News Details

The Ministry of Health of Turkish Republic has issued a comprehensive Regulation on Aromatherapy Products, effective upon its publication in the Official Gazette (No: 33298) on July 2, 2026. This mandate establishes stringent quality and safety standards for all products marketed under the category of aromatherapy in Turkey. The primary goal is to guarantee that these products are safe, efficacious, and suitable for supporting or treating human health.

Scope and Applicability

The regulation’s scope is comprehensive, covering both raw materials used in professional compounding and finished aromatic products requiring Ministry approval. The regulation aims to ensure high quality and efficacy when these products are used to maintain general human health.

Specifically, the rules apply to two main categories of applicants:

1. Compounding Materials: This includes entities registering volatile oils and stable oils—whether for direct use or in a magistral format within pharmacies—that adhere to established pharmacopeias and monographs.
2. Formulated Products: It covers finished aromatherapy product applications submitted directly to the Ministry, requiring approval of both composition and intended use.

Critical Compliance Boundaries and Exclusions

Industry professionals must strictly note the boundaries of this regulation. The mandate explicitly does not cover standard nutritional supplements, food marketed as such (regardless of plant components), or general cosmetic items. These excluded categories must comply with their own separate regulatory frameworks. Any product falling outside these defined parameters requires careful evaluation against Articles 1–4 before submission.

Key Technical Requirements for Compliance

To ensure compliance and accurate labeling, the regulation mandates adherence to precise technical definitions:

• Aromatherapy: Defined broadly as any method—including inhalation, gargling, topical application, massage, compress use, or bath methods—that utilizes volatile oils to support human health.
• Aromatic Product: A pharmaceutical product that uses volatile oils (alone or in compound form), derived from botanical sources, and formulated for targeted aromatic action.
• Floral Drug (Bitkisel Drog): Refers to unprocessed medicinal plant materials (leaves, flowers, etc.) that must be documented using the scientific binomial system for species identification.
• Distillation: The defined process of obtaining volatile oil from botanical material using steam, water, or a combination thereof.

Legal Basis and Market Entry Mandate

The regulation is not advisory; it is legally grounded in Article 3 of Law No: 3359 (Basic Law on Health Services, dated May 7, 1987). This strong legal foundation means that market entry requires strict adherence to established guidelines. Compliance necessitates meticulous documentation covering the entire production process; from raw botanical material sourcing through standardization methods and final pharmaceutical good manufacturing.