Peer review of the pesticide risk assessment of the active substance chlorpropham

Abstract

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, the Netherlands, and co-rapporteur Member State, Spain, for the pesticide active substance chlorpropham and the assessment of applications for maximum residue levels (MRLs) 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 chlorpropham as a plant growth regulator on potatoes and as a herbicide on glasshouse and field lettuce, field onion and field flower bulbs. MRLs were assessed in potato and animal commodities. The reliable end points, appropriate for use in regulatory risk assessment and the proposed MRLs, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union. 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 experts' consultation in the areas of mammalian toxicology, residues, environmental fate and behaviour, and ecotoxicology.In accordance with Article 13(1) of the Regulation, EFSA should adopt a conclusion on whether chlorpropham can be expected to meet the approval criteria provided for in Article 4 of Regulation The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of chlorpropham as a plant growth regulator on potatoes and as a herbicide on glasshouse and field lettuce, field onion and field flower bulbs, as proposed by the applicants. MRLs were assessed in potato and animal commodities. Full details of the representative uses and the proposed MRLs can be found in Appendix A of this report.Data were submitted to conclude that the uses of chlorpropham according to the representative uses proposed at European Union (EU) level result in a sufficient plant growth regulatory efficacy to control sprouting and in a sufficient herbicidal efficacy against the target weeds.There were no data gaps identified in the section identity, physical and chemical properties and analytical methods.For mammalian toxicology, data gaps are set for further investigations of the immunotoxic potential of chlorpropham, for further assessment of the toxicological relevance of one impurity, and for a resident and bystander exposure assessment during use of Chlorpropham Fog and Chlorpropham 300 EC. In addition, further scientific assessment of the potential endocrine disrupting proper...

Removal of 3-Chloroaniline from aqueous solution by Treated Coffee Waste: Isotherm Modelling and Thermodynamic Studies

“…There are still no studies which show the direct carcinogenic effect of 3CA, however, 3CA is especially toxic to renal and haematopoietic systems [16,17]. 3CA was also suggested to be toxic as it has a similar structure to 4-chloroaniline (4CA) which is considered to be genotoxic and carcinogenic [14,18,19].…”

Fate of Chlorpropham during High-Temperature Processing of Potatoes

“…Chlorpropham (isopropyl (3-chlorophenyl)­carbamate, CIPC, CAS 101-21-3; see Figure ) is used as a herbicide and plant growth regulator on several plant commodities. During storage of potatoes, chlorpropham is used as a postharvest sprouting inhibitor to prolong the storage period without loss of product quality. − The active substance acts by modification of the spindle formation and thereby inhibits mitosis and sprouting processes in treated potatoes. , …”

“…The exposure to high temperatures and to a variety of matrix components (starch, protein, water, or oil), however, may decrease the amounts of pesticide residues during such processing steps. On the one hand, dissipation of the active substance into the air by heat-induced volatilization or into the surrounding matrix (e.g., boiling water or frying oil) could mitigate the pesticide’s burden in the final product. , On the other hand, degradation processes of the active substance may alter the nature of chlorpropham residues by formation of (novel) degradation products . These again might pose a risk for consumers’ health due to lack of toxicological data.…”

“…Results of such studies with chlorpropham demonstrated a low-level degradation of chlorpropham and formation of up to 1.3% of 3-chloroaniline. According to the European Food Safety Authority (EFSA), the application of higher temperatures between 170 and 200 °C (preparation of French fries, crisps, or baked potatoes) leads to significantly higher levels of 3-chloroaniline . The current dietary risk assessment reveals the exceedance of the acute reference dose (ARfD) for chlorpropham (ARfD: 0.5 mg/kg body weight) by 797%.…”

Reasoned opinion on the setting of temporary maximum residue levels for chlorpropham in potatoes

“…For this assessment, the data requirements established in Regulation (EU) No 283/2013 6 and the guidance documents applicable at the date of submission to the EMS have been used (European Commission, 2000, 2010a,b, 2017OECD, 2008OECD, , 2009OECD, , 2011OECD, , 2013. The assessment is performed in accordance with the legal provisions of the Uniform Principles for the Evaluation and the Authorisation of Plant Protection Products adopted by Commission Regulation (EU) No 546/2011 7 .…”