Commission Regulation (EU) 2023/377 of 15 February 2023 amending Annexes II, III, IV and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for benzalkonium chloride (BAC), chlorpropham, didecyldimethylammonium chloride (DDAC), flutriafol, metazachlor, nicotine, profenofos, quizalofop-P, sodium aluminium silicate, thiabendazole and triadimenol in or on certain products

Commission Regulation (EU) 2023/1536 of 25 July 2023 amending Annex III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for nicotine in or on certain products

Update

The EU has issued two regulations during 2023 amending the maximum residue levels (MRLs) for nicotine, with impacts on rose hips, herbs and edible flowers, wild fungi, teas, herbal infusions and spices.

Impacted Products

rose hips, herbs, edible flowers, wild fungi, teas, herbal infusions, spices

What is changing?

The changes to nicotine MRLs in both Regulations are set out in Table 1. The MRLs for all other products are set to the limit of determination (LOD, the lowest level that can be detected using the most modern and reliable analytical methods).

Why?

New regulations were introduced to lower the EU MRLs for nicotine following a review of the temporary MRLs in place since 2011. In many cases, this was to bring them in line with recent residue monitoring data (rather than because of an identified consumer risk).

In the case of capers, however, there were concerns that the temporary MRL of 4 mg/kg could pose an acute risk to consumers (according to calculations performed with EFSA's Pesticide Residue Intake Model, PRIMo rev. 3.1).

A potential acute risk for consumers was also identified for the temporary MRLs for nicotine in rose hips and teas, taking into account recent food consumption data for these products representative for European consumers. Regulation (EU) 2023/377 sets the MRL for nicotine in seed spices and fruit spices to 0.02 mg/kg, and in cinnamon to 0.07 mg/kg.

Following the introduction of Regulation (EU) 2023/377, the EU Reference Laboratories (responsible for developing analytical methods) notified the Commission that, for analytical reasons, 0.05 mg/kg would be a more appropriate LOD for nicotine in seed spices and fruit spices. Also, new monitoring data for cinnamon indicated that residues occur at higher levels. Regulation (EU) 2023/1536 was introduced with further amendments to take account of this new information. The MRL for seed spices and fruit spices is now set at the LOD of 0.05 mg/kg, and a new MRL in cinnamon has been set to 0.2 mg/kg.

Timeline

The new MRLs for nicotine will apply from 15 September 2023.

Products (except rosehips) exported to the EU before 14 September 2023, that comply with the old MRLs but not the new levels in Regulation 2023/1536, may nevertheless remain on the EU market.

For rosehips, the new MRL applies from 15 September, including for products exported before 14 September 2023.

Recommended Actions

Suppliers to the EU market of rose hips, herbs and edible flowers, wild fungi, teas, herbal infusions and spices should maintain, and where necessary increase, systematic monitoring of nicotine.

It is also important to note that nicotine is not approved for use as an insecticide in the EU, and should not be applied to crops that are intended for export to the EU due to the likelihood of exceeding permitted residue levels.

Background

In 2009, the EU authorisation for the use of nicotine as an active substance in plant protection products was withdrawn. No specific MRLs for nicotine were set, and the default MRL of 0.01 mg/kg was applied to all products.

In 2009 and 2011, the European Commission asked the European Food Safety Authority (EFSA) to provide advice on the setting of temporary MRLs for nicotine for a number of commodities in which residue levels greater than the default MRL were repeatedly identified during controls by food business operators and/or national competent authorities (EFSA, 2009; EFSA, 2011). Based on the EFSA assessment, specific temporary MRLs were set in Annex IIIA of Regulation(EC) No 396/2005 for nicotine in wild fungi (Commission Regulation (EU) 765/2010) and for nicotine in rose hips, herbs and edible flowers, teas, herbal infusions and spices (Commission Regulation (EU) 812/2011).

The source of residues in these commodities has not been established. Contamination during harvest, drying, storage or transport are considered possible. Nicotine also occurs naturally as the main alkaloid in tobacco and related species, and is found in low concentrations in certain other crops. In the absence of scientific evidence on the source, the Commission decided to review the temporary MRLs after 10 years in order to take into account any new information available. On the basis of this review, two new draft Regulations were introduced in 2022 referencing recent monitoring and food consumption data (EFSA, 2022 EFSA, 2022).

MRLs are set in accordance with the rules set out in Regulation 396/2005. For information on current MRLs for other substances, please consult the EU Pesticide Residues database.

Resources

Sources

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