Now that the 2010 Registration deadline for high volume
and high risk substances has passed, the European Commission, the European
Chemicals Agency (ECHA), and the Member State Competent Authorities are gearing
up for Authorisation - the true "Heart of REACH".
The ECHA has released a document entitled: "General Approach for Prioritisation of Substances of Very High
Concern (SVHCs) for Inclusion in the List of Substances Subject to
Authorisation." This document is worth reading if your company is
concerned about the impacts of REACH on the market.
As more and more substances are added to the Candidate List of Substances of Very High Concern (SVHCs)
the question of how these substances will be prioritized for Authorisation
becomes more critical.
There is also a list that announces the Member State intentions, called the
"Registry of Intentions."
Article 58(3) of REACH contemplates a prioritization process
as it requires that whenever a decision is taken to move substances from the
Candidate List to Annex XIV (the Authorisation list) "priority shall
normally be given to substances with PBT or vPvB properties, or wide
dispersive use, or high volumes." Recital 78 of REACH calls on the
ECHA to provide advice on the prioritization of substances for Authorisation
"to ensure that decisions reflect the needs of society as well as
scientific knowledge and developments".
To that end, the ECHA has developed a prioritization
approach for ranking substances on the Candidate List that takes into account
the Article 58(3) criteria as well as the considerations identified in Recital
78. The prioritization approach has two tiers. First, a numerical ranking is
developed on the basis of the Article 58(3) criteria. In the second step,
considerations regarding "regulatory effectiveness and coherence" and
any other relevant factors are considered for final selection of those
substances on the Candidate List that should be given priority for inclusion in
In the ranking scheme, PBTs/ vPVBs are ranked more
heavily that carcinogens or mutagens, and those Inherent properties are scored
differently depending on whether the effect has a threshold or not. Wide
dispersive use is assessed on the basis of the number of use sites and the
potential for release with consumer and professional-use products generally
scoring highest. High volume is assigned by tonnage tiers for non-exempted uses
with volumes above 10,000 tonnes per year receiving the highest score. The
different factors are weighed as follows: Inherent properties (18%), High
volume (41%) and Wide dispersive use (41%), to obtain an overall score.
Consideration of regulatory effectiveness and coherence
is more qualitative and takes into account various factors, such as:
Companies with an interest in substances on the Candidate
List, the Registry of Intentions or the harmonized list of CMRs
should already be developing the data to ensure a low priority ranking. It is
important to bring this information to the attention of friendly Member States
as soon as appropriate.
This Article is part of a series on the REACH
Authorisation Process. The Brussels office of Keller and Heckman LLP has been
assisting clients on REACH Registration for a number of years, and is now
focusing its attention on Dossier and Substance Evaluation, Authorisation, Restriction,
and REACH Enforcement. For further information, contact Herb Estreicher (Tel:
01-202-434-4334; +32 (0)2 645 50 96; e-mail at firstname.lastname@example.org), Marcus
Navin-Jones (Tel: +32 (0)2 645 50 97); e-mail at email@example.com), or Mark Boelens
(Tel: +32 (0)2 645 50 68); e-mail at firstname.lastname@example.org.
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