> ## Documentation Index
> Fetch the complete documentation index at: https://docs.extractoseum.com/llms.txt
> Use this file to discover all available pages before exploring further.

# Regulatory traceability — from seed to product

> How EXTRACTOS EUM® legally operates each link in the industrial hemp ≤1% THC supply chain in Mexico: constitutional framework, SCJN case law, Art. 245 LGS, COFEPRIS criteria, DIGIPRIS notices, and per-batch Smart COA.

> The complete chain —**seed → cultivation → raw material → manufacturing → final product**— and the legal
> foundation that backs each link. It's the map that lets a seller understand *which activity is backed, under
> what condition, and with what verifiable citation*. *Informational content; it does not constitute legal
> advice.*

***

## The constant that ties the whole chain together

At each link, lawfulness rests on **three inseparable conditions**. If any one is broken, the coverage
collapses:

1. **THC concentration equal to or below 1%** — documented per batch (Art. 245 fracc. V LGS).
2. **Broad industrial uses**, for purposes **other than medical and scientific**.
3. **Monitoring, control, and security measures** that prevent diversion of the plant.

## Root legal foundation

The strategy rests on the fact that the **Supreme Court of Justice of the Nation (First Chamber)** declared
the *absolute prohibition* of industrial hemp unconstitutional:

* **Case law 1a./J. 99/2022 (11a.)** — *digital registry 2025003*: the prohibition of sowing, harvesting, and
  cultivating cannabis at concentrations **≤1% THC**, with broad industrial uses and purposes other than
  medical/scientific, *prima facie* affects **freedom of commerce**.
* **Case law 1a./J. 96/2022 (11a.)** — *digital registry 2025005*: that prohibition **is not a necessary
  measure** to safeguard health or protect public order; there are equally suitable alternative measures that
  affect freedom of commerce to a lesser degree.

Verifiable by registry number in the **Semanario Judicial de la Federación** (sjf2.scjn.gob.mx).

### Supporting legal basis (text in force)

| Provision | What it establishes |
| - | - |
| **Art. 245, fracc. V, last paragraph, LGS** | "Products containing cannabis derivatives at concentrations of 1% or less of THC and having broad industrial uses may be commercialized, exported, and imported in compliance with the requirements established in health regulation." |
| **Art. 5º of the Constitution** | Freedom of work, profession, industry, and commerce (when lawful). |
| **Art. 8º of the Constitution** | Right of petition — the basis for freely drafted submissions to COFEPRIS. |
| **Art. 200 bis LGS** | Operating notice for establishments that commercialize. |
| **Art. 25 RCSPS** | Identification/traceability label (denomination, manufacturer/importer/distributor, storage, expiration, and **batch**). |

Full and official text at [LeyesBiblio (Chamber of Deputies)](https://www.diputados.gob.mx/LeyesBiblio/index.htm):
[LGS](https://www.diputados.gob.mx/LeyesBiblio/pdf/LGS.pdf) · [CPEUM](https://www.diputados.gob.mx/LeyesBiblio/pdf/CPEUM.pdf) · [CPF](https://www.diputados.gob.mx/LeyesBiblio/pdf/CPF.pdf).

## The value chain and its coverage

Each phase has a foundation. This is how the chain reads, from seed to shelf:

| # | Link | Activity | Condition for it to be lawful |
| - | - | - | - |
| 1 | **Seed** | Import and commercialize hemp seed of lawful origin, ≤1% THC | Supplier's certificate of analysis ≤1% THC |
| 2 | **Sowing · cultivation · harvest** | Agricultural production with industrial uses | Monitoring, control, and phytosanitary/security measures (case law 99/2022 and 96/2022) |
| 3 | **Raw material import** | Industrial hemp, CBD, HHC as input | Fits within Art. 245 fracc. V LGS + COFEPRIS criteria; Art. 25 RCSPS label |
| 4 | **Manufacturing / transformation** | Process into chocolates, confectionery, food, candy, cosmetics, supplements | ≤1% THC documented; good practices (NOM-251) |
| 5 | **Final product / commercialization** | Sale of the finished product ≤1% THC | DIGIPRIS operating notice + traceability labeling + per-batch [Smart COA](../smart-coa.md) |

## Compliance conditions (mandatory throughout the chain)

The legal protection **is not unconditional**: it lives as long as these requirements are met. It's the
"contract" with the authority that keeps the operation within the law.

| Requirement | How it is evidenced |
| - | - |
| **≤1% THC** in raw material and product | Certificate of analysis **per batch**, issued by a laboratory with **ISO/IEC 17025:2017** accreditation (equiv. NMX-EC-17025-IMNC-2018), recognized by COFEPRIS |
| **Broad industrial uses**, non-medical and non-recreational purposes | Declaration of industrial destination; framing as input / supplement / cosmetic / food (registered SCIAN code) |
| **Monitoring, control, and security** | Cultivation/process logbook, phytosanitary and security measures to prevent diversion of the plant |
| **DIGIPRIS operating notice** | Notice in force (Art. 200 bis LGS) |
| **Traceability labeling** (Art. 25 RCSPS) | Denomination, manufacturer/importer/distributor, storage, expiration, and **batch** on each product |

## Catalog cannabinoids and their nature

| Substance | Type | Framing |
| - | - | - |
| CBD isolate | Purified natural cannabinoid | Raw material ≤1% THC |
| CBD broad spectrum | Natural multicomponent without THC | Raw material |
| CBD full spectrum | Natural with traces of THC | Raw material ≤1% THC |
| CBN · CBG | Natural cannabinoids | Present in finished product ≤1% THC |
| Δ9-THC | Natural tetrahydrocannabinol | **≤1% across the entire catalog** (Art. 245-V LGS) |
| Δ8-THC | Semisynthetic tetrahydrocannabinol | Finished product ≤1% THC |
| HHC (9S, 9R) | Semisynthetic hexahydrocannabinol | Raw material → manufacturing ≤1% THC |

## How the EUM system resolves it

The differentiator isn't "having an amparo" — it's that **each link is documented and traceable**, which is
exactly the *chain of custody* the law requires:

* **Per-batch traceability shield:** each product is linked to its [Smart COA](../smart-coa.md) —≤1% THC
  analysis from an ISO/IEC 17025 laboratory, with **QR** (contents/batch) and **CVV** (authenticity)— so that
  each piece is traceable back to its batch and its certificate. That is the evidence that neutralizes any
  accusation of diversion.
* **≤1% THC verified, not declared:** the analysis is done per batch and the number lives in the COA; it's
  not a marketing claim (anti-#9: the rule is enforced with real data, not with text).
* **Class-compliant label:** **Label Studio** generates the label (designer + templates + QR/CVV/barcode);
  the automatic compliance verification —layered on top— reads the product's class from
  `product_classes.json` and validates what the applicable NOM requires ([NOM-051 seals](sellos-nom051.md),
  legends, mandatory fields, INCI on cosmetics).
* **Claims under control:** `prohibitedClaims` blocks therapeutic/medicinal statements in any product class
  (Art. 79 of the Advertising Regulation of the LGS).

## Note on the scope of amparos (principle of relativity)

In Mexico, an amparo ruling protects **only the party that sought it** (Otero formula, Art. 107-II of the
Constitution). EXTRACTOS EUM®'s coverage protects **its own chain**. A third party (for example, an
agricultural producer) **is not automatically covered**: their protection derives from operating *documentarily
integrated within the authorized chain of EXTRACTOS EUM®* (as a documented supplier/contract manufacturer) or
from obtaining their own coverage. To shield an integrated producer, the following is recommended: a
supply/contract-manufacturing agreement, seed traceability (technical sheet + certificate of origin), a ≤1%
THC certificate per harvest batch (ISO/IEC 17025 laboratory), and a cultivation/security logbook.

## Sources

* **Constitution (CPEUM)** — arts. 5º, 8º, 107-II · **General Health Law (LGS)** — arts. 234, 235, 235 bis,
  245 (fracc. V, last paragraph), 247, 290, 200 bis · **Regulation on Sanitary Control of Products and
  Services (RCSPS)** — art. 25. Text in force at [LeyesBiblio](https://www.diputados.gob.mx/LeyesBiblio/index.htm).
* **SCJN case law**: 1a./J. 99/2022 (reg. 2025003) and 1a./J. 96/2022 (reg. 2025005), consultable by registry
  number at [sjf2.scjn.gob.mx](https://sjf2.scjn.gob.mx).
* **Laboratory accreditation**: ISO/IEC 17025:2017 (NMX-EC-17025-IMNC-2018).

*Last updated: 2026-08-01. Informational; it does not constitute legal advice. The amparo files and specific
notices of EXTRACTOS EUM® are internal documentation exhibited to the authority when required.*