Date: 11 September 2026 

Prepared for: Importers, Manufacturers, Suppliers and Buyers of Cosmetic Products for the EU Market 

EU Proposes Restriction on Piperonal (Heliotropine)

Piperonal (INCI: Heliotropine; CAS No. 120-57-0, EC No. 204-409-7) is currently not listed in any Annex of the EU Cosmetics Regulation (EC) No 1223/2009 and is freely used as a fragrance ingredient without concentration limits or labelling obligations.

This position is expected to change.

Following a recommendation by the European Chemicals Agency’s Risk Assessment Committee (RAC) to classify piperonal as a Reprotoxic Category 1B substance  and separately as a Skin Sensitiser Category 1B, the European Commission mandated the SCCS to assess whether piperonal could be exempted for specific cosmetic uses under Article 15(2) of the Cosmetics Regulation.

If the classification proceeds and no exemption is granted for a given product category, piperonal will be prohibited in that category. This is a significant tightening from the current position of no restrictions.

Background:  

Piperonal also known as heliotropine is an aromatic compound with a sweet, floral scent. It occurs naturally in some essential oils but is mainly produced synthetically. It is widely used as a fragrance ingredient in perfumes, lotions, creams, shampoos, and deodorants, and also functions as a fixative and masking agent.

In September 2024, ECHA’s RAC issued an opinion recommending a harmonised classification of piperonal as:

l Reprotoxic Category 1B (H360Fd) — may damage fertility or the unborn child

l Skin Sensitiser Category 1B (H317) — may cause an allergic skin reaction

Under Article 15(2) of the Cosmetics Regulation, substances classified as CMR 1A or 1B are prohibited in cosmetic products unless all of the following conditions are met: the substance complies with food safety requirements; no suitable alternatives are available; the application is for a particular product category with known exposure; and the SCCS has evaluated it as safe, taking into account overall exposure and vulnerable populations.

In June 2025, the European Commission received an industry dossier defending piperonal’s safe use in fine fragrances for adults under Article 15(2). The Commission subsequently requested the SCCS to assess this exemption.

On 15 April 2026, the SCCS published its preliminary opinion SCCS Preliminary Opinion (SCCS/1688/26). The opinion was open for public consultation until 15 June 2026.

The SCCS concluded that heliotropin is safe when used as a fragrance ingredient in fine fragrances for adults only at concentrations up to 1.8%. Critically, the SCCS did not establish a safe concentration for any other cosmetic product category. If the CMR 1B classification is adopted without a broader exemption, piperonal would be permitted only in adult fine fragrances at up to 1.8%, and prohibited in all other cosmetic products including body lotions, creams, shampoos, deodorants, and other fragranced products where it is currently used without restriction.

Skin Sensitisation – A Separate Risk to Consider

The SCCS opinion addresses the reprotoxic risk, however the RAC also recommended classification as a Skin Sensitiser Category 1B. These are two independent assessment endpoints.

For skin sensitisers, the CLP Regulation’s generic concentration limit for classification is ≥1%. If piperonal is classified as Skin Sens. 1B and is present in a finished product at ≥1%, the product itself may require classification as a skin sensitiser.

For practical planning, controlling piperonal below 1% is the more prudent approch. It avoids triggering CLP classification, reduces the risk of sensitisation, provides a safety margin in the toxicological Cosmetic Product Safety Report (CPSR) assessment, and this consideration also applies of the 1.8% SCCS limit.

Expected Regulatory Timeline:  

The dates below are based on the current legislative process and industry expectations. They are not yet officially confirmed.

What this means for you

1. Screen your product portfolio. Identify products containing piperonal that fall outside the adult fine fragrance category, as these face the greatest exposure to the expected restriction.

2. Begin identifying alternatives now. The SCCS has not approved piperonal for any product category other than adult fine fragrances. If your products fall outside that narrow category, reformulation planning should start immediately.

3. Confirm whether your fragrances contain piperonal. Ask your fragrance supplier for a written declaration confirming the presence or absence of piperonal (CAS 120-57-0) in every fragrance, flavour, and essential oil you use. Do not assume that a fragrance is piperonal-free, it has historically been unrestricted and is widely used.

4. Control piperonal below 1% for both SCCS and Toxicological assessment. The SCCS limit of 1.8% addresses reprotoxicity only, skin sensitisation is a separate concern. For toxicological assessment purposes in CPSR assessment, keeping piperonal below 1% is the more prudent formulation target, it avoids triggering product classification as a skin sensitiser and provides a safety margin beyond the SCCS conclusion.

5. Do not rely on the current unregulated status and monitor update closely. Piperonal is unrestricted today because the classification has not yet entered into force. The CLP classification will trigger the prohibition. Once the classification is published in the Official Journal, the six-month and twelve-month transition clocks begin.

For further information, the SCCS preliminary opinion (SCCS/1688/26) is available on the European Commission’s health website. The draft 24th ATP to the CLP Regulation is available on the European Commission’s CIRCABC platform. Should you require support with formulation review, CPSR updates, or regulatory compliance, please do not hesitate to contact us.

Reference: SCCS/1688/26 - Opinion on the safety of Heliotropin (Piperonal) used in cosmetic products (CAS No. 120-57-0, EC No. 204-409-7) - Preliminary version, 15 April 2026; Draft 24th ATP to CLP Regulation

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