Legal constraints in EU product labelling to mitigate the environmental risk of veterinary medicines at use

Montforts, Mark; Rijswick, H.F.M.W. van; Haes, Helias A. Udo de

doi:10.1016/j.yrtph.2004.08.006

Cited by 16 publications

(7 citation statements)

References 17 publications

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“…Predicted environmental concentration (PEC) calculations using exposure models suggest that in surface water, concentrations of 25 up to 60 ng/l can be reached (Montforts et al 2004; Sanderson et al 2007). Based on our study, an overall NOEC of 30 ng/l is suggested.…”

Section: Discussionmentioning

confidence: 99%

Effects of the Veterinary Pharmaceutical Ivermectin in Indoor Aquatic Microcosms

Boonstra

Reichman

Brink

2010

Arch Environ Contam Toxicol

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The effects of the parasiticide ivermectin were assessed in plankton-dominated indoor microcosms. Ivermectin was applied once at concentrations of 30, 100, 300, 1000, 3000, and 10,000 ng/l. The half-life (dissipation time 50%; DT50) of ivermectin in the water phase ranged from 1.1 to 8.3 days. The lowest NOECcommunity that could be derived on an isolated sampling from the microcosm study by means of multivariate techniques was 100 ng/l. The most sensitive species in the microcosm study were the cladocerans Ceriodaphnia sp. (no observed effect concentration, NOEC = 30 ng/l) and Chydorus sphaericus (NOEC = 100 ng/l). The amphipod Gammarus pulex was less sensitive to ivermectin, showing consistent statistically significant reductions at the 1000-ng/l treatment level. Copepoda taxa decreased directly after application of ivermectin in the highest treatment but had already recovered at day 20 posttreatment. Indirect effects (e.g., increase of rotifers, increased primary production) were observed at the highest treatment level starting only on day 13 of the exposure phase. Cladocera showed the highest sensitivity to ivermectin in both standard laboratory toxicity tests as well as in the microcosm study. This study demonstrates that simple plankton-dominated test systems for assessing the effects of ivermectin can produce results similar to those obtained with large complex outdoor systems.

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Section: Discussionmentioning

confidence: 99%

Effects of the Veterinary Pharmaceutical Ivermectin in Indoor Aquatic Microcosms

Boonstra

Reichman

Brink

2010

Arch Environ Contam Toxicol

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“…Data on the extent of use of veterinary medicines is not generally available in the public domain for countries in the EU (Kools, Moltmann, & Knacker, 2008). Montforts, Van Rijswick, and De Haes (2004) stated that it is imperative that the risk assessment methodology for veterinary medicines is further developed and correctly applied. The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (EMEA, 2009) identified the need for validated, standardised methods for assessing the fate of veterinary medicines in manure at either laboratory or field level.…”

Section: Veterinary Medicinesmentioning

confidence: 99%

Environmental risk assessment for food-related substances

Smith

König

2010

Food Control

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“…If not, then realistic best case conditions, characterising a possible safe use in vulnerable areas under the Nitrate Directive in the European Union, are proposed in a similar scenario, now assuming active incorporation of slurry into 20 cm of soil, at a nitrogen application rate of 170 kg N ha −1 year −1 in one time. If the trigger for further testing is exceeded, then further assessments should be made at the member state level, since environmental concerns can be a reason to refuse (mutual recognition of) marketing authorisation (Montforts et al, 2004).…”

Section: Scenario Development For Spreading Of Manurementioning

confidence: 99%

Validation of the exposure assessment for veterinary medicinal products

Montforts

2006

Science of The Total Environment

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Under the EU Directive 2004/28/EC, an environmental risk assessment of new veterinary medicinal products is required. Given the nature of risk assessment for new applications, there is a need to model exposure concentrations. Critical evaluations are essential to ensure that the use of models by regulators does not result in the propagation of misleading information. The empirical validations of soil exposure models, previously discussed in this journal, indicate that it is impossible to analyse the contribution of every model parameter to the variability in the predictions. In particular, the prediction of the slurry concentration is challenged by uncertainties concerning dilution, mixing and dissipation of residues. Surface water and groundwater models generated highly deviating results compared to the field results, questioning the usefulness of the available screening models. Animal husbandry, slurry handling and environmental conditions throughout Europe are considered in order to define realistic worst case scenarios, to be used in conjunction with distribution models for the environmental risk assessment of veterinary medicinal products at registration. Given the variability in manure management practice throughout Europe, a deterministic approach for the manure-to-soil model was selected. Both worst case and best case scenario were developed. Several modelling assumptions applied in the surface water exposure model for fish nursery effluent were validated against newly available data. Since the available data give no proof that a settling tank contributes to the removal of pesticides from waste water, it is recommended for risk assessment purposes to consider the contribution of the settling tank to removal of pesticides and medicines to be negligible. Surface water dilution factors may be considered to be rather small, a factor of 2, for low flow situations.

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Legal constraints in EU product labelling to mitigate the environmental risk of veterinary medicines at use

Cited by 16 publications

References 17 publications

Effects of the Veterinary Pharmaceutical Ivermectin in Indoor Aquatic Microcosms

Effects of the Veterinary Pharmaceutical Ivermectin in Indoor Aquatic Microcosms

Environmental risk assessment for food-related substances

Validation of the exposure assessment for veterinary medicinal products

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