Failure to Comply: Risks of Non-Compliance
Evidently, non-compliant products enter the EU Market everyday - whether the brand owner knowingly acts in this way or due to a lack of knowledge imparted from EU importers/distributors.
As there is no "pre-approval" in the EU Market, Competent Authorities focus almost exclusively on conducting systematic surveillance of products which are being made available on the market. This can include pulling products off shelves, stopping products at customs or even deploying online checks to identify EU or non-EU based e-commerce shops which mention that they ship to the EU Market.
Should you choose to take the risk to ship cosmetic products to Europe which have not followed the required path to compliance as detailed above, you should also be prepared for the consequences.
The main consequences include, but are not limited to:
- Being publicly reported to RAPEX
- Warehousing Fees
- Requested Withdrawal
- Mandated Withdrawal
- Product Recall (from end-users and/or the market)
- Complete ban on marketing of the product
- Destruction of the product
Ultimately, the prescribed actions that are to be taken in the case that a product is found to be non-compliant will vary depending on the EU Competent Authority which identified the breach, the EU Member State, the cooperation from the brand owner and the actions taken by the appointed EU Responsible Person. Above all else, the professionalism and expertise of the appointed EU Responsible Person in dealing with various Competent Authorities and handling such situations play a vital role in the successful recovery of your brand in the EU Market.
- Scope & Classification
- The Regulation: EC 1223/2009
- EU Responsible Person
- Product Information File
- Good Manufacturing Practices
- Cosmetic Product Safety Report (CPSR) - Part A & B
- Mandatory Safety Testing
- EU Labeling
- Pre-Market Notification: Cosmetic Product Notification Portal (CPNP)
- Post-Market Surveillance
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