Italy Publishes a New Decree Setting Penalties in Relation to the Cosmetics Regulation

Italy published a new decree setting detailed penalties in relation to the EU Cosmetics Regulation (Decreto Legislativo 4 dicembre 2015, n.204). Indeed, and as laid down in Article 37 of the EU Cosmetics Regulation, setting the penalties in case of non-compliance is an obligation of the EU Member States. This legislative text will fully apply on June 1st, 2016.

Infringement of the Cosmetics RegulationPrison sentenceFinancial penalty
Article 3
(failure to place a safe product on the market)
1 year to 5 yearsUp to 1.000€
Article 5
(general failure to comply with the obligations of the Responsible Person)
10.000 to 25.000€
Article 6
(failure to comply with the obligations of the distributor)
3.000 to 30.000€
Article 7
(failure to comply with the obligations of the Responsible Person
to know the distributors to whom the cosmetic product is supplied)
10.000 to 25.000€
Article 8
(failure to follow GMP)
1.000 to 6.000€
Articles 10 & 11
(failure to issue a good quality CPSR/PIF)
10.000 to 100.000€
Article 13
(failure to properly notify a product on CPNP)
1.000 to 6.000€
Article 14
(failure to respect annex II)
6 months to 2 years2.000 to 15.000€
Article 14
(failure to respect annexes III, IV, V and VI)
1 month to 1 year500 to 5.000€
Article 15
(use of a CMR while it is not authorized)
6 months to 2 years2.000 to 15.000€
Article 16
(failure to notify the nanomaterials that need to be)
1.000 to 6.000€
Article 18
(failure to apply the animal testing ban on the finished product)
1 month to 1 year500 to 5.000€
Article 18
(failure to apply the animal testing ban on the ingredients)
1 month to 6 months500 to 5.000€
Article 19
(failure to comply with the label requirements)
500 to 4.000€
Article 20
(failure to comply with the requirements on claims)
500 to 5.000€
Article 21
(failure to provide publicly available information)
1.000 to 6.000€
Article 23
(failure to communicate a serious undesirable effect)
500 to 5.000€
Article 24
(failure to provide information on a substance to the Authorities)
500 to 5.000€
Articles 25 & 26
(failure of the Responsible Person and/or the distributor to take
the appropriate corrective actions in case a compliance issue is identified)
10.000 to 25.000€

Some provisions of this decree are relatively similar to what is already implemented in other EU Member States while others differ significantly. In order to offer an element of comparison, UK set the following penalties in relation to the EU Cosmetics Regulation:

Infringement of the Cosmetics RegulationPrison sentenceFinancial penalty
Articles 3, 5, 6, 7, 10, 14, 15, 18, 19, 20, and 23
(such as described above) on summary conviction
Maximum 3 monthsMaximum £5.000
Articles 3, 5, 6, 7, 10, 14, 15, 18, 19, 20, and 23
(such as described above) on conviction on indictment
Maximum 12
months
Maximum £20.000
Articles 11, 13, 16, 21 and 24
(such as described above) on summary conviction
Maximum 3 monthsMaximum £5.000
Articles 25, 26
(such as described above) on summary conviction
Maximum 3 monthsMaximum £5.000
Articles 25, 26
(such as described above) on conviction on indictment
Maximum 12
months
Maximum £20.000

Furthermore, the offense to:

  • intentionally to obstruct any person acting in the execution or enforcement of the EU Cosmetics Regulation;
  • without reasonable cause, to fail to give to any such person any assistance or information which that person may reasonably require for those purposes;
  • knowingly or recklessly to furnish to any such person any information knowing it to be false or misleading in a material particular; or
  • fail to produce a document or record to any such person when required to do so.
    on summary conviction results in a fine not exceeding level 5 on the standard scale (£5.000).


In summary, the national provisions can significantly differ from a country to another when it comes to penalties. However, most of them are very dissuasive and it is crucial to be as cautious as possible when notifying a cosmetic product in Europe.

Any questions?