If you are associated with the fragrance industry or are interested in fragrances, you have most likely heard of IFRA. The International Fragrance Association (IFRA) is the global body that represents the fragrance industry. IFRA plays a vital role in ensuring that the fragrances produced and used worldwide are safe for people and the environment. This blog will outline what you need to know about IFRA and their Standards.
What is IFRA?
What are the IFRA Standards?
What are the types of IFRA Standards?
The IFRA has three main types of standards: Prohibited, Restricted, and Specification. These standards define the permitted usage levels or restrictions for fragrance ingredients in various product categories to ensure consumer safety. Here’s an explanation of each type:
- Prohibited Standards: Prohibited standards refer to fragrance ingredients that are not allowed to be used in specific product categories at all. These ingredients have been identified as posing significant risks to human health or the environment, and their use is strictly forbidden. The Prohibited standards aim to prevent the inclusion of harmful substances in consumer products, ensuring the safety and well-being of consumers.
- Restricted Standards: Restricted standards specify the maximum permitted usage levels of certain fragrance ingredients in different product categories. These limits are established based on scientific assessments and toxicological studies to ensure that the concentration of certain ingredients in products remains below levels that may cause adverse effects such as skin sensitization or irritation. Restricted standards aim to manage and control the potential risks associated with fragrance ingredients without entirely prohibiting their use.
- Specification Standards: Specification standards apply to fragrance ingredients for which specific chemical criteria are set. These criteria define the purity and composition requirements of the ingredient to be used in fragrance formulations. By having strict specifications for certain ingredients, the IFRA ensures that manufacturers use only high-quality and consistent materials, promoting the safety and reliability of fragranced products.
What are the IFRA Amendments?
The IFRA Amendments are updates made to the IFRA Standards to ensure they remain up to date with the latest scientific knowledge and safe use requirements. By constantly evaluating new scientific research, IFRA can identify and manage potential risks associated with certain fragrance ingredients. The amendments might involve restricting the usage of certain materials that could cause allergies or sensitivities, or even banning them altogether if necessary. Each Amendment is additive, in that it either adds new Standards or amends existing ones. All substances that have been issued with a Standard can be found in the IFRA Standards Library on the IFRA website. IFRA does not issue a Standard for every ingredient that may be used in a fragrance, and manufacturers should ensure that mixtures comply with regional regulatory requirements.
To illustrate, below is an outline of the key changes brought by the three most recent amendments to the IFRA Standards.
The 51st Amendment to the IFRA Standards
IFRA’s published notification of the 51st Amendment to the IFRA Standards on the 30th of June 2023 includes:
- The updated guidance document for the use of the IFRA Standards.
- 48 new fragrance standards.
- Revision to 12 existing standards.
- The Annex on contributions from other sources to the IFRA Standards.
An IFRA Certificate of Conformity in compliance with the 51st Amendment to the IFRA Standards is required by March 30, 2024, for NEW creations and by October 30, 2025, for EXISTING creations. This applies to the new Restriction and Restriction Specification Standards only.
The Amendment includes 1 new Prohibition Standard and the dates for compliance are different. For NEW creations by 30 August, 2023 and EXISTING creations by July 30, 2024. These dates apply to the supply of fragrance mixtures (formulas) only, not to the finished consumer products in the marketplace.
The 50th Amendment to the IFRA Standards
On 30th June 2021, IFRA announced the notification of the 50th Amendment to its Standards, for which the implementation dates of August 30, 2021, and July 30, 2022, for new and existing creations respectively, has now passed into force. The IFRA 50th Amendment includes:
- The Standard prohibiting the use of Mintlactone (CAS 13341-72-5) as a fragrance ingredient.
- The SOP (Standard Operating Procedure) for implementing an Amendment.
- The updated Index list.
According to IFRA’s Expert Panel for Fragrance Safety Rationale, Mintlactone has been reviewed and concluded to be an unsafe fragrance ingredient. If it’s found as an impurity in other fragrance ingredients, then the latest version of the Guidance to the IFRA Standards for the respective IFRA procedure should be checked.
It’s important to note that this new Amendment comes in addition to previous amendments to the IFRA Code of Practice. As a result, all elements of the 49th Amendment addressing other fragrance materials remain unchanged and in place.
The 49th Amendment to the IFRA Standards
IFRA 49th Amendment includes:
- Guidance for the use of IFRA Standards.
- The IFRA Standards under the scope of the IFRA 49th Amendment.
- Annex I of the IFRA Standards.
- Annex II of the IFRA Standards.
This update has brought some significant modifications to the existing regulatory framework, all thanks to a new scientific approach for determining the safe use of fragrance ingredients. One of the changes is the revised methodology of Quantitative Risk Assessment for fragrance ingredients, which we call QRA2. Additionally, the new approach combines skin sensitization, phototoxicity, and systemic toxicity assessment in one exercise, which leads to a change in the IFRA categorisation system. The 49th Amendment had 12 categories (some of which were divided into subcategories), and the old “IFRA Classes” terminology is no longer used.
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How do you comply with the IFRA Standards?
Complying with the IFRA Standards involves adhering to the guidelines and concentration limits set by the IFRA for the safe use of fragrance ingredients in consumer products. If you are a fragrance manufacturer, product formulator, or a company that uses fragrances in your products, here are the steps you can take to ensure compliance:
- Stay informed: Familiarise yourself with the latest version of the IFRA Standards. These standards are regularly updated based on new scientific research and safety data. Make sure you have access to the most recent guidelines to ensure compliance.
- Ingredient check: Review the list of fragrance ingredients used in your products against the IFRA Standards. Check the concentration limits specified by IFRA for each ingredient. Ensure that the concentration of each ingredient in your products falls within the maximum acceptable concentration limits.
- Product reformulation: If you find that certain fragrance ingredients in your products exceed the permitted concentration limits, consider reformulating the products to comply with the IFRA Standards. This might involve adjusting the concentration levels of specific ingredients or choosing alternative ingredients.
- Work with IFRA-certified suppliers: Collaborate with suppliers who provide IFRA-certified fragrance ingredients. IFRA-certified suppliers follow the IFRA Standards and can provide documentation regarding the compliance of their ingredients.
- Documentation: Maintain thorough records of the fragrance ingredients and their respective concentrations used in your products. This documentation will help demonstrate your commitment to compliance and can be useful in case of regulatory inquiries.
- Adherence to regional regulations: In addition to complying with the IFRA Standards, ensure that your products meet the fragrance-related regulations of the countries or regions where they will be sold. Different regions might have their own specific requirements for fragrance safety.
- Collaboration with regulatory bodies: Collaborate with regulatory authorities and industry organisations to ensure that your products meet all necessary safety and compliance standards.
It’s important to remember that anything you make and sell on or after May 10, 2022, must be made per the IFRA 49th guidelines to be compliant.
Are the IFRA Standards recognised by any industry groups or authorities?
Additionally, the Association of Southeast Asian Nations (ASEAN) explicitly refers to the IFRA Standards concerning fragrances in cosmetic products in its cosmetics directive, which came into effect on 1 January 2008.
Understanding IFRA standards is crucial for anyone involved in the fragrance industry. Whether you’re a perfumer, a fragrance formulator, or a consumer, knowing the limits and regulations set by IFRA can help ensure the safety and quality of fragrances.
It’s important to note that IFRA standards are not just arbitrary rules. They are based on extensive research and testing to determine the safe levels of fragrance ingredients. By adhering to these standards, manufacturers can create fragrances that are not only pleasant but also safe for everyone to use.
It’s also worth noting that IFRA standards are not set in stone. As new research and information become available, the standards may be revised to reflect the latest findings. This means that the fragrance industry must remain vigilant and adaptable to changes in the industry.
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