REACH
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A Special Focus
R E A C H = R E G I S T R AT I O N , E VA L U AT I O N , A U T H O R I S AT I O N & R E S T R I C T I O N o f C H E M I C A L S
CNW Summer Conference – REACH, A Time To Plan Big Interview – Dr Peter Jenkinson Dr Knoell Sponsors Article – REACH: Beyond the “R” REACHReady Exclusive Articles
REACH Specialists, sponsoring this special edition
GHS 2015
REACH 2018
Dossier update
Authorisation
Evaluation
More Challenges Ahead You have successfully scaled the heights of REACH 2013. Congratulations! Perhaps you can cross off the R (Registration) on your list, but have you had the time to consider what the next 2 letters mean for your business? Further challenges lie ahead which need your attention. Evaluation is ongoing and Authorisation has started for the first set of substances. The implementation of GHS for mixtures is due in 2015 and it is never too early to prepare for the next REACH deadline in 2018. knoell has prepared more than 800 lead dossiers in REACH phases I and II and offers comprehensive and tailor-made services to support your business in Europe and beyond: » » » » » » » » »
Literature searches and evaluation Data gap analysis and development of registration strategies Non-testing approaches (read-across, QSARS, WoE, waiving) Study management and monitoring Classification and labelling of substances and mixtures Technical Dossiers (IUCLID) and Chemical Safety Reports Extended Safety Data Sheets (eSDS) SIEF and consortium management Worldwide registration of chemicals
Agrochemicals » Industrial Chemicals » Pharmaceuticals » Cosmetics Biocides » Medical Devices » Veterinary Medicine » Training
We have been an independent service provider for the chemical and pharmaceutical industries since 1996, with currently over 400 employees at sites within the EU, Asia and the USA. For further information visit www.knoell-consult.co.uk
Dr. Knoell Consult Ltd. Dr. Iain A. MacKinnon Managing Director Tel +44 29 2034 9880 Cardiff CF11 9LJ United Kingdom www.knoell.com
WELCOME AND MEMBERSHIP
Contents 5 7 8 9 10 11
12 15 16 22 25 27 29 30
REACH: beyond the “R” Chemicals Notification for Global Markets Regulatory challenges in the years ahead The Plastics Industry perspective on REACH Getting an A grade in Authorisation Think REACH Does Not Apply to Your Company? Are You Certain? Read On 2020 SVHC Roadmap implementation plan Prediction of chemical properties to minimise testing costs The Big Interview Dossier evaluation: how compliant are you? Preparing my SME business for the 2018 REACH deadline REACH 2018: A Deadline not to Underestimate Sufficient capacity to REACH your compliance needs? Managing Supply Chain Chemical Compliance in the Decade of Regulatory Affairs
Contact details John Roche Operations Manager Email: RocheJ@CIA.org.uk Alex Heys Member Services & Events Manager Tel: 01928 515678 Email: alex.heys@ chemicalsnorthwest.org.uk Advertising Anthony McKeown, Distinctive Group Tel: 0845 887 3810 Mob: 0755 702 6900 Email: anthony.mckeown@ distinctivegroup.co.uk Disclaimer
Distinctive Publishing or Chemicals Northwest cannot be held responsible for any inaccuracies that may occur, individual products or services advertised or late entries. No part of this publication may be reproduced or scanned without prior written permission of the publishers and Chemicals Northwest.
Sponsor
This edition is sponsored by Dr Knoell Consult Ltd
Front cover image Clout Creative montage
Welcome Welcome to this supplement to Chemical Elements magazine which sets the scene for our special conference, “REACH a time to plan” which is being held at The Heath in Runcorn on 4th June 2014. We are also delighted to be staging this event alongside partners, Royal Society of Chemistry who like ourselves are keen to create an agenda that provides the best level of support and assistance to our member companies. An excellent programme of speakers has been compiled, with the aim of sharing the experiences of both large and small businesses. Presentations from our solution providers will add to the sources
John Roche Operations Manager, Chemicals Northwest
of help and we will hear about the current and future priorities of the regulator. We hope you enjoy this issue and look forward to seeing you at the conference in June!
REACH User group REACH is such a large piece of legislation that is impacting most of our chemical businesses here in the northwest. Supported by our colleagues at the REACHReady desk at the Chemical Industries Association (CIA), Chemicals Northwest (CNW) is proud to provide this source of help to our membership. The REACH regulations came into force in 2007 and over recent years, CNW has used this network to support our membership in understanding the wide range of complex issues and helping ensure they comply. Those key developments include: the 2010 registrations, the 2013 deadline and enforcement, intermediates, the 2012 review, extended safety datasheets and most recently substances of very high concern and authorisation.
participants, which is important as all believe the industry itself should move forward through learning and sharing. This focus that is at the heart of this forthcoming conference and with our partners, The Royal Society of Chemistry, we are keen to share examples of what companies have achieved so far with basic compliance and how they are preparing for the following phases of REACH implementation through to 2018.
There are over 50 people within this group representing twenty-five chemical companies and eleven technical service providers. The group meets three times each year with a regular agenda comprising a REACHReady update on the regulatory framework developments, a round table sharing of compliance experiences and good practice sharing. External speakers are also invited for example, the Health & Safety Executive who described their work covering intervention and enforcement.
The REACH user group is a valuable benefit of membership and is an example of how Chemicals Northwest is shaping its overall offering to help chemical businesses in the region succeed. J Roche, March 2014 Operations Manager, Chemicals Northwest
Discussions are always helpful and positive with constructive support amongst all
ELEMENTS SPRING 2014
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Reach a time to plan
Chemicals Northwest in partnership with the Royal Society of Chemistry
4th June 2014 - Heath Business Park, Runcorn This conference is different! This conference will draw out the practical aspects of complying with this complicated regulation. It will highlight the consequences for businesses if they don’t get it right and will provide some solutions for overcoming the barriers to compliance. The aims of the conference include helping you to understand what the implications will be for your business as you go about ensuring compliance. They also include key technical aspects such as: who has to register and when? What are the obligations of non-registrants in the supply chain? And how will downstream users be affected? As well as informative presentations from regulatory service providers, there will be speakers from industry who will share their first hand experience of dealing with REACH. These case studies will provide practical information about how companies can ensure compliance. The expectations placed on downstream users to ensure that upstream companies and fulfilling their requirements will also be highlighted. Sources of support and information will be covered as well as the next steps and timelines. There will also be a presentation from the competent authority which will cover their current and future priorities. Finally, looking to 2018 should be on all companies radar. What are those factors that need to be considered when planning for this stage?
9.30am
Registration & Coffee
10.00am
Welcome Ciara Dempsey, RSC & John Roche, Chemicals Northwest
10.10am
Introduction to REACH and aims of the conference Speaker TBC
10.40am
Global chemicals regulations and sustainable business growth Mark Pemberton, Global MSDS
11.10am
Getting through registration and anticipating the problems in 2018 Michael Goodwin, John Hogg Technical Solutions Ltd
11.40am
REACH - A customer viewpoint Steve George, Rolls Royce
12.10pm
Q & A session
12.30pm
Lunch, networking and exhibitions
1.25pm
Downstream user obligations …technical speaker to be confirmed
1.50pm
Title to follow.... Dr Trevor Rhodes, Harman Technologies Limited
2.15pm
Preparing my business for 2018. Dr Chris Eacott, Stewardship Solutions
2.40pm
Creating a ‘fit for purpose’ REACH/CLP function within a chemical organisation …a company case study to follow
3.05pm
Refreshment Break
3.20pm
REACH Enforcement - discussion of practical issues Michael Potts, Health & Safety Executive.
3.45pm
Mapping the landscape for authorisation. Dr Joanne Lloyd, Director of REACHReady, Chemicals Industries Association
4.10pm
Q & A session
4.30pm
Conference close
Costs Members of Chemicals Northwest, CIA, RSC EnterprisePlus companies or RSC corporate partners - £100 + VAT Non-members £250 + VAT Please state your membership on the booking form in the PO/other information box http://www.chemicalsnorthwest.org.uk/events/cnw/reach,_time_to_plan/
DR KNOELL
REACH: beyond the “R” Author: Dr Iain MacKinnon
By now you will have successfully submitted registration dossiers for any substances which you manufacture or import at >100 tonnes per annum, either as a Lead Registrant or as a Member of a Joint Registration. More than likely you are now gearing up to register all your substances manufactured or imported at >1 tonne per annum by 2018. For those substances for which you have a registration number, the temptation is to think that’s it all over, job well done! Sadly this is unlikely to be the case.
More Challenges Ahead The focus to date has indeed been on registration … obtaining that all important registration number. However, REACH is actually the “Regulation (…) concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals”.
made/lower purity” grade multiconstituent or even UVCB.
toxicological study has been proposed – in
Substance evaluation is not solely related
The main message is to keep an eye on your REACH-IT account. Your REACHIT account can be configured to send automatic update notice and should a Those of you who registered substances valid email address which is regularly You have successfully scaled the heights of REACH 2013. Congratulations! at >1000 tonnes may well have had some monitored. if you not the lead Perhaps you can cross off the R (Registration) on your list, butEven have youare had experience of the Evaluation process; registrant, it is extremely important to the time tomany consider thenonext 2 letters for your business? of you what will have inkling as to mean keep abreast of any compliance issues Further challenges lie ahead which needthere your attention. Evaluation what’s involved. Broadly speaking with your substance,is not least because are two distinct processes: Dossierfor the first itset could cost you money ongoing and Authorisation has started of substances. Theif, for example, Evaluation driven by ECHA and Substance required implementation of GHS for mixtures is due in 2015additional and it istesting neveristoo earlyby ECHA, Evaluation driven by Member States (MS) a read-across justification needs to be to prepare[the for Community the next REACH in 2018. knoell has prepared more Rollingdeadline Action Plan rewritten or you find yourself “cast out” as than 800 lead dossiers in REACH phases I and II and offers comprehensive and (CoRAP)]. your purity profile differs from that of the tailor-made services to support your business in Europe and beyond: lead registrant. ECHA will check dossiers where a
» » » » » » » » »
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Literature searches evaluation short, to see ifand this testing should be done to the individual registration dossier – or analysis not. ECHAand also development perform a compliance Data gap of registration strategies other criteria such as aggregated tonnage check approaches on at least 5% (read-across, of submitted QSARS, WoE, across all registrants and use/exposure Non-testing waiving) dossiers, selecting some dossiers at considerations also play a role. One Study management and monitoring random but also using “concern-driven possible outcome of substance evaluation Classification and labelling of substances and mixtures criteria”. Because the process is not totally via the CoRAP could be Restriction of a Technical Dossiers and Chemical Safety Reports random, it is (IUCLID) highly likely that if you were substance’s uses (see below). Therefore, to submit dossier with a(eSDS) large number Extended SafetyaData Sheets although there is no legal obligation for toxicological management end points filled using a MS to discuss with registrants or vice SIEF andofconsortium read-across, i.e., extrapolating data from a versa, registrants would be well advised to Worldwide registration of chemicals related substance, then it will be checked
discuss their substance with the relevant and you may receive a list of required MS. updates to bring the dossier Agrochemicals » needed Industrial Chemicals » back Pharmaceuticals » Cosmetics aim of the Authorisation process is compliance. Biocides »into Medical Devices » Veterinary MedicineThe » Training to control, restrict, and ideally eliminate Besides issues relating to read-across, the sale or use of Substances of Very High ECHA compliance checks may query Concern (SVHC). There is a two-step something as fundamental as the process whereby initially a MS or ECHA substance identity. For example, purity proposes that a SVHC is added to the may have been defined rather broadly so Candidate List (for authorisation). In the that in ECHA’s opinion the registration second step, a substance may be included actually encompasses two substances: a in the Authorisation List itself. Once “high purity” monoconstituent and an “ason this list, in general, a registrant must
apply for authorisation to use or sell the substance and only then under clearly defined circumstances, e.g., only for one use in one industry sector with prescribed safeguards. The Restriction process also seeks to limit the use of a given substance but in this case a particular use We have been an independent is restricted up front and other uses should service provider for the chemical be acceptable. and pharmaceutical industries sinceprincipal 1996, with currently overregarding The piece of advice 400 employeesand at sites within the Authorisation Restriction, as it was for EU, Asia andisthe USA. informed and to act Evaluation, to stay Fora further information visit “job done” in timely fashion. Assuming www.knoell-consult.co.uk after Registration could have serious financial implications.
Dr. Knoell Consult Ltd. Dr. Iain A. MacKinnon Managing Director Tel +44 29 2034 9880 Cardiff CF11 9LJ United Kingdom www.knoell.com
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INTERTEK LIFE SCIENCES
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REACH-OUT “Chemicals Notification for Global Markets” For those exporting new chemistry into global markets, the demands of notification regimes in jurisdictions other than the European Union should not be a post REACH afterthought. Exporters need to be aware of current and emerging notification obligations in their intended markets. Strategic planning at the outset can minimize costs, time to market and manage compliance. Often, at the marketing stage of bringing chemicals to a global market, companies find themselves unfamiliar with relevant national laws, orders and regulations. More than twelve jurisdictions (countries) now have controls over the placing of “new” chemicals on the market; awareness and planning for compliance is fundamental to the success of export sales. The desire to gain access to new markets, if not coordinated; can lead to regulatory non-compliance (with ensuing risks/ penalties for the business), and/or broken promises to customers (supply is delayed pending regulatory approval). The REACH adage “No data, no market” applies in an increasing number of jurisdictions. A global export strategy for a “new” chemical should consider: • Those jurisdictions with established notification legislation (many); • Those jurisdictions that are developing chemical notification legislation (several), and • Changes to existing legislation (plenty), e.g. China’s introduction of Order No. 7, the recasting of South Korea’s notification regime (K-REACH), Taiwan’s revision of their Toxic Chemical Substances Control Act (TCSCA), and there are planned reforms in the US, Japan and other jurisdictions. An understanding of regulatory requirements is critical to bringing “new” chemicals to the global market, in a timely and cost effective manner. At the beginning of any notification project there will be a point where, perhaps a Product Manager, a Sales Manager or a Researcher asks “what would it take to sell this chemical in ………..” From this point it is important that the requirements are properly addressed, to avoid wasting time, money and resources on a poorly executed plan that does not fulfil the business’s commercial needs. The expertise required, time frame and costs for the global notification of a “new”
chemical should not be under estimated. Outsourcing to notification experts can be the most cost and time effective solution. It is rarely practical to submit notifications remotely (a legal entity in the jurisdiction is generally required to be the applicant). Apart from local language, knowledge of local custom and practise is essential. Regulation of chemicals varies from jurisdiction to jurisdiction, however some basic principles and similarities are common across a number of regimes. Therefore, it makes sense to establish a single notification strategy and manage the differences as required. Notification of “new” chemicals is performed at the substance/polymer level, not the mixture/preparation level (Serbia is an exception). Before a substance or polymer can be placed on the market in a jurisdiction that regulates new chemicals, it must: • Be already listed on the relevant national chemical inventory(ies), or • By definition it is “new” and must be notified or fulfill exemption criteria, and • Comply with broader chemical control legislation, such as for safety data sheets, classification, packaging & labeling, transport, marketing & use and/or application specific controls, e.g. food contact, biocide or cosmetic use. Checking the relevant inventories to see if a chemical is listed is not straight forward, as notifiers can exercise confidentiality claims, and therefore checking a “public“ national inventory is not necessarily conclusive. Contacting the relevant Competent Authority to check the confidential part of an inventory is feasible. There are skills to performing such enquiries, to ensure that the right questions are asked and the right conclusions drawn. Correct characterization of the chemical is fundamental. For mono-constituent substances this maybe straight forward, for multi-constuent substances, substances of unknown or variable composition, complex reaction products, biological materials (UVCB substances) and polymers this can be more challenging. A representative sample is vital for characterization. It is important that all information on the chemical, such as known properties and impurities, physico-chemical, toxicological and eco-toxicological data is collated as a pre-cursor to a data gap analysis against notification requirements.
When considering the markets for global notification, one should plan the testing and notification strategy at the outset, with a view to minimizing testing by optimizing the use of read across, waiving arguments and Quantitative Structure Activity Relationship (QSAR) tools. An experienced notifier can save a business significant cost by justifying the need not to undertake a prescribed test where the chemistry and supporting data allow “no test” arguments to succeed. The adoption of OECD Guidelines means that the generation of test/study data is generally harmonized for global use. There are exceptions, e.g. for Japan Ames tests should be performed according to MITI Guidelines, China requires some ecotoxicological studies to be performed in authorized Chinese Laboratories. For jurisdictions of interest, tonnage per annum, intended applications/use patterns and timelines, should be decided at an early stage. Opportunities for early entry to a market through exemptions, low volume or R&D concessions should be considered, to optimize the strategy for the commercial needs of the business. The fees charged by Competent Authorities for notifications vary widely but need to be factored into an overall budget. Official English translations of relevant legislation may not be available. There is no substitute to understanding interpretation of detail via a local expert who has regular contact with the Authorities. Intertek’s global footprint and regulatory experts in key jurisdictions allows it to undertake notifications with the advantage of local presence, local language and local culture (which helps to get things done, i.e. using the right style/words in submission documents and knowing how to discuss/challenge issues with Competent Authorities). You may have a sound argument or summary of the facts, but if they are not expressed to the expectations of a particular Competent Authority, you risk delays, compromise, even rejection. A step change in notification requirements is approaching, e.g. South Korea and Taiwan, other jurisdictions are following. Being successful in export markets increasingly means understanding global chemicals management. Jeremy J Ramsden Head Regulatory Services UK, and Global Notification Projects Manager Intertek Health, Environment & Regulatory Services
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JSC INTERNATIONAL LIMITED
Regulatory challenges in the years ahead Companies are facing ever increasing regulatory hurdles which require specialist input to ensure both compliance with the law and development of regulatory competitive advantage. Over the past few years we have seen a number of major revisions to existing legislation within the EU, some key areas are summarised below:
Biocide legislation The BPR (Council Regulation (EU) No 528/2012) has now replaced the BPD and will have a significant impact on industry. The BPR requires that all suppliers of active substances are included on a list of approved suppliers published by ECHA by 01 September 2015; this means that companies that were previously not involved in supporting their active substances must now become actively involved in the regulatory process or exit the market. Another big change is that treated articles are now in scope of the biocides legislation, potentially this brings within scope a huge number of products e.g. those containing preservatives. The requirement to obtain product authorisation continues for biocidal products, practically this means that many products that were previously only lightly regulated under the old national rules in many countries will now require extensive product dossiers
to be submitted in order for products to remain on the market. Despite the fact that the BPR has only recently been introduced it is being redrafted. JSC is monitoring any changes closely.
the registration of large numbers of the smallest tonnage chemicals (1-100 tonnes/year), which creates its own challenges prompting ECHA to encourage companies to start work early.
Agrochemical Pesticides
In addition to the last tonnage phase, ongoing regulatory support will be required for existing dossiers submitted at the 2010 and 2013 registration deadlines, changes in tonnage bands, feedback on testing proposals as well as issues such as SVHC’s, endocrine disruptors and authorisation applications.
Council Regulation (EU) No 1107/2009 has introduced a number of significant changes to how agrochemical pesticides are regulated within the EU with a move away from risk based towards hazard based assessment. Like the BPR the agrochemical legislation includes exclusion/approval and substitution criteria. Uses of those substances identified as Candidates for Substitution will be subject to Comparative Assessment from 01 January 2015. The Regulation includes a requirement to consider endocrine disruptor effects. Fully agreed criteria for implementation of this requirement are now not expected to be in place before the end of 2015. In the meantime transitional measures apply.
REACH / CLP The third and final deadline for phase-in substances requiring registration under REACH (Regulation (EC) 1907/2006) is 01 June 2018. This deadline will involve
CLP (European Regulation (EC) 1272/2008) the EU’s version of GHS, will have a significant impact on preparations (mixtures) as the June 2015 deadline requires suppliers to classify, label and package according to CLP. Products already in the supply chain and classified according to the Dangerous Preparations Directive have a two year sell though to remove existing stock. Due to the ever increasing quantity and complexity of EU legislation companies are encouraged to seek regulatory support at an early stage to ensure regulatory compliance can be maintained and products can continue to be sold. JSC International Limited can support you in meeting these regulatory challenges and can supply the specialist technical expertise needed.
We provide regulatory support for: 3 Biocides 3 REACH 3 Agrochemicals JSC International, a leading regulatory affairs company, will help you to obtain regulatory approvals for all your products.
and presentations produced by the JSC team.
Our team of regulatory experts and technical specialists have a proven track record of guiding our clients to regulatory success.
Our advice is unbiased and ethical and will find the quickest and most economical route through the regulatory maze.
Visit our website to meet the team and access lots of useful and topical regulatory information; the Knowledge Library includes current legislation and guidance documents, as well as articles
Our reputation is your success JSC International Limited, Simpson House, Windsor Court, Clarence Drive, Harrogate, North Yorkshire, HG1 2PE UK
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REACH SPRING 2014
Tel: +44 (0)1423 520245 Email: enquiries@jsci.co.uk Web: www.jsci.co.uk
BPF
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The Plastics Industry perspective on REACH As the industry trade body for a manufacturing sector heavily affected by the REACH legislation the British Plastics Federation (BPF) has been at the forefront of efforts to explain the legislation, lobby for changes and engage with the plastics industry. Speaking to BPF Director General Designate Philip Law, he explained that the legislation has placed a burden on plastics companies and jeopardised the use of chemical products used as additives in plastics. This is often because the administrative burden and cost of REACH means that manufacturers of chemicals produced in small quantities can no longer justify their production.
REACH the BPF is hosting a REACH Masterclass seminar in London on 15th May. At this event attendees will explore the current state of the REACH legislation; they will learn what they need to do in the light of the evolving timetable and what the outstanding issues are.
Philip Law continued by saying that from the perspective of the plastics industry REACH is often perceived as a burdensome legislation which threatens to make the EU’s manufacturers uncompetitive in a world market.
process of ‘Authorisation’ under REACH. For example there has been a proposal to include the widely used blowing agent, Azodicarbonamide (ADCA) and the BPF has played a leading role into defending its ongoing use.
Another important issue is the listing of certain chemicals for the expensive
As part of its work in educating and informing the plastics industry about
EVENTS
www.bpfevents.co.uk
The conference will tackle the key topics in REACH today such as the potential for a registration scheme for polymers and an update on the authorisation and evaluation. The seminar will give attendees the opportunity to network with people with similar concerns and to learn what resources the BPF can offer. To find out more about the REACH seminar visit www.bpfevents.co.uk
REACH Masterclass 2014 A BPF Seminar
'A seminar exploring the impact of REACH legislation in the plastics industry' The seminar will also provide an examination of the impact of REACH on the aerospace and defence sector as well as detailed case studies on DEHP and the Authorisation process. Subjects include Where are we now and where are we headed Authorisation and SMEs Does REACH present a barrier for recycling? Price BPF Members - £199 + VAT Non Members - £299 + VAT
Date: Thursday 15th May 2014 Location: BPF House, London, EC2A 3JE Email: events@bpf.co.uk Tel: +44(0)207 457 5047 Web: www.bpfevents.co.uk
Book and find out more at www.bpfevents.co.uk
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RPA
Getting an A grade in Authorisation For the companies it affects, Authorisation is likely to be the biggest REACH challenge. But there’s no reason why it has to be – provided you stick to a few simple rules. Applications for Authorisation are on the rise. Eight were submitted last year and ECHA expects 20 more during 2014. With 151 substances on the candidate list, and new substances appearing all the time, this is really just the start. So it is no surprise that many companies are already investigating this relatively unknown part of the regulation. It is an intimidating prospect. An Application for Authorisation is both complex and costly, and most companies do not have the relevant expertise to call on. What is more, a failed Application will result in the inability to continue using the substance. So if your products are dependent on this use, you could suffer a significant blow to your business. “The Authorisation process was always designed to be challenging,” says Meg Postle, Director at RPA, a UK chemical
hazard consultancy. “The idea is to push companies towards substitution. They have to submit in-depth studies of the alternatives that should, to a large extent, pre-empt third party objections. For many companies, it will be much bigger than anything they’ve previously had to do for REACH”. RPA is working on a wide range of Applications, including six of the eight Applications relating to phthalates DEHP and DBP. In February, the company took part in the Trialogue meetings for these phthalates, which included discussion of the more than 120 comments received during the public consultation period and additional questions from the RAC and SEAC Committees. But there are encouraging signs. ECHA has said that companies can improve their chances of success by ensuring
their Applications are of a high standard. As an Application can take several years to put together, early preparation is essential. It is also important to get to know your supply chain. If it is not possible to ‘adequately control’ the risks associated with your substance, perhaps because there is no safe threshold exposure, you will need to accurately determine the impacts of a non-use scenario. Such an analysis is difficult, if not impossible, without the cooperation of downstream users.
Trusted REACH guidance Whatever your industry, your business is in safe hands with us. As trusted consultants to companies, regulators and industry associations alike, we know REACH inside out: • Authors of European Commission guidance on socio-economic analysis • European Chemicals Agency (ECHA) REACH Framework contract leaders • Authors of Applications for Authorisation for companies & consortia Give our experts a call on +44 (0)1508 528465 or email us at enquiries@rpaltd.co.uk.
Chemicals REACH Compliance Raw Materials Applications for Authorisation Nanomaterials GHS & CLP Regulation Managing Water Hazard, Risk & Safety Assessment Biocides & Pesticides Impact Assessment & Evaluation Cosmetics Stakeholder Consultation & Engagement Waste Enterprise & Industrial Policy
www.rpaltd.co.uk
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ACTA
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Think REACH Does Not Apply to Your Company? Are You Certain? Read On By Ruth C. Downes-Norriss, Leslie S. MacDougall, Gyöngyi (Pearl) Németh, M.Sc., The Acta Group According to the study, Impact of REACH on SMEs in the Netherlands,1 commissioned by the Dutch Ministry for Infrastructure and the Environment, 23% of SMEs belonging to the chemical industry are not aware that they do, in fact, have obligations under REACH. A company does not need to be an SME, however, to have the false impression that it has no obligations under REACH. This article outlines frequent misconceptions regarding REACH obligations and provides guidance to help confirm whether companies have responsibilities under REACH.
“We have already preregistered our substances.” Remember, submitting a pre-registration is an administrative task that allows for potential REACH registrants to benefit from extended registration deadlines. With the final deadline fast approaching, the expected number of unique substance registrations is estimated at 25,000 to 50,000.2 Many companies may find themselves in non-functioning SIEFs with no Lead Registrant, or with Lead Registrants who themselves are SME companies with limited regulatory and financial resources. If your company has pre-registered a substance, it is essential to check REACHIT regularly for new information on the progress of the SIEF and appointment of the Lead Registrant. If substances are considered essential within your business, now is the time to evaluate your ability to take the Lead Registrant role. It is also possible for your company to evaluate its business and determine if it wishes to continue to place its substances on the EU market. This activity should begin now so that your company can ensure compliance with REACH by the respective deadline.
“We are a downstream user, so our suppliers must register under REACH.” Even if you pre-registered your substances as a precaution, you should communicate with your supplier to request details on a substance’s registration status. More importantly, you should confirm with your supplier that your tonnage is covered by its, or its supplier’s, registration. A request for a REACH conformity/confirmation letter would suffice in this case. Remember, it does not matter where your company falls within the supply chain of a substance, confirmation of how these substances are addressed under REACH is essential. If a pre-registration or registration is not confirmed for your substances placed on the EU market at ≥1 tonne, you may have to consider an alternative supply to ensure compliance for your company.
“The SDS is the registrant’s responsibility.” The quality of SDSs has improved with significant increases in available hazard data. As a user of chemical substances, mixtures, or end products, you must understand and comply with the PNECs and DNELs/DMELs, Risk Management Measures, and Exposure Scenarios provided in the SDS within 12 months of receipt. It is essential to understand which Exposure Scenario refers specifically to your activities, potentially performing scaling calculations to ensure exposure is not higher than allowed. ECHA has recently updated its guidance on these processes.3
“We import articles; substance registration is not our concern.” Producers and importers of articles, defined at REACH Article 3, must ensure a pre-registration or registration for
1. See http://www.euconf.eu/reach2013/pdf/presentations/ eindrapport_panteia_ivam.pdf.
2. Industry submitted 3,400 substances during the 2010 registration, and 3,000 more in 2013.
substances intended for release in the article (>1 tonne) is in place and addresses the specific uses. If the substance is listed on the candidate list, ECHA must be notified of concentrations exceeding 0.1% and if ≥1 tonne. Communication obligations along the supply chain, however, are not restricted by tonnage thresholds. Producers and importers of articles will find themselves facing decisions on whether it meets the REACH “article” definition, whether there are substances intended for release, or if it is registered upstream in the supply chain for the same use. Understanding your obligations can seem overwhelming at first, but it does not need to be a long or complicated process. A good starting place is the Navigator application4 where, by answering a couple of simple questions, the system helps to identify obligations under REACH. If you have any concerns of your substance’s status or are unfamiliar with REACH expressions, a qualified consultant can assist in determining your compliance obligations. The only unacceptable option is to do nothing. REACH non-compliance can cause serious business disruption or a fine being issued by your local Competent Authority. Take the steps recommended here so you can answer with certainty whether REACH applies to your business.
The Acta Group, a scientific and regulatory consulting firm with offices in England, China and the United States, provides strategic, comprehensive support for global chemical registration, regulation, and sustained compliance. www.actagroup.com
3. ECHA, Guidance for Downstream Users, Version 2.0 (Dec. 2013), available at http://echa.europa.eu/documents/10162/13634/du_ en.pdf. 4. ECHA, Navigator, available at http://echa.europa.eu/web/guest/ support/guidance-on-reach-and-clp-implementation/identifyyour-obligations/navigator.
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REACH READY
2020 SVHC Roadmap implementation plan
By Richard Roy, REACHReady Following a commitment made by the European Commission earlier in the year to include ‘all relevant known’ Substances of Very High Concern (SVHCs) in the Candidate List by 2020, ECHA published in December an implementation plan to achieve this goal. The plan explains how the substances thought to meet the SVHC criteria will be prioritised and assessed over this period, whilst also defining the information which will be made publicly available. One of the objectives of REACH is the substitution of substances presenting significant risk with less hazardous alternatives. Steps towards achieving this aim are taken through the Authorisation process in Title VII. Authorisation requires those in the EU/EEA wishing to place on the market or use identified substances (listed in Annex XIV) to demonstrate that
the risks are adequately controlled or that there are no suitable alternatives available and that the societal benefits of using the substance outweigh the risks. The substances which may become subject to Authorisation are termed Substances of Very High Concern (SVHC) and appear on a ‘Candidate List’, updated biannually. To be included on this list, a substance must be identified as either: a category 1A or 1B carcinogen, mutagen or reprotoxin (CMR); Persistent, Bioaccumulative and Toxic (PBT); very Persistent and very Bioaccumulative (vPvB); or displaying an equivalent level of concern (e.g. endocrine disrupters or respiratory sensitisers). Following an update in December, there are now 151 substances on the Candidate List; although it is known that there are more than 400 substances fulfilling the criteria and not on the list. The 2020 SVHC Roadmap implementation plan sets out a two-phase process looking first at the screening of registration dossiers and other REACH/CLP databases for ‘known’ substances meeting the SVHC criteria, and then at the analysis of Risk Management Options (RMO) to identify those which are ‘relevant’ in the context of the roadmap. In the initial screening phase, individual activities are planned for each of the main substance groups identified,
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One of the objectives of REACH is the substitution of substances presenting significant risk with less hazardous alternatives
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however the basic approach will be the same for each. The ‘core activity’ will be the screening of dossiers for substances fully registered for non-intermediate uses, whilst a ‘supplementary activity’ will be carried out with the intention of identifying similar substances which have not been registered, or are registered as intermediates. It is expected that this activity will lead to the identification of a large number of substances; additional criteria may be developed to further prioritise those for assessment, such as include high annual volumes of use or registered uses with a significant potential for exposure. The second phase of the implementation, the RMO analysis, is undertaken with the aim of establishing whether Authorisation
REACH READY
is the most appropriate route to address the concern associated with the substance. It will be conducted on a caseby-case basis and establish: i) whether registrations include uses within the scope of Authorisation; ii) that the known uses are not already regulated by specific EU legislation that provides pressure for substitution and iii) that there is no need or basis for a Restriction and no overarching reasons as to why substitution is not the desired outcome for the substance. In order to ensure stakeholders and the public remain informed about the roadmap and implementation plan, an ‘SVHC Roadmap’ section has been added to the ECHA website. Via this section annual reports will be published, from
March 2015, providing a summary of activities carried out in the previous year as well as an outline of activities planned for the following year. In addition, a ‘Public Activities Coordination Tool’ (PACT) will be established providing substance-specific information on activities. Whilst no target figure has been set for the number of SVHCs which will be identified by 2020, it is apparent that there will be a significant number of additions to the Candidate List over the next six years, and an associated push to move those priority substances on the list to Annex XIV. Inclusion of a substance on Annex XIV, the ‘Authorisation List’, presents a potential threat to business continuity, so organisations would be advised to follow
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the progress of the roadmap closely. If you would like to know more about this area of REACH, come along to our workshop ‘The “A” of REACH: an introduction to Authorisation’ on 1 May. Please visit the training page on our website at http://www.reachready. co.uk/services_training.php to find out more or come along to Jo Lloyd’s talk on Authorisation at the Chemicals Northwest REACH conference on 4th June.
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ecotoxchem.co.uk High-level expertise rooted in the chemical industry
Integrated view of regulation from R&D to lasting regulatory compliance Informative property prediction
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Dedicated team of experienced chemists, toxicologists and ecotoxicologists
Peter Fisk Associates Ltd, Saxon House, John Roberts Business Park, Pean Hill, Whitstable, Kent CT5 3BJ UK
PETER FISK ASSOCIATES
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Prediction of chemical properties to minimise testing costs Commercial viability of chemical products is dependent on regulatory compliance, the costs of which can be considerable. Spending on compliance can be optimised to deliver safe products and efficient business practises. Targeted and strategic regulatory compliance offers a competitive advantage by optimising data generation and use, which in turn contributes to efficient spending and enhanced product value. Peter Fisk Associates Ltd. (PFA) has many years of experience in providing customised services that are underpinned by excellence in science and regulatory compliance, to meet client-specific requirements.
is necessary to conduct a data gap analysis of the required endpoints based on data requirements. Property areas where predictions can be made include physical chemistry, chemical hazards, toxicology, ecotoxicology and environmental fate. Under the REACH Regulation, data waivers are allowed for a number of reasons, which are not discussed here. Prediction of a property for REACH is not a waiver, but is a way of meeting the regulatory requirement for data, without testing. This may have technical, financial and ethical advantages. The mathematical prediction methods known as Quantitative Structure Activity Relationship (QSAR), are a vital part of reduction of testing costs. To meet regulatory requirements, QSARs must be fully-validated and usable as a part of a tiered approach to chemical property prediction. PFA works by using ‘off the shelf’ techniques augmented with projectspecific methods developed in-house. These are particularly useful when working on a specific chemical class or category.
At the heart of a cost-effective approach to regulatory compliance is the prediction of chemical properties to minimise testing costs. As the starting point, to identify where predictions can be implemented, it
The mathematical prediction methods known as Quantitative Structure Activity Relationship (QSAR), are a vital part of reduction of testing costs.
approach, and the appropriate use of property prediction within such groups, can be a useful approach to justify and optimise the application of predictive methods and read-across. This kind of approach has the scope to potentially save large amounts of money. PFA can advise on valid use of category approaches and the benefits it can bring. Property prediction forms a key part of business planning for the evaluation of a product development project. It is possible to predict the likely outcomes of key hazard properties and therefore to profile the substance before a decision to commercialise is made. The history of the chemical industry can show many examples of substances brought to the market that failed simply because they were not sustainable in terms of human health or environmental hazard and risk
Sourcing data to help fulfil the needs in the registration property set (e.g. to generate validated predictions), requires thorough searching of the literature. For example peer-reviewed chemical handbooks including references are reliable sources of physico-chemical property values. In addition, various online databases are available which allow effective searching of peer-reviewed scientific literature. A prospective REACHregistrant must establish legitimate data access where necessary, before using the data in the registration dossier. When existing measured data are not available strategic test-planning can be an effective means to reduce costs. Test planning takes into account the chemical category of a substance and maximises the value of a single study by using it as read-across to other analogous substances. A category
PFA offers services in complying with chemical legislation and advice to the chemical industry on the impact of its products and facilities, for human health and the environment. In order to achieve regulatory compliance in a cost-effective manner, an expert approach to the hazard and risk prediction is important. We offer full support in identifying the best strategy for each client and in planning an integrated and robust approach for gap analysis and testing.
Property prediction forms a key part of business planning for the evaluation of a product development project.
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BIG INTERVIEW
Making sure REACH works to your benefit As Toxicologist and Managing Director of CEHTRA, a regulatory consultancy, Peter Jenkinson has extensive experience of REACH. Here, he outlines his views on its impact. How do you think REACH has affected the sector? REACH has obviously affected all chemical companies, but the impact has been expressed in many different ways. For most it has meant that they must increase spending and recruitment in regulatory affairs at a time when the global economy is struggling and whilst the general industry public response to REACH has been cautiously positive, the private response has been less so. Inside Europe some have labelled REACH as anti-competitive and outside Europe it has been seen as a barrier to trade. Different companies have adopted different strategies; including: 1. the ostrich mentality, 2. the absolute minimum tactic, 3. the strategic approach of concentrating resources on key products, 4. the global approach of following REACH to the letter for all substances Each strategy has a risk/benefit calculation, not least in terms of the financial outlay. The majority of the larger chemical companies have taken option 3 or 4, whilst some non-European and smaller companies have gone for option 1 or 2. This is not surprising, particularly when you consider the likely resources available to these companies at the outset of REACH. Option 1 clearly has the least cost in the short-term but whether it is a truly viable option is highly doubtful. ECHA and national enforcement agencies will eventually apply the ‘no data, no market’ rule of REACH and even if this can be evaded then customers will insist on the provision of REACH registration numbers and eSDS. Legal sales of non-registered chemical products in Europe will become impossible. The second option, which essentially means to pre-register and be a dormant member of each SIEF (substance information exchange forum), and letting the other members do all the work of
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preparing the dossier, is viable but has produced some nasty surprises. The cost of the letter of access to the dossier, which is set by the lead registrant and active members of the SIEF (or consortium) can be much higher than expected, with little or no opportunity to challenge it. There is a little known element in the calculation of the cost of the LoA called “advantage compensation”, which is normally a percentage of the labour costs of the lead and active members, to take account of the fact that companies outside the consortium/SLT have been able to deploy their resources elsewhere. The dormant members of a SIEF have no control over such cost calculations, despite the “transparent” obligation in the REACH regulation. ECHA, unsurprisingly (because it is outside their mandate), has shown little interest in getting involved in financial disputes concerning the cost of LoA. Furthermore, sometimes the risk assessment excludes your particular use-scenario (because dormant members often do not share their use information with the SIEF), thereby requiring a new CSR to be developed at additional cost. The second option also includes the strategy of filling and submitting a REACH dossier by whatever means at the lowest possible cost. Dossiers have been submitted where data have been used without a valid LoA, or include non-valid read-across statements, unsupported QSARs and poorly thought out data waiver arguments. Indeed, ECHA has indicated that 70% of all dossiers submitted in 2010 are deficient. As ECHA improves its systems for the detection of invalid dossiers we can expect an increase in the number of REACH registration numbers that are revoked by ECHA because the dossiers are not compliant. Interestingly, some of those companies that followed options 3 and 4 are now beginning to realize some direct financial benefits from their activities in REACH. Those companies that are ‘data-rich’ have been able to recover some of the cost of their studies; whether old studies done for non-REACH purposes or new REACHspecific studies. Occasionally, access to studies can be sold both for the substance itself and also for use in the dossiers of one or more read-across substances, thereby giving the potential to recover more than the original cost of the study. If there are many dormant members in a SIEF then the lead-registrant may recover much of their registration costs by charging an
appropriate fee for the LoA. This has of course resulted in accusations from SIEF dormant members of profiteering by the lead-registrants!
Are all companies fully aware of REACH’s implications? The answer to this question is clearly ‘no’, although it is likely that few, if any, companies in Europe are still completely ignorant of their obligations under REACH. However, one major problem is that REACH is not static, it is evolving and companies need to be aware of this and to keep track of the changes. Areas such as nano, endocrine disrupters, authorization, etc., are in development and the REACH obligations of a particular company may change with time. Even companies that are aware of their obligations and dutifully submit their dossiers may not understand that a REACH dossier is a ‘living’ document. It needs to be maintained and updated in case new information becomes available or new uses appear that impact on the CSR.
What, in your view, have been the benefits of REACH? The chemical industry has probably benefitted from REACH in ways that it may not have anticipated. Apart from the primary aim of REACH to ensure the safety of industrial and consumer users of chemicals and to protect the environment, many companies have been forced to improve the accuracy of their inventory tracking systems. Some clients have told us that their annual tonnages were lower than their original estimates, which meant that the registration could be pushed into the next deadline. The data requirements for later deadline registrations are generally less than earlier ones, so cost is saved in these cases and the spending can be pushed into the budgets of future years. Many companies have been able to split the tonnage between different legal entities in Europe, again resulting in a reduced cost. We have seen some surprising results of the testing needed for REACH, which has required a reassessment of the hazard and risk associated with exposure to chemicals. Whilst these results may be seen as a nuisance and expensive to manage, knowledge of adverse effects is better than ignorance and in the long run it is better to know and manage the potential problems.
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About Peter Jenkinson Peter started his career in the late 70s as a sandwich student at the ICI Central Toxicology Laboratory in Cheshire, in the days when every large chemical company had its’ own toxicology and environmental research laboratory and in-house experts. Following a spell at BIBRA, where he did a PhD in reproductive/ genetic toxicology, he joined what was at that time, a small CRO in the Midlands called Safepharm Laboratories. He grew the Genetic toxicology group into a team of more than 30 by the start of the new century. Peter was an active member of Genetic toxicology societies in the UK and Europe and, in a small way, helped to develop the assays and testing strategies used in regulatory testing today. In 2001, he joined the Board of Directors at Safepharm and helped steer the company to become a niche CRO serving the chemical industry worldwide. In July 2007, just before the economic crisis hit the world economy, Safepharm Laboratories was acquired by Harlan Laboratories, which also owned a number of other CRO laboratories around the world. At the end of 2009 a number of senior members of the team were made redundant and Peter found himself on the job market for the first time in more than two decades.
Peter Jenkinson Toxicologist and Managing Director of CEHTRA, a regulatory consultancy
Another benefit, depending on your point of view, is that a lot of companies have taken the opportunity to stop the production of low-volume products, low-margin products and dangerous chemicals. Although it must be said, that this has caused some headaches for the downstream users that have been forced to identify alternative suppliers or raw materials. Finally, there is the almost impossible to verify claim that society overall will benefit by a reduction in health care costs resulting from lower exposure to hazardous chemicals.
Are there drawbacks to REACH? Industry has maintained that the cost of REACH will have a negative financial
impact on European manufacturers in comparison with their competitors outside of Europe, and may even result in the ‘export’ of chemical manufacturing capacity. Many would also argue that it has caused the loss of supply of ‘orphan’ low-margin products and it is difficult to know what may be the eventual economic impact of such changes. European industry may also find it difficult to compete with non-European manufacturers of articles who may import such products without any obligations under REACH. However, other countries around the world are looking to REACH as a model for their own regulations and European industry may look back and see REACH as a great advantage by allowing them to be ahead of their world-wide competitors.
He was fortunate to have several offers on the table within a short time, but he chose to join CEHTRA, the biggest consultancy of its kind in France. He opened their UK agency in 2010 and was made CEO of CEHTRA a year ago and divides his time between Bordeaux and Nottingham, still finding time to practice his first love, toxicology, by monitoring studies, advising clients on data interpretation, managing ‘positive’ genetox data, etc. A lot of his consulting time is taken up working on REACH projects.
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Full and complete services to help companies comply with their regulatory obligations Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) • Regulatory strategy and advice • SIEF and consortia management • Data evaluation and gap analysis • Study placement and monitoring • IUCLID dossier preparation and submission • Chemical safety reports • Evaluation and authorisation services • CLP and extended safety data sheets • Only representative and third party representative services
Worldwide Notification of New Chemicals • Extensive experience of all chemical regulatory schemes • Network of local agents • Development of harmonised notification strategies • Inventory searches and amendments or additions to inventories • Development of global intelligent testing strategies • Preparation of dossiers and risk assessments • Pre and Post notification support • Classification and labeling • Tracking of emerging issues and developing notification schemes
Offices in the UK, USA, Switzerland, Germany and China +44 (0) 1332 868000 • info@uk.exponent.com • www.exponent.com
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H2 COMPLIANCE
So Many Dossiers……So Little Time? For many companies handling chemicals in the EU, pre-registration in REACH IT between June and December 2008 may seem like a distant memory. At that time, with the final phase-in deadline a decade into the future, industry could have been forgiven for thinking that there was plenty of time to complete their joint registrations. The reality is, the half-way point is almost upon us. Initially, over 2 million pre-registrations for over 150,000 phase-in substances were submitted by Industry; however, the European Chemicals Agency (ECHA) later estimated the total number of substances to be registered by 2018 would be a more conservative 30,000. To date, just under 12,500 unique substances have been registered representing almost 50,000 industry submissions. ECHA has yet to officially estimate the remaining number of substances to be registered but this data suggests that at a minimum a further 17,500 substances equating to 70,000 industry dossiers (based on an average of 4 member registrants per substance) will be prepared and submitted to ECHA by the deadline. ECHAs forecast for submitted registrations for 2013 was only marginally away from what was actually received. Therefore it is reasonable to expect that that 2018 will not be different. It is also widely accepted that registrations for this deadline, (>1tonne per year) will largely be submitted by Small Medium Enterprise (SME) and this presents many new challenges. It is time to consider your registration strategy and plan for 2018.
Industry must work with, not against time While the data requirements for member dossiers are not extensive, there are many external factors that could impact upon a submission. At the onset, a member dossier cannot be submitted without a lead dossier in place. Many Substance Information Exchange Forums (SIEFs) have yet to appoint a Lead registrant and in many other cases the lead has resigned in the period since the initial submission. Contractual arrangements within the SIEFs need to be in place well in advance of any submission. It is important for potential registrants to stay informed about the activity within the SIEFs, be aware of the status of both the lead registrant and lead dossier. ECHAs dossier evaluation decisions may already be impacting the lead dossier and therefore may impact on a members ability to submit on time. ECHA has always specified that consistent substance identification is the foundation of REACH. In order to ensure that the correct data sharing arrangements are in place within the SIEF, each registrant must submit a unique set of analytical data for the substance as manufactured or imported. Recent reports from the Agency cite substance identification as one of the most commonly detected inconsistencies within registration dossiers. Moves are afoot to ensure submissions contain accurate analytical data and correct substance identifiers prior to submission. Where such inconsistencies are
encountered during compliance checks, registrants have been requested to update their data. It is important therefore that this data is accurate the first time. The projected number of registrations has the potential to place enormous pressure on industrys capacity to complete or have this testing completed ahead of the 2018 deadline.
Lessons and best practices learned Since the beginning of the REACH registration process, many hard lessons have been learned as industry grappled with IUCLID 5, substance identification, SIEFs and substance sameness rules. With ongoing updates to registration rules and ECHAs IT tools, failure in some cases of the Lead to submit the dossier on time and requests for further information from the regulatory authorities, compliance may seem like a moving target. In these dynamic times, we at H2 Compliance are confident that our Registration team with over 6 year’s registration experience can support your registration needs to 2018 and beyond. Speak to us about tailored registration programmes, laboratory testing oversight, substance identification and sameness determination and dossier build services. It’s time to REACH for 2018.
‘We have so much time and so little to do. Strike that, reverse it’. Roald Dahl 20
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Your partners in all aspects of REACH Proven experience and reputation H2 Compliance is the key support partner for over 150 companies including many EU and US blue chips. Sectors are diverse and include Chemicals, Cosmetics, Pharmaceuticals, Fine Chemicals, ICT, Medical Devices, Petroleum, Mining and Metals. Services range from comprehensive stewardship solutions, provision of software services, Only Representative services, Dossier construction, PIFs/CPSRs, Labelling, SDS Authoring and Translation Services. H2 Compliance has been awarded the REACH Ready Mark of Approval for quality of REACH services and recognized by Deloitte as one of the fastest growing technology companies in Ireland during 2013. The proliferation of worldwide chemical regulations, namely REACH, Cosmetic Regulations, Biocides, GHS and CLP has brought about a paradigm shift in the production, trade and use of chemicals, be it substances, mixtures or in articles.
Only Representative REACH requires all companies manufacturing or placing a substance on the EU market in quantities greater than one tonne per annum to register that substance with the European Chemicals Agency (ECHA). For legal reasons, only companies with a legal entity in Europe are allowed to submit a registration; however, non-EU companies may use their Importer or opt for an Only Representative (OR) to register on their behalf should they so choose.
irrespective of tonnage and placed on the market in the EU, must be notified to ECHA.
element1 for Management Information Systems
REACH Registration Dossiers REACH registration requires the submission of comprehensive documentation outlining the intrinsic properties of the substance, its hazards, uses and proposed risk reduction measures. Due to the workload involved, REACH provides for a phased period of substance registrations through extended registration deadlines. H2 Compliance has successfully prepared Registration Dossiers of all types.
Other Services Biocides The Biocidal Products Regulation has replaced the Biocides Directive as of 1st September 2013; this legislation places direct obligations upon manufacturers and importers who place either biocidal substances or products on the EU market. Legal persons who wish to place biocidal substances and/or products on the EU market must apply for Authorisation to do so from the European Chemicals Agency, in conjunction with Member States. Cosmetics The new Cosmetics Regulations place obligations upon manufacturers and importers who place cosmetic products on the market in the EU. The main purpose of the regulation is to ensure a high level of protection of human health, whilst enabling the proper functioning of the EU Internal market.
H2 Compliance has built a bespoke online management information regulatory compliance tool for service delivery. The service is available as “Software as a Service” and is available to clients on a 24/365 basis. • Directory of all entities, substances, projects, products and CLP substances • Automatically track every substance for its presence on dangerous substance lists: ECHA Candidate, ECHA Authorization, REACH restriction and SIN lists amongst others. • Email function to issue mails to all contacts or to a filtered list • Build and store information on product composition and calculation of tonnages in supply chain • Send tailored email campaigns to entities and EU Downstream Users • Creation of tailored certificates of declaration for use on demand and distribution by email
Unit 14 D Nutgrove Office Park Nutgrove Avenue Rathfarnham Dublin 14 Ireland Tel: +353-1-298-9146 Mobile: +353-87-204-5478 Email:grant.kinsman@h2compliance.com www.h2compliance.com
Classification, Labelling and Packaging (CLP) In January 2009, the EU’s Classification, Labeling and Packaging Regulation (CLP) entered into force and introduced a new method of classifying and labelling chemicals based on the United Nations’ Globally Harmonised System (GHS). There are transitional requirements until 2015 for classification and labelling of substances and mixtures in the EU. As part of the Regulation, any substance that is classified as hazardous under CLP,
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REACH READY
Dossier evaluation: how compliant are you?
By Lisa Allen, REACHReady Dossier evaluation is carried out by ECHA and seeks to instil confidence in the compliance of registrations. By the end of 2013, the Agency had completed compliance checks on 1,130 of the 19,772 registration dossiers (5.7%) submitted for the 2010 deadline. Earlier this month ECHA announced that 69% of the evaluated dossiers were found to be non-compliant. The most common shortcomings were deficiencies in the substance identification information, and insufficient justification where studies had been waived or where information was missing from the Chemical Safety Report. This article explains dossier evaluation and how we can help.
Dossier selection process REACH requires ECHA to evaluate at least 5% of the dossiers submitted per tonnage band, but the Agency may examine any registration dossier to ensure that the contents are in compliance. In this first series of dossier evaluation, the Agency used both random selection and electronic concern-based screening methods to identify dossiers, either for overall or for targeted compliance checks. In an overall compliance check, ECHA looks to verify that the information necessary for the safe use of the substance
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is part of the registration dossier. For the targeted checks, the focus is on specific parts of the dossier. ECHA may escalate a targeted compliance check to an overall check if significant non-compliance which requires further assessment is identified. However, registrants are not routinely informed that their dossier has been selected for evaluation.
Results of dossier evaluation There are three possible outcomes: a decision requesting more information, a Quality Observation Letter (QObL) recommending improvements, or no registrant action is required. QObLs and decisions are delivered electronically to the registrant’s REACH-IT message box; unfortunately ‘no action’ results are not currently communicated to the registrant, positive feedback which could prove useful. While a QObL is not a formal part of the legal text it is a pragmatic approach taken by ECHA to indicate where the registrant can improve the dossier. The QObL also suggests a deadline for the voluntary update, normally between six and twelve months. The relevant Member State Competent Authority is informed; follow-up action is monitored by ECHA and reported to the Member State. In the case of missing information, a draft decision triggers a more formal process. The registrant can participate in a conference call with ECHA within 10 days, and must submit any comments it has on
the draft decision within 30 days. A Member State review follows: where amendments to the draft decision are proposed there is a second 30-day commenting round for the registrant, followed by a 60-day period for the Member State Committee to seek agreement on the decision. If there is disagreement in that Member State Committee the European Commission will take the final decision; where there is unanimous agreement, or no proposed amendments, the final decision is taken by ECHA.
What can you do? If you have already registered and have received a final decision you must submit the required information to ECHA in an updated dossier by the deadline set. If the decision is still in draft, the commenting procedure may still be open to you – keep an eye on the dates and the information in your REACH-IT inbox! We recommend making use of the conference call with ECHA as it can resolve many issues raised by the draft decision. We also suggest that you keep a copy of any comments you submit via the web-form. Where a lead registrant receives a draft decision relating to shared information they should inform the members of the joint submission as soon as possible. Joint registrants are obliged to contribute to the shared costs arising directly from
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Dossier evaluation is carried out by ECHA and seeks to instil confidence in the compliance of registrations
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evaluation, such as the commissioning of new studies, in order to maintain their registrations. If shortcomings in the quality of your dossier were identified, but the required information was deemed to be complete, you should have received a QObL – prompting you to make a spontaneous update. Even if you don’t have a registration obligation until 2018, the results of this
first round of dossier evaluation should help you improve your dossier to avoid formal decisions or Quality Observation Letters in the future.
Help from REACHReady Whether you have already registered or still have an obligation, we will be running regular – Maintaining your REACH Registrations – workshops during 2014 to help you understand dossier quality requirements and the implications of
evaluation and CoRAP. The day is designed to help you understand what action you need to take to maintain your registration dossier and ensure that you can achieve requests made by the authorities. Please visit the training page on our website at http://www.reachready.co.uk/ services_training.php to find out more or speak to Jo Lloyd at the Chemicals Northwest REACH conference on 4th June.
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REACH Compliance
…we’re here to provide vital support
Access your free REACH and CLP guidance now: www.stewardshipsolutions.co.uk
The leading REACH and CLP Specialists LOA Valuations
Lead Registrations Supply Chain Compliance Auditing Safety Data Sheets Hazard classification reviews Opt-out Registrations Authorisations Strategy & Planning Downstream User Support Only Representative Services Training and more… Joint Registrations
We will be using Stewardship Solutions again in the build-up to the 2018 deadline UK SME chemical manufacturer
e: chriseacott@stewardshipsolutions.co.uk t: +44(0)1706 220901 m: +44(0)7834 676908
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Preparing my SME business for the 2018 REACH deadline Complying with REACH is a cause of much anxiety to SME businesses. The costs of compliance can be exorbitant and may threaten their very existence. Why is this, given that SMEs benefit from reduced ECHA registration and other fees? It is important to accept that the costs of REACH need sharing across industry. Historically, larger organisations have spent a lot of money on substance safety assessments from which SMEs have often benefited free-of-charge. Going forward, it is not unreasonable to expect SMEs to shoulder some of this financial burden in a fair manner. The problem lies with those aspects of REACH which the legislators handed over to industry to manage, where the term ‘fair’ will take on different meanings depending on your viewpoint. For example, did ECHA really expect ‘fairness and transparency’ to be the universal norm in REACH consortia, which largely operate as monopolies, charging essentially what they like for Letters of Access (LOA)? We have seen huge variability in LOA charges. Some are fair, but many are excessive, even extortionate. Under these circumstances, what are SMEs to do?
Choose your Consultant wisely Costly errors are being made by inexperienced SME businesses and poorer consultants in their approach to REACH compliance. When choosing your consultant, investigate their experiences of working with SME businesses. Ask for client testimonials. Does the consultant have in-depth knowledge and experience of REACH? Do they offer lowest-cost compliance options? Do they know how to value LOA charges, and have they ever negotiated with consortia to reduce these? Can the consultant perform optout registrations? Be wary of consultants who do not have the will or capability to defend your interests in the event you come up against unfair consortium practices.
Check SIEF & Consortium Agreements carefully If you choose to engage actively in a consortium, or buy a LOA in order to complete a Joint Submission registration, you will be asked to sign an agreement. Usually running to many pages and often containing a lot of legal language and industry jargon, it is important to resist the
temptation simply to sign the agreement and hope you are not disadvantaged. There could be clauses which compel you to contribute to future, as yet unknown costs, even though these may not be justified. Does the agreement make it clear what you are getting for your money? Some LOA documentation is poor value for money and requires significant rework. Some consortia are known to have undertaken unjustified animal testing – do you want to be associated with this? Don’t sign agreements or pay the consortium anything until you know exactly what you are getting for your money. If necessary, get expert advice. Preferably from skilled REACH practitioners, who can properly identify the potential traps in agreements.
Plan ahead Some SMEs say they will cease trading by the final REACH deadline of 31 May 2018, without bothering to assess if this is warranted or not. Others will continue to ignore REACH until it becomes necessary – by which time they could be in serious trouble. The positive news is that many SMEs are planning now for the final deadline, and there is good reason for this. Most substances placed on the EU market have yet to be registered and many more SMEs will be shouldering Lead Registrant responsibilities than was seen at the previous 2010 and 2013 deadlines. They will be inexperienced and require significant consultancy support over one
or two years. Furthermore, all SMEs need to establish a REACH plan and budget to identify registration and other obligations and costs, and the ‘who, what, when, how’ practical steps to achieve compliance. Preparing your SME business for the 2018 REACH registration deadline can be a daunting prospect, and we hope our suggestions are helpful to you. Please contact us if you would like to know more. We look forward to hearing from you. Dr. Chris Eacott is a chemicals management expert with over 30 years’ experience gained in the chemical industry. He founded Stewardship Solutions in 2003 and supports the REACH/CLP compliance needs of EU and non-EU companies in a wide range of industry sectors. Stewardship Solutions is a REACHReady-approved service provider. e: chriseacott@stewardshipsolutions.co.uk t: +44(0)1706 220901 m: +44(0)7834 676908 www.stewardshipsolutions.co.uk www.ReachRegistrationsSupport.com
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Scientific & Regulatory Affairs Consulting REACH 2018: A Deadline not to Underestimate info@bluefrogscientific.com www.bluefrogscientific.com
Chemicals I Human Pharmaceuticals I Veterinary Medicines I Agrochemicals I Feed Additives
BLUE FROG SCIENTIFIC
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REACH 2018: A Deadline not to Underestimate Strategy
By Damien Carson Director of Blue Frog Scientific
access to these resources will need to be planned and budgeted accordingly.
The phase-in period of the REACH Regulation presents a number of challenges to the chemical industry. Previously, these challenges included the preparation of complex registration dossiers for specific deadlines in 2010 and 2013 for the so-called “high tonnage” chemicals.
Annex VII data requirements comprise a minimal set of physico-chemical, toxicological, ecotoxicological and environmental fate studies. Annex VIII data requirements include a set of mandatory tests, in addition to tests that may be triggered, or waived, by certain properties of a substance. Expert knowledge is required to aid the decision-making steps during a testing programme. Testing programmes must also be meticulously designed considering the exposure scenarios and risk characterisations that must be prepared for each identified use of a substance. Poor quality data can make proving safe use in a risk assessment an extremely difficult task.
The forthcoming deadline in 2018 will present a slightly different undertaking than those previous; for many companies it will require the greatest number of registration dossiers to be submitted, for substances manufactured or imported in the 10-100 and 1-10 annual tonnage bands.
Lead Submissions For Lead Registrants, significant data sets will still need to be generated meeting strict quality requirements in accordance with Annexes VII and VIII of REACH (See below Table). Additionally for substances in the 10-100 tonnes per year band, chemical safety assessments covering the entire life cycle of a substance will have to be conducted. Preparing a lead registration dossier also carries a substantial accounting and administrative burden, as the lead dossier will have to be made available to all other potential registrants intending to prepare joint submissions, supported by a fair and transparent cost sharing mechanism. For some companies, the specialist skills and resources needed for Lead Registrant status may not be readily available, and Physico-Chemical Properties
Joint Submissions
1. How many substances need to be registered? 2. Is there a Lead Registrant for all of the substances in need of registration? 3. Do my personnel have the necessary skills and experience readily available to complete substance registrations? 4. How much will each registration cost? 5. How many registrations can realistically be completed per year? 6. Which departments within my organisation will have to support the registration (e.g. legal, purchasing, signatories)?
Companies intending to prepare joint submission dossiers have to rely on the communications made by the Lead Registrant concerning, in particular, when access to the lead dossier will be available and at what cost. Additionally, joint registrants may have to perform their own chemical safety assessments, if the Lead Registrant does not provide a chemical safety report covering the joint registrant’s identified uses as part of the Letter of Access. More worryingly for smaller companies with limited resources, there are many 2018 phase-in substances without a Lead Registrant. Should a volunteer for this role not step forward, these substances risk being lost from the market.
Toxicological Properties
The best strategy for successfully meeting the 2018 REACH deadline is simple; planning! It is essential that the following considerations are given to a registrant’s 2018 portfolio:
With the above information, a strategy for registering a company’s 2018 portfolio can be prepared, including an estimate of resource requirements and of course, costs. Blue Frog Scientific Limited is a leading UK-based scientific and regulatory affairs consultancy supporting Clients in all major sectors of the chemical industry. www.bluefrogscientific.com
Ecotoxicology & Environmental Fate
Annex VII Data Requirements (1-10 tonnes per year) † • Melting/Freezing Point • Boiling Point • Relative Density • Vapour Pressure • Surface Tension • Water Solubility • Partition Coefficient (n-octanol/water) • Flash Point • Flammability • Explosive Properties • Self-ignition temperature • Oxidising Properties • Granulometry † - If endpoints are to be waived, a comprehensive waiver argument needs to be included in the waiver justification
• Skin Irritation or skin corrosion • Eye Irritation • Skin Sensitisation • In vitro gene mutation study in bacteria • Acute toxicity by Oral Route
• Analytical Method Validation • Short term toxicity testing on invertebrates • Aquatic Plant growth inhibition test • Ready Biodegradability
Annex VIII Data Requirements (10-100 tonnes per year) † • In vivo skin irritation • In vivo eye irritation • In vitro cytogenicity study in mammalian cells or in vitro micronucleus study • In vitro gene mutation study in mammalian cells • Acute toxicity by Inhalation • Acute toxicity by Dermal Route • Short term repeated dose toxicity study (28 day) • Screening for reproductive/developmental toxicity • Assessment of toxicokinetic behaviour
• Short term toxicity testing on fish • Activated sludge respiration inhibition test • Hydrolysis as a function of pH • Adsorption/desorption screening
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Sufficient capacity to REACH your compliance needs? The next phase-in deadline for REACH is May 2018. This might seem like a date looming off into the distant future, but experienced has shown that time passes swiftly in the world of regulatory compliance and there is a finite number of reputable service providers with a limit on capacity. It might be essential to start sooner than you think to meet your REACH obligations and the continuation of your business opportunities. At the start of the REACH process CEFIC 1 estimated some 30,000 individual phasein substances would require registration by 2018, with an estimate of around 6,000 substances to be registered by the 2013 deadline. Following the 2013 registration deadline, ECHA2 released statistics which demonstrate that these estimates were remarkably accurate, with over 6500 phase-in substances having been registered since REACH entered force. ECHA’s figures also demonstrate an additional trend that was not necessarily foreseen; this being the concept of member registration. In fact for each substance that has been registered there was an average of 5 member submissions, under the OSOR3 principle of the regulation. Anecdotally, though, many of these substances have been registered using a significant amount of existing data and with a mixture of in-house and third party regulatory service providers. On the basis of the original CEFIC estimates it is anticipated that over 20,000 chemical substances are likely to require registration by 2018. A portion of these substances might well fall off the market, due to companies not supporting a registration. Equally a portion of these substances may have fewer registrants, being smaller volume, probably with more specialised uses. A much greater proportion of these substances are, nevertheless, likely to have no existing data available leaving
Registrations
Unique Substances
TOTAL
38095
7506
phase-in
35891
6545
non phase-in
2204
961
REACH dossiers (registrations by companies from 1st June 2008 - NONS excluded), published by ECHA registrants with a requirement to fill data gaps. These gaps may be filled by new data from testing, by grouping and read across to other substances, by literature data or by QSAR4 , as appropriate. All of these possibilities to complete the data gaps rely on there being adequate capacity with the testing and regulatory services industry to undertake and complete the requirements. Herein lies a very pertinent threat to a registrant’s ability to complete registration in time for the deadline, given that there might be as many as 20,000 substance registrants competing for the same services. There is an extremely high likelihood that demand will very quickly outstrip capacity for the support services. This also ignores the fact that many registrants will need to prepare and submit member registration dossiers for those substances that have already been registered.
dossier just prior to the deadline. There is no guarantee that someone else will have registered your substance(s), regardless of any stated intentions. There is even no guarantee that a reliable service provider will have the capacity to assist with completing your registration. It is imperative that company’s start now to assess their REACH obligations, to determine their position in the supply chain, to assure themselves that they can hit the target and also spread the cost of compliance. Work up of detailed requirements and the prioritisation of tasks now might just be the essential steps to ensuring that you don’t miss the 2018 deadline. And remember – 2018 is a deadline not a timetable.
There will be registrants for whom completing registration is imperative to the continuation of business. In such a case, missing the deadline and being forced to cease supply could be disastrous. Don’t be fooled either into thinking that someone else will take the lead to allow your company to simply submit a member
1 The European Chemical Industry Council, http://www.cefic.org 2 The European Chemicals Agency, http://echa.europa.eu 3 One Substance One Registration, as detailed in Article 11 of the REACH legal text 4 Quantitative Structural-Activity Relationship, regression or classification models for the chemical and biological sciences
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BAYTOUCH
Managing Supply Chain Chemical Compliance in the Decade of Regulatory Affairs Baytouch’s CEO Malcolm Pollard looks at the long-term impacts of REACH, the costs and opportunities it creates. It seems like only yesterday that the EU’s REACH Regulation, billed at the time as the World’s most ambitious chemicals legislation, came into force in 2007. At the time we were all anxiously considering the impact of the first registration deadline in 2010, and with such high stakes in play to get those fundamental high tonnage chemical substances through, had little time to consider what impact the phased registration process may have on the chemical manufacturing and handling supply chain in the longer term. Today, the wider impacts of REACH and other regulatory controls are now beginning to be felt within businesses of all sizes, and are affecting how products are purchased, manufactured, formulated and sold. Trade associations with a high number of small and medium size (SME) members, have commented on how the costs of REACH have fallen disproportionately on SMEs. So, what strategies can businesses adopt to deal with the tsunami of compliance paperwork, which affects all businesses but tends to be relatively more burdensome for SMEs? Satisfying REACHs objectives means unprecedented communication flows, all to be managed and directed, and additional data to be collected and stored. This exchange of standardised information applies in varying degrees to many businesses; manufacturers and importers, formulators, article manufacturers, distributors and retailers, especially those who import to the EU.
The key to controlling all of this is to have robust and structured business processes. Take a straightforward situation of a typical distributor, sourcing products to repackage and sell on. Some of the information they will need to collect includes: • SDSs from different suppliers of the same product, all to be reviewed and possibly re-edited before being made available to customers; • Multiple declarations of conformity which may be by supplier, by product, by product batch, and may have limited validity. Research carried out by Baytouch over the last 2-years has shown that many SMEs, especially those with lean sourcing and supply operations, are finding themselves especially vulnerable. The low-tech solutions used to address ever-increasing paperwork are typically PC-based office tools and filing cabinets, in conjunction with their accounts software. These are fast approaching breaking point and pose a long term threat to business viability because they are neither robust nor transparent enough to meet regulatory requirements.
Yet your business’ license to operate requires you to ensure that all of the above compliance information is collected, validated, stored and current. It is worth considering the opportunities these businesses might realise from improving processes to cope with the sheer volumes of compliance paperwork. For many, existing data handling processes are frequently manual and handled by small regulatory teams (sometimes 1 person wearing several hats). They can require the access and storage of information in differing formats and in different places. Periodic updates to some documents may be required but not automatically generated, nor visible to others in the organisation. Companies that have invested in Enterprise Resource Planning (ERP) systems won’t find it without pain to accommodate some centralised document storage and process automation into these. But once set up, the operations are more easily assimilated into everyday business management. For most SMEs on the other hand, the cost of such systems is way off the affordability scale. However, this needn’t and shouldn’t be a barrier to developing a structured approach to the long term storage and accessibility of compliance information. Nor does it preclude an integrated, technology-enabled solution. The benefits cannot be ignored; business risk is reduced and environmental impacts are minimised. Supply chain transparency and information at your fingertips will in turn create enhanced opportunities by being able to satisfy the information requirements of your customers (and those of the regulator, should they come calling). Baytouch has developed a cloud-based software solution, ProductTraq, which addresses these supply chain compliance and data storage challenges. We are presently engaging with a number of trial customers to develop case study materials and industry best practice exemplars. I look forward to sharing the outcomes of this in future issues. If you would like more information on ProductTraq or are interested in becoming a triallist, please email malcolm.pollard@ baytouch.com or connect with Malcolm on Twitter (@malcolmpollard) or LinkedIn (linkedin.com/in/malcolmpollard).
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A scientific and regulatory consulting firm providing strategic, comprehensive support for global chemical registration, regulation, and sustained compliance. • Global Chemical Notification (North and South America, Europe, Asia, Australasia) • Biocides, Pesticides, Antimicrobials, Nanomaterials • Hazard Communication, GHS Classification and Labelling, SDS • Global Agent and Representative Services • Testing Strategy and Co-ordination • Toxicology & Ecotoxicology • Transport and Dangerous Goods • Dossier Preparation and Expert Review • Data Compensation
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CEHTRA guarantees its regulatory services with: High scientific quality – Optimized cost – Respect for your deadlines CEHTRA is a major player in REACH. Our track record: REACH 2010: 3% of registered substances REACH 2013: 6% of registered substances We are ready to manage a bigger percentage for the 2018 deadline. 70% of our 2018 contracts are repeat business with blue-chip multinationals. If you need a reliable, high quality consultancy then contact us for more information or a cost proposal for your next project