ECHA

Evaluation is one of the key processes of REACH. It bridges together the registration of dossiers and the implementation of adequate risk management measures. The evaluation process as such can help registrants in complying with the REACH information requirements.

Evaluation can be broken down into three processes: the examination of testing proposals, conducting of compliance checks, and the evaluation of substances. The first two processes are under ECHA's remit. Substance evaluation is coordinated by ECHA but carried out in practice by Member States.

ECHA's Evaluation Directorate has three units with over 90 staff in total. The work is performed by evaluation teams that are cross-cutting the three units. The directorate depends further on support from other units and teams within the Agency. "Evaluation is a complicated process with many scientific challenges. Coming to a decision on a testing proposal or compliance check, requires input from many fields of expertise, including: substance identity and physical chemistry experts, (environmental) toxicologists, exposure specialists, risk assessors and lawyers from ECHA as well as the Member States - not forgetting interaction with experts from the registrants", says Claudio Carlon, ECHA Head of Unit for Evaluation II.

The evaluation decisions are based on sound scientific expertise and follow the legal text and procedures. "We have dossier evaluation groups that deal with individual dossiers. They include four to five experts in the field of ecotoxicology, toxicology and physico-chemistry. End-point experts are available to provide specialist advice if needed. In addition, we have the support from the team specialised in substance identity and computational methods, from the legal team, and horizontal scientific fora that act as a competence centre for a specific discipline", Mr Carlon adds. Everything is done under strict quality control measures.

In public consultations for testing propos­als, ECHA is requesting scientifically valid information that is available, accessible and free from commercial interests, says Watze de Wolf, ECHA Head of Unit for Evaluation III.

Testing proposals for public consultation

The evaluation of testing proposals is running at full speed. ECHA aims to have all draft decisions regarding the testing proposals on registration dossiers from the 2010 deadline prepared well before the legal deadline, 1 December 2012. The submission of a testing proposal to ECHA is required before the registrant can conduct any experiments concerning the information requirements under Annexes IX and X of REACH. "When we receive a testing proposal, we publish the proposals involving testing with vertebrate animals for consultation with third parties for 45 days. We request that scientifically valid information that is available, accessible and free from commercial interests is submitted. After the third party consultation, we assess the received information and start the decision making process, says Watze de Wolf, ECHA Head of Unit for Evaluation III. The registrant also receives the information submitted during the consultation phase.

The testing proposal may be altered or rejected by ECHA. "We need to be certain, that the proposed testing is necessary. Testing on vertebrate animals should only be carried out as a last resort. Registrants should propose testing in line with our guidance on testing strategies. Testing should not be done for the sake of it, but to fill the gaps in the safety information. In writing our decision, we need to make sure, that the registrant, by following our evaluation decisions, is able to meet the REACH information requirements", says Wim De Coen, Head of Unit for Evaluation I.

Looking for high quality dossiers

The compliance check aims to ensure that the registration dossiers meet the standard information requirements as defined in the REACH Regulation. The selection of dossiers for compliance check is done partially randomly and partially on a concern base. "We can select dossiers based on indicators of possible incompliance. We also consider the potential safety consequences of the incompliance. For example, if the substance appears to be potentially hazardous or widely used, we consider that possible information gaps in the registration dossiers may have relevant safety consequences", says Mr Carlon.

ECHA aims to check at least 5 % of the dossiers motivated by the 2010 deadline by the end of 2013. However, ECHA acknowledges that the percentage should be seen as a minimum threshold. "We see the 5% as a starting target and want to go beyond. However, this is not a unique indicator of the efficiency of our compliance check activity. The main thing is to act where it really matters in order to use our resources so that we contribute in an optimal way to the safe use of chemicals. That is where the areas of concern come into play", says Mr De Coen. Mr de Wolf points out that ECHA is mainly addressing the Lead Registrants that are also providing data on behalf of the member registrants – which actually might indicate a higher coverage of all dossiers. At present, ECHA is revising its strategies for performing compliance checks with the aim of increasing the efficiency of the overall process.

Bridging processes

Evaluation is an instrument that ensures the quality of the registration dossiers. It is seen as a bridge between registration and the implementation of adequate risk management measures. "Evaluation is essential to REACH because it focuses on the quality of information. A registrant can get a registration number without having any quality assessment of the information in the dossier. Without evaluation, REACH would be an empty box", says Mr De Coen. For Mr Carlon, having high quality dossiers means that adequate risk management measures have also been thought about. "Although evaluation has an element of control, its purpose is to help industry to comply with REACH, and to ensure that the ultimate aims of REACH are achieved."

All ECHA Heads of Unit believe that REACH can be a driver for innovation. Whether it is a question of replacing hazardous substances, or developing alternative testing methods, REACH is open to new developments. "Innovation is important for the development of a sustainable economy. In evaluation, we aim to ensure that everyone follows the rules of REACH, and are on a level playing field", Mr De Coen concludes.

Further information

Evaluation process

Top image: Wim De Coen (left), ECHA Head of Unit for Evaluation I and Claudio Carlon, ECHA Head of Unit for Evaluation II, say that evaluation requires a lot of scientific competence and cross-Agency collaboration. The evaluation process at ECHA is done under strict quality control measures.

Interview by Hanna-Kaisa Torkkeli