New Brazilian Resolution Improves Legal Security for Movement of Microorganisms

by | Nov 14, 2023 | Client Alert, Life Sciences

On November 13, the CGEN Resolution 41 of October 18, 2023, was published in the Brazilian Government’s Official Gazette. The resolution approved a declaration model establishing that the microorganism intended for transfer abroad is not isolated from substrates of the national territory, territorial sea, exclusive economic zone, or continental shelf.

The microorganisms mentioned in the resolution are not considered part of the national genetic heritage, even if the declarant does not have supporting documents regarding their entry into the national territory or where these documents do not contain information about their isolation location.

In addition, the user must declare that, since its entry into the national territory, the said microorganism has been kept in ex situ condition, under controlled laboratory conditions, within the indicated laboratory or collection point.

The user can complement the declaration with several documents, including related to deposit, transfer, donation terms or equivalents; the dispatch authorization issued by the Federal Revenue; invoices, and other tax documents; and original cataloging cards in a biological collection.

It is worth remembering that Decree 8.772/2016, which regulates Law 13.123/2015 (on access to genetic heritage, and associated traditional knowledge and the sharing of benefits for the conservation and sustainable use of biodiversity), determines that “the microorganism that has been isolated from substrates of the national territory, territorial sea, exclusive economic zone, or continental shelf” is considered part of the genetic heritage existing in the national territory.

The legislation also determines that the microorganism must be accompanied by proof of its isolation location and the regularity of its importation, to not be considered part of Brazilian biodiversity.

Considering said provisions, the CGEN Resolution 41 seeks to provide greater legal security for the movement of microorganisms that have been deposited in various collections in the country for decades and do not have information about their exact origin.


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