The resolution, which was published last month (January 9) and is already in force, updates the rules regarding the authorization and commercial launch of genetically modified organisms (GMOs) by the National Technical Biosafety Commission (CTNBio).
Created in 2005, CTNBio is responsible for evaluating and approving GMO crops and products in Brazil.
Article 10 of the resolution, which can be read here (in Portuguese), reads: “The legal representative of the applicant entity and the respective Internal Biosafety Commission - CIBio are responsible for ensuring the faithful compliance with this Normative Resolution.
“Whenever a commercial release of GMOs and their derivatives is authorized, it is the duty of the applicant's legal guardian or the president of its Internal Biosafety Commission (CIBio) to report any non-compliance with the conditions established in the CTNBio technical decision.”
'Consumer health risks'
The Brazilian Institute for Consumer Protection (IDEC) opposes the regulation on the grounds it increases consumer exposure to modified products without guaranteeing they are safe.
“The text […] facilitates the release of genetically modified products since it leaves the responsibility of testing the possible risks to health and the environment to the companies that intend to commercialize the transgenic in question,” it said.
Marcos Pedlowski, associate professor at the State University of Norte Fluminense, also denounced the bill as an attempt to relax the “already fragile legislation” on GM authorization in Brazil.
“A first reading of this resolution indicates that the intention is to expedite the approval for commercial use of GMOs,” he wrote in an online post. “It is difficult [to imagine] that companies that want to approve the commercial use of this or that GMO will correctly estimate the levels of risk, danger and damage to the environment and human health.”
However, not everyone agrees. According to Dafné Didier, regulatory and quality director at Sao Paolo-based Tacta Food School, it does not add much to the previous resolution on food safety evaluation of GMOs that was in force since 2008 and, before then, 2001.
He said the resolution intends to streamline the procedure for authorization - or not - rather than watering down the safety criteria.
“It has made the process for approval and evaluation more flexible [and] does not weaken food safety in Brazil," Didier told FoodNavigator-LATAM. "The resolution in force actually makes the procedures a little more ‘modern’, since it no longer requires several copies of the process and also increases the deadline for decisions by the CNTBio itself. In my view, this shows a concern to have a longer period for the commercial release of genetically modified organisms.”
Didier added that, according to article 22 of the resolution, companies that have previously filed a request for commercial launch have 90 days to submit any additional information or new data to ensure their application complies with the new conditions.