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Guidance for Industry: Action Level for Inorganic Arsenic in Rice Cereals for Infants

FinalHuman Foods Program08/04/2020

Description

This guidance provides information to manufacturers on the action level[2] for inorganic arsenic in rice cereals for infants (hereafter referred to as infant rice cereals) that is intended to help protect public health by reducing infants’ dietary exposure to inorganic arsenic and is achievable by industry with the use of current good manufacturing practices. This guidance applies to all types of infant rice cereals.

Scope & Applicability

Product Classes

2
Infant Rice Cereals

The primary product category covered by this guidance

Rice Cereals for Infants

Guidance provides information to manufacturers on the action level for inorganic arsenic in rice cereals for infants.

Stakeholders

2
Manufacturers

Responsible for declaring acceptable market names on labels.

Manufacturer

Entity responsible for submitting NDINs

Identified Hazards

Hazards

2
Microbiological Contamination

Environmental factors affecting biological products

Environmental Contamination

Arsenic is an element that occurs in the environment from natural and manmade sources.

Related CFR Sections (2)

See Also (3)

Guidance for Industry: Action Level for Inorganic Arsenic in Rice Cereals for Infants | Guideline Explorer | BioRegHub