Anderson Ribeiro, Aline Ferreira and Henryk Trelinski of Souto Correa Advogados contributed to the preparation of this article.
Foreign companies have long faced a practical challenge under Brazil’s access and benefit-sharing (“ABS”) regime: although registration obligations apply to activities involving Brazilian genetic heritage, foreign legal entities still cannot register directly in SisGen, Brazil’s electronic system used to register activities involving Brazilian genetic heritage and associated traditional knowledge.
Two developments in June 2026 sought to address this issue. While Brazil’s Genetic Heritage Management Council (“CGen”) postponed approval of the long-awaited foreign-user functionality in SisGen 3.0, the Brazilian Government simultaneously introduced a new mechanism that may enable foreign companies to register through Brazilian institutions.
Taken together, these developments suggest that Brazil is pursuing a dual-track approach: while direct foreign access to SisGen remains under development, foreign companies may soon have an alternative pathway to comply with Brazilian registration requirements.
Foreign Entities still cannot access SisGen directly
Brazil’s ABS framework requires the registration of activities involving access to Brazilian genetic heritage and associated traditional knowledge. However, SisGen continues to operate under a structure designed primarily for Brazilian users and institutions, and foreign legal entities still cannot independently register activities or carry out regularization measures through the system.
This limitation has long created practical challenges for foreign companies seeking to comply directly with Brazilian ABS requirements. As a result, many organizations have been awaiting the implementation of the foreign-user functionality that forms part of the planned SisGen 3.0 upgrade.
Against this backdrop, stakeholders were closely following the 45th Ordinary Meeting of CGen, held on June 10-11, 2026, where updates regarding SisGen 3.0 were on the agenda.
The meeting, however, did not result in approval of the foreign-user functionality. According to information presented during the meeting, the matter was postponed to allow completion of additional technical testing before the functionality is submitted to CGen for approval.
As a result, the next Ordinary CGen Meeting, currently scheduled for September 2026, is expected to be the next significant milestone for consideration of the foreign-user component of SisGen 3.0.
Government introduces Interim Registration Mechanism
While implementation of direct foreign access remains pending, the Brazilian Government has moved forward with an alternative registration mechanism.
On June 10, 2026, Decree No. 13.014/2026 amended the regulatory framework governing Brazil’s ABS regime to allow foreign legal entities to register access activities in SisGen through a Brazilian scientific and technological institution by means of a “term of association for registration purposes.” The Decree expressly allows such arrangements even where no scientific partnership exists between the parties.
According to the Decree, this mechanism is intended to facilitate compliance with registration obligations, ensure traceability of access activities, formalize institutional interaction with competent authorities, and support monitoring of information reported in SisGen.
Under this framework, the Brazilian institution is responsible for carrying out the registration within SisGen based on information provided by the foreign entity. The foreign legal entity, however, remains responsible for the accuracy of the information submitted and for compliance with applicable legal obligations.
From a practical perspective, the Decree creates a new route for foreign entities to meet Brazil’s registration requirements pending implementation of direct foreign access to SisGen. Nevertheless, the extent to which this pathway will be used in practice will depend on its operational implementation within SisGen and any further guidance issued by Brazilian authorities.
Why this matters?
The delay in approving SisGen 3.0 does not alter the underlying legal obligations applicable to companies that have accessed Brazilian genetic heritage or associated traditional knowledge. Foreign entities remain subject to Brazil’s ABS framework and may still need to evaluate whether their activities trigger registration obligations.
The future release of the SisGen 3.0 foreign-user functionality remains important because it is expected to activate a specific regularization period for foreign entities. Under current regulations, foreign legal entities will have one year from the availability of the foreign-user functionality to regularize activities that were carried out without prior registration.
Crucially, Decree No. 13.014/2026 does not appear to alter this regulatory timeline. The launch of the foreign-user functionality therefore remains the key triggering event for the start of the one-year regularization period.
For now, the Brazilian ABS framework remains in a transitional phase. While the legal obligation to register qualifying activities is already in force, the mechanism for direct compliance by foreign legal entities remains unavailable, and the timeline for its implementation continues to depend on the development and approval of SisGen 3.0.
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Covington & Burling LLP is closely tracking developments relating to SisGen 3.0 and the evolving compliance framework for foreign entities under Brazil’s ABS regime. Together with the Brazilian firm Souto Correa, we advise clients on assessing Brazilian ABS obligations, preparing for potential regularization requirements, and navigating registration pathways under SisGen.
If you have any questions, do not hesitate to reach out to Bart Van Vooren (bvanvooren@cov.com) and Anderson Ribeiro (anderson.ribeiro@soutocorrea.com).