IFRA Standards
Introduction to IFRA
IFRA regulations, also known as the IFRA Standards, are guidelines set by the International Fragrance Association (IFRA) to ensure the safe use of fragrances. These standards are based on scientific research and risk assessments by independent experts. IFRA membership is voluntary, but their standards are widely recognized by governments and followed by about 80% of the fragrance industry globally.
IFRA Standards are not the only requirement for fragrance safety. IFRA members are also obligated to follow good manufacturing practices and ensure their fragrance mixtures comply with all applicable laws.
Overall, compliance with IFRA standards is crucial for ensuring the safety and regulatory compliance of fragrance products in the market.
IFRA Standards
There are different types of IFRA (International Fragrance Association) Standards:
Prohibited Standards: These involve ingredients that are banned due to adverse health or environmental data or insufficient data to support safe use. Examples include Safrole, Isosafrole, and Dihydrosafrole due to carcinogenicity concerns, and Allyl isothiocyanate due to insufficient data.
Restricted Standards: These restrict ingredient use to minimize adverse effects on human health or the environment. This includes limitations on skin sensitization, phototoxicity, and systemic toxicity. Examples include limits on Rose Ketones, Estragole, Furfural, and Bergapten-containing oils.
Specification Standards: These standards specify requirements such as purity levels, peroxide values, or specific production methods for certain ingredients. Examples include limits on allyl esters, limonene, musk ketone, and nootkatone.
More information is available on the IFRA website: https://ifrafragrance.org/
Managing Compliance to IFRA
When applying IFRA Standards in the day-to-day business of a fragrance house, the key factors are:
Understand IFRA Standards: Familiarize yourself with the details of IFRA standards, including which ingredients are in scope, sources of IFRA-limited materials, and any flavour-safe considerations for specific categories.
Additionally, it is important to review IFRA standards thoroughly, paying attention to sections detailing restricted ingredients, their properties, and any special considerations. Furthermore, complications may arise with group limitations, where chemically similar ingredients are limited together, requiring careful consideration and accurate information about raw materials used.
Obtain and maintain accurate Input Data: To determine IFRA limits, you need accurate quantitative and qualitative data on your composition. If you buy a single substance (chemical) and this has an IFRA Standard (e.g. Geraniol) the IFRA limit should be obvious. To accurately determine IFRA limits for Natural Complex Substances such as essential oils, and in absence of quantitative and qualitative data, you can ask your supplier for an IFRA Certificate and request it shows which IFRA Limited substances are present and their percentage. If you buy fragrance formulations, you can also request from your suppler an IFRA certificate which displays the IFRA relevant substances and their percentage. This information should come from your suppliers, as different suppliers have different qualities of essential oils.
Perform Accurate Calculations: This involves considering all sources of IFRA-restricted materials and calculating the impact on IFRA limits across the different IFRA categories. Fundamentally, most restrictive scenario dictates the limit per application where.
Formulation IFRA Limit = RM limit / RM % present in formulation x 100.
This calculation is performed for all the limited substances in all the IFRA Applications (Formpak does this).
Conform to IFRA Standards during Product Development: This involves calculating IFRA Limits during formulation development so that compliant formulations are provided to customers. This can be achieved with Property Calculations and Suitability Management in Formpak.
Provide IFRA Certificates to Customers and keep them up to date: Provide IFRA Certificates demonstrating compliance, which typically show the dosage limit per IFRA category and means your customers know the usage limit for the products you provide. IFRA Certificates are routinely provided to Safety Assessors. Formpak can produce and manage IFRA Certificates.
Compliance Timelines: Understand and comply with the timelines provided for new or revised standards. Timelines vary depending on the nature of the standard and whether it applies to new creations or existing ones.
You may find the following related Support Articles useful:
How do I know which component to reduce to make my IFRA limit compliant?
March 2024
