Enactment of a noteworthy item of health legislation was finalized on the very last day of 2009. The new Regulation on Biocidal Products ("Regulation"), published in the Official Gazette on 31 December 2009, entered into force to fill the gap in Turkish legislation on biocidal products and to reflect the purpose of 1998's Directive 98/8/EC of the European Parliament and of the Council on placement of biocidal products on the market ("Directive"). Before the Regulation was enacted, biocidal products were regulated in Turkey under Circular No. 5677, issued by the Ministry of Health on 8 July 1983 and entitled "Guidelines Inferring the Particular Qualifications for Commodities and Equipment Related to Foodstuffs and Public Health."
The general public hasn't acquired much familiarity with the term "biocidal." In fact, we are all likely to come into contact with biocides or products which have been treated with them every day, in either our houses, our gardens, the workplace or shops. Biocidal products are used to control harmful organisms, and include disinfectants and insecticides. A biocide is a chemical substance capable of destroying a living organism, and may be added to other materials to protect them against biological infestation and growth. Article 4 of the Regulation defines biocidal products as active substances and preparations containing one or more active substances, presented in the form in which they are supplied to the user, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by chemical or biological means.
Article 1 establishes the aim of the Regulation as determining the principles and procedures for producing, authorizing and registering biocidal products by assessing the risks to the environment and to human and animal health before placing them on the market, and packaging, labeling, classifying and inspecting them. Article 5 introduces requirements for placement of biocidal products on the market, according to which a biocidal product shall not enter the market unless the Ministry of Healthy authorizes or registers it pursuant to the Regulation's procedures.
Biocidal products are to be classified, packaged and labeled in accordance with the provisions of the Regulation and safety data sheets, and advertisement of the biocidal products shall comply with the related provisions of the Regulation. Following these, Article 5 provides for the protection of humans and the environment, clearly classifying biocidal products as:
- very toxic;
- category 1 or 2 carcinogen;
- category 1 or 2 mutagen;
- toxic for reproduction (category 1 or 2);
- to be placed on the market for professional use or not to be used by the general public; and
- not to be authorized for marketing to the general public.
Article 6 holds that real persons and legal entities are to receive authorization for formulation only once. No second authorization will be granted to a formulation by the same galenic method and with the same qualities, even if the application is made under a different commercial name. Article 9 sets forth the period of validity of the authorization, specifying that authorizations are to be granted for a maximum of 10 years for biocidal products, including active-substance and biocidal products with low risk, while for products that include an active substance without an evaluation decision, authorizations are to be for a maximum of 6 years. However, under immediate and exceptional circumstances, authorization and registration granted for products to be used in cases where immediate medical attention is necessary will be valid for 4 months.
Producers, distributors and importers of biocidal products should pay close attention to the following in Articles 49 and 55, which regulate inspection and sanction mechanisms. According to Article 49, the Provincial Directorates of the Ministry of Health and the Ministry of Agriculture and Rural Affairs conduct inspections ex officio in cases of complaint, to verify the products' compliance with the Regulation. Pursuant to Article 55, the Health Ministry has the authority to ban manufacturing and import of products, cancel authorizations, and withdraw products from the market. Furthermore, penalty sanctions are regulated in Article 57, pursuant to which those acting contrary to the Regulation's provisions will be subject to the sanctions in Article 282 of the Public Health Law, as well as the Misdemeanors Law. In the event that these actions contravene the Regulation and relevant legislation, depending on the type of act, provisions of the Turkish Penal Code may apply. Moreover, the Regulation includes provisional articles to cover current applications, permits granted before the enactment of the Regulation, products without a permit, products already on the market, and products to be pulled from the market.
The Regulation's enactment is another step in the direction of harmonizing Turkish legislation with the European Union's regulatory regime, and introduces more developed regulations to reflect the Directive, as well as legal clarification for the placement of biocidal products on the market and use of biocidal products in terms of protecting human and environmental health.