1 June2014

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3 High-quality data - a key factor for industry and ECHA

Good quality information in registration dossiers is fundamental for the success of REACH in ensuring the safe use of chemicals. Without reliable information, it is not possible to carry out appropriate chemical safety assessments and to put the necessary operational conditions and risk management measures in place.

6 Progress in using alternative testing methodsECHA has published its second report on the use of alternatives to animal testing under REACH. The report shows that reg-istrants have made extensive use of the different possibilities outlined in REACH to avoid unnecessary testing on animals.

14 Enforcement - planning aheadThe Multi-Annual Work Programme of the Enforcement Forum foresees the continu-ation of harmonised REACH enforcement projects and a pilot project for REACH authorisation. Read what the re-elected Chair of the Enforcement Forum, Szilvia Deim, tells about the future plans.

20 From registrant to downstream user - implementing REACH the Yara wayYara International ASA gives an industry perspective on implementing REACH. The company operates in all of the roles defined in the REACH Regulation. Read about the organisational and management structures that Yara has put in place, both centrally and regionally, to address the challenge.

Through the deadlines towards safer chemicals

12 JUNE 2014

One of ECHA’s main events of the year, the Stakeholders’ Day for REACH and CLP, took place in May. We were happy to welcome over 200 participants in Helsinki where the event was organised in our premises for the first time. Additionally, over 1 000 took the chance to participate through the live webstream and sent their questions to the speakers through the Internet. A recording is now available on our website.

The event had three main themes:

• theroadtotheREACH2018registrationdeadline;• evaluationandsupplychaincommunication;• riskmanagement,andclassificationandlabelling. Manycompanieshavealreadystartedtopreparetheirdossiersforthe2018REACH registration deadline. Later in this issue, you can read interviews with industry representatives who spoke with ECHA Newsletter about their experiences and gave their advice on REACH registration. ECHA is currently planning its activities to support registrants, and SMEs in par-ticular,tomeetthefinalREACHregistrationdeadlinein2018.Stakeholderswillbe consulted on the plans later this year. Nevertheless, registrants can already find all the necessary information to start their preparations on ECHA’s website. I echo

annankatu 18, p.o. box 400, fi-00121 helsinki, finland | echa.europa.eu

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In this issue: 3 High-quality data - a key factor for industry and ECHA5 Guest column: Philip Copestake, Richard Young and Chris Waine, bibra6 Progress in using alternative testing methods 8 Evaluation underway for testing proposals from the 2013 REACH deadline10 Continuous development of the QSAR Toolbox11 TimetostartpreparingforREACH2018 12 Registration lessons from an SME14 Enforcement - planning ahead16 Biocides - important changes for companies17 Improving supply chain communication20 From registrant to downstream user - implementing REACH the Yara way22 Is the substance identifier in your registration correct?24 Follow-up of the December 2013 SME workshop

To subscribe to the ECHA news alerts and newsletter, register at: http://echa.europa.eu/subscribeDisclaimer: The views presented in the Newsletter do not necessarily represent the official position of the European Chemicals Agency. All the links are up to date at the time of publication.

ISSN:1831-4953

Editor-in-chief: Lindsay Jackson Editors: Päivi Jokiniemi, Hanna-Kaisa Torkkeli

European Chemicals AgencyAnnankatu18,P.O.Box400,FI-00121 Helsinki FinlandTel.+3589686180Fax+358968618210

http://newsletter.echa.europa.euechanewsletter@echa.europa.eu

“There are many challenges ahead

but there is also a lot of informa-

tion and support available.”

Executive DirectorGeert Dancet

what industry said at Stakeholders' Day - registrants should start now by looking into their product portfolios and clarifying their registration plans. Registrants can find useful information and valuable tips for their prepara-tions from ECHA’s annual evaluation reports. The 2013 report was pub-lished in February and one of its main messages is the importance of high quality information. This is the key to success, not only because it helps you to avoid regulatory interventions by ECHA or the Member States but also because it enables you to build trust with your customers and consumers. However, it is important to keep in mind that the registration deadline is only one step on the way to improving chemical safety and the information sent to ECHA and your customers needs to be continuously kept up-to-date.

Beforethe2018REACHregistrationdeadline,thereishowever,animpor-tant deadline for classification and labelling. The transitional period from theolddirectivetothenewregulationendsinJune2015andtheclas-sification and labelling of mixtures must be in place according to CLP by the same date. ECHA, the European Commission and the Member States are working together to raise awareness of this deadline, not least among SMEs.

There are many challenges for registrants ahead, but there is also a lot of information and support available. Join the webinars, look at the manuals and instructions available on ECHA’s website and use the various tools that can help you with your work. Remember that the prize of our efforts is that we have safer chemicals for human health and the environment as well as a better functioning EU market.

I wish you all an enjoyable and successful summer.

Next issue of the News-letter will be

published in mid-August

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Good quality information in registration dossiers is fun-damental for the success of REACH in ensuring the safe use of chemicals. Without reliable information, it is not possible to carry out appropriate chemical safety assessments and to put the necessary operational con-ditions and risk management measures in place. Concerns about the quality of data have, however, been raised by the Agency in the annual evaluation reports as well as by external stakeholders. ECHA Newsletter asked Director of Registration Christel Musset why quality matters and what ECHA has done to support companies to improve their dossiers.

The quality of REACH data has been a hot topic in recent years. Could you explain to our readers why it is important to improve the quality of information in dossiers, and what ECHA is doing about it?

High-quality data is important for both industry and authorities. For industry, it is crucial that the information in the registration dos-siers supports appropriate commu-nication in the supply chain through the extended safety data sheets. A high-quality registration signals that adequate safe use advice is given further down the supply chain, eventually to the end users like consumers and workers.

For the authorities like ECHA and the national authorities, it is impor-tant for the regulatory work done, for example, identifying substances of very high concern.

Good data enables effective deci-sion making for further risk man-agement measures and leads to better information being published for the general public.

Our first strategic objective for 2014-2018isto‘maximisetheavailability of high-quality data to enable the safe manufacture and use of chemicals’. We have taken a number of actions to achieve this objective, including a campaign to improve the substance identity informationintheregistrations;re-viewing the use descriptor system* to ensure a better identification ofuses;enhancingthesupportandtools available with a special focus on the next registration deadline in2018;andputtinginplacemoreefficient processes for evaluating the information received and giving feedback to registrants on how to improve.

In2015,wewilllaunchanimprovedpublic database of chemicals with simpler information that is more accessible for non-scientific users.

INTERVIEW BY MERCEDES VIÑAS AND ANNIKA MÄLKIÄ

How is ECHA helping companies to improve their dossiers?

ECHA has developed a wide range of support material and tools over the years. The Dossier Quality As-sistant (featured in the Validation assistant plug-in for IUCLID) is one of the main tools that ECHA offers to help companies improve. It can be used to check registration dos-siers before they are submitted to ECHA. It gives companies an over-view of the main inconsistencies found in the dossiers and advises on how to fix them.

We have also launched a web pagecalled‘How to improve your dossier’, which is a one-stop shop where registrants can easily find practical support to enhance the quality of their data. It includes information based on IT screenings of registrations for intermediates andrecentlyonsubstanceidentity;theDossierQualityAssistant;andwebinars.

In addition, the annual evaluation reports highlight the lessons learnt from dossier evaluation and give practical recommendations for registrants on how to improve their dossiers.

On top of the support offered by ECHA, the industry associations are an important source of information for companies. We work closely with many of the associations (they are accredited stakeholders of ours) and they provide valuable sector-specific support to their members.

Companies can also always seek advice from the network of national helpdesks and the ECHA Helpdesk, which can help with registrant-specific questions.

High-quality data - a key factor for industry and ECHA

Christel Musset says that improving the quality of data in REACH registrations is beneficial both for companies and authori-ties.

reach

© ECHA

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reach

You mention IT based screening on substance identity. Could you tell us a bit more?

We conducted an IT-based screen-ing on information elements for the substance identity of all REACH registrations.Over400companieswhose registrations were picked up by the screening received a let-ter from ECHA at the beginning of April giving advice on how to fix the identified shortcomings. We sent al-together1350letters.Companieswere given three months to update their registrations. First updates are now coming in and a number of companies have also contacted ECHA to agree on their update strategy.

Our aim with these letters is to help industry to proactively improve the quality of their information before we follow up with heavier regulatory actions such as a compliance check.

In addition, those registrants whose dossiers were picked up in the screening were invited to a webinar on substance identity held on 30 April. The presentations and record-ing of this webinar are available on our website for all to see.

Additional IT screenings may be done in the future as they appear to

be an efficient and effective way to inform companies about potential improvements which often trigger companies to update their dossi-ers.

What are your top three tips for companies that want to improve the quality of their dossiers?

Firstly, companies should consult thewebpage‘How to improve your dossier’ before updating their registration or submitting a new one. On this web page they can find out what ECHA expects from a good quality dossier. This page also includes links to the annual evalua-tion reports.

Secondly, registrants should use the latest version of the Dossier Quality Assistant and address the issues identified by the tool before submitting their dossiers to ECHA through REACH-IT.

Lastly, it is very important to keep the registration dossier up-to-date - for example, if new informa-tion becomes available. It is good practice to review the registration to make sure that it is in line with the latest advice on safe use and current supply chain practice, and that all new uses are described and covered by the chemical safety

report, where applicable. Only in this way, can we continue to make sure that chemicals are used safely in the whole supply chain. Remember that the regulatory deci-sions made by authorities are based on the information in the dossiers. By making sure that the information responds to the situation at hand, companies can potentially avoid un-necessary regulatory scrutiny while helping ECHA and national authori-ties take the right decisions, for example, in determining a need for further risk management measures.

*Use descriptor system: a system developed by ECHA to describe uses and standardise the descriptions in the supply chain. The system facilitates the identification of uses which need to be provided in the registra-tion dossier, the building of exposure sce-narios and the communication up and down the supply chain.

Further information:

How to improve your dossier http://echa.europa.eu/support/how-to-improve-your-dossier

Evaluation reportshttp://echa.europa.eu/regulations/reach/evaluation

Webinarshttp://echa.europa.eu/support/training-material/webinars

ECHA targets substance identity – letters sent to companies with shortcomings in their registrations, e-News9April2014http://echa.europa.eu/view-article/-/journal_content/title/e-news-9-april-2014

The information in the registration dossiers should support communication in the supply chain. High-quality data means that adequate safe use advice is given further down the sup-ply chain, eventually to the end users like consumers and workers.

© FOTOLIA

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people and perspectives

Guest column | Philip Copestake, Richard Young and Chris Waine Using existing information to support high-quality REACH registrationsWe can all recognise quality when we see it. There is a sense that expertise and appropriate resources have been employed in a focused and considered way. The result feels substantial and secure.

And so it is with REACH. ECHA has been making a lot of noise in recent months about the quality of registrations. Striving towards improved standards in the information provided by registrants, it is offering various forms of help and advice. At bibra, we think this should be applauded.

If this complex and challeng-ing piece of legislation is going to be effective, then those evaluating and using the information need to be confident that the details can be relied upon. In ECHA’s own words: REACH is about making Europe healthier, saferandmoreprosperous;knowingmoreaboutthechemicals we use is crucial to this.

There is much help available – including guidance, webi-nars, plug-ins and national helpdesks – and experience with the 2010 and 2013 deadlines has highlighted a number of key areas where further improvement can be made.

In March of this year, ECHA published its annual pro-gress report (2013) on evaluation under REACH, which made for some rather disappointing reading on quality. By the end of 2013, ECHA had evaluated 1 130 of the registration dossiers submitted for the 2010 regis-trationdeadline–exceedingthe5%targetsetoutinREACH.Ofthe928evaluationsconcludedin2013,ECHAfoundthat61%ofthedossiersdidnotcomplywith one or more REACH information requirements and sent draft decisions to registrants for more informa-tion or improvement.

Perhaps this high proportion of non-compliance is not that surprising, given the complexity and technical ex-pertise that is required by industry to manage REACH. Indeed, many of the registrants that we work with have had no, or little, direct experience of putting together a registration dossier. Like any technical skill, it is con-tinual hands-on practice and the knowledge that comes with this that can make achieving a satisfyingly high level of quality part of routine work.

One thing is for sure: ensuring high quality takes plan-ning, good organisation and an awareness of timelines. It is surprising how lengthy a process it can be to put together a satisfactory registration dossier, particu-larly when you need to consider all stakeholders.

Although the resources need-ed can be somewhat daunting, REACH does provide many opportunities to maximise the use of existing information and make reasoned argu-ments for non-testing.

Like ECHA, we would encour-age companies to conduct

comprehensive and ongoing literature searches to make sure they always have the most robust data at their fingertips, and to keep their dossiers up-to-date. This is a relatively straightforward and cost-effective first step to ensuring quality.

Bibra is fortunate in this regard, as we have been searching and collating physical-chemical and (eco)tox-icitydataonchemicalsforover50years,andthishasgiven us a good insight into the pitfalls and limitations of the numerous available data sources. Indeed, over 25yearsagowedesignedourownin-housetoxicitydatabase, TRACE, which is listed in ECHA’s guidance on information gathering as a valuable source of toxicity data. Since then, we have been maintaining, updating and populating this resource.

Our experience has shown the importance of good data searching for high quality dossier submission. In one example, pre-neoplastic lesions were observed in a repeated dose toxicity study with a substance intended for registration in 2010. Inclusion of a testing proposal in the dossier for a carcinogenicity study was recom-mended by the members of the consortium as they had failed to identify a long-term study. However, further searches were suggested. This was agreed and we identified an early, published, two-year carcinogenicity study in the TRACE database. Inclusion of this reli-able study enabled a successful registration in 2010, without the need for a testing proposal or a possible future (costly and animal-intensive) trip to the testing laboratory.

ECHA highlights that registrants still have difficulty in robustly substantiating any adaptations of the stand-

Philip Copestake, Richard Young and Chris Waine. © BIBRA

6

news from echa

Progress in using alternative testing methods ECHA has published its second report on the use of alterna-tives to animal testing under REACH. The Director for Evaluation, Leena Ylä-Mono- nen, highlights the main find-ings of the report.

Have registrants advanced in the use of alternative methods? Where do you see the most progress made?

Our report shows that registrants have made extensive use of the different possibilities outlined in REACH to avoid unnecessary animal testing.Over38000dossierswerethe main source of information for this report. The most frequently used alternative approach was read-across, which involves filling a data gap by using information on similar substances. This was used inmorethan70%oftheanalyseddossiers for at least one endpoint.The most progress was made re-garding the use of in vitro studies,

which use cells, tissues or organs. Registrants used them to test skin corrosion, skin irritation and eyeirritation.Almost20%oftheanalysed dossiers contained in vitro studies for these endpoints. Concerning toxicity towards the environment, (Q)SARs have increas-ingly been used for bioaccumula-tion in fish. This means computer

modelling to estimate properties of a chemical from its molecular structure.

However, this is a numerical report and does not address the quality of how the alternatives were used. We will address the quality issue in our dossier evaluation decisions and in next year's evaluation report, as usual.

What are ECHA’s priorities for pro-moting alternative methods?

We want to direct research towards the development of alternative test methods. A number of actions in our Multi-Annual Work Programme 2014-2018aimtosupportthedevelopment of scientifically-sound alternatives. For example, we will establish a framework for read-across assessment and improve the assessment of skin sensitisation.

Currently, we have prioritised those alternative methods that are developed well enough to be used

ard testing regimes using waivers, (Q)SAR and grouping or read-across approaches. Although the Agency has provided guidance, this is by no means straightforward and expert knowledge is a prerequisite.

Any move away from the standard REACH approach or guidance needs to be fully justified, using clear, scientifically-sound explanations. For example, in the absence of reliable and relevant data on the substance intended for REACH registration, reading across end-point-specific data from a suitable surrogate (or group of surrogates) is possible. The choice of appropriate read-across candidate(s), assessment of the suitabil-ity of the data and provision of a robust read-across justification (including generation of a comprehensive data matrix) requires considerable expertise. Indeed, ECHA has warned registrants that they will be asked to improve dossiers that lack a robust read-across justification.

But it can be done. We have been involved in a number of REACH registration projects that have included detailed read-across justifications for the 2010 and

2013 deadlines. This has enabled registrants to submit a scientifically robust registration dossier for their substance, with peace-of-mind and without the need to resort to testing. It is our expectation that an even greater reliance on adaptations of the standard testing regimes (including read-across data) will be a feature ofthelower-tonnagesubstancesatthe2018deadline.

It is clear from ECHA that these are the areas where particular focus on quality is needed and it is here that companies are likely to fall short of ECHA’s ever rising bar.

Philip Copestake, Principal Toxicologist at bibra Richard Young, Senior Toxicologist at bibra Chris Waine, Toxicologist at bibra

Bibra toxicology advice & consulting provides expert support in all aspects of chemical hazard and risk assessment. http://www.bibra-information.co.uk

TEXT BY TIIU BRÄUTIGAM

Leena Ylä-Mononen tells that the most frequently used alternative approach was read-across.

© ECHA

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news from echa

for regulatory purposes. As an example, we published illustrative examples on the use of read-across and (Q)SARs. We are planning to publish more examples of this kind. Our website contains a recently launchedsectioncalled‘Testing methods and alternatives’, having a page on the OECD and EU test guidelines. It refers to recent de-velopments in the test guidelines, e.g. in vitro methods concerning skin and eye irritation, and how registrants can use these test methods. There are new promising tech-niques for assessing skin sensi-tisation using in vitro methods, computer simulation or chemical reactivity methods. Together with the Commission’s Joint Research Centre, ECHA is currently assess-ing how these new methods could be used to fulfil the REACH infor-mation requirement for an in vivo skin sensitisation study. The aim is to publish guidance ahead of the 2018deadline.

Which alternative methods are especially relevant for the 2018 deadline? How is ECHA supporting registrants?

Regarding the registrations for 2018,read-acrosswillbean

important alternative approach to assess systemic toxicity endpoints. For registrations above 10 tonnes, REACHrequiresa28-daystudyonrepeated toxicity, and there are no suitable in vitro methods for this, so far.

For new and existing registrants, we offer an important source of information on existing alternative methods in practice – our dossier evaluation decisions. In December 2012, we started publishing non-confidential versions of all dossier evaluation decisions on our web-site. This gives registrants and third parties an opportunity to follow the outcome of compliance checks and testing proposal examinations and learn from them. For example, the decisions on testing proposals for the different categories and read-across give good insight into how these have been used by previous registrants. Registrants who re-cently submitted or are still prepar-ing their dossiers can still use the opportunity and review their data. If they learn important lessons by reviewing the published decisions, they can proactively update their dossiers.

We also strive to prevent unneces-sary animal testing in our recom-mendations and the advice we offer through webinars, guidance

updates, practical guides and tar-geted events for registrants.

Can alternative methods entirely replace testing on animals in the future?

Unfortunately, not in the near future. There are still areas where scientifically reliable results are not yet available using alterna-tive methods. If we talk about in vitro test methods – whether used alone or in combination with other techniques – we are still far away from replacing all animal tests. It is difficult to mimic a living organism especially when looking at systemic toxicity, for example, after re-peated exposure or developmental toxicity. Read-across is the method that shows the most promise. However, even this approach may sometimes need to be supported with animal studies, for example, on toxicokinetics.

ECHA contributes to the EU’s SEURAT1-project, promoting the use of read-across with a focus on repeated dose toxicity. The aim is to integrate the latest scientific developments with current regula-tory practice.

The development of alternative methods is an important issue for many stakeholders and policy makers at EU level. We hope that our report supports the Commis-sion in communicating about these alternatives and in considering fur-ther research initiatives and policy developments in this area.

Further information:

Report and summary http://echa.europa.eu/about-us/the-way-we-work/plans-and-reports

OECD test guidelines pagehttp://echa.europa.eu/en/support/oecd-eu-test-guidelines

Practical guideshttp://echa.europa.eu/practical-guides

ECHA's second report on the use of alternatives to animal testing under REACH shows that registrants have made extensive use of the different possibilities outlined in REACH to avoid unnecessary animal testing.

© FOTOLIA

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news from echa

public consultations. Regarding testing proposals submitted for the registration deadline in 2010, ECHAheld542consultationsandreceivedover640thirdpartycom-ments. Most of the comments were made by animal welfare organisa-tions, followed by industry groups.

In a few cases, the third parties found scientifically valid studies on the registered substance. For ex-ample, a non-governmental organi-sation identified a guideline study conducted outside the EU. ECHA passed this information onto the registrants. They considered that the information met their require-ments, obtained legal access to use the study and used it to fulfil the information requirements. Conse-quently, the registrants withdrew their testing proposal. More often, however, third parties provided information on a more general level: they highlighted the availability of information or suggested strategies to use the adaptation possibilities provided by REACH. In particular, they identi-

Evaluation underway for testing proposals from the 2013 registration deadline

ing a regular pattern due to their structural similarity.

ECHA checks if the proposed test-ing with another substance is prop-erly justified. If not, it will request a test with the registered substance. If registrants have any doubts about their read-across justifica-tion, they can update their dossier now. Updates submitted before the testing proposal proceeds to decision-making can then be taken into account in the decision.

THIRD PARTIES INVITED TO SUBMIT RELEVANT INFORMA-TION ON TESTING PROPOSALS

Every testing proposal involving vertebrate animals is published on ECHA’s website. The Agency invites third parties to submit scientifically valid information on the proposals within45days.ECHAevaluatesthisinformation and forwards it to the registrant together with the draft decision.

To stagger the evaluation of testing proposals, ECHA launches third party consultations in monthly batches. These will be published regularlyuntilearly2015.

BIG VARIETY IN INFORMATION RECEIVED FROM THIRD PAR-TIES

So far, third parties have partici-pated actively in responding to the

Most of the new testing proposals relate to human health: the most common endpoints are repeated dose toxicity and developmental toxicity. The studies proposed are those required in Annex IX of REACH, including sub-chronic toxic-itystudies(90days)andpre-nataldevelopmental toxicity studies. As the two-generation reproduction toxicity study is not a standard information requirement for Annex IX dossiers, there are now fewer proposals for these than in the dossiers submitted for the first registration deadline in 2010.

SUBSTANCE IDENTITY EXAMINED FIRST

To evaluate all testing proposals as efficiently as possible, ECHA’s scientists have started by screen-ing the substance identity of the relevant dossiers. Where there is an ambiguous substance identity, it is checked first, so the rest of the evaluation can then take place.

Clear substance identification is particularly important when regis-trants follow a category or grouping approach. So far, several testing proposals contain category or read-across references, with similar substances grouped to reduce ani-mal testing and costs. Read-across and chemical categories rely on the physicochemical, toxicological and ecotoxicological properties of substances being similar or follow-

TEXT BY TIIU BRÄUTIGAM

ECHA has started evaluating testing proposals in the registrations submitted for the 2013 deadline. In total, about 770 proposals in 374 dossiers will have been examined by 1 June 2016. Around 560 of these include tests on vertebrate animals. Third parties are able to provide scientifically relevant information on the proposals pub-lished on ECHA’s website.

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news from echa

fied information that might be used in predictions based on read-across and weight of evidence approaches. Applying such techniques is not always straightforward, but ex-perience is growing. For example, last year ECHA’s Member State Committee approved a number of decisions on testing proposals, where the read-across justifica-tions provided by registrants were considered to be plausible.

Further information:

Examination of testing proposalshttp://echa.europa.eu/regulations/reach/evaluation/examination-of-testing-proposals

� In the draft decision, ECHA can either:• accept the testing proposal,• accept it with modifications,• require additional tests, or• reject it.

� Bytheendof2014,thefirst100draftdecisionson2013proposalsare planned to be sent to registrants. The remaining decisions will be senttoregistrantsin2015and2016.

� Registrants have 30 days to comment on the draft decision and up-date their dossier. The deadline and the method for giving comments are specified in the draft decision.

� Testing on vertebrate animals is the last resort to obtain missing in-formation on a substance and to meet the information requirements of REACH. The aim of the evaluation of testing proposals is to make sure that the data is reliable and adequate. At the same time, unnec-essary animal testing will be prevented.

ECHA’S DECISIONS ON TESTING PROPOSALS

June - August 2014

Update to the Candidate List of SVHCs: June

Biocidal Products Committee: 16-19June

ECHAManagementBoard:17-18June

Upcoming

International cooperation

Speaking engagements

23rd SRA-E (The Society for Risk Analysis – Europe) conference, Istanbul,Turkey:15-18June

Organisation for Prohibition of ChemicalsWeapons2014Associ-ated Programme, The Hague, the Netherlands:6August

EnforcementForum:24-26June

First REACH registration deadline forCroatiancompanies:1July2014

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news from echa

ECHA in an online training on the Toolbox.

The training focused particularly on endpoints for the third REACH reg-istration deadline, giving examples of how to deal with a single chemi-cal with a data gap but also showing how to screen large inventories. Attention was also paid to check-ing the domains and consistency of chemical categories. It became clear during the training that a small change in chemical structure can significantly change the presence or absence of effect. Recordings from the training are available for self-training.

DEVELOPING THE TOOLBOX

The Toolbox is continuously de-veloped taking into account the feedback received from users. A new version (3.3) is planned for releaseattheendof2014.Itwillinclude new features to help justify the read-across hypothesis and category formation. Some improve-ments to the usability of the tool are also planned. These aim to, for example, extend database search functionalities, improve possibili-ties to document or save the profil-ers and exchange information on filling data gaps.

Planningforversion4.0isalsoon-going. This version is expected to be releasedinlate2016toallowcom-paniestouseitforthe2018REACHregistration deadline. It will include more fundamental changes to the software architecture and overall performance as well as making it more user-friendly, particularly for less experienced users. This is done by streamlining the prediction pro-

� The Toolbox project was initi-ated by the member countries of the Organisation for Eco-nomic Cooperation and Devel-opment(OECD)in2004,whena demand for a tool that could be used for regulatory purposes was identified.

� ECHA has been supporting the development of the tool since 2008andhascommittedtocontinue this work at least until 2018.

� The Toolbox is free of charge and the latest version, pub-lished in December 2013, can be downloaded from the OECD QSAR Toolbox website.

DID YOU KNOW?

cess for lower tier endpoints. More comprehensive tools supporting formations of chemical categories for higher tier endpoints will also be added.

Further information:

QSAR Toolboxhttp://www.qsartoolbox.org

Illustrative exampleshttp://echa.europa.eu/en/support/oecd-qsar-toolbox

Material for self-traininghttp://www.youtube.com/watch?v=iH7dRfkjSss&list=PLw5U07Jmc7Fu_1jTCPbwEP9hlW3iI53eO

Continuous development of the QSAR ToolboxTEXT BY PÄIVI JOKINIEMI

Interest in the OECD QSAR Toolbox continues to grow. With every release it gains new users, with more than 4 000 registered users at the moment. The tool is being improved continuously and to find out what the users think of the tool, ECHA conducted a user satisfaction survey and is taking action to improve.

The OECD QSAR Toolbox is a software that can be used to group chemicals into categories and fill gaps in (eco)toxicity data, which is needed to assess the hazards of chemicals. The tools that are integrated in the Toolbox consist of chemical inventories and toxico-logical databases, as well as sta-tistical tools for mining knowledge from existing data. It also includes ‘profilers’thatarecompilationsofstructural features and decision rules and some quantitative struc-ture-activity relationship (QSAR) models. These profilers can be used in various different ways. However, they were found to be particularly helpful when identifying mechanis-tic similarities between substances for read-across purposes.

ILLUSTRATIVE EXAMPLES

To support registrants preparing forthe2018registrationdeadline,ECHA has published examples of how to use the Toolbox. The two ex-amples illustrate a logical workflow that the user can follow to estimate various toxicological properties. These estimations are based on the test results obtained for similar substances.

TRAINING

In May, the EU Member States, ECHA’s accredited stakeholders, and OECD member countries joined

11

people and perspectives

Stakeholders' Day

Time to start preparing for REACH 2018The third REACH registration deadline is still some years away but preparations in companies are already ongoing. ECHA Newsletter talked with Dr Andrea Paetz from Bayer during the REACH & CLP Stakeholders’ Day, to find out what the challenges with REACH registration are for her and how companies can manage them.

Bayer has dedicated staff for REACH registration tasks and they have continued working on the registrations since the previous deadline. “When the registration for 2013 was finished, the staff members started working directly ontheregistrationsforthe2018deadline,” Dr Paetz explains. Since the work on new registrations con-tinued without a break, some of the registrationsforthe2018deadlinehave already been sent to ECHA. “Some of the registrations are fin-ished, some are under preparation and others are in a planning phase. The work is simultaneously ongoing in all stages.”

CHALLENGES AHEAD

The changing substance portfolio is one of the main challenges in prepa-rationsfor2018.“Wedonotknowat the moment which substances will be in that tonnage range in 2018.Thereisalwaysachangeinour portfolio. If we have some new products, we will also have new sub-stances that need to be registered. On the other hand, we might cease manufacturing other products,” Dr Paetz points out. Therefore, it is challenging to estimate in advance what the substance portfolio will look like at the time of the third registration deadline.

INTERVIEW BY PÄIVI JOKINIEMI

As a downstream user, Bayer is dependent on their suppliers. Since there are big differences in costs between the different tonnage bands, suppliers are carefully ana-lysing if they need to register in the higher tonnage band. Based on this analysis, they may decide to change their production and registration strategy. “For us, it is sometimes very difficult because we need to purchase these substances and we must plan how we can manage these situations,” Dr Paetz explains and continues, “therefore, our challenge is not only to manage our own registrations under REACH, but also to verify that our suppliers will register the substances that we need to buy”.

Finally, the existing registrations need to be kept up-to-date. “We are obliged to follow-up on our registrations. We need to, for example, monitor if the volume of the substance changes and if we, therefore, need to update the dos-sier and consider new tests. In ad-dition, we have to look whether the classification and labelling needs to be changed. We also need to always stay up-to-date on the new

guidance and know if there are new versions of the IT-tools available,” Dr Paetz reminds.

GUIDANCE AND IT TOOLS CAUS-ING CONCERN

According to Dr Paetz, the best way for ECHA to support registrants would be to make sure that there are no changes to the guidance documents. The launch of the new versions of REACH-IT and IUCLID in the coming years also causes concern for companies. “I hope everything will work as planned and hopefully we do not have to revise too much information, because at that point, the deadline is already very close,” Dr Paetz says. Apart from the registration preparations, she wishes to have a dedicated contact person at ECHA who could answer companies’ questions about dossier evaluation.

START PREPARING NOW

It is important to continuously follow the developments of REACH requirements to be able to act if there are any changes that may affect the registration. Dr Paetz

Dr Paetz recommends registrants to make use of all the available support material when preparing for the REACH 2018 registration deadline.

© ECHA

12

people and perspectives

BAYER

Bayer is a global enterprise with core competencies in the fields of healthcare, agriculture and high-tech polymer materials. It produces polymers, plant protection products and pharmaceuticals. It consists of three subgroups – Bayer HealthCare, Bayer CropScience and Bayer MaterialScience. Under the REACH Regulation, Bayer acts as producer, importer and downstream user.

http://www.bayer.com

Stakeholders' Day

Registration lessons from an SMEINTERVIEW BY PAUL TROUTH

Dr Fabio Stratta, Technical Director at the medium-sized SME Giusto Faravelli S.p.A., gave his company’s viewpoint on the registration process to the participants of the Stake-holders' Day. ECHA Newslet-ter had the chance to discuss with Dr Stratta the lessons his company has learnt from their registration experiences.

Giusto Faravelli S.p.A. has dealt with the registration process from the very beginning. The company made400pre-registrationsbeforethe first 2010 registration deadline. This early phase was particularly demanding as the company planned to register a hazardous copper salt in the highest tonnage band.

“To meet such demands, we had to make sure that we had effective strategiesinplace.From2009,wemade contact with the consortium of members of the SIEF. It was due to early contact with the secretariat

of the consortium and its efficient work that we were able to com-plete the work by the deadline,” Dr Stratta explains.

NEVER TOO EARLY FOR 2018

For the 2013 deadline, the company also registered a pair of substances and is planning to register more in2018.However,astraders,thecompany is left in a somewhat dif-ficult predicament. “We, of course, plan to register in 2018butitisimpossibletoknowatthe moment what we will register. In2008,weinitiallypre-registered300 substances and then had to perform 100 late pre-registrations because our customers needed new substances, and some of the suppliers were new and did not have a good knowledge of REACH processes. The previous deadlines have taught us that it is much too early for us to know exactly what substances we will register in 2018,”insistsDrStratta.

LEARNING FROM PREVIOUS DEADLINES

Having gone through two registra-tion deadlines, the company has learnt many lessons and, in its opin-ion, the registration process has become easier. “For sure, the first deadline was the hardest for us but we like to think of it as a learn-ing experience. Once you gain this experience, the process runs much smoother,” Dr Stratta says.

“For the second deadline, we had some time to employ more skilled personnel, and to train them on REACH processes. We also had the time to put some strategies in place and to create additional tools to make the process easier. However, for2018thereisastronglikeli-hood that we will need to rely more on consultants and we will have to hire more people due to the large number of possible registrations,” explains Dr Stratta.

reminds that although the third registration deadline is still some years ahead, it is time to kick-off the work. “Start your preparations now, do not wait. Make sure that you are well-informed – there are many conferences and webinars you can participate in and a lot of useful material to read”.

Although the REACH Regulation requires a lot of work, it makes sure that the data is gathered systemat-ically and is available for everyone. “REACH is a success because we have more data and we have better assessment of substances, and everybody can reach this data,” Dr Paetz concludes.

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people and perspectives

OVERCOMING CHALLENGES

“The main challenges are, of course, time and money, but in my view, these problems are always in focus no matter what size your company is,” Dr Stratta says.

“What companies have to do, and particularly SMEs, is to try to recover direct costs by saving indi-rect costs. If you are a small com-pany, you can do this by using your internal resources more efficiently. Check to see what expertise you have in-house. Your colleagues may work every day with regula-tory compliance in other fields, and so they will already have an understanding of how to approach regulatory work. What is important though is to give them enough train-ing to grasp REACH. Training your staff should be viewed as an invest-ment, as they can then go on to train other people and help to make the registration process easier for your company,” Dr Stratta encourages.

DEVELOPMENT OF INFORMATICS

For Giusto Faravelli, it was also important to assess their own IT systems and develop tools to bet-ter suit the company’s needs.

“Our systems work with the EINECs numbers. Firstly, we ask for infor-mation from suppliers about their REACH position and for documents that show they are in compliance with REACH. Once these data are received, we place these suppli-ers into our system,” Dr Stratta explains.

“If the supplier is European, the sys-tem searches for pre-registrations or a registration number. If the data is missing, the system will automat-ically lock and block the sale of the substance,” Dr Stratta continues.“If the supplier is from outside of Europe, the system acts in the same way looking for data. However, in this case, if it doesn’t find any information, it will also search for

substances covered by Giusto Fara-velli, keeping track of the maximum importation limit allowed by the pre-registration or registration we made as an importer for the spe-cific substance,” states Dr Stratta.

The substances are then only sold if REACH compliance can be dem-onstrated by the suppliers in the system.

CHALLENGES FOR SMES

In Dr Stratta’s opinion, working on indirect costs is the key for SMEs, but an in-depth knowledge of REACH is also extremely important. “Even if you are a small company, you can ask from your trade as-sociation to give some advice and support to help you better under-stand the legislation,” remarks Dr Stratta.

“You should not be afraid to ap-proach the authorities. You have to contact them and ask for advice if you are unsure of what to do. They are there to help. This is what we did through our trade association Federchimica and with ECHA, and the support we have received has been vital,” Dr Stratta says.

Communication skills are also viewed as integral throughout the process not only in terms of communicating along the supply

chain but also internally. “It is re-ally important that there is good communication at all levels of your company. You have to give your colleagues the tools to understand REACH,” Dr Stratta reiterates.

Part of these communication skills is to make sure that the company is notlookingat2018andseeingitasan issue for the future. “You cannot justthinkaboutthe2018deadlineas something to be dealt with in a few years. The work should begin immediately,” Dr Stratta concludes.

GIUSTO FARAVELLI S.P.A.

Giusto Faravelli S.p.A. is a medium-sized distributor of raw materials for the pharma, nutra, food, cosmetic and fine chemicals industry based in Milan. Under REACH, the company operates as an importer. The company is part of the Faravelli Group which has offices in Spain, Germany, the Czech Republic, China and the United States.

http://www.faravelli.it

Dr Stratta encourages registrants to contact authorities and trade associations to ask for advice.

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14

news from echa

Enforcement - planning aheadINTERVIEW BY PÄIVI JOKINIEMI

The Multi-Annual Work Programme of the Enforce-ment Forum – expected to be published during the summer – foresees, for example, the continuation of harmonised REACH enforcement projects, a pilot project for REACH authorisations and the devel-opment of activities on PIC enforcement. ECHA Newslet-ter spoke with Szilvia Deim, the re-elected Chair of the Forum, to hear about the future steps and plans.

PILOT PROJECT FOR REACH AUTHORISATION

One of the future Forum projects is the first authorisation pilot where inspectionswillkick-offin2015.Forum activities on authorisation will be carried out in steps. In the first project, the aim is to find a common approach to the enforce-ment of REACH authorisations. According to Ms Deim, this is particularly important because en-forcing authorisations is something new for all Member States. “The main goal of this project is to gain experience and build processes for controlling REACH authorisation-related enforcement activities,” Ms Deim clarifies. Future activities and potentially a second project, will build on the findings of the first project and expand the range of substances targeted.

INVOLVEMENT IN RESTRICTION PROCESS

Another area of interest for the Forum is the enforcement of re-strictions. “It is important that the Forum takes an active part in giving recommendations to the Commit-tee for Risk Assessment (RAC) and the Committee for Socio-Economic Analysis (SEAC) on the enforceabil-

ity of the new restriction propos-als,” she emphasises. “The Forum has also identified the need to recommend analytical methods for restrictions and this project is ongoing. The results will be very useful, not only to the Fo-rum and the enforcement authori-ties, but also to companies when they assess their own compliance”. In practice, when assessing their compliance, companies will be able to use one of the recommended analytical methods and they will know that also the enforcement authority is recommended to use the same method in their work.

Although it will take until the end of the year to complete the project, some key steps have already been taken. Forum members have, for example, contacted their national authorities and laboratories and collected analytical methods. The methods are currently be-ing assessed. The Forum has also involved ECHA’s accredited stake-holder organisations in this project.

COORDINATING ENFORCEMENT OF PIC

The Forum's plan includes work on further documenting the enforce-ment of PIC. “We need to find out how the enforcement is done at a national level and find the best practice that could be useful for all authorities,” Ms Deim says and continues, “It is also important to identify what kind of IT-tools would be needed to support the enforce-ment authorities.”

The customs authorities are in a unique position for PIC enforce-ment. “This needs to be taken into consideration when assessing the roles of different actors. Com-pared to the other regulations, the involvement of customs authori-ties is more direct in PIC since the regulation is all about exported and imported chemicals,” Ms Deim points out.

TIME FOR EASY QUESTIONS IS OVER

Ms Deim expects that the Forum will have challenging years ahead, both in terms of workload and the questions that will be discussed by

Szilvia Deim continues as the Chair of the Enforcement Forum.

© ECHA

15

news from echa

the Forum members. She mentions, for example, substance evalua-tion and restrictions as hot topics. Although the Forum has a freedom to set its own deadlines for some of its tasks, it is often bound by the deadlines of RAC and SEAC. “These bodies must have the Forum’s opin-ion at hand when they issue their own opinions. Therefore, their tight deadlines also affect our work and our timelines”.

REACH-EN-FORCE-3 is the third enforcement project of the Forum. It focuses on checking the registra-tion obligations of manufacturers, importers and only representa-tives in cooperation with customs authorities. The first operational phase of the project lasted between February and August 2013 with inspectorschecking528companiesandverifying3065substances.Since then the Forum has been ana-lysing the results and preparing the report that will soon be published.

The inspection of importers and imported substances were the main focus of the project, with customs providing information on imports to REACH inspectors who used it for risk assessment and targeting specificdutyholders.In85%oftheparticipating countries, REACH in-spectors targeted companies based oninformationfromcustoms.In15%ofthecountries,itwascustomswho made the risk assessment and selection of duty holders.

Theinspectionsshowedthat86%of the checked companies fulfilled their registration obligations. The remaining14%ofcompaniesdidnot comply with some of the obliga-tions. Where non-compliance was found, the main reasons included missingregistrations(76%),unful-filled only representative duties (20 %),substanceidentityissues(7%)

or wrongly indicated tonnage bands (4%).

Considering the non-compliance levelsfortypesofsubstances,9%of the inspected substances of very highconcernand12%ofinspectedsubstances with a harmonised classification and labelling were not registered.

The measures taken to address non-compliance were different de-pending on the national legislation of the Member States. The inspec-tors mostly gave companies written and verbal advice for corrective measures. Administrative orders

Findings from the third enforcement project

The time for simple questions is over and it will be a challenge for the Forum to address all the practical questions from the field inspectors. “They want to hear from the Forum about how to deal with problems and difficult situations. We discuss these questions in our meetings and also collaborate often with ECHA and the Commission col-leagues to find the right answers,” Ms Deim concludes.

Further information:

Enforcement Forum on ECHA's websitehttp://echa.europa.eu/about-us/who-we-are/enforcement-forum

were issued in about one third of the cases. Sanctions, such as fines or criminal complaints, were rarely used. The key finding after the first phase of the project was the high non-compliance rate for only representatives, which needs to be addressed by the importing indus-try. The project has now entered its second phase, which introduces inspections along multinational supply chains involving only repre-sentatives. The final report includ-ing findings from both phases will bedonein2015.

The third enforcement project shows that the non-compliance rate was highest among only representatives.

16

Product type and product suppliers in Article 95

Several important changes are intro-duced and they apply retroactively from 1 September 2013.

It is now mandatory for applicants to indicate the product types in their application.Anewconceptof‘prod-uct supplier’ is also introduced, to enable all types of product suppliers to make applications. Before the amendment, only the manufacturer or importer (of an active substance or biocidal product containing that active substance) could apply to be included in the list of suppliers. Now, formulators, actingas‘productsuppliers’,canalsosubmit the necessary information to ECHA and get themselves and their substance included in the list. In this way, formulators are not reliant on manufacturers or importers to make sure that they have a legal right to keep their products on the market after1September2015.

Extension of mandatory data shar-ing for Article 95

The requirement for companies to share data with others applies to all active biocidal substances. Usually, that only means sharing data from studies on vertebrate animals. The originalArticle95extendedthistonon-vertebrate toxicological and ec-otoxicological studies for substanc-es on the review programme. The new amendment extends this further to also include environmental fate and behaviour studies. Therefore, mandatory data sharing extends to all studies, even those not involving tests on vertebrate animals.

Product family

Thenewdefinitionof‘biocidalproduct family’ clarifies what prop-erties the members of the product family must have. This seeks to make sure that the members of the product family have a similar level of risk and efficacy. Companies can now better define the range of product combinations within a product family. In practice, that means that a larger number of products belonging to a product family can be placed on the market without the need for separate authorisations.

Data protection added for simpli-fied authorisation

The amendments also clarify that data submitted as part of any application for a product authori-sation is protected. This includes applications for simplified authori-sation.

More time to evaluate applica-tions

The Member States have three years (compared to two previously) to grant national authorisations and related mutual recognitions for biocidal products already on the market. Member States may also continue to apply their exist-ing national systems during that time period.

Clarification on scope of applica-tion of national laws

The amendments also clarify that existing national systems apply both to making biocidal products available on the market and for

their use. This means that separate authorisation under the BPR is not required for the use of the product while the assessment of the au-thorisation application is ongoing.

Treated articles

Another important amendment con-cernsArticle94,whichdealswithtreated articles. This also applies retroactively from 1 September 2013. The original legal text cre-ated an unintended ban on treated articles that were not on the market on 1 September 2013. The amend-ed text removes this market barrier. Now, newly treated articles can also be placed on the market. For all treated articles, an applica-tion for the active substance/prod-uct type must be submitted by 1 September2016(ifitisnotalreadyincluded in the review programme or approved). If an application for the approval of the active sub-stance is not made by 1 September 2016,thetreatedarticlemustbetaken off the market by 1 March 2017.

If approval is granted, the treated article can stay on the market until the approval expires. If the applica-tion is rejected the treated article can only remain on the market for 180daysafterthedecision.

The amendment also clarifies that the labelling requirements specific to treated articles have been in place since 1 September 2013.

Further information:

Biocidal Products Regulation and subsequent amendmentshttp://echa.europa.eu/regulations/biocidal-products-regulation/legislation

Biocides – important changes for companiesTEXT BY PÄIVI JOKINIEMI

biocides

The amendment of the Biocidal Products Regulation entered into force on 25 April 2014. The most important changes relate to access to the market for active substance and product suppliers; product family definitions; and treated articles. ECHA Newsletter explains what the changes mean for companies.

17

Improving supply chain communication TEXT BY PAUL TROUTH

Improving sector use maps as a tool to increase the quality of REACH chemical safety reports and ex-posure scenarios was one of the main themes of the sixth meeting of the Exchange Network on Expo-sure Scenarios (ENES) held at ECHA on 13-14 May.

“The CSR/ES Roadmap was pub-lished in July 2013, almost a year ago and progress is being made with products now ready for people to use. The development of sec-tor use maps is one such area of progress,” says ECHA’s Dr Andrew Murray.

The use map work aims to help the dialogue between downstream us-ers and registrants.

The use maps will help registrants to prepare structured and compre-hensive chemical safety assess-ments as part of their registration dossiers. They also mean that downstream users will receive in-formation in their extended safety data sheets that they can easily recognise and compare with their own situations of use.

Laura Portugal (DUCC), Sophie Mathieu (A.I.S.E.), Janice Robinson (CEPE) and Irene Cañas Sierra (Eu-rometaux) shared their experiences on the development and implemen-tation of use maps.

Laure-Anne Carton de Tournai (ECHA) presented ideas for refin-ing the existing sector use maps: improving their format so that they could be further developed to suit the needs of downstream users and registrants. For example, the addition of information that allows registrants to identify which uses are relevant for which substances.

Another suggestion is to link the more specific inputs for the regis-trant’s exposure assessments to the corresponding task or technical process that contributes to a use, such as the specific environmental

release category (SpERC) and the specific consumer exposure deter-minants (SCEDs). “With ECHA’s experience of look-ing at the registration dossiers submitted in recent years, as well as the feedback from downstream users on the exposure scenarios they receive, we feel that this is an opportunity to get better quality information for all. This can be done by introducing new and refining existing fields in the sector use map template,” says Dr Murray.

ENES will further develop the work and the use map format will be tested with some sector-level sup-ply chains. A refined proposal will be presented at the ENES7 meeting in November. Once the new tem-plate is agreed, sector associations should adapt or create use maps by completing the template with spe-cific sector information. Once the new use map format is available, it can be used to prepare registra-tionsforthe2018deadlineaswellas for registration updates.

STRUCTURED SHORT TITLES FOR EXPOSURE SCENARIOS

Sylvie Lemoine (DUCC) presented an overview on the work carried out to develop a rule-based approach for the harmonisation of structured short titles for exposure scenarios.

Testing confirms that harmonisa-tion of the short titles is possible but that the low quality of existing exposure scenarios is a practical limitation.

Rules on the life cycle stage and market information identifiers were finalised with a third optional identifier of either containment or technical process that could also possibly be included. Guidelines on the rules for the short titles are expected to be published soon. Once they are ready, they can be integrated into IT systems and will help registrants and suppliers prepare their extended safety data sheets. They will also allow down-stream users to navigate more easily through the extended safety

communicating about safety

The use map work aims to improve the dialogue between downstream users and registrants.

© ECHA

18

communicating about safety

data sheets and find relevant expo-sure scenarios.

DEVELOPMENTS IN THE ESCOM PROJECT

Dook Noij (Dow Benelux) presented the latest on the development of the Exposure Scenario Communica-tion (ESCom) Phrase Catalogue, which collects standard phrases for the communication of expo-sure scenarios. Supporting this work, Mathias Glockner (SAP AG) gave more detail about the ESCom XML standard - an IT communica-tion standard that harmonises the exchange of exposure scenario data between computer systems in the supply chain. An updated version of the phrase catalogue is available from Cefic’s website.

The catalogue is also being further cleaned to make sure that the standard phrases can be mapped more easily, ready for a new version attheendof2014.

ILLUSTRATIVE EXAMPLE OF EXPOSURE SCENARIOS

The templates for exposure sce-narios (from ECHA Guidance and Chesar) have been expanded to include additional explanations on what the fields are, what informa-tion the templates supply, and some examples.

“The examples are there so that people who prepare exposure scenarios can see what informa-tion from the CSR is relevant and the recommended format. The templates will help those receiving exposure scenarios to understand the information they get and pick out the key parts,” Dr Murray em-phasises.

The templates will be published in June.

AN UPDATE ON SPECIFIC CON-SUMER EXPOSURE DETERMI-NANTS (SCEDS)

The SCED guidance and templates werepublishedon25Aprilforsec-tors to use.

The updated SCED guidance helps to improve the information that registrants can use in their as-sessment for consumer exposure. Industry is strongly urged to follow up on this and continue to involve registrants and downstream users in its progress.

COMMUNICATION IS KEY

Fesil Mushtaq (ECHA) introduced some new tools to help registrants and downstream users to commu-nicate throughout the supply chain: an interactive map for downstream users to help them find online in-formation;anupdateofthemixtureclassification pages on ECHA's website(June);andthelaunchofan interactive safety data sheet eGuide (July).

“We are interested to know if there are more ways that we can help sec-tors to fulfil their roles,” explains Dr Murray and continues “we would also like to know how companies use the information from ENES within their organisations”. A LOOK FORWARD TO ENES 7

There are two major expectations for the upcoming ENES event in No-vember. The first of these is to re-fine the sector use maps. “We want to publish them and then promote their use,” expresses Dr Murray.

The second area will concern mix-tures. “We want to agree a frame-work for mixtures, with supporting guidelines that can be published after ENES7,” Dr Murray concludes.

The next meeting of ENES will take placeon18to19NovemberinBrussels.

Further information:

Programme, summaries and presen-tationshttp://echa.europa.eu/view-article/-/journal_content/title/sixth-meeting-of-the-echa-stakeholder-exchange-network-on-exposure-scenarios-enes-6-

What is ENES?http://echa.europa.eu/about-us/exchange-network-on-exposure-scenarios

CSR/ES Roadmaphttp://echa.europa.eu/csr-es-roadmap

ESCom Phrase Catalogue (version 1.4)http://www.cefic.org/Industry-support/Implementing-reach/Guidances-and-Tools1/

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communicating about safety

FROM OUR STAKEHOLDERS:Thomas Wolf, L'Oréal

“TheENES6meetingprovidedanexcellentupdateontheprogressoftheactionsendorsedintheCSR/ESRoad-map. From a downstream user’s standpoint, the roadmap is an essential element in the implementation of the REACH Regulation. For instance, it aims to provide downstream users with more realistic exposure scenarios and improve the compilation, communication and use of extended safety data sheets. The development of sector group extended use maps can genuinely be seen as an effective communication tool in the supply chain. For downstream users, it contributes to communicating upwards, in the supply chain, site-specific operational conditions and risk management measures that will subsequently need to be taken into consideration by registrants in their chemical safety reports. However, the communication of volume per use is seen as more problematic because of the sensitive nature of this information. The next ENES meeting is due to be held in November. Until then, in the context of enforcement, efforts should be made to enable more clarity on the demonstration of downstream user compliance, particularly with reference to the environmental contributing scenarios. Downstream users really do need easy-to-use scaling tools and guidance documents to be made available, as soon as possible.”

Renske Beetstra, Dutch Inspectorate SZW

"For enforcing authorities it is very important to keep up with the developments. Although industry is, and should be, leading in finding the most appropriate way to implement REACH, we will form an opinion about it in our inspec-tions. ENES offers a platform to achieve this in a rather informal way. When necessary, we can discuss the devel-oped approaches before they are widely used. We try to contribute to ENES by pointing out the overlap with workplace legislation that is sometimes forgotten when people concentrate on REACH. Furthermore, it should be reminded that ENES is a community of very active companies and sector organisations. In our inspections, we also see companies with less knowledge of REACH and we share these experiences too."

The next meeting of ENES will take place on 18 to 19 November in Brussels.

© ECHA

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communicating about safety

An industry perspective

From registrant to downstream user – implementing REACH the Yara wayTEXTBYRICCARDOMULATO,REACHDIRECTOR,YARAITALIASPA;REETTAPUSKA,REACHMANAGER,YARASUOMIOY;INGERAANDAHLRAASTAD,REACHMANAGER,YARAINTERNATIONALASA;MARIEBJØRGAN,CHEMICALCOMPLIANCESPECIALIST,YARAINTERNATIONALASA

Implementing the various aspects of REACH consistently throughout the whole organisation has been a challenge. Organisational and management structures have been put in place, both centrally and regionally, to help us address this challenge.

CENTRAL ORGANISATION

The first step was to establish a central service department, Yara Chemical Compliance (YCC). It has staff specialised in REACH, CLP, chemical safety and global chemi-cal legislation.

This central service department provides expert advice and guid-ance to the different Yara legal entities and manages registrations and notifications on their behalf. It

also prepares safety data sheets for all of Yara's products, which for the European legal entities also means preparing relevant exposure scenarios. In addition, the Yara Chemical Compliance department represents Yara in several industry associations and in ECHA’s working groups. However, despite its central role, ensuring REACH compliance is in the end the responsibility of each Yara legal entity.

QUALITY STANDARDS GUIDE THE WORK

Managing REACH and CLP obliga-tions successfully is possible only if the company management is com-mitted to promoting and supporting the work. Legal requirements need to be part of the company’s quality management system. To support this, Yara publishes technical and operating standards (TOPS) cen-trally, which describe the manda-tory internal requirements for im-portant operations. The application of these standards is monitored by internal audits.

One technical and operating stand-ard that is mandatory for all legal entities describes the responsibili-ties for compliance with REACH and other related regulations. This standard explains, for example, that preparing Yara’s safety data sheets is a central responsibility whereas the individual legal entities are re-sponsible for requesting, validating and releasing them, as well as for compliance in purchasing, manufac-turing and sales.

Yara International ASA is the world’s leading provider of nitrogen-containing fertilisers and indus-trial chemicals, with a presence in 51 countries. Our company operates in all of the roles defined in the REACH Regulation: as a manufacturer, downstream user, importer and an Only Representative (OR) for some of our non-EU subsidiaries.

According to Yara, good communication and easy access to documentation are essential to maintain awareness about REACH. From the left: Marie Bjørgan, Reetta Puska, Riccardo Mulato and Inger Aandahl Raastad.

© YARA

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communicating about safety

REGIONAL ORGANISATION

In each Yara legal entity based in the EU, a REACH Regional Contact person is nominated. The Yara Chemical Compliance department regularly invites these contact per-sons to meetings to discuss REACH and CLP related topics, organises training sessions and offers tools to support the legal entities to stay compliant with REACH. The Region-al Contact persons are responsible for cascading the information in their legal entity.

In addition, the Yara Chemical Com-pliance department supports the legal entities by making sure that they receive up-to-date instruc-tions on how to implement REACH and CLP, answering their questions and assisting in solving any non-compliance problems. Issues can vary from assessing the REACH compliance of new suppliers of raw materials, to checking the incom-ing extended safety data sheets and to spreading awareness of new chemicals added to the Candidate and Authorisation Lists or the List of Restrictions. Continuous mainte-nance and preparation of compliant safety data sheets for Yara prod-ucts is a key part of the service.

KEEPING THE WHOLE ORGANI-SATION UP-TO-DATE

To maintain the high level of awareness about REACH in the organisation, good communication and easy access to documentation are essential. All REACH relevant documentation in Yara is centrally archived on the intranet. The legal entities and users have controlled access to the documents relevant for them. The libraries work as repositories to store decisions and all steps of the REACH and CLP processes.

All documents, for example, on registrations, chemical analyses, lists of identified uses, inspection reports from authorities, business

decisions, training materials, and customer and supplier communica-tion are accessible to the personnel who need them. In addition, each legal entity is equipped with a local intranet platform where they can store relevant local REACH docu-ments. These can also be shared with the Yara Chemical Compliance department. In addition, the YCC department uses the intranet to regularly post news to key people in the organisation.

For Yara, implementing REACH is not a one-off task. It requires continuous follow-up on changes and updates in regulations and guidelines as well as in the releases ofITtoolssuchasIUCLID5andREACH-IT.

In addition, certain changes will trigger an update to a registra-tion and/or the chemical safety report. For example, manufacturing processes or raw materials may change and lead to changes in the composition of the registered sub-stance. Similarly, a new customer application may arise and trigger not only an update of the uses in the chemical safety report but also subsequent updates of all relevant (extended) safety data sheets. A change in substance classification

is another event that gives rise to updates. In practice, this means continuous work to improve the quality of registrations and keep them up-to-date.

WORKING TOGETHER

Overall, REACH demands that both the central and site organisations are prepared for changes and ad-justments. The Yara Chemical Com-pliance department is designed to react to these changes in time. However, REACH implementation would not be successful without the contribution of plant manag-ers, process engineers, laboratory analysts, site health, environment, safety and quality managers, or without the experience of our procurement, sales and marketing organisations.

Communication with the authori-ties and industry associations is also important. We are all working together towards a common goal.

We have learnt that good com-munication between central and local organisations as well as active internal and external networking are essential for applying REACH successfully.

YARA INTERNATIONAL ASA

� Delivers solutions for sustainable agriculture and environment.

� Global presence with operations and offices in 51countriesandsalestomorethan150 countries.

� Headquarters in Oslo, Norway.

� Employs around 10 000 people.

http://www.yara.com

22

news from echa

ECHA has launched a new service to enable registrants to change the chemical identi-fiers in their REACH dossiers. Registrants can change the main identifier in their registra-tion, i.e. the EC number, if the substance has been incorrectly identified. During this change process, the registrant's rights to manufacture and import are not affected.

The Agency has found incorrect identifiers in dossiers and has also received requests from registrants that have realised a mistake them-selves.

A change of a chemical identifier may be needed when a registrant has made a clerical error and provided the wrong identifier by mistake. Alternatively, registrants may also have wrongly considered the substance sameness in the substance information exchange forum (SIEF).

In the last year, ECHA has seen an increase in demand for such a service. It carried out a pilot project with a few registrants and has now formalised the service. The Agency charges for the administrative work to change the identifier. It is not a simple administrative change – the scientific validity has to be checked.

FLEXIBILITY FOR COMPANIES

The main benefit of the service for registrants is that it offers the pos-sibility to resolve any mistake they may have made in determining the scope of their individual registra-tion or their joint submission on their own initiative. Such a correc-

tion relieves them from possible harmful consequences of a breach of the REACH obligation to register the substance that they are manu-facturing or importing. In addition, by using the service, registrants will not need to submit a new registra-tion and can continue benefiting from the rights already granted under their current registration. ECHA encourages companies to use the service and request a change if they realise that they do not have the correct chemical identifier – even before a compliance check is done.

This service cannot be used to fulfil the registration obligations for a substance other than the substance originally intended to be covered in the registration. The new identifier proposed can therefore only refine the identity of the substance initial-ly concerned. It cannot correspond to a totally different substance.

TEXT BY HANNA-KAISA TORKKELI

HOW TO REQUEST A CHANGE OF CHEMICAL IDENTIFIER?

Registrants can request the change through the ECHA Helpdesk. If the change concerns and affects a joint registration, the lead registrant will need to submit a joint submis-sion plan to the Helpdesk. The joint submission plan should include the following:

• The chemical identifiers (EC number, CAS number, IUPAC/chemical name) of the sub-stance to which the existing registration of each co-regis-trantshouldrefer;

• An indication of which sub-stance identity information in the original dossiers demon-strates that the substance with the chemical identifiers men-tioned above is covered in that dossier. This information could be, for example, spectroscopic data, analytical information, the reported composition or the description of the manufac-turingprocess;

Is the substance identifier in your registration correct?

ECHA encourages companies to request a change if they realise that they do not have the correct chemical identifier.

© FOTOLIA

23

news from echa

• The identity (EC number, CAS number, IUPAC/chemical name) of any other substance that would require an additional registration as a result of the servicerequest;

• The identity of the legal entity that will be the lead registrant for the registration of the sub-stance subject to this service request;

• Documentary evidence that all co-registrants of the initial joint submission agree to the request specified in the joint submission plan. This can include signed confirmations or copies of communication between the registrants, for example, email exchanges.

After the service request has been received, ECHA checks that it is in order and can be processed. If the Agency considers that the service can be provided, it issues a service charge to each registrant depend-ing on the workload anticipated. Theminimumchargeis€445foreach registrant requiring the cor-rection of a substance identifier.

The scale of the charge is defined in a decision by ECHA’s Management Board. The deadline for payment is 30 days. The registrant will also be informed if the request cannot be processed.

The Agency will not verify the compliance of information pro-vided with the substance identity information requirements under REACH. In practice, this means that if the registrations are selected for compliance check, they may be found incompliant with regard to substance identity.

Once the Agency receives the pay-ment, it updates the identifier in-formation in REACH-IT. Registrants are informed about the completion of the task through REACH-IT and given a reasonable deadline by which to submit updates of their registration with the correct identi-fiers, if necessary.

More information about the service will be available on ECHA’s website in the near future.

Further information:

ECHA Helpdeskhttp://echa.europa.eu/contact/helpdesk-contact-form

Substance identityhttp://echa.europa.eu/regulations/reach/substance-identity

Management Board decision on the classification of services for which charges are leviedhttp://echa.europa.eu/about-us/who-we-are/management-board/management-board-meetings-2010

Registered substanceshttp://echa.europa.eu/information-on-chemicals/registered-substances

DID YOU KNOW?

For the identification of a substance the following most common chemical identifiers are used:

EC and list numbers are unique seven-digit identifiers that have been assigned to chemical substances for regulatory purposes within the European Union by the regulatory authorities. EC numbers (European Community numbers), comprising EINECS, ELINCS and NLP numbers, have been published by the European Commission in the Official Journal of the European Union. List numbers are technical identifiers and do not have legal significance.

CAS numbers are unique numerical identifiers assigned by the Chemical Abstracts Service to every chemical substance described in the open scientific literature including organic and inorganic compounds, minerals, isotopes, alloys and UVCB substances.

IUPAC names are systematic names that meet the recommended IUPAC rules.

SMILES code (Simplified Molecular-Input Line-Entry System) is a specification in the form of a line notation to describe the structure of chemical molecules.

InChI (IUPAC International Chemical Identifier) is a textual identifier for chemical substances, designed to provide a standard way to present molecular information and to enable the search of such information in databases and on the web.

24

reach

In December 2013, the European Commission hosted a workshop in Brussels. During the workshop, SME representatives, larger companies and consultants, gave voice to the needs of SMEs in complying with the EU chemical safety legislation, in particular REACH. ECHA attended in strength. The workshop took place after the May 2013 REACH registration deadline when all eyes were turning to smaller and less experienced companies having to fulfil their obligations as down-stream users or preparing for the 2018REACHdeadline.

ECHA has built on the feedback given to further develop and target its support to SMEs. Much of this is currently still “work-in-progress”, so SMEs can expect more support to become available in the coming months.

ECHAisworkingona2018REACHRegistration Roadmap and is con-sulting stakeholder organisations to make sure that it addresses the key challenges. This consultation will start at the end of June. In early July, ECHA will be discussing the road-map with the Member State competent authorities. Theplancoversitemssuchasforecasting;substancesameness;ITtools;guidanceandmanuals;support;communicationandawarenessraising;compliance;andmultilingualism.

The first concrete outcome will be a dedicated landing-pageforthe2018registrantsonECHA’swebsite.The web page will split the registration into different phases, and arrange ECHA’s support material in a tiered way from introductory to more advanced, to help com-panies to navigate through the registration process. ECHA is also meeting companies to benefit from their practical experience in using ECHA’s IT tools. This feedback will enable the next generation of simplified ITtoolstobereleasedin2016.Itwillalsoserveasasource of ideas for enhancing ECHA’s documents and customer support.

In improving support to SMEs, ECHA does not act alone. It collaborates closely with industry associations and other actors. The Directors’ Contact Group (DCG) has, for example, recently adopted two best practice documents. One is a “checklist to hire a good consult-ant”. The other spells out “considerations to be made

ECHA column | Andreas Herdina, Director of Cooperation

Follow-up of the December 2013 SME workshopwhen joining an existing SIEF”. In October, the DCG also intends to publish two further best practice documents on fair and transparent cost sharing in SIEFs and rec-ommendations on sound SIEF management.

To help SMEs in exposure scenario communication, an example for registrants on how to construct an expo-sure scenario will soon be made available. An annotat-

ed template showing downstream users what information they can expect to receive will also soon be published.

ECHA’s authorisation web pages have recently been updated to try to make it clearer which substances are affected. For2015,ECHAalsoforeseestherelease of a revamped version of its dissemination web portal, which will include innovative features that enable companies seeking information on the fate of specific substances to retrieve it in more accessible formats.

At the workshop in December, SMEs alsoraisedspecificissues.On8April,ECHA joined the European Commission

in meeting representatives of essential oil producers to better understand their challenges in registering their UVCBs. ECHA will support them in developing sector-specific solutions.

SMEs are encouraged to subscribe to ECHA’s e-News to keep them up-to-date as the various support products mature.

Further information:

SME workshop web page http://www.euconf.eu/reach2013

DCG web pagehttp://echa.europa.eu/about-us/partners-and-networks/directors-contact-group

Authorisation web pagehttp://echa.europa.eu/addressing-chemicals-of-concern/authorisation

Downstream user web pagehttp://echa.europa.eu/regulations/reach/downstream-users

© ECHA