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The final decision on what documentation is considered adequate evidence of a ‘sale of assets’ is determined on a ‘case by case' basis in accordance with the relevant national principles of private and corporate law of the Member State where the entity is established. For this reason ECHA Practical Guide 8 – How to report changes in identity of legal entities limits itself to the general example of the asset sales agreement and does not provide further information in this regard.
The relevant documents should be presented to the national enforcement authorities upon request. Ultimately, the REACH duty holders bear responsibility for the submission of adequate documentary evidence. To ensure that it complies with the national legal order they may seek legal advice from in-house or private practice lawyers, for example.
More information on changes in identity of legal entities can be found in the aforementioned Practical Guide 8 – available at http://echa.europa.eu/practical-guides.
Yes, according to Article 12 of the Fee Regulation (EC) No 340/2008 and the references therein to the definitions concerning micro, small and medium-sized enterprises as set out in the Annex to the European Commission Recommendation 2003/361/EC, both EEA and non-EEA companies are to be considered for the classification of partner and linked enterprises during the determination of the SME status of a company. Moreover, the non-EEA company is the very entity under consideration, in case when a submission is made by an Only Representative, as specified in Article 12 of the Fee Regulation.
There is no need to synchronise the company details in REACH-IT and IUCLID. The legal entity information is always extracted from the information in REACH-IT.
However, if you wish to do so, we recommend updating the information in REACH-IT, and later exporting it to your IUCLID 6. If you update your LEO information in your IUCLID 6 application, remember also to update your LEO information in REACH-IT.
Step by step instructions on how to update and synchronise the LEO information can be found in chapter 2.1 of ‘How to prepare registration and PPORD dossiers’ manual at: http://echa.europa.eu/manuals.
The legal successor should observe the following when a legal entity change is validated in REACH-IT:
Transferred items (i.e. registrations/notifications)
You must not transfer an item that is already available in the legal successor's account for the same substance. E.g. If a registration for a substance is transferred from the legal initiator to the legal successor, who already has a valid registration for the same substance, the transferred registration will overwrite the pre-existing registration in the account of the legal successor. The status of the pre-existing registration will be marked ‘Annulled’, because a legal entity can only have one registration for the same substance.
Tonnage band update
For transferred registrations when the originating legal entity has registered the same substance as the legal successor and the tonnage of the originating legal entity is higher than the registered substance of the legal successor, the system will keep track of the legal successor's right to a higher tonnage band. The legal successor will still need to submit a spontaneous update to indicate the higher tonnage band. For transferred pre-registrations, the tonnage band will not be updated when a legal entity change is completed for the same pre-registered substance. In this case, the legal successor will have to modify the pre-registration as explained in Q&A 345.
Transfer of joint submission roles linked to Registrations: Where the initiating legal entity has submitted registrations as part of a joint submission, the joint submission role (e.g. Member or Lead registrant) are transferred together with the registrations to the legal successor.
If no registrations were submitted, the roles are not transferred. The legal successor need to confirm their membership to the joint submission.
Transfer of joint submission roles linked to Pre-registrations: Where the initiating legal entity has confirmed membership to a joint submission based on his pre-registration, the joint submission role (e.g. Member or Lead registrant) is not transferred together with the pre-registration.
When a legal successor enters the pre-SIEF contact details during the validation of a legal entity change, these details will be updated in the pre-SIEF of all the pre-registrations of that legal successor. The pre-SIEF contact details will however need to be updated if you wish to add additional contact persons in the transferred pre-registrations once the transfer is complete. Pre-SIEF contact details will not be updated if you already have a successful registration for a pre-registration with the same substance identification.
The Agency will issue an invoice for the legal entity change pursuant to Commission Regulation (EC) No 340/2008 Article 5 (Fee regulation) if the item list contains one or more payable items.
- Items that trigger a fee during a legal entity change are: Registrations, Registration of on-site isolated intermediate, Registration of transported isolated intermediate.
- Items that do not trigger a fee during a legal entity change are: Pre-registrations, Product and Process Oriented Research and Development (PPORD) notifications, Classification and Labelling (C&L) notifications, Inquiry notifications.
Where an invoice is needed (i.e. the legal entity change includes at least one payable item), only one invoice will be issued per legal entity change.
Invoices are issued to the legal successor. The company size of the legal successor after the change of legal personality will determine the fee. Pursuant to Commission Regulation (EC) No 340/2008 Annex III Table 3, a reduced fee will be invoiced to SMEs.
Only once the invoice is paid in full, will the transfer of items take place and the legal entity change be completed in REACH-IT. If the invoice is not paid within the extended due date the legal entity change is deleted from the system and items will not be transferred.
Information about the fee regulation can be found at http://echa.europa.eu/regulations/reach/legislation.
You can use the ‘Request IUCLID file’ functionality to download the dossier in REACH-IT. The IUCLID file can be downloaded from the REACH-IT submission report page. You can get to the submission report page, by clicking --> Menu --> Search --> Submissions.
When a legal entity change (LEC) takes place, a new submission number is created and assigned to each transferred asset. This is done for technical reasons to keep track of the legal entity transfer, and is not linked to any new submission.
Therefore, when the legal successor submits a request for a dossier download, they should request the download for a submission that is linked to an ‘Initial submission’ or a ‘Submission update’, and not to the Event ‘Legal entity change’. The submission numbers with the related Events can be checked at the Reference number page, ‘Reference number history section’
You can get to the Reference number history section, by clicking Menu → Search → Reference number → click on the reference number displayed in the results page to open the Reference number page → click on the Reference number history section → click on the submission number under ‘Initial submission’ or ‘Submission update’. (see screenshot below)
Please note that it is not possible to download a NONS registration under Directive 67/548/EEC that was successfully claimed if no registration dossier update has been submitted. The owner of the NONS registration needs to contact the appropriate Member State competent authority to receive the files in IUCLID 5 format if the successfully claimed NONS registration needs to be updated. The list of MSCA contact details is available at http://echa.europa.eu/support/dossier-submission-tools/reach-it/nons.
The company size can be updated in REACH-IT via the ‘Company size’ functionality from the main menu and selecting the ‘Update company size’ functionality.
This will open a wizard that will guide you through the process of updating the company size. Read carefully the instructions and have the documentary evidence at hand to substantiate the companies involved in the ownership structure.
Note: This information will be considered by ECHA in future submissions to make an assessment on your eligibility for SME reductions for submissions subject to a fee and eligible for a reduced fee based on your condition as SME. ECHA strongly recommends that you keep your information on company size duly updated in your REACH-IT account.
Under REACH, registrants and applicants can benefit from reduced fees established for SMEs. ECHA has the responsibility to check the size of companies who claim to be eligible for reduced fees.
Before declaring SME status in REACH-IT, companies should be familiar with the rules set by Commission Recommendation 2003/361/EC on SME definition.
To support the claim for reduced fees, companies should upload documentary proof for SME status in their REACH-IT accounts only for those submissions, which are related to the SME fee reductions. You will be able to add relevant documents to your REACH-IT account at a later moment, if needed.
The documentary evidence should include:
- Information about the ownership structure (upstream, downstream) at the time of the submission.
- The financial statements (consolidated, if available) together with accompanying notes for the two latest accounting periods before the time of the submission.
- Official certificate/information confirming the average number of employees for each of the two latest accounting periods before the time of submission.
The above listed documents should be provided for all partner and linked enterprises, as defined by Article 3 of the Commission Recommendation 2003/361/EC.
If the company acts as an Only Representative, the assessment of whether the SME reduction applies should be done by reference to the headcount, turnover and balance sheet information of the non-EU represented company and its linked and partner enterprises.
The list of documentary evidence accepted by ECHA you can find here:
Instructions on how to upload documents and other useful information about new REACH-IT you can find in Discover REACH IT at: http://echa.europa.eu/documents/10162/22308542/discover_reach_it_en.pdf.
More information on company’s size assessment and links to relevant legislation you can find in ECHA’s webpage at:
If the original version of any document is not in one of the official languages of the European Union, a certified translation should be provided.
Legal basis for certified translations is Article 13(3) of the amended Regulation (EC) No 340/2008 on the fees and charges payable to the European Chemicals Agency pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Please see it at:
A certified translation is the one which is accompanied by a signed statement that the translator is competent in the source and target languages (a sworn translator) and that the translation is an exact and accurate translation of the source document. The certified translator should have a certificate or a stamp that identifies the services provider and his qualification.
The SME verification process relates to your information obligations at the time of submitting your registration, which includes the obligation to inform ECHA about the eligibility for a fee reduction in accordance with Article 13(1) of Regulation (EC) No 340/2008. Ceasing to manufacture or import of substances have no consequence on that obligation.
If after registering a substance, you have decided to stop manufacturing or importing it, you should still pay the applicable registration fee in full in case ECHA found that you were not eligible for the claimed SME fee reductions. Once the registration fee is paid and, therefore, your registration can be considered complete, you can indicate in REACH-IT that you have ceased the production or import of a substance. If at a later stage you decide to restart manufacturing or importing it, you would only need to report it again in REACH-IT and the registration would still be valid. Otherwise, you would need to submit a new registration and pay a new registration fee.
In case the balance to the correct registration fee is not paid, such registration will be de-activated in ECHA’s database and the rejection of the registration will be communicated to you by a decision.
The SME verification process relates to your information obligations at the time of submitting your registration, which includes the obligation to inform ECHA about the eligibility for a fee reduction in accordance with Article 13(1) of Regulation (EC) No 340/2008. The termination of the OR agreement has no consequence on that obligation.
Since your represented company benefited from reduced SME fee at the time of registration, therefore you, as the appointed OR at that time, are still liable to demonstrate the eligibility for the SME fee reduction obtained, once ECHA initiates the verification of your represented company size. The failure to provide complete documentation would result in ECHA finding your represented enterprise as non-eligible for the claimed SME fee reductions. In such case, the OR would be liable for the difference between the fee already paid and the correct registration fee, as well as the applicable administrative charge.