Search EFSA Journal
Précisez votre recherche
Type
All article types
Special Issue Item
Journal Editorial
Scientific opinions of Scientific/Scientific Panel
Opinion of the Scientific Committee/Scientific Panel
Statement of the Scientific Committee/Scientific Panel
Guidance of the Scientific Committee/Scientific Panel
Other scientific outputs of EFSA
Statement of EFSA
Guidance of EFSA
Conclusion on pesticides
Reasoned opinion on pesticide
Scientific report of EFSA
Technical Report
Subject
All subjects
Animal health & welfare
Biological hazards
Biological monitoring
Contaminants
Dietary & chemical monitoring
Emerging risks
Feed
Food Ingredients and Packaging
GMO
Nutrition
Pesticides
Plant health
Assessment and methodological support
Scientific Committee
Scientific cooperation
Article ID
Digital Object ID
Sort by:
Publication date
Relevance

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 II of III

EFSA Journal 2012;10(5):2703 [151 pp.]. doi:10.2903/j.efsa.2012.2703
  EFSA Panel on Contaminants in the Food Chain (CONTAM) Panel Members Jan Alexander, Diane Benford, Alan Raymond Boobis, Sandra Ceccatelli, Bruce Cottrill, Jean-Pierre Cravedi, Alessandro Di Domenico, Daniel Doerge, Eugenia Dogliotti, Lutz Edler, Peter Farmer, Metka Filipič, Johanna Fink-Gremmels, Peter Fürst, Thierry Guérin, Helle Katrine Knutsen, Miroslav Machala, Antonio Mutti, Martin Rose, Josef Rudolf Schlatter and Rolaf van Leeuwen Acknowledgment The Panel wishes to thank the members of the Working Group on the Re-evaluation of previous cargoes: 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-2010-01463 Adopted: 03 May 2012 Published: 30 May 2012 Last updated: 06 June 2013. This version replaces the previous one/s. 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 (SCF) criteria for acceptable previous cargoes and criteria proposed by the Codex Committee for Fats and Oils. This is the second of three scientific opinions by the Panel on Contaminants in the Food Chain (CONTAM Panel), in which thirty-five of these substances or groups of substances have been evaluated. The CONTAM Panel concluded that fatty acids, fatty alcohols, fatty alcohol blends,  fatty acid methyl esters, fatty acid esters, and animal, marine and vegetable and hydrogenated oils and fats, all as specified, and acid oils and fatty acid distillates, acetic acid, sulphuric acid, formic acid, acetic anhydride, acetone, n-heptane, n-hexane, cyclohexane, pentane, iso-propanol, propyl alcohol, methyl isobutyl ketone, methyl ethyl ketone, n-propyl acetate, ammonium hydroxide, limonene, methyl tert-butyl ether, urea ammonia nitrate solution, calcium chloride solution, magnesium chloride solution, potable water, potassium hydroxide, sodium hydroxide, silicon dioxide, sorbitol, molasses and beeswax would not be of health concern as previous cargoes. However, because of its insolubility in water and high melting point, silicon dioxide is not suitable for transport in tankers for edible fats and oils. There was insufficient information available on the composition of wine lees for the CONTAM Panel to conclude that it would not be of health concern when used as a 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) recently 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 of chemicals shipped as previous cargoes, as these might be more toxic than the chemical itself. 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 (EC), 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 second of three scientific opinions by the CONTAM Panel on the evaluation of the substances listed in the Annex to Commission Directive 96/3/EC. The CONTAM Panel considered that  fatty acids (individually specified), fatty alcohols (individually specified), fatty alcohol blends (lauryl myristyl alcohol (C12-C14) and cetyl stearyl alcohol (C16-C18)), fatty acid methyl esters (individually specified), fatty acid esters (produced by the combination of any of the individually specified fatty acids with any of the individually specified fatty alcohols), acid oils and fatty acid distillates (from vegetable oils and fats and/or mixtures thereof and  animal and marine fats and oils), animal, marine and vegetable and hydrogenated oils and fats (as specified by the Marine Environment Protection Committee of the International Maritime Organization), acetic acid, sulphuric acid, formic acid, acetic anhydride, acetone, n-heptane, n-hexane (technical grades), cyclohexane, pentane, isopropanol, propyl alcohol, methyl isobutyl ketone, methyl ethyl ketone, n-propyl acetate, ammonium hydroxide, limonene, methyl tertiary butyl ether, urea ammonia nitrate solution, calcium chloride solution, magnesium chloride solution, potable water, potassium hydroxide, sodium hydroxide, silicon dioxide (microsilica), sorbitol, molasses and beeswax (white and yellow), when used as previous cargoes, would not raise any concerns regarding their acute or longer term toxicity, genotoxicity, carcinogenicity or reproductive toxicity. In addition, there were no concerns regarding possible allergenicity or adjuvant effects from such transport. The Panel noted that a number of the substances are, or contain, normal constituents of food (fatty acids, fatty alcohols, fatty alcohol blends, fatty acid methyl esters, fatty acid esters, acid oils and fatty acid distillates, animal, marine and vegetable and hydrogenated oils and fats, calcium chloride solution, magnesium chloride solution, potable water and molasses). For several of the substances, acceptable daily intakes (ADIs) of “not specified” or “not limited” have been established by the FAO/WHO Joint Expert Committee for Food Additives (JECFA), SCF or the European Food Safety Authority (EFSA), because of low toxicological concern. These are fatty acids, acetic acid, sulphuric acid, acetic anhydride, ammonium hydroxide, potassium hydroxide, sodium hydroxide, silicon dioxide and sorbitol. A number of the substances have had ADIs or tolerable upper intake levels established by the JECFA, SCF or EFSA that are greater than or equal to 0.1 mg/kg b.w. per day. These are formic acid, acetone (United States Environmental Protection Agency - US-EPA), isopropanol, methyl ethyl ketone (US-EPA), limonene, calcium chloride, and magnesium chloride. Most of the remaining substances, or their constituents, (heptane, hexane, cyclohexane, pentane, propyl alcohol, methyl isobutyl ketone, n-propyl acetate, methyl tertiary butyl ether, urea ammonia nitrate and beeswax) are of relatively low toxicity and the margin of exposure that would occur comparing the maximum assumed carryover from their transport as a previous cargo and the respective critical no-observed-adverse-effect level would indicate no concern for human health. 

In general there were no possible reaction products with fats and oils of toxicological concern. The one potential exception is the formation of dioxolanes from acetone, methyl isobutyl ketone and methyl ethyl ketone. However, at the levels that would be present in subsequent cargoes of edible fats and oils there is no toxicological concern. All of these substances could easily be removed by cleaning of the tank, with the possible exception of silicon dioxide. Suitable analytical methods are available or are feasible for all of these substances. The remaining impurities of potential concern include dioxins and polychlorinated biphenyls (PCBs), which might be present in fat and oil-derived substances. For such substances, the levels of dioxins and PCBs should be such that the final concentration in edible fats and oils as subsequent cargoes complies with the European legislation. The only other impurity of potential concern is benzene, which might remain from the synthesis of acetone and cyclohexane. However, the levels that could be present in edible fats and oils as a subsequent cargo would be of no toxicological concern. No other impurities, either identified or anticipated, were considered of toxicological concern. The CONTAM Panel therefore concluded that these substances meet the criteria for acceptability as previous cargoes for edible fats and oils.

In the case of wine lees, there was insufficient information available for the CONTAM Panel to conclude that the risk from exposure to this substance when used as a previous cargo would not give rise to any toxicological concern. The product varies markedly in composition, is not well specified, there is no information on potential impurities, nor is there information on the presence of potential allergens. The CONTAM Panel therefore concluded that wine lees does not meet the criteria for acceptability as a previous cargo for edible fats and oils.

Although there are no health concerns should silicon dioxide be used as a previous cargo, because of its insolubility in water and high melting point, this substance is not suitable for transport in tankers for edible fats and oils. Hence, the CONTAM Panel recommends that silicon dioxide should be removed from the Annex to Commission Directive 96/3/EC.

In addition, the CONTAM Panel noted a number of inaccuracies in the chemical identification and inconsistencies in the restrictions or 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.

Keywords

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