The Limit Lies Not in the Total Fragrance Oil, but in the Contact
The first misconception most manufacturers have is this: "If I add X% fragrance oil, I'm safe." In reality, IFRA (International Fragrance Association) limits do not look at the total fragrance oil percentage. The real question is different: does the product remain on skin, or is it rinsed off? And where is it applied — to the lips, the arm, the hair? Change the answer, and the limit changes too.
The logic can be summed up in a single word: exposure. A product applied to the lips may be ingested; an underarm deodorant contacts thin, sensitive skin; a bar of soap lathers for a few seconds and washes away. IFRA builds its entire framework on exactly these distinctions.
The scientific name for this approach is QRA2 (Quantitative Risk Assessment 2). Just as we say the top note lifts away and the next layer takes the stage when talking about scent, in regulation it is the exposure model that takes centre stage. QRA2 brings together three endpoints — dermal sensitisation, phototoxicity, and systemic toxicity — within a single unified framework.
Enter the category limit from your fragrance oil's IFRA certificate to see the maximum oil for your batch.
⚠️ Always take the limit from the fragrance oil's own IFRA certificate — every oil differs by category. This tool is a convenience, not a substitute for the certificate. · esans.com.tr Akademi
QRA2 Weighs Three Risks at Once
A limit is not determined by a single test but by three separate risks; whichever yields the lowest value is the deciding one. The rest is the mathematics of your formula.
The QRA2 framework evaluates all three endpoints simultaneously when establishing the upper permitted limit for a substance, and applies the most restrictive one.
| Risk endpoint | What does it ask? | Relationship to category |
|---|---|---|
| Dermal sensitisation | Can repeated contact trigger an allergic response? | Stricter for leave-on products |
| Phototoxicity | Can it cause skin discolouration or burns in sunlight? | Decisive for products used on sun-exposed areas |
| Systemic toxicity | Is the total absorbed dose safe? | Critical for ingestible or large-surface-area products |
An important nuance: QRA2 operates on an aggregate exposure basis. IFRA assumes that a consumer is exposed to the same substance from multiple different products throughout the day; as a result, the permitted share from any single product is reduced.
This is also the point at which the natural-versus-synthetic assumption needs to be challenged. Safety depends not on whether a raw material is natural or synthetic, but on the identity of the molecule and the level at which it is used. Some of the most tightly restricted allergens — Citral, Eugenol, oakmoss — occur at high concentrations in natural essential oils. Natural bergamot is phototoxic and can cause pigmentation on sun-exposed skin. By contrast, certain pure synthetic ingredients such as Iso E Super or Ambroxan are virtually free of allergy concerns. In regulatory terms, "natural = safe" is simply incorrect.
Leave-on / Rinse-off and the 12-Category Map
The system is currently built on 12 main categories as defined by the 51st Amendment, some of which are further divided into sub-letters. The first distinction you need to know by heart is leave-on versus rinse-off.
A leave-on product remains on the skin (perfume, moisturiser, deodorant); exposure is prolonged and continuous, so limits tend to be strict. A rinse-off product is washed away (soap, shampoo, shower gel); contact is brief, so the same substance is often permitted at a higher level. This is precisely why IFRA splits Category 7 in two: 7A covers rinsed-off hair products, and 7B covers leave-on hair products.
| Category | Type | Typical products |
|---|---|---|
| 1 | Leave-on (lip) | Lipstick, lip balm |
| 4 | Leave-on | Fine fragrance; neck/wrist application (hydroalcoholic perfumes) |
| 5A–5D | Leave-on | Face/body creams, hand cream (5C), baby cream (5D) |
| 6 | Oral/lip contact | Toothpaste, mouthwash |
| 7A / 7B | Rinse-off / Leave-on (hair) | Rinse-off hair colour (7A) / hair spray, styling gel (7B) |
| 9 | Rinse-off | Soap, shampoo, shower gel, shaving cream |
| 10A | Home care / contact | Reed diffuser, car fragrance, laundry products |
| 11A / 11B | Minimal transfer from inert surface | Pads, wipes (11A) / scented socks, napkins (11B) |
| 12 | No direct skin contact | Candles, incense, room fragrance sticks |
One point deserves clarity: under the 51st Amendment, reed diffusers are no longer classified under Category 12 (candles) but under 10A, because consumers handle the sticks with their hands and transfer the fragrance to their skin. In other words, real-world consumer behaviour determines the category.
The same amendment introduced limits for phototoxic substances in certain rinse-off categories (7A, 9, 10A) for the first time, and Category 6 is now treated as rinse-off for phototoxicity purposes. These changes illustrate just how much of a living system the categories are.
The practical upshot: if you plan to use the same fragrance oil in both a perfume (Cat. 4) and a soap (Cat. 9), the soap may permit a significantly higher usage rate — but pushing that same rate in a perfume could breach an allergen limit. For more detail, see What Are IFRA Standards and How Do They Affect Your Product?
For Manufacturers: A Step-by-Step Compliance Workflow
Let's translate the theory into a practical workflow. The sequence below is the backbone that will keep you covered from the moment you purchase a fragrance oil to the moment it reaches the shelf.
- Identify your category first
Does the product remain on skin or is it rinsed off? Where is it applied? Select the correct category from the 12 available based on these answers. Choosing the wrong category is the most common — and most costly — mistake.
- Request the IFRA Certificate of Conformity
Obtain the Certificate of Conformity and the SDS (Safety Data Sheet) from your supplier. The certificate provides a ready-made maximum usage rate for each category.
- Read the row for your specific category
The certificate will list different rates such as "Cat. 4: X%, Cat. 9: Y%". The row that applies to you is the one for your product's category — not the highest number on the page.
- Keep your fragrance oil usage rate below that limit
The fragrance oil percentage in your formula must not exceed the limit for your category. If it does: reduce the rate, change the raw material, or — where appropriate — move the product to a less restrictive category (e.g. from leave-on to rinse-off).
- Work in grams; convert ml using density
Build your formula in grams (g). Bear in mind that the specific gravity of fragrance oils and solvents varies considerably: citrus oils run around 0.84, while heavy resins and some synthetics can exceed 1.10. If you ignore density when converting between ml and g, you will encounter overflow or underfill issues in volumetric bottling.
- Document and file everything
Record your calculations, the certificate, and your formula. Amendments change; when a new IFRA version is published, updating your documents is your responsibility.
There is also a safety dimension to consider. High-strength ethanol and room fragrance solvents (DPM, MMB, Dowanol, etc.) are highly flammable — they have low flash points. When working with these materials, avoid static electricity, ensure good ventilation, and wear gloves and eye protection.
Finally, IFRA compliance does not replace national legislation. In Turkey, selling cosmetics or perfumes requires company registration and product notification in the ÜTS (Product Tracking System) before placing them on the market; these are subject to official fees — do not assume that "notification is free." The procedure (notification steps) and the obligations (responsible person/manufacturer duties) are separate matters. For further detail, refer to our articles ÜTS Registration: What You Must Do Before Selling Cosmetic Perfumes and What You Need to Know About Fragrance Oil Trade Under KKDİK; for current procedures and fees, always refer to the official TİTCK source.
Common Mistakes and Frequently Asked Questions
Let's clarify the three questions that trip up prospective manufacturers most often. Everything else is down to your own judgement — but these three points are non-negotiable.
The three most common mistakes: choosing the wrong category; counting allergens only from added synthetics (and forgetting those present in natural oils); and accepting generalisations such as "fragrance oil is safe up to 20%." These three errors account for the vast majority of recall and non-compliance risks.
Can I safely use any fragrance oil at up to 20%?
If I use the same fragrance oil in both a perfume and a soap, do I apply the same usage rate?
If I use natural essential oils, am I exempt from IFRA limits?
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