Legal Obligations of Articles Treated with Biocidal Products
What is an Article Treated with Biocidal Products?
The procedures for the licensing of biocidal products are governed by the provisions of the Turkish Biocidal Products Regulation, published in the Official Gazette dated 31/12/2009 and numbered 27449. On the other hand, the regulation of articles treated with biocidal products is carried out in accordance with the Communiqué on Articles Treated with Biocidal Products, published in the Official Gazette dated 13/06/2018 and numbered 30420. These processes are conducted by the Ministry of Health, General Directorate of Public Health.
Both regulations define "Treated Article" as “a substance, mixture, or article that has been treated with or intentionally incorporates one or more biocidal products.” To make biocidal claims for any article, it must be treated with a biocidal product licensed by the Ministry or contain an active substance categorized as a biocidal product.
According to the Guideline to Articles Treated with Biocidal Products, “treated” refers to the application of one or more biocidal products to a substance, mixture, or article, while “intentionally incorporates” means using one or more biocidal products as a component of a mixture or article, typically during its production phase.
How to Distinguish Between Treated Articles and Biocidal Products?
The Guideline to Articles Treated with Biocidal Products provides a decision tree to determine whether an object is a treated article or a biocidal product based on its intended use.
As the first step, it is crucial to decide whether the object is a substance, mixture, or article. According to Article 4, Paragraph 1(c) of the Biocidal Products Regulation, a substance or mixture must have a primary biocidal function aligned with the definition of a biocidal product. In contrast, an article is considered a biocidal product if its primary function is biocidal.
There are three types of uses in terms of the effectiveness of biocidal products in articles:
- If a biocidal product is used to extend the lifespan of the article, prevent its deterioration, or protect it from pests, a biocidal product licensed under Product Type 9 (preservatives for fibers, leather, rubber, and polymerized materials) must be used. The protective content should be highlighted in the article's labeling and marketing under Product Type 9.
- If the intended purpose is to kill microorganisms on the article’s surface, a biocidal product licensed under the relevant product type must be used (e.g., Product Type 2 for surface disinfection, Product Type 3 for veterinary hygiene, Product Type 4 for food and feed areas, Product Type 5 for drinking water, etc.). Claims such as the ability to kill bacteria present on or within the product should be emphasized.
- If the article is intended to be marketed as a biocidal product, exceeding its original purpose (e.g., masks, socks, or home textiles that release antibacterial effects into the environment, surrounding area, or directly on the skin or feet), the article must be directly licensed as a biocidal product.
According to the Communiqué on Articles Treated with Biocidal Products, for these articles to be marketed, the biocidal products they are treated with or intentionally contain must be licensed under the relevant product type or registered in the biocidal product inventory. Additionally, they must comply with restrictions related to their active substances.
What Are the Legal Obligations for Articles Treated with Biocidal Products?
Manufacturers and importers must ensure that treated articles are classified, labelled, and packaged in accordance with the Regulation on Classification, Labelling, and Packaging of Substances and Mixtures, published in the Official Gazette dated 11/12/2013 and numbered 28848. In addition to the labelling requirements specified in Articles 19 and 20 of the regulation, treated article labels must also meet the requirements outlined in Article 6 of the Communiqué on Articles Treated with Biocidal Products.
Labels for treated articles must not include misleading statements regarding human and animal health, environmental risks, or the effectiveness of the article. Statements such as “non-toxic,” “harmless,” “natural,” “eco-friendly,” or “animal-friendly” are prohibited. Claims related to biocidal properties or functions cannot be made on the labels, promotional booklets, or advertisements of treated articles unless their biocidal efficacy and functionality have been verified.
Manufacturers or importers must conduct analyses of the biocidal functions of treated articles and determine their validity periods using internationally recognized standards in accredited laboratories.
Additionally, manufacturers or importers are required to prepare a technical dossier in accordance with the obligations stated in Article 9 of the Communiqué on Articles Treated with Biocidal Products. The technical dossier and/or other information and documents must be submitted to the Ministry or inspectors when requested during market surveillance and inspection activities.
There is no requirement to notify the Ministry about the label and technical dossier prepared for treated articles.
You can contact us for your questions about your transactions and belongings, and if you wish, you can benefit from our Biocidal Product Consultancy service.