The term ‘nano’ (from the Greek work for ‘dwarf’) is the term use to describe those materials that have at least one external dimension that measures 100 nanometers (1 nanometer = 1 billionth of a meter). As an example, a human hair has approximately between 80 000 and 100 000 nanometers (nm.).
Nanomaterials can occur in nature, may be an incidental product of human activity or deliberately manufactured and engineered to exhibit novel characteristics, such as increased strength, chemical reactivity or conductivity, compared to the same material without nanoscale features.
The fact that nanomaterials may exhibit different characteristics than their non-nano conventional forms may also be indicative of different behaviour in biological systems leading to different hazard profiles and resulting risks for human health and the environment.
As a result, the European Union has put in place regulations to properly define nanomaterials and assess any health and environmental risks that may result from their use in various applications. In addition, the European Union risk assessment bodies and agencies have developed guidance for the risk assessment of nanomaterials.
Commission Recommendation C(2022)3689 provides for a general definition of nanomaterials that revised and replaced the previous nanomaterial definition of Commission Recommendation 2011/696/EU.
In the context of foods, engineered nanomaterial is defined in Article 3(2)(f) of the Novel Food Regulation as:
“any intentionally produced material that has one or more dimensions of the order of 100 nm or less or that is composed of discrete functional parts, either internally or at the surface, many of which have one or more dimensions of the order of 100 nm or less, including structures, agglomerates or aggregates, which may have a size above the order of 100 nm but retain properties that are characteristic of the nanoscale”.
The Novel Food nanomaterial definition is similar to the general definition of Commission Recommendation C(2022)3689 but mainly differs in that
- it specifically refers to and defines ‘engineered nanomaterials’;
- it does not include a percentage threshold for the content in particles of less than 100 nm above which materials are to be classified as nanomaterials. Moreover, Commission Recommendation C(2022)3689 sets that threshold at 50% of the total particles in a given material to have one or more dimension below 100 nm for the material to be classified as a nanomaterial.
Properties that are characteristic of the nanoscale (dimensions measured in nanometers) include:
- those related to the large specific surface area of the materials considered; and/or
- specific physico-chemical properties that are different from those of the non-nanoform of the same material.
This definition is also applicable to the Food Additives Regulation and the Food Information to Consumers Regulation.
Activities in the area of Nanomaterials in Food
1. Implementation of the definition of ‘engineered nanomaterials’
Even before the entry into force of the Novel Food Regulation, the European Commission initiated activities to facilitate the implementation of the ‘engineered nanomaterial’ definition. A dedicated workshop co-organised by the Commission department for Health and Food Safety (DG SANTE) and the Joint Research Centre (DG JRC) in 2017 identified a number of activities that would need to be taken in order to support its implementation, most notably:
- review and access to state of the art methodologies;
- analytical method development and validation and analyses of nanomaterials in foods;
- support to Member States for analytical capacity building and training;
2. Risk assessment of engineered nanomaterials and material containing small particles including nanoparticles that are defined as engineered nanomaterials
The European Food Safety Authority (EFSA) is the European Union body responsible for the risk assessment of foods. Two EFSA guidance documents assist and support food business operators in preparing and submitting applications and in facilitating the risk assessment process:
- Guidance on risk assessment of nanomaterials to be applied in the food and feed chain: human and animal health - applicable to materials that are defined as ‘engineered nanomaterials’. It should be noted that this guidance is also applicable to nanomaterials that are defined as such under other Regulations and are used in foods or feed (e.g. plant protection products, food contact materials).
- Detailed guidance - issued to establish the presence of small particles, including nanoparticles, in those materials that are not engineered nanomaterials according to the definition of Article 3(2)(a)(f) of Regulation (EU) 2015/2283.
3. Revision of the definition of ‘engineered nanomaterials’
Article 31 of the Novel Foods Regulation requires the Commission to adjust and adapt, via a delegated act, the definition of engineered nanomaterials to technical and scientific progress or to definitions agreed at international level.
The underlying data, information and Commission activities leading to Commission Recommendation C(2022)3689 constitute the technical and knowledge basis on which to initiate and prepare an eventual adaptation and adjustment of the Novel Food ‘engineered nanomaterial’ definition.
To assist in the preparation of the delegated act revising the engineered nanomaterials definition, the Commission has created an Expert Group on Nanomaterials in Food. In addition, the involvement of stakeholders is ensured via the Advisory Group on Sustainability of food Systems (AGSFS).
The department for Health and Food Safety together with other services of the European Commission are following work and developments in standardisation carried out by the European Committee for Standardisation (CEN) concerning nanomaterials.