Safety of gaseous chlorine dioxide as a preservative slowly released in cold food storage areas

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Article
Panel on Food Additives and Nutrient Sources Added to Food
EFSA Journal
EFSA Journal 2016;14(2):4388 [18 pp.].
doi
10.2903/j.efsa.2016.4388
Panel members at the time of adoption
Fernando Aguilar, Riccardo Crebelli, Alessandro Di Domenico, Birgit Dusemund, Maria Jose Frutos, Pierre Galtier, David Gott, Ursula Gundert-Remy, Claude Lambré, Jean-Charles Leblanc, Oliver Lindtner, Peter Moldeus, Alicja Mortensen, Pasquale Mosesso, Dominique Parent-Massin, Agneta Oskarsson, Ivan Stankovic, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen, Matthew Wright and Maged Younes.
Acknowledgements

The Panel wishes to thank the members of the former Working Group ‘A’ Food Additives and Nutrient Sources (2011–2014) and the members of the Standing Working Group on Applications: Maria Jose Frutos, David Gott, Lieve Herman, Claude Lambré, Jean-Charles Leblanc, Peter Moldeus, Alicja Mortensen, Ivan Stankovic, Paul Tobback, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen and Matthew Wright for the preparatory work on this scientific output and EFSA staff members: Paolo Colombo, Ana Maria Rincon and Camilla Smeraldi for the support provided to this scientific output.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2012-00748
Adopted
26 January 2016
Published
16 February 2016
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

Following a request from the European Commission, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion regarding the safety of use of gaseous chlorine dioxide as a preservative that is slowly released in cold food storage areas. Gaseous chlorine dioxide is generated from tubes that contain two reactants, which upon mixing slowly release gaseous chlorine dioxide. The tubes are to be used in cold storage rooms or in refrigerators for domestic use. In consideration of the reactive nature of gaseous chlorine dioxide, the Panel assessed to what extent chlorinated species are generated by the interaction of gaseous chlorine dioxide, under the proposed conditions of use, with some model food matrices. According to the applicant, the only by-products resulting from the proposed use of gaseous chlorine dioxide are chlorite and chlorate; therefore, the safety of these by-products has also been assessed. From the data provided by the applicant, under domestic refrigerator-like experimental conditions, the treatment of model food matrices with gaseous chlorine dioxide led to low amounts of by-products and did not produce chlorinated organic by-products. Chlorate was not detected in the model food matrices tested. Consequently, considering the negligible amounts in model food matrices of the parent compound and of its by-products chlorite and chlorate, together with the available toxicity database, the Panel concluded that, under the domestic refrigerator-like conditions of use proposed by the applicant, the consumption of foods treated with gaseous chlorine dioxide would not be a safety concern. The risk resulting from exposure of the consumer to chlorine dioxide by inhalation was not assessed, because this is outside the remit of the Panel. The Panel considered that a new assessment would be warranted in case of any change in the conditions of use.

Summary

Following a request from the European Commission, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion regarding the safety of the use of gaseous chlorine dioxide (ClO2) as preservative that is slowly released in cold food storage areas.

The chlorine dioxide gas is generated in situ from tubes that contain two reactants, which upon activation slowly release gaseous ClO2. The tubes are to be used in cold storage rooms or in refrigerators for domestic use. The Panel noted that the mode of generation of ClO2 proposed by the applicant is different from the ones already used and accepted so far.

The Panel is aware that the use of the material proposed by the applicant may lead to inhalation of ClO2, but the possible risk resulting from exposure of the consumer by inhalation was not assessed because this is outside the remit of the Panel.

The evaluation of the preservative effect of gaseous ClO2 is outside the remit of the Panel.

The applicant has submitted a dossier in support of its application for the authorisation of gaseous ClO2 for use as a preservative in cold food storage areas. In consideration of the well-known reactive nature of gaseous ClO2, the Panel agreed to assess, as a first step, to what extent chlorinated species are generated by the interaction of gaseous ClO2, under the proposed conditions of use, with some model food matrices.

To this end, and upon request from the Panel, the applicant generated additional data showing that, under the measured in-use conditions in a refrigerator, only a small amount of the total releasable ClO2 from the tube was detected. The maximum detected concentration of ClO2 was 0.043 ppm, which corresponds to 15 μg/120 L. The mean concentration was 0.029 ppm, which corresponds to 10.2 μg/120 L. The applicant also provided experimental data showing that the release of one of the two reactants during use was very low. The data covering a period of 28 days showed that only < 0.005% of the total amount of the gaseous reactant will be released during the intended application duration.

From the data provided by the applicant, under domestic refrigerator-like experimental conditions, the treatment of model food matrices with gaseous ClO2 led to low amounts of by-products, did not produce chlorinated organic by-products, and chlorate was not detected in the model food matrices. The Panel considered that the data indicated the absence of formation of potentially adverse chlorinated compounds in the model food matrices used by the applicant. However, the Panel noted the limitations of the model food matrices; in addition owing to the type of cold area used (a domestic refrigerator) in which a small size tube was used to generate the gaseous chlorine ClO2, the consideration of absence of formation of potentially adverse compounds is restricted to these conditions and do not apply to larger areas where bigger tubes can be used.

According to the applicant, the only by-products resulting from the proposed use of gaseous ClO2 are chlorite and chlorate; therefore, the safety of these by-products has been assessed. The toxicity database for chlorite and chlorate is limited, but did not indicate concern about a genotoxic or carcinogenic potential.

The ANS Panel did not perform an estimate of exposure, because no potentially adverse substances were identified in the initial step of the assessment.

The Panel concluded that, under the conditions of use proposed by the applicant, the consumption of foods treated with use of gaseous ClO2 under the proposed domestic refrigerator-like conditions of use would not be of safety concern.

A new assessment would be warranted in case of any change in the conditions of use.

The Panel recommended that the risk of inhalation of gaseous chlorine should be considered, particularly in the case of large cold storage areas. In this respect, the Panel draws attention to the risk of misuse e.g. large tubes for the production of ClO2 being used in domestic refrigerators. 

Keywords
gaseous chlorine dioxide, ClO2, preservative, food, storage, safety
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Number of Pages
18