Infant and Child Foods: HMTc Program Manual

Governing Principles

The five objectives are co-equal. None may be sacrificed to advance another. Cited from docs/governance/hmtc-governing-principles.md (the ruling named in the readiness manifest).

Program lifecycle and statuses

A SKU enters by baseline testing, is assigned a status, and stays under surveillance for as long as the mark is used. Status attaches to the product, not the brand. A product is Certified only when every one of the eight limit analytes is at or below 100% of its published limit, the government floor or disclosed read-across for that cell, confirmed under the measurement-uncertainty rule. There is no band above the limit that still earns the mark.

Certified is the only status that carries the mark. A lot in violation of a government legal limit at entry is a hard stop; a lot above any published HMTc limit is not certified and enters Remediation.

Tiering sets how hard and fast the program reacts to an exceedance, never permission to exceed a limit and keep the mark. Tier 1 (Pb, Cd, iAs, mercury as tHg) is zero-tolerance: the most severe reaction. Tier 2 (Ni, Al, Sn, Cr) still bars the mark and enters Remediation, at an elevated rather than immediate hard-stop reaction. Any quantifiable Cr(VI) on a credible pathway is a hard fail, treated as Tier 1. No metal has a transitional band or an allowed overage.

Mark, measurement uncertainty, CAPA, remediation, ratchet

The mark

The mark may be used only on Certified product: every analyte at or below 100% of its published limit. A product in Remediation carries no mark, at any margin and on any metal, and is not listed as certified while any analyte is above its limit. Suspension and Revocation remove the mark. Claims of heavy-metal free, no toxic metals, or 100% safe are prohibited. The mark certifies testing against published limits under ongoing surveillance; it does not certify safety.

Measurement uncertainty

Every result is read with the laboratory's expanded measurement uncertainty at coverage factor k = 2 (95%). Pass only when (result + MU) ≤ limit. Fail when (result − MU) > limit. Anything between is borderline and requires confirmatory action before status issues. A borderline result alone shall not certify. Testing into compliance is prohibited.

CAPA

A Tier 2 exceedance in Remediation has a 12-month default to return to Certified. A CAPA closes only after verification of effectiveness and Operator approval.

Remediation

The Confidential Remediation Track is a confidential entry-and-support pathway for products not yet at 100% of every published limit. It is expressly not a certified status and displays no mark. After certification, Corrective Action follows the published status rules. Concealment of a known exceedance is grounds for revocation. Confidentiality never delays a recall, never overrides a reporting duty, and never withholds evidence from a regulator who asks.

Standards ratchet

A published limit tightens only through the Standards Ratchet: a stated trigger, a capped step, and a dated edition. Limits do not loosen because a brand found them inconvenient. The subcategory page, not this manual, is the live derivation of each cell.

Lot Testing Schedule

Certification is a standing obligation. Totals are run on every completing lot. Speciation is a pathway reflex, not an extra panel seat. Risk tier and the surveillance schedule are assigned after application, from the brand's laboratory capability as well as the product class.

Product risk tiers

These are the nine subcategory standard pages of the live Infant and Child Foods taxonomy. The Program Operator may raise a specific SKU (for example a rice-based teething product) on documented rationale.

Baseline frequency matrix

This grid is the starting point, not the assigned schedule. Certified is the only status that carries the mark; Remediation carries none. Reaction severity follows the tier of the exceedance and the brand's conduct, never an allowed overage: any Tier 1 exceedance, any quantifiable Cr(VI), or a concealment concern takes the every-lot, Operator-directed row regardless of risk tier.

Baseline

Every SKU is tested across three distinct production lots on the full eight-total panel, with required pathway speciation, before any status is assigned. Status is taken from the worst-performing lot. A single passing lot certifies nothing. Qualifying ISO/IEC 17025 prior data from the preceding twelve months may credit up to two lots, per analyte actually measured. That pathway is not available on the Confidential Remediation Track.

Reflex

A new ingredient, supplier, origin, water source, product-contact equipment, packaging, formulation, or process change triggers a full-panel reflex on the next one or two lots. A Tier 1 result at or above 80% of its limit triggers confirmatory testing, Operator notice, and speciation where a speciated form applies.

Speciation

Species ≤ parent. The speciated result does not replace the parent total; both ceilings must be met. Failure to perform a required speciation renders the lot ineligible. The Operator may lower the 50% trigger and shall not raise it.

Sampling and chain of custody

Certification testing is lot-based composite sampling with a complete custody record from collection through laboratory receipt. A custody breach invalidates the result. Testing is ISO/IEC 17025 for the methods and matrices in scope. The LOQ for each claim-surface analyte must sit at or below the published limit; where it does not, a non-detect is indeterminate. Results are reported as structured data, with MU, on the finished-product basis. PDF-only submissions are not accepted.

Lab-informed schedule

The frequency matrix is not assigned by itself. After application, the Program Operator reads what the brand's laboratory actually states and writes the schedule from that evidence.

A brand is not certified against a fantasy grid. If the laboratory cannot support the published panel, LOQ, MU, or pathway speciation, the SKU stays uncertified until the capability exists.

90% stay-in-program certification gate

The program certifies only if there is at least 90% confidence the brand can remain in the program. A one-lot pass that will fail the next surveillance cycle is not a certification. This gate protects brands who enter as much as it protects consumers: entering a program the brand cannot keep is a harm.

Cat-1 Standards Register

Every Cat-1 compiled record and every live subcategory page. Cert-ready means the live page carries a house DOI under prefix 10.83138 and every joined compiled variant has a complete claim-surface (Big-8 totals numeric; rice rows have numeric iAs; species ≤ parent). Incomplete cells stay listed as not cert-ready. This table is generated from the compiled corpus and page frontmatter; it is not typed.

Claim-surface panel: the eight totals (Pb, tAs, Cd, tHg, Ni, Sn, Al, Cr). Species (iAs, MeHg, Cr-VI) are pathway reflexes and never replace the parent. Rice and rice-derived infant cereals require numeric iAs. A blank claim-surface cell is HOLD, not cert-ready.

About this edition

This is Manual v3, the Method v2 governing instrument for Category 1. It supersedes the earlier deposited Zenodo edition 10.5281/zenodo.20771543 (concept DOI 10.5281/zenodo.20270511). That earlier deposited edition never certified a brand. V1 is retired. It remains citable only as an earlier deposited edition.

House mint, when the CEO deposits live, uses suffix hmtc.manual.infant-and-child-foods under prefix 10.83138 (Fabrica VAJU.HDAWAI). This page does not invent that DOI.