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Low-calorie sweeteners are authorised food additives in the European Union (EU). The safety of these sweeteners has been evaluated in accordance with internationally agreed principles for the safety evaluation of food additives. In the EU, the European Commission’s Scientific Committee for Food (SCF) was the scientific guarantor for the safety of food additives until March 2003. Since then this has been taken over by the European Food Safety Authority (EFSA), notably its Scientific Panel on Food Additives and Nutrient Sources Added to Food (ANS Panel). Based on the large number of toxicological studies that are requested for the safety evaluation of food additives, a no observed adverse effect level (NOAEL) is identified for the most sensitive effect in the most sensitive animal species. A safety factor of 100 is normally applied to the NOAEL in order to establish an acceptable daily intake (ADI) for humans. The ADI is the amount of the food additive, expressed on a milligram per kilogram of body weight (bw) basis, that can be ingested daily over a lifetime without any appreciable health risk. The following low-calorie sweeteners have been allocated an ADI by either the SCF or EFSA: acesulfame K, aspartame, cyclamates, neotame, saccharin, steviol glycosides and sucralose.

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion evaluating the safety of glycerol esters of tall oil rosin (GETOR) for the proposed use as a stabilising and emulsifying food additive in certain beverages up to a maximum level of 100 mg/l. In view of the limited toxicity studies for GETOR, analytical data were submitted to demonstrate that GETOR are chemically equivalent to glycerol esters of wood rosin (GEWR) which have already been authorised as a food additive by Directive 95/2/EC. The Joint FAO/WHO Expert Committee on Food Additives decided that it could not evaluate GETOR without additional information on its composition, in order to clarify the extent and significance of any differences relative to other glycerol esters of rosins. GETOR are obtained by esterification of tall oil rosin and are described as a complex mixture of mono-, di- and tri-glycerol esters of resin acids (fraction (a)). Besides these esters, free resin acids (fraction (b)) and other saponifiable and unsaponifiable substances (fraction (c)) including sulphur compounds are present in GETOR. Conclusive analytical data on the proportions of fractions (a), (b), and (c) are not provided and also data on the identity and quantity of their individual components are absent. The results of two acute oral toxicity studies are the only toxicological data available for GETOR. Overall the Panel concluded that the chemical and toxicological characterisation of GETOR is not adequate. The Panel also could not conclude that GETOR is chemically equivalent to GEWR thus the toxicological data obtained with GEWR could not be used for read across. Therefore, the Panel concluded that the available data are too limited to conclude on the safety of GETOR as a food additive at the proposed uses and use levels. (C) European Food Safety Authority, 2011

Lutein is a carotenoid colour authorised as a food additive in the EU (E 161b) and reevaluated by the Panel on Food Additives and Nutrient Sources added to Food (ANS) in 2010. The ANS Panel established an ADI of 1 mg/kg bw/day and noted that this ADI refers to lutein derived from Tagetes erecta containing at least 80% carotenoids. In the present opinion the Panel considered whether additional studies made available address the gaps identified by the Panel in the toxicological database for lutein preparations other than lutein with high concentrations of total saponified carotenoids at levels of at least 80%. The Panel noted that in all additional studies made available, a specific lutein ester preparation extracted from Tagetes erecta was tested, containing > 60% carotenoid esters (> 93% lutein esters, remainder zeaxanthin esters). No additional data were provided on lutein with levels of similar to 5-12% total carotenoids. The Panel concluded that lutein esters are not of concern with respect to genotoxicity. The additional data also included a 90-day toxicity study and a reproductive and developmental toxicity study. The Panel established for both studies a NOAEL of 1000 mg/kg bw/day, the highest dose level tested (equivalent to 538 mg lutein equivalents/kg bw/day). The Panel noted that this NOAEL of 538 mg lutein equivalents/kg bw/day is higher than the NOAEL of 200 mg/kg bw/day (the highest dose level tested) in the 90-day rat study with lutein from which the ADI has been derived. Based on these results, the Panel concluded that the additional database supports the conclusion that the ADI of 1 mg/kg bw/ day also refers to lutein with high concentrations of total carotenoids extracted from Tagetes erecta and present as esters at levels of >= 60%. The Panel concluded that the toxicological data-base available is too limited to conclude that the ADI also applies to lutein preparations of lower purity or from other sources. (C) European Food Safety Authority, 2011

The Scientific Committee reviewed the current state-of-the-science on genotoxicity testing and provided a commentary and recommendations on genotoxicity testing strategies. A step-wise approach is recommended for the generation and evaluation of data on genotoxic potential, beginning with a basic battery of in vitro tests, comprising a bacterial reverse mutation assay and an in vitro micronucleus assay. Consideration should be given to whether specific features of the test substance might require substitution of one or more of the recommended in vitro tests by other in vitro or in vivo tests in the basic battery. In the event of negative in vitro results, it can be concluded that the substance has no genotoxic potential. In case of inconclusive, contradictory or equivocal results, it may be appropriate to conduct further testing in vitro. In case of positive in vitro results, review of the available relevant data on the test substance and, where necessary, an appropriate in vivo study to assess whether the genotoxic potential observed in vitro is expressed in vivo is recommended. Suitable in vivo tests are the mammalian erythrocyte micronucleus test, transgenic rodent assay, and Comet assay. The approach to in vivo testing should be step-wise. If the first in vivo test is positive, no further testing is necessary and the substance should be considered as an in vivo genotoxin. If the test is negative, it may be possible to conclude that the substance is not an in vivo genotoxin. However, in some cases, a second in vivo test may be necessary (e.g. if the first test is negative but more than one endpoint in the in vitro tests are positive, an in vivo test on a second endpoint may be necessary). The combination of assessing different endpoints in different tissues in the same animal in vivo should also be considered.