Biocidal Product

What Is Biocidal Product?

Active substances and preparations containing one or more active ingredients, offered for sale ready to use, controlling over the target organism in terms of chemical or biological aspects or restricting the activity of such organisms and making it harmless or destroying are classed as biocidal products.

According to the purpose of use named such as “disinfectant, antiseptic, antiviral, insecticide, and rodenticide, antibacterial.”

According to the biocidal products regulation prepared by the Republic of Turkey Ministry of Health in accordance with EU directive 98/8/EC, firstly the active substance of the biocidal product must be within the active substances listed in the regulation then it must comply with the specified uses of use for the active substance.

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Process regarding biocidal products production and import licenses is in the form of “preliminary applications, rejection of those who are found unsuitable for their reasons, receiving sample from those of which preliminary application is accepted and analysis to be performed and passing to licensing process together with the reports and analysis.

Applicants who wish to fight against pests by using biocidal products must apply to the directorate in person or through the responsible manager with a petition.

1. Petition Annex (documents to be included in the file)

a) In accordance with the regulation on workplace opening and working licenses enacted by the decision of the Council of Ministers dated 14/7/2005 and numbered 2005/9207, an example of a work place opening and working license taken from the relevant authority as a third class non-sanitary institution in the place where no more than 100 kg/liter of products cannot be kept and if more than 100 kg/liter of products will be kept then work place opening and working license taken from the relevant authority as a second class non-sanitary institution, ‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎‎

b) the contract of the responsible manager or the assignment of the responsible manager made by the Authorized Public representative, the original of the responsible manager certificate to be maintained by the Directorate and the document indicating that the responsible manager is registered to the Social Security Institution and that the insurance premiums have been paid,

c) Trade registration number and circular of signature regarding the authority to represent the place of business,

d) A copy of the contract and diploma or temporary graduation certificate belonging to the team officer approved by the Directorate,

e) Undertaking to be given by the responsible manager or the owner of the workplace or authorized public representative that he will comply with the recommendations and directives of the Health Organization and that he will not use chemicals and pesticides used in the field of agriculture except biocidal products licensed by the Ministry,

f) Biocidal product practitioner certificate belonging to the implementing staff to be maintained by the original Directorate,

g) Document showing the type, number and characteristics of the tools, devices and equipment to be used in the application,

h) Document on the number of teams and qualifications of team members, provided that there is at least one team,

i) Explanation report about First Aid Cabinet, first aid bags and their contents,

j) Copy of vehicle license or lease agreement approved by the Directorate indicating that at least one vehicle belonging to or suitable for use by leasing is allocated,

k) The document indicating that the personnel responsible for the team and the implementing personnel are registered to the Social Security Institution and that the insurance premiums are paid,

(3) In applications to be made by municipalities, special provincial administrations and applications to be made by public institutions wishing to provide this service and entitled to use biocidal product in accordance with its legislation under the first paragraph of Article 5 of the declaration, documents listed in (a) and (c) paragraphs of this article are not required.

(4) In applications to be made by public institutions and agencies through the purchase of services from natural and legal persons, if it is documented that workplace having minimum requirements specified in the 11th and 12th articles has been allocated then conditions specified in the subparagraph (a) of first paragraph of this article are not required by real and legal persons.

Applications for the registration or licensing of a biocidal product are processed by the Ministry according to one of the following procedures:

1. Licensing for biocidal products containing new and evaluated active substances included in Annex- I or annex-IA,                                                   

2.Licensing for a low-risk biocidal product containing new and assessed substances included in Annex-IA,

3. Licensing for biocidal products containing an existing substances that is not included in the lists in Annex – I or annex-IA,

4. Licensing for biocidal products that should be used for exceptional and emergency response,

5. Licensing for the framework formulation of biocidal products, whose main formulation was previously licensed or registered,