YING ZHU
REACHLaw Oy, Vänrikinkuja 3, 02600 Espoo, Finland

 

Abstract

This article explains the process and estimated timetables related to the risk management option analysis (RMOA) and the two most important risk management options under REACH: authorisation and restriction. From a company’s point of view, there is an imminent need to actively manage the regulatory risks, because any of the regulatory actions being decided can mean considerable investment for improving current operation conditions, significant obsolescence management and/or replacement cost, potential supply chain disruption, as well as dramatic market reactions. The pre-emptive risk management option analysis (PRMOA) and strategic planning offers a structured concept to safeguard the company’s future business in the best possible way.

As part of the European Commission’s SVHC Roadmap to 2020, the risk management option analysis (RMOA) has been introduced as a step in the decision-making process for the authorities, although there is no legal obligation for it. Associated with it, the Public Activities Coordination Tool (PACT) was published by ECHA, listing the substances for which a RMOA or an informal hazard assessment for PBT/vPvB (persistent, bioaccumulative and toxic/very persistent and very bioaccumulative) properties or ED (endocrine disruptor) properties is either under development or has been completed since the implementation of the SVHC Roadmap commenced in February 2013. The PACT list has been welcomed widely for increasing transparency, but it has also caused quite some confusion among the industry. This article aims to explain the processes and estimated timetables related to the RMOA and the two most important risk management options under REACH: authorisation and restriction; and introduces the concept of the pre-emptive regulatory risk management option analysis for individual companies. 

Screening
In February 2013, the European Co ...