On April 15, 2019, the ECHA Board of Appeal (BoA) rejected the claim of a consortium of dye manufacturers (REACH & Colours) and found in favor a group of dye importers that has been disputing a fair way to share chemical and study data with manufacturers for years. The concrete case involves Case A-010-2017 and fair access to chemical data on textile dye Acid Orange 7 (CAS, No 633-96-5).
The member of the BoA based their judgement on Article 30 of REACH, which states, “The participant(s) and the owner shall make every effort to ensure that the costs of sharing the information are determined in a fair, transparent and non-discriminatory way.” The BoA found that the back-and-forth behavior of the dye importers met those conditions, but that the behavior of the dye manufacturers did not.
Ralf Knauf of Centro Reach, a consulting firm, represented the dye importers with attorney Claudio Mereu of Fieldfisher (Brussels) in the case and praised the judgement. In a conversation with Chemical Watch, he stated that it could provide legal precedent of similar cases.
The judgement comes at the end of a long dispute that goes back to 2008. One side involved 14 small and midsize dye importers who had formed the Dye Staff Cooperation Group (DSCG). The other side involved dye manufacturers, represented by a consortium, REACH & Colours. In 2012, DSCG contacted the manufacturers to negotiate joint use of data owned by the manufacturers. Five years later, the DSGC companies broke off negotiations and, disappointed, turned to the ECHA. It claimed that the manufacturers would not publish either the title or the authors of the studies and that they demanded inappropriately high administrative and usage fees.
In July 2017, the ECHA found in favor of the importers. Under the direction of REACH & Colours Hungary, the leading registrant of Acid Orange 7, the manufacturers appealed the ECHA decision – to no avail.
Controversies are always ignited when dealing with the joint use of data as part of chemical registration. The dispute about data goes back to the requirements of REACH itself. Simply put, the requirement is, “no data, no market.” Conflicts of interest will therefore inevitably arise between the owners of data (who must sponsor expensive toxicity studies) and smaller companies that must purchase access to such data through a Letter of Access.
Article 27 of REACH defines how the available data is to be used jointly when chemicals are registered. But because there is always room for interpretation, the judgement is seen as a precedent.
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