Safety evaluation of certain food additives - ipcs inchem

PHOSPHOLIPASE C EXPRESSED IN PICHIA PASTORIS
First draft prepared by
Dr U. Mueller, 1 Dr Gérard Pascal, 2 Dr Z. Olempska-Beer, 3
Dr J.-C. Leblanc 4 and Mrs I. Meyland 5
1 Food Standards Australia New Zealand, Canberra, ACT, Australia
2 National Institute for Agricultural Research (INRA), L’Etang-La-Ville, France
3 Center for Food Safety and Applied Nutrition, Food and Drug Administration,
College Park, MD, United States of America (USA)
4 French Food Safety Agency (AFSSA), Maisons Alfort, France
5 Technical University of Denmark, Søborg, Denmark
Explanation ................................................................................
Genetic modification ...........................................................
Product characterization .....................................................
Biological data ...........................................................................
Biochemical aspects ...........................................................
Toxicological studies ...........................................................
Acute toxicity .................................................................
Short-term studies of toxicity ........................................
Long-term studies of toxicity and carcinogenicity .........
Genotoxicity ..................................................................
Reproductive toxicity .....................................................
Multigeneration studies ..........................................
Developmental toxicity ...........................................
Observations in humans .....................................................
Dietary exposure .......................................................................
Intended use, use levels and residual level ........................
Assessment of per capita dietary exposure based on data
from food balance sheets ...............................................
Assessment of dietary exposure based on individual dietary
records ............................................................................
Comments .................................................................................
Biochemical aspects ...........................................................
Toxicological data ...............................................................
Assessment of dietary exposure .........................................
Evaluation ..................................................................................
References ................................................................................
1. EXPLANATION
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At the request of the Codex Committee on Food Additives at its Thirty-ninth
Session (Codex Alimentarius Commission, 2007), the Committee evaluated a
preparation containing the enzyme phospholipase C from a genetically modified
strain of Pichia pastoris. Phospholipase C has not been evaluated previously by
the Committee. The systematic name of phospholipase C is phosphatidylcholine
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