TITLE XXIV

STIMULANTS

Paragraph I

Tea

ARTICLE 452.- Tea, with no other name, is the product obtained from the healthy and clean tender leaves, buds, stalks, or stems of the Thea genus, prepared by dehydration, with or without fermentation/enzymatic oxidation. [1]

Article 453.- The raw materials for the manufacture of various types of tea must meet the following requirements:

a) Contain a maximum of:

20% stalks or stems as a whole.

12% moisture.

8% total ash and 1% ash insoluble in hydrochloric acid at 10%, both expressed on a dry basis.

b) Contain a minimum, expressed on a dry basis, of 1% caffeine.

Processed teas may be marketed in various forms, such as leaves, crushed, prepared teabags, or liquid as an infusion or reconstituted with water, either alone or in mixture, which like all foods must be labeled and marketed in accordance with the provisions in Title II, Paragraph II of the Sanitary Food Regulations, according to their characteristics and composition.

Soluble tea powder or instant tea is the product resulting from the dehydration of the extract obtained exclusively from tea to a powder consistency. There must not be less than 2.0% caffeine on a dry basis and humidity must be no more than 5%. [2]

Paragraph II

Yerba Mate

ARTICLE 454.- Yerba mate is the product made of leaves, young shoots, buds, dried stalks, or stems, lightly toasted or shredded, of the species of the genus Ilex (I. brasiliensis, I. paraguariensis). Prepared yerba mate must meet the following requirements:

a)contain at least 0.7% caffeine and 25% aqueous extract, expressed on a dry basis;

b)not contain more than 11% moisture, 9% total ash, 1.5% ash insoluble in hydrochloric acid at 10%, and 30% stalks that do not pass through a sieve with perforations of 70 mm in length and 2.5 mm in width.

c)contain no extraneous vegetable substances: 1.0% maximum; yerba mate seeds: 1.0% maximum; and must not be burned, altered, or depleted.
Yerba mate may be marketed in various forms, such as leaves, powder, preparations, or liquid as an infusion or reconstituted with water, either alone or in mixture, which like all foods must be labeled and marketed pursuant to the provisions in Title II, Paragraph II of the Sanitary Food Regulations, according to their characteristics and composition. [3]

Paragraph III

Coffee

ARTICLE 455.- Roasted coffee is the product made of clean and healthy seeds of the different species of the genus Coffea, which by heat have taken on a dark color and characteristic aroma. It must not contain more than:

5% carbonized grains

1% foreign matter

5% moisture

It must contain at least 0.9% caffeine and 20% aqueous extract, both expressed on a dry basis.

Decaffeinated roasted coffee must have no more than 0.1% of caffeine, expressed on a dry basis. [4]

ARTICLE 456.- Soluble coffee or instant coffee is the product resulting from the dehydration of the extract obtained exclusively from newly roasted and dried coffee beans to a powder consistency, without the addition of other ingredients. There must not be less than 2.5% caffeine on a dry basis, and its humidity must be no more than 5%.

Decaffeinated soluble or instant coffee must have no more than 0.3% caffeine, expressed on a dry basis. [5]

Roasted and soluble or instant coffee, both decaffeinated or caffeinated, may be marketed in various forms, such as beans, powder, preparations, or liquid as an infusion or reconstituted with water, either alone or in mixture, which like all foods must be labeled and marketed pursuant to the provisions in Title II, Paragraph II of the Sanitary Food Regulations, according to their characteristics and composition. [6]

ARTICLE 457.- Coffee substitutes are products of plant origin (soybean, fig, chicory, or other), dried and/or roasted or roasted with sugars or as a mixture, used for the preparation of infusions similar to coffee. The nature of the coffee substitute must be clearly indicated on the label. [7]

ARTICLE 458.- Instant or soluble coffee substitutes are the products resulting from the dehydration of the aqueous extract of the coffee substitutes mentioned in the previous article. Its moisture must not exceed 5%. The nature of the instant or soluble coffee substitute must be clearly indicated on the label.

Coffee substitutes and soluble or instant coffee substitutes may be marketed in various forms, such as powder, preparations, or liquid as an infusion or reconstituted with water, either alone or in mixture, which like all foods must be labeled and marketed pursuant to the provisions in Title II, of Paragraph II of the Sanitary Food Regulationss, according to their characteristics and composition. [8]

Paragraph IV

Aromatic Herbs

ARTICLE 459.- The name aromatic herbs includes certain plants or parts of plants (roots, rhizomes, bulbs, leaves, bark, flowers, fruits and seeds) containing aromatic substances and flavors, and that due to their flavor characteristics, are used for the preparation of pleasing infusions. [9]

ARTICLE 460.- Aromatic herbs must be genuine, healthy, and present the macroscopic and microscopic characteristics that are natural to them. They must not contain materials or bodies that are foreign to their nature or more than 20% from other parts of the plant that have no value as flavoring agents.

ARTICLE 461.- Aromatic herbs must contain all of their active ingredients and other important secondary metabolites for chemical characterization.

ARTICLE 462.- Aromatic herbs can be sold whole or ground, either alone or in mixtures. [10]

ARTICLE 463.- Aromatic herbs must not have materials or pollutants at levels that are harmful to health, nor active substances in therapeutic concentrations; also, aromatic herbs/infusions must not be affected by Law No. 19.366, which sanctions the illicit trade of narcotic drugs and psychotropic substances.[11][12]

ARTICLE 464.- Aromatic herbs must be packaged in suitable materials that enable them to maintain their flavor and aroma in optimal conditions.

Aromatic herbs may be marketed in various forms, such as leaves, powder or bags, preparations, or liquid as an infusion or reconstituted with water, either alone or in mixture, which like all foods must be labeled and marketed pursuant to the provisions in Title II, Paragraph II of the Sanitary Food Regulations, according to their characteristics and composition. [13]

[1] Article amended, as shown in the text, by Article 1, No. 1, of Decree 32/12, of the Ministry of Health, published in the Official Gazette on 26/01/13 (effective: 24 months after its publication in the Official Gazette)

[2] Article replaced, as shown in the text, by Article 1, No. 2, of Decree 32/12, of the Ministry of Health, published in the Official Gazette on 26/01/13 (effective: 24 months after its publication in the Official Gazette)

[3] Letter added, as shown in the text, by Article 1, No. 3 of Decree 32/12, of the Ministry of Health, published in the Official Gazette on 26/01/13 (effective: 24 months after its publication in the Official Gazette)

[4] Article amended, as indicated in the text, by Decree No. 475/99, of the Ministry of Health, published in the Official Gazette on 01/13/00

[5] Article amended, as indicated in the text, by Decree No. 475/99, of the Ministry of Health, published in the Official Gazette of 01/13/00

[6] Subsection added, as shown in the text, by Article 1, No. 4, of Decree 32/12, of the Ministry of Health, published in the Official Gazette on 26/01/13 (effective: 24 months after its publication in the Official Gazette)

[7] Expression replaced, as shown in the text, by Article 1, No. 11.-, of Decree 68/05, of the Ministry of Health, published in the Official Gazette on 01/23/06

[8] Subsection added, as shown in the text, by Article 1, No. 5, of Decree 32/12, of the Ministry of Health, published in the Official Gazette on 26/01/13 (effective: 24 months after its publication in the Official Gazette)

[9] Article amended, as indicated in the text, by Decree No. 475/99, of the Ministry of Health, published in the Official Gazette of 01/13/00

[10] Article amended, as indicated in the text, by Decree No. 115/03, of the Ministry of Health, published in the Official Gazette on 11/25/03 (previous amendment: Decree No. 855/98, Ministry of Health)

[11] Article amended, as shown in the text, by Decree 115/03, of the Ministry of Health, published in the Official Gazette on 11/25/03

[12] Article amended, as shown in the text, by Decree 475/99, del Ministerio de Salud, publicado en el Diario Oficial de 13.01.00

[13] Subsection added, as shown in the text, by Article 1, No. 6, of Decree 32/12, of the Ministry of Health, published in the Official Gazette on 26/01/13 (effective: 24 months after its publication in the Official Gazette)