Baby Food Council Laboratory Listing

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Listing of proficient laboratories on behalf of the Baby Food Council for the analysis of As, Cd, and Pb in foods at low levels, hosted by Fapas^®

Introduction

In 2022, Fapas^® was invited to host this laboratory listing on behalf of the Baby Food Council. This follows the successful operation of Fapas^® proficiency tests to establish the capability of laboratories for the quantitative analysis of specific heavy metal residues in vegetable purées at low concentrations. The laboratories meet certain criteria in order to be listed but the listing does not imply any endorsement of these laboratories either by Fapas^® or the Baby Food Council, nor is it any guarantee of their performance. The laboratories listed provided sufficient information to meet the criteria for listing at the time of the assessment and it is with their permission that they are listed here. The laboratories cannot be identified in any Fapas^® reports.

Analysis of baby food ingredients

The food industry regularly tests foods for heavy metals, including arsenic, cadmium and lead. These contaminants commonly occur naturally or from pollution in the environment. Both organic and conventional crops alike will absorb heavy metals from soil and water. Their presence in baby food raises a concern because babies are more sensitive to their harmful impacts at this early developmental stage. There is no known safe level of exposure to these metals; even low levels of contamination are a concern.

Baby food manufacturing companies, their suppliers, and the food safety agencies that oversee them need reliable, relevant results from laboratory tests to determine if ingredients meet legislated and internal limits. The Baby Food Council has previously found that laboratory proficiency and reporting practices for heavy metals testing are highly variable and can lead to false assurance that an ingredient does not contain the substances. For example, a test result indicating “Below reporting limit” or “0.0” from a laboratory with a high Limit of Quantitation (LOQ) can result in a faulty conclusion that the tested ingredient is appropriate for baby food even when its metals levels are relatively high.

The Baby Food Council developed four criteria to identify laboratories that were proficient at quantifying arsenic, cadmium, and lead at low levels of concern.

To be accredited to ISO 17025:2017, General requirements for the competence of testing and calibration laboratories.
Use an analytical method at least as sensitive as the US FDA’s Method EAM 4.7. In 2014 FDA updated its [1] Elemental Analysis Manual for Food and Related Products (EAM) by adding new [2] Method 4.7 that uses inductively-coupled plasma and mass spectrometry (ICP-MS) as its most sensitive analytical method. Pursuant to [3] FDA Guidelines the Limit of Detection (LOD), the minimum concentration of a substance that can readily be distinguished from zero, for arsenic, lead, and cadmium was 1.3, 1.2, and 0.4 µg/kg respectively. The LOQ, the minimum concentration of a substance that be quantified with acceptable precision, for arsenic, lead, and cadmium was 11.6, 10.9, and 3.7 µg/kg respectively.
Demonstrate proficiency in quantifying each of arsenic, lead, and cadmium to at least 6 µg/kg in relevant Fapas^® [4] proficiency tests. This is a continuation of the programme of proficiency tests initiated by the Baby Food Council in early 2020 to evaluate laboratories that volunteered to participate in a study by analysing four blinded samples of common pureed baby food ingredients prepared by Fapas^®. Proficiency means that laboratories achieve a z-score ≤ ±2. A redacted report of the initial proficiency test is available [5].
Provide a written report of its results at these levels. For the results to be useful as a best practice to identify and resolve potential problems, the Baby Food Council determined that a listed laboratory should report: a) a numerical result for any level at or above 6 µg/kg (though it can go lower); and b) identify both its LOD and LOQ. This is equivalent to the highest FDA LOQ and similar to the levels found in Fapas^®’ spiked samples to which the laboratory demonstrated proficiency. If a laboratory’s LOQ is above 6 µg/kg, it would have the option to report results between the LOD and LOQ as an estimated value.

Continuation of laboratory listing

Laboratories that continue to be listed are required to undertake an annual Fapas^® proficiency test that meets the quantification, LOD and LOQ requirements defined above. Fapas^® will include such a proficiency test in its annual scheduled programme. The Baby Food Council may choose to add further relevant proficiency tests that are not advertised in the Fapas^® annual scheduled programme. If a laboratory wishes to become listed and the next relevant Fapas^® proficiency test is not available within the desired timeframe, Fapas^® will provide Proficiency Assessment on Demand (PAD) [6] in order that the candidate laboratory can meet the qualification criteria.