Wednesday, August 1, 2012

New Resolution Establishes Use and Sanitary Provisions
for Additives in Food, Beverage and Dietary Supplements

A new resolution establishing use and sanitary provisions for additives in food, beverages, and dietary supplements (the “New Resolution”) was published in the Federal Official Gazette on July 16, 2012, and will become effective October 8, 2012.

This New Resolution replaces the resolution that previously regulated the substances permitted as additives in food, beverages, and dietary supplements, which was published in the Federal Official Gazette on July 17, 2006.

The New Resolution establishes a considerable number of new definitions, references to international and foreign provisions, and a biannual review of the New Resolution.

Substances permitted for use as additives and maximum dosage

The substances permitted for use as additives are included in eleven appendices, which specify the additives, the product category in which they may be used, and the maximum dosage, as follows:

Product categories
  1.      Additives with various uses and with a recognized daily admissible intake (“DAI”);
  2.      Additives with various uses that may be used in accordance with good manufacturing practices (“GMP”);
  3.      Coloring with established DAI;
  4.      Purified chewing substances;
  5.      Enzymes;
  6.      Sweeteners with established DAI;
  7.      Sweeteners that may be used based on GMPs;
  8.      Additives permitted for infants;
  9.      Child formula and special nutrition use;
  10.      Manufacturing aides; and
  11.      Flavorings.
Maximum dosage
The reference for the maximum permissible dose in the case of appendices i, iii, and vii is the UN Codex Alimentarius and the corresponding provisions of the United States, Canada, and the European Union.

In the case of appendices ii, iv, v, vi, viii, x and xi, all categories of products may be used in accordance with the applicable GMPs.

In the case of infant formula, continuation formula, and special nutrition formulas, only certain specific additives may be used under specific maximum limits.

The use of natural flavorings is permitted, provided they are based on applicable GMPs and comply with the Regulations on Sanitary Control of Products and Services.

The use of several natural oils, essences, and vegetable-origin products is limited and restricted in the manufacturing of flavorings and other additives and aides that may represent health hazards.

Other obligations and use of other additives after October 8, 2013
The Resolution establishes the obligation to include additives, colorings and sweeteners in the declaration of ingredients included in the labeling of food products.

Likewise, the New Resolution establishes the possibility that other additives contemplated by other provisions or Mexican Official Standards, also known as “NOMs,” be used within the year following the date the New Resolution takes effect, which is October 8, 2013.

Entry into force for sweeteners and request for extension to adjust labeling
In the case of sweeteners having an IDA, the New Resolution will not take effect until September 16, 2013.

Prior to July 16, 2013, interested parties may request an additional period to adjust their labeling on a product-by-product basis.  The technical and economic reasons for the additional period must be justified.

Further considerations regarding the New Resolution
In our view, the enactment of the New Resolution may have a significant impact on those engaged in the manufacturing, importation and marketing of food and beverage products for human consumption.  On one hand, the New Resolution contradicts other provisions currently in force, which may lead to confusion, since the requirements for labeling are included in specific NOMs.  On the other hand, the New Resolution seems intended to prohibit the use of products not expressly contemplated.  This would contradict the general principle by which all that is not expressly prohibited is considered permitted.

Likewise, we consider it possible that a considerable number of products have not been correctly included or have not been included at all in the New Resolution.  The New Resolution contains an exhaustive list of some 250 pages, but this does not mean that each and every existing additive, coloring, and sweetener has been listed, since these products change constantly.  

José Alberto Campos-Vargas
Sanchez Devanny
Mexico City, Mexico

Humberto Morales-Barrón
Sanchez Devanny
Mexico City, Mexico


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