Foodlaw-Reading
Dr David Jukes, The University of Reading, UK
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EFSA News Item, 2 August 2019
The pesticide chlorpyrifos does not meet the criteria required by legislation for the renewal of its approval in the European Union, EFSA has said in a statement.
The approval period for chlorpyrifos expires in January 2020, and the manufacturers’ application for renewal is currently being evaluated under the EU’s peer review system for approval of pesticides.
Although the peer review is not yet fully completed, the European Commission asked EFSA to provide a statement on the available results of the human health assessment. EFSA has identified concerns about possible genotoxic effects as well as neurological effects during development, supported by epidemiological data indicating effects in children.
This means that no safe exposure level – or toxicological reference value – can be set for the substance.
The following is the Summary of the full scientific report:
Summary
Chlorpyrifos is an active substance covered by the third batch of the renewal programme for pesticides ('AIR3') in accordance with Commission Implementing Regulation (EU) No 844/2012.
Applications (June 2013) and supplementary dossiers (July 2015) for the renewal of approval of the active substance chlorpyrifos were submitted by a Task Force (comprising of Dow AgroSciences and Adama Agriculture B.V.) and by Sapec Agro SA.
An initial evaluation of the dossiers was provided by the rapporteur Member State (RMS) Spain in the Renewal Assessment Report (RAR) which was submitted to EFSA in July 2017. Subsequently, EFSA initiated a peer review of the pesticides risk assessment on the RMS evaluation in line with the provisions of Commission Implementing Regulation (EU) No 844/2012.
The commenting period was completed and included a public consultation on the RAR. Following evaluation of the comments received as well as the additional information provided by the applicants in response to a request in accordance with Article 13(3) of Regulation (EU) No 844/2012, a meeting of experts from EFSA and Member States, including relevant experts from the EFSA Panel on Plant Protection Products and their Residues (PPR Panel), took place to discuss certain elements related to mammalian toxicology.
In July 2019, prior to completion of the full peer review process, EFSA was mandated by the European Commission to provide a statement on the available outcomes of the human health assessment in the context of the peer review of chlorpyrifos.
The present statement contains a summary of the main findings of the assessment related to mammalian toxicology and human health following the Pesticides Peer Review Expert discussions in mammalian toxicology held between 1 and 5 April 2019. It also comprises EFSA’s additional considerations, including whether the active substance can be expected to meet the approval criteria which are applicable to human health as laid down in Article 4 of Regulation (EC) No 1107/2009.
Due to the fact that the genotoxic potential of chlorpyrifos remains unclear, toxicological reference values could not be established. Moreover, significant uncertainties were linked to the neurodevelopmental toxicity study, where effects were observed at the lowest dose tested in rats (decrease in cerebellum height corrected by brain weight). These concerns were supported by the available epidemiological evidence related to developmental neurological outcomes in children. In the absence of toxicological reference values, a risk assessment for consumers, operators, workers, bystanders and residents cannot be conducted. This issue represents a critical area of concern for chlorpyrifos.
In addition, the recorded toxicological effects meet the criteria for classification as toxic for reproduction category 1B (regarding developmental toxicity).
Based on the above results, it is considered that the approval criteria which are applicable to human health as laid down in Article 4 of Regulation (EC) No 1107/2009 are not met.
To see the full reports, use the following links:
