Reach USA 2010 conference proceedings

Dr Allan Jemi-Alade, Global Manager HS&E, Afton Chemical, USA SESSION 2: IMPLEMENTATION Paper 4 Foibles and frustrations with the ECHA Use Descriptor System: One downstream user’s exp

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Organised by

Event sponsored by:

Chicago, USA

13-14 April 2010

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ISBN: 978-1-84735-492-1

© Smithers Rapra Technology Ltd, 2010

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 do 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

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Contents

SESSION 1: NO DATA, NO MARKET

Paper 1 No data, no market – what does it mean in practice for trade?

Peter van der Zandt, The European Commission, Belgium

Paper 2 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 3 Consortia – should I join them?

Dr Allan Jemi-Alade, Global Manager HS&E, Afton Chemical, USA

SESSION 2: IMPLEMENTATION

Paper 4 Foibles and frustrations with the ECHA Use Descriptor System: One downstream

user’s experience

Barry Clayton, Industrial Hygiene Manager, Reichhold, USA

Paper 5 Experiences in a SIEF

Ton van der Kaaij, Co-ordinator Safety, Health, Environmental & Quality REACh Specialist &

Henry van Amsterdam, Quaker Chemical BV, The Netherlands

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Paper 6 2013: The next deadline

Dr Steffen Erler, Global Technical Director, Smithers REACH Services, UK

Paper 7 Minimal essential solutions to effectively operationalize REACH

Walter Creech, CSC, USA

SESSION 3: COMPLIANCE STRATEGIES

Paper 8 Only Representative: Gateway or necessary evil?

Kevin Hoban, H2 Compliance, Ireland

Paper 9 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

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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

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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

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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

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Page 1 of 2 pages Paper 1

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

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Paper 1 Page 2 of 2 pages

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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

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

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 do 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 do you have to export your products to the EU ?

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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 do 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 ;

1 European, any one of the 27 member states will do

2 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

3 Financially solvent – they will be paying all the costs Remember, some high volume substances may run into millions in costs

4 Reliable – after all, this is their registration, not yours

5 Trustworthy – they could well be handling very confidential business information

6 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 do 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

do 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

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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

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challenged by an enforcement authority, then the details of the supplier (and the Only Representative) are also present, so they know who they can go talk to)

There is no set format to the DRC – we have developed a concept / template which each company has interpreted in their own way This example is from my own company, Innospec The key features are that it doesn’t list substances, it lists the product that a customer actually buys, and we warrant that all the substances in that product (or preparation) conform to REACH – either we have (pre) registered, or we have similar assurances from our suppliers

The concept for a simple substance to a single importer is easy The OR issues the DRC to the importer, and in return, the importer agrees to report his identity and his annual tonnage to the OR If there are issues

of confidential business information, this can be taken care of using independent Only Representatives, and suitable confidentiality agreements

There is no prescription in REACH as to how often this data needs to be collected – most companies are taking a view that an annual process is sufficient – so right now, we have the data being collected for 2009 Some companies are using manual or paper methods of collecting data, whereas others are using on-line portals and survey tools

Once the data is collected, the non-EU manufacturer can check that his volume bands are correct, and then the data can sit there, quietly in its graveyard, until such time (if ever) that someone in an enforcement agency wants to see it

In the case where the non-EU customer is a formulator, then our concept is that this customer can use our DRC, plus forms of assurance on any other substances they are formulating with, to create their own DRC,

in the knowledge that all of their purchased components are covered by Only Representatives In some cases, companies are choosing to list all the Only Representatives on the DRC

I won’t pretend that this is a perfect solution Unless you get some decent estimates of how much of your product is going to the EU, you could get a surprise on data collection, and find that you need to move up a tonnage band quickly And, like any system, there is always the possibility that someone will misuse the process

I said that I’d review two processes in this paper, and the second of these is the BASF CODE process It is similar in that it employs a central certification process, but it differs in that the process is firmly managed through an intermediate third party who issues codes, which relate to specific substances, and a specific volume

In this case, the exporter can apply to the Trustee (ChemService) for a CODE, which will allow importation under that certificate number This has the advantages of limiting importers tonnages, and therefore potentially avoiding nasty tonnage band surprises On the other hand, this costs €100 per certificate, because someone has to pay for the third party work

But, as I said right at the start, I believe that both of these processes will work

What really worries me is not the weaknesses of either of these processes, what worries me is that BASF’s

OR ChemService tell me that they have issued around 500-600 CODEs to around 50 downstream users, and I guess the ATC process probably has about the same number So, what am I missing? What is everyone else doing?

So, in summary:

Whether you like it or not, the Only Representative is the only mechanism whereby a non-EU manufacturer can participate in the EU market and comply with REACH You need someone competent, and someone you can trust

And you need to set up a mechanism to support your importers – one which will stay within the law, collect the right information, and provide your importers with the ability to reassure any enforcement agencies

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CONSORTIA – SHOULD I JOIN THEM?

Dr Allan Jemi-Alade, Global Manager HS & E,

Afton Chemical

500 Spring St, Richmond, Virginia, USA, 23219 Tel: +1-804-788-6037 Fax: +1-804-788-6038 email: allan.jemi-alade@aftonchemical.com

Allan Jemi-Alade was born in Dundee, Scotland He was educated at Dundee University and Cambridge

University, where he was awarded a PhD in Gas Phase Kinetics After completing a post-doctoral fellowship

at Bordeaux University, France, he joined Afton Chemical (formerly Ethyl Petroleum Additives) in Bracknell, England, in 1992 as a Research Chemist working on fuel additives After a period managing Afton’s European quality system he joined the Health, Safety & Environment department in 1997 He relocated to Richmond, Virginia in 2002 and has been managing Afton’s Product Stewardship Group and REACH implementation effort since then He was promoted to Global Manager, HS&E in 2009

ABSTRACT

This paper explores the advantages and disadvantages of joining REACH consortia It draws from Afton’s experiences of membership of several consortia and many SIEFs The factors of cost, manpower and influence over the registration process can be deciding factors on whether a company chooses to join a consortium or prefers to remain outside of a consortium and purchase a Letter of Access in order to obtain the information required for registration

Introduction

Companies who have an obligation to register one or more substances under REACH will naturally look for the most efficient and cost effective way of achieving this For those with a 2010 registration deadline, the path they have chosen to achieve this will (or should have) by now been defined, as time is very short Depending on a whole host of factors, a company may have chosen to work with others in a consortium if one exists, or made a conscious decision to remain outside of a consortium with the intention to purchase a Letter of Access to the data and information it needs to complete registration of a substance Small and Medium Sized Enterprises (SMEs) have particular challenges when deciding whether or not to join a consortium If an SME has limited resources (manpower and money) and a lack of data, the prospect of letting the consortium do the “heavy lifting” and simply buy a Letter of Access at the end, can seem particularly attractive However, the cost of the Letter of Access can be a lot higher than envisaged and in some cases can prove to be a false economy For some SIEF members the opportunity to join a consortium for a particular substance is no longer available, as some of the largest consortia have closed their membership to potential new members

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within a Substance Information Exchange Forum (SIEF) for the specific purpose of registering one substance

For some trade organizations, who were effectively operating as consortia before REACH, the progression to form a REACH consortium has been fairly straightforward, although usually not without challenges One of the main challenges for most REACH consortia has been agreeing the rules and terms of operation of the consortium via a legally binding Consortium Agreement It can take many months, and in some cases well over a year for a consortium agreement to be agreed and signed by all parties

Competition Law

Never far from the minds of a consortium’s members and their legal representatives is the need to operate in

a manner that is fully compliant with competition law REACH effectively forces companies to share data on

a level that most will have never experienced before Companies may find themselves in consortia and SIEFs with their competitors as well as customers and suppliers Companies must take particular care not to become involved in exchanging information on product prices, market share, terms of sale, costs of production, names of customers, exact import volumes etc Cefic has produced a very useful document to help in this area entitled “Cefic REACH Competition Law Compliance Guidance”

Costs

The initial cost of joining a consortium may be considerable For example in 2009 the Lower Olefin and Aromatics Consortium (LOA) charged €121,000 (~$175,000) as an initial membership fee This cost covered both finance, operational and technical activities whose costs were equally shared between all members This membership cost can be compared to a three-tier cost structure of up to €20,000 (~$28,000) for obtaining a Letter of Access for a substance that needs to be registered in 2010 A critical determining factor

of whether or not to join this consortium in 2009 would have been the number of substances covered by LOA that one’s company needed to register The higher the number of substances, the more attractive consortium membership becomes

SMEs may face difficulties in affording the initial and ongoing costs of a consortium Any new studies that need to be run will need to be financed by existing members of the consortium that require the study for their registration Although this expense may not be of concern to large companies, it can pose a significant outlay for SMEs who hope to get back some of the costs, eventually, from members of the SIEF who are not in the consortium Depending on the registration deadlines and the number of SIEF participants who will actually proceed to registration, the recuperation of costs may take many years to be realized

Influence

A benefit of joining a consortium, particularly in its early days, is that one can play an influential part in how the consortium is operated, how monies are spent, and indeed how studies are selected for remuneration In addition, by being part of the decision making process of the consortium a company has more control and certainty that its registration deadline will be met

For example, Afton decided to join a particular consortium that only covers one substance This substance has a 2010 registration deadline for some of the consortium members, but for Afton the registration deadline

is 2018 The decision to join this consortium was primarily based on Afton being a data holder and wanting to ensure remuneration for the use of its data An additional benefit has been that Afton has been able to positively influence the joint hazard classification and labeling of this substance If Afton had not joined the consortium, then it is very likely that the substance would have been classified more severely than it needed

to be

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Manpower

The amount of time that a company needs to commit to consortium activities should not be underestimated

It can easily amount to several man-days per consortium per month, as many consortia expect each of its members to put in its fare share of “sweat equity” Where a company joins a consortium with the expectation that as long as it pays its share of costs, it can escape the “sweat equity” contribution, this can lead to disharmony within the consortium Other members of the consortium may decide to bill the erring consortium member for sweat equity

For an SME with limited manpower and expertise available, the time commitment for consortium activities can be prohibitive and it may choose to appoint a consultant to represent its interests on the consortium Consultants can easily charge $1,000+ per day plus out of pocket expenses for such work

Conclusion

A company’s decision on whether or not to join a consortium should be taken only after careful consideration

of the costs, manpower and perceived benefits involved

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FOIBLES AND FRUSTRATIONS WITH THE ECHA USE

DESCRIPTOR SYSTEM: ONE DOWNSTREAM

Barry Clayton, CIH is the Industrial Hygiene Manager for Reichhold, Inc in

Research Triangle Park, NC As a member of the Corporate EHS team, he is responsible for assessing and controlling employee exposure to chemical, physical, and biological agents at Reichhold’s 18 resin manufacturing plants and three R&D facilities He is also co-chair of Reichhold’s REACH Implementation Team and the primary contact for its Only Representative function, consortium activities, and SIEF participation

Prior to joining Reichhold in 2004, Barry worked as an industrial hygiene consultant, plant industrial hygienist, and regional safety manager for a large microelectronics company He began his career as an industrial hygiene officer in the U.S Navy Barry holds a M.S degree in Industrial and Environmental Hygiene from the University of Cincinnati and a B.A degree in Biology and Environmental Studies from Augustana College He certified in comprehensive practice by the American Board of Industrial Hygiene

ABSTRACT

The EHCA Use Descriptor System (UDS) is intended to provide a structured approach for communication of substance uses up and down the supply chain These standardized descriptors allow the building of short titles for exposure scenarios and in some cases link to available Tier 1 exposure estimation tools A common understanding of the UDS among suppliers and downstream users is therefore essential to meeting REACH requirements and developing realistic exposure scenarios to demonstrate safe use This presentation will review the process used by one European resin manufacturer to assign use descriptors to several hundred raw materials and communicate them to the next actor in the supply chain Challenges and questions presented by the available guidance document and recommendations for improvement will also be discussed

Slide 1

Foibles and Frustrations with the ECHA Use Descriptor System:

One Downstream User’s Experience

Barry Clayton, CIH Industrial Hygiene Manager Reichhold, Inc.

Research Triangle Park, NC USA barry.clayton@reichhold.com

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Slide 2

2

Overview

• Who is Reichhold?

• Reichhold and REACH

• Use Communication under REACH

• ECHA Use Descriptor System (UDS)

• Market leader in coatings and graphic arts

• A global supplier with 18 manufacturing sites in

11 countries (5 in European Economic Area)

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Slide 4

4

Coatings Composites

We don’t make Coatings…

We produce resins and other polymers used to make paints, stains, varnishes, and other coatings products.

We don’t make Composites

We produce resins and other products used to fabricate composite products such as bath tubs, boats, and cultured marble.

Reichhold’s Businesses

Slide 5

5

Composites Markets Served

• Unsaturated Polyester Resin, Vinyl Ester Resin, and Formulated Resin

– Building & Construction – Transportation – Marine – Consumer Goods – Industrial Applications – Bath and Spa – Wind Energy – Infrastructure

• Resins are reinforced and cured upon end use to form various plastic articles.

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• Closed Mold

– Wind Energy – Pultrusion – Vacuum Infusion – SMC / BMC – RTM – Automotive – Heavy Truck

• Cast Polymers

– Cultured Marble – Solid Surface – Body Putty – Polymer Concrete – Gel Coat Base

• CR-FR

– Corrosion Resistance – Flame Retardant – Cured-in-Place Pipe

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Slide 8

8

REACH and Reichhold

• Mostly a downstream user (DU) of substances

as polymers are exempt from registration

• Finished products use 5-30 unique substances

• “Double” pre-registered monomers for polymers produced in EEA plants

• Appointed UK plant as Only Representative for exports from U.S., Mexico, and Brazil

• Participant in over 250 SIEFs

• Founding member of UPR/VER consortium

– Lead registrant for EC 500-090-6 (no-longer polymer)

• Member of Cefic UPR sector group

– Distributors must pass use information to the next actor in the supply chain.

– For phase-in substances, downstream users must provide use information at least 12 months before their supplier’s registration deadline.

– For substances due in 2010, use information should

be communicated before 30 November 2009.

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Slide 10

10

Use Communication Under REACH

• Providing use information does not guarantee a use will be supported but makes it more likely:

– Supplier can assess use and include in his Chemical Safety Report and exposure scenarios if deemed

“safe” (i.e., risk characterization ratio <1).

– Supplier can assess use and advise against if deemed “unsafe” (i.e., risk characterization ratio >1).

– Unsafe uses must be communicated in writing to ECHA and downstream users.

– Supplier may choose not to assess uses deemed infeasible or not economical.

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11

• A DU that does not communicate his uses may need to prepare his own Chemical Safety Assessment if the substance is dangerous

• ES not required for substances manufactured

or imported <10 tons/year/registrant

• For substances and preparations not classified

as dangerous or regarded as PBT or vPvB, there is no obligation to develop ES and include

in extended Safety Data Sheet (SDS)

• Identified uses must be stated in the supplier’s registration dossier (Chapter 3.5 of IUCLID5)

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Slide 12

12

• Although not required by REACH, ECHA recommends a “structured approach” for communicating use information up and down the supply chain

• Consistency between identified uses in the supplier’s registration dossier and exposure scenario (ES) titles is required by REACH

• The ECHA Use Descriptor System (UDS) is intended to provide a common language for communication of identified uses

Slide 13

13

ECHA Use Descriptor System

• See Chapter R.12 of ECHA Guidance on information requirements and chemical safety

– Version 1 issued May 2008 – Version 1.1 issued July 2008 – Version 1.2 issued October 2008 – Draft Version 2.0 issued in May 2009 – Draft Version 2.0 issued October 2009 – Updated Draft Version 2 issued 7 November 2009 – Final Chapter R.12 expected in 2010?

• See also Chapter R.16: Environmental Exposure Estimation

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Slide 14

14

• UDS is intended to provide consistency in:

– Identification of uses in registration dossiers – Building of exposure scenarios by suppliers – Building of short titles of exposure scenarios

• Contains 5 pick lists for briefly describing uses:

– Sector of Use (SU) – Chemical Product Category (PC) – Process Category (PROC) – Environmental Release Category (ERC) – Article Category (AC)

Slide 15

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• UDS pick lists do not aim for completeness

• Some PROCs and ERCs link to available Tier 1 exposure estimation tools such as:

– ECETOC Targeted Risk Assessment (TRA) – CONSEXPO Consumer Exposure and Uptake model – European Union System for the Evaluation of Substances (EUSES)

• In most cases, a registrant will need more specific information (operating conditions, risk management measures, etc.) to assess exposure or estimate emissions

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Slide 16

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SU Sector of Use Category

worker exposure Industry and service sectors of

end-use

No link to exposure estimation tools

consumer exposure

PROC Process Category Application techniques or process

types from worker perspective

Link to Tier 1 tools for worker exposure

Release Category Broad conditions of use from the environmental perspective Link to EUSES for release estimate

AC Article Category Article types in service and waste

life

No link to exposure estimation tools Selected articles used by

• Used draft version 2.0 of Chapter R.12

• Identified raw materials purchased by European plants since 1 January 2008

• Assigned SU, PC, PROC, and ERC codes to each raw material (substance or preparation)

• Worked with Cefic UPR group and EuCIA to map industrial and professional uses of UPR, VER, and formulated resins

• Communicated use descriptors to each supplier via email by 30 November 2009

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Slide 18

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Reichhold Approach

• 265 materials identified from purchase records

• Each reviewed by an experienced Product Safety Specialist familiar with raw materials, processes, products, applications, and UDS

• Materials grouped by general functional use:

– Monomer – Reactive Diluent – Reaction Aid – Additive – Filler – Solvent

Slide 19

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Reichhold Approach

• Functional uses confirmed by Technical

• “Best fit” descriptors assigned based on our uses and typical applications by customers

• E-mailed Use Descriptor letter to each supplier REACH contact with spreadsheet(s) listing:

– Supplier name and vendor code – Material name

– Reichhold location of use – General use

– Material code # – SU, PC, PROC, ERC codes and descriptions – Reichhold REACH contact information

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Slide 20

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Email to SuppliersDear Valued Reichhold Supplier:

The REACH regulation (EC) No 1907/2006 gives downstream users of chemical products the right to make their uses known

to suppliers in writing so that these uses can be covered in substance registration dossiers, chemical safety assessments, and exposure scenarios This aim of this supply chain communication is to provide standardized use descriptors for materials that Reichhold has purchased from your company since 1 January 2008

The Reichhold plants in Great Britain, France, Italy, Norway, and Czech Republic produce unsaturated polyester resins, vinyl ester resins, and formulated resins (i.e., gelcoats, topcoats, bonding paste) for the European composites market

These polymer preparations are used by Reichhold’s industrial and professional customers to fabricate, coat, and bond reinforced and cast plastic products using a variety of application methods and processes.

The attached spreadsheet uses the ECHA Use Descriptor System to describe the sector of use (SU), chemical product category (PC), process category (PROC), and environmental release category (ERC) for Reichhold uses (generally SU8 or SU10 and occasionally SU3) of materials supplied by your company and, where applicable, additional customer uses (SU3, SU12, or SU22) of Reichhold finished products containing these materials

The use descriptors are based on the 2009 draft (version 2.0) of Chapter R.12 of the ECHA Guidance on Information Requirements and Chemical Safety Assessment

( http://guidance.echa.europa.eu/docs/guidance_document/Inforeq_CSR_R12_en.pdf ) The 2009 draft was used because the October 2008 guidance document (version 1.2) does not include environmental release categories necessary to perform Tier

1 release estimates It is our understanding that an updated version of Chapter R.12 will be published on the ECHA website

in early 2010

In accordance with Article 37 of REACH, Reichhold requests that you or your upstream supplier(s) cover uses described in the attached material spreadsheet in registration dossiers, chemical safety assessments, and exposure scenarios for the substances concerned If the registrant is unable to include these uses for any reason, we ask that you promptly inform us

in writing of the specific use advised against and the reasons for that decision

Thank you for your cooperation We trust that you and your suppliers will find Reichhold’s use descriptors helpful in your require further information regarding conditions of use at various life cycle stages, please contact me

( barry.clayton@reichhold.com ) or my European colleague, Ms Maria Loffellehner ( maria.loffellehner@reichhold.com ).

Slide 21

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Slide 22

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Cefic UPR Sector Use Map

Hand lay-up lamination SU 3, 12 PC 32 PROC 10 ERC 6 D Gelcoat brushing / rolling SU 3, 12 PC 32 PROC 10 ERC 6 D Spray-up lamination SU 3, 12 PC 32 PROC 7 ERC 6 D

Filament winding and variations like spray winding (chop-hoop) SU 3, 12 PC 32 PROC 7 ERC 6 D Pultrusion with open impregnation baths SU 3, 12 PC 32 PROC 13 ERC 6 D Continuous production of flat panels and laminates SU 3, 12 PC 32 PROC 10 ERC 6 D Semi-continuous production of flat panels and laminates SU 3, 12 PC 32 PROC 10 ERC 6 D Casting of polymer concrete and artificial marble SU 3, 12 PC 32 PROC 5 ERC 6 D Application of repair putties SU 3, 12 PC 32 PROC 10 ERC 6 D Application of bonding pastes / adhesives SU 3, 12 PC 32 PROC 10 ERC 6 D Application of floorings, mastics, coatings SU 3, 12 PC 32 PROC 10 ERC 6 D Centrifugal casting SU 3, 12 PC 32 PROC 5 ERC 6 D Resin injection processes, infusion, vacuum injection, RTM, etc SU 3, 12 PC 32 PROC 3 ERC 6 D Pultrusion with injection dies SU 3, 12 PC 32 PROC 14 ERC 6 D Manufacturing of SMC SU 3, 12 PC 32 PROC 5 ERC 6 D Manufacturing of BMC, TMC , DMC etc SU 3, 12 PC 32 PROC 4 ERC 6 D

Processing of BMC , TMC, DMC etc SU 3, 12 PC 32 PROC 14 ERC 6 D Impregnation of sewer relining sleeves SU 3, 12 PC 32 PROC 3 ERC 6 D Sewer relining operation SU 3, 12 PC 32 PROC 4 ERC 6 D Formulating / blending resins, gelcoats, bonding pastes, putties etc SU 3, 12 PC 32 PROC 5 ERC 2

Slide 23

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Questions on UDS

• What sector of use are we?

– SU3: industrial uses of substances as such or in preparations?

– SU8: manufacture of bulk, large scale chemicals?

– SU10: formulation (mixing) of preparations?

• We chose SU8 for most materials used to manufacture UPR and VER, and SU10 for materials used in gel coats, bonding paste, etc (no synthesis, strictly blending)

• SU3 also possible, particularly for monomers used as “intermediates” to make polymers

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• Other sectors of end-use also possible given the wide variety of composite materials and applications

• What is impact of main user or specific sector?

– Main user groups are relevant for ECETOC TRA – Specific sector is important if use advised against

• End use by customers may involve other PCs

• No article codes were assigned

– limited selection in the UDS pick list – many possibilities, some only known to customer

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• PROCs and ERCs for customer uses vary by product, application method, and user group

• Cefic UPR group assigned 10 PROCs and 2 ERCs for 22 applications when mapping FRP manufacturing and related industrial activities

• ERC6d (i.e., industrial use of styrene in polyester production) used only for customers

• Styrene is reacted on end-use to form articles so any remaining substances in resin are bound in

a polymer matrix (is ERC5 relevant?)

• Composite materials may be subject to abrasive processing (sanding, grinding, drilling, cutting) after curing – PROC 21, 24, ERC 12a, 12b?

• Unclear how/if use descriptors apply for article life cycle stages including waste disposal

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Slide 28

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Results and Feedback

• Distributed 292 use descriptor spreadsheets to over 200 supplier REACH contacts

• Most feedback from suppliers was positive

– Further communication requested or expected

• Few customers provided descriptors for their uses of Reichhold finished products

– General inquiries referred to Cefic UPR use maps

• Customers who did not specify products used,

or listed nearly every possible SU, PC, PROC, ERC, and AC were less than helpful

Slide 29

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At the End of the Day

• We tried to apply the UDS as intended but we still have questions

• ~9000 substances will be registered in 2010

– Many suppliers are not due until 2013 or 2018.

– Will we need to do this again in 2012 or 2017?

• Top-down approach recommended by Cefic works well for starters, but only if suppliers and DUs understand the UDS and its implications

• The 7 November 2009 draft of Chapter R.12 is improved, but arrived too late to be of use for the 30 November deadline

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Slide 30

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Recommendations

• Chapter R.12 is still “under construction.”

Further refinement, explanation, and examples are needed to improve clarity and achieve the consistency required under REACH

• Final ECHA guidance documents must be available 3-6 months prior to hard deadlines to give industry time to digest and apply

• Industry has responded with many practical guides and tools Official recognition of and external links to these would improve access and ensure SMEs are on the same page

Slide 31

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Special Thanks To:

• Pat McKelvey – Product Safety Manager

• Maria Loffellehner – Product Safety Specialist

• Mark DuBois – Product Safety Specialist

• Dave Hill – Product Safety Specialist (retired)

• Tom Grzybala – REACH IT consultant

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He is involved with the introduction of REACh in 2005 in the Quaker organization since the very beginning and chairs the Quaker Reach Team In order to share information regarding how to handle REACh in a SME* Several presentations have been given at; Euroforum, REACh information day organized by the Dutch government, Chemical Week and to a series of customers of Quaker

He is a member of the FEUC** and is responsible as LR*** to submit 4 substances before Dec 2010 and started in 2009 as SFF**** which resulted in the LR role of a strategic substance which also needs to be registered before Dec 2010

* Small Medium size Enterprise

** Fatty Ester Umbrella Consortium

*** Lead Registrant

**** Substance Formation Facilitator

+++ paper unavailable at time of print +++

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2013 - THE NEXT DEADLINE

Dr Steffen Erler, Global Technical Director

Smithers REACH Services Shawbury, Shrewsbury, Shropshire, SY4 4NR, UK

Tel: +44 (0) 1939 252318 Fax: +44 (0) 1939 251118 Email: serler@rapra.net

Dr Steffen Erler has been following REACH for a decade, since working with the OECD Existing Chemicals

Programme His academic background is in chemistry combined with studies on toxicology Steffen’s practical knowledge of regulation includes work on REACH at the European Commission Over the past five years, he has acted as a researcher and consultant for companies, investors and regulators preparing for REACH

Smithers REACH Services was established in 2009 to co-ordinate activities between The Smithers Group companies In particular, Smithers REACH Services works on testing with Springborn Laboratories, a CRO based in the USA and Switzerland, and on exposure assessment with Smithers Rapra, the polymer experts

in the USA and UK

ABSTRACT

A significant part of implementing REACH involves ‘learning by doing’ By the second wave of registration in

2013, there will be considerable fewer uncertainties and unknowns with the registration process than exist today Substances due for registration in 2013 are however likely to involve more confidential information on product use applications and are relatively ‘data-poor’ to those being registered this year 2013 will therefore bring a new set of hurdles to registration that may prove to be equally challenging to industry This paper presents ‘lessons’ that may be learnt in 2010 and examines what companies and consultants should be considering for 2013

1 Introduction

Submitting a registration dossier is not just a scientific and technical exercise Preparing a joint registration dossier involves a variety of tasks and considerations: legal contracts, valuation of studies, cost-sharing agreements, IT security for data-sharing, competition rules, etc

Industry must contend with completely new processes, such as the ‘Substance Information Exchange Forums’ and new tools, such as Reach-IT The required skill set is generally lacking across industry, but rapidly growing as experience is gained with REACH

By the end of 2010, one can expect a massive ‘sigh’ of relief to resonate from REACH managers and consultants across the EU chemical industry This may be coupled with a ‘gasp’ from those that proved unsuccessful in meeting the deadline

Getting through 2010 is however only one small piece of REACH implementation While activity is currently focused on 2010 registrations, as indeed it should be, the next deadline for registration follows in just 2 ½ years

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Between 2011 and mid 2013, companies and consultants will need to continue contending with other REACH processes, for example:

- dossier Evaluation

a number of registration dossiers will be reviewed by ECHA

- substance Evaluation

actual substances will be evaluated to ensure chemical safety

- downstream user Chemical Safety Assessments

after registration, downstream users may need to perform their own assessments, if the specific use

of a chemical is not sufficiently covered in the registration dossier from their supply chain

- Restriction

the restriction process formally began in 2009 but may become more prominent in coming years

- Communication and notification requirements for Substances of Very High Concern (SVHCs)

the Candidate List of SVHCs for Authorisation is expected to be updated every six months, with notification requirements beginning in mid 2011

- Authorisation

applications for authorisations will be underway and sunset dates may begin to apply

In addition to registration, 2013 will see the addition of many companies to 2010 joint registration dossiers, requiring 2010 registrants to remain actively engaged in managing the SIEF and dossier, particularly with regards to cost-sharing

With all this effort that may be required for REACH, making most use of the lessons learnt in 2010 may prove critical to successfully meeting the 2013 registration deadline

2 Lesson to be Learnt

Tools, methods, guidance and IT systems are frequently subject to revisions and changes For instance, IUCLID5.1 has been updated to IUCLID5.2, a module for the joint registration process should soon be available, and the Chemical Safety Assessment and Report plug-in tool is also currently expected

Technical Issues

Questions asked by registrants often involve:

(i) analytical data requirements

exactly what analytical data each registrant must submit to ECHA in its dossier; for instance, what waivers may be accepted and how many supply chains must be covered

(ii) study waiving justifications

the level of detail of information that must be provided as justifications for certain data omissions according to type of waiver (e.g Column 2, technical, weight of evidence, exposure-based)

(iii) description of use

the various methods and ‘levels’ of describing use, e.g ‘use’ in an IUCLID dossier, an Exposure Scenario and a Safety Data Sheet

(iv) scope of DNELs

what DNELs (e.g how many) are needed and whether they are needed for non-hazardous substances (v) use of read-across

as with data-waivers, the methods and justifications to justify and report the use of read-across

(vi) Chemical Safety Assessment and Report (Chesar) tool

use of the Chemical Safety Assessment and Report tool, which is still under development

(vii) demonstration of strictly controlled conditions

documentation required for demonstrating strictly controlled conditions

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(viii) definition of intermediates

e.g ability for an intermediate to be used by an article producer

(ix) potential for more that one joint dossier

possibility for there two be a separate joint registration dossier for an intermediate vs a non-intermediate dossier

The above-listed issues largely concern interpretation of the regulation and guidance that companies must resolve amongst themselves during the joint registration process The first two points can particularly affect the ability of a company to register a substance and receive a register number from ECHA

Successful Registration

*relates to admin errors in submission forms, incorrect company sign-up, etc

**refers to technical completeness check

Table 1 Dossiers submitted as 11 December 2009 (ECHA Newsletter 6, 2009)

Statistics from ECHA in Table 1 demonstrate the difficulty of the actual technical process of submitting an IUCLID5 dossier via Reach-IT There are up to 9000 possible data entry fields in IUCLID5 Missing a single entry point can result in the dossier being rejected

Figure 1 Steps of the registration process (ECHA Newsletter 6, 2009)

Figure 1 shows an overview of the registration process Companies are already deploying a number of strategies in order to ‘test’ the system For example, filling out dossiers in different manners to see which gets through to what ECHA refers to as the ‘end of the pipe’

The ‘two strikes and you pay again’ rule provides a strong incentive to companies to get it right the first time! Recently, a Technical Completeness Check tool has been made available by ECHA This allows companies

to predict what the result will be during the ECHA process, immediately after a dossier is submitted

But the tool does not provide absolute certainty – there is still case-by-case review by ECHA Parts of the tool are also not fully explained Nevertheless, the tool is already proving instrumental in increasing the success rate of registration dossiers that are being submitted as passing

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Downstream Use

Another key area for experience to be gained, concerns how downstream users will cope with any ‘use’ outside an Exposure Scenario In 2009, there was a mass flurry of supply chain communications on use that made little, if no, sense at all

There can be some repercussions from these communications, which can even have implications to 2013 registration dossier For instance, downstream users must supply exposure data upstream if they have communicated the use at least 12 months prior to any registration dossier

Internal Management

Based on experience gained so far, each company in the EU probably requires a person to be appointed as REACH co-ordinator In particular, this is necessary to manage supply chain communications Any company submitting more than a couple non-intermediate registration dossiers in 2010 probably requires this person

to be dedicated full-time to REACH, unless a significant amount of work is to be outsourced Regardless, there is a need to involve staff responsible for sales, procurement, etc

3 Efforts for 2010

ECHA has been active assisting companies prepare for registration Over 170 documents have been translated from ECHA into all other 21 official EU languages – see Figure 2

Figure 2 ECHA translations (ECHA Newsletter 6, 2009)

The number of guidance documents and manuals available illustrate the complexity of REACH One could argue that the tremendous volume of guidance makes implementation more difficult, especially as it is subject to frequent change On the other hand, too much guidance may be better than a lack thereof

ECHA has also organised a series of webinars to guide Lead Registrants through the registration process Feedback from the first 40 or so attendees indicated a 95% positive response to the webinar helping with the role of lead registrant These webinars are made available via its website

Following experience with the large number of users and number of pre-registrations submitted via Reach-IT

in 2008, ECHA is ensuring that the Reach-IT system will be able to cope with registration in 2010 The system requirements may be even greater than for pre-registration, which was at that time similar to those required by major credit card companies This may be exceeded as the first deadline for registration coincides with the classification & labelling notifications under the Classification, Labelling on Packaging Regulation

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IUCLID5 has recently been upgraded and several additional tools are being made available, including the Chemical Safety Assessment and Report (Chesar) tool Hopefully, there will not be any further significant changes between 2010 and 2013

3 2013

Based on European Commission estimates, there will be around 2700 substances registered in 2010 and

2700 substances registered in 2013 Generally, around 10% of substances will need some physchem testing and between 20% and 40% will need toxicological and environmental testing

Due to many 2010 registrations being part of existing chemical programmes, such as the OECD High Production Volume scheme, these substances are generally regarded as being ‘data rich’ In comparison,

2013 registrations are ‘data poor’ The most notable differences (lack of data) are in ecotoxicological and environmental fate data

A significant bottleneck in the capacity of Contract Research Organisations (CROs) to meet the testing demand resulting for REACH is likely to peak in 2012 This is because testing for 2010 registrations will overlap with 2013 registrations

Specifically:

 test plans for Annexes IX and X for 2010 registrations must be reviewed by ECHA by (end) 20121

 a majority of testing for 2013 is expected to occur in 2012

 Annex VII and VIII data-gaps for 2013 will be more significant than 2010 registrations

Tremendous cost-savings may be achieved through various ‘integrated’ or ‘intelligent’ testing strategies, where data from various sources are used, including (Q)SARs This is because up to 80% of the cost for registration could be for test data on the intrinsic properties of substances, even when accounting for existing studies1

Consequently, planning for 2013 should really focus on where testing may be required However, testing under REACH is largely driven by the use of a substance and the resulting exposure levels Compared to

2010 registrations, the specific application of chemical substances in industrial settings and consumer products for substances in 2013 may be more specialised and therefore company/downstream user specific This type of confidential information may limit companies collaborating on Chemical Safety Assessments (and therefore data-gap analyses) within SIEF

Avoiding Testing

Test waiving, read-across, (Q)SARs etc can require expert time So while it saves on testing costs, and reduces demand for testing, it does not necessarily reduce overall costs for a registration being completed While (Q)SARs can save time (relative to testing), if a result appears invalid or otherwise unreliable, then testing needs to follow Therefore, it is critical to have a full data-gap performed, one which includes (Q)SARs for example, well ahead of possible testing

When alternative methods for filling certain endpoints are available, then there is the issue of the potential acceptance of that endpoint result, whether it is accepted as reliable and robust by regulators, as well as whether it is acceptable under other legislation (not just REACH) as well as experience from labs

1 Only test proposals need to be submitted as part of a registration for Annexes IX and X Apart from basic parameters, such as molecular weight and solubility, the tests under Annexes VII & VIII are not so dependent on a tiered approach Instead, these tend set the basis for the higher tier Annex IX and Annex X studies, which are organised in a very systematic way

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Planning for Testing

It is therefore not the time taken for the actual test to be performed that determines testing timelines When planning for testing it is important to consider:

 availability of analytical methods in the matrix tested (e.g in water)

 necessity for any reference standards

 potential preliminary testing, such as a rangefinder to determine dose levels for definitive testing

 time necessary for the CRO to perform the test

 CRO schedule for the testing

 selection of the sample for testing (e.g representative of companies under a joint submission)

 need for radiolabelled material and ability to obtain such samples

Delays can occur due to inaccurate or unreliable data being provided as a basis for the testing For instance,

if incorrect solubility parameters and analytical technique references are provided to the lab a test may need

to be restarted or even redesigned

Time (years) Figure 3 Timing considerations for environmental testing

Timing for environmental testing is illustrated in the Figure 3 Because data may not be as readily available

as for 2010, substances, it is particularly important to identify missing points and check the validity of any information provided to a CRO

Chemical Safety Assessment

Thee tiered testing under REACH means that companies face having to conduct CSAs with limited data Experience with previous EU chemical legislation indicates that PNECs can often be lowered as a result of higher testing2 As higher level studies are performed, uncertainty is reduced thereby allowing lower assessment factors to be used in the PNEC derivation

Companies must therefore carefully manage the balance between ‘safety’ and ‘over-protection’ Over protective measures can themselves result in increased risks For instance, the use of gloves over long periods can result in dermal issues, such as from fungus There is also the risk that a downstream user selects an apparently ‘less hazardous’ substance where the classification is a result of missing data (i.e perhaps the substance is hazardous, but test data have not yet been generated) Of course, over-stringent risk management measures also result in companies incurring unnecessary costs

601504002/2002: The Hague

Annex X Annex IX Annex VIII

Annex VII

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Traditionally, a chemical risk assessment follows a linear approach:

Hazard identification Hazard characterisation Exposure assessment Risk characterisation Risk management Risk communication

Under REACH, these processes must be performed in parallel, with reviews and adjustments made as data become available

Conclusion

2010 represents a critical year for REACH Even if it may prove to be arduous and strain resources, at least

a significant proportion of registrations can be expected to be successfully submitted

In many ways, registration in 2010 will be paving the way for the next set of substances which may prove more complicated to assess in terms of data-gaps and more difficult to manage due to the corresponding testing requirements This is because 2013 substances can generally be expected to be relatively data poor and involve specialty applications compared to many commodity chemicals that will be registered in 2010 Given that capacity in the CRO market is limited A significant bottleneck in CRO testing is anticipated, which

is likely to peak in 2012 Companies should keep this in mind when prioritising their REACH implementation activities

Acknowledgments

Arthur Putt, Smithers REACH Service

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