Mexico Reach Regulation for Various Sectors

Mexico has adopted and ratified a number of key conventions relating to chemicals, such as the Basel, Rotterdam, Stockholm and Minamata conventions. However, Mexico’s national law on chemicals is pending. In 2019 the General Health Council (CGS) proposed the General Law for the Integral Management of Chemical Substances (LGGISQ) as an initiative to regulate the use and import of high-risk chemicals in Mexico. According to the CGS, the draft law will establish a National Registry of Chemical Substances (ReNaSQ) and require industries to provide information on risks. The objective of LGGISQ is to have a comprehensive and adequate State policy, which will ensure rigorous protection of the health of the population and the environment from the risks associated with exposure to chemical substances and products.

Before the new national law is formally introduced, companies need to comply with the existing chemical laws. The two most important general regulations that govern chemical substances and products in Mexico are the General Health Law and Regulations of the General Health Law on Sanitary Control of Activities, Establishments, Products and Services (Sanitary Control Regulations).

The General Health Law and the Sanitary Control Regulations establish the definitions of pesticides, fertilizers and toxic substances, stipulate a registration, license and permit regime for pesticides, fertilizers and toxic substances, in addition to providing standards for the labelling of chemical substances.

Mexico’s national inventory the National Inventory of Chemical Substances: Base 2009 was elaborated by the Mexican National Institute of Ecology in 2009 and updated in 2015. The Inventory is a consultation system about the identity of 5,852 substances that are sold, produced, or imported in Mexico. It also comprises the substances’ persistence, bioaccumulation, and toxicity in water organisms. The Inventory lists the chemicals by CAS number, their synonyms, formula, molecular structure, and eco-toxicological data.  The Inventory aims to increase the control of commerce in Mexico with the aim of protecting the environment.

The National Inventory of Chemical Substances: Base 2009 is not compulsory, meaning that it does not impose any obligation on the national market. However, in 2018 the National Institute of Statistics and Geography (INEGI) published guidelines for the use of the National Inventory of Chemical Substances for statistical and geographic purposes. This guideline document employs information provided by the chemical industry and importers.

In 2020, the National Chemical Industry Association proposed an update to the National Inventory of Chemical Substances. This proposal included the possibility to improve the management of chemicals by evaluating the substances through all the stages in their life cycles. According to the Association, this would serve as a basis for future chemical regulation advancements.

In 2019 the General Health Council (CGS) proposed the draft General Law for the Integral Management of Chemical Substances (LGGISQ) as an initiative to regulate the use and import of high-risk chemicals in Mexico. According to the draft of LGGISQ it will establish a National Registry of Chemical Substances (ReNaSQ) which obliges the chemical producers and importers to provide information on chemicals. Companies will need to prepare registration dossiers, include general data, physical properties, environmental fate properties, and uses of substance. It also mentions chemical safety assessment for those chemicals that pose risks to the environment and human health.

Under LGGISQ, classification, labelling and Safety Data Sheets (SDS) will be required for substances and mixtures in accordance with the Global Harmonized System of Classification and Labelling of Chemical Products (UN GHS). According to the draft law, the registration period will be available for two years. The Ministry of Health will prioritize chemicals with high volume of use. 

Chemicals in Mexico are regulated by a number of technical standards including Official Mexican Standards (NOM), Mexican Standards (NMX), and Reference Standards (NRF).

• Official Mexican Standards (NOM): These are mandatory technical regulations.

• Mexican Standards (NMX): These are prepared by a national standardization body. They establish the minimum quality requirements for products and services, with the aim of protecting and guiding consumers. The application NMXs is voluntary, with the exception of cases in which individuals state that their products, processes, or services are in accordance with them or when a NOM requires the observance of a NMX for specific purposes.

• Reference Standards (NRF): These are prepared by public administration entities to apply them to the goods or services they purchase, lease or contract when Mexican or international standards do not cover their requirements, or their specifications are obsolete or inapplicable.

Chemicals in Mexico are regulated by different authorities depending on their categories and uses. The authorities that are in charge of importation, transportation, manufacture and use of chemical substances and products are described below.

The most important public authority with regard to Chemical Management in Mexico is the Ministry of Health (MOH) which in collaboration with other related authorities, is in charge of establishing the Official Mexican Standards (NOM) as stipulated by the General Health Law. The Ministry of Health supervises the granting of permits in relation to toxic substances, pesticides, and fertilizers that are not intended for commercial agricultural and forestry use.

The Ministry of Environment and Natural Resources (SEMARNAT) is the authority that, together with the Ministry of Economy (SE), the Ministry of Agriculture and Rural Development (SADER), and the MOH, develops regulations and NOMs for the prevention and control of pollution of the environment with respect to chemical substances. The SEMARNAT also has exclusive jurisdiction over the management of all hazardous waste. States and municipalities are responsible for the regulation, administration, authorization, and enforcement of solid and non-hazardous waste standards.

The Ministry of Economy (SE) and the Federal Attorney for Consumer Protection under the Federal Consumer Protection Law is the authority concerning regulations on labelling, registration, storage, and usage of chemicals.

The Ministry of Labor and Social Welfare (STPS) together with the Ministry of Health have jurisdiction over the application of regulations regarding protection of workers according to the Federal Labor Law and the Safety and Hygiene Regulations in the Workplace.

The Ministry of Communications and Transportation (SCT) has jurisdiction over the transportation regulations of hazardous chemical products. The SCT grants permits to every person or company that transports hazardous chemicals, materials, or residues.

Before the implementation of the national chemical law, companies that manufacture or import chemicals to Mexico need to follow the country’s existing chemicals laws.

In Mexico, the management of chemical products has been carried out basically through the creation of lists of specific substances for which companies are required to have records and authorizations to sell or use their products. Companies have to take all measures to comply with NOM-018-STPS-2015 with regard to classification, labelling, and the authoring of safety data sheets for chemical substances. As stated before, NMX-R-019-SCFI-2011 will be applied for classification. To transport chemical substances, companies and any person must get a permission from the Ministry for Communications and Transportation.

In Mexico, the regulation of the importation and production of chemical substances is limited to certain groups through permits or registrations. For substances subject to sanitary control, an authorization must be obtained from the Federal Commission for the Protection against Sanitary Risks (COFEPRIS).

Importers and Exporters 

Exporters or importers of non-toxic chemical products must inform the COFEPRIS about their import/export activities by filling out a form online. The form does not require a physical signature or validation by public authorities. Along with the form, the importer/exporter must attach documents that prove their legal status within the company, including the name of authorized personnel to receive notifications. The interested party or their legal representative must sign the document, or it must be signed electronically. Additionally, if companies have a Unique Registry of Accredited Persons (RUPA) number, they may also include it in a separate application. There is no fee in this application.

To import or export toxic chemicals for distribution, trade, application, or manufacture, certain steps must be followed. Required documents include a form, proof of legal identity, proof of payment, a Notice of Operation or Sanitary License number, and a safety data sheet in Spanish or accompanied by a translation. Legal persons must provide the reference number of their Registry of Accredited Persons or other documentation proving legal status. Requests must be made in writing and signed by the interested party or legal representative. The legal representative must provide proof of their legal status and name authorized personnel to receive notifications. Instead of providing proof of legal status, companies may provide RUPA numbers or other documentation. All documents must be signed by the legal representative or signed electronically.

There is no fee structure related to the chemical regulations in Mexico at the moment. However, for the application for the import permit for pesticides, plant nutrients, substances or toxic or dangerous materials for toxic substances, there is a fee of 4,650 MXN (approximately US$ 250).