“Biosafety trends: perspectives based on the evolution of science and regulation.” Article by Senior Partner João Emmanuel Cordeiro Lima is published in Debate Jurídico.
The 10th Biennial Biosafety Meeting (EBBIO 2025), in the city of Vitória, reinforced the perception that the agenda on the topic is rapidly evolving, with regulatory, scientific and communicational advances that deserve attention not only from legal experts, but also from public policy makers and economic agents. Below, I highlight some of the main trends discussed, with an emphasis on the opportunities and challenges for regulatory governance in a context of accelerated innovation.
Reduction of regulatory costs
The regulatory scenario for biosafety, in Brazil and internationally, reveals a clear trend towards reducing costs for the development and release of biotechnological products. This movement is due to three main factors: the accumulation of technical and scientific knowledge on the risks associated with Genetically Modified Organisms (GMOs); the improvement of regulatory frameworks, with greater predictability and rationality; and the advancement of Innovative Precision Improvement Techniques (IMPs), which allow the development of more precise and lower-cost products.
These elements have enabled assessment processes that are more proportional to risk and more efficient, facilitating the entry of innovative solutions into the market, without compromising the protection of human, animal and environmental health. Countries such as Brazil have been adopting differentiated regulatory approaches for products developed by IMPs — such as gene editing without the insertion of exogenous genetic material —, which has allowed for more agile and lower-cost innovation cycles, especially relevant for startups and smaller companies.
Growth in the use of bioinputs
The use of agricultural bioinputs — such as growth-promoting microorganisms, biodefensives and biofertilizers — continues to expand strongly in Brazil. According to a survey by Blink and CropLife Brasil, the sector generated R$5 billion in the 2023/2024 harvest, with a 15% growth compared to the previous harvest. Over the last three years, the national market has shown an average growth rate of 21% per year, a rate four times higher than the global average.
This dynamism poses challenges to regulation: it is necessary to ensure product safety without creating disproportionate obstacles to innovation. In this context, the proposal for adaptive biosafety is gaining strength, based on differentiated risk analysis according to the technological profile and intended use, capable of keeping up with the pace of innovation without losing technical rigor.
Regulatory harmonization in Mercosur
The resumption of efforts to harmonize regulations within Mercosur was also a prominent topic. The diversity of technical criteria and administrative procedures among the countries of the bloc can hinder the trade of biotechnological products and generate legal uncertainty for companies with regional operations. The creation of common guidelines, based on internationally recognized scientific parameters, is seen as a promising path to increase regulatory predictability and foster productive integration. Initiatives such as the creation of the International Network for Biosafety of Products Derived from Modern Biotechnology (ABRE-Bio) symbolize and catalyze this moment.
TIMPs and the regulatory treatment of new techniques
The so-called TIMPs, such as gene editing by CRISPR (acronym for Clustered Regularly Interspaced Short Palindromic Repeats), are transforming the development of agricultural varieties and solutions in health and industry as a whole. Experts have highlighted that most countries that have already regulated the topic have chosen not to automatically equate products originating from TIMPs with GMOs. Brazil follows this approach, providing for the possibility of a case-by-case analysis through the presentation of a consultation to the National Technical Commission on Biosafety, which favors greater agility in innovation. However, the challenge remains to ensure a robust and harmonious legal basis between countries, which provides security for regulatory decisions in the face of scientific and technological developments and does not create unjustifiable barriers to international trade.
Biosafety communication
The urgent need to improve public communication about GMOs and biotechnology was emphasized. Despite the broad scientific support for the safety of these products, some unfounded resistance persists among consumer groups and sectors of society. In this context, social networks play an ambiguous role: they are, at the same time, vehicles for misinformation and powerful tools for disseminating knowledge.
The construction of clear, evidence-based narratives and the active engagement of researchers, regulatory bodies and companies in these digital environments were highlighted as fundamental strategies for reversing this trend.
The growing role of so-called influencers was also discussed, as they can both contribute to the dissemination of qualified information and reinforce misinformation. Furthermore, investment in scientific education and strengthening public trust in regulation were highlighted as pillars of effective and ethical communication in biosafety.
Conclusion
Biosafety governance will increasingly be challenged to balance technological innovation, socio-environmental protection and dialogue with society. Strengthening an intelligent regulatory environment — based on science, proportionality and transparency — is essential for biotechnology to fulfill its potential to contribute to sustainability, competitiveness, innovation and food security.
João Emmanuel Cordeiro Lima – partner at Nascimento e Mourão Advogados. PhD and master’s degree in Diffuse and Collective Rights. University professor.
Debate Jurídico, June 16, 2025
