BASF SE, 67056 Ludwigshafen, Germany

To whom it may concern 18. October 2019

Dr. Dominik Odenbach
Phone: +49 621 60 68788
dominik.odenbach@basf.com

Page 1 / 1

Statement: Label information retest date vs. expiry date

Dear Sir or Madam,

As most pharmaceutical ingredients manufacturers, BASF is using the terminology “retest date” for APIs
and excipients. Per definition the retest date of a material is the date when the material must be re-
examined to assure that the material still meets all specification parameters and is still suitable for its
intended use. According to the GMP Guide for Active Pharmaceutical Ingredients (ICH Q7) “Common
practice is to use a retest date, not an expiry date”.

Major health authorities like the US-FDA and EMA as well as the WHO accept the terminology retest date
for APIs and excipients. Only for a finished pharmaceutical product an expiry date is mandatory. Moreover,
in certain countries (e.g. Germany) a product is classified as waste once it has passed its expiry date.
Since this is scientifically unreasonable in case of a (stable) chemical substance the use of re-test date is
more appropriate.

If compliance with the currently valid specification is demonstrated at or after the end of a retest period,
the batch may be used immediately, or a new retest period can be established (max 12 months). The new
retest period will be given from the day retesting is complete (“new release date”). A batch of an ingredient
therefore might be retested multiple times depending on the new release data, storage conditions applied,
stability kinetics, etc.

Therefore, we highly appreciate your understanding that we are using a globally harmonized labeling
system indicating a retest date.

Yours sincerely,

i.V. Dr. Dominik Odenbach

Director Global Regulatory & External Affairs
Pharma Solutions
BASF SE
BASF SE, Registered Office: 67056 Ludwigshafen, Germany
Registration Court: Amtsgericht Ludwigshafen, Registration No.: HRB 6000
Chairman of the Supervisory Board: Juergen Hambrecht
Board of Executive Directors:
Martin Brudermueller, Chairman; Hans-Ulrich Engel, Vice Chairman;
Saori Dubourg, Sanjeev Gandhi, Michael Heinz, Markus Kamieth, Wayne T. Smith