Scientific Opinion on the criteria to be used for safety evaluation of a mechanical recycling process to produce recycled PET intended to be used for manufacture of materials and articles in contact with food
Competing interests: One member of the Panel, Roland Franz declared an interest as his Institute has submitted applications for the evaluation of recycling processes. This was considered as a conflict of interest and he was requested to leave the room during discussion and adoption of the opinion.
This scientific opinion of EFSA deals with the criteria to be used for safety evaluation of a recycling process to produce recycled PET intended to be used for manufacture of materials and articles in contact with food.
The principle of the evaluation is to apply the cleaning efficiency of a recycling technology or process, obtained from a challenge test with surrogate contaminants, to a reference contamination level for post consumer PET, conservatively set a 3 mg/kg PET for a contaminant resulting from possible misuse. The resulting residual concentration of each contaminant in recycled PET (Cres) is then compared to a modelled concentration in PET (Cmod). This Cmod is calculated using generally recognized conservative migration models such that the related migration does not give rise to a dietary exposure exceeding 0.0025 μg/kg bw/day, the human exposure threshold value for chemicals with structural alerts raising concern for potential genotoxicity, below which the risk to human health would be negligible.
The default scenario, when the recycled PET is intended for general use, is that of an infant weighing 5 kg and consuming every day 0.75 l of water coming from a water bottle manufactured from 100% recycled PET. According to this scenario, it can be derived that the highest concentration of a substance in water that would ensure that the dietary exposure of 0.0025 µg/kg bw/day is not exceeded, is 0.017 μg/kg food. Taking into account that generally agreed diffusion modelling overestimates migration by at least 5 times, a calculated migration less than 0.1 µg/kg in food would satisfy the above criterion for the default exposure scenario. In the case of the other exposure scenarios for adults and toddlers, the relevant migration criterion will accordingly be 0.75 and 0.15 µg/kg food.
Therefore if a recycling process is able to reduce an input reference contamination of 3 mg/kg PET to a Cres not higher than a Cmod corresponding to the relevant migration criterion, the potential dietary exposure cannot be higher than 0.0025 µg/kg bw/day and recycled PET manufactured with such recycling process is not considered of safety concern.
The Panel considered appropriate that the proportion of PET from non-food consumer applications should be no more than 5% in the input to be recycled.