The World of Supplements Regulation

A look at the similarities, differences, and harmonization of supplements regulation across Latin America, the EU, and Southeast Asia.

by Ainhoa Larrañaga, Anja Derijck, and Wai Mun Poon

Launching a supplement product in the global market may be challenging as the

regulatory frameworks across countries widely vary. Even within the same region, differences emerge when there is no harmonized legislation in place. Here similarities and harmonized rules that may ease product launch across several markets are examined, namely in Latin America, the EU, and Southeast Asia.

Latin America

Latin America is comprised of more than 20 countries. The regulatory framework of food supplements can be very diverse across the region as there is little work done yet at the harmonized level. However, there are some similarities within the region.

Classification & Definition

Most countries classify supplements as foods and have a common approach to the definition of food/dietary supplements.

However, some countries classify them as drugs, and Colombia treats them as a separate category completely.

Most definitions agree that supplements are intended to supplement the diet of healthy individuals and they generally allow the use of nutrients with a nutritional or physiological effect. Products in pharmaceutical form are generally accepted.

Classification is the first step into potential harmonization, as a common product categorization will ease the path for future common rules on product composition, claims requirements, and market access.

Product Composition

The composition of food supplements is governed by national rules. What is encouraging in this regard, is that the countries that have recently changed their regulations, such as Brazil, Ecua- dor, and Guatemala, have adopted a broader and fairer definition of supplements, allowing a wider range of nutrients as part of their composition, including plants, probiotics, and other bioactive substances, such as caffeine or creatine.

Maximum levels of vitamins and minerals are likewise not harmonized. However, there is a tendency to move from maximum levels set at Recommended Daily Allowance (RDA) levels, which are used to ensure micronutrient recommendations in the dietary guidelines for the general population, to higher levels based on safety-risk assessments such as Upper Levels (UL) or Non-Observable Adverse Effect Levels (NOAEL). Countries that follow a safety-risk assessment are Argentina, Brazil, Colombia, Costa Rica, Ecuador, Guatemala, Paraguay, and Uruguay.

Claims Requirements

Nutrition claims are generally accepted in food supplements across Latin America, with harmonized rules for the Southern Common Market (MERCOSUR) countries, composed of Argentina, Brazil, Paraguay, and Uruguay, and for the Central American Economic Integration System (SIECA), which is formed by Costa Rica, El Salvador, Guatemala, Honduras, and Nicaragua.

For health claims, only SIECA has a harmonized list of 14 dis-ease risk-reduction claims and permits the use of nutrient function claims that have already been approved in the US and the EU. The trade bloc of the Pacific Alliance, which is formed by Chile, Colombia, Mexico, and Peru, is also working on a harmonized list of health claims. As a result of this, Chile has already proposed the adoption of 13 nutrient function claims in its public consultation. Currently, Chile does not permit the use of any health claims on supplements. Other countries with restrictions on the use of health claims are Argentina and Mexico.

Apart from these examples, most countries in Latin Ameri- ca authorize claims permitted by recognized international authorities such as the US Food and Drug Administration, Health Canada and the European Commission. However, in Brazil and Colombia, they have developed their own lists of permitted claims with about more than 180 and 60 claims approved respectively.

Market Authorization

Although currently the market access in Latin America is very much restricted to a registration process, there are grounds to move to a notification process in the future, as most countries classify supplements as food. Brazil and Ecuador recently adopted a notification process, which could change as well in Colombia and Peru, if this is agreed through the Pacific Alliance. Other countries with a notification system in place are Chile and Mexico.

Additionally, some countries recognize the registration of food supplements in other markets. This is the case in the Central American countries of SIECA. Argentina recognizes the registration from other MERCOSUR member countries (i.e., Brazil, Paraguay, and Uruguay) and vice versa. This means that Argentine products are also exempt from registration in the other MERCO- SUR member countries. However, this mutual recognition principle has not been implemented throughout all member countries and in the case of Brazil, there is only a bilateral agreement in place with Argentina.

This article originally appeared in the July/Aug 2020 edition of The World of Food Ingredients. Click here for the full version on page 45.