ISO 45001, health and safety at work

ISO 45001 is the international standard that establishes the requirements of a management system for health and safety at work (OHSM). It was published by the International Organization for Standardization (ISO) on March 12, 2018, and replaced the British standard BS OHSAS 18001. In 2024 it was integrated by an amendment on climate change (ISO 45001:2018/Amd 1:2024). In Europe, it was adopted as UNI EN ISO 45001:2023 (ISO, 2018; Accredia & INAIL, 2024).

It is the only certifiable standard of the 45000 family. Others, including ISO 45002 on implementation and ISO 45003 on psychosocial risks, are guidelines. According to the latest ISO Survey, as of December 31, 2025, ISO 45001 is the third certification of system most widespread worldwide after ISO 9001 and ISO 14001, with over one million certified sites (Accredia, 2026). TheItaly è second in the world by number of certificates, according to the survey referring to 2023 (Accredia, 2025).

In thefood industry this certification today has substantial legal relevance. From 2025, ISO 45001 is indeed the technical reference expressed for organization and management models that oversee negligent crimes in occupational safety. The article examines the regulatory framework, the structure of the standard, the certification process, the evidence of its effectiveness, the advantages, and the burdens.

Legal reference context

The Legislative decree 81/2008 (Consolidated text on health and safety at work) reorganizes the implementation discipline of the Framework Directive 89/391/EEC, already transposed into Italy with Legislative Decree 626/1994. It also adopts the general prevention criteria, including:

– avoid risks and assess those that cannot be avoided;

– fight risks at the source;

– take into account the degree of technical progress;

– plan prevention;

– give priority to collective protection measures over individual ones (Dir. 89/391/EEC, Art. 6.2; Legislative Decree 81/2008, Art. 15).

The organization and management model

Article 30 of the Consolidated Text regulates the organization and management models suitable to have an exonerating effect on the administrative liability of entities. This liability is provided by Legislative Decree 231/2001 for crimes of manslaughter and serious or very serious negligent personal injuries committed in violation of accident prevention rules (Legislative Decree 231/2001, Art. 25-septies). Sanctions against the entity are financial and prohibitive.

The model must ensure a company system for compliance with all legal obligations relating to a series of areas (Legislative Decree 81/2008, Art. 30.1):

– legal technical-structural standards on equipment, plants, workplaces, and chemical, physical, and biological agents;

– risk assessment and consequent prevention and protection measures;

– emergencies, first aid, contract management, periodic meetings, and consultation of workers' safety representatives (RLS);

– health surveillance, information, and training;

– monitoring compliance with procedures, periodic checks, and mandatory documentation.

The model also provides for the recording of activities, a structure of functions with the necessary technical skills and powers, and a disciplinary system. The system is completed by a control system on the implementation of the model and on the maintenance over time of the measures (Legislative Decree 81/2008, art. 30, paragraphs 2-4).

The presumption of conformity

The Decree-law 31 October 2025, no. 159, converted by law 29 December 2025, no. 198, updated the technical reference, from the British Standard OHSAS 18001:2007 to the standard UNI EN ISO 45001:2023+A1:2024 (d.l. 159/2025, art. 10.5). It follows that ‘at the time of first application’ the models defined in accordance with the UNI-INAIL 2001 Guidelines or ISO 45001 ‘are presumed to be compliant with the requirements of this article for the corresponding parts’ (Legislative Decree 81/2008, art. 30.5).

The same decree has provided agreements between INAIL and UNI for free consultation of the technical standards referred to in the Consolidated Text (Legislative Decree 81/2008, art. 30.5-ter). It has also delegated to the Ministry of Labor, in agreement with INAIL, guidelines for the identification, tracking and analysis of near misses (near miss) in companies with more than fifteen employees (Legislative Decree 159/2025, art. 15).

The MOG 231

The certification of the occupational health and safety management system does not replace the organizational and management model established by Legislative Decree 231/2001, the so-called MOG 231, which aims to prevent the commission of 27 categories of crimes and must include the Supervisory Body, the disciplinary system and the protocols on other predicate offenses. However, the Court of Cassation has recognized the evidentiary value of the certification and its related limits:

– the existence of a model certified according to recognized international standards ‘constitutes an element that must be overcome by a complete demonstration of the substantial inadequacy of the adopted organizational system’ (Cass. pen., sect. IV, no. 30039/2025);

– certification, on the other hand, is not sufficient to exclude the entity's liability when operational procedures and effective controls on the specific risk are lacking (Cass. pen., sect. IV, no. 18410/2025).

The bill for the comprehensive revision of the administrative liability of entities, approved by the Council of Ministers on August 4, 2026, moves in the same direction. The text elevates the organizational fault as a criterion for attribution: the entity would only be liable when the public prosecution demonstrates a causal link between the organizational deficiency and the crime. The organizational, management, and control model (MOG 231) would thus become the cornerstone of prevention, to be implemented and updated in business processes, not just adopted (Dongo, 2026b).

On occupational health and safety, the reform project introduces two rules of opposite sign:

– one presumption of conformity for organizations that oversee the matter with models built on UNI ISO standards, in continuity with the effectiveness already recognized by Article 30 of the Consolidated Act to systems compliant with the UNI-INAIL Guidelines and, today, with UNI EN ISO 45001;

– for negligent crimes, a presumption of interest or advantage of the entity when the violation has produced, to an appreciable extent, a cost saving or an increase in production. It is the codification of the direction expressed by the United Sections of the Court of Cassation in the ThyssenKrupp case (Cass. pen., SS.UU., no. 38343/2014).

The bill also provides for a presumption of adequacy of models compliant with guidelines of associations representing entities, which the judge can override with adequate motivation (Dongo, 2026b). The provision is yet to be examined by the Chambers and the content may change. The direction already traced by case law nevertheless strengthens the role of certified systems, provided they are actually implemented and documented.

Sustainability reporting and supply chains

The health and safety of workers also falls within the social dimension of sustainability reporting provided for by the Corporate Sustainability Reporting Directive (CSRD, EU Directive 2022/2464). The scope of obligations has moreover been reduced by Directive (EU) 2026/470 (Omnibus I), to companies with more than 1,000 employees and 450 million euros of net turnover (Dongo, 2026c; 2026d). Suppliers are in turn sometimes subject to contractual reporting requirements through codes of conduct, qualification questionnaires, and conditions for access to supplier lists.

It should be noted that the ISO 45001 standard certifies a management system, not a product. It is recalled that the accreditation rules of certification bodies (ISO/IEC 17021-1) prohibit the use of system certification marks on products and packaging seen by consumers, and any other use that might suggest product conformity. Certification is therefore subject to communication in B2B relationships (business-to-business), on institutional websites and in sustainability reports, not on labels.

The ISO 45001 standard

Harmonized structure and integration

The ISO 45001 adopts the harmonized structure common to ISO standards on management systems (Harmonized Structure, already High Level Structure): same sequence of chapters, core text and common definitions. The cycle follows the scheme Plan-Do-Check-Act:

– context of the organization;

– leadership and worker participation;

– planning;

– support;

– operational activities;

– performance evaluation;

– improvement.

In the food industry, the integration is direct with the ISO 9001 (quality), ISO 14001 (environment), and ISO 22000 (food safety) standards, as well as with the scheme FSSC 22000. The integration with IFS Food and BRCGS schemes instead occurs at the process level (internal audits, non-conformity management, training, maintenance), since they have their own documentary structures (Dongo, 2026a).

The amendment of 2024 has added to all ISO management system standards two requirements on climate change. The organization must:

– establish whether climate change constitutes a relevant issue for its context;

– consider that interested parties may express requirements on the matter.

Leadership and worker participation

Compared to OHSAS 18001, ISO 45001 shifts the responsibility to thetop management, tasked with integrating health and safety objectives into the strategy and business processes and ensuring their resources. Safety therefore cannot be entirely delegated to the prevention and protection service.

The consultation and participation of workers, starting from the Workers’ Safety Representatives (RLS), becomes a structural requirement and includes the possibility to report dangerous situations without fear of retaliation (whistleblowing; Accredia & INAIL, 2024). The notion of ‘worker’ is broad and includes employees, top management, external collaborators and other persons present at the workplace.

Hazards, risks, and preventive measures

The standard requires continuous identification of hazards, risk and opportunity evaluation, and change management. In the food sector the analysis cross-references typical risks, many of which are reflected in the interventions awarded by INAIL (INAIL, 2026):

– confined spaces such as silos, tanks, vats, and reservoirs, with gas detectors and worker recovery systems;

– machines and safe delivery procedures (lock out – tag out) for cleaning, sanitization and maintenance;

– wet floorswith grates and pavements for liquid drainage;

– combustible dusts of flour and sugar, with certified antistatic bars for explosive atmospheres (ATEX);

– manual handling of loads, noise and thermal stress near ovens and cooking lines.

The thermal risk is likely to require greater consideration. The ISO/PAS 45007:2026 specification provides guidance on health and safety risks arising from climate change, including extreme heat (DQS, 2026).

Contracts, suppliers, and external labor

ISO 45001 regulates the procurement of goods and services, the contractors and the outsourced processes. It is often among these actors that accidents occur (Accredia & INAIL, 2024). The issue is sensitive in the food supply chain, where sanitation, internal logistics, maintenance, and seasonal peaks are frequently entrusted to cooperatives, agencies, and third-party companies. The system must therefore coordinate interfering risks, supplier qualification and field controls, in line with legal procurement obligations.

Certification and accreditation process

Certification is issued by accredited bodies according to the ISO/IEC 17021-1 standard and mandatory documents of international cooperation among accreditation bodies (Accredia, n.d.). In Italy, the sole accreditation body is Accredia. The EA and IAF mutual recognition agreements ensure certificate recognition in other participating countries.

The process includes an initial audit in two phases (documentation and on-site verification), a three-year certificate e surveillance audit at least annually, up to renewal. In October 2023, there were about 32,000 Italian sites with an accredited OHSMS (Occupational Health and Safety Management System) certificate (Accredia & INAIL, 2024).

The ongoing revision

ISO started in 2024 the revision of the standard, whose draft (ISO/DIS 45001) is intended to replace the 2018 edition with a new edition scheduled for 2027 (ISO, 2018). Certification bodies foresee a transition period of three years.

The topics under discussion according to the drafts are:

– psychosocial risks;

– new forms of work;

– climate risks and resilience;

– diversity of workers;

– greater involvement of external suppliers.

The basic structure should remain unchanged (DQS, 2026). Until publication, ISO 45001:2018 with the 2024 amendment remains the reference standard, also for the purposes of article 30 of the Consolidated Law.

The evidence on effectiveness

The study of Accredia and INAIL on about 26,000 certified companies and a homogeneous sample of non-certified companies compared injuries from the period 2017-2021. Certified companies show:

– a frequency index lower by 22.6%, with variations from a minimum of 14% to a maximum of 41% depending on the economic activity;

– a severity ratio lower by 29.2%, between 13% and 39% (Accredia & INAIL, 2024).

Organizational measures are therefore more effective in preventing serious injuries than minor ones.

International literature confirms the positive trend and clarifies its extent. In the United States, OHSAS 18001 certification, the basis of ISO 45001, reduced overall injury and illness cases by 20% and those involving transfer or restriction of duties by 24%. The same study found that the standard attracts establishments already safer than average (Viswanathan et al., 2024).

In Denmark, 805 certified companies compared with 12,297 non-certified showed a 14% lower risk of serious injuries already two years before certification, with no further reductions in the following three years (Dyreborg et al., 2024). Certified companies nevertheless report more structured prevention efforts, both in processes and content (Uhrenholdt Madsen et al., 2022).

The framework is consistent with the stance of the Court of Cassation. Certification is a reliable indicator and support for prevention, but the result depends on the concrete implementation of the system.

Advantages and burdens related to the adoption of ISO 45001

Advantages

The adoption of the standard offers advantages of different kinds:

– on the legal level, the presumption of conformity to the requirements of article 30 of Legislative Decree 81/2008 for the corresponding parts and an evidentiary weight recognized by case law in the proceedings pursuant to Legislative Decree 231/2001. The presumption would be strengthened by the reform under discussion in Parliament;

– on the economic level, the reduction of the INAIL premium for prevention;

– on the commercial level, a third-party verification usable in supplier qualification and tenders, which can reduce the number of second-party audits by clients;

– on the managerial level, the integration with existing quality, environmental and food safety systems, with unified audits and reviews.

The possession of a SGSL certified UNI EN ISO 45001 by an accredited body is a ‘type A’ intervention of the OT23 model of INAIL, sufficient in itself to access the reduction of the average tariff rate provided it is extended to all territorial insurance positions (PAT) of the company and valid for the entire reference year (INAIL, 2026). After the first two years of activity, the reduction is 28% up to 10 worker-years, 18% between 10 and 50, 10% between 50 and 200, and 5% over 200. The application must be submitted by February 28, which in 2027 moves to March 1.

Burdens

Thesystem setup requires context analysis, hazard mapping, procedure review, training and often external consultancy. In addition to audit fees, there are indirect maintenance costs: records, internal audits, management reviews and corrective action management. Adaptation to the new edition of the standard, expected from 2027, is also added.

The most significant burden, however, concerns theeffectiveness. A certified system but disconnected from operational procedures, risk assessment documentation and flows to the Supervisory Body does not protect either workers or the entity, as jurisprudence has already made clear.

Conclusions

The ISO 45001 standard has replaced OHSAS 18001 in a few years, inheriting it within an international framework and can be directly integrated with other management systems. The Italian legislator acknowledged this with decree law 159/2025, which identifies it as the technical reference for the organizational models pursuant to article 30 of the Consolidated Law.

For food businesses, accredited certification is a prevention tool with measured effects on the frequency and especially on the severity of accidents. It is also a basis for reducing insurance premiums, a qualification element in the supply chains, and an organizational safeguard according to the logic of Legislative Decree 231/2001. However, its value depends on the consistency between the certified system, operating procedures, and effective controls.

Dario Dongo

References

Normative sources of the European Union

Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work. Consolidated text: 11/12/2008. http://data.europa.eu/eli/dir/1989/391/2008-12-11

Directive (EU) 2022/2464 of the European Parliament and of the Council of 14 December 2022 amending Regulation (EU) No 537/2014, Directive 2004/109/EC, Directive 2006/43/EC and Directive 2013/34/EU, as regards corporate sustainability reporting. Consolidated text: 18/03/2026. http://data.europa.eu/eli/dir/2022/2464/2026-03-18

Directive (EU) 2026/470 of the European Parliament and of the Council of 24 February 2026 amending Directives 2006/43/EC, 2013/34/EU, (EU) 2022/2464 and (EU) 2024/1760. Official Journal of the European Union, L, 26.2.2026. http://data.europa.eu/eli/dir/2026/470/oj

Italian normative sources

Legislative Decree 8 June 2001, no. 231. Regulation of the administrative liability of legal persons, companies, and associations without legal personality, pursuant to Article 11 of Law 29 September 2000, no. 300. Normattiva. Latest consolidated version: 01/07/2026. https://www.normattiva.it/uri-res/N2Ls?urn:nir:stato:decreto.legislativo:2001-06-08;231

Legislative Decree 9 April 2008, no. 81. Implementation of Article 1 of Law 3 August 2007, no. 123, regarding the protection of health and safety in workplaces. Normattiva. Latest consolidated version: 23/03/2026. https://www.normattiva.it/uri-res/N2Ls?urn:nir:stato:decreto.legislativo:2008-04-09;81

Decree-law 31 October 2025, No. 159. Urgent measures for the protection of health and safety in workplaces and in matters of civil protection. Official Gazette of the Italian Republic, General Series no. 254 of October 31, 2025, converted with amendments by law of December 29, 2025, no. 198. Coordinated text in Official Gazette, General Series no. 301 of December 30, 2025 (25A07009). https://www.gazzettaufficiale.it

Case law

Criminal Court of Cassation, United Sections, hearing April 24, 2014, filing September 18, 2014, no. 38343 (ThyssenKrupp). https://olympus.uniurb.it/index.php?option=com_content&view=article&id=12658

Criminal Court of Cassation, section IV, filing May 15, 2025, no. 18410. https://olympus.uniurb.it/index.php?Itemid=138&catid=17&id=34492

Criminal Court of Cassation, section IV, hearing May 13, 2025, filing September 1, 2025, no. 30039.

Scientific studies

Dyreborg, J., Thorsen, S. V., Uhrenholdt Madsen, C., & Hasle, P. (2024). Effectiveness of OHSAS 18001 in reducing accidents at work. A follow-up study of 13,102 workplaces. Safety Science, 177, 106573. https://doi.org/10.1016/j.ssci.2024.106573

Uhrenholdt Madsen, C., Vester Thorsen, S., Hasle, P., Leonhardt Laursen, L., & Dyreborg, J. (2022). Differences in occupational health and safety efforts between adopters and non-adopters of certified occupational health and safety management systems. Safety Science, 152, 105794. https://doi.org/10.1016/j.ssci.2022.105794

Viswanathan, K., Johnson, M. S., & Toffel, M. W. (2024). Do safety management system standards indicate safer operations? Evidence from the OHSAS 18001 occupational health and safety standard. Safety Science, 171, 106383. https://doi.org/10.1016/j.ssci.2023.106383

Technical documents and institutional sources

Accredia. (n.d.). Workplace safety. Accredia Observatory. Consulted on October 20, 2026. https://www.accredia.it/osservatorio/sicurezza-sul-lavoro/

Accredia. (2025, January 25). Results and projects of the Certification and Inspection Department: the 2025 Conference. https://www.accredia.it/comunicazione/notizie/risultati-e-progetti-del-dipartimento-certificazione-e-ispezione-il-convegno-2025/

Accredia. (2026, October 15). ISO Survey 2025: over 3.28 million accredited certificates worldwide. https://www.accredia.it/comunicazione/notizie/iso-survey-2025-oltre-328-milioni-di-certificati-accreditati-nel-mondo/

Accredia & INAIL. (2024). The effectiveness of accredited certifications for occupational health and safety management systems. Technical standards, regulations, support, and results assessment: from current state to perspectives. INAIL, Milan. ISBN 978-88-7484-850-8. https://www.accredia.it/wp-content/uploads/2024/11/Indagine-Accredia-INAIL-Sistemi-di-gestion-Salute-e-Sicurezza-Lavoro-2024.pdf

DQS. (2026). The most important facts about the revision of ISO 45001 at a glance. Consulted on 20 October 2026. https://www.dqsglobal.com/en/about/newsroom/the-most-important-facts-about-the-revision-of-iso-45001-at-a-glance

INAIL. (2026). Reduction of the average prevention rate – Year 2027 (OT23). Application form (version 17/7/2026) and compilation guide. https://www.inail.it/portale/it/atti-e-documenti/moduli-e-modelli/associazione/moduli-associazione/premio-associazione/riduzione-del-tasso-medio-per-prevenzione—anno-2027–ot23.html

ISO. (2018). ISO 45001:2018. Occupational health and safety management systems — Requirements with guidance for use, with Amendment 1:2024. Climate action changes. International Organization for Standardization. https://www.iso.org/standard/45001

In-depth articles

Dongo, D. (2026a, 1 September). Certifications for food safety: FSSC 22000, IFS and BRCGS compared. GIFT (Great Italian Food Trade). https://www.greatitalianfoodtrade.it/certificazioni-e-analysis/certificazioni-sicurezza-alimentare-fssc-22000-ifs-brcgs/

Dongo, D. (2026b, 19 September). Administrative liability of entities, expected news. FARE (Food and Agriculture Requirements). https://fareagrifood.com/2026/09/19/responsabilita-amministrativa-enti-novita/

Dongo, D. (2026c, 3 September). Corporate social responsibility and SA8000 certification. GIFT (Great Italian Food Trade). https://www.greatitalianfoodtrade.it/certificazioni-e-analysis/sa8000-certificazione-responsabilita-impresa/

Dongo, D. (2026d, September 2). Social sustainability, the FSSC 24000 certification scheme. GIFT (Great Italian Food Trade). https://www.greatitalianfoodtrade.it/certificazioni-e-analisi/fssc-24000-certificazione-sostenibilita-sociale-industria-alimentare/