Suchergebnisse

Abstract
Hexane (called 'technical hexane' in this report) is authorised for use as an extraction solvent in the production of foodstuffs and food ingredients under Directive 2009/32/EC. Following a request from the European Commission, EFSA assessed the need for a re‐evaluation of its safety, which was addressed by the Scientific Committee on Food (SCF) in 1996. To this end, EFSA focused on the composition of technical hexane, its established and potential toxicological adverse effects and the potential exposure of consumers. Technical hexane is defined in the Directive as 'a commercial product consisting essentially of acyclic saturated hydrocarbons containing six carbon atoms and distilling between 64°C and 70°C'. Specifications, including the identity and fraction of constituents, are not defined. n‐Hexane is reported to be the main constituent. Impurities may be of concern, as they may be transferred to the extracted food, depending on their physicochemical properties and the extraction procedure. An exposure assessment based on regulatory limits showed that the exposure of infants, toddlers and other children may be higher than that considered by the SCF. Regarding genotoxicity, EFSA reiterated the absence of concern. The information provided by the 90‐day study in rats considered by the SCF was no longer considered sufficient to adequately conclude on the safety of technical hexane. Moreover, as n‐hexane is absorbed in humans, additional toxicity studies exploring more end points may be needed. A scoping literature search showed that recent toxicological information on the safety of technical hexane is available, although its relevance was not appraised during this activity. EFSA concluded that there is a need for a re‐evaluation of the safety of the use of technical hexane as an extraction solvent in the production of foodstuffs and food ingredients.

EFSA was asked by the European Commission to provide information on levels of lipophilic shellfish toxins in whole scallops that would ensure levels in edible parts below the regulatory limits after shucking, i.e. removal of non‐edible parts. This should include the okadaic acid (OA), the azaspiracid (AZA) and the yessotoxin (YTX) groups, and five species of scallops. In addition, EFSA was asked to recommend the number of scallops in an analytical sample. To address these questions, EFSA received suitable data on the three toxin groups in two scallop species, Aequipecten opercularis and Pecten maximus, i.e. data on individual and pooled samples of edible and non‐edible parts from contamination incidents. The majority of the concentration levels were below limit of quantification (LOQ)/limit of detection (LOD), especially in adductor muscle but also in gonads. Shucking in most cases resulted in a strong decrease in the toxin levels. For Pecten maximus, statistical analysis showed that levels in whole scallops should not exceed 256 μg OA eq/kg or 217 μg AZA1 eq/kg to ensure that levels in gonads are below the regulatory limits of 160 μg OA or AZA1 eq/kg with 99% certainty. Such an analysis was not possible for yessotoxins or any toxin in Aequipecten opercularis and an assessment could only be based on upper bound levels. To ensure a 95% correct prediction on whether the level in scallops in an area or lot is correctly predicted to be compliant/non‐compliant, it was shown that 10 scallops per sample would be sufficient to predict with 95% certainty if levels of OA‐group toxins in the area/lot were 25% below or above the regulatory limit. However, to predict with a 95% certainty for levels between 140 and 180 μg OA eq/kg, a pooled sample of more than 30 scallops would have to be tested.

EFSA was asked by the European Commission to provide information on the levels of domoic acid (DA) in whole scallops that would ensure that levels in edible parts are below the regulatory limit after shucking. This should include five species of scallops. In addition, EFSA was asked to recommend the number of scallops to be used in an analytical sample. To address these questions, EFSA received suitable data on DA for only one scallop species, Pecten maximus, i.e. data on pooled samples of edible and non‐edible parts. A large part of the concentration levels was above the limit of quantification (LOQ) and only these data were used for the assessment. Shucking in most cases resulted in a strong decrease in the toxin levels. Statistical analysis of the data showed that levels in whole scallops should not exceed 24 mg DA/kg, 59 mg DA/kg and 127 mg DA/kg to ensure that levels in, respectively, gonads, muscle and muscle plus gonads are below the regulatory limit of 20 mg DA/kg with 99% certainty. Such an analysis was not possible for the other scallop species. In the absence of data from member states, published data of variations between scallops were used to calculate the sample size to ensure a 95% correct prediction on whether the level in scallops in an area or lot is correctly predicted to be compliant/non‐compliant. It was shown that 10 scallops per sample would be sufficient to predict with 95% certainty if DA levels in the area/lot were twofold below or above the regulatory limit for the highest reported coefficient of variance (CV) of 1.06. To predict with 95% certainty for levels between 15 and 27 mg DA/kg, a pooled sample of more than 30 scallops would have to be tested.

Acknowledgements: The Panel wishes to thank the following hearing experts for the supportprovided to this scientic output: Laurent Guillier, Mari na Nicolas and Micheal O'Mahony. ThePanel wishes to acknowledge all European competent institutions, Member State bodies and otherorganisations that provided data for this scientic output ; Peer reviewed ; Publisher PDF

Acknowledgements: The Panel wishes to thank the following hearing experts for the support provided to this scientific output: Marina Nicolas and Micheal O'Mahony. The Panel wishes to acknowledge all European competent institutions, Member State bodies and other organisations that provided data for this scientific output. ; Peer reviewed ; Publisher PDF

66 p.-22 fig.-18 tab-Appendix A-B (45-65) ; EFSA was asked by the European Commission to provide information on levels of lipophilic shellfish toxins in whole scallops that would ensure levels in edible parts below the regulatory limits after shucking, i.e. removal of non‐edible parts. This should include the okadaic acid (OA), the azaspiracid (AZA) and the yessotoxin (YTX) groups, and five species of scallops. In addition, EFSA was asked to recommend the number of scallops in an analytical sample. To address these questions, EFSA received suitable data on the three toxin groups in two scallop species, Aequipecten opercularis and Pecten maximus, i.e. data on individual and pooled samples of edible and non‐edible parts from contamination incidents. The majority of the concentration levels were below limit of quantification (LOQ)/limit of detection (LOD), especially in adductor muscle but also in gonads. Shucking in most cases resulted in a strong decrease in the toxin levels. For Pecten maximus, statistical analysis showed that levels in whole scallops should not exceed 256 μg OA eq/kg or 217 μg AZA1 eq/kg to ensure that levels in gonads are below the regulatory limits of 160 μg OA or AZA1 eq/kg with 99% certainty. Such an analysis was not possible for yessotoxins or any toxin in Aequipecten opercularis and an assessment could only be based on upper bound levels. To ensure a 95% correct prediction on whether the level in scallops in an area or lot is correctly predicted to be compliant/non‐compliant, it was shown that 10 scallops per sample would be sufficient to predict with 95% certainty if levels of OA‐group toxins in the area/lot were 25% below or above the regulatory limit. However, to predict with a 95% certainty for levels between 140 and 180 μg OA eq/kg, a pooled sample of more than 30 scallops would have to be tested. ; Peer reviewed