Reach - A Special Focus 2 by Distinctive Media Group Ltd

REACH

two

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

ACTA GROUP

The next step for REACH: Lessons learned and tips for success regarding authorisation As all chemical companies doing business in the European Union (EU) should know, the “A” in REACH stands for Authorisation, the last of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) processes to be implemented since the regulation entered into force in 2008. Authorisation aims to “assure that risks from substances of very high concern (SVHCs) are properly controlled and that they are progressively replaced by suitable alternatives.” See the European Chemicals Agency’s (ECHA) website at http://echa.europa.eu/regulations/ reach/authorisation. On February 1011, 2015, ECHA convened a “Lessons Learnt on Applications for Authorisation” conference with participation of industry, non-governmental organizations (NGO), the European Commission (EC), and Member States’ competent authorities to share their experiences of the Authorisation process. To find out more about the ECHA conference, please visit http://echa.europa.eu/view-article/-/ journal_content/title/conference-onlessons-learned-on-applications-forauthorisation. As the Authorisation process is still relatively new, and all parties involved are on a learning curve, a significant part of the conference objective was to allow for feedback on the current Authorisation process and receive recommendations for further improvement. The Acta Group (Acta®) assists many clients in developing effective business strategies around SVHC issues, and Acta’s Pearl Németh, M.Sc., was among the 150 applicants selected to participate in the conference. This article reviews the path to Authorisation and reports on key developments shared during the ECHA conference.

Roadmap to Authorisation The route to Authorisation begins when a Member State proposes that a substance be identified as an SVHC, and evaluated for placement on the SVHC Candidate List. Substances on the Candidate List are prioritized by ECHA to determine which should be placed on the Authorisation List

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Substances requiring Authorisation cannot be used or placed on the market after a set date (sunset date) without an Authorisation or an exemption for that particular use.

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(Annex XIV of REACH), and thus become subject to Authorisation. Substances requiring Authorisation cannot be used or placed on the market after a set date (sunset date) without an Authorisation or an exemption for that particular use. While only three Authorisations have been granted by the EC (DBP for SasolHuntsman, DEHP for Rolls-Royce, and both DBP and DEHB for Roxel), many more substances and applications are in the queue awaiting review and comment. According to ECHA’s SVHC Roadmap to 2020 Implementation Plan, ECHA is committed to having “all relevant currently known SVHCs included in the Candidate List by 2020.” This will mean significant

work, costs, and commitment of resources from both industry and regulatory bodies. Preparing an Application for Authorisation (AfA) starts with considering if a safe threshold exists for the particular hazard for which the substance has been listed on the Authorisation List. If the answer is “yes,” then the applicant must demonstrate the risks are adequately controlled in the submitted Chemical Safety Report (CSR), commonly referenced as following the “adequate control route” of Authorisation application. An Analysis of Alternatives (AoA) must also be submitted, and if that identifies a technically and economically feasible alternative, then a Substitution Plan must be submitted as well. If ECHA’s Risk Assessment Committee (RAC) decides the risks are not adequately controlled, Authorisation might still be granted if the socio-economic benefits outweigh the risks of continued use that can be documented in the SocioEconomic Analysis (SEA), assessed by the Committee for Socioeconomic Analysis (SEAC). If, however, no safe threshold is believed to exist, Authorisation may only be granted if the socio-economic benefits outweigh the risks and there is no suitable alternative (SEA-route). In this case, the application must include a CSR, AoA, and SEA. Persistent bioaccumulative and toxic (PBT) and genotoxic substances usually follow this route. For substances that are classified as endocrine disruptors (ED), it is up to the Applicant to demonstrate if a safe threshold exists and to then determine that threshold, which will be assessed or overruled by RAC. After submitting an AfA in a so-called “submission window,” the road is still long before the EC will grant or refuse the Authorisation, taken into consideration of the RAC and SEAC opinions.

ACTA GROUP

Notes from the February 10-11, 2015, ECHA “Lessons Learnt on Applications for Authorisation” Conference Geert Dancet, Executive Director of ECHA, opened the Authorisation workshop with the message that, like the registration and evaluation processes, “the ‘A’ of REACH is equally working well.” According to Thierry Nicot from the Risk Management Implementation Unit of ECHA, ECHA received no AfAs for about 50 percent of substances on the Authorisation List for which the Last Application Date (LAD) has past. This demonstrates to ECHA that companies are no longer using these substances. Furthermore, about 50 percent of the submitted AfAs are so-called “bridging Authorisations,” which means companies have already identified a feasible alternative, but need time to transition to the alternative. From these numbers, ECHA drew the conclusion that the ultimate goal of Authorisation, which is substitution, works well. The main message from industry emphasized the business uncertainty arising from the Authorisation process. Even with Authorisation granted,

companies cannot be sure of the length of the review period (4-12 years), which hampers investments. Presenters from industry reiterated this message. To ease this burden and uncertainty, a joint task force comprised of ECHA and EC members is working to streamline and make transparent the process, with emphasis on special cases subject to Authorisation such as low volume and legacy spare parts. Anna Borràs, Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (Growth) of the EC, confirmed the aim of the joint task force is to avoid creating a system where economic imbalances are perpetuated to the detriment of any business sector. With more experience being gained in industry and among consultants, the average cost of preparing an application for Authorisation has fallen by about 30 percent and is now below 200,000 Euros per applicant and use, as Geert Dancet said in his opening remarks. Björn Hansen, Deputy Head of the Chemicals Unit, Directorate-General Environment, EC, provided concluding remarks for the two-day event. Hansen’s remarks emphasised the need for advocacy:

“Companies that can demonstrate a well documented business case will (be strong candidates for receiving an) authorisation.” Authorisation applicants were, however, advised to start the AfA process as early as possible, as the preparation of AfA is complex and time-consuming. It is also a one-shot process: companies have to get it right on the first try.

Regulatory consulting firm Acta, with offices in Manchester, Washington, D.C., and Beijing, as well as in Brussels through partner EPPA, offers comprehensive REACH services, including assistance in the strategic development and implementation of Authorisation applications.

By Gyöngyi (Pearl) Németh, M.Sc (left) and Leslie S. MacDougall

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ITAL LOGISTICS

Putting it off Despite signing the order form on the 30th January, I’ve been putting off writing this particular editorial. A variety of reasons no doubt, but now, with a day or so left, I find myself fumbling around in haste trying to write something of either use or interest. It is human nature to set things aside in favour of something that is easily dealt with, especially when there is a lead time of a couple of months to play with. But something always crops up, and before you know it, you are left ‘chasing your tail’ and scrambling something together like this. Or even worse, ignoring it and repeating ‘what I did last time’ because it was simply so much easier. And that’s my point. Putting it off. There are some things which you simply can’t put off. It’s hard not to sound patronising, and believe me, it is not my intention. But ignorance simply isn’t bliss, especially where dangerous goods are concerned. After all, dangerous goods are what they say they are – dangerous. We all want to comply, don’t we?

Especially here in Britain. We even plant our potatoes in orderly lines. However, endless regulations, written in greyish ink, make it extremely difficult to do so. Interpretation. Application & Compliance. Enforcement. Money. Ah yes… money. Which side of the bed did I get out of this morning you may be wondering? As a freight forwarder who wants to do things right, we have to do our best to interpret the various sets of rules which apply to our role, and apply them. We could all cut a few corners to save money (I fear a higher percentage than we would like to think so, do, and I have had firsthand experience of this on occasion). But we want to do things right. A few editions ago I wrote about the stacking of dangerous goods and how German local regulations appear to

disallow, or at least think differently from ADR. But as an ADR contracting party, for transient carriers, ADR should be applied, even if it does not agree with local rules. As for enforcement, as the MCA (Maritime Coastguard Authority) commented to me a couple of years ago, it is the interpretation of such regulations by the traffic officer at the time that a vehicle is stopped for checking that can allow or disallow the vehicle to continue on its journey. So where does this all leave us? Whom do we go to in order to obtain the exact interpretation? Likewise, when there

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ITAL LOGISTICS

are confusingly grey topics such as the example mentioned above, where do we go for guidance, assistance, and even representation if required?

thought it an impossible task is there any hope for clarity and harmonisation? In any event, we consider obstacles as challenges to be overcome. So on we go.

I may be about to shoot myself in the foot here with our industry governing body (sorry BIFA), but a year or so ago I asked for their assistance with this matter, and they responded - “there is simply so much regulation that it is physically impossible for one trade association or individual to gather it together and maintain it.” Perhaps so, but I cannot help but consider that, in view of their status, they would better disposed. Although, if they themselves

And round in a circle I get back to the fact that regulations, once you have whittled down the dozen or so that may appertain to your role, are written in a greyish text that leaves them open to interpretation, questions enforcement, and costs money in the meantime. Think I’ll go back to bed. But before I do, as one of the sponsors for this year’s Chemical Northwest

Awards, may I sincerely congratulate all those companies who reached the finals, winners or not, who didn’t put it off, and navigated their way through the hoops of regulation to place their mark on the business world.

Phil Denton Managing Director ITAL Logistics Limited

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ROYAL HASKONINGDHV

Authorization â&#x20AC;&#x201C; some success factors When substances are considered as Substance of Very High Concern (SVHC) they can become prioritized for Authorization upon recommendation by EU member states and subsequently included in Annex XIV of REACH. Since the number of actual Authorization applications is limited, the success factors for a proper Authorization application are not well-known. Royal HaskoningDHV prepared in collaboration with EPPA the application for 2 substances and shares some of the lessons learned.

Authorization in a nutshell. VHCâ&#x20AC;&#x2122;s included in Annex XIV (Authorization list) of REACH may not be used after the sunset date (lights out), unless 1. an exemption for the use is included in Annex XIV, or 2. no alternative is available for a particular use and the socio-economic analysis demonstrates that the benefits to society of the use outweigh the costs (SEA route), or 3. the risk of using the substance is controlled (adequate control route). For the latter two routes an application for authorization is required and use is allowed until the final decision is made. The dossier and all comments from the public consultation are discussed by the independent expert Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) of ECHA who prepare an independent opinion that is sent to the European Commission (EC). The opinion includes a recommendation on the review period and on conditions. The EC will prepare a proposal which will be voted on by the Member States.

Some success factors In case you apply for authorization as a producer or importer and want to include your supply chain, we find it essential to involve the downstream users during the preparation of the dossier. First of all this helps you to verify the lack of alternatives and it also allows you to define your uses based on realistic and reliable information. This will be the framework in which you can use your substance during the review period. It also provides assurance to your downstream users that the substance will remain available for them. For your risk

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assessment it is crucial to understand the actual operational conditions and risk management measures that are in place in your supply chain. Your downstream users can also be of great support during the public consultation phase as their constructive feedback is vital. In order to deliver a robust Risk Assessment a thorough validation of the hazard- and exposure data is required. For hazard data it should be evaluated whether the use of alternative data is sufficient to appreciate the properties of the substance as such, or whether testing should be considered for the endpoints of interest. Actual exposure measurements allow you to validate data from exposure models and demonstrate safe use. In the risk assessment you will not only have to demonstrate that exposure is below the selected limit value but also that the hierarchy of control has been applied as instructed by other relevant (local) legislation on worker protection or the Carcinogens Directive (in case of CMR substances).

The Socio-Economic Analysis needs to be written from the standpoint of the applicant and be based on sound and scientifically accepted economic models as well as detailed information on the supply chain and market environment in which the substance is expected to function. It is crucial that the risk assessment is reliable and realistic to estimate the actual costs of continued use that are to be weighed against the costs of the non-use scenario. In order to avoid substances to be prioritized in the first place (which may lead to inclusion in Annex XIV ultimately) it is advisable to critically review the quality of the registration dossier. Although certain hazard properties and Classification and Labelling may be a given, ECHA will also pay attention to exposure (wide dispersive use) and the total market volume. Data submitted in the years since 2007 may therefore need a critical review in order to provide ECHA with more precise information on the actual risk for human health and the environment. If a substance is prioritized it may also advisable to see if a listing on the restriction lists of annex XVII is more beneficial.

Chemicals Management Royal HaskoningDHV provides a unique combination of knowledge in chemicals management, safety and engineering to deliver cost effective and sustainable organizational and technical solutions. Our support includes the full range of REACH services, from Consortium management to the preparation of IUCLID dossiers, Chemical Safety Reports and extended Safety Data Sheets. Our experts prepare and submit both lead- and individual registration dossiers and support clients to develop their own REACH strategy and in day-to-day practical operations. Our team has successfully prepared and submitted numerous REACH registration dossiers as well as applications for authorization. We have a strong international presence with offices around the globe, amongst others in Turkey and Indonesia, as well as a solid network of partnerships.

Contact: Christiaan van Daalen, +31 88 3486918, christiaan.van.daalen@rhdhv.com Bart van der Velpen, +31 88 348 67 56, bart.van.der.velpen@rhdhv.com

royalhaskoningdhv.com

INTERSOLIA

Smart Safety Data Sheet Services!

REACH, GHS and CLP as well as additional national legislation places ever increasing demands on companies and organisations to administrate safety related information to employees everywhere. For many, this development means increasing cost and great challenges keeping up with the authority requirements. Now there is help available, at least when it comes to administration of chemicals. One of the pioneers in developing automated services simplifying the manual administration work is the company Intersolia, who, for over 15 years have been helping companies remaining legally compliant. The Scandinavian region has long been trendsetters in new technology showing a reduction in manual working hours used on the laborious administration tasks. Outsourcing is seen as a costeffective solution and the same benefits are now being recognised throughout Europe with Intersolias expansion in to the UK and German markets. Intersolia has developed a service for smart collection of safety data sheets (SDS) from the suppliers of chemical products. With a database boasting several hundred thousand products, and thousands more been added every month, the original and most up to date SDS is made available through an internet based cloud service. Intersolia gives its customers access to the data they need, when they need it, where they need it. Applications are also already available for smartphones. On average, a company will spend two

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to three hours annually per chemical product in use, ensuring they first have all the correct information available to be able to conduct risk assessments, issue safety sheets, assess substitution possibilities and other things required by law. The majority of this preparation time is spent checking if information is up to date and registering new data. “We find by removing this administration task our customers are able to spend more time on creating a safer work place for all staff. No doubt, the suppliers of chemicals have a legal obligation to deliver the most recent version SDS but in reality it seldom works the way it is supposed to and if in fact distributed, the SDS ends up in a pile on someone’s desk” – John Wayman says. It is Intersolias ambition to ensure their customers can focus their efforts on more qualified tasks – naturally based on updated information. “One of the most common nonconformities resulting from internal and external audits being out of date SDS’ or failure to demonstrate an audit trail with manufacturers to check validity of

these; Intersolias updating service ensures companies will not fall foul to these heightened regulations” John states. The web-based services provide full auditing and full visibility of required procedures available upon request from auditors. With a comprehensive archiving system, all records are maintained and stored for decades. Another upside with the information registered in the database seems to be that you can get a daily comparison with any substances on international or national restriction lists such as for instance the REACH annex XIV, XVII, SVHC and water frame directive. “Our customers can even compare with restriction requirements placed with them through their own customers and thereby can be turned into a competitive benefit,” - Erik Norlander adds. Not only does Intersolia check and verify SDS are legally compliant and up to date; they also offer translation into over 50 different languages, help their customers create new safety data sheets, and conduct fire-, risk-, site- and environment assessments just to mention a few things.

Tired of trying to collect safety data sheets?

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Intersolia delivers complete solutions with products and services primarily in the field of chemicals management, REACH, Coshh and CLP to customers in the private and public sectors throughout Europe. Tel.: 0161-713 17 10, Email: info@intersolia.com, Web: www.intersolia.com

GLOBAL MSDS

Hazmix® setting a new standard in SDS production The chemical industry is an important driver of the global economy, with estimated annual sales of €3156 billion in 2014. The EU remains a significant chemicals production area, valued at €432 billion and accounting for 16.7 per cent of world chemicals production in 2014. However, the outlook is for continued levelling of EU production and consumption in the context of greater global competition, particularly from Asia. Looking within the EU, the trend is for continued clustering of European capacity combined with greater constraints due to insufficient infrastructure, assets and capable operators. At the same time the industry is experiencing increased regulation, not only within the EU, focusing on raising Environmental, Safety and Security standards. The challenges ahead are significant. So, it will be ever more important for businesses to maintain competitiveness if they are to survive and grow. As a successful business you will know only too well the importance of controlling revenue expenditure, even if it relates to business-critical activities such as regulatory or HSE compliance and product liability. As companies are increasingly driven to focus on core competencies, there is an inevitable pressure to outsource these activities which drives up revenue expenditure thereby threatening profitability and ability to compete in a market with tight margins. We at Global MSDS Ltd are acutely aware of these pressures and this has driven

us to critically assess the process of SDS production in terms of fit-for-purpose for the next 10 years. With the strident changes in IT and informatics, the vast amount of high quality information available through the internet together with the obvious advantages of webbased service delivery, it was inevitable that we should turn our expertise in toxicology, global regulatory affairs and IT to the production of a low cost/high value tool for SDS production. Building on the success of Writer®, our freestyle SDS authoring adjunct to

Microsoft Word® we have harnessed the very latest technologies to develop a completely new web-browser based product that we call “Hazmix®”. This is a very low cost pay-as-you-go product that will not entail any expensive capital outlay or maintenance charges. As you only pay for the SDS on output it provides free access to a wealth of Wiki based data using deep web-spiders directly linked to ECHA’s on-line Registration and Classification databases (fully approved by ECHA). This is supported by intelligence based classification algorithms for Supply (CLP) and Transportation combined with an intuitive interface that uses intelligence based SMART logic and ‘drag and drop’ editing to deliver a push-button authoring tool. What is more, it gives Wiki-based access to all global chemical regulations for no charge whatsoever. We are understandably very excited about Hazmix® as it delivers a high quality product at a price point that is 10-20 times below the marketplace. Our growing customer base confirms that it is set to revolutionise the process of SDS authoring to the advantage of the chemical industry. Hazmix® will go live towards the end of March 2015 and can be accessed at Hazmix.com. For the first few weeks even printing will be free so there is no reason not to give it a try. Images by Adrian Waine (Photography for Industry) – www.photographyforindustry.com

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GLOBAL MSDS

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GlobalMSDS leads from the front in developing innovative, high quality/ low cost products to meet all your SDS needs. GlobalMSDS Ltd, Rotterdam House 116 Quayside Newcastle upon Tyne NE1 3DY

BIBRA

Have you started preparing? What once seemed a far-off legislative deadline is now very much a presentday reality. The final REACH registration deadline, for phase-in substances manufactured or imported in the EU at 1-10 or 10-100 tonnes per annum (tpa), is only three years away.

Whilst many companies and service providers have experience in the preparation of REACH registration dossiers following the 2010 and 2013 deadlines, other companies - notably small and medium-sized enterprises (SMEs) and manufacturers/importers of high-value and low-tonnage substances - may not. The key message is to start the process early, plan well and allocate sufficient resources (technical and financial) to what is a complex and challenging piece of legislation to navigate. Notably, where testing is required, this should be identified and progressed with the appropriate laboratories as soon as possible. As an early reminder, in Autumn 2014 the European Chemicals Agency (ECHA) urged all companies to “start preparing now for the REACH registration deadline of 31 May 2018”, publishing several new web pages (http://echa.europa.eu/ reach-2018) covering different phases of the registration process. This is a useful starting point for those relatively new to REACH (or in need of a refresher). There is also specific guidance and special provisions for SMEs, including reduced fees. REACH is not just a matter of ticking boxes and it is surprising how protracted (and expensive) a process it can be to put together a satisfactory registration dossier. There is much help available from ECHA (e.g. guidance, webinars), national agencies (e.g. help desks), sector-specific trade associations, and IUCLID itself (e.g. the Validation Assistant plug-in). But if you don’t have appropriate skills in-house, then consider getting support from experienced service providers with a proven REACH track record. This will

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“

REACH is not just a matter of ticking boxes and it is surprising how protracted (and expensive) a process it can be to put together a satisfactory registration dossier.

”

be particularly important for Annex VIII (10-100 tpa) substances classified as dangerous for human health and/or the environment. Several additional tasks are required here (e.g. drafting DNELs/ PNECs, exposure scenarios, RCRs, RMMs, CSR etc) that demand extensive technical knowledge and practical experience. Nanomaterials are a current subject of debate and “although there are no explicit requirements for nanomaterials under REACH or CLP, they meet the regulations’ substance definition” and the same REACH provisions apply. Registrants are obliged to ensure the ongoing safe use of their substances.

This can only be achieved with carefully prepared dossiers based on a backbone of reliable and up-to-date data. Companies should be encouraged to conduct comprehensive and ongoing literature searches, ensuring they always have the most robust hazard, exposure and risk data at their fingertips. Any changes in manufacture/formulation, tonnage and use should also trigger a reassessment of previously submitted dossiers. In its seventh annual Progress Report (2014), ECHA identified a number of key areas where submitted dossiers can be improved, and highlighted what it expects from a good quality dossier. A significant portion of the dossier is made publicly available on the ECHA website. A poor quality dossier will not reassure the authorities, potential clients or the public regarding the safety of your substances. Although the resources needed can be daunting, there are opportunities to maximise the use of existing information and make reasoned arguments for nontesting. Bibra scientists have the skills and knowledge to assist with your REACH registration obligations for 2018 and beyond. If you haven’t already started preparing for your 2018 REACH registrations, act now!

expert support in all aspects of chemical hazard and risk assessment

Within the field of chemical hazard and risk assessment, we are undoubtedly one of the most experienced and mature companies around. Our seven most experienced toxicologists (all SB/BTS and EUROTOX registered) can look back on up to 39 years at bibra, and the average tenure of our 20 highly skilled toxicologists exceeds 13 years. There are very few human health risk assessment problems that we haven’t faced and solved. We have worked with clients and trade associations (e.g. CEFIC) across a range of sectors, and have also advised government departments/international agencies (e.g. UK EA, Health Canada, OECD and WHO) on various toxicological issues. What makes bibra different is its history. In what was essentially a management buy-out eleven years ago, the company was transformed successfully into one that is owned and led by toxicologists, all of whom work with clients on a daily basis. We understand the importance of bringing scientifically robust, defensible solutions to problems in a cost-effective, timely manner. There are two

critical areas where we have a competitive advantage over other companies in our field: First, the quality, training and experience of our staff is unsurpassed, worldwide. Second, we own and use one of the finest chemical toxicology databases and databanks in the world. This unique data source – TRACE – developed by bibra over the past 50+ years, is a supremely effective tool for identifying documents critical to the toxicological risk assessor, especially Expert Group reports (which are not well indexed in other data sources). What makes TRACE so special is the greater selectivity and speed with which key documentation can be accurately identified and accessed. With such a focused and fast information retrieval system, our consulting team can offer an unrivalled efficiency and level of toxicological advice and support to clients. TRACE is listed as a valuable data source in the official ECHA Guidance (Chapter R.3) on Information Gathering for REACH.

OUR AREAS OF EXPERTISE • Chemical Hazard & Risk Assessments • IUCLID 5 Web Hosting Service • Extractables & Leachables • Pharmaceuticals • Cosmetics • REACH

Our scientists have first-hand experience of producing and submitting dossiers to regulatory authorities. We helped with the successful REACH registration of over 100 substances for the 2010 and 2013 deadlines and are currently working with industry on 100s more targeted

• Food & Food-contact Materials • Plant Protection Products • Consumer Products • Medical Devices • Animal Feeds • Biocides

for the 2018 deadline (including petrochemical additives, precious metals, fragrances, SVHCs and intermediates). We can minimise the disruption to normal commercial activities by taking responsibility for registration of chemicals on behalf of companies or assisting with specific tasks.

CS REGULATORY LTD

Time to REACH your compliance goals? 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 needed to ensure compliance can be considerable 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. A key factor with compliance is to ensure that you have pre-registered the correct substances. It may sound obvious, but the business picture may well be clearer now than it appeared on 2008 when conducting pre-registration. There are a significant number of cases where companies have pre-registered the wrong substance or have changed the focus of the business, making significant changes to the essential product portfolio. In other cases, a company’s REACH focus may have changed to introduce a new registration obligation, e.g. by importing a substance from outside the EU that was previously sourced locally from within the EU. In the event that the pre-registration does not actually represent the correct substance, now is the time to update the pre-registration working with the Member State Authority (MSA) or, if possible, within REACH IT. It is also not too late to preregister a substance in the 1-10 or 10-100 tonnage bands. Having a pre-registration for the correct substance is essential to ensure that you are working in the correct SIEF. At the start of the REACH process CEFIC1 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 is 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.

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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 and probably with more specialised uses. A much greater proportion of these substances are, nevertheless, likely to have no existing data available leaving 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. There is, though, an extremely high likelihood that demand will very quickly outstrip the capacity for the support services. 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; there is no guarantee that someone

else will have registered your substance(s), regardless of any stated intentions. There is also no guarantee that a reliable service provider will still 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. Steven Green Director CS Regulatory Ltd

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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STEWARDSHIP SOLUTIONS

Managing REACH registration risks to 2018 The 2018 REACH registration deadline for substances manufactured in, or imported to, the EU at one tonne per annum (tpa) or more is looming. There is an increasing sense of urgency about this deadline, which will see a huge number of new EU companies, especially SME businesses, caught up in the REACH process for the first time. Some of the main REACH risks, and how to manage them, are considered in this article. Substance Manufacturers By now, most EU substance manufacturers will have had experience of registering under REACH, or at least should be aware of their registration obligations. The big issue for them is usually the cost of the Letter of Access (LOA) which enables manufacturers to be party to the Joint Submission registration process. LOA charges vary enormously from a few hundred to many tens of thousands of pounds. Good consultants will know how to mount effective challenges to excessively-high LOA charges, and help with opt-out registrations if necessary. SME businesses should not fear assuming the role of Lead Registrant, if their situation warrants it, since it puts them in control of the registration process. Key next-steps: understanding potential registration costs; assessing and if necessary challenging unfair LOA charges; deciding on which substances to support through REACH, or abandon; establishing a registrations budget covering several years.

Importers Importers are a particularly vulnerable group due the high degree of uncertainty they may face up to the 2018 registrations deadline. Ultimately, they are responsible for assuring correct REACH compliance of imported substances and/or formulations, not their non-EU suppliers and associated Only Representatives. Although most EU importers hope they can escape registration obligations themselves, in many cases there is no certainty this will happen. Importation of formulated products is a particular risk since registrations of many ingredients could be required, and eventual total costs could be very high. See the Case Study example. Key next-steps: frequent checks with non-EU suppliers about their registration intentions; identifying alternative suppliers in case of registration failures; assessing the benefits and possibility of performing

Case Study:

UK importer of formulated products A specialist UK retailer imports a range of formulated lubricant products for the engineering and automotive sectors; these account for 50% of its UK sales. For the non-EU formulator, the EU market represents an attractive, but not business-critical source of revenue. The non-EU supplier has undertaken a REACH registrations cost-assessment and is alarmed to discover that the total costs to register fifteen substances exported to the EU in the 1-10 tpa band, across all its relevant formulated products, will be approx. ÂŁ200 000. The non-EU formulator has requested that its EUbound substances tonnage be covered

own registrations; business contingency planning in the event of imports ceasing altogether (especially applicable to formulated products).

Formulators Most formulators generally assume that by using EU-sourced raw materials, they will escape registration obligations themselves. This is a reasonable assumption if sourcing solely from EU substance manufacturers with REACH registrations already in place. However, many EU-based suppliers, especially distributors, are struggling with registration issues in much the same way as importers are doing. Upstream registration failures could yet hurt formulators buying from EU sources, as a consequence of supply chain disruptions. If a formulator is importing raw materials from non-EU suppliers, clearly they face the same challenges described above for importers.

under the REACH registrations of its non-EU substance suppliers; most have declined, or stated they will not be registering under REACH. The non-EU supplier concludes that it cannot justify the costs of performing registrations itself and will probably not continue to sell into the EU after the 31 May 2018 registrations deadline. It decides not to inform the UK importer until the last possible moment. The UK importer takes no action to probe the REACH registration intentions of its non-EU supplier and a major business failure potentially awaits it.

Key next steps: frequent checks with EU and non-EU suppliers about their registration intentions; identifying alternative suppliers in the event of registration failures; assessing the benefits and possibilities of performing own registrations, especially in relation to imports from non-EU companies. To discuss your EU regulatory compliance needs, please contact:

Dr Chris Eacott Stewardship Solutions Ltd E: chriseacott@stewardshipsolutions.co.uk T: +44(0) 1706 220901 M: +44(0) 7834 676908

REACH SPECIAL 2015

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Our services: We offer Safety Data Sheets (SDS) in 46 languages for all regions in the world as well as extended SDS (eSDS) according to REACh. On demand we host your complete product portfolio in our EH&S-system, check and update your SDS with regard to country-specific jurisdictions with all the relevant regulatory Our services: We offerand Safety Data Sheets (SDS)according in 46 languages for all regions in theSystem world content. We classify label your products to the Globally Harmonized as wellforassubstances extended SDS according to REACh. (GHS) and(eSDS) mixtures and take care of the transport classification (DG). On demand we host your complete product portfolio in our EH&S-system, check and update SDSanwith regard to country-specific with all relevant regulatory We haveyour been independent service providerjurisdictions for the chemical andthe pharmaceutical content. We classify andwith label your products according to the Harmonized System industries since 1996, currently over 450 employees at Globally sites within the EU, Asia (GHS) for USA. substances and mixtures andplease take care ofwww.knoell.com the transport classification and the For further information visit or contact(DG). us via sds-helpdesk@knoell.com We have been an independent service provider for the chemical and pharmaceutical industries since 1996, with currently over 450 employees at sites within the EU, Asia and the USA. For further information please visit www.knoell.com or contact us via sds-helpdesk@knoell.com

www.knoell.com www.knoell.com 26.03.15 12:29

26.03.15 12:29

TSGE

Europe’s Final REACH Countdown The REACH legislation’s final deadline, for substances already on the European market, is 31 May 2018. Having worked in the REACH dominated chemicals regulatory business since before 2009’s pre-registration deadline, this date is etched into my brain. By this date, all substances manufactured or imported into the European Union at more than 1 tonnes per annum (tpa) will need a registration. All EU chemical manufacturers and importers will have registered. It’s an amazing thought, reflecting massive effort by the European Chemical Industry in complying with the most demanding environmental legislation for chemicals globally. We’ll all deserve a pat on the back, or a lie-down, in June 2018. 2017 in order to submit that amount of information onto ECHA’s Helsinki server in time. The best advice really is to start early and beat the crazy rush. It’s coming.

By Dr Craig Kelly TSGE Consulting Ltd Alternatively, if you have not registered by June 2018 within manufacturing or importing, then you’ll no longer be operating legally. Title 2, Chapter 1, Article 5, another REACH-ism tattooed inside my head; “No data, No market.” It couldn’t be clearer! Written at the front of this extensive EU legislation; you’re either with us or you’re out of business! It will, however, be very different in 2018. This deadline applies to lower tonnage substances. The big names have been and

done it and only their specialist businesses still need to act. Like the sixth formers when you first went to senior school, they know exactly what they are doing! They’ve been there (possibly twice) before. The 2018 tonnage bands are 1 to 100 tpa, so it will be the turn of smaller companies, the one-man importers, the specialist producers, to all be in the firing line. ECHA also estimates there will be around 25,000 substances to register in 2018. Previous registration deadlines produced around 7,800 substance registrations. This suggests it will be really busy in

Craig has extensive experience of the REACH regulation. He has also worked in industry with the US EPA on IRIS priority chemicals. He can provide guidance and strategy advice as well as having experience of data requirements and waivers. In addition, he has experience of Chemical Safety Reports, exposure scenario development, regulatory issues in the supply chain and how complex mixtures fit within REACH.

REACH SPECIAL 2015

As REACH is all-encompassing, the most difficult thing is realising there might be a problem. Often it’s not clear something needs to be done. Imagine if late or no activity threatened your supply to an important manufacturer who has robust contracts protecting their business. Perhaps a formulated product you use is imported from the US. REACH potentially sees the EU company as the importer of each substance in that product, requiring a registration for each substance in the formulation. Similarly, it could be a formulated preservative product. Even if your supplier has a biocidal registration for the active substance, what about the other non-active components? If any of those are imported at > 1tpa, you have an unexpected REACH issue. REACH requires someone in the EU supply chain to have done something. IT REALLY COULD BE YOU. The best advice is don’t panic, just act now if you suspect an issue. TSGE Consulting has an experienced REACH team and an excellent track record. In industry, I utilised their expertise in 2010. Like Harvey in the 70’s electric razor ads, I was so impressed I now work for them!

Craig is a graduate in Agriculture and Environmental Sciences, has a PhD in Pesticide Formulation Efficacy and is presently studying for an MSC in Applied Toxicology. Dr Craig Kelly TSGE Consulting Ltd E: craig.kelly@tsgeurope.com T: +44 (0) 1425 838 995

REACh ChemAdvice GmbH

Challenges of REACH Regulation Introduction Regulation (EC) No. 1907/2006 (REACH) regarding the Registration, Evaluation, Authorisation and restriction of Chemicals entered into force on the 1st of June 2007. The European Chemicals Agency (ECHA) based in Finland is coordinating the implementation of REACH in the EU. The registration obligation applies for substances manufactured or imported above 1 ton/year. A transitional period applied for phase-in substances that could be pre-registered until 1 December 2008 or one year before the respective registration deadline. For those substances depending on the tonnage band three registration deadlines apply: 30 November 2010, 31 May 2013 and 31 May 2018. The Regulation includes also some exemptions that companies should check including Annex IV and V.

Registration The registration is based on the â&#x20AC;&#x153;one substance, one registrationâ&#x20AC;? principle. Manufacturers and importers of the same substance have to prepare a joint registration. This avoids the duplication of testing and data sharing is promoted. Companies that pre-registered and need to register the same substance

REACH SPECIAL 2015

communicate in SIEFs (Substance Information Exchange Forum) but may also organize in Consortia. The SIEF choses a Lead Registrant that will coordinate the preparation of the so called Lead Dossier for submission to the ECHA. This dossier will include common information on classification & labelling, physical-chemical, toxicological and ecotoxicological properties. Usually a joint Chemical Safety Report is also included in the Lead Dossier. The Substance Information Profile and uses are agreed among all members of the SIEF. Costs are equally shared among the members of the SIEF that need to buy a Letter of Access to the Lead Dossier. Each member of the SIEF has to prepare and submit a co-registration dossier which will include information about the company and own substance including spectral data and analytical data. Registration dossiers are prepared using the IUCLID 5 and submission to the ECHA is done through the online platform REACHIT. Registrants must be aware that the registration process does not end with receiving the registration number as updating obligations may apply, further information may be requested by the ECHA under dossier evaluation. This also means that additional costs with possible

updates must also be considered as well as testing included in test proposals or further requested by the ECHA. Until January 2015, the total number of registrations received by the ECHA was 40791 corresponding to 6127 substances in joint submissions. Industry faces now a big challenge with the 31 May 2018 registration deadline that unlike the previous deadlines in 2010 and 2013 will affect mainly SMEs with lower knowhow and resources needed to achieve a successful registration. Start of registration process should start not later than 2016 to ensure that a registration may be submitted before the deadline.

Downstream Users Companies that do not manufacture substances neither import them on their own or in mixtures are still affected by obligations under REACH. Most important are related with Safety Data Sheets including Exposure Scenarios and Risk Management Measures. Carlos Miguel Fazendeiro Director Regulatory Affairs at REACh ChemAdvice GmbH carlos.fazendeiro@reach-chemadvice.com

BRENNTAG

REACh – Do you know the final registration deadline is approaching? REACh is the EU chemicals legislation that deals with the Registration, Evaluation, Authorisation and Restriction of chemicals which came in to force in 2007.

This affects every chemical substance whether on it’s own, in preparations or in articles intended to be released within the EU market. This legislation impacts not only manufacturers and importers but also gives certain responsibilities to downstream users so all of the supply chain is affected.

If any of your uses / conditions of use appears not to be covered in the extSDS you have 12 months to make the missing use REACh compliant. According to Article 39-1 you may continue to use the substance during that 12-month period, which starts the date you receive the registration number communicated via the extSDS.

For manufacturers and importers of chemical substances the legislation means that dependant on the hazard classification and the manufactured/imported volume of the substance that it would need to be registered with ECHA, The European Chemicals Agency from 2010 onwards.

Why is my substance no longer available?

Two of the registration deadlines have passed and the final deadline, 31st May 2018, may seem like a long time away but it is fast approaching. Laboratory testing houses are warning now to prepare and plan for the final registration deadline due to their workload with other concurrent legislation such as The Biocidal Product Regulation. It is likely that if you leave it until 2017 to prepare for the 2018 deadline that you will struggle to find a laboratory with time to conduct your sameness tests etc.

Downstream Users – Do you need to do anything? Downstream users will have noticed that the introduction of REACh has meant that the information received in safety data sheets has increased dramatically. This is because REACh registration involves ensuring that the substances are used safely, therefore only safe uses can be included in the registration dossier. The registered uses, or exposure scenarios, are communicated via the SDS, known as an extended SDS (extSDS).

REACH SPECIAL 2015

Chemical substances are starting to become banned in the EU with those that qualify classed as a Substance of Very High Concern (SVHC). These substances are subject to further scrutiny before being placed on to the Authorisation list known as Annex XIV or more commonly as the ‘Sunset List’. The Sunset List details the substance subject to authorisation, the date after which it can no longer be used in the EU i.e. the ‘sunset date’ and the final date by which authorisation must be applied for. ECHA may grant authorisation i.e. further use of these ‘banned’ substances but this must be applied for and is likely to create a number of restrictions in the supply chain. For further details please refer to http://echa.europa.eu/support/authorisation If you require any further REACH information, in particular the authorisation aspect then please email your enquiry to reach@brenntag.co.uk www.brenntag.co.uk Follow us on: LinkedIn – Brenntag UK and Ireland Twitter - @BrenntagUK

REACH BEYOND Brenntag as a full-line distributor covers various roles in the chemical supply chain and therefore is involved by REACH within several aspects. As a distributor in the sense of REACH, Brenntag has to fulfill its obligations with regards to communication; as a formulator Brenntag is a Downstream User and has to comply with the obligations under REACH (make sure own uses are covered in registration, apply recommended risk management measures) and finally Brenntag is a manufacturer and a direct Importer of substances and therefore it has to fulfill obligations as a registrant. To appropriately cover these tasks requires REACH involvement on all operational levels and a strong internal interaction and alignment. Brenntag looks at REACH as an opportunity to serve our customers and suppliers.

www.brenntag-reach.com

THE REACH CENTRE

REACH Registration and Sameness – lessons learned for 2018 According to the “one substance one registration” (“OSOR”) principle of REACH, companies are required to work together in a “SIEF” (substance information exchange forum) to share the costs of compiling the hazard data, and submit these jointly. Apart from reducing animal testing, this means companies can make significant cost savings compared with having to generate all the data by themselves. Sharing hazard data is only possible if the jointly registered substances are “the same”. By Dr Sandra Meijer, Director of Business Development, The REACH Centre Ltd Dr Kath Carr, Director of Science, The REACH Centre Ltd

What does this mean for companies having to register in 2018? As agreeing sameness is the first and crucial step in the joint registration process, you need to start the discussions sooner rather than later. Analytical characterisation is required to prove the identity of your substance to ECHA, and it will provide you with the detailed information you need to engage in any SIEF conversations regarding substance identity. It may be that once you have carried out the analysis you find that you pre-registered the wrong substance and need to change SIEFs. You will then be faced with the task of finding other closely related substances and examining the SIPs (Substance Identification Profile) for these in order to determine where you fit. Over the years, The REACH Centre has supported many clients with all aspects of sameness checking and with the below case studies we share some of our learning in this area.

Case Study 1 A client had pre-registered a long-chain fatty acid which was a multi-constituent substance, comprising several acids of differing carbon chain lengths. The results of the client’s analytical characterisation unexpectedly revealed that the substance did not fit into the SIP (Substance Identification Profile) issued by the SIEF. By examining closely related substances and their respective SIPs, The REACH Centre was able to demonstrate sameness with a more appropriate substance. As a result, the client was able to fulfil their regulatory obligations and remain compliant.

REACH SPECIAL 2015

Case study 2 A number of alkyl substituted aromatic sulphonic acids exist, differing principally in the length and distribution of the alkyl substituents. These substances are UVCBs. Some of them have been registered and others have not, the latter principally because they have been found to fall into the SIP for other related substances. A client planning to begin manufacture of one of these substances commissioned The REACH Centre to undertake their substance characterisation which defined the all-important alkyl chain length and distribution. It was then possible to compare the identity and composition

of the client’s substance with the known options and demonstrate sameness with the most appropriate of these. It is clear that proving sameness is not always straightforward. In many cases, companies have registered their substances under a CAS/EC number that was different from what they preregistered. By starting your sameness checking activities early you can ensure registration of the right substance in the most cost-effective way. The REACH Centre Ltd enquiries@thereachcentre.com +(44) 1524 510278 www.thereachcentre.com

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TOXCEL INTERNATIONAL

Still not done anything about 2018? Maybe it’s time to kick start your SIEF! The last registration deadline for REACH will be here soon and will cover the tonnage bands 1 – 10 and 10 – 100 tonnes/year. Many more registrations from small and medium enterprises (SME’s) are expected; these may have less experience with regulatory work and many will face the challenge of acting as lead registrant for the first time. The task ahead may seem daunting, but there is much useful information available from ECHA and commercial companies who support registrants. Taking on this task will secure your EU market and will give you some control over the process. ECHA does not pick the lead registrant, this must be done by the members of the pre-SIEF. So, how should you get things started? n Look at your REACH-IT account. All

pre-SIEF members will be listed with their contact details and some may have provided additional information (for example, if they have any data). n Test the water to see who is serious

about registration. Send a general email to establish who intends to register. The SIEF process must be transparent, so include every one and keep a copy of all correspondence. Setting a deadline for responses, together with a reminder nearer the date, is a good strategy. n Clearly define the substance you wish

to register. Ensure other SIEF members are in agreement; circulate details such as CAS number, structure, purity, main impurities, method of analysis. n Take advantage of the information

already out there. A number of examples of SIEF agreements and documentation are available on the

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web (e.g., CEFIC) and some companies run webinar and information days. n Understand your responsibilities.

Being a lead registrant comes with a number of responsibilities, most of which are good working practices and designed to ensure the whole process is transparent. Get a good SIEF agreement in place to share the process and the cost (the process must be cost neutral). Consider securing a down payment as part of the initial agreement. n Propose yourself as lead registrant.

If the other members agree, then nominate yourself via the ECHA website. n Prepare for registration. Assess the

available data (both company held and public), understand the registration requirements, identify any data gaps and propose how to address them.

n Schedule your work and get help

where you need it. All registrants (lead and joint) need to provide analytical information to confirm substance sameness. Even if you need to generate the minimal amount of data for the chemical safety assessment, it will take time and laboratories will start to get busy. Identify the skills present in your SIEF. Lots of companies offer support services, so identify where you need help and get a tailored service to keep your costs down. n Lastly, don’t procrastinate! If you

want to keep your market, you need to register. Just a little understanding about REACH will help identify the steps you need to take, and there is lots of available information out there to help you. Christine McAlinden toXcel International Ltd

Scientific Services and Registration Meeting the 2018 REACH deadline

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toXcel International Ltd. P.O. Box 93 Ledbury, HR8 9JE United Kingdom Phone: +44 (0) 1531 638999 Email: Christine.McAlinden@toxcel.co.uk

toXcel, LLC 7140 Heritage Village Plaza Gainesville, Virginia 20155 USA Phone: +1 703-754-0248 Email: Alan.Katz@toxcel.com

THE NEXT REACH ‘PHASE-IN’ DEADLINE IS FAST APPROACHING TSGE has the experience, the TEAM, the experts and the right package to guide you through the last deadline. – – – – – – – – –

Substance identification Lead Registrant assistance Registration strategy advice Data waivers and gap analysis Study placement and monitoring Literature search and testing strategy advice Chemical Safety Assessment/Chemical Safety Report Consortium management Only Representative services and importing advice

Don’t be caught out, there is much to do to complete a 2018 registration if you want to stay on the EU market.

A European Presence TSGE has offices in the UK, Ireland, Germany, Spain, Slovenia, Slovakia, Poland and France offering local knowledge and forging relationships with the authorities in the different European regions. This network is fundamental to achieving the regulatory and commercial objectives of our clients.

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Europe: Final EEA REACH registration deadline 31 May 2018. The final European Chemicals Regulation registration deadline captures pre-registered chemicals manufactured or imported into the EEA between 1-100 tonnes per year. Quantities exceeding 100 tonnes should already have been registered by previous deadlines. The final deadline may seem a long way away. However, the European Chemicals Agency’s recent REACH 2018 Roadmap provides a timely reminder to companies of the significant amount of work, time and cost involved in registering a substance. Eversheds is a leading advisor to the chemicals industry. We have strong relationships with EU and member state regulators responsible for the REACH regulation. We work with consultants, in-house technical experts and lobbyists to achieve our clients’ goals and we have successfully disputed ECHA decisions.

For further information about how we can help you REACH compliance please contact: Elizabeth Shepherd

Partner – Head of Environment Direct: +44 845 497 8215 Main: +44 20 7497 9797 elizabethshepherd@eversheds.com

www.eversheds.com ©EVERSHEDS LLP 2015. Eversheds LLP is a limited liability partnership. DT04513_03/15

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EVERSHEDS

REACH An Inspector Calls…. For many businesses receiving notification that you are to be the subject of a REACH audit is a stressful experience. However, if you seek appropriate legal and technical support and are well prepared it may prove useful. The starting point for the Inspector will be Article 36 – the obligation on each manufacturer, importer, downstream user and distributor to “assemble and keep available” all the information he requires to carry out his duties under REACH for at least 10 years after he last manufactured, imported, supplied or used the substance. Whilst individual members of a group require their own REACH registrations/pre registrations, in practice many companies will have centralised REACH compliance. This approach brings many benefits but it does not absolve a particular subsidiary in a particular EU Member State from complying with the requirements of Article 36. Often the Inspector will initially request some basic information. It goes without saying that if your people on the ground can respond knowledgeably about REACH a good impression is created and potentially a site audit may be avoided. However the converse is also true – if those responding to the initial request display little or no knowledge then a site audit is almost inevitable. Decide early on who should attend the audit. If you have a centralised REACH/ chemical compliance function they will be required. A presence from head office and involving external advisors can demonstrate the importance you are placing on the audit. Are your representatives speaking the same language as the inspector? Not just literally but in terms of REACH. Businesses may use expressions such as “manufacturer” “intermediate” “polymer” in the general sense of the word rather than in a REACH specific context. Misuse of key REACH terms creates a bad impression.

Different Member States have different priorities – do your research on the particular inspector. Don’t assume that what you did in one Member State will necessarily satisfy a different regulator in another. However, don’t be surprised if issues which were identified in one Member State are picked up again. One of the key areas to focus on is data management – you are obliged to keep track of all of the substances you manufacture or import, and those benefitting from an Only Representative arrangement. The inspector may also be interested in how you justify the classification of substances and the content of your SDSs. This encompasses a wide range of data and potentially representatives from different internal groups from sales and purchasing to product stewardship.

If you have centralised your REACH compliance function it is key to ensure that you communicate relevant information to the people on the ground, wherever they are based, to demonstrate that each member of the group is meeting its Article 36 obligations. On the positive side, in our experience, regulators are often pragmatic and appreciative of the massive challenges which REACH presents. Valuable feedback can be obtained and then incorporated into your compliance approach going forwards. For more information please contact: Elizabeth Shepherd Head of Environment Tel: 0845 497 8215 Intl: +44 161 831 8215 elizabethshepherd@eversheds.com

REACH SPECIAL 2015

SUSTAINABILITY SUPPORT SERVICES (EUROPE) AB

REACH Regulation: The Journey from Pre-registration and Beyond! The European chemical policy on Registration, Evaluation, Authorization & Restriction of Chemicals (REACH) has been one of the most wide followed chemical policy globally. During the period leading up to the Pre-registration period there was a general lack of clarity mostly amongst the non-European chemical exporters to Europe as well as certain European manufacturers on how effective REACH would be in accomplishing its ambitious objectives. The pre-registration window period of six months (1st June – 30th Nov’ 2008) saw most of the chemicals being preregistered by European manufacturers as well as non-EU manufacturers through their “only representative”. The total number of substances pre-registered matched the expectations of the European Chemicals Agency (ECHA); since preregistration provided the benefit of extended Registration deadline within REACH depending upon the tonnages put on the European markets. Pre-registration was followed by hectic preparatory activities on the part of the companies that were looking at the first REACH Registration deadline of 30th Nov’ 2010 by virtue of their chemical volumes being over 1000 tons per annum or due to the chemical being a Carcinogen, Mutagen or Repro-toxic (CMR) category 1 and 2. Also the information to be provided in the registration dossier was enormous. Many large sized companies felt that the 1st REACH Registration deadline was too short. It was rumored that ECHA would extend the 1st REACH Registration deadline by certain sections of the European as well as non-European chemical industry; but it was not to be. ECHA stuck to its words and the 1st REACH registration deadline ended on 30th Nov’ 2010 (some people believe it to be 1st Dec’ 2010). The chemicals registered by the 1st REACH registration deadline fell short of the expectations and projections of ECHA as well as the European chemical industry association (CEFIC). This was attributed to lack of clarity about the data sharing process, lack of transparency within the substance information exchange forum (SIEF), high data costs as well as lack of familiarity with the IUCLID software, using which one had to submit the REACH registration dossiers to ECHA via the REACH-IT portal. There were certain chemicals for which extremely high letter of access (LoA) cost for data sharing was

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charged by the Lead Registrants (LRs). All this notwithstanding, the companies that has assured orders and saw long term business benefits, did pay the high LoA cost and complete their REACH registration. On its part, ECHA tried its best to facilitate compliance within the 1st REACH registration deadline by the chemical companies by publishing elaborate guidance documents that explained the various aspects of the REACH regulation like substance identity, data sharing process, registration process, IUCLID guidance manuals, REACH-IT (the web platform created by ECHA for REACH submissions), etc. as well as its helpdesk services in English and other languages of the European member States. It also organized stakeholder’s day once a year beginning 2009; and still continues to do so each year, to provide a platform to the European as well as non-European companies to get firsthand information to their REACH related queries from the ECHA staff. After the 1st REACH Registration deadline was completed, ECHA started identifying chemicals for the second stage of REACH i.e. Evaluation. ECHA undertakes two types of evaluation; dossier evaluation and substance evaluation. The Member State competent authorities are the coordinating agency for substance evaluation. Member States evaluate certain substances to clarify whether their use poses a risk to human health or the environment. The objective is to request further information from the registrants of the substance to verify the suspected concern, if necessary. In cooperation with the Member States, ECHA defines risk-based criteria and then selects the substances that are to be evaluated. The selected substances are listed by ECHA in the Community Rolling Action Plan (CoRAP) following the opinion of the Member State Committee. An evaluating Member State is designated

for each substance on the final CoRAP and it works closely with the lead registrant or the consortia manager to achieve the objectives of substance evaluation. The 2nd REACH registration deadline was completed on 31st May’ 2013. Given the time period between pre-registration and also learning form the experience of the industries from the 1st REACH registration deadline, medium sized companies were better prepared and more chemicals were registered by this deadline. The issue of high LoA, lack of transparency by certain lead registrants, etc. however continued. At this point in time, the small sized companies are gearing themselves to meet the last REACH registration deadline of 31st May’ 2018. Considering that this is the last deadline and most companies looking to register more than a couple of chemicals, they have lined up chemicals for registration in each financial year; leading up to 2018, so that the REACH registration costs can be split over a few years rather than incurring a huge cost, all at one time. REACH seems to have achieved what it had set out for. This chemical policy is serving as a basis for many countries to align their internal chemical policies by incorporating the “best practices of REACH”. The success of the REACH regulation would not have been possible without the collective efforts of ECHA, industry associations (EU as well as nonEU), the chemical industry (EU as well as non-EU) and of course the hard work of the only representatives of the non-EU chemical manufacturers!

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HUNTINGDON LIFE SCIENCES

REACH 31st May 2018 – Where to start and what to consider We are down two deadlines and approaching the third; for many companies this could be your first foray into REACH registration and the start of a journey that impacts your future ability to operate. So assuming you want to operate then it is essentially a “Return on Investment” analysis heavily influenced by the regulatory and capacity issues discussed in the article. So where to start?

Know your substance(s) - ECHA’s wording is “unambiguous” substance identification. Sounds simple but this has been a cause of major problems in the previous deadlines. This will determine if you can be part of an existing joint registration SIEF (Substance Information Exchange Forum) or whether there may be more work ahead as a potential LR (Lead Registrant). The data you need for a single substance (>80% of one component) may be more than you currently hold including impurity identification. For a UVCB substance (Unknown or Variable composition, Complex reaction products or Biological materials) the identification process can be even more complicated. If you are assured of your substance identification and you have established that it is registered then you can contact the LR (or Consortia) to purchase a LOA (Letter of Access). You should be aware of how the SIEF agreement relates to the status of a legal entities or affiliates. With the LoA you should be able to register

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with a simplified co-member dossier. The LoA allows you to “refer to data”; you do not own the data and the price can vary greatly – confirm that it covers your uses and exposure scenarios. There may also be continued costs associated with being part of a SIEF, for example if additionally data needs to be generated. If your substance has not been registered then you or another supplier will need to take the LR role. The contact details of your potential co-registrants can be found in the pre-SIEF pages of REACH-IT. The LR has greater responsibilities as well as upfront costs to develop the data you need to fulfil the Annex VII (1 tonne or more) and/or Annex VIII (10 tonne but less than 100 tonne) registration requirements. As LR you have a legal obligation to share (required) data with other companies but importantly to be compensated. Additionally, if you are LR you should complete your IUCLID dossier and submit ideally at least three months in advance of the 31st May 2018 deadline so any

joint registrants can also meet the legal submission deadline. The Annex VII and VIII are mandatory data sets and unlike the higher tier studies do not require testing proposals. Potentially data can be filled by read across, modelling and literature but if not you will need studies most of which will need to be to GLP (Good Laboratory Practice) standards. ECHA is expecting anywhere between 25,000 to 50,000 substances and around 70,000 dossiers for 2018. So even looking at the lower end this is still a lot of substances and laboratory space will be a major factor. Act now to secure your business -“No data, no market.” If you have not preregistered, late pre-registration may still be an option until 31st May 2017. Dr Sean McCarthy Head of Regulatory Affairs for Harlan Laboratories Ltd smccarthy@harlan.com

Huntingdon and Huntingdon and Harlan Harlan The number one provider of The number one provider of REACH testing and regulatory REACH testing and regulatory services for the chemical industries services for the chemical industries www.harlan.com

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UTRECHT UNIVERSITY

Training on Chemical Safety Assessment under REACH: organized in the Netherlands, open for an international audience

Who are we How to keep ourselves and our environment healthy? That is the challenge facing government authorities at all levels, from the local to the international. The National Institute for Public Health and the Environment (RIVM) conducts research and provides advice to assist them in this task. RIVM is also the Dutch institute responsible for providing information on REACH, and further developing existing and new methods and models to improve the chemical safety assessment under REACH. IRAS, the Institute for Risk Assessment Sciences, is an interfaculty research institute within Utrecht University. IRAS provides education and research on the human health risks of exposure to potentially harmful agents in the environment, at the workplace and through the food chain. Effects on ecosystems are also considered. These two institutes RIVM and IRAS in 2005 joined forces to provide education in the field of REACH Since then they have organized already 10 editions of a course for professionals in Chemical Safety Assessment under REACH. The first edition of this course was organized

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years ago before REACH had even become reality, and ever since this course has been adapted and modernized to inform participants about the latest methods in chemical safety assessment and insights about REACH. Over the years the course has attracted over 200 participants from industry, government and academia both from within and outside Europe. In general participants considered the quality of this course to be high and the content to be very relevant. The next course is scheduled June 16-19, 2015.

Content of the course Leading theme in this course in the Chemical Safety Assessment under REACH, with the REACH regulatory background as backbone. The complete risk assessment chain is discussed, from emission and distribution of industrial chemicals to exposure of man and ecosystems, and finally to risk characterization. Experienced speakers from governmental institutions and private consultants will make the course participants familiar with exposure scenarios, risk management measures, and teach them how to collect,

evaluate and estimate exposure and effect data, including alternative data and integrated testing strategies.

Structure of the course The four days course is divided in two parts. In the first two days a general overview of the REACH legislation, regulatory processes and the chemical safety assessment (under REACH) is provided. The second part consists of two additional days with a more in depth and hands-on training on how to perform a chemical safety assessment by making use of available tools. These tools comprise REACH-IT, IUCLID, CSA-tool & CHESAR, QSAR-toolbox demo, analogue and (Q) SARs for human endpoints, CONSEXPO and EUSES. The course provides a combination of lectures and exercises with practical examples. Depending on oneâ&#x20AC;&#x2122;s personal expertise and training needs one can choose to follow only the first part in which an overview is provided or the whole training of 4 days, including the in depth, hands on training.

ELEMENTS SPECIAL 2015

ERM

Reaching Forward The final June 2018 deadline for registration of phase-in substances under the REACH Regulations may not exactly be looming, but as we’re now well into the final lap of this Olympian task, it’s not an inappropriate time to take stock. As a marathon event, rather than a sprint, we’d all be advised to be wary of hitting the ‘wall’ after a promising start and running an exemplary tactical race so far. Whilst many businesses will now be well-practised and efficient in preparing dossiers of substance and risk characterisation information in order to complete registrations, there is the potential for being unexpectedly resource-constrained as a larger number of substances in the 1-100 tonne range, some of which are potentially more exotic, need to be addressed. At the same time, importers or manufacturers specialising in chemicals used in smaller tonnages, including those who wouldn’t consider themselves to be a ‘chemicals company’ may be dealing with the process for the first time. The Candidate List and Annex XIV Authorisation List also continue inexorably

to expand, and it’s worth reminding ourselves that the need for authorisations will continue long beyond May 2018. For many businesses, the need to prepare authorisation dossiers, demonstrate adequate control, analyse alternatives and explain the socio-economic case for the continued use of its chemistries is just beginning. Experience tells us that assessing the business implications of substances subject to authorisation and restriction and developing strategies to minimise the impact on business continuity is best done early. There is also no substitute for engaging with suppliers and customers as early as possible in order that evidence can be assembled in a timely fashion for the most robust defence of chemistry. The experience of REACH, and the evidence and expertise that industry has compiled, also positions it well

for a paradigm shift in strategy. The opportunity, from a comprehensively informed standpoint, to consider the impact of regulatory developments in other jurisdictions, with their subtle differences, to weigh up the changing needs and objectives of customers, and to articulate the benefits of products and the lost opportunity associated with unnecessary substitutions, is an attractive one, and offers the prospect of the best possible product stewardship outcomes. Perhaps there has never been a better time for re-examination of one’s plans for addressing the future needs of global markets. Simon Aumônier, Partner ERM (Environmental Resources Management Limited) simon.aumonier@erm.com

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ELEMENTS SPECIAL 2015

EXPERIEN CHEMICAL SERVICES

Preparation for the final REACH deadline in 2018

2018

Do you have a plan in place to ensure that all of your substances are registered before the 2018 deadline? Since the pre-registration phase of REACH ended in 2008 we have seen two registration deadlines in 2010 and 2013. Companies who registered substances that they manufacture or import before one of these deadlines have a good understanding of the registration process and in most cases will have a plan already in place to register any remaining substances before the final deadline in May 2018. There are other companies who do not manufacture or import any substances in a quantity of more than 100 tonnes per year. Some of these companies may have hardly used their REACH-IT accounts in the last six years other than to submit an occasional late pre-registration or their CLP notifications. This article is concerned with these companies. Now is an excellent time to prepare a plan to ensure that all substances are registered before the deadline. Here are a few questions to consider. 1. Which of your substances have already been registered by other companies? For these substances do you have contact details for the lead registrant and do you know the cost of a letter of access to the joint registration? Are you sure that the substance you are placing on the market meets the substance identification profile of the substance which has been registered â&#x20AC;&#x201C; it is not enough to say that the CAS number is the same?

Do you have the analytical data that you will need to include in the registration dossier? If not, how are you planning to obtain this data? 2. Which of your substances have not yet been registered by other companies? For these substances has any company proposed themselves as the lead registrant? If not, are you going to: Do nothing and hope that a lead registrant emerges in time for you to participate in a joint registration. Initiate contact with the other preregistrants to find out who is planning to register the substance, and perhaps volunteer to act as lead registrant for some substances. Reformulate your products so that unregistered substances can be eliminated from your portfolio before the final registration deadline.

the requirement for extended safety data sheets? Is there a value in starting the registration process this year rather than waiting until 2017/18? There are many companies who would be able to help you with this gap analysis and have experience of the registration process gathered over the last six years. As one of these companies, we have registered substances on behalf of our non-EU clients, acting as an only representative. We have also prepared dossiers for EU companies. We encourage our clients to have a plan in place to ensure that all required registrations are in place with plenty of time to spare before the final registration deadline. We would advise all companies with 2018 registration deadlines to do the same.

3. How are you going to prepare your registration dossiers? Do you have the resource to prepare multiple dossiers in IUCLID 5.6 or will you need external support? If your registrations are in the 10-100 tonne per year band are you ready to meet

Gordon Baird Experien Chemical Services

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Major players in todayâ&#x20AC;&#x2122;s chemicals sector face challenges that call for advisers with worldwide capabilities and reach. We work with more than a third of the worldâ&#x20AC;&#x2122;s top global chemicals companies, and are leading lawyers in the sector in the UK. We work alongside our clients managing their concerns and helping them capitalise on growth opportunities, wherever they operate. Our global team of more than 100 includes lawyers with doctorates in chemistry or chemical engineering as well as those who have worked in-house as general counsel and in other senior positions. As a result we bring first-hand knowledge of the strategic, technical and commercial aspects of the industry including mergers and acquisitions, commercial finance, environmental construction, regulatory, litigation, intellectual property, public policy and international expansion. To find out how we can help you contact: Darren Warburton Partner, Manchester Co-chair, Global Chemicals Industry Group +44 161 830 5069 darren.warburton@squirepb.com

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Meeting your legal business and regulatory challenges Squire Patton Boggs is one of few law firms with both the experience and global capacity to advise clients in the chemicals and performance materials sector locally or worldwide. We have a team of more than 100 dedicated chemicals lawyers across North America, Europe, Middle East and Asia Pacific, able to advise on both legal and regulatory challenges. Key expertise We provide industry experienced lawyers, who are not only legally qualified but many of whom also hold alternative qualifications in chemistry or chemical engineering, together with direct industry experience. This brings unique first-hand knowledge of the strategic, technical and commercial aspects of the sector.

Recognition We are proud to be differentiated within the sector and have earned recognition from industry clients, media organizations and third party groups including; • The Challenge Award from DuPont, honoring the firm as one of the best among a group of primary law firms and service providers; • Selected as the ‘go to’ counsel on M&A, securities and litigation matters by Ashland Inc. The acknowledgements demonstrate our commitment to providing value to your business and meeting your changing needs wherever they arise. Communications & Industry Events Our Chemicals & Performance Materials group host regular seminars, workshops, round tables and updates to ensure clients are kept up to date with any legal changes, case studies and issues facing the industry. These communications and events give clients access to a wealth of information from sector experts and provide opportunities to network with like-minded business people in the industry. With 44 offices in 21 countries, we provide insight at the point where law, business and government meet, giving you a voice and achieving successful outcomes.

We currently act for more than a third of the top worldwide chemical companies; a clear demonstration of our depth of experience and understanding. These blue chip companies include specialty chemical manufacturers, petrochemical groups, chemical trading companies, fertilizer suppliers, plastics and rubber makers, powder coating producers, recyclers of petroleum refining residuals, performance material manufacturers and rare earth element suppliers. Our extensive experience and knowledge of cross-border deals and transactions ensures we can assist clients with the issues that regularly arise in international M&A matters. A multidisciplinary team of over 1,500 lawyers across a range of practice groups means we can draw on the experience of lawyers from teams across the board working in: Antitrust & International Trade, Construction & Engineering, Corporate Transactions, Finance & Governance, Environmental, Safety & Health, Intellectual Property, Labor & Employment, Litigation & Dispute Resolution, Public Policy and Toxic Torts. Working with our colleagues both locally and globally, we ensure we provide a seamless service for clients.

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DHI

How to comply with requirements for authorisation The list of Substances of Very High Concern (SVHC) currently counts 161 substances of which 31 now require authorisation before use (the authorisation list). The list is intended to grow and currently another 22 substances are prioritised for uptake. This may become highly critical to a number of industries. “Some products such as medicinal products are exempted from this regulation as pharmaceutical legislation applies to this area. However, drug manufacturing processes using chemical substances that are on the authorisation list must comply with these requirements,” Jens Tørsløv says. Jens Tørsløv is Ph.D and Head of Projects at DHI, Environment and Toxicology, where they have specialized in chemical management and act as consultants. He stresses the sense of urgency in this matter. “Many manufacturers may not be fully aware of the impact the authorisation requirements under REACH may have, or they may have the misconception that REACH is inapplicable to their production,” he says. “REACH is putting pressure on the industry to identify new methods and replace problematic substances with other substances. Acknowledging that this is not done easily or rapidly, the users must apply for permission to use substances on the authorisation list to continue the use,” Jens Tørsløv explains.

Have DHI provide a SVHC strategy A lot of industries may use SVHC or substances-soon-to-become SVHC during manufacturing. This calls for action! The companies need to identify SVHC in use and develop a strategy on how to act. Intermediates are exempted but for other substances on the authorisation list applying for permission is an option. The experts at DHI know how to trouble shoot in this matter, firstly by knowing what to look for and secondly by knowing what to do with their knowledge. It should be explored if authorities can be convinced not to place a critical substance on the authorisation list, by documenting the impact it has on business and by exploring other ways of regulation. In situations where no alternatives are available and the only use is in well controlled industrial settings, it may be worthwhile to try to argue to keep the substance off the list.

has recently announced that they wish to simplify the process for authorisation, for instance of low volume substances and SVHCs for repair of certain long life articles. DHI is following the development closely in order to support each industry client with the best strategy.

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REACH does make it possible to influence the decision process. The REACH authorisation procedure is expected to be simplified as the European Commission

REACH SPECIAL 2015

UNIVERSITY OF BRADFORD

Quality analytical services REACH came into force on the 1st June 2007 and covers the registration of all materials manufactured or imported into the EU at quantities of 1 tonne or more per year. The system has been phased in gradually since 2007, with phase 1 (December 2010) covering materials manufactured at ≥1000 tonne / year and highly toxic materials and phase 2 (June 2013) covering substances supplied at ≥100 tonne / year. Phase 3 is the final phase and covers the remaining materials that are supplied at ≥ 1 tonne / year. The deadline for this final phase of registration is 1st June 2018, so organisations that have not yet started the registration process have only 3 years to complete. To comply with REACH it is necessary to identify all chemical substances using a series of analytical tests.

Who REACH applies to: n Manufacturers and Importers n Downstream users – Businesses

that use chemicals supplied by manufacturers or importers are downstream users n Distributors and users – Businesses

that sell chemicals (distributors) have specific duties to pass information to customers and also pass information to their suppliers The upcoming REACH deadline will affect a huge number of UK businesses over the next few years, in particular SME’s and speciality chemical companies manufacturing or importing smaller quantities of material will be affected. It is clear that some SMEs do not have enough internal resources to manage the REACH process. The Centre for Chemical and Structural Analysis (CCSA) at the University of Bradford has supported a number of regional companies including

REACH SPECIAL 2015

SME’s with their REACH submissions by providing cost effective and responsive services in the generation of analytical data to support the process. The Centre has both the equipment, including NMR, Mass Spectrometry and a range of chromatography options, and the expertise to provide high quality data presented in a report suitable for a REACH submission. We are able to provide data ranging from basic ID information, through to analytical data provision in support of sameness packages. In addition, the Centre can also offer bespoke problem solving and analysis for more complex products. We can also offer guidance and advice through our experience and relationship with specialist REACH consultants. A summary of our services is provided below: n Basic identity information including

public and trade names, Chemical Abstracts Services (CAS) nomenclature

and numbers, IUPAC naming and EINECS numbers and molecular and structural formulae including SMILES notation; n Analytical data provision including

NMR, vibrational and electronic spectroscopy (FTIR, Raman and UVVis), mass-spectrometry and solid state techniques (X-ray diffraction, differential scanning calorimetry and solid state NMR where required); n Sameness testing including purity and

composition analysis, chiral purity and impurity identification as required in addition to the services listed above. n We are also able to provide

further bespoke testing of more complex substances using a range analytical techniques such as; HPLC, Mass Spectrometry, Vibrational Spectroscopy ,Thermal Analysis, X-ray Diffraction, Microscopy, Particle and Powder characterisation

The Centre for Chemical and Structural Analysis at the University of Bradford offers contract analytical services to the chemical, pharmaceutical and healthcare sectors. The Centre provides a wide range of sophisticated analytical instrumentation and techniques, deployed in a commercially focused environment under a quality management system. The Centre draws on academic know-how and a dedicated industry savvy and highly professional team to deliver challenging analytical projects including support for REACH submissions.

Contact details: Centre for Chemical and Structural Analysis (CCSA), University of Bradford, Bradford, BD7 1DP. www.bradford.ac.uk/business/ccsa Dr. Jason Jones: T. +44 1274 236193 E: j.r.jones@bradford.ac.uk Dr. Richard Telford: T. +44 1274 236143 E: r.telford@bradford.ac.uk

n Basic ID Information including public / trade names, CAS

and IUPAC nomenclature, and molecular formula. n Sameness testing including generation of spectral data

(NMR, MS, UV-Vis, FTIR/Raman and purity assessment). n Bespoke analytical research including method development

activities, impurity identification & purity assessment. n Access to an independent REACH Regulatory consultancy

organization.

Understanding and facilitating the effective management of risk is our core business. Only when the risk facing an organisation is well understood can it be effectively managed. Key to the successful identification, assessment and management of risk is engagement with the right people, using the right processes at the right time. We believe we are different to many of our competitors and that our approach is distinctive; we don’t always walk the welltrodden path but look at each client’s particular risk context and develop a tailored solution, working in partnership with our client.

Safety Risk Our safety risk assessment and management expertise covers risk identification techniques such as HAZIDs and HAZOP, predictive modelling advice and the facilitation of risk management techniques, particularly in the demonstration of ‘ALARP’. The area of Control of Major Accident Hazards (COMAH) is a particular specialism within the company.

Environmental Risk Our services in the Environmental Risk area range from the assessment of the risks related to the environment in relation to Major Hazards, based on our Source, Pathway, Receptor risk assessment model, through to the preparation of Environmental Permits (PPC in Scotland) – full applications or variations of existing permits – particularly in relation to planning for new developments.

Business Risk It could be argued that all risk – whatever its label – can be defined as ‘Business Risk’. Ultimately, whatever risk is being considered, whether safety, environmental, commercial or financial, if it’s not understood and managed effectively, it becomes a risk that affects the whole organisation.

RAS Who we are RAS Ltd is an independent firm of risk specialists established in 1993. We are founded on a set of simple principles: recruit the best people in the industry, only work in our areas of expertise, and work with our clients, not for them. It’s an approach that has seen us grow from being a handful of specialists in the North West to a rapidly developing company working with the leading companies in the oil & gas, pharmaceuticals and specialist chemical sectors across the world. Our team have worked on some of the biggest and most influential projects in the industry, and continue to expand their specialist knowledge.

RISK & HAZARD MANAGEMENT

We’re proudly independent. Our independence gives us the freedom to do what’s right for our clients without being slowed down by corporate structures and consultancy models. That’s not to say that we don’t have our own methodology and risk models – we do – but we approach every single project differently, and don’t provide uniform services ‘off the shelf’. We also work closely with a number of specialist consultancies when the need arises, to ensure we provide best practice advice. We’re quick, efficient and cost-effective. Why not put us to the test?

What we do Everything we do is about managing risk in three areas: safety, business and environment. As you’d expect, we work to internationally recognised standards. We have particular capabilities in accident risk in the oil & gas, pharmaceutical and chemical sectors and work with the key industry players.

A lot of organisations initially come to us with a regulatory compliance need, but they come back for support on wider risk issues. Our entire approach is about adding value to your business. By understanding your challenges we can provide best practice advice – and by sharing our past experiences and knowledge, we can help you better manage the risk within your organisation.

Because we specialise in these core areas, our clients can be certain of up-to-date knowledge and an undiluted focus on the specific risk challenges of their business.

How we work Every report, strategy or project we undertake is bespoke to our clients’ needs and unique set of circumstances. Only when we understand your challenges fully can we provide best practice advice and apply our skills and creative thinking to problem solving. Often, we find this leads us down a different path than was expected. We don’t see ourselves as suppliers, we see ourselves as partners. Not in a clichéd ‘we’ll hold your hand’ way, but more in a pragmatic, practical way: one that’s all about giving you the tools and knowledge to manage your own challenges.

is why we question everything and don’t work in isolation, looking at a project holistically to see how it impacts on the entire organisation.

As your risk partner, our job is to make sure you are protected and your best interests are looked after. Which

It’s the only way we can confidently say ‘we’ve got your back.’

T +44 (0) 1244 674 612 E jo.condon@ras.ltd.uk W www.ras.ltd.uk

1922-SBanner-ICIS Adv v2.qxp_Layout 1 09/04/2015 15:13 Page 1

About 2M Holdings Ltd: 2M Holdings was founded by Mottie Kessler in 2004, the present Chairman and CEO, with a long term objective to grow an international chemicals distribution portfolio based on excellent companies with strong brands. 2M Holdings includes a portfolio of branded companies of chemical distribution and related chemical services of sample management, storage and blending. 2M Holdings has customers worldwide and is headquartered in the UK and with subsidiaries in: China, Benelux, Ireland, Poland, Scandinavia and Brazil. 2M Holdings’ business focus is on automotive, precision cleaning, coating, emission reduction AdBlue, oil-field & refineries, flavours & fragrances and surfactants for: personal-care, household & industrial hygiene cleaning and pharmaceuticals. 2M Holdings Companies produce AdBlue, SamSol Products, Packed Chlorine (cylinders and drums) and TRIKLONE™ & PERKLONE™ (Chlorinated Solvents).

2M Holdings Ltd

INTERNATIONAL BRANDED CHEMICAL COMPANIES OF

Banner Chemicals

MP Storage & Blending

E: info@2m-holdings.com T: +44 1928 597 000 www.2m-holdings.com

GET EXPERTS ON YOUR SIDE “You can do your business, we remove the regulatory roadblocks.”

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www.chemservice-group.com • info@chemservice-group.com www.chemservicegroup.com info@chemservicegroup.com

RANDIS CHEMWISE

New Chemical Substance Registration for China IECSC Different from EU REACH, Taiwan REACH and Korea-REACH, China currently only requires registration of New Chemical Substances i.e. chemicals not listed in Inventory of Existing Chemical Substances of China (IECSC) before placing the substance onto mainland China market (excluding Hongkong, Macau). Regulation on Registration of existing chemical substances in China is at drafting stage. Similar to other countriesâ&#x20AC;&#x2122; Regulation, there are also several types of registration under China regulation system.

Selection of Registration Type To make which type of registration depends on the chemicalâ&#x20AC;&#x2122;s property, annual quantity, usage purpose and preference of registrant. A judgment flowchart can be concluded as in fig1 (right) (1) Scientific Record Notification It is only to NOTIFY China authority what chemicals for what purpose. China authority will not issue approval (certificate) for this notification. Chemicals used for scientific research purpose with <100kg/year, and chemical sample sent to China for physic-chemical/ toxic/eco-toxic tests by China labs can apply for this registration. Once the registration dossier is submitted, the registrant can send the sample to China. (2) Simplified Registration It consists of 2 types, 2.1 Special Type Intermediates (<1ton/year), Export from China only (<1ton/year), Scientific Research purpose (100~1,000kg/year), Process and Product Development purpose (<10ton/year) can apply for this type registration. No test report for the substance is needed. Polymer can also apply for this type registration (no quantity limitation). A molecular weight distribution analysis report is needed to verify the definition of polymer is met. This type registration takes about 1.5 months after registration dossier is submitted. A registration Certificate will be issued to the registrant.

REACH SPECIAL 2015

fig1

2.2 Basic Type Substances that do not meet above criteria but annual quantity is <1ton/year can apply for this type registration. 1~3 ecotoxic tests shall be conducted by China certified lab(s). Tests take ca. 4 months, then the registration takes 2~3 months. A registration Certificate will be issued to the registrant. (3) Typical Registration Substances that do not meet above criteria can apply for this type registration. Registrant can also apply for this type registration even above criteria are met.

substance listed into IECSC after 5 years, and then the substance will not be managed as New substance anymore.

Registrant China local manufacturer/importer and companies outside mainland China (overseas registrant) that export chemical substances to China can be the registrant. Afterwards, the registrant is entitled to manufacture/import/export the substance to China. For oversea registrant, a China Representative (similar to EU OR) shall be appointed.

This type of registration needs dozens of tests reports on physic-chemical properties, toxic and eco-toxic properties, among which 2~5 eco-toxic tests shall be conducted by China certified lab(s). Remarkable point is that QSAR and ReadAcross data are normally not sufficient for this type registration. The registration takes more than 3 months after the whole registration dossier is submitted. A registration Certificate will be issued to the registrant. This type registration will get the registered

Frank Wang

Randis ChemWise (Shanghai) Co., Ltd General Manager: Frank Wang E-mail: frankwang@randis.cn www.randis.cn www.randischem.com

Need help in China? Randis ChemWise (Shanghai) Co. Ltd is located in Shanghai, established in 2004, focusing on China and Taiwan chemical regulatory compliance. Experts in Randis provide professional consulting service on: •

China IECSC(China REACH)

•

Taiwan Chemical Substance Registration

•

GHS

•

China Cosmetics

•

Hazardous Chemical Notification

•

Food Contact (GB9685)

•

Other China Chemical Regulations Consultation

Randis provides comprehensive, prompt and cost-effective services, to help you explore your business in China and Taiwan. Client’s information is always our confidentiality. Randis is your professional and reliable service provider.

Randis ChemWise (Shanghai) Co., Ltd Unit 505, KeChuang Building, #350 Xianxia Road, Changning District, Shanghai, 200336 P.R.China Tel +86(21) 62757818 E-mail: frankwang@randis.cn www.randis.cn | www.randischem.com

Our Knowledge, Your Advantage

Introducing High Accuracy QSARs – KREATiS’ solution to tackle REACH 2018 What is the scope of QSARs in the registration of chemicals under REACH?

Dr. Paul THOMAS, Managing Director of KREATiS, answers some of the frequently asked questions from the chemical industry concerning the use of in-silico models under REACH.

There is a significant growth in the number of registrants opting for in-silico approaches under REACH. The 2018 challenge of registering a huge number of substances has put great pressure on the industry to look for faster, reliable and affordable alternatives to experimentation. Amongst these methods, Quantitative Structure Activity Relationships (QSAR) is one of the acceptable choices for regulatory dossiers. To recognise QSARs that are valid and fit for regulatory use, OECD has defined five principles for model validation. In the same way, in order to facilitate a harmonised way of reporting QSAR predictions, the EU Joint Research Centre has introduced two QSAR reporting formats, QMRF (QSAR Model Reporting Format) and QPRF (QSAR Prediction Reporting Format). Recently, KREATiS’ QMRF on the cascade approach to predict physicochemical and ecotoxicological endpoints has been verified by the EU Joint Research Centre and was included in their QMRF database. This report can be downloaded from their database using the QMRF identifier: Q19-46-41-422.

Several QSAR tools are available on the market. How are KREATiS’ High Accuracy QSARs different from the existing ones? It is true that today the industry has a wide range of free and commercially available QSAR packages capable of making QSAR predictions, however the majority of them do not fulfil the five OECD principles necessary to validate QSARs for regulatory purposes and strictly speaking this limits their use to screening purposes only. Thus, it is necessary to distinguish between QSARs created to provide approximations of experimental values and those specifically designed to substitute for specific experimental endpoints. At KREATiS, we termed these latter models “High Accuracy QSARs” or simply “HA-QSARs”.

Can you explain what makes your HA-QSARs High Accuracy?

23 rue du Creuzat, 38080 L’Isle d’Abeau, France Tel: +33 (0)4 28 19 01 06 Email: contact@kreatis.eu Visit us at: www.kreatis.eu

Data validation is the crucial first step of HAQSAR creation. Only the best experimental study results are included after expert judgement.

All the HA-QSARs are developed and validated based on a “cascade approach” which interlinks different endpoints based on thermodynamic relationships*.

The validation of our models includes all statistical approaches necessary to complete the QMRF and QPRF reports to the highest level. These reporting formats are essential to get your REACH dossier successfully registered.

* Note: to date, not all chemicals and all studies can be replaced using KREATiS HA-QSARs. Visit our website or contact us for more information on the applicability domain of KREATiS HA-QSARs and available endpoints.

Why High Accuracy-QSARs?

WHY NOT

 Predictions are at least as accurate as values measured with best available experimental technique for that endpoint.

TRY OUR HIGH ACCURACY QSAR SOLUTIONS FOR YOUR REACH NEEDS?

 Our service is time-efficient and offered at a fraction of the price of a laboratory study.  KREATiS HA-QSARs are developed and validated on the basis of a cascade approach where every endpoint is interlinked based on thermodynamic principles.  Model predictions are accompanied by reporting formats (QMRF and QPRF) necessary for REACH compliance.

NEED MORE INFORMATION? Further details on available HA-QSARs can be found at

www.kreatis.eu “At KREATiS, we believe in precision and quality. Our High Accuracy QSARs are the outcome of a quality data selection, sophisticated modelling algorithms and a validation in compliance with REACH guidelines.” Dr.Paul THOMAS

iSafeRat® (in Silico Algorithms For Environmental Risk And Toxicity) is the name of the KREATiS HA-QSAR toolbox.

Managing Director of KREATiS

KREATiS 23 rue du Creuzat, 38080 L’Isle d’Abeau, France

Call us: +33 (0)4 28 19 01 06 Send your queries to: contact@kreatis.eu Visit us at: www.kreatis.eu

Scan this code using your smartphone or tablet to get redirected to our website.

ECTS

Findings on supporting companies in REACH compliance

By Expert Centre for Chemical Risk Management, The Netherlands The Expert Centre for Chemical Risk Management (ECTS)1 is a Dutch organization that translates scientific knowledge into practical solutions for the workplace. It combines the expertise in the fields of toxicology, occupational hygiene and occupational medicine. Concerning REACH, the main perspective herein is the downstream user who has to comply with the user description described in the extended Safety Data Sheets (e-SDS). Downstream users need to identify and apply appropriate measures to adequately control the risks at their site, this has to be done within one year after receiving the e-SDS. ECTS helps them by performing a compliance check. In the Netherlands larger, often internationally based companies have their own experts on REACH and are less in need of external support on this topic. Smaller companies tend to be less aware of their obligations to the REACH legislation. They are often confronted by the Dutch Labour Inspection (The Inspectorate SZW) and their supervision of compliance with the regulations concerning hazardous substances. These companies request the ECTS for assistance to create their substance register. It is very common that these smaller companies have not even heard of REACH or are not aware of their obligations to it. 1 info@ects.nl 2 http://gevaarlijkestoffen.zelfinspectie.nl/ only in Dutch

REACH SPECIAL 2015

Dutch legislation on hazardous substances in some fields even goes beyond information provided / needed within REACH. The Inspectorate SZW therefore has implemented a simple four step selfinspection method2 to help companies to check whether they comply with the legislation on hazardous substances. These steps are; 1. Iventarise (present substances, properties (of high concern), 2. Assess (exposure, limit values), 3. Take measures (temporary, structural measures), 4. Secure (changes in the workplace, instruction of employees, medical examination). ECTS assists companies to go through the four-step-method and incorporates REACH in the process. When making an inventory of present substances, the company is supported in gaining the needed information from suppliers like REACH compliant safety data sheets. To assess the exposure, information from the e-SDS can be used if it matches the company’s situation. If not, ECTS helps the company decide if they want to adapt the measures described in the e-SDS, ask the supplier to make it an identified use, change from supplier, make

their own chemical safety assessment, or cease the usage of the substance. To check the assessed exposure a limit value is needed. DNEL’s / DMEL’s can be used if available but Dutch lawful TLV’s need to be taken into account as well. When deciding which preventive measures need to be taken the information from e-SDS can be used. However in many cases these are not applicable in the company’s situation. In those cases alternative measures are often advised and the ECTS helps them to perform their own chemical safety assessment by scaling or other assessment methods. To secure the company’s policy on hazardous substances ECTS advices how to use the information from the SDS to make brief Substance Attention Sheets that helps to instruct employees. We also point out the need to check for changes in work processes and supplied substances accompanied by REACH compliant SDS regularly. ECTS also advices on medical examinations that are indicated when working with certain substances.

ECTS on REACH – Always finding a solution

WSP | PARSONS BRINCKERHOFF

SIEFs and consortia for 2018 registration 2018 sees the final registration deadline for lower tonnage substances to be registered under REACH. Here are five key recommendations from the consortium management specialists in WSP | Parsons Brinckerhoff 1. Don’t assume someone else is going to take the lead Our experience shows it’s wrong to assume your trade association or the larger manufacturers will be taking the lead. This is especially the case if your use is extremely niche or specialised. There may be progress, but get on the front foot and start checking now.

2. Set up consortia to share data and effort between users REACH effectively mandates the formation of Substance Information Exchange Forums (SIEF) to manage joint registrations. A SIEF agrees the appointment of a lead registrant, agrees a Substance Identity Profile, and can exchange and agree the valuation of data. However, a SIEF is not a legal entity, so cannot spend money or hold funds. A consortium is a group of organisations that come together to achieve common objectives and typically forms around one substance, a group of substances, and/or specific registration objectives. Consortia can often be more efficient than SIEFs in managing registration programmes. If there is no consortium, the lead registrant may have to carry all costs until Letters of Access (LoAs) are sold. For SMEs, this can be an impossible burden. Furthermore, consortia offer an opportunity for shared work and to avoid the need for registrants to invoice their competitors. A consortium facilitates substance grouping or read across for multiple substances, reducing testing costs.

3. Use independent managers to run your consortia Independent consortium management draws on experience of registering previous substances, the legal requirements of cost sharing mechanisms and gives a clear, independent overview. This makes the process quicker, less expensive and not subject to unexpected issues. It also helps avoids competition concerns with sharing confidential data.

4. Commission a scoping study at the outset There’s considerable uncertainty on just how much toxicology and use data is likely to be already available for smaller tonnage chemicals. Carrying out a scoping study at the outset will help identify the likely registration costs at the outset, helping budgeting, planning and resource management. Costs can also be reduced by grouping substances together, drawing on the results of testing of similar chemicals, intelligent waiving of tests and by challenging LoA prices where appropriate. An independentlycommissioned REACH “scoping study” can be valuable in tabulating all of the likely costs of registration.

5. Start work now Decide whether the expertise or time exists in house to manage required REACH compliance programmes. Either way, although there’s still three years until registration is needed, now is the time to start planning and acting. Alan Ritchie alan.ritchie@wspgroup.com, +44 (20) 7314 4413 WSP | Parsons Brinckerhoff Alan has 25 years of chemical regulatory and REACH and consortium management. He is happy to provide informal advice on REACH and consortia management.

REACH SPECIAL 2015

JSC International – providing expert support for:  REACH/CLP  Biocides  Agrochemicals Providing expert independent regulatory and risk assessment advice to Chemical industries, JSC can help you navigate through the complexities of the EU regulatory system. Our team of regulatory experts and technical specialists have a proven track record of guiding our clients to regulatory success. Visit our website to meet the team and access lots of useful and topical regulatory information, as well as articles produced by the JSC team. At JSC we recognise the complexity of the EU regulatory systems and use our experience and knowledge to support you and your products to ensure regulatory compliance and continued sales. For further information on how JSC can help you please contact enquiries@jsci.co.uk JSC International Limited The Exchange | Station Parade | Harrogate | North Yorkshire | HG1 1TS | UK T. +44 (0)1423 520245 | F. +44 (0)1423 520297 www.jsci.co.uk 62

REACH SPECIAL 2015

JSC INTERNATIONAL LIMITED

Authorisation – The biggest challenge of REACH Authorisation is a complex process under the REACH Regulation (EC) 1907/2006, which is required for substances identified as a substance of concern and listed on Annex XIV of the Regulation. The aim of the authorisation process is to control and restrict the sale or use of Substances of Very High Concern (SVHC). A SVHC is a substance that may have serious and often irreversible effects on human health and the environment, for example substances which are classified as a carcinogen category 1A or 1B. Those substances listed in Annex XIV cannot be placed on the EU market or used after the so-called “sunset date” unless an authorisation has been granted for a specific use, or if the use has been exempted from authorisation. An authorisation can only be granted by submitting an authorisation dossier for the specific use to ECHA for evaluation. Authorisation is a two-step process whereby initially a Member State or ECHA proposes that a SVHC is added to the Candidate List (for authorisation)1. These substances can be tracked on the Registry of Intentions (ROI)2, which is a public list of substances for which a SVHC, classification or restriction dossier is intended to be submitted. In the second step, a substance may be included in the Authorisation List itself (Annex XIV of the REACH Regulation). Applications for authorisation will only be successful if applicants can demonstrate that the risk from use of the substance is adequately controlled (adequate control route). If not, an authorisation may still be granted if it can be proven that the socio-economic benefits of using the substance outweigh the risks and there are no suitable alternative substances or technologies (socio-economic route). The application should include the substance identity, the use for which authorisation is sought, a chemical safety report, an analysis of the possible alternatives and, where alternatives are available, a plan to substitute the substance including a timetable for proposed actions. A socio-economic analysis (SEA) is required where the applicant cannot show adequate control of risks. However, it is suggested that a

SEA is provided as supporting evidence to demonstrate the impact of the availability of the substance. The application process requires the investment of time and resources, so companies should consider if this is the best course of action for their business or whether an alternative substance formulation might be more suitable than an authorisation. A robust analysis can help determine whether an authorisation is the best option and will also be useful for compiling an argument to support the application. If the authorisation route is chosen, applicants must notify ECHA well in advance (i.e. 8 months) of the intended date of submission of an application for authorisation. At the time of notification a pre-submission information session (PSIS) with ECHA can be requested, to ask casespecific questions regarding the regulatory and procedural aspects related to the application. To aid ECHA with work planning, specific windows for submitting applications have been established with the aim of synchronising the submissions with scheduled meetings. If the dossier is submitted in any of the submission windows, applicants can benefit from the transitional arrangements of Art. 58(1)(c) (ii) of REACH – transitional arrangements allowing the continued use after the sunset date until a decision on the application for authorisation is taken by the Commission. It should be noted that the transitional arrangements only apply if the application is submitted before or at the latest application date and pass the Business Rules check.

n Cannot cover use(s) further up the supply chain It is important to note that the rules regarding who can be the authorisation holder may have the potential to cause supply disruptions if there are missing links in the supply chain. The application for authorisation is a complex process requiring a new dossier to be submitted detailing the use of the substance. The key message is to start and prepare early enough to ensure your application contains all the documentation required. Check ECHA’s website regularly to follow new developments and track if a substance is of particular interest. For more information on Authorisation or any aspects of REACH please contact JSC International Limited. JSC is a Regulatory Affairs consultancy firm providing regulatory support for companies on REACH, CLP, Biocides and Agrochemical legislation. Samantha Wright & Richard Elsmore JSC International Limited The Exchange, Station Parade, Harrogate, North Yorkshire HG1 1TS Tel: +44 1423 520245 Fax: +44 1423 520297 e-mail: sam.wright@jsci.co.uk richard.elsmore@jsci.co.uk Website: www.jsci.co.uk

Manufacturers, importers and downstream users (DU) can apply and hold authorisations for their own uses or for uses down their supply chains. Therefore a DU can use a substance without applying or holding an authorisation provided that: n ECHA is notified [Art 66] n The substance is used in accordance with the conditions of an authorisation granted to an actor further up the supply chain [Art 56(2)] A company may also supply the substance to his immediate DU for a use, provided that this immediate DU holds an authorisation for that use [Art 56(1)(e)]. In other words, a DU holding an authorisation: n Can cover the placing on the market for his use(s) only one level up his supply chain

1. http://echa.europa.eu/candidate-list-table 2. http://echa.europa.eu/en/addressing-chemicals-of-concern/registry-of-intentions

REACH SPECIAL 2015

LAUS GmbH

We test your products

LAUS is a private and independent GLP laboratory which was founded in 1991. We support our customers in the field of chemicals, pesticides, biocides, pharmaceuticals and medical devices with all necessary studies for the registration and approval. Due to our experience with registration authorities and our wide network of consultants and partner laboratories, we can work out an individual testing scenario for regulatory purposes together with our customers.

Quick and flexible decisions and completion without delay assure you a cost effective use of resources. We keep you regularly updated on the current stage of all processes until authorities acceptance.

We offer individual services from one hand. For each particular product we develop an individual notification/registration strategy, based upon the actual legal requirements. We are also well prepared to come up with all requirements that will be caused (requested) by REACH. Together with our collaboration partners we carry out all necessary studies:

All services are available as complete package or as individual components.

n Physico-chemical Properties

Our GLP-laboratory has got in work more than 40 employees (chemists, biologists, ingenieurs and technicians) and can present all services in our new laboratory.

n In vitro Toxicity n In vivo Toxicity*

Actual situation:

n Aquatic and Terrestrial Ecotoxicity

We are working according the international GLP-standards for industrial clients out of:

n Biodegradability

n Chemistry

n Mutagenicity/Genotoxicity

n Agrochemistry

n Analytical Chemistry

n Biocides

All our test procedures comply with the official guidelines of organisations such as OECD, ISO, EPA OPPTS, EPPO, IOBC and SETAC. For cases that are not covered by any standards, we will develop tailor-made protocols that fulfill (both) the requirements of the registration authorities and of your product. All tests and studies comply with the internationally recognised OECD GLP quality standards.

n Veterinary Medicinal Products

We compile all data and prepare all necessary documents for your dossier, including material data sheets and risk assessments and their submission to the authorities.

We support you preparing your company for the new Chemicals legislation.

REACH SPECIAL 2015

n Pharmaceuticals n Lubricants n Medical Devices

With our collaboration partners we can offer you the full range of GLP-studies. For field studies or efficacy trials we have different partnerships in Europe (Spain, Italy, France and Greece). *Toxicity studies (in vivo) will be done by our collaboration partners

Your competent GLP testing facility

Registration and Testing of:

Our Expertise:

• Pesticides / Biopesticides

• Physico-chemical Properties

• Chemicals (REACH and CLP)

• In vitro Toxicology

• Biocides

• Mutagenicity / Genotoxicity

• Veterinary Medicinal Products

• Ecotoxicology

• Human Medicinal Products

• Biodegradability

• Cosmetics

• Environmental Fate

• Medical Devices

• Analytical Chemistry

• Feed Additives

We support you to develop an individual test strategy for your substance

LAUS GmbH Mr Dietmar Kuhn Auf der Schafweide 20 D-67489 Kirrweiler

T: +49 (0) 6321 - 96 299 – 0 or - 21 F: +49 (0) 6321 - 96 299 – 29 E: dietmar.kuhn@laus.de www.laus.de

BIG

Downstream User’s Compliance Check Every employer is required to guarantee the welfare of his employees, as well as a moral obligation to care for both them and the environment. In particular, when contact with hazardous substances is suspected everything possible should be done to avoid exposure to such products As an industrial or professional user you receive information concerning the hazards of products, the risks when handling them and relevant safety measures through ‘Safety Data Sheets’ (SDS’es). As a result of the REACH regulation, so-called extended SDS’es containing use-specific exposure scenario’s (ES’es) are now circulating. These ES’es give information on the possible exposure to man and environment per use identified by the REACH registrants, and describe safe use of and responsible care for the product. The REACH regulation stipulates that these exposure scenarios are evaluated and implemented within your organisation within 12 months after receiving the extended SDS. In case of deviation and where the supplier will not re-assess, you must guarantee safe use through your own Downstream User Chemical Safety Report (DU-CSR).

Receiving ext-SDS

Implementation ES

Compiling DU-CSR

• Analyses ES

• Notification to ECHA

• Check ES to work floor reality

• Performing DU-CSA (chemical safety assessment)

• Implement shortcomings

• Compiling DU-CSR (chemical safety report) • Update of own ext-SDS based upon DU-CSR

BIG can help you with the implementation of the exposure scenario or if you prefer, the compilation of your own Downstream User Chemical Safety Report (DU-CSR). However, it might be more efficient to compile your own DU-CSR from the start when you deal with many substances and ES’es. Why? When you compile your own DU-CSR you are independent of your supplier concerning availability of data. The data used to perform the chemical safety assessment will be specific to your identified use and scaled for your actual situation. In addition, when you receive updated ES’es, you won’t need to assess them again for applicability to your own situation.

REACH SPECIAL 2015

Product Risk Advice module (PRA) This module developed by BIG allows you to quickly and systematically assess the risks of substances present in your organisation. Based on the intrinsic hazards, the exposure limits, the physical properties and the identified use, the tool provides a fairly good idea on the risk potential and also gives precautionary measures for the user. The module will allow you to create a priority list within the dynamic risk management plan containing the most high-risk substances. These need then be examined closer using other available tools like ECETOC TRA, ART,... For further information, please do not hesitate to contact BIG at info@big.be

BIG, Reliable Quality BIG was founded in the mid-seventies as a subsidized non-profit institution. It was the answer to the growing need for information on chemicals in terms of both incident intervention and prevention. More than 35 years later we are now a self-funding non-profit organization. Our priority remains however aiding and assisting industry to be compliant. BIG offers full and complete REACH services n Inventory of substances, mixtures and articles n Pre-registration n Registration: drafting Chemical Safety Report & Technical Dossier (IUCLID 5) - Data Gap Analyses - Evaluation, summary and advice on chemical tests and studies - Exposure and risk assessment n CLP & Drafting Safety Data Sheet (SDS)

n Exposure Scenarioâ&#x20AC;&#x2122;s

n REACH audit

n Drafting Downstream user reports and downstream user chemical safety reports

n REACH & CLP training

n Expert, independent and objective consultancy n Notifications: C&L, SVHC in articles n Third party representative of EU manufacturers or importers

n Expert knowledge on Detergents & Biocides BIG prides itself in its many partnerships with national and international bodies and that we count as many numerous multinationals as local SMEâ&#x20AC;&#x2122;s amongst our users.

n Only representative of non-EU manufacturers

Big Problems need BIG Solutions

BIG vzw Technische Schoolstraat 43A B-2440 Geel Tel: +32 14 58 45 47 info@big.be www.big.be