BIO Latin America Conference

Regulatory Barriers to Growing the Bio-Based Economy

Novozymes Latin America Ltda. Pedro Luiz FernandesSão Paulo, 2016.10.28

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Biosafety Legislation Must Not Be a Barrier

BIO-BASED ECONOMY

Biodiversity Biosafety

IP

Biosafety Legislation Must Not Be a Barrier

• Law 8974/95 - Biosafety Legislation was approved by Congress after five years of proceedings.

• Law 11.105/2005 - Applicable Biosafety Legislation

AGRICULTURE

BIO-BASED ECONOMY

Brazilian Biosafety Regulatory Framework

• Challenges:• RN º 02 (2006.11.27) - It provides for the classification of risks of Genetically

Modified Organisms (GMOs) and biosafety levels to be applied to activities and projects with GMO and its derivatives in contention.

• Art. 3º, • X - Large-scale - projects and GMO cultivation activities in contention using volumes

exceeding 10 liters;

• Proposed amendment:• Art. 3º - For the purposes of this Resolution is considered:

• X - Large Scale - Projects and cultivation activities with GMO in contention whose individual unit volumes are greater than 20 liters for GMO belonging to Hazard Class 1 and 10 liters for GMO belonging to risk class 2, 3 and 4.

Brazilian Biosafety Regulatory Framework

• Challenges: • RN º 05 (2008.03.12) - It regulates standards for commercial release of

genetically modified organisms and its derivatives.

• Proposal:• Adequacy of risk assessment procedures considering the complexity of the

microorganisms without, however, losing the necessary rigor.

• Simplified risk assessment for microorganisms Risk Class 1.

OBRIGADO