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Food and feed area disinfectants

2013.04.25. Print
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Product:

Products used for the disinfection of equipment, containers, consumption utensils, surfaces or pipework associated with the production, transport, storage or consumption of food, feed or drink (including drinking water) for humans and animals.

  • Main Group I: Product type 4 (Food and feed area disinfectants)

Applicable law:

Process description:

  1. The application for authorisation (which should be addressed to: Office of the Chief Medical Officer of State (Országos Tisztifőorvosi Hivatal); 1097 Budapest, Albert Flórián út 2-6.) and the application for the expert’s report together with the requested attachments should be sent to the following address:

    Dr. Éva Martos
    Director General
    National Institute for Food and Nutrition Science (OÉTI, Országos Élelmezés- és Táplálkozástudományi Intézet)
    H-1097 Budapest, Albert Flórián út 3/a.
    Hungary

  2. Expert’s report of OÉTI 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.

  3. 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).

  4.  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.

  5. If you already have an Expert's Report from OÉTI please indicate this in application form

I. EXPERT’S REPORT:

Issuer of the expert’s report:
National Institute for Food and Nutrition Science (Országos Élelmezés- és Táplálkozástudományi Intézet)

Contact person:
Ms Krisztina Navratil navratil.krisztina@oeti.antsz.hu
Phone: 00 36 1 476 6453
Direct phone: 00 36 1 476 1100

National Institute for Food and Nutrition Science (Országos Élelmezés- és Táplálkozástudományi Intézet)
Food Chemical – Analytical Depertment Group of Notification and Experts
Address: 1097 Budapest, Albert Flórián út 3/a
Post address: 1437 Budapest, Pf. 839.

Documents needed to the application:

  1. Data of the applicant and distributor( name, address, phone, e-mail)

  2. Data of the manufacturer of the product and the active substance (name, address, phone, e-mail)

  3. Name of the product, area of use, and users, Using Instruction and using parameters

  4. Composition of the product: active substance(s) other ingredients (chemical name, CAS- and EC-number, Index-number) composition ( in %) of the product, function of the components

  5. Material Safety Data Sheet of product and the components

  6. Quality certificate of the components

  7. Short description of the manufacturing, and its quality issurance

  8. Physical-chemical properties,specification, quality statement, quality control parameters of the product

  9. Efficacy, antimicrobial spectrum, microbiological test results performed at dirty conditions according to EN-1276 and EN-1650 standards from an accredited laboratory

  10. Draft Hungarian label hatás mód

  11. Istructions for storage, shelf life, packaging units

  12. Toxikological, ecotoxicological data

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

II. AUTHORIZATION:

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

Contact Person for further information:
Office of the Chief Medical Officer of State (Országos Tisztifőorvosi Hivatal)
Department of Epidemiology
Mr. Béla Gergely gergely.bela@oth.antsz.hu
Phone:    00 36 1 476 1222 
H-1097 Budapest, Albert Flórián út 2-6.

Administration fee:
96 000 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