2011 | Apr | № 2 ECHA nEwslEttEr | 1

ECHA|Newsletter №2April 2011

3 Communicate and share your safety information

10 Companies should start to prepare applications for authorisation early

12 International Year of Chemistry 2011

Sixth ECHA Stakeholders' Day

18 May 2011

2 | ECHA nEwslEttEr № 2 | Apr | 2011

14 In this issue

84 Evaluation report 20105 ECHA term8 sVHC in articles14 stakeholders' Day16 Executive Office18 Interview21 Committees & Forum22 Forum working Group23 Dissemination

24 Evaluation statistics

To subscribe to the ECHA news alerts and newsletter, send your e-mail address to: info@echa.europa.euDisclaimer: 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.

European Chemicals AgencyAnnankatu 18, P.O. Box 400,FI-00121 Helsinki FinlandTel. +358 9 6861 80Fax +358 9 6861 8210 ISSN 1831-4953

http://echa.europa.eupress@echa.europa.eu

Lindsay JacksonHead of Communications

© E

CHA

Greetings from Helsinki where we are in the glorious first flush of spring. It's always the case that in Spring our thoughts and energies turn to the new - new challenges, new opportunities and change. This year is no exception. With a de-

manding but successful winter behind us, we now look forward to the work ahead.

Excellent communication is the cornerstone of this edition of the Newsletter and one of the fundamental challenges facing all of us. In fact, REACH and CLP are, at their heart, all about communication - communicating up and down the supply chain and communicating with the wider world about chemicals. Communicating honestly, clearly and as simply as we can about substances, their hazards and how to use them safely so that we can reap the benefits of chemicals without harming people or the environment. This responsibility lies primarily with companies – manufacturers, im-porters and also downstream users. Thousands of downstream users for example are now preparing to fulfil their responsibilities to communicate through extended safety data sheets. They are trying to find a pragmatic balance between providing enough information to enable safe use and too much, which risks simply confusing users and making safe use less likely. Workers and consumers throughout Europe are depend-ent on them striking that balance well. You will find more on this in this edition and hints and guidance on our website.

Spring also brings our Stakeholders’ Day – on May 18 in Helsinki. Once again, we will be looking forward to the key issues this year and helping companies to successfully register in 2013. Our popular one-to-one sessions will also be repeated, giving you the chance to ask for answers to your individual questions from one of our in house experts. I hope that you will join us, and also take advantage of the chance to attend the Helsinki Chemicals Forum on the following day.

I wish you a bright and successful spring and look forward to seeing you here in Helsinki in May.

Visit the ECHA website for

up-to-date news: http://echa.europa.eu/

news_en.asp

© ISTOCkPHOTO

© ECHA

2011 | Apr | № 2 ECHA nEwslEttEr | 3

News from ECHA

I n the run-up to the first REACH registration deadline of 30 November 2010, the manufacturers and import-ers of the most widely used and the

most hazardous chemicals collected a vast amount of information concerning the safe use of these substances. In cases where the existing information was in-sufficient to characterise the inherent properties of a substance and/or the con-ditions of use, the companies concerned generated new data to ensure that the risks related to the environmental and health hazards could be adequately con-trolled. This was a major achievement in the new European chemicals regulation regime.

The flow of information down the supply chain has started

Implementation of REACH has now moved to the next phase, and both reg-istrants and their customers face the challenge of communicating the results of the chemical safety assessment with-in the supply chain. The objectives of REACH cannot be achieved if the safety information generated in the course of registration is only used by a few thou-sand registrants. It must be made ac-cessible and understandable to tens or maybe hundreds of thousands of their customers and eventually to all European citizens as consumers.

The vehicle for communicating this safety information among industry play-ers is the extended safety data sheet, where the attached exposure scenarios detail the operational conditions and the risk management measures ensuring the control of risks for each identified use.

Reading, understanding and responding to the extended SDS

Downstream users have a challenging task ahead of them, starting from the comparison of the information in the exposure scenarios supplied by the reg-istrants to their own uses. It is best that this is done in a step by step manner, first determining whether one’s own uses are covered by the registrant’s exposure scenarios and then checking if one’s own conditions of use match those in the rel-evant exposure scenario.

If the result of this comparison re-veals a significant mismatch, the down-stream user can either change his use, change supplier, ask his current supplier to include his use in the registration, or conduct a chemical safety assessment of his own. If he chooses the last option, in most cases he needs also to report such a use, not supported by the registrant, to ECHA. And finally, he has the task of compiling the safety information he has received and passing it on to his custom-ers further down the supply chain.

Two-way communication from the very first step is the key

It is essential that the content of the mes-sage - in this case safety information- is clear and unambiguous from the very first step. In REACH it is the formulators of mixtures who are now receiving the first messages from their suppliers in the form of extended safety data sheets.

ECHA encourages such formulators to have an open dialogue with the reg-istrants if the safety information they receive is not clear. It is better to clarify the issue at this first step than to pass on cryptic messages down the supply chain.

Only in this way can it be ensured that meaningful information is transferred within the supply chain.

ECHA supports industry efforts

Communication in the supply chain is clearly an industry responsibility, and a fairly limited role is foreseen for ECHA in the legislation. However, ECHA rec-ognises the importance of the function-ing of supply chain mechanisms for the successful implementation of REACH, and is therefore prepared to cooperate with industry to support this challenging phase of REACH implementation.

ECHA has and will further clarify the various roles under REACH as well as the related obligations and timelines in a series of publications. In addition, ECHA is prepared to publish practical examples of good quality communication in order to promote best practices.

Furthermore, ECHA has developed Chesar, a tool for Chemical Safety As-sessment and Reporting. With this tool registrants will be able to generate ex-posure scenarios for communication in a standardised, electronic exchange for-mat directly from their own assessment. ECHA also supports industry efforts to standardise the phrases used in exposure scenarios and to develop an electronic exchange standard for exposure scenario information.

Finally, in order to provide an easy entry to all relevant information, ECHA will soon open a dedicated section for downstream users on its website.

Communicate and share your safety information

registrants and their customers should make safety information accessible and communicate it in a clear and unambiguous way both up and down the supply chain and eventually to all European citizens as consumers.

4 | ECHA nEwslEttEr № 2 | Apr | 2011

News from ECHANews from ECHA

Evaluation report 2010:

Comments from interested parties on animal testing should fulfil the information requirements of rEACH From February onwards, ECHA will regularly publish brief conclusions on the third party information it has received concerning testing proposals involving vertebrate animals.

T he information will be pub-lished after ECHA has made its final decision on the test-ing proposal. By publish-

ing such conclusions, ECHA wishes to improve the transparency of the process and to encourage all parties to submit relevant scientific information.

In three testing proposal cases, ECHA´s comments on third party information have already been published. Both the comments as well as information on the outcome of the testing proposal evalua-tions can be found in the consultation table on the ECHA website.

ECHA's Evaluation Report 2010, pub-lished at the end of February 2011, also in-cluded brief comments on the third party information received last year. The report states that “the information submitted by third parties on testing proposals involving vertebrate animals was usually not sufficient to fulfil the information requirement under REACH.”

The evaluation report also contains rec-ommendations to third parties submit-ting information as part of the public consultation:

In order to be considered relevant, •the information submitted during the public consultation should fulfil REACH information requirements specified for the endpoint under examinationTest data submitted should contain •a sufficient level of detail in order to allow an independent assessmentIf non-test data is provided, e.g. •read-across, QSAR etc., they should fulfil the same requirements as the data submitted by the registrants and specified in REACH

The Evaluation under REACH Progress Report 2010 is a good source of informa-tion on the evaluation process, including testing proposals, and it contains recom-mendations to registrants. The report is available on the ECHA website.

Evaluation report 2010:http://echa.europa.eu/doc/evaluation_un-der_reach_progress_report_2010.pdf

Dossier evaluation process:http://echa.europa.eu/reach/evaluation/evaluation_process_en.asp

▶ ECHA has published a new Fact Sheet on substance evaluation. The document which is available on the ECHA website provides information on the evaluation process, on how substances are selected for evaluation and how the Community Rolling Action Plan will be established.http://echa.europa.eu/doc/reach/substance_evaluation_fact_sheet_20110414_en.pdf

Fact sheet on substance evaluation

safer management of chemicals – submit relevant information!Consultations: http://echa.europa.eu/consultations_en.asp

2011 | Apr | № 2 ECHA nEwslEttEr | 5

News from ECHA

The database provides the main REACH and CLP terms in 22 EU languages, including the CLP pictograms and hazard and

precautionary statements. The database can be used free of charge for various purposes including the translation of terms, search for their definition and as a source for hazard and precautionary statements for safety data sheets in mul-tiple languages. The database offers:

Around 900 REACH and CLP •terms, phrases and definitions Pictograms for 9 CLP hazard •classes6 substances of very high con-•cern (as a test)An alphabetical index contain-•ing all entriesSearch preferences with the pos-•sibility to customise the inter-faceHelp section•Possibilities for registered users •to download the terminology, comment on entries and receive news on the database updates

During the first week of the launch, almost 3 500 visits from 58 countries were registered at the database. The countries at the top of the list were Ger-many, Luxembourg and Finland.

The database will be extended in the future, taking into account the needs of potential users such as translators, in-dustry, national authorities and ECHA staff. The database is very easy to use and no registration is needed. However

only registered users can download or comment on the data. The database is managed on behalf of ECHA by the Translation Centre for the Bodies of the EU (CdT) in Luxembourg. ECHA-term supports you in 22 EU languages! Database: http://echa.cdt.europa.euECHA-term leaflet and ECHA-term quick guide in 22 languages: http://echa.cdt.europa.eu/doc.jsp

rEACH and Clp terminology in 22 EU languages available now onlineA test version of a multilingual terminology database was launched for use by the public on 5 April.

▶ A new release of ECHA’s Chemical safety assessment and reporting tool Chesar (v1.1.3) can now be downloaded from the Chesar website. The version is fully compatible with IUCLID 5.3.

Chesar is a comprehensive tool devel-oped by ECHA to assist companies in car-rying out Chemical Safety Assessments for the different uses of a substance and in preparing the Chemical Safety Report. Each registration dossier for substances above 10 tonnes has to contain a Chemi-

cal Safety Report. The tool can be down-loaded as a plug-in to IUCLID 5.

With Chesar, the registrant can create a full Chemical Safety Report once the hazard assessment and - when required - the exposure assessment have been finalised. The Chemical Safety Report is created in text format as well as in ex-changeable database format (XML Doc-book format).

Chesar 1.1.3 can only be installed on the IUCLID 5.3, standalone or distributed version. The new Chesar 1.1.3 installation packages and manuals for IUCLID 5.3 distributed and standalone versions are available on the Chesar website.

User feedback is very welcome and will be taken into account in the develop-ment of future upgrades of Chesar.

Chesar website:http://chesar.echa.europa.eu/

CHESAR 1.1.3 available

6 | ECHA nEwslEttEr № 2 | Apr | 2011

News from ECHA

▶ On 1 April, ECHA issued an update to the Guidance on Requirements for Sub-stances in Articles. This update replaces the previous guidance document.

From 1 June 2011, companies may have to notify ECHA in relation to Substances of Very High Concern (SVHC) which are on the Candidate List and are present in articles companies produce or import.

The guidance describes the registration, notification and communication require-ments related to substances in articles and helps producers, importers and sup-pliers of articles identify and fulfil their legal obligations. It further clarifies the decision-making process as to whether

Two new dossier types can now be submitted through REACH-IT: Notifi-cations of Substances in Articles and Downstream User Reports. All dossier types should be created using the new version of IUCLID 5.3. (See also page 9). In addition, REACH-IT has been updated to comply with the second Ad-aptation to Technical Progress of the CLP Regulation.

The following two dossier types can now be submitted through REACH-IT:

notifications for substances in articles and downstream user reports can now be submitted through rEACH-It

Downstream User Reports (Article •38 of the REACH Regulation).Notifications of Substances in Ar-•ticles (Article 7(2) of the REACH Regulation).

REACH-IT has also been updated to include new features such as the ad-aptation of all C&L notification tools (online, IUCLID 5.3 and bulk) to the second ATP (Adaptation to Technical Progress) of the CLP Regulation. Due to the importance of the modifications, this version of REACH-IT only accepts dossiers created with the latest IUCLID

Guidance on Substances in Articles updated

an object is present in an article.

The guidance explains how to check if a substance is already registered for a par-ticular use, in addition to whether a reg-istration or notification will be needed.

Guidance website: http://guidance.echa.europa.eu/

Candidate List of Substances of Very High Concern for Authorisation:http://echa.europa.eu/chem_data/au-thorisation_process/candidate_list_table_en.asp

Second adaptation to CLP Regulation published in Official Journal

▶ The second adaptation to technical progress (ATP) of the classification, label-ling and packaging (CLP) Regulation has been published in the Official Journal. The adaptation largely brings the CLP Regulation into line with the third and most recent revision of the UN’s Globally Harmonised System (GHS) of classification and labelling of chemicals.

OJ L 83, Volume 54, 30 March 2011http://eur-lex.europa.eu/LexUriServ/LexUriS-erv.do?uri=OJ:L:2011:083:FULL:EN:PDF

5.3 format, and with the latest version of the bulk Excel tool (2.0) for the bulk C&L notifications.

IUCLID 5.3 and related plug-ins (TCC-BR, Fee calculation and Dissemination plug-ins) are also updated and avail-able on the IUCLID website. The latest version of the bulk Excel tool for bulk C&L notifications is available on ECHA website.

More information: http://echa.europa.eu/news/na/201104/na_11_19_notifica-tions_sia_through_reach-it_20110413_en.asp

© ISTOCkPHOTO

Notify substances in articles! 1 June 2011

Register! 31 May 2013

2011 | Apr | № 2 ECHA nEwslEttEr | 7

© ISTOCkPHOTO

News from ECHA

Call for information to avoid unnecessary animal testing▶ ECHA publishes all testing proposals which involve ver-tebrate animals for endpoints specified in Annexes IX and X under REACH on its website before the testing is carried out. The call for information is published to ensure that the best use will be made of existing information, particularly informa-tion on existing vertebrate tests. Third parties have 45 days to submit scientifically valid information and studies that address the relevant substance and the hazard endpoint relating to the testing proposal.

▶ Call for information for 21 substances: 15 April - 30 May 2011▶ Call for information for 10 substances: 05 April – 20 May 2011▶ Call for information for 14 substances: 15 March – 29 April 2011

http://echa.europa.eu/consultations/test_proposals/test_prop_cons_en.asp?consultations_status=current

Public consultations on harmonisedclassification and labelling▶ The EU Regulation on the Classification, Labelling and Pack-aging of substances and mixtures (EC) No 1272/2008 invites EU Member States and industry to submit proposals for the harmo-nised classification and labelling of substances. ECHA publishes on its website such proposals and calls for comments.

Currently ECHA is consulting on proposals to harmonise the classification and labelling of five substances. The deadline is 09 May 2011. To submit comments, please use the link in the consultation table on ECHA's website at:http://echa.europa.eu/consultations/harmonised_cl_en.asp

Consultation on a SVHC proposal▶ Member States Competent Authori-ties or ECHA on request of the European Commission may propose a substance to be identified as a Substance of Very High Concern (SVHC). The Substances of Very High Concern are defined in Arti-cle 57 of REACH and include substances which are carcinogenic, mutagenic or toxic to reproduction (CMR); persistent, bioaccumulative and toxic (PBT); or very persistent and very bioaccumulative (vPvB). On a case by case basis, propos-

als may also be prepared in relation to substances that, according to scientific evidence, cause serious effects to hu-man health or the environment and are at an equivalent level of concern as CMR, PBT and vPvB substances. For instance endocrine disrupters could be such sub-stances of equivalent concern.

Substances identified as SVHCs may be placed on the Candidate List for possible inclusion in the Authorisation List.

▶ Interested parties are invited to com-ment on the draft opinion of the Com-mittee for Socio-economic Analysis (SEAC) on restricting the placing on the market of jewellery products which con-tain lead or its compounds. The deadline for comments is 28 May 2011. ECHA also calls for comments on SEAC´s draft opinion on restricting the placing on the market and use of dimethylfumarate (DMFu) in articles and sachets added to them. The deadline for comments is 17 May 2011. Comments should be submit-ted by using the substance specific com-menting link on the ECHA website:

The press release on the opinions of ECHA Scientific Committees on restric-tion proposals on DMFu and lead and its compounds in jewellery can be found at:http://echa.europa.eu/news/pr/201103/pr_11_07_scientific_committees_first_opin-ion_restriction_20110314_en.asp

Restriction process under the REACH Regulation:http://echa.europa.eu/reach/restriction_en.asp

http://echa.europa.eu/reach/restriction/re-strictions_under_consideration_en.asp

The Committee for Socio-economic Analysis will take the comments into account when adopting its final opinion. The Committee for Risk Assessment has already given its opinion on these is-sues. The European Commission will take both opinions into consideration when it establishes its final decision through a regulatory committee procedure with scrutiny.

ECHA is currently consulting interested parties on cobalt dichloride. The dead-line for comments is 03 May 2011.

Link to commenting form:http://echa.europa.eu/consultations/au-thorisation/svhc/svhc_cons_en.asp

Consultation on restrictions: Lead in jewellery and DMFu in articles

8 | ECHA nEwslEttEr № 2 | Apr | 2011

News from ECHA

On 1 June 2011, all EEA produc-ers and importers of articles will have to notify ECHA about any Substances of Very

High Concern (SVHC) on the EU Can-didate List1 if both of the following con-ditions are met:

the substance is present in arti-•cles produced and/or imported above a concentration of 0.1% (weight by weight) the total amount of the sub-•stance present in all articles exceeds 1 tonne per producer/importer annually.

To support producers and importers of articles in complying with their legal requirements, ECHA has made available web pages on this specific issue. These pages include questions and answers and a data submission manual contain-ing practical advice on how to carry out a notification. An updated version of the Guidance on requirements for sub-stances in articles was published on the ECHA website on 1 April.

Establishing SVHC presence

There are different ways in which pro-ducers and importers can find out whether a substance included in the Candidate List is present in their article. In general, they receive this information from actors in their supply chain, so fur-ther chemical analysis of the article may not be the first thing to consider. When in doubt, Chapter 5 of the Guidance on requirements for substances in articles can be consulted for more information.

Other important information that

First notification deadline substances of Very High Concern in articles

needs to be included in the notification dossier includes for instance the type of the article and the function of the sub-stance in the article.

Once producers and importers have established that their article contains a substance included in the Candidate List, the next issue they need to address is the level of its concentration in the article.

To determine whether the threshold of 0.1% has been reached, the concentra-tion of the substance in the article needs to be calculated. If the article has several different components, the concentration should be calculated in relation to the article as produced or imported. This means that if a car is imported, the con-centration in the whole car can be calcu-lated. If a hubcap for a car is imported, it is the concentration in the hubcap that should be calculated 2.

Section 4.4 of the REACH guidance on requirements for substances in ar-ticles provides further explanation and some examples on how to proceed.1Candidate List of Substances of Very High Concern for Authorisation2See Guidance on requirements for substances in articles

Exemptions in two cases

Companies are exempted from notify-ing ECHA in two cases. The first case is when they can exclude the exposure of humans or the environment to the SVHC in the article during normal or reasonably foreseeable conditions of use, including disposal. However, pro-ducers and importers should be aware

that it may be more difficult and costly for them to demonstrate “no exposure” rather than proceeding with their noti-fication.

The second case is when the sub-stance is already registered for the in-dicated use. Section 6.4 of the Guid-ance on requirements for substances in articles provides some advice on how to find out if the substance is already registered for that use. If it is not certain that a specific use of the relevant SVHC is already registered, companies are ad-vised to notify.

When to notify?

The notification of substances in articles should be made at the latest 6 months after the substance has been included on the Candidate List. The obligation how-ever only starts to apply from 1 June 2011. This means that for substances included in the Candidate List before 1 December 2010, notifications have to be submitted not later than 1 June 2011. For substances included in the Candidate List after 1 December 2010, notifications have to be submitted no later than 6 months after the inclusion of the substance.

Producers and importers are advised to update the notification if the infor-mation they have included has under-gone changes. Examples of such chang-es could be: change in tonnage range, production/import of different articles (with e.g. different use) containing the same SVHC etc.

If the production/import ended be-fore the obligation to notify enters into force (i.e. 1 June 2011 for substances placed on the Candidate List before 1

2011 | Apr | № 2 ECHA nEwslEttEr | 9

News from ECHA

December 2010 or 6 months after a sub-stance has been included in the Candi-date List) then producers and importers do not need to notify.

The information submitted in the notifications will add to a better un-derstanding of how Substances of Very High Concern are used in articles in the EU.

Further information: Web page on substances in articles, in-cluding Q&A:http://echa.europa.eu/reach/sia_en.asp

Data Submission Manual: How to pre-pare and submit a Substance in Articles Notification using IUCLID:http://echa.europa.eu/reachit/dsm_en.asp

Guidance on requirements for substanc-es in articles:http://guidance.echa.europa.eu/guidance_en.htm

Candidate List of Substances of Very High Concern for Authorisation:http://echa.europa.eu/chem_data/au-thorisation_process/candidate_list_table_en.asp

Article 7 of the REACH regulation:http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2007:136:SOM:EN:HTML

The national REACH helpdesks are the first point of contact:http://echa.europa.eu/help/nationalhelp_en.asp

If you have questions on technical is-sues on REACH-IT and IUCLID 5 or you are not in the European Economic Area (EEA) you may contact the ECHA helpdesk instead:http://echa.europa.eu/help/echahelp_en.asp

To determine your general obligations under the REACH Regulation and how to fulfil them, you can use the Naviga-tor:http://guidance.echa.europa.eu/naviga-tor_en.htm

▶ To start a notification, producers and importers should use the IUCLID soft-ware available free of charge on ECHA’s IUCLID 5 web page. The Data Submission Manual for “How to prepare and submit a Substance in Articles notification” pro-vides assistance on how to proceed with the notification.

Datasets for all substances on the Candidate List can be found on the ECHA website. The datasets contain the iden-tity (substance name, EC and/or CAS number), composition and the classifi-cation and labelling of the substance. After downloading the dataset for the substance whose presence in articles producers and importers need to notify, the datasets are imported into IUCLID 5.

How to prepare and submit a notification

The notification can then be com-pleted by adding the company’s iden-tity and contact details, the registration number if available, the tonnage range of the substance, a brief description of the uses of the substance in the article itself (technical function) and the uses of the article (e.g. industrial, consumer or professional use, indoor/outdoor use, high/low release). The description of use can include information on how the ar-ticle is foreseen to be handled (e.g. in contact with skin), how it is likely to be disposed of and in which part of the article the SVHC is present (for complex articles made of various parts).

Once the Substance in Articles notifi-cation dossier has been created, produc-ers and importers are advised to use the

Technical Completeness Check (TCC) tool. This IUCLID 5 plugin will detect any missing information in the dos-sier before the dossier is submitted to ECHA. The latest version of the TCC plug-in can be downloaded from the IUCLID 5 web page (http://iuclid.echa.europa.eu/). The notification should then be submitted to ECHA via REACH-IT (https://reach-it.echa.europa.eu/) .

10 | ECHA nEwslEttEr № 2 | Apr | 2011

T he first Authorisation List (or Annex XIV of the REACH Regulation), containing six sub-stances subject to authorisation,

entered into force on 21 February 2011. Companies either placing on the market or using these substances can now check the Authorisation List to establish the date by which they should apply for au-thorisation if they wish to continue the use of the substances after the deadline, or the “sunset date”. The applications for authorisation need to be submitted to ECHA, and are subject to a fee.

“As the authorisation process is new to everyone, it will take a lot of work for stakeholders and ECHA to ensure that the authorisation process func-tions well,” estimates Rémi Lefèvre from ECHA's Risk Management Directorate. Mr Lefèvre is coordinating preparations within ECHA for the receipt of applica-tions.

The European Commission makes the final decisions as to whether or not, and under which conditions, an authori-sation is to be granted. However, ECHA’s scientific committees - the Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) – “play a major role in this process as they issue opinions which support the European Commission in its decision making” un-derlines Pilar Rodríguez Iglesias, Head of the Committees’ Secretariat Unit.

Joint applications possible

Applicants for authorisation can be manufacturers, importers or down-

stream users of substances included in the Authorisation List. Applicants may apply for authorisation jointly. REACH also foresees the possibility for compa-nies to make an application for more than one use of a substance. An applica-tion can also cover several substances if they all meet the definition of a group of substances. This “category” approach is defined in Annex XI of REACH.

ECHA’s committees may request ap-plicants to provide further information during the 10-month opinion-making process. Third parties will also be invited to provide information as to possible alternatives to the use of the substance for which an authorisation is sought. Furthermore, applicants will have the opportunity to comment on the draft opinions of the committees.

Companies should start to prepare applications for authorisation earlyFrom last February onwards, companies using substances included in the Authorisation list (Annex XIV) have been able to start preparing applications for authorisation. During an ECHA seminar on applications for authorisation on 12 April 2011, it became clear that there were differences in the state of readiness of European companies in terms of preparing their applications.

Transparency and confidentiality

Transparency of the opinion-making process is important, stresses Pilar Ro-dríguez Iglesias. ECHA is designing a new section for its website to ensure that through the public consultations, all relevant information on possible al-ternatives will become available. At the same time, ECHA needs to ensure that no commercially sensitive information is released during the process. For this reason, ECHA’s formats and templates have been developed to separately docu-ment the different parts of an application for authorisation, so that applicants can clearly distinguish confidential informa-tion from public data.

“It is likely that it will take some time for companies to prepare their applica-tions,” says Rémi Lefèvre. One of the first important steps for potential applicants is to decide on the uses for which they need to seek authorisation. Potential applicants for a substance need also to decide how to organise themselves during – on the one hand - the prepara-tion stage and - on the other hand – the actual submission of their applications. These two important aspects were par-ticularly stressed at the first ECHA semi-nar on applications for authorisation in Helsinki on 12 April 2011.

Reports from chemical safety to socio-economic impacts

An application for authorisation should be created in the newest version of IU-CLID (5.3), and several reports must be

"In the coming months...we need

to improve the general awareness

and understanding of this new risk

management instrument.”

ECHA introduces

2011 | Apr | № 2 ECHA nEwslEttEr | 11 11 | ECHA nEwslEttEr № 1 | FEB | 2011

included in the IUCLID file. The starting point is a Chemical Safety Report which addresses the risks arising from the uses applied for. The application also needs to provide an Analysis of Alternatives and – if suitable alternatives are available – a Substitution Plan describing when and how the substance will be substituted. Although not legally required, it is es-sential that an applicant also includes a Socio-economic Analysis as part of his application.

“In practice, we recommend that applicants carry out the analysis of the socio-economic impacts in particular for non-threshold substances” says Matti Vainio, Head of the Risk Management Implementation Unit. “However, this may also be important for threshold substances where applicants might be well advised to give additional informa-tion if adequate control of risks is not demonstrated.”

New web pages for applicants

ECHA has published new dedicated web pages dealing with applications for authorisation. These web pages allow potential applicants and third parties to gain a better insight into the authorisa-tion procedure and also provide links to two new guidance documents produced in order to support applicants. The first explains how to prepare an application for authorisation, an analysis of alterna-tives and a substitution plan and also gives information as to how third parties may prepare and submit information on

alternatives. The second new document provides guidance on how to prepare a socio-economic analysis.

“We have made a special effort to design these web pages as a one-stop-shop for all potential applicants,” says Rémi Lefèvre. The web pages contain all formats and templates that are needed for an application for authorisation, in-cluding the web forms for submitting an application to ECHA and a user manual to help applicants file and submit their applications.

A tool for estimating the level of the fee related to the application is also available on the new web pages.

ECHA will update these pages regu-larly, based on the feedback received from all parties involved in the authori-sation procedure. The helpdesks in both the EU Member States and at ECHA will also answer questions.

Time to start preparations

“In the coming months, we will pay special attention to communication through different means to all stake-holders. In short, we need to improve the general awareness and understand-ing of this new risk management instru-ment,” underlines Rémi Lefèvre.

Matti Vainio stresses that potential applicants should, however, not stay pas-sive and wait for information to arrive. During ECHA’s seminar on applications for authorisation on 12 April it was evi-dent that some companies have already started to work on certain aspects of

their applications. It was equally clear that many are still at a very early stage in their preparations. One clear mes-sage was that all potential applicants need to start their preparatory activities now. The application for authorisation process is new to all. Therefore ECHA intends to be proactive to ensure that potential applicants have the necessary guidance and know where to find the relevant information.

ECHA also needs to ensure that it plans the use of its own resources properly. This will lead to the smooth processing of all incoming applications for authorisation, “Therefore we encour-age potential applicants to notify us well before their expected submission date in the way suggested on our website” explains Matti Vainio. ”As we are all learning, good, early communication between potential applicants and ECHA will help to make the system work as the REACH Regulation intended,” he concludes. ECHA’s new pages on application for authorisation http://echa.europa.eu/reach/authorisa-tion_under_reach/authorisation_applica-tion_en.asp

Authorisation List is available at:http://echa.europa.eu/reach/authorisation_under_reach/authorisation_list_en.asp

Seminar on Applications for Authorisa-tion:http://echa.europa.eu/news/events/semi-nar_authorisation_en.asp

▶ ECHA has established specific sub-mission dates for authorisation applica-tions so that both ECHA and especially its Committees for Risk Assessment for Socio-economic Analysis can plan and distribute their workloads efficiently.

Submission dates for authorisation applications 2011-2012

Companies should submit their applica-tions by the following dates:2011:▶ 1 June, 1 September and 1 December2012:▶ 1 March, 1 June, 3 September and 3 December

ECHA advises applicants to consider these dates and to notify the Agency of their intention to submit an application. Submission dates for 2013 will be an-nounced by January 2012.

ECHA introduces

12 | ECHA nEwslEttEr № 2 | Apr | 2011

International Year of Chemistry

▶ The International Year of Chemistry 2011 organised by UNESCO, United Na-tions Educational, Scientific and Cultural Organization in cooperation with IUPAC, the International Union of Pure and Ap-plied Chemistry, is a worldwide celebra-tion of the achievements of chemistry and its contribution to the well-being of

In 2011, the International Year of Chemistry, the ECHA newsletter will publish interviews related to personalities that have contributed to the development of modern chemistry and their significance for the present and future. Mr Alexis Brouhns, Director for Corporate Government and public Affairs at the solvay Group, visited ECHA in February on the occasion of the International Year of Chemistry and the naming of the Ernest solvay meeting room*.

Mr Brouhns, how would you describe Er-nest Solvay from today's perspective?

Ernest Solvay was an entrepreneur, a philanthropist and a passionate believer in the value of education and in the forces of progress. He was a product of his time (the late 19th century) but he was also ahead of his time which is why it is still so easy to associate oneself with his vision even in the 21st century. Ernest Solvay hoped that there might be a grand Universal Law which unified all things. Of course, Solvay's Law was to remain hypothetical but the journey of discovery that it took him on brought him and others great benefit. And the cross-disciplinary approach he champi-oned has since become mainstream.

Is there movement in the chemical indus-try towards an integrated approach in the spirit of Ernest Solvay?

The basic message of Ernest Solvay is still relevant. You might contest specific parts of his scientific, social or economic vi-sion, but his drive towards an integrated

humankind. The year also coincides with the 100th anniversary of the Nobel Prize in Chemistry that was awarded to Marie Skłodowska Curie in 1911. During the year, a lot of events are organised around the world under the slogan "Chemistry - our life, our future".

The closing ceremony which will be held in Brussels on 1 December 2011 will discuss how to solve great problems of humanity with the help of science and technology.

International Year of Chemistry website:http://www.chemistry2011.org/

"the basic message of Ernest solvay is still relevant"

approach and balance between economy, profitability, industrial innovation, re-spect for people and social issues is still a valid programme today.

In your lecture, you said that studying chemistry has become less popular among young people. Could such an integrated approach help to improve the image of the chemicals industry in their eyes?

Virginia Mercouri from ECHA Communications, Executive Director Geert Dancet and Mr Alexis Brouhns at the inauguration of the Solvay meeting room at ECHA. Mr Brouhns gave Mr Dancet the photo of the first world Physics Council in Brussels in 1911.

© ECHA

* The opinions and views expressed in this interview do not necessarily reflect the views of ECHA.

2011 | Apr | № 2 ECHA nEwslEttEr | 13

International Year of Chemistry

Yes, definitely such an approach is a huge asset to bright young people. The chemi-cal industry is aware of its image and is making efforts to better communicate all that it is doing. Responsible Care has been a response by the chemical industry to attain continuous improvements in its health, safety and environment perform-ance together with open and transparent communication. REACH has also been helpful in increasing the credibility and responsibility of the industry.

However we still need to do more. The Chemical industry can contribute to the main challenges affecting mankind in the coming decades but it needs to be less defensive and reach out to people to help them understand all the innovations that it enables. I am convinced that without chemistry and a chemical industry we could not find solutions to many of the challenges affecting us.

In the 18th century, Malthus said that if the world’s population continued to grow at the same pace, it would be impossible for the earth to provide food and a decent life for the increasing popu-lation. Some centuries later, we can now

▶ The Belgian industrialist Ernest Solvay (1838–1922) developed with his brother a new process for the industrial production of sodium carbonate. He supported phys-ics and chemistry, among other sciences, in many ways, and founded the International Solvay Institute for Physics in 1912 and the International Solvay Institute for Chemistry in 1913.

In 1911, Solvay organised the famous first International Physics Council in Brussels. It was a gathering of many of the leading

say that it has been possible to find solu-tions to these difficulties. Why? Because of technological and scientific progress! And chemistry was part of that general progress enabling the planet to achieve more than it could one or two centuries ago, in terms of food, habitat, health, and so on. To avoid a Malthusian check in the XXI century, it is clear that sustainable development is more and more becom-ing the key for the development of the chemical industry.

At Solvay, we have a beautiful example of this which is the Solar Impulse Plane, a project launched by Bertrand Picard. We are one of the main sponsors of this project, contributing Solvay products and know-how to make it possible for a plane to fly around the world by night as well as by day with only solar energy. When the idea was first raised people said it was impossible. Today, the plane has already flown for 26 hours non-stop. This is precisely the kind of dream which can convince young people of the value of pursuing careers in science.

Should there be a better dialogue between society and the chemical industry about the future?

The short answer is yes. Chemistry will be crucial in making our societies more sus-tainable. People are naturally concerned about new scientific breakthroughs which haven’t been tried and tested. It’s our job to demonstrate their value. We also need to address the NIMBY1 effect. You have to find a balance between the interests of the community and those of individuals. If you open a factory or put up windmills in a specific area, it might create some problems, but this is a price worth paying if it is in the interest of the general community.

The closing ceremony of the 2011 In-ternational Year of Chemistry which will take place on 1 December in Brussels will be an excellent opportunity to have an open and frank dialogue about the future of chemistry and its role in tackling the huge challenges facing us all. I hope that many of your readers will join us for what will be a truly exceptional day.

1 Not In My Backyard

Ernest Solvay (16 April 1838 - 26 May 1922)

physicists of the time as well as future Nobel laureates. In the same year, Solvay also supported the creation of the Interna-tional Association of Chemistry Societies. The association was the precedessor of IUPAC, the International Union of Pure and Applied Chemistry.

Ernest Solvay introduced the 19th century pensions for workers, an eight-hour work day and paid vacations, all innovations that were ahead of their time.

14 | ECHA nEwslEttEr № 2 | Apr | 2011

News from ECHAStakeholders

Adetailed agenda of the day is available on the ECHA web-site. The Sixth Stakeholders’ Day will begin at 8.30 a.m.

with registration and morning coffee fol-lowed by an opening speech by ECHA’s Executive Director, Geert Dancet. The programme will be split into three main sessions where the priorities for industry and ECHA in 2011 are reflected. The ses-sions focus on Registration, Authorisa-tion and Restriction; Downstream User Obligations; Evaluation and Dissemina-tion

During each session, there will be presentations given by both ECHA’s own staff and by external speakers. ECHA’s experts will cover the following topics:

REACH Deadline in 2013: the way •forward Authorisation and restriction: over-•view Notification of substances in arti-•cles Downstream user reports •Chesar, Chemical Safety Assess-•ment and Reporting tool: overview Public information on chemicals: •overview Feedback from Evaluation •

In addition to ECHA’s own speakers, the floor will also be taken by private chemi-cal companies, industry associations and NGOs who will share their experiences and advice on the aforementioned topi-cal issues.

The Eastman chemical company will reflect on its own experiences and best practice on SIEF formation, while the International Association for Soaps, Detergents and Maintenance Products

sixth stakeholders' Day

One-to-one sessions, interesting topics and training ECHA is inviting stakeholders, downstream users, public and private authorities, industry representatives and compa-nies to participate in the Agency’s largest annual event – the stakeholders’ Day. the event will take place at the Helsinki Exhibition and Conference Centre (Messukeskus) on 18 May 2011. ECHA has already received over 350 registrations for the event.

(AISE) is expected to share the industry perspective on downstream user obliga-tions. The NGO perspective on dissemi-nation will be presented by the Spanish Union Institute of Work, Environment and Health (ISTAS), and the European Coalition to End Animal Experiments (ECEAE) will share their concerns about animal welfare during the evaluation phase. Each plenary session will be fol-lowed by ample time for questions from the audience and answers by panel mem-bers. A comprehensive list of speakers with more detailed information about the topics of individual presentations and short biographies is available on the ECHA website.

One-to-one sessions offered

Participants of the Sixth Stakeholders' Day will have a chance to ask questions about both REACH and classification

and labelling issues in one-to-one ses-sions with ECHA staff members. The 20-minute one-to-one slots will take place during the afternoon, from 14:10 to 18:00, and will be allocated on a first-come first-served basis. Participants will be able to register for the sessions as part of their online registration for the event and also at the venue itself during the lunch and coffee breaks.Participants will also have the possibility to discuss their experiences and concerns during the informal session with ECHA staff at the end of the day.

For those unable to attend, a web-stream will be available live during the event. After the event, a recorded ver-sion of the plenary sessions will be ac-cessible on the ECHA website.

ECHA will draw on the expertise of both its staff and invited external speakers to deliver a high quality and informative Stakeholders' Day.

© ECHA

2011 | Apr | № 2 ECHA nEwslEttEr | 15

Stakeholders

December 2010Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.5: Adaptation of information require-ments (version 2)

http://guidance.echa.europa.eu/docs/guid-ance_document/information_requirements_en.htm?time=1302778425

Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8: Characterisation of dose [concentra-tion] – response for human health (version 2)

http://guidance.echa.europa.eu/docs/guid-ance_document/information_requirements_en.htm?time=1302778425

Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.18: Exposure scenario building and envi-ronmental release estimation for the waste life stage (version 2)

http://guidance.echa.europa.eu/docs/guid-ance_document/information_requirements_en.htm?time=1302778425

Guidance on intermediates (version 2)http://guidance.echa.europa.eu/docs/guidance_document/intermediates_en.htm?time=1302778527

Guidance on the communication of information on the risks and safe use of chemicals (new guidance)

http://guidance.echa.europa.eu/docs/guidance_document/risk_communications_en.htm?time=1302778580

January 2011

Guidance on the preparation of an application for authorisation (new guidance)

http://guidance.echa.europa.eu/docs/guid-ance_document/authorisation_application_en.htm?time=1302779025

Guidance on Socio-Economic Analysis – Authorisation (new guidance)

http://guidance.echa.europa.eu/docs/guidance_document/sea_authorisation_en.htm?time=1302779052

Corrigendum to the Guidance on registrationhttp://guidance.echa.europa.eu/docs/guidance_document/registration_en.htm?time=1302779079

April 2011

Guidance on requirements for substances in articles (version 2)http://guidance.echa.europa.eu/docs/guidance_document/articles_en.htm?time=1302779131

Guidance on labelling and packaging in accordance with Regu-lation (EC) No 1272/2008 (new guidance)

http://guidance.echa.europa.eu/docs/guidance_document/clp_labelling_en.htm?time=1302779155

Corrigendum to the Guidance on the application of the CLP criteria

http://guidance.echa.europa.eu/docs/guid-ance_document/clp_en.htm?time=1302779272

Guidance published after 1 December 2010

The Third Global Helsinki Chemicals Fo-rum brings together high-level speakers and panelists representing key stake-holders from around the world to discuss and contribute to global chemicals leg-islation and the competitiveness of the global chemical industry. The event will be held at the Helsinki Exhibition and Convention Centre on 19–20 May 2011.

The four panels of the Forum will discuss the greatest challenges facing the global chemical industry today, and a special focus will be put on the implementation of REACH. The topics are:

Helsinki Chemicals Forum 2011

Discussing global challenges and REACH

REACH Review – Making It Work •BetterRegulatory Information – Global •UseSustainable Chemistry – the Chal-•lenge for Industry and SocietyBioeconomy – Creating Global and •Local Opportunities

Participants of the ECHA Stakeholders' Day are entitled to a reduced attendance fee for the first day (19 May) of the HCF.

Final programme and online registration: www.helsinkicf.eu

Stakeholders

Great interest for training

The Sixth Stakeholders' Day will be pre-ceded by an in-depth training session on the Chemical Safety Assessment and Reporting tool (Chesar). This training session will be held on 17 May at ECHA. The training was initially open to all stakeholders interested in extending their understanding of the Chesar tool and the Chemical Safety Assessment (CSA) process it implements. However, as the maximum number of registra-tions for the Chesar training session has been reached, the online registration form is now closed. ECHA is consider-ing organising a similar training event at a later stage depending on the interest and feedback received.

The Sixth Stakeholders’ Day will be followed by the annual Helsinki Chemi-cals Forum (HCF). More information: http://echa.europa.eu/news/events_en.asp

© ECHA

16 | ECHA nEwslEttEr № 2 | Apr | 2011 2011 | FEB | № 1 ECHA nEwslEttEr | 16

Executive Office

new appointmentsNew Head of Human Resources▶ Shay O'Malley from Ireland joined ECHA at the beginning of March 2011. He has substantial experience in the fields of human resources and operational management, in both the public and private sectors, and possesses a number of profes-sional HR qualifications. Shay's most recent role was with the Irish telecommunications regulator, where he was Director of Retail and Consumer Services and where he was previously HR Director and Corporate Services Director. Shay has also worked with the European Community mission to the former Yugosla-via. He was also an officer in the Irish Defence Forces, where he served with the United Nations in Lebanon.

New Head of Management Information Systems▶ François Mestre from France joins ECHA as Head of Unit for Management Information Systems (I3). He has extensive expe-rience in both Information Systems and management within an international environment. He has worked for ten years for the French Treasury and Economic Policy General Directorate. Most recently Francois worked as Director of ICT at the Univer-sitad Autònoma de Madrid. His career has taken him to several destinations in Europe and South America.

New Head of Risk Management Implementation▶ Matti Vainio was appointed Head of Unit for Risk Manage-ment Implementation. He is Finnish and holds a Ph.D in eco-nomics. Before joining ECHA in 2007, he worked for ten years in the European Commission Directorate General for the Envi-ronment and Economic Affairs developing policies on air pol-lution and climate change issues. Earlier he worked in the UN on international trade policies, as a director/economist in two companies, project officer in the Finnish foreign ministry and a UN Volunteer in Zimbabwe.

© E

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© E

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© E

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Management Board

▶ ECHA's Management Board held its 21st meeting on 24-25 March 2011 in Helsinki. Among the topics discussed were me-dium-term strategy documents, such as the Multi-Annual Work Programme, Staff Policy Plan and evaluation planning. Staffing issues were also on the agenda, especially in relation to biocides.

Management Board members discussed extensively ECHA's future resource needs on biocides, stressing the need to ensure adequate staffing in order to meet the deadlines. They agreed that ECHA will start the first preparatory activities for biocides tasks on 1 April 2011, based on a Service Level Agreement with the Euro-pean Commission.

The further subsidy and staff needs for biocides in 2012-2012 are yet to be nego-tiated with the budgetary authority.

The Management Board approved the Agency's draft budget for 2012, which includes the establishment plan (staff numbers).

The draft budget for REACH and CLP will increase by € 2.8 million. It will be entirely financed by new fee revenue and the cash reserve of fee revenue from 2010. The budget includes a request for 20 additional temporary agent posts, mainly for evaluation, authorisation and scientific advice.

For biocides, € 1.9 million is budgeted to be entirely financed by subsidies. A request has been made for 30 temporary agent posts to build up capacity for en-try into operation by 1 January 2013. The budget for PIC (Prior Informed Consent) is € 1.4 million and foreseen to be entirely financed by subsidies. For the prepara-tory activity, four temporary agent posts have been requested.

The Board members adopted the Gen-eral Report 2010 and the analysis and assessment of the Executive Director's annual activity report. According to the

Opportunities to work at ECHAhttp://echa.europa.eu/opportunities_en.asp

2011 | Apr | № 2 ECHA nEwslEttEr | 17

Agency networking News from ECHA

ECHA's draft Multi-Annual Work Programme 2012-2014 presents an overview of the

Agency's planned activities during an important three-year period. In his in-troduction, Executive Director Geert Dancet states that ECHA will need to manage a wider range of new tasks than ever.

“It is the first Multi-Annual Work Pro-gramme in which ECHA will operate in all areas of its enlarged responsibilities covering Registration, Evaluation, Au-thorisation, Restriction, Classification and Labelling as well as managing Bio-cides and PIC. This represents a tremen-dous challenge for us,” he writes.

The Executive Director is however con-fident that with the support of the Man-agement Board, the European Com-mission, the Member States and the stakeholders and with the continued hard work of the staff, ECHA will again reach its goals and be able to provide the services required.

Biocides and PIC possibly in 2013

The Commission has proposed a new Regulation concerning the placing on the market and use of biocidal products, according to which ECHA would review the applications for their authorisation.This work could start in 2013.

If ECHA receives additional funding for this purpose prior to the entry into force

Your opinion on ECHA's Multi-annual work programme 2012-2014 ECHA would be happy to hear your opinion on its draft Multi-Annual work programme 2012-2014 and its revised mission, vision and values.

of the Regulation, it can start the neces-sary recruitment procedures, adjusting of its IT tools and building up of exper-tise from 2011.

Some tasks contained within the so-called PIC Regulation concerning the ex-port and import of dangerous chemicals may be transferred to ECHA as of 2013, and it is expected that ECHA will pro-vide the Commission, on request, with technical and scientific input and assist-ance. ECHA would like to start with PIC preparations before the entry into force of the revised legislation, provided that additional funding is made available.

Readers are invited to express their opin-ion on ECHA's new mission, vision and values.

“We very much welcome your continued interest in our work and, in that spirit, would appreciate your feedback on this Multi-Annual Work Programme,” writes Mr Dancet in his overview.

Draft Multiannual Work Plan 2012-2014http://echa.europa.eu/doc/work_pro-gramme/2012_2014/FINAL_MB_07_2011_DRAFT_MAWP_2012_2014.pdf

Submit your opinion at:http://echa.europa.eu/forms/form_wk_prog_2012_2014/form_wk_prog_2012_2014_en.asp

assessment, the Agency managed the challenges of 2010 extremely well. The Management Board also congratulated ECHA staff for their successful operations related to the first registration deadline, the development of IT and communica-tion tools, the support given to regis-trants, the building up of dissemination and evaluation tasks and the high qual-ity of the Agency's scientific advice and opinions.

The ambitious Multi-Annual Work pro-gramme 2012-2014 was endorsed and will be submitted for public consultation (see news on the right). The Board also adopted the multi-annual staff policy plan 2012-2014.

The Management Board was informed about ECHA's evaluation plans and had an animated discussion about the heavy workload for both ECHA and the Mem-ber States. Several new RAC and SEAC members were appointed and some mandates renewed. The Board had a long discussion about the growing work-load of the Committees. It supported a package of efficiency improvement measures, which will be submitted to the Committees for their consideration.

Guidance procedure and the dissemina-tion of information on registered sub-stances were also discussed. The Board approved a proposal to organise a first planning meeting with the Directors of the Competent Authorities at ECHA in December 2011.

The next Management Board meeting will take place on 21-22 June in Helsinki.

18 | ECHA nEwslEttEr № 1 | FEB | 2011

Interview

Adequate risk management makes rEACH successful

Mr Bruijn, what is vital for good risk management under REACH?

Jack de Bruijn: Risk management un-der REACH includes both the tasks that industry has and regulatory risk management by authorities. The latter should actually serve as a safety net. Industry is responsible for gathering information on their chemicals in a systematic and structured way and for registering them, but also in particu-lar for risk management on their site and providing the right safety advice to downstream users. So they have to demonstrate that they can properly manage their chemicals. A relatively small but important part of our activi-ties are related to that, and our Directo-rate will try to provide further support to industry in the coming years.

How can ECHA support industry risk management?

Exposure scenarios are a major new element of risk management under REACH. They are delivered with the safety data sheets to customers and they describe the correct operational conditions; how to use the chemical; under which conditions and with what kind of risk management measures. If we look at how REACH should be implemented, in my view we could pay more attention to how industry is implementing exposure scenarios be-cause that is what professional users of chemicals will be confronted with.

the Director for risk Management at ECHA, Jack de Bruijn; Elina Karhu, Head of ECHA's new risk Management Identification Unit and Matti Vainio, Head of the new risk Management Implementation Unit discussed with the ECHA newsletter questions related to regulatory and industry risk management.

It is particularly the implementation of the exposure scenarios that industry is struggling with at the moment. This dif-ficulty is partly related to the fact that no standardised mechanism exists yet. ECHA has provided a lot of guidance and information on exposure scenarios, but we will indeed have to engage with industry more to support their imple-mentation. We could think of a series of regular meetings and workshops. Industry has also already started to pre-pare examples of exposure scenarios. One example which we developed last year together with the semiconductor industry is available on our website.

Exposure scenarios can have a major impact on how downstream user com-panies handle chemicals, because it is the workers, also within smaller scale industries, who are exposed to chemi-cals. Downstream users take decisions on which substances they include in their formulations and about how and with which substances or formulations they treat the final articles.

This part is very important in terms of risk management, and if that is im-plemented well under REACH, we can potentially have a huge effect on safety down the supply chain and in the wider use of chemicals in Europe.

Matti Vainio: Here is a paradox. We do not see the many changes in order to manage risks that users of chemicals make due to REACH. Such information does not come to the press. These small changes are happening at company

level. They are not actually communi-cated anywhere. They just happen as a result of better information. However, if this evolution takes place well, these dispersed risk reductions will result in important environmental and public health improvements in Europe.

Jack de Bruijn: Through REACH we will also have a lot of information on registered substances and the Classi-fication and Labelling Inventory with information about the classification of chemicals. If downstream users would like to replace their substance, they can search for a less hazardous one.

“If we look at how REACH should be

implemented, in my view we could

pay more attention to how industry is implementing

exposure scenarios because that is what

professional users of chemicals will be

confronted with.”Jack de Bruijn

2011 | Apr | № 2 ECHA nEwslEttEr | 19

Jack de Bruijn, Matti Vainio and Elina Karhu stress the importance of good risk management of chemicals.

© ECHA

Interview

How is the situation with chemical safety assessment?

Jack de Bruijn: Chemical safety assess-ment - risk assessment in the past - can be complicated, but it really depends on the case, the information you have to assess, on the information relating to the use(s) of the substances that is available and on what kind of model-ling you need to do.

Under REACH, manufacturers and im-porters with a volume from 10 tonnes upwards must do a chemical safety as-sessment, which means that a lot more companies are probably now involved and need more expertise and data gath-ering. It is definitely an expert task. It is a skill and often needs experienced people to perform it. Also the question related to environmental and human health risk assessments may be differ-ent in nature.

Elina Karhu: On the other hand it is good to remember that there are dif-ferent cases. In some the assessment is really scientifically difficult. We nor-mally concentrate on those cases. But then there are a lot of standard cases where the science may not be so com-plicated. It is more a question of peo-ple understanding the system: How to use the information to identify correct risk management measures and how to document and communicate these measures in a clear way. I would claim that for the majority of the chemicals and uses a standard chemical safety assessment and good quality exposure scenarios can already make a differ-ence to the level of human health and environmental protection.

When is regulatory risk management needed?

Jack de Bruijn: The main part of the activities of our Directorate relate to regulatory risk management activities which implies setting up and imple-menting restriction and authorisation

and also classification and labelling processes. They are actions taken by the authorities, either Member States or ECHA on request by the Commission, to actually deal with specific chemicals for which we believe there is regulatory action needed.

What we have been particularly pro-moting is that authorities who want to take action to cover a concern for a chemical carefully choose the instru-ment. Should the substance be put on the Candidate List and do they want to have it under authorisation or would they prefer a restriction? Or would Candidate Listing followed by specific restrictions be most effective? Or would there be some other kind of (Commu-nity) regulatory measures which would better achieve the regulatory goals?

Elina Karhu: If authorities identify a concern and start thinking of regulato-ry action, then we are normally past the

phase when industry could themselves implement better exposure scenarios in their registration. But REACH gives both a framework and the possibility for industry to systematically docu-ment what risk management measures at company level they are implement-ing and recommending in their supply chain, to document that and to show that the risks are adequately controlled. Compared to the past this information will be an important new source for authorities to identify possible cases where risks are not adequately control-led.

An example could be where for one company and their tonnages and iden-tified uses the situation is OK but when looking at all uses across different reg-istrants, there starts to be a problem, for instance for the environment. In such cases there might be a need to start reg-ulatory action by authorities who then need to select the best risk management instrument for the action.

20 | ECHA nEwslEttEr № 2 | Apr | 2011

How are the problematic cases found?

Jack de Bruijn: There is always some in-formation here and some ideas and sus-picions there, but experience from the past has taught us that very often there is not good coverage of how industry is actually using certain chemicals. The situation is of course improving now we have registration dossiers for a large number of important substances but I expect that we will still not have the full picture of what is happening.

We have now at least for quite a number of chemicals the real contact details of all the manufacturing and import-ing companies. Earlier, it was always a problem getting the right informa-tion, getting the context and knowing who was actually doing what. Still we are only talking about manufactur-ers and importers, not about all the downstream users who directly use the chemicals.

Now REACH risk management is work-ing and there will be reactions to it. How do you react to possible negative reactions?

Jack de Bruijn: It is important that we at ECHA carefully follow the relevant consultation procedures and try to en-

sure that everyone who potentially has something to say on a specific dossier is being heard. As we deal with issues which in the end have either an eco-nomic, public or another kind of effect or interest, there will always be people challenging us. I am not afraid of that at all as I am confident that we will be able to explain properly what we are doing and why we are doing it.

The stakeholders are of course very im-portant, and we try to keep everybody informed and involved. However, it is in the end our own decision or opinion making that counts. We need to ensure that this fits the needs and interests of our clients. At least in our work area, the Commission is often our direct cli-ent and they have to get results which they can easily use to propose final de-cisions on regulatory risk management measures.

Matti Vainio: The procedure for for-mulating opinions on proposed restric-tions was developed ex ante, based on the REACH Regulation. We can now start seeing how the regulatory risk management process is working in practice as ECHA’s committees are for-mulating their opinions. We are learn-ing from this process and will adapt so

that we can provide a better service to our customers.

***

In the May issue: Jack de Bruijn, Elina karhu and Matti Vainio on authorisation, restrictions and new developments.

In your language!

ECHA wants to both reach and support our stakeholders across Europe by pro-ducing the information regarded as the most useful and user-friendly in 22 offi-cial languages of the EU. At the moment, you can already access more than 4000 pages of material in your own language. We are continuously translating more, so consult ECHA’s website regularly to find the latest!

Bulgarian • Czech • Danish • Dutch • Estonian • English • Finnish • French • German • Greek • Hungarian • Italian

• Latvian • Lithuanian • Maltese • Polish • Portuguese • Romanian •

Slovakian • Slovenian • Spanish • Swedish

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Interview

2011 | Apr | № 2 ECHA nEwslEttEr | 21

News from ECHA

survey on secretariat services to the Committee & Forum members and observers

Members, stakeholders and Commission observers of the three ECHA com-

mittees – RAC, SEAC, MSC and the Forum, were invited to evaluate the work of the Secretariat. Respondents were asked to provide their feedback on two broad areas of activity: 1) practical issues relating to how the meetings are run and 2) Committee and Forum-specific aspects relating to the REACH and CLP processes. In the following interview, Steve Hollins, a Senior Sci-entific Officer in the Secretariat of the Committees Unit, answers questions about the outcome of the survey.

Steve, are there any surprising results in comparison to last year’s survey?

We carried out the last annual survey in 2009, which was in the very early days of the Committees’ functioning. This was the second survey and both last year’s and this year’s survey results showed a very high level of satisfac-tion on almost all the issues we asked about from the members, stakeholders and the Commission observers of the Committees and the Forum. We are of course delighted with these results.

Which are the priority areas for the Committee and Forum Secretariat in 2011?

Notwithstanding the high level of sat-isfaction overall, there were some re-curring themes in the survey which we will work on to continue to improve the quality of the service we provide for our members. One issue is the question of the visibility of the Committees and the Forum and how members and other interested parties can find out what we are doing. This was particularly the case in relation to finding us on the ECHA website. Previously, you had to click seven times on the website to get to one of the Committees, so even our own members couldn’t find us. Now, on the right hand-side of the ECHA website homepage, we have a direct link to each of the Committees.

The second thing we need to ensure is that we run our meetings in the most efficient way possible. The Committees have a huge workload at the moment, which is getting bigger and bigger. For example, our members are really keen

that we don’t spend unnecessary time in meetings talking about administra-tive issues. They want us to focus on the core work – scientific discussions on the REACH and CLP processes and the dossiers associated with them. There-fore, we will be making a big effort this year to try to make everything work as efficiently as possible.

The third area we need to look at in more detail is in relation to stakehold-ers. The stakeholders play an important role in the work of the Committees. They make sure that we have transpar-ency in what we do and they provide valuable scientific and technical input into the discussions. However, some stakeholders expressed concern in the survey that their level of involvement in the proceedings of meetings was not yet adequate. So, this year we will be exploring ways in which to maximise the involvement and value of our stake-holders’ contributions.

How about the general working condi-tions of the Committees, for example as regards the support by the Member States or extra time requirements?

This year and forthcoming years are set to see significant rises in the workloads of all the Committees and the Forum. To meet this challenge it is important that Member States give adequate sup-port to the members of the Committees and Forum so that they can carry out their roles most effectively. We see the successful functioning of the REACH and the CLP processes as being un-derpinned by successful collaboration between ECHA, the Member States and the Commission.

the Committee and Forum secretariat of the European Chemicals Agency (ECHA) has carried out a satisfaction survey on how the members and observers feel about the services of the secretariat.

Mr Steve Hollins says that the Commit-tee and Forum Secretariat will continue to improve their services to both the members and observers.

© ECHA

22 | ECHA nEwslEttEr № 2 | Apr | 2011

News from ECHA

Although it is clear to all REACH and CLP players that goals can only be achieved if their ac-tions are coupled with strong

and coordinated enforcement efforts, it is much less obvious how they can set up effective channels of information and communication among themselves to serve the practical needs of the national inspectors.

The scenario is somewhat complex because ECHA, the Member State Com-petent Authorities and the European Commission mainly focus on regulatory decision-making and on policies, while the daily work of national inspectors con-sists of verifying on-site conditions on the basis of the information provided by industry to ECHA. Fostering interlinks by defining procedures, responsibilities

A new Forum working group will look at interlinks between ECHA, Member state Competent Authorities and national Enforcement Authorities.

Interlinking is crucial to the rEACH and Clp Enforcement strategy

and roles as well as arranging appropriate communication channels among such different actors are pivotal to assuring effective enforcement.

As the Forum is due to publish a posi-tion paper on these issues by the end of 2011, a Forum Working Group (WG) has been set up with the mandate of drafting a document on the interlinks which will open the floor for discussions ideally during the Forum plenary meeting in October 2011.

“We have established an action plan and we intend to set up a pilot project to make use of all our knowledge and expe-rience on our information flow. Our first objective is to describe some procedures to facilitate the future work of inspec-tors,” says Mihaela Albulescu, the WG’s chair. “The expected impact of the WG

activities will also have beneficial effects at the national level,” she remarked dur-ing the kick-off meeting at ECHA at the beginning of January.

“I expect that the output of this work-ing group will smoothen and facilitate the flow of information within Member States. Special attention will be paid to those cases where competent and en-forcement authorities are managed sepa-rately and the flow of information needs to be enhanced to ensure efficient inspec-tion activities,” explains Ms Albulescu. She says that ECHA and the European Commission have also manifested a lot of interest in the project.

Ms. Albulescu sees three challeng-es ahead: to develop common working methods, to improve the tools for in-spectors and finally to keep all the actors involved in the enforcement process up-dated and informed.

“I accepted the chair of the WG

with enthusiasm; I consider it a

very important project for many

authorities. It will make our work

more coherent and efficient.”

Chair Mihaela Albulescu and Ulrike Kowalski from ECHA talk during the Working Group meeting in mid January.

Mihaela Albulescu© ECHA

2011 | Apr | № 2 ECHA nEwslEttEr | 23

Registered Disseminated

SUBSTANCES

Phase-in* 3 400 3 079 (91 %)

Non-phase-in 1 300 332 (26 %)

Total substances 4 700 3 411 (73 %)

DOSSIERS

Lead 2 969 2 734 (92 %)

Member 19 817 2 (0 %)

Individual 2 337 1 030 (44 %)

Total dossiers 25 123 3 766 (15 %)

Dissemination

Making information on the chemicals registered publicly available

ECHA works continuously to develop the dissemination procedure in order to ensure that information from registra-tion dossiers is available for the public as quicky as possible. However, while disseminating as much information as possible, ECHA always needs to consider the confidential information in the dos-siers and ensure that this confidentiality is respected. Another part of the process involves assessing any confidentiality claims made by companies to ensure that they are adequately justified.

The IUCLID dissemination plug-in is a useful tool to check beforehand what information of the dossier will be dis-seminated. The plug-in can be down-loaded from the IUCLID website at http://iuclid.echa.europa.eu

73 % of all registered substances have been disseminated by 27 April 2011. This re-sults in 3 411 disseminated substances and 3 766 disseminated dossiers. For now the priority for dissemination has been on the lead dossiers and invidual sub-missions received in the context of the 2010 registration deadline, of which 91% are disseminated. Dissemination of the member dossiers will follow.

Dossiers that represent Substances of Very High Concern (SVHC) or include testing proposals have been prioritised in the dissemination. One reason for this is to faciliate public consultation. At the moment the dissemination is done in EC-number order and a new batch of ap-proximately 1 000 dossiers is being made available every two weeks on the ECHA website, with the time in between being spent preparing quality and checking the batches.

Dissemination Progresss

Data as of 27 April 2011.

* phase-in

substances subject to transitional arangements in the REACH registration

Balancing beween a citizen's right to know and a company's right to protect confidential business information.

More information on dissemination and confidentiality claims can be found in the following Data Submission Manuals:

▶ Data Submission Manual Part 15: How to determine what will be published on the ECHA website from the registration dossierhttp://echa.europa.eu/doc/reachit/dsm_15_dissemination_manual.pdf

▶ Data Submission Manual Part 16: Confidentiality Claimshttp://echa.europa.eu/doc/reachit/dsm_16_confidentiality_claims.pdf

▶ Data Submission Manual Part 17: How to derive a Public Name for a substance for use under the REACH Regulationhttp://echa.europa.eu/doc/reachit/dsm17/dsm17_public_name_en.pdf

Information on registered substances can be found on the ECHA website http://apps.echa.europa.eu/registered/registered-sub.aspx

24 | ECHA nEwslEttEr № 2 | Apr | 2011

B. Compliance check: dossiers and output processed between 1 June 2008 and 31 March 2011.

Evaluation Statistics

Phase-in* Non phase-in Total

No of registered dossiers 1

Containing testing proposals

538 35 573

Containing testing proposal for vertebrate animals

404 25 429

No of endpoints

Covered by registered testing proposals

1 090 72 1 162

Covered by registered testing proposals for vertebrate animals

667 42 709

No of third party consultations

Closed 32 18 50Ongoing 31 March 2011 17 2 19

Planned 355 5 360Dossiers with testing proposals opened for examination 2

146 31 177

Draft Decisions sent to the registrant 3 6 15 21Final Decisions sent to the registrant 0 6 6Terminated testing proposal examinations 4 1 3 4

A. Testing proposals: dossiers received and output processed between 1 June 2008 and 31 March 2011.

Phase-in* Non phase-in Total

No of dossiers opened for compliance check 1 105 123 228

Draft Decisions sent to the registrant 2 9 28 37Final Decisions sent to the registrant 4 14 18Quality Observation Letters sent to the registrant 3

11 34 45

Terminated compliance checks 4 5 31 36

1 Dossiers ever opened for compliance check notwithstanding their current status.2 Draft decisions which had not become final by 31 March 2011. 3 Some quality observation letters have been sent together with draft decisions.4 Terminated upon further information being provided by the registrant or terminated without administrative action.

1 Successfully registered (accepted and fee paid).2 Dossiers ever opened for examination notwithstanding their current status3 Draft decisions which did not become final by 31 March nor withdrawn due to termination of TPE.4 Terminated at the decision-making stage upon further information provided by the registrant (e.g. cease of manufacture, tonnage downgrade or withdrawal of a testing proposal).

▶ Dossier evaluation covers compliance checks of registration dossiers and examinations of testing proposals. In the examination of testing proposals, all dossiers containing proposals for higher-tier testing, including testing on animals are evaluated. The aim is to check that tests are justified and adequate, thereby avoiding unnecessary animal testing. Testing proposals that involve tests on vertebrate animals are pub-lished on ECHA's website and third parties are invited to provide scientifically valid information. The compliance check determines whether or not the information submitted is in compliance with the REACH information requirements. At least 5 % of the dossiers received by ECHA per tonnage band are compliance checked. Details of the REACH dossier evaluation processes and their results can be found in the annual progress report on evaluation at http://echa.europa.eu/doc/evaluation_under_reach_progress_report_2010.pdf .

Tables A and B report on the statistics of the dossier evaluation processes from 1 June 2008 to 31 March 2011. The phase-in status is reported as indicated by the registrant in the dossier and this may have changed when the dossier has been updated. The dossier updates may also have testing proposals withdrawn or new ones submitted.

* phase-in

substances subject to transitional arangements in the REACH registration