Request for the evaluation of the toxicological assessment of the co-formulant POE-tallowamine

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2015;13(11):4303 [13 pp.].
doi
10.2903/j.efsa.2015.4303
Type
Statement of EFSA
On request from
European Commission
Question Number
EFSA-Q-2014-00874
Approved
30 October 2015
Published
12 November 2015
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

The European Food Safety Authority (EFSA) was asked by the European Commission to prepare a statement on the co-formulant polyethoxylated (POE) tallowamine based on the toxicological evaluation of POE-tallowamine presented by the rapporteur Member State Germany in the context of the peer review of the active substance glyphosate required by Commission Regulation (EU) No 1141/2010 as amended by Commission Implementing Regulation (EU) No 380/2013 (the evaluation is presented for the section on mammalian toxicology). Missing information identified is listed. The context of the evaluation was that required by the European Commission in accordance with Article 31 of Regulation (EC) No 178/2002.

Summary

Under the process for the renewal of the approval of the active substance glyphosate for the use in plant protection products under Commission Regulation (EU) No 1141/2010, the rapporteur Member State (RMS) Germany included toxicological information on the co-formulant POE-tallowamine in chapter B.6.13 of the renewal assessment report (RAR) ‘Toxicological data on non-active substances’. The European Commission mandated EFSA to prepare a statement on the toxicological evaluation prepared by the RMS. EFSA received the mandate on 19 November 2014. EFSA accepted the mandate and the EFSA Question Number EFSA-Q-2014-00874 was allocated to this task.

Polyethoxylated (POE)-tallowamine belongs to a group of substances used as surfactants, which are present in many glyphosate-based formulations. The RMS considered that a toxicological assessment of this surfactant characterised by the CAS no. 61791-26-2 could be necessary at Member State or zonal level for plant protection product authorisations, and therefore a toxicological evaluation including health-based reference values was provided in the RAR.

EFSA did not have the possibility to review the original data for most of the endpoints summarised in chapter B.6.13 of the RAR, and some endpoints are not fully addressed, therefore EFSA cannot support the RMS’s current assessment and considers that reliable reference values Acceptable Daily Intake (ADI), Acceptable Operator Exposure Level (AOEL), and Acute Reference Dose (ARfD) cannot be established and further data have to be submitted. Therefore the exposure assessment for operators, workers, bystanders, residents and consumers could not be performed. Compared to glyphosate, a higher toxicity of the POE-tallowamine was observed on all endpoints investigated.

The hypothesis of a possible synergistic toxicity between glyphosate and tallowamine co-formulant could not be verified. Dose additivity may be expected, at least regarding the irritation potential of the mixture to eyes and possibly mucosal tissues as both compounds share these irritation properties. Considering the low oral toxicity of glyphosate after single or repeated administrations, a likely explanation for the poisoning occurrences observed in humans is that it is mostly driven by the POE-tallowamine component of the formulation.

The genotoxicity, long-term toxicity and carcinogenicity, reproductive/developmental toxicity and endocrine disrupting potential of POE-tallowamine should be further clarified. There is no information regarding the residues in plants and livestock. Therefore, the available data are insufficient to perform a risk assessment in the area of human and animal health for the co-formulant POE-tallowamine.

Keywords
POE-tallowamine, co-formulant, mammalian toxicology, glyphosate
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Number of Pages
13