The latest regulation applies EU-wide, and introduces a revised definition for nanomaterials

On November 16th, 2015, the Council of the European Union adopted the new ‘novel food’ regulation, as was approved by the European Parliament on October 28th, 2015. This newly approved European Union ‘novel food’ proposal updates a 20 year-old regulation, and clarifies the categories of foods that constitute novel foods, including specific reference to nanomaterials. Novel foods are those that were not consumed by humans in significant amounts within the EU prior to 15 May 1997. The new regulations stipulate that all engineered nanomaterials will require a novel food authorization at the EU level before being used in foodstuffs.

A new definition for engineered nanomaterials has been established that will apply to all areas of E.U. food law, replacing the former definition in EC regulation 1169/2011 (food labelling). The new definition reads:

“Engineered nanomaterial means any intentionally produced material that has one or more dimensions of the order of 100 nm or less or that is composed of discrete functional parts, either internally or at the surface, many of which have one or more dimensions of the order of 100 nm or less, including structures, agglomerates or aggregates, which may have a size above the order of 100 nm but retain properties that are characteristic of the nanoscale. Properties that are characteristic of the nanoscale include: (i) those related to the large specific surface area of the materials considered; and/or (ii) specific physico-chemical properties that are different from those of the non-nanoform of the same material.”

This definition replaces the former definition, which stated: “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’ (EC regulation 1169/2011)

The revised definition may be updated and adjusted to keep up with technical and scientific progress via a delegated act. There is concern surrounding the new definition, especially regarding the unclear term “discrete functional parts”.

To ensure harmonization, the European Food Safety Authority (EFSA) will perform all assessments. EFSA found that existing information on nanotoxicokinetics and toxicology is limited and that modifications on existing methods may be necessary. Therefore, applicants will be required to submit scientific assessments and details on test method adaptations used specifically for nanomaterials. The regulation also states that EFSA will verify that the “most up-to-date methods” are used to assess the safety of nanomaterials. demand may cause uncertainty and further burden, as there are few explicit guidelines regarding the “most up-to-date” methods.

EFSA will still consider whether the novel food poses a safety risk, and whether it is as safe as a food in a comparable food category already in the market. In accordance with Directive 2010/63/EU, animal testing should be replaced, reduced, or refined where possible. Once a novel food is authorized, it can be sold in any EU member state, and will be placed on a list of novel foods that are transparent and easily accessible.

The regulation is intended to speed up authorization; the current length is approximately 3.5 years. Newly developed scientific evidence and proprietary data will not be able to be used for the benefit of another application for 5 years after novel food authorized without the agreement of the initial applicant.

The regulation must still be formally published in the EU’s Official Journal and will then enter into force 20 days later.

The new regulation:

• http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:PE_38_2015_REV_1&rid=3
• http://data.consilium.europa.eu/doc/document/PE-38-2015-INIT/en/pdf
• http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+TA+P8-TA-2015-0380+0+DOC+PDF+V0//EN
•  http://www.consilium.europa.eu/en/policies/novel-foods/