An article is defined as an object which during its production is given a specific shape, surface or design which determines its function to a greater degree than does its chemical composition, e.g. a laptop or a paperclip. Although articles themselves are not subject to registration, certain obligations are triggered if the article contains a substance intended for release or if it contains an SVHC.
Substances with Intended Release
Substances intended for release from articles under normal or reasonably foreseeable conditions of use are treated as normal substances or preparations. Thus, they must be registered if produced or placed on the market in quantities greater than 1 tonne per annum.
If you breached the one tonne threshold after December 1st, 2008, a late pre-registration may be submitted; however, if the threshold was breached before December 1st, 2008 and you have not already pre-registered the substance, then you must proceed with Inquiry and immediate registration.
Articles Containing SVHCs
Substances of Very High Concern (SVHC) are defined as substances that meet any of the following criteria:
Carcinogenic, Mutagenic or Toxic to Reproduction
- Category I or II (CMR)
- Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB)
- Of an Equivalent Level of Concern (ELC) e.g. Endocrine Disruptors
Substances identified as meeting these criteria may be nominated as candidates for inclusion in Annex XIV. Inclusion on the Candidate List triggers immediate obligations for suppliers and manufacturers of articles containing a combined 0.1% w/w or greater of one or more SVHCs.
If you would like to talk to a member of H2 Compliance about your requirements please call us today on +353 1 2989136 (for Cork office +353 21 4868120, or New York office +1 518 5123553) or email us at email@example.com.
Alternatively you can use our enquiry form here and a member of our team will be in touch ASAP.
Notification (From 2011 onwards)
A dossier must be submitted to ECHA detailing the substance, its classification, tonnage and use.
Communication (From date of inclusion)
Professional users of these articles must be informed of the presence of SVHC in the article and given information regarding its safe use.
Immediate registration may be required should ECHA consider the release of the substance from an article to pose a risk to human health or the environment.
Provide Information (From date of inclusion)
Requests for information from the general public regarding SVHCs in articles must be responded to at no cost within 45 days.
The date of inclusion above refers to the date when the SVHC is included on the candidate list. This is a varying time with groups of approximately ten substances every 6 months.
- Article Analysis
- Situation Review and Strategic Planning
- SVHC List Tracking
- SDS Review, Creation and Translation
- Downstream User Communications