ECHA

ECHA´s sixth Stakeholders' Day on 18 May gathered around 460 participants in Helsinki. A video recording and the presentations of the event are available on the ECHA website.

One of the most important messages of this year´s Stakeholder Day was: To be ready by the 2013 deadline, you need to start the preparations now. Executive Director, Geert Dancet, congratulated registrants, Lead Registrants and all notifiers. He said that more information on substances is now available than ever before. The process will extend beyond 2018. The quality of the dossiers received may not always have been of the kind that ECHA would have liked to have seen, he said, reminding companies to update their dossiers whenever needed.

No time to lose

ECHA's Director of Registration, Christel Musset, called on the registrants to get ready for the deadline which is on 31 May 2013 and concerns phase-in substances from 100 to 1000 tonnes per year and per manufacturer or importer.

Ms Musset said experience has shown that it takes in average one year to prepare the chemical safety assessment and the chemical safety report after the registrants have collected all data on the properties of the substance and all hazard data. The SIEF members should be ready with substance identity clarification, data sharing and hazard data gathering in the next seven months, by the end of 2011. Ms Musset reminded the 2010 Lead Registrants of their responsibilities towards the new registrants and said that non-EU manufacturers should make sure that their importer or Only Representative also gets ready for the 2013 deadline.

ECHA expects to receive less than 15 000 dossiers for about 3500 substances. These early figures are based on 2007 estimates which were revised after the first registration deadline.

Smaller SIEFs, less data available

Mr Jan Schüller, Director REACH & Regulatory Affairs EMEA at Eastman Chemical B.V thinks that there may be more than 3500 substances registered by 2013 and there will be smaller SIEFs registering specialty chemicals and less consortia or SIEF Leadership Teams. "I expect to see more SIEFs run by just the Lead Registrant, who has to do all the work, and others will just buy in to the end results and buy a letter of ac­cess," said Mr Schüller. He estimates that there is less data available this time. A scientific justification is needed for test­ing proposals using alternative methods, he reminded. "More of those proposals will be need for 2013, as we expect the substances to be less data-rich".

Make a strong case

ECHA´s Head of Risk Management Im­plementation Unit, Matti Vainio, gave an overview of authorisation and restric­tions. He underlined that risk manage­ment under REACH happens above all in the industry that is registering sub­stances, assessing their chemical safety and sharing the information in the sup­ply chain.Mr Vainio said that ECHA informs the registrants if a restriction is planned for their substance. As the REACH restric­tions will apply throughout the EU, they create a level playing field for companies. Restrictions usually lead to technical innovations that benefit workers and reward innovators. Applicants for au­thorisation should make a strong case. The authorisation is given for a limited period, so it is good to look for alterna­tives, recommended Mr Vainio.

Challenges and tools

Scientific Officer, Lisa Anfält, from ECHA explained that producers and importers of articles need to notify Candidate List substances in articles to ECHA, if their total volume in the articles is more than one tonne per year and the substance is present in the article above a concentra­tion of 0.1% weight by weight. Compa­nies also need to pass on information down the supply chain or to consumers on request.

A notification is not needed if the pro­ducer or importer can exclude exposure to humans or the environment during normal and reasonably foreseeable con­ditions of use, including disposal, or if the substance has already been registered for that use, said Ms Anfält. Ms Sylvie Lemoine, Director for Techni­cal and Regulatory Affairs at the Interna­tional Association for Soaps, Detergents and Maintenance Products (A.I.S.E.), presented the view of downstream users who are taking up the challenge. Read her interview on page 24.Senior Scientific Officer Hélène Magaud presented the Chesar tool in detail and explained how it can be used for chemi­cal safety assessments and reporting, to create chemical safety reports and prepare exposure scenarios for the safety data sheet.

Dissemination is crucial

Scientific Officer, Catherine Cornu, from ECHA showed how the Agency is dis­seminating information from registra­tion dossiers on its website. ECHA´s dis­semination portal is participating in the OECD eChemPortal where searches by chemical properties are possible. ECHA is linking the substances in its dissemina­tion database to the eChemPortal and will add a link to the portal from its own dissemination web page in future. Ms Cornu introduced the tools with which registrants can find out which information from a dossier will be dis­seminated. By 18 May, 95% of the phase-in substances and 77% of all substances had been disseminated.

NGOs expect more information

Ms Tatiana Santos Otero, Chemical Ex­pert at Spanish Union Institute of Work, Environment and Health (ISTAS), dis­cussed dissemination from a civil society perspective. She said that ECHA should better ensure the balance between pri­vate and public interests and improve the dissemination page. There was improve­ment already, she acknowledged. But she stressed that the quality of industry data is crucial for the protection of workers and public interest.The civil society did not see their inter­ests represented in the dissemination process until an Advisory Group for Dis­semination was set up in 2009. "So far we have discussed very important issues, and now we feel part of the process," Ms Santos Otero confirmed. She said that the way ECHA assesses confidentiality claims should be more transparent.

Feedback on evaluation

Head of Evaluation II, Norbert Fedtke, explained how dossier and substance evaluation works and how ECHA can request for more information from reg­istrants. A detailed process description is available on ECHA's website. Mr Fedtke said that it is very important to have, for instance, a clear description of the substance identity, to classify and label in line with the hazard data or with harmonised classification and labelling, and that robust study summaries should allow an independent assessment of the information provided. Mr Fedtke reminded that the registrant has several options to reply to ECHA´s comments. He also recommended that companies look at their intermediate dossiers and check they contain the required information described in the guidance. "You need to update your dos­sier when new information on hazards or uses becomes available," he reminded.

Animal tests could be avoided

Ms Michelle Thew, Chief Executive of the European Coalition to End Animal Experiments (ECEAE) referred to the REACH principle that animal testing should be the last resort. ECEAE have commented on all testing proposals in the public consultations so far. Ms Thew thinks that for a lot of the consulted tests, animal tests could be avoided and she said that in one consultation case, her or­ganisation found the data that belonged to the registrant proposing the test. ECEAE are pleased with some solutions reached, like avoidance of a 28 day and reproductive screening test; the possibil­ity to use in-vitro skin irritation tests and the new guidance on how to avoid un­necessary animal testing. However, there are still issues that need to be resolved. "If we get more specific information, we can provide more specific comments in the consultation," she said.

"You can do it"

The three sessions were each followed by question and answer sessions. Over 100 participants took the opportunity of meeting ECHA staff in one-to-one sessions. In his closing words, Geert Dancet re­minded that help, tools, documents, we­binars, translated news as well as indus­try associations´ support, are available for registrants. "Thousands of companies have already registered, or are preparing to register, so there is no reason why you could not do it," encouraged Mr Dancet.Over 40 stakeholders participated in the in-depth training on the Chesar tool in ECHA on 17 May. The next Stakeholders' Day will be held in 2012.

Stakeholders' Day video recordings and presentations