Regulatory Update: EFSA Issues Pesticide Evaluation

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The European Food Safety Authority (EFSA) has released a new statement regarding its evaluation of proposed temporary EU Maximum Residue Levels for pesticides. (Full text below.) Therein, EFSA details its opinion on possible health issues in relation to food and feed residue level proposals. The organization’s ultimate goal is national maximum pesticide residue level harmonization throughout the EU.

The opinion in full—in addition to annexes—are available here.

The full EFSA announcement:

EFSA has issued an opinion on the possible health risks from certain proposed residue levels of pesticides in food and feed. This is one of the first steps in the full EU harmonisation of national maximum residue levels[1] for pesticides in the Member States. MRLs that are considered safe for the population in one Member State may not necessarily be safe for the population in other countries due to different food consumption habits across Europe. An EU risk assessment of national MRLs is therefore necessary before they can be included in EU legislation in order to ensure that they do not pose unacceptable risks to consumers across Europe. EFSA has performed an initial risk assessment screening of the proposed temporary Maximum Residue Levels (MRLs)[2] based on available data provided by the European Commission. EFSA undertook model calculations which aimed to estimate the exposure of European consumers. According to the risk assessment, 92 of the 236 active substances[3] evaluated by EFSA were unlikely to present a risk to consumers. For the remaining 144 substances, the first screening could not exclude a potential consumer risk. More work will now be carried out on these substances by the Member States and the European Commission with a view to establishing temporary MRLs. EFSA is ready to provide further scientific advice to risk managers in the context of the harmonisation of temporary MRLs for pesticides. 

EU wide Maximum Residue Levels are already set for about 250 active substances (ingredient compounds used in pesticides). For the remaining substances, the EFSA evaluation is now the first step in the full harmonization of the Maximum Residue Levels for pesticides which are presently subject to different national Maximum Residue Levels in the Member States. EFSA performed an assessment of the safety of proposed temporary MRLs for 236 active substances based on model calculations which aimed to estimate the exposure of European consumers. EFSA’s exposure assessment took into account food consumption patterns across Europe and considered specific vulnerable subgroups of the population such as children and infants. More than 62.000 individual MRLs were assessed. EFSA applied a conservative screening model and identified those MRLs that are unlikely to present a risk to consumers.

The risk assessment methodology developed for this specific risk assessment task is based on internationally recognized methodologies. Owing to the high number of temporary MRLs that had to be evaluated and the limited availability of data[4], additional conservative elements were introduced in the calculations to overcome the data gaps and to have an efficient tool to manage the high number of calculations necessary. Therefore, the results of the calculations have to be considered as a first screening in order to identify those proposed temporary MRLs that are not likely to pose risk to consumers. According to EFSA’s risk assessment, 92 of the 236 active substances MRLs were unlikely to present a chronic[5] or acute[6] risk to consumers. For the remaining 144 substances, the first screening could not exclude a potential consumer risk and therefore further scientific assessment and/or risk management considerations are necessary. EFSA is ready to provide additional scientific advice to risk managers in harmonising temporary MRLs for pesticides at EU level.

EFSA has finalised its evaluation within the 6-month timeframe agreed with the Commission and will now forward it to the European Commission, Member States and the European Parliament.

[1] There are presently different permitted residue levels in the EU Member States. Until now each Member State has set its residue levels based on national diets and its own risk assessments. In order to ensure better protection for consumers in the EU internal market, the European Commission will now set EU-wide MRLs. The establishment of harmonised Maximum Residue levels for the active substances considered by EFSA is a precondition to make the Regulation (EC) 396/2005 on Maximum Residue Levels of pesticides fully operational.

[2] The temporary MRLs will be established as an interim measure. They will be subject to a detailed scientific assessment leading to the establishment of final MRLs following the comprehensive assessment of the active substances.

[3] The European Commission forwarded data for evaluation to EFSA on 236 active substances.

[4] Available data were limited to highest national MRLs. Data such as national authorisations, results of supervised field trials, residue definitions and the effect of processing, amongst others, were not available.

[5] Chronic health risk, i.e. causing harm if exposed repeatedly over a significant period of time. 110 pesticides will have to be further assessed for potential chronic health risks.

[6] Acute health risk, i.e. causing harm over a much shorter period of time (e.g. several hours). 109 pesticides will have to be further assessed for potential acute health risks.

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