echa newsletter · 2012-12-07 · echa newsletter 3 on 28 october 2008, echa published on its...

8
In this issue page Editorial 1 From the Executive Office 2 News from ECHA 2 Agency Bodies 4 Interview 4 IT tools and Guidance 6 Stakeholders 6 Statistics 7 Living in Helsinki 8 Editorial No 1 - January/February 2009 Newsletter ECHA ECHA-09-NL-01 Winter scenery in Helsinki. Photo by ECHA Communications ECHA is still growing rapidly and developing procedures as new REACH tasks come on stream to build on the achievements of our first year of operation. Registration will begin in earnest later this year in advance of the 2010 deadline, so ad- ditional scientists are being recruited and trained and the working procedures and IT tools are being finalised for the dossier compliance and completeness checks. The first substances of very high concern will enter the process for authorisation this year by being listed on the authorisation list after public consultation. More will follow. The system for substances to be nominated for possible restriction begins operating from 1 June. Similarly there are dossiers for harmonised EU classification of substances caught in the old process for the ECHA scientific committees to co-ordinate. The work on classifi- cation is extended due to the new Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation, and now ECHA has obligations under this new legislation. The central challenges detailed in the 2009 Work Programme are: - Confirm our reputation for timely, science-based decisions and opinions. - Prepare for the registration and authorisation work. - Build our capacity to evaluate dossiers and substances. - Become an international authority on information on chemicals, open to the public. To these ends there are detailed management objectives and priorities with an agency budget, and detailed contingency plans as an institutional risk management exercise. We look forward to working with industry and other stakeholders in successfully operating REACH in 2009. Geert Dancet

Upload: others

Post on 25-Jul-2020

5 views

Category:

Documents


0 download

TRANSCRIPT

In this issue page

Editorial 1

From the Executive Office 2

News from ECHA 2

Agency Bodies 4

Interview 4

IT tools and Guidance 6

Stakeholders 6

Statistics 7

Living in Helsinki 8

Editorial No 1 - January/February 2009

NewsletterECHA

ECHA-09-NL-01

Winter scenery in Helsinki. Photo by ECHA Communications

ECHA is still growing rapidly and developing procedures as new REACH tasks come on stream to build on the achievements of our first year of operation.

Registration will begin in earnest later this year in advance of the 2010 deadline, so ad-ditional scientists are being recruited and trained and the working procedures and IT tools are being finalised for the dossier compliance and completeness checks.

The first substances of very high concern will enter the process for authorisation this year by being listed on the authorisation list after public consultation. More will follow. The system for substances to be nominated for possible restriction begins operating from 1 June. Similarly there are dossiers for harmonised EU classification of substances caught in the old process for the ECHA scientific committees to co-ordinate. The work on classifi-cation is extended due to the new Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation, and now ECHA has obligations under this new legislation.

The central challenges detailed in the 2009 Work Programme are:- Confirm our reputation for timely, science-based decisions and opinions.- Prepare for the registration and authorisation work.- Build our capacity to evaluate dossiers and substances.- Become an international authority on information on chemicals, open to the public.

To these ends there are detailed management objectives and priorities with an agency budget, and detailed contingency plans as an institutional risk management exercise.

We look forward to working with industry and other stakeholders in successfully operating REACH in 2009.

Geert Dancet

From the Executive Office

ECHA Newsletter 2

News from ECHA

Nomination news

Database for experts - follow-up

Member State Competent Authorities and stakeholder organisations have been in-vited to indicate names of suitable experts to ECHA. On this basis an expert data base is being prepared. The data base functions as a source of experts that can support the work of the Agency, by participating for example in partner expert groups as foreseen in the guidance to update procedure or supporting the work of the Committees and the Forum. Fifteen out of the 27 Member States have so far nominated in total 341 experts. ECHA has received a total of 362 expert nominations from 29 of the 40 stakeholder organisations. There were about 10 % double nominations. These experts have subsequently been in-vited to provide detailed information on their expertise via a webform on the ECHA website http://echa.europa.eu/opportunities/stakeholdercallform_en.asp.

From the 640 experts nominated so far 150 ex-perts were registered in the ECHA database. The database will be open for new experts at any time. Remuneration of experts is judged against consistency with the principles of economy, efficiency and effectiveness and with the principles of sound financial management. More details on such remuneration are provid-ed in the document “Rules for the Remunera-tion of Experts” (MB/77/2008) which was ad-opted by the Management Board in December.

The ECHA Management Board saw a number of changes to its composition in December 2008.

Ms Pirkko Kivelä (Finnish member) will re-place Mr Jukka Malm, Mr Armands Plãete (Latvian member) will take the place of Ms Ilze Kirstuka and Ms Maria Fernanda Santiago (Portuguese member) will replace Mr António Nuno Fernandes Gonçalves Henriques.

Mr Martin Fuehr is nominated by the Com-mission to represent interested parties.

Moreover, Ms Anne Beate Tangen was nomi-nated as observer for Norway and Ms Kristin Rannveig-Snorradottir as observer for Iceland.

The CV of the new members and observ-ers will be available on the ECHA web page.

New Members of the Management Board

ECHA has decided to prolong the deadline for submitting comments on it’s first multi-annual work programme until 27 February 2009 and reiterates its invitation to all stakeholder to actively contribute. The document and a web form for submitting comments can be found at http://echa.europa.eu/publications_en.asp.

Consultation on the Multi-Annual Work Programme prolonged

ECHA’s Management Board adopted at its meeting in December 2008 the first an-nual ECHA Work Plan for International Ac-tivities. The objective of ECHA's work in this field is to provide the Commission with scientific and technical support in its inter-national activities. Therefore ECHA's inter-national work is based on the obligations assigned to it by legislation, focusing on is-sues which concern scientific and technical harmonisation, as well as contributing to in-creased knowledge on REACH worldwide.

In 2009, ECHA will give priority to: activities that develop international standards which can be directly applied for the implementation of REACH (in particular OECD activities); ac-tivities which directly support the understand-ing of the implementation of REACH in third countries; international activities which assess

Mr Henricus (Harry) Spaas is nominated as the technical mem-ber of the Board of Appeal, where he is especially looking af-ter the technical as-pects of appeal cases.

He previously worked many years and in various positions

with the Dow Chemi-cal Company in multiple European coun-tries, most recently in Switzerland as direc-tor for Environment, Health & Safety Affairs.

Nomination in the Board of Appeal

Management Board adopts work plan for ECHA’s internationalactivities

chemicals falling within the scope of REACH; and activities which exchange practical expe-rience between the ECHA and similar agen-cies in third countries, bi- or multilaterally.

Another important part of the work is support-ing candidate countries and potential candi-dates in their efforts to implement REACH and to prepare them for taking part in the activities of ECHA. The intensity of ECHA’s relations with such third countries will have to be closely synchronised with progress made by that country in aligning with Community legislation, policies and practices for the implementation of the REACH Regulation.

For more details please see ECHA website: http://echa.europa.eu/about/organisation/management_board_en.asp

The Executive Director has appoint-ed Mr Finn Pedersen as the Head of Unit for the new unit B3 - Classification.

Finn is a Danish ecotoxi-cologist who has been working in ECHA as Se-nior Scientific Officer and Team Leader in Director-ate B since January 2008. Previously he has worked for the Environmental Protection Agency of Den-mark, the Danish consul-

tancy company DHI, and DG Environment of the European Commission.

Formation of Substance Information Exchange Forums (SIEFs)SIEF members have to agree upon their membership, and the roles that their mem-bers will play – gathering information and preparing registration dossiers for submis-sion among them. The Agency does not have

ECHA interacts with international parties e.g. during stakeholders’ days. Photo taken at ECHA’s First Stakeholders’ Day in October 2008 by ECHA Communications.

a role in setting up or managing SIEFs, al-though it is keen to ensure that SIEFs share best practice in solving their problems.

The Agency will be alert to the problems

ECHA Newsletter 3

On 28 October 2008, ECHA published on its website the so-called Candidate List, a list of Substances of Very High Concern which may become subject to Authorisa-tion. The list will be regularly updated when further substances are identified as Sub-stances of Very High Concern (“SVHC”s).

The publication of the Candidate List trig-gered new legal obligations for compa-nies. They need to provide information to recipients and to ECHA about the SVHCs in substances, preparations and articles, in accordance with the requirements and timelines set by the REACH Regulation.

Information for safe use

Since 28 October 2008 EU & EEA suppliers of articles which contain substances on the Candidate List in a concentration above 0.1% (w/w, weight by weight) must provide informa-tion (available to them) to their customers and on request to a consumer within 45 days of the receipt of this request. This information must enable the safe use of the article and, as a minimum, include the name of the substance.

From 2011, EU and EEA producers or import-ers of articles will have to notify ECHA if their article contains a substance on the Candidate List. This obligation applies if the substance is present above 0.1% (w/w) and its quantities in the produced/imported articles are above

The new Regulation (EC) No 1272/2008 on Classification, Label-ling and Packaging of Substances and Mixtures (CLP Regulation)

The new CLP Regulation entered into force 20 January 2009. This regulation is supple-menting REACH. According to these two reg-ulations, ECHA will have the following tasks:

> Managing the proposals for harmonisation of Classification & Labelling (C&L) made by Member State Competent Authority or industry, including submitting a scientific opinion to the Commission on the proposal> Managing the C&L inventory including the list of harmonised C&L> Providing guidance to industry and Member States> Providing support to the helpdesks estab-lished by Member States> Handling requests for use of an alternative name of substances in mixtures

ECHA is currently preparing for these tasks and is looking forward to a smooth cooperation with Member States and industry.

Consultations on substances for authorisation

On 14 January 2009, ECHA invited inter-ested parties to submit comments on the first draft recommendation for prioritised sub-stances by 14 April 2009. ECHA would also like to receive comments on the general ap-proach developed for the priority setting.

The comments are expected to be relevant and with a sound scientific basis. They will provide support to the Member State Committee which will give its opinion to ECHA for the final recom-mendation. By 1 June 2009, ECHA will send to the European Commission a recommenda-tion on substances that should be included in the Authorisation List. The final decision on the inclusion of substances in the Autho-risation List will be taken by the Commission.

The consultation is part of the authorisation process under REACH. The main objective is to obtain additional information on the sub-stances proposed for inclusion in the Autho-risation List (Annex XIV), especially on their uses, on exposure to them and releases but also on the availability of alternative substanc-es in the various processes. See also page 4.

Consultation section: http://echa.europa.eu/consultations/autho-risation/draft_recommendations_en.asp

Review of the Guidance on requirements for substances in articles

The Guidance on requirements for substances in articles assists REACH actors in deciding whether they are manufacturers or importers of substances (on their own or in preparations) or suppliers of articles and helps article sup-pliers to comply with the requirements under REACH related to substances in their articles.

ECHA initiated a study on reviewing this guidance last year in order to identify any elements that need updating. To this end, ECHA launched a call for tender on 17 No-vember 2008. The work has started and it is expected to be completed this autumn.

The study will focus on scientific and technical aspects and on shortcomings in the current guidance that were identified during the finali-sation of the document. It will in particular fo-cus on the workability and practicalities of the application of the 0.1% threshold for the noti-fication and communication obligations under Articles 7(2) and 33 of the REACH Regulation. The current guidance document states that the 0.1% threshold applies to the ar-

ticle as produced/imported. However, six EU Member States have informed ECHA that according to their view, the 0.1% threshold should apply to components or homogeneous parts of the articles.ECHA has published the comments of Aus-tria, Belgium, Denmark, France, Germany and Sweden on its website under http://guidance.echa.europa.eu/docs/ guidance_document/dissenting_en.pdf.

We recommend that companies con-sult the websites of the enforcement au-thorities of these EU Member States to be sure about exactly how the informa-tion requirements for substances in ar-ticles will be enforced by the authorities. The guidance review process will be managed in an open and transparent way, so that all interested parties can take account of the re-sults and duplication of work can be avoided.

More information:http://guidance.echa.europa.eu/docs/guidance_document/articles_en.pdf

1 tonne in total per year per company. REACH requires that for substances included in the Candidate List before 1 December 2010, the notifications have to be submitted not later than 1 June 2011, and for substances included in the Candidate List on or after 1 December 2010, the notifications have to be submitted no later than 6 months after the date of inclusion.

As explained in the Newsletter article on the review of the guidance on requirements for substances in articles companies should be aware that differing views with regard to the ap-plication of the 0.1 % threshold on articles have been expressed by six EU Member States.

Since the publication of the Candidate List, EU & EEA suppliers of a substance have to provide a safety data sheet to their cus-tomers if the substance is on the Candidate List. EU and EEA suppliers of a preparation not classified as dangerous according to Di-rective 1999/45/EC have to provide the re-cipients, at their request, with a safety data sheet, if the preparation contains at least one substance on the Candidate List and its in-dividual concentration is at least 0.1% (w/w) for non gaseous preparations and at least 0.2% by volume for gaseous preparations.

More information: http://echa.europa.eu/chem_data/candidate_list_en.asp

Obligations for companies regarding Substances of Very High Concern

raised during SIEF development in so far as our legal position allows, and to provide the opportunity for discussion in our meet-ings with industry stakeholders. The key principles of SIEF formation are given in an ECHA News Alert to be published shortly.

Substance Information Exchange Fora, are intended to ensure that companies that

pre-registered the same substance share the data that they have on their substances and minimise the need for further animal testing. The very large number of pre-reg-istrations (ca 2 750 000 on ca 146000 sub-stances) has in turn led to some very large SIEFs; 140 have over 1000 members, 3500 over 100 members. Most of these are ex-pected to submit their registrations in 2010.

Interview: Jukka Malm, Director of Assessment

ECHA Newsletter 4

Agency BodiesForum for Exchange of Information on Enforcement

The pre-registration of phase-in chemicals, i.e. most of the substances which were on the EU market before entry into force of REACH in 2007, is now over, and ECHA is getting ready for the arrival of the great bulk of regis-tration dossiers in the next few years.

Jukka Malm leads the Directorate in ECHA which performs the scientific evaluation of the registration dossiers and will be extremely busy when large numbers of registration dos-siers arrive before the first deadline in 2010. The Directorate has many scientific tasks and is an important centre of competence where scientific decisions and proposals of ECHA are prepared.

“On the basis of our evaluation of the dos-siers, we prepare the draft decisions of ECHA which are then presented to the Member

ECHA Directorate of Assessment is responsible for the scientific and technical tasks re-lated to key operations of the Agency. The Directorate is still building up its capacity and will recruit and train large numbers of scientists this year. Jukka Malm, Director of Assess-ment, is confident: the start of ECHA was positive and the preparations are on schedule.

ECHA is preparing to prioritise 7 substances from the candidate list for the draft recommen-dation of the ”authorisation list” (Annex XIV of the REACH Regulation). Priority should nor-mally be given to substances with PBT (Per-sistent, Bioaccumulative and Toxic) or vPvB (Very Persistent and Very Bioaccumulative) properties or wide dispersive use or high vol-umes. Due to lack of robust information on re-leases and uses ECHA has applied the criteria mostly in a qualitative way. The combination of all available information has been used as a proxy for potential risk to human health or the environment: the higher hazard, the volume used and the potential for release of a sub-stance, the higher potential risk and thereby the priority of the substance for authorisation.

Consultation of the Member State Committee

ECHA’s pragmatic approach on prioritisation of substances for the “authorisation list” was generally well received by the Member State Committee in its meeting in December 2008. The Member State Committee appointed a rapporteur to draft the Committee’s opinion on ECHA’s draft recommendation for the “authori-sation list”. The opinion of the Member States Committee on the recommendation will be ad-opted in the Committee’s meeting in May 2009.

Rationale for ECHA’s draft recommendation for the”authorisation list”

States and when necessary, discussed in the Member State Committee,” explains Jukka Malm. “As regards examining testing pro-posals, the main work load will start when dossiers concerning high production volume substances are submitted to us. This very challenging scientific task will require capac-ity building, and we have very strict deadlines for these examinations,“ says Jukka Malm.

The Directorate manages the overall pro-cess of authorisation and restriction, dealing with proposals for restrictions, for identifica-tion of substances of very high concern and proposals for harmonised classification and labelling. “We are now also in charge of the scientific and technical parts of the implemen-tation of the new Classification, Labelling and Packaging of Substances and Mixtures (CLP) regulation*,” explains Jukka Malm.

After the set-up phase, the Forum now works on measures and strategies directly related to enforcement. The coordinated inspections and collecting of information for reports will soon start in the EU and in the European Economic Area (EEA).

A first coordinated enforcement project will start soon. It will focus on checking whether substances were registered or pre-registered and whether correct safety data sheets are available. Over 20 countries will participate. Inspectors in each participat-ing country will perform enforcement activi-ties. The results of all inspections made in accordance with the project will be aggre-gated and analysed. A dedicated Forum Working Group will oversee the implemen-tation and reporting phases of the project.

The results and report of the project is ex-pected by March 2010. The Forum will also prepare another enforcement project for 2010, and is now setting its project priorities.

The Forum has agreed on the issues that should be included in the enforcement reports which the EU and EEA countries need to sub-mit to the European Commission every five years. The first report is due in 2010, and the authorities will soon start to collect data for it.

A broad strategy including the aspects of ef-fective enforcement and a list of essential pri-orities has been drafted by the Forum. The Member States and the EEA countries can use this strategy paper to develop their na-tional enforcement strategies, adapted to their circumstances. The common strategy should ensure that even if specific enforcement strategies differ from each other, they still have similar core elements. The framework strategy developed by the Forum will be pub-lished on the ECHA website by March 2009.

Minimum criteria for inspections under REACH will be worked out by the end of this year, to ensure that the inspectors in different EU and EEA countries take into account similar issues. The minimum cri-teria should be ready by the end of 2009.

Forum is also actively working to provide the inspectors with necessary IT tools. Their in-formation needs concerning REACH-IT have been identified, and a special access solution for enforcers will be developed before the end of 2010. Currently the Forum is consider-ing the first proposal for this access solution.

A special information exchange system will be set up to further coordinate the work of enforcers in different EU Member States and EEA coun-tries. This system will allow inspectors to alert one another about cases of non-compliance.

E C H A C A L E N D A RFebruary-March 2009

23-24 Feb Socio-Economic Analysis Committee (SEAC-3)26 Feb Management Board11-12 March Risk Communication Network (RCN-2)

April-May 2009

1-2 Apr Member State Committee (MSC-7)21-24 Apr Risk Assessment Committee (RAC-6)23 Apr Management Board28-30 Apr Forum meeting 418-20 May MSC-827 May ECHA’s Second Stakeholders’ DayJune-July 2009

(25 June Management Board)29 June-3 July RAC-7 and SEAC-4

September-October 2009

8-10 Sept Forum-516-18 Sept MSC-922-24 Sept SEAC-528 Sept-2 Oct RAC-830 Sept Management Board

November-December 2009

10-12 Nov MSC-1018-20 Nov SEAC-6 30 Nov-4 Dec RAC-98-10 Dec Forum-617 Dec Management Board

Presented dates are tentative

REACH philosophy applied

For Jukka Malm, the year 2010 signifies a first major milestone in the implementation of REACH. “We are still suffering from the lack of data on chemicals, and the data we receive will enable both industry and authorities to as-sess the hazards and risks of chemicals much better. Not all information will be perfect and complete, but still it is a major improvement. It will cover high production volume chemi-cals and carcinogenic, mutagenic, toxic for reproduction (CMR) substances and will help us screen substances for possible An-nex XV dossiers and to manage risks.”

The general philosophy of ECHA´s decisions is set by REACH. “The Regulation defines what we can do and what not, for example in the evaluation process. REACH sets the focus and the scope of the work which are then fur-ther developed in the guidance documents.”

“REACH is now put into practice for the first time, and of course we still have many dis-cussions on how to apply the Regulation and the guidance documents. It is important that we and the industry follow one of the key prin-ciples in REACH – that the burden of proof was transferred from authorities to industry. ECHA needs to check the compliance with the REACH provisions, but this does not mean that we take responsibility away from industry!”

For ECHA, stakeholder involvement is es-sential. “It is important that we are not work-ing as scientists in isolation but are open to the views of our partners and stakeholders for new scientific information, and keen to listen to the views of stakeholders on our pro-cesses. Consultations are part of our general

ECHA Newsletter 5

Recently, ECHA published its first draft rec-ommendation for substances that should be included in the Authorisation list of REACH (Annex XIV). ECHA proposed seven of the15 substances that are currently on the Candi-date list. A public consultation is taking place on ECHA’s website; comments can be sub-mitted until 14 April 2009.

“Our approach was not to limit the number of the substances in the Authorisation list but it was a case by case consideration whether there is a justification for giving the substanc-es priority at the moment”, says Jukka Malm. He reminds that this is only the start of a very long process. The Candidate list and the An-nex XIV recommendations will be regularly updated when ECHA receives new proposals from the Member States or requests from the Commission.

The Directorate also participates in the devel-opment of testing and assessment methods. “We are for example contributing to meth-odologies and approaches for dealing with nanomaterials, work currently coordinated by the Commission.”

Work load cannot be predicted yet

ECHA received 15 times more pre-registra-tions than anticipated, but these figures may not directly be linked to the expected number of registrations. “We are keen to understand how industry will respond in terms of send-ing registration dossiers. It directly affects our work load, and we follow this very closely and discuss with industry,“ says Jukka Malm.

“We have the quantitative obligation to carry out a compliance check for at least five per-cent of the dossiers for each tonnage band. If we receive tens of thousands of dossiers, this task will be very demanding. We also cannot yet predict very precisely the number of au-thorisation applications by industry.”

The quality of the registration dossiers is very important. “Not only from a regulatory point of view, but also how industry is applying the Regulation and the guidance and what kind of support and dialogue we can create with industry on the basis of that,” says Jukka Malm.

Uncertainties relate also to the number of dossiers sent in by the Member States. “In the classification and labelling area we have a better picture, but we do not yet know the restriction plans of the authorities. We are of course having dialogue with them to get a better idea.“

“All this work is very resource-demanding, and one of our main tasks this year is to grow, to employ and train new staff,” explains Malm. The number of staff in the Directorate will grow from 40 to around 100 by the end of the year.

Jukka Malm plans to build up his Directorate’s ca-pacity to meet the future challenges.Photo by ECHA Communications.

approach to stakeholder dialogue and trans-parency. It is really key to our work that we receive information from all interested par-ties,” says Malm.

About Jukka

Jukka Malm was involved in the practi-cal coordination and preparation for the start of ECHA in Helsinki from summer 2004. At that time he headed the Chemi-cals Division at the Finnish Environmen-tal Institute, and later he worked as Direc-tor of the Expert Services in the Institute. In 2007, Jukka Malm was elected the first Chair of ECHA Management Board and in the summer 2008, Director of Assessment.

In his current work, he benefits from the ex-perience he gained in preparing for ECHA. Jukka Malm also very much enjoyed the period as the first Chair of the Manage-ment Board. “That was very challenging and rewarding, the spirit of cooperation was very good, the Board Members were enthusiastic and it was a fruitful mixture of people with different backgrounds.”

Jukka Malm considers the outcome of the set-up of ECHA as very positive. “It is going very well and according to plan. Some things have even been changed for the better; for in-stance the size and importance of the Agen-cy has grown compared to the original plan.”

“We have very good staff here, well-function-ing contacts with the partners in the Member States and in the Commission and a very good dialogue with the industry and other stake-holders. Of course there is still a lot of work to be done, but it is a very promising start.”

Currently, the ECHA Director of Assess-ment does not have much free time, but if it happens, he enjoys long walks out in the nature and lets off steam in the gym. “I also try to stay in contact with friends and relatives - quite normal things.”

* Regulation (EC) No 1272/2008

ECHA Newsletter 6

Stakeholders

IT tools and GuidanceREACH-IT improved

A new upgraded version of REACH-IT (1.2.6) was introduced on 26 January. This ver-sion has improved stability and performance by amending some of the query processes and removing automatic message genera-tion within pre-SIEFs. The next new release (1.2.7) is currently being tested at ECHA. This version should further improve the searches related to pre-registrations and pre-SIEFs. Release 1.2.7 will be introduced when the tests are completed satisfactorily.

IUCLID* 5.1 - New release

On January 16th 2009, ECHA published a service release of IUCLID 5, the soft-ware application essential to submit data on chemical substances according to the requirements of the REACH legislation.

IUCLID 5.1 is available free of charge from http://iuclid.echa.europa.eu, for both the stand alone and distributed versions. The service release fixes several known bugs and is compatible with Windows Vista®.

An important improvement introduced in ver-sion 5.1 is the ability to run the plugin IUCLID 5 Query Tool. This plugin extends the ways in which data can be queried within and re-trieved from a IUCLID 5 database. Com-plex queries can be performed that combine multiple administrative and/or scientific pa-rameters within datasets and/or dossiers.

The IUCLID 5 Query Tool was released by ECHA on January 26th 2009. It is available free of charge, from the same website as IUCLID 5.

All the installation manuals have been revised and updated.

* International Uniform Chemical Information Data-base

ECHA first Stakeholders’ day was held in Helsinki on 10 October 2008. Three weeks after the event, a questionnaire was sent to all 237 participants collecting feedback on the contents of the presentations and on the usefulness of the information desks, practical organisational aspects, and an overall assessment and suggestions for im-provement of these events in the future. About 35% of the participants returned the form, giving ECHA an overall average rat-ing ’good’ for the contents and the organi-sation of the day. This was encouraging with an eye to ECHA’s ambition to con-tinue organising these events annually. Building on the feedback received and the experiences gained from the first Stakehold-ers’ day, ECHA is now preparing for its sec-ond such event. It will be held in Helsinki on 27 May 2009. The main focus will shift from pre-registration, which was the central topic of the first conference, towards preparation for registration: data sharing and tools for the preparation of registration dossiers. It will also give the industry an opportunity to share its first practical experiences from the building up and functioning of the Substance Information Exchange Forums (SIEFs). In addition, different consultation processes and stakeholders’ experiences from the con-sultations are planned to be included in the program for the second stakeholders’ event.

More information on ECHA’s Stake-holders’ Day will be published on the

Planning for ECHA’s second stakeholders’ day on 27 May

Agency’s web site in the coming weeks.Interestingly, ECHA’s second Stakeholders’ event will be organised in connection with the ‘Helsinki Chemicals Forum’ (HCF) to be held in Helsinki from the evening of 27 May until 29 May. By bridging the two events, participants to either event will be offered the chance, if they so wish, to attend also other event. Moreover, both conferences are foreseen to be on the same venue, Hel-sinki Fair Centre, which enhances the pos-sibility for both participants and the media to attend both conferences back-to-back.

The Helsinki Chemicals Forum will provide a high level platform for politicians, officials, ac-ademicians, industry, NGOs and other interest group representatives to engage in open dia-logue on themes related to global sustainable development by taking broader perspectives to the field of chemicals. The Stakeholders’ Day of the European Chemicals Agency fo-cuses on REACH processes and obligations ensuring high level of protection of the envi-ronment and human health. The two confer-ences will provide complementary, not com-peting perspectives to the pursuit of the same common goal: sustainable development. This concordance is ensured by ECHA participat-ing in the Advisory Board and the Steering Committee of the Helsinki Chemicals Forum.

More information on the Helsin-ki Chemicals Forum can be found at: http://www.helsinkichemforum.eu

REACH Guidance and IUCLID 5 websites are now hosted by ECHA

The REACH Guidance and the IUCLID 5 web-sites previously hosted by JRC were transferred to ECHA at the end of December 2008. Due to their migration from the JRC server the links to these two websites have changed as follows:

The REACH Guidance webpages: http://guidance.echa.europa.euThe IUCLID 5 webpages:http://iuclid.echa.europa.eu

From the end of January 2009 the webpages can only be consulted through the new links. The previous JRC links do not work any more.

Phase-in substances (on their own or in a preparation) may be pre-registered after 1 December 2008 by manufactures or im-porters established in the European Com-munity, if it is proved that the substances have been manufactured or imported for the first time after 1 December 2008 in quantities of 1 tonne or more per year.

Manufactures or importers can also pre-reg-ister phase-in substances in articles if they are able to prove that they are producing or importing for the first time after 1 Decem-ber 2008 articles that contain substances intended to be released under normal and reasonable conditions of use and that they are established in the European Community.

Pre-registration of phase-in substances after 1 December 2008

For these pre-registrations, the following deadlines apply:

- at the latest six months after the manufac-turing or importing exceeds the one-tonne threshold;

and

- at least 12 months before the relevant tran-sitional deadline for registration.

Detailed information on the possibility to submit a late pre-registration can be found in Article 28(6) of the REACH Regulation, in the guidance documents ‘Guidance on data sharing’ (Section 3.6 – First time Manu-facturers or Importers) and ‘Guidance on requirements for substances in articles’ (Section 6.4 - Time of checking compliance).

ECHA Newsletter 7

Statistics

Graph 1: Comparison of submissions forecasted and actually received at ECHA

Table 1 shows the number of dossiers re-ceived at ECHA since 1 June 2008 by 9 Feb-ruary 2009. Table 1a shows the manual tem-porary submission procedure and dossiers received, whereas table 1b shows the online submissions via REACH-IT.

Graph 1 shows the amount of submissions received in comparison with the forecasted numbers. Additionally ECHA received 2 752 646 pre-registrations; the original esti-mate was 132 292.

Table 2 shows the number of companies in a pre-SIEF/substances. (SIEF= Substance Information Exchange Forum)

Table 1 Table 1a

Table 1b

Number of participants in a

pre-SIEF

Number of pre-SIEFs

1-9 93 42810-24 35 43925-49 9 73450-74 2 73375-99 1 290

100-199 2 006200-499 1 114500-999 287

1 000-4 999 138> 5 000 2

Total 146 171

Table 2

.

European Chemicals Agency Annankatu 18, P.O. Box 400,

FI-00121 Helsinki FinlandTel. +358 9 6861 80

Fax +358 9 6861 8210

http://[email protected]

Living in Helsinki

Disclaimer: The views presented in the News-letter do not necessarily represent the official position of the European Chemicals Agency. All the links are up to date at the time of the

publication.

ECHA Newsletter 8

_____________________________________To subscribe to the ECHA news alerts and

newsletter, send your e-mail address to: [email protected]

The City of Helsinki has offered assis-tance for the relocation of ECHA employ-ees since 2007. Relocation Advisor Henni Ahvenlampi is the contact point for ECHA employees in this three-year project.“We provide additional support by of-fering hands-on information, e.g. via a specific extranet site, on settling in the Helsinki Metropolitan Area. Our aim is to make the experience in Helsinki as pleas-ant as possible”, says Ms. Ahvenlampi.

According to Ms. Ahvenlampi the City of Helsinki is proud of its new status as the Chemical capital of Europe and has wel-comed the Agency and its staff with open arms. “The experiences with foreign em-ployees and the feedback received also help us to develop primary ser-vices in the City. And there is no ques-tion about the image value a European Agency brings”, says Ms. Ahvenlampi.

Since the establishment of the Europe-an Chemicals Agency on 1 June 2007, over 150 people have moved to Hel-sinki from all over Europe to take up jobs in the Agency. Many have come with spouses, partners, and children. All have brought their lives and lifestyles with them.

Kirsi Irrmann is responsible for the coordina-tion of relocation and social welfare issues in ECHA’s HR department. She helps incoming staff members find housing, schooling for their children and negotiate the many administra-tive and practical hurdles facing newcomers arriving for the first time in Finland. In this she has valuable assistance from the City of Hel-sinki which has organised an information and advice service for incoming ECHA employees.

“As we are growing very fast, one of the big-gest challenges to the Human Resources team is to keep up. At the same time as we are receiving lots of newcomers, we are try-ing to develop best practice for our employ-ees and their accompanying family mem-bers. I have been very impressed to see how all the different operators in the Helsinki area have been supporting us to provide as smooth a landing as possible for our employ-ees and their families“, says Kirsi Irrmann. Before arrival, future staff members re-ceive an information package with links and contacts to help them prepare for their arrival here. New arrivals can get help in finding a place to live in the Helsinki region via the housing service offered by an es-tate agency under contract to the Agency.

The Finnish Government has taken the ini-tiative to set up an associated European School only a few blocks from the Agency where children of Agency staff can follow the European School curriculum in French, Eng-lish or Finnish, while keeping in touch with their mother tongue. ECHA staff also benefit from the excellent Finnish child-care system which guarantees universal day-care for all children aged 10-months to 6 years in mu-nicipal crèches or family-based play groups.

Networking

The ECHA Spouses Club is an important forum for social networking and information exchange among spouses and partners who have accompanied staff members to Helsinki and are discovering a completely new envi-ronment. Employment prospects and family matters are a main focus of attention. A “Work-ing in Finland” initiative has been recently launched by a group of spouses, in order to help them finding a professional activity in Fin-land and connect to strategic networks. Finn-ish language and cultural awareness classes organised by ECHA are also open to family members. The ECHA Staff Club helps staff members and their families make the most of what Finland has to offer, by organising a va-riety of cultural, sports and outdoor activities. Finding out about integration The University of Helsinki, in collaboration with ECHA and the City of Helsinki, is conducting a research project on the integration of inter-national professionals working for the Agency (InterProF). All international employees com-ing to Helsinki during 2008 and 2009 are invit-ed to participate in the study consisting of two stages: questionnaire 1 concerns data related to pre-departure and questionnaire 2 follows up the situation after four to six months’ stay in Finland. The study, related to the field of social and cross-cultural psychology, will be completed by the end of 2009. First conclu-sions on the integration process will be pre-sented in late spring or early autumn this year.

“Helping staff members and their families find their feet quickly on arrival in Helsinki and get settled into their new life here is an important part of our recruitment policy”, says Head of HR Alastair Macphail. “Our longer term aim is to support them as best we can in build-ing a satisfying and rewarding life here. As an expert organisation, ECHA depends entirely on the knowledge and skills of the staff we are able to attract and retain: we want them to be happy here and stay for a long time.”

Smooth landing in HelsinkiCity of Helsinki – a proud partner of ECHA

Group of ECHA newcomers are ready to roll up their sleeves and get to work after the formal welcoming session. Photo taken in February 2009 by ECHA Communications.