Guidance on selected default values to be used by the EFSA Scientific Committee, Scientific Panels and Units in the absence of actual measured data

EFSA Journal

Volumn 10, Issue 3, 2012, Pages

[No Author Info available]

Author keywords

Body weight; default values; dose conversion; liquid intake; rounding of figures; uncertainty factors

Indexed keywords

EID: 84996465324     PISSN: None     EISSN: 18314732     Source Type: Journal    
DOI: 10.2903/j.efsa.2012.2579     Document Type: Article

References (40)

1. Bitsch A, Jacobi S, Melber C, Wahnschaffe U, Simetska N, Mangelsdorf I. 2006. REPDOSE: a database on repeated dose toxicity studies of commercial chemicals – a multifunctional tool. Regulatory Toxicology and Pharmacology. 46: 202–210.
2. Chen JJ, Moon H, Kodell RL, 2007. A probabilistic framework for non-cancer risk assessment. Regulatory Toxicology and Pharmacology, 48: 45–50.
3. Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT), 2007. Variability and uncertainty in toxicology of chemicals in food, consumer products and the environment. UK. (www.food.gov.uk/science/ouradvisors/toxicity/COTwg/wgvut/)
4. Dourson ML, Felter SP, Robinson D, 1996. Evoluation of science-based uncertainty factors in noncancer risk assessment. Regulatory Toxicology and Pharmacology, 24: 108–120.
5. European Commission (EC), 1967. Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. Official Journal of the European Communities P 196, 16/08/1967 pp. 0001–0098
6. European Commission (EC), 1996. Technical Guidance Document in support of Directive 93/67/EC on risk assessment of new notified substances and Regulation (EC) No. 1488/94 on risk assessment on existing substances, Paris, I, II, III, IV, Luxembourg, Office Publications of the European Community, 1996:L-2965, EC catalogue numbers CR-48-96-001, 002, 003, 004-EN-C.
7. European Commission Scientific Committee on Food (EC SCF). 1993. Nutrient and energy intakes for the European Community. Reports of the Scientific Committee for Food (thirty-first series). Office for Official Publications of the European Communities. ISBN 92-826-6409-0
8. European Commission Scientific Committee on Food (EC SCF), 2001. Guidelines of the Scientific Committee on Food for the presentation of an application for safety assessment of a substance to be used in food contact materials prior to its authorisation. ec.europa.eu/food/fs/sc/scf/out82_en.pdf
9. o79. Exposure factors sourcebook for European populations (with focus on UK data).
10. European Chemicals Agency (ECHA), 2010. Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose[concentration]-response for human health. Guidance for implementation of REACH (echa.europa.eu/).
11. EFSA, 2006. Conclusion on the peer review of metconazole. EFSA Scientific Report; 64, 1–71. Available at www.efsa.europa.eu
12. EFSA, 2011. Use of the EFSA comprehensive European food consumption database in exposure assessment. EFSA Journal; 9 (3): 2097. [34 pp.] doi:10.2903/j.efsa.2011.2097.
13. EFSA Panel on Contaminants in the Food Chain (CONTAM), 2009. Scientific Opinion on a request from the European Commission on cadmium in food. The EFSA Journal; 980, 1–139. doi:10.2903/j.efsa.2009.980.
14. EFSA Panel on Dietetic Products, Nutrition, and Allergies (NDA), 2010. Scientific opinion on dietary reference values for water. The EFSA Journal; 8 (3): 1459. [48 pp.]. doi:10.2903/j.efsa.2010.1459.
15. EFSA Scientific Committee (SC), 2005. Scientific opinion on a request from EFSA related to a harmonised approach for risk assessment of substances which are both genotoxic and carcinogenic. The EFSA Journal; 282, 1–31. doi:10.2903/j.efsa.2005.282.
16. EFSA Scientific Committee (SC), 2009. Guidance on a request from EFSA on the use of the benchmark dose approach in risk assessment. The EFSA Journal; 1150, 1–72. doi:10.2903/j.efsa.2009.1150.
17. European Medicines Agency/International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (EMEA/ICH), 1997. ICH Topic Q 3 C. Impurities: guideline for residual solvents. www.ich.org/products/guidelines/quality/article/quality-guidelines.html
18. Falk-Filipsson A, Hanberg A, Victorin K, Warholm M and Wallén M, 2007. Assessment factors – Applications in health risk assessment of chemicals. Environmental Research, 104: 108–127.
19. Gaylor WG, Kodell RL, 2000. Percentiles of the product of uncertainty factors for establishing probabilistic reference doses. Risk Analysis, 20 (2): 245–250.
20. Groeneveld CN, Hakkert BC, Bos PMJ, de Heer C, 2004. Extrapolation for exposure duration in oral toxicity: A quantitative analysis of historical toxicity data. Human and Ecological Risk Assessment, 10: 709–716.
21. Hasegawa R, Hirata-Koizumi M, Dourson ML, Parker A, Sweeney LM, Nishikawa A, Yoshida M, Ono A, Hirose A, 2010. Proposal of new uncertainty factor application to derive tolerable daily intake. Regulatory Toxicology and Pharmacology, 58: 237–242.
22. International Commission on Radiological Protection (ICRP), 1975. Report of the Task Group on Reference Man. ICRP Publication No. 23. Oxford, Pergamon Press.
23. Interdepartmental Group on Health Risks from Chemicals (IGHRC), 2003. Uncertainty factors: their use in human health risk assessment by UK government. Institute for Environment and Health –IEH, UK (www.le.ac.uk/ieh/).
24. International Programme on Chemical Safety (IPCS), 1987. Environmental Health Criteria 70, Food additives and contaminants in food, principles for the safety assessment of food additives and contaminants in food. Geneva, Switzerland, World Health Organization, International Programme on Chemical Safety.
25. International Programme on Chemical Safety (IPCS), 1994. Environmental Health Criteria 170: Assessing human health risks to chemicals: derivation of guidance values for health-based exposure limits. Geneva, Switzerland, World Health Organization, International Programme on Chemical Safety.
26. International Programme on Chemical Safety (IPCS), 1999. Environmental Health Criteria 210: Principles for the assessment of risks to human health from exposure to chemicals. Geneva, Switzerland, World Health Organization, International Programme on Chemical Safety.
27. International Programme on Chemical Safety (IPCS), 2009. Environmental Health Criteria 240, Principles and methods for the risk assessment of chemicals in food. Geneva, Switzerland, Food and Agriculture Organization/World Health Organization, International Programme on Chemical Safety.
28. Kalberlah F, Schneider K, Schuhmacher-Wolz U, 2003. Uncertainty in toxicological risk assessment for non-carcinogenic health effects. Regulatory Toxicology and Pharmacology, 37: 92–104
29. Kersting M, Alexy U, Sichert-Hellert W, Manz F and Schöch G. 1998. Measured consumption of commercial infant food products in German infants: results from the DONALD study. Journal of Pediatric Gastroenterology & Nutrition; 27 (5), 547–552
30. Lehman AJ, 1954. Approximate relation of parts per million in the diet to mg/kg D.W./day. Association of Food and Drug Officials Quarterly Bulletin, 18:66.
31. Lehman AJ and Fitzhugh OG, 1954. 100-fold margin of safety. Association of Food and Drug Officials Quarterly Bulletin; 18, 33–35
32. Luijckx NBL, Rao GN, McConnell EE, Würtzen G and Kroes R, 1994. The intake of chemicals related to age in long-term toxicity studies – considerations for risk assessment. Regulatory Toxicology and Pharmacology, 20: 96–104.
33. Merten C, Ferrari P, Bakker M, Boss A, Hearty A, Leclercq C, Lindtner O, Tlustos C, Verger P, Volatier J-L and Arcella D, 2011. Methodological characteristics of the national dietary surveys carried out in the European Union as included in the European Food Safety Authority (EFSA) Comprehensive European Food Consumption Database. Food additives & contaminants. Part A; 28 (8): 975–95
34. US Environmental Protection Agency (US EPA), 2002. A review of the reference dose and reference concentration processes. EPA/630/P-02/002. Risk Assessment Forum, US Environmental Protection Agency, Washington DC.
35. Vermeire TG, Stevenson H, Pieters MN, Rennen M, Slob W, Hakkert BC, 1998. Assessment factors for human health risk assessment: a discussion paper. RIVM Report 620110007, TNO Report V97.880.
36. Vermeire TG, Pieters MN, Rennen M and Bos P, 2001. Probabilistic assessment factors for human health risk assessment. RIVM Report 601516005, TNO Report V3489.
37. World Health Organisation (WHO), 2011. Guidelines for drinking-water quality – Fourth Edition. (www.who.int/water_sanitation_health/publications/2011/dwq_guidelines/en/)
38. o2.
39. Zarn JA, Hänggi E, Kuchen A and Schlatter JR, 2010. The significance of the subchronic toxicity in the dietary risk assessment of pesticides. Regulatory Toxicology and Pharmacology, 58: 72–78.
40. Zarn JA, Engeli BE and Schlatter JR, 2011. Study parameters influencing NOAEL and LOAEL in toxicity feeding studies for pesticides: exposure duration vs. dose decrement, dose spacing, group size and chemical class. Regulatory Toxicology and Pharmacology, 61: 243–250.