ECHA

ECHA's fourth Stakeholders´ Day brought 392 participants to Helsinki on 19 May. The programme focused in particular on advice to registrants and those who need to notify the classification and labelling of their chemicals. All presentations are available as videos and presentations on ECHA's website under "Events".

In the various sessions of the day, ECHA's scientists presented the latest tools that are available and gave tips on the preparation of a Chemical Safety Report and classification and labelling. ECHA hopes that registrants and notifiers will use the tools and provide ECHA with feedback. Participants were able to present their questions during the Question and Answer sessions, and a new approach where Lead and candidate Lead Registrants had the possibility to book, in advance, one-to-one sessions with ECHA's experts was introduced for this stakeholders' day. This opportunity was welcomed by the stakeholders, and ECHA intends to offer the sessions at the next Stakeholders' Day as well. For both the stakeholders and ECHA, the event provided a chance for networking and to get to see the faces behind the names.

"Want to hear your concerns"

"We are leading the world in our quest for safer chemicals that will protect human health and the environment and enhance competitiveness and innovation," said Executive Director Geert Dancet in his opening speech. "This year is crucial for you and us. Many of you need to register and even more of you need to notify your chemicals to ECHA.

Around 65 000 manufacturers and importers still need to react this year, and hundreds of thousands of downstream users will be affected." The Executive Director said that we all know that REACH and CLP are rather demanding, but the deadlines are fixed and ECHA asks the registrants and notifiers to respect them. He congratulated the SIEFs that are active now but stated that the number of received dossiers so far is not high. "We want to hear your concerns and answer your questions on the spot as much as we can and explain why we do things like we do" Mr Dancet stressed.

Useful tools

In view of the obligation to notify classification and labelling, Terhi Kuljukka- Rabb from ECHA's Classification and Labelling Unit reminded the audience that the first deadline is approaching fast. Substances on the market on 1 December 2010 must be notified to the Classification and Labelling Inventory, by 3 January 2011. All information concerning the notification is available on ECHA's website in the "CLP/Notification to the C&L Inventory" section.

Ms Kuljukka-Rabb discussed in detail the obligations and who is concerned. She also presented an option in the online notification tool, a button which allows the notifier to simply agree with a notification made by another registrant or notifier. In this case the classification and labelling fields will be automatically filled in. Sandrine Lefèvre-Brévart from the Scientific IT Tools Unit presented the IT tools which have been developed to assist notifiers. ECHA expects millions of notifications, and different types of users will be using the tools, from small and medium sized companies to large companies with huge databases of classification and labelling information. Ms Lefèvre-Brévart explained which tool is suitable for which type of submission and said that the Bulk Excel Tool has also been translated. "Do not wait until the last minute with your notification," she stressed.

Registration explained

"Every registrant has to know what is a Chemical Safety Report," emphasised Andreas Ahrens from the Guidance and Helpdesk Unit. He focused on the information requirements for the Chemical Safety Report, especially the practical conditions for safe manufacture and use, as well as risk characterisation and exposure estimation. He presented examples of the type and content of exposure scenarios and introduced the guidance available. Hélène Magaud from the Scientific IT Tools Unit described Chesar, the IT tool developed by ECHA in consultation with industry to support the preparation of the Chemical Safety Assessment and the Chemical Safety Report. She stressed that the tool helps prepare the assessment in an effective and efficient way and ensure a transparent assessment and harmonised structure.

The Chemical Safety Report is created from the information in the database, which facilitates the process and makes updates easier. With Chesar, you can currently manage your substances, report uses, manage assessment, build exposure scenarios, generate Chemical Safety Reports and perform administrative tasks, Ms Magaud explained. Kevin Pollard, Head of the Registration and Dossier Submission Unit said that on the basis of the latest estimations, ECHA has scenarios for receiving 25 000–75 000 registration dossiers by 30 November. One assumption is that there could be around 40 000 dossiers submitted for 5 000 substances. The Head of Unit said that all the tools and information are already in place for a successful registration and explained the different phases of the submission process. Registrants should make sure they understand what business rules verification means and submit all necessary information as required. They should use the Technical Completeness Check tool to check the completeness of their dossier. It is also important to remember that if the invoice is not paid by the extended due date, the IT system will reject the registration.

Dossier evaluation update

Wim De Coen, Head of ECHA's Evaluation Unit 1, explained the division of work in the evaluation process under REACH. Substance evaluation is a responsibility of Member States whereas ECHA is in charge of dossier evaluation. The latter covers both the compliance check as well as testing proposal evaluation. The compliance check aims at verifying compliance with the information requirements and checking whether adaptations are justified. The compliance check is done to at least five per cent of dossiers in each tonnage band. Testing proposal evaluation deals with examining registrants' proposals for tests specified in Annex IX and X of REACH. All testing proposals received are being evaluated, and this process provides a way for ECHA to avoid unnecessary animal testing. Mr De Coen also made some recommendations concerning the registrants' commenting options and shared recent experiences of the dossier evaluation process.

REACH from the outside

Alison Cohen, a US-EU Fulbright Scholar, presented results of her study on REACH implementation and attitudes of stakeholders towards the legislation. One of her main findings was that there is a joint will to comply. 

Informing about chemicals

As a result of the REACH implementation, a lot of information on chemicals will be publicly available. ECHA is publishing information from registration dossiers. Catherine Cornu, the project manager of the dissemination project, explained in her presentation which information is made available and which will remain confidential. The dissemination site is in the "ECHA Chem" section on ECHA's website and was published last December. It has been viewed around 115 000 times by altogether 32 000 viewers. A IUCLID 5 plugin which allows the registrants to see which information in their dossier will be available for the public is planned to be released in June. This information is defined in Article 119 of REACH.

All kinds of registration dossiers are disseminated and the information from joint submissions will be merged into one dossier.

Twofold impact

Tony Musu from the European Trade Union Confederation (ETUC) said that chemicals provide jobs for 1.3 million workers and many more millions in the downstream industries, but there is also growing evidence of their links to diseases like cancer and allergies. He quoted ETUC statistics that around 30 percent of all occupational diseases recognised in the EU each year are related to exposure to chemicals. According to the EU Agency for Occupational Health and Safety, 74 000 work related deaths in the EU per year are due to exposure to hazardous substances. Therefore workers, industrial hygienists, medical doctors, researchers, inspectorates, general public, poison centres – and competitors – are interested in information on chemicals. Mr Musu listed information which ETUC thinks should be published, including the REACH registration number, the CAS number, the most common uses, the contact details of the manufacturer, importer or downstream user, and uses advised against by the supplier.

For informed decisions

Antonello Lapalorcia, Deputy Chair of ECHA's Management Board, discussed in his presentation the importance of public information on chemicals for citizens and the requests for nondisclosure. "We in the Management Board consider of course that dissemination is a corner stone of REACH," said Mr Lapalorcia. He explained that the Management Board have already decided on a review of partial or full rejection of a confidentiality claim and has created an Advisory Group on Dissemination to provide the dissemination and to provide strategic advice to ECHA's management. Mr Lapalorcia encouraged the participants to look for information gaps in the way ECHA presents the information on its dissemination site and to react. "We need advice from citizens and enterprises", said the Deputy Chair of the Management Board.

Practical help needed

Marko Sušnik from the European Association of Craft, Small and Mediumsized Enterprises (UEAPME) discussed the importance of making information available. The association has 84 member organisations, representing 12 million enterprises which employ 50 million people. The level of knowledge and awareness on REACH varies among the members. Most of them are downstream users or distributors. The information sources offered by ECHA are very important for them and the association. Mr Sušnik said that the members ask for sector-specific information in their own language. SMEs are overburdened with the legal obligations and often do not have a scientific background on testing of chemicals, competition law or legal issues in consortia. He called for translations of important sections on ECHA's website, easier guidance and practical assistance by helpdesks.

Keeping research and development in Europe

The chemical industry in Europe still remains the most important chemical industry in the world, said Erwin Annys from the European Chemical Industry Council (Cefic). However, its world market share decreased from 32 to 28 percent in five years. Cefic agrees that innovation is one of the major goals of REACH. Mr Annys stressed that confidentiality and respect for research and development are preconditions for innovation. "There is no remedy possible if the wrong information is becoming publicly available." Cefic is looking forward to the ECHA software that will allow companies to check in advance which data will be public and the fee calculator to estimate the cost of confidentiality claims. Industry expects that old confidentiality claims accepted before REACH are maintained and that registrants will be given sufficient time to update the claims. The dissemination database should be easy to use and contain information that the public can understand. Industry will contribute to dissemination by publishing their own safety summaries, Mr Annys said.

More work to be done

"We will do more work on resolving the confidentiality question with regard to classification and labelling," promised Executive Director Dancet in his closing remarks. "We also would like to progress in reaching the Only Representatives and responding to their needs." Mr Dancet also promised that ECHA will translate as many documents as possible. He addressed the downstream users and said that it is in their interest to provide information on their uses and the volumes. Otherwise they may need to prepare a Chemical Safety Report themselves. It would also be important for them to check whether the substances they need are on the list of substances to be registered in 2010.