Scientific Opinion on Flavouring Group Evaluation 63, Revision 3 (FGE.63Rev3): aliphatic secondary alcohols, ketones and related esters evaluated by JECFA (59th and 69th meetings) structurally related to saturated and unsaturated aliphatic secondary alcohols, ketones and esters of secondary alcohols and saturated linear or branched-chain carboxylic acids evaluated by EFSA in FGE.07Rev4

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Safety evaluation of the food enzyme pullulanase from genetically modified Bacillus subtilis strain NZYM-AK

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Safety evaluation of the food enzyme β-amylase from genetically modified Bacillus licheniformis strain NZYM-JA

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Safety evaluation of food enzyme glucan 1,4-α-maltohydrolase produced with a genetically modified Bacillus subtilis (strain MAM)

Acknowledgements: The Panel wishes to thank the member of the Working Group on Applications: Davor Zeljezic for the preparatory work on this scientific output and EFSA staff members: Margarita Aguilera-Gomez and Magdalena Andryszkiewicz for the support provided to this scienti fic output.Publisher PD

Safety evaluation of the food enzyme α-amylase from a genetically modified Aspergillus niger (strain NZYM-SB)

Acknowledgements: The Panel wishes to thank EFSA staff members: Jaime Aguilera, Ana Gomes,Christine Horn, Joaquim Maia and Annamaria Rossi for the support provided to this scientic outputPublisher PD

Safety evaluation of the food enzyme β-galactosidase from the genetically modified Escherichia coli NCIMB 30325

Abstract The food enzyme is a β‐galactosidase (β‐D‐galactoside galactohydrolase; EC 3.2.1.23) produced with the genetically modified Escherichia coli strain NCIMB 30325 by Clasado Ingredients Ltd. The β‐galactosidase encoding gene is introduced into the recipient strain of E. coli using a self‐replicating plasmid which also contains a gene, which confers resistance to an antibiotic listed as a critically important antimicrobial. This gene was detected in the food enzyme. The absence of viable cells of the production strain in the food enzyme was not demonstrated. The food enzyme is intended to be used only for the production of a mixture of galacto‐oligosaccharides (GOS). Genotoxicity tests did not raise a safety concern. Subchronic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level at the highest dose tested of 900 mg total organic solids (TOS)/kg body weight (bw) per day. Similarity of the amino acid sequence to those of known allergens was searched and no match was found. The Panel considered that under the intended conditions of use the risk for allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood is considered low. Given the risk associated with the presence of antibiotic resistance gene in the food enzyme and the lack of data showing the absence of viable cells, the Panel concludes that the use of β‐galactosidase produced with the genetically modified E. coli NCIMB 30325 cannot be considered safe

Some food toxic for pets

According to world statistics, dogs and cats are the species that owners most frequently seek assistance with potential poisonings, accounting 95–98% of all reported animal cases. Exposures occur more commonly in the summer and in December that is associated with the holiday season. The majority (>90%) of animal poisonings are accidental and acute in nature and occur near or at the animal owner's home. Feeding human foodstuff to pets may also prove dangerous for their health

In vitro effect of pesticides (dichlofluanid, endosulfan, simazine, tolylfluanid and triallate) on proliferative activity of animal derived cell cultures

In this study pesticides with different chemical structures (dichlofluanid, endosulfan, simazine, tolylflu- anid and triallate) were examined for their potential cytotoxic effect on proliferative activity of cell cul- tures of mammalian origin. Cell lines Madin-Darby Bovine Kidney (MDBK), Rabbit Kidney (RK13), Porcine Kidney (PK15), and semicontinual line of Bovine Embryonic Pulmonary Cells (BEPC) were used in the study. From these cell cultures cell proliferative activity was suppressed most intensively in PK15 culture by endosulfan (10 –1 –10 –6 M). The least effect on cell proliferation in all cell cultures test- ed, with the exception PK 15 (10 –1 –10 –2 M), was recorded after simazine exposure. On the basis of IC 50 values the cytotoxic effect was: dichlofluanid (IC 50 = 10 –3.94 M) > tolylfluanid (IC 50 =10 –3.69 M) > endo- sulfan (IC 50 =10 –3.24 M) > triallate (IC 50 =10 –3.12 M) > simazine (IC 50 =10 –1.78 M). The comparison of average IC 50 values of cell cultures revealed that the most sensitive cell lines were PK15 (IC 50 =10 –3.27 M) and RK13 (IC 50 =10 –3.21 M), whereas MDBK (IC 50 =10 –2.55 M) and BEPC (IC 50 =10 –2.52 M) were less sensitive to pesticide exposure

INDUCTION OF MICRONUCLEI IN RAT BONE MARROW AFTER SUBCHRONIC INHALATION EXPOSURE TO MIXTURE OF BENZENE, CYCLOHEXANONE AND CYCLOHEXANE

Abstract The induction of micronuclei was evaluated in 24 Wistar rats (12 male and 12 female) after subchronic inhalation exposure to the mixture of benzene, cyclohexanone and cyclohexane, in the dose of 0.72 g/m 3 ; 5 d per week; for 105 d, against control group (6 male and 6 female). In the exposed group of females the frequency of micronucleated polychromatic erythrocytes (MNPCEs) was significantly increased compared with the control group (10.5 ± 5.419/1000 PCEs against 3.833 ± 1.722/1000 PCEs; P < 0.05). The significant increase in MNPCEs was observed also in exposed group of males compared with the control (12.917 ± 6.431/1000 PCEs against 6.166 ± 1.472/1000 PCEs; P < 0.05). This showed the genotoxic effect of the mixture in the tested animals. The significant changes in the frequency of micronucleated normochromatic erythrocytes (MNNCEs) as well as the ratio of PCEs/NCEs in exposed animals were not recorded