STC Number - 412

EU MRLs for bitertanol, tebufenpyrad and chlormequat (G/SPS/N/EU/168)

Maintained by: European Union
Raised by: India
Supported by:
First date raised: October 2016 G/SPS/R/84, paras. 3.2-3.4
Dates subsequently raised:
Number of times subsequently raised: 0
Relevant documents: G/SPS/N/EU/168
Products covered: 0806 Grapes, fresh or dried.; 1001 Wheat and meslin.
Primary subject keyword: Food safety
Status: Not reported
Date reported as resolved:

Extracts from SPS Committee meeting summary reports

In October 2016, India expressed concerns regarding proposed amendments to Regulation (EC) No. 396/2005 to change maximum residue levels (MRLs) for bitertanol, tebufenpyrad and chlormequat in certain products. India had provided detailed comments on the proposed regulation intended to come into effect in February 2017. India highlighted its particular concern with the lowering of MRLs for chlormequat in table grapes from 0.05mg/kg to 0.01mg/kg, which would seriously impact Indian grape exports to the European Union, which accounted for almost 25% of India's grape exports. India further noted that according to a European Food Safety Authority (EFSA) study conducted in 2010, residue concentrates of chlormequat in table grapes were safe up to 1.06mg/kg. Codex had not fixed any acceptable daily intake limits for chlormequat in table grapes, but had recommended an MRL of 0.05mg per kg. India further highlighted that other countries had set higher MRLs for chlormequat in table grapes, such as Australia and New Zealand at 0.75mg/kg or Japan at 0.10mg/kg. The scientific reference included in the EU notification did not provide any specific recommendation on grapes. Thus the proposed lower MRL had no scientific justification, was not based on any relevant international standard and would have negative trade effects.

India further expressed its concern with respect to residue levels for bitertanol in wheat, set at a default level of 0.01 mg/kg from 0.05 mg/kg. India questioned the rationale behind the European Union decision of undertaking a detailed assessment on the Codex limit. India requested the European Union to provide relevant scientific justification in light of Articles 5.4 and 5.8 of the SPS Agreement, and to maintain the current MRLs. India welcomed bilateral discussions.

The European Union recognised Indian producers' and regulatory bodies' efforts to comply with the existing MRL of 0.05 mg/kg for chlormequat. Since 2010 table grapes from India had complied with this MRL. For the time being, the European Union had decided to maintain the current MRL of 0.05mg/kg in grapes because the manufacturer had submitted new trial data supporting this level, and to review it on the basis of the 2017 JMPR evaluation aimed at establishing a Codex standard. In light of the above, the European Union considered that this concern of India had been addressed. The European Union explained that the default value of 0.01mg/kg for bitertanol resulted from a recommendation of the EU reference laboratories and not from EFSA's reasoned opinion. EFSA had highlighted that the lack of information on the toxicological relevance of certain impurities prevented the assessment of Codex levels and the inclusion of such levels in the EU legislation. The same issue had been raised in a previous EFSA opinion in 2010. The European Union informed India that it could make a request for an import tolerance under Article 6(4) of Regulation (EC) No. 396/2005 and submit additional data that would support re-establishing an MRL and alleviate any concerns about the metabolites. The European Union finally expressed its openness to bilateral consultations.