On June 11, 2026, Decree No. 13,014/2026 was published, amending Decree No. 8,772/2016 (which regulates Law No. 13,123/2015, known as the Brazilian Biodiversity Legal Framework) and establishing the Association Term for registration purposes.

The new rule allows access activities involving Brazilian genetic heritage or associated traditional knowledge (ATK), carried out by a legal entity domiciled abroad, to be registered in SisGen by a national research institution, whether public or private, even where there is no scientific collaboration between the parties.

The Association Term is exclusively instrumental and regulatory in nature, intended to enable registration, traceability of access, and monitoring of information within SisGen. The national institution acts on the basis of the data provided by the foreign company, bearing no technical, scientific, or operational responsibility for activities outside the scope of its own activities.

The national institution is responsible for registering the activity, maintaining the record of the Association Term and related information, reporting any indications of irregularity, and cooperating with monitoring efforts. The foreign company, in turn, is responsible for providing complete and up-to-date data, ensuring the accuracy of such data, complying with the obligations set forth in Law No. 13,123/2015, and disclosing the SisGen registration number in intellectual property applications or in the registration of any product or process resulting from the access.

The regime does not apply where there is scientific collaboration between the parties, or where the national institution is an importer, subsidiary, controlled company, affiliate, related party, or commercial representative of the foreign company.

The Decree also establishes the Alliance of National Public Scientific and Technological Research Institutions for Biodiversity (APBio), participation in which is voluntary; meaning that a foreign company may enter into term with an institution that is not a member of APBio.

This new pathway expands the available routes for regularization, but does not remove the substantive obligations imposed by Law No. 13,123/2015, which remain the responsibility of the foreign company. It is therefore important to precisely define, within the Association Term, the scope of the counterparty’s activities and its duties regarding the provision and accuracy of information. Furthermore, the exclusion applicable to importers and companies belonging to the same corporate group requires a case-by-case corporate analysis in multinational structures.

Decree No. 13,014/2026 entered into force on June 11, 2026, the date of its publication.

We remain available to assist with the interpretation of the Decree and with the assessment of its legal and regulatory impacts on activities involving access to Brazilian genetic heritage and associated traditional knowledge.