IDEA - International Dialogue for the Evaluation of Allergens

About IDEA

1. A work plan developed by the industry and the EU Commission to address the issue of fragrance allergens 

In December 2011, the SCCS (Scientific Committee on Consumer Safety) advising the European Commission released its draft Opinion on fragrance allergens in cosmetic products (SCCS/1459/11). The recommendations made in this Opinion was eye-opening for the industry which became even more aware of the communication gap existing between all parties and, as a consequence, the knowledge gap of all on fragrance allergens and, more specifically, on the methods to characterize them, assess them and diagnose them.
 
On this basis, IFRA (the International Fragrance Association) developed a work plan of what should be done to improve the risk assessment of fragrance allergens and make even safer the use of scented-products. Industry's scientists at the origin of this document met several times in Nyon (Switzerland) and, because the work plan was born at the second meeting, this advisory group is called the "Nyon II" group. The intent of this initiative was strategic: a consumer adequately protected and safely enjoying fragrance products is the best way for the industry to secure its business and preserve its competitiveness.
 
Once fully drafted, the work plan was handed over to the European Commission (DG SANCO, Risk Assessment Unit) for review and critical comments. It is noteworthy that this project has been crafted from the beginning to be conducted in partnership with the European Commission and its Scientific Committees on consumer safety - the active involvement of these stakeholders being essential for its success. On March 14th, 2013, after a thorough review process involving IFRA and the Commission, the project was fully endorsed by Tonio Borg, Commissioner for Health.
 
The final work plan, consisting of four tasks, has meanwhile moved into its implementation phase and this phase is the IDEA project. Both IFRA and the European Commission assumed that this project can be completed in three to seven years.

 

 

 

2. IDEA is a long-term project conducted in partnership with the EU Commission

IDEA consists of a series of two to three-day workshops bringing leading international scientists together to reach consensus on improving existing methodologies. Each workshop focuses on a specific task of the work plan but the tasks are not necessarily addressed in the order outlined in the work plan. In 2013, three IDEA workshops were organized: the first was dedicated to the refinement and the validation of the QRA methodology (task IV), the second one focused on the risk assessment of pre- and pro-haptens (task III) and the last one aimed at characterizing fragrance allergens (task I). The order in which the tasks have to be addressed is jointly defined by IFRA and the European Commission.

At the end of each year, an Annual Review is organized by the European Commission to monitor and validate the progress recorded over the past year, update the program and priorities when needed and ensure that all stakeholders can express their views and get further clarification on the project.

The workshop participants are identified by the IDEA Management Team ("Nyon II" group plus the IFRA staff) and by the European Commission. Scientific expertise is the sole criteria for being invited in an IDEA workshop and the number of observers (e.g. representatives of the EU Commission and trade associations) is always kept to a strict minimum. The required expertise can be general (e.g. dermatology, toxicology, chemistry, epidemiology, etc.) or specific (e.g. specialist of hydroperoxides, specialist in aggregate exposure, etc.). However, the IDEA Management Team tries, as much as possible, to keep a good balance between academia, industry experts and SCCS representation:

 

A typical 2-day workshop starts with one day of formal lectures to set the scene of the task to address and to share background knowledge and positions between all workshop participants. These presentations are given by academics, industry representatives and EU Scientific Committees' members. The first day finishes by a moderated discussion where the workshop Rapporteur presents his conclusions and the Moderator helps the participants to phrase consensus and common understanding. The second day starts by the formation of several working groups. A theme identified by the IDEA Management Team (the Rapporteur, the Moderator and the IFRA staff) is assigned to each working group. The working groups get half a day to work on the theme, draw conclusions and make recommendations. The Moderator of each working group presents these conclusions and recommendations in plenary session. Then, a moderated discussion takes place and the final workshop conclusions and recommendations are drawn.

 

Every workshop leads to the preparation and the publication (on this website) of three important documents:

  • The 'Key conclusions' is a one to two-page document that represents the consensus, common understandings and conclusions recorded by the participants during the workshop. This document is collectively prepared by all participants with the help of the Moderator. The document is formatted by the IDEA Management Team and submitted to the workshop Rapporteur for approval in case editorial changes are absolutely necessary.

  • The 'Progress report' is a more comprehensive summary of what was discussed and concluded at the workshop, prepared by the Rapporteur in a factual and transparent way. The draft progress report is reviewed by the workshop participants who have three weeks to submit comments. Like the key conclusions, the final progress report is made publicly available.

  • The 'Recommendations' is a one to two-page document prepared by IFRA and RIFM transposing the recommendations made by the workshop participants into concrete action items (step 2). The industry is committed to address all these action items in a timely manner and via a suitable action plan (step 3). These action items can be very diverse in nature (toxicological studies, clinical studies, analytical developments, restrospective analyses, etc) and resources-demanding but all of them are conducted or initiated by the industry (step 4). Preliminary results of these studies and investigations are presented at the Annual Review and consolidated results are presented at the next IDEA workshop addressing the same task (step 5). It is noteworthy that the workshop participants are fully entitled to critically review the work done by the industry.

 

3. IDEA is a project conducted in full transparency

All guarantees have to been taken to avoid conflicts of interest and biased opinions. First of all, the IDEA project is controlled by a 'Supervisory Group' of four to seven members with no vested interests in industry activities and jointly nominated by the European Commission and IFRA. 

The role of this group is to scrutinize all aspects of the project execution in order to guarantee the neutrality of scientific debates and experts’ selection procedures. The Supervisory Group also reviews and approves the (draft) agenda of all IDEA workshops.
Furthermore, for each workshop, the Supervisory Group nominates a Rapporteur amongst its members. This Rapporteur attends the workshop and writes the report based on its outcome. This progress report is reviewed by the Supervisory Group which draws conclusions and sets recommendations in view of improving the overall process. Rapporteurs of the workshops held during the year present their progress reports at the Annual Review.

The current IDEA Supervisory Group members are:

  • Prof. James Bridges (Chairman) - University of Surrey and former Chairman of SCENIHR
  • Prof. Helmut Greim - Technical University of Munich and former Chairman of SCHER
  • Dr. Alain Khaiat - Consultant and former vice president to R&D for Johnson & Johnson
  • Dr. Christen Mowad - Geisinger Medical Center and President of the American Contact Dermatitis Society
  • Dr. Ian White - Guy’s & St Thomas’ NHS Hospitals and former Chairman of SCCS

Furthermore, the IDEA Management Team and the IDEA Supervisory group established a Modus Operandi that lays down all the rules that have to be followed during the workshops. This document precisely specifies which types of costs related to the workshop participation are going to be reimbursed and to whom.

Finally, all workshop documents (including presentations, key conclusions, progress reports, recommendations) are made publicly available on this website (please, consult the 'Events' section).