Monitoring and reporting of contamination levels
Article 13
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. 4. The developer shall publish every 6 months a report on its website, based on the latest information from all installations using the novel technology received in accordance with paragraph 3. 5. The report shall contain at least: (a) a brief description of the novel technology on the basis of the information referred to in Article 10(3), including the information required under points (a), (b), (d) and (f) thereof; (b) a summary of the reasoning on the capability of the novel technology and the recycling process(es) to manufacture recycled plastic materials and articles that comply with Article 3 of Regulation (EC) No 1935/2004 and that are microbiologically safe on the basis of the information included in points (a) to (f) of Article 10(3), and taking into account the information received in accordance with paragraph 3; (c) a list of all substances with a molecular weight below 1 000 Dalton found in the plastic inputs to each of the decontamination installations and in the recycled plastic output thereof, sorted in descending order by their relative occurrence and of which at least the first 20 detected incidental contaminants in the input have been identified, and their amounts specified as weight fraction of the input and output; (d) a list of contaminating materials regularly present in the plastic input, including polymer types that differ from that in the intended plastic input, plastics not intended for contact with food, and other materials that are found in the inputs and outputs referred to in point (c), and their amounts specified as weight fraction of the input and output; (e) an analysis of the most likely origin of the identified contaminants referred to in points (c) and (d), and of whether those origins could give rise to the simultaneous presence of other substances of concern that are either undetected or unidentified with the applied analytical techniques; (f) a measurement or estimation of the migration levels to food of contaminants present in the recycled plastic materials and articles; (g) a detailed description of the applied sampling strategy; (h) a detailed description of the analytical procedures and methods used, including sampling procedures and limits of detection and quantification, as well as validation data and reasoning on their suitability; (i) an analysis and explanation of any discrepancies observed between contaminant levels expected in the input plastic and in the output of the installation and its decontamination efficiency based on the reasoning provided under point (b) and the actual results under point (c). (j) a discussion of the differences with previous reports published in accordance with this paragraph, if any.