*1.2. Legislation and Standardization*

It is important to emphasize that, in 2014, the European Commission published a recommendation regarding the definition of nanomaterials, which has recently been revised (Commission Recommendation of 10 June 2022):

"Nanomaterial means a natural, incidental or manufactured material consisting of solid particles that are present, either on their own or as identifiable constituent particles in aggregates or agglomerates, and where 50 % or more of these particles in the number-based size distribution fulfil at least one of the following conditions: (a) one or more external dimensions of the particle are in the size range 1 nm to 100 nm; (b) the particle has an elongated shape, such as a rod, fiber or tube, where two external dimensions are smaller than 1 nm and the other dimension is larger than 100 nm; and (c) the particle has a plate-like shape, where one external dimension is smaller than 1 nm and the other dimensions are larger than 100 nm" [2].

Within the European Union, there is legislation in place to protect workers from the potential risks associated with nanomaterials, even though the legislation does not explicitly mention these materials. The Framework Directive 89/391/EEC, the Chemical Agent Directive 98/24/EC, and the Carcinogen and Mutagen Directive 2004/37/EC, as well as the regulations on chemicals such as Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) and Classification, Labelling and Packaging (CLP), are particularly relevant in this context. This means that employers must assess and manage the risks of nanomaterials in the workplace.

If the use and generation of nanomaterials cannot be eliminated or substituted by less hazardous materials and processes, the exposure of workers must be minimized through preventive measures following a hierarchy of control that prioritizes elimination, substitution, engineering controls, administrative controls, and personal protective equipment in that order. Although many uncertainties still exist, there is a high level of concern about the safety and health hazards of nanomaterials. Therefore, employers and workers must take a precautionary approach to risk management and the selection of prevention measures [1,4].

Standard documents are essential to support the effective implementation of legislation. Standards cover terminology, test methods, material specifications, management systems, and other relevant areas. The authors of this text recently published a review of standards related to the occupational risk and safety of nanotechnologies [6]. A summary and update of this review is presented below.

At the international level, ISO has been developing a large set of standards related to nanotechnology, especially within ISO Technical Committee 229, created in 2005. Working group three deals specifically with health, safety, and environmental aspects of nanotechnologies.

At the European level, the Technical Committee CEN TC 352, created in 2006, is engaged in standardization in the field of nanotechnologies. The standards that have already been published or are under preparation include those that deal with science-based health, safety, and environmental practices.

The European Commission has recognized the importance of standards in supporting legislation and has issued a mandate to the European standardization bodies to develop testing methods and tools for characterizing, understanding the behavior of, and assessing the exposure to nanomaterials. This exposure assessment takes into account the health and safety of workers, as well as the protection of the consumers and of the environment [5].

The coordination of this mandate falls under CEN/TC 352, but multiple CEN and ISO technical committees are involved in its execution. Several European standards have already been published under this mandate, and others are currently being developed. Many of these standards are related to occupational health and safety.

Up to now (April 2023), 32 European standards have been published, including 26 EN/ISO documents developed in conjunction with ISO/TC229. Nine new standards are being prepared. The updated list can be consulted at https://standards.cen.eu/, accessed on 15 April 2023.

Related to ISO/TC229, up to now (February 2023), 102 standard documents have already been published and 32 are under development covering health and safety aspects. The following documents are especially relevant:


In 2006, the Organization for Economic Co-operation and Development (OECD) established the Working Party on Manufactured Nanomaterials (WPMN) as a subsidiary body of the OECD Chemicals Committee. This program is focused on examining the implications of manufactured nanomaterials for human health and the environment. Since its inception, the WPMN has published more than 100 documents under the "Safety of Manufactured Nanomaterials" series, some of which are related to standards. A complete list of all freely downloadable documents can be found at: http://www.oecd.org/env/
