STC Number - 519

EU regulatory approach to maximum levels for contaminants

Maintained by: European Union
Raised by: Canada
Supported by: United States of America
First date raised: July 2021 G/SPS/R/102 paras. 4.11-4.13
Dates subsequently raised: November 2021 (G/SPS/R/104 paras. 3.44-3.47)
Number of times subsequently raised: 1
Relevant documents: G/SPS/N/EU/466 G/SPS/N/EU/479 G/SPS/GEN/1980
Products covered:
Primary subject keyword: Food safety
Keywords: Contaminants; International Standards / Harmonization; Food safety; Human health
Status: Not reported
Date reported as resolved:

Extracts from SPS Committee meeting summary reports

In July 2021, Canada stated that the EU implementation of hazard-based regulatory decision-making requirements under Regulation (EC) 1881/2006 was leading to the lowering of maximum levels (MLs) for contaminants in many food products. In Canada's view, the EU approach did not take into account consumption patterns and levels of dietary risk. Canada was particularly concerned with the negative trade implications of the lowering of MLs of cadmium in cereals and pulses and oilseeds, of ergot and ergot alkaloids in cereals, and of hydrocyanic acid in linseed (flax), and looked forward to responses to its letters addressed to the European Union. Recalling that these substances were naturally occurring and difficult to control, Canada underlined the importance of providing significant advance notice between the adoption of regulations and their entry into force, to give industries sufficient time to adapt.

Firstly, the EU proposed MLs for cadmium did not align with MLs set by Codex, and would negatively affect exports of cereals, pulses, flaxseed, mustard seed and canola. The uncertainty for major grain suppliers and exporters created by the immediate implementation of the lower MLs could affect market availability, and potential mitigation measures could raise the cost of grains. Canada requested the extension of the transition period until June 2022. Secondly, Canada noted that some of the EU proposed MLs for ergot were half of the MLs established by Codex. The immediate implementation of MLs for ergot and ergot alkaloids could affected market availability and prices of barley, wheat, rye and oats. Since Codex had yet not set MLs for ergot alkaloids, Canada encouraged the European Union to delay the adoption of MLs for ergot alkaloids until the release of the full report of the 91st meeting of Joint FAO/WHO Expert Committee on Food Additives (JECFA). Canada also requested information on the scientific basis of the EU proposed MLs for ergot and ergot alkaloid and on how the European Union intended to apply a sampling scheme. Required mitigation measures would raise the cost of grains destined for the European Union. Canada requested the extension of the transition period until September 2023. Finally, Canada requested information on EU deliberations on proposed MLs for hydrocyanic acid, and urged the European Union to take into account dietary risks and consumption patterns of flaxseed. Canada also hoped the European Union would take into account the risks associated with hydrocyanic acid released from linseed.

The European Union indicated that it would shortly respond to Canada's comments on notification G/SPS/N/EU/479. The European confirmed that the new ML established for ergot sclerotia in wheat and durum wheat (0.2 g/kg, established on safety considerations) was lower than the one established in CXS 199/1995 (0.5 g/kg, established as a quality factor). Taking into account EFSA's scientific opinion and JECFA's assessment in its 91st meeting, it was necessary to establish MLs for ergot alkaloids in cereals and cereal products to ensure a high level of human health protection. According to the European Union, the established level was readily achievable by applying good practices. The European Union further confirmed that the proposed ML for ergot alkaloids did not apply to bulk raw grain and that detailed sampling provisions would be elaborated and adopted before the MLs would apply. Sampling provisions were identical to those applicable for the control of other mycotoxins in cereal and cereal products, as laid down in Regulation (EC) 401/2006. Concerning the ongoing discussion on possible MLs for hydrocyanic acid in certain foods, including linseed, Canada's comments were being considered, and the outcome of the technical discussions would be notified as a draft for the Members to comment.