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Editor-in-chief: Maurizio Roncaccia

Editors: Paul Trouth and Päivi Jokiniemi

Article related to: People and perspectives

ECHA's Stakeholders' Day: Focus on quality information

STK day

ECHA's eighth Stakeholders' day provided last minute tips and recommendations for REACH 2013 registrants. Good quality information in registration dossiers was once again emphasised as the means of ensuring the safe use of chemicals - as well as avoiding legal action either from ECHA or the national enforcement authorities.

More than 300 participants attended the event in Helsinki, with a record high of over 1 600 viewers following online. The day brought together colleagues from 32 countries - ECHA experts, industry representatives, consultants, NGOs and representatives of Member - to sunny Helsinki to learn and share best practice on three main areas: registration and REACH 2013; evaluation and communication in the supply chain; and risk management and applications for authorisation.

The key message for 2013 registrants was ‘to pay attention to the quality of information in the registration dossiers'. In his opening words, ECHA's Executive Director, Geert Dancet, said that ECHA is ready to help registrants in their efforts. "ECHA is ready to support you today and later. During the last days before the deadline, we will offer intensive assistance to you," he said.

For the first time, registrants could get direct support onsite on issues concerning their own registration dossiers. The one-to-one sessions attracted altogether 62 stakeholders, with the majority of questions concerning communication in the supply chain, data sharing, SIEFs and substance identity.

Lead registrants: come forward

Registration - and in particular REACH 2013 - was the focus of the first session.

Kevin Pollard, ECHA's Head of Unit for Registration & Dissemination, gave an outlook on REACH 2013 registrations as well as key tips for member registrants.

"ECHA is expecting around 4 000 substances to be registered for the upcoming deadline, of which 870 were already registered for the 2010 deadline," he said and continued, "for some 600 substance the lead registrant is still unknown. We ask you to come forward if you know that you will be a lead registrant or you know a company that will. Only if we know who you are, can we help you."

Verify your intermediate status

ECHA's Romanas Cesnaitis draw the audience's attention to the registration of intermediates. He stressed that ECHA is taking action on intermediates for a good reason: intermediates have reduced requirements under REACH, e.g. intermediate dossiers do not have to include a full hazard dataset or a chemical safety assessment. It is important for human health and the environment that only intermediates are benefiting from this reduced requirement.

"It is very important that registrants provide information to back the fact that the substance is an intermediate and used under strictly controlled conditions. They will also have to be certain that their downstream users are using the substance as an intermediate," he said.

ECHA to check substance identity

Mike Rasenberg, ECHA's Head of Unit for Computational Assessment, asked registrants to pay attention to quality and consistency of registrations. "Is the information you have fit for the purpose?" he asked and reminded that registration as such is not the purpose of REACH. "The aim of REACH is to make sure chemicals are used safely - registration and dissmination are there to make this transparent," he stated.

ECHA has now developed advanced data analysis methods to analyse the information it receives in REACH registration dossiers.

Mr Rasenberg announced that ECHA will screen the 2013 dossiers for substance identity deficiencies as they come in and write to registrants, where possible, with advice on how to improve the information. The screening of all dossiers will start before the end of 2013.

He also pointed out that the 5% target for compliance checks is not a lottery. "It is all well thought through; we know what we want to pick up."

Registration is your business card

The second session of the day focused on evaluation and communication in the supply chain.

Kaihsu Tai from ECHA presented the lessons learnt from evaluation. He said that the new targeted compliance check strategy for areas of concern was designed to pick out dossiers with ‘a pattern of non-compliance'. "The dossiers are picked up by a computer and further analysed by ECHA's scientists. Poor dossiers will be caught," he said.

The European Chemical Industry Council's Erwin Annys gave advice to industry on dossier and substance evaluation. Regarding testing proposal examinations, he pointed out that ECHA does not analyse testing proposals in isolation. "The substance identity is checked before. For multi-constituents or UVCBs, clearly define the substance that will be tested."

As for compliance checks, he reminded industry that the 5% target set in each tonnage band relates to checks of the dossiers as a whole. "In reality, every single dossier will be screened in one way or another."

For substance evaluation, Mr Annys expressed the concern that the selection criteria of substances to be evaluated is not well understood by the majority of industry. He recommends that industry nominates a representative among the substance information exchange forum (SIEF) for the substance under evaluation. "Organise the upcoming work and contact the evaluating Member State to get a better understanding of their concerns and to inform it on the planned update by registrants," he said.

Growing interest on nanomaterials

The position of nanomaterials in REACH was elaborated by ECHA's Head of Unit for Evaluation, Wim De Coen.

He reminded that nanomaterials are covered by the substance definition under REACH and that ECHA is using the European Commission's definition of nanomaterial as its benchmark.

"There is a growing interest and a need to understand and regulate the possible adverse effect of nanomaterials. However, ECHA is not blacklisting nanomaterials. Our aim is to simply ensure safe use," he said.

"Good communication in the supply chain is good for business"

Bridget Ginnity of ECHA gave advice to registrants and downstream users on communication in the supply chain. She asked registrants to show consideration to the other actors in the supply chain. "Harmonisation, realistic operational conditions and risk management measures promote good communication in the exposure scenarios," she pointed out, and added "in the long run, good communication in the supply chain saves time and is good for business."

Uta Jensen-Korte from the European Association of Chemical Distributors (Fecc) made a plea to registrants: "Use the new Chesar. Prepare and submit joint chemical safety reports as much as possible. We would appreciate getting more consistency in the exposure scenarios from suppliers. Working together for a joint chemical safety report could support that," she said.

Convergence of classifications

The third session addressed risk management and applications for authorisation.

ECHA's Palmi Atlason gave the audience an overview of the Classification and Labelling Inventory. He said that, at the moment, around 25% of substances in the inventory have different notified classifications. "Differences can be legitimate, for example because of impurities or differences in physical form, but also different access to data or disagreements on data can have an effect."

Mr Atlason encouraged notifiers to use the C&L Platform to come to an agreement on a classification. "The platform is very easy to use. It is basically a web discussion room, with one discussion per substance. It is free to use and you can also remain anonymous if you so wish."

"In time, classifications should converge on one or a few entries for each substance," he said.

Applications for authorisation becoming a reality

"Applications for authorisation have been in the planning for a long time," said ECHA's Head of Risk Management Implementation Matti Vainio. "We are now expecting the first applications to arrive in May."

The key question to address when applying for authorisation is the impact on business if the substance cannot be used any longer. "It is a core business strategy issue. You should apply for authorisation if the use of the substance clearly adds value in the European Union and the risks related to its use are very small," said Matti Vainio.

Another important issue is to weigh the benefits and the risks. "The clearer the difference is between the benefits and risks, the stronger the case."

Mr Vainio encouraged applicants to act when they are ready and not to wait for the latest application window. "Remember that the work starts immediately after we receive the application. So, apply as soon as you are ready. This way you will get the opinions and the decision earlier."

Bill Frazee, Technical Director at Huntsman Performance Products, shared his ideas on how industry can cooperate in making an application for authorisation. He reiterated the fact that an application has to be a core business decision. "It is a project not to be outsourced to a consultant or the health and safety department. It is a business decision and needs to be resourced accordingly."

From ECHA, he wanted more transparency on the Committees' decision-making processes and a revision of some of the templates by cutting down the need for redundant information.

The European Environmental Bureau's (EEB) Tatiana Santos gave an NGO view on the authorisation process. She said that NGOs and trade union stakeholders will be very active in the process "to ensure that authorisations are not granted for substances of very high concern (SVHC) for which feasible alternatives are available in the market".

She wants ECHA to better promote the substitution of hazardous chemicals. "The Agency has invested too much resources in helping companies to have applications granted and not in helping downstream users who want to get rid of hazardous chemicals."

Ms Santos sees that it is time for greener chemicals. "The European Union has the opportunity to really facilitate sustainable innovation and make the chemical industry a forerunner worldwide."

Notify substances in articles

Different roles in the supply chain for substances in articles was highlighted by ECHA's Lisa Anfält. She pointed out that the chemical safety reports in registrations should cover the life-cycle steps resulting from the identified uses. "This is clearly an area for improvement in registrations," she said.

ECHA is currently working on further advice about how to describe and assess the service-life of articles in the chemical safety assessment.

Notification of SVHCs in articles is now easier by using a web form.

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