By Wolfgang Urhahn and Martina Schneider
Evaluation process for dossiers
The European Chemicals Agency (ECHA) and the EU Member States evaluate the information submitted by registrants to examine the quality of the REACH registration dossiers as well as the testing proposals, and to determine if a substance might pose a risk to the human health or the environment.
The evaluation under REACH covers three areas:
- Examination of the testing proposals submitted by the registrant;
- Compliance check of the dossier(s) submitted by the registrant;
- Evaluation of the substance(s).
Once the evaluation is finished, registrants may be required to submit additional or modified information on the substance. This will require an update to the registration dossier, resubmission of the updated dossier and paying an update fee to ECHA. The fee depends on the type of update and the tonnage band.
Substance identity information in dossiers
ECHA recently conducted an IT-based screening on the substance identity of all REACH registration dossiers received to date. ECHA will send letters in the first quarter of 2014 to all registrants of those dossiers which do not comply with the required substance identification information and provide advice on how to repair the identified mistakes in their dossier(s). Substance identity is an obligation for each registrant in a Substance Information Exchange Forum (SIEF). Registrants will have to update their dossiers by a pre-set target date. ECHA will also update the Dossier Quality Assistant tool in 2014 with additional substance identity-related rules. ECHA recommends that registrants use the tool before submitting the updates of their dossiers to the Agency.
Reports on evaluation
ECHA has to publish an evaluation report on the progress it has made during the previous calendar year regarding its obligations to evaluate registration dossiers, substance identification information and testing proposals. The requirement is based on Article 54 of the REACH Regulation. ECHA is required to include recommendations in the reports for potential registrants to help improve the quality of future registrations.
The evaluation reports are published by February 28 of each year and are available to download on the ECHA website.
Community rolling action plan
In addition to the ongoing evaluation of registration dossiers, ECHA and the EU Member States focus on substances which are to be evaluated over a period of three years. The community rolling action plan (CoRAP) specifies these substances. Substances subject to immediate evaluation are listed in the first year of the CoRAP. But, an EU Member State may notify ECHA at any time that it has information suggesting that a particular substance should be prioritized for evaluation, even though it is not yet included in the CoRAP list. In such cases, the CoRAP may be amended to add the substance prior to the annual update of the CoRAP. Together, ECHA and the EU Member States develop risk-based criteria on which substances are selected for the CoRAP. ECHA has adopted the first CoRAP in 2012 for evaluation during 2012-2014. ECHA submits a draft to update the CoRAP to the EU Member States every year. The current draft, the update for the years 2014-2016, is available on the ECHA website, and it is expected to be approved in early 2014. Registrants of those substances that are or will be listed on the CoRAP need to pay attention to the ongoing substance evaluation discussions. The outcome of the evaluation might have a direct impact on the marketability of their substances in the EU.
ECHA Work Programme 2014
The Agency’s planning in the Work Programme 2014 is founded upon the baseline numbers presented in Annex 3 of the programme document, which are an update of the EU Commission estimates made at the time the REACH, CLP and Biocides Regulations were prepared. Three important deadlines for REACH registrations and CLP notifications passed in 2010, 2011 and 2013. With real data available to ECHA, in 2014 the Agency will identify the necessary steps for the final REACH registration deadline in 2018, the targets on the safe use of chemicals in 2020, and prepare the path for the Authorization process of Substances of Very High Concern (SVHCs). Small and Medium sized Enterprises (SMEs) will definitely benefit from these efforts, so that they can prepare for a successful registration of their substances in 2018.
REACH SME workshop
ChemADVISOR Europe was among the 50 participants, together with representatives from the ECHA and the European Commission, to join a 2 day workshop in Brussels discussing the concerns of Small and Medium sized Enterprises (SMEs) involved in the upcoming 2018 REACH registration deadline.
An important topic for SMEs is the awareness of their obligations under REACH. Participants agreed on a need for an additional information campaign by ECHA to ensure that SMEs are aware of the needed action steps to undertake before the 2018 registration deadline.
A big concern for SMEs is how to approach an existing Substance Information Exchange Forum (SIEF) with their reduced resources. Finding the responsible Lead Registrant (LR) is not always easy and communication within the SIEF can be delayed and therefore prolong the whole registration process. Since the cost for the data sharing is the biggest financial burden, participants emphasized that fair and transparent cost sharing is important.
For the individual substances that have not yet been registered, many SMEs are concerned that they cannot take on the burden of the role of LR. Therefore, organizing a SIEF among SMEs and how to simplify the overall registration process was discussed in depth.
Possible solutions of the issues were discussed in small groups to ensure that the SMEs would have a chance to speak up and share their concerns and suggestions. ECHA and the European Commission will analyze the outcome of the workshop and, if possible, consider the suggestions in their future steps and information campaigns.
ECHA Evaluation webpages: http://www.echa.europa.eu/regulations/reach/evaluation
ECHA Evaluation decisions
ECHA Substance identity information: http://echa.europa.eu/view-article/-/journal_content/title/is-your-substance-identity-information-up_to_date
EU/ECHA Community rolling action plan http://www.echa.europa.eu/web/guest/regulations/reach/evaluation/substance-evaluation/community-rolling-action-plan
ECHA Work Programme 2014: http://www.echa.europa.eu/documents/10162/13608/final_mb_39_2013_wp_2014_en.pdf
ECHA Public Procedures: http://www.echa.europa.eu/about-us/the-way-we-work/procedures-and-policies/public-procedures
EU/ECHA SME Workshop