Authorized Approval for Biocidal Treated Articles
What Are the Requirements of Related Regulations In This Context?
Biocidal Products Regulation dated 31.12.2009 and numbered 27449; The Communiqué on Articles treated with Biocidal Products dated 13.06.2018 and numbered 30420 came into force after being published in the Official Gazette.
In this context; in order to make a biocidal claim in any article, it must be treated with a biocidal product or with an active ingredient used as a biocidal product authorized by the Ministry of Health.
According to the Authority Letter published by the Ministry of Health, General Directorate of Public Health on 13.11.2020 and numbered 19020089-105.99 “Points to consider while applying for the authorization of articles treated with biocidal products”; three types of usages have been determined with regard to efficacy for the use of biocidal products on articles.
- If a Biocidal Product will be used for the purpose of extending the life of the treated article, preventing its deterioration, and protecting the product from hazardous products;
Using authorized biocidal products such as Product Type 9 fiber, leather, rubber, and polymerized material preservatives (While placing on the market and labelling of the treated article, to give the preservative content of the product prominence under the scope of PT9.)
- If there is an intended use for killing microorganisms on the treated article; Use of an authorized biocidal product (Product Type 2 for surface, Product Type 3 for veterinary hygiene, Product Type 4 for food and feed, and Product Type 5 drinking water) in the relevant product type (While placing on the market and labelling of the treated article, to give the claims that it will kill the microorganisms on and within it, etc. prominence.)
- If it is wanted to be placed on the market as a biocidal product by exceeding the original purpose of use of the treated article; (antibacterial effects caused by release from the products such as masks, socks, and home textiles on the environment, its surroundings, or otherwise on feet and skin) direct authorization of the article as a biocidal.
In addition to these; if it is wanted to gain biocidal properties on the articles produced in Turkey, by treating with a biocidal product, obtaining a biocidal product authorization for the active ingredient used as a product or product to be treated with the article, conducting analyses on the product to be treated with the article, after treating the licensed product, and repeating analyses on the article after treating the authorized product with the article according to the Treated Articles Communiqué and preparing a technical file are required. If it is an imported product that is intended to be placed on the Turkish market, after being treated with biocidal products, obtaining the import license from the Ministry of Health for the active ingredient used as a product or product to be treated with the article, conducting analyses on the product to be treated with the article, after treating the licensed product, and preparing a technical file by repeating analyses on the articles after treating the authorized product with the article according to the Treated Articles Communiqué are required.