Where vitamins, minerals or other substances used in accordance with Directive 2002/46/EC, Regulation (EC) No 1925/2006 or Regulation (EU) No 609/2013 result from a production process not used for food production within the Union before 15 May 1997, which gives rise to significant changes in the composition or structure of a food, affecting its nutritional value, metabolism or level of undesirable substances, or where those vitamins, minerals or other substances contain or consist of engineered nanomaterials, they should also be considered novel foods under this Regulation and should be re-assessed first in accordance with this Regulation and subsequently in accordance with the relevant specific legislation.
I gcás gurb ann do vitimíní, mianraí nó substaintí eile a úsáidtear i gcomhréir le Treoir 2002/46/CE, Rialachán (CE) Uimh. 1925/2006 nó Rialacháin (AE) Uimh. 609/2013 mar thoradh ar phróiseas táirgthe nár úsáideadh do tháirgeadh bia laistigh den Aontas roimh an 15 Bealtaine 1997, agus a n-eascraíonn athruithe suntasacha ar chomhdhéanamh nó ar struchtúr an bhia as a dhéanann difear do luach cothaitheach an bhia, dá mheitibileacht nó do chion na substaintí neamh-inmhianaithe atá ann, nó i gcás nana-ábhair a ndearnadh innealtóireacht orthu a bheith sna vitimíní, mianraí nó substaintí eile sin nó iad a bheith déanta de nana-ábhair a ndearnadh innealtóireacht orthu, ba cheart iad a mheas mar bhianna núíosacha freisin faoin Rialachán seo agus ba cheart iad a athmheasúnú ar dtús i gcomhréir leis an Rialachán seo agus ina dhiaidh sin i gcomhréir leis an reachtaíocht shonrach ábhartha.