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Abstract Low‐substituted hydroxypropyl cellulose (L‐HPC) is a low‐substituted poly(hydroxypropyl) ether of cellulose. L‐HPC is proposed for use as a food additive in food supplements in solid form (tablet), with a maximum use level of 20,000 mg/kg and a typical use level of 10,000 mg/kg. Exposure estimates to L‐HPC from its proposed use were calculated for both typical and maximum use levels. Due to the close chemical relationship between L‐HPC and other celluloses recently re‐evaluated by EFSA, the Panel decided to read‐across the biological data already evaluated in the context of the re‐evaluation programme. The Panel concluded that there was no safety concern from the proposed use and use levels of L‐HPC.

Abstract The Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion on the safety of hydroxyanthracene derivatives and to provide advice on a daily intake that does not give rise to concerns about harmful effects to health. Hydroxyanthracene derivatives are a class of chemical substances naturally occurring in different botanical species and used in food to improve bowel function. The ANS Panel reviewed the available scientific data on a possible relationship between hydroxyanthracene derivatives exposure and genotoxic and carcinogenic effects. On the basis of the data currently available, the Panel noted that emodin, aloe‐emodin and the structurally related substance danthron have shown evidence of in vitro genotoxicity. Aloe extracts have also been shown to be genotoxic in vitro possibly due to the presence of hydroxyanthracene derivatives in the extract. Furthermore, aloe‐emodin was shown to be genotoxic in vivo and the whole‐leaf aloe extract and the structural analogue danthron were shown to be carcinogenic. Epidemiological data suggested an increased risk for colorectal cancer associated with the general use of laxatives, several of which contain hydroxyanthracene derivatives. Considering the possible presence of aloe‐emodin and emodin in extracts, the Panel concluded that hydroxyanthracene derivatives should be considered as genotoxic and carcinogenic unless there are specific data to the contrary, such as for rhein, and that there is a safety concern for extracts containing hydroxyanthracene derivatives although uncertainty persists. The Panel was unable to provide advice on a daily intake of hydroxyanthracene derivatives that does not give rise to concerns about harmful effects to health.

Abstract The present scientific opinion deals with the evaluation of the safety of nisin (E 234) in the light of new toxicological data and with the proposed extension of use in unripened cheese and heat‐treated meat products. Nisin (E 234) is currently an authorised food additive in the EU under Annex II of Regulation (EC) 1333/2008 for use in several food categories. The safety of nisin (E 234) as a food additive has been evaluated in 2006 by the EFSA Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food, where an acceptable daily intake (ADI) of 0.13 mg/kg body weight (bw) was confirmed as previously established by Scientific Committee on Food (SCF). In addition to the studies previously evaluated by EFSA in 2006, the Panel considered in the present opinion, data from a new subchronic toxicity study. No adverse effects were observed in a repeated dose oral toxicity study in which rats were administered nisin A for 90 days. A no observed adverse effect level (NOAEL) of 225 mg nisin A/kg bw per day, the highest dose tested, was identified for this study. Using this NOAEL, an ADI of 1 mg nisin A/kg bw per day for nisin (E 234) was calculated applying a default uncertainty factor of 200 for extrapolation of subchronic to chronic exposure and inter‐ and intra‐species variability. The Panel calculated exposure estimates for both the current and the proposed uses based on the data available in the EFSA Comprehensive Database. The Panel considered that the overall exposure estimate was below the new ADI for nisin A for all population groups. The Panel concluded that the proposed extension of use of nisin (E 234) as a food additive in unripened cheese (at maximum level of 12 mg/kg) and in heat‐treated meat products (at maximum level of 25 mg/kg) would not be of safety concern.

Abstract The present scientific opinion deals with the safety of the extension of use of lycopene (E 160d) in certain meat preparations, meat products and fruit and vegetable preparations. Lycopene (E 160d) is an authorised food additive in the EU for use in several food categories and an acceptable daily intake (ADI) of 0.5 mg/kg body weight (bw) per day was established. In the present opinion, the Panel decided that a comparison of the exposure resulting from the current uses and use levels with the exposure resulting from this additional proposed extension of uses would be sufficient to address the safety of lycopene. The Panel calculated that, considering the current maximum permitted levels (MPLs) and the proposed extension of uses and use levels, the mean dietary exposure to lycopene (E 160d) in the total population ranged from 0.01 mg/kg bw per day in infants to 0.82 mg/kg bw per day in toddlers. At the high level, dietary exposure to lycopene (E 160d) ranged from 0.03 mg/kg bw per day in infants to 1.39 mg/kg bw per day in toddlers. The Panel concluded that the proposed extension of uses of lycopene (E 160d) as a food additive in meat preparations, meat products and fruit and vegetable preparations up to 60 mg/kg would not add significantly to the intake of the food additive at its current MPL. However, the Panel noted that the overall intake at the MPL scenario would exceed the currently established ADI. The Panel acknowledged the uncertainties in the current estimates which could result in an overestimation of the exposure to lycopene (E 160d) as a food additive in European countries and therefore concluded that a refined exposure estimate would be recommended focusing on food categories contributing the most to its estimates, in order to decrease uncertainties in its current estimates.