Fragrance Regulation: What's The Deal?

Fragrances are a combination of chemicals that give perfumes and colognes a pleasant scent. They are regulated by the US Food and Drug Administration (FDA), which classifies fragrances according to their intended use. Fragrance products can be categorized as drugs, cosmetics, or both. While fragrances in cosmetics must adhere to FDA requirements for cosmetic ingredients, they are exempt from FDA approval before entering the market. Fragrance ingredients are often regarded as trade secrets, allowing manufacturers to list them simply as fragrance or flavor on product labels. However, companies have a legal responsibility to ensure the safety of their products and comply with labeling regulations.

Fragrance products are categorised as cosmetics, drugs, or both

Fragrance products are classified by the US Food and Drug Administration (FDA) according to their intended use. They can be categorized as cosmetics, drugs, or a combination of the two.

A product is considered a cosmetic if it is intended to be applied to a person's body to make them more attractive. This includes perfumes, colognes, aftershaves, skin moisturizers, deodorants, and shaving creams. These products are regulated as cosmetics by the FDA.

On the other hand, if a product is intended for therapeutic use, such as treating or preventing disease or affecting the structure or function of the body, it is considered a drug under the law. This includes products with labeling statements such as helping people sleep or relieving muscle pain.

Some fragrance products may fall into both categories, depending on their intended use. For example, a massage oil intended to lubricate the skin is a cosmetic, but if it claims to have therapeutic benefits such as relieving aches, it is considered a drug.

It is important to note that fragrance products must meet safety requirements, and companies are legally responsible for ensuring their products are safe and properly labeled. While FDA approval is not required before entering the market, fragrance ingredients should comply with FDA requirements for cosmetic ingredients and adhere to labeling regulations to ensure consumer well-being.

Fragrance ingredients are not subject to FDA approval

In the United States, the Food and Drug Administration (FDA) classifies fragrances according to their intended use. Fragrance products can be categorized as drugs, cosmetics, or both. If a product is intended to be applied to a person's body to make them more attractive, it is categorized as a cosmetic. This includes perfumes, colognes, and aftershaves.

While fragrance and flavor formulas are complex mixtures of many different natural and synthetic chemical ingredients, they are often considered "trade secrets" by cosmetic manufacturers. Therefore, under U.S. regulations, these ingredients can be listed simply as "Fragrance" or "Flavor" on product labels.

It is important to note that some fragrance ingredients may cause allergic reactions or sensitivities in some individuals, even if they are generally considered safe. The FDA does not have the same authority to require allergen labeling for cosmetics as it does for food. Therefore, consumers concerned about fragrance sensitivities may need to choose fragrance-free products and carefully check the ingredient list.

Fragrance formulas are considered trade secrets

Fragrances are a combination of chemicals that give off a pleasant scent. They are commonly used in perfumes, colognes, and other cosmetic and personal care products. While the US Food and Drug Administration (FDA) regulates fragrances in cosmetics, companies are not required to disclose the specific ingredients that make up their fragrance formulas. Instead, these formulas are often protected as trade secrets.

The FDA requires cosmetics to have an ingredient list on their packaging. However, under the Fair Packaging and Labeling Act (FPLA), companies are not forced to disclose trade secrets. Fragrance formulas are considered trade secrets because they are complex mixtures of many different natural and synthetic chemical ingredients. These formulas are unique to each company and are considered the lifeblood of their industry.

The protection of fragrance formulas as trade secrets has come under scrutiny due to concerns about the safety of certain fragrance chemicals. Some fragrance chemicals have been linked to health issues such as hormone disruption, cancer, asthma, and skin irritation. Additionally, there is a lack of independent review of the safety studies conducted by fragrance manufacturers.

To address these concerns, some consumer advocacy groups and legislators have called for increased transparency and regulation in the fragrance industry. For example, the Safe Cosmetics and Personal Care Products Act of 2018, introduced by Rep. Jan Schakowsky (D-IL), calls for full fragrance ingredient disclosure to consumers. Additionally, some manufacturers have started to voluntarily disclose more fragrance ingredients in their products.

While the protection of trade secrets may be important for companies, it is also crucial to ensure the safety and well-being of consumers. Finding a balance between these two interests is an ongoing process and a topic of discussion among various stakeholders, including government agencies, consumer advocacy groups, and the fragrance industry.

Fragrance allergens must be disclosed under a new federal law

In the United States, the Food and Drug Administration (FDA) regulates fragrances in cosmetics and personal care products. If a product is intended to be applied to a person's body to make them more attractive, it is categorized as a cosmetic. This includes perfumes, colognes, and aftershaves.

Before entering the US market, fragrance ingredients must comply with the FDA's requirements for cosmetic ingredients. While they are exempt from FDA approval before being sold, fragrances and their ingredients must adhere to labeling regulations and ensure consumer safety during usage. The FDA requires cosmetics marketed at a retail level to list their ingredients. However, under US regulations, fragrance formulas can be listed simply as "Fragrance" or "Flavor" as they are considered trade secrets.

The FDA does not have the same authority to require allergen labeling for cosmetics as it does for food. However, this is set to change with the passing of a new federal law in December 2022, which will require companies to disclose some fragrance allergens. This law is known as the Fragrance and Flavor Right to Know Act (HR 5538). It mandates the on-pack disclosure of any fragrance or flavor chemicals that appear on 21 designated hazard lists, including updates to these lists. It also requires the disclosure of 26 EU-designated fragrance allergens, with updates to this regulation also being included.

The new federal law will also require the disclosure of hazardous chemicals on product labels and websites. If a hazardous chemical is added to a finished cosmetic product at or above 100 ppm, it must be disclosed. This aligns with the current industry best practice. Additionally, the law will require the FDA to formulate and publish regulations on fragrance allergen labeling, including a list of specific fragrance allergens and their labeling requirements.

The requirements of this new federal law will not go into effect until at least 2025, and the list of allergens to be disclosed is yet to be released by the FDA. However, this law marks an important step towards protecting consumers from toxic chemicals and fragrance allergens, as well as improving transparency and safety in the cosmetic and personal care product industry.

Fragrance safety is assessed by the International Fragrance Association (IFRA)

Fragrances are a combination of chemicals that give off a pleasant scent. They are used in perfumes, colognes, aftershaves, cosmetics, and personal care products like makeup, moisturisers, shampoos, shaving creams, and body lotions. Fragrances are also used to mask unpleasant odours in a formulation.

The safety of fragrances is assessed by the International Fragrance Association (IFRA), a global trade organisation that represents the fragrance industry. The IFRA was established in 1973 and works in collaboration with fragrance houses, regulatory authorities, and scientific experts to develop and update standards that promote the safe and sustainable use of fragrances. The IFRA Standards ban, limit, or set criteria for the use of certain ingredients, based on scientific evidence and consumer insights. These standards are compulsory for all IFRA members, who produce around 80% of the global volume of fragrances.

The IFRA Standards encompass a wide range of factors, including the composition of fragrance ingredients, maximum concentration levels in consumer products, and labelling requirements. By adhering to these standards, fragrance manufacturers demonstrate their commitment to producing safe, high-quality products that meet consumer needs and expectations, while also ensuring compliance with regulatory requirements.

In addition to IFRA standards, fragrance manufacturers operating in Europe must comply with specific regulatory requirements set forth by the European Union (EU), such as the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) framework, which governs the use and handling of chemicals in consumer products, including fragrances. Under REACH, fragrance ingredients must undergo rigorous safety assessments to ensure they meet strict criteria for human health and environmental protection.

Compliance with IFRA standards and regulatory requirements offers several benefits, including consumer safety, quality assurance, market access, and environmental responsibility. It ensures that fragrance manufacturers produce safe, high-quality products that meet regulatory requirements and minimise the risk of adverse reactions or health concerns.

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