Safety Assessment of Cosmetics in the EU
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Owner/Developer: Vrije Universiteit Brussel (VUB)
This course is realized in close collaboration with the cosmetic industry and teaching is done at high standard academic level. Particular emphasis is given to key issues in safety evaluation of cosmetics including the application of alternative methods and the interpretation of the results, how and when animal testing can be done or remains a necessity, what are the toxicological requirements by the Commission for cosmetic ingredients testing. At the end of the theoretical course, practical training in which the realization of a Product Information File (PIF) according to Annex I of Regulation EC 1223/2009 for a finished cosmetic product is central, is included. The possibility will be given to all participants to pass a written exam (open book exam) during the last day of the course.
Optional / Voluntary
Regulators and policy-makers, Managers
Industry, Governmental bodies, SMEs
Continuing Professional Development
Legislative aspects, Computational methods, In vitro methods
Substantial coverage (e.g. multiple modules)
|Details on the topic or technology covered:||
Key questions to be tackled by the course
What are the key points of Regulation EC 1223/2009?
What rules apply for borderline products?
What are the current challenges in safety assessment of cosmetics in the EU?
Which role does risk perception play in our society and how does it affect the cosmetic industry?
What are “validated” and “valid” alternative methods?
What validated replacement tests do we actually have? How to interpret the results?
How to integrate these in vitro tests in a PIF?
What in silico methodology is available that is useful in safety assessment of cosmetics and their ingredients?
Which role does local toxicity testing play in the safety assessment of cosmetics?
Which role does systemic toxicity testing play in the safety assessment of cosmetics?
How to deal with nanoparticles in cosmetic products?
How to make a Product Information File for a finished cosmetic product according to the actual EU Regulation?
How to make a Product Information File for a cosmetic ingredient to be taken up in the Annexes of the Regulation?
What are the packaging requirements under Annex I?
How to practically use the SCCS Notes of Guidance?
Cosmetics Regulation (EC) No 1223/2009 or equivalent
|Accreditation body and/or authority that approved the education or training:||
Vrije Universiteit Brussel (VUB)
Diploma and 6 ECT
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