19th Amendment to the Plastics Regulation: Transition Period Expiring – What Companies Need to Know Now

The transition period for the 19th Amendment to the Plastics Regulation (EU) No 10/2011 ends on September 16, 2026. In the Innoform web seminar “19th Amendment to the Plastics Regulation (EU) No 10/2011”, Heike Schwertke explained the impact of the new regulations on manufacturers, converters, and users of food contact materials.

The focus was on the stricter requirements regarding the high degree of purity of substances, the evaluation and documentation of NIAS (Non-Intentionally Added Substances), new regulations on the reprocessing of plastic by-products, and changes to declarations of compliance and testing procedures.

High degree of purity comes into stronger focus

One of the central topics of the regulation amendment is the specification of the term “high degree of purity”. In the future, manufacturers of monomers, additives, and other starting substances must evaluate and document the composition of their products as well as contained impurities and degradation products significantly more precisely.

In the web seminar, it became clear that the main responsibility lies with the manufacturers of the starting substances. However, converters and users must ensure that the declarations of compliance provided meet the current requirements and that necessary information is passed along.

NIAS must be given greater consideration

Another key topic was the assessment of NIAS. The speaker explained the various options for risk assessment as well as the regulation’s requirements for passing on relevant information along the supply chain. Particularly in the case of composite packaging, identical NIAS can originate from different components, which is why their documentation is becoming increasingly important.

The discussion also showed that analytical screening of the final product alone is not sufficient to fully verify the required high degree of purity. Rather, information about the raw materials used and their evaluation is essential.

Reprocessing of plastic by-products regulated more clearly

Another important aspect of the 19th Amendment concerns the reprocessing of plastic by-products. The regulation now distinguishes more clearly between plastic waste and reusable by-products. New requirements apply to reprocessing with regard to collection, labeling, traceability, and quality assurance.

In the future, companies must be able to prove that reused by-products are collected and processed in controlled processes. In addition, corresponding information is required in the declarations of compliance.

Changes to declarations of compliance and testing

The requirements for declarations of compliance have also been expanded. For example, additional information on substances and, where applicable, on relevant NIAS must in future be provided along the supply chain.

In addition, specifications for evaluating test results and taking measurement uncertainties into account have been clarified. Furthermore, the speaker explained the changes regarding the surface-to-volume ratio and the impact on migration testing. These adjustments are intended to contribute to a more uniform evaluation of food contact materials in the future.

Reusable materials: New requirements for stability and labeling

For reusable materials, the requirements for material stability have been specified. Companies must demonstrate that migration does not increase with repeated use. In addition, the regulation contains new requirements for the labeling of reusable articles as well as instructions regarding potential material changes and misuse.

Conclusion

The 19th Amendment to the Plastics Regulation brings numerous clarifications and additional documentation obligations. In particular, the requirements regarding the high degree of purity, the evaluation of NIAS, and the expanded information duties in declarations of compliance will keep companies along the entire supply chain busy. With the expiration of the transition period, affected companies should now check whether their documentation, supplier information, and internal processes comply with the new requirements.