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Practical advice for sharing data and submitting jointly with co-registrants

Data sharing and joint submission are not designed to generate profit for anyone, but to share the actual costs between all co-registrants (you, other potential registrants and existing registrants) who need that data.

You and your co-registrants operate in the same market. You should critically assess all the information you receive while interacting with the co-registrants with whom you share the cost.

Co-registrants have to make every effort to reach an agreement on sharing data, submitting together and sharing cost in a fair, transparent and non-discriminatory way.

Making every effort to find an agreement means:

  • being clear about your needs
  • asking questions to make sure the price has been decided in a fair, transparent and non-discriminatory way
  • requesting clarification when there are misunderstandings
  • challenging any items that are disagreed with valid arguments.

Practical advice for sharing data and submitting jointly with co-registrants

Negotiation advice

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Make every effort to come to an agreement. These dos and don'ts can help you make your negotiations successful.

Dos and Don'ts

Know your needs

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Compare the information requirements for the tonnage band of the substance you manufacture or import (1-10 or 10-100 tonnes a year) and type of registration (standard or intermediate) with data that you already have.

Information requirements

Practical advice

 

1. Clearly ask for what you need

The first step is to ask your co-registrant for a price for what you need, for example, the data you need for the tonnage band you plan to register (considering the type of your registration).

You can negotiate access to individual studies or to all data that was already submitted. If you only need access to the joint submission but not to any of the data, you need to agree on how to receive the token from the lead registrant.

Normally, the price consists of costs related to data and costs related to the administrative work.

You will typically be able to purchase a letter of access (LoA), which allows you to refer to the data you need for your registration. This could help to avoid lengthy and detailed negotiations, and make it easier for you to register by making use of documents that your co-registrants have already used and prepared. If you agree with the cost proposal you can proceed with your registration. 

If you have questions or disagree with how the price was decided, you have the right to ask for explanations and justifications.

 

2. Make sure you only pay for the data you need

You only have to pay for data that you actually need for your registration.

You don't need to pay for:

  • data you already have to fulfil your requirement (endpoint)
  • data you don't need for the tonnage band of your registration
  • data you don't need for the type of your registration (such as intermediates under strictly controlled conditions)
  • data submitted more than 12 years ago for substances with EC numbers starting with "4", as this can be used free of charge.

You are:

  • obligated to ask for data involving testing on vertebrate animals to be shared,
  • able to ask for data not involving testing on vertebrate animals to be shared,
  • obligated to share your own data if your co-registrants ask for it.

Once you ask for access to any kind of data, you and your co-registrants have to make every effort to reach an agreement in a fair, transparent and non-discriminatory way.

If you prefer to rely on other data than your co-registrants’, for example, because their data is not of sufficient quality and detail or because you have equivalent data and do not want to pay again, you may consider opting-out from the specific endpoint and provide your own data. 

Keep in mind, however, that you still need to be part of the same joint registration. In some cases, instead of test data, you can also consider waivers, non-testing methods and read-across, if they are scientifically justified. 

 

3. Clarify what you get for your money

You need at least a right to refer to the data you require for your registration. You need to make sure that this covers all your needs related to your registration, including for example preparation of your safety data sheets and development of risk management measures. You can, however, also negotiate access to hard copies of the studies, or a right to use the data for purposes other than REACH.

You also need access to the joint submission. In practice, this means that the lead registrant gives you a token (password) to become a member of the joint submission in REACH-IT. You always need to submit your registration as a member of a joint submission, even if you do not share some or all of the data submitted by the lead registrant. You may still need to pay your part of getting access to the joint registration and receiving the token.

You can also consider negotiating on any of the following, keeping in mind that neither you nor your co-registrant is obligated to buy or sell any of these:

  • Chemical safety report (CSR):

For registrations above 10 tonnes a year, you need to submit a CSR. You can buy it from your co-registrant or prepare it yourself. If you decide to prepare your own CSR, you should not pay any costs related to the preparation of your co-registrant's CSR. For registrations between 1-10 tonnes a year, a CSR is not required.

  • Guidance on safe use of the substance:

As the chemical safety report is not needed for registrations between 1–10 tonnes a year, 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 of preparing the guidance on safe use jointly with your co-registrants.

 

4. Request a cost breakdown

Sharing of costs needs to be fair, transparent and non-discriminatory. To be able to assess if this is fulfilled, you need information on the individual items that make up the price. You may request a cost breakdown, including an explanation of how the overall costs have been calculated.

This breakdown is mandatory and must list the costs related to data (endpoint-by-endpoint) and administrative work. Each item needs to be justified, and the price has to relate to the information you require for your registration.
 
It is your right to ask for and receive a cost breakdown. There are no preconditions to get it. You cannot be forced to pay a deposit, sign a non-disclosure agreement or pay any fee for that information.

You also have the right to ask for more information if the cost breakdown you receive is not detailed enough. However, in some cases having a very detailed cost breakdown may be difficult and not helpful. You may agree unanimously to be pragmatic and not to itemise certain or all elements – potentially for a decrease in price.

 

 

5. Analyse the cost breakdown

Firstly, there is the cost of the data. This can consist of the costs for performing a test, costs for buying access to required data or costs of fulfilling your information requirement with a non-testing method. 

If there are no invoices available for an item, the costs for performing the test again or another estimate could indicate the value. 

Secondly, there are administrative costs. These can relate to the general administration of the substance information exchange forum (SIEF) and joint submission.

Both data and administrative costs need to be shared in relation to the information requirements. 

It is not always possible to precisely divide between data and administrative costs. Nevertheless, all cost items should be justified so that you are able to determine what parts of them relate to your information requirements. See Annex III to the Guidance on data sharing for examples of data and administrative costs. 

6. Make sure you only pay the appropriate administrative costs

Some of the administrative costs may be data-specific. For example, costs to conduct a literature search or to develop the reasoning for a data waiver clearly relate to an endpoint and not to the entire dossier.

As you only have to pay for data that you actually need, you do not have to pay data-specific administrative costs if they relate to an endpoint which you do not need or which you already have.

Some of the administrative costs, however, are not data-specific, but related to general administration of the SIEF and joint submission. For example, the costs of communicating within the SIEF or managing the access (token) to the joint submission could apply to all members equally.

In any case, you have the right to know how the costs are shared. Also, all the costs need to be justified.

 

 

7. Discuss the reimbursement scheme

Your proportion of the costs depends on how many co-registrants share the data. It makes a significant difference if the costs are shared between 2 or 200 registrants.

The final number of co-registrants who share the costs may not be clear while you negotiate. This means that the calculation of the price may be based on the current number of co-registrants. You can check the current number of co-registrants on ECHA’s website and, once you register, you can monitor it in REACH-IT.

Having a reimbursement scheme is mandatory and will make sure that the costs are equally shared. Each time a new potential registrant buys access to the data, the overall costs for each co-registrant should reduce. When and how frequently the price is re-calculated needs to be agreed.

However, having a reimbursement scheme may be more costly than the potential reimbursement. In this case, you may agree unanimously not to have one – potentially for an additional decrease in price. To waive the obligation to set up a reimbursement scheme, you need the agreement of each registrant – including future ones, who have the right to ask for a reimbursement scheme even if all earlier registrants agreed not to have it. 

 

 

8. Request information on the method used for calculating cost

Co-registrants may agree on any cost-sharing method they find appropriate. For example, either historical costs or replacement costs can be used. Historical costs are based on actual invoices whereas replacement costs refer to costs for performing the test again.

The most obvious way of sharing data is when each registrant pays their share of the information they need. 

In addition, co-registrants may apply increases and decreases to the overall price. These have to be mutually agreed. 

For further information, check the Fact sheet on typical cost elements in data-sharing.

In any case, it is important that you understand the method used. If you have doubts, you have the right to request further details and justifications.

 

9. Find an agreement on future costs

You cannot be forced to pay upfront for potential costs that might take place later.

However, you must agree with your co-registrants to establish a system that covers potential future costs, for example, for spontaneous dossier updates or for generating studies requested under dossier evaluation. In that agreement, make sure that you only pay for what you need to be compliant with REACH. See more in Chapter 5.5.5 ‘New studies’ of the Guidance on data-sharing for more information. 

 

10. Discuss the payment methods

Registrants are free to agree on any payment option they wish. There is no legal obligation that requires special treatment for small and medium-sized enterprises (SMEs), but it is important to adjust the negotiations to their specific situation. This can be part of making every effort as required by REACH. You could, for example, agree on payment in instalments.

What if...?

In most cases, you and your co-registrants come to an agreement which satisfies both parties of the negotiations. However, you might also face difficult situations in your negotiations.

 

What if I do not get a reply?

Try other means of communication and keep records – registered letter, telephone, identifying other people in the company, etc. If the message reaches the addressee and you still do not get an answer, send a reminder with a realistic deadline for replying, and inform that you will file a dispute with ECHA if  your request is ignored.

 

What if the reply does not answer my questions?

Repeat your questions and emphasise that if you do not receive a reply by a certain date, this will be considered non-transparent or not making every effort. Also, inform that you will file a dispute with ECHA if your request is ignored.

 

What if I do not agree with the proposed price?

You need to objectively challenge the proposed price. You could, for example, provide an alternative price quotation from a different laboratory; challenge the cost of items, increases and decreases; or suggest an alternative price and explain why you consider that price to be more suitable. 

Note that while the proposed price may seem too high to you, it can be objectively justified by evidence. While data sharing and joint submission under REACH are ‘not for profit’, fair cost-sharing still requires each registrant to cover their share of the costs for registration.

For further information, see Fact sheet on typical cost elements in data-sharing negotiations

 

 

What if everything is fair, transparent and non-discriminatory but I still cannot afford the price?

If you consider the costs to be justified but still cannot afford them, you may seek advice regarding alternative sources for funding from your sector organisations or local authorities.

 

What if I have asked all my questions and am still convinced that the price is not fair, transparent or non-discriminatory?

Make sure you communicate clearly to your co-registrants why you consider the price to be unfair, non-transparent or discriminatory.  If you still cannot agree on data and cost sharing, and access to the joint submission (token) with your co-registrants, as a last resort, ECHA can assess your case. Filing a dispute with ECHA is free-of-charge and you do not need legal support to do it. You will only be asked to submit all the records of your negotiations.

Before you submit a dispute to ECHA, you need to make sure you are able to show you have made every effort to reach an agreement, and that you have addressed all of your concerns directly with the other party. 

Once a dispute is filed, ECHA assesses the efforts made to reach an agreement on the sharing of data and its cost and access to the joint submission (token) in a fair, transparent and non-discriminatory way. 

ECHA does not assess the price as such or whether it is appropriate. If ECHA finds that you made every effort to reach an agreement, while your co-registrants failed to do so, ECHA may grant you permission to refer to the disputed data and access to the joint submission (token).

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