THE REGISTRATION PROCESS OF BIOCIDAL PRODUCTS AND CIRCUMSTANCE OF ARTICLES WHICH ARE TREATED WITH THE ACTIVE SUBSTANCE

Turkchem Magazine - 2013 July-August

We meet with Biocidal products, which are used by professionals in a wide range of applications and industry segments in so many ways such as drinking water treatment, water treatment plants, paper industry, antifouling paints,etc. not only in industrial areas but also in our daily life from hand soaps till surface cleaners, paints that we use in our homes and pest control. These products which are frequently used in our daily life have quite special and specific characteristics with their usage area, contents that provide biocidal impacts and biocidal claims of being.

As many other chemical products, there are specific applications and procedures concerning these products with the claim being biocidal. What does biocidal product mean that we meet from professional applications till every area in our daily life widely?

Biocidal product is a product which containing one or more active substances to obtain efficacy of product; intending to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by chemical or biological means and are available in ready to use for this aim. According to the Biocidal Products Regulation which is harmonized to the Directive 98/8/EC of the European Union and published on Official Gazette, numbered 27449 and dated 31 December 2009, by Republic of Turkey Ministry of Health, principally, active substance(s) of product must be found in the active substance list of the Regulation and also must match the use area(s) which is/are specified for this active substance(s). For example ethanol, is usable as biocidal active substance in products on the purpose of human hygiene, however formaldehyde is not suitable to be used in this group due to its negative effects on human health.

Authorization Procedure of biocidal products which ones active substance itself and conformity of use area are considerably important is composed of many detailed processes. The first of these, as mentioned above, the convenience of the active substance. During the evaluation of provisional-application by the authorities of Ministry, primarily, the control of the active substance convenience is applied. At the same time, indicating function of each item in the product is significant. Sample label related to the product must satisfy the criteria that specified in the Regulation. Some of these cases for instance: the name of the active substance and percentage% within the product should be indicated on the label; if any, the classification of the product should be indicated with its symbol and it should be compatible with Safety Data Sheet of biocidal product and this Safety Data Sheet should be prepared by an authorized person that is trained in preparation of SDS and certified by an accredited organization; the names of organisms which the product is claimed to be effective on should be found on the label; any printed, audio or visual media that bears misleading information about the product and that cause misconception may not be utilized on the product label.

If we pay attention to the details that mentioned, we can see that Biocidal Products Regulation is not only a free regulation, also relates to the other regulations which are currently effective on chemicals. Biocidal Products Directive is related to the below regulations:
* Regulation on Good Laboratory Practice Principles and Authorization of Test Laboratories
* Regulations on Prevention of Exposure Risks to Biological Actives
* Regulation on Classification, Packaging and Labelling of Dangerous Substances and Preparations
* Regulation on Restrictions in the Use and Placing on the Market of Certain Hazardous Substances, Preparations and Goods
* Regulation On Preparation And Distribution Of Safety Sheets Regarding To Dangerous Substances And Preparations

Following the evaluation of provisional application by the authorities affirmatively, sampling procedure is applied in production sites if the product is manufactured in Turkey and if it is an imported product, sampling is performed into customs and all samples of the product are sealed by authorized person and they must be delivered by the producer/importer to the authorized laboratories. In that time period, specifying suitable laboratory is an important criteria related to the tests about determination of active substances in the product, duration of stability and proving the effectiveness of the product; every single authorized laboratory, does not study for each product type. Following completion of the product tests and transmission to the product owner by the laboratory, test results of the product and other detailed information about toxicological and ecotoxicological are compiled as an authorization dossier and submitted to the Ministry of Health for evaluation and if the assessment is positive by the authority, the product is licensed as a biocidal product in the scope of Regulation.

Together with starting implementation of regulation process, undetermination about the current circumtances of some products is come into view. Especially, not being identified within the current Biocidal Product Regulation in force, there is already undetermination about the situation the articles that are treated with a biocidal product. These articles are not identified in the Turkish Biocidal Products Regulation however, in the new Regulation of The European Union dated 22 May 2012 and numbered 528/2012 which is about Biocidal Products, circumstances of treated articles are mentioned. According to EU Regulation, if the only purpose is controlling target organism on the treated article and if it is not possible to affect the organism outside the treated article, it is beside the point to define that the article is a biocidal product; active substances must not sweep out of the treated article. Biocidal product, should only create an ‘’interior impact’’ in the treated product; should not create ‘’exterior impact’’. Forming external impact of the treated article causes itself falling under the scope of the Biocidal Products Regulation as a biocidal product. Additionally, the active substance information should be indicated on the label of the treated article.

Clarification about the status of treated articles with hereinafter updates in the regulation which is in force in Turkey is the awaited issue by all manufacturers impatiently who produce products in this group. Having said that, the correct use, convenient advertisement and promotion, the authorization process and analyses procedures of biocidal products which are used very commonly in public and professional usage areas, have still been discussed subjects.

REFERENCES
* Numbered 27449 (4th Bis.), dated 31 December 2009 Biocidal Products Regulation
* EU 528/2012, dated 22 May 2012 Biocidal Products Directive

 

Esra ÖZDEMİR

Environmental Engineer/ Environmental Official

Chemical Legislation Specialist