Mexico Regulatory News

In July 2022, it was published in the Diario Oficial de la Federación (DOF) in Mexico a regulation about good manufacturing practices for cosmetic products. This regulation establishes good manufac...

In July 2022, it was published in the Diario Oficial de la Federación (DOF) in Mexico a regulation about good manufacturing practices for cosmetic products. This regulation establishes good manufacturing practices (GMP) for cosmetic products, as well as the organizational manual of the Ministry of Health. 

The standard states: "Considering that every company or establishment dedicated to the production of cosmetic products has the responsibility to guarantee that the products it manufactures do not pose risks to the consumer's health, it must have a system for prevention, control, and verification of sanitary quality in order to ensure that cosmetic products are safe." 

It further explains that GMP is a set of guidelines that must be applied in the cosmetic product manufacturing process.The GMP standard for cosmetic products was developed taking into account the specific needs of this sector.

The objective of this regulation is to provide a description of the basic requirements that must be followed throughout the process, such as the conditions that the personnel, production, control, storage, packaging, and other activities must meet. Another goal of this standard is to ensure that the manufactured products meet sanitary quality standards, can be consumed safely, and are effective for their specific cosmetic applications. 

The regulation emphasizes that companies have the responsibility to guarantee to consumers that the manufactured product does not pose a health risk. GMP serves as the sanitary foundation under which any company involved in the process and handling of cosmetics must operate, ensuring that even the simplest operation throughout the manufacturing process of a cosmetic product is carried out under conditions that ensure its sanitary quality. 

Furthermore, the regulation states that due to the continuous evolution of the cosmetics industry, it is necessary to take actions that protect the health of the population and, at the same time, prevent Mexico from lagging behind in this field. 

The regulation came into force in May 2023.

Link in Spanish: DOF - Diario Oficial de la Federación

On 3 May 2023 the Mexican government published a decree adding, amending, and repealing various provisions of the Federal Law for the Control of Chemical Precursors, Essential Chemical Products and Ma...

On 3 May 2023 the Mexican government published a decree adding, amending, and repealing various provisions of the Federal Law for the Control of Chemical Precursors, Essential Chemical Products and Machines to Manufacture Capsules, Tablets and/or Pills (in short, the Law on Chemical Precursors and Essential Chemical Products). The changes went into effect the day after the publication in the Official Gazette of the federation (i.e. on 4 May 2023) but the amendment to the regulation will be published within 180 days.

Some of the changes are:

• A synthetic drug is now defined as ‘Any substance of synthetic origin with psychoactive effects available in the illicit drug market and used for non-medical purposes.’

• Chemical precursors are defined as ‘Fundamental substances for the production of synthetic drugs, which incorporate their molecular structure into the final product.’

• Essential Chemicals are defined as ‘Substances that, without being chemical precursors, can be used to produce synthetic drugs, such as solvents, reagents, and catalysts.’

• The time for submitting Annual Reports has been changed to 60 calendar days.

• Affected companies and individuals must now register each activity the involves precursor chemicals or essential chemicals in the Comprehensive System of Substances within 24 hours.

• Penalties will now be as follows: A person who diverts or makes use of chemical precursors or essential chemicals for the production of synthetic drugs, will be sentenced to ten to fifteen years in prison and a fine equivalent to ten percent of the income obtained by such activities. A person who is in possession of chemical precursors, essential chemical products or machines to make capsules, tablets or tablets in the national territory, who does not have the corresponding authorizations or permits, will be sentenced to seven to ten years. imprisonment and a fine of one thousand to five thousand times the daily value of the Measurement and Update Unit.
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The full text of the decree can be found here:

https://www.dof.gob.mx/nota_detalle.php?codigo=5687756&fecha=03/05/2023#gsc.tab=0

On 2 March 2023, a draft standard was disclosed that involves two standards on marking and labelling requirements from 2008. The draft standard aligns Mexico’s rule with the UN model regulation. It ...

On 2 March 2023, a draft standard was disclosed that involves two standards on marking and labelling requirements from 2008. The draft standard aligns Mexico’s rule with the UN model regulation. It describes the contents and sizes of labels when they are used on packages, containers, tank wagons, and freight containers.

Until 1 May, Mexico’s Secretariat of Infrastructure, Communications, and Transport (SICT), is consulting on the draft standard on marking and labelling.

The Secretariat of Infrastructure, Communications and Transportation (SICT) of Mexico is the national federal entity that regulates commercial road traffic and broadcasting. It sets and conducts policies and programs to develop transport and communications in line with the country's needs. It also regulates, inspects, and oversees mail and telegraph services.

As per the 2008 edition of the standard, shipping of different dangerous goods items in multi-compartment tanks require labels to be displayed on both sides of each compartment. The updated version of the standard from 2023 explains that the labels need to be displayed only once along the sides of the transport unit if all compartments require the same labels.

Also, the provisions in the 2008 edition describe that if a transport unit contains multiple items having different hazard classes for shipping, the labels should identify the two most dangerous items. This requisite has been eliminated from the updated version as there is no information available on the identification of the two dangerous items from the multiple products. Furthermore, a lithium battery mark is introduced in the updated standard for packages containing defined amounts of lithium-ion cells or batteries.

For a substance in quantities of more than 4,000 kg, the standard will associate with the International Maritime Dangerous Goods (IMDG) code to include UN number labels for multimodal containers transported by sea.

23 standards on dangerous goods transport are being revised by the SICT. The standards which are already published involve standards on transport documents, packaging construction and testing, as well as correct use of packaging.

The Mexican government has expressed its interest in promoting the application of a national policy on chemical substances, considering the life cycle of such substances. The General Health Council, r...

The Mexican government has expressed its interest in promoting the application of a national policy on chemical substances, considering the life cycle of such substances. The General Health Council, responsible for the health sector in Mexico, has stated that the new policy will ensure the safe management of chemical substances throughout their entire life cycle, from production to disposal, to protect the health of people and the environment.  

To support this initiative, Aniq, a working group consisting of representatives from different companies, has been formed to develop a conceptual proposal for the management of chemical substances in Mexico. The proposal aims to align with international regulations and avoid trade barriers. However, there is no official document that includes the proposal at this stage.  

The potential impact of this new regulatory framework has generated curiosity and concern among other organizations. As a result, a telephone conference was held with officials from other representative organizations of the chemical industry, including the International Council of Chemical Associations (ICCA) and the American Chemistry Council (ACC) to share the information that is currently available regarding this project in Mexico. During the conference, representatives from Aniq expressed their intention to generate information that serves as a basis for position documents related to the regulation of chemicals, such as those that take place at summit meetings on international agreements and conventions on safety and the environment, such as the Strategic Approach to International Chemicals Management promoted by the United Nations.  

To further advance this initiative, a new conference call will be scheduled with the counterparts of Aniq in Latin America to comment on the matter and define a joint agenda that allows the chemical industrial sector to improve the management of chemical substances. Representatives of ICCA and ACC suggested a cooperation strategy for the regulation of chemical substances in Latin America. This strategy is based on the participation of Latin American Chemical Associations, coordinated by ICCA, for the exchange of information and experiences in the matter, including training courses for both companies and governments in the region.  

Aniq plans to participate in this strategy by holding monthly conferences with those involved to define the steps to follow. The participation of international organizations would also be sought, as well as the participation of an expert adviser financed by ICCA.  

Overall, the goal of the proposed regulatory framework is to ensure the safe management of chemical substances in Mexico and Latin America, protect human health and the environment, and align with international regulations. The involvement of various organizations and the cooperation strategy suggested by ICCA and ACC will facilitate the exchange of information and experiences in the matter, ultimately leading to the effective regulation of chemical substances in the region. 

The Secretariat of Health of Mexico through the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) indicated that regulations on cosmetics, perfumes and products for the personal ...

The Secretariat of Health of Mexico through the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) indicated that regulations on cosmetics, perfumes and products for the personal and home care industry will be updated in the country. 

This entity highlighted that with the participation of industry and other actors involved in the sector, three regulatory norms are going to be modified: 

• The Official Mexican Standard 259 on good manufacturing practices. 

• The Official Mexican Standard 189 on the labeling and packaging of products for personal hygiene. 

• The Agreement on Substances used to regulate the manufacture of cosmetics and perfumes 

According to the Secretariat, these three regulatory norms are sensitive for the industry and must be improved to avoid raising transaction costs and discouraging investment. Thus, over-regulations that affect consumers will not be maintained. The objective of these proposed new regulations is to protect the population against health risks by facilitating entry into the market of quality and safety products. 

The Mexican Ministry of Health indicates that these measures will be an example for the Pacific Alliance, an international organization made up of Chile, Colombia, Mexico, and Peru. 

The Mexican government is currently consulting on proposed updates to its standard governing Transport Documents for dangerous goods (NOM-043-SCT/2003). The proposed new standard (NOM-043-SCT-SEMAR-AR...

The Mexican government is currently consulting on proposed updates to its standard governing Transport Documents for dangerous goods (NOM-043-SCT/2003). The proposed new standard (NOM-043-SCT-SEMAR-ARTF-2022) would update Transport Document requirements to bring them into line with the most recent revision of the UN Model Regulations on the Transport of Dangerous Goods (Revision 2022), which was adopted in 2021. 

The proposed standard would be of general application, being required of shippers, carriers and recipients across all transportation methods. 

Comments on the draft – accessible here – can be submitted for 60 days after its publication in the Mexican Official Journal, which took place on September 7, 2022. 
 

On February 28, 2022, the Secretariat of Infrastructure, Communications and Transportation (SCT) issued an Official Mexican Norm (NOM in Spanish). This regulation assigns specifications for transpor...

On February 28, 2022, the Secretariat of Infrastructure, Communications and Transportation (SCT) issued an Official Mexican Norm (NOM in Spanish). This regulation assigns specifications for transporting certain classes of dangerous goods, including consumer goods containing small quantities of hazardous substances. The aim is to establish new safety provisions.

NOM-011-1-SCT-2-2022 aligns the national standards with the international guidelines related to the transportation of excepted quantities of hazardous materials. The Official Mexican Norm reduces the transportation exigencies, consequently lowering cost and encouraging commercialization. It will also leverage the competition of the national products into international commerce. Concomitantly, NOM-011-1-SCT-2-2022 addresses labeling and packing of hazardous substances initially exempted from compliance with the NOM-002-SCT/2011 (due to exception quantities). They refer to NOM-002-SCT/2011’s column 7b:

1 expressed in grams for solids and milliliters for liquids and gases; or the sum of grams and milliliters in the case of ordinary packaging

In the case of Explosives and Radioactive goods, they must also comply with the provisions of the Ministry of National Defense and the Ministry of Energy through the National Commission for Nuclear Safety and Safeguards, respectively. According to NOM-011-1-SCT-2-2022, the transport of hazardous substances and materials in excepted quantities and final consumption must be carried out based on their hazard classification and quantities to be transported.

NOM-011-1-SCT-2-2022 will enter into force 60 calendar days after its publication. And concerned businesses in Mexico need to fully comply.