Italy: PAPR for welding — D.Lgs 81/2008, CE marking under Regulation (EU) 2016/425, and the UNI standards framework

In Italy, powered air-purifying respirators (elettrorespiratori) used in welding sit under D.Lgs 81/2008 (the Testo Unico) — Titolo III, Capo II for PPE use and Titolo IX for the chemical and carcinogen risks in welding fume — with CE certification governed by Regulation (EU) 2016/425 (Category III). Selection and management follow UNI EN 529:2006 and the national guide UNI 11719, revised in November 2025; device performance standards UNI EN 12941/12942 were replaced with 2024 editions, which adopt the EN 12941:2023/EN 12942:2023 texts first given EU harmonised-standard status by Commission Implementing Decision (EU) 2024/2599 of 4 October 2024. Recent changes welders should know: the transitional chromium VI welding limit expired on 17 January 2025, and D.Lgs 135/2024 extended Titolo IX Capo II’s carcinogen-grade duties to reprotoxic substances. This hub is information, not compliance advice.

Which rules apply

The core law is Decreto Legislativo 81/2008 (the “Testo Unico” on health and safety at work). Titolo III, Capo II (Articles 74–79) governs the use of personal protective equipment (DPI): Article 74 defines PPE, Article 75 states PPE must be used when risks cannot be avoided or sufficiently reduced by technical prevention measures, collective protection or work reorganisation, Article 76 requires PPE to conform to Regulation (EU) 2016/425, and Article 77 sets employer obligations. Allegato VIII contains the indicative list of PPE, including respiratory protective devices (APVR). Because welding fume is a hazardous chemical agent — and, in stainless or high-alloy welding, contains carcinogens such as hexavalent chromium and nickel compounds — Titolo IX also applies: Capo I, ‘Protezione da agenti chimici’ (Articles 221 onward, with the chemical risk assessment duty at Article 223), and Capo II, which starts at Article 233 and — after a 2024 amendment transposing Directive (EU) 2022/431 — is now titled ‘Protezione da agenti cancerogeni, mutageni o da sostanze tossiche per la riproduzione’ (protection from carcinogenic, mutagenic agents or substances toxic to reproduction), extending its duties to reprotoxic substances alongside carcinogens and mutagens. Article 79 links PPE selection criteria to a ministerial decree; pending a new decree, the criteria of D.M. 2 May 2001 are reported by legal commentaries as remaining applicable, read with current UNI standards.

Approval and certification of PAPR

PAPR sold in Italy must be CE-marked under Regulation (EU) 2016/425 on personal protective equipment, which applies directly in all EU states; Italy adapted its national framework and sanctions regime to the Regulation through D.Lgs 17/2019, which rewrote large parts of D.Lgs 475/1992 (Italy’s pre-existing national PPE law) rather than replacing it outright — D.Lgs 475/1992 remains formally in force as the national adaptation and sanctions framework alongside the directly-applicable EU Regulation. Respiratory protective devices are Category III PPE — equipment protecting against risks that can cause death or serious irreversible harm. Category III requires EU type-examination by a notified body plus ongoing conformity surveillance (production quality module), and the notified body’s four-digit number appears next to the CE mark. Article 76 of D.Lgs 81/2008 makes this conformity a workplace-law requirement, not just a market-access one: employers may only issue conforming PPE. The applicable performance standards are the UNI-adopted European standards — for welding PAPR, the EN 12941 series (hood/helmet devices, classes TH1–TH3) and EN 12942 series (mask devices, classes TM1–TM3). Because APVR are Category III, worker training including practical instruction (addestramento) is mandatory under Article 77.

Employer duties and the respiratory protection programme

Article 77 of D.Lgs 81/2008 requires the employer to analyse and assess risks that cannot otherwise be avoided, identify suitable PPE based on the risk magnitude, exposure frequency and workplace characteristics, supply conforming PPE, maintain it in efficient and hygienic condition, and provide information, training and — mandatory for all Category III PPE such as APVR — practical hands-on training (addestramento). Article 78 places duties on workers to use and care for the PPE provided. The organisational framework is the national standard UNI 11719 (2025 edition), which implements UNI EN 529:2006 as a guide to establishing a respiratory protection programme covering selection, use, maintenance and management of APVR. INAIL’s communiqué on the 2025 revision states it adds concrete training rules — minimum hours, maximum participants, trainer-to-user ratios and periodic refreshers — and confirms fit testing (per its Annex A) for tight-fitting facepieces. Loose-fitting welding hoods and helmets are not fit-test devices, but the training and programme duties still apply.

Welding fume as a chemical and carcinogenic risk

IARC evaluated welding fumes at its Monograph Volume 118 meeting in March 2017, classifying them (and ultraviolet radiation from welding) as Group 1, carcinogenic to humans — an upgrade from the earlier Group 2B classification; the evaluation was announced in The Lancet Oncology in May 2017, with the full monograph volume published in 2018. INAIL cites this classification in its risk-profile documentation. INAIL’s “Conoscere il rischio” pages on carcinogens list stainless-steel welding among activities involving exposure to hexavalent chromium and nickel compounds, both EU category 1A/1B carcinogens. Where such carcinogens are present, Titolo IX, Capo II of D.Lgs 81/2008 (Articles 233 onward) applies: substitution where technically possible, otherwise closed systems, otherwise reduction of exposure to the lowest technically achievable level, plus health surveillance and registration of exposed workers. Binding limit values sit in Allegato XLIII: for chromium VI compounds the limit is 0.005 mg/m³, after a transitional value of 0.025 mg/m³ for welding, plasma cutting and similar fume-generating processes that expired on 17 January 2025 (documented in INAIL’s Allegato XLIII fact sheet). Nickel compound limits (0.01 mg/m³ respirable, 0.05 mg/m³ inhalable fractions) derive from Directive (EU) 2022/431, transposed by D.Lgs 135/2024. Local exhaust ventilation remains the priority control; PAPR addresses residual exposure, consistent with Article 75’s hierarchy. On air recirculation from fixed extraction: this is not subject to a flat Italian ban even where Cr(VI) or nickel are present. The relevant equipment standard, EN ISO 21904-1, defines a W3 fume-separation class (at least 99% separation efficiency against welding fume) whose certification permits recirculation of cleaned air back into the workroom using a W3-certified capture-and-separation system, subject to conditions such as continuous performance monitoring and an alarm or automatic switch to fresh air if separation efficiency or airflow falls below the set threshold. A flat prohibition on recirculation in the presence of confirmed carcinogens is a feature of some other Member States’ technical rules (e.g. German TRGS-derived guidance), not an established Italian primary-source rule; Italian practice instead turns on whether the extraction equipment holds valid W3 certification and is operated within its conditions.

Selection and protection factors (FPO)

Selection guidance in Italy combines UNI EN 529:2006 with UNI 11719. EN 529 defines the Assigned Protection Factor (FPA); regional health authority guidance (ATS Brianza, based on UNI 11719:2018) states that for Italy the FPA corresponds to the national Operational Protection Factor (FPO) — a realistic, precautionary protection value assigned to each device class. The selection rule: the device’s FPO must exceed the required protection level, i.e. the workplace concentration divided by the limit value (FPO > Ce/VLEP). The FPO values published in that guidance for particle-filtering powered devices are: TH1P hood/helmet 5, TH2P 20, TH3P 100; TM1P full-mask 10, TM2P 100, TM3P 400. For comparison, an FFP3 filtering facepiece carries FPO 30. The same guidance notes a practical difference relevant to welders: a hood/helmet PAPR (TH type) provides greatly reduced protection if the blower stops, whereas a tight-fitting mask device (TM type) retains mask-level protection with the motor off. For stainless welding against the 0.005 mg/m³ chromium VI limit, the required protection factor should be calculated from measured exposure data, and the chosen device’s FPO must exceed that calculated requirement — these FPO figures come from a 2020 regional document based on the 2018 edition of UNI 11719, and should be re-checked against the 2025 edition once its full text is available (see gaps).

Device standards: UNI EN 12941 and UNI EN 12942, 2024 editions

The two device standards for welding PAPR are UNI EN 12941 (powered filtering devices incorporating a helmet or hood — loose-fitting, classes TH1/TH2/TH3) and UNI EN 12942 (powered filtering devices with full-face, half or quarter masks — tight-fitting, classes TM1/TM2/TM3). The class reflects maximum total inward leakage: for TH classes, 10% (TH1), 2% (TH2) and 0.2% (TH3). The UNI catalogue shows UNI EN 12941:2009 was withdrawn and replaced on 14 March 2024 by UNI EN 12941:2024, which adopts the underlying EN 12941:2023 text and describes its scope in the newer ISO-derived terminology of “powered filtering RPD with a reduced-fit breathing interface”; UNI EN 12942:2024 followed in June 2024, adopting EN 12942:2023. At EU level, EN 12941:2023 and EN 12942:2023 were first cited in the Official Journal as harmonised standards under Regulation (EU) 2016/425 by Commission Implementing Decision (EU) 2024/2599 of 4 October 2024 (OJ L series, published 8 October 2024), which inserted them into the standing list in (the then-current) Decision (EU) 2023/941 and set 8 October 2026 as the withdrawal date after which the older 1998-series editions (EN 12941:1998+A1:2003+A2:2008 and EN 12942:1998+A1:2002+A2:2008) no longer confer presumption of conformity. That standing list has since been consolidated and re-issued as Commission Implementing Decision (EU) 2026/1279 of 12 June 2026, which still lists EN 12941:2023 and EN 12942:2023 and repeals Decision 2023/941, but the presumption of conformity for the 2023 editions has run continuously since October 2024. Devices on the market certified to the earlier editions remain lawfully in circulation until the October 2026 withdrawal date. Buyers should check the marking on the device (e.g. “EN 12941 TH3”) and match spare parts to the certified configuration.

What changed recently and what is changing

Several developments are current as of mid-2026. First, on 17 January 2025 the transitional Allegato XLIII values for chromium VI expired: welding and plasma-cutting work moved from 0.025 mg/m³ to the definitive 0.005 mg/m³ limit, an 80% cut that pushes many stainless-welding tasks toward higher protection factors and better extraction. Second, nickel compound transitional arrangements ended at the same date under Directive (EU) 2022/431. Third, D.Lgs 135/2024 (in force 11 October 2024) transposed Directive (EU) 2022/431, retitling Titolo IX Capo II (from Article 233) to cover carcinogens, mutagens and reprotoxic substances and adding obligations on training, health surveillance and the exposure register. Fourth, UNI 11719:2025 was published on 20 November 2025, replacing the 2018 edition; INAIL announced it on 27 November 2025, highlighting new minimum-hours training requirements, trainer/instructor competencies, the “training environment” concept and confirmed fit testing for tight-fitting facepieces. Fifth, on the product-standards side, EN 12941:2023/EN 12942:2023 (adopted nationally as UNI EN 12941:2024 and UNI EN 12942:2024) gained EU harmonised status from October 2024 (Decision 2024/2599) and remain harmonised under the consolidating Decision 2026/1279 of 12 June 2026, with the 1998-series editions losing presumption of conformity from 8 October 2026 — signalling the ongoing transition of European RPE standards toward the ISO 17420 framework.

Sources & disclaimer

This page is information, not legal or safety advice. It summarises the cited public sources as of the date above; regulations change — verify against the primary source before relying on it. Product-level approval status is covered by our four-tier compatibility system.