelatine, pharmaceuticals and many food products. This ban seemed to be more restrictive than necessary to achieve its public health objectives, especially as it applied to the United States and other regions where BSE was not known to exist. The European Communities indicated that since scientific studies had shown that its previous measures might not be sufficient, it had raised its level of protection. Members who considered themselves to present no risk with regard to TSEs could present an application for examination by the EC Scientific Committee. Argentina indicated that in its view, measures which failed to distinguish between countries infected with BSE and countries not infected were contrary to the OIE recommendations and the SPS Agreement. He distributed copies of a BSE risk analysis.
In March 1998, the United States reiterated that the European Communities should recognize the BSE-free status of the United States and other regions. Several delegations welcomed the EC decision to provide additional time to review all the scientific evidence and other important implications of the proposed measure and provided comments. The European Communities clarified that entry into force of its measure had been postponed from 1 April to 1 July 1998, and that BSE-free countries could apply for an additional derogation until 1 January 1999.
In June 1998, the European Communities reported that EC member States were still unable to reach a common position on the issue, and that the EC Decision would therefore not enter into force until 1 January 1999. In the meantime, member States had introduced a number of measures. The EC Commission was also submitting new legislation for approval, taking into account the OIE classification of countries with respect to BSE.
In July 2001, the United States indicated that the EC legislation on specified risk materials had entered into force for third countries on 1 April 2001 (G/SPS/GEN/265). The United States encouraged the European Communities to ensure that its measures took account of the disease situation in countries where BSE did not occur, such as the United States.