M exican Official Standard NOM-012-SAG/ZOO-2020, Specifications for the regulation of products for animal use or consumption

On November 6, 2023, the Mexican Official Standard NOM-012-SAG/ZOO-2020, Specifications for the regulation of products for animal use or consumption (the “NOM-012”) was published on the Federal Official Gazette (the “DOF”). This new standard, which represents a modification and update of the 2004 regulation, is intended to establish the minimum requirements for the production, storage, distribution, commercialization, quality control, and verification processes that products for animal use or consumption must comply with, in accordance with the Federal Law of Animal Health and its Regulations.

The provisions of NOM-012 are applicable to facilities located within the Mexican territory that engage in the production, import, export, conditioning, storage, distribution, and marketing of products for animal use or consumption, including mobile facilities, maquila facilities, and all those that represent risks to animal health.

According to the transitory articles, NOM-012 is to be effective within 180 calendar days from the day following its publication. Additionally, a specific entry into force is foreseen for section (which determines a requirement for biological product labels). Therefore, NOM-012 will enter into force on May 5, 2024, and the obligations set forth under section will enter into force on November 7, 2025.

Key Highlights

– Storage:

+ Products and raw materials must have a quality control analysis granted by the supplier before entering the warehouse.

+ Warehouses must have the necessary infrastructure and equipment, including reception, sampling, and storage sites, to prevent any type of contamination, cross-contamination, or spoilage.

– Raw Materials:

+ All raw materials used in the manufacture of products must have a quality analysis document issued by the manufacturing or commercializing party, including imported raw materials.

– Manufacture:

+ The manufacturing area must comply with infrastructure and hygiene requirements, including requirements for physical isolation, sterilization, cleaning, and requirements regarding the personnel involved.

+ Each type of product must have a processing protocol and each batch must have a manufacturing order that allows traceability and tracking of the raw materials used and of the finished product.

+ Facilities that provide total or partial maquila services must comply with the provisions of NOM-012 and submit the maquila agreements to the Ministry of Agriculture and Rural Development (“SADER”), through the National Service for Agri-Food Health, Safety and Quality (“SENASICA”).

– Quality control and verification:

+ Each batch of finished product commercialized in Mexico must be analyzed in a quality control laboratory.

+ Facilities must guarantee the quality of imported lots by presenting analysis or quality control documents issued by the manufacturing company.

+ Specific requirements are established for quality control tests, sampling, retention samples, as well as stability tests for chemical, pharmaceutical and biological products.

– Containers, packaging, and labeling:

+ General labeling provisions are determined, including requirements for language, legibility, materials used and mandatory content on labels and packaging.

+ Special requirements are established for containers, packaging and labeling of food, biological and pharmaceutical products, both domestic and imported.

– Imported products:

+ Products for animal use or consumption can only be imported by registered title holders before SENASICA.

+ Raw materials used in production must be identified from their origin for traceability purposes.

The SADER through the SENASICA, will verify and monitor compliance with NOM-012 and the rest of the legal framework applicable to products for animal use and consumption. In case of non-compliance, the authority may impose a series of security measures and sanctions, including a temporary or definitive shutdown of the facility, suspension or revocation of any registration, authorization, or permit, or monetary fines.

In case you require an in-depth analysis concerning NOM-012 and the regulatory changes that this new provision entails, please contact our Life Sciences team.

The preceding information is intended as a timely update on the relevant on general administrative provisions. This content is informational only and does not constitute legal or professional advice. To obtain such advice or a deeper summary of the legal developments addressed in this document, please do not hesitate to contact our counsel Guillermo Govela or associate David Campos.