Updating of AIFA’s Director-General Decision DG 442/2023 Annex 1 - Renewal of the provisional authorisation to use haptens for patch tests in the absence of commercially-available clinical alternatives.

Following

• the request received from the Company Chemotechnique MB Diagnostics to replace the hapten present in the baseline patch test series textile dye mix (TDM) 6.6% in petrolatum with a mixture having a final concentration equal to 5.6% in petrolatum without the dispersed orange 3 due to an ascertained cross-reactivity between dispersed orange 3 and paraphenylenediamine and other haptens of the para group; 
• the opinion expressed by the experts of the AIFA Working Group on the clinical use of haptens for patch test in the session of 13 May 2025; 
• the publication in the European Baseline Series of this modified mixture without the dispersed orange 3 and with a final concentration equal to 5.6% in petrolatum (ref. Isaksson M, Antelmi A, Stenton J, et al. Exclusion of Disperse Orange 3 From the Textile Dye Mix Present in the Baseline Patch-Test Series: A Study by the International Contact Dermatitis Research Group. Dermatitis. 2025 May-Jun;36(3):227-234. doi: 10.1089/derm.2024.0036. Epub 2025 May 7. PMID: 40332782)

the textile dye mix 5.6% without the orange disperse mix 3 is added to the current textile dye mix 6.6% in Annex 1 to AIFA’s Director-General Decision DG 34/2024.

The updated list of haptens is attached to this press release (Annex 1 rev. 1).