US EPA

2243418 

Journal Article 

Abstract 

Risk assessment of di-isobutyl phthalate and di-n-butyl phthalate in food 

Woelfle, D; Pfaff, K; Platzek, T; Luch, A 

2009 

1 

Toxicology Letters
ISSN: 0378-4274
EISSN: 1879-3169 

189 

S272 

English 

10.1016/j.toxlet.2009.06.845 

WOS:000269778800805 

https://search.proquest.com/docview/20197850?accountid=171501
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Phthalate esters are ubiquitously present in the environment and some of them, e.g. di-n-butyl phthalate (DnBP) and di-isobutyl phthalate (DiBP), cause reproductive tract malformations in male rats. The European Food Safety Authority has evaluated five phthalate esters, which migrate into food, including DnBP (EFSA, 2005). Consequently, these phthalates were regulated by the European Commission for use in plastic materials in contact with food (Directive 2007/19/EC). DiBP, which was not evaluated by EFSA, has recently been shown to migrate primarily from paper and board packaging into foods with a maximum of almost 30 mg/kg. Considering the similar toxicity of DiBP and DnBP and the substantial exposure of humans, particularly infants, to both phthalates the Federal Institute for Risk Assessment (BfR) discussed a guidance value for DiBP: as an initial measure a specific migration value up to 1 mg DiBP/kg food and 0.5 mg/kg baby food was proposed. Additionally, the question arises whether DnBP and DiBP have to be evaluated for their combined exposure to humans.

Phthalates classified for reproductive toxicity have been shown to have a similar mode of action. Recent data from studies with combined exposure to several phthalates showed a dose cumulative reduction of fetal rat testosterone production (Howdeshell et al., 2008). Based on dose additive effects and the exposure to both DnBP and DiBP via multiple pathways the potential health impact particularly for children is discussed along with the actions taken together with the Federal Environmental Agency (UBA) and manufacturers of paper and board to reduce the exposure from food contact materials. 

Food; Phthalates; Risk assessment; (September 13; 2009)