On the draft Commission regulation amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for acetamiprid, aclonifen, deltamethrin, oxathiapiprolin and potassium phosphonates in or on certain products

B100592/2025

European Parliament resolution on the draft Commission regulation amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for acetamiprid, aclonifen, deltamethrin, oxathiapiprolin and potassium phosphonates in or on certain products (D110096/02 – 2025/2975(RPS))

The European Parliament,

– having regard to the draft Commission regulation amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for acetamiprid, aclonifen, deltamethrin, oxathiapiprolin and potassium phosphonates in or on certain products (D110096/02),

– having regard to Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC, and in particular Article 14(1), point (a), thereof,

– having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, and in particular Article 4(1) and Article 4(2), first subparagraph, point (a), and points 3.6.2, 3.6.4 and 3.6.5 of Annex II thereof,

– having regard to Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, and in particular Article 5(1) thereof,

– having regard to Articles 11, 13, 168 and 191 of the Treaty on the Functioning of the European Union,

– having regard to the 2022 statement adopted on 29 November 2021, and published on 24 January 2022 by the European Food Safety Authority (EFSA) on the active substance acetamiprid,

– having regard to the 2024 statement adopted on 27 March 2024, and published on 15 May 2024 by EFSA on the toxicological properties and maximum residue levels of acetamiprid and its metabolites,

– having regard to the reasoned opinion approved by EFSA on 23 February 2025, and published on 18 March 2025,

– having regard to the opinion delivered on 3 October 2025 by the committee referred to in Article 45 of Regulation (EC) No 396/2005,

– having regard to Article 5a(3), point (b), and Article 5a(5) of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission,

– having regard to Rule 115(2) and (3), and (4)(c) of its Rules of Procedure,

– having regard to the motion for a resolution of the Committee on the Environment, Climate and Food Safety,

A. whereas the draft Commission regulation proposes, in particular, to raise the maximum residue levels (MRLs) for acetamiprid in honey to 1 mg/kg, following a previous increase in July 2025 from 0,05 mg/kg to 0,3 mg/kg;

B. whereas the request to modify the existing MRLs for acetamiprid in honey was submitted to the Slovenian competent authority by Albaugh Europe Sàrl; whereas Albaugh Europe Sàrl, founded in 2007, operates as the European branch of Albaugh, LLC, a company based in the United States;

C. whereas acetamiprid was initially approved in 2004 and subsequently re-approved in 2018 for a period of 15 years; whereas, in May 2020, the Risk Assessment Committee classified acetamiprid as a reproductive toxicant of category 2 (R2), having concluded that observed reductions in the body weight and postnatal survival of pups and delayed puberty in male rats in a developmental neurotoxicity (DNT) study were sufficient to classify the substance as category 2 for reproductive toxicity, H361d, due to its harmful effects on development;

D. whereas, under Regulation (EU) No 528/2012 of the European Parliament and of the Council, acetamiprid is classified as a very persistent (vP) substance in water and its authorisation was consequently granted for a limited period of seven years, from 2020 to 2027 under Commission Implementing Regulation (EU) 2018/1129; whereas the biocide dossier explains the differences in persistence assessment between the pesticide and biocide regulations, with Germany and Belgium noting that the model used in the pesticide dossier was inappropriate and not aligned with the recommendations of the 2017 persistent, bioaccumulative and toxic guidance update;

E. whereas on 15 May 2024, EFSA published a statement on the toxicological properties of acetamiprid, indicating that significant uncertainties remain regarding its potential DNT and that further data are therefore required to support an adequate hazard and risk assessment; whereas EFSA’s Working Group consequently proposed lowering both the acceptable daily intake and the acute reference dose from 0,025 mg/kg bw/day to 0,005 mg/kg bw/day; whereas that assessment subsequently led the Commission to reduce a number of MRLs to their limits of determination, ranging from 0,01 to 0,05 mg/kg, for bananas, currants, asparagus, lettuces, escaroles, chards and spinach;

F. whereas, since 2013, EFSA has been urging the Commission to require industry to conduct a DNT study, in light of concerns regarding potential effects on foetal and infant brain development; whereas in January 2022, EFSA’s Panel on Plant Protection Products and their Residues concluded that there was no conclusive evidence of higher hazards from acetamiprid compared to previous assessments with respect to genotoxicity, developmental toxicity, neurotoxicity including developmental neurotoxicity and immunotoxicity; whereas the Commission failed to take action for more than a decade and has only recently requested such data; whereas EFSA validated the corresponding study plan in September 2024;

G. whereas, since EFSA’s 2024 Statement on the toxicological properties and maximum residue levels of acetamiprid and its metabolites, a number of peer-reviewed studies have been published demonstrating adverse effects on human health; whereas, with respect to DNT alone, new in vivo studies further strengthen an already extensive and growing body of evidence of negative effects of acetamiprid on brain development;

H. whereas acetamiprid’s high toxicity to bees and wild pollinators is well documented; whereas, in the last two years alone, numerous peer-reviewed studies have reported harm to bees at field-realistic exposure levels; whereas those findings include, inter alia: greater susceptibility to acetamiprid in solitary bee species, which constitute the majority of the bee species in Mediterranean areas and which are not considered model species in the current bee risk assessment, sublethal effects on behaviour, the microbiome, olfactory learning and memory or immunity, newly identified in relation to acetamiprid also for queens, increased susceptibility to Varroa destructor following exposure, synergistic effects with certain fungicides, particularly through microbiome disruption, and demonstrated negative impacts on pollination services delivered by solitary bees;

I. whereas, in the draft Commission regulation, the Commission proposes setting the MRLs for acetamiprid in honey at 1 mg/kg; whereas this increase in the MRLs is likely to lead to a higher use of acetamiprid, in particular as a seed treatment on crops such as rapeseed, thereby exposing pollinators through nectar, consistent with the systemic properties of neonicotinoids; where this would result in exposure levels that have been demonstrated to be toxic to honeybees, as documented in scientific studies;

J. whereas Regulation (EC) No 396/2005 indicates that residues are not to be present at levels presenting an unacceptable risk to humans and, where relevant, to animals;

K. whereas Article 1(3) of Regulation (EC) No 1107/2009 provides that the purpose of that Regulation ‘is to ensure a high level of protection of both human and animal health and the environment’; whereas Article 4(2) of that Regulation (EC) No 1107/2009 provides that residues of plant protection products are not to have any harmful effects on human health, and any unacceptable effect on the environment;

L. whereas Article 5(1) of Regulation (EC) No 178/2002 provides that food law is to pursue one or more of the general objectives of a high level of protection of human life and health and the protection of consumers’ interests, taking into account, where appropriate, the protection of animal health and welfare, plant health and the environment;

M. whereas the Commission should protect the environment and Union citizens on the basis of the available scientific information, using the obligations and legal possibilities that Regulations (EC) No 396/2005 and (EC) No 178/2002 provide for to ensure a high level of protection of human and animal health and the environment; whereas the Commission should apply the precautionary principle;

1. Opposes adoption of the draft Commission regulation;

2. Considers that the draft Commission regulation exceeds the implementing powers provided for in Regulation (EC) No 396/2005;

3. Considers that the draft Commission regulation is not compatible with the aim and content of Regulations (EC) No 396/2005 and (EC) No 178/2002, as well as with Regulation (EC) No 1107/2009, including points 3.6.2 of its Annex II;

4. Considers that, in light of the scientific uncertainty regarding the toxicity of acetamiprid, in particular regarding its developmental neurotoxicity, including on solitary bees, and other than worker bees of A. mellifera, including queens, the Commission should apply the precautionary principle;

5. Calls on the Commission to withdraw the draft regulation and to submit a new draft regulation to the committee lowering MRLs for acetamiprid;

6. Instructs its President to forward this resolution to the Council and the Commission, and to the governments and parliaments of the Member States.