1) The most relevant regulation regarding microsystems implementations in the food sector is the legislation on food contact materials (EC regulation no. 1935/2004 and 2023/2006, plus the legislation on specific materials). This regulation applies to microsystems directly in contact with food: for example in the case of a polymer-packaged sensor used for in-line monitoring of processes, the system has to comply with the regulation on plastic materials, which means that the components and additives of the polymer should be authorised and migration limits of the material should be respected.
2) Another relevant regulation is the no. 450/2009 on active and intelligent materials and articles intended to come into contact with food. This regulation applies when the use of microsystems is intended in packaging. In that case of intelligent packaging application, a dossier for safety evaluation will have to be submitted to EFSA to comply with the regulation 450/2009.
3) In some specific cases, the regulation on Novel Foods 258/97 may apply: in the specific case of micro-devices that enable new product and/or process innovation (for example micro-emulsification devices), the product will need to be evaluated by EFSA.
4) In conclusion microsystems should be evaluated case by case according to the nature of the microsystem materials in contact with food and their intended use. Other aspects such as end of life and waste management of microsystems should also be considered.
D3.4 Report on the EU regulatory situation of Microsystems in the food sector (main author: Fraunhofer IME)
EU Regulatory situation