- Europe Gears Up to Attack High Risk Substances
- February 10, 2011 | Authors: Herbert Estreicher; Marcus Navin-Jones
- Law Firms: Keller and Heckman LLP - Brussels Office ; Keller and Heckman LLP - Washington Office ; Keller and Heckman LLP - Brussels Office
With the end of the 30 November 2010 registration deadline under REACH for high volume and high risk substances, there is now available in Europe an unprecedented level of information about the hazards and risks associated with chemicals. The information in the registration dossiers will be disseminated to the public on the website of the European Chemicals Agency (ECHA) sometime in March 2011.
Some of the substances that were registered in 2010 will undergo Substance Evaluation, which is a process where registrants can be asked to provide additional information about their substances as needed to assess safe use. The process is Member State-driven and information obtained in the process can be used by Member States in preparing Annex XV dossiers to propose and justify the identification of a substance of very high concern (SVHC), to initiate the Authorisation or restriction of the manufacture, placing on the market or use of a substance, and/or to propose a harmonized classification and labeling.
The "Heart of REACH" is not data gathering. Registration and Substance Evaluation are only preludes to the main event ¿ the identification and elimination of high risk substances. The "Heart of REACH" is Authorisation and to some extent Restriction.
Authorisation applies to SCHCs that are included in Annex XIV of REACH. These are the carcinogens, mutagens, reproductive toxicants, PBTs, vPvBs, endocrine disruptors and the like. There is no tonnage limit for the Authorisation requirement. The overall process involves several steps including identification of SVHCs, prioritization of these substances for inclusion in Annex XIV, the listing of these substances on Annex XIV, application for Authorisations, granting or refusing of Authorisations and reviewing of granted Authorisations.
To date relatively few substances have entered the Authorisation process. Only a few dozen substances have been added to the Candidate List and most have been fairly exotic in nature, although there have been a few high profile substances listed, such as acrylamide and benzoic acid. But the Candidate list is due for significant expansion and the Authorisation process is gearing up.
The Commission and the ECHA are moving forward with the process. A series of important guidance documents have been recently published. These are:
- Commission Guidance on the preparation of an application for authorisation (2011/C 28/01), available online at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2011:028:0001:0121:EN:PDF
- ECHA Guidance on te preparation of an application for authorization, available on-line at ttp://guidance.echa.europa.eu/docs/guidance&under;document/authorisation&under;application&under;en.htm?time=1297007307
(This document describes how to prepare an application for authorisation and provides guidance on analysis of the alternatives and substitution plan. It also describes how third parties may prepare and submit information on alternatives).
- ECHA Guidance on Socio-Economic Analysis -Authorisation, available on-line at: ttp://guidance.echa.europa.eu/docs/guidance&under;document/sea&under;authorisation&under;en.htm?time=1297007252
The lawyers and scientist at Keller and Heckman LLP can shepherd companies through the Authorisation process by among other things:
Providing effective advocacy to forestall Candidate Listing
Deprioritize substances for Annex XIV inclusion
Secure Use Exemptions
Prepare Authorisation petitions
Prepare Socioeconomic analysis
Pursue Administrative appeals
Bring appropriate Court actions