August 7, 2020 SC Labs

Label claim considerations when dealing with volatile terpenes

Service Notification

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VULNERABILITY SUMMARY: Terpenes are often volatile compounds which can make listing terpene content on product packaging problematic, potentially leading to failed label claims. This vulnerability has been identified for clients that listed exact terpene content before receiving compliance test results.

Potential Impact

Failed label claim for California compliance batch, possible relabeling and repackaging by the distributor.

Background

This bulletin is to notify clients that a few regulatory compliance batches have recently needed to be relabeled for missed terpene label claims. Due to their volatility, and depending on factors like storage conditions or the amount of time lapsed between R&D and compliance testing, it is possible for terpene concentrations to change significantly over time making pre-labeling terpenes potentially problematic.

Terpene Variability: Terpenes are volatile compounds, meaning they have a tendency to evaporate over time. Conditions during growing, harvesting, drying, and storage can alter terpene levels. Making label claims with unpredictable terpene variability, particularly at low volumes, means a greater risk of mislabeled claims.

Regulation at a Glance: In California, cannabis products are not required to be tested for terpene content. However, if terpene concentrations are listed on labeling, the values must be within +/- 10% of the measured value by the laboratory performing the batch testing.

Guidelines established by the Bureau of Cannabis Control (BCC) indicate the following criteria:

If cannabis goods are pre-labeled prior to regulatory compliance testing, and are found to be inaccurately labeled following testing, the licensed distributor must re-label the cannabis goods with the amounts listed on the COA.

California Code of Regulations, section 5303(c). Packaging, Labeling, and Rolling

…terpenoid claimed to be present shall not be considered inaccurate if the difference in percentage on the certificate of analysis is plus or minus 10.0%.

California Code of Regulations, section 5307.1. Quality-Assurance Review for Labeling Cannabinoids and Terpenoids

Resolution

Along with distributing this support bulletin to all clients that could be impacted, SC Labs will provide ongoing technical support and resources.

We believe that labeling products with their terpene profile is a great way to drive value for clients, patients, and consumers. However, we also understand that labeling cannabis products can be incredibly complex.

Terpene Labeling Recommendations

Below are some suggested resources and recommendations from SC Labs that you may wish to consider:

  • If production workflow permits, add terpene label claims after compliance testing is complete. NOTE: SC Labs offers downloadable artwork for test results. Artwork supports Avery Label templates 5160 and 8160.
  • If the cannabis product must be pre-labeled for terpene content, it is advisable to have the batch terpene tested before labeling, then have the batch sampled for compliance testing as soon as possible to allow for the shortest possible time lapse between the two tests.
  • Consider listing whole integers, e.g., 3% rather than 3.11% for total terpene content or individual terpene.
  • Consider listing details like dominant terpene, or the top three dominant terpenes (instead of measured values).
  • Exercise extreme caution when referencing previous R&D test results where significant time has passed since testing.

Labeling option to add terpene results to packaging

SC Labs suggests adding label claims after compliance testing is complete. We offer Avery Label templates that include both terpenoid and cannabinoid results. Depending on your packaging requirements, these labels could be an option to consider.

SC Labs custom result labels

Resources

SC Labs Resources

For questions or assistance implementing the considerations in this bulletin, contact your SC Labs Support Representative. For access to label artwork with cannabinoid and dominant terpenoid results, clients can download a PDF preformatted for Avery Templates 5160 and 8160 from the Client Service Portal.

Excellent service and support are always our top priority. If there is anything that we can do to improve your service experience, please contact us at (866) 435-0709, or via email info@sclabs.com.

Additional Labeling Resources

You can find additional resources and information from the Manufactured Cannabis Safety Branch (MCSB), a division of the California Department of Public Health (CDPH).

Website: www.cdph.ca.gov/mcsb
Email: mcsb@cdph.ca.gov

SC Labs is broadly distributing this bulletin in order to bring to the attention of users of the affected SC Labs tests. SC Labs recommends that all users determine the applicability of this information to their individual situations and take appropriate action. SC Labs does not warrant that this information is necessarily accurate or complete. SC Labs shall not be liable for technical or editorial errors or omissions contained herein.

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