The Modernization of Cosmetics Regulation Act (MoCRA) revises the regulatory framework for cosmetics in the U.S., introducing new requirements for fragrance labeling. The precise ingredients of fragrance blends are shielded under trade secret protections, allowing manufacturers to list these ingredients collectively as "fragrance" or "perfume." This practice is upheld by FDA regulations that require the disclosure of ingredients in cosmetics, with an exemption for the detailed composition of fragrances. MoCRA's changes aim to enhance transparency and consumer safety without compromising the proprietary formulas of fragrances.[I]

In the creation of cosmetic fragrances, an intricate blend of numerous ingredients, ranging from tens to hundreds, is utilized. This blend comprises both naturally sourced elements and synthetic compounds, carefully curated to forge distinct aromatic profiles.[ii] The precise formulation of these ingredients remains a closely guarded secret, unique to each fragrance, thus imbuing every scent with its signature uniqueness. This proprietary approach to fragrance formulation is fundamental in distinguishing one fragrance from another, offering a rich tapestry of scents that cater to diverse preferences and olfactory experiences.

Fragrance allergens in cosmetics are compounds that may trigger allergic responses in certain individuals. These allergic reactions can manifest in various forms, from skin-related issues such as dermatitis, characterized by scaly, red patches, and blisters, to more severe respiratory conditions particularly in those with pre-existing conditions like asthma. Symptoms can range widely, encompassing itchy and peeling skin to facial swelling, and in extreme cases, could escalate to anaphylaxis, a potentially life-threatening reaction.

In regions like the European Union, there's a mandate for the explicit listing of specific fragrance allergens on cosmetic product labels if their concentrations surpass designated thresholds. [iii]This policy aims to enhance consumer awareness by providing critical information about the presence of potential allergens in cosmetics, enabling individuals to make informed choices regarding their use of such products.

In 2011, the European Scientific Committee on Consumer Safety conducted a thorough assessment of fragrances, identifying 82 substances as potential contact allergens, encompassing both synthetic compounds and natural extracts, with some flagged for their pronounced sensitizing capabilities.[iv] Subsequently, the European Union has curated a definitive list of 26 fragrance allergens, such as limonene, linalool, and eugenol, which necessitate explicit labeling on cosmetic products when their concentrations exceed specific limits, enhancing consumer awareness of allergen presence.[v]

• Disclosure of Fragrance Allergens: MoCRA mandates that each fragrance allergen present in a cosmetic product be listed on the product label. This requirement aims to inform consumers about the potential allergens they are exposed to, allowing those with sensitivities or allergies to make informed choices.
• Implementation Timeline: The specific requirements for fragrance allergen labeling under MoCRA are to be defined by the U.S. Food and Drug Administration (FDA). The FDA is expected to publish its list of required fragrance allergens for labeling under MoCRA by mid-year 2024.[vi] These allergens must then be included on product labels by the end of 2024. This move is anticipated to align with the European Union's listing requirements for fragrance allergen.

• Understanding the Regulations: To effectively navigate the new labeling requirements, it's crucial for companies to have a deep understanding of MoCRA and its implications for the cosmetic industry. This includes staying informed about the specifics of the fragrance allergen labeling rules once they are finalized by the FDA.
• Partnering with Regulatory Experts: Collaboration with regulatory experts[vii] and services can provide cosmetic companies with the knowledge and confidence to ensure compliance with MoCRA. Experts can offer guidance on adapting product formulations, labeling practices, and overall regulatory strategies to meet the new standards.

The anticipation surrounding MoCRA's fragrance allergen labeling requirements is palpable across the industry. Set against a backdrop of international precedent, these forthcoming regulations are expected to align with global best practices, offering a clear directive for the disclosure of allergens. This harmonization is crucial, bridging the gap between consumer safety and industry innovation, and setting a standard that resonates on a global scale.

In this landscape of change, the opportunity for brands to distinguish themselves through proactive engagement with MoCRA's requirements is immense. By embracing this shift, companies can not only align with regulatory expectations but also forge deeper connections with consumers, anchoring their brand in the values of safety, trust, and transparency. As we navigate the intricacies of this new regulatory framework, let us view MoCRA not as a hurdle, but as a beacon guiding the cosmetic industry towards a future where beauty and safety are inextricably linked, and where every scent tells a story of innovation, artistry, and care.