cw10.1108/cwCircuit World0305-6120Emerald Group Publishing Limited10.1108/cw.2007.21733cac.002e-non-articleSecondary articleExhibitions and conferencescat-ENGGEngineeringcat-EEEElectrical & electronic engineeringReach International ConferenceJ.H. Ling28082007333© Emerald Group Publishing Limited2007peer-reviewednoacademic-contentyesrightslinkexcludedReach International Conference

Reach International Conference

Hotel Metropole, Brussels, 17th and 18th April 2007

It was a measure of the interest in, and concern at, the imminent impositionby law of the REACH regulations that well over 200 delegates filled the ballroomat the Hotel Metropole in Brussels, to attend the first REACH Conference,organised by RAPRA. The Keynote speech was given by Otto Linher, head of the DGEnterprise REACH team at the European Commission. He is no stranger toregulation creation, having been involved with the WEEE Directive amongst otherprojects.

You can usually rely upon an EC Commissioner to make a complicated subjecteven more abstruse in a presentation, and Mr Linher did not let us down. Thereis some strange nomenclature; for instance, no one manufactures anythinganymore, they now “produce articles”. Be warned, acronyms abound,and there is a fair amount of commission-speak, which requires fierceconcentration to decipher. However, our translation of the facts is as follows:-

REACH is the new EU chemicals regulation, all 850 pages of it, which comesinto effect on 1st June, and all (chemical) substances of more than 1t per annumhave to be registered by the manufacturers. However, the guidelines forcompliance will not be published until October, which is helpful.

A new European Chemical Agency, (ECHA) based in posh new offices in Helsinki,and employing some 500 people, will control the system. There will be a focus onvolumes of products which are of the greatest concern, and now it is not thelocal authorities who will have control of regulation, it is the industry itselfthat will. Information will have to pass right through the supply chain betweenmanufacturers and downstream users. Some member states will valuate somesubstances, and authorisation will be need for substances of very high concern(VHC).

REACH applies to the manufacturing, importation and placing on the market anduse of chemical substances. Chemical substances of more than 1t per annum willneed to be registered, and a Chemical Safety Report (CSR) will be needed forsubstances of more than 10t per annum. A SIEF – Substance InformationExchange Forum – will be established comprising companies sharing apre-registration for the same chemical, and this forum is the platform forexchange of information on data available on the substance and on classificationand labelling.

Pre-registration can be performed between 1 June 2008 and 1 December 2008,but if you do not register, then you do not manufacture. It is as simple asthat. No data = no market. The ECHA will publish a list of registeredsubstances in January 2009, and SIEFs will then be needed with a 30 November,2010 deadline for classification and labelling agreement to be sent to theagency for “harmonisation”.

Downstream users – these are the companies that use chemical substancesthat they do not themselves make or import. If you do import chemicals on yourown account for your own use, then REACH considers you an importer, and not adownstream user.

If downstream users receive Safety Data Sheets from their suppliers, and theyhave made the use of the products known to the suppliers, then they have toapply the relevant risk management measures identified in these Safety DataSheets. They may of course, wish to produce their own Chemical Safety Report,and contribute to SIEFs.

There are things called RIPs. This does not mean Rest in Peace on theheadstone of manufacturing in Europe but stands for Reach ImplementationProjects. RIP 1, for instance, is a process description; RIP 2 covers IT. RIP 3sare all the rage at the moment.

There are helpdesks, and each Member State of the European Union has one,there is a correspondence network called “REHCORN” there will be anIT-based exchange forum called “RHEP”; the ECA will have a FAQdocument on their web site, and of course, the industry associations will beable to provide “hands-on” advice to their members. There are alsosome good consultancy companies who, inevitably and invaluably, emerge at timeslike this.

Every legal entity has to register. If you use, buy, manufacture, import orare in any way involved with chemicals, then you are not out of REACH. Therewill be lots and lots of information, there will be lots and lots of work, andlots and lots of costs. Mr Linher, closing his speech, seemed to think that allthis information would allow for innovation, but the idea of using informationalone to be innovative seemed a strange one.

As a complex, bureaucratic, expensive, lifetime exercise in paperwork onlegislation and information, REACH has no equal, but one does wonder what mighthave happened had the same costs been applied as investment in R&D for theEuropean manufacturing industry. Sorry, paper producing industry.

Andrew Fasey used to work at the European Commission, where he was one of thevery few authors of the REACH proposal, and worked on the development of REACHsince its inception in 1998. Now he is consultant, so is therefore a gamekeeperturned poacher. With regard to REACH, he said, there is a lot of reading to bedone, and quickly. REACH will impact the chemical use and supply globally; itdoes not only affect the EU. There will be some withdrawals of substances;imports to EU will be affected; importers will need support from their own EUmanufacturers. There will be opportunities as well as threats, and one shouldsee REACH as a way in which to maximise benefits, and minimise costs. Mr Faseyis an optimist.

Existing HSE legislation is largely “technical” but REACH isdifferent, as it is applied across all operations, so organisations have tothink differently. There will be a significant cultural change, with a tightlyregulated market, with responsibility now for and by industry and manufacturingindustry in particular. For the supply chain – where will REACH bite? Itwill bite most where certain chemical substances are banned, and wheresubstitutes have to be found. As there are inevitably threats of withdrawalwithin the supply chain, companies must identify alternatives, and run anidentification of future activities.

However, the most important thing now is pre-registration, which must be doneby the end of November 2008. The manufacturers will have to pre- register allchemical substances; the importer will have to pre-register all substances inpreparations, and the downstream user will have to ensure that the substancesbeing supplied are registered. Andrew Fasey was concerned that non-EUmanufacturers do not perhaps appreciate the demands that will be placed on them.For further, information please visit the web site: www.ptkltd.com

Ineke Gubbels-van Hal is the REACH Manager at Ciba Speciality Chemicals. Sheis also a classical pianist and a nutritionist, which shows wonderfulversatility. She spoke on their preparation for REACH at Ciba, and said thatthere are three simple steps to be understood.

1 How it affects you, your customers, your suppliers and your products.Define resource implications; plan your strategy. Note the implications ofProduct and Process Oriented Research and Development (PPORD, according toArticle 9, substances that are related to PPORD are exempt from registration fora period of five years.) If you are into R&D. Look at your in-house areasand communication. Portfolio assessment – how many substances have to bepre-registered? There are the well defined substances, and substances of Unknownor Variable Composition (UVCB), which are vulnerable substances.

2 Define available technical expertise; what do your customers expect fromyou? REACH is about strategy, not about regulation. Plan on a substance bysubstance level.

3 Undertake market evaluation – the competition; what data isavailable; how much data do you have?

A REACH Manager, she said, should be an expert in toxicology, ecotoxicology,hazard and risk assessment, classification and labelling, legal issues,regulatory issues, business strategy, R&D, sales and marketing and almostanything else. Quite what university degree they would need was not clear.

A Pre-registration dossier was explained; then the planning needed forpre-registration, which includes an inventory of substances, an identificationof legal entity; identification of substances; investigation of possibleanalogues; identification of company- owned, and publicly available data-gapanalysis. Mrs Gubbels-van Hal has already been down the REACH path. For further,information please visit the web site: www.cibasc.com/expertservices

Louise Howarth from Eversheds LLP talked about the legal perspective.

The pre-registration stages come into force in June this year, and REACH islaw in all EC member states, it is a regulation. Companies have a duty of careto ensure that they manufacture, place on the market, import or use suchsubstances that do not adversely affect the human health of the environment. Forchemical manufacturing companies, Louise suggested that they pre-register, andthen join a SIEF, where they can share data, and pay a contribution for theright to use the data, or they can opt out of joint submission of data, wherecommercial confidentiality is compromised. Where data is shared, companies needto be careful not to enter into agreements that could distort the market, of beseen as price fixing. Need a consortia agreement to avoid difficulties, retainconfidentiality and data rights; they will need to have a management committeethat can deal with downstream users, resolve disputes, and ensure compliancewith competition laws.

Who will enforce REACH? Each Member State has its own responsibility, in theUK it will be the HSE authority, the Environment Agency plus the localauthority. Compliance with REACH is down to each legal entity, it cannot be doneas a group, i.e. by a holding company on behalf of subsidiary companies. Shealso provided a very helpful list of key definitions concerning what and who isinvolved in REACH. There are rights of appeal should a product be banned, infact there are five specific areas of appeal. You have obligations, understandthem and observe them. You have rights, so use them. Be vigilant and keep apaper trail, she advised.

For further, information please visit web site: louisehowarth@eversheds.com

Cyril Jacquet was an administrator at the European Commission, but he is nowwith Keller and Heckman in Belgium, where he advises on EU chemical,environmental and trade law. Cyril wanted to expound on various effects ofREACH.

.The effect of registration – some 30,000 substances areexpected to be registered. And there is likely to be a concentration on generic,high volume or the most profitable substances. Other substances may bewithdrawn, and there will be an impact on downstream users, who will find itnecessary to reformulate or register themselves for alternatives. This will allbe particularly difficult for smaller producers with a large product portfolio.

.The effect of restriction is that there will be EC-widerestrictions or bans on the use of substances as, in preparation or in articles(products to you and me) that present “unacceptable risk”.

.The effect of authorisation is that substances of very highconcern (SVHC) will require approval, but prohibition of them is the basicprinciple of REACH, and the idea is that SVHCV will be replaced by lesshazardous substitutes. That way users should not be taken by surprise, therewill be efforts to develop suitable substitutes, and there will be a change incustomer's product strategy. Determination of SVHC will have severe regulatoryand practical impact on the availability of substances.

For further, information please visit web site: www.khlaw.com

Peter Chandler has been involved with REACH for a long time, and he runs the.Centre for Process Innovation in the North-East of England. Peter came alongwith some useful additions to our collection of knowledge, such as the fact thatsubstances for R&D purposes do not have to be registered, and a nominatedthird party can be used to pre-register substances whilst maintainingconfidentiality. Where a company has joined a SIEF, this company may not wantformulae and technical details to be known by other members of the forum, sothis is a useful way to ensure that:

you can safely and effectively; and

protect your IP. Peter emphasised that you should, as a downstream user,make sure that you are informed where substances that you use in manufacture maybe phased out.

Peter also gave us some useful definitions:

Definition of “Substitution”

Substitution means “the replacement or reduction of hazardoussubstances in products and processes by less hazardous or non-hazardoussubstances, or by achieving an equivalent functionality via technological ororganisational measures” (Lohse et al., 2004).

Everyone would like industry to develop chemical substances that can delivertheir desired properties or effects without negative side effects, though thereare clearly many cases where this is impossible., e.g. flame retardant clothesare desirable: but for flame retardant chemicals to continue to provideprotection, they must be very stable and long-lived, and hence they are by theirvery nature persistent. REACH pays particular attention to substances that are“PET” – Persistent, Bio-accumulative, Toxic (or vPvB -VeryPersistent and Bio-accumulative) or “CMR” – Carcinogenic,Mutagenic and Reprotoxic. These are referred to in REACH as Annex XIVsubstances.

Substitution must be considered for a substance that falls within one ofthese categories, in order to reduce the associated risk – it is a balanceof hazard and exposure.

Definition of “Hazard”

Hazard refers to the intrinsic adverse or harmful property of a substance,e.g. flammability or toxicity.

Definition of “Risk”

Risk is the likelihood that the intrinsic hazard will cause harm, and istherefore a function of hazard and exposure.

Risk Evaluation

If the hazardous material is handled correctly and users are not exposed tothe harmful property, the risk is being adequately managed or controlled.

Substitution within REACH is based on actual risk and not intrinsic hazard.It does no need to be mandatory if the risk can be adequately controlled. Ifsubstitution were based on hazard alone, but the original hazard was wellcontrolled and posed a low risk, a replacement might not actually improveoverall safety. In some instances, there may be less information available aboutthe risks posed by the substitute and its management. Sometimes the substitutecan even be found to present a higher risk than the original substance inmanufacture, use or disposal.

The substitution principle is frequently simplified to “chemicalsshould be substituted where a safer alternative exists”. This isproblematic from a practical point of view. As a minimum the words “safer”and “alternative” need clear definitions.

Definition of “Safer”

In the context of substitution, a “safer” substance is one thatcan be shown to have a substantially lower risk overall than the one to which itis being compared. Substitution by an alternative substance should also not leadto any materially important reduction in sustainability.

Definition of Alternative'

A substance that is capable of providing a level of performance that isacceptable to the regulator, the user, (and the consumer if relevant) at a costthat is not prohibitive and whose supply is adequately assured.

For further, information please visit web site: www.orbichem.com

Paul Ashford is the MD of Caleb Management Services, one of the experts atthis conference whose services would be invaluable to a company looking at REACHand contemplating early retirement. Paul talked about developing strategies forcomplex registrations involving speciality chemicals. First of all, you need toknow what you have to register. A useful timeline chart showed that pre-registration of ALL substances would need to take place between 1 June, 2007 and1 December, 2008. Phase-in substances would be need to be registered bycompanies producing more than 1,000t per annum by 1 December, 2010, by companiesproducing between 100-999t per annum by 1 June, 2013, and for companiesproducing between 1t and 100t per annum 1 June, 2018 is their deadline. Paulgave us the definition of a substance. It is a chemical element and itscompounds in the natural state or obtained by any manufacturing process,including any additive necessary to preserves its stability and any impurityderiving from the process used, but excluding any solvent which may be separatedwithout affecting the stability of the substance or changing its composition.Substances have constituents, and a substance can have its own constituents, andyet be a constituent of a preparation. REACH is not for the faint-hearted.

For further, information please visit web site: www.calebgroup.net

Paul Whitehead is the Chairman of the EH&S Committee of the Royal Societyof Chemistry, and he looked at chemical substitution in practice. The RoyalSociety of Chemistry had hosted a number of conferences for all the variouspeople involved in, and potentially affected by REACH. The Royal Society ofChemistry sees itself as an honest broker in the complex REACH process, theSociety wants chemicals that are safe, but which provide advantages. Paulrelated the story of a hair shampoo manufacturer who had found that if theanti-dandruff element of the formulation was to be replaced by a substitution,it would probably end the business of the manufacturer. So, there are hazardsahead. REACH requires that chemicals be authorised as a risk management process,and this authorisation provides a regularity context for substitution. Risk isthe likely hood that the hazard will cause harm. Substitution should be based onactual risk ands not intrinsic hazard, and substitution should be goalorientated and no prescriptive. Substitution is not mandatory if the risk can becontrolled. If substitution is based on hazard it may not contribute to safetybecause the hazard may pose a low risk. There may be less information available,about the risk posed by the substitute and its management, and the substitutemay not be fit for purpose. Indeed, innovation could be impacted due to a lossof chemical diversity.

The need to have the right data for the substitution of chemicals iscritical. Many other factors come into play, such as increased energy use, ormay generate more waste, balance between safety and sustainability. Under REACHsocio-economic benefits have to be in place, and the final substitution decisionwill be a value judgement on the balance of risk and benefit made by the ECHA onbehalf of society.

For further, information please visit web site: www.rsc.org

Dr Herbert Estreicher from Keller and Heckman wanted to form a coalition tolobby the EC to answer many of the questions that have arisen on polymers. He isworried about the nomenclature, which is extremely narrow. Pre-registrationdepends on status, as much as anything else. Polymers are not subject toregistration, but that is not the end of the story. Polymers could be requiredto be registered at some time in the future, and already we have notifiedpolymers that are required to be registered.

Registration for components of 2 per centw/w or more is specified, so theregistration for the EU polymer producer is most costly at the 100t an abovelevel. It is likely that suppliers will register polymer components at thosetonnage levels. Speciality polymers may suffer less ingredient selection.Certain classes of polymers are not considered low risk; they arewater-absorbing, high- molecular weight insoluble, cationic, polyflourinated;unstable or degradable; and contain reactive functionality. Point 16 of theinternet consultative document covered the possibility of polymers beingdangerous. Herbert painted a positive minefield of caveats and maybes linked topolymers and REACH, and there appeared to be very little by way of a set orrules and regulations that could be followed, which begs the question aboutpolymer registration being a black and white matter. Lots to do yet in thisarea, it seems.

For further, information please visit web site: www.khlaw.com

Dr Peter Oldring is a Director of the Valspar Corporation in Europe, and hewas in good form, and spoke from the experience of a manufacturer who would liketo be compliant, but is unable to understand the rules. He had a lot ofquestions, but none too many answers. What they call intermediates are notintermediates as specified by REACH. Some of them might be monomers, which wouldneed to be registered. Unless his suppliers tell him what substances have beenregistered, he will not know what to use as a substitute. There was some valiantsparring with the unknown here. Raw materials will disappear; all raw materialswill increase in cost. There will be a significant increase in theadministrative burden on them, and their suppliers, and their customers. Theindustry bodies have to take the initiative, alone if necessary, to resolve anunsatisfactory situation.

For further, information please visit web site: www.valspareurope.com

Dr Chris Howick from Ineos Vinyls was worried about the implications of REACHfor the PVC manufacturer. They are that it will cost his company, his suppliersand his customer's time and money. The need for an allocation of theresponsibility for REACH within an organisation, the need for an inventory ofall chemicals manufactured, or used, or imported; the need to find suitablepartners to work with, this is going to take up an enormous amount of time, andtherefore costs.

There will be a loss of IP, a loss of sensitive information, a loss of timewhich could be spent being creative, being innovative. There will be thedisappearance of safe substances from the market; the cost of testing andregistration maybe too much for some low tonnage speciality companies, whichwill see a loss in innovation; there are lots of questions that need answers.Chris foresaw a distorted market, where importers do not have to register in thesame way as manufacturers.

He cited the case of a PVC cable manufacturing company, based in Europe, whowould have to file no less than twenty Chemical Safety Reports. There would needto be extensive assessment of additives to the PVC compound being used toproduce the cable, and some of these additives may be excluded, whilst morehazardous chemicals may require authorisation. For the miscellaneous additives,REACH status would need to be confirmed. Whilst the PVC resin itself, as apolymer, is exempt, the raw materials upstream will require registration. Theinevitably protracted and costly authorisation system of REACH is of greatconcern to him.

Of course, the solution to this problem is to just ship it in from Taiwan, orChina, as a finished paper without any of the REACH costs. It is not just theimplications for a PVC cable manufacturer that are deeply worrying – it isthe implications for manufacturing in Europe in general.

Douglas Leech, the Technical Manager of the Chemical Business Association,talked about the distributor's perspective. There was a lot of uncertainty,there will be a loss of substances, articles and preparations, there will beincreased costs, there will be increased administration, there will be increasedcommunications. There will be a lot of extra work. There are, amongstdistributors, people who blend chemicals, and these are classified as “downstreamusers” as long as the source is European. We have 11 years in which tocomplete registration (June 2018) if you are a company who manufacture between 1and 10t per annum, six and a half years for 100t, but only three years if youmanufacture more than 1,000t.

For his members, there are some outstanding issues, not least the protectionof intellectual property, given that formulae have to be disclosed; althoughthis it seems may be done through a third party to retain confidentiality. Theindirect costs will include the employment of extra staff, the retention ofconsultants; there will be the costs of communication where personnel arediverted from their normal duties; raw materials may be discontinued, so therewill be R&D costs on alternatives; there will be changes in sourcing, andthere will be raw material price increases. However, all is not gloom, any newlegislation will generate job opportunities, and REACH is no exception.Profitability? Ah! that's something else. Douglas concluded by introducing theREACH Facilitation Company Ltd (ReFaC) who will help people get through REACH.An extremely useful presentation. For further, information please visit the website: www.refac.biz

Keith Huckle from Dow Corning S.A in Belgium talked about the importance ofdialogue in the supply chain. You need to get to grips with the facts that30,000 chemical substances have to be registered over a staged timeline of 11years; there are 800 pages of the Test Procedures, and 1,500 pages of the RIPProcedures. Information is required from both upstream and downstream in thesupply chain, and his experience so far is that many people think it does notapply to them. It does.

Getting to grips with REACH starts with data – what do I require? Whohas it? What about the quality of the data? There needs to be an Exposure UseMatrix, which covers the human and environmental aspects of hazardous substancemanagement. The essential need for complete exchange of information wasstressed, not of course, always possible but it must be done.

Dr Volker BoÍrger is with SchillþSeilacher AG, Germany, anddiscussed how it was possible to bring down costs by using the OSOR (OneSubstance, One Registration) principle. His company produce additives forchemical fibres, textiles, paper, leather and products for the rubber and latexindustries: they are a classical medium size company who wish to survive, sothey would like to be prepared. They do not want to lose market share, and theydo not want to be caught napping. So, Dr Borger said that one should notover-estimate the amount of time available to become Reach compliant, there is alot of work to be done.

They started with the classification of all raw materials, and have sent aquestionnaire to all their suppliers asking if they were aware of REACH, andwhat steps they were taking to become compliant. They are also in communicationwith their customers. OSOR means one substance – one registration. Thiswas proposed by Hungary and the UK in October 2004, and is designed to minimisecosts, with an obligation that animal testing has to be avoided. However, OSORassumes only one animal testing series should be performed, which in turn meansthat the data is common knowledge. For those companies who do not wish to sharesuch data, there are consortia, such as a SIEF. However, you will find that youmay be joining a competitor into a consortium, and although you may be sharingcosts, you may also find yourself sharing confidential information, socompetition law has to be considered. You cannot refuse anyone to join aconsortium, and a SIEF member can ask for information from a consortium, but theconsortia could sell this information to the SIEF member. A third party is bestfor running such a forum, or consortium.

Concerning raw materials from outside the EU, the manufacturers generallyhave said that they would pre-register, as the European market is important forthem. Can the importer pre-register all materials which are imported? Yes, butits expensive for the importer, and it would be good to be supported by thesupplier.

Dr Volker Soballa from Degussa came along to tell us about how his companywas dealing with it. He is their man in charge of their REACH ImplementationWorking Group as well as other responsibilities. He set out the meaning of REACHquite clearly.

R is for Registration – which means that a manufacturer, orimporter, has to submit a Registration Dossier to the European Chemical Agencyfor a substance that is p[roduced in a quantity of at least 1 metric ton/year/manufacturer.

E is for the Evaluation of substances – the ECA reviews thecompleteness of the dossier and assigns a registration number. The ECA thenchecks the proposal for further tests of all substances over 100 metric tonnesp.a., with random sampling for smaller quantities.

A is for Authorisation, and individual approval – for a specificuse of a substance needs to be obtained, especially in the case of materials ofdangerous properties.

CH is for Chemicals, some of which are exempt from REACH – theseinclude radio-active substances, non-isolated intermediates; waste matter andsubstances being subject to Customs supervision. There are other materials whichare exempt from registration, evaluation and information duties, which includewater starch, Vitamin A, glucose, etc. and polymers – but only fromregistration and evaluation.

Concerning costs he provided a useful chart showing the cost assessment forregistration (Table I)

Dr Soballa is a realist who has found out some of the anomalies of REACH,such as a 15-page Safety Data Sheet His paper was good: terrifying, but good.What one might expect from a giant in the industry. But, one worries for thesmaller company, the SME, of whom our Commissioners are reported to be so fond.How do they deal with all of this?

For further, information please visit web site: Volker.soballa@degussa.com

Stephen Doe from MBDA in the UK gave a really useful paper which explainedwhat a downstream user is, and what they should be doing. Start with aninventory of chemicals that are used, and inventory of substances, where do youuse it, how do you use it, why do you use it, is your use confidential, whatcontrols do you apply, and how much do you use per annum. Substances that willapply from 2010. Who supplies it to you? Look at your supply chain. Getting asubstitution for toxic substances is always a good move. Article 36 requires youto maintain data, as a producer of article. He mentioned the words foreseeablerelease, which is where a chemical may be released deliberately, (as in aprinter cartridge, or an ink-jet printer), then Article 7 applies. But, you cando nothing until it is applied, so it is best to start gathering data now, andotherwise you will find that your use has not been registered and your productcan no longer go to market. Which raises a question for the PCB manufacturer, inthat as a printed circuit board is an paper, and foreseeable releases would beconfined to metals, more than chemicals, would they not? Questions here to beasked.

Dr Paul Wilkes is the Head of Regulatory Affairs for The Body Shop, who selltheir own brand goods through own brand stores. Part of L'Oreal, they don notdevelop and manufacture themselves, they go to contractors who manufacture themfor them. So, his view of REACH is one of a responsible retailer – supplychain mapping was undertaken, covering all chemicals and materials, decidingwhich ones are covered by legislation, looking at paper – definitions andwhat constitutes “release” of a chemical; looking at substances ofvery high concern, and looking at information exchange, the information thatmust be provided to consumers.

The Body Shop, understandably, are very keen to have control of chemicals inorder to refute scare stories. REACH will ensure better flow of information upand down supply chain, and therefore to customers. Some of their products aremade in China, some in the USA, and concerns include the possibility that alarge number of raw materials maybe lost because the necessary studies will notbe supported. Dr Wilkes said that trade associations can help to saveduplication of effort by individual companies, and they should take a pro-activerole here to assist their smaller members, and they should be in a position tobe helpful with Reach Implementation Projects.

Obtaining information about imported products is difficult. Should we besurprised?

Reach compliance costs were covered by Steffen Erler, who is the TechnicalManager at REACH Ready in the UK. REACH Ready is an enterprise within the UKChemical Industries Association formed to help companies around the worldprepare for REACH. They are going to be busy.

REACH will create €between 1.9 and 3.2 billion costs to industry, andbetween €2.8 and 5.2 billion to downstream users.

Table II looks at the costs (in Euros) for Registration.

Other costs, such as those for the registration of Intermediate, varied from€2,000 for 1-10t per annum to €24,000 for more than 1,000t per annum.Testing is a complex area, where much depends upon the testing regime, be itminimum or maximum, here it can vary from 1 to 10t/a at e2,000 for minimumtesting, to e287,000 for maximum testing where production is greater than 1,000tper annum.

Forming consortia can reduce costs significantly, here SIEFs and downstreamuser consortia can control their own exposure exercise. As an example, fivecompanies' costs from Registration to Testing vary from €2,000 to 140,000.REACH Ready UK has an online tool which will allow their clients to assess alltheir likely costs more precisely.

For further, information please visit web site: Steffen.erler@reachready.co.uk

Dr Wolfgang Ihme of RCC Limited in Switzerland spoke on consortiummanagement. RCC Ltd offer testing and regulatory services, and are well- placedto assist companies with REACH. There are several impact factors, he said. Thenon-availability of IT tools for REACH does not help much, but running aconsortium needs management, scientific, legal, and economic expertise. Legalbeing IP protection; economic includes budget management, cost reductionstrategy, the value of data and allocation of income, this is income from peoplepaying for the data. RCC can of course, do the whole thing, if you would likethem to.

For further, information please visit web site: Ihme.wolfgang@rcc.ch

Dr Derek Knight is Director of Regulatory Affairs at SafePharm LaboratoriesLtd in the UK. Dr Knight believed that the registration of new chemicals willhave an advantage. It means that there will be a systematic review system forold chemicals, so REACH maybe seen as a review programme; here, it is thehighest volume (in tonnes) of chemicals that indicate the highest risk. The ECAwill only have a completeness check on the most popular chemicals. In fact,there are not enough labs in the world to do them all, for all the chemicalsconcerned, so the ECA will have to accept dossiers, where the risk assessment isdefined by the company. Whilst Annex XI asks us to adopt an intelligent approachto animal testing, it is inevitable that there will be some.

Frederick Verdonck is an expert in risk assessment, and he looked atintelligent data collection strategies, and explained in detail the requirementsfor a chemical safety assessment (CSA) for human health and environmentalaspects. Once you have the minimum requirements, you can make your own CSA, alsoyou will need to make an exposure assessment – here you try to predictexposure concentration (PEC), and predicted no effect concentration (PNEC), sothat they are balanced. CSA is an iterative process and a complex one. Frederickcan explain if you contact him.Frederik.verdonck@euras.be

Matthew Curl is from TSG Europe, and looked at the technical issues relatedto consortia building. Working together may not be problem, pre- registration isneeded only for the substance, for which you need a chemical name and anEuropean inventory of existing commercial chemical substances (EINECS). number,a CAS number, and what they call a trivial name. The chemical abstract service(CAS) has 30 million numbers listed, which increase by 4,000 a day. Matthewexplored some of the variables that arise once you go down this path, thequality of existing data. Collecting end-points and generating new data werecovered, as was harmonised risk assessment.

Dr Irene McGrath comes from Rivendell International. She related twointeresting case studies, highlighting two different elements of cooperationbetween companies on REACH, one from Ireland one from Spain. Irish miningcompany – precious metals mined, and she described the refining process,which yields high purity ore particles. They came late 2006 to Rivendell onREACH, and they had a working group in place by then. They had a list ofchemicals, supplier listings, and annual volumes in tonnages. Ore concentratesare not exempt from the authorisation and restriction and classificationelements. The mine uses chemical substances from a number of sources, frominside and outside the EU. Some of the chemical substance manufacturers mightnot know that their products are being used in mining. If one of these productsbecame unavailable this would be difficult for the mine to continue working. Themine thought that they could import these critical substances from outside theEU to ensure continuity of supply. If less than one tonne per annum, they wouldbe exempt. More than one tonne per annum – then there would need to bepre-registration under REACH. In that case, the operation of the mine wouldcease before the Registration phase of REACH is complete.

In Spain, they have a Spanish Help Desk on REACH, with a technical teamliaising with the ECA, and a R&D team is planned but is not yet inexistence. Few are aware of the REACH requirements, and different industrialsectors are demanding information, conferences and assistance. In Spain, 3,600chemical companies produce 10 per cent of GDP and employ 500,000 people.Chemicals are the second largest export. Few chemical companies seem to have agood knowledge of REACH, and only a small number of companies (four to beprecise) are taking actions to comply with REACH.

The Spanish Chemical Industry Association will produce guidelines andquestionnaires to standardise the formats. They are gathering information onconsultancies to assist companies in meeting legal obligations under REACH;cooperation at a national level is through universities with toxicology andchemistry knowledge. Overall, conclusions – companies in Spain are notaware of REACH, and the implications are worrying. She did not mention any othercountries, but the inference was clear. Much better availability of informationis required, Irene.mcgrath@rivendell.ie

Opportunities for deep innovation were presented by the cheerfully optimisticRichard Miller, from Chemistry Innovation Knowledge Transfer Network in the UK.REACH is a market disruption, which means that the old ways will have to change.Our ways of doing things are under threat – if ingredients are at risk,then products are at risk, which means that markets are at risk. So, one couldconsider reformulating the product, redesigning the product, finding new ways todeliver the function, and one could redesign the system altogether. The latterwould be better. He cited the example of it taking nine man years of research tochange one ingredient in aircraft paint. Another example of finding new ways todeliver the function was at Ford, where the cooling liquid for metal working waschanged over to a renewable vegetable oil-based product, and they cut effluentby 2 million litres per annum.

The key is developing sustainable competitive advantage. Look at thetechnology roadmap for the industry you are in, and carry something called aneco-innovation compass, which tells you there are seven directions to go –service; durability; re-use; mass; energy; safety; and resource use. Richardgave some good examples, and provided a positive note upon which to end theconference.

Summing up, Professor Martin Goosey of the IeMRC thanked all the speakers forbringing the delegates in the real, harsh world of REACH, during the two days avast amount of information and knowledge had been imparted, for those alreadydown the REACH path this would have been invaluable; for those who have to taketheir first steps, the word terrifying is applicable. Professor. Goosey andRAPRA are to be congratulated on this first REACH Conference, of which more areplanned this year including one in the USA early 2008.

J.H. LingAssociate Editor