Under the BPR, new studies involving vertebrate animals can be conducted only as a last resort and, therefore, mandatory data sharing applies.
The prospective applicants, intending to perform new tests on vertebrate animals, have the obligation to find out which tests and studies are already available, by submitting an inquiry through R4BP 3 to ECHA.
The prospective applicants may also inquire about tests and studies not involving tests on vertebrate animals. Accordingly, an inquiry is mandatory when the intention is to perform tests on vertebrate animals and is optional when the intention is to perform tests which do not involve vertebrate animals. An inquiry is also a pre-requisite before a data sharing dispute claim can be submitted to ECHA under Article 63(3) of the BPR (including in cases where the prospective applicant already knows the identity of the data owner).
Once a request for test data (on vertebrate animals or not) has been made to a data owner (or any data submitter that is entitled to negotiate on behalf of the data owner), the parties must make every effort to reach an agreement to ensure that the cost of sharing the information is determined in a fair, transparent and non-discriminatory way, in accordance with the provisions of Article 63(1) and (4) of the BPR. ECHA will provide the inquirer with the contact details of all previous data submitters, when tests or studies were already submitted to the competent authorities or ECHA in connection with an application under the former Directive 98/8/EC or the BPR. Where applicable, the data submitters are required to facilitate the contacts between prospective applicants and data owners.
The data sharing obligation also applies to the inclusion in the list of relevant substances and suppliers under Article 95 of the BPR. Note that mandatory data sharing for the purpose of Article 95 extends to all toxicological, eco-toxicological and environmental fate and behaviour studies relating to substances listed in Annex II to Regulation (EC) No 1451/2007, including any such studies not involving tests on vertebrate animals.
Please consult the ECHA website on data sharing (and the related documents), available at Data sharing.
As described in Article 62(1) and Recital 57 of the BPR, the purpose of data sharing is to minimise the number of tests on animals. Accordingly, applicants should not duplicate studies on vertebrate animals for the purposes of the BPR. Instead, applicants should make every effort to share studies in exchange for equitable compensation.
Data sharing increases the efficiency, reduces costs and reduces testing, in particular, on vertebrate animals.
If no agreement is reached, in certain circumstances for certain types of data, the Agency can help prospective applicants by granting permission to refer to the requested data.
In the context of Article 95, for active substance in the Review programme, this includes certain non-vertebrate studies (toxicological, ecotoxicological, environmental fate and behaviour).
Data sharing obligations only apply for data that is still within the period of data protection. For most active substance in the Review programme, this expires on 31 December 2025.
For more information see the Practical Guide on Biocidal Products Regulation Special Series on Data Sharing - Data Sharing.
The BPR data sharing obligations apply to data owners and prospective applicants. A prospective applicant is "any person intending to perform tests or studies" (Article 62(2) and Article 63(1). Data submitters have the obligation to facilitate contacts between the prospective applicant and the data owner(s).
Any person intending to perform tests on vertebrates is required to first inquire with ECHA whether such tests or studies have already been submitted to a competent authority under the BPR or Directive 98/8/EC (the previous legislation).
Such an inquiry is optional in case of tests not on vertebrates.
If such tests or studies have been submitted, ECHA will provide the prospective applicant with the contact details of the data submitter. In cases where the data submitter is not entitled to negotiate access to the data, they are required to facilitate the contact between the prospective applicant and the actual data owner.
More information on how to inquire to ECHA (manuals and tools) is available on the ECHA website dedicated to BPR.
Where such an inquiry is made, and the studies have been submitted under either the BPR or Directive 98/8/EC, data sharing obligations apply.
If such tests do not exist and you would like to initiate them then as laid out in the introduction to Annex III to the BPR "The applicant shall initiate a pre-submission consultation. In addition to the obligation set out in Article 62(2), applicants may also consult with the competent authority that will evaluate the dossier with regard to the proposed information requirements and in particular the testing on vertebrates that the applicant proposes to carry out" (emphasis added). Therefore, we would encourage you to contact the Member State Competent Authority in charge of your application in order to discuss this test including potentially applicable additional legislative requirements.
Following an inquiry and, according to Article 63(1) and (4), the parties involved must:
- make every effort to reach an agreement on the sharing of the results of tests or studies requested (whether involving or not vertebrate animal studies);
- ensure that the costs of sharing these tests or studies are determined in a fair, transparent and non-discriminatory way.
Further information is available in ECHA's Guidance on data sharing.
ECHA will not determine what the compensation should be. The parties have the option of settling this matter before a national court.
The obligation to reach an agreement on the sharing of the results of the tests and studies requested is the exclusive responsibility of the negotiating parties which bear the obligation to make every effort to reach an agreement.
Negotiating parties shall consider the following in order to fulfil their data sharing obligations in a timely manner:
- To ensure the sharing of the tests or studies, parties are encouraged to allow a reasonable time for the negotiations between their inquiry to ECHA and before the actual planned submission of the dossier.
- The prospective applicant should define clearly the scope of the negotiations, by being explicit on the studies and tests requested (regarding vertebrate or non-vertebrate studies).
- As it is the responsibility of the parties to make every effort, the argumentation against any claim or element of the negotiation shall be expressed between the parties; ECHA is never a party in the negotiations.
- Both the prospective applicant and the data owner should be constructive, reliable and consistent negotiating partners, make sure to provide precise information and be proactive and transparent at all times in the negotiations.
More information is available in the "Key Messages" document in the BPR Data sharing web page.
Where no agreement is reached during the negotiations, the prospective applicant can, as a last resort, inform ECHA of the failure to reach an agreement with the data owner on the sharing of the data or of its costs, at the earliest one month after the original receipt from ECHA of the contact details of the data owner (or data submitter). The prospective applicant shall also notify the data owner that they have informed ECHA. The ECHA data sharing dispute procedure should be initiated after all possible efforts have been made and the negotiations have failed. Having submitted an inquiry is the pre-requisite before lodging a data sharing dispute claim with ECHA, including in situations where the prospective applicant already knew the data owner(s) or where negotiations had already started before the entry in force of the BPR.
ECHA strongly recommends continuing the negotiations also after a data sharing dispute claim has been filed.
The BPR requires as a minimum of 1 month (Article 63(3)) after the prospective applicant receives the name and address of the data submitter from ECHA. However, when submitting the data sharing dispute claim the prospective applicant and data owner have to demonstrate that they have made every effort and exhausted all possibilities in the negotiations.
The BPR data sharing obligation applies to data owners whether they are established in the EU or not. In most cases the data submitter will be based in the EU. The data submitter has the responsibility to facilitate contacts between the prospective applicant and the data owner.
No, the data sharing under BPR is not limited to the same substance. Technical equivalence is not a condition for data sharing under Article 62 and 63 of the BPR (in contrast to the same substance condition under the REACH data sharing provisions). For example, shared data can be used for bridging and read across.