Regulatory FAQ

As explained in the Cosmetics Europe’s ​‘Guidelines on the ​‘Fragrance Allergens Requirements’, the new ​‘fragrance allergens’ labelling regulation (Commission Regulation (EU) ²⁰²³⁄₁₅₄₅ of 26 July
2023 amending Regulation (EC) No ¹²²³⁄₂₀₀₉ of the European Parliament and of the Council as regards labelling of fragrance allergens in cosmetic products), which expands the list to 80+ allergens, aims to protect allergic individuals through providing them labelling information that allows them to make a proper choice when buying products.

This Commission Regulation sets out new obligations for the labelling of an extended list of so called ​‘fragrance allergens’ in addition to the one set by directive 2003/15/CE.

On the Regulation implementation, the Regulation entered into force on 16 August 202. There is a transition period for new restrictions foreseen:

• until 31 July 2026 for placing products on the market,
• until 31 July 2028 for withdrawal of products from the market.

Labelling is mandatory if the substance is present in the cosmetic product above specific threshold concentrations, which are different for leave-on and rinse-off products.

The above-mentioned Cosmetics Europe guidance document aims to help companies to understand and correctly interpret the ​‘fragrance allergens’ labelling requirements and adapt its practices to ensure continued compliance.

Labeling or finished products containing fragrance oil on drums must comply with applicable national and regional regulations, which may include elements of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).

To request a copy of the IFRA-IOFI Labelling Manual on GHS, please submit an enquiry via our contact form.

Fragrance manufacturers are required to comply with the regulations in force within the countries where they operate and market their products.

In addition to legal requirements, companies may also choose to follow the IFRA Standards, which form a voluntary, globally accepted and recognized risk management system for the safe use of fragrance ingredients and are part of the IFRA Code of Practice.

In some instances, safety assessments for a fragrance material may differ between national regulations and IFRA Standards. For example, Butylphenyl Methylpropional (BMHCA), also known commercially as Lilial, has been banned in cosmetic products (both existing and new) in the European Union as of March 2022. t is important to note that this restriction applies exclusively within the EU.

The use of BMHCA remains permitted in markets outside the EU, subject to local regulations.

With respect to the IFRA Standards, the Research Institute for Fragrance Materials (RIFM) has conducted a comprehensive aggregate exposure risk assessment. This assessment supports the continued safe use of p‑BMHCA in both cosmetic and non-cosmetic applications at the concentrations currently in use.

Given the near-extinction status of some musk deer populations and increasing regulatory protection under CITES (the Convention on International Trade in Endangered Species of Wild Fauna and Flora), IFRA requested that all fragrance manufacturers cease the use of natural musk since 31 October 2000, as stated in IFRA’s Information Letter nr 608.

Currently, all species of musk deer are listed in CITES Appendix I or Appendix II. For those musk deer populations listed under in CITES Appendix I, the international trade in these specimens is prohibited. For all other musk deer populations listed under Appendix II, the international trade of those specimens are allowed but strictly monitored.

The IFRA Board restated its commitment under the Information Letter 608:
- to the protection of animals and particularly of endangered species;
- to the use of materials, the collection of which does not involve cruelty to animals and does not put at risk endangered species.

Fragrance manufacturers are required to comply with legally binding regulations in force within the countries where they operate and market their products.

The IFRA Standards is a voluntary risk management system for the safe use of fragrance ingredients but mandatory for IFRA members, as part of the IFRA Code of Practice.

In some instances, IFRA Standards may differ from legal regulatory risk management measures (i.e. bans or restrictions) .This is the case for Butylphenyl Methylpropional (BMHCA,CAS n° 80−54−6), also known commercially as Lilial, which has been banned in cosmetic products (both existing and new) in the European Union as of March 2022.

The use of BMHCA remains permitted in markets outside the EU (subject to local regulations, if any) but IFRA members must comply with the concerned Standard.

The Research Institute for Fragrance Materials (RIFM) has conducted a comprehensive aggregate exposure risk assessment. This assessment supports the continued safe use of p‑BMHCA in both cosmetic and non-cosmetic applications at the concentrations currently in use