January 14, 2020
On January 10, 2020, the International Fragrance Association (IFRA) announced the notification of the 49th Amendment to the IFRA Code of Practice (CoP).
Since 1973, IFRA has been representing the interests of the fragrance industry and, through the IFRA Standards of the CoP, promotes the safe use of fragrances in products. This voluntary self-regulatory system, used by almost 90 percent of the global fragrance industry, has evolved through several amendments and sets rules for the safe use of fragrance materials in products by either prohibition, concentration restrictions and/or restriction of fragrance materials depending on product, or other conditions on the type of materials (specifications). To determine safe use levels, restrictions have been based on exposure-based Quantitative Risk Assessments (QRA) and the products were categorized by grouping consumer products according to skin sensitization assessment factors and exposure.
Most important changes in the 49th IFRA Amendment
- The 49th IFRA Amendment introduces a revision of the existing QRA, to the new QRA2. The new assessment is the work of industry, academia and other parties which form the International Dialogue for the Evaluation of Allergens (IDEA) and uses the aggregate exposure model (exposure to the same fragrance ingredient contained in different products) for skin sensitizers which is a much more realistic exposure model for safety assessments.
- With the revised QRA2, the skin sensitization endpoints and the systemic toxicity endpoints are now harmonized.
- Due to application of the aggregate exposure within the QRA2, the IFRA Categories have increased from 11 to 12. Further subcategorization of some of the Categories in order to achieve harmonization with the systemic toxicity endpoints, has led to a final total of 16 IFRA Categories.
- Revised Safety Assessment Factors (SAFs) for use in QAR2 Upper Use Levels calculations.
- QRA2 limit levels are compared to levels derived from a systemic toxicity point of view, and the lower of the two drives the Standard.
- Concerning raw materials, the 49th IFRA Amendment introduces 25 new Standards, 91 revised standards, and 3 revised specification Standards. For several other Standards, there have been changes such as in wording, clarifications, and format.
The 49th Amendment Notification includes:
- Guidance for the use IFRA Standards
- The IFRA Standards under the scope of the 49th Amendment
- Annex I of the IFRA Standards (an indicative list of typical natural presence for a fragrance ingredient)
- Annex II to the IFRA Standards (potential restrictions of Schiff bases attributed to each Standard)
What does this mean for you?
- Due to all the major changes, the transitional compliance period is longer than in previous amendments, allowing a 13-month transition for new fragrance creations and a 25-month transition for already existing creations after the Notification date.
- The Certificate of Conformity to the IFRA Standards, which is a declaration of conformity to the Standards has been changed to reflect the 49th Amendment and the nomenclature ‘Classes’ is now obsolete since the new IFRA categories already include skin sensitization, systemic toxicity, and phototoxicity considerations.
- There may be need for company IT systems updates, and information exchange within fragrance houses and customers on potential reformulations.
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IFRA website: www.ifrafragrance.org
Link to the notified 49th Amendment documents: https://ifrafragrance.org/safe-use/standards-guidance