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Safety evaluation of certain food additives - ipcs inchem

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ALIPHATIC LINEAR ,-UNSATURATED ALDEHYDES, ACIDS AND RELATED<br />

ALCOHOLS, ACETALS AND ESTERS (addendum)<br />

First draft prepared by<br />

Mrs M.E.J. Pronk 1 and Pr<strong>of</strong>essor J.R. Bend 2<br />

1 Centre for Substances and Integrated Risk Assessment, National Institute<br />

for Public Health and the Environment (RIVM), Bilthoven, Netherlands<br />

2 Department <strong>of</strong> Pathology, Siebens-Drake Medical Research Institute,<br />

Schulich School <strong>of</strong> Medicine & Dentistry, University <strong>of</strong> Western Ontario,<br />

London, Ontario, Canada<br />

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

Introduction .........................................................................<br />

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

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

Application <strong>of</strong> the Procedure for the <strong>Safety</strong> Evaluation <strong>of</strong><br />

Flavouring Agents ..........................................................<br />

Consideration <strong>of</strong> combined intakes from use as flavouring<br />

agents ............................................................................<br />

Consideration <strong>of</strong> secondary components ............................<br />

Conclusion ..........................................................................<br />

Relevant background information ..............................................<br />

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

Additional considerations on intake ....................................<br />

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

Biochemical data ..........................................................<br />

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

Acute toxicity ..........................................................<br />

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

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

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

1. EVALUATION<br />

331<br />

331<br />

332<br />

344<br />

1.1 Introduction<br />

The Committee evaluated a group <strong>of</strong> flavouring agents consisting <strong>of</strong> 22<br />

aliphatic linear ,-unsaturated aldehydes, acids and related alcohols, acetals<br />

and esters. This group included 1 2-alkenal (No. 1803), 2 2-alken-1-ols (Nos 1793<br />

and 1794), 2 2-alkenoic acids (Nos 1804 and 1805), 14 related alkenoic esters<br />

(Nos 1795–1799 and 1806–1814), 2 2-alkenal acetals (Nos 1800 and 1801) and<br />

1 unsaturated methoxy compound (No. 1802) that is predicted to be metabolized<br />

to an ,-unsaturated alcohol. The <strong>evaluation</strong>s were conducted according to<br />

the Procedure for the <strong>Safety</strong> Evaluation <strong>of</strong> Flavouring Agents (see Figure 1, Introduction)<br />

(Annex 1, reference 131). None <strong>of</strong> these agents has previously been<br />

evaluated by the Committee.<br />

- 331 -<br />

344<br />

344<br />

345<br />

345<br />

346<br />

346<br />

346<br />

346<br />

346<br />

346<br />

346<br />

347<br />

348<br />

349

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