Nano definition must be pinned down, warns FSA

If a legal definition of nanomaterials is to be established, it must be more precise than what is currently on the table, the Food Standards Agency (FSA) has warned.

The FSA's comments came as the Council of Ministers reached an agreement on a proposed amendment to the Novel Food Regulation, which offers a definition of 'engineered nanomaterial' as: 'Any intentionally produced material that has one or more dimensions of the order of 100nm or less or is composed of discrete functional parts, either internally or at the surface, many of which have one or more dimensions of the order of 100nm or less, including structures, agglomerates or aggregates, which may have a size above the order of 100 nm but retain properties that are characteristic to the nanoscale.'

Dr Chris Jones, who heads up the FSA's novel foods additives and supplements division, said: "We cautiously support the proposed approach that there should be a definition for nanomaterials and that all nanomaterials which fall within this definition should undergo a pre-market safety evaluation.

"However, we have reservations that the proposed definition lacks clarity and would prefer a more precise definition that will assist enforcement bodies and reduce uncertainty for operators."

The Council document - which reflects the view of Member States and the EU presidency, will in due course be formally adopted as a 'common position'. It will then be sent to the European Parliament for a second reading towards the end of this year, which means it could be adopted by spring 2010.

As the composition of the Parliament has just changed, however, it was quite possible that the new set of MEPs would propose substantial changes, which could set the whole process back several months, said Dr Sandy Lawrie, head of the FSA's novel foods branch.

According to the Council, there is agreement amongst Member States on all of the key aspects of the proposed amendment, which aims to streamline the authorisation procedure for novel foods; create an accelerated procedure for traditional foods from third countries and protect applicants' proprietary
data in order to stimulate innovation.
The proposed amendment has been broadly welcomed by industry associations, which claim the current authorisation procedure for novel foods is time-consuming, costly and unfair, with the average application taking three years to gain approval and some taking five years.