ECHA

ECHA Directorate of Assessment is responsible for the scientifi c and technical tasks related to key operations of the Agency. The Directorate is still building up its capacity and will recruit and train large numbers of scientists this year. Jukka Malm, Director of Assessment, is confi dent: the start of ECHA was positive and the preparations are on schedule.

The pre-registration of phase-in chemicals, i.e. most of the substances which were on the EU market before entry into force of REACH in 2007, is now over, and ECHA is getting ready for the arrival of the great bulk of registration dossiers in the next few years.

Jukka Malm leads the Directorate in ECHA which performs the scientific evaluation of the registration dossiers and will be extremely busy when large numbers of registration dossiers arrive before the fi rst deadline in 2010. The Directorate has many scientific tasks and is an important centre of competence where scientifi c decisions and proposals of ECHA are prepared. "On the basis of our evaluation of the dossiers, we prepare the draft decisions of ECHA which are then presented to the Member States and when necessary, discussed in the Member State Committee," explains Jukka Malm.

"As regards examining testing proposals, the main work load will start when dossiers concerning high production volume substances are submitted to us. This very challenging scientifi c task will require capacity building, and we have very strict deadlines for these examinations," says Jukka Malm. The Directorate manages the overall process of authorisation and restriction, dealing with proposals for restrictions, for the identifi cation of substances of very high concern and proposals for harmonised classifi cation and labelling.

"We are now also in charge of the scientifi c and technical parts of the implementation of the new Classification, Labelling and Packaging of Substances and Mixtures (CLP) regulation," explains Jukka Malm.Recently, ECHA published its fi rst draft recommendation for substances that should be included in the Authorisation list of REACH (Annex XIV). ECHA proposed seven of the15 substances that are currently on the Candidate list. A public consultation is taking place on ECHA's website; comments can be submitted until 14 April 2009. "Our approach was not to limit the number of substances in the Authorisation list but it was a case by case consideration whether there is a justifi cation for giving the substances priority at the moment", says Jukka Malm. He reminds that this is only the start of a very long process. The Candidate list and the Annex XIV recommendations will be regularly updated when ECHA receives new proposals from the Member States or requests from the Commission.

The Directorate also participates in the development of testing and assessment methods. "We are for example contributing to methodologies and approaches for dealing with nanomaterials, work currently coordinated by the Commission."

Work load cannot be predicted yet

ECHA received 15 times more pre-registrations than anticipated, but these fi gures may not directly be linked to the expected number of registrations. "We are keen to understand how industry will respond in terms of sending registration dossiers. It directly affects our work load, and we follow this very closely and discuss with industry," says Jukka Malm. "We have the quantitative obligation to carry out a compliance check for at least fi ve percent of the dossiers for each tonnage band. If we receive tens of thousands of dossiers, this task will be very demanding. We also cannot yet predict very precisely the number of authorisation applications by industry."

The quality of the registration dossiers is very important. "Not only from a regulatory point of view, but also how industry is applying the Regulation and the guidance and what kind of support and dialogue we can create with industry on the basis of that," says Jukka Malm. Uncertainties relate also to the number of dossiers sent in by the Member States. "In the classifi cation and labelling area we have a better picture, but we do not yet know the restriction plans of the authorities. We are of course having dialogue with them to get a better idea."

"All this work is very resource-demanding, and one of our main tasks this year is to grow, to employ and train new staff," explains Malm. The number of staff in the Directorate will grow from 40 to around 100 by the end of the year.

REACH philosophy applied

For Jukka Malm, 2010 signifi es a first major milestone in the implementation of REACH. "We are still suffering from the lack of data on chemicals, and the data we receive will enable both industry and authorities to assess the hazards and risks of chemicals much better. Not all information will be perfect and complete, but still it is a major improvement. It will cover high production volume chemicals and carcinogenic, mutagenic, toxic for reproduction (CMR) substances and will help us screen substances for possible Annex XV dossiers and to manage risks." The general philosophy of ECHA's decisions is set by REACH. "The Regulation defines what we can do and what not, for example in the evaluation process.

REACH sets the focus and the scope of the work which are then further developed in the guidance documents." "REACH is now put into practice for the fi rst time, and of course we still have many discussions on how to apply the Regulation and the guidance documents. It is important that we and the industry follow one of the key principles in REACH – that the burden of proof was transferred from authorities to industry. ECHA needs to check the compliance with the REACH provisions, but this does not mean that we take responsibility away from industry!" For ECHA, stakeholder involvement is essential. "It is important that we are not working as scientists in isolation but are open to the views of our partners and stakeholders for new scientifi c information, and keen to listen to the views of stakeholders on our processes. Consultations are part of our general approach to stakeholder dialogue and transparency. It is really key to our work that we receive information from all interested parties," says Malm.

About Jukka

Jukka Malm was involved in the practical coordination and preparation for the start of ECHA in Helsinki from the summer of 2004. At that time he headed the Chemicals Division at the Finnish Environmental Institute, and later he worked as Director of the Expert Services in the Institute. In 2007, Jukka Malm was elected the fi rst Chair of ECHA Management Board and in the summer 2008, Director of Assessment. In his current work, he benefi ts from the experience he gained in preparing for ECHA.

Jukka Malm also very much enjoyed the period as the first Chair of the Management Board. "That was very challenging and rewarding, the spirit of cooperation was very good, the Board Members were enthusiastic and it was a fruitful mixture of people with different backgrounds." Jukka Malm considers the outcome of the set-up of ECHA as very positive. "It is going very well and according to plan. Some things have even been changed for the better; for instance the size and importance of the Agency has grown compared to the original plan." "We have very good staff here, well-functioning contacts with the partners in the Member States and in the Commission and a very good dialogue with the industry and other stakeholders. Of course there is still a lot of work to be done, but it is a very promising start."

Currently, the ECHA Director of Assessment does not have much free time, but if it happens, he enjoys long walks out in the nature and lets off steam in the gym. "I also try to stay in contact with friends and relatives - quite normal things."