Ethylene oxide in packaging and food contact materials

According to FDA food contact regulations, perfluorocarbon resins intended for use as coatings or components of coatings must meet extractability requirements after being refluxed for 2 hours separately with distilled water, 8 percent ethanol, and n-heptane. The extracted surfaces shall meet the following extractability limits: Total extractives not to exceed 3.1 milligrams per square decimeter (0.2 milligrams per square inch)., Fluoride extractives calculated as fluorine not to exceed 0.46 milligram per square decimeter (0.03 milligram per square inch).. This analysis package includes the determination of total and fluoride extractives into the three previously mentioned simulants.

Analysis of bisphenol AF (CAS 1478-61-1) content in packaging and food contact materials, such as plastics and rubber. In particular, bisphenol AF is used in some FKM rubbers as a curing agent. Analysis is conducted with LC-MS from solvent extraction of the sample. Upon request, analysis can also be converted into a migration test using food simulants.

Analysis to determine the specific migration of fluorescent whitening agent 2,5-bis(5-tert-butyl-2-benzoxazolyl)thiophene, known by the trade name Uvitex OB [CAS: 7128-64-5], from a sample or material intended for food contact. The substance is listed under FCM 500 and Ref No. 38560 in European Commission Regulation No 2011/10 on plastic food contact materials. The specific migration limit (SML) for Uvitex OB is 0.6 mg/kg of food.

Analysis for quantifying dioxins and furans (PCDD/F) in various packaging materials (e.g. food and cosmetics packaging) and their raw materials, including plastics, paper, and rubber. Dioxins and furans are a family of chlorine-containing chemicals considered bioaccumulating, persistent organic pollutants (POPs) that can be toxic even at low doses. While regulatory limits apply mainly to food and feed, packaging materials can be a source of indirect exposure to dioxins and furans. Recycled materials tend to pose relatively high risks, depending on the quality of the raw material and the effectiveness of the decontamination process. The following substances are included in the analysis: Dibenzo-p-dioxins (PCDDs) Polychlorinated dibenzofurans (PCDFs) 2,3,7,8-TCDD. 2,3,7,8-TCDF. 1,2,3,7,8-PeCDD. 1,2,3,7,8-PeCDF. 1,2,3,4,7,8-HxCDD. 2,3,4,7,8-PeCDF. 1,2,3,6,7,8-HxCDD. 1,2,3,4,7,8-HxCDF. 1,2,3,7,8,9-HxCDD. 1,2,3,6,7,8-HxCDF. 1,2,3,4,6,7,8-HpCDD. 1,2,3,7,8,9-HxCDF. OCDD. 2,3,4,6,7,8-HxCDF. 1,2,3,4,6,7,8-HpCDF. 1,2,3,4,7,8,9-HpCDF. OCDF. Testing is often performed for the following reasons: Analyzing recycled PE, PP, and LDPE intended for cosmetics packaging according to CosPaTox guidelines., Analyzing paper and board bleached with elementary chlorine according to the requirements of TemaNord 2008:515 guidelines..

N-nitrosamines and N-nitrosatable substances are present, usually in trace quantities, in various environmental media, certain food products, cosmetics, and rubber products. In particular, those found in rubber products are thought to originate from certain additives used in the vulcanization of rubber. Regulatory reference / standard Applicable materials Compliance limits Applicable reference method Commission Directive 93/11/EEC Elastomer or rubber teats and soothers N-nitrosamines released: 0.01 mg/kg N-nitrosatable substances released: 0.1 mg/kg EN 12868 EN 14350 Drinking accessories made of rubber and other elastomers BfR recommendation XXI/1 Commodities based on natural and synthetic rubber in contact with food N-nitrosamines: not detected above 1 µg/dm2 (sum of substances) - N-nitrosamines and N-nitrosatable substances are controlled by Commission Directive 93/11/EEC. In addition, recommendation XXI by Germany’s Federal Institute for Risk Assessment (BfR) has set the migration limit of N-nitrosamines from elastomers to food at ≤ 1.0 µg/dm². The test package covers analysis of the release of the following N-nitrosamines (free and after nitrosation) into artificial saliva simulant or a food simulant: Substance Abbreviation CAS No N-Nitrosodimethylamine NDMA 62-75-9 N-Nitrosodi-n-propylamine NDPA 621-64-7 N-Nitrosodi-n-butylamine NDBA 924-16-3 N-Nitrosopiperidine NPIP 100-75-4 N-Nitrosopyrrolidine NPYR 930-55-2 N-Nitrosomorpholine NMOR 59-89-2 N-Nitrosobenzylamine NDBzA 937-32-6 N-Nitrosodi-n-amylamine NDiNA 2050-92-2 N-Nitroso-methylphenylamine NMPhA 937-35-9 N-Nitrosoethylphenylamine NEPhA 612-64-6

Determination of vinyl chloride [CAS: 75-01-4] content in plastics. Both the European Chemicals Agency (ECHA) and the US Environmental Protection Agency (EPA) have identified vinyl chloride as a carcinogen. According to Regulation (EU) No 10/2011 on plastic food contact materials, vinyl chloride content in the final product must not exceed 1 mg/kg. In addition, the substance has a specific migration limit of ND, which means that there must be no detectable migration into food.

Determination of total extractives from rubber articles intended for repeated use in accordance with U.S. regulation 21 CFR 177.2600. The regulation applies to both natural and synthetic rubber as well as elastomers (such as silicone) intended for food contact. The applicable limits for the total extractables are: Food type Food simulant Test conditions Limit Aqueous Distilled water 9 hours at reflux ≤ 20 mg/inch^2 (during the first 7 hours of extraction) ≤ 1 mg/inch^2 (during the last 2 hours of extraction) Fatty Hexane 9 hours at reflux ≤ 175 mg/inch^2 (during the first 7 hours of extraction) ≤ 4 mg/inch^2 (during the last 2 hours of extraction) The test package includes testing with both distilled water and hexane.

Overall migration (OM) is the sum of all the non-volatile compounds that migrate from a food contact material into food. According to Regulation (EU) No 10/2011, food simulant C shall be used to assess overall migration into alcoholic foods with an alcohol content of up to 20 % and those foods that contain a relevant amount of organic ingredients that render the food lipophilic. To comply with Regulation (EU) No 10/2011, the overall migration must not exceed 10 mg/dm2 (or 60 mg/kg). The lower end of the displayed price range applies to single-use materials and articles, while the higher one applies to repeated-use materials.

Accredited laboratory analysis for determining the amount of volatile organic matter in silicone used in food contact materials or childcare articles. Testing can be conducted according to the following methods and references: Applicable materials Drying phase Treatment phase Compliance limit Test method Reference General food contact materials made from silicone elastomer 1 h / 100 °C 4 h / 200 °C ≤ 0.5 % Bestimmung von flüchtigen Verbindungen in Bedarfsgegenständen aus Silikon (version 02, 09/2023) BfR XV. Silicones (as of 01.08.2024) Childcare articles intended for drinking 1 h / 100 °C 4 h / 200 °C ≤ 0.5 % EN 14350, art 8.4.2 EN 14350 Childcare articles intended for feeding 1 h / 100 °C 4 h / 200 °C ≤ 0.5 % EN 14372, art. 6.3.3 EN 14372

Specific migration of octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate, known by the trade name Irganox 1076 [CAS 2082-79-3], from a plastic material intended for food contact. The substance is listed under FCM No 433 and Ref No 68320 in European Commission Regulation 10/2011 with an SML value of 6 mg/kg of food. Test is available for all conventional food simulants. For repeated use articles, the test is done with three subsequent migrations.