[Updated] Fragrance Allergens Labeling Regulations for Cosmetics in Global Major Countries

Editor's note: This article was originally published on June 2, 2023, and was updated on August 1, 2023, as per the latest developments. The updated section is highlighted in red.

Legislated

1. Chinese Mainland

Adult Cosmetics

In 2018, the National Committee on the Assessment of the Protected Traditional Chinese Medicinal Products (Center for Food Evaluation, State Administration for Market Regulation), commented on the issue of cosmetic fragrance allergen labeling on their official website.

Cosmetic products often contain fragrances or vegetable oils, in which allergens may exist. In some countries/regions, such as the European Union (EU), manufacturers are required to label allergens above a certain concentration on the product label to warn consumers. If such products are sold in the Chinese market, the enterprise must include the warning "This product/ ** ingredient contains [allergen]" in the "precautions" section on the Chinese label. However, such ingredients are not allowed to be listed in the "full ingredients" section, unless they are added separately to the formula.

Children Cosmetics

Technical Guidelines for Children’s Cosmetics (Draft for Comments) released on April 11, 2022, encourage to avoid the use of fragrance and flavors in children's cosmetics, particularly those that may contain any of the 26 fragrance allergens.

If fragrance or flavors containing these 26 allergens are used,

• A full safety assessment must be conducted;

• For leave-on products containing fragrance allergens exceeding 0.001%, or rinse-off products with a concentration of fragrance allergens exceeding 0.01%, the name of the specific fragrance allergens should be labeled, guided by "Contains Allergens".

This draft requirement for children's cosmetics is significant, as it marks the first time that China has proposed the labeling of 26 fragrance allergens. This shows that the Chinese regulatory authorities are prioritizing the safety supervision for children's cosmetics.

2. South Korea

Enterprises in South Korea are required to label 25 fragrance allergens on the “full ingredients” section on cosmetic packaging, but only when they exceed certain concentrations. Specifically, rinse-off products require labeling when fragrance allergens exceed 0.01%, while leave-on products require labeling when fragrance allergens exceed 0.001%. The 25 allergens that must be labeled and their CAS numbers are listed below.

Table 1: South Korea – 25 Fragrance Allergens that Must Be Labeled

3. India

India requires companies to indicate the presence of 26 fragrance allergens in the list of ingredients when concentrations exceed 0.01% in rinse-off products and 0.001% in leave-on products. The 26 allergens that must be labeled and their CAS numbers are listed below.

Table 2: India – 26 Fragrance Allergens that Must Be Labeled

4. EU

The EU requires companies to indicate the presence of 24 fragrance allergens in the list of ingredients when concentrations exceed 0.01% in rinse-off products and 0.001% in leave-on products, whether or not they are added directly as an ingredient or are present as a component of a fragrance ingredient. The 24 allergens that must be labeled and their CAS numbers are listed below.

Table 3: EU - 24 Fragrance Allergens that Must Be Labeled

Expanding the Scope of Fragrance Allergens

In September 2022, EU notified WTO of a draft regulation that would extend individual labeling requirements for 56 newly identified fragrance allergens. The finalized regulation was released in the EU's official journal on July 27, 2023, and will come into effect on August 16, 2023. The new regulation imposes the same labeling requirements for the newly identified fragrance allergens as for the existing 24. Additionally, some existing fragrance allergens have undergone name and CAS number revisions, as presented in Table 3. Some of the newly identified fragrance allergens include:

Table 4: EU - Excerpt of 56 Newly Identified Fragrance Allergens that Must Be Labeled

To ease the burden on the industry due to the large number of new fragrance allergens, the European Commission has established transition periods of 3 and 5 years for compliance with the new restrictions. Beauty brands will need to adapt their product labels to meet the new requirements according to the following timelines:

• New cosmetic products entering the EU market must comply within 3 years, by July 31, 2026.

• Cosmetic products already on the EU market must comply within 5 years, by July 31, 2028.

5. UK

The UK's labeling requirements for fragrance allergens are similar with those of the EU. Companies must indicate the presence of 24 fragrance allergens in the list of ingredients when concentrations exceed 0.01% in rinse-off products and 0.001% in leave-on products, regardless of whether they are added directly as an ingredient or are present as a component of a fragrance ingredient. For a complete list of the 24 allergens and their CAS numbers, please refer to Table 3.

Currently, the UK government (England, Scotland, and Wales) has not announced compliance with the EU's new fragrance allergen restrictions. However, since Northern Ireland still adheres to EU rules, products sold there must comply with the EU's new fragrance allergen labeling requirements.

6. New Zealand

New Zealand requires companies to indicate the presence of 26 fragrance allergens in the list of ingredients when concentrations exceed 0.01% in rinse-off products and 0.001% in leave-on products, whether or not they are added directly as an ingredient or are present as a component of a fragrance ingredient. The 26 allergens that must be labeled and their CAS numbers are listed below.

Table 5: New Zealand – 26 Fragrance Allergens that Must Be Labeled

7. The United Arab Emirates (UAE)

Product ingredients must be listed on the container or on the product itself if no container is used. Allergens must be included in the ingredients list on the container label. If a perfume contains an aromatic allergenic substance at a concentration above 0.001%, it must be listed among the substances that compose the product on the container's packaging.

In the Process of Legislation

1. US

Currently, cosmetics in the United States are not required to be labeled with fragrance allergens. However, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), passed on December 29, 2022, indicates a legislative trend towards requiring such labeling in the future.

MoCRA establishes federal standards for cosmetic business registration, product listing, recordkeeping, adverse event reporting, safety substantiation, GMP, recalls, and more. It also mandates FDA to formulate and publish regulations on fragrance allergen labeling. A list of fragrance allergens and specific labeling requirements will be published by the FDA in the future.

2. Canada

Currently, Health Canada (HC) does not require cosmetics to be labeled with fragrance allergens on the label. However, in February 2023, HC proposed amendments to require the labeling of identified 24 fragrance allergens in the ingredient list on the package of cosmetics when their concentration exceeds 0.001% in leave-on products or 0.01% in rinse-off products. The 24 allergens are consistent with those listed by the EU (refer to Table 3) and also subject to change by the EU.

This would make it easier for people with allergies to identify and avoid potential allergens in these products, which improves consumer safety. In addition, it would provide consistency in labeling requirements.

It's important to note that the proposed regulations are not yet finalized and may be subject to change based on feedback from stakeholders and the public. Nevertheless, if implemented, they would represent a significant step towards improving the safety of cosmetic and personal care products sold in Canada.

Notes:

Fragrance allergen labeling is not currently required in Hong Kong (SAR of China), China’s Taiwan, Japan, or ASEAN.