Safety assessment of the substance Ln 1,4-benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the additive Ln 1,4-benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials. It is a family of mixtures combining the four lanthanides lanthanum (La), europium (Eu), gadolinium (Gd) and/or terbium (Tb) in different proportions as their 1,4-benzene dicarboxylate complexes, used as a taggant in plastics for authentication and traceability purposes. The powdered additive, not in nano form, is intended to be used at up to 100 mg/kg in polyethylene, polypropylene and polybutene. Materials and articles made of these plastics are intended for contact with all foods types at up to 4 h/100°C or for long-term storage at ambient temperature. In tests with food simulants, migration of each Ln was below 5 µg/kg. The Panel considered that irrespective of the composition of the lanthanides, these would dissociate completely from the terephthalic acid salt under aqueous conditions. Evaluation of the genotoxicity studies provided on the individual complexes (La, Eu, Gd and Tb) and on their mixture, taken together with data available in the scientific literature, allows ruling out concern for genotoxicity. Consequently, the CEP Panel concluded that the substance Ln 1,4-benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) does not raise a safety concern for the consumer under the proposed conditions of use and if the migration of the sum of the four lanthanides in ionic form does not exceed 50 µg/kg food.

Safety assessment of the substance 1,2,3,4-tetrahydronaphthalene-2,6-dicarboxylic acid, dimethyl ester for use in food contact materials.

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing aids (CEF Panel) deals with the safety assessment of 1,2,3,4-tetrahydronaphthalene-2,6-dicarboxylic acid, dimethyl ester (TDCM) for use as a co-monomer to manufacture polyester layers. The polyester layer is not intended to be in direct contact with food. The finished multilayer articles are intended for packaging aqueous, acidic and low alcoholic foodstuffs. Contact conditions include sterilisation followed by long-term storage at room temperature. No thermal degradation of TDCM is expected during the manufacture of the middle polyester layer and of the multilayer articles. Total mass transfer of the substance from a polyester monolayer was calculated to be up to 0.032 mg/kg food. Based on three in vitro genotoxicity tests, the CEF Panel considered that the substance does not raise concern for genotoxicity. When tested behind a polypropylene layer, migrating TDCM-related oligomers, their oxidation products and other related reaction products were identified. The major components were TDCM dimers. When tested behind a cyclo-olefin polymer layer, none of the TDCM-related substances were found to migrate. Based on the lack of genotoxicity of the co-monomer, the ester nature of the oligomers and on (quantitative) structure-activity relationship ((Q)SAR) analysis, the CEF Panel considered that there is no indication of genotoxicity for the oligomers, their oxidation products and other TDCM-related reaction products. The CEF Panel concluded that the substance is not of safety concern for the consumer if used as a co-monomer for the manufacture of a polyester layer intended to be used as an inner (non-food contact) layer of a multilayer material for contact with foods simulated by simulants A, B, C, D1 (as set in Regulation (EU) 10/2011). The migration of the sum of the substance and the dimers (cyclic and open chain) should not exceed 0.05 mg/kg food.

Safety assessment of the substance dimethyl carbonate for use in food contact materials.

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of dimethyl carbonate used as monomer for making a polycarbonate prepolymer with 1,6-hexanediol and then reacted with 4,4'-methylenediphenyldiisocyanate (MDI) and diols, such as polypropylene glycol and 1,4-butanediol, to form a thermoplastic polyurethane containing 29% of the polycarbonate prepolymer. This polymer is intended for repeated use articles with short-term contact (≤ 30 min) at room temperature for types of food, simulated by 10% ethanol and 3% acetic acid. In the third migration test performed at 40°C during 30 min, overall migration was below 2 mg/dm2. Complete migration of the residual dimethyl carbonate would have amounted to less than 1.5 µg/kg food. The migration of two cyclic hexanediol carbonate oligomers was below 50 µg/kg food when determined by the third migration test; that of all others was below 1 µg/kg food. Three in vitro genotoxicity studies performed in accordance with OECD Guidelines and covering the three endpoints gene mutation, structural and numerical aberrations were provided and were considered negative by the CEF Panel. The oligomers detected by the migration tests are formed from dimethyl carbonate and 1,6-hexanediol (FCM ref No 1067) do not give rise to concern for genotoxicity. The CEF Panel concluded that the use of dimethyl carbonate does not raise safety concern in the application described above. It is aware that dimethyl carbonate may be used for other polycarbonates and/or under other conditions. These are likely to result in different migrates which need to be evaluated by the business operators. In such cases, the migration of dimethyl carbonate and the total polycarbonate oligomers below 1,000 Da is of no safety concern, if each of them does not exceed 0.05 mg/kg food.

4-Methylbenzophenone and benzophenone are inactive in the micronucleus assay.

Many materials in contact with food, including printing inks, the lack of deeper knowledge about possible toxic effects is a problem. Furthermore, some of these substances are not only produced for packaging of foods, they are produced for a variety of purposes and are not meant to come into direct contact with foodstuffs. Two examples on such chemicals in printing inks are benzophenone and 4-methylbenzophenone. Recently, authorities reported that high levels of the photoinitiator 4-methylbenzophenone had been detected in cereal products. Based on this information we have studied 4-methylbenzophenone and the chemically similar benzophenone using the micronucleus assay in vivo and in vitro. To increase the sensitivity we have used the in vivo flow cytomer-based micronucleus assay in mouse. Although doses up to lethality were used and an average of hundred thousand young erythrocytes, polychromatic erythrocytes, analysed from each animal, no genotoxic effect occurred. The 4-methylbenzophenone was also analysed in the in vitro micronucleus assay, using human lymphocytes. The result does not show any dose-related effect. These results show that the occurrence of 4-methylbenzophenone that so far has been detected in foodstuff does not increase the cancer risk through chromosome breaks or mal-distribution of chromosomes.

Furan is not genotoxic in the micronucleus assay in vivo or in vitro.

Furan, a potential human carcinogen, is formed during heat-treatment of food. Previous studies of the genotoxicity of furan have given disparate results. Hence, there is a need for complementary data to clarify the mechanism behind the carcinogenicity of furan. In this study, we have used the flow cytometer-based micronucleus assay in mice and the cytokinesis-block micronucleus assay in human lymphocytes to investigate the genotoxic potential of furan. Three in vivo experiments were performed: intraperitoneal or subcutaneous injection of furan in male Balb/C mice (0-300 and 0-275 mg/kg body weight, respectively) and intraperitoneal injection of male CBA mice (0 and 225 mg/kg body weight). No increased level of micronucleated erythrocytes was detected in any of the in vivo experiments. In the in vitro setup, human lymphocytes from two donors were treated with furan in concentrations from 0 to 100 mM, either with or without metabolic activation (liver homogenate from rat). In parity with the in vivo results there was no significant increase in the frequency of micronucleated cells here either. As neither the in vivo nor the in vitro studies disclose any significant increase in the micronucleus frequency after treatment with furan, our results support that the carcinogenicity of furan is caused by a non-genotoxic mechanism.