Six SVHCs Selected for Burdensome Authorization Process under REACh
On February 11, 2011, the European Commission (EC or Commission) announced that six substances of very high concern (SVHC) have been moved from the so-called “Candidate List” to Annex XIV of the regulation known as “REACh.” Annex XIV lists those substances subject to the “authorisation” procedures set out in Title VII of the regulation. The six substances are the first to be selected for authorisation. They are: 5-ter-butyl-2,4,6-trinito-m-xylene (musk xylene); 4,4′-diaminodiphenylmethane (MDA); hexabromocyclododecane (HBCDD); bis(2-ethylexyl) phthalate (DEHP); benzyl butyl phthalate (BBP); and dibutyl phthalate (DBP). The substances were selected for authorisation because it was determined that they are carcinogenic, toxic for reproduction, or persist in the environment and accumulate in living organisms.
Now that the substances are subject to authorisation, they will be banned from use or placement on the market within the next three to five years, unless an authorisation is granted to individual companies to continue their specific use(s). Companies wanting to use these substances or place them on the market will need to demonstrate that the required safety measures have been taken to adequately control the risks, or that the benefits for the economy and society outweigh the risks. Where feasible alternative substances or techniques exist, a timetable for substitution will also have to be submitted.
For each substance, a “sunset date” is provided, ranging from 2014 to 2015. From this date, the substance may only be placed on the market or used if an authorisation has been granted or an application for authorisation has been made before the “latest application date” (i.e., the date by which anyone wishing to keep using a listed chemical after the sunset date must make an application). Companies must submit their applications to the European Chemicals Agency (ECHA). The Agency’s Risk Assessment Committee and Socio Economic Committee will then consider each application and submit their opinions to the Commission. The Commission will make the final decision concerning whether to grant authorisation.
Readers should recall that the authorisation requirements apply regardless of the tonnage at which the substance is placed on the market or used. There are no lower limits for the authorisation requirement. However, some uses of substances, such as intermediates, may be excluded.
More information about this development is available here. An overview of the authorisation process is available here and here. Guidance on preparing an application for authorisation is available here. And a current version of the SVHC Candidate List is available here.