title: Considering new methodologies in strategies for safety assessment of foods and food ingredients.
abstract: Toxicology and safety assessment are changing and require new strategies for evaluating risk that are less depending on apical toxicity endpoints in animal models and relying more on knowledge of the mechanism of toxicity. This manuscript describes a number of developments that could contribute to this change and implement this in a stepwise roadmap that can be applied for the evaluation of food and food ingredients. The roadmap was evaluated in four case studies by using literature and existing data. This preliminary evaluation was shown to be useful. However, this experience should be extended by including examples where experimental work needs to be included. To further implement these new insights in toxicology and safety assessment for the area of food and food ingredients, the recommendation is that stakeholders take action in addressing gaps in our knowledge, e.g. with regard to the applicability of the roadmap for mixtures and food matrices. Further development of the threshold of toxicological concern is needed, as well as cooperation with other sectors where similar schemes are under development. Moreover, a more comprehensive evaluation of the roadmap, also including the identification of the need for in vitro experimental work is recommended.
authors.affiliation: Utrecht University, Division of Toxicology, Institute for Risk Assessment Sciences, PO Box 80.177, 3508 TD, Utrecht, The Netherlands.
authors.forename: Bas J
authors.initials: BJ
authors.lastname: Blaauboer
authors.affiliation: Imperial College London, Department of Medicine, Centre for Pharmacology & Therapeutics, London, W12 0NN, United Kingdom.
authors.forename: Alan R
authors.initials: AR
authors.lastname: Boobis
authors.affiliation: Unilever, Safety & Environmental Assurance Centre, London, EC4Y 0DY, United Kingdom.
authors.forename: Bobbie
authors.initials: B
authors.lastname: Bradford
authors.affiliation: University of Newcastle, Toxico-Logical Consulting Ltd, The Old Boiler House, Moor Place Park, Kettle Green Lane, Much Hadham, Hertfordshire, SG10 6AA, United Kingdom.
authors.forename: Andrew
authors.initials: A
authors.lastname: Cockburn
authors.affiliation: Nestlé Research Centre, Vers-Chez-les-Blanc, 1000, Lausanne 26, Switzerland.
authors.forename: Anne
authors.initials: A
authors.lastname: Constable
authors.affiliation: University of Konstanz, Center for Alternatives to Animal Testing-Europe CAAT-Europe, 78457, Konstanz, Germany.
authors.forename: Mardas
authors.initials: M
authors.lastname: Daneshian
authors.affiliation: Consultant, 63 Woodlands Road., Sonning Common, Reading, Berkshire, RG4 9TD, United Kingdom.
authors.forename: Gareth
authors.initials: G
authors.lastname: Edwards
authors.affiliation: Danone Food Safety Centre, Utrecht, 3584 CT, The Netherlands.
authors.forename: Jossie A
authors.initials: JA
authors.lastname: Garthoff
authors.affiliation: Mars, Global Chemical Food Safety Group, Slough, SL1 4JX, United Kingdom.
authors.forename: Brett
authors.initials: B
authors.lastname: Jeffery
authors.affiliation: University of Applied Sciences, Research Centre Technology & Innovation, Dept. Innovative Testing in Life Sciences & Chemistry, PO Box 12011, 3501 AA, Utrecht, The Netherlands; TNO Healthy Living, PO box 360, 3700 AJ Zeist, The Netherlands.
authors.forename: Cyrille
authors.initials: C
authors.lastname: Krul
authors.affiliation: ILSI Europe, Avenue E. Mounier 83, Box 6, 1200, Brussels, Belgium. Electronic address: publications@ilsieurope.be.
authors.forename: Jeroen
authors.initials: J
authors.lastname: Schuermans
mesh_terms: D000818:Animals; D001711:Biotransformation; D018929:Cell Culture Techniques; D059022:Food Safety; D006801:Humans; D021281:Quantitative Structure-Activity Relationship
keywords: Food safety; In silico methods; Integrated assessment strategies; In vitro methodologies