L 243/20
EN
Official Journal of the European Union
20.9.2022
(c) information on estimated residual contamination present in the output of the decontamination process taking the decontamination efficiency into account, including that of potentially remaining genotoxic and endocrine disrupting substances and substances referred to in Article 13(4)(a) of Regulation (EU) No 10/2011, even if their occurrence is below the limit of their detection of the applied analytical techniques; (d) information on the fate of contaminants removed in the decontamination process; (e) information on the migration to food of the residual contamination present in the recycled plastic material or article, post-processed in accordance with the requirements of the recycling process, and taking into account the conditions of use defined for the concerned materials and articles; (f) an overall reasoning, discussion and conclusion on the safety of the recycled plastic materials and articles based on the information set out in points (a) to (e).
The information referred to in this paragraph shall be kept up to date and be based on the latest information relevant to these elements, including information provided by the suppliers of the plastic input and the users of the recycled plastic, and information forthcoming from the monitoring in accordance with Article 13 and the dialogue referred to in Article 10(7).
Article 13
Monitoring and reporting of contamination levels 1.
A recycler operating a decontamination installation in accordance with Article 11 shall monitor the average contamination level on the basis of a robust sampling strategy which samples the plastic input batches and the corresponding decontaminated output batches.
The sampling strategy shall take account of all factors potentially affecting the composition of the plastic input, and particularly address variations in the origin thereof, whether geographic or otherwise.
The sampling shall initially include all input batches and corresponding output batches, but the sampling frequency may be reduced once stable averages are obtained.
The sampling frequency shall in any case be maintained at a suitable level to detect trends and/or other changes in the contamination levels of the input batches, and to identify whether the presence of contaminants is reoccurring.
Where determining the sampling frequency based on plastic input batches is impractical due to the particularities of the recycling process, the frequency shall be determined on the basis of batches used at the closest pre-processing operation for which such determination is practical.
Residual contaminant levels in the output shall be determined before any dilution of the output material by addition of other material.
Where contaminant levels in the output are below the level of quantification of the applied analytical methods for monitoring, the monitoring of the output may be replaced with one or more studies that determine the residual contaminant level in a limited number of output batches with analytical methods with a limit of quantification sufficiently low for determining the real decontamination efficiency obtained in the decontamination installation.
In case residual contamination in the output is so low that quantification thereof is not possible, the level of detection of those methods shall be sufficiently low to support reasoning on whether the decontamination efficiency is sufficient to ensure that recycled plastic materials and articles comply with Article 3 of Regulation (EC) No 1935/2004. 2.
For the analyses and tests required to determine the contamination level in accordance with paragraph 1, laboratories performing these activities shall take part regularly and with satisfactory performance in proficiency tests appropriate for this purpose.
The first time a laboratory participates in such a proficiency test shall be before the start of the operation of the recycling facility. 3.
Recyclers shall provide the developer at least every 6 months with the data forthcoming from the monitoring and their updated reasoning in accordance with Article 12 (3)(f) if that has changed on the basis of the data.