Hi Susan.
I am not sure if this would be sufficient for the portal but I can tell you that this is not sufficient for the Product Information File (PIF) that is required for all cosmetic products sold in the EU and for which your responsible party in the EU is expected to have on file in their offices prepared for inspection at any reasonable time.
These are all elements of the requirements (the SDS for all ingredients, the SDS for the finished product and the COA and labeling) but there are other pieces to the puzzle that are just as important. First, you need to have both a quantitative and qualitative formulation available both to the level of the individual INCI names as well as the more general information on the individual raw material trade names. These should match to the information on the SDS and the specifications for the individual raw materials that are also required in the PIF.
Next, the EU requires that a safety assessment be performed of the formulation before being placed on the market. This must be completed by a certified safety assessor who has completed the course in the EU before they can sign off on the actual assessments. The safety assessment must account for all possible exposures to the product and must be completed without any additional animal testing (which is strictly prohibited in the EU for cosmetic products).
Third, you have the issue of ensuring that you have all of the necessary data for things like microbiological challenge testing and any claims/safety of the formulation that you claim or that your safety assessor has used on the product formulation. In your case (a beard oil) it might not make sense to perform a challenge test for micro but you then need to have a qualified individual provide you with a rationale as to why the testing is not necessary in this particular case. However, you might have done some sort of HRIPT or some type of safety in use testing that should also be placed in the PIF for review as future needs might arise.
There is also a requirement to provide the EU responsible party with a copy of the general method of manufacturing the product. This doesn't need to be extremely detailed but the EU competent authorities are going to need to have something in the PIF that provides them with some type of processing information for manufacturing the product which can be reviewed for potential contamination/cross-reactions/exposure scenarios, etc. and will also likely be required to be reviewed as part of your safety assessment.
On top of all of this, you need specific information about the packaging for review. This again is required by the regulation and needs to provide information about the type and quality of the packaging and is also starting to be expected to be included in the product safety evaluations.
So there is a lot to get this product into the EU. Oh - and please don't get me started on Brexit and the impacts on companies with EU responsible parties that are based in the UK which is almost certain to cause a fair bit of turmoil over the next 2 years! Hope some of this helps!
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Victor Mencarelli
Director Regulatory Affairs
United States
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Original Message:
Sent: 21-May-2018 06:29
From: Susan Jackson
Subject: Selling a cosmetic in theUK
In selling a cosmetic product. ( beard oil)in the U.K. and to comply with the European Cosmetics Regulation1223/2009.
Is the Sds for all ingredients and and one for the finished product along with Certificate of analysis and the labeling sufficient evidence in a dossier through the portal.
Or am I excluding something? Any advise is appreciated
Sent from my iPad