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Regulatory

Keystone Products Mean Guaranteed Compliance

Keystone Industries has a quality management system in compliance with FDA’s cGMP requirements that is also ISO 22716 and ISO 13485 certified, governing the requirements for cosmetics and medical devices. In addition, our experienced regulatory team ensures conformance to foreign regulatory requirements for all activities performed.

Product support includes preparation and maintenance of product information (PI) files on all cosmetic products sold into the European Union. These files contain confidential information required under Cosmetics Regulation (EC) No. 1223/2009 of the European Parliament, including the quantitative product formulations, hazard/safety information and raw material technical data. PI files are available to European regulatory officials through our European office located in the Netherlands.

Quality. Compliance. Excellence.

EC Regulation 1907/2006 (REACH)

We understand the potential impact of EC regulation 1907/2006 (REACH) on the chemical industry in the European community. For that reason, we have completed registrations for all applicable substances, ensuring we can continue to operate in this vital marketplace. We also have ongoing communication with our suppliers and are continually evaluating our own registration needs to confirm that our products maintain conformity with reach regulations.