Legislation

Brazil first biosafety legislation was published in 1995. Ten years later, after a comprehensive debate – which included several public hearings with the participation of civil society – and after a 2-year course in the Congress, Law 11,105/05, or the Biosafety Law, was enacted.

The law establishes control mechanisms that range from product development to market monitoring. Upon its implementation, Brazil structured the regulatory framework regarding this issue, giving the country the legal safety required by companies to invest in the development of techniques that in addition to being more modern, are also appropriated to local conditions and characteristics.

Brazil’s biosafety regulatory system has attained international recognition as one of the strictest and most comprehensive in the world, having become a reference for other countries.

Considering the fast adoption of biotechnology by Brazil’s agricultural sector and the wide range of possibilities offered by technological innovation, the legal framework that regulates the activities in the area is a major focus of dedication for AgroBio.

Biotecnology

Federal Government Decree Federal Decree nº 6.041, of February 8, 2007
MDIC Ordinance Ordinance MDIC nº 161, of August 25, 2009

Biosafety

Federal Government Law Federal Law nº 11.105, of March 24, 2005
Decree Federal Decree nº 5.591, of november 22, 2005
CTNBio Ordinance MCT Ordinance nº 146 of March 06, 2006
Resolution Resolution nº 01, of June 20, 2006
Resolution nº 02, of November 27, 2006
Resolution nº 04, of August 16, 2007
Resolution nº 05, of March 12, 2008
Resolution nº 06, of November 6, 2008
Resolution nº 07, of April 27, 2009
Resolution nº 08, of June 3, 2009
Resolution nº 09, of December 2, 2011
Resolution nº 10, of October 2, 2013
Resolution nº 11 of October 22, 2013
Resolution nº 12 of October 22, 2013
Communication Communication nº 02, of June 12, 2007
Normative Instruction Normative Instruction nº 02, of September 10, 1996
Normative Instruction nº 04, of December 19, 1996
Normative Instruction nº 08, of July 9, 1997
Normative Instruction nº 09, of October 10, 1997
Normative Instruction nº 13, of June 1, 1998
Normative Instruction nº 17, of November 17, 1998
Normative Instruction nº 18, of December 15, 1998
Normative Instruction nº 19, of April 19, 2000
Communication Communication nº 01, of August 9, 2006
Communication nº 03, of November 28, 2007
Communication nº 04, of June 24, 2008
Communication nº 05, of June 28, 2008
Communication nº 06, of March 18, 2010
CNBS Resolution Resolution nº 01, of January 29, 2008
Resolution nº 02, of March 5, 2008
Resolution nº 03, of March 5, 2008
Resolution nº 04, of July 31, 2008
Orientation Orientation nº 1, of July 31, 2008
Orientation nº 2, of July 31, 2008

Conservation Units

Federal Government Law Federal Law nº 9.985, of July 18, 2000
Federal Law nº 11.460, of March 21, 2007
Decree Federal Decree nº 5950, of October 31, 2006

Seeds and Seedlings

Federal Government Law Federal Law nº 10.711, of August 5, 2003
Decree Federal Decree nº 5.153, of July 23, 2004

Labeling

Federal Government Decree Federal Decree nº 4.680, of April 24, 2003
Normative Instruction Inter-Ministerial Normative Instruction nº 01, of April 1, 2004
MJ Ordinance Ordinance nº 2.658, of December 22, 2003

Intellectual Property

Federal Government Law Federal Law nº 9.279, of May 14, 1996
Federal Law nº 9.456, of April 25, 1997
Decree Federal Decree nº 1.355, of December 30, 1994
Federal Decree nº 2.366, of November 5, 1997
INPI Resolution INPI Resolution nº 69, of July 19, 2013