Fragrance safety in cosmetics: Regulations and guidelines

Like all cosmetics, fragrances are regulated by specific rules to ensure their safety. Perfume is used within a cosmetic product, which is defined under Regulation (EC) No. 1223/2009 (see the latest consolidated version, including recent regulatory updates). As such, it is subject to various obligations regarding its content, the packaging in which it is marketed, and the documentation required to be available to Authorities in the form of a Product Information File (PIF).

Additionally, the initial version of the Regulation mandated that the Responsible Person declare 26 ingredients in fragrance compositions in the ingredient list if their concentration exceeded specific thresholds. Recently, this list was expanded (by Regulation 1545/2023, which amends the Cosmetics Regulation) to include an additional 56 allergens.

Further assurances of fragrance safety in cosmetics come from the IFRA (International Fragrance Association) code and standards, which member perfumers must follow. For instance, the IFRA code specifies the maximum allowable quantity of a given component in a cosmetic product.

IFRA

The International Fragrance Association (IFRA), founded in 1973, is the official self-regulatory body representing the fragrance industry worldwide. IFRA represents manufacturers and preparers of fragrance ingredients.

Its purpose is to promote and ensure the safety of products in the fragrance industry through risk assessments conducted by an independent Expert Panel.

What is the role of the IFRA?

The role of the IFRA is to evaluate data on fragrance ingredients to ensure they pose no risk to consumers. If a safety assessment conducted does not support current use, the Scientific Panel of the Research Institute for Fragrance Materials (RIFM) requires the IFRA to issue a standard. This standard may restrict, prohibit, or provide additional instructions for the use of the ingredient.

When safety concerns regarding a specific ingredient are identified by RIFM, the IFRA issues an IFRA standard as part of an amendment. These standards may prohibit or restrict the use of certain ingredients or establish purity requirements for them.

IFRA standards and related documents are subject to periodic updates when new safety information becomes available. These updates, known as IFRA amendments, undergo extensive consultation with all interested parties before being finalised.

The development of IFRA standards involves collaboration between IFRA, RIFM, and the Expert Panel. Currently, the fifty-first revision of the IFRA standards is in force. This new amendment introduces changes to the restrictions of 11 perfume ingredients and adds 48 new ingredients to the list of regulated substances.

What Has Changed in the Course of the Last Amendment regarding Fragrance Safety in Cosmetics?

As an example, here are the changes that occurred between the 50th and 51st revisions to illustrate how the standard is updated between revisions:

New standards:

• 1 new IFRA Restriction Specification Standard (Allyl-3-cyclohexylpropionate)
• 32 new IFRA Restriction Standards to control potential dermal sensitisation effects for which the systemic toxicity endpoints have also been evaluated (like Isobutyl cinnamate, cis-3-Nonenyl acetate and Ethyl and methyl furaneol).
• 11 new IFRA Restriction Standards to control potential dermal sensitisation effects based solely on QRA2 (including carvyl acetate, methyl lavender ketone and 3-Octen-2-one).
• 2 new IFRA Restriction Standards, for which Risk Management is based on, Threshold of Toxicological Concern (TTC) for Methoxycyclododecane and 7-Methoxy-3,7-dimethyloct-1-ene.
• 1 new IFRA Restriction Standard due to potential of depigmentation for Cresols.
• 1 new IFRA Prohibition Standard due to potential genotoxicity effects for 3-Acetyl-2,5-dimethylfuran.

Revised standards:

• 7 Revised IFRA Restriction Standards to control potential dermal sensitisation effects for which the systemic toxicity endpoints have now also been evaluated.
• 1 Revised IFRA Restriction Standard based on new dermal sensitisation data.
• 1 Revised IFRA Restriction Standard based on phototoxicity and systemic toxicity (and 1 updated Standard with regard to MAC in Category 6).
• 2 Revised IFRA Restriction Standards based on systemic toxicity.
• Minor updates to existing Standards and format change.

One of the consequences of IFRA 51, is the new approach concerning phototoxic ingredients. This approach now includes setting limits for rinse-off products in Categories 7A, 9, and 10A. Specifically, this change has been implemented for Methyl-N-Methyl Anthranilate (MNMA).

Furthermore, the Fragrance Safety Expert Group has determined that products in Category 6 can now be classified as rinse-off products in terms of phototoxicity. Consequently, the allowed concentration of Methyl-N-Methyl Anthranilate in Category 6 products has increased from 0.1% to 0.5%, as compared to the previous consultation.

What Is the Transition Period?

A grace period, starting from the release date of June 30, 2023, has been established, based on four scenarios.

These scenarios depend on the current presence of the related product in the market and whether the fragrance is prohibited or restricted:

– If the fragrance is created after the 51st amendment notification and your raw material contains a (future) prohibited ingredient, you would have had 2 months to be compliant with this new amendment. (August 30, 2023)

– If the fragrance is created after the 51st amendment notification and your perfume does not contain prohibited ingredients but contains restricted ingredients or ingredients with specifications, you would have had 9 months. (March 30, 2024)

– If the fragrance is already on the market before the 51st amendment notification and your raw material contains a (future) prohibited ingredient, you would have 13 months to be compliant with this new amendment. (July 30, 2024)

– If the fragrance is already on the market before the 51st amendment notification and your perfume does not contain prohibited ingredients but contains restricted ingredients or ingredients with specifications, you would have 28 months. (October 30, 2025)

Regulatory Update: New Rules On the Labelling of Allergenic Substances in Cosmetics

More than a decade after the opinion of the Scientific Committee for Consumer Safety, a new regulation has come into force, as we mentioned at the beginning of this article. The regulation introduces substantial changes to the labelling of allergenic substances in cosmetic products.

This regulation, EU Regulation No. 2023/1545, issued on July 26, 2023, and published in the Official Journal of the European Union (L 188/1) on July 27, 2023, updates Regulation (EC) No. 1223/2009 of the European Parliament and of the Council. The update specifically focuses on the labelling of allergenic fragrances in cosmetic products. The primary purpose of this revision is to ensure compliance with safety criteria and to protect consumers’ health.

The new regulation takes into account that the percentage of individuals allergic to allergenic fragrances in the European Union is estimated to range between 1% and 9%. Contact allergies are specific immune reactions that persist throughout life.

Repeated exposure to enough of an allergen can trigger allergic contact dermatitis, better known as eczema. If you have a history of sensitisation to an allergen, even small amounts can cause allergic symptoms. A restriction on the use of allergenic fragrances may be an option for primary prevention.

However, sensitised individuals may experience allergic reactions even at concentrations lower than the permissible maximums. Therefore, in order for sensitised people to avoid contact with triggers, it is essential to provide information about the potential presence of allergenic fragrances in cosmetic products.

Fragrances are organic compounds widely used in perfumes and other cosmetic items, but also in detergents, fabric softeners and other household products. It should be noted that the rules governing cosmetic products also extend to products for domestic use.

At present, the list of ingredients must specify precisely 26 allergenic fragrances listed in entries 45 and 67 to 92 of Annex III to Regulation (EC) No 1223/2009.

In response to the Commission’s request to revise the list of allergenic fragrances for individual labelling, the Scientific Committee on Consumer Safety (SCCS) issued an opinion in June 2012 (SCCS/1459/11).

This opinion validated the relevance of the fragrances already listed, and added a further 56 that caused human allergies, even though they had not previously been subject to the individual labelling requirement. We discussed this in an article describing this extension of the allergens list. 

On the basis of this opinion, and in order to address the potential risk to public health, the Commission has decided to inform consumers about the presence of these new allergenic fragrances. As a result, Annex III to Regulation (EC) No 1223/2009 has been updated, requiring the individual labelling of those allergenic fragrances when their concentration exceeds 0,001% in leave-on products and 0,01% in rinse-off products.

Similarly, the same regulatory standards and requirements have been applied to fragrances such as prehaptens and proaptenes, which can be transformed into contact allergens via oxidation or bioactivation. These substances are now treated in the same way as allergenic fragrances.

In order to improve the clarity and consistency of the rules, changes have been made to the existing entries in Annex III, aligning the names of the substances with those of the latest version of CosIng and grouping similar substances under a single heading.

In the case of several common names for a substance, the label will use the specific name given in the list of ingredients in Article 19(1)(g) in order to simplify the labelling and make it more comprehensible to consumers and economic operators.

The update of Annex III also includes the revision of the existing entries related to allergenic fragrances, including the updating of isomers and the modification of their CAS and EC numbers. These amendments aim to simplify the work of economic operators and national authorities.

In Conclusion

There are various regulations and guidelines from different bodies and associations that oversee the safety of fragrances and, consequently, of finished cosmetic products. As a result, several documents must be considered and carefully examined.

Contact us, and we will help you evaluate your cosmetic product.