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Legislation

Chemical contaminants in food: new updates to regulation (EU) 915/2023

Two important updates concerning chemical contaminants in food have been published, with significant changes that extend and strengthen European legislation.

Legislation

New nitrosamine guidelines: FDA and EMA

The FDA (Food and Drug Administration) has released the final guidelines for controlling nitrosamine impurities in pharmaceuticals, providing crucial directions for manufacturers of active pharmaceutical ingredients (APIs) and drugs.

Legislation

Green light for the approval of Prallethrin as a biocidal active substance

The European Commission recently published the draft regulation approving Prallethrin as a biocidal active substance for use in insecticides and acaricides (PT 18).

Legislation

Revision of the EMA Guideline on Nitrosamines

In the 1 July 2024 revision of the EMA document, new compounds and new limits were introduced for some existing nitrosamines.

Legislation

New EMA guideline: environmental risk assessment of pharmaceuticals

On March 21, 2024, the EMA released the new guideline for the Environmental Risk Assessment (ERA) of pharmaceuticals intended for human use.

Legislation

FRANCE: new guidance on substances with endocrine disrupting properties

France, regulation amendments have been made for endocrine disrupting substances.

Legislation

USA: Proposition 65 update on PFOA and BPA

Proposition 65: New guidelines for certain products containing perfluorooctanoic acid (PFOA) or bisphenol A (BPA).

Legislation

FDA Guideline's Update on Nitrosamines

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