Ensuring safety of cosmetic products: evaluation of packaging-content interactions

By Davide Tartaglione, Eurofins BioPharma Product Testing Italy,  DavideTartaglione@eurofins.com

Assurance of consumer health is one of the main focuses of Cosmetic Regulation (EU 1223/2009). According to Annex I, the assessor should evaluate the safety of the product through an in-depth toxicological assessment. He/she should also take into account any impurities, traces and information on packaging, "including its interaction with the product, its barrier properties and substance migration from/to the packaging material." A correct choice of container ensures that the characteristics of the products are maintained through its shelf life, without any modification of performance and safety.

As no specific guidelines have been issued on this topic by now, main knowledge comes from food contact material regulation and guidelines where interaction/ compatibility with packaging is strictly regulated.

Accelerated stability in a climate chamber is a useful tool as it simulates long-term storage, while rapidly allowing detection of unwanted interactions. Appropriate controls for inert packaging, such as glass containers, should always be carried out.

In general, alterations in the formulation, appearance, colour, odour, pH and appearance/functionality of the package are assessed. Adsorption/absorption, leaching, permeation and chemical reaction should also be evaluated on a case-by-case analysis, depending on nature of package and formulation. Specific attention is given to potential leaching of substances that can arise in toxicological concern. For example plastics can release phthalates as degradation products or additives, heavy metals as manufacturing process catalysts, additives such as antioxidants or polymerisation stoppers and nitrosamines and aldehydes as degradation products could also be eventually monitored. A wide range of analytical techniques, from wet chemistry to HPLC to mass spectroscopy, are employed for this scope.

Eurofins specialists will be happy to support you in defining the best study design suitable for your product and your needs.

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