On October 7th, 2019, the Regulatory Impact Analysis and the draft amendment of the Official Mexican Standard NOM-051-SCFI/SSA1-2010 – “General Labelling Specifications for Pre-packaged Foods and Non-Alcoholic Beverages – Commercial and Health Information” were published in the portal of the National Commission on Regulatory Improvement. The foregoing was the result of the proposal for amendment of the General Health Law in terms of the front labeling warnings, submitted by the Health Commission of the House of Representatives.

Below please find some of the main modifications included in the aforementioned draft amendment:

i. It introduces new applicable terms and definitions, such as sugar added and sugar-free, natural or artificial sweetener, front labeling system; supplementary nutrition facts, children, critical nutrients, genuine and substitute products, warning stamp, among others.

ii. It now forbids the use of legends which refer to recommendations or endorsements by professional companies or associations.

iii. The use of characters, drawings, celebrities, gifts, offers, toys or contests is now forbidden for certain product categories.

iv. Likewise, the new draft amendment now limits the advertising of certain product categories in social media.

v. New rules apply for the use and declaration of the denomination of foods, mainly in terms of genuine and substitute products.

vi. Furthermore, the draft amendment sets out new guidelines for the declaration of ingredients, among which the following stand out:

  • Declaration of sugars, their categories, and quantities.
  • Declarations of allergens and ingredients which may cause hypersensitivity and/or intolerance, including new categories thereof (e.g. syrups).
  • Tighter regulations for additives.

vii. Draft amendments introduce the obligation to declare added sugars and trans-fats, as part of the Nutritional Declaration of products.

viii. It now broadens the supplementary nutritional facts chapter.

ix. Adopts the Front Labeling System, the purpose of which is to warn and inform the consumer regarding nutrients which, according to the provisions of the Official Mexican Standards (NOM), constitute a health risk. For example:

  • The use of warning stamps in connection with nutrients (for example: “Excess Calories”).
  • The use of warning stamps in connection with sweeteners (for example: “It contains sweeteners, should be avoided for children”).
  • Precautionary legends (for example: “It contains caffeine, should be avoided in children”).
  1. Finally, the draft amendment provides for a Conformity Assessment Procedure, and now introduces the obligation to obtain a compliance opinion.

The Hogan Lovells Global Regulatory team is ready to assist you and clarify any questions you have on this matter.

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Photo of Ernesto Algaba Ernesto Algaba

With more than 20 years of experience in the Life Sciences industry under his belt, Ernesto Algaba leads the Life Sciences practice for Hogan Lovells in Mexico.

He focuses on health law and regulatory compliance matters for the pharmaceutical and medical devices industries.

With more than 20 years of experience in the Life Sciences industry under his belt, Ernesto Algaba leads the Life Sciences practice for Hogan Lovells in Mexico.

He focuses on health law and regulatory compliance matters for the pharmaceutical and medical devices industries. He also has broad experience in the cosmetics, food, alcohol, and tobacco, and consumer products industries. His wealth of knowledge covers matters relating to Mexican Official Standards (NOMs), Consumer Protection Law, overland transport, foreign trade, and contracts.

Ernesto tackles clients’ pressing problems by handling their needs to meet expectations. He advises clients on planning and development of innovative projects and on strategic business decisions with respect to the launching of new products, restructuring of activities and businesses, approval and marketing authorization pathways and standards for regulated and nonregulated products, labeling and advertising issues, product liability, and highly specialized regulatory compliance matters. The Latin American Corporate Counsel Association included Ernesto on its 2015 list of recommended lawyers for administrative law.

Photo of Cecilia Stahlhut Cecilia Stahlhut

Cecilia Stahlhut Espinosa represents life sciences and consumer products companies in Mexico, with a focus on health and consumer law matters. She works with clients throughout all stages of complex and innovative projects. Her years of experience as external counsel to many life…

Cecilia Stahlhut Espinosa represents life sciences and consumer products companies in Mexico, with a focus on health and consumer law matters. She works with clients throughout all stages of complex and innovative projects. Her years of experience as external counsel to many life sciences companies offer her unique insight into the industry.

She has a wealth of experience in regulatory drug matters (pharmaceutical), medical devices and equipment, research and development, biotechnology, compliance of new product technologies, and general health regulatory compliance. Cecilia has particular experience in the regulation of cosmetics, food, alcohol, tobacco, and consumer products in Mexico.

She has also participated in the planning and adoption of regulatory strategies for various companies, with respect to product advertising and labeling, product liability, marketing of high-tech products, and the launching of new products. She also advises clients on sophisticated regulatory structures and the restructuring of business models and operations, clinical research projects, approval and marketing authorization pathways, standards for regulated products, and challenging labeling and advertising issues.

Cecilia has reviewed promotional materials for an extensive range of products and advised clients on promotional activities and compliance of regulations regarding interactions with health care professionals and related organizations.

Recently, Cecilia was seconded to a major orphan drug company to advise on regulatory framework applicable to orphan drugs as well as the ongoing business activities of the client, including contracts, advertising, marketing, pharmacovigilance, and health-corporate governance.