Opinion of the Scientific Panel on food additives, flavourings, processing aids and materials in contact with food (AFC) related to Flavouring Group Evaluation 22 (FGE.22): Ring-substituted phenolic substances from chemical groups 21 and 25 (Commission Regulation (EC) No 1565/2000 of 18 July 2000)
doi:10.2903/j.efsa.2007.393
EFSA Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Foods (AFC)
Panel Members
Fernando Aguilar, Herman Nybro Autrup, Susan Barlow, Laurence Castle, Riccardo Crebelli,
Wolfgang Dekant, Karl-Heinz Engel, Nathalie Gontard, David Michael Gott, Sandro Grilli, Rainer
Gürtler, John Chr. Larsen, Catherine Leclercq, Jean-Charles Leblanc, F. Xavier Malcata, Wim
Mennes, Maria Rosaria Milana, Iona Pratt, Ivonne Magdalena, Catharina Maria Rietjens, Paul P.
Tobback, Fidel Toldrá.
Acknowledgment
The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact
with Food wishes to thank Rainer Gürtler (rapporteur), Wim Mennes, Henrik Frandsen, Harriet
Wallin, Karl-Heinz Engel, Jørn Gry, Vibe Beltoft, Karin Nørby and Trine Klein Reffstrup for their
contribution to the draft opinion.
Fernando Aguilar, Herman Nybro Autrup, Susan Barlow, Laurence Castle, Riccardo Crebelli,
Wolfgang Dekant, Karl-Heinz Engel, Nathalie Gontard, David Michael Gott, Sandro Grilli, Rainer
Gürtler, John Chr. Larsen, Catherine Leclercq, Jean-Charles Leblanc, F. Xavier Malcata, Wim
Mennes, Maria Rosaria Milana, Iona Pratt, Ivonne Magdalena, Catharina Maria Rietjens, Paul P.
Tobback, Fidel Toldrá.
Acknowledgment
The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact
with Food wishes to thank Rainer Gürtler (rapporteur), Wim Mennes, Henrik Frandsen, Harriet
Wallin, Karl-Heinz Engel, Jørn Gry, Vibe Beltoft, Karin Nørby and Trine Klein Reffstrup for their
contribution to the draft opinion.
Type:
Opinion of the Scientific Committee/Scientific Panel
Question number:
EFSA-Q-2003-165
Adopted:
27 September 2006
Published:
04 May 2007
Last updated:
04 May 2007. This version replaces the previous one/s.
Abstract
No abstract available
The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food 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 23 flavouring substances in the Flavouring Group Evaluation FGE.22, using the procedure as referred to in the Commission Regulation EC No 1565/2000. These 23 flavouring substances belong to chemical groups 21 and 25, Annex I of the Commission Regulation EC No 1565/2000.
The present Flavouring Group Evaluation deals with 23 ring-substituted phenolic substances.
None of the 23 flavouring substances can exist as geometrical or optical isomers.
Twenty of the flavouring substances are classified into structural class I and three are classified into structural class II.
Twenty-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 Scientific 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 Scientific 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 Scientific 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 Scientific Panel to make a more realistic estimate of the intakes of the flavouring substances, the Scientific 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 substance might exceed its corresponding threshold of concern, the Scientific Panel decided not to carry out a formal safety assessment using the Procedure. In these cases the Scientific Panel requires more precise data on use and use levels.
According to the default MSDI approach, the 23 flavouring substances in this group have intakes in Europe from 0.001 to 2.2 microgram/capita/day, which are below the thresholds of concern for both structural class I (1800 microgram/person/day) and structural class II (540 microgram/person/day) substances.
One of the flavouring substances, 3,4-methylenedioxyphenol [FL-no: 04.080] was reported to have a genotoxic potential in vitro while in vivo studies were not available for this candidate substance. Therefore, the Panel decided that the Procedure could not be applied to this flavouring substance until adequate genotoxicity data become available. The genotoxicity data available for the other flavouring substances in the present Flavouring Group Evaluation do not preclude their evaluation through the Procedure.
The flavouring substances in this group are conjugated with glucuronic acid or sulphate very efficiently, pathways which are not easily saturated. At high dose levels reactive metabolites (quinones, catechols, quinone methides) may be formed, but it is not expected that at intake levels estimated from the use as flavouring substances the formation of these metabolites would overwhelm the detoxication capacity through conjugation with sulphate, glucuronic acid or in particular glutathione. Thus, it is concluded that all 22 substances in this group which have been evaluated using the Procedure may be expected to be metabolised to innocuous substances at the estimated levels of intake, based on the MSDI approach.
It was noted that where toxicity data were available they were consistent with the conclusions in the present flavouring group evaluation using the Procedure.
It was considered that on the basis of the default MSDI approach the 22 substances, which have been evaluated using the Procedure, would not give rise to safety concerns at the estimated levels of intake arising from their use as flavouring substances.
When the estimated intakes were based on the mTAMDI approach they ranged from 400 to 1600 microgram/person/day for the 19 flavouring substances from structural class I. Thus, the intakes were all below the threshold of concern for structural class I of 1800 microgram/person/day. The estimated intakes for each of the three other flavouring substances [FL-no: 04.091, 04.092 and 07.234] assigned to structural class II, based on the mTAMDI approach are 400 microgram/person/day, which are below the threshold of concern for structural class II of 540 microgram/person/day. Additionally, the 22 substances evaluated using the Procedure are expected to be metabolised to innocuous products.
In order to determine whether this evaluation could be applied to the materials of commerce, it is necessary to consider the available specifications.
Adequate specifications including complete purity criteria and identity tests for the materials of commerce have been provided for all 22 flavouring substances evaluated through the Procedure and these would present no safety concern at the levels of intake estimated on the basis of the MSDI approach.
Phenolic, ring-alkyl, ring-alkoxy, flavourings, safety
