The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate 56 flavouring substances in the Flavouring Group Evaluation 6, Revision 4, using the Procedure in Commission Regulation (EC) No 1565/2000. This revision is made due to the inclusion of six additional flavouring substances, (-)-3,7-dimethyl-6-octen-1-ol .229], dec-4(cis)-enal .137], neral .170], trans-3,7-dimethylocta-2,6-dienal (geranial) .188], trans-3-hexenyl formate .562] and cis-3-hexenyl 2-methylbutanoate ]. None of the substances were considered to have genotoxic potential. The substances were evaluated through a stepwise approach (the Procedure) that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern and available data on metabolism and toxicity. The Panel concluded that the 56 substances 02.138, 02.152, 02.170, 02.175, 02.176, 02.195, 02.201, 02.222, 02.229, 02.234, 05.061, 05.082, 05.137, 05.143, 05.170, 05.174, 05.188, 05.203, 05.217, 05.218, 05.220, 05.226, 08.074, 08.100, 08.102, 09.341, 09.368, 09.377, 09.562, 09.567, 09.569, 09.572, 09.575, 09.612, 09.638, 09.640, 09.643, 09.672, 09.673, 09.674, 09.831, 09.838, 09.854, 09.855, 09.871, 09.872, 09.884, 09.885, 09.897, 09.898, 09.928, 09.937, 09.938, 09.939 and 09.950] do not give rise to safety concern at their levels of dietary intake, estimated on the basis of the MSDI approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered. Adequate specifications including complete purity criteria and identity for the materials of commerce have been provided for all 56 Forty-one of the flavouring substances in the present group have been reported to occur naturally in a wide range of food items.In its evaluation, the Panel as a default used the "Maximised Survey-derived Daily Intake" (MSDI) approach to estimate the per capita intakes of the flavouring substances in Europe. However, when the Panel examined the information provided by the European Flavour Industry on the use levels in various foods, it appeared obvious that the MSDI approach in a number of cases would grossly underestimate the intake by regular consumers of products flavoured at the use level reported by the Industry, especially in those cases where the annual production values were reported to be small. In consequence, the Panel had reservations about the data on use and use levels provided and the intake estimates obtained by the MSDI approach.In the absence of more precise information that would enable the Panel to make a more realistic estimate of the intakes of the flavouring substances, the Panel has decided also to perform an estimate of the daily intakes per person using a "modified Theoretical Added Maximum Daily Intake" (mTAMDI) approach based on the normal use levels reported by Industry. In those cases where the mTAMDI approach indicated that the intake of a flavouring subs...

This is a call for action to scientific journals to introduce reporting requirements for toxicity and ecotoxicity studies. Such reporting requirements will support the use of peer‐reviewed research studies in regulatory decision‐making. Moreover, this could improve the reliability and reproducibility of published studies in general and make better use of the resources spent in research.

An extensive literature search to identify and collect studies related to the toxicity of grayanotoxins and 5‐hydroxymethylfurfural (5‐HMF) was performed in the three databases PubMed, Web of Science and SciFinder® for six and four Areas, respectively. After combination of the searches from the three databases and removal of the duplicates, the total number of references for the grayanotoxins was 652 and for 5‐HMF Area 1b was 3,862, for Area 2b was 37, for Area 3b was 221 and for Area 4b was 500. The evaluation of all retrieved references for relevance by screening the title and abstract (if available) and applying eligibility criteria (inclusion/exclusion) resulted in a total number of relevant references for the grayanotoxins for Area 1a of 71, for Area 2a of 3, for Area 3a of 5, for Area 4a of 75, for Area 5a of 141, and for Area 6a of 78 and for 5‐HMF for Area 1b of 55, for Area 2b of 14, for Area 3b of 15 and for Area 4b of 8.

An extensive literature search to identify and collect studies related to the toxicity of polybrominated diphenyl ethers (PBDEs), tetrabromobisphenol A (TBBPA) and brominated phenols (BPs) was performed in the three databases PubMed, Web of Science and SciFinder® for four Areas. After combination of the searches from the three databases and removal of the duplicates, the total number of references for Area 1 was 6,231, for Area 2 was 8,236, for Area 3 was 4,994 and for Area 4 was 6,363. The evaluation of all retrieved references for relevance by screening the title and abstract (if available) and applying eligibility criteria (inclusion/exclusion) resulted in a total number of relevant references for Area 1 of 378 (PBDEs), 46 (TBBPA) and 29 (BPs), for Area 2 of 188 (PBDEs), 37 (TBBPA) and 4 (BPs), for Area 3 of 518 (PBDEs), 180 (TBBPA) and 49 (BPs), and for Area 4 of 717 (PBDEs), 59 (TBBPA) and 18 (BPs).

This report describes the tasks performed in the period 1/3/2016 to 28/2/2017 under the EFSA contract OC/EFSA/GMO/2014/01, Lot 2 on toxicological studies and animal feeding studies included in applications for market authorisation of genetically modified feed/plants under Regulation (EC) No 1829/2003. The tasks cover the check for study adherence to relevant EFSA guidance documents and to OECD Test Guideline no 407 (1995/2008), OECD Test Guideline no 408 (1998) and OECD Principles on Good Laboratory Practice. During the period covered by this report, preparatory work has been performed on six applications for GM plants submitted under Regulation (EC) No 1829/2003 for a total of three 28-day studies on newly expressed proteins and six 90-day studies in rodents on GM food/feed, using comprehensive checklist templates.

This report describes the tasks performed in the period 28/11/2018 to 5/12/2019 under the EFSA contract OC/EFSA/GMO/2018/02, Lot 2 on toxicological studies and animal feeding studies included in applications for market authorisation of genetically modified feed/plants under Regulation (EC) No 1829/2003. The tasks cover the check for study adherence to relevant EFSA guidance documents and to OECD Test Guideline no 407 (2008), OECD Test Guideline no 408 (1998) and OECD Principles on Good Laboratory Practice. During the period covered by this report, preparatory work has been performed on five applications for GM plants submitted under Regulation (EC) No 1829/2003 for a total of two 28-day studies on newly expressed proteins and six 90-day studies in rodents on GM food/feed, using comprehensive checklist templates.

This report describes the tasks performed in the period 6/12/2019 to 16/07/2020 under the EFSA contract OC/EFSA/GMO/2018/02, Lot 2 on toxicological studies and animal feeding studies included in applications for market authorisation of genetically modified feed/plants under Regulation (EC) No 1829/2003. The tasks cover the check for study adherence to relevant EFSA guidance documents and to OECD Test Guideline no 407 (2008), OECD Test Guideline no 408 (1998) and OECD Principles on Good Laboratory Practice. During the period covered by this report, preparatory work has been performed on five applications for GM plants submitted under Regulation (EC) No 1829/2003 for a total of one 28-day study on newly expressed proteins and five 90-day studies in rodents on GM food/feed, using comprehensive checklist templates.

An extensive literature search to identify and collect all studies related to fumonisins and their modified forms was performed in the two databases PubMed and Web of Science for nine Areas. After combination of the searches from the two databases and removal of the duplicates, the total number of hits for Area 1 was 4456, for Area 2 was 2261, for Area 3 was 1649, for Area 4 was 3555, for Area 5 was 1632, for Area 6 was 2424, for Area 7 was 5087, for Area 8 was 3284, and for Area 9 was 3283. The evaluation of all retrieved references for relevance by screening the title and abstract (if available) and applying eligibility criteria (inclusion/exclusion) resulted in a total number of relevant references for Area 1 of 532, for Area 2 of 114, for Area 3 of 273, for Area 4 of 87, for Area 5 of 138, for Area 6 of 38, for Area 7 of 270, for Area 8 of 709, and for Area 9 of 270.