Protection of health – Microbicides in the environment

1 4.3.1 Introduction

In any registration procedure, risk assessment is now becoming an integral part of the regulatory evaluation dossier and decision-making criteria of regulatory authorities. Most regulatory authorities, particularly in the European Union and the United States, require that a risk assessment should be conducted by industry and this forms the overall decision to the acceptability or otherwise of placing a microbicide product on the market.

A risk assessment, as defined by many international organisations (OECD, 1989; ECETOC 1994; EU TGD, 1996, 2003; EUSES 1996) on an active substance or substance of concern within a microbicide formulation is the evaluation of the following stages:

• 1. Hazard identification of the substance and subsequent identification of the adverse effects that a substance has an inherent capacity to cause.

• 2. Dose (concentration) — Response assessment that includes an estimation of the relationship between the dose or level of exposure to a...