Specific migration of di-(2-ethylhexyl)adipate (DEHA) from plasticized PVC film: results from an enforcement campaign

A control campaign on the correct labelling of plasticized PVC film according to current legislation on food contact materials has been performed. Analytical methods based on the isotope dilution technique were developed. For enforcement purposes, the films were exposed to the official food simulant, olive oil, followed by clean-up using size exclusion chromatography and final determination of di-(2-ethylhexyl) adipate (DEHA) by combined capillary gas chromatography and mass spectrometry (GC-MS). In the initial screening, the samples were exposed to the alternative food simulant, isooctane, and DEHA could be determined by GC-MS without further clean-up. A good consistency between results from the two different methods was obtained. During the campaign, 49 samples of PVC films, the majority intended for use in retail shops, were sampled from importers and wholesalers by the Municipal Food Control Units. Initially, all films were screened for the migration into isooctane (exposed 2 h at 40 degrees C) of DEHA and other potentially present low molecular weight plasticizers using full scanning mass spectrometry. Films showing a substantial migration of DEHA were further tested with olive oil according to the declared field of application (exposed for 10 days at 40 degrees C). In 47 of the 49 films the migrate contained a substantial amount of DEHA. In 46 films the migration exceeded the specific migration limit of 3 mg/dm2 after use of the relevant reduction factor given in legislation. However, because of the general uncertainty of the analytical method and because the variation in the thickness of the films was calculated to be 1 mg/dm2, the action limit in this campaign was 4 mg/cm2. A migration higher than this action limit was found in 42 films (89% of the samples) and these films were deemed to be illegal according to their present declared field of application as given by their labelling. In a few cases, some migration of the plasticizer di-n-butyl phthalate was seen.