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Companies should start to prepare applications for authorisation early
From last February onwards, companies using substances included in the Authorisation List (Annex XIV) have been able to start preparing applications for authorisation. During an ECHA Seminar on applications for authorisation on 12 April 2011, it became clear that there were differences in the state of readiness of European companies in terms of preparing their applications.
The first Authorisation List (or Annex XIV of the REACH Regulation), containing six substances subject to authorisation, entered into force on 21 February 2011. Companies either placing on the market or using these substances can now check the Authorisation List to establish the date by which they should apply for authorisation if they wish to continue the use of the substances after the deadline, or the "sunset date". The applications for authorisation need to be submitted to ECHA, and are subject to a fee. "As the authorisation process is new to everyone, it will take a lot of work for stakeholders and ECHA to ensure that the authorisation process functions well," estimates Rémi Lefèvre from ECHA's Risk Management Directorate. Mr Lefèvre is coordinating preparations within ECHA for the receipt of applications.
The European Commission makes the final decisions as to whether or not, and under which conditions, an authorisation is to be granted. However, ECHA's scientific committees - the Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) – "play a major role in this process as they issue opinions which support the European Commission in its decision making" underlines Pilar Rodríguez Iglesias, Head of the Committees' Secretariat Unit.
Joint applications possible
Applicants for authorisation can be manufacturers, importers or downstream users of substances included in the Authorisation List. Applicants may apply for authorisation jointly. REACH also foresees the possibility for companies to make an application for more than one use of a substance. An application can also cover several substances if they all meet the definition of a group of substances. This "category" approach is defined in Annex XI of REACH.
ECHA's committees may request applicants to provide further information during the 10-month opinion-making process. Third parties will also be invited to provide information as to possible alternatives to the use of the substance for which an authorisation is sought. Furthermore, applicants will have the opportunity to comment on the draft opinions of the committees.
Transparency and confidentiality
Transparency of the opinion-making process is important, stresses Pilar Rodríguez Iglesias. ECHA is designing a new section for its website to ensure that through the public consultations, all relevant information on possible alternatives will become available. At the same time, ECHA needs to ensure that no commercially sensitive information is released during the process. For this reason, ECHA's formats and templates have been developed to separately document the different parts of an application for authorisation, so that applicants can clearly distinguish confidential information from public data."It is likely that it will take some time for companies to prepare their applications," says Rémi Lefèvre. One of the first important steps for potential applicants is to decide on the uses for which they need to seek authorisation. Potential applicants for a substance need also to decide how to organise themselves during – on the one hand - the preparation stage and - on the other hand – the actual submission of their applications. These two important aspects were particularly stressed at the first ECHA seminar on applications for authorisation in Helsinki on 12 April 2011.
Reports from chemical safety to socio-economic impacts
An application for authorisation should be created in the newest version of IUCLID (5.3), and several reports must be included in the IUCLID file. The starting point is a Chemical Safety Report which addresses the risks arising from the uses applied for. The application also needs to provide an Analysis of Alternatives and – if suitable alternatives are available – a Substitution Plan describing when and how the substance will be substituted. Although not legally required, it is essential that an applicant also includes a Socio-economic Analysis as part of his application. "In practice, we recommend that applicants carry out the analysis of the socio-economic impacts in particular for non-threshold substances" says Matti Vainio, Head of the Risk Management Implementation Unit. "However, this may also be important for threshold substances where applicants might be well advised to give additional information if adequate control of risks is not demonstrated."
New web pages for applicants
ECHA has published new dedicated web pages dealing with applications for authorisation. These web pages allow potential applicants and third parties to gain a better insight into the authorisation procedure and also provide links to two new guidance documents produced in order to support applicants. The first explains how to prepare an application for authorisation, an analysis of alternatives and a substitution plan and also gives information as to how third parties may prepare and submit information on alternatives. The second new document provides guidance on how to prepare a socio-economic analysis. "We have made a special effort to design these web pages as a one-stop-shop for all potential applicants," says Rémi Lefèvre. The web pages contain all formats and templates that are needed for an application for authorisation, including the web forms for submitting an application to ECHA and a user manual to help applicants file and submit their applications. A tool for estimating the level of the fee related to the application is also available on the new web pages. ECHA will update these pages regularly, based on the feedback received from all parties involved in the authorisation procedure. The helpdesks in both the EU Member States and at ECHA will also answer questions.
Time to start preparations
"In the coming months, we will pay special attention to communication through different means to all stakeholders. In short, we need to improve the general awareness and understanding of this new risk management instrument," underlines Rémi Lefèvre.
Matti Vainio stresses that potential applicants should, however, not stay passive and wait for information to arrive. During ECHA's seminar on applications for authorisation on 12 April it was evident that some companies have already started to work on certain aspects of their applications. It was equally clear that many are still at a very early stage in their preparations. One clear message was that all potential applicants need to start their preparatory activities now. The application for authorisation process is new to all. Therefore ECHA intends to be proactive to ensure that potential applicants have the necessary guidance and know where to find the relevant information.
ECHA also needs to ensure that it plans the use of its own resources properly. This will lead to the smooth processing of all incoming applications for authorisation, "Therefore we encourage potential applicants to notify us well before their expected submission date in the way suggested on our website" explains Matti Vainio. "As we are all learning, good, early communication between potential applicants and ECHA will help to make the system work as the REACH Regulation intended," he concludes.
Submission dates for authorisation applications 2011-2012
ECHA has established specific submission dates for authorisation applications so that both ECHA and especially its Committees for Risk Assessment for Socio-economic Analysis can plan and distribute their workloads efficiently. Companies should submit their applications by the following dates:
2011:1 June, 1 September and 1 December
2012:1 March, 1 June, 3 September and 3 December
ECHA advises applicants to consider these dates and to notify the Agency of their intention to submit an application. Submission dates for 2013 will be announced by January 2012.
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Biocidal Products Committee:
30 November-4 December (tentative)
Committee for Risk Assessment:
6-8 October (RAC-52B);
30 November-4 December (tentative);
7-11 December (tentative)
Committee for Socio-Economic
30 November-4 December (tentative);
7-11 December (tentative)
Member State Committee:
7-11 December (tentative)
Management Board meeting: