Adverse reactions to cosmetics? What next?

-Regulation 1223/2009 defines adverse reactions as ‘an adverse effect on human health resulting from the normal or reasonably foreseeable use of a cosmetic product’.

-Serious adverse reactions are defined as ‘adverse reactions which result in temporary or permanent functional impairment, disability, hospitalisation, birth defects, immediate danger to life or death’.

- As the definitions themselves indicate, not every adverse reaction will be severe.

- Serious adverse reactions caused by the use of a cosmetic product should be reported to the System for Reporting Serious Adverse Reactions Caused by the Use of Cosmetic Products at the Institute of Occupational Medicine in Łódź.

- Reporting such cases is regulated by Regulation 1223/2009. Pursuant to Article 23 of this Regulation, responsible persons and distributors are required to report serious adverse reactions caused by the use of a cosmetic product.

- The Institute of Occupational Medicine verifies whether the report concerns a serious adverse reaction.

- Pursuant to Article 39 of the Cosmetic Products Act, a responsible person or distributor who fails to comply with the obligation to report a serious adverse reaction is subject to a financial penalty of up to PLN 100,000.

- The financial penalty is imposed by decision of the competent state district sanitary inspector, and the proceeds from such a penalty constitute state budget revenue.

- The Institute of Occupational Medicine verifies whether the report concerns a serious adverse reaction.

- Pursuant to Article 39 of the Cosmetic Products Act, a responsible person or distributor who fails to comply with the obligation to report a serious adverse reaction is subject to a financial penalty of up to PLN 100,000.

- The financial penalty is imposed by way of a decision by the competent state authority.