The Turkish Medicine and Medical Devices Agency ("Agency") of the Ministry of Health issued an announcement on February 8, 2019 declaring that Version 5.0 of Guidelines for Cosmetic Claims ("Guidelines") [1] has been published.
The Agency stated that the amendments within the latest version were implemented due to feedback received from cosmetic companies regarding the increased costs of new package designs and on the inclusion of disclaimers such as "does not contain paraben / phthalate / alcohol / SLES, SLS, dye" on packages as a marketing policy and in line with consumer requests.
Accordingly, several provisions within the Guidelines have been amended, removed or introduced and can be summarized as follows:
- Legal requirements cannot be displayed on the images of the product or its price tag and package as an extra quality or benefit.
- Removed from the Guidelines is the article governing that a specific opinion on a claim cannot be utilized in a manner to verify the claim if there are contradicting opinions on that claim.
- Within Version 4.0 of the Guidelines, manufacturers were required to determine convenient and sufficient methods to verify claims and submit these methods to the Agency's evaluation, whereas the amended Guidelines do not require such evaluation of the Agency.
- Tests that are run by companies concerning ex vivo or in vitro studies are now required to be conducted within supervised laboratory environments which provide the necessary conditions, and to include predicting results with regard to in vivo effects.
- Cosmetic efficacy testing on humans is required to be conducted with the target population and with defined terms of inclusion and exclusion of volunteers.
- Usage of scientific information is now only possible if the information relates to the cosmetic product, its components, combinations or claims. Moreover, the Guidelines enable the use of market data that supports a cosmetic product's claim.
- Claims pertaining to a product's exclusion of a certain component or components can now be used on the condition that the certificate analysis received from laboratories that meet the standards of TSE ISO IEC 17025 has been submitted to the Directorate of Cosmetic Products Department during the application stage of the product.
- Conditions pertaining to the usage of hypoallergenic claims have been removed through the amended Guidelines and now only indicate that usage of hypoallergenic claims are deemed inappropriate, since they cannot ensure a product will not cause allergies in any circumstances.
This article was first published in Legal Insights Quarterly by ELIG Gürkaynak Attorneys-at-Law in June 2019. A link to the full Legal Insight Quarterly may be found here
[1] The Guidelines can be accessed at https://www.titok.gov.fr/duyuru/kozmetik-firmalarinin-dikkatine-08022019173049 (last accessed on May 9, 2019)
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