Mexico City, June 12th, 2020.
Last June 3rd, 2020, the Ministry of Health presented before the National Commission for Regulatory Improvement (“CONAMER”), Regulatory Impact Analysis over the proposal of Decree by which various provisions of the Regulation of Sanitary Control of Products and Services and of the Regulation of the General Act on Health in Matters of Advertising are reformed, added and repealed, herein after “Decree”.
The Decree incorporated the following modifications, same that we consider are intended to be the legal basis of the modifications incorporated to Mexican Official Standard NOM-051-SCFI/SSA1-2010, General labelling specifications for pre-packaged food and non-alcoholic beverages – Commercial and sanitary information, published in the Federal Official Gazette last March 27, 2020:
A. Regulation of Sanitary Control of Products and Services.
- The Flavoured beverages, Snacks, Chocolate, Multiple or collective packaging and Pre-packaging definitions set forth in article 2 are eliminated and the following definitions are added:
- Warning labelling frontal system, a simplified information system in the main display area of the container, which truthfully, clearly, quickly and simply warns on the content that exceeds maximum levels or which meets nutritional profiles for energy content, added sugars, saturated fats, trans fats, sodium and other critical nutrients and ingredients determined by the Ministry.
- Portion, quantity of product that is suggested for consumption or which is generally consumed in one ingestion, expressed in units of measurement of the General System of Units of Measurement.
- Critical nutrients, those components of a diet that may be a risk factor for chronic non-transmissible diseases.
- Among the criteria for the identification of the products subject to the Regulation of Sanitary Control of Products and Services, as set forth in article 9, the nutrimental characteristics of the product are included, in addition to the physical, chemical and biological characteristics of such.
- It is established that, those products which components, raw materials, ingredients and additives may represent a mediate or immediate risk factor for the health of the consumers, either by ingestion, application or manipulation of the product; must warn the presence of such in the label, through the necessary precautionary legends, in accordance with the corresponding standards [new article 11 Bis].
- For purposes of the sanitary control of products and raw materials, in accordance with the provisions of article 13, the Ministry of Health may require interested parties, in addition to the biological, chemical and physical specifications; the nutritional specifications of those.
- The norms, in accordance with article 15, in addition to establishing the microbiological, toxicological or health risk specifications of the products, must establish the nutritional
- Regarding the labelling of products that must comply with the Regulation of Sanitary Control of Products and Services, and in accordance with the provisions of article 25, the nutritional labelling and not the nutritional contribution is considered part of the general health information, among others.
- The standards corresponding to each type of product will determine the general health information that the label must contain or the specific information when, due to the size of the package or container or to the conditions of the process or any other particular condition, all the required information cannot appear.
- The information contained in the label must be truthful and it must be described and presented in such a way that it does not mislead the consumer regarding its nature.
- Article 25 Bis is simplified, in the sense that it is established that the labelling of pre-packaged food and non-alcoholic beverages must include the frontal labelling established in the corresponding standard [NOM-051] and must not use any other.
- The label of those products aimed at girls and boys must not contain elements that incite, promote or encourage their consumption, purchase or choice; nor make reference to other elements for the same purposes [new article 25 Bis 1].
- The Ministry of Health, in coordination with research and higher education institutions, both public and private, will establish the portions of food and non-alcoholic beverages to be taken as a reference, which will be published by the authority on the corresponding official webpage and which will be permanently updated by the Ministry itself or at the request of the interested parties [new article 25 Bis 2].
- The Ministry of Health will determine those additives, ingredients or substances that, present in the products or at certain levels, may create a health risk, in which case the products that contain them must include a precautionary legend on their consumption, with particular emphasis on products aimed at girls and boys, as established in the corresponding standards [new article 25 Bis 3].
- The labelling of pre-packaged products may include graphic or textual elements that indicate that said products have been recommended or recognized by companies or professional associations, when the appropriate documentation is presented, with scientific, objective and reliable evidence, supporting the evaluation of the product in accordance with the provisions of article 32 of the Federal Act on Consumer Protection. In order to grant said support, in the case of pre-packaged food and non-alcoholic beverages, these products must not have an excessive energy content or critical nutrients according to the corresponding standard [NOM-051] and must specify the target population and its specific health condition to which the consumption of these products is directed [new article 25 Bis 4].
- Based on the provisions of article 161, nutrients may not be added to unprocessed or fresh foods, nor to pre-packaged foods and non-alcoholic beverages that meet the nutritional profiles established for the frontal warning labelling established by the standard. corresponding [NOM-051], with the exception of those that must be added on a mandatory basis.
B. Regulation of the General Act on Health in Matters of Advertising.
- Advertisement incorporated to products or services, on the basis of the provisions of article 6, in addition to what is already established in said article, must not include stamps or legends of recommendation or recognition by professional organizations or associations when they do not present documentation with Scientific, objective and reliable evidence of the evaluation of the product, as established in article 32 of the Federal Law on Consumer Protection.
- Publicity of pre-packaged products whose label includes excess energy content, critical nutrients and ingredients that represent a health risk in excessive consumption, must include the stamps and legends established in the respective Mexican Official Standard [NOM-051] and must not include stamps or legends of recommendation or recognition by professional organizations or associations [new article 24 Bis].
- Advertising of pre-packaged products that include one or more warning stamps or the legend of sweeteners on their label, in accordance with the corresponding standard, must not include children’s characters, animations, cartoons, celebrities, athletes or pets, interactive elements, such as visual-special games or digital downloads, aimed at children who incite, promote or encourage the consumption, purchase or choice of said products [new article 24 Bis 1].
- In order to obtain an advertising permit, and in accordance with the requirements set forth in article 80 of the Regulation of the General Act on Public Health, one must submit, in addition to the official format and the information and documentation established in said article; the product label, in the case of pre-packaged food and non-alcoholic beverages and food supplements.
Finally, the Decree, once it comes into force, will render without effect the Accord that issues the Guidelines referred to in Article 25 of the Regulation of Sanitary Control of Products and Services that must be observed by pre-packaged food and non-alcoholic beverage producers, for the purposes of the information that they must display in the front display area, as well as the criteria and characteristics for obtaining and using the nutritional label referred to in Article 25 Bis of the Regulation of Sanitary Control of Products and Services.
Since the Decree is under evaluation by CONAMER, the new provisions set forth in this document are not yet mandatory. However, if approved by CONAMER, it will be published in the Federal Official Gazette and will enter into force the day after its publication.
The file of this proposal will be available, for private persons to file remarks, for a minimum period of 20 business days.
The lawyers of the Health Law Practice are at your disposal to clarify any query you may have over these topics.
S I N C E R E L Y,
Daniel Del Rio
Rodolfo Barreda
Ricardo Evangelista
Mariana Arrieta
