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  • Contents

  • Paper 01 - NO DATA, NO MARKET – WHAT DOES IT MEAN IN PRACTICE FOR TRADE?

  • Paper 02 - REACH & IMPORTATION INTO THE EU: MAKING THE BEST OF A ROUGH PLAYING FIELD

  • Paper 03 - CONSORTIA – SHOULD I JOIN THEM?

  • Paper 04 - FOIBLES AND FRUSTRATIONS WITH THE ECHA USE DESCRIPTOR SYSTEM: ONE DOWNSTREAM USER’S EXPERIENCE

  • Paper 05 - EXPERIENCES IN A SIEF

  • Paper 06 - 2013 - THE NEXT DEADLINE

  • Paper 07 - MINIMAL ESSENTIAL SOLUTIONS TO EFFECTIVELY OPERATIONALIZE REACH

  • Paper 08 - ONLY REPRESENTATIVE ROLE – GATEWAY OR NECESSARY EVIL?

  • Paper 09 - GENERIC EXPOSURE SCENARIOS FOR ADHESIVES AND SEALANTS HOW TO USE THE “USER DESCRIPTORS” TO SIMPLIFY THE COMMUNICATION IN THE SUPPLY CHAIN

  • Paper 10 - CASE STUDY – FULFILLING TESTING REQUIREMENTS FOR A CONSORTIUM

  • Paper 11 - REACH AND TSCA REFORM

  • Paper 12 - CHEMICALS MANAGEMENT REFORM

  • Paper 13 - 2010 – Chicago, USA Page 1 of 16 pages Paper 13

  • Paper 14 - A NEW PATH FORWARD: A COLLABORATIVE PATH TO PRODUCT STEWARDSHIP

  • Paper 15 - GLOBALLY HARMONISED SYSTEM (GHS): THE CHANGING LANDSCAPE OF CHEMICAL CLASSIFICATION

  • Paper 16 - A MODEL FOR THE IDENTIFICATION OF SUBSTANCES OF VERY HIGH CONCERN

  • Paper 17 - HAZARDOUS CHEMICALS ARE FOR LIFE, NOT JUST FOR CHRISTMAS!

  • Paper 18 - ROGERS' JOURNEY TO COMPLY WITH REACH REQUIREMENTS

  • Paper 19 - MANAGING REACH REGULATORY COMPLIANCE AND CONSUMER CONCERNS ACROSS THE ATLANTIC

  • Paper 20 - THE GLOBAL AUTOMOTIVE INDUSTRY’S RESPONSE TO REACH: ADDRESSING THE DATA MANAGEMENT PROBLEM FOR SUBSTANCES OF VERY HIGH CONCERN (SVHCs)

  • Paper 21 - CHEMICAL MANAGEMENT SERVICES – AN ENABLER OF REACH

  • CSC Ad for last page

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iSmithers, working alongside Smithers Rapra and still part of the Smithers group, has expanded its service offering to cover other business areas and industries harnessing the expertise of the iSmithers management team and the knowledge from other companies within the group REACH USA 2010 Smithers Rapra has provided a world leading portfolio of Rubber, Plastic and other Polymer Information products and services for 85 years To improve the delivery and range of products a new business was formed in July 2008 called iSmithers Please visit our webside for more information: www.polymerconferences.com 8th International Conference on the Registration, Evaluation and Authorisation of Ch Chemicals and its Impact on US Trade 13-14 April 2010, Chicago Conference Proceedings Conference Proceedings Bronze Sponsor: iSmithers ©iSmithers 2010 ISBN 978 84735 492 Organised by: Organised by Event sponsored by: Chicago, USA 13-14 April 2010 ISBN: 978-1-84735-492-1 © Smithers Rapra Technology Ltd, 2010 All rights reserved No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form by any means, electronic, mechanical, photocopying, recording or otherwise, without prior written permission of the publisher, Smithers Rapra Technology Ltd, Shawbury, Shrewsbury, Shropshire, SY4 4NR, UK The views expressed in this publication are those of the individual authors and not necessarily correspond to those of Smithers Rapra Technology Ltd This publication is published on the basis that no responsibility or liability of any nature shall attach to Smithers Rapra Technology Ltd arising out of or in connection with any utilization in any form any material contained in this publication Contents SESSION 1: NO DATA, NO MARKET Paper No data, no market – what does it mean in practice for trade? Peter van der Zandt, The European Commission, Belgium +++ paper unavailable+++ Paper REACH and importation into the EU: Making the best of a rough playing field Brian Watt, Vice President Strategic Planning & Regulatory Affairs, Innospec Inc, UK Paper Consortia – should I join them? Dr Allan Jemi-Alade, Global Manager HS&E, Afton Chemical, USA SESSION 2: IMPLEMENTATION Paper Foibles and frustrations with the ECHA Use Descriptor System: One downstream user’s experience Barry Clayton, Industrial Hygiene Manager, Reichhold, USA Paper Experiences in a SIEF Ton van der Kaaij, Co-ordinator Safety, Health, Environmental & Quality REACh Specialist & Henry van Amsterdam, Quaker Chemical BV, The Netherlands +++paper unavailable+++ Paper 2013: The next deadline Dr Steffen Erler, Global Technical Director, Smithers REACH Services, UK Paper Minimal essential solutions to effectively operationalize REACH Walter Creech, CSC, USA SESSION 3: COMPLIANCE STRATEGIES Paper Only Representative: Gateway or necessary evil? Kevin Hoban, H2 Compliance, Ireland Paper Generic exposure scenarios for adhesives and sealants How to use the “user descriptors” to simplify the communication in the supply chain Dr Hermann Onusseit, Technical Director, Henkel AG & Co KGaA & The Association of European Adhesives & Sealants Manufacturers (FEICA), Germany Paper 10 Case study – fulfilling testing requirements for a consortium Jonathan Dale, Regulatory Affairs Specialist, Exponent International Ltd, UK SESSION 4: NORTH AMERICAN CHEMICALS POLICY Paper 11 REACH and TSCA reform Jim Willis, Director Chemical Control Division, Environmental Protection Agency, USA Paper 12 Chemicals management reform Dr Roger McFadden, VP, Senior Scientist, Staples, USA +++ paper unavailable +++ Paper 13 The Canadian Chemicals Management Plan Gordon Lloyd, Vice-President, Technical Affairs, Chemistry Industry Association of Canada (CIAC), Canada Paper 14 A new path forward: A collaborative path to product stewardship Greg Bond, Corporate Director of Product Responsibility, The Dow Chemical Company, USA SESSION 5: HAZARDOUS CHEMICALS Paper 15 Globally Harmonised System (GHS): the changing landscape of chemical classification Jytte Syska, President, Ariel Operations & Managing Director, 3E Company Europe ApS, Denmark Paper 16 The SIN list: model for the identification of Substances of Very High Concern Nardono Nimpuno, Senior Policy Advisor & Jerker Lighart, Project Coordinator, International Chemical Secretariat, Sweden Paper 17 Hazardous chemicals are for life, not just for Christmas! Paul Ashford, Caleb Management Services Ltd, UK SESSION 6: ENSURING PRODUCT SAFETY Paper 18 Rogers' journey to comply with REACH requirements Anita Jain, Director Environmental, Health & Safety Engineering, Rogers Corporation, USA +++paper unavailable +++ Paper 19 Managing REACH regulatory compliance and consumer concerns across the Atlantic Dr Mathias Rietzel-Röhrdanz, Senior Director Regulatory Affairs, Johnson & Johnson GmbH, Germany Paper 20 The global automotive industry’s response to REACH: addressing the data management problem for Substances of Very High Concern (SVHCs) Arnold J Guikema, REACH Program Manager for the North American Automotive Industry, Automotive Industry Action Group, USA & Bing Xu, Ford Motor Co, USA Paper 21 Chemical Management Services – an enabler of REACH Hal Ehrhardt, Senior Manager - Energy & Environmental Programs, Lockheed Martin, USA +++ paper unavailable +++ REACH USA 2010 13-14 April 2010 – Chicago, USA NO DATA, NO MARKET – WHAT DOES IT MEAN IN PRACTICE FOR TRADE? Peter van der Zandt, Policy coordinator European Commission, DG Environment, Chemicals & Nanomaterials Unit Brussels, Belgium Contact: Peter.VAN-DER-ZANDT@ec.europa.eu BIOGRAPHICAL NOTE Peter van der Zandt is a biologist specialised in toxicology He started his working life in 1989 at the Ministry of the Environment in the Netherlands where he was a senior policy officer In 1997 he joined the National Institute for Public Health and the Environment (better known as RIVM) where he was head of the Chemicals Unit Since 2004, he is working at the European Commission in DG Environment, where he is REACH implementation coordinator and is involved in policy development (including nanomaterials) ABSTRACT Substances on their own, in mixtures or in articles manufactured or placed on the market in the EU have to be registered under REACH This presentation will provide an overview of registration under REACH and addresses what substances should be registered, who has to register, what are the registration requirements, the requirements for substances in articles and relevant tools and guidance +++ Paper unavailable at time of print +++ Page of pages Paper 13-14 April 2010 – Chicago, USA Paper REACH USA 2010 Page of pages REACH USA 2010 13-14 April 2010 – Chicago, USA REACH & IMPORTATION INTO THE EU: MAKING THE BEST OF A ROUGH PLAYING FIELD Brian Watt, Vice president Strategic Planning & Regulatory Affairs, Innospec Inc Innospec Manufacturing Park, Oil Sites Road, Ellesmere Port, Cheshire, UK Tel: +44 (0)151 356 6241 Fax: +44 (0)151 356 6106 email: brian.watt@innospecinc.com BIOGRAPHICAL NOTE Brian Watt - Innospec Inc is a specialty chemical company with interests in personal care ingredients, fragrances and fuel additives Brian Watt is Vice President for a portfolio of activity covering Safety, Health, Environment, Regulatory Affairs, Strategic Planning and Risk Management In this, he has responsibility for the companies REACH compliance Brian has been involved with REACH for five years, including leading the REACH Consortium for the Petroleum Additive companies between 2007 and 2009 He has been with in the specialty chemical industry for almost 30 years, previously having worked with Shell, ICI, Zeneca and Avecia, prior to joining Innospec ABSTRACT When many of us first got involved with REACH, we had a naïve view that this was EU legislation that would largely impact EU companies Little did we know that, years later, REACH would appear relatively straightforward from a European perspective, and yet horribly complex when viewed by any non-EU company exporting to the EU And the issue is equally applicable to US companies exporting to customers in the EU, and multinationals, moving product between their own daughter companies Perhaps, most complex of all is the situation where a US downstream user exports a formulated product to the EU This paper will review the roles and legal responsibilities of the various actors in the supply chain, and explores pragmatic methodologies for assuring that the Only Representative is able to facilitate the trading of his overseas company, which remaining compliant to the satisfaction of 27 member state competent authorities When I first became involved in REACH, some six years ago, there were a number of things that struck me First, the number of people who said ‘if you are involved with REACH, you’ll have a job for life’ Well, it didn’t take me long to realise that if you are involved with REACH you need to get a life…… Secondly, I went through the same early emotions about REACH as I think most people the first time they read it – what I call the “John McEnroe” reaction, or something akin to “you cannot be serious”…… And a few months later, when I got a real understanding of what was involved, my third thought was – “I can see how this works inside Europe, but how on earth does this work for imported substances, or perhaps more pointedly, imported preparations.” And, since that day, this particular issue has exercised the minds of myself and my colleagues, perhaps more than any other REACH issue At this point, I’d like to acknowledge my “sparring partners” who have helped in all this thinking over those years – and I refer to the Petroleum Additive manufacturers in Europe Without that team effort, we would never have got this far So, if you are a US chemical manufacturer, or perhaps a formulator, what options you have to export your products to the EU ? Page of pages Paper 13-14 April 2010 – Chicago, USA REACH USA 2010 Remember in everything I’m going to say – the first line of enforcement in the EU will be with the importers They are the people with the legal obligation, and they are the people who will suffer if they are out of compliance So, I hear you say, what’s all the fuss – if the legal liability lies with the importer, let’s just leave them to get on with it Well, one of the features of REACH is that cost and control go together Just remember that, when you leave it to the importers, they effectively hold the licence – they can buy from anyone they like (as long as the product is the same specification), but you can only sell to importers who have registered So the power and control from here on in will lie with the importers One of the things which have fascinated me about REACH is how many companies have left the implementation of REACH to the regulatory department, without perhaps realising the long-term strategic implications of some of these decisions Walking away may look attractive in the short-term, but it might be a costly decision in the long run So, let’s assume that you have decided that you want some control over your own destiny in the future, and therefore, as a US company, you want to be involved with your own registration Well, the bad news is that its not that simple REACH applies only to European companies (legal entities), and therefore, non-EU manufacturers cannot directly participate This was recognised quite late in the legislative process, so the concept of an Only Representative was developed.Never before in the field of chemical regulation have two words spelt out some much confusion, dread and sheer panic, in some many people ! In short, the Only Representative is a European company who can act on behalf of a non-EU manufacturer and register for REACH, and assume their legal responsibilities Sounds straightforward, but it is anything but First, you need to find an Only Representative – if you work for a multi-national you may be in luck, as the most obvious route is to use one of your own European companies to this If not, then you will have to find someone, and pay them Now, you can’t just use anyone This is rather more than just a job of administration They need to be ; European, any one of the 27 member states will Competent – they need to understand REACH, its legal requirements, and indeed, it is desirable if they have some understanding of toxicological and ecotoxicological testing – there is a lot of money at stake Financially solvent – they will be paying all the costs Remember, some high volume substances may run into millions in costs Reliable – after all, this is their registration, not yours Trustworthy – they could well be handling very confidential business information No Conflict of Interest – could you share an Only Representative with your Competitors? Remember, they can act for as many non-EU companies as they like, as long as they hold a separate registration for each one And with an apology to some of those Only Representatives present – caveat emptor – buyer beware ! There are many consultancies out there who are not adding a lot of value, and quite frankly being a damned nuisance and getting in everyone’s way So, once you’ve got your Only Representative, then they will act for you in the process, so that you can be just like an EU manufacturer – well, not quite, and this is where the rather unlevel playing field comes in Within the EU, all a manufacturer need to satisfy the enforcers is to produce a REACH registration number In the case of a preparation / formulation, they may have to produce several, and the formulation recipe, to prove compliance But that really shouldn’t be that difficult But if you are an Only Representative, working on behalf of a non-EU manufacturer, then you have more to You have data to collect and records to keep You are legally obliged to hold records of every importer that is taking the substance into the EU, and the volumes And although this doesn’t sound like a major Paper Page of pages REACH USA 2010 13-14 April 2010 – Chicago, USA issue, you need to consider that the identity of the importers, and the volumes they buy from you may well be confidential business information, which importers may not want to share with their non-EU supplier Not only that, but so far we have only considered the rather straightforward case of substances – and so much of the chemical industry is based around preparations (formulations) rather than substances So, in this data collection exercise, someone, somewhere needs to be able to break the formulation down into its constituent substances, and account for the registration status of each and every one And, this is almost always confidential business information I have heard REACH described in many ways – in one extreme case, I heard a lawyer claim that its was anti-competitive, a restraint of trade, and even a highly-effective trade barrier! Well, I wouldn’t go as far as to claim any of these things, but there is no doubt that the playing field is not entirely level – the process for imported products is undoubtedly more complex than that for an EU manufacturer So, how is the Only Representative process going to work? Well, the easy part is the substance registration In essence, the Only Representative has the same role as an Importer or a Manufacturer He or she must participate in the SIEF, help assemble the registration dossier, and submit his or her own registration And two other factors we must not forget, the OR needs to pay for all of this, and may being doing this several times over on behalf of several non-EU manufacturers Just as a reminder, an Only Representative can act on behalf of as many non-EU manufacturers as he likes, but he must have a discrete separate registration for each one There is, of course, the question of whether the costs are paid by the OR, or by the non-EU manufacturer Well, that’s entirely up to you, and the agreement you have with your OR – but beware, as the non-EU manufacturer, you might well pick up the costs, but the registration will always be in the name and the control of the OR – remember what I said about trust earlier? So, this is where the competence factors of the OR come in If they are going to interact with the SIEF, and agree costs and testing strategies, they must have some idea of what they are talking about Of course, this isn’t essential if the rest of the SIEF is made up of knowledgeable multinationals, but then will you ever know that the costs (which may be very substantial) are fair and reasonable or not? But, let’s assume for a moment that this part is done, and that the registration is in place, and that we are now actually moving product from the USA to the EU As I stand here, I am still really struggling with this I felt this should be something of a ‘literature review’ – a scan of all the current operating and available ways of managing this situation And yet, although I will stand to be corrected, I can only find two models which have been developed One has been developed by the Petroleum Additive Manufacturers, who are a very small part of the chemical industry, whilst the other has been developed by the mighty BASF, in conjunction with a third party service provider called ChemService I understand that ChemService have had some enquiries from others, but the chemical industry is vast – so what is everyone else doing ? So, I have a question for the audience – What is everyone doing? Right now Today This is a legal requirement right now, has been since the end of 2008 If you haven’t had an enforcement authority ask the question of one of your importers, then you’ve just been lucky – and if you don’t take immediate action, then, at best you’ll get cargoes stopped at customs, and, at worst, you’ll find your importers will face legal action I’d like to just give you an outline of the two models which are in action (and I’d like to thank BASF for permission to reference their process) Before I start, let me emphasis that I’m not here to push one system over another Personally, I think both of these systems work, both have their own strengths and weaknesses I’m not advising you to use one or either of these I am advising you to Do Something Now! There are common features of both systems – they are designed to work with the law, to provide the relevant information, to maintain confidentialty of business information, and to keep costs and administration to a minimum The ATC ‘DRC’ System – the heart of both this and the BASF CODE system is a certification process – a document which can be passed from supplier to customer This is the DRC – The Declaration of REACH Conformity - which broadly says – ‘the substances in this product are conform to REACH, and if you are ever Page of pages Paper REACH USA 2010 13-14 April 2010 – Chicago, USA electronics manufacturers request data from suppliers on an ad-hoc basis, using fairly standardized data exchange formats and substance lists and importing the data into their own proprietary software Some firms supplement this dataset with the third-party libraries of electronic component substance information; others rely on internally available design information to fill in the gaps One of the challenges this sector faces is the large number of components supplied from foreign manufacturers in regions where accurate substance information is much more difficult to obtain This may be one of the reasons that the industry has relied more heavily on internal data and on external libraries of materials information for commodity components AEROSPACE The aerospace industry has some supply chain overlap with the automotive sector and the part complexity is comparable to that of automotive The concept of widespread substance disclosures is quite new to aerospace, although many companies have already had to address elimination of hexavalent chromium and other corrosion preventive coatings European aerospace groups have developed a Priority Declarable Substance List (PDSL) TR-9536; a substance declaration form for data exchange TR-9535, and made movement toward a common reporting database which was piloted in 2009 These developed tools have been seeing more widespread use in the EU than in the US so far Limited trainings have been conducted for several hundred suppliers, but these trainings have been more focused on general REACH awareness than on the mechanics of any particular reporting processes or tools In summary, aerospace groups (at least in Europe) have actually created all the elements of a common approach but have not put them to significant use on a global level It remains to be seen whether aerospace will further develop these tools and processes or whether they will remain largely underutilized This may hinge on the IT approaches taken by global aerospace firms If investments are made in internal systems there may be pressures to ensure that any common approaches conform to the integration needs of the internal systems As many aerospace companies have not decided upon an internal IT approach yet, it is not clear which approaches will suit their needs APPAREL AND FOOTWEAR The apparel industry has a commonly-used Restricted Substance List (RSL) and generally requires full disclosure of all suppliers for substances on that list SVHC information is fully integrated into the apparel sector’s RSL list and most companies in the industry currently require SVHC disclosure currently as a condition of selling product There are also some common reporting formats used on a voluntary basis by some segments of the industry Part complexity is not high for most items of apparel and this simplifies the task of data collection Rather than tens of thousands of purchased items in an article, there may be less than fifty in many items of apparel, even considering buttons, zippers, rivets, labels, yarns, etc This lack of complexity probably reduces the drive for developing the robust software applications needed to organize the multiplicity of part and supplier information needed for tracking SVHCs in industries like automotive is doing However there is a great deal of complexity in the sheer number of unique end products (articles) sold One of the drivers for this complexity is the rapid part turnover due to changing of dyes and patterns in response to seasonal market conditions The industry has often shown a reliance on laboratory testing for substances of concern in addition to, or in place of, supplier disclosures One of the reasons for this reliance on testing is the lack of reliability of substance data typically provided by suppliers from certain regions of the world where the data quality is often suspect Laboratory testing is also often used to corroborate supplier data since the products are designed for use for extended periods of time in proximity to the human body and therefore the need to be certain about identifying SVHCs is very high COSMETICS/FRAGRANCES/TOILETRIES Cosmetics and toiletries are in contact with the human body, and thus face similar challenges to those of apparel and furniture Laboratory testing is common; well-known lists of substances of concern exist which encompass the current list of SVHCs, and suppliers are aware of their obligations to report and eliminate Page of 12 pages Paper 20 13-14 April 2010 – Chicago, USA REACH USA 2010 hazardous substances Fairly simple supply chains mean there is limited need for standardized data exchange mechanisms or software applications FURINITURE The Business and Institutional Furniture Manufacturers Association (BIFMA) has a Chemicals of Concern list (Annex B of the BIFMA E-3 Standard) These chemicals of concern are selected on the same criteria as the REACH SVHCs (carcinogens; mutagens; reproductive toxins; persistent, bioaccumulative and toxic; and endocrine disruptors) Best practices have been established for reporting these chemicals but companies tend to use their own software and data exchange formats and deal directly with their own suppliers on an ad-hoc basis rather than rolling out requirements to the supply chain in a coordinated fashion As in the apparel and cosmetics sectors, laboratory testing of materials is fairly common; partly due to the fact that the products are designed to be used in close proximity to the human body for extended periods of time, and partly due to the fact that the most common route for exposure would be via emissions PHARMACEUTICALS/MEDICAL DEVICES Medical device and pharmaceuticals manufacturers evidence a lack of coordination on common tools and processes for SVHC communication, perhaps due to high proprietary interests, contractual obligations and trade secret concerns There are also factors that lend to a lower compliance risk in the sector, e.g various exemptions for medicinal products and the low number of products that would be considered articles The primary concerns for SVHCs in articles may actually be due to the potential for SVHCs in packaging rather than in the products themselves A few medical device manufacturers have evaluated their products and concluded that it would not be worthwhile to purchase or develop any software even within their own organizations to track SVHCs Those with complex electronic components in their products with more complex Bills of Materials are the ones most likely to develop an SVHC database For other companies in the sector, the task can be manageable using spreadsheets or other simple applications since the amount of parts data and supplier data is low GENERAL RETAIL/CONSUMER PRODUCTS The diverse array of consumer products sold at retail is so vast that there is little opportunity to have focused collaboration across the sector Major retailers such as Wal-Mart are developing their own reporting tools and providing trainings for suppliers to use them Companies like Wal-Mart with 100,000 suppliers have enough economies of scale within their own supply chains to drive the adaptation of best practices, standardize tools and processes within the industry without the need to draw on external organizations to achieve efficiencies of scale RAW MATERIALS AND CHEMICALS SUPPLIERS There is a high level of common development of tools, processes and supplier support mechanisms in organizations like CEFIC (Conseil Européen de l’Industrie Chimique) and CONCAWE (Conservation of Clean Air and Water in Europe) which represent members with large registration requirements under REACH However these industries fundamentally differ from automotive by having a much simpler supply chain Industries that are predominantly manufacturers and importers of substances and preparations have low data management requirements for tracking SVHCs in articles since the number of products that would be considered articles is low Tracking SVHCs in preparations or in very simple articles is far less data intensive than tracking them in complex assemblies such as automobiles, airplanes or computers Packaging, however is still a concern in this industry, especially when the packaging may contain recycled content of unknown origin Paper 20 Page of 12 pages REACH USA 2010 13-14 April 2010 – Chicago, USA Figure Four summarizes the above discussion for each industry sector and indicates the extent to which the sector has developed common tools and processes for SVHC communications Some of this information is too complex to be simply rendered in this format, so a category of “TBD- To Be Determined” is used for ambiguous areas For example, a common approach may have been developed but is not being widely used; an approach may be in the works but not complete, or there may be controversy within the industry as to how far to take a common approach These and other complex scenarios are rendered as “TBD” in Figure Four Substance database Declarable substance list SVHC reporting practices guidance Supplier support systems (trainings, workshops, etc) Electronics Aerospace Apparel/Footwear Cosmetics/Fragrances/Toiletries Furniture Pharmaceuticals/Medical Devices General Retail/Consumer Products Raw Materials/Chemicals Suppliers Data exchange format best Figure Four –Industry-wide common approaches to SVHC reporting Yes Yes No No No No No No No TBD No No No No No No Yes Yes Yes Yes Yes No No TBD Yes Yes Yes No No No No TBD No No Yes No No No No Yes ASSESSING YOUR ORGANIZATION’S NEEDS Given the current global regulatory landscape in general and the REACH SVHC requirements in particular, there are several steps that companies should take in order to plan SVHC compliance strategy This planning can take place in the context of an industry organization but ultimately each company must decide what its long-term goals are with respect to SVHC compliance The first recommendation is to conduct an internal assessment on what approaches will best suit your company’s goals Some of this will be influenced by conditions within your industry sector (see previous section); some of it will depend on strictly internal factors, i.e how does your company value cost control via collaboration versus maintaining internal control of compliance processes The task of collecting, compiling and managing SVHC data can be organized around an industry-sector collaborative approach or it can be managed completely internally But these are not the only options to consider For example, if the task is to be conducted entirely internally, there is still the question of how to structure this internal effort Should there be a centralized corporate-wide software application and centralized supplier management effort or should each business area (e.g division/profit center) use its own software, manage its own suppliers, track its own metrics and be ultimately responsible for its own compliance? How about a mixed approach - are there some elements that should be centralized and others that should be delegated to the respective business areas? Page of 12 pages Paper 20 13-14 April 2010 – Chicago, USA REACH USA 2010 Should costs be evenly spread across overhead or allocated on a direct cost basis to support individual programs? What about delegation of responsibility all the way down to the program/product line level? Each of the program managers or directors can bear responsibility for SVHC compliance within their areas of accountability What functional areas need to be involved in decision-making and assigned responsibilities: legal, engineering, sales, environmental, IT, purchasing, design, manufacturing, etc? In other words, before you determine how much collaboration you are open to with your peer organizations, you will have to determine how much collaboration you can achieve within your own organization It can even conceivably be more difficult to share resources across internal profit centers than to share them with external organizations Most industry groups however are at least going to benefit from some discussion and sharing of best practices, even if development of common approaches is not feasible Or perhaps there is opportunity for better economies of scale if collaboration is conducted at an even higher level than the industry-sector level For example, what about cross-industry-sector collaboration on substance reporting tools and processes? While this would require significant consensus-building efforts, various governmental entities have had discussions about funding tools at the national level as a competitive advantage for domestic exporters A final consideration is how to manage your supply chain Most of the SVHC data you generate will probably come from your suppliers and will only be as accurate as the data they supply to you Indeed your whole approach may need to be designed to facilitate the supply chain’s ability to get data to you quickly and accurately Selection of a software approach must take the supply chain into consideration If data is difficult to collect, import and manage; or if the software is cumbersome or confusing supplier compliance may be difficult to achieve Some training may be necessary, both on the requirements and on the mechanics of reporting the information Will your organization provide it or will it require suppliers to obtain their own expertise? How will you enforce compliance? Will it be incorporated into standard terms and conditions or written into specific scopes of work for specific suppliers? What are the consequences if a supplier fails to comply? Figure Five summarizes the key criteria for determining your own company’s SVHC communication strategy Figure Five – Key Criteria for SVHC Communication Strategy Development     Software Strategy o Common cross-industry platform o Common industry group approach o Centralized corporate system o Division/business are level system(s) o Each product/program uses its own tools Substance Lists o Adopt standard industry list o Develop corporate substance-of-concern list o Allow each business area or program to determine its own list o Ask only for SVHC information and repeat requests when new SVHCs are listed by the EU Internal functional areas to be tasked with responsibilities/accountabilities o Legal o IT o Purchasing o Engineering o Design o Manufacturing o Sales o Import/export o Environmental Supplier management o How to enforce SVHC reporting (terms and conditions, scopes of work) o How to provide training and instructions on requirements and systems o How to ensure data quality o How to ensure timely reporting o How to manage re-design for removal of newly banned substances Paper 20 Page 10 of 12 pages REACH USA 2010 13-14 April 2010 – Chicago, USA CONCLUSION The automotive industry has leveraged its IMDS-GADSL substance-of-concern reporting process and system to address the SVHC communication requirements mandated in Article 33 of REACH The utilization of this existing system has afforded a cost avoidance of several billions of dollars for the industry versus building an ad-hoc reporting process for SVHC reporting Other industry sectors can benefit by studying this example and drawing upon the lessons learned over the past ten years Each company will need to decide what level of collaboration within the industry is appropriate for its own compliance needs; but prior to making that analysis companies will need to determine how they will manage the process internally and then align their overall industry strategy with that approach One of the key questions for all companies will be how they manage their supply chains and how well their chosen SVHC data management approach integrates with their suppliers’ capabilities All these factors point to the fact that compliance with REACH’s SVHC requirements is not possible to achieve without substantial engagement with suppliers, customers, and in some cases – even with competitors Page 11 of 12 pages Paper 20 13-14 April 2010 – Chicago, USA Paper 20 REACH USA 2010 Page 12 of 12 pages REACH USA 2010 13-14 April 2010 – Chicago, USA CHEMICAL MANAGEMENT SERVICES – AN ENABLER OF REACH Hal Ehrhardt, Senior Manager - Energy & Environmental Programs Lockheed Martin Corporate Energy, Environment, Safety & Health Located at Mail Drop 0574, 1801 State Route 17C, Owego, NY 13827, USA Tel: +1 607 751 2230 Fax: +1 607 751 4730 CELL: +607-761-5287 email: hal.ehrhardt@stny.rr.com BIOGRAPHICAL NOTE Hal Ehrhardt is currently the Senior Manager for Energy and Environment on Lockheed Martin’s corporate Energy, Environment, Safety and Health staff His responsibilities include expanding Chemical Management Services (CMS) across the corporation and utilizing CMS to enable ESH success in addition to achieving cost savings Hal has 30 years of environmental, chemical management and safety experience in both engineering and management roles with three companies in multiple locations, as well as at the corporate staff level As the ESH manager at Lockheed Martin’s Owego, NY facility he implemented CMS as the corporate pilot in 2005 and it is now in use at more than a dozen facilities in the country ABSTRACT Chemical Management Services (CMS) involves using a 3rd party provider to manage chemicals from initial identification and approval through procurement, receiving inspection, inventory management, delivery, usage and finally waste collection and disposal/recycle A Chemical Information Management System (CIMS) ties the entire process together and is the source of needed data and reports The CIMS provides the visibility to storage and use of chemicals that may be on any regulatory list (such as REACH SVHC's) Lockheed Martin has implemented CMS at more than a dozen manufacturing facilities of various sizes since 2005 This presentation will provide an overview of their CMS experience including:  CMS Overview  CMS Experience and Results at Lockheed Martin  Use of CMS to help assure compliance with REACH and other emerging chemical regulations Page of pages Paper 21 13-14 April 2010 – Chicago, USA REACH USA 2010 +++ paper unavailable at time of print +++ Paper 21 Page of pages           iSmithers, working alongside Smithers Rapra and still part of the Smithers group, has expanded its service offering to cover other business areas and industries harnessing the expertise of the iSmithers management team and the knowledge from other companies within the group REACH USA 2010 Smithers Rapra has provided a world leading portfolio of Rubber, Plastic and other Polymer Information products and services for 85 years To improve the delivery and range of products a new business was formed in July 2008 called iSmithers Please visit our webside for more information: www.polymerconferences.com 8th International Conference on the Registration, Evaluation and Authorisation of Ch Chemicals and its Impact on US Trade 13-14 April 2010, Chicago Conference Proceedings Conference Proceedings Bronze Sponsor: iSmithers ©iSmithers 2010 ISBN 978 84735 492 Organised by: ... of print +++ Page of pages Paper 13-14 April 2010 – Chicago, USA Paper REACH USA 2010 Page of pages REACH USA 2010 13-14 April 2010 – Chicago, USA REACH & IMPORTATION INTO THE EU: MAKING THE BEST... benefits involved Page of pages Paper 13-14 April 2010 – Chicago, USA Paper REACH USA 2010 Page of pages REACH USA 2010 13-14 April 2010 – Chicago, USA FOIBLES AND FRUSTRATIONS WITH THE ECHA USE... Declaration of REACH Conformity - which broadly says – ‘the substances in this product are conform to REACH, and if you are ever Page of pages Paper 13-14 April 2010 – Chicago, USA REACH USA 2010 challenged

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