The National Center for Chemicals, Cosmetic Products and Consumer Protection evaluates the dossiers for the marketing authorization of PMCs. PMC (Presidi medico chirugici) are disinfectants and pest control (insects and mites for home use, etc.) whose formulation contain active substance(s) under revision for application in biocides; the authorizations are those foreseen by art. 89 (transitional period) of the Reg. UE 528/2012. The Center plays a supporting role for companies with scientific works, preparation of guidelines, training activities and ad hoc conferences.
The Center is also involved in the authorization of technical modifications of already authorized products (variation of composition, modification of the field and/or methods of use, effectiveness extension, etc.). These activities are subjected to fee payable to the ISS, according to the Disposizione Commissariale n. 44/2015, published into G.U. n. 82 del 09/04/2015 and integrated with D.P. n. 5 del 30/03/2017 G.U. Serie Generale n. 88 del 14/04/2017.
Furthermore, the Center evaluates the classification and labelling of these products according to Regulation (EC) N.1272/2008 (CLP Regulation) and collaborates with the European Chemical Substances Agency (ECHA) to assess the harmonized classification reports (CLH) for those active substances for which Italy is the rapporteur Member State.
The Center participates with its experts, in meetings of the technical working group "PMC borderline products" with the Ministry of Health, in ECHA’s WGs, and CEN TC 216 meetings.
