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.

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 – strategic, commercial, regulatory, as well as scientific.
▶ Complex commercial environment:
Under REACH, there is a ‘one substance, one registration’ 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 Covance’s 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.
▶ 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.
▶ 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.

2. Covance’s strategic regulatory guidance and negotiation restructured consortia to deliver the
company’s priorities
Covance regulator experts unraveled the complexity of the existing SIEF relationships, establishing
priorities and data availability. Covance renegotiated SIEFs, gained access to data and supported the client
in setting up as a lead registrant for all their priority substances. This included successfully challenging
one lead registrant to an ECHA inquiry process, resulting in the transfer of the role to the client. This
ensured that the commercial viability of the company was independent of possible competitive barriers
within the regulatory process.
Covance’s regulatory expertise and intelligent approach ensured streamlined testing
Covance established the data gaps through research and analysis and identified a robust but efficient
testing approach. The planning was done proactively, in a staged fashion, to tie in with the client’s
financial cycles and priorities.
Covance’s scientists leveraged their experience in tackling difficult substances
With years of expertise, the Covance scientists knew how to modify existing tests to make them suitable
for use with the pigments and valid from a regulatory perspective.
Covance’s project management ensured successful navigation through the registration process
With approximately 18 months to complete the six submissions, exacting project management kept
the integrated team of regulatory experts and scientists at Covance aligned, so all deadlines were met.
Covance’s assistance helped to free up valuable planning time that enabled the company to accelerate plans
for new product development and registration.
Conclusions
This case study underlines the value of agricultural insight when running field studies and the importance
of working with an experienced team with a problem-solving attitude and the on-site capabilities to
conduct complex studies.
Visit www.covance.com/chemical to find out more.
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life sciences company. COVANCE is a registered trademark and the marketing name for Covance Inc.
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