Intralaboratory validation of an analytical method for determining the migration of bis(2-ethylhexyl) adipate from packaging to fat foods

Polyvinylchloride (PVC) has been widely used in the packaging industry in the form of flexible films for food packaging. Among the main plasticizers used in flexible PVC films is bis(2-ethylhexyl) adipate, DEHA. Brazilian law provides a specific migration limit for DEHA of 18 mg kg^?1 of food simulant. Although Brazilian Sanitary Surveillance Agency Resolution no. 51 (passed on November 26, 2010) establishes conditions for the migration test, there is a need for intralaboratory validation of the method involved. This paper presents the validation of a method for determining the migration of DEHA from food packaging using fatty food simulant. The DEHA migration test was performed through contact between a 1 dm² PVC film cutout and 100 ml of a food simulant, 2,2,4-trimethylpentane (isooctane), for 48 h at 20 °C. The mass fraction of DEHA in the migration solutions was determined by gas chromatography with a flame ionization detector. The method was validated and determined to be well suited to the intended purpose. The working range was defined as 5–25 mg kg^?1 and was determined to be linear, with no observed lack of fit to the model. There was no matrix effect, and the selectivity of the method was considered adequate. The method showed adequate repeatability, intermediate precision, and robust results for migration temperature and migration time: 20 °C with tolerance limit of ±3 °C and 48 h with tolerance limit of ±30 min, respectively.