SAFEGUARDS | Food NO. 081/16

SafeGuardS fruits and vegetables

On March 29, 2016, the European Commission published Regulation (EU) 2016/452 [1], amending Annexes II and III to Regulation (EC) No 396/2005 [2] concerning maximum residue levels (MRLs) for captan, propiconazole and spiroxamine in or on certain products.

The European Food Safety Authority (EFSA) has submitted a ‘reasoned opinion’ on existing MRLs for these three substances. EFSA identified that some information was not available, and that the issue requires further consideration by risk managers. In the interim however, as there is no immediate risk to consumers, Regulation (EU) 2016/452 applies MRLs at the levels identified by EFSA, or in line with Annex II to Regulation (EC) No. 396/2005. These will be reviewed, taking into account any information that becomes available within two of the Regulation’s publication.

Captan: EFSA has proposed changing the residue definition for plant commodities, and recommended raising or keeping the existing MRLs for certain products. It concluded that some information was not available and that further consideration by risk managers was required concerning the MRLs for apples, pears, quinces, medlar, loquat, apricots, cherries, peaches, plums, strawberries, blackberries, raspberries, blueberries, currants, gooseberries and tomatoes. In addition, based on comments received by the Word Trade Organization from several third countries and consultation with the EU, existing MRLs for wine grapes will be maintained, though this will be reviewed as information becomes available within 2 years.

Propiconazole: EFSA has concluded that some information was not available and that further consideration by risk managers was required concerning the MRLs for grapefruit, lemons, limes, mandarins, apples, apricots, table and wine grapes, bananas, rape seed, barley grain, oats grain, rice grain, rye grain, wheat grain, sugar beet (root), swine muscle and fat, bovine muscle and fat, sheep muscle and fat, goat muscle and fat, poultry muscle and fat, cattle, sheep and goat milk and birds' eggs. In addition, EFSA concluded that no information was available concerning the MRLs for almonds, cherries, plums, strawberries, currants (red, black and white), gooseberries, peppers, cucumbers, globe artichokes, peanuts and tea, and that further consideration by risk managers was required. The MRLs for these products should be set at the specific limit of determination.

Spiroxamine: EFSA has proposed to change the residue definition and concluded that some information was not available concerning the MRLs for table and wine grapes, banana, barley, oats, rye, wheat, poultry muscle, fat and liver and birds' eggs, and that further consideration by risk managers was required. As it is appropriate to set the residue definition for animal origin commodities as spiroxamine carboxylic acid metabolite M06, expressed as spiroxamine (sum of isomers)’, sufficient information is available to set MRLs for swine muscle, fat, liver and kidney, bovine muscle, fat, liver and kidney, sheep muscle, fat, liver and kidney, goat muscle, fat, liver and kidney, cattle, sheep and goat milk. As the MRLs for barley and oats of 0.4 mg/kg are based on a good agricultural practice that is no longer supported, the MRLs for those commodities should be reduced to 0,05 mg/kg.

Transition Arrangements

This Regulation provides a transition arrangement for the normal marketing, processing and consumption of products which have been produced before the modification of the MRLs, and for which the available information demonstrates that a high level of consumer protection is maintained. Therefore, Annexes II and III to Regulation (EC) No 396/2005 are amended in accordance with the Annex to Regulation (EU) 2016/452, with effect from October 19, 2016.

What do the changes mean?

EU Member States, third countries and food business operators have some time to prepare to meet the new requirements, which will result in the modification of MRLs for captan, propiconazole and spiroxamine on October 19, 2016.  For more information, or to discuss your testing, analysis and certification requirements contact a food safety expert, such as SGS.

SGS is committed to keeping you informed of regulation news and developments. Leveraging our global network of laboratories and food experts, SGS provides a comprehensive range of food safety and quality solutions including analytical tests, audits, certifications, inspections, and technical support. We continually invest in our testing, capability, and state-of-the art technology to help you reduce risk, and to improve food safety and quality. For more information, please visit our website:

For enquiries, please contact:

Naovarat Dachprasat
Food Technical Support Center

t: +66 2683 0541 ext 2168

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