Can Safety Assessment be done in a lab outside of the EU?

The Safety Assessment procedure is a crucially important part of the cosmetics compliance process for all manufacturers and distributors seeking to introduce a cosmetic product to the European Market for the first time. Under Annex 1 of European Cosmetics Regulation EC 1223/2009, the safety assessment makes up an entire part (Part B) of the Product Information File – without either of which a product cannot be brought to any European member states.

When it comes to where and how the safety assessment procedure can be carried out, there are a couple of guidelines and conditions laid out in regulation EC 1223/2009 which can help manufacturers more easily navigate the compliance process. In this blog, we will outline the most important issues and conditions for manufacturers and distributors who wish to carry out their safety assessments outside the boundaries of a laboratory inside the European Union.

The Safety Assessor must hold a relevant degree from a European university

As outlined in regulation EC 1223/2009, a Safety Assessor is a person or body in possession of a diploma or formal qualification awarded in the area of pharmacy, medicine, dermatology, toxicology, or another related discipline. One major stipulation to this is that the assessor’s diploma, degree, or qualification must come from a recognized European university.

It is also recommended that each Safety Assessor has a minimum of three years’ experience in the industry before being appointed to the role.

Manufacturers seeking to compromise on this aspect of the process will find themselves at a standstill when completing the safety assessment as notation of the Assessor’s credentials and qualifications are a mandatory inclusion of Part III of a product’s safety assessment file (in the product’s PIF).

If the Safety Assessor does not hold a European degree, they must have a degree recognized by a European member state

In instances where a manufacturer’s Safety Assessor does not have a degree or relevant qualification issued by a European university, but does have a qualification issued by another reputable body, they may apply to have the qualification officially recognized. For this to happen, the qualification must be recognized officially by the relevant appointed national bodies within at least one of the EU member states in which the product will be sold.

With many years of industry experience in a range of compliance issues, Obelis’ team of regulatory experts are always happy to answer any questions you may have about the safety assessment process. You can also contact us to find out more about Obelis’ European Responsible Person services.

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