ANNEX VInformation required for the notification referred to in Articles 6, 8 and 9

PART A

Information required for the notification referred to in Article 6:

  • name of user(s), including those responsible for supervision and safety,

  • information on the training and qualifications of the persons responsible for supervision and safety,

  • details of any biological committees or subcommittees,

  • address and general description of the premises,

  • a description of the nature of the work which will be undertaken,

  • the class of the contained uses,

  • only for class 1 contained uses, a summary of the assessment referred to in Article 4(2) and information on waste management.

PART B

Information required for the notification referred to in Article 8:

  • the date of submission of the notification referred to in Article 6,

  • the names of the persons responsible for supervision and safety and information on their training and qualification,

  • the recipient, donor and/or parental micro-organism(s) used and, where applicable, the host-vector system(s) used,

  • the source(s) and the intended function(s) of the genetic material(s) involved in the modification(s),

  • the identity and characteristics of the GMM,

  • the purpose of the contained use, including the expected results,

  • the approximate culture volumes to be used,

  • a description of the containment and other protective measures to be applied, including information about waste management, including the wastes to be generated, their treatment, final form and destination,

  • a summary of the assessment referred to in Article 4(2),

  • the information necessary for the competent authority to evaluate any emergency response plans, if required under Article 13(1).

PART C

Information required for the notification referred to in Article 9:

  1. (a)
    • the date of submission of the notification referred to in Article 6,

    • the names of the persons responsible for supervision and safety and information on their training and qualification;

  2. (b)
    • the recipient or parental micro-organism(s) to be used,

    • the host-vector system(s) to be used (where applicable),

    • the source(s) and intended function(s) of the genetic material(s) involved in the modification(s),

    • the identity and characteristics of the GMM,

    • the culture volumes to be used;

  3. (c)
    • a description of the containment and other protective measures to be applied, including information about waste management, including the type and form of wastes to be generated, their treatment, final form and destination,

    • the purpose of the contained use, including the expected results,

    • a description of the parts of the installation;

  4. (d)

    information about accident prevention and emergency response plans, if any:

    • any specific hazards arising from the location of the installation,

    • the preventive measures applied, such as safety equipment, alarm systems and containment methods,

    • the procedures and plans for verifying the continuing effectiveness of the containment measures,

    • a description of information provided to workers,

    • the information necessary for the competent authority to evaluate any emergency response plans, if required under Article 13(1);

  5. (e)

    a copy of the assessment referred to in Article 4(2).