White Label Skincare Brands Face a Fragrance Allergen Gap
Brands buying white label skincare are carrying a documentation gap most of them do not know about: the breakdown of what is inside the word “Fragrance” usually sits with the fragrance house and the factory, not with the brand whose name is on the label. That matters now because the FDA’s fragrance allergen labeling rule has moved to a November 2026 target on the federal Unified Agenda, and the EU’s expanded allergen list has been mandatory for products newly placed on that market since 31 July 2026. Under US law, the obligations land on the brand, not the manufacturer.
What is scheduled, and what has not happened yet
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) told the FDA to write a rule identifying which substances count as fragrance allergens and requiring them to be disclosed on cosmetic labels. The statutory deadline for the proposal was 29 June 2024. It has not been met. The Unified Agenda entry for RIN 0910-AI90 still lists the item at the proposed rule stage, with a notice of proposed rulemaking timetabled for November 2026.
Until that rule exists, nothing about US fragrance labeling has changed. FDA’s own guidance is explicit that fragrance and flavor ingredients may be listed simply as “Fragrance” or “Flavor”, because the Fair Packaging and Labeling Act cannot be used to compel disclosure of a trade secret. A brand reading that and concluding there is nothing to do is making a planning error rather than a compliance error. There is no US allergen list, no threshold and no compliance date to quote yet, which is exactly why the preparation work is documentary.
The EU version is already live, and it reaches white label ranges
Commission Regulation (EU) 2023/1545 added 56 fragrance allergens to the 24 that already required individual naming, taking the disclosable list past 80 substances. Each must appear in the ingredient list above 0.001% in a leave-on product or 0.01% in a rinse-off. The European Commission’s summary confirms the operative dates: non-compliant products can no longer be placed on the EU market as of 31 July 2026, and stock placed before that date may only be made available until 31 July 2028.
The detail that catches white label buyers is in the Irish regulator’s reading of it. A formulation that is rebranded, repackaged, reformulated or relabelled may count as a new product being placed on the market. Taking a stock formula, putting your name on it and shipping it to the EU is not inheriting someone else’s compliance date. It is starting a new one.
Under MoCRA, the name on the label owns this
MoCRA defines the responsible person as the manufacturer, packer or distributor whose name appears on the label. On a white label or private label range, that is the brand. FDA’s MoCRA page assigns the responsible person product listing, safety substantiation, labeling compliance and serious adverse event reporting within 15 business days. Facility registration is the factory’s duty. Neither side can take the other’s.
So when a fragrance allergen rule does land, the relabelling work, the reprinting and the ingredient data gathering sit with the brand. The brand cannot do any of it without a quantitative allergen breakdown from the fragrance supplier, routed through the manufacturer. That document either exists in your file or it does not, and finding out during a label reprint is the expensive version.
What to ask a manufacturer before the next run
- Ask for an allergen declaration per fragrance, with concentrations in the finished formula, not just an IFRA certificate.
- Confirm in writing who requests updated allergen data from the fragrance house when a list changes, and how fast.
- Check whether your artwork files can absorb a longer ingredient list without a full redesign at the next reprint.
- Get the manufacturing facility’s FDA Establishment Identifier now. FDA states it issues no certificate confirming registration or listing, and that neither is an approval program, so ask for the FEI rather than a certificate.
- If you sell or plan to sell into the EU, treat your relabelled version as a new placing on the market and check it against the current Annex III list before the run, not after.
Why this is a formula question, not a label question
A brand with one unscented and one lightly scented SKU has a much shorter list to manage than a brand with six fragrance variants sourced from three houses. That choice is made at formulation, long before anyone designs a carton. Moe’s Group formulates, fills and labels in one FDA registered facility in Chatsworth, California, which is the practical reason allergen data and artwork should be discussed in the same conversation: white label runs start at 200 units and custom formulations at 1,000, and the fragrance decision is cheapest to revisit before either.
If you are planning a 2027 launch or a reprint and want the allergen documentation question handled at the formulation stage, send us the brief.
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