The European Parliament has rejected the revised Novel Foods definition of ‘engineered nanomaterial’. Concerns about the threshold for defining a material as an engineered nanomaterial being too high prevented its adoption. Consequently, the existing nanomaterial definition will continue to apply. This results in continued ambiguity and lack of alignment between different EU European Union (European Union) regulations.

Current ‘Engineered nanomaterial’ definition has limitations

For food regulation the term ‘engineered nanomaterial’ is defined in Regulation (EU) 2015/2283 on Novel Foods determines which novel foods and new ingredients clearly require nanospecific considerations. It also establishes whether ingredients need to be indicated as ‘[nano]’ on the ingredient list of food packaging, as regulated by the Food Information to Consumer (FIC) Regulation (EC) 1169/2001.

The current definition of ‘engineered nanomaterial’ in the Novel Food Regulation has proven challenging to implement for both food business operators and enforcement authorities. This is because it allows for different interpretations regarding whether a material is intentionally produced. Additionally, the lack of a default threshold value for particles at the nanoscale complicates the use of the current definition. These challenges also have implications for the FIC Regulation. It is currently unclear when a food ingredient needs to be labelled as ‘[nano]’ on the ingredients list of food packaging. Therefore, in 2022, the European Commission recommended revising the definition of ‘engineered nanomaterial’ in its Commission Recommendation C(2022)3689.

Proposed definition aligns with EU definition

An EU Expert committee revised the Novel Foods definition of ‘engineered nanomaterial’ to align with the revised EU definition of a nanomaterial. Among the changes of the EU revision was an extended clarification on the size limit (< 100 nm), exclusion of certain materials, and definitions of ‘particle,’ ‘aggregate,’ and ‘agglomerate.’ A default threshold value of 50% of particles at the nanoscale was introduced as a criterion for defining a material as a nanomaterial. The definition of ‘engineered nanomaterial’ was further clarified as a ‘manufactured material’ with a detailed description of the term ‘manufactured’. Adopting these changes in the Novel Foods definition of ‘engineered nanomaterial’ aimed to provide clear and objective criteria and alignment with the EFSA risk assessment guidance documents on nanotechnology. The European Commission adopted the proposed amendment on March 14, 2024.

European Parliament rejects proposed definition due to 50% threshold

However, on April 24th, 2024, the European Parliament voted in favour of a resolution from the Committee on the Environment, Public Health and Food Safety to object to the Regulation with the amended definition. One of the main reasons set out in this resolution is the 50% threshold. This threshold was considered unreflective of the technical and scientific progress, thereby arbitrary and not protective enough.

Especially French organisations, including the Agency for Food, Environmental and Occupational Health & Safety (ANSES), would prefer a more protective threshold of 10%. A 10% threshold would also better enable consumers to check whether a food product contains nanoparticles. The rejected 50% threshold would allow companies, for example, to use an ingredient composed of 49% particles below 100 nm without labelling it as ‘[nano]’. As a result of the rejection, the existing ‘Engineered nanomaterial’ definition will presently continue to apply.

Reflections by RIVM

The European Parliament’s rejection of the revised Novel Food definition of ‘engineered nanomaterial’ has several drawbacks. One major disadvantage is the lack of alignment between the Novel Food definition and the EU recommendation of ‘engineered nanomaterial’. This results in different definitions of nanomaterials being used across various EU regulations.

It is doubtful that lowering the threshold to 10% and subsequent labelling of more food ingredients as ‘[nano]’ will lead to a better protection of consumers. According to the EFSA risk assessment guidance on nanotechnology, nano-specific risk assessment of Novel foods or Food additives is also performed for substances containing less than 50% nanoparticles. An example of this is the assessment of titanium dioxide (E 171), which consists of less than 50% nanoparticles.

Also, the 50% threshold reflects the median value for specific analytical techniques determining particle-size distributions. The current definition, without a threshold, allows for interpretation. In addition, the revised definition would have clarified which particles to count to determine the ingredient’s particle size: single particles only, or aggregates or agglomerates too. The revised definition clearly indicates that the particle size should be based on the minimum diameter of identifiable constituent particles in these aggregates and agglomerates, referred to as the ‘counting rules’. The 50% threshold and the counting rules would have helped food business operators, enforcement authorities, and others to determine relatively simple and precise whether a material contains nanoparticles below a defined threshold. The current definition allows for interpreting whether a material is considered a nanomaterial.

Overall, the revised definition of an ‘engineered nanomaterial’ would have eliminated ambiguity in the current definition of an ‘engineered nanomaterial’, which now continues to exist.