Main penalties

Legislative Decree N° 204 of December 4, 2015 contains information about the rules on penalties for infringement of Regulation (EC) N ° 1223/2009 on cosmetic products.


Below, we will list the main sanctions:


Art 3: Security

Anyone who produces, possesses or puts on the market cosmetic products that can be harmful to human health, will pay with imprisonment from one to five years and to pay a higher fine of 1000 Euros. If it is committed by negligence, the penalty is reduced by one-third to one-sixth.

Art 5: Obligations of responsible persons

- Take immediate corrective actions to bring the product into compliance if it does not comply

- Withdraw / recall from the market if it does not comply.

- Inform the competent authorities about the dangers of the product if it does not comply.

- Provide the necessary documentation to evaluate compliance

If these obligations are not respected, you have to pay a fine of 10,000 to 25,000 euro.

Article 6: Obligations of distributors

- Carry out the verification on the label compliance, language requirements and minimum product life

- Take corrective actions to bring the product into compliance if it does not comply.

- Withdraw / recall from the market if it does not comply.

- Inform the competent authorities about the dangers of the product if it does not comply.

- Provide the necessary documentation to evaluate compliance

If these obligations are not respected, you have to pay a fine of 3,000 to 30,000 Euros

Article 7: Identification within the supply chain

the identification requirements in the supply chain from the person responsible / supplier at the request of a competent authority.
If these obligations are not respected, you have to pay a fine of 10,000 to 25,000 EUR

Article 8: Obligations of good manufacturing practices

It has the obligation to follow good manufacturing practices

If these obligations are not respected, you have to pay a fine of 1,000 to 6,000 EUR

Article 10: Obligations concerning the safety assessment and product information file:

The responsible person who places on the market a cosmetic has an obligation to assess the hazards of cosmetics and keep track of the literature.

If these obligations are not respected, you have to pay a fine of 10,000 to 100,000 EUR

Article 13: Notification

The responsible person is obliged to notify a product before placing it on the market, as well as the distributor is obliged to provide the information when feeding into another member state a product already on the market.

If these obligations are not respected, you have to pay a fine of 1,000 to 6,000 EUR

Article 14-15: Restrictions for substances listed in the Annexes, substances classified as CMR substances

Everyone who uses in the manufacture of cosmetic products substances that are prohibited in accordance with Annex II of the Regulation shall be punished with imprisonment from six months to two years and by a fine of 2,000 to 15,000 Euros. If the offense is committed culpably, by imprisonment from three months to one year and with a fine from 1,000 to 10,000 Euros.

Everyone who uses in the manufacture of cosmetic products substances found in Annexes III, IV, V, VI (respectively Restrictions, dyes, preservatives, UV filters) of the Regulations shall be punished with imprisonment from one month to one year and with the payment of a from 500 to 5000 euro fine. If the offense is committed culpably it applies imprisonment up to six months or a fine from 250 to 2,500 Euros.

Everyone who uses CMR substances shall be punished with imprisonment from six months to two years and with the payment of a fine of 2,000 to 15,000 Euros, if the offense is committed culpably by imprisonment from three months to one year or a fine from 1,000 to 10,000 Euros.

Article 16: Nanomaterials

The responsible person who fails to notify the Commission by electronic means six months before being put on the market must pay a fine of 1,000 to 6,000 EUR

Article 18: Animal testing

Whoever places on the cosmetics market contrary to the prohibitions of Article 18 of the Regulations with regard to animal experiments, shall pay a fine of 500 to 5,000 euro and is punished by imprisonment from one month to one year.

Persons engaged in violation of animal experiments with the prohibitions of Article 18 must pay a fine of 500 to 5,000 Euros and will be punished by imprisonment from one to six months.

Article 19-20: Labelling Related Product Declarations

The responsible person who places on the market a cosmetic product labeling does not comply with Article 19 and 20 must pay a fine of 500 to 4000 euro.

The person responsible for employing the label and / or presentation on the market and / or in advertising endorsements, images or figurative signs that give their product features or functions that do not possess is subject to a fine from 500 to 5,000 Euros.

Article 21: Public access to information

The person in charge that does not guarantee public access to information (qualitative and quantitative composition, perfume and aromatic compositions, the name and code number of the composition, identity of the supplier, as well as existing data on undesirable effects and serious undesirable effects ) is subject to a penalty of 1,000 to 6,000 Euros.

Article 23-24: Communication of serious undesirable effects, information on substances

The responsible person and distributors who do not comply with Article 23 (communication to the competent authorities of the serious undesirable effects) are subject to a penalty from 500 to 5,000 Euros.

The responsible person who fails to comply with a request from the authorities to provide a list of all cosmetic products that contain substances that may raise some doubts is subject to a 500 to 5,000 Euros penalty.

Article 25-26: Non-compliance by the responsible person, not compliance by the distributor

The responsible person or the distributor who does not take the measures required by the authorities or do not take adequate measures to make the make-compliance is subject to sanction from 10,000 to 25,000 EUR

 

The sanctions provided for by this decree shall not apply to the dealer who offers for sale / distributing a cosmetic in the original packaging, if the problems encountered with the intrinsic requirements or composition of the product, this only happens if the dealer is not aware of inconsistencies and the packaging shows no signs of alteration.