- Greetings from a sunny and increasingly light Helsinki
- ECHA updates its key IT tools ahead of the 2013 deadline
- Stakeholders' Day focused on registration, evaluation and authorisation
- Regulation on biocidal products enters into force
- Simplified submission of downstream user reports available
- "To achieve the common REACH goals, cooperation with EU Member States is crucial"
- To apply or not to apply - that is the question for business
- Targeting evaluation where safety matters most
- Users help to test the new version of Chesar
- Guest column: Five year of REACH
- REACH and CLP impact : Chemicals legislation changing in Asia
- MEP Julie Girling visits ECHA: Understanding the role of the agencies
- Blogging about chemicals
- Helsinki Chemicals Forum 2012: Chemical safety in the spotlight
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Päivi Jokiniemi and Paul Trouth
Article related to: REACH
Stakeholders' Day focused on registration, evaluation and authorisation
ECHA's seventh Stakeholders' Day on 23 May focused on three areas: preparations for the next registration deadline on 31 May 2013, feedback from the evaluation of the registration dossiers submitted in 2010 and applications for authorisation. Over 300 participants attended the event on-site and a further 350 followed online via web streaming. A video recording and the presentations from the event are available on the ECHA website.
The most important message to registrants from this year's Stakeholder Day was ‘to step up dossier preparation efforts now and to pay special attention to the quality of their dossiers'. In his opening words, ECHA Executive Director, Geert Dancet, said that "REACH aspires to protect people and the environment, and at this year's Stakeholders' Day, we are really getting to grips with the core of this aim: helping companies to provide quality data on their chemicals so that they can be used safely, and beginning the authorisation process to limit and ultimately phase out the most hazardous chemicals in Europe today."
CALLING FOR ‘MISSING' LEAD REGISTRANTS
ECHA Head of Unit for Dossier Submission & Dissemination, Kevin Pollard, drew the attention of registrants to the timely preparation and quality of their REACH registration dossiers for the next registration deadline on 31 May 2013. He gave an update on the estimated number of substances to be registered in 2013 and encouraged lead registrants to make themselves know to ECHA. "We have identified 3 551 substances that industry have signaled would be registered for next year. There are 2 685 substances which have not yet been registered by a lead. Of these 2 685 substances we have nearly 2 000 where lead registrants have nominated themselves to ECHA, and around 140 which actually have been registered since the 2010 deadline. This is very encouraging; it shows a reasonable level of activity in this area. Then we have 746 substances that have not yet been registered and for which lead registrants have not nominated themselves to ECHA. For these substances we encourage everyone to work within the SIEFs and signal to ECHA once a lead registrant has been found."
ADVICE FOR SMES AND DOWNSTREAM USERS
Benjamin Noel, a REACH Coordinator from Stéarinerie Dubois, shared the SME perspective on implementing REACH. He pointed out three aspects that help with meeting the REACH requirements: communication, outsourcing and preparing for the unprepared. "You have to be aware of the impact of REACH on your activity, and also stay aware. So follow the ECHA website and newsletters from ECHA and the different trade associations, the national helpdesk, Cefic etc. Also, remember to tick the box in REACH-IT, so that you will get a message in your personal email once there is a message from ECHA on REACH-IT. This is very crucial and will save a lot of time", he said.
Laura Walin from ECHA presented key messages for downstream users and announced ECHA's new improved web pages with targeted information for downstream users. She highlighted the benefits of good communication in the supply chain. "It allocates the responsibilities between the actors and enables the downstream user to benefit from the supplier's assessment of their substance. It also allows a systematic consideration of safe use by consumers and helps authorities to give an overview of where communication in the supply chain does not work or where there are uses not covered by the registrants' CSA. All in all, it gives us better and more information on how chemicals are used in practice", she said.
NEW COMPLIANCE CHECK STRATEGY INTRODUCED
ECHA Senior Scientific Officer George Cartlidge spoke about dossier quality and presented ECHA's new compliance check strategy, which complements the current evaluation activities. The new strategy aims to systematically target dossier elements that are immediately relevant for the safe use of the substance. Rather than evaluating the full dossier content at once, a part of the compliance checks will address, for example, targeted endpoints related to the Persistent, Bioaccumulative and Toxic (PBT) or Carcinogenic, Mutagenic or Toxic to reproduction (CMR) status of a substance. Mr Cartlidge encouraged registrants to keep up to date with the annual Evaluation Progress Reports and act to avoid common pitfalls presented in the reports. "The likelihood of a dossier being checked is now much greater and the chance of finding those inadequacies, where safety matters, is much higher. Don't wait for a draft decision from ECHA – improve your dossier quality now", he concluded", he concluded.
SUBSTANCE EVALUATION EXPLAINED
Claudio Carlon, ECHA Head of Unit for Evaluation, introduced the substance evaluation process that started in March 2012 and described how it is functionally interlinked with other evaluation and regulatory risk management processes. "It is clear that substance evaluation deals with information, it is an important instrument to increase information about chemicals. The inclusion of a substance in the Community Rolling Action Plan (CoRAP) is just a start of the evaluation process, it is not a pre-judgment of a risk", he highlighted.
Amanda Cockshott, senior regulatory scientist from the UK REACH competent authority spoke about the role of Member States in substance evaluation, the interaction with registrants, with other Member States and with ECHA, and shared her first experiences with substance evaluation in the UK. "Substance evaluation is a new process and as yet we have only limited experience. There are tight deadlines and there is limited flexibility, but hopefully with good communication we can work towards being prepared for those. There are opportunities to communicate and collaborate - these are very important to ensure a harmonised approach", she said.
APPLICATIONS FOR AUTHORISATION – A NEW KID ON THE BLOCK
Matti Vainio, ECHA Head of Unit for Risk Management Implementation, focused on the challenges of applying for authorisation. He described how applicants and stakeholders can best contribute to the authorisation process and explained which parts of the applications will be made publicly available in order to support interested parties in providing pertinent information on the availability of alternative substances or technologies. These may be used to substitute the substances of very high concern (SVHCs).
ECHA's Richard Duborg spoke about the analysis of alternatives and socio-economic analysis with regard to authorisation. His presentation focused on the impacts of a substance being listed in Annex XIV and being subject to authorisation. "The first question is not how you apply for authorisation; it is what will happen to my business if the Annex XIV substance can no longer be used in the EU? It is much more of a core business question, it is something that needs to be owned by the company, and not just left to consultants. You need to think outside of your business to find the right scope for your assessment and make sure that you are looking at all the impacts and all the possibilities. A strong case for authorisation is a simple case", he said.
Hugo Waeterschoot from Eurometaux presented the challenges for industry in making applications for authorisation. "Authorisation applications is a new game, they are new to us all. So we are learning by doing. We are going to have to build practices and experience in tools when all the rules are not yet clear. We all need to contribute to that. It takes time", he stated.
Dr Anna Lennquist from ChemSec brought the NGO aspect into the discussion. She criticised the speed at which chemicals are being added to the Candidate List of substances of very high concern. "We have had five years of REACH with one of the main purposes of replacing hazardous chemicals with safer alternatives. We have today 73 substances in the Candidate List, 14 substances on Annex XIV and the first sunset dates are in 2013. So it is easy to see that with this speed it will take hundreds of years to phase out the most hazardous chemicals from the market. We would also like to have a fully transparent process to make the third party consultations meaningful", she said. Ms Lennquist announced a new internet portal SUBSPORT developed by ChemSec and its partners, which intends to help companies to fulfil the substitution requirements of EU legislations. She expects the portal to contribute to the authorisation process. "The portal is addressing a need for publicly available information on alternatives that is often mentioned as a barrier for substitution. It also encourages companies and organisations to share information on alternatives", she explained.
All the presentations and a video recording are available on the ECHA website.
Text by Hanna-Kaisa Torkkeli
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Biocidal Products Committee:
26 February-1 March
Committee for Risk Assessment:
Committee for Socio-Economic
18-22 March (tentative)
Management Board meeting:
Member State Committee:
13-17 May (tentative)