The ANS Panel provides a scientific opinion re‐evaluating the safety of Indigo Carmine (E132). The Panel observed that Indigo Carmine was poorly absorbed and does not raise concern for genotoxicity. No adverse effects in subacute, chronic, reproduction and developmental toxicity studies, and no modifications of haematological and biological parameters in chronic toxicity studies have been identified at doses less than or equal to 500 mg/kg bw/day. The only report of an adverse effect was in testis with a LOAEL of 17 mg/kg bw/day which would give rise to a safety concern if confirmed. The Panel considered that this study has shortcomings since it is not clear to the Panel whether the adverse effects observed were due to the food additive itself or to impurities and/or contaminants present in the material tested and/or to the conduct of the study. The Panel considered that the current ADI of 5 mg/kg bw/day for Indigo Carmine was applicable to a material with the same purity and manufacturing process as material used in studies without adverse effects on testis (93% pure colouring and 7% volatile matter) and concluded that any extension of this ADI to Indigo Carmine of lower purity and/or manufactured using a different process would require new data which would need to address the adverse effects on testis. The Panel noted that at the MPL, exposure estimates of Indigo Carmine would exceed the ADI for toddlers and children at the high level. Exposure estimates using the available usage and analytical data did not show an exceedance of the ADI for any population groups.

The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific statement presenting a conceptual framework for the risk assessment of certain food additives re‐evaluated under Commission Regulation (EU) No 257/2010. This framework will be used in the evaluation made by the Panel, but the expert judgement of the scientific background, on a case‐by‐case basis, remains essential to reach a final conclusion. The outcome of the re‐evaluation of food additives taking into account all available information is presented in the document, as well as the exposure assessment scenarios to be carried out by the Panel considering the use levels set in the legislation and the availability of adequate usage or analytical data.

The Panel on Food Additives and Nutrient Sources added to Food (ANS Panel) has previously provided a scientific opinion re-evaluating the safety of Sunset Yellow FCF (E 110) as a food additive in the EU and establishing a temporary acceptable daily intake (ADI) of 1 mg/kg bw/day (EFSA ANS Panel, 2009). Following a request by the European Commission, the ANS Panel was asked to assess newly submitted data from a study conducted as a result of the recommendations contained in the 2009 opinion. In addition, EFSA was requested to carry out the refined exposure assessment of Sunset Yellow FCF. The new information assessed comprised an evaluation of the 28-day study report, the data considered by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in its latest evaluation from 2011, and any additional toxicological information that had become available since the completion of the previous evaluation by the ANS Panel. The ANS Panel has considered that the newly submitted data from the 28-day study and the overall available toxicological database on Sunset Yellow FCF provides a basis to revise the established temporary ADI and concluded that, based on the NOAEL of 375 mg/kg bw/day from the long-term feeding study in rats and an uncertainty factor of 100, a new ADI for Sunset Yellow FCF of 4 mg/kg bw/day can be established, in agreement with the latest evaluation by JECFA. Exposure estimates for Sunset Yellow FCF based both on the currently authorised MPLs and reported use levels provided are well below the new ADI of 4 mg/kg bw/day for all population groups. Overall, the Panel concluded that, using data provided by the food industry and Member States, the reported uses and use levels of Sunset Yellow FCF (E 110) would not be of safety concern. © European Food SUMMARYIn 2009 the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS Panel) has adopted a scientific opinion on the re-evaluation of Sunset Yellow FCF (E 110) as a food additive in the EU. In its opinion, the ANS Panel established a temporary acceptable daily intake (tADI) of 1 mg/kg bw/day and requested a 28-day study with Sunset Yellow FCF to be performed in accordance with OECD guidelines and with well-defined material, in order to clarify the histopathological changes in the testes and the changes in the blood lipid profile observed by Mathur el al. (2005aMathur el al. ( , 2005b in rats, after 90-day dietary exposure to Sunset Yellow FCF at dose levels equivalent to 250 and 1 500 mg/kg bw/day.Following a request from the European Commission, the ANS Panel was asked to deliver a scientific opinion on the data generated from a 28-day study conducted as a result of the recommendations contained in the 2009 opinion and whether, on the grounds of these new data, the ADI should be reconsidered.Furthermore, following the conclusions of the 2009 opinion as regards exposure to Sunset Yellow FCF (E 110), EFSA was requested to carry out a refined exposure assessment for this food additive. In that opinion, the ANS Panel had evaluated t...

Soybean MON 87769 was developed using Agrobacterium tumefaciens transformation and was intended to modify the lipid profile of the extracted oil. Soybean MON 87769 contains a single insert consisting of the Pj.D6D gene encoding the Δ6 desaturase protein from Primula juliae and the Nc.Fad3 gene encoding the Δ15 desaturase protein from Neurospora crassa, both involved in the desaturation of endogenous fatty acids into stearidonic acid. The molecular characterisation of soybean MON 87769 does not raise safety issues. Soybean MON 87769 differs from the conventional counterpart in its fatty acid profile. The safety assessment of the newly expressed desaturases identified no concerns regarding potential toxicity and allergenicity. Nutritional assessment of soybean MON 87769 and derived food products did not identify concerns about human health and nutrition. Consumption of MON 87769 soybean oil replacing other oils in food is not expected to result in adverse effects from increased SDA intake as shown in different exposure scenarios. There are no indications of an increased likelihood of establishment and spread of feral soybean plants. Considering the scope of the application, potential interactions of soybean MON 87769 with the biotic and abiotic environment were not considered a relevant issue. Environmental risks associated with a theoretically possible horizontal gene transfer from soybean MON 87769 to bacteria have not been identified. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean MON 87769. Since the use of oil derived from the soybean MON 87769 will result in a higher intake of SDA, a post-market monitoring plan is recommended to confirm the exposure assessment using realistic consumption data for the European population. Since the use of oil derived from the soybean MON 87769 will result in a higher intake of SDA, a post-market monitoring plan is recommended to confirm the exposure assessment using realistic consumption data for the European population. A comparative analysis of soybean MON 87769 identified no phenotypic or agronomic differences with respect to its conventional counterpart (soybean A3525) and to non-GM soybean reference varieties. However, it confirmed that the composition of soybean MON 87769 differs from that of the conventional counterpart and non-GM soybean reference varieties. The newly expressed desaturases in soybean MON 87769 seeds resulted in an alteration of the fatty acid profile, leading to the appearance of four new fatty acids (stearidonic acid (SDA), -linolenic acid and two trans-fatty acids) and a reduction in linoleic acid (LA). The safety assessment identified no concerns regarding the potential toxicity and allergenicity of the newly introduced desaturase proteins. There are no indications that the genetic modification might change the overall allergenicity of soybean MON 87769 when compared with that of its conventional counterpart. The EFSA GMO Panel concludes that the estimated changes in fat...

Oilseed rape MON 88302 was developed by Agrobacterium tumefaciens-mediated transformation to express the CP4 EPSPS protein, which confers tolerance to glyphosate. The molecular characterisation of oilseed rape MON 88302 did not raise safety issues. Agronomic and phenotypic characteristics of oilseed rape MON 88302 tested under field conditions revealed no biologically relevant differences between oilseed rape MON 88302 and its conventional counterpart, except for days-to-first flowering. No differences in the compositional data requiring further safety assessment were identified. There were no concerns regarding the potential toxicity and allergenicity of the newly expressed CP4 EPSPS protein, and no evidence that the genetic modification might significantly change the overall allergenicity of oilseed rape MON 88302. The nutritional value of oilseed rape MON 88302 is not expected to differ from that of non-GM oilseed rape varieties. There are no indications of an increased likelihood of spread and establishment of feral oilseed rape MON 88302 plants or hybridising wild relatives, unless these plants are exposed to glyphosate. It is unlikely that the observed difference in days-to-first flowering would lead to any relevant increase in persistence or invasiveness. Risks associated with an unlikely, but theoretically possible, horizontal transfer of recombinant genes from oilseed rape MON 88302 to bacteria were not identified. The post-market environmental monitoring plan is in line with the intended uses of oilseed rape MON 88302. In conclusion, the EFSA GMO Panel considers that the information available addresses the scientific requirements of the EFSA GMO Panel and the scientific comments raised by the Member States, and that oilseed rape MON 88302, as described in this application, is as safe as its conventional counterpart and non-GM commercial oilseed rape varieties with respect to potential effects on human and animal health and the environment in the context of the scope of this application. ABSTRACTOilseed rape MON 88302 was developed by Agrobacterium tumefaciens-mediated transformation to express the CP4 EPSPS protein, which confers tolerance to glyphosate. The molecular characterisation of oilseed rape MON 88302 did not raise safety issues. Agronomic and phenotypic characteristics of oilseed rape MON 88302 tested under field conditions revealed no biologically relevant differences between oilseed rape MON 88302 and its conventional counterpart, except for days-to-first flowering. No differences in the compositional data requiring further safety assessment were identified. There were no concerns regarding the potential toxicity and allergenicity of the newly expressed CP4 EPSPS protein, and no evidence that the genetic modification might significantly change the overall allergenicity of oilseed rape MON 88302. The nutritional value of oilseed rape MON 88302 is not expected to differ from that of non-GM oilseed rape varieties. There are no indications of an increased likelihood of spread and est...