scholarly journals Safety assessment of the substance zinc oxide, nanoparticles, for use in food contact materials

EFSA Journal ◽  
2016 ◽  
Vol 14 (3) ◽  
Author(s):  
Keyword(s):  
Zinc Oxide ◽  
Zinc Oxide Nanoparticles ◽  
Safety Assessment ◽  
Oxide Nanoparticles ◽  
Contact Materials ◽  
Food Contact Materials ◽  
Food Contact

scholarly journals Safety assessment of the process Reco‐Kavala, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

EFSA Journal ◽  
2019 ◽  
Vol 17 (10) ◽  
Author(s):  
◽  
Vittorio Silano ◽  
José Manuel Barat Baviera ◽  
Claudia Bolognesi ◽  
Andrew Chesson ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Contact Materials ◽  
Food Contact Materials ◽  
Food Contact

scholarly journals Safety assessment of the substance ‘Tungsten Oxide’ for use in food contact materials

EFSA Journal ◽  
2017 ◽  
Vol 15 (1) ◽  
Author(s):  
◽  
Vittorio Silano ◽  
Claudia Bolognesi ◽  
Jean‐Pierre Cravedi ◽  
Karl‐Heinz Engel ◽  
...  
Keyword(s):  
Tungsten Oxide ◽  
Safety Assessment ◽  
Contact Materials ◽  
Food Contact Materials ◽  
Food Contact

scholarly journals Utility of generational developmental and reproductive toxicity and juvenile animal study protocols for the infant safety assessment of food contact materials

2018 ◽  
Vol 2 ◽  
pp. 239784731880604
Author(s):  
April Neal-Kluever ◽  
Queenster Nartey ◽  
Jason Aungst ◽  
Federica Basso ◽  
Karen Davis-Bruno ◽  
...  
Keyword(s):  
Animal Study ◽  
Safety Assessment ◽  
Food Additives ◽  
Chemical Exposure ◽  
Contact Materials ◽  
Food Contact Materials ◽  
Food Contact ◽  
Juvenile Animal ◽  
Study Protocols ◽  
Infant Safety

The US Food and Drug Administration (FDA) Division of Food Contact Notifications (DFCN) performs infant lifestage-specific exposure and safety assessments during the premarket review of FCNs proposed for use with infant formula or human milk. DFCN previously identified two protocols that may be best suited to support infant safety: the multigenerational developmental and reproductive toxicology (Gen-DART) protocol and the juvenile animal study (JAS) protocol. The Gen-DART protocol tests chemical exposure from prior to mating through one or two generations in rodents, while JAS protocols test a chemical during a specific developmental window. At FDA, Gen-DART studies are currently recommended to support the safety of food additives (FAs), including food contact substances, across lifestages (from conception through adulthood). JAS protocols are recommended in the nonclinical safety assessment of drugs seeking pediatric indications. To improve our recommendations regarding the use of either Gen-DART or JAS protocols for the infant safety assessment of food contact materials, we created a database of FDA-reviewed Gen-DART or JAS. Our database contains information from 41 Gen-DART studies (38 FAs) and 51 JAS (29 drugs). Both protocols can detect toxicity relevant to infant safety assessment, such as developmental toxicity in neurological, endocrine, reproductive, immunological, or skeletal systems. Selection of either protocol will depend on the amount of information available for the chemical under study. The Gen-DART protocol may be preferred when limited data on the mode of action or target organ of the chemical are available. However, if these data are available, a JAS may provide the best assessment of potential juvenile toxicity.

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