The Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation is the most complex piece of legislation ever to emerge out of Europe, and is the most complex chemical regulatory system in the world. Because of the inherent complexity in the 800+ page regulation, with thousands of pages of guidance, the global manufacturing and brand holder community has unfortunately fell victim to the multiple sources of misinformation that perpetuate in times of confusion. This is particularly the case for foreign article importers that do not produce chemicals or preparations.
REACH is manageable, as evidenced by the great strides taken by European enterprises, but when companies approach REACH they need to have the right information in order to make suitable management decisions. This brief article is meant to highlight some of the fallacies that have circulated about the impacts of REACH so that businesses can move beyond the scoping stage and towards action; something that should have happened a long time ago.
10 common fallacies:
1. Substances of Very High Concern (SVHCs) on the Candidate List do not require notification, they are 'candidates' only:
The 'Candidate' nature of the Candidate List centers solely on the fact that the substances on the list are 'candidates' for Authorisation, a step towards substance control under REACH. A substance on the SVHC Candidate List means the substance has been identified by the European Community as an SVHC and notification requirements are now required.
2. All SVHCs will need to have Safety Data Sheets or labels:
The only SVHCs that require extended Safety Data Sheets are those that are supplied as substances on their own or are in preparations (Art. 31(1)). These substances require safe handling because they have a high exposure risk; substances inside articles do not pose the same threat. Labels are also a part of REACH, but they are associated with the Authorisation component (Art. 65) and apply to substances and preparations. One could place an 'SVHC label' on their finished article, however as the SVHC list constantly changes this may not be a suitable option for addressing your Notification requirement.
3. Every SVHC will need to be authorised:
Only SVHCs which are supplied on their own (i.e. as a substance) or in a preparation require authorisation (Art. 56). SVHCs within products have to abide by the Notification (Art. 7; Art. 33) requirements and any Restrictions, but they do not have to be Authorised.
4. Companies will need to remove SVHCs from their products:
The only SVHCs that are required to be removed from product bill of materials are those listed in Annex XVII (Restrictions). SVHCs that are not considered substances on their own or are in preparations will not be required to be designed out until this takes place. However, many companies have already started requiring these to be removed for business requirements, so this is only from a legislative perspective.
5. SVHCs will have to be registered (pre-registered):
The requirements for registration only apply to those substances that satisfy the Art. 6 requirements (i.e. one ton threshold). The fact that a substance may be a SVHC does not change its registration status; however, other obligations could be triggered.
6: Notification requirements do not begin for several years:
Notification to the European Chemicals Agency is not required until June 2011 (Art. 7(2)), but notification to your customers and responding to the 45-day consumer request window (Art. 33) apply as soon as a substance is placed on the Candidate List for Authorisation and initial publication of this list is expected in October 2008.
7. Companies that do not manufacture chemicals do not need to register (pre-register):
Even though you may not 'produce' chemical substances, this does not mean you are exempt from registration. If you import substances for use in your own facilities, and you meet the registration requirement, then you may have to register (pre-register) your substances.
8. Obtaining certificates of compliance from suppliers will satisfy REACH obligations:
Governmental authorities have dismissed the idea of certificates of compliance as being demonstrative of due diligence for some time (see www.rohs.gov.uk), but utilizing these documents under REACH is nearly impossible given the constantly changing nature of the SVHC Candidate List; the list is not static and will constantly be updated.
9. REACH only affects companies with legal European presence:
Business obligations are separate from legal obligations. Even if you do not sell directly into Europe, if one of your customers, or customers' customers, sells into Europe, then REACH applies.
10. REACH does not affect the electronics industry because it has RoHS:
REACH and RoHS are two separate legal instruments. They have a different scope and a different purpose. REACH and RoHS both apply to the electronics industry. REACH is a matter of business continuity for every supply chain because chemicals are in everything we use from bleached paper to computers. Determining liabilities and developing a compliance strategy can only be done correctly if you have the correct information. There is a wealth of guidance documentation and help available from the European Community; always make sure you have the correct information.
About the author: Will Schreiber is managing consultant, Regulatory Compliance and Sustainability, with Foresite Systems Ltd. in the UK. You can reach him at: Will.Schreiber@foresitesystems.com