Reach International Conference

Citation

Ling, J.H. (2007), "Reach International Conference", Circuit World, Vol. 33 No. 3. https://doi.org/10.1108/cw.2007.21733cac.002

Reach 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 imposition by law of the REACH regulations that well over 200 delegates filled the ballroom at 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 DG Enterprise REACH team at the European Commission. He is no stranger to regulation creation, having been involved with the WEEE Directive amongst other projects.

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

REACH is the new EU chemicals regulation, all 850 pages of it, which comes into effect on 1st June, and all (chemical) substances of more than 1t per annum have to be registered by the manufacturers. However, the guidelines for compliance will not be published until October, which is helpful.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 on volumes of products which are of the greatest concern, and now it is not the local authorities who will have control of regulation, it is the industry itself that will. Information will have to pass right through the supply chain between manufacturers and downstream users. Some member states will valuate some substances, and authorisation will be need for substances of very high concern (VHC).

REACH applies to the manufacturing, importation and placing on the market and use of chemical substances. Chemical substances of more than 1t per annum will need to be registered, and a Chemical Safety Report (CSR) will be needed for substances of more than 10t per annum. A SIEF – Substance Information Exchange Forum – will be established comprising companies sharing a pre-registration for the same chemical, and this forum is the platform for exchange of information on data available on the substance and on classification and 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 as that. No data = no market. The ECHA will publish a list of registered substances in January 2009, and SIEFs will then be needed with a 30 November, 2010 deadline for classification and labelling agreement to be sent to the agency for “harmonisation”.

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

If downstream users receive Safety Data Sheets from their suppliers, and they have made the use of the products known to the suppliers, then they have to apply the relevant risk management measures identified in these Safety Data Sheets. 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 the headstone of manufacturing in Europe but stands for Reach Implementation Projects. RIP 1, for instance, is a process description; RIP 2 covers IT. RIP 3s are 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 an IT-based exchange forum called “RHEP”; the ECA will have a FAQ document on their web site, and of course, the industry associations will be able to provide “hands-on” advice to their members. There are also some good consultancy companies who, inevitably and invaluably, emerge at times like this.

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

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

Andrew Fasey used to work at the European Commission, where he was one of the very few authors of the REACH proposal, and worked on the development of REACH since its inception in 1998. Now he is consultant, so is therefore a gamekeeper turned poacher. With regard to REACH, he said, there is a lot of reading to be done, and quickly. REACH will impact the chemical use and supply globally; it does 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 EU manufacturers. There will be opportunities as well as threats, and one should see REACH as a way in which to maximise benefits, and minimise costs. Mr Fasey is an optimist.

Existing HSE legislation is largely “technical” but REACH is different, as it is applied across all operations, so organisations have to think differently. There will be a significant cultural change, with a tightly regulated market, with responsibility now for and by industry and manufacturing industry in particular. For the supply chain – where will REACH bite? It will bite most where certain chemical substances are banned, and where substitutes have to be found. As there are inevitably threats of withdrawal within the supply chain, companies must identify alternatives, and run an identification of future activities.

However, the most important thing now is pre-registration, which must be done by the end of November 2008. The manufacturers will have to pre- register all chemical substances; the importer will have to pre-register all substances in preparations, and the downstream user will have to ensure that the substances being supplied are registered. Andrew Fasey was concerned that non-EU manufacturers 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. She is also a classical pianist and a nutritionist, which shows wonderful versatility. She spoke on their preparation for REACH at Ciba, and said that there 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 of Product and Process Oriented Research and Development (PPORD, according to Article 9, substances that are related to PPORD are exempt from registration for a period of five years.) If you are into R&D. Look at your in-house areas and communication. Portfolio assessment – how many substances have to be pre-registered? There are the well defined substances, and substances of Unknown or Variable Composition (UVCB), which are vulnerable substances.

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

3 Undertake market evaluation – the competition; what data is available; 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 almost anything else. Quite what university degree they would need was not clear.

A Pre-registration dossier was explained; then the planning needed for pre-registration, which includes an inventory of substances, an identification of legal entity; identification of substances; investigation of possible analogues; identification of company- owned, and publicly available data-gap analysis. 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 is law in all EC member states, it is a regulation. Companies have a duty of care to ensure that they manufacture, place on the market, import or use such substances that do not adversely affect the human health of the environment. For chemical manufacturing companies, Louise suggested that they pre-register, and then join a SIEF, where they can share data, and pay a contribution for the right to use the data, or they can opt out of joint submission of data, where commercial confidentiality is compromised. Where data is shared, companies need to be careful not to enter into agreements that could distort the market, of be seen as price fixing. Need a consortia agreement to avoid difficulties, retain confidentiality and data rights; they will need to have a management committee that can deal with downstream users, resolve disputes, and ensure compliance with competition laws.

Who will enforce REACH? Each Member State has its own responsibility, in the UK it will be the HSE authority, the Environment Agency plus the local authority. Compliance with REACH is down to each legal entity, it cannot be done as a group, i.e. by a holding company on behalf of subsidiary companies. She also provided a very helpful list of key definitions concerning what and who is involved in REACH. There are rights of appeal should a product be banned, in fact there are five specific areas of appeal. You have obligations, understand them and observe them. You have rights, so use them. Be vigilant and keep a paper 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 now with Keller and Heckman in Belgium, where he advises on EU chemical, environmental and trade law. Cyril wanted to expound on various effects of REACH.

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

^.The effect of restriction is that there will be EC-wide restrictions 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 high concern (SVHC) will require approval, but prohibition of them is the basic principle of REACH, and the idea is that SVHCV will be replaced by less hazardous substitutes. That way users should not be taken by surprise, there will be efforts to develop suitable substitutes, and there will be a change in customer's product strategy. Determination of SVHC will have severe regulatory and 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 along with some useful additions to our collection of knowledge, such as the fact that substances for R&D purposes do not have to be registered, and a nominated third party can be used to pre-register substances whilst maintaining confidentiality. Where a company has joined a SIEF, this company may not want formulae and technical details to be known by other members of the forum, so this is a useful way to ensure that:

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  you can safely and effectively; and

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  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 may be phased out.

Peter also gave us some useful definitions:

Definition of “Substitution”

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

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

Substitution must be considered for a substance that falls within one of these categories, in order to reduce the associated risk – it is a balance of 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 is therefore a function of hazard and exposure.

Risk Evaluation

If the hazardous material is handled correctly and users are not exposed to the 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. If substitution were based on hazard alone, but the original hazard was well controlled and posed a low risk, a replacement might not actually improve overall safety. In some instances, there may be less information available about the risks posed by the substitute and its management. Sometimes the substitute can even be found to present a higher risk than the original substance in manufacture, use or disposal.

The substitution principle is frequently simplified to “chemicals should be substituted where a safer alternative exists”. This is problematic 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 that can be shown to have a substantially lower risk overall than the one to which it is being compared. Substitution by an alternative substance should also not lead to any materially important reduction in sustainability.

Definition of Alternative'

A substance that is capable of providing a level of performance that is acceptable to the regulator, the user, (and the consumer if relevant) at a cost that 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 at this conference whose services would be invaluable to a company looking at REACH and contemplating early retirement. Paul talked about developing strategies for complex registrations involving speciality chemicals. First of all, you need to know 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 and 1 December, 2008. Phase-in substances would be need to be registered by companies producing more than 1,000t per annum by 1 December, 2010, by companies producing between 100-999t per annum by 1 June, 2013, and for companies producing between 1t and 100t per annum 1 June, 2018 is their deadline. Paul gave us the definition of a substance. It is a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserves its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition. Substances have constituents, and a substance can have its own constituents, and yet 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 Society of Chemistry, and he looked at chemical substitution in practice. The Royal Society of Chemistry had hosted a number of conferences for all the various people involved in, and potentially affected by REACH. The Royal Society of Chemistry sees itself as an honest broker in the complex REACH process, the Society wants chemicals that are safe, but which provide advantages. Paul related the story of a hair shampoo manufacturer who had found that if the anti-dandruff element of the formulation was to be replaced by a substitution, it would probably end the business of the manufacturer. So, there are hazards ahead. REACH requires that chemicals be authorised as a risk management process, and this authorisation provides a regularity context for substitution. Risk is the likely hood that the hazard will cause harm. Substitution should be based on actual risk ands not intrinsic hazard, and substitution should be goal orientated and no prescriptive. Substitution is not mandatory if the risk can be controlled. If substitution is based on hazard it may not contribute to safety because 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 substitute may not be fit for purpose. Indeed, innovation could be impacted due to a loss of chemical diversity.

The need to have the right data for the substitution of chemicals is critical. Many other factors come into play, such as increased energy use, or may generate more waste, balance between safety and sustainability. Under REACH socio-economic benefits have to be in place, and the final substitution decision will be a value judgement on the balance of risk and benefit made by the ECHA on behalf of society.

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

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

Registration for components of 2 per centw/w or more is specified, so the registration for the EU polymer producer is most costly at the 100t an above level. It is likely that suppliers will register polymer components at those tonnage levels. Speciality polymers may suffer less ingredient selection. Certain classes of polymers are not considered low risk; they are water-absorbing, high- molecular weight insoluble, cationic, polyflourinated; unstable or degradable; and contain reactive functionality. Point 16 of the internet consultative document covered the possibility of polymers being dangerous. Herbert painted a positive minefield of caveats and maybes linked to polymers and REACH, and there appeared to be very little by way of a set or rules and regulations that could be followed, which begs the question about polymer registration being a black and white matter. Lots to do yet in this area, 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 he was in good form, and spoke from the experience of a manufacturer who would like to be compliant, but is unable to understand the rules. He had a lot of questions, but none too many answers. What they call intermediates are not intermediates as specified by REACH. Some of them might be monomers, which would need to be registered. Unless his suppliers tell him what substances have been registered, he will not know what to use as a substitute. There was some valiant sparring with the unknown here. Raw materials will disappear; all raw materials will increase in cost. There will be a significant increase in the administrative burden on them, and their suppliers, and their customers. The industry bodies have to take the initiative, alone if necessary, to resolve an unsatisfactory situation.

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

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

There will be a loss of IP, a loss of sensitive information, a loss of time which could be spent being creative, being innovative. There will be the disappearance of safe substances from the market; the cost of testing and registration maybe too much for some low tonnage speciality companies, which will 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 the same way as manufacturers.

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

Of course, the solution to this problem is to just ship it in from Taiwan, or China, as a finished paper without any of the REACH costs. It is not just the implications for a PVC cable manufacturer that are deeply worrying – it is the 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 be increased costs, there will be increased administration, there will be increased communications. There will be a lot of extra work. There are, amongst distributors, people who blend chemicals, and these are classified as “downstream users” as long as the source is European. We have 11 years in which to complete registration (June 2018) if you are a company who manufacture between 1 and 10t per annum, six and a half years for 100t, but only three years if you manufacture more than 1,000t.

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

Keith Huckle from Dow Corning S.A in Belgium talked about the importance of dialogue in the supply chain. You need to get to grips with the facts that 30,000 chemical substances have to be registered over a staged timeline of 11 years; there are 800 pages of the Test Procedures, and 1,500 pages of the RIP Procedures. Information is required from both upstream and downstream in the supply chain, and his experience so far is that many people think it does not apply to them. It does.

Getting to grips with REACH starts with data – what do I require? Who has it? What about the quality of the data? There needs to be an Exposure Use Matrix, which covers the human and environmental aspects of hazardous substance management. The essential need for complete exchange of information was stressed, not of course, always possible but it must be done.

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

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

Concerning raw materials from outside the EU, the manufacturers generally have said that they would pre-register, as the European market is important for them. Can the importer pre-register all materials which are imported? Yes, but its expensive for the importer, and it would be good to be supported by the supplier.

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

R is for Registration – which means that a manufacturer, or importer, has to submit a Registration Dossier to the European Chemical Agency for 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 the completeness of the dossier and assigns a registration number. The ECA then checks the proposal for further tests of all substances over 100 metric tonnes p.a., with random sampling for smaller quantities.

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

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

Concerning costs he provided a useful chart showing the cost assessment for registration (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 the smaller 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 explained what a downstream user is, and what they should be doing. Start with an inventory of chemicals that are used, and inventory of substances, where do you use it, how do you use it, why do you use it, is your use confidential, what controls do you apply, and how much do you use per annum. Substances that will apply from 2010. Who supplies it to you? Look at your supply chain. Getting a substitution for toxic substances is always a good move. Article 36 requires you to maintain data, as a producer of article. He mentioned the words foreseeable release, which is where a chemical may be released deliberately, (as in a printer cartridge, or an ink-jet printer), then Article 7 applies. But, you can do nothing until it is applied, so it is best to start gathering data now, and otherwise you will find that your use has not been registered and your product can no longer go to market. Which raises a question for the PCB manufacturer, in that as a printed circuit board is an paper, and foreseeable releases would be confined to metals, more than chemicals, would they not? Questions here to be asked.

Dr Paul Wilkes is the Head of Regulatory Affairs for The Body Shop, who sell their own brand goods through own brand stores. Part of L'Oreal, they don not develop and manufacture themselves, they go to contractors who manufacture them for them. So, his view of REACH is one of a responsible retailer – supply chain mapping was undertaken, covering all chemicals and materials, deciding which ones are covered by legislation, looking at paper – definitions and what constitutes “release” of a chemical; looking at substances of very high concern, and looking at information exchange, the information that must be provided to consumers.

The Body Shop, understandably, are very keen to have control of chemicals in order to refute scare stories. REACH will ensure better flow of information up and down supply chain, and therefore to customers. Some of their products are made in China, some in the USA, and concerns include the possibility that a large number of raw materials maybe lost because the necessary studies will not be supported. Dr Wilkes said that trade associations can help to save duplication of effort by individual companies, and they should take a pro-active role here to assist their smaller members, and they should be in a position to be helpful with Reach Implementation Projects.

Obtaining information about imported products is difficult. Should we be surprised?

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

REACH will create €between 1.9 and 3.2 billion costs to industry, and between €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 it minimum or maximum, here it can vary from 1 to 10t/a at e2,000 for minimum testing, to e287,000 for maximum testing where production is greater than 1,000t per annum.

Forming consortia can reduce costs significantly, here SIEFs and downstream user consortia can control their own exposure exercise. As an example, five companies' 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 all their 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 consortium management. RCC Ltd offer testing and regulatory services, and are well- placed to assist companies with REACH. There are several impact factors, he said. The non-availability of IT tools for REACH does not help much, but running a consortium needs management, scientific, legal, and economic expertise. Legal being IP protection; economic includes budget management, cost reduction strategy, the value of data and allocation of income, this is income from people paying for the data. RCC can of course, do the whole thing, if you would like them to.

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

Dr Derek Knight is Director of Regulatory Affairs at SafePharm Laboratories Ltd in the UK. Dr Knight believed that the registration of new chemicals will have an advantage. It means that there will be a systematic review system for old chemicals, so REACH maybe seen as a review programme; here, it is the highest volume (in tonnes) of chemicals that indicate the highest risk. The ECA will 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 chemicals concerned, so the ECA will have to accept dossiers, where the risk assessment is defined by the company. Whilst Annex XI asks us to adopt an intelligent approach to animal testing, it is inevitable that there will be some.

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

Matthew Curl is from TSG Europe, and looked at the technical issues related to consortia building. Working together may not be problem, pre- registration is needed only for the substance, for which you need a chemical name and an European 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. Matthew explored some of the variables that arise once you go down this path, the quality of existing data. Collecting end-points and generating new data were covered, as was harmonised risk assessment.

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

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

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

Opportunities for deep innovation were presented by the cheerfully optimistic Richard 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 could consider reformulating the product, redesigning the product, finding new ways to deliver the function, and one could redesign the system altogether. The latter would be better. He cited the example of it taking nine man years of research to change one ingredient in aircraft paint. Another example of finding new ways to deliver the function was at Ford, where the cooling liquid for metal working was changed over to a renewable vegetable oil-based product, and they cut effluent by 2 million litres per annum.

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

Summing up, Professor Martin Goosey of the IeMRC thanked all the speakers for bringing the delegates in the real, harsh world of REACH, during the two days a vast amount of information and knowledge had been imparted, for those already down the REACH path this would have been invaluable; for those who have to take their first steps, the word terrifying is applicable. Professor. Goosey and RAPRA are to be congratulated on this first REACH Conference, of which more are planned this year including one in the USA early 2008.

J.H. LingAssociate Editor