- Through the deadlines towards safer chemicals
- High-quality data - a key factor for industry and ECHA
- Is the substance identifier in your registration correct?
- Follow-up of the December 2013 SME workshop
- Biocides – important changes for companies
- Improving supply chain communication
- From registrant to downstream user – implementing REACH the Yara way
- Progress in using alternative testing methods
- Evaluation underway for testing proposals from the 2013 registration deadline
- Continuous development of the QSAR Toolbox
- Enforcement - planning ahead
- Findings from the third enforcement project
- Time to start preparing for REACH 2018
- Registration lessons from an SME
- Guest column: Using existing information to support high-quality REACH registrations
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Article related to: REACH
Is the substance identifier in your registration correct?
ECHA has launched a new service to enable registrants to change the chemical identifiers in their REACH dossiers. Registrants can change the main identifier in their registration, i.e. the EC number, if the substance has been incorrectly identified. During this change process, the registrant's rights to manufacture and import are not affected.
The Agency has found incorrect identifiers in dossiers and has also received requests from registrants that have realised a mistake themselves.
A change of a chemical identifier may be needed when a registrant has made a clerical error and provided the wrong identifier by mistake. Alternatively, registrants may also have wrongly considered the substance sameness in the substance information exchange forum (SIEF).
In the last year, ECHA has seen an increase in demand for such a service. It carried out a pilot project with a few registrants and has now formalised the service. The Agency charges for the administrative work to change the identifier. It is not a simple administrative change – the scientific validity has to be checked.
Flexibility for companies
The main benefit of the service for registrants is that it offers the possibility to resolve any mistake they may have made in determining the scope of their individual registration or their joint submission on their own initiative. Such a correction relieves them from possible harmful consequences of a breach of the REACH obligation to register the substance that they are manufacturing or importing. In addition, by using the service, registrants will not need to submit a new registration and can continue benefiting from the rights already granted under their current registration.
ECHA encourages companies to use the service and request a change if they realise that they do not have the correct chemical identifier – even before a compliance check is done.
This service cannot be used to fulfil the registration obligations for a substance other than the substance originally intended to be covered in the registration. The new identifier proposed can therefore only refine the identity of the substance initially concerned. It cannot correspond to a totally different substance.
How to request a change of chemical identifier?
Registrants can request the change through a specific webform. If the change concerns and affects a joint registration, the lead registrant will need to submit a joint submission plan. The joint submission plan should include the following:
- The chemical identifiers (EC number, CAS number, IUPAC/chemical name) of the substance to which the existing registration of each co-registrant should refer;
- An indication of which substance identity information in the original dossiers demonstrates that the substance with the chemical identifiers mentioned above is covered in that dossier. This information could be, for example, spectroscopic data, analytical information, the reported composition or the description of the manufacturing process;
- The identity (EC number, CAS number, IUPAC/chemical name) of any other substance that would require an additional registration as a result of the service request;
- The identity of the legal entity that will be the lead registrant for the registration of the substance subject to this service request;
- Documentary evidence that all co-registrants of the initial joint submission agree to the request specified in the joint submission plan. This can include signed confirmations or copies of communication between the registrants, for example, email exchanges.
After the service request has been received, ECHA checks that it is in order and can be processed. If the Agency considers that the service can be provided, it issues a service charge to each registrant depending on the workload anticipated. The minimum charge is €300 for each registrant requiring the correction of a substance identifier. The scale of the charge is defined in a decision by ECHA's Management Board. The deadline for payment is 30 days. The registrant will also be informed if the request cannot be processed.
The Agency will not verify the compliance of information provided with the substance identity information requirements under REACH. In practice, this means that if the registrations are selected for compliance check, they may be found incompliant with regard to substance identity.
Once the Agency receives the payment, it updates the identifier information in REACH-IT. Registrants are informed about the completion of the task through REACH-IT and given a reasonable deadline by which to submit updates of their registration with the correct identifiers, if necessary.
- Substance identity
- Joint submission plan template
- Management Board decision 14/2015 amending decisions on the classification of services for which charges are levied
- Registered substances
Did you know?
For the identification of a substance the following most common chemical identifiers are used:
EC and list numbers are unique seven-digit identifiers that have been assigned to chemical substances for regulatory purposes within the European Union by the regulatory authorities. EC numbers (European Community numbers), comprising EINECS, ELINCS and NLP numbers, have been published by the European Commission in the Official Journal of the European Union. List numbers are technical identifiers and do not have legal significance.
CAS numbers are unique numerical identifiers assigned by the Chemical Abstracts Service to every chemical substance described in the open scientific literature including organic and inorganic compounds, minerals, isotopes, alloys and UVCB substances.
IUPAC names are systematic names that meet the recommended IUPAC rules.
SMILES code (Simplified Molecular-Input Line-Entry System) is a specification in form of a line notation to describe the structure of chemical molecules.
InChI (IUPAC International Chemical Identifier) is a textual identifier for chemical substances, designed to provide a standard way to present molecular information and to enable the search for such information in databases and on the web.
Text by Hanna-Kaisa Torkkeli
Top image: Fotolia
Edited on 25 February 2016: added a link to the webform and the joint submission plan template.
Edited on 7 April 2016: charge amended from €445 to €300. Link to Management Board decision updated.
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Committee for Socio-Economic
1-4 and 8-11 June (tentative);
7-11 and 14-18 September (tentative)
Committee for Risk Assessment:
1-5 and 8-12 June;
7-11 and 14-18 September (tentative)
Member State Committee:
Biocidal Products Committee:
Management Board meeting: