Covance was approached by a company based in Europe, which produced pigments and needed to register six of these pigments in time for the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) 2018 submission deadline. This pigment producer did not have the time required to plan comprehensive testing programs or develop regulatory submissions. The company chose to partner with Covance for support and guidance through the commercial and regulatory maze.
How Partnership Working Ensured a Colorful Future - Chemical Services Case Study
1. Chemical Services Case Study
HOW PARTNERSHIP WORKING
ENSURED A COLORFUL FUTURE
Background
Covance was approached by a company based in Europe, which produced pigments and needed to
register six of these pigments in time for the Registration, Evaluation, Authorization and Restriction of
Chemicals (REACH) 2018 submission deadline. This pigment producer did not have the time required to
plan comprehensive testing programs or develop regulatory submissions. The company chose to partner with
Covance for support and guidance through the commercial and regulatory maze.
The Challenges
The company faced challenges on several fronts ā strategic, commercial, regulatory, as well as scientific.
ā¶ Complex commercial environment:
Under REACH, there is a āone substance, one registrationā rule, which requires all competitive parties to work
together to submit a single dossier as part of a Substance Information Exchange Forum (SIEF). The client
was the lead registrant despite having many larger competitors with the same substance in various levels of
development. The commercial needs of Covanceās client did not always align with the commercial priorities
of the competitors within the SIEF. It was critical that all six pigments were successfully registered in a timely
fashion to ensure the continued commercial success of the company.
ā¶ A maze of regulation to navigate, with poor visibility of existing data to guide the way:
Although they owned a large portion of the data, the client was unclear of its relevance or suitability in the
regulatory process and had little understanding of what additional tests were required. It was also unclear what
other data existed for the six substances within the SIEFs, and gaining access to these data was more difficult
than anticipated. For the client, registering six different substances at the same time, also presented financial
and staffing challenges.
ā¶ Pigments are recognized as difficult substances from a testing perspective:
Pigments by their very nature are colored, often insoluble, substances, and this can make even the simplest
physiochemical test difficult to perform and validate, not to mention the complexity of aquatic ecotoxicology
testing.
The Solutions
At the heart of the success of this solution was the strong partnership that developed between Covance and the
client from the very start of the project. By working closely and transparently, Covance could provide strategic
guidance that went beyond the goal of successful registration of six pigments to help enhance the commercial
success of the client.