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A substance must be registered before the manufacture or import can start at an annual quantity of one tonne or more. Before the registration of such substances, the manufacturer or importer has to make an inquiry to ECHA regarding any previous registration for the same substance.
Upon registration, the registrant may have to wait for three weeks after the registration dossier is submitted before starting or continuing the manufacture or import of the substance (Article 21 of the REACH Regulation).
You can cease manufacture due to the following scenarios:
- You ceased manufacture/import due to commercial reasons according to Article 50(2) of the REACH Regulation. The registered volume in your registration is updated to zero and the status of your registration is changed to "inactive". If you restart manufacture/import of the substance, you should inform ECHA via the 'Restart manufacture or import' button available on the reference number page in REACH-IT.
- You ceased manufacture following a draft decision according to Article 50(3) of the REACH Regulation. The status of your registration will be changed to "Invalid". A new registration must be submitted if you wish to restart manufacturing/importing your substance.
Below are the steps on how to cease/restart manufacture in REACH-IT.
You should use the functionality ‘restart manufacture or import’ to reactivate the reference number, when a substance is manufactured/imported again.
Your registration remains your responsibility, so keep it always up-to-date.
Safety Data Sheet
If you need to give your customers safety data sheets, you will need to include your registration number in the safety data sheets the next time you update them. In addition, if you have conducted a chemical safety assessment and needed to develop exposure scenarios, you have to attach them to the safety data sheet, outlining the use-specific conditions of safe use of the substance. This needs to be done as soon as possible.
If you have claimed you are an SME and have benefited from the reduced registration fees, ECHA may verify the size of your company. Make sure that your REACH-IT account includes all the necessary documentation to justify the size of your company.
Joint Submission management and Data sharing
We strongly recommended that you put in place a mechanism discuss within your joint submission and for dossier update, when necessary. For example, you must also share data and give access to the joint submission to newcomers. You can charge for access to the data by sharing the costs in a fair, transparent and non-discriminatory way.
ECHA will check the compliance of at least 20% of the received registration dossiers to verify that the information submitted is compliant with the legal requirements. The outcome of this dossier evaluation may be a request for additional information. Additionally, ECHA will examine the testing proposals included in the dossiers. This will happen by 1 June 2022 for registrations submitted for the deadline of 31 May 2018, and within 180 days for other registrations.
ECHA will communicate with you via REACH-IT, if the information of your registration dossier is being assessed, so we invite you to check your account regularly.
No. The importer is the natural or legal person established within the European Union (EU, for REACH and CLP also covering the European Economic Area, EEA) who is responsible for import, i.e. the physical introduction (of goods) into the customs territory of the EU (Article 3(10) of REACH).
The responsibility for import depends on many factors such as who orders, who pays, and who deals with the customs formalities or the "INCOTERMS" chosen, but these might not be conclusive on their own. In many instances, the end receiver of the goods (the consignee) will also be the legal entity responsible for the import. However, this is not always the case.
If, for example, you order goods from a company (Company B) established in the EU, which acts as a distributor, you probably do not know where the goods originate from. Company B may choose to order the goods from either an EU-based manufacturer or from a non-EU-based manufacturer.
If the Company B chooses to order from a non-EU-based manufacturer, the goods may be delivered directly from them to you to save on transportation costs. If this happens, your company will be stated as the consignee on the simplified administrative document form and customs handling will take place in your country. Payment for the goods will, however, be settled between you and Company B.
Company B should be considered the legal entity responsible for the physical introduction of the goods into the customs territory of the EEA (importer). You would then be a downstream user. The obligation to register would consequently lie with Company B.
You, on the other hand, will have to be able to prove through documentation to the enforcement authorities that you are a downstream user, for example, by showing that the order was placed to the distributor.
In addition, when interpreting the term "importer" according to the REACH Regulation, it is not possible to fall back upon the Community Customs Code (Regulation (EEC) No. 2913/92), recast in Regulation (EU) 952/2013.
Only a natural or legal person established within the European Economic Area (EEA)/EU can be a registrant. Registration must take place when this person:
1. manufactures a substance within the EU in quantities of 1 tonne or more per year;
2. imports a substance into the EU of quantities of 1 tonne or more per year; or
3. has been appointed as an only representative according to Article 8 of REACH (see FAQs on Only Representative of non-EU manufacturer).
The national law of each country provides the specific provisions concerning natural or legal personality and when such a natural or legal person is established in its territory.
A company not established within the EU does not have direct obligations under REACH. For obligations of a non-EU company, please see to Q&A 12.
You can use the Navigator tool to determine your obligations under REACH and find the appropriate guidance.
A toll manufacturer is normally understood to be a company that manufactures a substance (on its own, in a mixture or in an article) in its own technical facilities following the instructions of a third party in exchange for an economic compensation. The substance is generally put on the market by the third party. This construction is, for example, used for an intermediate step in the production process for which sophisticated equipment is needed (distillation, centrifugation etc.). According to the REACH Regulation, manufacturers of substances are required to register the substances they manufacture above one tonne per year. From this point of view the toll manufacturer is a manufacturer and has to register the substance.
This scenario is further discussed in the factsheet Toll manufacturer under the REACH Regulation.
International companies sometimes have several daughter companies in the EEA/EU, often spread over several countries. If these subsidiaries of the parent company are separate legal entities from it, (a natural or legal person as defined under applicable national law), then each of those must determine if they qualify as registrant under REACH.
Please see Q&A 27 on who has to register a substance.
No. The obligation to register a substance applies only to actors established within the EEA. Thus, the registration of substances imported into the EEA on their own, in mixtures or, in certain cases, in articles will have to be done by the importer established in the EEA. This implies that each individual importer needs to register the substance. However, according to Article 8(1) of the REACH Regulation manufacturers of substances, formulators of mixtures or producers of articles established outside the EEA, can nominate an only representative established within the EEA to carry out the required registration. This will relieve the individual EEA importers within the supply chain of that non-EEA manufacturer from their registration obligations for these substances. They will be regarded as downstream users of this only representative. However, the registration obligation may still apply if the EEA-importers import the same substance from other non-EEA manufacturers.
More information on the only representative role can be found in Only Representative of non-EU manufacturer and in section 22.214.171.124-'Only representative of a "non-EU manufacturer"' of the Guidance on registration.
For more information, see: http://echa.europa.eu/contact/helpdesk-contact-form/enquiry-on-reach-from-non-eu-countries.
Yes. Companies are free to register a substance for a tonnage band which is above the actual tonnage of the substance. This is also reflected in Section 126.96.36.199- 'Calculation of the total volume' of the Guidance on registration.
A registration at a higher tonnage band will trigger a higher registration fee in accordance with Regulation (EC) No 340/2008. In addition, the technical dossier will need to comprise all the information required for the registered tonnage band. Practical advice on how to complete a IUCLID dossier is provided in the Manual How to prepare registration and PPORD dossier at: http://echa.europa.eu/manuals.
Each registrant has to calculate the yearly tonnage for the registration dossier. The yearly tonnage is calculated as the volume per manufacturer/importer per calendar year.
A registrant needs to update their registration without undue delay as soon as the ‘annual or total quantities’ they manufacture or import reach the next tonnage band threshold, as required by Article 22(1)(c). As soon as the annual volume of a substance that has already been registered reaches the next tonnage threshold, the manufacturer or importer has the duty to inform ECHA of the additional data required, following Article 12(2).
The list numbers published by ECHA are not official EC entries. However, we recommend you to assign such an entry to the substance you intend to register provided this list number is linked to a CAS number (list numbers starting with 6 or 8) or a chemical name (list numbers starting with 9) corresponding to a correct and specific identifier for your substance. If this entry is too generic for your substance and there is no appropriate EC entry available, you should not assign any list/EC number to your substance.
If your registration dossier fails the technical completeness check (TCC) for the first time, you are given a deadline of 4 months during which you have one chance to amend the incompleteness. If you fail to submit the complete dossier by this given deadline, your submission will be rejected.
Rejection of a new registration means that the registration number is not assigned to your substance and any fees paid for this registration will not be refunded or otherwise credited. Consequently, you may only start to manufacture/import the substance or to produce or import an article once you have a complete registration and ECHA has issued you a registration number. If you wish to proceed with your registration you need to make a new initial submission. It will be subject to a new completeness check and registration fee.
Rejection of a registration update means that you maintain your existing registration number but any new information included in that update will not be included in the ECHA’s database. Any fees paid for this registration update will not be refunded or otherwise credited. If the update covered a change of tonnage band, you may not manufacture/import the substance or produce or import an article containing it at the increased tonnage band until ECHA has confirmed that your registration update is complete.
If the update of the registration dossier was submitted to include nanoforms of the substance then the rejection means that, even though you maintain your existing registration number for the non-nanoforms of the substance, the registration does not cover the manufacture or import of the nanoforms of the substance. Registrants that manufacture/import nanoforms of the substance after 1 January 2020 without a registration that covers these nanoforms are in breach of the REACH regulation which may trigger enforcement measures. Therefore, if your registration update to include nanoforms was rejected, you need to, at earliest possible, submit a new registration update in order to fulfil your obligations for nanoforms.
As a first step, prepare your registration/PPORD dataset and dossier according to the advice given in the manual ‘How to prepare registration and PPORD dossiers’ available at: http://echa.europa.eu/manuals. Annexes 1-3 of the manual also give an overview of the business rules and technical completeness check rules that apply to registration and PPORD dossiers.
Next, use the IUCLID Validation assistant plug-in to help you detect business rules and technical completeness check failures present in your dataset and dossier. To run the Validation assistant, right click on your dataset in the Navigation panel → Validate → follow the steps in the wizard. The same validation should be performed on the dossier to make sure that no failures have been introduced during dossier creation.
While the Validation assistant cannot replicate all the checks performed by ECHA, it simulates the majority of the verifications done and helps you minimise the chance of failure during submission. It is important to keep in mind, that any failure in the Validation assistant Submission checks tab, that is left uncorrected before submitting your dossier in REACH-IT, will lead to your submission not being accepted by ECHA.
You can find a video tutorials on the use of the IUCLID Validation assistant in the link below:
Please note that if the Validation assistant does not indicate any failures, this is not an automatic confirmation of that your dossier is complete. As of 21 June 2016, the technical completeness check includes additional manual verifications of the registration dossier by ECHA staff. These checks cannot be replicated using the Validation assistant plug-in; the related completeness issues cannot be displayed by the tool.
Information on the areas of the additional verifications can be found in the following location; https://echa.europa.eu/documents/10162/13652/manual_completeness_check_en.pdf.
We also recommend you to have a look at our webinars on the completeness check process:
If your dossier is submitted before the compliance check deadline has passed, you may follow the deadline given in the TCC letter. ECHA will not continue with the Evaluation process before you have submitted the requested update for the technical completeness check failure(s).
If you fail TCC for the second time while submitting the requested update, your submission will be rejected.
If at this point the compliance check deadline has already passed, it means that ECHA has not received a response to the compliance check decision and may proceed with further regulatory actions. It is therefore advisable not to leave the submission of updates to regulatory requests to the last moment.
You can inform ECHA about not meeting the compliance check deadline via the contact form: https://echa.europa.eu/contact
There is no need to change the data waiving justification from free text to an available picklist phrase. A free text justification will be considered equally complete to a picklist value, if it is in line with column 2 of REACH Annexes VII-X, or sections 2-3 of Annex XI.
However, when preparing a dossier in IUCLID 6 from IUCLID 5 data, please review the selection in the field ‘Endpoint’ in particular for IUCLID sections where different information requirements can be addressed (e.g. 4.13, 7.8.1) to ensure that you have clearly indicated that the appropriate requirement is being waived.
The quality rules warn the user of common inconsistencies and shortcomings in the dossier. These warnings will not prevent you from successfully submitting your dossier in REACH-IT. However, leaving quality warnings uncorrected may lead to future clarification requests by ECHA.
The manual verification applies to all registration dossiers submitted to ECHA. The manual checks focus on ensuring that registrants who waive or deviate from the standard information requirements provide justifications foreseen by the legislation. Therefore, the extent of the verification depends on whether the dossier contains waiving of standard information or deviations from substance identification conventions, as well as on the specific requirements that apply to the registration type (i.e. lead, member, individual registration) and the registration scope (tonnage band, isolated intermediate).
For further information, please refer to the document ‘Information on manual verification at completeness check’ available at: https://echa.europa.eu/manuals.
In the task you have a link to the “Submission page” of the submission. Follow this link and go to the “Key documents” section at the bottom of the page. Here you can download the technical completeness check communication which contains all the relevant information regarding the failure, as well as the steps required by you.
The completeness check is based on REACH Article 20(2). It applies to all registration dossiers submitted to ECHA, (i.e. initial submissions and updates). The completeness check consists of two parallel verifications: (i) the technical completeness check, in which ECHA verifies that all the required elements have been provided in the registration dossier; and (ii) the financial completeness check, in which ECHA verifies that the registration fee has been paid, if applicable to that submission.
If during the technical completeness check the registration dossier you submitted is found incomplete, ECHA will issue a deadline by which you have only one attempt to submit the complete information. If you do not provide the requested information by the set deadline in the form of an update dossier, the submission will be rejected. In such a case, any registration fee you had paid in relation with this submission will not be refunded or otherwise credited.
You can find more information about the registration process on "From sbmission to decision" .
We also recommend you to have a look at our webinar on the technical completeness check process.
IUCLID 6 v.4.14.1 includes the new Validation assistant rule TCC_0305_08 which checks that a service life is provided in case a specific technical function has been indicated for the substance. The rule is based on the list of technical functions and their definition in ECHA Guidance R.12.
Contrary to its indication as a completeness check rule by the Validation assistant, this rule should be interpreted as a quality warning. The rule will not cause a completeness check failure when the dossier is submitted in REACH-IT. The rule type will be corrected from a completeness check rule to a quality rule in the October 2020 IUCLID release.
As for all quality rules reported by the Validation assistant, when TCC_0305_08 is triggered, it is recommendable to review the corresponding information reported in IUCLID:
- If you realise that your substance is indeed included in or onto articles, you should report the corresponding service life records in IUCLID section 3.5.6.
- If you confirm that service life in articles is not relevant for your substance, and that the reporting of the technical functions is accurate, you do not need to modify the use description of the substance despite the indication by the Validation assistant. You may find the Q&A 1669 helpful to further clarify when a technical function is expected to lead to a service life in/on articles.
When reporting the technical function, please bear in mind the following:
- Reporting the technical functions of the substance should be limited to what the substance itself (technically) actually does in a mixture and/or in a material/article and should not refer to the function of the final mixture or article.
- The technical function of the substance should only be reported for the particular life cycle stage and use where this function is delivered. Where a substance is present in a use without particular function, the option ‘no technical function’ should be selected.
- The technical functions reported should only include those that the registrant is aware of (including those emphasised in marketing) or has been made aware of by its customers.
- Where the actual substance function cannot be described by one of the technical functions in ECHA Guidance R.12, the function should be described using the picklist option ‘other:’ and adding a brief explanation of this function.
Note that all other completeness check rules related to article service life will lead to a completeness check failure when the dossier is submitted in REACH-IT. The exception applies only to TCC_0305_08.
In general, testing for human health endpoints can be adapted (‘waived'), if the substance is used in the EEA exclusively in cosmetic products falling within the scope of the Cosmetics Regulation, and if the testing would not be necessary to fulfil the REACH requirements for the assessment of worker exposure.
Two main scenarios are foreseen where cosmetics-based waiving could be applied.
- In cases where imported products fall within the scope of the Cosmetics Regulation (EC No 1223/2009) and which, from the time of import, are neither further processed nor repackaged inside the EEA, an adaptation of animal testing requirements for human health endpoints can be sought, based on the absence of relevant worker exposure;
- In other cases, you may be able to seek an adaptation of an information requirement by demonstrating that the substance is handled under strictly controlled conditions during all stages of the life-cycle, other than the use as a cosmetic product (i.e. manufacture, formulation and/or packaging stage).
In all circumstances, you shall provide a reasoned justification for requesting the waiver.