Regulation (EU) 528/2012 is a relatively new, complex and ever evolving legislation that establishes the pathway for placing on the market biocidal products. The most important features are the inclusion of a list of approved active substances, a list of approved suppliers and the need for an authorisation before placing the product on the market.

The status of the active substances present on the product will determine which body will evaluate the authorisation since this regulation delegates on national authorities the decision on the registration process for products containing active substances not yet approved and intended to be placed on the market of that member state.

Depending on the intended use, different studies must be carried out to ensure efficacy and human and environmental protection, allowing for a simplified authorisation process in cases when the product has limited impact.

Some products, depending on their characteristics and uses, may be at the border with other regulations or directives, such as detergency, cosmetics or even medical devices.

Our team of experts can help your company define the authorisation strategy most fitting for your needs, offering a complete service from formula development and necessary studies to authorisation submission.

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