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Berggren E.,European Commission - Joint Research Center Ispra | Amcoff P.,Cosmetics Europe | Benigni R.,Organisation for Economic Co-operation and Development | Blackburn K.,Procter and Gamble | And 20 more authors.
Environmental Health Perspectives | Year: 2015

BACKGROUND: Safety assessment for repeated dose toxicity is one of the largest challenges in the process to replace animal testing. This is also one of the proof of concept ambitions of SEURAT-1, the largest ever European Union research initiative on alternative testing, co-funded by the European Commission and Cosmetics Europe. This review is based on the discussion and outcome of a workshop organized on initiative of the SEURAT-1 consortium joined by a group of international experts with complementary knowledge to further develop traditional read-across and include new approach data. OBJECTIVES: The aim of the suggested strategy for chemical read-across is to show how a traditional read-across based on structural similarities between source and target substance can be strengthened with additional evidence from new approach data—for example, information from in vitro molecular screening, “-omics” assays and computational models—to reach regulatory acceptance. METHODS: We identified four read-across scenarios that cover typical human health assessment situations. For each such decision context, we suggested several chemical groups as examples to prove when read-across between group members is possible, considering both chemical and biological similarities. CONCLUSIONS: We agreed to carry out the complete read-across exercise for at least one chemical category per read-across scenario in the context of SEURAT-1, and the results of this exercise will be completed and presented by the end of the research initiative in December 2015. © 2015 Public Health Services, US Dept of Health and Human Services. All rights reserved. Source


Muller-Graf C.,Bundesinstitut furRisikobewertung | Berthe F.,EFSA European Food Safety Authority | Grudnik T.,EFSA European Food Safety Authority | Peeler E.,CEFAS - Center for Environment, Fisheries and Aquaculture Science | Afonso A.,EFSA European Food Safety Authority
Fish Physiology and Biochemistry | Year: 2012

The Treaty of Amsterdam, in force since 1 May 1999, has established new ground rules for the actions of the European Union (EU) on animal welfare. It recognizes that animals are sentient beings and obliges the European Institutions to pay full regard to the welfare requirements of animals when formulating and implementing Community legislation. In order to properly address welfare issues, these need to be assessed in a scientific and transparent way. The principles of risk assessment in terms of transparency and use of available scientific data are probably well suited for this area. The application of risk assessment for terrestrial and aquatic animal welfare is a relatively new area. This paper describes the work developed in the context of the European Food Safety Authority (EFSA) opinions on the application of a risk assessment methodology to fish welfare. Risk assessment is a scientifically based process that seeks to determine the likelihood and consequences of an adverse event, which is referred to as a hazard. It generally consists of the following steps: (i) hazard identification, (ii) hazard characterisation, (iii) exposure assessment and (iv) risk characterisation. Different approaches can be used for risk assessments, such as qualitative, semi-quantitative and quantitative approaches. These are discussed in the context of fish welfare, using examples from assessments done to aquaculture husbandry systems and stunning/killing methods for farmed fish. A critical review of the applications and limitations of the risk methodology in fish welfare is given. There is a need to develop appropriate indicators of fish welfare. Yet, risk assessment methodology provides a transparent approach to identify significant hazards and support recommendations for improved welfare. © 2011 Springer Science+Business Media B.V. Source

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