We recently had this inquiry on our website so we thought we would use the opportunity to share our findings. This is quite a process so good luck.
We recently had this inquiry on our website so we thought we would use the opportunity to share our findings. This is quite a process so good luck. Please note if you require NON-GMO certification, there is another article in this regard.
The legal requirements for GMO status in South Africa
The primary legislation in South Africa dealing with genetically modified organisms (GMOs), including their contained use, trial release, commercial release, and import and export is the Genetically Modified Organisms Act of 1997 (GMO Act) and it's subsidiary legislation.
Legislation Quality Genetically-modified-organisms-act-15-of-1997
Legislation Quality Genetically-modified-organisms-act-15-of-1997-regulations
In order to work with GMO products(plant products) you need to adhere to the following requirements
You need a permit if you want to participate in activities relating to genetically modified organisms in South Africa. Apply for a permit at the Registrar of Genetically Modified Organisms (GMOs).
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 authorized activities
• commodity clearance (authorization for food, feed, or for processing and excludes planting) of GMOs
• commodity use (authorization 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:
1. Complete the relevant application form for the type of activity you want authorization for.
2. Note the following prerequisites for certain applications:
• field trial activities within South Africa must be done over a period of three growing seasons before you can apply for general release
• applications to continue with an activity will only be accepted if that activity was previously authorized.
3. Submit the application with the stipulated number of copies to the Registrar of GMOs.
4. Submit an additional copy of the application, which contains no confidential business information, to the Registrar of GMOs.
5. Pay the prescribed fee (tariffs are adjusted every year).
6. Submit a report of previous activities conducted (where applicable).
7. Submit proof of public notifications (where applicable).
Applicants can use the following guidelines:
• Guideline document for work with GMOs - Download 1 GUIDELINE4WORKwithGOM (1).pdf
• Guideline document for making a public notification in terms of regulation 6 of the GMO Act – Download 2 publicnotice (1).pdf
• Standard operating procedures with regard to regulation 4 of the GMO Act, 1997 (Act 15 of 1997) - Download 3 SOP_for_Regulation_4.pdf
• Standard operating procedures with regards to regulation 2(2) of the GMO Act – Download 4 SOP_Regulation (1).pdf
• Standard operating procedure for GMO status certification from DALRRD – Download 5 Standard Operating Procedures for GM Status Certification (1).pdf & Download 6 GMO CERTIFICATE REQUIREMENTS PDF (1).pdf
The process following your application
The Registrar of GMO determines compliance of the application with the provisions of the GMO 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 takes a decision, taking into consideration the application, recommendation by the Advisory Committee, public input, and potential impacts on sectors such as agriculture, health, environment, labor, trade and science, and technological development.
If the decision of the Executive Council is positive, the Registrar is authorized to issue a permit.
All permits are accompanied by containment conditions.
Inspectors from the Department of Agriculture, Forestry, and Fisheries monitor the implementation of the permit conditions.
The details of how long it takes and how much it costs can be found here.
You can find more information about the Department of Agriculture’s activities here.
Labeling of GMO’s
South Africa has had compulsory GM labeling regulations in place since 2004 when the Department of Health (DOH) introduced labeling regulations under the Foodstuffs, Cosmetics, and Disinfectants Act (1972) – Regulation 25. The regulation states that “foodstuffs produced through genetic modification – where they differ significantly from existing foodstuffs in terms of their composition, nutritional value, mode of storage, preparation or cooking, allergenicity or genes with human or animal origin – must be labeled”. As all current GM foods are considered substantially equivalent, i.e. they do not differ from the conventional counterpart in any of the aspects listed, these regulations have never been triggered and therefore no GM-containing foods on the market were labeled under this regulation.
The more recent Consumer Protection Act (CPA, 2008) Regulation 293 from the Department of Trade and Industry (dti) states that ALL GM goods must be labeled. So, where Regulation 25 is based on health and food safety concerns, Regulation 293 is purely value-based, hinging on the consumer’s intrinsic right to information.
According to the CPA regulations, food producers, importers, and packagers currently have to choose one of three mandatory labels for GM foods: (i) “containing GMOs” where the GM content is at least 5%; (ii) “produced using genetic modification” for food produced directly from GMO sources; or (iii) “may contain GMOs” when argued that it is scientifically impractical and not feasible to test food for GM content. Voluntary labels include: (i) “does not contain GMOs” where the GM content is less than 1%; (ii) “GM content is less than 5%” where GM content is between 1% and 5%; and (iii) “may contain genetically modified ingredients” if it can’t be detected.
It is important to remember that you would have to prove by accredited laboratory testing that your product does not contain more than 5% GMO’s if you make any claims in this regard.
Regulations-Relating-To-The-Labelling-Of-Foodstuffs-Obtained-Through-Certain-Techniques-Of-Genetic-Modification
References:
biosafety.org.za
gov.za
