8.2.2022
EN
Official Journal of the European Union
C 67/73 Thursday 10 June 2021
AC. whereas Regulation (EC) No 470/2009 states that maximum residue limits must be established in accordance with generally accepted principles of safety assessment, taking into account any other scientific assessment of the safety of the substance concerned, which may have been undertaken by international organisations, in particular the Codex Alimentarius or, where such substances are used for other purposes, by scientific committees established in the Community; AD. whereas the Codex Alimentarius does not recommend imidacloprid for use in the aquatic environment, and ECHA suggests why this might be the case: ‘According to the harmonised classification and labelling (ATP01) approved by the European Union, this substance is very toxic to aquatic life with long lasting effects and is harmful if swallowed’ (31); AE. whereas Article 37 of Regulation (EU) 2019/6 provides that marketing authorisation is to be refused if risks to public or animal health or to the environment are not sufficiently addressed; considers this a justification for not establishing the MRL; AF. whereas the four major salmon-producing nations: Norway, Chile, the United Kingdom and Canada are not Member States and the Commission would therefore not be able to conduct appropriate audits of competent authorities in those countries, or to assess the adequacy of controls; 1.
Considers that Implementing Regulation (EU) 2021/621 exceeds the implementing powers provided for in Regulation (EC) No 470/2009; 2.
Considers that Implementing Regulation (EU) 2021/621 is not consistent with Union law, in that it violates the freedom of information and the fundamental principles of transparency, democratic scrutiny, and accountability, in so far as the underlying opinion by the Committee for Medicinal Products for Veterinary Use has only been made available in summary; 3.
Calls on the Commission to repeal Implementing Regulation (EU) 2021/621 and to submit a new draft to the committee including imidacloprid in the list set out in Annex IV to Regulation (EC) No 396/2005 of pharmacologically active substances for which no maximum levels can be fixed for aquatic use; 4.
Considers that all veterinary medicines, pesticides and pharmacological and chemical residues should go through standard tests and peer-reviewed evaluations because of their risk of causing further and permanent damage; 5.
Considers that the Agency should make publicly available the full opinion of the Committee for Medicinal Products for Veterinary Use consisting of the scientific risk assessment and risk management recommendations and the scientific evidence on which they are based; considers the risk assessment of imidacloprid is deficient as regards the consideration of acute endpoint values and that it ignores delayed, cumulative and chronic effects; recalls that research in aquatic invertebrates revealed a delayed effect on mortality, especially among aquatic insect species that could not be detected in standard acute tests demonstrating that risk assessments for neonicotinoids have been inadequate in relation to protection of the environment (32); 6.
Considers it essential to evaluate pharmacologically active substances and their classification regarding MRLs in foodstuffs of animal origin in conjunction with the rules laid down by Regulation (EC) No 178/2002 of the European Parliament and of the Council (33), Regulation (EC) No 396/2005, Regulation (EC) No 1367/2006 of the European Parliament and of the Council (34), and Regulations (EU) 2019/6 and (EU) 2019/1381; 7.
Considers that Directive 2001/82/EC is in urgent need of revision vis-à-vis protecting biodiversity, the aquatic and terrestrial environment and taking account of animal welfare and non-target organisms and microorganisms;
(31) (32) (33) (34)
https://echa.europa.eu/substance-information/-/substanceinfo/100.102.643 Sánchez-Bayo F., Tennekes, H.A., ‘Time-Cumulative Toxicity of Neonicotinoids: Experimental Evidence and Implications for Environmental Risk Assessments’, International Journal of Environmental Research and Public Health.
2020,17(5),1629, https://www.mdpi.com/1660-4601/17/5/1629 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 (OJ L 31, 1.2.2002, p. 1).
Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies (OJ L 264, 25.9.2006, p. 13).