Draft Guidance for Industry: Action Levels for Lead in Juice | Guideline Explorer

Description

FDA is committed to reducing lead in food to the extent feasible. FDA’s Closer to Zero action plan is a science-based, iterative approach to decreasing toxic elements (such as lead) in foods over time, including by setting action levels. This guidance provides information to industry on the action levels for lead in juice. The action levels for lead in juice in this document would, if finalized, replace the current level of 50 parts per billion (ppb) described in the Guidance for Industry: Juice Hazard Analysis Critical Control Point Hazards and Controls Guidance (Juice HACCP Guidance), First Edition (Ref. 1). FDA considers the action levels described in this guidance to be achievable by industry (or you) when measures are taken to minimize the presence of lead.

Scope & Applicability

Product Classes

2

Apple juice

Specific juice type with a 10 ppb action level

Juice

Product category subject to FDA HACCP regulations.

Stakeholders

2

Juice Industry

FDA recommends that the juice industry continue to work to lower the lead concentrations

manufacturers

manufacturers are responsible for ensuring that their labels conform to all applicable FDA labeling laws

Regulatory Context

Attributes

1

interim reference levels

Levels for dietary lead used to inform action levels

Identified Hazards

Hazards

1

Microbiological contamination

Potential for contamination of covered produce; Known or reasonably foreseeable hazards in water

Related CFR Sections (5)

21CFR109.4§ 109.4 Establishment of tolerances, regulatory limits, and action levels.
(a) When appropriate under the criteria of § 109.6 , a tolerance for an added poisonous or deleterious substance, which may be a food additive, may be established by regulation in subpart B of this part under the provisions of section 406 of the act. A tolerance may prohibit any detectable amount ofRead 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 →
21CFR189.240§ 189.240 Lead solders.
(a) Lead solders are alloys of metals that include lead and are used in the construction of metal food cans.Read full regulation →
21CFR120.1§ 120.1 Applicability.
(a) Any juice sold as such or used as an ingredient in beverages shall be processed in accordance with the requirements of this part. Juice means the aqueous liquid expressed or extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or anyRead full regulation →
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 →