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Scientific Opinion on the evaluation of the substances currently on the list in the annex to Commission Directive 96/3/EC as acceptable previous cargoes for edible fats and oils – Part III of III

EFSA Journal 2012;10(12):2984[82 pp.]. doi:10.2903/j.efsa.2012.2984
  EFSA Panel on Contaminants in the Food Chain (CONTAM) Panel Members Diane Benford, Sandra Ceccatelli, Bruce Cottrill, Michael Dinovi, Eugenia Dogliotti, Lutz Edler, Peter Farmer, Peter Fürst, Laurentius (Ron) Hoogenboom, Helle Katrine Knutsen, Anne-Katrine Lundebye Haldorsen, Manfred Metzler, Carlo Stefano Nebbia, Michael O’Keeffe, Ivonne Rietjens, Dieter Schrenk, Vittorio Silano, Hendrik van Loveren, Christiane Vleminckx, and Pieter Wester Acknowledgment The Panel wishes to thank Alan Boobis, Lanfranco Conte, Eugenia Dogliotti, Albert Duschl, Konrad Grob, Martinus Løvik and Iona Pratt for the preparatory work on this scientific opinion and the hearing expert: John Hancock, and EFSA staff: Gina Cioacata and Luisa Ramos Bordajandi for the support provided to this scientific opinion. Contact contam@efsa.europa.eu
Type: Opinion of the Scientific Committee/Scientific Panel On request from: European Commission Question number: EFSA-Q-2010-01464 Adopted: 22 November 2012 Published: 18 December 2012 Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

Shipping of edible fats and oils into Europe is permitted in bulk tanks, in which substances, included in a positive list, had been previously transported. The European Commission requested EFSA to evaluate the list of substances in the Annex to Commission Directive 96/3/EC as acceptable previous cargoes for edible fats and oils, taking into account its review of the Scientific Committee on Food criteria for acceptable previous cargoes and criteria proposed by the Codex Committee for Fats and Oils. This is the third and last scientific opinion of the EFSA Panel on Contaminants in the Food Chain (CONTAM Panel) on this topic, in which sixteen of these substances or groups of substances have been evaluated. The CONTAM Panel concluded that sodium silicate (water glass) solution, iso-octanol, iso-nonanol, iso-decanol, 1,3-propanediol, isobutyl acetate, sec-butyl acetate, tert-butyl acetate, n-butyl acetate, propylene tetramer, paraffin wax, candelilla wax, white mineral oils and glycerol would not be of health concern as previous cargoes. The CONTAM Panel concluded that carnauba wax was not acceptable as a previous cargo because of its insolubility in water and high melting point, which raise concerns regarding the efficiency of tank cleaning. There was insufficient information available on the composition of montan wax for the CONTAM Panel to conclude that it would be of no health concern when used as previous cargo and hence it does not meet the criteria for acceptability as previous cargo. The CONTAM Panel made several recommendations regarding the way in which the substances are described in the Annex to Commission Directive 96/3/EC, to correct inaccuracies and to better reflect current transport practices.

© European Food Safety Authority,2012

Summary

The worldwide trade of edible fats and oils in bulk requires their transport by road, railroad, inland waterways and sea. The carriage by sea of edible fats and oils into Europe is also permitted in bulk tanks that have previously been used to transport substances included in a positive list of acceptable previous cargoes. The EFSA Panel on Contaminants in the Food Chain (CONTAM Panel) reviewed the Scientific Committee on Food (SCF) criteria for acceptable previous cargoes and criteria proposed by the Codex Committee for Fats and Oils in 2009. In addition, the CONTAM Panel identified the importance of taking into account possible impurities and reaction products with edible fats and oils of the chemicals shipped as previous cargoes, as these might be more toxic than the chemical itself. Since usually no specifications of the impurities are available for the often rather crude substances shipped in bulk, those potentially present were determined primarily by assessing information on the source or starting substances, making worse case assumptions in each case. In November 2009, the CONTAM Panel published an opinion on a limited number of substances that had been proposed at Codex level for addition to the list of Codex acceptable previous cargoes, which were evaluated against the criteria in the previously mentioned opinion of the CONTAM Panel.

Following a request from the European Commission, the CONTAM Panel was asked to deliver a scientific opinion on the evaluation of the substances listed in the Annex to Commission Directive 96/3/EC as acceptable previous cargoes for edible fats and oils. This was to ensure that substances currently on the list of acceptable previous cargoes had been evaluated against the same criteria as recently agreed by EFSA.

This is the third and last scientific opinion of the CONTAM Panel on the evaluation of the substances listed in the Annex to Commission Directive 96/3/EC. The CONTAM Panel considered that sodium silicate (water glass) solution, 1,3-propanediol, isobutylacetate, sec-butyl acetate, tert-butyl acetate, n-butyl acetate, propylene tetramer, paraffin wax, candelilla wax, white mineral oils and glycerol when used as previous cargoes would not raise any concerns regarding their acute or chronic toxicity, genotoxicity, carcinogenicity or reproductive toxicity. In addition there were no concerns regarding possible allergenicity or adjuvant effects from such transport. In the case of iso-octanol, iso-nonanol and iso-decanol, because of data gaps in the respective toxicological profiles, the CONTAM Panel used ‘read-across’ from the assessment profile of oxo-alcohols C9-C13 category and concluded that the iso-alcohols under consideration are of low toxicity following acute and chronic exposure, they are not genotoxic or allergenic and therefore they are of no toxicological concern when used as previous cargoes.

The CONTAM Panel noted that four of these substances are authorized for use in food either as flavouring (isobutyl acetate, sec-butyl acetate, n-butyl acetate) or glazing (candelilla wax) agents. For two substances, acceptable daily intakes of ‘not specified’ or ‘not limited’ have been established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) or SCF because of low toxicological concern. These are sodium silicate (water glass) solution and glycerol. n-Butyl acetate has an ADI established by the SCF greater than 0.1 mg/kg body weight (b.w.) per day. In the case of sec-butyl acetate, it is a Cramer Class I substance for which exposures below a threshold of toxicological concern of 1 800 mg/person per day (30 mg/kg b.w. per day) would not be expected to be of safety concern, and the available information does not indicate any toxicological concern at the exposure levels that might occur from transport as a previous cargo. The remaining substances (iso-octanol, iso-nonanol and iso-decanol, 1,3-propanediol, tert-butyl acetate, propylene tetramer) are of relatively low toxicity and the margin of exposure that would occur comparing the maximum assumed carryover from their transport as previous cargo and the respective no-observed-adverse-effect level would indicate no concern for human health.

For all these substances no reaction products with fats and oil of toxicological concern were identified or anticipated. The CONTAM Panel noted that the only impurities of potential concern are aromatic hydrocarbons, which may be present in paraffin wax and white mineral oils. While in the case of white mineral oils they are controlled to very low levels, in the case of paraffin waxes the CONTAM Panel concluded that this entry should be restricted to paraffin waxes that have been treated to remove aromatic hydrocarbons and which otherwise meet relevant standards to be considered as ‘food grade’. 

Regarding mineral oil hydrocarbons the CONTAM Panel notes that some aliphatic hydrocarbons bioaccumulate in the body, such as branched and cyclic species in the mass range of 16 - 35 carbon atoms. However, since exposure to mineral oil hydrocarbons via contamination of edible fats and oils from previous cargoes occurs only rarely and mostly at levels lower than those observed anyway in edible oils, it will contribute little to overall exposure.

In the case of montan wax, there was insufficient information available on the composition and toxicological profile of this substance for the CONTAM Panel to conclude that it does not contain components that would be of concern to human health when used as previous cargo. The CONTAM Panel therefore concludes that it does not meet the criteria for acceptability as a previous cargo for edible fats and oils.

Although the CONTAM Panel considered that there would be no health concerns arising from the use of carnauba wax as a previous cargo, using normal assumptions regarding worst case carryover, the Panel concluded that it does not meet the criteria for its acceptability as previous cargo because of its insolubility in water and high melting point and hence doubts concerning the efficiency of tank cleaning.

In addition, the CONTAM Panel noted a number of inaccuracies in the chemical identification and inconsistencies in the chemical specification of substances with respect to current transport practices, in the Annex to Commission Directive 96/3/EC. The CONTAM Panel therefore made a number of recommendations regarding the way in which the substances are described in this Annex, to correct such inaccuracies and inconsistencies.

The CONTAM Panel also made recommendations on the information that should be provided by interested parties when new substances are to be evaluated as previous cargoes.

Keywords

acceptable previous cargo, edible fats and oils, sea transport, criteria for acceptability of previous cargoes