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Safety Assessment of Cosmetics in the EU 2016

maandag, 1 februari, 2016 - 09:00 to zaterdag, 6 februari, 2016 - 15:30
Campus: Brussels Health Campus
Faculteit: Medicine and Pharmacy
Vrije Universiteit Brussel, Medical Campus Jette, Laarbeeklaan 103, 1090 Brussels, Belgium

Read more about the programme


Safety of cosmetics is a key issue in the EU.  Until now, 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 rather slow and not always perfect. From July 2013, the Directive is replaced 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 27 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. Practical courses, 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, are included. The possibility will be given to all participants to pass a written exam at the end of the last day of the course.

Key questions to be tackled by the course:

- What are the major practical and legislative changes between Directive 76/768/EEC and Regulation EC 1223/2009?
- 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 is the impact of REACH on the cosmetic industry?
- What are “validated” and “valid” alternative methods? What is their actual use and how to perform these tests?
- Which role does systemic toxicity testing play in the safety assessment of cosmetics?
- 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 one of the positive lists present in the actual Regulation?
- What are the packaging requirements under Annex I?
- Can the process of risk assessment be improved by new methodologies?


Course Administrators

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 Toxicology; 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. Organizer of the course: “Safety Assessment of Cosmetics in the EU”. At the European level, co-chair of the SCCS (Scientific Committee on Consumer Safety), till April 2013, now invited expert. Chairperson of ecopa (European Consensus Platform on 3R-Alternative Methods) from 2000-2009.

Research partner in several FP6 and FP7 EU projects (CarcinoGENOMICS, Liintop, ESNATS, DETECTIVE and HemiBio) and from 2008 - 2010 coordinator of the START-UP project. Member of the mirror group of epaa (The European Partnership for Alternative Approaches to Animal Testing). Member of ESAC (ECVAM Scientific Advisory Committee), till April 2013.



Date and location 

The Safety Course will be held from Monday 1 February to Saturday 6 February 2016 at the Vrije Universiteit Brussel, Medical Campus Jette, Laarbeeklaan 103, 1090 Brussels, Belgium.


The official language of the course is English. No simultaneous translation will be provided.

Course notes

Complete course notes will be available for all the participants.

Course fee

The registration fee for the Safety Course 2016 is 4.150 euro.
The course fee, payable in advance, covers all lessons, examination costs, course notes, welcome reception, coffee breaks, daily shuttle bus between the hotel and the university and the guided excursion in Antwerp on Wednesday 3 February 2016 with get-together and dinner. Lunches are served at the university and are also included in the course fee.

Social programme

Sunday 31 January 2016: welcome gathering.
Wednesday 3 February 2016: guided visit to Antwerp, get-together and course dinner.


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 register as soon as possible for the 2016 session. Registration will be carried out on a first come first served basis.


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.


Hotel BLOOM! ****
Rue Royale 250, 1210 Brussels, Belgium
T: +32 (0)2 220 66 11 - F: +32 (0)2 217 84 44

A free shuttle bus service will operate on a daily basis between Hotel BLOOM! and the university.


During the course you can stay at Hotel Bloom! at very special, well-negotiated rates.
The rates are 99,00 euro/night during the weekend and 139,00 euro/night from Monday till Thursday (breakfast, internet, fitness… included).

By ticking ‘Hotel BLOOM!’ on the registration form, you will find a link to the reservation form in the confirmation email.

Please fill out the ‘Hotel reservation form’ and email to meeting@hotelbloom.com. Payment is not included in the course fee and will be asked at check-out.


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