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Products used for the disinfection of swimming pools, aquariums, bathing and other waters

2013.04.25. Print
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Product:

Products used for: - water disinfection in swimming pools and other bathing facilities and the surfaces of these, which come in contact with water,
- algicides used in water.

  • Main Group I: Product Type 2. (Private area and public health disinfectants and other biocidal products)

Applicable law:

Process description:

  1. a.) The application for authorisation (which should be addressed to: Dr. Márta Kovács, Head of Department; Office of the Chief Medical Officer of State (Országos Tisztifőorvosi Hivatal); Public Health Department (Közegészségügyi Főosztály); 1097 Budapest, Albert Flórián út 2-6.) together with the requested document should be sent to the following address:

National Institute of Environmental Health (Országos Környezet-egészségügyi Intézet)
H-1097 Budapest, Albert Flórián út 2-6.
Hungary

b.) When the documentation is correct National Institute of Environmental Health sends a request for paying the administration fee and issues the expert’s report

  1. a.) Expert’s report together with the attachments will be forwarded automatically to the Office of the Chief Medical Officer of State for authorisation. The latter sends a request to the applicant for paying the administrational fee. Authorisation can only be given after the payment of the fee.

b.)    On the ground of the expert’s report OTH issues the authorisation.

  1. The applicant has to register the product within 90 days after placing the product on the market at the National Institute of Chemical Safety (Országos Kémiai Biztonsági Intézet).

  1. In case of hazardous materials a separate registration has to be made within 90 days after placing the product on the market at the National Institute of Chemical Safety.

I. EXPERT’S REPORT:

Issuer of the expert’s report:
National Institute of Environmental Health (Országos Környezet-egészségügyi Intézet-OKI)

(Országos Környezet-egészségügyi Intézet-OKI)

Contact person:
Dr. Gyula Dura 
dura.gyula@oki.antsz.hu
Phone: 00 36 1 476 1283

Mr. Károly Törő 00 36 1 476 1200

National Institute of Environmental Health (Országos Környezet-egészségügyi Intézet-OKI)
H-1097 Budapest, Albert Flórián út 2-6.

Documents requested for the expert’s report:
For the OKI expert’s report tax number, account number of the applicant and the request for authorisation is needed together with the documents listed below:

1.      Name of the product and its active substances, their chemical composition (structure), physical-chemical properties, CAS and EINECS

2.      The list of the used compounds in the course of manufacturing (chemical names)

3.      Name and address of the manufacturer and distributor

4.      The technology used for the manufacturing of the product

5.      Quality assurance regarding the manufacturing

6.      Quality assurance issued at an accredited laboratory which is independent from the manufacturer (measurement results concerning impurities defined in product standards)

7.      Efficacy test results on target organisms

8.      Area of use of the product

9.      Method of dosage and dosage-control

10.  Method of determining drinking water concentration

11.  Material Safety Data Sheet according to paragraph 21. (2) of the national biocide regulation

12.  Material Safety Data Sheet issued by the manufacturer

13.  Plan of handling the produced waste

14.  Other authorisations, tests results (Hungarian or foreign) if available

15.  Draft Hungarian label and using instructions

Administration fee for the expert’s report:
80.000 HUF + 25% VAT/product

Duration of issuing the expert’s report:
Depending on the active substance

II. AUTHORISATION:

Issuer of the authorisation:
Office of the Chief Medical Officer of State (Országos Tisztifőorvosi Hivatal)

(Országos Tisztifőorvosi Hivatal)

Contact person:
Ms Krisztina Csanád-Vajas 
vajas.krisztina@oth.antsz.hu
Phone: 00 36 1 476 1100 extension: 2530

Office of the Chief Medical Officer of State (Országos Tisztifőorvosi Hivatal)
Public Health Department (Közegészségügyi Főosztály)
H-1097 Budapest, Albert Flórián út 2-6.

Authorisation fee:
96000 Ft (according to the fee regulation 1/2009. (I.30.) EüM)

Duration of the authorisation:
22 working days in case of a complete documentation and arriving of the fee

III. REGISTRATION:

If the product requires authorisation during transitional period, following the authorisation process, OCMO notifies the product in question to the National Institute of Chemical Safety (NICS).

Administration fee:
Free of charge

Contact person:
Mrs. Istvánné Vándor vandor.istvanne@okbi.antsz.hu
Phone: 00 36 1 476 1180

National Institute of Chemical Safety (Országos Kémiai Biztonsági Intézet)
Department for Registration and Notification of Dangerous Substances and Preparations (Veszélyes Anyagok és Készítmények Bejelentése és Törzskönyvezése Osztály)
H-1097 Budapest, Nagyvárad tér 2.

IV. HAZARDOUS MATERIAL REGISTRATION

In case the biocidal product or active substance is classified as hazardous, and the biocidal product requires authorisation, following the authorisation process, OCMO notifies the product in question to NICS.

Regarding the notified data as well as concerning missing administration fee NICS is the assigned authority. In these cases staff members of NICS contacts the applicant.

Administration fee:
9200 HUF

Contact person:
Mrs. Istvánné Vándor vandor.istvanne@okbi.antsz.hu
Phone: 00 36 1 476 1180

National Institute of Chemical Safety (Országos Kémiai Biztonsági Intézet)
Department for Registration and Notification of Dangerous Substances and Preparations (Veszélyes Anyagok és Készítmények Bejelentése és Törzskönyvezése Osztály)
H-1097 Budapest, Nagyvárad tér 2.
National Public Health and Medical Officer Service
www.antsz.hu/en