Table 5.
Several key regulation and legislation.
| Year | Policy (change/update) | Reference |
|---|---|---|
| 2011 | “Official” definition of nanomaterial. | EU Commission Recommendation [164], available at https://ec.europa.eu/research/industrial_technologies/pdf/policy/commission-recommendation-on-the-definition-of-nanomater-18102011_en.pdf |
| 2011 | Provide data on the stability of the nanomaterials in the proposed formulations and under the proposed conditions of use (in feed). | FDA final guidance [165], available at https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM401508.pdf |
| 2012 | Mandatory labelling for nano-ingredients in food introduced in labelling Regulation, Labelling applicable from December 2014 | Second Regulatory Review on Nanomaterials (by EU) [166], available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52012DC0572&from=EN |
| 2012 | Evaluation of REACH registration dossiers concerning nanomaterials prioritised by ECHA for compliance check. Substance of the “CoRAP” list includes silicon dioxide (NL 2012), silver (NL 2013) and titanium dioxide (F 2014). | Second Regulatory Review on Nanomaterials (by EU) [166] |
| 2012 | Assess the coverage of nanomaterials in environmental legislation such as waste, water and air legislation. | EU MEMO [167], available at http://europa.eu/rapid/press-release_MEMO-12-732_en.htm?locale=en |
| 2012 | Case-by-case safety evaluation for nanomaterials. | EU Press Release [168], available at http://europa.eu/rapid/press-release_IP-12-1050_en.htm?locale=en |
| 2014 | FDA does not categorically judge all products containing nanomaterials (or involving application of nanotechnology) as intrinsically benign or harmful. | Final guidance for industry, by FDA [169], https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM616225.pdf |
| 2017 | Taiwan FDA considers nanomaterials as new food contact substances and enforces food packaging nanomaterials to go through safety assessment and obtain pre-market approval. | Taiwan FDA guidelines (in Chinese), available at https://www.fda.gov.tw/TC/newsContent.aspx?id=21901&chk=8b47bc84-e1c1-4c36-b410-4ff637bf7f05¶m=pn&cid=3&cchk=46552e96-810a-42c3-83e1-bd5e42344633#.WMqh0zuLS71 |