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EFSA opens consultation on aspartame safety evaluation

January 16, 2013
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The European Food Safety Authority (EFSA) has opened a public consultation on its safety assessment of aspartame, which is used as a sweetener for a wide range of products in the global food and drink industry. The consultation is open for comments and recommendations on the draft scientific opinion, released after an extensive review of scientific and other publications on aspartame and its breakdown products, EFSA announced in a statement.

The online consultation will remain open until Feb. 15 and the authority hopes that stakeholders and interested parties will express their stance on its draft opinion. In order to ensure that it is fully engaging stakeholders on the issue, EFSA will also be organizing a meeting to discuss its draft opinion and present the feedback it receives from the online consultation.

Aspartame has been at the center of scientific and regulatory studies for more than three decades but this is the most in-depth and comprehensive analysis and in fact the first that has been formally conducted by EFSA, after it was commissioned by the European Commission in 2011. The evaluation was conducted by the Authority's Scientific Panel on Food Additive and Nutrient Sources Added to Food (ANS Panel).

In their research, scientists from the panel examined all available information on the artificial sweetener, as well as on its breakdown products, and concluded that they pose no toxic threat to consumers if consumption remains at current levels. The Acceptable Daily Intake (ADI) is considered safe for most people and the current consumer exposure to the substance is lower than the ADI, EFSA announced. The ADI was set after analyzing findings from a series of studies carried out on animals, in relation to toxicity and carcinogenicity. The ANS Panel also examined the possible negative impact that phenylalanine, one of aspartame's key breakdown products, could have on developing fetuses.

Phenylalanine is an amino acid that makes up protein found in many food products. Scientific studies indicate that it is toxic if consumed at high levels and pregnant women have been warned against it, as it can have an adverse effect on the fetus, especially in women suffering from the medical condition of phenylketonuria (PKU). This is an inherited condition which leads to increased blood phenylalanine concentrations that could damage the developing brain of the fetus. The ANS Panel concluded that the ADI is not safe for people who suffer from PKU.

The draft opinion also used data from two recent public calls for data which granted access to a large body of scientific information, including some previously unpublished studies. This body of information included the 112 original documents on aspartame which were submitted in the 1980s when the substance was first launched in Europe. EFSA published the full list of these scientific studies and also made publicly available previously unpublished scientific data in a bid to make the whole evaluation process transparent.

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