Labelling – ANMAT Provision 6924/2022

Labelling – ANMAT Provision 6924/2022

By Mateo Darget.

On August 26, 2022, Provision No. 6924/2022 (“Provision”) of the National Administration of Medicines, Food and Medical Technology (“ANMAT”, for its acronym in Spanish) was published in the Official Gazette. This Provision regulates advertising aspects related to the regime of Law No. 27,642 on the Promotion of Healthy Eating, its Regulatory Decree No. 151/22 and ANMAT’s Provision No. 2673/22.

The Provision establishes the complementary rules regarding the advertising, promotion and/or sponsorship in traditional and digital mass media of food and non-alcoholic beverages (“Product/s”) containing at least one warning label on their packaging, including those with sweeteners and/or caffeine.

Article 2 of the Provision stipulates that the Products must comply with Annex I “General Standards” of ANMAT Provision No. 4980/05. All advertising or publicity must:

1. Make an adequate use of the Product by presenting its properties objectively and providing truthful, accurate and clear information.

On the other hand, any advertising or publicity shall not:

1. Infringe the interests of public health.

2. Be concealed, misleading, indirect, subliminal or disloyal.

3. Use messages that provoke fear or distress, suggesting that a subject’s health will be affected in the event of not using the Product.

4. Assign to the Product therapeutic, nutritional, cosmetic, diagnostic, and preventive or any other type of actions or properties that have not been expressly recognized or authorized by the health authority.

5. Advertise Products without the required authorization from the health authority.

6. Suggest that a medicinal Product is a food or cosmetic or other consumer Product. In the same way, it shall not be suggested that a food or cosmetic or other non-medicinal consumer Product has therapeutic action.

Article 3 approves Annex I which develops the specific standards that the Products must meet. The most important points are listed below:

1. It is forbidden to advertise, promote and/or sponsor the Products when they are especially directed to children and adolescents.

2. Products that are not especially directed to children and adolescents shall:

  • a) Encourage their proper consumption and represent their properties objectively without deception or misleading, using truthful, accurate and clear information
  • b) Include warning labels in a clear manner for the recipient and respecting the corresponding requirements;
  • c) Be made in Spanish language.

3. Advertising, promotion and/or sponsorship of the Products shall not:

  • a) Refer to Products that are not authorized by the competent health authority, with exceptions.
  • b) Advertise Products that do not comply with the Sworn Declaration before the ANMAT through the NATIONAL FOOD INSTITUTE (INAL).
  • c) Include a series of resources that incite, promote or encourage the consumption, purchase or choice thereof.
  • d) Highlight complementary nutritional statements that emphasize positive and/or nutritional qualities.
  • e) Be presented in the market as “new” after two years have passed since the date of its commercialization.
  • f) Promote or give away for free
  • g) Promote the purchase of the Product for donation or humanitarian purposes
  • h) Include messages related to approvals or recommendations of experts, medical, scientific or similar associations;
  • i) Modify the composition and specific properties of the Product labels;
  • j) Determine that consumption of the Product reduces the risk of contracting diseases.
  • k) Include particular phrases and/or messages to promote its consumption.

4. Comparative messages shall not:

  • a) Create confusion with the comparison
  • b) Deride or denigrate the competitor’s Product
  • c) Deforming the image of other Products
  • d) Attempt against the prestige of third parties
  • e) Attempt to create a situation of rejection towards the Products of competitors or their users;
  • f) Mention components not contained in the advertised Product;
  • g) Mentioning possible adverse or collateral effects of components not contained in the advertised Product;

5. Advertising, promotion and/or sponsorship of the Products may include a telephone number or website to answer inquiries.

Article 6 states that the Products must comply with the Provision once the labels have been adjusted according to the terms of the schedule established by Article 19 of Annex I of Decree No. 151/22 and in accordance with ANMAT Provision No. 2673/22.

Regarding the limits for the first stage, the deadline for big companies to make the adaptation of the labeling ended in August 2022. On the other hand, small and medium-sized companies have until February 2023.

Regarding the limits of the second stage, in May 2023, the Products of big companies must have the corresponding labels. In the case of small and medium-sized companies, the deadline is November 2023.

Finally, article 7 warns that infringements to the Provision will make the holder of the advertised Product and the person in charge of the technical management, when applicable, liable to the penalties provided for in Law No. 18,284, Decrees No. 2126/71 and No. 341/92 and ANMAT Provision No. 1710/08. Such penalties may reach fines of up to 1,000,000 Argentine pesos (approximately 3300 dollars).

For further information please contact:

Share post: