Module 16 2024

22/10/2024

Precautionary Principle - Basis

Art. 174 EC Treaty

● General requirement that Community actions ensure a high level of protection of human health, consumers and the environment

Council Resolution (13 April 1999)

Commission Communication on the precautionary principle (2 February 2000)

The Organisation for Professionals in Regulatory Affairs

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The Precautionary Principle

Ensures

● High level of protection of the environment and of human, animal and plant health ● When the available scientific data do not permit a complete evaluation of the risk

May be invoked when

● The potentially dangerous effects of a phenomenon, product or process have been identified by a scientific and objective evaluation ● This evaluation does not allow the risk to be determined with sufficient certainty

Can act without awaiting further scientific information

● Can see the principle reflected in the subjective “…has reason to believe …” language in MDR

Cannot be a pretext for protectionist measures

Can including shifting the burden of proof

The Organisation for Professionals in Regulatory Affairs

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