Document g3ejzQ9ooxd58aZ2R3pB4Zka

AR226-3337 Migration ofApFQfrQ^ PTF^ It was decided to develop a new method of extraction of APFO from PTFE samples (extraction during 8 h at reQux with 95 % ethanol at pH = 10 on finely ground material) as well as a new method of detection of APPO using capillary gg$ chromatography. This method allows the detech'on down to 1 pg. which corresponds to a detection limit of 10 ppb in the polymeric sample. The methods of extraction and titration are described in detail in attachments I and II. It was then decided to determine the residual APFO in five samples produced by the four manufacturers of the common Interest group. The samples were chosen in such a way that the worst case situation Is covered (maximum initial content of APPO, softest post treatment in terms of temperature, time, washing etc.. ensuring the potentially highest residue). The five samples were tested by three different companies to make sure that the developed methods are sufficiently robust. The results are summarised in the attached table I. The table shows cleariy that the highest residual amount found was 30 ppb. Using the convention of 6 dm2 in contact with 1 kg of food and considering a maximum wall thickness of 6 mm, the amount of PTFE in contact with 1 kg of food becomes 60cm x 10cm x 0,6cm x 2.169/0^=777.69 The residue of APFO in this material is 30 ppb or 30,10 -9 x 777,6 = 23328 10 - ^ g or 23328 10 - S mg or 0,023328 mg Assuming a 100 % migration, which is probably a large overestimation for a 6 mm thick sample, we see that the migration would be around 0.025 mg/kg food or 25 ppb. In other words, the maximum potential migration in food simulant is 0,025 mg/kg. which is twice below the limit set for a reduced technical dossier. TabSa I Samples 1 2 3 4 5 APPO residues in ppb as detgnnined by company A B C 15-30 10-20 <10 23 10-19 <10 29 11-12 <10 31 16-20 <10 31 9-14 <10