The new Italian SIDAPA Baseline Series for patch testing (2023): an update according to the new regulatory pathway for contact allergens

Abstract

Allergic contact dermatitis (ACD) is a common inflammatory skin disease caused by delayed hypersensitivity to chemical and biotic contact allergens. ACD significantly affects the patients' quality of life negatively impacting both occupational and non-occupational settings. Patch testing is the gold standard diagnostic in vivo test to precise the aCD etiology and to correctly perform prevention. according to the Italian medicines agency (aIfa) legislative decree no. 178 of 29 th May 1991, allergens are defined as medicines and therefore they are subject to strict regulation. In 2017, aIfa (decree no. 2130/2017) started a procedure to regulate contact allergens on the Italian market and actually the contact allergens temporarily authorized are reported in aIfa decree no. 98/2022, valid until November 2023. the availability on the market of contact allergens to diagnose ACD and continuous updating on the basis of new epidemiological trends are mandatory, jointly with the continuous update of the baseline and integrative series for patch testing. For this reason, the scientific community represented in Italy by the Skin Allergies Study group of SIDemaSt (Italian Society of Dermatology and Venereology) and SIDaPa (Italian Society of allergological, occupational and Environmental Dermatology) are constantly working, in close relationship with the European scientific communities with large expertise in this important sector of the modern Dermatology. Herein, we report the setting up of regulatory legislation by aIfa and the new Italian adult Baseline Series for patch testing.