Characterization of fragrance allergens
The IDEA Work Plan is the detailed roadmap we use to address fragrance allergens. Its four Tasks focus on building a common understanding and definition of allergens, assessing materials and mechanisms, and evaluating and refining risk assessment methodologies.
Characterization of fragrance allergens
Definition/characterization of ‘allergens of specific concern’
Risk assessment of pre and pro-haptens
Validating and refining the QRA methodology
IDEA was established as a multi-stakeholder initiative by the fragrance industry in partnership with the European Commission. The draft Work Plan was drawn up following a 2011 draft Opinion by the EU’s Scientific Committee on Consumer Safety (SCCS) and meetings of an industry advisory group.
Based on talks with the Commission and the outcome of a 2012 public hearing on fragrance allergens, the industry saw the need for further scientific work to develop the framework for assessing fragrance ingredients, as well as involving other academics, dermatologists, and downstream users.
The Work Plan is intended to lead to a shared common understanding of methodologies, processes and criteria, and should become the basis of a robust approach for a multi-stakeholder risk assessment program.
The Work Plan proposes four specific Tasks that, in combination, set out an open and transparent dialogue for a common understanding and risk assessment of fragrance allergens.
This scientific approach ensures that we always monitor the relevance of IDEA's findings in real life. Regular reviews are critical to the advancement of consumer protection and maintaining confidence in the safe use of fragranced products.
The initial IDEA Work Plan was adopted in October 2012. The text of the Work Plan is detailed below and on the individual Task pages, or you can download the Work Plan as a PDF.
Some fragrance ingredients can cause dermal sensitization, but such allergens may be described in different ways – so we need to find a common definition.
This first Task of the IDEA Work Plan, ‘Characterization of fragrance allergens’, focuses on developing a clear understanding of skin sensitizers and the tools to identify them. IDEA, with its multi-stakeholder, collaborative approach, provides the ideal platform for finding a common definition.
> Read more about the characterization of fragrance allergens
Fragrance allergens can present different levels of risk - so there is a need to gather and assess data to define and characterize allergens of specific concern.
This second Task of the IDEA Work Plan, ‘Definition and characterization of allergens of specific concern’ brings together the fragrance industry, the dermatological community and regulators to establish a common understanding on how to integrate clinical, cosmetovigilance and exposure data into the risk assessment and produce an accurate definition of ‘allergens of specific concern’.
> Read more about the characterization of allergens of specific concern
We assess how allergenic species can arise via abiotic transformations (pre-hapten - such as via sunlight or temperature) or biotic transformations (pro-hapten - due to metabolic activation).
This third Task of the IDEA Work Plan, ‘Risk assessment of pre- and pro-haptens’ seeks to establish a better understanding of biological and chemical mechanisms responsible for pre- and pro-haptens activation, to improve the risk assessment of these materials.
> Read more about the risk assessment of pre- and pro-haptens
First implemented by the fragrance industry in 2006, and since updated, the dermal sensitization Quantitative Risk Assessment (QRA) is considered an important step forward.
This fourth Task of the IDEA Work Plan, ‘Validity of the QRA methodology and possibilities of further refinement’, seeks to further improve QRA for those fragrance ingredients identified as allergens and refine the methodology so that it can became a standard risk management tool.
> Read more about the QRA methodology and possibilities of further refinement