Thuyones in Spanish sage oil: what changes for manufacturers in 2026

Key data

If your company manufactures or markets products with Spanish sage essential oil, there is a regulatory change you need to apply now. The Implementing Regulation (EU) 2026/516, in force since 10 March 2026, corrects a technical error in Regulation (EU) 2025/1403 on the maximum concentration of thuyones in the essential oil of Salvia lavandulifolia.

This is not a new regulation from scratch, but a correction of a specific data point already published. But that does not reduce its operational impact: the corrected values are those that have legal validity, and any formulation or labeling based on the previous data may be out of compliance.

What does this regulation establish?

Regulation (EU) 2026/516 is a technical correction to Regulation (EU) 2025/1403. The purpose of the correction is the maximum concentration value of thuyones in Spanish sage essential oil (Salvia lavandulifolia).

Thuyones are chemical compounds naturally present in certain essential oils. Their regulatory relevance derives from their toxicological potential: at high concentrations they can be harmful to health. This is why European legislation sets maximum limits for their presence in consumer products.

The specific value of the corrected concentration is not detailed in the available published information. To find out the exact figure, it is necessary to consult the full text of the regulation in the official source of EUR-Lex.

Economic and operational impact

The impact is not only regulatory: it has direct consequences for the production and marketing chain. Affected companies must assess the following scenarios:

• Product reformulation: If the thuyones concentration in a current formulation exceeds the corrected value, the composition will need to be adjusted before continuing to market the product in the European market.
• Labeling review: Labeling that makes reference to the composition or that must comply with the limits of Regulation (EU) 2025/1403 must be updated to reflect the values corrected by Regulation (EU) 2026/516.
• Risk of market withdrawal: Non-compliance with the corrected values may result in sanctions or product withdrawal from the European market, with the reputational and economic cost that this entails.
• Supplier review: Companies that purchase Spanish sage essential oil from third parties must verify that their suppliers provide raw materials that comply with the new limits.

Who does it affect?

This correction affects all companies that use Spanish sage essential oil (Salvia lavandulifolia) in their production processes or in their final products:

• Manufacturers of flavorings for food use
• Manufacturers of cosmetics (perfumes, creams, lotions) that incorporate this essential oil
• Manufacturers of food supplements with extracts or oils from Spanish sage
• Manufacturers of pharmaceutical products that use Salvia lavandulifolia as an ingredient
• Marketers of essential oils in the European market
• Importers of finished products containing this essential oil and distributed in the EU

Practical example

A Spanish company that manufactures a cosmetic cream with Spanish sage essential oil (Salvia lavandulifolia) formulated its product in 2025 taking as reference the thuyones limits established in Regulation (EU) 2025/1403.

With the entry into force of Regulation (EU) 2026/516 on 10 March 2026, the reference values have changed. This company must:

1. Consult the text of Regulation (EU) 2026/516 to find out the exact corrected value.
2. Analyze whether the thuyones concentration in its current formulation complies with the new limit.
3. If it does not comply, adjust the formulation before continuing to distribute the product in the EU.
4. Update the technical documentation and labeling if applicable.

Failing to act in time exposes the company to inspections, sanctions or product withdrawal from the European market.

What should companies do now?

1. Consult the full text of Regulation (EU) 2026/516 on EUR-Lex to find out the exact corrected value of thuyones concentration in Spanish sage essential oil.
2. Review all active formulations that include Salvia lavandulifolia essential oil and compare the thuyones concentration with the new limit.
3. Verify supplier compliance: request from suppliers of this essential oil the documentation that proves that the product complies with the corrected values.
4. Update labeling and technical documentation if the correction affects the information that must appear on the product or in its technical sheet.
5. Reformulate if necessary: if any product does not comply with the new limit, adjust the composition before continuing its marketing in the European market.
6. Document the actions taken to be able to demonstrate compliance in the event of a possible regulatory inspection.