ILMA Compoundings January 2017 - 8
INDUSTRY RUNDOWN
International Insight
EU REACH 2018:
End-Game Risks
and Strategies
By James Eggenschwiler
Like it or not, the June 2018 registration deadline is just around
the corner, and a low percentage of registration dossiers have
been filed for pre-registered substances. Some firms have
made their decisions to not proceed. A larger number continue to wrangle. During this process, with roughly 16 months
remaining as of this publication, potential registrants should
make note of available strategies and some less obvious risks.
ORPHAN SUBSTANCES
This risk is new for final-tier registrants and might be hiding in
8
JANUARY 2017
| COMPOUNDINGS | ILMA.ORG
plain sight. Its newness results from the nature of the substances
related to the tonnage band. Unlike previous registrations for higher-volume substances, this tier of registrations involves substances
produced at lower volume and which are more likely to involve
unique chemistry and fewer manufacturers. Hence the risk - that
a registrant might fail to discover a prospective Lead Registrant and
face the cost of registration alone, as the Lead Registrant.
Many pre-registrants develop and debate the business case for
registration without first identifying a Lead Registrant. While the
product's financial performance might be well considered, the
assumed cost of registration might not be. Without identifying a
Lead Registrant sufficiently early in the process, the reality associated with the registration process could be harshly different from
expectations in these situations.
The cost associated with registering as the Lead Registrant, and
without Joint Registrants, can be enormous. Physical chemical,
mammalian toxicology, environmental fate and eco-toxicology data
must be generated. In addition, a risk assessment must be developed,
along with supporting exposure profiles where annual volumes greater than 10 metric tons per year are involved. In a Joint Registration,
http://www.ILMA.ORG
ILMA Compoundings January 2017
Table of Contents for the Digital Edition of ILMA Compoundings January 2017
Letter from the CEO
Inside ILMA
What's Coming Up
Industry Rundown: International Insight
Industry Rundown: Market Report
Industry Rundown: Perspective
Industry Rundown: In the Know
Beth Ann Jones & ILMA: A Family Matter
Squeaky Wheels
Infineum Perspective
Business Hub
Counsel Compound
Washington Landscape
State of the States
In Network: Member Connections
In Network: Cross Connections
Portrait
ILMA Compoundings January 2017 - Cover1
ILMA Compoundings January 2017 - Cover2
ILMA Compoundings January 2017 - 1
ILMA Compoundings January 2017 - 2
ILMA Compoundings January 2017 - Letter from the CEO
ILMA Compoundings January 2017 - Inside ILMA
ILMA Compoundings January 2017 - 5
ILMA Compoundings January 2017 - What's Coming Up
ILMA Compoundings January 2017 - 7
ILMA Compoundings January 2017 - Industry Rundown: International Insight
ILMA Compoundings January 2017 - 9
ILMA Compoundings January 2017 - 10
ILMA Compoundings January 2017 - 11
ILMA Compoundings January 2017 - Industry Rundown: Market Report
ILMA Compoundings January 2017 - 13
ILMA Compoundings January 2017 - Industry Rundown: Perspective
ILMA Compoundings January 2017 - Industry Rundown: In the Know
ILMA Compoundings January 2017 - Beth Ann Jones & ILMA: A Family Matter
ILMA Compoundings January 2017 - 17
ILMA Compoundings January 2017 - 18
ILMA Compoundings January 2017 - 19
ILMA Compoundings January 2017 - 20
ILMA Compoundings January 2017 - 21
ILMA Compoundings January 2017 - 22
ILMA Compoundings January 2017 - 23
ILMA Compoundings January 2017 - Squeaky Wheels
ILMA Compoundings January 2017 - 25
ILMA Compoundings January 2017 - 26
ILMA Compoundings January 2017 - 27
ILMA Compoundings January 2017 - Infineum Perspective
ILMA Compoundings January 2017 - 29
ILMA Compoundings January 2017 - 30
ILMA Compoundings January 2017 - 31
ILMA Compoundings January 2017 - Business Hub
ILMA Compoundings January 2017 - 33
ILMA Compoundings January 2017 - 34
ILMA Compoundings January 2017 - 35
ILMA Compoundings January 2017 - Counsel Compound
ILMA Compoundings January 2017 - 37
ILMA Compoundings January 2017 - 38
ILMA Compoundings January 2017 - Washington Landscape
ILMA Compoundings January 2017 - State of the States
ILMA Compoundings January 2017 - 41
ILMA Compoundings January 2017 - In Network: Member Connections
ILMA Compoundings January 2017 - 43
ILMA Compoundings January 2017 - In Network: Cross Connections
ILMA Compoundings January 2017 - 45
ILMA Compoundings January 2017 - 46
ILMA Compoundings January 2017 - 47
ILMA Compoundings January 2017 - Portrait
ILMA Compoundings January 2017 - Cover3
ILMA Compoundings January 2017 - Cover4
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