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Contained
Use of GMOs and pathogens
Procedures in the Brussels
Region
(Last revised:
August 17, 2011
)
Contained use of genetically modified organisms and/or pathogens can only take place in installations that possess a environmental permit. An environmental permit or attestation is needed according to section 84 of the list classified installations in annex to the decree of 4 march 1999. The environmental permit is usually delivered for 20 years. Both the environmental permit and the authorization(s) for the contained use are deliverd by the same competent authority (IBGE-BIM).
Besides, depending on the risk class of the contained use, either a simple notification or a written authorization is needed for the contained use(s) as such.
For the Brussels-Capital Region, 2 procedures exists, depending on the fact the contained use is either a first or a subsequent use.
A "First use" refers to a contained use notified for the first time in the frame of the regional legislation on contained use of GMO's and or pathogens (decree of 8 november 2001 FR / NL).
In case of a contained use of risk class 1:
- no authorization needed
- a complete biosafety dossier (public and technical dossier) is sent to the SBB and only a public dossier is sent to the competent authority (IBGE-BIM).
- the SBB sends an advice to the competent authority (IBGE-BIM) within 30 days after reception of the dossier. If the SBB or the competent authority asks for complementary informations, there is a 'stop the clock' of the procedure.
- the contained use can start the day after the biosafety dossier is submitted and on the condition the proposed containement measures are applied.
In case of a contained use of risk class 2:
- an authorization is required.
- a complete biosafety dossier (public and technical dossier) is sent to the SBB. Only a public dossier is sent to the competent authority (IBGE-BIM).
- the SBB sends an advice to the competent authority (IBGE-BIM) within 30 days after reception of the biosafety dossier. The competent authority delivers the decision within 45 days after reception of the public dossier addressed to her. If the SBB or the competent authority asks for complementary informations, there is a 'stop the clock' of the procedure.
- the contained use can start 45 days after submission of the biosafety dossier to the competent authority .
- the authorization is generally delivered for a period 5 to 10 years but cannot exceed the date the environmental permit expires.
In case of a contained use of risk class 3 and 4:
- an authorization is required.
- a complete biosafety dossier (public and technical dossier) is sent to the SBB. Only a public dossier is sent to the competent authority (IBGE-BIM).
- the SBB sends an advice to the competent authority (IBGE-BIM) within 60 days after reception of the biosafety dossier. The competent authority delivers the decision within 90 days after reception of the public dossier addressed to her. If the SBB or the competent authority asks for complementary informations, there is a 'stop the clock' of the procedure.
- the contained use can start when a written authorization is delivered.
- the authorization is generally delivered for a period of 5 to 10 years but cannot exceed the date the environmental permit expires.
A " subsequent use" refers to each new contained use or every modification or renewal of a previously authorized or notified contained use.
In case of a contained use of risk class 1:
- a technical dossier is sent to the SBB only.
- the SBB confirms to the competent authority (IBGE-BIM) the notified contained use is indeed of risk class 1 or alternatively, informs the competent authority if there is any problem with respect to the notified risk class.
- the contained use can start the day after the technical dossier is submitted.
In case of a contained use of risk class 2:
- a complete biosafety dossier (public and technical dossier) is sent to the SBB. Only a public dossier is sent to the competent authority (IBGE-BIM).
- the contained use can start the day after the biosafety dossier is submitted and on the condition the proposed containement measures are applied.
- no authorization is needed. However the user can ask for a written authorization.
- the SBB sends an advice to the competent authority (IBGE-BIM) within 30 days after reception of the biosafety dossier. In the case a written authorization is asked, the competent authority delivers it within 45 days after reception of the public dossier. If the SBB or the competent authority asks for complementary informations, there is a 'stop the clock' of the procedure.
- if an authorization is delivered, it will end the day the environmental permit expires.
In case of a contained use of risk class 3 and 4:
- an authorization is always required
- a complete biosafety dossier (public and technical dossier) is sent to the SBB. Only a public dossier is sent to the competent authority (IBGE-BIM).
- In the case an authorization has already been delivered for a contained use of risk class 3 or 4 in the concerned installation, and the conditions for this previous authorization are fulfilled , the SBB sends an advice to the competent authority (IBGE-BIM) within 30 days after reception of the biosafety dossier. The competent authority delivers the decision within 45 days after reception of the public dossier. In other cases the SBB sends her advise within 60 days and the competent authority delivers the decision within 90 days.
- If the SBB or the competent authority asks for complementary informations, there is a 'stop the clock' of the procedure.
- the contained use can start when a written authorization is delivered.
- the authorization is generally delivered for a period of 5 to 10 years but cannot exceed the date the environmental permit expires.
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