The EU Cosmetic Regulation EC 1223/2009, published in the official journal of the European Union on November 30th 2009 and introduced on July 11th 2013, requires all cosmetic products to apply a specific compliance process – this compliance process may take between 4-8 months on average.
When evaluating whether or not to take the plunge and initiate this process, the first question brand owners and manufacturers ask is, “How long is this going to take?” There are 3 main determinants which can support brand owners with an answer to this question.
Main determinants of EU compliance
- Raw Material Suppliers/Producers:
Given that most Brand Owners are not producing or formulating their own cosmetic or personal care products, the biggest predictor of their EU Compliance time frame is the cooperation of the “middle-men”. Ultimately, providing product and raw material specifications is the #1 cause of delay in the compliance process. By choosing an ISO 22716 certified (GMP compliant) producer who is familiar with the EU process will be instrumental towards a streamlined process.
2. Safety Information:
Along with the information to be collected from raw material suppliers and producers, there are a number of mandatory Safety Tests along with substantiation of any claims (safety or marketing) which must be completed prior to undergoing the Safety Assessment. If products have already been submitted to Stability, Packaging Compatibility and Challenge tests in accordance to accepted Protocols, this will save time and money in the process.
3. In-House Resources:
While the EU Responsible Person plays a pivotal role in bringing products into compliance and ensuring continued compliance, collection of the necessary documentation will require the active support of the manufacturer/brand owner. This does not require in-house EU expertise but rather devoting a person within the organization which ‘owns the problem’ with the available time and resources to accompany the compliance process.
Ensure a swift EU Registration
In the addition to the factors above, partnering with an agency which provides professional EU Responsible Person services with the mandatory in-house Regulatory expertise, will play a major role in your EU Market success. Such an agency should also be able to provide guidance and support when dealing with suppliers, importers, and distributors in Europe.
For more about how to best prepare your products for EU Market entry, please contact us.