Food Irradiation - conditions for obtaining the approval and application requirements

1. 5. 2014 | Source: Point of Single Contact (PSC) Czech Republic

The document sets forth the conditions and further information for obtaining approval to conduct the activity of a Food Irradiation.

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Conditions for granting a licence

The application for a resolution granting approval for an irradiation facility must meet the conditions specified. An inspector from the Czech Agriculture and Food Inspection Authority shall examine the correctness of the data in the application and the attached documentation in order to ascertain that the irradiation facility is capable of meeting the conditions specified in the documentation submitted. They shall examine the hygiene of the food production process and based on the completed investigation, draft a report on its results, the conclusion of which shall state whether the ascertained facts mitigate for or against a resolution approving the irradiation facility. Where the report finds in favour of the applicant, the director of the local Czech Agriculture and Food Inspection Authority shall issue a resolution to approve the irradiation facility.

Application requirements

The request must contain the following:

  • identification number of the applicant, address of the irradiation facility
  • subject and scope of activity for which the approval is sought, place at which the activity is to be carried out, method for assuring its provision, and the duration of the activity
  • certified signature of the individual or the statutory body of a legal entity (and/or any other representative of the statutory body empowered by conferred powers of attorney) applying for the approval

The request must be supported with:

  • a licence to manage sources of ionising radiation from the State Office for Nuclear Safety
  • CZK 1000 stamp
  • type approval for the source of ionising radiation
  • appointment of an individual in charge of ensuring compliance with the irradiation conditions
  • justification of the technological need for the irradiation of food and raw materials
  • specification of the sources of radiation
  • documentation that determines those technological sections (critical points) exhibiting the greatest risk of threatening the health safety of food
  • Hygiene Code

Further information on the licence proceedings

Type of licence

  • Resolution approving the irradiation facility

Respective authority

  • Czech Agriculture and Food Inspection Authority

Control and supervisory bodies

  • The State Office for Nuclear Safety grants the licence to handle sources of ionising radiation
  • The Czech Agriculture and Food Inspection Authority issues resolutions approving irradiation facilities and informs the relevant body of the European Commission; suspends or withdraws resolutions approving irradiation facilities; checks the labelling of food and raw materials subjected to ionising radiation and sends annual reports to the European Commission

Procedure for granting a licence

  • The applicant shall send their written request to the Czech Agriculture and Food Inspection Authority. The Czech Agriculture and Food Inspection Authority shall review the request and issue the resolution approving the irradiation facility. An on-site investigation shall take place under a review of the application.

Application clearing deadline

  • Within 30 days of the start of proceedings

Fees

  • As specified under Act No. 634/2004 Coll., on administrative fees, as amended, the licence application must be accompanied with a stamp worth CZK 1000 item 92(i) of the tariff scale of administrative fees

Validity period of licence

  • The time limit for a resolution approving an irradiation facility is identical to the validity period for the licence from the State Office for Nuclear Safety to manage sources of ionising radiation

Legal Regulation

  • Directive 1999/2/EC, on the approximation of the laws of the Member States concerning foods and food ingredients treated with ionising radiation
  • Directive 1999/3/EC, on the establishment of a Community list of foods and food ingredients treated with ionising radiation
  • Act No. 110/1997 Coll., on foodstuffs and tobacco products and on amendment of some related Acts, as amended (Article 4)
  • Act No. 146/2002 Coll., on the Czech Agriculture and Food Inspection Authority and amendment of certain related Acts, as amended  Article 3 (4)(r) (Article 6,4)
  • Decree No. 133/2004 Coll., on irradiation conditions for foodstuffs and raw materials, on the maximum tolerable dose of radiation and on the means of identifying radiation on the packaging

Professional liability insurance

  • A person contacting the State Office for Nuclear Safety with a request for a licence to manage sources of ionising radiation must attach to their request a document attesting to liability insurance covering nuclear damage, or a document attesting to any other financial insurance cover pursuant to Article 36 Act No. 18/1997 Coll., on peaceful utilisation of nuclear energy and ionising radiation (Atomic Act) and amendment of and additions to certain Acts, as amended.
  • The Czech Agriculture and Food Inspection Authority does not require any further professional liability insurance.

Related legal regulations

  • Act No. 110/1997 Coll., on foodstuffs and tobacco products and on amendment of some related Acts, as amended
  • Act No. 146/2002 Coll., on the Czech Agriculture and Food Inspection Authority and amendment of certain related Acts, as amended
  • Decree No. 133/2004 Coll., on irradiation conditions for foodstuffs and raw materials, on the maximum tolerable dose of radiation and on the means of identifying radiation on the packaging

Current Community regulations

  • Directive 1999/2/EC, on the approximation of the laws of the Member States concerning foods and food ingredients treated with ionising radiation
  • Directive 1999/3/EC, on the establishment of a Community list of foods and food ingredients treated with ionising radiation

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