In December 2013 the European Commission (EC) proposed a new definition of ‘engineered nanomaterial’ for Regulation (EU) No. 1169/2011. This was rejected by members of the European Parliament’s Committee for Environment, Public Health and Food Safety (ENVI) on the grounds that ‘the definition could lead to existing nanomaterials not being labelled’.
The changes in the proposed Regulation submitted by the EC to the European Parliament on 24th of November 2014 includes a modified definition: “'engineered nanomaterial' means any intentionally 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 to 100 nm. By way of derogation, fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm shall be considered as engineered nanomaterials.” Notification of the proposed changes was made to the World Trade Organisation (WTO) which summarised the changes in approach. http://bit.ly/1Ab5tIB
However, a European Parliament report dated December 1st raised the problem that if instead of the European Food Standards Agency (EFSA) preferred benchmark of 10%, a 50% threshold was applied “even for risk assessment purposes, there would be the serious risk that some nano-ingredients will not be captured by the definition, and would therefore not be subject to risk assessment.” http://bit.ly/1zIc5P3
There is clearly room for further change in the proposed regulations assuming formal objections are submitted following the release of the new regulation. Additionally, there are still unresolved issues around the reliability of measurement of nanomaterials particularly in complex mixtures. The International Organization for Standardization (ISO) has set up working groups to investigate appropriate standard methods for characterizing nanomaterials ISO TC 229/ WG3 and WG4 http://bit.ly/1g3IMvC.
For clarification, it is worth reiterating the EC requirements around novel foods and food ingredients into which nanomaterials fall. The term “Novel foods and food ingredients” generally refers to products which were not consumed in the European Union (EU) to a significant degree before 15th May 1997, i.e. before the current Regulation entered into force.
These products must be:
- Safe for consumers
- Properly labelled to not mislead consumers
Also: “To market a novel food or ingredient, companies must apply to a EU country authority for authorisation, presenting the scientific information and safety assessment report.
- The competent authority decides if additional assessment is necessary;
- It allows the marketing of the product if no additional assessment is necessary, and if the Commission and EU countries do not object.
- Before approving, the Commission asks the Standing Committee on Food Chain and Animal Health for an opinion.”
According to the same EC website on the subject (http://bit.ly/1BIzHk6): “Requirements for labelling of novel food and ingredients are additional to the general EU requirements on food labelling and where necessary, labelling of novel food and novel food ingredients may mention:
- Characteristics - composition, nutritional value, intended use;
- Materials which may affect the health of some individuals;
- Materials that give rise to ethical concerns.”
If adopted, the new regulations will encompass nanomaterial when the appropriate definition is approved and we will see “(nano)” appearing after nanoengineered ingredients on labels.
Currently, if a EU country considers a novel food, or ingredient, a risk to human or environmental health because of new information, it may suspend or temporarily restrict the marketing and use of any novel food or ingredient on their territory. In the current climate different attitudes towards nanomaterials across member states may result in an on-going degree of uncertainty in the industry. Typically, a country instituting national regulations will inform the Commission of their findings and concerns of risk and the Commission may either extend the national measures to all EU countries or asks that they are repealed. If food ingredients, previously used exclusively in food supplements, were given new uses in other foods, they would fall under the Novel Food Regulation and require authorisation.
It is important to understand what the Novel Food Regulation does not cover. It does not cover foods and ingredients for which an approval exists:
- Food additives within Regulation EC 1333/2008;
- Flavourings for use in foods within Regulation EC 1334/2004;
- Extraction solvents used in the production of foods within Directive 2009/32/EC - approximating EU countries' laws;
- GMOs for food and feed - Regulation EC 1829/2003;
By the end of April 2015, there should be a degree of clarity emerging in this area but I suspect that we will witness a prolonged period of uncertainty. As a result, companies may be hesitant to embark on new developments in nanotechnology based food ingredients whilst the picture across European member states is fragmented. Hopefully, the updated regulatory framework will resolve these issues sooner rather than later.