The Decree of the Minister of Health of 27 September 2018 describes the control procedures of the internal market of cosmetic products, including activities related to controls of products, sector operators and good manufacturing practices.
The Decree also defines the obligations and communications that operators in the sector are required to comply with, as part of the supervision and surveillance activities envisaged by Regulation (EC) No. 1223/2009.
Producers of cosmetics on their own or on behalf of third parties, within thirty days of starting the activity, must send to the Ministry, for each site involved, a communication of cosmetics production, including extemporaneous and small-volume production.
The 2018 Decree also contains the provisions relating to the methods of communication of the information provided for in Article 19 of the Regulation for non-pre-packaged cosmetics or for cosmetics packaged by the seller at the request of the buyer or pre-packaged with a view to their immediate sale, as well as the indications of the language in which some specific information must be written for products sold on the Italian market.
Communications must be received exclusively through the use of the editable PDF form. Are available:
Cosmetics production site information communication model
instructions for filling out the form.
The "Communication of production site information" form, approved with the Provision of 30 November 2023, must be sent via certified e-mail to the Ministry of Health - General Directorate of medical devices and pharmaceutical services, to the certified email address: dgfdm@postacert .sanita.it and to the Region or autonomous Province where the production site is established, to the certified mail address indicated by the Region or Province.
The model is an editable PDF, which must be filled in exactly with all the required data from which the useful information for updating the database of cosmetic product workshops is then automatically extracted. No modifications, scans or conversions to other formats of the form to be filled out must be made.
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