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Safety Assessment of Cosmetics in the EU

TRAINING COURSE • 6 - 11 FEBRUARY 2017 • 6 ECTS • BRUSSELS • BELGIUM

Objectives of the training course

Safety of cosmetics is a key issue in the EU. 

Until July 2013, Directive 76/768/EEC and its 6th and 7th Amendment applied. They were implemented in the different national laws of the Member States which was a rather slow process and not always perfect. The Directive is replaced now by Regulation EC 1223/2009 which is instantly and directly enforced across the EU. Main drivers are codification, streamlining and simplifying to obtain a better harmonization between the 28 Member States.

The same basic principles, however, remain the same. Thus a cosmetic product on the EU market must be safe and one must be in the position to demonstrate this safety and to provide adequate information to the Authorities as well as to the consumers. Safety of cosmetics and their ingredients is guaranteed through safety assessment and for that purpose a unique dossier (Product Information File) need to be composed. It must be judged by a qualified professional, in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognized as equivalent by a Member State (Art. 10.2).

Several reasons can be given that urge potential safety assessors of cosmetics to follow additional specific academic training in safety evaluation of cosmetics. Reasons include the unadapted traditional lesson packets of the diplomas mentioned in the EU Regulation, the difficulties generated by moving from in vivo to in vitro testing in safety assessment of cosmetic ingredients and finished products, the special needs for small and medium sized enterprises (SMEs), the important tasks of the Responsible Person, the growing awareness of the consumer and the changing role of raw material suppliers for cosmetics. This course, therefore, offers an intensive training programme designed for safety assessors of cosmetics in the EU. It is also open to raw material suppliers, Responsible Persons, SMEs, contract laboratories, inspectors and legislators.

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.

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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?
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Organisation of the training course

Course Organiser • Prof. Vera ROGIERS
  • Doctor in Pharmaceutical Sciences. Master in Applied Toxicology.
  • Full-time professor at the Vrije Universiteit Brussel (VUB) in the faculty of Medicine and Pharmacy; head of department of In Vitro Toxicology and Dermato-Cosmetology (IVTD); lecturing the courses of toxicology, chemical quality and toxicity of cosmetics, and galenics (dermatological preparations) to pharmacy students; responsible for two research teams, one in experimental in vitro toxicology and one in dermato-cosmetology.
  • Organiser of the annual postgraduate course "Intensive Course in Dermato-Cosmetic Sciences" at the VUB.
  • At the European level, co-chair of the SCCS (Scientific Committee on Consumer Safety); chair of the subgroup Methodology.
  • From 2000 - 2009 chairperson of Ecopa (European Consensus Platform on 3R-Alternatives).
  • Coordinator and research partner in EU projects of FP6/FP7 (CONAM, START UP, Predictomics, Liintop, carcinoGENOMICS, ESNATS, DETECTIVE, HemiBio...).
  • Member of the mirror group of EPAA (The European Partnership for Alternative Approaches to Animal Testing).
  • Previous member of ESAC (ECVAM Scientific Advisory Committee) till April 2013, now representative for SCCS in PARERE.

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Please note that the number of participants is limited to 77. In view of the high number of participants in the Safety courses organised during the last years, it is highly advisable to send in your registration form as soon as possible. Registration will be carried out on a first come first served basis.

CANCELLATION POLICY

Registered participants who cannot attend the course may apply for a refund of the registration fee. A substitute delegate is, of course, welcome. Notification is made via e-mail. The participant is entitled to a refund, minus a service fee, according to the following guidelines:

  • 14 to 11 business days before starting date of the course - 25 % of the total amount
  • 10 to 6 business days before starting date of the course - 50 % of the total amount

Regrettably, no refunds will be made if notification is made less than 5 business days prior to the course.