- How Are Candidate List Substances Prioritized for Authorisation?
- 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
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," available online at http://echa.europa.eu/doc/authorisation/annex&under;xiv&under;rec/axiv&under;priority&under;setting&under;gen&under;approach&under;20100701.pdf 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. The Candidate List of SVHCs is available at: http://echa.europa.eu/chem&under;data/candidate&under;list&under;table&under;en.asp
There is also a list that announces the Member State intentions, called the "Registry of Intentions", available on-line at http://echa.europa.eu/chem&under;data/reg&under;intentions&under;en.asp
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 Annex XIV.
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:
Whether all identified uses are already subject to specific Community legislation to control risks.
Whether all or most known uses can easily be replaced by another ‘form' of the substance with a similar (or even worse) hazard profile, which is not on the Candidate List.
Whether uses have been identified where the resulting releases are insignificant or comparable to releases resulting from natural sources.
Whether significant use of the substance is outside the scope of Authorisation.
Companies with an interest in substances on the Candidate List, the Registry of Intentions (http://echa.europa.eu/chem&under;data/reg&under;intentions&under;en.asp) 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.