Reproductive and developmental toxicity studies have been conducted in rat and rabbit on triclopy... more Reproductive and developmental toxicity studies have been conducted in rat and rabbit on triclopyr acid and its active-ingredient variants, triclopyr butoxyethyl ester (T-BEE) and triclopyr triethylamine salt (T-TEA). In this paper the results of a rat two-generation study on triclopyr acid are presented, together with a review of all the reproductive and developmental toxicity data available from the rat studies. In the rat two-generation study, triclopyr acid was administered in the diet, giving doses of 0, 5, 25 or 250 mg/kg bw per day. Parental toxicity, especially maternal toxicity, occurred at 250 mg/kg bw per day with reduced body weight and feed intake, organ weight changes, and kidney toxicity. Slight kidney toxicity was also evident at 25 mg/kg bw per day. Developmental toxicity, in the form of reduced postnatal survival in the F1 and F2 generations and reductions in pre-weaning offspring body weight in both generations, was seen only at a dose causing significant parental toxicity. There were no effects on any other reproductive or developmental parameters at any dose. It is concluded that the developmental toxicity, seen only at the highest dose, was most likely attributable to maternal toxicity. The no-observed-adverse-effect levels were 5 mg/kg bw per day for parental toxicity and 25 mg/kg bw per day for developmental toxicity. From the multigeneration and developmental toxicity studies on triclopyr and its variants, it can also be concluded that triclopyr is not specifically toxic to reproduction and is not selectively toxic to the embryo, fetus or neonate in the rat.
The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact wit... more The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (the Panel) is asked to advise the Commission on the implications for human health of chemically defined flavouring substances used in or on foodstuffs in the Member States. In particular, the Scientific Panel is asked to evaluate 20 flavouring substances in the Flavouring Group Evaluation 17, Revision 1 (FGE.17Rev1), using the procedure as referred to in the Commission Regulation (EC) No 1565/2000. These 20 flavouring substances belong to chemical group 24 of Annex I of the Commission Regulation (EC) No 1565/2000. The present Flavouring Group Evaluation (FGE) deals with 20 pyrazine derivatives. Three of these derivatives are quinoxalines. Five of the 20 flavouring substances possess a chiral centre. For two of these substances the stereoisomeric composition has not been specified. Sixteen of the flavouring substances are classified into structural class II and four are classified into structural class III. Nineteen of the flavouring substances in the present group have been reported to occur naturally in a wide range of food items.
The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact wit... more The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (the Panel) is asked to advise the Commission on the implications for human health of chemically defined flavouring substances used in or on foodstuffs in the Member States. In particular, the Scientific Panel is asked to evaluate nine flavouring substances in the Flavouring Group Evaluation 26, Revision 1 (FGE.26Rev1), using the procedure as referred to in the Commission Regulation (EC) No 1565/2000. These nine flavouring substances belong to chemical group 34, Annex I of the Commission Regulation (EC) No 1565/2000. The present Flavouring Group Evaluation deals with nine amino acids. Seven of the nine flavouring substances possess one chiral centre and two possess two chiral centres.
The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact wit... more The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (the Panel) is asked to advise the Commission on the implications for human health of chemically defined flavouring substances used in or on foodstuffs in the Member States. In particular, the Scientific Panel is asked to evaluate 33 flavouring substances in the Flavouring Group Evaluation 24, Revision 1 (FGE.24Rev1), using the procedure as referred to in the Commission Regulation (EC) No 1565/2000. These 33 flavouring substances belong to chemical group 28 of Annex I of the Commission Regulation (EC) No 1565/2000. The present Flavouring Group Evaluation deals with 33 pyridine, pyrrole, indole and quinoline derivatives. None of the 33 candidate substances can exist as geometrical or optical isomers. Twenty-six of the flavouring substances are classified into structural class II and seven are classified into structural class III. Thirty 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 Intakes (MSDIs) approach to estimate the per capita intakes of the flavouring substances in Europe. However, when the Panel examined the information provided by the European Flavouring 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 Pyridine, pyrrole, indole and quinoline derivatives from chemical group 28 Flavouring Group Evaluation 24, Revision 1 (FGE.24Rev1)
SUMMARY Following a request from the Commission, the Panel on Food Additives, Flavourings, Proces... more SUMMARY Following a request from the Commission, the Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food was asked to deliver a scientific opinion on the safety in use of synthetic lycopene as a food colour for use in the food categories specified in the dossier.
The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact wit... more The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (the Panel) is asked to advise the Commission on the implications for human health of chemically defined flavouring substances used in or on foodstuffs in the Member States. In particular, the Scientific Panel is asked to evaluate 47 flavouring substances in the Flavouring Group Evaluation 2, Revision 1 (FGE.02Rev1), using the procedure as referred to in the Commission Regulation (EC) No 1565/2000. These 47 flavouring substances belong to chemical groups 1 and 2, Annex I of the Commission Regulation (EC) No 1565/2000. 1 For citation purposes: Scientific Opinion of the Panel on Food Additives, Flavourings, Processing Aids and Materials in contact with Food (AFC) on a request from the Commission Flavouring Group Evaluation 2, Revision 1 (FGE.02Rev 1): Branched-and straight-chain aliphatic saturated primary alcohols and related esters of primary alcohols and straight-chain carboxylic acids and one straight-chain aldehyde from chemical groups 1 and 2 * 1 member of the Panel did not participate in the discussion due to a declared interest. For details see the minutes of the 21th AFC
Trends in Food Science and Technology, Dec 1, 2015
Users may download and print one copy of any publication from the public portal for the purpose... more Users may download and print one copy of any publication from the public portal for the purpose of private study or research. You may not further distribute the material or use it for any profit-making activity or commercial gain You may freely distribute the URL identifying the publication in the public portal If you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediately and investigate your claim.
Background: Acrylamide (AA) (CH 2 =CHCONH 2) has recently been found in a range of food items as ... more Background: Acrylamide (AA) (CH 2 =CHCONH 2) has recently been found in a range of food items as a result of certain cooking procedures. As it is a neurotoxic agent and a probable, human carcinogen (IARC 2A), human exposure to this chemical might constitute an important public health issue. Objective: to assess the exposure to AA via food in Flemish adolescents on the basis of a probabilistic model. Methods: Data on food consumption, derived from a 7-day food record dietary survey (1997) in 341 adolescents, were combined with contamination data for following food groups: fried (potato derived) products, crisps, biscuits, breakfast cereals, beer and chocolate. Levels below the limit of determination (LOD=100 µg AA/kg product) were put equal to half LOD. As the Belgian data for bread were all below the LOD, we used data from the Netherlands, based on analyses with a lower LOD (30 µg AA/kg product). Exposure modelling was based on Monte Carlo simulations. Results: At median uncertainty, the exposure via these food items ranged from 68 ng/kgBW/day at the 5 th percentile, over 229 ng/kgBW/day at the 50 th percentile, to 573 ng/kgBW/day at the 95 th percentile. Bread, despite its low AA content, seems relevant as source of AA exposure at the lower percentiles. At higher percentiles the contribution of french fries and crisps is more important. Conclusion: An intake assessment, based on consumption patterns in Flemish adolescents and on a limited nummber of contamination data, generated levels of AA-exposure via food in the lower range of intake, calculated for other Western-European countries. The relevance of such exposure levels for public health in terms of cancer risk remains a subject of scientific debate.
Proceedings of the Royal Society B: Biological Sciences, 1979
From a number of disasters which have already occurred throughout the world, it is known that the... more From a number of disasters which have already occurred throughout the world, it is known that the reproductive process in both animals and man may be severely affected by chemicals. The range of effects that might occur include not only foetal death or malformation, but also effects on the subsequent development, behaviour, intelligence and reproductive capacity of offspring which appear otherwise normal at birth. The special sensitivity of the foetus to some environmental carcinogens is also discussed. Some of the problems in screening for such effects in animals are mentioned along with the need for adequate monitoring programmes to detect reproductive toxicity both from industrial exposure to chemicals and from more general environmental exposure.
The use of additives in foods traded within the EU is strictly controlled by legislation, which c... more The use of additives in foods traded within the EU is strictly controlled by legislation, which can be amended to include newly approved additives or to delete additives that are no longer approved. Food additives can only be approved for inclusion in EU permitted lists by decision of the European Commission and Member States, which are the risk managers. Before making any approvals, a full risk assessment is carried out by the European Food Safety Authority (EFSA), which advises the risk managers. EFSA considers all safety aspects of an additive, including technical toxicological and exposure data. If there are no safety concerns, EFSA sets an acceptable daily intake (ADI). The ADI is compared with estimates of overall exposure to the food additive, which include both average and high exposure estimates for the population and relevant sub-groups. If estimated exposure exceeds the ADI, it is the task of the risk managers to impose any necessary restrictions on the uses and use levels of the additive in foods. Once marketed, the monitoring of consumer intakes of food additives by the Member States enables checks to be carried out to ensure ADIs are not being exceeded. EFSA is also conducting a re-evaluation of all currently permitted food additives on the EU market that includes consideration of all published literature and documentation submitted by manufacturers and other interested parties. This has already resulted in some additives being removed from the permitted lists and in the lowering or raising of ADIs set previously.
Following a request from the European Commission the Scientific Committee was asked to develop 8 ... more Following a request from the European Commission the Scientific Committee was asked to develop 8 principles and guidance for the establishment of protocols for 90-day feeding studies in rodents with 9 whole food and feeds. The design of such protocols should be based on the specific properties of 10 food/feed derived from genetically modified plants and other novel food under investigation and in 11 line with the purpose of the study. In view of the multidisciplinary nature of this subject, the task was 12 assigned to the Scientific Committee. 13
SUMMARY The European Food Safety Authority (EFSA) is asked to advise the Commission on substances... more SUMMARY The European Food Safety Authority (EFSA) is asked to advise the Commission on substances used as flavouring substances or present in flavourings or present in other food ingredients with flavouring properties for which existing toxicological data indicate that restrictions of use or presence might be necessary to ensure safety of human health. In particular, EFSA is asked to advise the Commission on the implications for human health of the presence of d-camphor in the diet. Dietary exposure to camphor arises from the consumption of foods flavoured by using either herbs (e.g. basil, coriander, marjoram, rosemary, sage), their essential oils or the chemically defined flavouring substance d-camphor. Camphor is easily absorbed in the gastrointestinal tract. The major metabolic pathway is the oxidation to 5- and 3-hydroxycamphor, followed by conjugation and excretion. Camphor did not show mutagenic activity in Salmonella typhimurium strains and did not induce chromosome aberrations in vitro with and without metabolic activation. There was no evidence of reproductive and developmental toxicity after oral administration to rats and rabbits.
Reproductive and developmental toxicity studies have been conducted in rat and rabbit on triclopy... more Reproductive and developmental toxicity studies have been conducted in rat and rabbit on triclopyr acid and its active-ingredient variants, triclopyr butoxyethyl ester (T-BEE) and triclopyr triethylamine salt (T-TEA). In this paper the results of a rat two-generation study on triclopyr acid are presented, together with a review of all the reproductive and developmental toxicity data available from the rat studies. In the rat two-generation study, triclopyr acid was administered in the diet, giving doses of 0, 5, 25 or 250 mg/kg bw per day. Parental toxicity, especially maternal toxicity, occurred at 250 mg/kg bw per day with reduced body weight and feed intake, organ weight changes, and kidney toxicity. Slight kidney toxicity was also evident at 25 mg/kg bw per day. Developmental toxicity, in the form of reduced postnatal survival in the F1 and F2 generations and reductions in pre-weaning offspring body weight in both generations, was seen only at a dose causing significant parental toxicity. There were no effects on any other reproductive or developmental parameters at any dose. It is concluded that the developmental toxicity, seen only at the highest dose, was most likely attributable to maternal toxicity. The no-observed-adverse-effect levels were 5 mg/kg bw per day for parental toxicity and 25 mg/kg bw per day for developmental toxicity. From the multigeneration and developmental toxicity studies on triclopyr and its variants, it can also be concluded that triclopyr is not specifically toxic to reproduction and is not selectively toxic to the embryo, fetus or neonate in the rat.
The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact wit... more The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (the Panel) is asked to advise the Commission on the implications for human health of chemically defined flavouring substances used in or on foodstuffs in the Member States. In particular, the Scientific Panel is asked to evaluate 20 flavouring substances in the Flavouring Group Evaluation 17, Revision 1 (FGE.17Rev1), using the procedure as referred to in the Commission Regulation (EC) No 1565/2000. These 20 flavouring substances belong to chemical group 24 of Annex I of the Commission Regulation (EC) No 1565/2000. The present Flavouring Group Evaluation (FGE) deals with 20 pyrazine derivatives. Three of these derivatives are quinoxalines. Five of the 20 flavouring substances possess a chiral centre. For two of these substances the stereoisomeric composition has not been specified. Sixteen of the flavouring substances are classified into structural class II and four are classified into structural class III. Nineteen of the flavouring substances in the present group have been reported to occur naturally in a wide range of food items.
The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact wit... more The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (the Panel) is asked to advise the Commission on the implications for human health of chemically defined flavouring substances used in or on foodstuffs in the Member States. In particular, the Scientific Panel is asked to evaluate nine flavouring substances in the Flavouring Group Evaluation 26, Revision 1 (FGE.26Rev1), using the procedure as referred to in the Commission Regulation (EC) No 1565/2000. These nine flavouring substances belong to chemical group 34, Annex I of the Commission Regulation (EC) No 1565/2000. The present Flavouring Group Evaluation deals with nine amino acids. Seven of the nine flavouring substances possess one chiral centre and two possess two chiral centres.
The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact wit... more The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (the Panel) is asked to advise the Commission on the implications for human health of chemically defined flavouring substances used in or on foodstuffs in the Member States. In particular, the Scientific Panel is asked to evaluate 33 flavouring substances in the Flavouring Group Evaluation 24, Revision 1 (FGE.24Rev1), using the procedure as referred to in the Commission Regulation (EC) No 1565/2000. These 33 flavouring substances belong to chemical group 28 of Annex I of the Commission Regulation (EC) No 1565/2000. The present Flavouring Group Evaluation deals with 33 pyridine, pyrrole, indole and quinoline derivatives. None of the 33 candidate substances can exist as geometrical or optical isomers. Twenty-six of the flavouring substances are classified into structural class II and seven are classified into structural class III. Thirty 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 Intakes (MSDIs) approach to estimate the per capita intakes of the flavouring substances in Europe. However, when the Panel examined the information provided by the European Flavouring 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 Pyridine, pyrrole, indole and quinoline derivatives from chemical group 28 Flavouring Group Evaluation 24, Revision 1 (FGE.24Rev1)
SUMMARY Following a request from the Commission, the Panel on Food Additives, Flavourings, Proces... more SUMMARY Following a request from the Commission, the Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food was asked to deliver a scientific opinion on the safety in use of synthetic lycopene as a food colour for use in the food categories specified in the dossier.
The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact wit... more The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (the Panel) is asked to advise the Commission on the implications for human health of chemically defined flavouring substances used in or on foodstuffs in the Member States. In particular, the Scientific Panel is asked to evaluate 47 flavouring substances in the Flavouring Group Evaluation 2, Revision 1 (FGE.02Rev1), using the procedure as referred to in the Commission Regulation (EC) No 1565/2000. These 47 flavouring substances belong to chemical groups 1 and 2, Annex I of the Commission Regulation (EC) No 1565/2000. 1 For citation purposes: Scientific Opinion of the Panel on Food Additives, Flavourings, Processing Aids and Materials in contact with Food (AFC) on a request from the Commission Flavouring Group Evaluation 2, Revision 1 (FGE.02Rev 1): Branched-and straight-chain aliphatic saturated primary alcohols and related esters of primary alcohols and straight-chain carboxylic acids and one straight-chain aldehyde from chemical groups 1 and 2 * 1 member of the Panel did not participate in the discussion due to a declared interest. For details see the minutes of the 21th AFC
Trends in Food Science and Technology, Dec 1, 2015
Users may download and print one copy of any publication from the public portal for the purpose... more Users may download and print one copy of any publication from the public portal for the purpose of private study or research. You may not further distribute the material or use it for any profit-making activity or commercial gain You may freely distribute the URL identifying the publication in the public portal If you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediately and investigate your claim.
Background: Acrylamide (AA) (CH 2 =CHCONH 2) has recently been found in a range of food items as ... more Background: Acrylamide (AA) (CH 2 =CHCONH 2) has recently been found in a range of food items as a result of certain cooking procedures. As it is a neurotoxic agent and a probable, human carcinogen (IARC 2A), human exposure to this chemical might constitute an important public health issue. Objective: to assess the exposure to AA via food in Flemish adolescents on the basis of a probabilistic model. Methods: Data on food consumption, derived from a 7-day food record dietary survey (1997) in 341 adolescents, were combined with contamination data for following food groups: fried (potato derived) products, crisps, biscuits, breakfast cereals, beer and chocolate. Levels below the limit of determination (LOD=100 µg AA/kg product) were put equal to half LOD. As the Belgian data for bread were all below the LOD, we used data from the Netherlands, based on analyses with a lower LOD (30 µg AA/kg product). Exposure modelling was based on Monte Carlo simulations. Results: At median uncertainty, the exposure via these food items ranged from 68 ng/kgBW/day at the 5 th percentile, over 229 ng/kgBW/day at the 50 th percentile, to 573 ng/kgBW/day at the 95 th percentile. Bread, despite its low AA content, seems relevant as source of AA exposure at the lower percentiles. At higher percentiles the contribution of french fries and crisps is more important. Conclusion: An intake assessment, based on consumption patterns in Flemish adolescents and on a limited nummber of contamination data, generated levels of AA-exposure via food in the lower range of intake, calculated for other Western-European countries. The relevance of such exposure levels for public health in terms of cancer risk remains a subject of scientific debate.
Proceedings of the Royal Society B: Biological Sciences, 1979
From a number of disasters which have already occurred throughout the world, it is known that the... more From a number of disasters which have already occurred throughout the world, it is known that the reproductive process in both animals and man may be severely affected by chemicals. The range of effects that might occur include not only foetal death or malformation, but also effects on the subsequent development, behaviour, intelligence and reproductive capacity of offspring which appear otherwise normal at birth. The special sensitivity of the foetus to some environmental carcinogens is also discussed. Some of the problems in screening for such effects in animals are mentioned along with the need for adequate monitoring programmes to detect reproductive toxicity both from industrial exposure to chemicals and from more general environmental exposure.
The use of additives in foods traded within the EU is strictly controlled by legislation, which c... more The use of additives in foods traded within the EU is strictly controlled by legislation, which can be amended to include newly approved additives or to delete additives that are no longer approved. Food additives can only be approved for inclusion in EU permitted lists by decision of the European Commission and Member States, which are the risk managers. Before making any approvals, a full risk assessment is carried out by the European Food Safety Authority (EFSA), which advises the risk managers. EFSA considers all safety aspects of an additive, including technical toxicological and exposure data. If there are no safety concerns, EFSA sets an acceptable daily intake (ADI). The ADI is compared with estimates of overall exposure to the food additive, which include both average and high exposure estimates for the population and relevant sub-groups. If estimated exposure exceeds the ADI, it is the task of the risk managers to impose any necessary restrictions on the uses and use levels of the additive in foods. Once marketed, the monitoring of consumer intakes of food additives by the Member States enables checks to be carried out to ensure ADIs are not being exceeded. EFSA is also conducting a re-evaluation of all currently permitted food additives on the EU market that includes consideration of all published literature and documentation submitted by manufacturers and other interested parties. This has already resulted in some additives being removed from the permitted lists and in the lowering or raising of ADIs set previously.
Following a request from the European Commission the Scientific Committee was asked to develop 8 ... more Following a request from the European Commission the Scientific Committee was asked to develop 8 principles and guidance for the establishment of protocols for 90-day feeding studies in rodents with 9 whole food and feeds. The design of such protocols should be based on the specific properties of 10 food/feed derived from genetically modified plants and other novel food under investigation and in 11 line with the purpose of the study. In view of the multidisciplinary nature of this subject, the task was 12 assigned to the Scientific Committee. 13
SUMMARY The European Food Safety Authority (EFSA) is asked to advise the Commission on substances... more SUMMARY The European Food Safety Authority (EFSA) is asked to advise the Commission on substances used as flavouring substances or present in flavourings or present in other food ingredients with flavouring properties for which existing toxicological data indicate that restrictions of use or presence might be necessary to ensure safety of human health. In particular, EFSA is asked to advise the Commission on the implications for human health of the presence of d-camphor in the diet. Dietary exposure to camphor arises from the consumption of foods flavoured by using either herbs (e.g. basil, coriander, marjoram, rosemary, sage), their essential oils or the chemically defined flavouring substance d-camphor. Camphor is easily absorbed in the gastrointestinal tract. The major metabolic pathway is the oxidation to 5- and 3-hydroxycamphor, followed by conjugation and excretion. Camphor did not show mutagenic activity in Salmonella typhimurium strains and did not induce chromosome aberrations in vitro with and without metabolic activation. There was no evidence of reproductive and developmental toxicity after oral administration to rats and rabbits.
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