It isn’t always easy to determine just how long it takes to register a cosmetic product for release on the European Market. In some cases it can be a lengthy process, in others quite brief.
In general, the EU compliance process takes between 4-8 months. There are two main factors determining the timeline of the registration process:
- How ready the technical documentation (Product Information File) is
- If all the safety test have been done
In order to shed some more light on this, here we will outline some of the steps in the compliance stage which are crucial to shorten the timeline of the registration process.
1. Appointing a European Responsible Person
According to European Regulation EC 1223/2009 (Article 4.1), “Only cosmetic products for which a legal or natural person is designated within the community as ‘responsible person’ shall be placed on the market.” This, of course, counts for the registration of the cosmetic product equally. As a result, all manufacturer are advised to appoint a European Responsible Person as early as possible in order to expedite the compliance process.
2. Completing the Product Information File
Another important step in reaching the product registration process is compiling the Product Information File (PIF). The PIF is a mandatory collection of technical documentation required of each cosmetic product before it can be placed on the European Market. The file is to be held at all times by the Responsible Person inside the bounds of the European Union for a period of at least 10 years after the last batch of a given product was put on the market. It must be accessible at all times by European Competent Authorities.
Some of the elements required within the PIF include:
- Product Description
- Safety Report:
- Part A: Cosmetic Product Safety Information
- Part B: Cosmetic Product Safety Assessment Report
- Method of Manufacturing
- Evidence of compliance with Good Manufacturing Practices (GMP)
- Proof of the effect claimed (where justified)
- Data on Animal Testing
- Labelling (taking into account the container and outer packaging)
- Data on Serious Undesirable Effects
3. Completing all the necessary Safety Tests
Safety Testing is another important, mandatory step in the registration process. The main tests required for cosmetic products in the EU include:
- Stability testing (ensuring the consistency of the product remains intact in stressful environments),
- Compatibility testing (testing of the product in conjunction with the packing to ensure no packaging materials have any adverse effects on the product, e.g. discoloration or change of odor or appearance),
- Challenge testing (tests made to ensure the product undergoes no undesirable reactions due to exposure to preservatives or other elements introduces to prolong the storage process).
It has to be stressed that while 4-8 months is the usual timeframe, the timeline of the registration process depends greatly on the Manufacturer. Appointing Responsible Person early on in the process, completing all the necessary testing and having PIF ready will speed up the process.
To get a free quote or to learn more about how Obelis’ team of expert regulatory consultants can help facilitate the registration process for you, whether it’s with our European Responsible Person services or otherwise, contact us today!