Processes to reduce maximum residue levels for iprodione and linuron

The European Commission has notified the World Trade Organisation of two processes to change the maximum residue levels for iprodione and linuron. Under Commission Implementing Regulation (EU) 2017/2091 of November 2017, the approval for the plant protection product iprodione as an active agent was not renewed. The grace period for all plant protection products containing this active agent ended on 5 June 2018.

This is due to the concerns of the EFSA (peer review of the pesticide risk assessment of the active substance iprodione, October 2016), which could not be resolved due to a lack of data. Moreover, the EFSA proposed a new acute reference dose (ARfD) of 0.06 mg/kg body weight in this review.

Previous maximum residue levels not deemed to be safe

In the case of iprodione, consultations about a reduction of the maximum residue level have been ongoing since February 2018. Based on a recommendation of the European Commission to review the current maximum residue levels, the EFSA published a further assessment (follow-up assessment of MRLs for the active substance iprodione) in March 2018.

This assessment indicated that the current acute reference dose in certain raw materials (e.g. table grapes, broccoli, salads, peaches, pears, apples, carrots, curly salads and endives, brambles, raspberries, headed cabbage, tomatoes, bell peppers, lemons, strawberries, kiwis, cucumbers, melons, apricots, aubergines, watermelons, cherries, zucchinis, currants, plums, grapes and blueberries) is maxed out by more than 100% if the maximum residue level is used in full. These maximum levels are not deemed to be safe by the EFSA.

In terms of the Commission project SANTE/11836/2017 Rev.0, the iprodione maximum residue levels for all types of goods pursuant to Annex I of Regulation (EC) No. 396/2005 are to be reduced to the level of analytical determination (0.02 mg/kg each for fresh herbs and edible flowers, 0.05 mg/kg each for tea, herbal and fruit infusions, coffee, cocoa, carob, hop, spices and honey, 0.01 mg/kg each for all other types of goods).

No transitional provision is to be made for goods produced before the new maximum residue levels take effect

Goods produced before this date that do not comply with the new maximum residue levels must be sold off before the new levels take effect. It is envisaged that the corresponding regulation will enter into force in February of next year, subject to a period of six months from that date after which the new maximum residue levels will become effective.

This means that the new maximum residue levels could take effect from around September 2019

In the case of linuron, an assessment was likewise made by the EFSA (peer review of the pesticide risk assessment of the active substance linuron, June 2016), in which they state that a review of the toxicological reference values could not be completed due to a lack of data. In addition, the substance has been classified as reproductive toxic (Category 1B) and carcinogenic in accordance with Regulation (EC) No. 1272/2008.

Based on the above, the approval for this substance was not renewed in terms of the Commission Implementing Regulation (EU) 2017/244 of February 2017. The approval of plant protection products that contain linuron was revoked with effect as from 3 June 2017. The grace periods for these products were to have ended at the latest on 3 June 2018. The project SANTE/10145/2017 Rev. 2 sought to implement an equivalent approach (reduction to the level of analytical determination, no transitional phase) for linuron as that adopted for iprodione. In this case, too, the corresponding regulation is to enter into force in February of next year and become effective as from September 2019.