EU nanomaterial regulations receive criticism

A NUMBER of experts have criticised a change to regulations surrounding nanomaterials in food introduced by the European Food Safety Authority (EFSA).

Leaders in the food and nanotechnology industries have been divided on the issue with some warning about health concerns, and others arguing that the food industry could be hampered by “over-application” of the new regulations.

The new EU regulations – agreed in November 2015, and come into effect by the end of 2017 – state that, “Engineered nanomaterials require a Novel Food authorisation before being used in foodstuffs.”

Nanomaterials are a concern to the EFSA as they can have different properties to their macro-sized counterparts. At the nanoscale, the size and shape of a molecule becomes increasingly important. Single atom changes can affect the physio-chemical characteristics, resulting in potentially toxic effects.

A nanomaterial is being defined by the EU as an “intentionally manufactured material where one or more external dimensions is in the size range 1 nm to 100 nm.”

Such a broad definition covers most materials, and experts are warn that many food-stuffs proven to be safe will be caught up in blanket regulations without considering the one-molecule differences that can make a material safe or unsafe for human consumption.

David Carlander, director general at the Nanotechnology Industries Association believes that the regulations must provide clearer responsibilities on the part of food producers to reduce uncertainty.

He said, “The complications and difficulties in using the definition of a nanomaterial are still not fully understood, and therefore we are still likely to see uncertainties on practical aspects of nanomaterials in the novel foods regulation,”

Camilla Stice, a food and nutrition analyst at Lux Research said that there are “many unknowns remaining within the nanotechnology landscape,” and that with such a high threshold of what constitutes a food-based nanomaterial, the regulations “could backfire” if adequate safety tests are not performed.

She added, “This leaves a lot of wiggle room for developers to incorporate nanomaterials into their products while flying under the radar of this new regulation.”

Some experts are in favour of the new regulations, claiming they will help innovation in the food industry and allow the process for market approval to be simplified, with approval given to all member states at once.

Vytenis Andriukaitis, commissioner for Health and Food, said, “This agreement brings us closer to a more effective regulatory environment that will allow businesses to bring innovative food to market, whilst ensuring the highest possible levels of food safety for European consumers.”

The problem with reaching a consensus on this issue is balancing the changing definition of a nanomaterial from a scientific view with the broad and slow-to-change letter of the law.

Legal experts from Squire Patton Boggs suggested a specific “substance-based approach” that would rule on each case, however they highlight the main disadvantage with the approach would be that “the multiplication of definitions could make the legislation unreadable.”

Anthony Bochon, associate attorney with Squire Patton Boggs, said the biggest concern with the legislation as it currently stands is a “risk of over-application of the precautionary principle when regulating nanomaterials.”

Bochon concludes that the legislation could work effectively for food safety under the following conditions: There is increased clarification for where member states’ competences lie when regulating chemicals; the regulations must also avoid broad legal definitions that will catch out substances with no provable health risks; and companies must communicate their data more effectively.