- 3. Maak afspraken met uw mederegistranten
- Deelnemen aan een bestaande gezamenlijke indiening
Deelnemen aan een bestaande gezamenlijke indiening
Deelnemen aan een bestaande gezamenlijke indiening
REACH requires existing registrants and potential registrants to make every effort to reach an agreement on sharing data. The legislation also requires that the costs of sharing the information for a registration are determined in a fair, transparent and non-discriminatory way. For further information, you can consult the Guidance on data sharing.
Each registrant is individually responsible for making sure that the information they submit in their registration complies with the REACH information requirements, which are relevant to their registration.
Therefore, once you as a potential registrant have identified your co-registrants and have agreed on substance sameness (for further information, please read phase 2: Finding your co-registrants), you need to identify what data you need.
Find the information you need for the tonnage band that you intend to register. Consider the type of your registration, i.e. whether it is for full (standard) or intermediate use under strictly controlled conditions.
Based on the identified information requirements, you can see whether you already have relevant studies and whether you need further data. If you will use some of your own data to register the substance, you will be obliged to share the data if co-registrants ask for it, whether it involves testing on vertebrate animals or not.
If you need further data:
- You can negotiate access to individual studies or to all data that was already submitted. You have to make sure that it covers all the information needed for your registration.
- You need at least a right to refer to the data that you require for your registration.
You can also consider negotiating the following items, keeping in mind that neither you, as the potential registrant nor the existing registrants, are obliged to share any of these:
- Chemical safety report (CSR): For registrations above 10 tonnes a year, registrants need to submit a CSR. You can submit the same as the existing registrants or prepare one yourself. If you decide to prepare your own CSR, you should not pay any costs related to the preparation of the existing registrant’s CSR.
- Guidance on safe use of the substance: For registrations between 1–10 tonnes a year, as the chemical safety report is not needed, you will need to submit more information in the guidance on safe use section of your registration dossier. The guidance on safe use needs to be consistent with the safety data sheets you supply to your customers. You may consider sharing the costs, and preparing the guidance on safe use, jointly with the co-registrants.
Once you have clarified your needs and what studies you already have, you can start the negotiations and send a request to the existing registrants.
If you do not need further information to submit a registration, please continue at step 6. ‘If no more data is needed’.
If you, as the potential registrant, need studies to complete your registration dossier, you should contact the existing registrants. You are:
- obliged to request studies involving testing on vertebrate animals to be shared;
- entitled to request studies not involving testing on vertebrate animals to be shared.
When contacting the existing registrants to ask whether they hold relevant studies, you need to make sure that you address the right person. To do so, you need to use all the relevant contact details in REACH-IT and potentially other contact information on the existing registrant’s company website.
When contacting an existing registrant, you should make a clear request of what you need including:
- explaining which substance you intend to register;
- the tonnage band at which you intend to register;
- whether its use will be full (standard) or intermediate use under strictly controlled conditions; and
- whether you would like to have access to the whole data submitted by the existing registrants or only to some of the studies.
You can also indicate if you would like to have access to the existing registrant’s CSR or Guidance on safe use.
The existing registrant is expected to react promptly when they receive a data-sharing request from you as the potential registrant.
The existing registrant must clearly inform you about which data they have the right to negotiate access to. They will also need to inform you about this data and its corresponding costs. If the existing registrant does not have the right to negotiate access to the data, they need to provide the contact details of the data owner.
Sharing of costs needs to be fair, transparent and non-discriminatory. To be able to assess whether this is fulfilled, the existing registrant needs to provide in particular:
- an itemisation of the data to be shared;
- a cost itemisation; and
- a cost-sharing model that includes a reimbursement scheme.
This is explained further in Commission Implementing Regulation (EU) 2016/9.
As a potential registrant, you do not need to pay for a study that was submitted more than 12 years ago. This study can be used free of charge for the purpose of registration under REACH.
Keep in mind that data sharing is not designed to generate profit for anyone, but to share the actual costs between all co-registrants who need that data.
Note that the level of detail of this information that the existing registrant should provide you with may vary from one situation to another. This may also depend on whether you as the potential registrant ask for further information (also see step 4).
Once you, as the potential registrant, have received the information on the sharing of data and costs, you will be able to assess the information provided.
You only have to obtain access rights to the data that you need for your registration. You don’t need to get:
- data when you already have data to fulfil your information requirement for that specific endpoint;
- data that you do not need for the tonnage band of your registration;
- data that you do not need for the type of your registration (such as intermediate use under strictly controlled conditions).
You should critically assess the suitability and quality of the data.
You may consider that some data is not of sufficient quality or that you already have equivalent data. In this case, please continue at step 6 ‘If no more data is needed’.
Regarding the costs, if you have questions or disagreements with how the costs are calculated or shared, you have the right to ask for explanations and justifications.
Potential and existing registrants have to make every effort to reach an agreement on the sharing of data and of the costs in a fair, transparent and non-discriminatory way.
Making every effort to find an agreement means:
- being clear about your needs;
- replying consistently and in a timely manner to the other party;
- asking questions, if necessary, to make sure that the costs have been calculated in a fair, transparent and non-discriminatory way;
- requesting clarification to avoid or clarify misunderstandings;
- challenging with valid arguments items of disagreement;
- replying to the points of disagreements or concerns raised by the other party.
As a potential registrant you may submit a dispute as a last resort when:
- the parties have negotiated for over a month;
- the parties cannot agree on certain issues; and
- attempts to overcome the disagreement have failed.
Filing a dispute with ECHA is free of charge and you do not need a lawyer. The dispute is submitted by filling in a webform with details on the dispute.
ECHA will assess the efforts made by the parties during the negotiations based on documentary evidence (such as email exchanges) that the parties submit. This means that you need to record and collect all communication between you and the other party, for example, in a ZIP or a PDF file and submit it with your dispute.
Neither party needs to submit any additional information (e.g. legal arguments, internal messages, documents or calculations) which were not exchanged during the negotiations as they are not efforts in the negotiations.
ECHA will request the existing registrants to submit, within 10 working days, their documentary evidence regarding the negotiations. ECHA then starts to assess the dispute after the documentary evidence is submitted by the existing registrant or after the expiry of the 10-working day deadline.
Based on the documented communication between you and the existing registrants, ECHA will assess whether you have made every effort to reach an agreement that is fair, transparent and non-discriminatory, while the existing registrants have not. Note that ECHA does not assess whether the claims made in the negotiations are justified or not, or whether the discussed costs are accurate.
Several outcomes are possible:
- If ECHA concludes that you as the potential registrant have made every effort to reach an agreement but the existing registrants have not, ECHA will issue a decision granting you permission to refer to the data. This decision will be conditional to the submission to ECHA of a proof that you have paid the existing registrant an appropriate share of the costs within two months of the decision. You will also receive a copy of the robust study summaries from the existing registration. In addition, ECHA will give you access to the joint submission with a token. This token is a passcode which allows you to register as a full opt-out member within the existing joint submission. However, you are not allowed to make use of this permission to refer before (i) having submitting a proof of payment to ECHA within two months of the decision and (ii) having received from ECHA an acknowledgment of receipt of this proof of payment.
- If you submit a proof of payment within two months, ECHA will acknowledge its receipt and you can then make use of the permission to refer to submit your registration dossier.
- If you do not submit a proof of payment within two months, ECHA will revoke its decision granting you permission to refer.
- If ECHA concludes that you did not make every effort to reach an agreement, you will not get permission to refer to the requested data. You will then need to continue the negotiations with the existing registrant.
Both parties are encouraged to continue making every effort to find an agreement that will satisfy both of them despite having initiated a dispute procedure (and even after receiving ECHA’s decision). The outcome of the dispute can never satisfy any party in a way that a voluntary agreement would.
As a potential registrant, you may think that the quality of some data is not good enough, or that you already have equivalent data. In this case, you may consider opting out from the specific endpoint and providing your own data. You can then request the existing registrants to provide an updated cost calculation, taking into account this opt-out.
After assessing the available information and discussing with the existing registrant, you may conclude that you only need access to the joint submission, not to any data. In this case, you can submit your dossier as a full opt-out registration. You can ask the lead registrant to give you access to the joint submission with the agreement that you will submit a full opt–out registration. Alternatively, you can ask ECHA to give you a token to access the joint submission. Please note, that if you submit a full opt-out dossier, you must provide all the data needed for your information requirements in your opt-out dossier.
If you opt out from all or some of the jointly submitted information, the information will still need to be part of the same joint submission, and you need to be able to justify the opt-out decision. Three possible reasons are foreseen in REACH:
- disproportionate costs;
- disclosure of commercially sensitive information; and
- disagreement on the selection of data.
As a potential registrant, you need to make sure that you have exhausted every means of contact to reach the existing registrant; try using the other contact details specified in REACH-IT. Keep records of the attempts to contact the company, e.g. sending registered letters, phone calls, identifying and contacting other people in the company. If the message reaches the addressee and you still do not get an answer, send reminders stating clearly that you will file a dispute with ECHA if the request is ignored.
Repeat the question and try to explain it in a different way. It can also be a good idea to explain why those questions are relevant. If the existing registrant does not reply to a question, there may be a lack of effort from their side.
Registrants need to reach an agreement on how to share the costs related to data. If the potential registrant disagrees with the proposed costs, they need to objectively challenge them. They could, for example, provide an alternative cost quotation from a different laboratory, challenge the cost of items or suggest an alternative cost and explain why they consider that cost to be more suitable.
Note that while the proposed cost may seem too high, it may still be objectively justified by evidence. While data sharing under REACH is ‘not for profit’, fair cost sharing still requires each registrant to cover part of the costs for the data they share.
For further information, see Fact sheet on typical cost elements in data-sharing negotiations.
As part of the obligation to make every effort, it is important to adjust the negotiations to the specific situation of micro, small and medium-sized enterprises (SMEs). As in any other negotiation, the negotiator must take the situation of its counterpart into account. SMEs typically have fewer resources available for regulatory issues such as data sharing.
For example, when facing a potential registrant that is an SME, the existing registrants may need to be particularly clear and extensive in their explanations, but also to make sure that they do not overload the potential registrant with non-relevant information.
The existing registrants may also agree to take into account the possible difficulties for the SME to pay the cost compensation at once. For example, they can agree to a payment in instalments.