SCIENTIFIC OPINION. EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) 2,3

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1 EFSA Journal 2015;13(7):4174 SCIENTIFIC OPINION Scientific Opinion on the safety of use of dimethyl ether as an extraction solvent under the intended conditions of use and the proposed maximum residual limits 1 EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) 2,3 ABSTRACT European Food Safety Authority (EFSA), Parma, Italy Dimethyl ether was previously evaluated by the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) and considered to give rise to no safety concerns under the conditions of use and the maximum residual limits proposed by the applicant. The present scientific opinion of the EFSA CEF Panel deals with the re-evaluation of the safety of dimethyl ether as an extraction solvent under new intended conditions of use and new maximum residual limits. The applicant requests a change in the residual limit of dimethyl ether in defatted animal protein products (in particular collagen) from mg/kg to 3 mg/kg, and a new use for the extraction of protein products to yield gelatin with a residual limit of mg/kg is also requested. The Panel notes the maximum residual limit requested by the applicant is much higher than the existing limit. Nonetheless, the margin of exposure for this new application is considered to be adequate. No new toxicity data were provided for dimethyl ether and, since the previous EFSA evaluation, only two in vitro genotoxicity studies have become available. These studies do not indicate any genotoxic potential for the assessed substance. The Panel thus considers that the use of dimethyl ether as an extraction solvent, under the intended conditions of use and with the proposed residual limits of 3 mg/kg in the defatted protein products and 9 μg/kg specifically in gelatin, is of no safety concern. European Food Safety Authority, 2015 KEY WORDS extraction solvent, dimethyl ether, CAS Registry Numbers On request from the European Commission, Question No EFSA-Q , adopted on 24 June Panel members: Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Konrad Grob, Rainer Gürtler, Trine Husøy, Wim Mennes, Maria Rosaria Milana, André Penninks, Vittorio Silano, Andrew Smith, Maria de Fátima Tavares Poças, Christina Tlustos, Fidel Toldrá, Detlef Wölfle and Holger Zorn. Correspondence: fip@efsa.europa.eu 3 Acknowledgement: The Panel wishes to thank the members of the Working Group on Food Contact Materials, Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Roland Franz, Konrad Grob, Martine Kolf-Clauw, Eugenia Lampi, Maria Rosaria Milana, Maria de Fátima Poças, Philippe Saillard, Kettil Svensson and Detlef Wölfle, for the preparatory work on this scientific opinion and EFSA staff member: Joaquim Maia for the support provided to this scientific output. Suggested citation: EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), Scientific Opinion on the safety of use of dimethyl ether as an extraction solvent under the intended conditions of use and the proposed maximum residual limits. EFSA Journal 2015;13(7):4174, 13 pp. doi: /j.efsa Available online: European Food Safety Authority, 2015

2 SUMMARY Following a request from the European Commission, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) of the European Food Safety Authority (EFSA) was asked to deliver a scientific opinion on an application submitted by the company Akzo Nobel Industrial Chemicals BV for re-evaluating the use of dimethyl ether as an extraction solvent. More specifically, a re-evaluation was sought for the use of dimethyl ether under the new intended conditions of use and proposed maximum residual limits (MRL), namely: preparation of defatted animal protein products (collagen), MRL of 3 mg/kg in the defatted protein products; specific preparation of gelatin, MRL of mg/kg in the gelatin. The Commission asked EFSA to issue a scientific opinion on the assessment of the safety of dimethyl ether when used as an extraction solvent for the preparation of defatted animal protein products. Specifically, the applicant proposes to use dimethyl ether in the preparation of collagen and gelatin. These products are used, amongst others, by the meat industry in the preparation of processed meat products and other food products. The used level of collagen is typically 2.0 % (w/w) of the finished product, but up to 3.5 % (w/w) may be used. For gelatin, the maximum use level in food is 9.0 % (w/w). Dimethyl ether toxicity has been tested mainly upon atmosphere exposure. Upon inhalation, dimethyl ether is rapidly taken up and distributed in various tissues and organs. It is reported that, upon exposure in the atmosphere to ppm (equivalent to mg/m 3 ) in rats, dimethyl ether levels of 14 to 22 mg/kg have been found in different organs and tissues. Organ distribution appears to be proportional with atmosphere concentrations in the range of 750 to ppm (equivalent to a concentration in atmosphere of and mg/m 3 ). The Panel considers that, in general, inhalation exposure toxicity data cannot be extrapolated directly to an oral exposure situation. However, in this particular case, considering that animal studies have shown that dimethyl ether is distributed throughout the body following inhalation exposure, similarly as through oral exposure, the Panel estimates that results from inhalation studies can be used to assess dimethyl ether oral toxicity. Observations from inhalation studies suggest that dimethyl ether is of low toxicity potential. Dimethyl ether has not shown genotoxicity potential in vitro, and sub-chronic, chronic and carcinogenicity inhalation studies carried out in rats and hamsters exposed to high levels of the compound (up to mg/m 3 ) have not identified any significant toxic effect. One of two reproductive and developmental inhalation toxicity studies reported with dimethyl ether has shown no compoundrelated effects at doses up to mg/m 3, whereas the other study has established a no-effect level of ppm (equivalent to mg/m 3 ). Assuming that the rat body weight is 0.25 kg, that rats have a breathing rate of 200 ml/min and an inhalation absorption efficiency of 75 % for an exposure duration of six hours per day, the daily internal exposure to dimethyl ether arising from the lowest no effect level identified in the embryo foetal inhalation toxicity study in rats (2 355 mg/m 3 ) can be estimated to be approximately 518 mg/kg body weight (bw)/day 4. A residual limit of 3 mg dimethyl ether/kg of extracted animal proteins is proposed by the applicant. In a conservative exposure scenario (3.5 % of collagen is added to the food and a consumption of 1 kg food per day by a 60-kg person), the concentration of 0.11 mg/kg food would correspond to an intake of 2 μg/kg bw/day. The applicant proposes a MRL of 9 μg/kg dimethyl ether in gelatin (equal to the limit of detection of the analytical method used). In a conservative exposure scenario (9 % of gelatin is 4 Internal dose (rat) = / / mg/kg bw/day. EFSA Journal 2015;13(7):4174 2

3 added to the food and a consumption of 1 kg food per day by a 60-kg person), the concentration of 0.8 μg/kg food would correspond to an intake of μg/kg bw/day. A conservative estimate of exposure is therefore around 2 μg/kg bw/day. This level of exposure would be approximately times lower than the lowest no effect levels identified for dimethyl ether in an embryo foetal inhalation toxicity study (518 mg/kg bw/day). The margin of exposure for this new application is considered to be adequate. Consequently, the Panel considers that the use of dimethyl ether as an extraction solvent, under the intended conditions of use and with the proposed residual limits of 3 mg/kg in the defatted protein products and 9 μg/kg specifically in gelatin, is of no safety concern. EFSA Journal 2015;13(7):4174 3

4 TABLE OF CONTENTS Abstract... 1 Summary... 2 Background as provided by the European Commission... 5 Terms of reference as provided by the European Commission... 5 Assessment Introduction Data available in the dossier used for this evaluation Non-toxicity data Toxicity data Assessment Non-toxicity data Chemistry Specifications Manufacturing process Methods of analysis Reaction and fate in foods to which the source is added Case of need and proposed uses Exposure Information on existing authorisations and evaluations Biological and toxicity data Bioavailability, metabolic fate and biological distribution Toxicity data Discussion Conclusions Documentation as provided to EFSA References Appendix Appendix A. Existing authorisations and risk assessments Abbreviations EFSA Journal 2015;13(7):4174 4

5 BACKGROUND AS PROVIDED BY THE EUROPEAN COMMISSION The use of extraction solvents is regulated under Directive 2009/32/EC (recast) on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients. Dimethyl ether (DME) is authorised for use as an extraction solvent (according to Directive 2009/32/EC 5 ) for the preparation of defatted animal protein products with a maximum residual limit of mg/kg in the defatted protein product. The European Food Safety Authority (EFSA) expressed its opinion on the safety in use of dimethyl ether as an extraction solvent in 2009 (EFSA, 2009). It considered that the use of DME as an extraction solvent to remove fat from animal protein raw materials (with a maximum residual limit of 9 μg/kg) is of no safety concern. The Commission received a request vis-à-vis an amendment of Part II of Annex I to Directive 2009/32/EC, specifically on the use of DME. Therefore, the European Commission asks EFSA to provide a scientific opinion on the safety in use of DME as an extraction solvent under the intended conditions of use and the proposed maximum residual limits (MRL), namely: 1) Preparation of defatted animal protein products, MRL of 3 mg/kg in the defatted protein products; 2) Specific preparation of gelatin, MRL of mg/kg in the gelatin. TERMS OF REFERENCE AS PROVIDED BY THE EUROPEAN COMMISSION In accordance with Article 29(l)(a) of Regulation (EC) No 178/ the European Commission asks the European Food Safety Authority to provide a scientific opinion on the safety in use of dimethyl ether as an extraction solvent under the intended conditions of use and the proposed maximum residual limits (MRL), namely: 1. Preparation of defatted animal protein products, MRL of 3 mg/kg in the defatted protein products; 2. Specific preparation of gelatin, MRL of mg/kg in the gelatin. Interpretation of the terms of reference The Panel has evaluated the safety of dimethyl ether if present as a solvent residue in defatted protein products and specifically in gelatin, at the MRLs proposed. The Panel did not evaluate any other aspects of the source materials used for the defatted animal protein products, the industrial processes applied, nor the products coming from these processes. 5 Directive 2009/32/EC of the European Parliament and of the Council of 23 April 2009 on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients (Recast) (Text with EEA relevance), OJ L 141, , p Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. OJ L 31, , p EFSA Journal 2015;13(7):4174 5

6 ASSESSMENT 1. Introduction Dimethyl ether is used as processing aid to extract lipids from proteins used by the meat industry in the preparation of meat products. Specifically, dimethyl ether is proposed by the applicant to be used for the preparation of collagen and gelatin. 2. Data available in the dossier used for this evaluation 2.1. Non-toxicity data Data on identity, physical and chemical properties. Data on purity and impurities. Information on the production technology and technical need. Data on intended use and authorisation. Data on residual content of the substance Toxicity data None. 3. Assessment 3.1. Non-toxicity data Chemistry Dimethyl ether is a vapour at ambient temperature and pressure. Dimethyl ether is reported as having a relative vapour density of 1.59 (air = 1), a density of 2.11 kg/m 3 as a gas at 0 C, a density of 669 kg/m 3 (± 0.01) when liquefied under pressure at 20 C, a melting point of 141 C, a boiling point of 25 C (at kpa), an autoignition temperature of 235 C (BAM, DIN 51794) and a flash point of 41 C. Dimethyl ether has a vapour pressure (20 C) of 510 kpa, an octanol/water partition (log K o/w ) of 0.18 and explosion limits of % (percentage of volume in air) (Technical dossier, 2007). It is described as being soluble in methanol, ethanol, isopropyl alcohol, chlorinated hydrocarbons and toluene. Its water solubility is reported in the application to be 328 g/l (20 C at 410 kpa). Synonyms are dimethyl oxide, oxybismethane, methoxymethane, wood ether and others. The Chemical Abstracts Service (CAS) Registry Number is and the European Inventory of Existing Commercial chemical Substances (EINECS) number is The molecular mass is 46 g/mol and the chemical formula is CH 3 OCH 3. Figure 1: Dimethyl ether chemical structure Specifications Dimethyl ether is reported as being % pure, colourless, with no residual odour, with a C1 C4 hydrocarbons (alkanes, alkenes and CO 2 ) content of less than 100 mg/kg (by gas chromatography), with a methanol content less than 10 mg/kg (by gas chromatography) and with a water content less than 100 mg/kg (by Karl Fisher titration). EFSA Journal 2015;13(7):4174 6

7 Manufacturing process Dimethyl ether The manufacturing process is well described. Dimethyl ether is produced by catalytic dehydration of vaporised methanol (> % purity) in a fixed-bed reactor and then purified from the reactor effluent by distillation (Technical dossier, 2007) Methods of analysis Specific analytical methods to measure the content in dimethyl ether of alkanes and alkenes (methane, ethane, propane, butane, ethene, propene, 1-butene, iso-butene, trans-2-butene, cis-2-butene), CO 2, methanol and water are described in detail. A method for the determination of dimethyl ether in collagen, gelatin and animal proteins is described (Technical dossier, 2007). The method is based on gas chromatography with headspace injection and flame-ionisation detection and has a detection limit of 9 μg/kg Reaction and fate in foods to which the source is added No specific information was provided. The applicant states that dimethyl ether is very stable and does not form peroxides, unlike other ethers. No interactions with food substances are known or expected (EFSA, 2009) Case of need and proposed uses Collagen is a group of naturally occurring proteins found in animals, especially in the flesh and connective tissues of vertebrates. Animal skins contain mainly collagen, fat and water. To produce collagen, normally animal skins from slaughterhouses are used. According to the applicant, the new manufacturing process for collagen using dimethyl ether for defatting and dewatering is said to offer technical advantages. It consists of four main stages: 1) Extraction of the raw skins by means of liquefied dimethyl ether. 2) The liquefied dimethyl ether (containing the water and fat extracted from the skins) is recovered by means of evaporation and condensation and/or compression and can be re-used. 3) A vacuum step is applied to remove most of the residual solvent from the collagen. The collagen agglomerates are also exposed to fresh air at atmospheric pressure to allow dimethyl ether to dissipate further. 4) The collagen agglomerates are dried, ground and packed. Samples of collagen from different stages of this production process were analysed for residual dimethyl ether. The results showed that dimethyl ether is progressively removed during steps 3 and 4. Levels in the range of 1.5 to 2.8 mg/kg were found in the final ground product. Gelatin is a water-soluble derivative made from collagen. The use of dimethyl ether to produce collagen is as described above, up to and including the application of vacuum in step 3. Thereafter, in further steps, the collagen agglomerates are soaked in acid solution, followed by extraction, hydrolysis and then a series of refining and recovery treatments, including filtration, clarification, evaporation, sterilisation, drying, rutting, grinding and sifting, to obtain the final gelatin product. Two samples of gelatin were prepared from non-ground collagen agglomerates using a small-scale laboratory procedure. These samples were analysed and dimethyl ether was below the detection limit of the method used (limit of detection (LOD) = 9 μg/kg). According to the applicant, the laboratory process conditions were relatively mild compared with commercial process conditions. Therefore, it may be expected that the final residual dimethyl ether content would be even lower in gelatin from a commercial plant. EFSA Journal 2015;13(7):4174 7

8 Animal proteins are used by the industry in the preparation of processed meat products. The use level of collagen is typically 2.0 %, but in some cases (where extra fibrillation and water binding is required) up to 3.5 % may be used. For gelatin used in the food industry (e.g. in dairy, candy), the maximum use level in food is 9.0 % Exposure The applicant proposed two worst-case exposure scenarios based on the maximum residual levels that are requested. The applicant proposes a maximum residual limit (MRL) of 3 mg/kg dimethyl ether in collagen. Assuming that a maximum of 3.5 % of collagen is added to the food and a consumption of 1 kg food per day by a 60-kg person, the concentration of mg/kg food would correspond to an intake of 1.75 μg/kg body weight (bw)/day. The applicant proposes a MRL of 9 μg/kg dimethyl ether in gelatin, equal to the LOD of the analytical method used. Assuming that a maximum of 9.0 % of gelatin is added to the food and a consumption of 1 kg food per day by a 60-kg person, the concentration of 0.8 μg/kg food would correspond to an intake of μg/kg bw/day. Given the conservative nature of these calculations, using the maximum addition levels and the maximum residual levels proposed along with a high food consumption, and also given the high margin of exposure thus derived (see later), the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) considered that these estimates for adults also adequately cover the potential exposure of other age groups, including children Information on existing authorisations and evaluations In the European Union (EU), dimethyl ether is authorised for the preparation of defatted animal protein products with a maximum residue limit of mg/kg in the defatted protein product (EU Directive 2009/32/EC, as amended). In the previous opinion (EFSA, 2009), a health-based reference value for dimethyl ether was not derived, but the maximal residual amount of dimethyl ether in the final product (less than or equal to 9 µg/kg) was evaluated against the toxicity data available, based on a margin of safety approach Biological and toxicity data No new toxicity data on dimethyl ether were provided. Two in vitro genotoxicity studies have become available since the EFSA evaluation of Bioavailability, metabolic fate and biological distribution Upon inhalation, dimethyl ether is rapidly taken up and distributed in various tissues and organs in rats, reaching a steady state concentration 30 minutes after exposure. It is excreted unchanged, largely via exhaled air within a very short time, and levels return to background levels within 90 minutes (Kemper and Eckard, 1978). It has been reported that, in rats, exposure to ppm of dimethyl ether (equivalent to mg/m 3 ) leads, after 60 minutes, to concentrations in the order of 14 mg/kg in the muscle, 15 mg/kg in the lungs and liver, 16 mg/kg in the spleen, 17 mg/kg in the kidney and the heart, 18 mg/kg in the brain and 19 to 22 mg/kg in blood and fat tissue, respectively (Kemper and Eckard, 1978). In this study, organ distribution appeared direct proportional with concentrations of dimethyl ether in the atmosphere at the range of 750 to ppm (equivalent to and mg/m 3 ). 7 Equivalent concentrations were calculated in this opinion according to EFSA Journal 2015;13(7):4174 8

9 Toxicity data Dimethyl ether Dimethyl ether has been tested via the inhalation route and no information is available on oral exposure. The following text summarises major toxicological findings following inhalation exposure with dimethyl ether reported in the dossier (Technical dossier, 2007) Genotoxicity Bacterial mutagenicity Ames tests involving incubation of the plates in gas chambers containing up to ppm (equivalent to mg/m 3 ) dimethyl ether have not shown mutagenic effects in Salmonella typhimurium TA1535, TA1537, TA1538, TA98 and TA100 with or without metabolic activation (CIVO, 1978). In vivo sex-linked recessive lethal testing on Drosophila melanogaster exposed by inhalation to levels of up to ppm (equivalent to mg/m 3 ) for 14 days show no signs of mutagenic effects (RIVM, 1981). No mutagenic effect of dimethyl ether was observed in a host-mediated assay with Escherichia coli K12 and S. typhimurium TA1538 in N:NIH (sw) mice exposed to atmospheres of up to ppm dimethyl ether (equivalent to mg/m 3 ) for three hours (RIVM, 1981). One in vitro UDS-assay in primary rat liver cells and a HGPRT forward mutation assay in V79 Chinese hamster cells done with dimethyl ether concentrations of up to 75 mmol/l dissolved in the medium, have shown no genotoxic effects (RIVM, 1981). In addition, an in vitro chromosomal aberration study carried out in human peripheral lymphocytes exposed to a concentration of dimethyl ether up to 70 % with and without S9 is reported in an unpublished study cited by the United States Environmental Protection Agency (EPA, 2000). No increase in chromosomal damage, evaluated as structural and numerical aberrations at any concentration tested, was reported (EPA, 2000) Sub-chronic and long-term toxicity Repeated dose studies with 4- or 13-week exposure via the inhalation route in rats and hamsters did not result in any consistent treatment-related effects on behaviour, growth, urinalysis, organ weights gross pathology and histopathology examinations. Some significant changes in haematology were observed in two 13-week rat studies; however, these effects (e.g. on lymphocytes or white blood cells) were not consistent between the studies and were not considered toxicologically relevant due to a lack of dose response (EFSA, 2009). In a two-year good laboratory practice inhalation rat study, a non-significant slight decrease in survival time in animals exposed to and ppm dimethyl ether was observed. Exposure up to ppm of dimethyl ether showed no evidence of increased cancer in any of the tissues or organs examined. Based on the slight decrease in survival, a no effect level at the lowest dose in this study of ppm (equivalent to mg/m 3 ) was proposed Reproductive and developmental toxicity One of two reproductive and developmental inhalation toxicity studies reported with dimethyl ether in rats has shown no compound-related effects at doses up to mg/m 3, whereas, for the other study, a no effect level of ppm (equivalent to mg/m 3 ) was identified. This no effect level was based on some embryo foetal toxicity (decreased foetal body weight, increased incidence on skeletal variation) at the intermediate dose (EFSA, 2009) Other information In humans, inhalation of dimethyl ether can provoke cough, sore throat, confusion, drowsiness and unconsciousness. Contact with eyes can cause redness and pain and, in the liquid form, dimethyl ether can cause frostbite on the skin (ICSC, 2002). EFSA Journal 2015;13(7):4174 9

10 4. Discussion Dimethyl ether The Panel considers that, in general, inhalation exposure toxicity data cannot be extrapolated directly to an oral exposure situation. The Panel recognises that the approach taken here comprises route-toroute extrapolation, which is not trivial (Pepelko, 1987; Rennen et al., 2004). However, given the absence of toxicity in tissues of first (possible) contact, the limited metabolism, the fast distribution and excretion, and the non-reactive character of the substance in this particular case, the Panel considered it appropriate to evaluate the safety of the proposed used of this substance on the basis of the available inhalation toxicity data. Observations from inhalation studies suggest that dimethyl ether is of low toxicity potential. Dimethyl ether has not shown a genotoxic potential in vitro and a chronic rat inhalation study did not identify any carcinogenic effect up to ppm (equivalent to mg/m 3 ). To estimate an internal exposure to dimethyl ether without toxic effect in repeated dose studies, the no effect level of ppm (equivalent to mg/m 3 ) from a developmental inhalation study in rats was used as a conservative approach. Assuming that the rat body weight is 0.25 kg, that rats have a breathing rate of 200 ml/min and an inhalation absorption efficiency of 75 % for an exposure duration of six hours per day, the daily internal exposure to dimethyl ether arising from the lowest no effect level identified in the embryo foetal inhalation toxicity study in rats (2 355 mg/m 3 ) can be estimated to be approximately 518 mg/kg bw/day 8 (ECHA, 2012). The applicant proposes a MRL of 3 mg/kg dimethyl ether in the animal protein product that is collagen. In a conservative exposure scenario (3.5 % of collagen is added to the food and a consumption of 1 kg food per day by a 60-kg person), the concentration of 0.11 mg/kg food would correspond to an intake of 2.0 μg/kg bw/day. The applicant proposes a MRL of 9 μg/kg dimethyl ether in gelatin (equal to the LOD of the analytical method used). In a conservative exposure scenario (9 % of gelatin is added to the food and a consumption of 1 kg food per day by a 60-kg person), the concentration of 0.8 μg/kg food would correspond to an intake of μg/kg bw/day. A conservative estimate of exposure from these two sources is therefore around 2 μg/kg bw/day. This level of exposure would be approximately times lower than the lowest no effect levels identified for dimethyl ether in an embryo foetal inhalation toxicity study (518 mg/kg bw/day). The Panel notes that the maximum residual limit requested by the applicant for defatted animal protein is much higher than the existing limit (3 mg/kg vs mg/kg, respectively) and also that the use level of the animal protein product proposed to be added to food has been raised from 2 to 3.5 %. Combined, these two changes would reduce the margin of exposure from approximately 10 8 to approximately Nonetheless, the margin of exposure for this new application is considered to be adequate. The Panel considers these estimates of exposure and the resulting margins of exposure are adequate and did not request specific estimates of exposure for age groups other than adults. The Panel noted that there are other sources of exposure such as the use of dimethyl ether as a propellant gas in consumer products sold in aerosol cans. The Panel noted that there are uncertainties in the evaluation of dimethyl ether because of the extrapolation from inhalation studies to oral exposure and, in addition, because consumers can be exposed via other sources. However, considering the very large margin between the lowest no effect level in repeated dose studies and the anticipated maximum exposure, no safety concern is expected from the intended use as an extraction solvent. 8 Internal dose (rat) = / / mg/kg bw/day. EFSA Journal 2015;13(7):

11 5. Conclusions Dimethyl ether The Panel considered the intended use of dimethyl ether as an extraction solvent to remove fat from animal protein raw materials. Considering (i) that the defatted animal protein is submitted to vacuum and other processing which assures that most of the volatile dimethyl ether is eliminated from final animal protein products, (ii) that the MRL of dimethyl ether is 3 mg/kg in extracted animal proteins or 9 μg/kg in the case of gelatin and (iii) that the maximum use level in the final food is 3.5 % for collagen and 9 % for gelatin, the Panel considered that there is no safety concern in relation to the new maximum residue limits proposed. DOCUMENTATION AS PROVIDED TO EFSA 1. Technical dossier, Application for the approval of dimethyl ether (DME) as an extraction solvent used in the production of foodstuffs and food ingredients according to the provisions of the Council Directive 88/344/EEC (as amended). Submitted by Akzo Nobel Technology & Engineering AE Amersfoort. The Netherlands. August Dossier Dimethyl ether. December Submitted by Akzo Nobel Industrial Chemicals V. REFERENCES CIVO (Centraal Instituut voor Voedingsonderzoek), Report no R5293. Evaluation of dimethyl ether in the Salmonella/microsome mutagencity test (final report). ECHA (European Chemical Agency), Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health. Available online: EFSA (European Food Safety Authority), Scientific Opinion of the Panel on Food Contact Materials, Enzymes, Flavourings and Processing aids (CEF) on dimethyl ether as an extraction solvent. The EFSA Journal 2009, 984, EPA (Environmental Protection Agency), Robust summary for dimethyl ether. Available online: ICSC (International Chemical Safety Cards), Dimethyl ether. ICSC Available online: Kemper FH and Eckard R, Massenfragmentographische Untersuchungen zum pharmakokinetischen Verhalten und zur Organverteilung von Dimethyläther (DME). Universitat Münster, Germany. Pepelko WE, Feasibility of route extrapolation in risk assessment. British Journal of Industrial Medicine, 44, Rennen MAJ, Bouwman T, Wilschut A, Bessems JGM and De Heer C, Oral-to-inhalation route extrapolation in occupational health risk assessment: a critical assessment. Regulatory Toxicology and Pharmacology, 39, RIVM (Rijksinstituut voor Volksgezondheid en Milieu), Rijksinstituut voor de Volksgezondheid Bilthoven. Rapport no Onderzoek naar de genotoxiciteit van dimethylether in vier kortdurende testen. EFSA Journal 2015;13(7):

12 APPENDIX Appendix A. Existing authorisations and risk assessments According to the applicant: Dimethyl ether has been approved by Food Standards Australia New Zealand in February 2012 as: (i) processing aid for dairy ingredients and products and (ii) processing aid for nondairy ingredients and products. Consequently, dimethyl ether is approved in Australia and New Zealand for all kind of foods with a residual limit of 2 mg/kg final food (listed on Standard table to clause 13). Dimethyl ether is mentioned on the German Guideline for Sanitary Assessment of Organic Coatings in Contact with Drinking Water (Coating Guideline), on Annex 1 Part 1 (list of assessed substances), below as blowing agent. Dimethyl ether is listed as propellant and solvent on the Inventory of Ingredients Employed in Cosmetic Products (EU Commission Decision 96/335/EC, as amended). Dimethyl ether is on the list of Indicative Exposure Limit Values of EU Directive 2000/39/EC, as amended, with a threshold limit of ppm (1 920 mg/m 3 ). The EU Member States National Occupational Exposure Limits have been set accordingly. US EPA has evaluated inhalation toxicity studies on dimethyl ether and concluded that there is no need to establish a maximum permissible level for residues of dimethyl ether arising from its use in pesticide formulations. This regulation eliminates the need to establish a maximum permissible level for residues of dimethyl ether. Consequently, the U S EPA has granted an exemption from the requirement of a tolerance for residues of dimethyl ether arising from its use as an inert ingredient (propellant) in pesticide formulations applied to growing crops or raw agricultural commodities after harvest according to 40 CFR and, furthermore, has granted an exemption from the requirement of a tolerance when dimethyl ether is used in accordance with good agricultural practice as an inert ingredient (propellant) in pesticide formulations applied to animals in accordance with 40 CFR (Code of Federal Regulations) Dimethyl ether is listed on the following inventories: EU: EINECS, registered under Registration, Evaluation, Authorisation and Restriction of Chemicals USA: Toxic Substances Control Act Australia: Australian Inventory of Chemical Substances Canada: Domestic Substance List China: Inventory of Existing Chemical Substances Produced or Imported in China Japan: Existing and New Chemical Substances: (2)-360 Korea: Korea Existing Chemicals Inventory: KE New Zealand: New Zealand Inventory of Chemicals Philippines: Philippines Inventory of Chemicals and Chemical Substances Mexico: National Inventory of Chemical Substances Turkey. EFSA Journal 2015;13(7):

13 ABBREVIATIONS AICS Australian Inventory of Chemical Substances bw CAS CEF CFR DME DSL EINECS ENCS EU FSANZ IECSC INSQ KECI LOD MRL NZIoC PICCS REACH US EPA TSCA body weight Chemical Abstracts Service EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids Code of Federal Regulations dimethyl ether Domestic Substances List European Inventory of Existing Commercial chemical Substances Existing and New Chemical Substances European Union Food Standards Australia New Zealand Inventory of Existing Chemical Substances Produced or Imported in China National Inventory of Chemical Substances Korea Existing Chemicals Inventory limit of detection maximum residual limit New Zealand Inventory of Chemicals Philippines Inventory of Chemicals and Chemical Substances Registration, Evaluation Authorisation and Restriction of Chemicals United States Environmental Protection Agency Toxic Substances Control Act EFSA Journal 2015;13(7):

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