If You Smell What the IFRA Is Cooking, It’s Time to Prepare for the 49th Amendment
On Jan. 10, 2020, the International Fragrance Association, known as the IFRA, officially issued the 49th Amendment to the IFRA Code of Practice. Originally, IFRA members had until Feb. 10, 2021, to comply with the new standards for new fragrance creations and until Feb. 10, 2022, for existing creations. However, due to COVID-19, a three-month extension was granted on April 2, 2020. The new deadline is May 10, 2021, for new creations and May 10, 2022, for existing creations.
Who Is IFRA?
IFRA is a self-regulatory body that has represented the interest of the fragrance industry since 1973. It is a globally recognized association that promotes the safety and benefits of fragrances while setting rules that are compulsory for all of its members.
Criteria for safe use of fragrance ingredients is prescribed within IFRA standards, which can either prohibit, restrict or set purity requirements for specific ingredients based on the findings of the Research Institute for Fragrance Materials (RIFM). As new information is made available, IFRA standards are updated or new ones are issued as part of the IFRA amendment process.
What’s New With the 49th Amendment?
The 49th Amendment introduced several improvements to the risk assessment methodology.
These improvements specifically relate to the revised methodology of quantitative risk assessment for fragrance ingredients (QRA2), which includes the revision of the safety assessment factors (SAFs) and the new method to assess systemic toxicity based on aggregate exposure model.
As a result of these improvements:
• All new and existing IFRA standards for the dermal sensitization endpoint are now based on QRA2 and include 12 categories.
• The IFRA categories for systemic toxicity have been harmonized with the IFRA categories for QRA2.
What Does It All Mean?
• New categories and subcategories were introduced, which incorporate and harmonize systemic effects, dermal sensitization and phototoxicity.
• Twenty-five new standards and revision of 88 existing standards have been published to reflect the changes to the upper concentration limits, categories and subcategories.
• Changes related to the format, content and clarification have been made to several prohibition and specification standards.
• Format of several other standards have also been updated.
• The IFRA certificates have been enhanced to reflect the newest categories and subcategories.
• Several product types have been rationalized to align with the QRA2 categories potentially impacting certain fragrance mixtures.
From a company IT system update standpoint, Sphera provides a complete solution to ease the implementation of the 49th Amendment.
For example, all applicable data from the IFRA standards to help determine the appropriate product categories are incorporated. With the complex rule logic, IFRA certificates are automatically generated, which significantly reduces the amount of time and effort. And finally, audits are provided to help organizations assess the impact of specific fragrance ingredients in their final products.
The 49th Amendment introduced some significant changes, but with the proper tool, the time and effort needed to stay in compliance becomes a walk in the park.