08 Mar IFRA Standards and Certificate of Conformity for fragrances
What is IFRA?
The International Fragrance Association (IFRA), founded in 1973, represents the interests and is the voice of the fragrance industry worldwide. It promotes the safety and benefits of the fragrance industry’s products through stakeholder dialogue on a global basis.
When warranted by concerns regarding the safe use of a specific ingredient identified by the Research institute for Fragrance Materials (RIFM) safety assessment program, IFRA will issue an IFRA Standard as part of an IFRA Amendment.
To ensure the safety of fragrances, IFRA has established rules (known as IFRA Standards) recognized by government authorities and commercial entities around the world.
IFRA Standards can either prohibit, restrict or set purity requirements for specific ingredients. The safety of ingredients, whether the subject of an IFRA Standard or not, remains the responsibility of IFRA members. Compliance with IFRA Standards is therefore necessary for compliance with the IFRA Code of Practice but may not be sufficient to ensure regulatory compliance and the safety of fragrance mixtures or ingredients.
The IFRA Standards and related documents are subject to regular changes as new information relevant to the safety of fragrance ingredients become available. All these changes are part of an IFRA Amendment, which is designed pursuant to an inclusive procedure and is subject to a broad consultation of all relevant stakeholders before its Notification. Last one is the 50th Amendment, an ‘off-cycle’ amendment for one ingredient, Mintlactone, published on 30 June 2021.
The Expert Panel for Fragrance Safety is an independent panel of experts that reviews the activities of the Research Institute for Fragrance Materials (RIFM). They determine safety of use for fragrance ingredients through consideration of available information and active generation of additional data. If the Expert Panel for Fragrance Safety determine that a restriction of use is necessary for consumer and environmental protection, an IFRA Standard will be published.
All fragranced consumer products are in the scope of the IFRA Standards except for products clearly not covered in the RIFM Safety Assessments, such as:
– medical devices;
– prescriptive drugs;
– aromatherapy applications;
– consumer products used in occupational settings (e.g. shampoos applied in hair salons, hand sanitizers applied in hospitals, etc.).
A detailed list of the products covered under the scope of the IFRA Standards is provided in “Guidance for the Use of IFRA Standards”. In case a final product application is not included therein, it remains the responsibility of the final consumer product manufacturing company to adequately categorize this final product application in order to comply with the requirements of the IFRA Standards.
For practical reasons, IFRA Standards are set per product category, each covering a range of product types which can be grouped together based on risk assessment considerations.
With IFRA 49th Amendment, issued at the beginning of 2020, the number of categories in the IFRA Standard has changed from 11 categories for dermal sensitization Standards and 4 for systemic toxicity-based Standards to 12.
Product categorization is achieved by grouping consumer product types based on functional type, and major factors in habits and practices of consumers such as area of use (head, face, axillae, etc.) and whether they are rinse-off or leave-on applications.
Certificate of conformity
The Certificate of Conformity to the IFRA Standards is a document established by companies creating fragrance mixtures, which declares compliance with the requirements expressed in the IFRA Standards and confirms that a specific fragrance mixture up to a certain concentration can be used in a specified consumer product in compliance with up to and including a specific Amendment (the number and the Notification date of the Amendment should be stated in the Certificate).
The Certificate is only applicable for fragrance mixtures intended to be directly included in a finished consumer product. By using a Certificate, a fragrance supplier assures its customer that the product they supply is in compliance with the requirements set by the IFRA Standards for an intended use.
It is important to note that IFRA is not involved in its preparation and that the Certificate of Conformity declares compliance with the requirements expressed in the IFRA Standards but does not replace a safety assessment.