On September 11, 2013, the European Commission (EC) submitted to the World Trade Organization (WTO) a proposed regulation amending Regulation 1169/2011 concerning the provision of food information to consumers as regards the definition of engineered nanomaterials (ENM). The proposed regulation states that since the regulation refers to ENMs and not nanomaterials in general, natural and incidental nanomaterials should not be included in the definition. The proposed regulation states further that “it is appropriate to link the definition of ‘engineered nanomaterials’ to intentionally manufactured material, which should be explicitly defined.”

The proposed regulation includes the following statements:

(11)      Certain food additives included in the Union lists as established by Commission Regulations (EU) No 1129/2011 and (EU) No 1130/2011 could be in the form of ‘engineered nanomaterial’ in the final food. However, indicating such food additives in the list of ingredients preceded by the word ‘nano’ may confuse the consumers as it may suggest that those additives are new while in reality they have been used in foods in that form for decades.

(12)      Taking into account the potential risk of confusing consumers, food additives included in the Union lists by Regulations (EU) no 1129/2011 and (EU) No 1130/2011 should not be mandatorily qualified as ‘nano’ in the list of ingredients and should therefore not be covered by the definition of engineered nanomaterials. The need for specific nano-related labelling requirements relating to those additives should be addressed in the context of the re-evaluation programme, by amending, if necessary, the conditions of use in Annex II to Regulation (EC) No 1333/2008 and the specifications of those food additives, set out in Commission Regulation (EU) No 231/201215. That exception should not apply to food additives inserted in those lists at a later date, including new entries pursuant to Article 12 of Regulation (EC) No 1333/2008.

(13)      The number based size distribution threshold of 50% should be replaced by a threshold between 1% and 50% in the future in light of technological developments concerning detection and quantification methods and where warranted by concerns for health and safety.