Commission’s anticipated nano definition delayed

By Annie Harrison-Dunn contact

- Last updated on GMT

The Nanotechnology Industries Association (NIA) has its fingers crossed for a unified reaffirmation of the 50% threshold for food. ©iStock/cybrain
The Nanotechnology Industries Association (NIA) has its fingers crossed for a unified reaffirmation of the 50% threshold for food. ©iStock/cybrain
The European Commission’s much-anticipated definition of engineered nanomaterial has been pushed back, but is still expected this year.  

The definition had been expected by September or October this year​, Dr Rafael Pérez Berbejal of the Commission’s Directorate-General for Health and Food Safety (DG SANTE) unit on food processing technologies and novel foods said in April. 

Yet as we nudge towards the end of November, there is still no sign.

“We are currently preparing a public consultation of the draft revised recommendation – still to be launched this year,”​ a spokesperson for the Commission told us this week.

Adoption of the recommendation is expected “sometime”​ in 2017.

The question at stake is what threshold of nanomaterial means a food should be classed as being produced by nanotechnology.

What is nanotechnology?

Nanotechnology is the manufacture and use of materials and structures at the nanometre scale, which is one millionth of a millimetre.

In the widest sense of the term, nanomaterials are a natural part of food processing and conventional foods, because the characteristic properties of many foods rely on nanometre sized components such as nanoemulsions and foams, the UK's Food Standard Agency says.

However, technological developments mean manufactured nanoparticles can be added to food via finely divided forms of existing ingredients or completely new chemical structures.

Yet the technology has uses in many different sectors from packaging to cosmetics. 

Definitions within the EU Food Information to Consumers (FIC) regulation and the recently updated Novel Food regulation – which nanomaterials now officially fall under – have differed as have levels favoured by the Commission and the European Food Safety Authority (EFSA).

Commission’s 50% mark

In 2011 the Commission published a recommendation​stating the term nanomaterial referred to natural, incidental or manufactured material containing “particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50% or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm”.

It added that in specific cases “warranted by concerns for the environment, health, safety or competitiveness”​ the threshold of 50% could be lowered to between 1 and 50%.

Yet EFSA has been much more conservative on the new technology, which it has said “may manifest toxic effects differently from the conventional forms”.

In a letter to the Commission​ back in 2012, EFSA advised: “In view of the current uncertainties over safety, a lower nanoparticle number threshold, e.g. 10%, should be considered for food related applications instead of the currently proposed (50%) in the [Commission’s] Recommendation.”

Industry call for clarity

The Nanotechnology Industries Association (NIA) has its nano- crossed for a unified reaffirmation of the 50% threshold for food.

“Our position at NIA, is that the definitions should refer to a fixed threshold as the current situation creates uncertainty,”​ public and regulatory affairs officer at NIA, Guillaume Flament, told us.

“As stated by the JRC, a threshold under 50% would be inappropriate for it would result in naming a material by the minority of its components.”

A 2015 report​ from the Commission's science service the Joint Research Centre (JRC) said there was no “compelling reasons” ​to lower the threshold of 50%.

From cosmetics to food

Nanoparticles 2
©iStock

The issue is a complex one since nano can be used in many different products from cosmetics to food.

Flament said within food the technology held the most promise for packaging, where nano silver has been tipped as a promising anti-bacterial agent.

Within nutrition researchers have looked at nano-carrier systems as a simple and affordable way to protect nutrients like resveratrol from photodegradation and to boost absorption across the intestinal barrier.

EFSA guidance also pending

EFSA has also begun work on an update of its 2011 guidance, with a public consultation on course for the first half of 2018, a spokesperson told us this week.

There were a few questions on the definition of nanomaterials in a recent public consultation on EFSA’s guidance for the novel food regulation​.

EFSA referred these inquiries to the 2011 opinion, which remains valid for any applications that may come in before the update.

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