| | Sl. no. | Country | Regulation on nanomaterials |
| | 1 | EU | Guideline (EU) No. 10/2011 with changes and rectifications indicated in Regulation (EC) 2016/1416 is a structured guideline that conceals all resources and training planned to originate into contact with food (Commission Regulation (EU) 2016/1416, 2016). In this specific guideline, just a single proviso explicitly specifies nanoforms measurable to be utilized as added substances in all plastics. It expresses that substances in the nanoform will possibly be utilized if the nanoform is unequivocally approved and referenced in the details of Annex I of the guideline. In EU 10/2011, titanium nitride is named as an NM for use as an added substance or polymer creation with the help of Annex 1; however, “covered and uncoated ZnO for use in the unplasticized polymer” has been included in the change. What is more, carbon dark and nebulous SiO2 are recorded without being explicitly named as “nanoparticle” but with sizes reached determined, which are underneath or around 100 nm, while, in the corrected variant, another material which is silanated silicon dioxide with essential particles of 1–100 nm is permitted when the particles are accumulated to a size of 0.1–1 μm and shape agglomerates inside the size circulation of 0.3 μm. The changes mirror the openness of new data on the security of NMs, and in this way, further revisions or adjustments will be expected as more specialized and well-being appraisal on NMs is accomplished. | | 2 | FDA | Multiple governmental agencies, including the Environmental Protection Agency (EPA), the FDA, the Occupational Safety and Health Administration (OSHA), and the Consumer Product Safety Commission (CPSC), in the United States, have been part of the decentralized approach toward the regulation of NT to provide the regulatory oversight responsibility for NT regulation. Basic regulations regarding the evaluation of the safe use of nanomaterials remain effective, whereas the proposed guidance has been amended several times later. For example, guidance proposed by the EFSA was first issued in 2006, then modified in 2009 and 2011, and we have the up-to-date version, known as “NT applications in the agricultural, feed and food sector.” | | 3 | Japan | In Japan, several governmental agencies including the several ministries (MEXT, METI, MHLW, and MOE) make regulatory decisions cooperatively. However, regulations on the safety issues of nanomaterials or NT remain mostly unclear. As recently as January 2016, the MHLW issued new safety standards for agriculture and food in the 190th Conference for the Promotion of Food Import Facilitation report. Nevertheless, the report did not include any specifications on NT or nanomaterials. | | 4 | Australia and New Zealand | Currently, the utilization for new food substances manufactured with NMs or by means of NT is evaluated under existing Australian and New Zealand laws and standards. Food Standards Australia New Zealand (FSANZ) is an independent standard developing agency of the Australian government, established by the FSANZ Act, for developing food regulatory measures. A variety of approaches have been adopted by FSANZ to assess and manage hazardous risks associated with food nanoingredients or packaging nanomaterials. Working together with other Australian regulatory agencies, the Application Handbook, which provides practical guidance for application to FSANZ, was amended in 2008 to incorporate the application information for the use and approval of food NT, considering thorough risk assessment as a required component. Through such legislation advancement, the food NT industry has to observe new regulations and ensure public health and safety with the production and use of novel nanomaterials.
In addition, a Scientific NT Advisory Group (SNAG), with experts from NT, nanotoxicology, and nanosafety, was also established by FSANZ to advise the safe application of food nanomaterials. | | 5 | India | Food safety laws in India are currently under the existing Food Safety and Standards Act, established by the Food Safety and Standards Authority of India (FSSAI). The launch of the Nano Mission, a Mission Mode Program within the Department of Science and Technology (DST), steered by a Nano Mission Council (NMC), stimulated concerns over the potential health and environmental risks associated with NT. Regulatory efforts regarding novel nanomaterials in the food industry have been advocated to offer scientific support and legal guidance for the public concerns about the regulation status on NT. In 2015, the Insecticides (Amendment) Bill in the Lok Sabha was aimed at limiting the registration to nanoinsecticides, with a mandatory requirement for assessing and reporting the potential risks of the nanoinsecticides on humans and the environment. With a comprehensive review on reports from regulatory agencies such as the ISO, the OECD, the US National Institute for Occupational Safety and Health (NIOSH), and the OSHA, the DST issued a guidance document in 2016 to provide information for the safe use and disposal of manufactured nanomaterials in research and industries. | | 6 | China | In China, the National Center for Nanoscience and Technology (NCNST), founded in March 2003, has the responsibility for establishing national NT standards. Protocols for characterization of nanomaterials and safety requirements for manufacturing then started to develop. In 2005, the Commission on NT Normalisation, connected with the NCNST, was founded and began to regulate nanomaterial engineering and production and safety assessment. However, the current code is still based on the China national standard at that time, and there is no clear legislation regarding a specific nanomaterial or any NT associated with the food and agricultural sectors. |
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