Ferré & Consulting Blog (English Version)

The European Food Safety Authority has today published a guidance document for the risk assessment of engineered nanomaterial (ENM) applications in food and feed. The guidance is the work of the Authority’s Scientific Committee and is the first of its kind to give practical guidance for addressing potential risks arising from applications of nanoscience and nanotechnologies in the food and feed chain. The guidance covers risk assessments for food and feed applications including food additives, enzymes, flavourings, food contact materials, novel foods, feed additives and pesticides.

The EFSA guidance, prepared in response to a request from the European Commission, sets out the considerations for risk assessment of ENM that may arise from their specific characteristics and properties. Importantly, the ENM guidance complements existing guidance documents for substances and products submitted for risk assessment in view of their possible authorisation in food and feed. It stipulates the additional data needed for the physical and chemical characterisation of ENM in comparison with conventional applications and outlines different toxicity testing approaches to be followed by applicants.

Commenting on the publication of the EFSA guidance, Professor Vittorio Silano, Chair of EFSA’s Scientific Committee explained, “A thorough characterisation of the engineered nanomaterials followed by adequate toxicity testing is essential for the risk assessment of these applications. Yet we recognise uncertainties related to the suitability of certain existing test methodologies and the availability of data for ENM applications in food and feed. The guidance makes recommendations about how risk assessments should reflect these uncertainties for food and feed applications.”

To assist with the practical use of the guidance, six scenarios are presented which outline different toxicity testing approaches. For each scenario, the guidance indicates the type of testing required.

EFSA conducted a public consultation on its preparatory work, acknowledging the importance of developing risk assessment methodologies in this field to support innovation whilst ensuring the safety of food and feed. In total 256 comments were received from 36 organisations spanning from academia, NGOs, industry to Member State and international authorities. All of these contributions were considered and incorporated into the guidance document where appropriate.

Risk assessment of engineered nanomaterials is under fast development and consequently, in keeping with EFSA’s commitment to review its guidance for risk assessment on an ongoing basis, this work will be revised as appropriate.

• Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain

• Outcome of the public consultation on the draft scientific opinion on Guidance on risk assessment concerning potential risks arising from applications of nanoscience and nanotechnologies to food and feed

Food Safety, Technology EFSA, Nanomaterial

A lack of scientific evidence means no clear verdict can yet be reached on the health risks posed by nanomaterials – but the carcinogenic potential of some nanoparticles should be “taken seriously”, cautioned German authorities.

The Federal Institute for Risk Assessment (BfR) and the Federal Environment Agency (UBA) said that while several studies on animals indicated that some nanomaterials could cause cancer, they added there was currently insufficient data to label them as “potentially carcinogenic to humans”.

The bodies also concluded that no firm verdict could yet be reached regarding the release of nanomaterials from products nor to their exposure.

But they stressed sufficient concerns existed to warranted close scrutiny of their effects – particularly regarding daily exposure to nanomaterials.

Nano assessments

The statement is the latest in a string of opinions issued recently over the safety of nanomaterials, whose use is becoming increasingly widespread in consumer products such as packaging and food.

In January, the European Food Safety Authority (EFSA) issued draft guidance on nano risk assessment. Two weeks later the International Organisation for Standardisation (ISO) published a guide to assess the potential threat of exposure to nanomaterials in the workplace.

Last year, the BfR itself declared that nanosilver should be excluded from foods or cosmetics until the potential hazards from the substance had been fully scrutinised. The body urged companies considering use of nanosilver in consumer products to hold off until studies have fully confirmed its safety. The agency said the case had not been made.

No firm conclusions

The BfR/UBA said that research on animals had shown that some nanomaterials such as carbon nanotubes (CNTs) and titanium dioxide (TiO2) may be carcinogenic when breathed in. But the scientists said a water-tight scientific case to apply these findings to humans could not yet be made.

“This mainly results from the fact that the extent to which data from animal testing applies to humans and whether these effects are specific to the nanoscale or are rather due to other properties inherent to these substances is uncertain,” said the German experts

The scientists said that no reliable conclusions could also be drawn on exposure to nanomaterials nor regarding their release from products – because of the scarcity of research and the absence of a “reliable measurement technology to detect nanomaterials in different media”.

“It is therefore not yet possible to assess the health risks of these materials for humans with reasonable certainty,” concluded the bodies.

Taken seriously

But the BfR and UBA said: “Despite existing uncertainties findings on the carcinogenic potential of some nanomaterials should be taken seriously”.

The toxicological properties of nanostructures should also be assessed through the development of valid methods on all possible routes of exposure – such as inhalation, dermal and oral pathways.

Proper evaluation of potential carcinogenic hazards of nanomaterials– in line with general scientific principles – can only be characterised for a specific substance in a specific case.

Source: Food production daily

Health health risks, Nanomaterial

Concerns have been raised that a new European regulation forcing cosmetic manufacturers to list nanoparticles Hill be applied to food product labelling.

The decision made by the EU´s ingredients present in cosmetic products clearly indicated in the list of ingredients, by inserting the word “nano” in brackets after the ingredient listed.

Nanomaterial is defined as “an insoluble or bio-persistent and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nanometres”.

Nanomaterials may have different properties compared to the same substances at normal scale, so could have a substantial impact on foods in the future, in that they can enable better management of the functionalities of food ingredients, provided there is no safety risk attached to these changed properties. For example, engineered nanomaterials (ENMs) could have applications as food additives, enzymes, flavourings, and novel foods, as well as food contact materials and supplements.

The European Food Safety Authority’s (EFSA) scientific opinion published last year recommends that risk assessments should be undertaken case-by-case, but also that at present “a lack of validated test methodologies could make risk assessment of specific nano products very difficult and subject to a high degree of uncertainty.” The European Commission asked EFSE to prepare a “guidance document” on how to assess potential risks related to food-related uses of nanotechnology; the first draft of this document is due to be completed by July 2010, for consultation.

Nanomaterial research and development has not yet reached the mainstream food market inn the EU, but bread containing nanoparticles of fish oils is reported to be on sale in Australia.

Meanwhile in the UK, a House of Lords committee on nanotechnologies has called on the UK´s Food Standards Agency (FSA) to draw up a list of nanoderived foods.

“We believe there are many potential benefits to consumers and industries from nanotechnology in food and food packaging”, says Andrew Wadge, FSA´s chief scientist.

“However, we share the view that there is a lack of knowledge about the potential effects and impacts of nanomaterials on human health and the environment.

Openness and cooperation from the food industry and support from consumer groups will he needed, Wadge asserts, to ensure that any register provides information that consumers need.

Health, Ingredients list of ingredients, Nanomaterial, nanoparticles