-Abstract-

The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA’s scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for talc E553B are presented. The context of the evaluation was that required by the European Commission in accordance with Article 23 of Regulation (EC) No 1107/2009 following the submission of an application for approval of talc E553B as a basic substance for use in plant protection as repellent (fungifuge and insectifuge) on fruit trees and grapevines. The current report summarises the outcome of the consultation process organised by EFSA and presents EFSA’s scientific views on the individual comments received.

-Summary-

Talc E553B is an active substance for which, in accordance with Article 23(3) of Regulation (EC) No 1107/2009, the European Commission received an application from Compo Expert France SAS for approval as a ‘basic substance’. Regulation (EC) No 1107/2009 introduced the new category of ‘basic substances’, which are described, among others, as active substances, not predominantly used as plant protection products but which may be of value for plant protection and for which the economic interest in applying for approval may be limited. Article 23 of Regulation (EC) No 1107/2009 lays down specific provisions for consideration of applications for approval of basic substances.

In March 2013, the European Commission requested the European Food Safety Authority (EFSA) to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. By a further specific request, received from the European Commission on 4 March 2016, EFSA was asked to organise a consultation on the basic substance application for talc E553B, to consult the applicant on the comments received, and to deliver its scientific views on the specific points raised in the format of a reporting table within three months of acceptance of the specific request.

A consultation on the basic substance application for talc E553B, organised by EFSA, was conducted with Member States via a written procedure in October-December 2015. Subsequently, EFSA also provided comments and the applicant was invited to address all the comments received in the format of a reporting table and to provide an application update as appropriate, within a period of 30 days.

The current report summarises the outcome of the consultation process organised by EFSA on the basic substance application for talc E553B and presents EFSA’s scientific views on the individual comments received in the format of a reporting table.

Talc E553B is a powdered natural hydrous magnesium silicate containing varying proportion of such associated materials as alpha quartz, calcite, chlorite, dolomite, magnesite and phlogopite. The product proposed in the submission, Invelop, is a mixture of Talc E553B with maximum 15 % of natural water.

Invelop is intended to be used as spraying application on grapevines and fruit trees as an insectifuge and fungifuge. The submission provided does not contain sufficient data to show efficacy with regard to the representative uses.

With regards to the impact on human and animal health, since the specification for talc E553B complies with the one referring to food additive use, no concern is raised if exposure to talc is by oral route according to the conditions referred in the Commission Regulation (EC) No 889/2008. However, if talc E553B is inhaled, it could potentially accumulate in the lungs and be of concern for operators and bystanders. A field study of short duration (1-2 hours) where only 1-2 hectares were treated, showed that operators’ exposure appear to remain below the level of detection for inhalable dust. However, in order to perform an exposure risk assessment for a full working day (6h) the setting of an acceptable operator exposure level (AOEL) is needed. The proposed AOEL is based on a 1971 study (Bethge-Iwanska, 1971) where either technical talc or pharmaceutical talc was administered to rats by inhalation for a period of 7 days to 9 months at air concentrations of 346-383 mg/m3 without causing death. EFSA does not support this proposal since both types of exposure produced pathological changes in the respiratory tract of the animals (catarrhal and atrophic inflammation, atrophy and focal emphysema, thickening of pulmonary arteries walls and narrowing of their lumen). Therefore, the concentrations used in the study cannot be considered as no-observed adverse effect concentrations (NOAEC) on which an AOEL could be derived. Estimates of operators’ exposure by inhalation could not be considered as insignificant (44% of the proposed AOEL according to the EFSA calculator (EFSA, 2014)), therefore, it has not been demonstrated that no adverse effect by inhalation is to be expected from the application of talc E553B on fruit trees and grapevines.

Since talc E553B is assumed to comply with the specification as food additive and since following application, talc is partly removed by rain and by washing, no residues of concern are expected to be present in plant commodities at harvest and a quantitative consumer risk assessment is not needed.

Whether the representative uses might result in groundwater exposure above the parametric limit of 0.1 μg/L, that is the water quality limit pertinent for decision making in accordance with the Uniform Principles remains open, based on the information available in the application.

In the area of ecotoxicology a low risk was concluded for birds and wild mammals, aquatic organisms, non-target arthropods other than bees, soil macro-fauna and soil microorganisms for all the representative uses. For bees a low risk could be concluded only when mitigation measures are taken into account (e.g. applications outside the flowering period of the crop/weeds in the field). A low risk to organisms involved in the sewage treatment could be concluded due to the low exposure.

http://www.efsa.europa.eu/en/supporting/pub/1044e