BELGIAN BIOSAFETY SERVER : Directive 90/219/EEC
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ANNEX V - PART A

Information required for the notification referred to in Article 8:

- name of person(s) responsible for carrying out the contained use including those responsible for supervision, monitoring and safety and information on their training and qualifications;

- address of installation and grid reference; description of the sections of the installation;

- a description of the nature of the work which will be undertaken and in particular the classification of the micro-organism(s) to be used (Group I or Group II) and the likely scale of the operation;

- a summary of the risk assessment referred to in Article 6 (2).

ANNEX V - PART B

Information required for the notification referred to in Article 9 (2):

- the date of submission of the notification referred to in Article 8;

- the parental micro-organism(s) used or, where applicable the host-vector system(s) used;

- the source(s) and the intended function(s) of the genetic material(s) involved in the manipulation(s);

- identity and characteristics of the genetically modified micro-organism;

- the purpose of the contained use including the expected results;

- the culture volumes to be used;

- a summary of the risk assessment referred to in Article 6 (2).

ANNEX V - PART C

Information required for the notification referred to in Article 10 (1) :

- the information required in Part B;

- description of the sections of the installation and the methods for handling the micro-organisms;

- description of the predominant meteorological conditions and of the potential sources of danger arising from the location of the installation;

- description of the protective and supervisory measures to be applied throughout the duration of the contained use;

- the containment category allocated specifying waste treatment provisions and the safety precautions to be adopted.

ANNEX V - PART D

Information required for the notification referred to in Article 10 (2):

If it is not technically possible, or if it does not appear necessary to give the information specified below, the reasons shell be stated. The level of detail required in response to each subset of considerations is likely to vary according to the nature and the scale of the proposed contained use. In the case of information already submitted to the competent authority under the requirements of this Directive, reference can be made to this information by the user:

(a) the date of submission of the notification referred to in Article 8 and the name of the responsible person(s);

(b) information about the genetically modified micro-organism(s):

(c) information about personnel:

(d) information about the installation:

(e) information about waste management:

(f) information about accident prevention and emergency response plans:

(g) a comprehensive assessment (referred to in Article 6 (2)) of the risks to human health and the environment which might arise from the proposed contained use;

(h) all other information required under Parts B and C if it is not already specified above.


BELGIAN BIOSAFETY SERVER : Directive 90/219/EEC
[Contents] [Previous]