Safety tests for food additives
Food Standards Australia New Zealand (FSANZ) is responsible for the approval of which food additives are allowed in Australian foods. All food additives used in Australia undergo a safety assessment, which includes rigorous testing before they are approved.
Toxicological tests on animals are used to determine the amount of the additive that is expected to be safe when consumed by humans. This is usually an amount 100 times less than the maximum daily dose at which ‘no observable effects’ are produced by an additive consumed over the test animal’s lifetime.
If there is any doubt over the safety of an additive, approval is not given. If new scientific information becomes available suggesting that a food additive is no longer safe, the approval to use the food additive would be withdrawn.
Most food additives are tested in isolation, rather than in combination with other additives. The long-term effects of consuming a combination of different additives are currently unknown.
Plant Extracts: The Original Food Additives
Plant and herb extracts have long been used to enhance the healthfulness, color, and even taste and flavor of foods, beverages and supplements. With an often “natural” positioning, their popularity is assured.
Ginny Bank, Contributing Editor
October 2011/NutraSolutions -- In 399 BC, the Greek philosopher Socrates was executed by drinking an infusion of the poisonous hemlock plant. In ancient Egypt, Cleopatra used henbane extract to dilate her eyes and make her appear more alluring. Also in Egypt, red fabric found in the tomb of King Tut contained alizarin, a pigment extracted from the roots of the madder plant. While such historical accounts documenting human use of plant-based extracts can be traced back over 3,000 years, their use is possibly as old as civilization itself. From the very first Chinese dynasties, Mesopotamia and ancient Greece, and westward to the empires of Mesoamerica, early civilizations had a surprisingly sophisticated understanding of botanicals and their extracts, especially for use as medicine. Flowers, fruits, roots, bark and leaves of plant material were extracted by various techniques to concentrate not only their therapeutic properties, but also their pigments, aromas and flavors. The simplest method of extraction, used for plants that have high oil content, was the expression of the essential oils. Other techniques included steeping the plant part in water to make an infusion (also known as a tisane) or mashing them and boiling in water to make a decoction. This method was also used to make natural dyes, sometimes boiling the decoction for days to concentrate the pigments further. Elixirs were produced by extracting the plant parts in alcoholic beverages to dissolve the active components.
Today, the use of plant extracts to flavor, color and improve health are not that different from ancient times. Even the extraction methods are fundamentally the same. And, with hundreds, if not thousands, of years of traditional use behind many plant extracts, their safety (and often their efficacy) has been well-documented. Even so, when one takes into account the massive number of plant-based extracts used in traditional medicinal systems, such as Ayurveda and traditional Chinese medicine, very few are approved for use in foods or have Generally Recognized as Safe (GRAS) status. This may be changing, as self-affirmation of GRAS status for such ingredients is steadily increasing. Within the last 18 months alone, a number of extracts received GRAS status through self-affirmation, with or without FDA notification
Pharmaceutical manufacturing is a strictly regulated, process-driven industry. A mistake in manufacturing can be costly in the best-case scenario and at worst, it can be life-threatening, particularly if a product has reached consumers.
The industry must adhere to numerous guidelines that are laid out by the Food & Drug Administration (FDA), for example, the Current Good Manufacturing Practices (cGMP). Product quality is at the center of cGMP, which assures the correct monitoring, design, and control of manufacturing facilities and processes.
