MoCRA Fragrance Allergen Labeling: What's Coming and How to Prepare

What MoCRA Says About Fragrance Allergens

Section 609(b) of the FD&C Act, as added by MoCRA, directs FDA to issue regulations requiring the disclosure of individual fragrance allergens on cosmetic labels. Prior to MoCRA, FDA regulations (21 CFR §701.3) allowed cosmetics companies to list fragrance ingredients simply as "fragrance" or "parfum" on the ingredient label — a practice that has been in place since the 1970s.

This blanket exemption meant consumers with known fragrance allergies had no way to determine which specific allergenic ingredients were in a product. MoCRA changes this by requiring individual disclosure of specific allergens that have been scientifically linked to allergic contact dermatitis.

The statute gives FDA 18 months from MoCRA's enactment (December 29, 2022) to issue a proposed rule, meaning the proposed rule was due by June 2024. As of early 2026, FDA has not yet published the proposed rule, though the agency has indicated it is actively working on it. Once proposed, there will be a public comment period before the final rule is issued.

The EU Model: 26 Fragrance Allergens

The EU has required individual fragrance allergen labeling since 2005 under EC Regulation No 1223/2009 (the EU Cosmetics Regulation). The EU framework provides a likely template for FDA's approach:

Under EU rules, 26 specific fragrance allergens must be individually listed on the ingredient label when present above certain concentration thresholds:

• 0.001% (10 ppm) in leave-on products (moisturizers, makeup, perfume)
• 0.01% (100 ppm) in rinse-off products (shampoos, body wash, cleansers)

The 26 EU-regulated allergens include well-known ingredients such as:

In 2023, the EU expanded its allergen list further, adding 56 new substances to the mandatory disclosure list (effective 2026–2028). FDA may adopt a similar or narrower list depending on U.S.-specific exposure data.

Impact on Professional vs. Consumer Products

MoCRA's fragrance allergen provisions apply to all cosmetic products marketed in the United States, but the practical impact differs between product categories:

• Consumer products (retail): Will require individual allergen listing on the consumer-facing label. This means reformatting ingredient lists that currently use the blanket "fragrance" term. For products with complex fragrances containing multiple allergens, the ingredient list could become significantly longer.
• Professional-use products (salon/spa): MoCRA includes a provision for professional-use products that are not marketed directly to consumers. These products may have modified labeling requirements, potentially allowing allergen information to be provided through a Safety Data Sheet (SDS) rather than the product label itself. The final rule will clarify this distinction.
• Fragrances (perfumes, colognes): Products where fragrance is the primary product (not just an ingredient in another product) will be particularly affected. These products often contain dozens of allergenic fragrance ingredients that will need individual listing.

Companies should begin auditing their fragrance formulations now to understand which allergens are present and at what concentrations. This requires working with your fragrance supplier to obtain complete allergen declarations for each fragrance blend.

Industry Impact and Supply Chain Considerations

Fragrance allergen disclosure will create ripple effects throughout the cosmetics supply chain:

• Fragrance houses will need to provide detailed allergen declarations to their customers (cosmetics manufacturers). Many already do this for EU compliance, but some formulations sold exclusively in the U.S. may lack this documentation.
• Contract manufacturers must ensure allergen information flows from fragrance suppliers through to the finished product label. This requires updating supply chain documentation systems.
• Labeling and packaging will need to be redesigned for many products. Ingredient lists that currently fit on a small panel may need additional space for individual allergen names.
• Reformulation decisions: Some companies may choose to reformulate products to remove or reduce allergenic fragrance ingredients rather than list them. This is particularly relevant for products marketed as "clean" or "hypoallergenic."
• Inventory management: Once the rule takes effect, old-label inventory will need to be sold through or relabeled. Plan print runs and packaging orders accordingly.

Timeline and How to Prepare

While the exact timeline remains uncertain, here is the expected regulatory sequence and recommended preparation steps:

What you should do now:

1. Request allergen declarations from fragrance suppliers. Ask for a complete list of EU-26 allergens and their concentrations in each fragrance blend you use.
2. Audit your product portfolio. Identify which products contain fragrance, which allergens are present, and at what concentrations (compared to likely thresholds).
3. Review label real estate. Assess whether your current packaging has sufficient space for expanded ingredient lists. Begin planning label redesigns for products that will need more space.
4. Consider reformulation opportunities. If certain fragrances contain high concentrations of multiple allergens, evaluate whether reformulation makes business sense.
5. Ensure current MoCRA compliance is up to date. Fragrance allergen labeling will be an additional requirement on top of existing MoCRA obligations (registration, listing, adverse event reporting).