-Abstract-

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Denmark and co-rapporteur Member State Belgium for the pesticide active substance maleic hydrazide are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of maleic hydrazide as a plant growth regulator on onion, shallot, garlic, potato and carrot. The reliable end points, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

-Summary-

Commission Implementing Regulation (EU) No 844/2012 (hereinafter referred to as ‘the Regulation’) lays down the procedure for the renewal of the approval of active substances submitted under Article 14 of Regulation (EC) No 1107/2009. The list of those substances is established in Commission Implementing Regulation (EU) No 686/2012. Maleic hydrazide is one of the active substances listed in Regulation (EU) No 686/2012.

In accordance with Article 1 of the Regulation, the rapporteur Member State (RMS), Denmark, and co-rapporteur Member State (co-RMS), Belgium, received an application from EU Maleic hydrazide Task Force (EMHTF) composed of Chemtura Europe Limited, Drexel Chemical Company and Agriphar s.a. for the renewal of approval of the active substance maleic hydrazide. Recently, Chemtura Europe Limited and Agriphar s.a. became part of Arysta LifeScience Great Britain Limited.

Complying with Article 8 of the Regulation, the RMS checked the completeness of the dossier and informed the applicants, the co-RMS (Belgium), the European Commission and the European Food Safety Authority (EFSA) about the admissibility.

The RMS provided its initial evaluation of the dossier on maleic hydrazide in the renewal assessment report (RAR), which was received by EFSA on 30 April 2015. In accordance with Article 12 of the Regulation, EFSA distributed the RAR to the Member States and the applicants for comments on 30 June 2015. EFSA also provided comments. In addition, EFSA conducted a public consultation on the RAR. EFSA collated and forwarded all comments received to the European Commission on 31 August 2015.

Following consideration of the comments received on the RAR, it was concluded that additional information should be requested from the applicants and that EFSA should conduct an expert consultation in the areas of mammalian toxicology and residues.

In accordance with Article 13(1) of the Regulation, EFSA should adopt a conclusion on whether maleic hydrazide can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council.

The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of maleic hydrazide as a plant growth regulator on onion, shallot, garlic, potato and carrot, as proposed by the applicant. Full details of the representative uses can be found in Appendix A of this report.

Data were submitted to conclude that the uses of maleic hydrazide as a plant growth regulator according to the representative uses proposed at the EU level result in a sufficient efficacy as a sprout suppressor.

A formal data gap was identified in the residue section for the RMS to report the full assessment of the results of the scientific peer-reviewed open literature search in a revised RAR.

Data gaps were identified for a method for the determination of the relevant impurity in the technical material (TC) at the level of the accepted specification and for a method for the determination of residues in body fluids and tissues.

In the mammalian toxicology area, data gaps were identified for genotoxicity studies performed with the representative TC containing 1 ppm (or lower) of the relevant impurity hydrazine, for identification of the analytical methods used in the toxicity studies (except for the acute inhalation and dermal sensitisation studies), interspecies comparative in vitro metabolism including human material and clarification of the endocrine disrupting potential of maleic hydrazide considering in particular level 2 and 3 tests currently indicated in the Organisation for Economic Co-operation and Development (OECD) Conceptual Framework. To address the consumer risk assessment, clarification of the genotoxic potential of the metabolite 3-pyridazinone is necessary, as well as toxicological information on the metabolite relevant to consumer exposure, i.e. upon repeated-dose exposure. As the technical specification is not supported by the toxicological assessment with regard to the specified level of hydrazine and positive results were obtained in non-standard genotoxicity studies with a test material containing 0.31 ppm hydrazine, a critical area of concern was identified.

In the residue section, the consumer risk assessment could not be finalised with regard to the toxicity profile of 3?pyridazinone metabolite included in the residue definition for risk assessment for animal commodities as a data gap has been identified to address the genotoxic potential of 3-pyridazinone and its toxicity upon repeated-dose exposure (see Section 2). A data gap was also identified for the determination of the residues in pollen and bee products for human consumption resulting from residues taken up by honeybees from potatoes at blossom.

With respect to fate and behaviour in the environment, data available allow finalising the necessary exposure assessment. However, a data gap has been identified for data to address the effect of water treatment processes on the nature of residues present in surface water, when surface water is abstracted for drinking water needs to be provided to demonstrate that the approval criteria in Article 4 of Regulation (EC) 1107/2009 are satisfied.

In the ecotoxicology section, a data gap was identified for submitting a valid study on Lemna. Also, the available acute study onMysidopsis bahia should be submitted for peer-review. Data gaps were also identified in the risk assessment to honeybees. These include data gaps for refining the chronic risk due to exposure to contaminated pollen and nectar, and the risk due to exposure to contaminated water (guttation, puddle water). Furthermore, data gaps were identified for assessing sub-lethal effects (i.e. hypopharyngeal glands (HPG)) and for assessing the risk due to exposure to metabolites in pollen and nectar. A data gap was identified for the technical specification used in the ecotoxicology studies with regard to the maximum level of hydrazine.

http://www.efsa.europa.eu/en/efsajournal/pub/4492