What are the legal consequences if I am not compliant?

By maintaining batch traceable, up-to-date dossiers/PIFs for each of your products, following Cosmetics Good Manufacturing Practices (GMP) and exercising due care by consulting with a qualified, competent safety assessor, you will be positioned well for gaining compliance in whichever country you sell your products.

In our experience, most businesses fall foul of the regulators due to simple mistakes, or by not understanding the requirements of GMP ISO 22716 Unfortunately, some smaller businesses are still ignoring the regulations altogether! By using Cosmetri software you mitigate your risk and reduce the amount of time working on admin and compliance tasks instead of creating and selling your products.

For the E.U., Cosmetics Regulation (EC) No 1223/2009 states:

“Member States shall lay down the provisions on penalties applicable for infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission by 11 July 2013 and shall notify it without delay of any subsequent amendment affecting them.”

In the event of infringement of the regulation, the so-called Competent Authority will first contact the Responsible Person. Remedial action will be required, and in cases where a real threat to human health is determined, a penalty will be incurred 'proportionate to the violation'. In other words - make sure your products are compliant and that they stay compliant.

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