STC Number - 353

EU renewal of GMO approvals

Maintained by: European Union
Raised by: Argentina
Supported by:
First date raised: June 2013 G/SPS/R/71, paras. 4.5-4.6
Dates subsequently raised:
Number of times subsequently raised: 0
Relevant documents: EC Regulation 1829/2003
Products covered:
Primary subject keyword: Food safety
Keywords: Animal health; Food safety; Human health; Plant health; Sufficiency of scientific evidence; Territory protection
Status: Not reported
Date reported as resolved:

Extracts from SPS Committee meeting summary reports

In June 2013, Argentina raised its concerns over the EU renewal procedures and processes for GMO approvals. Argentina contended that risk assessment reviews should only be undertaken in cases of new scientific justification. Further, as the entire EU approval process took approximately four years, granting a licence for only ten years was impractical and without scientific justification. The EU process was already overly burdensome and the new requirements were unclear, adding to the heavy burden of seeking GMO approval. Argentina asked the European Union to clarify and rectify their GMO approval process.

The European Union responded that it was not intending to adopt legislation as was done for the food/feed new authorizations but rather to prepare a guidance document which would complement Articles 11 and 23 of Regulation 1829/2003 already providing general guidance on the renewal process. The European Food Safety Authority was currently working on this more detailed guidance which should be available in autumn 2013, before the first renewal request expected in March 2014.