IDEA - International Dialogue for the Evaluation of Allergens

Work plan

Develop a shared common understanding of risk assessment methodologies, processes and criteria to identify fragrance allergens of concern

Note: This page is a living version of the work plan. The historic document endorsed by Commissioner Tonio Borg can be accessed here.

 

Background

Based on regular contacts with EU Commission (DG Sanco) and the conclusions of the Public Hearing on Fragrance Allergens which took place on March 5th, 2012, the Industry understood the need for further scientific work enabling the definition of explicit criteria and the clarification of identified areas of concern in order to provide an agreed and transparent framework for assessing fragrance ingredients in a prospective way. This work does not only concern the Fragrance Industry but embraces many stakeholders, including Academia, the relevant services of the EU Commission, Dermatologists and the Downstream User Industry.

This joint work plan related to risk assessment covers:

  • The definition of fragrance allergens
  • The definition of fragrance allergens of specific concern
  • The study of pre- and pro-haptens
  • The Refinement of the Dermal Sensitization QRA (Quantitative Risk Assessment) methodology

 

The Strategic Intent

The strategic intent of this plan is to prevent further uncertainty for the fragrance and downstream industries in an area which is critical to consumer safety. It is also intended to provide the industry with better visibility for business continuity. Indeed, it is vital for business to rely on a robust prospective risk assessment approach securing the most predictive extrapolation in the area of fragrance allergy. This scientific approach should also take into account the relevance of its findings in real life, through regular review. This is critical to enhance consumer confidence in the safe use of products. In addition, without such a prospective approach, the current situation could jeopardize investments in innovation leading to a significant loss of added value and competitiveness for business. 

 

The work plan

This document represents a scientific work plan intended to lead to a common understanding of methodologies, processes and criteria, and could become the basis of a robust approach for a multi-stakeholder risk assessment program.

The work plan proposes four specific tasks which should be addressed in order to develop a common understanding of the risk assessment process:

In combination, these tasks should set out an open and transparent dialogue which should lead to a comprehensive understanding of fragrance allergens and the assessment of their risk to the population.

The aim of the workshops and the whole program is to lead to procedures and guidance documents for all parties involved. Those guidance documents, if meaningful and efficiently applied, should help create the required certainty in the evaluation process and master the management of fragrance allergens in the future.

The overall timeline of accomplishing all 4 tasks is assumed to be about 3 to 7 years. For the completion of the technical aspects a minimum time period of 3 years is foreseen and additional time will be needed to discuss and translate agreed actions into a framework that will provide all stakeholders involved with a secure business environment in which to operate in the future. A more detailed outline of timelines, organizational aspects and deliverables is available on the IDEA website.

 

The Supervisory Process

In order to secure the optimal governance of the project, a Supervisory Group has been set-up. Its mission is to supervise the process and to ensure the scientific integrity and full transparency of the overall project.

Today, the Supervisory Group (SG) is composed of 5 members with no vested interests in Industry activities. The members are jointly nominated by the EU Commission and IFRA. For an up to date list of the members of the Supervisory Group see the IDEA website www.ideaproject.info.

The remit of this group is to scrutinize all aspects of the work plan implementation in order to guarantee the neutrality of scientific debates and experts’ selection procedures. The Supervisory Group reviews the draft agenda and related activities.

Furthermore, for each workshop, the Supervisory Group nominates a rapporteur from amongst its members. This rapporteur attends the workshop and, assisted by IFRA project management, writes the report based on its outcome. This progress report is reviewed by the Supervisory Group to draw conclusions and set recommendations in view of improving the overall process.

 

The monitoring Process

An annual review of the work plan’s progress is organized by the EU Commission (DG Sanco). The review is designed to monitor and validate the progress made by the experts and to update the program and priorities when needed. Rapporteurs of the workshops held during the year present their reports at this occasion. This event is the appropriate platform to ensure that all stakeholders can express their views and ask questions.

As stated before, the Industry must engage with a broader group of stakeholders. This group will inevitably bring with it a variety of perspectives and positions. This collaborative effort not only results in a stronger method of managing allergens, but will also build a lasting relationship which may serve as a model for other fragrance associated topics relating to the on-going enhancement of consumer safety.

The yearly review organized under the auspices of the EU Commission involves broad stakeholder participation with the aim to build common understanding of fragrance allergens and implement a new integrated forward looking management process, based on a number of components that can easily be enacted.

The participation in the Review is globally oriented as the topic of fragrance allergens is not limited to Europe and such a fundamental discussion should be carried out with a global perspective. Therefore members of the International Cooperation on Cosmetic Regulation (ICCR) are also invited.