Heliotropin at 1.8%: Only Adult Fine Fragrance Is Left

What is the signal?

Two entries appeared on the European Commission's SCCS opinions list. The final opinion on Heliotropin (CAS No. 120-57-0, EC No. 204-409-7) is SCCS/1688/26, adopted on 12 October 2026 and published on 15 October. The final opinion on Acetophenone (CAS No. 98-86-2, EC No. 202-708-7) is SCCS/1689/26, listed as of 14 October, and it also appears in the committee's latest updates dated 15 October 2026.

Each conclusion is one line. For Heliotropin, the SCCS considers the substance safe when used as an ingredient in fine fragrances for adults, up to a maximum of 1.8%. For Acetophenone, it considers the substance safe when present up to a maximum of 100 ppm (0.01%) in cosmetic products, and states that this conclusion applies to Acetophenone only as a constituent of natural complex substances (NCS), with the NCS themselves not assessed.

The two arrived in the same month because they share a starting point. Neither review was raised on the cosmetic side; both began because of a possible reproductive toxicity Category 1B (Repr. 1B) classification under the CLP Regulation. For Heliotropin, ECHA's Risk Assessment Committee (RAC) issued an opinion in September 2024 recommending that classification, and for Acetophenone the RAC proposed Repr. 1B under CLP as well. Without a safety finding, such a classification would normally lead to prohibition in cosmetic products under Article 15(2) of the EU Cosmetics Regulation. So 1.8% and 100 ppm are not widened allowances; they are the narrow exceptions left standing after a ban.

The basis for the numbers is public too. The 1.8% figure for Heliotropin was derived through a margin-of-safety approach, using a value of 300 mg/kg body weight per day from an oral reproductive toxicity study in rats as the point of departure. The SCCS stated that it weighed exposure beyond cosmetics, including food, household products and e-cigarettes. The Acetophenone assessment likewise accounted for non-cosmetic routes such as food and tobacco smoke.

Let us mark the limits of this reading. An SCCS opinion is a scientific judgement, not legislation. For 1.8% and 100 ppm to become actual limits, the European Commission still has to amend the Annexes to the Cosmetics Regulation, and no date for that appears in these opinions. The Repr. 1B classification itself is described as possible or proposed. The Acetophenone page also still read "Opinion being finalised" at the time of checking, alongside a list entry showing it as a final opinion, and the publication date of the preliminary Heliotropin opinion is recorded differently across sources. This article therefore treats only the two substances' identifiers and the final opinions' conclusion figures as settled, and leaves the implementation timing open. For development purposes, though, the direction is already single: a formula designed now is safer treating these two numbers as ceilings.

1. Watching the banned list alone does not show this change

The usual way to check a formula bound for Europe is to look at the prohibited and restricted substance Annexes of the Cosmetics Regulation. That method would not have caught this in advance. The preliminary Heliotropin opinion states that the EU Cosmetics Regulation does not currently list Heliotropin as a restricted substance. The sequence is that the SCCS review concludes while the substance is absent from the restricted list, and the usable range narrows as a result.

The trigger sat outside the cosmetic framework. A hazard classification under CLP is not decided by looking at cosmetics alone, and once a substance is classified CMR 1A or 1B, Article 15 of the Cosmetics Regulation blocks its use in cosmetics as a matter of principle. So seeing ingredient risk early in a formula bound for the EU means watching two places: amendments to the cosmetic Annexes, and ECHA RAC classification opinions. The second is not usually carried as cosmetic industry news.

The practical way to run this is not a longer list but a different question. Asking "is this substance in a reproductive toxicity or carcinogenicity classification discussion?" rather than "is this substance on a banned list?" reduces what you need from a supplier or a regulatory contact to a single sentence. A substance under classification discussion may be usable today and unusable within the product's life, and that is the difference.

• Whether you asked suppliers in writing whether key ingredients are in a CLP classification discussion
• Whether restricted-list checks and classification-opinion checks are separate items on your review
• Whether regulatory change longer than the product's renewal cycle is written into the brief
• Whether an alternative route is noted for ingredients under classification discussion

2. For Heliotropin, the product category narrowed, not the level

The heavier part of this conclusion in practice is not the figure 1.8% but the qualifier "fine fragrances for adults". The scope the SCCS found safe is use in adult fine fragrance, and the same opinion also covered use in non-nicotine liquids for e-cigarettes. It is not a conclusion that lowering the level makes the substance available in other product categories.

The applicant did submit margin-of-safety calculations for other cosmetic products, including those for children, and on those calculations the aggregated use fell within the margin of safety. Even so, the scope the committee recognised came back narrowed to adult fine fragrance. The development reading is clear: do not write into a brief the assumption that submitting margin-of-safety calculations widens the scope.

Where this touches product planning is line extension. When a fragrance sells, the next step is usually a body lotion, hand cream or hair mist in the same scent. Keeping the accord intact is easiest by carrying the same fragrance composition over, which makes line extension the act of putting one fragrance into other formats. This conclusion breaks that premise. If the composition used in the perfume contains this substance, the same composition cannot move into a leave-on skincare or a children's product.

That reverses the order of work. If the plan is to launch a fragrance and attach a line later, the intended extent of that extension has to reach the perfumer or fragrance house at the point the fragrance is chosen. Saying it later means re-matching the accord, and an accord's impression shifts with even small changes in composition.

• Whether the formats you intend to extend into were given to the fragrance house when the accord was chosen
• Whether the brief states a plan to use the same accord outside fine fragrance
• Whether you decided first if children's or leave-on products are in the plan
• Whether the time needed to re-match an accord is in the schedule

3. For Acetophenone, natural fragrance is hit first

The Acetophenone opinion carries a notable piece of background. The industry did not defend Acetophenone as a standalone ingredient; it submitted a dossier defending its safe use as a constituent of natural complex substances (NCS). The SCCS's 100 ppm conclusion is therefore confined to Acetophenone inside NCS, and the safety of the NCS themselves was not assessed.

That structure means the opposite of what intuition suggests. It is not a formula with Acetophenone added as a separate fragrance material that meets this number first, but a formula using natural raw materials such as essential oils. A natural material brings in constituents that are not declared separately on the ingredient list, and their amounts vary with origin, harvest timing and extraction method. "We only used natural fragrance" is not an answer that clears 100 ppm.

So the unit of verification moves down as well. What you need is not the name of the fragrance composition but the constituent analysis for each natural material inside it. Fragrance houses generally treat compositions as trade secrets, so obtaining the full composition is difficult, but receiving a documented finished-product concentration for a specific substance is already how allergen declaration is handled. Changing the question from "please disclose the composition" to "please state the maximum concentration of this substance in the finished product" raises the chance of a reply.

Read the nature of the number too. 100 ppm is 0.01%. In a formula dosing fragrance at 1%, that corresponds to roughly 1% in the fragrance oil itself; in a formula dosing at 0.1%, the headroom in the oil is ten times wider. The same fragrance reaches a different conclusion depending on format and dose rate, so the calculation has to be done per SKU.

• Whether constituent analysis was obtained for formulas using natural raw materials
• Whether the question to the fragrance house was framed as a finished-product maximum
• Whether the same fragrance was recalculated per SKU at its own dose rate
• Whether the variation range by origin and lot was confirmed

4. The limits sit in the finished product, not the fragrance oil

Both opinions state concentration on the finished-product side: up to 100 ppm in cosmetic products for Acetophenone, and up to 1.8% as an ingredient of adult fine fragrance for Heliotropin. The documents a fragrance house sends are usually written against the fragrance composition, so comparing those figures directly misreads the position. One conversion step, through the dose rate, sits in between.

Who performs that conversion is the real problem. The dose rate is known to whoever holds the formula; the concentration in the composition is known to the fragrance house. While each number sits on its own side, nobody can state the finished-product concentration. So this check does not end at "we requested documents from the fragrance house" — it runs through multiplying the figure received by the dose rate and writing the result down per SKU.

That the SCCS counted non-cosmetic exposure is worth remembering as well. The Heliotropin assessment weighed exposure from food, household products and e-cigarettes; the Acetophenone assessment weighed food and tobacco smoke. These are methods the committee used, not calculations a company has to repeat, but a number derived that way is safer read as one without much headroom. Designing close to the limit is likely to be caught again at the next amendment.

Heliotropin carries one more condition. The SCCS noted that the substance is also a skin sensitizer, which is consistent with its role as a fragrance allergen. A concentration ceiling arising from reproductive toxicity classification and an allergen declaration threshold are standards from different frameworks, so whichever is lower becomes the real design ceiling. Checking both and writing the lower one per SKU reduces confusion.

• Whether you recorded if the fragrance house figure is composition-based or finished-product-based
• Whether finished-product concentration was calculated per SKU using the dose rate
• Whether the allergen declaration threshold and the concentration ceiling were checked separately
• Whether the lower of the two was written down as the design ceiling

5. An opinion is not a regulation, but development takes longer

An SCCS final opinion does not by itself change the market. Becoming an actual restriction requires the European Commission to amend the Annexes to the Cosmetics Regulation, and no timetable for that appears in the material published here. So this is not the answer to "do we have to change the formula right now?"

What has to be compared, though, is not the amendment date but the development period. Fixing an accord, running stability and sensory testing, reaching production, and then adding labelling and registration work for the export market leaves a sizeable gap between planning and shipment. A product fixing its fragrance now may well be sold after an amendment. A product already on sale, conversely, is one where you check the transitional terms when the amendment lands.

Splitting the judgement in two is therefore practical. For items on sale, first confirm whether the substances are present and keep only a list; for items in development, write these two figures in as design ceilings before the accord is fixed. The first is information gathering and the second is a design condition, and they cost differently.

One thing is clear. These two substances will not be the last. Both passed through the same route, starting from a CLP classification discussion and ending with a narrowed cosmetic use. That route has now been shown to work, so asking whether any material in a fragrance composition is under classification discussion is not a one-off question.

• Whether items on sale and items in development were separated with different responses
• Whether the two figures were entered as design ceilings before the accord was fixed
• Whether the gap between planning and shipment is written down in months
• Whether classification discussions on fragrance materials became a recurring check

The first question for the brief

Instead of writing "fragrance: composition no. 00", try adding one more line: what formats this fragrance will go into, and how far beyond adult fine fragrance the extension will reach. Because the Heliotropin conclusion narrowed a product category rather than a level, a brief without an extension plan ends up matching the accord twice.

The second thing to write is the converted figure. Next to the concentration received from the fragrance house, write the dose rate and their product — the finished-product concentration — per SKU. A cell holding only a composition-based number is a cell you cannot use for a decision. In a formula built on natural raw materials, this is the cell most likely to be empty.

The last is the shape of the question. Write down "is this substance in a reproductive toxicity or carcinogenicity classification discussion?" rather than "is it on the banned list?" Both of these substances had their scope narrowed while absent from the restricted list. A question that reads lists catches only changes that already happened; a question that reads classifications catches the next one first.