My product has been found to be non-compliant – now what?

Full compliance is vital for all cosmetic products that are seeking to enter or have already been placed on the European Market. Under European Cosmetics Regulation 1223/2009, the onus falls to the manufacturer or distributor to ensure each product they have introduced to the market is fully compliant not only with Regulation 1223/2009 but all other applicable regulations or directives. It is for this reason that those responsible should be aware of the consequences of non-compliance, and in the event of such an occurrence, how to deal with the situation.

Firstly, it’s important to be aware of the consequences of non-compliance. Though full compliance is a prerequisite to introducing a product to the EU market, sometimes non-compliant products can slip though the net. In the long run, the result can be overwhelmingly negative for both the manufacturer and the cosmetic product. Consequences of non-compliance for cosmetic products, other than damage to a manufacturer’s reputation and trustworthiness within the EU zone, can include: removal of the product from the EU market on a temporary/permanent basis, refusal of free movement for the product with the EU zone, product recall, and in some scenarios a blanket ban on the product within Europe or even destruction of the product. There can also be many indirect knock-on effects of non-compliance, like fines associated with found cases of non-compliance, or warehousing and storage costs for non-compliant inventory (for example, non-compliant products found to be so by customs officials and duly turned away). In all cases, however, the most important consequence to be aware of is that a product found to be non-compliant must restart the compliance process.

In cases where a manufacturer is based outside of the European Union, under Regulation 1223/2009, all compliance related issues must be handled by a legally appointed Responsible Person with a registered address inside the EU. It is the duty of the Responsible Person to act as the main point-of-contact between the manufacturer and the relevant Competent Authorities inside Europe. This includes the notification process, safeguarding compliance processes, and the holding of a product’s Product Information File within the bounds of the EU for a minimum of 10 years after its release on the market. The Responsible Person is also responsible for consulting with and advising the manufacturer on EU laws and regulations. In non-cosmetic markets, many of these duties would fall to a European Authorized Representative (EAR).

It’s also important for manufacturers and distributors to note that Competent Authorities have historically been known to take a product or manufacturer’s previous behaviours and history into account. For example, products with a history of non-compliance in the EU will be met with much greater scrutiny when the time comes to enter the EU market again. Similarly, if a manufacturer is found to have a non-compliant product, questions may be raised regarding whether or not that might signal a history of non-compliance on one or more of their products. Competent Authorities also reserve the right to have constant access to a manufacturer’s Responsible Person, and may dictate many non-compliance consequences and rectification processes, including: timeline for bringing a product into full compliance, reporting, or removal from market. The severity of such consequences can vary depending on a number of factors, such as EU member state or the individual Competent Authority in question.

While, for the sake of example, we are talking about cosmetic products in this instance, these implications and consequences hold true for all products affected by all relevant EU regulations and directives, e.g. construction products, motor vehicles, or personal protective equipment, as well as a whole range of other products or devices. Notification of and information regarding such non-compliant products or devices can be accessed by anyone through the RAPEX database – a Europe-wide alert system allowing the free exchange of compliance status and infringement made mandatory under General Products Safety Directive 2001/95/EC.

For more information on the Compliance process, to find out about Obelis’ Responsible Person or Authorized Representative services, or for advice on European regulations and legislation, contact us today.

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