DECISION OF THE BOARD OF APPEAL OF THE EUROPEAN CHEMICALS AGENCY. 7 March 2018

Transcription

1 A (11) DECISION OF THE BOARD OF APPEAL OF THE EUROPEAN CHEMICALS AGENCY 7 March 2018 (Biocidal products Data sharing dispute Every effort Permission to refer Chemical similarity Contractual freedom) Case number Language of the case Appellant Representatives A English Solvay Solutions UK Limited, United Kingdom Koen Van Maldegem and Peter Sellar Fieldfisher (Belgium) LLP, Belgium Intervener Representatives Dow Benelux B.V., the Netherlands Darren Abrahams and Indiana de Seze Steptoe & Johnson LLP, Belgium Contested Decision DSH-63-3-D of 14 November 2016 adopted by the European Chemicals Agency pursuant to Article 63(3) of Regulation (EU) No 528/2012 of the European Parliament and the Council regarding the making available on the market and use of biocidal products (OJ L 167, , p. 1; the BPR ) THE BOARD OF APPEAL composed of Mercedes Ortuño (Chairman), Andrew Fasey (Technically Qualified Member) and Sari Haukka (Legally Qualified Member and Rapporteur) Registrar: Alen Močilnikar gives the following

2 A (11) Decision Background to the dispute 1. By the Contested Decision, the European Chemicals Agency (the Agency ) granted the Intervener permission to refer to certain studies owned by the Appellant for the biocidal active substance tetrakis(hydroxymethyl)phosphonium sulphate (2:1) (EC No ; the active substance ). The permission to refer was granted following a data sharing dispute submitted by the Intervener under Article 63(3) of the BPR (all references to Articles concern the BPR unless stated otherwise). 2. The Intervener wanted access to the studies owned by the Appellant so that they could be used in an application for inclusion in the list of suppliers of biocidal products and substances which have not been approved (the Article 95 list ). Suppliers of biocidal products and substances can no longer place them on the market if they have not been included in the Article 95 list, published by the Agency, by 1 September On 10 October 2012, the Intervener first contacted the Appellant to discuss a data sharing agreement. 4. On 2 October 2013, the Intervener and the Appellant met to discuss a data sharing agreement for the active substance. It was agreed that the Appellant would prepare a secrecy agreement and, once agreed, the Appellant would share with the Intervener a list of studies and a summary of their results. Between 8 November 2013 and 28 January 2014, s were exchanged between the Parties on the possibility of using a secrecy agreement drafted by the Intervener for another active substance as a template for the secrecy agreement for data sharing on this active substance. On 11 June 2014, the Intervener sent a draft secrecy agreement to the Appellant which it had prepared on the basis of a secrecy agreement used for data sharing on another active substance. 5. On 15 and 25 August 2014 respectively, the Appellant and the Intervener signed the every effort and secrecy agreement under the BPR for the active substance (the secrecy agreement ). Clause 7.1 of the secrecy agreement provides that [n]o information will be disclosed to either Party pursuant to Article 3 of this Agreement, unless and until Every Effort has been made by the [Intervener] to establish Chemical similarity of its source of [the active substance] with that of the [Appellant]. Clause 7.2 states that the chemical similarity of the Appellant s and the Intervener s respective active substance specifications would be assessed by a technical consultant chosen by the Parties. Clause 7.3 states that the Intervener would provide, within two weeks following the execution of the secrecy agreement, a list of three European Union based technical consultants. By the common consent of the Appellant and the Intervener, the technical consultant would then be selected to perform a chemical similarity assessment (the chemical similarity assessment ). Clause 7.5 of the secrecy agreement provides that [w]hen, irrespective of the will of the Parties, no Chemical similarity can be established between the specifications, by the appointed consultant, the Parties will have to stop negotiating a Data Sharing Agreement. 6. On 25 September 2014, the Appellant provided the Intervener with a list of quotations from five different technical consultants to perform the chemical similarity assessment. 7. On 11 March 2015, the Intervener chose a technical consultant (the consultant ) from the list sent by the Appellant. The Intervener contacted the consultant on 18 March 2015 to negotiate a contract to conduct the chemical similarity assessment (the contract for the chemical similarity assessment ). 8. On 28 August 2015, before the contract for the chemical similarity assessment was signed, the Intervener sent a letter to the Appellant expressing its concern about delays with the chemical similarity assessment. The Intervener stated that it wanted to progress with the data sharing negotiations while waiting for the results of the chemical

3 A (11) similarity assessment. The Intervener asked the Appellant to provide, by 11 September 2015, a list of studies performed on the active substance owned by the Appellant and subject to mandatory data sharing under Articles 62(2) and 95(1) (the list of studies ) and a quotation for a letter of access to the studies listed (the quotation ). 9. On 3 September 2015, the Appellant confirmed that it had received a copy of the signed contract for the chemical similarity assessment. On the same day, the Appellant agreed to meet the Intervener to discuss data sharing and reminded the Intervener of Clause 7.1 of the secrecy agreement. 10. On 8 September 2015, the Intervener wrote to the Appellant claiming that Clause 7.1 did not prevent disclosure of information on the active substance before chemical similarity was established. The Intervener therefore considered that data sharing negotiations could start immediately. It asked the Appellant again for the list of studies and the quotation. 11. On 18 September 2015, the Appellant sent to the Intervener the list of studies, a quotation for a letter of access (the 18 September 2015 offer ), and a spreadsheet detailing the valuation of each of the studies for the purposes of data sharing. On the same day, the consultant informed the Parties that it was in a position to begin the chemical similarity assessment. 12. On 29 September 2015, the Appellant and the Intervener met to discuss the next steps in the data sharing negotiations. 13. On 17 October 2015, the Intervener sent comments on the 18 September 2015 offer and made a counter offer (the 17 October 2015 counter offer ). 14. On 18 November 2015, the consultant informed the Appellant and the Intervener that the chemical similarity assessment was inconclusive. On the same date, the Appellant informed the Intervener that, consequently, Clause 7.5 of the secrecy agreement applied and the data sharing negotiations should stop. 15. On 23 November 2015, the Intervener replied that the fact that the consultant s chemical similarity assessment was inconclusive did not mean that chemical similarity could not be established. The Intervener added that the report does not say the criteria specified in [the Agency s] Guidance on applications for technical equivalence are not met, it says that it was not possible to determine it. The Intervener considered that it had complied with Clause 7.1 of the secrecy agreement because it had made every effort to establish chemical similarity. It therefore considered that Clause 7.5 did not apply and asked the Appellant to continue the data sharing negotiations and reply to the 17 October 2015 counter offer. 16. On 30 November 2015, the Appellant repeated to the Intervener that Clause 7.5 of the secrecy agreement applied. It asked the Intervener what it planned to do to establish chemical similarity. The Appellant added that if sufficient progress was made with regard to proving chemical similarity it would reply to the 17 October 2015 counter offer. 17. On 8 December 2015, the Intervener replied that it would request the Agency to conduct a chemical similarity check (the Agency s chemical similarity check ). According to Article 1(2) of the Agency s Management Board Decision 31/2013 of 18 December 2013, the chemical similarity check shall mean an assessment similar to technical equivalence assessment described in Article 54 [of the BPR], but performed solely on the substance identity and chemical composition of a substance with the aim of establishing its similarity as regards the chemical composition of a second substance. Article 2(1) of the Management Board Decision provides further that this service is only available for the purposes of facilitating the implementation of [the BPR], in particular submissions under Article 95 of [the BPR]. The Intervener also asked the Appellant to respond to the 17 October 2015 counter offer by 8 January Otherwise, the Intervener reserved the right to submit a data sharing dispute to the Agency under Article 63(3).

4 A (11) 18. On 8 January 2016, the Appellant replied to the Intervener and repeated that chemical similarity should be established before the data sharing negotiations could continue. The Appellant also considered that the Agency s Practical Guide on the BPR special series on data sharing (version 1, April 2015, the Practical Guide ) allowed the Parties to contract freely between themselves as they had done in this case. The Appellant stated that the Agency s data sharing decisions published on the Agency s website supported this principle. The Appellant asked the Intervener to inform it of the outcome of the Agency s chemical similarity check and reaffirmed that if the outcome showed their sources of the active substances to be similar it would continue the data sharing negotiations. 19. On 17 May 2016, the Intervener informed the Appellant of its intention to submit a data sharing dispute to the Agency under Article 63(3). The Intervener considered that the Appellant had unilaterally discontinued the negotiations. According to the Intervener, making chemical similarity a pre-condition for data sharing negotiations was contrary to the BPR and the Practical Guide. The Intervener insisted that chemical similarity should not be a pre-condition for data sharing negotiations and requested the Appellant to reply to the 17 October 2015 counter offer. 20. On 23 May 2016, the Appellant replied that the negotiations had not failed and that it would respond to the 17 October 2015 counter offer if the Agency established chemical similarity between the two sources of the active substance. 21. On 22 July 2016, the Agency notified the Intervener of its conclusions on the chemical similarity check of the two sources of the active substance. The Agency concluded that the Appellant s source of the active substance was not chemically similar to the Intervener s source. The Agency stated that this finding was based on the information available on the reference source at the time of the assessment. The Agency stated that [the] assessment of chemical similarity carried out by [the Agency] is without prejudice to the final reference source of the active substance which will be established if the active substance is approved in the future. The Agency added that whilst a technical equivalence assessment under Article 54 would have legal consequences for the Intervener, the chemical similarity check that it had conducted does not. 22. On 10 August 2016, the Intervener informed the Appellant that it would submit a data sharing dispute under Article 63(3) within one week unless the Appellant agreed to conclude a data sharing agreement in absence of conclusive proof of chemical similarity. The Intervener had not at this point shared the Agency s communication on the chemical similarity check with the Appellant but stated that [the Agency s] conclusion is that [the Intervener s] alternative source is considered not chemically similar. The Intervener continued that [the Agency s] communication confirms our view that clause 7.5 [of the secrecy agreement] is incapable of being satisfied because the reference source in [the Appellant s] dossier is not sufficiently precise. 23. On 23 August 2016, the Appellant sent a letter to the Intervener stating that the Intervener s intention to submit a data sharing dispute was premature and emphasised that Clauses 7.1 and 7.5 of the secrecy agreement had been agreed by the Intervener and that it could therefore not unilaterally deviate from them. It noted that the Intervener had not shared the Agency s chemical similarity check with it in its entirety. The Appellant invited the Intervener to meet to discuss the chemical similarity problem and possible solution. 24. On 26 August 2016, the Intervener replied that it disagreed with the Appellant s reading of Clauses 7.1 and 7.5. The purpose of Clause 7.5 was not to circumvent the rules on mandatory data sharing in the BPR. The Intervener added that even when active substances are not identical, mandatory data sharing still applied under the BPR. Therefore it could not duplicate the studies already performed by the Appellant for the purposes of the application to be included in the Article 95 list. The Intervener informed the Appellant that it was submitting a data sharing dispute to the Agency.

5 A (11) 25. On the same date, the Intervener submitted a data sharing dispute to the Agency (the data sharing dispute ). 26. On 31 August 2016, the Agency informed the Appellant that the Intervener had submitted a data sharing dispute and requested the Appellant to provide documentation on the negotiations, including any correspondence, minutes from any telephone calls and meetings, demonstrating the efforts made by the Parties to reach an agreement. 27. On 14 September 2016, the Appellant submitted to the Agency the documentation on the data sharing negotiations. 28. The Parties continued the data sharing negotiations after the Intervener had submitted the data sharing dispute. 29. On 14 November 2016, the Agency adopted the Contested Decision granting the Intervener access to the Appellant s data listed in Annex 1 to the Contested Decision. Procedure before the Board of Appeal 30. On 16 December 2016, the Appellant filed this appeal. 31. On 21 February 2017, the Agency filed its Defence. 32. On 7 April 2017, Dow Benelux B.V. was granted leave to intervene in this case in support of the Agency. 33. On 24 April 2017, the Appellant submitted its observations on the Defence. 34. On 6 June 2017, the Intervener submitted its statement in intervention. 35. On 6 June 2017, the Agency submitted its observations on the Appellant s observations on the Defence. 36. On 6 July 2017, the Appellant submitted its observations on the statement in intervention. 37. On 7 July 2017, the Agency indicated that it had no observations on the statement in intervention. 38. On 19 October 2017, a hearing was held at the Appellant s request. At the hearing, the Parties and the Intervener made oral submissions and answered questions from the Board of Appeal. Form of order sought 39. The Appellant requests the Board of Appeal to: - declare the appeal admissible, - annul the Contested Decision, and - order the Agency to pay the costs of these proceedings. 40. The Agency, supported by the Intervener, requests the Board of Appeal to dismiss the appeal as unfounded. Reasons 41. In support of its appeal, the Appellant raises four pleas: 1. the Agency did not follow the procedure in Article 63(3). It adopted the Contested Decision even though no payment had been made by the Intervener and the Contested Decision was adopted outside of the 60-day deadline, 2. the Agency committed a manifest error of assessment of the every effort condition in Article 63,

6 A (11) 3. the Agency infringed the principle of freedom of contract and frustrated the Appellant s legitimate expectations, and 4. the Agency infringed the Appellant s right to be heard. 42. The Board of Appeal will examine first the Appellant s second plea, alleging that the Agency made an error of assessment of the every effort condition in Article 63(3). The second plea, alleging that the Agency committed a manifest error of assessment of the every effort condition in Article 63(3) Arguments of the Appellant 43. The Appellant argues that the Agency did not assess the balance of the Appellant's and the Intervener's efforts correctly. With regard to the different steps in the negotiations, the Appellant argues, amongst other things, that: - it did not refuse to pursue the data sharing negotiations after the consultant s findings but constructively progressed the discussions on chemical similarity. The Appellant highlights its communications, and the proposals therein, of 8 January, 23 May and 23 August 2016, as well as its proposals in its other communications made after the data sharing dispute was lodged, - it took the Intervener four months to reply to the Appellant s of 25 September 2014 on the choice of consultant and five months to react to the letter of 8 January 2016 asking for information on the outcome of the Agency s chemical similarity check, and - the BPR does not state that data sharing must proceed every time a data owner is requested to share data. The chemical similarity clauses in the secrecy agreement meant that if chemical similarity could not be established the data sharing negotiations would stop. These clauses did not contradict Article 63(3). That Article does not mean that every data sharing negotiation will be successful. 44. The Appellant argues that as establishing chemical similarity was mutually agreed between the Appellant and the Intervener the latter could not then waive this requirement. The Appellant argues that the Intervener acted unilaterally, and in contradiction with the Appellant s and the Intervener s mutual agreement, by ignoring Clause 7.5 of the secrecy agreement and requesting the Agency s chemical similarity check despite the negative result of the chemical similarity assessment performed by the consultant. 45. The Appellant states that it disagrees with the Agency's interpretation of the role of chemical similarity in data sharing under the BPR and how the Agency interpreted the results of the consultant s chemical similarity assessment. In particular: - the chemical similarity assessment is in the public interest because the objective of the BPR is to avoid exposure of humans and the environment to biocidal products for which no data exists or no risk assessment has been made. Therefore, using the Appellant s data for the Intervener s active substance, which is not similar to the Appellant s, risks undermining the public policy interest of the BPR, - the results of the chemical similarity assessment performed by the consultant were inconclusive. The Intervener s source of the active substance was therefore not demonstrated to be similar to that of the Appellant, and - the Agency should have based the Contested Decision on the premise that chemical similarity had not been demonstrated and not on the premise that chemical similarity may be established at a later stage, during the approval of the active substance. The Agency should have based its assessment of every effort on the fact that the sources of the active substance were different at the time of the data sharing negotiations.

7 A (11) Arguments of the Agency 46. The Agency considers that any agreement concluded by the parties to limit their data sharing obligations is in breach of Article 63 and therefore void. It considers that: - data sharing obligations under the BPR apply regardless of the similarity of the substances supplied by data owners and prospective applicants. Therefore, even if the sources of the active substance were not chemically similar, the Appellant was still under an obligation to make every effort to find an agreement to share data with the Intervener, and - sharing data on an active substance that has not yet been approved under the BPR is subject to uncertainties. A prospective applicant cannot know for certain whether the data to which it negotiates access will actually be useful for its application. Therefore, the Intervener had an interest in establishing chemical similarity before negotiating access to data or making a payment to the Appellant. However, as the consultant s chemical similarity assessment was inconclusive and the Agency concluded that the active substances were not similar, the Agency argues that the risk in using the Appellant s data for an Article 95 application therefore fell on the Intervener. 47. Concerning its assessment of the balance of the Appellant's and the Intervener's efforts, the Agency argues that it did not err in finding that the Intervener made more efforts to find an agreement. The Agency argues that it is unclear whether the Appellant claimed in its Notice of Appeal that there should be no data sharing at all due to the lack of chemical similarity or that it made every effort to find an agreement. 48. The Agency argues that, on the one hand, the Intervener continued to negotiate despite the lack of chemical similarity between the two sources of the active substance. The Appellant, on the other hand, refused to negotiate in the absence of proof of chemical similarity. The Intervener s delays in the negotiations are therefore outweighed by the Appellant s refusal to negotiate. Arguments of the Intervener 49. The Intervener argues that the Agency s finding that chemical similarity between the Appellant s and the Intervener s sources of the active substance was uncertain was not the core premise of the Contested Decision. The Contested Decision rather focuses on an assessment of the efforts made by both Parties and the balance of these efforts. The Agency s finding that data sharing obligations cannot be waived contractually, and apply also when substances are not chemically similar, does not constitute an interpretation of the legal provisions of the BPR but is rather an argument to support its assessment of the balance of efforts. Findings of the Board of Appeal 50. The second subparagraph of Article 63(3) provides that [w]ithin 60 days of being informed, the Agency shall give the prospective applicant permission to refer to the requested tests or studies on vertebrates, provided that the prospective applicant demonstrates that every effort has been made to reach an agreement and that the prospective applicant has paid the data owner a share of the costs incurred [ ]. 51. Where an appellant claims that the Agency has made an error of assessment, the Board of Appeal must examine whether the Agency has examined, carefully and impartially, all the relevant facts of the individual case which support the conclusions reached. In assessing the Agency s decisions on data sharing disputes taken under Article 63, the Board of Appeal considers in particular the balance of efforts between the data owner and the prospective applicant, and whether this balance is correctly reflected in the

8 A (11) Contested Decision (see Case A , Thor, Decision of the Board of Appeal of 23 August 2016, paragraphs 64 and 65). 52. In the present case, the main source of disagreement between the Appellant and the Intervener concerned chemical similarity between their sources of the active substance and the consequences if chemical similarity could not be established. The balance of their efforts must therefore be evaluated against this background. 53. The Appellant and the Intervener signed the secrecy agreement which set out certain conditions of their data sharing negotiations (see paragraph 5 above). Clause 7.1 of the secrecy agreement provides that [n]o information will be disclosed to either Party pursuant to Article 3 of this Agreement, unless and until Every Effort has been made by the [Intervener] to establish Chemical similarity of its source of the [active substance] with that of the [Appellant]. Clause 7.5 of the secrecy agreement provides that when, irrespective of the will of the Parties, no [c]hemical similarity can be established between the specifications, by [the consultant], the Parties will have to stop negotiating a Data Sharing Agreement. 54. The Appellant and the Intervener had the contractual freedom to insert a clause relating to chemical similarity in the secrecy agreement (see Case A , Thor, Decision of the Board of Appeal of 23 August 2016, paragraph 74). Although establishing chemical similarity is not a requirement for applications under Article 95, the Appellant and the Intervener decided nevertheless to be bound by a contractual agreement according to which chemical similarity was a pre-requisite to the continuation of negotiations and to data sharing. The Agency does not dispute this in the Contested Decision when it states that the parties may thus contractually agree [to make] their data sharing agreement conditional upon the performance of the chemical similarity check. 55. It is clear from Clause 7.1 of the secrecy agreement that the data sharing negotiations depended on the Intervener s efforts to establish the chemical similarity of their sources of the active substance. 56. It is also clear that the secrecy agreement does not leave room for doubt as to the consequences if chemical similarity was not established. Clause 7.5 clearly states that the Parties would in that case have to stop negotiating a Data Sharing Agreement. 57. On 18 November 2015, the consultant informed the Appellant and the Intervener that the chemical similarity assessment was inconclusive (see paragraph 14 above). The Board of Appeal must therefore analyse whether the Appellant was correct in considering that this result triggered Clause 7.5 of the secrecy agreement. In other words, it must be determined whether chemical similarity being inconclusive could be interpreted as meaning that no [chemical similarity] can be established. 58. The Appellant, the Agency, and the Intervener have different interpretations of what the term inconclusive meant for the negotiations. The Agency and the Intervener both consider that it meant that the result of the consultant s chemical similarity assessment was uncertain and that data sharing negotiations could continue. The Appellant however considers that this result meant that chemical similarity had not been established and that data sharing negotiations therefore had to stop. 59. According to its plain English meaning, the word inconclusive means not ending doubt or dispute or not leading to a firm conclusion or result (see Oxford Dictionary of English, 2 nd edition (revised) 2006, Oxford University Press). Therefore, when the consultant stated that the chemical similarity assessment was inconclusive, this must be understood as meaning that the chemical similarity assessment did not lead to a firm conclusion and that the chemical similarity of the Appellant s and the Intervener s sources of the active substance had not been established.

9 A (11) 60. It follows that Clause 7.5 of the secrecy agreement was triggered. The Appellant was therefore correct when it informed the Intervener that Clause 7.5 of the secrecy agreement applied (see paragraph 14 above). 61. As stated in paragraph 54 above, the Appellant and the Intervener had the contractual freedom to insert a clause relating to chemical similarity in the secrecy agreement. This means that if such a clause is triggered, the Appellant and the Intervener must adhere to it unless they mutually and explicitly agree to change or ignore it. As it has been established that Clause 7.5 of the secrecy agreement applied, the assessment of the Appellant s and the Intervener s conduct in the negotiations must be examined in this context. 62. On 30 November 2015, the Appellant asked the Intervener what actions it planned to take as a follow up to the consultant s findings and the application of Clause 7.5 of the secrecy agreement (see paragraph 16 above). The Appellant further indicated that it was ready to continue the negotiations if progress was made with regards to establishing chemical similarity. In so doing, the Appellant was following the terms of a mutually agreed contract. The Appellant was also continuing negotiations by giving the Intervener the possibility to act on the consultant's findings and to make progress on establishing chemical similarity thereby helping the Intervener to comply with Clause 7.1 relating to every effort. It follows that the Agency s finding in the Contested Decision that the Appellant refused to continue the discussions on the sharing of the requested data and its cost while the chemical similarity between the active substance sources had not [been] established is incorrect. 63. The Intervener informed the Appellant that it would make use of the Agency s chemical similarity check service (see paragraph 17 above). The Appellant replied that if the Agency s assessment yielded a positive result it would continue the data sharing negotiations (see paragraph 18 above). This approach demonstrates that the Appellant was open to resolving the chemical similarity issue irrespective of the findings of the consultant. On 22 July 2016, the Agency however found that the Appellant s and the Intervener s sources of the active substance were not similar (see paragraph 21 above). Nevertheless, on 23 August 2016, the Appellant invited the Intervener to meet and discuss the problem of chemical similarity and its possible solution (see paragraph 23 above). 64. The actions explained in the previous paragraphs show that, contrary to the Agency's finding in the Contested Decision, the Appellant was still negotiating to find a solution to the problem of chemical similarity when the Intervener lodged the data sharing dispute. 65. The Agency therefore made an error in the Contested Decision by finding that the Appellant refused to continue the discussions on the sharing of the requested data and its cost while the chemical similarity between the two active substance sources had not [been] established. 66. The Agency therefore did not assess in a balanced manner the efforts of both Parties when stating in the Contested Decision that [the Intervener] took steps to explore additional options to help the parties progress with their negotiations with regard to the chemical similarity of their active substance sources whilst ignoring the efforts made by the Appellant. 67. Furthermore, on 23 November 2015, 8 December 2015, 17 May 2016, 10 August 2016, and 26 August 2016, the Intervener re-iterated its position of principle that it did not believe Clause 7.5 to apply and asked the Appellant to continue the data sharing negotiations (see paragraphs 15, 17, 19, 22 and 24 above). As chemical similarity was still an open issue, and taking into account the application of Clause 7.5 of the secrecy agreement, the Intervener s behaviour deviated from the explicit terms of the secrecy agreement, freely agreed and based on a template it had drafted itself. The Intervener sought to progress the data sharing negotiations without resolving the chemical

10 A (11) similarity issue which was a requirement in the secrecy agreement. By insisting on the continuation of the negotiations without having established chemical similarity, the Intervener acted contrary to the mutually agreed contractual terms. 68. In light of the above, it is clear that the Agency focussed its assessment primarily on the Intervener s efforts and failed to fully take into account, in a balanced assessment, the Appellant s efforts. The Agency also failed to correctly apply its own finding concerning the Parties contractual freedom with respect to chemical similarity in the context of BPR data sharing. It follows that the Agency, in the Contested Decision, did not assess the efforts of the Appellant and the Intervener in a balanced manner and did not examine, carefully and impartially, all the relevant facts of the individual case which support the conclusions reached. 69. The Agency therefore made an error of assessment in the Contested Decision as regards the assessment of the Parties efforts. 70. As regards the Agency s arguments, raised for the first time in its Defence, that the data sharing obligations apply even when the parties substances are not chemically similar and that any provisions aiming to limit the data sharing obligations are void, it is sufficient to note that these reasons do not constitute part of the justification put forward in the Contested Decision. The Board of Appeal notes that, first, those reasons have not been considered or used in support of the contested data sharing decision. Second, according to the settled case-law the statement of reasons must in principle be notified to the person concerned at the same time as the decision adversely affecting him. Third, a failure to state the reasons cannot be remedied by the fact that the person concerned learns the reasons for the decision during the proceedings before the Board of Appeal (see, by analogy, judgments of 29 September 2011, Elf Aquitaine v Commission, C 521/09 P, EU:C:2011:620, paragraph 149, and of 19 July 2012, Alliance One International and Standard Commercial Tobacco v Commission, C 628/10 P and C 14/11 P, EU:C:2012:479, paragraph 74). Therefore, these arguments cannot be considered as part of the Contested Decision and cannot therefore be examined by the Board of Appeal. 71. In light of the above, the Appellant s second plea, that the Agency committed a manifest error of assessment of the every effort condition in Article 63(3), should be accepted and the Contested Decision annulled. 72. Since the Contested Decision has been annulled, it is not necessary to examine the Appellant s other pleas. Claim for the reimbursement of costs 73. In its Notice of Appeal the Appellant requested the Board of Appeal to order the Agency to pay the costs of these proceedings. 74. Commission Regulation (EC) No 771/2008 of laying down the rules of organisation and procedure of the Board of Appeal of the European Chemicals Agency (OJ L 206, , p. 5, the Rules of Procedure ) does not make provision for the reimbursement of costs that are not, as provided in Articles 17 and 21(1)(h) thereof, related to the taking of evidence. This has been further clarified by Commission Implementing Regulation (EU) 2016/823 amending the Rules of Procedure (OJ L 137, , p. 4). Article 17a now provides that the parties shall bear their own costs. 75. Consequently, and as in the present case no costs arose in relation to the taking of evidence, the Appellant s request for reimbursement of costs is rejected. Refund of the appeal fee 76. In accordance with Article 4(4) of Commission Implementing Regulation (EU) No 564/2013 on the fees and charges payable to the European Chemicals Agency pursuant

11 A (11) to Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products (OJ L 167, , p. 17), the appeal fee shall be refunded if the decision is rectified in accordance with Article 93(1) of Regulation (EU) No 1907/2006 of the European Parliament and of the Council (OJ L 396, , p. 1) or if the appeal is decided in favour of the appellant. 77. As the Board of Appeal has decided the appeal in favour of the Appellant, the appeal fee must be refunded. On those grounds, THE BOARD OF APPEAL hereby: 1. Annuls decision DSH-63-3-D adopted by the Agency on 14 November Remits the case to the competent body of the Agency for re-examination. 3. Decides that the appeal fee must be refunded. Mercedes ORTUÑO Chairman of the Board of Appeal Alen MOČILNIKAR Registrar of the Board of Appeal