The REACH window closes
20 November 2008
At the end of 30th November, St Andrew’s Day, the REACH window of opportunity for pre-registration of existing substances will be closing, and it’s my mid-November prediction that, despite some IT problems, there will not have been any extension to that date. Martin Tarr reports on the legislation and its consequences for the electronics industry.
The chemical industry has made a major effort to comply: with the number of pre-registrations standing at 1.25M on 18 November (as against an original estimate of 180,000!) and reportedly hundreds of pre-registrants for common materials such as titanium dioxide. Even by 1st November, the published list showed that over 50,000 different substances had been pre-registered, of which a surprising 15,000 were in the 100+tonne category which is scheduled for full registration in less than two years’ time.
By the beginning of January 2009, we will know what has been pre-registered, and by whom, and the industry will have the challenge of making SIEFs work. These Substance Information Exchange Forums are the mechanism which ECHA intend will manage the preparation of the detailed risk assessments and other documentation needed for full registration. It’s unlikely to be a smooth process, unless the work can be distributed in a fair way, so that the burden doesn’t fall too heavily on the willing few, and it will be expensive, even where costs can be shared.
The task will not be made easier by staggered registration deadlines, as these are dictated by the actual tonnages for each of the individual legal entities manufacturing or importing. If one SIEF member imports in the 1–10 tonnes range, their deadline for full registration will be 2018, even though another company in the same SIEF makes over 1,000 tonnes of the same substance and has a 2010 deadline. It seems likely, however, that such smaller companies will register well ahead of the deadline, as they will have paid through the SIEF for access to all the information needed to support a registration. Doing this may well become the norm, as it allays customer confusion as to why someone can still trade an “un-registered” product in 2015, when a larger competitor is supplying a registered product.
The impact on electronics
What REACH pre-registration will have achieved is to define who is active in manufacturing and importing substances, whilst weeding out some substances that have been supplied illegally over recent years, without the pre-requisite EINECS registration. However, at this stage, pre-registration will have little effect on the electronics community. If you or your suppliers are using a substance as part of the manufacturing process, or it is contained within or released by your products, you can find out whether that substance has been pre-registered, but currently not who has pre-registered it, nor the intended scope of that registration. Whilst suppliers have an obligation to supply compliant materials, they may rightly be reluctant to give their pre-registration numbers, on the grounds that doing so might lead to confusion. This is because the same substance, pre-registered by different manufacturers or importers, is given different pre-registration numbers.
For the user, where REACH will first make a real difference relates to the Authorisation process. Not only did REACH consolidate a raft of old legislation, but it also introduced the new idea of Authorisation, arguably a different mind set from earlier legislation, which generally prohibited just specific uses, whereas, in REACH, every use of authorised substances is banned unless positively permitted.
Substances of Very High Concern (SVHCS)
The focus of Authorisation is on SVHCs, on account of their listing as carcinogens, mutagens, or other materials toxic to reproduction (CMR substances), or being more general environmental “nasties”. Eventually these will end up in Annex XIV of the regulations, and have their use tightly controlled. But Annex XIV is still a blank sheet, although a Candidate List of 15 substances has recently been put forward. About the correctness of proscribing these particular substances there is little debate, but the same can’t be said for everything on the definitive list of substances contained in Annex XVII of the Directive, which is 450 pages of heavy reading!
There are many substances that cause concern: for example, there are 850+ known CMRs and around 700 substances that are toxic to aquatic organisms, or may cause long-term adverse effects in the aquatic environment, and not all of these will immediately be subject to Authorisation. Which will be selected next depends on political processes, and the starting point may well be the so-called REACH SIN* List (*Substitute It Now!) prepared as a “tool for phasing out chemicals of high concern” by ChemSec in collaboration with leading NGOs. The aim of their project is “to ensure that Authorisation is an effective tool to fast-track the most urgent Substances of Very High Concern for substitution, and to facilitate toxic use reduction by businesses.”
We can expect with confidence that substances with significant hazards will migrate to Annex XIV, and be phased out within a relatively short time. For each item on the list there will be debate, but many will end up becoming unavailable. For electronics, the problem will be with substances such as tetrabromobisphenol-A (TBPPA), a key flame retardant used in PCB laminates, which is on the SIN list and under threat as persisting for a long time in the environment.
That is not to say that SVHCs will not continue to be used in the interim, and there are (unquotable!) examples in other industries where manufacturers still prefer to use “cheap and dirty” substances rather than more expensive, safer alternatives. Provided that manufacturers are aware that their materials will be affected by the legislation, they will have an 18-month phase-out period after the regulations are finally approved. The moral is to be ready to make the switch when it becomes necessary.
Substances in Articles
In most cases, registered substances used during manufacture that remain as part of the item produced, such as metal components, do not require any documentation. Unless, that is, the substances are on the Candidate List, in which case their presence has to be declared downstream: from 2011, producers or importers of articles have to notify ECHA if such a substance is present above 0.1% (w/w) and its quantities in the articles total over 1 tonne per year per company.
When does a substance become an “article”? And when is that important? This is one of the REACH minefields that has already been mapped out, but still needs some clarification. From the practical perspective, the 0.1% concentration limit doesn’t have the homogeneous material interpretation used in RoHS, and there isn’t a problem if an aircraft is taken as the article! The real problem is with items such as spares, where the 0.1% is much more onerous, and there will be a particular problem with second-hand and legacy goods.
Driving the change
Whilst REACH is a European-wide directive, there are variations in how the legislation is being enforced. The emphasis in the UK is, as with RoHS, more carrot than stick, concentrating on educating the users. The same sort of specialist advice that NWM provide for RoHS compliance won’t be available, although HSE will be giving advice and support, and already have a very good help desk.
The surveillance work will be given to the Health & Safety Executive, who will have a watching brief on REACH issues as part of their normal inspections. So the effectiveness of enforcement will depend on inspection awareness, fuelled by education, experience and informal information: if you have heard of the debate about a particular substance, you are more likely to spot it on your factory tour.
The expectation is that the main focus will be on investigating incidents through the supply chain: if your product gives problems, the investigators will look at whether the substances involved had included the application in their risk assessment. Naturally this requires information on the actual registration, so work of this sort can’t start at least until November 2010, and much later for material imported in smaller quantities.
Although some scare stories have been circulating, we should not anticipate a whole new tier of inspection, at least in Western parts of the EU. However, the situation might be different in Eastern Europe, because their enforcement teams are larger, and activities such as the screening of import documentation will probably take place.
It is almost certain that some users will find themselves with substances that have not been properly registered and, as with RoHS, the penalties will vary from country to country. However, in the UK, it is likely still to be the case that, if your company has gone through the correct thought processes, made safe use of chemicals, and has an appropriate paper trail to prove this, there should be no major penalty.
Of course, it may well be that the change will be forced, not so much by the legislation as by the companies who are involved. There are reports of what is being described as “consumer-led compliance”, with large end-users calling the shots, and a greater emphasis on hazard and risk assessment. Companies such as Airbus are reported as having made a policy decision to seek out SVHCs and as quite aggressively interrogating their supply chain. The concern is about items that might become unavailable, or whose presence in the article would need to be disclosed.
Can I wriggle out if I’m a defence supplier? Well, there is a general exemption in Article 2 of REACH that allows member states to make national exemptions in the interest of defence. The UK has done that in respect of the duty to register, setting up a parallel system that provided a confidential umbrella. However, applications for that limited exemption needed to be in place by August 2008. It will also be of doubtful benefit, given that defence is NATO-wide, and UK exemptions on registration don’t necessarily apply in other NATO countries. So your “stealth paint” could be applied in the UK, but perhaps not in Germany!
What changes can we expect?
We are unlikely to see changes to the legislation in terms of scope, apart from a few minor tweaks to cope with areas that weren’t satisfactorily covered by earlier legislation. However, it is likely that thorny problems such as embracing polymers within the legislation will be considered sooner, rather than later. We can also expect that some materials and processes will become unavailable as the Directive begins to bite, but there is always the work-round for small users that companies will be able to import speciality products themselves, in quantities of up to 1 tonne per substance, provided of course that all the appropriate controls are put in place.
You may soon see minor changes in Safety Data Sheets, with some slight reordering and extra contact information. However, as information becomes available as a result of the registration risk assessment exercises, one can expect continuing change, and a consequent need to control the paperwork. There will also be changes in the names used for some chemicals, as a result of the move to GHS, a Globally Harmonized System of Classification and Labelling of Chemicals, with EU agreement to adopt the implementing regulations expected to be finalised in a matter of weeks.
What is there to do?
By now, you should have already examined the way in which REACH might impact your company, by carrying out an inventory of the substances that you use, and a corresponding inventory of the uses to which they are put. Hopefully you will have used that opportunity to identify and eliminate any “rogue materials” lurking in cupboards and brought out only occasionally – holding a “chemical amnesty” has even been recommended!
For much of the electronics industry, this inventory task will have involved passing the search back up the chain to suppliers of components, as well as investigating the substances contained in the “preparations” such as solvents, adhesives and solder paste that might be used in-house or by your sub-contractors. As with RoHS, you need to keep a good paper trail and to document any decisions made and the reasoning behind them.
Especially if you are using substances (or preparations containing them) in unusual ways, you should be engaging in dialogue with your suppliers, to ensure that your uses are included in the scope of registration, and appropriate risk assessment performed. If you have identified any SVHCs, especially those on the SIN List, you can anticipate a potential problem, if only the requirement to pass on information about the material to your downstream users, and it would be prudent to start the search for alternatives sooner rather than later.
As a result of the inventory, you will also know where your biggest risk areas are, and whether there is any potential for business interruption from critical materials, for example from suppliers not managing REACH or from substances being withdrawn rather than pre-registered. And you will be managing that part of the risk by rationalising your chemical stocks, ensuring that you are using products in the way the manufacturers recommend, and choosing appropriate chemical suppliers.
If you haven’t done any of these things, it’s not too late to start, and you will probably find that your suppliers will have done much of the groundwork. But remember that an IPC on-line survey this summer found that one in three senior managers had no knowledge of the legislation, so you should be prepared for a significant expenditure of time and effort, especially in making others REACH-aware.
I am grateful to the many industry colleagues who, over the past three years, have willingly shared their insights into REACH, and for recent inputs from Steve Dowds and Richard Boyle (Henkel), Neil Stanton (BSI Product Services) and Marion Quarrington (Measurement Technology). Especial thanks to the helpful team at REACHReady, headed by Dr Jo Lloyd, who have provided speedy and insightful answers to my many questions, and safe direction through the morass of legislation.
A fuller list is on my web site at http://www.mtarr.co.uk/reach_refs.html
Agencies and consortia
The European Chemicals Agency (ECHA) aims to be a single point of entry for all information on REACH. The official documents will probably be a touch “heavy-duty” for the average user, but there are some useful guidance notes. Unfortunately there isn’t a single manual that contains all you need to know, and useful pages such as the one on Information requirements in the context of safety assessment have amazing lists of linked documents. The Navigator may help you determine your obligations under REACH and lead to the appropriate guidance.
The UK Health & Safety Executive REACH home pagehas clear advice and some helpful case studies. The NickAlchemy case study is particularly relevant to those seeking advice about alloys as “special preparations”.
The International Chemical Secretariat (ChemSec) is a non-profit organisation “dedicated to working towards a toxic free environment” that has worked in collaboration with an NGO Advisory Committee to develop the SIN (Substitute It Now) list.
REACHReady (run by the Chemical Industries Association) has an informative web site, with a “scoping tool”, a “REACHReckoner” to indicate compliance costs/work, and a “matchmaking” service to facilitate joint registration.
The European Automobile Manufacturers’ Association has REACH news and links: the zip file, updated September 2008, contains v2 of their particularly enlightening Automotive Industry Guideline on REACH and some supporting documents.
The Orgalime Environment page has a broad scope, with REACH at the Chemicals Policy link. The Orgalime Practical Guide for downstream users, article producers and article importers for understanding REACH, updated May 2008, is well worth reading, and the required registration is free.
The European Chemical Industry Council has a useful section on REACH, with advice on implementation and some practical tools such as pro forma questionnaires.
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