1 December 2012 6 3 “REACH resembles an iron man contest” Companies may feel that they are on the REACH homestretch when they have sub- mitted their dossiers. That it is the end of an exhausting marathon. But this belief is mistaken. 5 National helpdesks - your first point of contact ECHA Newsletter spoke with the repre- sentatives of the Belgian, French, German and British helpdesks to learn more about what they are doing in their own countries to help industry to comply with REACH keeping the upcoming 2013 deadline in mind. 12 ECHA has examined all testing proposals from the first REACH deadline This is an important step forward in the implementation of REACH – making sure that more information about chemicals is available while ensuring that unnecessary testing on animals is avoided. 16 Moving forward with exposure scenarios The third meeting of the Exchange Network on Exposure Scenarios (ENES) in November discussed topics such as ex- posure scenarios for mixtures, preparing and communicating good quality chemical safety assessments, scaling and the progress made since the previous meeting in May 2012. Greetings from a very snowy Helsinki. This is our last newsletter of 2012 and I would like to take this opportunity to wish all of you a happy Christmas and a healthy and successful 2013. This publication is our little Christmas gift for you – our first online Newsletter. We have responded to your feedback and, by using an online format, we are making the Newsletter more interactive and modern. You will also find it much easier to share articles of interest with your colleagues – indi- vidual stories can be sent as a simple link which won’t clog up e mail inboxes. Also, by providing the newsletter in its own little website makes it easier for you to find what you’re looking for from past editions. The newsletter website is very simple to find your way around. The current issue will always be shown in the front page http://newsletter.echa.europa.eu. The other issues are accessible under the link ‘All issues’ on the left hand side. At present all the 2012 issues are there and, early next year, all the newsletters from August 2008 onwards will be there too. The column in the middle displays all the articles included in the particular newslet- ter issue that you’re looking at. The articles are divided under the different sections as usual: Editorial, REACH 2013, CLP, Biocides, News from ECHA, Stakeholders, Featuring and Interview. You can read each article in full by clicking on the title. The upcoming events are shown on the right hand side. There you can also find the ‘Search function’ , which you can use to search for stories from all the newsletter issues – just type in the word you are looking for. The e-Newsletter is here! annankatu 18, p.o. box 400, fi - 00121 helsinki, finland | echa.europa.eu
Transcript
1 December2012
6
3 “REACH resembles an iron man contest”
Companies may feel that they are on the REACH homestretch when they have sub-mitted their dossiers. That it is the end of an exhausting marathon. But this belief is mistaken.
5 National helpdesks - your first point of contact ECHA Newsletter spoke with the repre-sentatives of the Belgian, French, German and British helpdesks to learn more about what they are doing in their own countries to help industry to comply with REACH keeping the upcoming 2013 deadline in mind.
12 ECHA has examined all testing proposals from the first REACH deadline
This is an important step forward in the implementation of REACH – making sure that more information about chemicals is available while ensuring that unnecessary testing on animals is avoided.
16 Moving forward with exposure scenarios The third meeting of the Exchange Network on Exposure Scenarios (ENES) in November discussed topics such as ex-posure scenarios for mixtures, preparing and communicating good quality chemical safety assessments, scaling and the progress made since the previous meeting in May 2012.
Greetings from a very snowy Helsinki. This is our last newsletter of 2012 and I would like to take this opportunity to wish all of you a happy Christmas and a healthy and successful 2013. This publication is our little Christmas gift for you – our first online Newsletter. We have responded to your feedback and, by using an online format, we are making the Newsletter more interactive and modern. You will also find it much easier to share articles of interest with your colleagues – indi-vidual stories can be sent as a simple link which won’t clog up e mail inboxes. Also, by providing the newsletter in its own little website makes it easier for you to find what you’re looking for from past editions.
The newsletter website is very simple to find your way around. The current issue will always be shown in the front page http://newsletter.echa.europa.eu. The other issues are accessible under the link ‘All issues’ on the left hand side. At present all the 2012 issues are there and, early next year, all the newsletters from August 2008 onwards will be there too.
The column in the middle displays all the articles included in the particular newslet-ter issue that you’re looking at. The articles are divided under the different sections as usual: Editorial, REACH 2013, CLP, Biocides, News from ECHA, Stakeholders, Featuring and Interview. You can read each article in full by clicking on the title. The upcoming events are shown on the right hand side. There you can also find the ‘Search function’, which you can use to search for stories from all the newsletter issues – just type in the word you are looking for.
The e-Newsletter is here!
annankatu 18, p.o. box 400, fi-00121 helsinki, finland | echa.europa.eu
In this issue: 4 Reaching the deadline7 New version of REACH-IT available8 Smaller companies gain confidence in managing REACH dossiers9 REACH, CLP and biocides to be covered in two Stakeholders’ Day conferences in 201310 REACH from two NGOs' points of view Biocide stakeholders11 Give us your feedback on how to improve ECHA’s information on chemicals 14 ECHA publishes its decisions on dossier evaluation15 Better environmental assessment18 Nina Cromnier leads ECHA's Management Board19 Directors of national authorities support ECHA’s strategy; Events20 Helping consumers to request information about substances of very high concern in articles 21 ECHA and its stakeholders at the same table: Strategic objectives in the spotlight23 Evaluation statistics Guidance published
To subscribe to the ECHA news alerts and newsletter, register at: http://echa.europa.eu/en/news-and-events/news-alertsDisclaimer: The views presented in the Newsletter do not necessarily represent the official position of the European Chemicals Agency. All the links are up to date at the time of publication. ISSN: 1831-4953
Editor-in-chief: Lindsay Jackson Editor: Hanna-Kaisa Torkkeli
European Chemicals AgencyAnnankatu 18, P.O. Box 400,FI-00121 Helsinki FinlandTel. +358 9 6861 80Fax +358 9 6861 8210
The top navigation compiles all the stories related to a certain topic in one web page. If you click, for example, on ‘REACH 2013’, you will find all the newsletter stories written about the 2013 deadline, and the issue they were published in. These topic specific archives will be fully working as soon as we have all the newsletter issues from 2008 inserted into the system. As a reminder, here’s what you can find under each of the top navigation topics:
• ‘Editorial’ is all the editorial texts; • ‘REACH 2013’ is everything related to the 2013 campaign;• ‘CLP’ collects all articles written about classification, labelling and packag-
ing;• Under ‘Biocides’ you will find all the stories written about the new Biocidal
Products Regulation;• ‘News from ECHA’ is a general topic, which includes articles about ECHA’s
work (e.g. meetings, legal deadlines, new IT tools, new appointments), in-cluding the Management Board;
• ‘Stakeholders’ compiles stories about ECHA’s stakeholders or stories re-lated to stakeholders’ activities;
• Under ‘Featuring’ you will find all the guest columns and news pieces about chemicals in our lives; and
• ‘Interview’ – as the name says – brings together all the interviews.
In future, when we publish a new newsletter, we will send the highlights by email to you and you can then click and visit the Newsletter website to read more.
As with all Christmas gifts, we hope that you like this one but, unlike the gifts that you will get this year from your family, we really do want your honest feed-back! Please get in touch with Hanna and me at: [email protected].
Many companies believe they are on the REACH home stretch: upon submitting the final dossiers for the second phase of REACH, they see themselves at the end of an exhausting marathon. Once the deadline for registration passes on 31 May 2013, they believe that the effort and resources expended on REACH can be reduced for the time being. But this belief is mistaken. REACH is not a marathon; it resembles an iron man contest - merely running 42 kilometres is not enough.
A BASF example: we have registered 679 substances in the first phase of REACH. Around 600 will be registered additionally by the end of the second phase. At BASF, this workload is taking up 250 people. Manpower which will not be reduced, even after the end of the next registration period. Why? A number tells the story: BASF has submitted more than 700 dossier updates to ECHA since 1 December 2010. This means that 700 of the dossiers previously submitted had to be revised and updated. Business aspects constitute one reason, for example when tonnages, compositions or applications change.
But on the other hand, ECHA itself with its feedback and enquiries, ensures that the post-registration work does not dry up. This is a matter of dossier evaluations – examining test proposals, reviewing the registration dossiers to ensure they meet the requirements, and so on and so forth. BASF has received 250 such evaluation letters from ECHA to date. An example: ECHA noted that BASF described a substance as a mixture of two isomers in a registration dossier. The analytical information provided shows that one isomer predominates. In response, ECHA enquired whether it would be better to describe one isomer as the main component and the other one as an impurity.
Guest coloumn | Dr Martin Kayser “REACH resembles an iron man contest”
The possible economic consequences of such a purely formal change must not be underestimated. The “new” substance identity communicated via the safety data sheet can question the legal status in other regions outside the EU. Customers also have to be informed of the new specification, and product recertification by the customer may be required as well.
In the end, BASF may agree with the proposal of ECHA, which results in the revision of all relevant sections and the submission of an updated dossier.
This example shows that processing such ECHA enquiries demands significant resources. It means the effort for REACH is by no means decreasing, but actually going up continuously as new substances are registered. BASF alone expects a total cost for REACH to be in the range of EUR 500 to 550 million by 2018. All companies are therefore encouraged to refrain from reducing the required resources and underestimating the necessary
effort.
Intensive communication between all participants, especially between the registrant and authorities, is crucial in order to jointly achieve the objectives of REACH.
All participants have accumulated great expertise on REACH over the last few years. This should be used in order to make REACH more practical, decrease bureaucracy and explore room to manoeuvre.
Dr Martin Kayser, Head of Global Product Safety, BASF SE
Manufacturers and importers must register each of their substances together with other producers of the same substance. They must share information and costs in substance information exchange fora (SIEFs). Each SIEF should select a lead registrant who takes the main responsibility for preparing the registration dossier. Member registrants then join the lead registration by providing information specific to their own production and use of the particular substance.
If you have not yet started your registration process, the first step is to contact the companies who pre-registered the same substance as you and join a SIEF for that substance. You can see the companies in the pre-SIEF pages of REACH-IT.
If your substance is already registered either for the 2010 deadline or for the 2013 deadline, contact the lead registrant to verify that your substance is the same and make a SIEF agreement to obtain your REACH-IT member token.
EARLY REGISTRATIONS GET FASTER TREATMENT
ECHA recommends that the lead registrants prepare their dossiers well in time before the deadline, preferably by the end of March 2013, so that the members will have enough time to register.
If you register your substance before the end of March, you will benefit from faster processing of your dossier by ECHA (21 days),
whereas if you register after the end of March, the processing time will be three months.
If you are already a SIEF member, ensure with the lead registrant that you will have sufficient time for your registration after they have submitted theirs and that all actions and preparations are well under way.
If your substance is not yet registered, clarify that the reason is legitimate (for example the SIEF is active but the lead registrant has not yet informed ECHA) and that you are still able to submit your registration on time.
SUPPORT AVAILABLE
All registration tools as well as other support - ranging from tools to help identify your roles and obligations, formal guidance and Q&As, to online training materials - are available
The sprint to the finish line has started: six months to go until the second REACH registration deadline on 31 May 2013. In the beginning of December, ECHA began a six month moratorium on Guidance and IT-tool updates, to provide stability for registrants and allow them to concentrate on preparing dossiers.
on ECHA’s website. Additionally, the national helpdesks and ECHA Helpdesk will continue to provide support to registrants during the coming months.
Closer to the deadline, ECHA will announce its last-minute direct support service for member registrants. Registrants are also invited to the next Stakeholders’ Day taking place on 26 March 2013 in Helsinki with the opportunity for one-to-one sessions and hands-on training.
FURTHER INFORMATION
Six-month moratorium before the second REACH registration deadline to start, News alert, 28 November 2012:http://echa.europa.eu/view-article/-/
Data Submission manuals:http://echa.europa.eu/support/dossier-
submission-tools/reach-it/data-submission-
industry-user-manuals
Webinars: http://echa.europa.eu/support/
training-material/webinars
The REACH 2013 registration deadline concerns all substances manufactured in or imported into the EU at amounts of 100 - 1000
tonnes a year.
The last day to submit registration dossiers to ECHA is 31 May 2013.
ECHA expects that up to 3 850 substances will be registered by the deadline. Of these, 860 substances were already registered by the 2010 registration deadline and 2 990 are ‘new’ substances for the 2013 deadline.
In 2013, the Agency is expecting to process between 7 500 and 23 000 registration dossiers related to the 2013 deadline. The span in the number of dossiers expected is due to the differences in the data from the industry survey and the lead nomination scheme.
A further 7 500 dossier updates are expected to be processed during 2013 due to updates for substances registered in 2010.
INTERVIEWS AND TEXT BY VIORICA NAGHY AND HANNA-KAISA TORKKELI
National REACH helpdesks – your first point of contact
ECHA Newsletter spoke with the representatives of the four REACH helpdesks to learn more about what they are doing in their own countries to help the industry to comply with REACH with the upcoming 2013 deadline in mind.
Dr Suzanne Wiandt from the German REACH and CLP helpdesk says that they offer information and support to registrants through their website, reply to enquiries by email and phone, and organise events to raise awareness of REACH obligations. “We also offer registrants, whose enquiry we cannot reply to by email or phone, or whose issue is complicated, the possibility to come to Dortmund, our headquarters, for bilateral discussions. During these discussions, we take the time to go into the subject and get to know where the problems are, and offer our best advice. The responsibility for the appropriate action remains with the registrant, of course,” Dr Wiandt explains.
The German helpdesk receives on average 200 enquiries each month and arranges monthly one to two bilateral discussions with companies. The number of enquiries received has gone down from the peak period in 2008 but the nature of questions has changed. “In the past two years, the questions have become more complex and take longer to reply to,” Dr Wiandt points out.
IT ALL STARTS WITH SUBSTANCE IDENTITY
To promote the 2013 deadline, the German authorities organised a big event for around 200 participants in June 2012, which managed to attract a lot of newcomers. The helpdesk also cooperates with the industrial chamber of commerce to reach smaller companies. “Topic-wise we consider substance identity as one of the key issues for the upcoming deadline. It has to be determined very precisely. We have also focused on the registration of nanomaterials under REACH. Another important issue is communication in the supply chain. If substance identity is the start of the REACH process, communication down the supply chain is crucial for achieving the aims of REACH. There is a lot to be done with harmonisation of safety data sheets,” Suzanne Wiandt says.
For the first time, national helpdesks contributed to ECHA's Lead Registrant Workshop and training held in Helsinki from 11 to 12 October 2012. ECHA invited representatives from the national helpdesks with the largest number of registrants to the event: Belgium, France, Germany and the United Kingdom. The Lead Registrant Workshop offered an opportunity for the national helpdesks to meet lead registrants,and promote their work. The helpdesk experts conveyed an unambiguous message: “We are committed to supporting industry towards the second registration deadline in 2013.”
Dr Wiandt calls on the registrants to follow the principles of joint submission as well as fair and transparent cost and data sharing. “We see big discrepancies in data and cost sharing. Some companies are not willing to share data, or the price of the Letter of Access is too high for a small company. Unfortunately, in the helpdesk we cannot help much with data or cost sharing problems. It is up to the registrants to reach an agreement or ultimately up to ECHA to resolve potential disputes.”
The German REACH and CLP helpdesk is located in the Federal Institute for Occupational Safety and Health (BAuA) in Dortmund, but it works closely with different experts from the Environmental Agency (UBA) and the Federal institute for risk assessment (BfR).
German REACH and CLP Helpdesk http://www.reach-clp-helpdesk.de
***
The REACH and CLP helpdesk in the Health and Safety Executive (HSE) in the United Kingdom is a joint effort of different specialists. “We have a lot of different resources we can draw upon: toxicologists, chemists, biologists, economists and occupational hygienists,” says Dr Lindsay Peppin, one of the key staff in the helpdesk. She emphasises that the UK helpdesk does not work in isolation. “We spend a lot of time building up good working relationships with our stakeholders as well as with other national helpdesks. We see ourselves as more of a gateway to a network of resources and I think this is important for companies to realise.”
On average the UK helpdesk receives 40 questions per week on the application of REACH and CLP. “For
the 2013 registrants we are there to support them as best as we can. According to the feedback we have received from our stakeholders and industry, there will not be many newcomers for the 2013 deadline, so the registrants already have practical experience. However, we do appreciate that each registration deadline is different and brings different challenges: 2013 is about lower tonnage substances, and the calls and emails we receive suggest there is less data available, more testing required or more alternative strategies, like QSARs and read-across, needed. Our support is going to be different in terms of the advice that we give but we will maintain our usual helpdesk functions - answering questions by email and phone or meeting with industry if that is more appropriate,” Ms Peppin explains.
Having already experienced one REACH deadline, there is now a good deal of information available and lessons learnt as a result of dossier evaluation. More guidance has also been published to help companies find their way in the REACH registration process. “One of our key roles is helping companies to navigate through all the guidance that is available and
helping them work out how it applies to them in their situation,” Ms Peppin concludes.
HSE REACH and CLP Helpdeskhttp://www.hse.gov.uk/reach/
***Nathalie Hayaud and Stephanie Copin-Vivier from the French helpdesk say that they work together with the French competent authority, the Ministry of Ecology, Sustainable Development and Energy, and chambers of commerce on a specific national action plan for REACH 2013. “We raise awareness on the REACH registration and try to get companies that might not be aware that they are impacted, involved. We also talk a lot about communication in the supply chain and authorisation. According to our research these are topics that need to be addressed,” says Ms Copoin-Vivier.
The helpdesk staff travel to local events to meet industry. “Our message is that if you are impacted by REACH you need to comply for the sake of your business. And we are here to help you do that. I sometimes feel that especially the smaller companies are not aware that there is a REACH helpdesk,” Ms Copin-Vivier explains.
The French helpdesk receives on average 250 enquiries each month by email and phone. The quickest way to get a response is to call. “At present, we receive quite many questions from downstream users. They are worried whether their use is covered by the registration or whether they should receive an exposure scenario or not. We try to highlight the importance of communication with the producers and the lead registrant because often there is a lack of information,” Ms Hayaud adds.
The helpdesk also publishes its own newsletter and various fact sheets. They can all be found online.
French REACH and CLP helpdeskhttp://www.reach-info.frhttp://www.clp-info.fr
***
Jean-Pierre Feyaerts from Belgium says that the Belgian REACH helpdesk receives around 250 questions annually in Dutch (45%), French (30%) and English (25%). Currently, most of the questions coming in are in English. “Many companies have their main offices in Belgium but are present in different Member States. For that reason they prefer to have the replies in English. It
Nathalie Hayaud (left) and Stephanie Copin-Vivier.
is easier to pass the message inside the company in English. The second factor is that there are quite many Only Representatives positioned in Belgium,” Mr Feyaerts says. At present, the majority of questions are coming from consultants working on REACH on behalf of the companies. “These questions in general are not specific for Belgium, so we believe the consultants are working for international businesses.”
The Belgian helpdesk is supporting the national federations with their REACH activities. “We attend their meetings and remind people of the obligations of REACH. It is important to work together with the federations. In the helpdesk, we offer information on the legal aspects, whereas the federations can give more practical advice,” Mr Feyaerts points out.
HelpNet - the network of national REACH and CLP helpdesks was established in October 2009 to promote consistent and harmonised responses within the EU and to ensure the best possible advice to companies seeking to fulfil their obligations under the REACH and CLP Regulations.
National helpdesks have an important role as the first point of contact for duty holders situated in their country. They are best placed to communicate with their domestic industry, also giving advice in the respective languages.
Further information:
HelpNet section on ECHA's website http://echa.europa.eu/about-us/partners-and-networks/helpnet
Competent network with a variety of services, Newsletter 2/2010http://echa.europa.eu/documents/10162/13584/echa_newsletter_2010_04_16_en.pdf
ECHA Information Desk:http://echa.europa.eu/echa-information-desk
The new release of REACH-IT introduced the Co-Registrants page, which gives potential and existing registrants direct access to each other's contact details. The new release was published on 30 November 2012. With the launch of this new version of REACH-IT, ECHA has fulfilled its commitment to stabilise the guidance, IT tools, manuals and Q&As for registrants preparing for the upcoming deadline.
REACH-IT 2.5 will help both existing and potential registrants
New version of REACH-IT available
to better fulfil their data sharing and joint submission obligations within and outside the inquiry process. The main benefit of the enhanced inquiry process is that users will be able to access the contact details of existing registrants directly within REACH-IT once ECHA has ascertained the identity of the substance.
The new release also contains other minor improvements aimed at supporting the use of the system, for example an update of the login screen with links to other dossier
submission processes that are not yet covered by REACH-IT. Further information
Last update of REACH-IT ahead of the 2013 deadline, News alert 21 November 2012http://echa.europa.eu/view-article/-/journal_content/0ef9bf18-f6bd-433a-9f6d-ee9065721b7a
How can I find my co-registrants? ECHA Newsletter 5/2012http://echa.europa.eu/documents/10162/13584/newsletter_0512_en.pdf
Smaller companies gain confidence in managing REACH dossiers
For the 2013 deadline, Endura SPA will register two substances as a member of an already existing joint submission from the 2010 deadline, as well as three intermediates. For one of these intermediates, Endura proposed its nomination for the role of lead registrant. “We will do this internally, without seeking help from consultants,” says Mr Prota. A good reason for this, according to him, is the fact that ECHA provides a lot of support to companies that are serious about complying with the legislation. “For smaller compa-nies, the ECHA Helpdesk service is very important.”
In October, Mr Prota attended ECHA’s lead registrant workshop for the first time. He finds partici-pation in the Agency’s events very useful. “This was a great opportu-nity to meet scientists from ECHA, to listen to interesting presenta-tions, and to start networking.” He appreciated the practical training on IUCLID, but he says he benefit-
ted most from the one-to-one session: “Endura’s main business is biocides and in the one-to-one session I also had the possibility to clarify important questions about the links between REACH and the new legislation for biocides.”
“It would be perfect if, in the future, in addition to the webinars, there would be a possibility to have online one-to-one sessions,” he concludes.
TEXT BY VIRGINIA MERCOURI
Italian firm Endura SPA is a small and medium sized enter-prise (SME) taking a leading role in the REACH registration pro-cess. Mr Giovanni Prota, work-ing in Endura SPA’s Regulatory Affairs Department, is managing the dossier for piperonyl butox-ide (PBO). The substance was registered in 2010. At that time, the registration dossier was prepared by external consult-ants. “We have now changed our REACH strategy and taken over the dossier from the consult-ants. We are already managing the updates internally,” says Mr Prota.
“The consultants were of great help for preparing the registration,” Mr Prota admits, “but it is both easier to comply with the legislation and more beneficial for the company if it is in charge of the activities following the registration. We are in contact with our customers, monitor the use of the substance in the supply chain and receive a lot of information for updating the exposure scenarios. It is clear to us that if we manage the dossier, we are also able to enter the market more actively. When our clients and partners ask questions, we are able to answer them.”
Asked if he would advise a friend or a colleague from an SME to become a lead registrant for a substance, he is clear: “If the substance is the core business of the company, it is better to choose the role of lead registrant. This means that you take an active role in the prepara-tion of the registration dossier to ensure that you meet your obliga-tions in an appropriate manner.”
Mr Giovanni Prota says that smaller companies should be encouraged to take on the role of lead registrant. “If the substance is the core business of the company, it is better to choose the role of lead registrant," he says.
1. EIGHTH STAKEHOLDERS’ DAY, 26 MARCH 2013, HELSINKI, FINLAND
The day provides plenary sessions ranging from registration to evaluation and authorisation and focuses specifically on giving key information for registrants ahead of the 2013 REACH registration deadline. Participants can also discuss one-to-one with ECHA experts about topical issues.
Registration and a preliminary agenda will be launched in January.
View material from the previous Stakeholders’ Dayhttp://echa.europa.eu/en/view-article/-/journal_content/40bb6ef5-03b0-496f-8c4c-a8f8d04ab68c
REACH, CLP and biocides to be covered in two Stakeholders’ Day conferences in 2013
2. BIOCIDES STAKEHOLDERS’ DAY, 25 JUNE 2013, HELSINKI, FINLAND
In preparation for the application date of the Biocidal Products Regulation (BPR) on 1 September 2013, ECHA will organise a conference to provide biocides stakeholders with information about the new regulation, to ensure that companies are aware of their roles and the available tools and resources to assist them in meeting their obligations.
The day is open to all. The content will be of particular relevance to European and National trade associations, SMEs, large companies, alternative suppliers and public interest NGOs. The registration date will be announced in January.
Information about the BPR on the ECHA websitehttp://echa.europa.eu/regulations/biocidal-products-regulation
HELSINKI CHEMICALS FORUM (HCF) 18 – 19 JUNE 2013, HELSINKI, FINLAND
The annual HCF is an independent forum engaging in open dialogue on key issues of global relevance on chemicals policy and the control of chemical safety. The discussion panel topics and preliminary agenda are now available online.
During the last year, many reports have been published on the implementation and impact of REACH at the request of the European Commission and in light of the upcoming REACH review.
In October, the European Environmental Bureau (EEB) and ClientEarth published their own version.
This is the first time that ECHA’s activities have been scrutinised by an NGO independently, and although the Agency does not
REACH from two NGOs' points of view
agree with all the comments made in the report, particularly those with respect to independence and transparency of decision making, it shares some of the concerns highlighted in the report.
ECHA invited the two NGOs to discuss the issues raised on 21 November. The discussion emphasised the shared common goal, namely the successful implementation of REACH and the achievement of its goals.
Having analysed all the topics raised in the report, it was agreed that regular meetings would be held between ECHA staff and the public interest NGOs in order to encourage a more structured dialogue between the parties.
ECHA is looking to involve stakeholders in its work under the new Biocidal Products Regulation, which enters into operation in September 2013.
Umbrella organisations, whose members represent biocide-related sectors or have an interest in the implementation of the
Biocide stakeholders
Regulation, can express an interest in having an active role in ECHA’s work.
This includes participating in scientific consultations, updating Guidance documents and other forms of cooperation.
To qualify, organisations must be an ECHA Accredited Stakeholder
Organisation. Accreditation is based on a set of criteria that includes being not-for-profit and functioning at an EU-wide level.
For further information please visit ECHA's stakeholder webpage at:http://echa.europa.eu/about-us/partners-and-networks/stakeholders
More about the Biocidal Products Regulation:http://echa.europa.eu/regulations/biocidal-products-regulation
Give us your feedback on how to improve ECHA’s information on chemicals
ECHA is currently investigating ways of restructuring the presenta-tion of this information, in order to make it more user friendly for a wider group. Users vary from EU Member States and European Authorities to industry specialists and from environmental NGOs to workers and members of the gen-eral public.
As a first step, ECHA has launched a survey on the features and func-tionalities of the website search.
It includes questions related to improvements on the presentation of the content, additional query functionalities, design and naviga-tion.
Your opinion is important to us and we would greatly appreciate it if
The European Chemicals Agency has a unique opportunity to make information on chemical substances accessible to the public. This is done via the website, where users can for example, search for data related to the properties of a sub-stance that has been registered under REACH, its classification and labelling and how to use the chemical safely.
TEXT BY VASILEIOS TSIFOUTIS
you could take 20 minutes of your time to respond to our questions. The survey will be online until 21 December.
As a second step, selected ECHA stakeholders are being contacted for a brief phone interview on the same topic. We would like to thank you in advance for your cooperation and participation in this study. You can really help by making your spe-cific needs known and playing your part in improving the readability and user friendliness of informa-tion on chemicals.
Survey – reply by 21 Decemberhttp://surveys.eworx.gr/index.php?sid=81639&lang=en
ECHA successfully met the legal deadline of 1 December 2012 for examining testing proposals from the registration dossiers submitted for the first REACH deadline. The Agency has now issued either draft or final decisions to companies concerning their testing proposal. This is an important step forward in the implementation of REACH – making sure that more information about chemicals is available in the future while avoiding unnecessary testing on animals.
The REACH Regulation requires registrants to submit proposals for testing to ECHA when they identify a data gap for certain information requirements. ECHA has the obligation to examine all the proposals within timeframes set out in the legislation. For every testing proposal submitted by the first registration deadline of 30 November 2010, ECHA had to prepare a draft decision by 1 December 2012.
A total of 571 dossiers with 1 184 individual testing proposals have been examined. Of these, 445 dossiers had proposals to test on vertebrate animals covering 770 endpoints. The other testing proposals concerned environmental studies, in vitro human health studies, or even simple physical chemical studies such as dissociation constant or viscosity. Draft decisions were issued in 436 cases, of which 146 have already resulted in a final decision. Nearly 130 cases were terminated due to the withdrawal of the proposals, testing already being initiated or for other reasons.
“For the first registration deadline the registrants had to assess whether they needed more experimental studies on the so called higher tier information requirements set out in Annexes IX and X of REACH. If they identified a data gap, they submitted a testing proposal to ECHA. So, the 571 dossiers with testing proposals submitted to ECHA reflect the status of registrants’ understanding of the information gaps in their dossiers,” says Leena Ylä-Mononen, Director of Evaluation, explaining the background.
By examining the testing proposals, ECHA ensures that the tests proposed are necessary and adequate for meeting the REACH information requirements. This is an important step forward in filling the data gaps and getting more information about the old, phase-in chemicals that have
been on the market for a long time already. However, the process is long. “We are still quite far from having received the test data. Once the study is available the registrant submits a dossier update where the study is to be reflected. They might also need to update their chemical safety assessment and report and even change the self-classification. Ultimately, we should have significantly more information on chemicals helping the registrants to decide what measures need to be taken to ensure the safe use,” Ms Ylä-Mononen says.
CHALLENGES WITH SUBSTANCE IDENTITY AND ANALOGUE APPROACHES
Examining the testing proposals is a new process introduced by REACH and therefore has never been done before. The big wave of dossiers arriving for the first deadline and the two-year window for processing, created a
ECHA has examined all testing proposals from the first REACH deadlineINTERVIEW BY HANNA-KAISA TORKKELI
considerable challenge for ECHA’s scientists. “We began by screening the dossiers. Early on, we tried to identify the dossiers where the substance identity information was not sufficient to allow a meaningful examination of the testing proposals. In 25 % of the cases we actually had to open a compliance check first in order to clarify the identity of the substance. I was not expecting so many cases with ambiguous substance identity. Clearing the substance identity required a lot more work than expected and caused a slowing up of the whole process,” says Leena Ylä-Mononen.
Another challenge was the testing proposals built on read across or category approaches. This means that the testing proposal was not about testing the registered substance but another substance - an analogue or a member of a wider category or group. “In these cases, the registrant needs to present a more thorough assessment. It is not enough to assess whether testing is necessary but also whether the hypothesis for the read across or analogue approach is acceptable and sufficiently justified. Unfortunately, in most cases we found that the justifications were not adequate for accepting the testing strategy or approach proposed by the registrants.” Cases proposing read across, category or grouping approaches are complex and therefore mainly still in the draft decision phase. “In many cases ECHA has had to reject the approach and simply request a test on the registered substance(s),” Ms Ylä-Mononen clarifies.
ECHA encourages registrants to improve their justifications and the substance identity information. “The ball is, in many cases, thrown back to the registrant. Hopefully they can make a better justification for their approach so that we can avoid any unnecessary animal testing.”
COMMISSION TO DECIDE ON THE NEW OECD TEST GUIDELINE
After the first registration deadline, in July 2011, a new test guideline addressing reproduction toxicity (extended one-generation reproductive toxicity study, EOGRTS) was adopted by the OECD. Soon after the adoption of this new test guideline, ECHA announced that the test could, with certain conditions, be used instead of the two-generation test, which is the current information requirement. When addressing testing proposals for reproduction toxicity, ECHA has in the draft decisions, proposed to give the choice between the two methods to the registrant. However, these draft decisions have not received backing by all Member States and the Member State Committee has not reached an agreement on the issue. Consequently, ECHA has been obliged to send already nearly fifty proposals to the Commission for decision making.
“The Commission has been working together with ECHA and the Member States to find a consensus, and we hope that it will reach a decision soon. It has already been one and a half years that we have not been able to issue any decision concerning this important endpoint. Next year, as we are moving on with the compliance checks we need to have a clear path on how to proceed. Uncertainty is also not good for the companies: they have an information gap but cannot move forward,” Leena Ylä-Mononen says, and continues, “the Commission is clear that it wants to add the EOGRTS into the test method regulation as well as update Annexes IX and X of REACH to allow this new guideline to take preference, but this is still work in progress and so far the Commission has not concluded on any of the cases referred to it.”
LOOKING AHEAD
The work on testing proposals will continue in 2013, as ECHA still needs to conclude 290 pending cases with a final decision. Another area of intense work will be the compliance checks. “In 2013, we aim to reach the 5 % target of compliance checks for the substances manufactured in the highest tonnages. It is an ambitious target, which will continue to keep us very busy. In addition, the next wave of testing proposals will arrive with the second REACH deadline at the end of May. We have until 1 June 2016 to process those. We now have learnt our lessons from the first wave and will tackle the potential substance identity issues upfront so that we can proceed with the examination of testing proposals more smoothly,” Leena Ylä-Mononen says.
In addition, new testing proposals for non phase-in substances are constantly submitted to ECHA. Those need to be processed in 180 days. “Our estimation at present is 50 new testing proposals per year. The 180-day legal deadline is demanding especially if the proposal involves testing with vertebrate animals and we need to launch a third party consultation.”
The testing proposal examination has been a learning experience for ECHA and great proof that the whole Agency can function well together to reach a common goal. “ECHA has really managed to recruit top experts in their field,” says Ms Ylä-Mononen, and carries on “we should not forget the invaluable cooperation with the Member States and the Member State Committee. The scientific discussions have been extremely useful and given us clear direction.”
FURTHER INFOMATION
ECHA examines testing proposals from the first REACH deadline, Press release 3 December 2012http://echa.europa.eu/view-article/-/journal_content/adee7857-f7cd-4842-b7e2-0da69e8a1f15
ECHA publishes its decisions on dossier evaluation
ECHA has started publishing non-confidential versions of dos-sier evaluation decisions originating from the compliance checks and examination of testing proposals. These documents provide a unique insight into the Agency’s decision-making process. Regis-trants and other stakeholders can now see how ECHA reaches its decisions, and better understand the rationale behind them.
The database of final dossier evaluation decisions is available on the ECHA website and anyone can access it. Users can search the da-tabase by evaluation process, deci-sion number, date of issue, and also by the substance name, EC or CAS number when this data is public.
Looking at the published decisions, registrants can learn how ECHA as-sesses the documentation and the arguments included in the dossiers. For example, in cases of compli-ance check, registrants can under-stand how certain argumentations for the adaptation of information requirements may have not been accepted by ECHA, and see what was missing in the proposed adap-tations. This way, they may be able to prepare better documentation for future occasions. The decisions also show what type of argumenta-tion ECHA can accept.
The publication of the decisions should also help companies, especially smaller companies with less expertise in the regulatory language, to see what decisions look like, and better understand a decision relevant to their own dos-siers. It will also benefit non-gov-ernmental organisations and other interested parties. Not only does the evaluation process become more transparent, but also those who have provided comments dur-ing a public consultation, can now see how ECHA addresses those arguments in the full context of the decision.
For many, the dossier evaluation decisions can become an entry point for the information available
on a particular substance. Along with the decisions, users can find a link to the registered substances database which provides all the non-confidential data available from the registered substances.
CONFIDENTIALITY CLAIMS TAKEN INTO ACCOUNT
ECHA has taken the necessary steps to safe guard the confidential information that may be included in the evaluation decision. All the data claimed confidential in the dossiers has been blanked out from the pub-lished decision. In the future, when registrants receive a dossier evalu-ation decision, they will also receive the non-confidential version of the decision. This version will protect the information that the registrant claimed confidential when submit-ting the technical dossier.
TEXT BY EDUARDO ALONSO
Before the decision is published, registrants will have the possibility to comment on the public version and request further information to remain confidential. In these cases, compa-nies will have to provide valid justi-fication on why publishing certain information could harm their com-mercial interests. ECHA will assess these argumentations on a case-by-case basis.
ECHA has published more than 70 evaluation decisions so far, and will publish more decisions as soon as the registrants have been notified and offered a chance to comment on the non-confidential version. In the future, the Agency aims to publish decisions on a regular basis.
DID YOU KNOW? Dossier evaluation work involves examining testing proposals and checking dossiers for compliance with REACH.
ECHA initiates compliance checks for at least 5 % of all dossiers received within each tonnage band. ECHA can decide which dossiers to check and whether only part of any dossier will be investigated. The REACH Regulation provides dossier selection criteria but additional criteria are used, including a random selection. A compliance check can start at any time in respect of any dossier.
ECHA evaluates all testing proposals within set deadlines. For non-phase-in substances, the examination takes place within 180 days of receipt of a dossier with a testing proposal. For phase-in substances there are three examination deadlines (1 December 2012, 1 June 2016 and 1 June 2022) depending on the registration deadlines.
Help is at hand to improve assessment of the environ-mental impacts of chemicals - specific environmental release categories (SpERCs).
REACH requires that registrants prepare a chemical safety assess-ment defining the conditions of use for substances that are produced over 10 tonnes per year. If the sub-stance is considered hazardous, the registrant is required to prepare an exposure scenario laying down the appropriate risk assessment meas-ures to ensure that the chemical can be used safely. Assessing the environmental effects originating from the use of a chemical is part of these processes. This assess-ment was not required prior to REACH and therefore poses a new challenge for registrants and down-stream users. This is where the so called specific environmental release categories come into play.
Specific environmental release categories (SpERCs) are sets of information that characterise spe-cific conditions during the use of a substance and provide correspond-ing environmental release factors for this use. This information will help registrants to estimate re-leases during the use of a chemical e.g. to air, water and soil, and help in identifying the proper risk manage-ment measures. SpERCs are usu-ally developed by different sector organisations and documented in SpERC factsheets.
“We hope that the sector organi-sations develop new high quality SpERCs, improve and update the existing ones and that the reg-istrants really use them. Using SpERCs will result in better quality information for the chemical safety report and the exposure scenario for communication downstream,” says Hélène Magaud from ECHA’s Computational Assessment Unit.
“Chesar can take the full set of infor-mation – such as the SpERC refer-ence, the conditions of use for the exposure scenarios and the related release factors as well as the expla-nations and justifications for those release factors – from the SpERC file and feed it directly into the chemical safety report. As far as I know, other similar tools can only incorporate partial information from the SpERCs, namely the release factors, which leads to a less transparent environ-mental assessment,” Ms Magaud says.
The European Chemical Industry Council (Cefic) has recently published updated guidance on SpERCs, which includes instructions for improving their documentation. It also contains a mapping of the information re-quirements in Chesar and the SpERC factsheets. This guidance is useful for those developing SpERCs.
FURTHER INFORMATION
ECHA Guidance on Information Requirements & Chemical Safety Assessment, chapter R.16: Exposure estimation related to the environ-menthttp://echa.europa.eu/guidance-documents/guidance-on-information-requirements-and-chemical-safety-assessment
ECHA documentation on the use of SpERCs in Chesar – Chesar 2 User manual: Part 6 – Library http://chesar.echa.europa.eu/docu-ments/2326902/2424433/chesar2_user_manual_part6_en.pdf
Cefic guidance on Specific Environ-mental Release Categories (SPERCs)Chemical Safety Assessments, Supply Chain Communication and Downstream User Compliancehttp://www.cefic.org/Documents/Indus-trySupport/REACH%20Implementation/SPERC%20Guidance.pdf
BENEFITS OF SPERCS
SpERCs are designed to help iden-tify realistic conditions of use at sector level and the corresponding environmental release factors. By using SpERCs, registrants will be able to include realistic conditions of use into the extended safety data sheet sent to their supply chain. Consequently, when down-stream users receive the extended safety data sheet from suppliers, it will be easier for them to compare their own conditions of use with the conditions described in the expo-sure scenario.
Using SpERCs increases the ef-ficiency of preparing registration dossiers by providing easier access to information on conditions of use as well as a more harmonised presentation of the information. In addition, SpERC information can be reused for many substances. They are also expected to enable consist-ent exposure scenario information across suppliers of the same sub-stance and across substances being part of the same mixture.
From ECHA’s point of view, SpERC based information can increase authorities' understanding of the environmental assessments and lead to better decision making e.g. on evaluation, the identification of substances of high concern, or restrictions.
CHESAR SUPPORTS SPERCS
Chesar, ECHA’s IT application to help with chemical safety assess-ments, supports the use of SpERC information in the preparation of the chemical safety reports. It is im-portant, however, to make sure that the SpERC includes all the infor-mation required for a high quality chemical safety report.
ing and communicating the information they receive from manufacturers. The sectors exemplified were the lubri-cants, coatings and adhesives sectors.
Although one approach does not fit all, the meeting concluded that the presented case studies were an incen-tive to start developing sector specific solutions. For example, the approach taken by the lubricants sector, which is due to be published by the end of the year, is based on generic exposure scenarios for the main use groups and typical compositions. This approach could be relevant for similar industry sectors which have a mature product range, a short supply chain and a reasonably well defined and struc-tured sector.
NEW TOOLS DEVELOPED
Since the ENES meeting in May, the industry sectors have made a lot of progress in providing tools to help those who have to carry out safety assessment and exposure scenarios. ENES3 discussed the specific environ-mental release categories (SpERCs), the specific consumer exposure de-terminants (SCEDs) as well as the use mapping library.
The SpERCs will help companies to refine the inputs for the exposure estimation for the environment, so that people have a more accurate es-timation of the environmental impact
and how to control it. The SCEDs are a similar approach for products which will go into the consumer domain.
The use mapping library, developed by the European Chemical Industry Coun-cil (Cefic) and the Downstream Users of Chemicals Coordination Group (DUCC), helps registrants who pre-pare the chemical safety assessment and report in the technical dossier by encouraging downstream users to provide registrants with a broader set of information on how and under what conditions they use the substances. This will eventually improve the quality of communication down the supply chain in the form of safety data sheets. In addition, downstream users can be more assured that their use is cov-ered by the registrant submitting the REACH dossier.
SCALING REMAINS A CHALLENGE
Despite the advancements made in developing supporting tools and shar-ing best practice, the meeting was not all plain sailing. Downstream users are currently struggling with the exposure scenarios received from suppliers from the first registration deadline and are unsure whether they are able to cover their conditions of use with the registrants’ exposure scenario. This is where the concept of scaling comes in. Scaling is about the risk bounda-ries of the exposure scenario. It is a mathematical tool to assess whether
TEXT BY HANNA-KAISA TORKKELI
The third meeting of the Exchange Network on Exposure Scenarios (ENES) in November discussed topics such as exposure scenarios for mixtures, preparing and com-municating good quality chemical safety assessments, scaling, and the progress made since the previous meeting in May 2012.
The meeting concluded that signifi-cant development has been made by industry on exposure scenarios as well as communication in the supply chain. Nevertheless, effort is still needed to raise awareness of the work and share best practice to an even wider group of sectors to make the benefits of REACH have an impact in the long term.
HELPING MIXTURE FORMULA-TORS IN PREPARING SAFETY DATA SHEETS
Although REACH regulates sub-stances, its legal duties also apply to the millions of mixtures placed on the market that may pose a risk to human health or the environment. One of the legal duties of formulators is to com-municate enough information down the supply chain to allow the safe use of their products.
Formulators receive a wealth of safety information about the specific substances they use as ‘ingredients’ in their mixtures from the extended safety data sheet. This combines the traditional safety data sheet with an exposure scenario. The challenge that mixture formulators are facing is to understand, consolidate and communi-cate this information down the supply chain to promote the safe use of their mixture. ECHA tabled some principles for discussion at the meeting that may help formulators to work through this task systematically.
The ENES3 meeting looked at four case studies from different sectors on how to support formulators in process-
REACH exposure scenarios are discussed in the meetings of the Exchange Network for Exposure Scenarios. The third meeting of the network took place in November in Brussels.
ENES aims to identify good industry practice on drafting exposure scenarios and building a dialogue between supply chain actors to improve the protection of human health and the environment. ECHA, the European Chemical Industry Council (Cefic), Eurometaux, CONCAWE (the oil companies’ European association), the European Association of Chemical Distributors (Fecc) and the International Association for Soaps, Detergents and Maintenance Products (AISE) on behalf of the Downstream Users of Chemicals Coordination Group (DUCC), have established the cross-sector collaborative network to share knowledge, techniques and approaches to building and applying (REACH) exposure scenarios.
Safety data sheets include information about: the properties of a substance; its hazards; instructions for handling; disposal and transport; and also first-aid, fire-fighting and exposure control measures. They are the main tool for ensuring that manufacturers and importers communicate enough information along the supply chain to allow safe use of their substances and mixtures.
An exposure scenario contains the appropriate risk management measures and operational conditions to ensure that all the risks arising from the use of a substance can be controlled adequately. Exposure scenarios may appear in an annex of the safety data sheet, in which case the document is referred to as an 'extended safety data sheet'.
the downstream user can still use the substance within a boundary of adequate control described in the exposure scenario.
The ENES3 meeting concluded that the issue of scaling needs further work and that a clear understanding needs to be achieved before ECHA revises its guidance for downstream users in 2013.
LOOKING BEYOND 2013
Many of the topics discussed at the ENES meetings aim to help regis-trants prepare for the 2013 deadline or to assist registrants who have to update their dossiers. However, a long term perspective is needed to also ensure a target-oriented devel-opment beyond 2013. To that end, the meeting participants received an update from the ENES coordination group on setting a road map and a long term action plan. The road map and action plan include ideas from the different players – authorities, the industry sectors and Member States – on what improvements can still be made on exposure scenarios. The road map and the action plan will be published by summer 2013.
FURTHER INFORMATION
Summary, presentations and case studies: http://echa.europa.eu/view-article/-/journal_content/850ed1fa-f5e5-490e-ad67-4224b230d271
New tools developed
Cefic The overview table of all sector associations’ activities related to ES/CSA can be found here: http://www.cefic.org/Industry-support/Implementing-reach/Libraries/
Information on the ESCOM, SPERCs etc. under Cefic guidance and tools: http://www.cefic.org/Industry-support/Implementing-reach/Guidances-and-Tools1/
Downstream users (DUCC)All guidance and tools published by DUCC, including the UseR template: http://www.ducc.eu/Publications.aspx
“From an authority point of view, it has been really instructive to better understand where industry met problems while building their exposure scenarios and to have the opportunity to share our comments and experience during substance evaluation in order to improve the quality of these exposure scenarios. It has also been a good opportunity for exposure experts from different Member States to meet and to communicate their difficulties. This network is not only a network between manufacturers, downstream users and end users, it has also become a place where Member States can exchange views.” Dr Cécile Rousseau, ANSES, mandated national institution on behalf of the French competent authority
Our stakeholders’ views on ENES
“The collaboration between industry, ECHA and other stakeholders through the ENES workshops has come a long way and resulted in many accomplishments, such as improvement in the quality of chemical safety report author-ing; development, harmonisation and sharing of best practices for exposure scenarios for substances; realisation of specific environmental release categories (SpERCs); the ongoing work to catalogue standard phrase libraries and codes; and the evolution of common views between industry, ECHA and the Member States on the concept and boundaries of scaling.” Dr Steven Signs, the Lubrizol Corporation
“The major added value of ENES is in providing all stakeholders with an overview of the current deficiencies and the different initiatives to overcome the practical difficulties for implementation of the communication of exposure scenarios in the supply chain. ENES also allows streamlining the work towards improvements in the supply chain communication based on the common accord gained within the network. The work on a cross stake-holder road map will help in making this valuable progress of ENES more concrete and tangible to a broader audience of affected stakeholders.”Eugen Anwander, Vorarlberg State Government, Austrian enforcement authority
“I am impressed by the positive atmosphere in the meeting. And I realize the importance of ENES as part of ECHA in relation to the practical use of chemicals.”Janna Koppe, Women in Europe for a Common Future (WECF)
“In view of the complexity of the subject and all facets of it, the network has made significant progress since the start. Further promotion of what has already been achieved and formalising good practice, even standard-setting, should further happen.”Sylvie Lemoine, A.I.S.E.
Ms Cromnier is Director General of the Swedish Chemicals Agency and has been a member of ECHA’s Board since 2010. Her interest in chemicals started from an early age at school because of an excellent chemistry teacher. She studied chemical engineering in Stockholm and took a second degree in business administration focusing on policies and organisational change.
LONG EXPERIENCE IN CHEMICALS MANAGEMENT
Nina Cromnier started her career at the Swedish Environmental Agency and the Swedish Waste Research Council, changing then to the Ministry of Environment, her last position being the Director for Chemicals and Waste Division. She led EU delegations to international negotiation meetings under the auspices of the UN Environment Programme. During the Swedish Presidency of the EU in 2009, she chaired the EU’s international working group on chemical issues. Since 2010, Ms Cromnier has led the Swedish Chemicals Agency Kemi, an authority working on chemicals, biocides and pesticides.
”I am interested in making the REACH processes work – for example, the quality of registration dossiers is important for the credibility of the whole system. Identifying and addressing chemicals of concern is crucial for the environment and human health,” she explains.
STRATEGIC DEVELOPMENT OF ECHA A PRIORITY
Strategic development of organisations is one of her professional interests. ”I am interested in the further strategic development of ECHA. It will be a challenge to integrate new tasks related to PIC and Biocides with limited resources. On the other hand, it is a great possibility to create new working methods and procedures. My main goal is to support the Agency in achieving its
Nina Cromnier leads ECHA's Management Board
interview
The new chair of ECHA's Management Board, Ms Nina Cromnier, sees further strategic development of the Agency as her main objective.
Nina Cromnier started as Chair of ECHA’s Management Board in October 2012. Her goal is to support the Agency in achieving its strategic aims and fulfilling its vision and mission.
INTERVIEW BY BY TIIU BRÄUTIGAM
strategic aims and fulfilling its vision and mission,” she continues.
In her opinion, there are many similarities between ECHA and Kemi. ”The staff in both organisations have good scientific competence and solid skills to do the demanding work. Resource constraints are present - also Kemi needs to prioritise its tasks for the coming years. For the Swedish authority, the financial situation is quite stable until 2014, but it is hard to plan for the years after that.”
Cooperation with different stakeholders plays an important role for both authorities. For example, Kemi organises an annual conference on a toxic-free environment to increase the dialogue between different actors; ECHA invites stakeholders to Stakeholder days and different workshops.
”Regarding the cooperation, it is always important to find the right balance between our basic values: transparency, efficiency and democracy,” she explains.
LOOKING FORWARD TO THE NEW TASK
”ECHA is a very impressive organisation for me. It had been built up extremely fast – meeting all deadlines was a very challenging and significant achievement. The Agency’s staff is very competent and working in an effective manner. I am really looking forward to the cooperation,” Ms Cromnier says.
With her previous experience in chairing global negotiations, she is well prepared to find solutions for complex issues and dealing with cultural differences. ”The former Chair, Thomas Jakl, did an excellent job. It is always a challenge to take over from someone who has performed well and I will do my best in this new task.”
• Workshop on dissemination for biocides: 15 January 2013
• Public C&L Inventory workshop: 15 January 2013
• Nanomaterials working group: 21-23 January 2013
• Seminar on applications for authorisation: 11-12 February 2013 http://echa.europa.eu/view-article/-/jour-nal_content/33f61510-49e4-43dc-93da-26ffa49a83e4
• Substance identification sameness workshop: 13-14 February
Tentative dates:
• Member State Committee (MSC): 4-8 February 2013
Webinars:
• Last minute webinar on dossier submission for lead registrants: February 2013
• How to prepare/fill in the member dossier: February 2013
• How to submit the member dossier: March 2013
Event Calendar
International cooperation
Visits to ECHA
17-19 December 2012: Study visit of Croatian Authorities to the ECHA Helpdesk and to the Finnish REACH and CLP Helpdesk, under ECHA’s IPA project
Events
28-29 January 2013: ECHA’s Workshop for Croatian enforcement authorities under ECHA’s IPA project, Zagreb, Croatia
Directors from the Member State competent authorities came to ECHA on 8 November to discuss joint planning for 2013-16 and the Agency’s strategic objectives.
The aim of the meeting was to improve cooperation between ECHA and the Member States and to receive feed-back on ECHA’s next Multi-annual work programme, built on the Agency’s four strategic objectives.
COMMON PLANS TO IMPROVE SAFETY OF CHEMICALS IN EUROPE
To have an overall picture of substance evaluation and risk management meas-ures for the coming years, the Agency had collected plans from the Member States. The Executive Director Geert Dancet emphasised that reaching these common goals required joint effort and commitment from all parties. The Agency was ready to support national authorities through training, workshops and guidance. The capacity-building was important especially for those countries which did not have much previous expe-rience with these tasks.
With regard to identifying and ad-dressing chemicals of concern, the participants supported ECHA’s plans to help the Member States with risk management measures. However, they emphasised a need to prioritise these
measures on a national level. The expectations regarding quantitative targets should also be proportionate to the size of the countries.
Several Directors mentioned the unsure national financial situation and highlighted the need for more political support to ensure enough resources for the work. The Commis-sion also introduced its draft 2020 roadmap.
QUALITY OF REGISTRATION DOSSIERS IN FOCUS
The participants held a long discus-sion regarding the quality of registra-tion dossiers and various methods to improve them. Both carrots and sticks were needed. However, many stated that small and medium enter-prises and downstream users espe-cially needed more support to comply with the new obligations. To ensure effective enforcement throughout Europe, a close cooperation with countries through the Forum and with customs authorities was crucial.
IMPROVE EFFICIENCY IN ALL PROCESSES
To improve efficiency, all Member States should ensure their access to the IUCLID database. The Direc-tors believed that REACH-related
data could also be used for the imple-mentation of other legislation. They discussed how IT could further help with efficiency gains and whether ECHA’s communication channels could be simplified. With ECHA’s new tasks on biocides, synergies should be found with the REACH and CLP legislation.
Directors of national authorities support ECHA’s strategyTEXT BY BY TIIU BRÄUTIGAM
The European Consumers’ Organisation, BEUC, published a report report last year on consumers’ possibility to get information from retailers about substances of very high concern (SVHCs) in articles. The report concluded that it was not easy for consumers to get this information and retailers were also often not even aware of this new obligation.
Ms Sylvia Maurer, Senior Policy Officer at The European Consumers’ Organisation, BEUC - what has BEUC done in order to communicate about Article 33 to consumers?
BEUC has cooperated with national consumer associations in Member States and a draft letter has been produced for consumers to use in order to request the information from retailers. Last year we also published a leaflet for consumers on how to request information from retailers. The translated versions of the draft letter and the leaflet can now be found on many consumer associations’ websites. Articles have also been published in consumer association magazines, for instance in Sweden, Denmark, Austria and Greece.
What in your opinion is the main problem with fulfilling the requirements of the Article 33?
The companies do not have an obligation to answer if the product does not contain substances of very high concern. In those cases, the consumers might not get any reply at all, which is a problem.
Helping consumers to request information about substances of very high concern in articles
INNOVATIVE SOLUTIONS
The German chapter of the Friends of the Earth, BUND, has developed an online tool in cooperation with the German Environmental Agency. Consumers can enter a product barcode number in the tool and a request is then automatically sent to the product manufacturer.
Mr Jurek Vengels Policy Officer for Chemicals Policy and Nanotechnology, Friends of the Earth, Germany - what products does the service cover?
The tool works very well with most barcodes. However, there are some companies that use their own barcode systems that the tool does not yet recognise. In those cases, consumers can download a sample letter from our website to exercise their right-to-know. All substances of very high concern on the REACH Candidate List are covered by the tool.
stakeholders
INTERVIEWS BY PIA FALLSTRÖM MUJKIĆ
Article 33 of the REACH Regulation gives European consumers the right to ask whether consumer articles contain the most harmful substances, also known as substances of very high concern (SVHCs). According to research, both consumers and retailers aren't aware of this possibility. To change this, many organisations are working to make it easier for consumers to benefit from the possibility.
Article 33 of REACH concerns the suppliers' duty to communicate information on substances of very high concern in articles.
The tool is the most visited part of BUND’s entire website. Several thousand consumers have already used it. We do not have precise figures on the response rate, because the companies answer direct to the consumers. However, we have heard from many consumers that they have not received a response. At the same time, some companies manage to answer within hours. There are huge differences when it comes to compliance with the right to know. We are now considering whether to investigate this further, and to publish examples of the best and worst practice in this respect.
Sources:
www.beuc.orgwww.bund.net http://www.chemicalshealthmonitor.org/spip.php?rubrique111 www.whatsinproducts.com 'How much are we told' report:
A model letter for requesting information from retailers and information on consumers’ right-to-know are available in national languages on the consumer association websites at least in Austria, Belgium, Denmark, Poland and Germany.
In Sweden, the information and model letter is available on the website of the Swedish Chemicals Agency.
According to Article 33 suppliers of articles containing SVHCs on the Candidate List shall, on the request of a consumer, provide the consumer with sufficient information to allow safe use of the article (including the name of the SVHC). The information shall be provided free of charge within 45 days.
Data on Candidate List substances in articles:http://echa.europa.eu/information-on-chemicals/candidate-list-substances-in-articles
ECHA and its stakeholders at the same tableStrategic objectives in the spotlight
Accredited Stakeholder Organisations repre-senting industry, academia, animal-welfare and environmental NGOs and the social sector, met in Brussels to discuss future priorities and ways to enhance cooperation.
The focus of this year’s workshop was on two of ECHA’s strategic priorities: improving the quality of data; identifying and addressing chemicals of concern. These objectives, and ways of reaching them, will be reflected in the Multi-Annual Work Programme 2014-2018. An-other key topic of the one-day event was cooperating through ECHA’s Committees.
DIFFERENT VIEWS - SHARED RECOMMENDATIONS
Participants broke into groups to discuss the topics, offering different perspectives and concluding on a number of shared recommendations for the Agency to consider.
Christa Hennes from the European Centre for Ecotoxi-cology and Toxicology of Chemicals (ECETOC) took part in the Committee discussion.
“It was a timely topic for ECETOC which is looking to be more active in the Agency’s work,” she said, welcom-ing the opportunity to share her view that the current scope of involvement is too substance focused.
“There should be some consideration about how more general scientific input can be brought into the work of the Risk Assessment Committee.”
Kirsty Reid from the Eurogroup for Animals joined the group discussion on better chemicals management. It recommended clearer explanations about interactions between REACH and other legislations to promote bet-ter data sharing and new scientific methods, as well as reducing animal test duplications.
“These (scientific) methods look at replacing, reducing or refining animal experimentation. We’d like to see them taken up as soon as possible because the quicker they are integrated into REACH the quicker they’ll be used.”
David Carlander from the Nanotechnologies Industries Association was involved in the group looking at the importance of high quality data.
The focus of this year’s workshop was on two of ECHA’s strategic priorities: improving the quality of data; and using it intelligently. Here some of the participants are in a breakout session with ECHA's Director Leena Ylä-Mononen and Press Officer Mikko Väänänen.
“There have been difficulties in generating data in the nanotechnology field, due to missing information that is now remedied due to the recent European definition, JRC reports and updated ECHA guidance,” Dr Carlander said, welcoming the Agency’s active work in the field.
“It’s important to take the message back to members about the usefulness of putting in the effort to provide good quality data,” he said, following the group discus-sions he described as “useful, open and transparent”.
“Understanding and listening to where everyone was coming from helped get a common understanding of the difficulties we are all facing.”
MOVING FORWARD
The workshop recommendations will be taken into account in the Multi-Annual Work Programme and suggestions on Committee work will be given to the Committee chairs. More detailed information will be available in the workshop proceedings document to be published on the ECHA website.
The Accredited Stakeholder Workshop is a recur-ring event designed to facilitate open and strategic discussions between different stakeholder groups and ECHA.
Accredited Stakeholder Organisations representing industry, academia, animal-welfare and environmental NGOs and the social sector, meet regularly with ECHA to openly discuss topical issues.
containing testing propos-als for vertebrate animals
393 42 435
No of endpoints
covered by registered testing proposals
981 116 1 097
covered by registered testing proposals for
vertebrate animals649 68 717
No of public third party consultations
closed 465 48 513ongoing on
30 November 20120 0 0
planned 6 0 6Dossiers with testing proposals opened for examination 2
584 89** 673
Draft Decision sent to the registrant 3 295 25 320
Final Decision sent to the registrant 146 36 182Terminated testing proposal examinations 4 124 20 144
1 Successfully registered (accepted and fee paid). Note: this number changes over time as dossiers may be updated by the registrant (e.g. test endpoints added and/or withdrawn)2 Dossiers ever opened for examination notwithstanding their current status.3 Draft decisions which did not become final by 30 November 2012 nor withdrawn due to termination of testing proposal examination (TPE).4 Terminated either at the decision-making stage and/or upon further information provided by the registrant (e.g. cease of manufacture, tonnage downgrade or withdrawal of a testing proposal).
TABLE A. Testing proposals: dossiers received and output processed between 1 June 2008 and 30 November 2012.
Phase-in Non phase-in TotalNo of dossiers opened for compliance check1 539 146 685Draft Decision sent to the registrant 2 120 3 123Final Decision sent to the registrant 134 47 181Only Quality Observation Letter sent to the registrant 3
13 47 60
Terminated compliance checks4 68 45 113
TABLE B. Compliance check: dossiers and output processed between 1 June 2008 and 30 November 2012.
1 Dossiers ever opened for compliance check notwithstanding their current status.2 Draft decisions which did not become final by 30 November 2012.3 Some additional quality observation letters have been sent together with draft decisions, but are not counted here.4 Terminated upon further information being provided by the registrant or terminated without administrative action.
Evaluation statisticsREPORT ON DOSSIER EVALUATION ACCORDING TO ARTICLES 40 AND 41 REACH
Dossier evaluation covers the compliance checks of registration dossiers and the examination 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, and thereby avoid unnecessary animal testing. Testing proposals that involve tests on vertebrate animals are published 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 infor-mation requirements. At least 5 % of the dossiers received by ECHA per tonnage band are checked for compliance. Details of the REACH dossier evaluation processes can be found at:http://echa.europa.eu/documents/10162/17207/procedure_dossier_evaluation_20110329_en.pdf.The results obtained so far can be found in the annual progress report on evaluation: http://echa.europa.eu/evaluation
Tables A to C report on the dossier evaluation processes from 1 June 2008 to 30 November 2012. The phase-in status is reported as indicated by the registrant in the dossier and this may have changed when the dossier has been updat-ed. The dossier updates may also have testing proposals withdrawn or new ones submitted.
* Phase-in: substances subject to transitional arrangements in the REACH registration
** Some registration dossiers were opened for examination more than once, hence the difference vs. the number of registered dossiers.
annankatu 18, p.o. box 400, fi-00121 helsinki, finland | echa.europa.eu
Phase-in
No of registration dossiers 2 19 772
5% target for the compliance checks on registration dossiers motivated by the 2010 deadline 3 989
No of dossiers opened for compliance check 4 493
Draft Decision sent to the registrant 5 97
Final Decision sent to the registrant 123
Only Quality Observation Letter sent to the registrant 6 9
Terminated compliance checks 7 56
1 Dossiers for normal registrations and transported isolated intermediates which comply with the criteria for the first REACH dossier submission deadline for phase-in substances (1 December 2010). Submissions containing more then one type of registration in one submission (combined submissions containing e.g. both a normal registration and a registration as transported intermediate) are accounted for only once and only if one of the registration types within such a submission satisfies the criteria of the 2010 registration deadline. 2 All submissions registered by 1 December 2010 including those which were handled with a delay.3 This is the target for the 19 772 registration dossiers motivated by the 2010 deadline. According to Article 41(5) of the REACH Regulation ECHA shall select for compliance check at least 5 % of the registration dossiers received by the Agency for each tonnage band. 4 Dossiers which meet the 2010 registration deadline criteria and that have been ever opened for compliance check notwithstanding their current status.5 Draft decisions which did not become final by 30 November 2012.6 Some additional quality observation letters have been sent together with draft decisions, but are not counted here.7 Terminated upon further information being provided by the registrant or terminated without administrative action.
TABLE C. Status of compliance checks on registration dossiers motivated by the 2010 deadline 1
October 2012Corrigenda to the following parts and chapters of the Guidance on Information Requirements and Chemical Safety Assessment: • Part D: Exposure scenario building • Part G: Extending the SDS• Chapter R.13. RMM library • Chapter R.15 Consumer exposure estimation • Chapter R.16 Environment exposure estimation • Chapter R.17 Estimation of exposure from articles • Chapter R.18: Exposure scenario building and environmental
November 2012Guidance on the Application of the CLP Criteria (update of Part 3 - Health Hazards relating to specific concentration limits (SCLs) for 4 hazard classes, and the inclusion of a new Annex)
Practical guide 3: How to report robust study summaries (update) http://echa.europa.eu/practical-guides
Corrigendum to the Guidance for Annex V http://echa.europa.eu/guidance-documents/guidance-on-reach
Corrigenda to the following chapters of the IR&CSA Guidance: • Chapter R7:Endpoint specific guidance (chapters: R7b and R7c) • Chapter R.8 Characterization of dose [concentration]-response
for human health • Chapter R.11 PBT Assessment • Chapter R.14. Occupational exposure assessment • Chapter R.19: Uncertainty analysis • Chapter R.20: Table of terms and abbreviation • Exposure Scenario Format
