Guidance for Industry: Action Levels for Lead in Processed Food Intended for Babies and Young Children | Guideline Explorer

Description

FDA is committed to reducing lead in food. FDA’sCloser to Zeroinitiative is a science-based, iterative approach to decreasing toxic elements, including lead, in foods over time, including by setting action levels. The purpose of this guidance is to provide information to industry on the action levels for lead in processed food intended for babies and young children (i.e., those less than two years old). FDA considers the action levels described in this guidance to be achievable by industry when control measures are taken to minimize the presence of lead. Although action levels are levels at which FDA may regard a food as adulterated, ourCloser to Zeroinitiative outlines other actions we will take to further reduce lead (as well as other toxic elements) in food and our expectation is that industry will strive for continual reductions over time.

Scope & Applicability

Product Classes

4

Processed Food Intended for Babies and Young Children

Scope of the guidance including purees and dry infant cereals; Scope of the action levels for lead

Dry infant cereals

Specific category of processed food with a 20 ppb action level; processed foods into the following food categories: dry infant cereals; Specific food category with a 20 ppb action level; Category of processed food intended for babies and young children

Single-ingredient root vegetables

Specific category including carrots or sweet potatoes with a 20 ppb action level; Single-ingredient root vegetables had a mean of 8.2 ppb; Specific food category with a 20 ppb action level; Category of processed food with specific action levels

Processed foods intended for babies and young children

this guidance addresses processed foods intended for babies and young children

Regulatory Context

Attributes

5

90th Percentile Lead Exposures

Statistical measure used to estimate dietary exposure

IRL for lead

Interim Reference Level of 2.2 µg/day for children

Achievability

Percentage of samples meeting the proposed action levels

Interim reference levels

Reference levels for lead exposure in children and women

Interim Reference Level

IRL for lead of 2.2 µg/day for children

Identified Hazards

Hazards

2

Lead exposure

Public health concern regarding brain and nervous system development

Dietary lead exposure

reduce dietary lead exposure while also considering achievability

Related CFR Sections (2)

21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
21CFR109.6§ 109.6 Added poisonous or deleterious substances.
(a) Use of an added poisonous or deleterious substance, other than a pesticide chemical, that is also a food additive, will be controlled by a regulation issued under section 409 of the act when possible. When such a use cannot be approved under the criteria of section 409 of the act, or when the adRead full regulation →