Two systems govern what a perfume may contain and what its label must say, and they are constantly confused with one another. One is the industry's own set of usage standards, issued and maintained by the fragrance association. The other is the labelling requirement that makes certain fragrance materials declareable above a threshold. A brand can satisfy one and fail the other, and the mistake is usually made at the brief stage rather than at the printer.
This article separates the two, explains how a compliance certificate is produced and what it actually covers, and sets out the documentation a brand should hold before the first shipment.
Two systems that are not the same thing
The first system is a set of voluntary usage standards for individual fragrance materials, maintained and periodically revised by the international fragrance association. A fragrance house that is a member commits to selling compounds that comply with the current version of those standards.
The second system is the labelling obligation that applies to a defined list of fragrance materials when they are present above a stated concentration in a finished cosmetic product. It has nothing to do with whether the material is safe to use; it exists so that people who react to those specific materials can see whether the product contains them.
The two interact but they answer different questions. The standards ask how much of a material may be used in a given product category. The labelling rules ask whether the consumer must be told that it is there. A compound can be fully compliant with the standards and still require three allergens on the label, and a compound that needs no allergen declaration can still be non-compliant if a restricted material is overdosed. Our fragrance development article covers how the two are handled together during development.
What the usage standards actually say
The standards are organised by material and by product category, and the category is the part that most often surprises brands.
For each restricted or newly assessed material, the standard sets a permitted concentration for each of a set of categories. The categories distinguish between products that are rinsed off and products that are left on, and they distinguish further by the area of skin it is applied to and by the way the product is used: a body lotion, a deodorant, a fine fragrance and a lip product are separate cases even when they contain the same material.
That structure is the reason a compound cannot simply be moved between products. A fragrance developed for a body wash may contain a material at a level that is permitted in a rinse-off product and above the permitted level in a leave-on lotion. The same fragrance placed in a body lotion is then non-compliant even though nothing in the formula changed. Our scent strength article covers the same boundary from the formulation side.
The standards are also revised. New materials are assessed, existing limits are lowered when new data appears, and the revision cycle means a compound that was compliant five years ago may need adjusting today. A brand that refills the same fragrance without asking has no way of knowing whether it still complies, which is why the certificate has a date and a version on it.
Altering the compound without altering the scent
When a limit is lowered or a material becomes restricted, the compound has to be adjusted, and the perfumer's job is to make that adjustment invisible.
The techniques are the ordinary ones of the trade. A restricted material is reduced and its function is taken over by a combination of others, sometimes by more than one, which is why the ingredient count of a modern compound is often higher than the older version it replaces. A natural absolute with a variable composition is replaced by a reconstruction, which has the side benefit of being more consistent batch to batch.
The practical consequence for a brand is that the compound code changes, which means the finished product must be re-tested: the allergen declaration may change, the stability may change, and the odour has to be re-approved on both blotter and skin. A reformulation driven by a standards revision is therefore a project rather than an edit, and it should be scheduled rather than squeezed in. Our reformulation article covers how that work is scoped.
The allergen list and where the thresholds come from
The allergen labelling list is a defined set of fragrance materials that must be declared on the label when they exceed a stated concentration in the finished product.
The list has grown over time from the original twenty-six and continues to be amended, which is one reason the number in the article title is now a shorthand rather than an accurate count. The thresholds differ by product type: the level that triggers a declaration is lower for products left on the skin and higher for products that are rinsed off. That difference exists because exposure is different, and it follows the same logic as the preservative rules. Our preservation article sets out that logic in another context.
Two details cause most of the confusion. The first is that the calculation is based on the concentration of the material in the finished product, not in the compound. A compound that contains two percent of a declarable material may still be under the threshold once it is diluted into the product, and a compound that contains twenty percent may not be. This means the same compound can require a declaration in one product and not in another, which is why allergen lists are drawn per product rather than per fragrance.
The second is that the declaration is an ingredient list entry, not a warning. It appears in the list in the usual position, using the standard name for the material. A brand that moves the allergens into a separate paragraph, or that prints them in a way that suggests a hazard, has made a labelling choice that is not supported by the rule it is trying to satisfy.
Who calculates it and what the certificate covers
The declaration has to be calculated from the actual composition of the compound, and the party that can do that is the fragrance house rather than the brand.
The fragrance house supplies, with each compound, a document that lists the declarable materials present above the relevant threshold and gives the maximum concentration at which the compound may be used in each product category without exceeding them. That document is what the brand uses to write the ingredient list and what a regulatory reviewer will ask for.
There is a common misunderstanding about what such a document guarantees. It states the composition of the compound at the dose specified. It does not certify the finished product, it does not cover materials added elsewhere in the formula, and it does not transfer the responsibility for the label to the fragrance house. The finished-product declaration remains the brand's or the responsible person's obligation in the market concerned.
That is why a manufacturer should ask for the compound documentation, the maximum permitted dose per category, and confirmation that the dose used in the product is within it. Our labelling requirements guide covers how that evidence fits into the pack review.
What differs between markets
The two systems are international in origin but the obligations that bind a brand are national, and they do not match perfectly.
Some markets incorporate the allergen list into their cosmetic labelling rules and enforce it on the pack. Others rely on the standards as an industry commitment without a separate declaration requirement. Some require the cosmetic product to be notified before it is placed on the market, and the notification includes the ingredient list, which means the declaration has to be correct before the product can be sold rather than merely before it can be printed.
There is also the question of language and of what counts as the ingredient list in a market that permits an off-pack reference. And in markets with an ingredient positive list or an additional national restriction, a material that is permitted elsewhere may be excluded altogether.
The practical rule is that the declaration is drawn for the destination market, not for the brand's home market, and a product sold in several markets may need several ingredient lists. Building those from one master document with per-market annotations is far cheaper than re-deriving them each time a variant is launched.
Documentation a brand should hold
- The current certificate or declaration for each fragrance compound used, with its version date.
- The maximum permitted dose of that compound in each product category the brand sells into.
- The actual dose used in each finished product, so the two can be compared.
- The resulting list of declarable materials per product, and the same list after any reformulation.
- A record of every change to a compound, with the date and the reason.
- The ingredient list per market, in the form required there.
- Confirmation that any material added outside the compound, such as an essential oil blend, has been assessed on the same basis.
- The revision date on which the compound documentation will next need re-checking.
System, instrument and obligation at a glance
| Item | What it is | Who issues it | What it obliges a brand to do |
|---|---|---|---|
| Fragrance usage standards | Permitted concentrations per material and product category | The international fragrance association | Use compounds that conform, and re-check when the standards are revised |
| Certificate of conformity | Statement that a compound conforms to the current standards | The fragrance house | Keep it on file and confirm the version date is current |
| Declarable material list | The fragrance materials that must appear in the ingredient list above a threshold | Set by the market's cosmetic rules | Calculate against the finished product and print correctly |
| Declaration document for a compound | Which declarable materials are present and at what dose | The fragrance house | Compare the dose used with the maximum permitted |
| Threshold | The concentration at which a declaration is triggered | Set by the market and differs by product type | Confirm per product, not per fragrance |
| Assessment of the finished product | The safety assessment required for the market | The assessor appointed for the market | Supply the compound documentation as an input |
The table describes the roles rather than the numbers. The specific threshold values, the exact list of declarable materials and the applicable version of the standards all change over time and differ between markets, and they should be confirmed against the current published version before the artwork is finalised.
What to put in the brief
- The product categories the fragrance will be used in, since the limits differ by category.
- The target markets, so the applicable list and notification requirements are known from the start.
- The maximum dose the brand intends to use in each product, stated as a percentage of the finished product.
- Whether the compound will also be used in a rinse-off and a leave-on version of the product, and at what doses.
- A requirement that the compound documentation be supplied with each delivery, not once at the outset.
- A note of how the brand will be told if a standard changes during the product's life.
- The intended product name and pack format, since the ingredient list has to fit the artwork.
Where our capability fits
We keep the two systems separate in the way we work: the compound documentation is checked against the dose actually used in each finished product, and the declaration is then calculated per product and per market rather than copied from the fragrance sheet. When a compound is adjusted, the affected products are re-tested rather than simply relabelled.
We work with brands on private label (your brand on a proven base), OEM/ODM contract manufacturing, and full custom formula development — whichever matches where your brand is today. Our fragrance work includes perfume and fragrance manufacturing built on documented compounds, and a gardenia-led floral developed for more than one market.
Tell us the markets and the product categories, and we will tell you what the compound documentation has to state and what the label will carry. Start at our inquiry page, email capsulebiotech@163.com, or message the right team on WhatsApp: Capsule Series (capsules only) +86 158-7655-5319, Cosmetics Series (serum, hair care, body care, fragrance) +86 158-7655-5319.
General manufacturing information, not regulatory or legal advice. Standards, declarable material lists, thresholds and market requirements change over time and should be confirmed against the current published versions.