About applying for approval of all activities relating to genetically modified organisms in South Africa

Do you want a permit that will allow you to participate in activities relating to genetically modified organisms in South Africa? Apply for a permit at the Registrar of Genetically Modified Organisms (GMO).
The various permits allow the following activities:

• Importation of GMOs into South Africa
• Exportation of GMOs from South Africa
• Contained use of GMOs within a laboratory, growth room or greenhouse
• Introduction of  a GMO into the environment of South Africa
• time extension of previously authorised activities
• commodity clearance (authorisation for food, feed or for processing and excludes planting) of GMOs
• commodity use (authorisation for use as food, feed or for processing)  of GMOs
• registration of  facilities that are involved in activities with GMOs
• GMO status certificates for export.

What you should do

• Determine what type of activity you want authorisation for and complete the relevant application form.
• Note the following prerequisites for certain applications:
• general release applications must be preceded by completion of field trial activities within the environment of South Africa over a period of three growing seasons
• applications to continue with an activity will only be accepted if that activity was previously authorised.
• Submit the application with stipulated number of copies to the Registrar of GMOs.
• Submit an additional copy of the application, which contains no confidential business information, to the Registrar of GMOs.
• Pay the prescribed fee (tariffs are adjusted every year).
• Submit a report of previous activities conducted (where applicable).
• Submit proof of public notifications (where applicable).
• Applicants can use the following guidelines:
• guideline document for work with genetically modified organisms
• guideline document for making a public notification in terms of Regulation 6 of the GMO Act
• Standard operating procedures with regard to regulation 4 of the GMO Act
• Standard operating procedures with regards to regulation 2(2) of the GMO Act
• Standard operating procedure for GMO status certification

How long does it take

• The Registrar of GMO determines compliance of the application with the provisions of the Genetically Modified Organisms Act, 1997.
• The Advisory Committee evaluates the scientific data submitted with the application and makes a recommendation on the safety of the proposed activity to the Executive Council.
• The Registrar receives public input within the time period allowed.
• The Executive Council makes a decision on an application, taking into consideration the application, recommendation by the Advisory Committee, public input and potential impacts on sectors such as agriculture, health, environment, labour, trade and science and technological development.
• If the decision of the Executive Council is positive, the Registrar is authorised to issue a permit.
• All permits are accompanied by containment conditions.

Inspectors from the Department of Agriculture monitor implementation of the permit conditions.\

Application	No.  of days
Importation/exportation of genetically modified organisms with general release/commodity clearance approval	30
Use of genetically modified organisms with commodity clearance  approval	30
Contained use of genetically modified organism and/or import or export permit*	120
Trial release of genetically modified organisms and/or import or export  permit*	120
General release of genetically modified organisms	270
Commodity clearance of genetically modified organisms	270
Registration of facilities (new, renewal and amendment)	60

*import/export of genetically modified organisms that do not have a general release or commodity clearance approval 

How much does it cost

Importation/exportation of GMOs	R400 each
Contained use of GMOs	R1 180 each
Trial release	R2 800 each
General release and marketing	R21 800 each
Appeal	R4 280 each
GMO status certificate	R170 each
Registration of facilities (new, renewal and amendment)	R410 each
Commodity use for food or feed or processing	R240 each

Forms to complete

(Forms are provided in PDF format. To open PDF documents, you need to have Adobe Acrobat Reader 4 or higher installed on your computer.)

• Application for authorisation to import GMOs into South Africa that are destined for contained use
• Application for authorisation to import GMOs into South Africa that are destined for intentional introduction (trial release) into the environment
• Application for authorisation to import GMOs that have general release and/or commodity clearance status in South Africa
• Application for authorisation to export GMOs from South Africa that are destined for (i) contained use or (ii) use as food, feed or processing
• Application for authorisation to export GMOs from South Africa that are destined for intentional introduction into the environment
• Application for contained use of GMOs
• Application for intentional introduction(conduct a trial release) of a GMO
• Application for an extended permit (continuation) for activities with GMOs in SA
• Application for commodity clearance of GMOs
• Application for general release of GMOs
• Application to register a facility for activities involving genetic modification
• Affidavit to be completed in the presence of a Commissioner of Oaths

Who to contact