We are often asked why there are limits for adding essential or fragrance oils to products when other crafters in different countries tend to use much higher amounts than we include on reports.
One of the most important aspects is the need for a CPSR which is not necessary if you are outside of the UK/Europe. The contents of a CPSR are explicitly defined in the Cosmetic Regulation (as adopted into UK legislation after Brexit) and those qualified individuals who write them have no choice but to adhere to these requirements.
The majority of toxicological concerns in products comes from fragrance oils and their components (terpenes, allergens and other composition ingredients) that are applied to the skin but also may possibly be inhaled. Higher concentrations need more details, for example, margin of safety calculations and accuracy in supporting documentation to justify the safety of the level of addition.
IFRA Certificates are used to give information on the theoretical maximum amount of a particular fragrance that can be used safely. This data is based on the ingredients that are restricted in certain products.
Margin of Safety (MOS) calculations for each product are based on the amount of fragrance used. In some cases, this is much lower than the IFRA limit, because we also take into account substances that are not restricted by IFRA but must also be included in the overall assessment for safety.
The amount of fragrance that can be used is always the LOWEST of the two values above.
If a fragrance contains no IFRA restricted ingredients, then the theoretical IFRA maximum will be 100%. However, in a leave on product, for example, the calculated MOS will generally allow for around 2% fragrance so even though the IFRA certificate says 100%, the true amount that is actually safe to use is just 2%.
In addition, adding large quantities of fragrance or essential oils to a product can affect the chemical integrity of the finished product. As an extreme example, if soap was made with the 75% fragrance allowed on an IFRA – the final product would not really be soap.
IFRA is an advisory (although no sensible assessor will disregard IFRA) and considered a global standard. However, within the EU and UK post brexit, there are regulated chemicals that appear in essential oils and fragrance oils.
Regulated trumps advisory and, when the IFRA classes were changed with the updated 49th amendment it has led to some disparities in usage data. These IFRA and regulatory aspects also impact essential oil allowances due to the chemicals included naturally in the composition eg Citral is restricted by IFRA, Methyl Eugenol is restricted by annex III of the Cosmetic Regulation and Atranol gained prohibited status due to regulatory procedures through ECHA.
We hope this helps to explain why our limits will sometimes seem more onerous than suggested by makers in other countries.
