Title : Regulatory safety assessment in the European Union of food additives containing nanoparticles
Abstract:
The European Union (EU) legislation contains provisions for nanotechnology and nanomaterials and a definition of nanomaterial is given in Commission Recommendation 2022/C 229/01. In the EU, the safety of substances proposed for use as new food additives as well as the re-evaluation of all food additives that were already permitted in the EU before 20 January 2009 is carried out by the European Food Safety Authority (EFSA). Since 2009, the re-evaluation of around 73% of the authorised food additives has been finalised, however some of them finished with data gap. When a food additive is already included in the Union list but there is a significant change for example in its production methods, in the starting materials used, or there is a change in the particle size of the material, the food additive must be subject to a new risk assessment. Since the risk assessment of materials that retain properties at the nanoscale during the use of the product needs special consideration of their physicochemical properties, toxicokinetics, potential uptake into cells and tissues and physiological fate, EFSA has issued Guidance documents that provide indications on how to identify if conventional risk assessment is sufficient or how to perform the safety assessment of nanomaterials. Within the programme of re-evaluation of permitted food additives, EFSA has identified some food additives for which a fraction of the material falls in the nano-range and their reevaluations were finalised recommending further data on the physicochemical characterisation (in particular particle size distribution) of the material used as a food additive. After a full characterisation of the material, the approach, this means if conventional risk assessment has to be complemented by nano specific aspects, is decided to complete the safety evaluation. The European Commission has an approach for the follow-up of the re-evaluation of permitted food additives for which some concerns or data gaps have been identified that implies the submission of the data needed for the completion of the risk assessment. The final decision on whether a food additive remains permitted for use in the EU will be taken by the EU risk managers based on the outcome of the EFSA’s final scientific assessment.
