Following a request from the European Commission, an exposure assessment was carried out based on the maximum permitted levels (MPLs) authorised in Annex II of Regulation (EC) No 1333/2008 for thaumatin (E 957) and the proposed increase in its use level in flavoured drinks and proposed extension of use in several food categories at the levels proposed by the applicant. The safety of thaumatin as a food additive was previously evaluated by the EU Scientific Committee on Food (SCF) in 1984 and 1988 and by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1989. Following these assessments, thaumatin was considered acceptable for use, and the ADI was established as 'not specified'. In these evaluations it was, moreover, noted that thaumatin, being a protein, undergoes digestion to normal food components. In providing a scientific opinion on the safety of the proposed extensions of use and use levels, the ANS Panel has decided that a comparison of the exposure resulting from the current uses and use levels with the exposure resulting from these additional proposed uses would be sufficient to address the safety of thaumatin. The Panel calculated that a maximum daily intake of 1.03 mg/kg bw/day of thaumatin, resulting from the exposure assessment at the current proposed uses, or 1.10 mg/kg bw/day, at the proposed new Maximum Permitted Levels (MPLs), would represent 0.12 % or 0.13 %, respectively, of the total daily protein intake for an adult. These percentages would be even lower for children of all ages. The Panel concluded, based on the existing toxicological evaluations, that the proposed extension of uses and changes to use levels would result in a margin of safety of approximately 1 300 which would not represent a safety concern.

Chlorophylls (E 140(i)) were previously evaluated by Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1969 and the Scientific Committee on Food (SCF) in 1975 and 1983 and, in relation to special medical purposes, for young children in 1996. Neither of the Committees established a numerical Acceptable Daily Intake (ADI). Specifications should be updated to adequately cover chlorophylls (E 140(i)), as currently up to 90 % of the extract is unidentified and chlorophylls (E 140(i)) may be obtained from sources that could not be regarded as regular edible plant materials or foods (grass, lucerne, nettle) for humans. Based on the origin of chlorophylls (E 140(i)), the Panel also concluded that data on pesticides, mycotoxins and other components with biological activity (e.g. phytoestrogens, phytotoxins and allergens) should be included in the specification and kept as low as possible to avoid any potential adverse effects (allergenicity, endocrinal effects). The few biological data available indicate that chlorophylls are poorly absorbed by humans and are not metabolised to chlorophyllins (the dephytylated form of chlorophylls). The Panel considered that the few toxicological studies available for chlorophylls were limited and did not comply with the Organisation of Economic Co‐operation and Development (OECD) guidelines or current regulatory requirements, and therefore did not allow for an ADI to be established. The Panel concluded that the available database for chlorophylls was inadequate for risk assessment. However, chlorophylls are natural dietary constituents, which are present at relatively high concentrations in a number of foods. In addition, the exposure resulting from the use of chlorophylls (E 140(i)) as food additives is lower than the exposure to chlorophylls from the regular diet. Therefore, the Panel concluded that, at the reported use levels, chlorophylls (E 140(i)) are not of safety concern as regards their current use as food additives.

Following a request by the European Commission the Scientific Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to conclude on the possible link between the ingestion of β-carotene and cancer enhancement in heavy smokers. The safety of (synthetic) β-carotene [E 160a (ii)] has been evaluated previously by JECFA (1975) and by the SCF (2000a). In 2000, the SCF concluded that there were insufficient data to set a precise figure for a Tolerable Upper Intake Level (UL) of β-carotene (SCF, 2000b). Unexpectedly, two independent trials revealed that heavy smokers (at least 1 package/day for 36 years on average) receiving long-term β-carotene (20 mg/day) supplementation or β-carotene (30 mg/day) + retinol (25 000 International Unit (IU) vitamin A) supplementation, showed increased rather than decreased incidences of lung cancer. A meta-analysis of randomized controlled trials (RCT) demonstrated absence of any protective effect associated with β-carotene supplementation with regard to cancer risk. Epidemiological studies reported no increased lung cancer incidence in heavy smokers at supplemental dose levels of β-carotene varying from 6 -15 mg/day for about 5 up to 7 years. The Panel concluded that exposure to β-carotene from its use as food additive and as food supplement at a level below 15 mg/day do not give rise to concerns about adverse health effects in the general population, including heavy smokers.

Following a request from the European Commission, a refined exposure assessment was carried out based on the maximum permitted levels (MPLs) authorised in Annex II of Regulation (EC) No 1333/2008 for extracts of rosemary (E 392) and the extension of its use in fat‐based spreads at the levels proposed by the applicant of 30 mg/kg and 100 mg/kg. This was not covered by the previous re‐evaluation of the safety of extracts of rosemary (E 392) as a food additive performed by EFSA in 2008. In that previous opinion, it was noted that, whilst the data were insufficient to establish a numerical ADI, the margin of safety was high enough to conclude that dietary exposure resulting from the proposed uses and use levels was not of safety concern. In providing a scientific opinion on the safety of the proposed extensions of use, the ANS Panel has decided that a comparison of the exposure resulting from the current uses and use levels with the exposure resulting from these additional proposed uses would be sufficient to address the safety of extracts of rosemary. The Panel concluded that, since the two additional uses for rosemary extracts in fat‐based spreads would not change the estimated exposure to the food additive compared with the already approved permitted uses in any part of the population, the conclusions made by the AFC Panel in 2008 regarding safety remain valid. Therefore, the Panel considered that it is unlikely that there is a safety concern with the current permitted uses together with the additional proposed extension of uses compared with the current permitted uses alone. The Panel recommends that a refined exposure assessment is carried out to decrease the existing uncertainties arising from its conservative estimates based on current MPLs.

Potassium polyaspartate (A-5D K/SD) is proposed for use as a stabiliser in wine, with a maximum use level of 300 mg/L and typical levels in the range of 100-200 mg/L. The data provided in support of the current application were in accordance with the Tier 1 requirement of the Guidance for submission for food additive evaluations issued by the ANS Panel in 2012. In the in vitro tests provided by the applicant, potassium polyaspartate (A-5D K/SD) showed minimal proteolytic digestion and no absorption of the intact compound. Potassium polyaspartate (A-5D K/SD) tested negative in a bacterial reverse mutation assay performed in accordance with OECD TG 471 and in an in vitro mammalian cell micronucleus test performed in accordance with OECD TG 487. From a 90-day oral toxicity study in rats performed in accordance with OECD TG 408, a no observed adverse effect level (NOAEL) was set at 1,000 mg/kg bw per day, the highest dose tested. The Panel considered these data as fulfilling the requirements for the evaluation of the new food additive and did not request additional testing for chronic toxicity and carcinogenicity, nor for reprotoxicity and developmental toxicity. Exposure estimates to potassium polyaspartate (A-5D K/SD) from its proposed use were calculated for both typical and maximum use levels. In the worst case scenario of high-level intakes of potassium polyaspartate (A-5D K/SD) when used at the maximum proposed use level of 300 mg/L, the maximum estimated intake would be 1.8 mg/kg bw per day in the elderly and 1.4 mg/kg bw per day in adults, resulting in a margin of safety of approximately 550. The Panel concluded that there was no safety concern from the proposed use and use levels of potassium polyaspartate (A-5D K/SD). Acknowledgements:The Panel wishes to thank the members of the Working Group on Applications for the preparatory work on this scientific output and EFSA staff members: Paolo Colombo, Juho Lemmetyinen, Camilla Smeraldi and Alexandra Tard for the support provided to this scientific output.