The Swedish Medical Products Agency published the results of the last supervisory project conducted last year (in 2021). Safety reports and labelling of 12 cosmetic spray products were thoroughly inspected. Among others, the Swedish Medical Products Agency focused on checking whether the secondary inhalation exposure was taken into account by Responsible Persons while assessing the safety of cosmetic spray products.
Results of the supervisory project
In terms of the safety reports, 10 out of 12 products had one or more shortcomings:
- Two companies did not submit the requested documentation for safety reports and assessments.
- Exposure calculations where secondary inhalation was taken into account were missing in all received safety reports.
- Evaluation of any local adverse health effects on the respiratory tract was lacking.
- The calculation of the expected systemic exposure dose (SED) was missing.
- The calculation of the safety margin for the ingredients (Margin of Safety, MoS) was missing.
Regarding the labeling and marketing claims, 5 out of 12 products had the following deficiencies:
- The Swedish translation of special precautions for use was missing.
- The Swedish translation of sustainability labeling was missing.
- Many ingredients were incorrectly displayed on the product label.
- Inappropriate marketing claims occurred (e.g., "Not tested on animals", "paraben-free" and "silicone-free").
Therefore, one product has been voluntarily removed from the market, one product has been temporarily removed from the market waiting for the correction of the safety report and the remaining products have taken corrective measures to ensure that the safety report, safety assessment, and/or labelling meet applicable requirements.