Heidi Norton
Fragrance oils are an integral part of cosmetic products, often regarded as an overriding factor in the selection of cosmetics among consumers. While the regulatory process for essential oils used as fragrance ingredients is not as rigorous as that for food products and drugs, cosmetic manufacturers are responsible for ensuring that their products are safe, properly labelled, and of high quality. This includes providing a list of ingredients in descending order of predominance, except that fragrance or flavour may be listed as simply “fragrance” or flavour. In this paragraph, we will explore how to list fragrance oils on cosmetic labels to ensure compliance with regulations and provide transparency to consumers.
| Characteristics | Values |
|---|---|
| Ingredient declaration | All ingredients must be listed in descending order of predominance. |
| Flavor oils | Should be identified as "flavor" in the ingredient declaration. |
| Essential oil blend | Can be identified as "fragrance" in the ingredient declaration. |
| Individual essential oils | Can be listed individually or with some oils listed as "fragrance". |
| Marketing text | Can be used to promote the use of essential oils. |
| Scientific names | Should be used in Canada, Europe, and other countries. |
| Fragrance allergens | Must be listed in Europe if present at more than 0.001% in leave-on products or 0.01% in rinse-off products. |
| FDA requirements | The FDA does not require approval for fragrance ingredients but mandates a list of ingredients and safe usage instructions. |
| Trade secrets | Manufacturers are not required to disclose trade secrets, including fragrance formulas. |
| Allergens | Must be indicated on cosmetic labels, especially for consumers with sensitive skin. |
| Natural fragrances | Are in high demand due to the potential health risks associated with artificial fragrance chemicals. |
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What You'll Learn
International labelling requirements
United States:
In the United States, fragrance ingredients in cosmetics are not subject to approval by the Food and Drug Administration (FDA). However, enterprises must ensure that their products are safe for consumers and properly labelled. Fragrance ingredients are often considered trade secrets and can be listed simply as "'fragrance'" or "Flavor" on cosmetic labels without specifying the individual components. The FDA requires a list of ingredients under the Fair Packaging and Labeling Act (FPLA), but this law does not force companies to disclose trade secrets. Manufacturers are responsible for ensuring the safety of their products, and labels must include instructions for safe use. Additionally, products containing restricted substances above allowed limits require a warning label.
Canada and Europe:
In Canada and Europe, essential oils should be listed by their scientific names accepted in the International Cosmetic Ingredient Dictionary. For example, "Orange (Citrus sinensis) peel oil". Europe has strict requirements for labelling fragrance allergens, with 80 recognized allergenic ingredients and groups that must be disclosed on cosmetic labels. These include vanillin, terpineol, menthol, Mentha piperita oil, and Lippia citriodora absolute. The threshold for labelling is 0.001% for leave-on products and 0.01% for rinse-off products.
China:
China has proposed labelling requirements for 26 fragrance allergens in cosmetic products, prioritizing the safety of children's cosmetics. Labels must include a warning statement such as "This product/ingredient contains [allergen]" in the "precautions" section. However, these ingredients cannot be listed in the "full ingredients" section unless added separately to the formula.
South Korea:
South Korea mandates the labelling of 25 fragrance allergens in the "full ingredients" section of cosmetic packaging. However, this requirement only applies when the allergens exceed certain concentration thresholds.
United Kingdom:
The UK's labelling requirements for fragrance allergens align with those of the European Union.
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Allergens and sensitivities
Fragrance oils are a complex mixture of many different natural and synthetic chemical ingredients. Some individuals may be allergic or sensitive to certain ingredients in cosmetics, food, or other products, even if those ingredients are generally safe for most people. Some fragrance oil components have the potential to cause allergic reactions or sensitivities in some people.
In the United States, there are no fragrance allergens that are required to be identified in the ingredient declaration. However, the Modernization of Cosmetic Regulations Act of 2022, which was signed into law in December 2022, requires that the FDA identify any fragrance allergens that should be listed in the ingredient declaration. In Canada, Europe, and other countries, essential oils should be listed by their scientific name as accepted in the International Cosmetic Ingredient Dictionary. In Europe, there are 26 fragrance allergens that must be listed in the ingredient declaration if they are present at more than 0.001% (10 ppm) in leave-on products or 0.01% (100 ppm) in rinse-off products. An amendment to increase the number of allergens that must be identified is expected to come into effect in 2023.
A fragrance allergy occurs when certain fragrance components, called allergens, come into contact with the skin, causing the immune system to react by making protective proteins called antibodies to defend against the allergens. This inflammatory response leads to allergy symptoms. The reaction typically results in allergic contact dermatitis (ACD), an itchy rash that appears on the skin directly exposed to the irritating substance. Skin allergies to fragrance ingredients often involve the skin of the face, hands, or armpits.
To definitively understand what is causing the reaction and whether it is related to fragrance compounds, one must undergo skin patch testing. Patch testing involves placing patches with extracts of substances that can cause contact dermatitis on the skin of the arm or back for 48 hours. Skin responses are evaluated after 48 hours and again at between 72 and 96 hours for delayed hypersensitivity reactions.
It is important to note that even if a personal care product is labelled "unscented" or "fragrance-free", it may still contain fragrance components, known as masking fragrances, which cover up offensive odours that may naturally occur in a product. People can also develop allergies over time, so a product that was once safe may become problematic if an allergy develops.
To reduce the risk of having an allergic reaction, it is recommended to use air purifiers with HEPA filters, which have been shown to effectively reduce aerosolized chemicals and allergens. Additionally, those with allergies or asthma exacerbations triggered by fragrances should consider creating an allergy action plan, a detailed document outlining the steps to take in case of an allergic reaction.
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Marketing and consumer appeal
However, there are strategies to enhance marketing and consumer appeal when listing fragrance oils. One approach is to highlight the use of natural, plant-based essential oils instead of synthetic fragrance oils. This can be particularly appealing to consumers who value natural, organic, or "back-to-nature" products. For example, the label could state, "Scented with plant-based essential oils" or "We only use pure plant-based essential oils to scent this lotion." This approach leverages the growing consumer demand for natural ingredients and the perceived health benefits associated with essential oils.
Additionally, providing detailed information about the specific essential oils used can be advantageous. This transparency can build trust with consumers, especially those with sensitive skin or allergies who need to carefully consider the ingredients in the products they purchase. By listing individual essential oils, companies can highlight any unique benefits or properties associated with those oils, such as skin-soothing or antioxidant properties. This approach also allows for creative and descriptive language that can enhance the appeal of the product, such as "Infused with calming lavender and uplifting grapefruit essential oils."
Furthermore, in certain cases, expanded content labels can be utilised to provide more detailed information about the fragrance oils used. This could include booklet labels, foldout labels, or peel-back labels, which offer additional space for ingredients, instructions, warnings, and consumer information. This approach ensures that all relevant information is provided to the consumer while also maintaining a visually appealing and uncluttered primary label.
In summary, when listing fragrance oils on cosmetic labels, companies can enhance marketing and consumer appeal by emphasising the use of natural, plant-based essential oils, providing detailed information about specific oils, and utilising expanded content labels when necessary. These strategies allow for transparency, build trust with consumers, and highlight the unique benefits and properties of the fragrance oils used.
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Safety and legal responsibilities
Regulatory Definitions and Classifications:
The classification of fragrance oils as cosmetics, drugs, or both is crucial. In the United States, the Food and Drug Administration (FDA) regulates fragrance products based on their intended use. Fragrances applied to the body for aesthetic purposes, such as perfumes and colognes, are considered cosmetics. On the other hand, fragrances with therapeutic uses, like sleep aids or muscle relief products, are classified as drugs. This distinction is significant because drugs must be approved by the FDA before distribution, whereas cosmetics are only FDA-regulated but not FDA-approved.
Ingredient Listing Requirements:
Cosmetic products must adhere to specific ingredient listing requirements. In the United States, the Fair Packaging and Labeling Act (FPLA) mandates that ingredients be listed, but it does not force companies to disclose "trade secrets." This means that fragrance ingredients can simply be listed as "fragrance" without disclosing individual components. However, it is important to note that the Modernization of Cosmetic Regulations Act of 2022 requires the FDA to identify any fragrance allergens that should be listed. Additionally, in Canada, Europe, and other countries, essential oils should be listed by their scientific names as accepted in the International Cosmetic Ingredient Dictionary.
Allergen Labeling:
The presence of allergens in fragrance oils is a critical safety concern. In Europe, there are strict requirements to list specific fragrance allergens in cosmetic products. As of July 2023, the EU allergen list includes 82 fragrance allergens, and manufacturers must indicate their presence on labels if the concentration exceeds a certain threshold. In the United States, the FDA has been working to propose fragrance allergens for mandatory allergen labeling, with a deadline of June 29, 2024.
Safety and Proper Labelling:
All cosmetic ingredients, including fragrance oils, must meet safety requirements. Companies bear legal responsibility for ensuring their products are safe and properly labelled. Fragrance ingredients must be tested and safe for consumers when used as instructed on the product labelling. Labels must also include any necessary instructions and warnings in a prominent and conspicuous manner. This includes considerations for label size and design to ensure the required information is easily visible to consumers.
Marketing Claims:
Marketing claims and consumer expectations play a role in determining a product's intended use. It is important to be cautious when making claims about the effects of essential oils or fragrance oils. If a product claims to treat, cure, or prevent a condition, it may be classified as a drug and subject to different regulatory requirements.
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Ingredient declaration order
The ingredient declaration order for cosmetic labels must follow a descending order of predominance, with the ingredient used in the highest quantity listed first. However, there is an exception to this rule when it comes to fragrance oils. Fragrance oils can simply be listed as "fragrance" or "parfum" without disclosing the individual components of the blend. This is because fragrance formulas are often considered "trade secrets" and are not required to be disclosed under the Fair Packaging and Labeling Act (FPLA).
In the United States, essential oils used in cosmetic products can be listed as "fragrance" in the ingredient declaration. Alternatively, you may choose to list the individual essential oils if you know the specific oils used in the blend. You also have the option to list some oils as "fragrance" and list the remainder individually. If you choose to identify the essential oils as "fragrance", you can still include marketing text on the product label that states that essential oils are used and which ones. For example, you could include text on the front of the label that says "Scented with plant-based essential oils". It is important to note that in the US, botanical essential oils should be listed by their English common name followed by the plant part and form, for example, "Lavandula angustifolia (lavender) flower oil".
In Canada, Europe, and other countries, essential oils should be listed by their scientific name as accepted in the International Cosmetic Ingredient Dictionary. For example, "Citrus sinensis peel oil". Additionally, in Europe, there are 26 fragrance allergens that must be listed in the ingredient declaration if they are present above a certain percentage (0.001% or 0.1% depending on the product type). An amendment to increase the number of allergens that must be identified is expected to come into effect in 2023.
While using the term "fragrance" to encompass the entire essential oil blend is the easiest option, it may be a purchasing deterrent in markets where the use of synthetic fragrances is abhorrent. In such cases, you can use marketing text to emphasize the use of pure plant-based essential oils.
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Frequently asked questions
You can simply list fragrance ingredients as "fragrance" or "parfum". However, if you use essential oils, you may want to list them individually, especially if your target market is conscious of the difference between synthetic and plant-based fragrance oils. In Canada, Europe, and other countries, essential oils should be listed by their scientific name. In the US, they should be listed by their English common name.
In the US, fragrance ingredients are regulated by the Food and Drug Administration (FDA) and must be listed on the product label. However, the FDA does not require the disclosure of trade secrets, so manufacturers can choose to list fragrance ingredients as simply "fragrance". In Europe, there are 26 fragrance allergens that must be listed if they are present at more than 0.001% (10 ppm) in leave-on products or 0.01% (100 ppm) in rinse-off products.
The information on the label must be easily readable and not obscured by other information or design elements. If there is not enough space, consider using expanded content labels such as booklets, foldouts, or peel-back labels.
