Sanctions foreseen for violations of the Cosmetic Regulations

2020-11-06T21:12:35+01:00 November 6th, 2020|Pratical tips, Regulations|0 Comments

Violations of the Cosmetic Regulations entail a wide range of administrative sanction and, in the most serious cases, criminal sanctions.
The individual Member States describe the violations contemplated, the related sanctions and the person affected by these sanctions. For Italy, these data are described in detail in Legislative Decree 4 December 2015, n. 204 published in the Official Gazette.

Let’s see together some of the most significant cases in the following summary table:

Violations of obligations regarding: Example of the subject of sanctions: Sanctions:
Safety of cosmetic products Anyone who manufactures or markets cosmetic products that, under normal conditions of use or reasonably foreseeable, they can be harmful to human health. Imprisonment from one to five years and a fine of not less than €1,000
Obligations of responsible persons The responsible person
who fails to bring into conformity, withdraw or recall a product that he has placed on the market and for which he assumes non-compliance with Regulation (EC) No 1223/2009.
Fine from €10,000 to €25,000
Obligations of distributors The distributor who, believing that a product is not compliant, while places it on the market or does not withdraw or recall it. Fine from €3,000 to €30,000
Obligations of identification in the supply chain The distributor who does not identify the responsible person who supplied the product and its downstream distributors. Pecuniary administrative sanction from €10,000 to €25,000
Good manufacturing practices Anyone who contravenes the provisions of good manufacturing practices established by Regulation (EC) no. 1223/2009. Pecuniary administrative sanction from €1,000 to €6,000
Safety assessment and product information documentation Responsible person who places on the market cosmetic products that have not undergone safety assessment, or without PIF. Fine from €10,000 to €100,000.
Notification The responsible person who did not notify a cosmetic product before placing it on the market. The same sanction is also applied to the distributor who violates the notification obligation. Administrative sanction for the payment of a sum from €1,000 to €6,000
Restrictions applicable to substances listed in the annexes to the regulation and to substances classified as CMR substances Anyone in the manufacture of a cosmetic product uses the substances prohibited by regulation (EC) no. 1223/2009. Imprisonment from one month to two years and a fine from €1,000 to €15,000
Nanomaterials Responsible person who places a cosmetic product containing nanomaterials on the market without first submitting the data via the notification. Pecuniary administrative sanction from €1,000 to €6,000
Animal experimentation Anyone who places on the market a cosmetic product that has followed an animal experimentation prohibited by Regulation (EC) No. 1223/2009, article 18. Arrest from one month to one year and with a fine from €500 to €5,000
Product labeling and claims Responsible person who places on the market a cosmetic product with non-compliant labeling or who gives misleading marketing information to consumers. Pecuniary administrative sanction from €500 to €5,000
Public access to information The responsible person who does not guarantee public access to the information established by the regulation (formulation, undesirable effects, etc.). Pecuniary administrative sanction from €1,000 to €6,000
Information to be made to the competent authorities The responsible person and the distributor who has not notified to the authorities of the information regarding serious undesirable effects. Pecuniary administrative sanction from €500 to €5,000
Non-compliance The responsible person or distributor who fails or insufficiently adopts the measures required by the authority. Pecuniary administrative sanction from €10,000 to €25,000