EU and US food contact compliance.
After verifying that the starting and reaction materials of Saniconcentrate™ are well-known and can be used to further process as part of a medical device, Zwiers Regulatory Consultancy now also finalised its evaluation of the compliance of Saniconcentrate™ in food contact applications according to EU and US regulations.
To proof food contact material compliance with EU and US regulation, research has been done for each substance within Saniconcentrate™. Moreover, to proof safety for each of them, regulation and databases of food additives, cosmetic ingredients, handbook of pharmaceutical excipients, CLP regulation (to ensure a high level of protection of health and the environment), regulatory agencies inventories and other sources such REACH, Pesticide and Plant protection product regulation have been consulted.
About Zwiers Regulatory Consultancy
Zwiers Regulatory Consultancy provides full regulatory and pharmacovigilance support, throughout the entire product lifecycle. Besides medicinal products, Zwiers Regulatory Consultancy also supports the development of medical devices and IVDs.