Dose Issues: Acceptable Daily Intake of Food Additives
Coloring in food additives
Colors are used in a large number of processed foods (candy, dairy products, breakfast cereals, dry pasta, canned and preserved vegetables and fruits, etc.) and beverages, including concoctions.
Recent studies have found carcinogenic effects associated with levels of exposure much lower than the levels previously considered acceptable. As a consequence of these recent findings, changes in the California legislation include the requirement of a warning label indicating the possible carcinogenic effects of these products, inconvenient for manufacturers. Media attention has triggered a series of requests for clarification by Member States.
Acceptable daily intake by different organisms
Colorants are classified according to the reagents used in their manufacturing process, as specified below.
Derived components include 4-methylimidazole (4-MI) and 2-acetyl-4-tetrahydroxybutylimidazole (THI), both under test studies for carcinogens, mainly looking for alveolar / bronchial neoplasms, lung cancer; that is, in laboratory animals.
The Joint FAO / WHO Expert Committee on Food Additives (JECFA) has published in 2011, the levels of acceptable daily intake (ADI) that had been identified in 1985 and 2000 by the following:
CLASS I natural colorant or caustic colorant: not specified for ordinary colorant
CLASS II caustic sulfite dye: 0-160 mg / kg of body weight
CLASS III ammonia dye: 0-200 mg / kg body weight
CLASS IV ammonium sulfite dye: 0-200 mg / kg of body weight
The European Food Safety Authority has re-evaluated the toxicity and carcinogenicity of colored candy in 2004, and established an ADI group of 300 mg / kg of body weight. This figure is based on a review of dose-response studies using laboratory rats, for which health effects, i.e. lung cancer, were not observable at levels of 30 g / kg body weight, using an uncertainty factor of 102 as a precautionary measure. The EFSA also evaluated the exposure in the European population and found mean ADI values that is not very different, and eventually above the IDA identified.
Recent results (2011) published by the study of the US National Toxicology Program, used different methods and reached different results. The US NTP was based on dose-response tests with laboratory mice, taking into account the uncertainty observations observed in laboratory rats. However, based on partial results available from the US NTP, EFSA states that dose responses, observed results in mice were threshold, and alveolar / bronchiolar neoplasia occurs spontaneously in high incidence mice.
By the precautionary principle, the US NTP study uses the non-significant risk level of less than 1 in 105 to arrive at the total ADI of 16 µg / day. This result was available for public comment and scientific peer review, prior to modifications to the Safe Drinking Water and Toxicity Enforcement Act, also known as Proposition 65. As a result, consumer manufacturers in California were will ask you to provide warning signs indicating that the product contains potentially carcinogenic substances. At this point, reactions from manufacturers and media attention have been raised.
In summary, the FAO / WHO JECFA ADI figure of 200 mg / kg of body weight, which can translate into a total consumption of 14 × 106 µg / day for a person of 70 kg of body weight, differs significantly from the NTP figure 16 µg / day for a person of similar body weight. For comparison, the Science Center for the Public Interest published observed levels of about 14 x 104 µg of 4-MI in a 12-ounce can of the beverage.
In other words, a person can reach the FAO / WHO ADI with 100 cans of soft drinks, or a person cannot drink a can of soda to stay below the acceptable daily intake NTP, not counting exposures to through many other processed foods that contain similar additives. These differences are not trivial, and they deserve further scientific investigation and public debate, including multi-stakeholder participation. Methodological comparison is needed to further clarify these ADI figures, including better recognition in the precautionary figures to be used (102 used by FAO / WHO JECFA and EFSA, and 106 used by US NTP).
Furthermore, based on the general precautionary principle, policy makers should encourage manufacturers to seek safer alternative products. This is a significant task considering the wide use of these candy products in the processed food industry.
http://oehha.ca.gov/public_info/facts/4MEIfacts_021012.html http://www.efsa.europa.eu/en/efsajournal/pub/2004.htm http://www.cspinet.org/new/ 201203051.html