Under the European chemicals legislation known as REACH, any chemical
substances intended for the EU market must undergo registration through the
European Chemicals Agency (ECHA). This process is based on the fundamental
principle of "one substance, one registration."
Most of the
regulations have followed the example of ECHA, hence there is a need to
share this information across regions. All registrants dealing with the same
substance are required to participate in a Joint Submission, sharing common
data to eliminate redundant animal testing.
Access to this shared
data within the Joint Submission is governed by what is known as the "Letter
of Access" (LoA). When co-registrants sign the Joint Submission Agreement,
they commit to contributing to the overall expenses associated with
registering a specific substance. These costs encompass data, dossier, and
administrative expenses, all of which are outlined in the LoA fee. Once the
LoA fee is settled, co-registrants receive the agreed-upon files necessary
for registration, a token granting access to the Joint Submission, and a LoA
document certifying their data access rights.
