scholarly journals Environmental risk assessment of human and veterinary medicinal products - Challenges and ways of improvement

2018 ◽  
Vol 136 ◽  
pp. 67-70 ◽  
Author(s):  
István Sebestyén ◽  
Katalin Monostory ◽  
Gábor Hirka
Keyword(s):  
Risk Assessment ◽  
Environmental Risk ◽  
Environmental Risk Assessment ◽  
Medicinal Products ◽  
Veterinary Medicinal Products

scholarly journals Critical discussion of the current environmental risk assessment (ERA) of veterinary medicinal products (VMPs) in the European Union, considering changes in animal husbandry

2021 ◽  
Vol 33 (1) ◽  
Author(s):  
Ruth Haupt ◽  
Céline Heinemann ◽  
Jason Jeremia Hayer ◽  
Simone Magdalene Schmid ◽  
Miriam Guse ◽  
...  
Keyword(s):  
Risk Assessment ◽  
European Union ◽  
Phase I ◽  
Environmental Risk ◽  
Environmental Risk Assessment ◽  
Animal Husbandry ◽  
The European Union ◽  
Medicinal Products ◽  
The Eu ◽  
Veterinary Medicinal Products

Abstract Background Veterinary medicinal products (VMPs) administered to livestock might affect the environment. Therefore, an environmental risk assessment (ERA) is conducted during the approval process of VMPs. In the European Union (EU), the ERA, which was established approximately 10 years ago, consists of two phases. In the present review, we examined the first phase. In this phase, VMPs are subjected to a decision-making process comprising 19 questions and several tables with default values published in the “Guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38 (European Medicines Agency 2016).” Since a proportion of livestock husbandry systems is currently shifting toward ecological husbandry and free-range production systems, there is a lower risk of VMP consumption in general, but livestock excretions possibly containing VMPs might be directly released into the environment instead of being stored and applied as manure. In the present study, the first phase of the current ERA of VMPs in the EU was critically discussed with respect to the changes in animal husbandry. The large number of default values used in the ERA were checked for topicality. In a three-step approach, firstly trends and changes in animal husbandry in Europe that might be relevant for the ERA were collected, secondly, the interactions between Phase I and animal husbandry were evaluated and thirdly, the default values used in Phase I were verified in order to identify research gaps. Results Several default values used in the current ERA were identified as outdated. Together with the lack of valid data (e.g., on animal husbandry systems or VMP treatments), this may have an impact on the predicted environmental concentration (PEC) as the central decision threshold of the ERA. Conclusions The results of the present study indicate that an update of the ERA of VMPs in the EU is required to consider the changes in animal husbandry. Several aspects related to this issue are critically discussed.

scholarly journals Environmental risk assessment of veterinary medicinal products intended for use in aquaculture in Europe: the need for developing a harmonised approach

2021 ◽  
Vol 33 (1) ◽  
Author(s):  
Irene de la Casa-Resino ◽  
Michael T. Empl ◽  
Sara Villa ◽  
Boris Kolar ◽  
Julia Fabrega ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Phase I ◽  
Environmental Exposure ◽  
Phase Ii ◽  
Environmental Risk ◽  
Environmental Risk Assessment ◽  
Medicinal Products ◽  
Regulatory Guidance ◽  
Guidance Documents ◽  
Veterinary Medicinal Products

AbstractThe current and future expansion of aquaculture production appears to be only manageable by using veterinary medicinal products (VMPs) to prevent and reduce disease outbreaks. However, only a very low number of VMPs are available for use in aquaculture systems. In addition, the environmental risk potentially emanating from the use of these products has gained increased attention in the last years. In this context, the present review represents an in-depth analysis of the current two-tiered (phase I and phase II) approach for the environmental risk assessment (ERA) of VMPs mandatory in the European Union and the European Economic Area (EU/EEA), and its applicability to medicinal products intended for use in aquaculture. The following conclusions are drawn: (i) the current regulatory guidance documents detailing the phase I and II ERA procedure should be updated and harmonised across Member States and simple approach(es) applicable to the assessment of the environmental exposure of VMPs intended for use in aquaculture facilities should be devised; (ii) current and future regulatory guidance documents detailing the phase II ERA procedure for VMPs intended for use in aquaculture should comprise advanced mathematical models suitable for addressing different exposure scenarios relevant across the whole EU/EEA (including scenarios addressing the exposure of VMPs to agricultural soils from fish sludge); and (iii) it is recommended that any updates of relevant ERA guidelines clearly detail the types of studies needed to determine potential adverse effects of VMPs used in aquaculture on non-target organisms. Furthermore, the application of risk mitigation measures tailored to the reduction of the environmental exposure of VMPs on an individual aquaculture farm level should be considered in any future or updated guideline. Finally, it is anticipated that the present analysis of the main drawbacks surrounding the current ERA regulatory framework will help competent authorities to harmonise and facilitate the approval process for VMPs intended for use in aquaculture.

scholarly journals Three methods for integration of environmental risk into the benefit-risk assessment of veterinary medicinal products

2017 ◽  
Vol 605-606 ◽  
pp. 692-701 ◽  
Author(s):  
Jennifer L. Chapman ◽  
Lucas Porsch ◽  
Rodrigo Vidaurre ◽  
Thomas Backhaus ◽  
Chris Sinclair ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Environmental Risk ◽  
Medicinal Products ◽  
Benefit Risk Assessment ◽  
Veterinary Medicinal Products
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