- REACH 2013 – Act now!
- REACH Conference: What did we achieve in 2010 – how can we ease the way for 2013?
- From 2010 to 2013: Experiences with REACH
- Inquiry process - enabling data sharing between potential and previous registrants
- Reaching the "Unreachable" at the European SME week summit
- Invalid pre-registrations removed from the REACH-IT database
- Biocides and PIC coming under ECHA's umbrella
- ECHA sets up ENES - an Exchange Network on Exposure Scenarios
- New ECHA guidance on Safety Data Sheets
- New ECHA policy on handling conflicts of interest
- Paving the way for easier and more effective enforcement
- ECHA Management Board adopts Work Programme for 2012
- Executive Director appeals to MEPs for EU and national support: "REACH should continue to be seen as a priority"
- New Head of Evaluation II
- ECHA welcomes the decisions of the Board of Appeal
- ECHA refers a draft decision for one testing proposal to the Commission for the first time
- Preparing for EU membership
Send your feedback to:echanewsletter (at) echa.europa.eu
Article related to: REACH
Inquiry process - enabling data sharing between potential and previous registrants
Data sharing is a cornerstone of REACH and therefore mechanisms have been introduced to help companies share existing data before registration.
For pre-registered phase-in substances, data sharing occurs in Substance Information Exchange Fora (SIEFs) without ECHA's involvement. For non-phase-in substances and substances that have not been pre-registered, a duty to inquire applies and an inquiry process takes place. In this process, ECHA has an active role in placing the registrants and potential registrants of same substances in contact with each other.
Inquiry process at ECHA
To ensure that potential registrants are put in contact with registrants of the same substance and their contact information is handled securely, ECHA needs to be certain of the identity of the inquired substance. Th erefore, each inquiry dossier goes through substance identification assessment where it is ensured that the information provided is suffi cient and consistent so that the substance can be unambiguously identifi ed. Aft er the substance identity verification, it is checked whether there are previous registrants for the same substance. If the potential registrant specifi es their information requirements in the inquiry, also the availability of the studies is checked. The potential registrant will receive the results of their inquiry via REACH-IT. If ECHA is unable to identify the substance, due to missing or inconsistent information, the potential registrant is informed of the deficiencies via REACH-IT and encouraged to submit a new inquiry dossier.
Since REACH entered into force ECHA has received 4788 inquiries. Th e number of inquiries submitted remained quite stable from June 2008 to August 2010, aft er which the number of inquiries received per month almost doubled. Of the submitted inquiries to date, 45 % have been successful but 55 % could not be processed due to missing or inconsistent information. The quality of the inquiry dossiers had improved steadily aft er the REACH's entry into force, but started to deteriorate with the increase in the quantity of submitted inquiries at the end of 2010. During 2011, the quality of the dossiers has started to improve again and has now reached the level that it had been before September 2010.
Current state of play
Even though the legal text does not specify a deadline for ECHA to process an inquiry, the Agency has set itself an internal target of 20 working days for processing an inquiry (in line with its Code for Good Administrative Behaviour), which was respected with only a few exceptions up to October 2010. Due to the high number of inquiries received and their poor quality on average, processing times started to lengthen towards the end of 2010. In order to improve the situation, ECHA started several projects in 2011 to improve the effi ciency of the inquiry process and reduce processing times. As the efficiency of the inquiry process depends on the quality of the dossiers received and on the productivity of the process, initiatives were launched that targeted both aspects. Firstly, in order to improve the productivity in house, ECHA streamlined its working procedure on inquiries and reinforced the staffing of the Substance Identifi cation and Data Sharing unit. Secondly, in order to improve the quality of the inquiry dossiers an Inquiry plug-in tool for IUCLID 5 was launched as part of the TCC plug-ins.
This tool will allow companies to check the dossier's substance identity section before they submit it to ECHA. By using this tool, companies can check that the relevant fi elds of their inquiry dossier are complete. Even though the tool will be unable to verify whether the data is correct, it can help to improve dossier quality. In addition, to provide further advice, ECHA published an updated version of the Q&A on Inquiry in June 2011, containing a new section on substance identifi cation. The revised document covers several topics that, from ECHA's fi ndings, have proven to be diffi cult for inquirers.
Unambiguous substance identity is a prerequisite to enable efficient data sharing. It is however, not always simple to ensure the adequacy, correctness and coherence of the substance identity information. ECHA has identified the following main deficiencies in the inquiry dossiers:
- Absence of spectral data or chromatographic data without justification;
- Absence of a description of the methods used to identify the substance;
- More than one substance is inquired about;
- Submitted spectral data is for a different substance than the one manufactured or imported;
- Counter-ion in salt substance is not identified or quantified;
- Description of the process/origin for the manufacturing of UVCB substances is not included;
- Known constituents of UVCB substances are not identified.
The required analytical data has to be generated for the manufactured substance and a clear and concise description of the quantitative and qualitative analyses should be provided. It is important for the information presented to be readable without a need for industry specific knowledge. Industry specific abbreviations, trade names and jargon should be avoided.
ECHA has also noticed that some companies may be reluctant to provide certain information for confi dentiality reasons. However, the required information is needed for unambiguous identifi cation of the substance and must be submitted. ECHA will only provide previous registrants and other inquirers with the name of the substance being inquired about, the name and address of the inquirer and a list of information requirements specifi ed by the inquirer. No other substance identifi cation information will be disclosed.
Further information on substance identification and inquiry can be found on the ECHA website.
Figure 1: Trend in the number of inquiries received since June 2008. Data as of 30 September 2011.
Figure 2: Figure 2. Ratio of successful inquiries and those which could not be assessed due to missing or inconsistent information since June 2008. Data as of 30 September 2011.
Manufacturers or importers of phase-in substances in quantities of one tonne or more per year or who use a phase-in substance in production of articles or import articles containing phase-in substances for the first time after 1 December 2008, may use the late pre-registration option (Article 28(6) of the REACH Regulation) instead of inquiring about their substance.
To benefit from the late pre-registration option the pre-registration needs
to be submitted:
First-time manufacturers or importers will therefore have to submit their pre-registrations before 31 May 2012 or 31 May 2017, whichever is relevant in view of their tonnage thresholds. Companies that are entitled to submit late pre-registrations, should do so instead of inquiring about their substances.
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Committee for Risk Assessment:
Committee for Socio-Economic
Biocidal Products Committee:
Member State Committee:
4-8 February (tentative)
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