News for the REACH Regulation regarding lead and its compounds in polyvinyl chloride (PVC). In fact, Regulation (EU) 923/2023 was published on May 8, 2023, amending and supplementing Annex XVII entry 63 "lead and its compounds." The new restriction will apply from November 29, 2024, but through some exemptions longer transition periods may be provided.

Increase attention to contaminants. This is the direction taken by the new Regulation (EU) 915/2023, which, as of May 25, 2023, will replace the previous Regulation (EC) 1881/2006. The new provisions regulate maximum levels in food related to mycotoxins, plant toxins, halogenated POPs-such as dioxins, PCBs and perfluoroalkyl substances-, metals and other contaminants.

The amendment involves polytetrafluoroethylene (PTFE) micropowders, so the 1 mg/kg limit can now be applied to placing on the market in order to reduce the concentration of PFOA and its salts below the 0.025 mg/kg limit.

In the 20 November 2023 revision of the EMA document, new compounds and new limits were introduced for some existing nitrosamines.

Verification of the integrity of container closures is a growing concern in the pharmaceutical packaging industry. Recently, the new version of Annex 1 of the European Union's GMP was introduced, dedicated precisely to the Manufacture of Sterile Medicinal Products.

The Food and Drug Administration has released new guidance regarding tolerable levels of nitrosamine-related impurities (NDSRIs) in pharmaceutical products.