Technical Dossiers for Air Aromatizers

According to the Communiqué on Air Aromatizer Products published by the Republic of Türkiye, manufacturers are required to keep a technical dossier ready, which may be requested for review by the provincial directorate or the Ministry. This dossier serves as proof that the product is safe and legally compliant, indicating that it can be placed on the Turkish market.

Chemleg helps ensure your air aromatizer products are safely available on the Turkish market.

What Should the Technical Dossier for Air Aromatizers Include?

Annex-3 of the Communiqué on Air Aromatizer Products outlines the required contents of the technical dossier. According to this annex, the dossier must include the following:

1. Formulation: The percentage by weight of chemical substances in the product formulation (min. and max. 10%), and the function of each substance in the formulation.
2. Specifications: Final product specifications and the Safety Data Sheet (SDS) of the active substance. If the product label includes a usage-related claim, scientific tests, reports, or expert opinions from independent scientific institutions supporting the claim must be provided.
3. Fragrance Compliance Certificate (IFRA/Manufacturer): A copy and translation of the certificate proving that the fragrance substances used comply with international standards.
4. Label sample.
5. Certificate of analysis for the finished product.
6. Business License for the manufacturing site (the licensed activity must be indicated).
7. Copy of the diploma of the responsible manager.
8. Responsible manager contract: A certified copy of the agreement between the manufacturer and the responsible manager.
9. Turkish Trade Registry Gazette.
10. Trademark registration certificate or a copy of the application from the Turkish Patent and Trademark Office.
11. Product evaluation report: A production site evaluation report prepared by the Ministry or provincial staff according to Annex-2.
12. Health and Free Sale Certificate: The original document and notarized translation of the document issued by the authorized institution of the country of origin stating that the product is authorized or free to be sold for the same purpose in the country of origin (the date cannot be older than one year and is approved by the embassy) (The list of authorized institutions is published on the official website of the Ministry). If contract manufacturing will be done, in the contract manufacturing contract;
13. If contract manufacturing is used, a notarized agreement between the company commissioning the production and the contract manufacturer, including:
    a) The total quantity and packaging count of the product to be manufactured,
    b) The validity period of the agreement.

Note 1: Items 1, 2, 3, 4, 5, and 9 are general. Items 6, 7, 8, 10, 11, and 13 apply to domestic manufacturers, while the conditions in item 12 apply to imported products.

Note 2: If deemed necessary, the Ministry may request additional documents or information approved by the manufacturer/responsible manager beyond those listed above.

Let Chemleg Handle Your Technical Dossier Preparation

Failure to submit a technical dossier may result in the prohibition of placing products on the market, administrative fines, product retention at customs, or market recalls.

With an experienced team well-versed in the relevant legislation, Chemleg prepares fully compliant technical dossiers tailored to your company. You may also benefit from Chemleg’s other services for comprehensive compliance.

Click here to fill out the form and get in touch with our experts.