A four-part series on REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) compliance began with an article on registration [“REACH compliance explained,” PN, March 23, Page 6]. This article, part two of the series, looks at the identification of substances of very high concern (SVHCs) and authorization. Future articles will examine the authorization and restriction processes and enforcement; and current issues in substance information exchange forum (SIEFs) and consortia of particular relevance to the plastics industry.
(April 17, 2009) — REACH defines SVHCs as substances that are classified as carcinogenic, mutagenic or toxic for reproduction (CMR) category 1 or 2; persistent, bioaccumulative and toxic (PBT); very persistent and very bioaccumulative (vPvB); endocrine disruptors; or those that raise equivalent health and environmental concerns.
Manufacturers, importers or downstream users must not place on the market or use an SVHC that appears in Annex XIV — the list of substances subject to authorization — unless the necessary authorization has been granted by the European Commission.
This authorization establishes specific conditions under which the holder may use the SVHC.
The path to Annex XIV: Inclusion of SVHCs in Annex XIV is a multistep process with interested parties invited to comment at each phase.
Beginning with the registry of intentions, the European Commission — through the European Chemicals Agency (ECHA) or a member state — proposes to identify a substance as an SVHC and include it in the authorization process.
From the registry of intentions, the substance can migrate to the candidate list for authorization, at which point certain obligations kick in. Substances currently on the candidate list include di(2-ethylhexyl) phthalate (DEHP), benzyl butyl phthalate (BBP), and dibutyl phthalate (DBP).
From the candidate list, the substance can be prioritized and, ultimately, placed in Annex XIV. Substances currently proposed include DEHP, BBP and DBP.
Do I have new obligations throughout this process?
As soon as a substance is added to the candidate list, any “supplier” into the market must provide customers with a safety data sheet (SDS). Suppliers of preparations (that are not classified as dangerous according to Directive 1999/34/EC) must provide recipients, at their request, with an SDS if the preparation contains at least one substance on the Candidate List and its individual concentration is at least 0.1 percent weight/weight (w/w) for non-gaseous preparations and at least 0.2 percent by volume for gaseous preparations.
The “SIN” list: Non-governmental consumer and environmental organizations actively campaign for the progressive phaseout of SVHCs. The International Chemical Secretariat, with the assistance of a number of non-governmental organizations recently published its substitute-it-now (SIN) list, which contains more than 200 hazardous substances that they believe should be added urgently to the candidate list. Companies that use substances that appear on the SIN list will need to have in place strategies to manage increasing pressures from consumer groups and customers that may use the list on a voluntary basis in their product specifications.
Suppliers of articles containing SVHCs included in the candidate list must forward information on the listed SVHCs contained in the article (above a concentration of 0.1 percent w/w) to the industrial or professional user, or distributor, being supplied with the article directly after the inclusion of the SVHC in the candidate list. If requested, suppliers must also provide a consumer with the same information within 45 days of receipt of the request. Companies should anticipate pressure from NGOs, and possibly customers, to phase out substances in articles from the time at which they appear on the candidate list.
Notification, after inclusion in the candidate list, is required for substances present in articles when:
* The substance is present in those articles above a concentration of 0.1% weight by weight.
* The total amount in those articles exceeds one metric ton per producer or importer per year.
* The substance has not been registered for that specific use.
There is no obligation to notify if the manufacturer or importer of the article can exclude exposure to humans or the environment during normal or reasonably foreseeable conditions of use and disposal.
For substances included in the candidate list before Dec. 1, 2010, the notifications must be submitted not later than June 1, 2011. For those included on or after Dec. 1, 2010, the notifications have to be submitted no later than six months after the inclusion.
Nancy Russotto, former executive director of Brussels-based PlasticsEurope, today is a Brussels-based European affairs adviser for law firm Steptoe & Johnson LLP.