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Safety evaluation of certain food additives - ipcs inchem

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PAPRIKA EXTRACT<br />

First draft prepared by<br />

Dr I.C. Munro, 1 Dr E.R. Nestmann 1 and Ms J. Baines 2<br />

1 Cantox Health Sciences International, Mississauga, Ontario, Canada<br />

2 Food Standards Australia New Zealand, Canberra, ACT, Australia<br />

Explanation ................................................................................<br />

Chemical and technical considerations ...............................<br />

Biological data ...........................................................................<br />

Biochemical aspects ...........................................................<br />

Absorption, metabolism, distribution and excretion ......<br />

Humans ..................................................................<br />

Rats ........................................................................<br />

Toxicological studies ...........................................................<br />

Short-term studies <strong>of</strong> toxicity ........................................<br />

Mice ........................................................................<br />

Rats ........................................................................<br />

Long-term studies <strong>of</strong> toxicity and carcinogenicity .........<br />

Genotoxicity ..................................................................<br />

Reproductive toxicity .....................................................<br />

Observations in humans .....................................................<br />

Dietary exposure .......................................................................<br />

Poundage data ....................................................................<br />

Food balance sheet data (chillies and peppers) .................<br />

Household economic survey data (paprika extract) ............<br />

Individual dietary records data (paprika extract) .................<br />

Individual dietary records from national survey consumption<br />

data (peppers) ................................................................<br />

Estimated dietary exposure to capsaicin ............................<br />

Evaluation <strong>of</strong> dietary exposure ............................................<br />

Comments .................................................................................<br />

Toxicological data ...............................................................<br />

Assessment <strong>of</strong> dietary exposure .........................................<br />

Evaluation ..................................................................................<br />

References ................................................................................<br />

Appendix 1. Results <strong>of</strong> NATCOL survey <strong>of</strong> paprika oleoresin<br />

usage ....................................................................................<br />

1. EXPLANATION<br />

At its fifty-fifth meeting in 2000 (Annex 1, reference 149), the Committee<br />

concluded that paprika oleoresin is acceptable as a spice, confirming the outcome<br />

<strong>of</strong> an <strong>evaluation</strong> performed by the Committee at its fourteenth meeting in 1970<br />

(Annex 1, reference 22), which stated that the product was derived from a widely<br />

consumed natural <strong>food</strong>stuff and there were no data indicative <strong>of</strong> a toxic hazard. The<br />

use as a spice was considered to be self-limiting and obviated the need for an<br />

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