Single-use plastic food contact materials (FCM) – EU compliance testing package

Test package for single-use nitrile gloves to assess food contact compliance (for all foodstuffs) according to Germany's BfR XX1/1 "Commodities based on natural and synthetic rubber in contact with food" (as of 01.09.2024) and Regulation (EC) No 1935/2004. The test package covers selected general requirements for nitrile rubber. Analysis to determine the specific migration of nitrile rubber monomers (i.e., acrylonitrile and 1,3-butadiene) is also included. The substances have specific migration reference (SMR) values defined in Table 1 of BfR XXI. The table below lists the covered parameters, test methods, and compliance requirements: Test parameter Simulant(s) Test method Requirement Overall migration 10% ethanol, 3% acetic acid, olive oil EN 1186-1, -2, -3 ≤ 10 mg/dm2 Sensory analysis Water DIN 10955 No transfer of taste or odor Total transfer of zinc 3% acetic acid In-house ICP-MS ≤ 25 mg/kg of food Total transfer of aluminum 3% acetic acid In-house ICP-MS ≤ 1 mg/kg of food Total transfer of lead 3% acetic acid In-house ICP-MS ≤ 0.01 mg/kg of food Extractable primary aromatic amines 3% acetic acid In-house LC-MS/MS ≤ 0.002 mg/l of extract (per substance) Total transfer of formaldehyde 3% acetic acid In-house method ≤ 6 mg/kg of food Specific migration of butadiene olive oil In-house GC-MS/FID ≤ 0.01 mg/kg of food Specific migration of acrylonitrile 10% ethanol, 3% acetic acid, olive oil In-house GC-MS/FID ≤ 0.01 mg/kg of food The following parameters are not included in the package, but they can be analyzed separately upon request: Colorfastness, Release of N-nitrosamines and nitrosatable substances, Release of secondary aliphatic amines, Transfer of antimicrobial components (EN 1104).

This analysis package is intended to determine if food packaging and beverage bottles can be considered reusable in the framework of the Single-Use Plastic (SUP) Directive (Directive (EU) 2019/904). The following tests are included: Overall migration testing for repeated use with 10% ethanol, 3% acetic acid, and olive oil (simulants A, B, and D2), Dishwasher resistance testing according to EN 12875-1 with 25 wash cycles. The EU Commission’s interpretations of the SUP legislation declare that reusability can evaluated using test method EN 12875-1 (Mechanical dishwashing resistance of utensils). If plastic articles can be washed 25 times in a dishwasher, they can be considered to have been designed for multiple uses without losing their effectiveness and properties. Additionally, food packaging and beverage bottles tested for single-use are not compliant for reuse according to Regulation (EU) No 10/2011. Hence, the test package includes overall migration testing for repeated use to ensure that the article remains inert when reused. By default, testing is done to establish compliance with all types of foods (i.e., moist and dry foods, acidic and non-acidic, fatty foods). Note: this test package is only applicable for articles that have already been tested for food contact as single-use articles. This does not constitute a full test package for compliance according to Regulation (EU) No 10/2011. Please consult our experts for further support.

Overall migration (OML) testing with simulants A, B, and D2 is used to ensure the compliance of food packaging, cling film, freezer bags, nitrile gloves, takeaway boxes, and all other materials or articles that are intended for contact with all types of foods. Overall migration is the sum of all the non-volatile compounds that migrate from the food contact material into food. According to Regulation (EU) No 10/2011, materials and articles intended for contact with all types of food shall be tested with food simulants A (10% ethanol), B (3% acetic acid), and D2 (olive oil). To comply with the regulation, overall migration must not exceed 10 mg/dm2 (or 60 mg/kg). If testing with simulant D2 is not technically feasible, it is substituted with simulants D2e (95% ethanol) and D2i (isooctane). In case the contact temperature exceeds 100 °C, testing overall migration with simulant E (Tenax) is also necessary (not included in the cost). Our experts will provide guidance for selecting the appropriate simulants and migration conditions. Do not hesitate to ask for more information or a quote for testing repeated-use articles (the displayed price applies to single-use materials).

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.

Overall migration (OM) is the sum of all the non-volatile compounds that migrate from a food contact material into the food. According to Regulation (EU) No 10/2011, food simulants D1 and D2 are assigned for foods that have a lipophilic character and are able to extract lipophilic substances. Food simulant D2 shall be used for foods that contain free fats at the surface. In order to comply with Regulation (EU) No 10/2011, the overall migration must not exceed 10 mg/dm2 (or 60 mg/kg). We offer testing for both single-use and repeated-use articles. Due to the destructive nature of simulant D2, repeated-use tests are carried out on three sets of sample material with varying exposure times.

Overall migration (OM) into simulant E (Tenax) measures the sum of volatile and semi-volatile compounds that migrate from a food contact material into food via the gas phase. According to Regulation (EU) No 10/2011, food simulant E is assigned for materials that are intended for contact with dry foods (e.g., salt, dried spices, semolina, sugar) or which can be considered to have a dry surface (e.g. unpeeled fruits, frozen foods). Simulant E can be also used if the tested material absorbs or is otherwise not able to withstand a liquid simulant (e.g. uncoated paper, napkins, tissue paper). Due to its thermal stability, Tenax is used as a simulant for the overall migration testing of materials intended for high-temperature applications (> 100 °C) if testing with olive oil is not technically feasible. Typical instances include e.g. ovenable paperboard packaging, baking paper, cooking utensils made from polyamide, and ovenable silicone molds. The test methods intended for plastics and paper have been described in standards EN 1186-13 (method B) and EN 14338, respectively. The standard overall migration limit (OML) is either 10 mg/dm2 or 60 mg/kg, depending on the regulation. Compliance can be evaluated according to various regulations/guidelines; see Table 1 for details. Table 1. Examples of available safety references for compliance evaluation of the results. Material Regulatory or other safety reference Plastics Regulation (EU) No 10/2011 (Uncoated) paper and board Resolution CM/Res(2020)9; DGCCRF MCDA sheet n°4 (V02 – 01/01/2019) Silicone Silicones Europe guidelines; French Arrêté du 25 novembre 1992 Rubber BfR XXI Coatings, varnishes, adhesives Regulation (EU) No 10/2011

Overall migration (OM) is the sum of all the non-volatile compounds that migrate from the food contact material into the food. By convention, simulant D2e (95% ethanol) is used to simulate contact with fatty foods in cases where using simulant D2 (olive oil) is not technically feasible. 95% ethanol is also a suitable simulant for materials that are intended for the storage of ethyl alcohol. In case simulant D2e is used to substitute simulant D2, Regulation (EU) 10/2011 mandates using simulant D2i (isooctane) as well. When the migration temperature exceeds 100 °C, testing overall migration with simulant E (Tenax) is also needed. Tests with simulant D2i and simulant E are not included in the cost of this analysis. The contact temperature with simulant D2e is not allowed to exceed 60 °C. In addition, the simulant can cause swelling of certain types of polymers (PLA, ABS, PA, PET, HIPS, etc.), resulting in increased migration. Therefore, the migration conditions for this test should be chosen with care. To comply with Regulation (EU) No 10/2011, the overall migration must not exceed 10 mg/dm2 (or 60 mg/kg).

Standard DIN 10955 specifies test methods for the sensory analysis of food contact materials and articles that are intended for direct food contact. This analysis is performed according to the standard to determine the migration of odor and flavor from the packaging material into the food. By default, test is performed as Difference from Control-Test (DfC-Test) with a scoring scale. Test is also available as a triangle test for an additional cost.

Overall migration (OM) is the sum of all the non-volatile compounds that migrate from a food contact material into food. By convention, simulant D2i (isooctane) is used to simulate contact with fatty foods in case simulant D2 (olive oil) is not technically feasible. In case simulant D2i is used to substitute simulant D2, Regulation (EU) 10/2011 mandates using simulant D2e (95% ethanol) as well. If the migration temperature exceeds 100 °C, testing overall migration with simulant E (Tenax) is mandated additionally. The contact temperature with simulant D2i is not allowed to exceed 60 °C. The simulant can also cause an overestimation of migration with polyolefins (e.g., PE, PP). Therefore, the migration conditions for this test should be chosen with care. The method expert will help choose the appropriate conditions, if necessary. To comply with Regulation (EU) No 10/2011 on plastic food contact materials, the overall migration must not exceed 10 mg/dm2 (or 60 mg/kg). This test is intended for repeat-use articles and materials and is repeated three times for the same article/sample. Compliance is evaluated from the 3rd migration.

Overall migration (OM) is the sum of all the compounds that might migrate from a food contact material into food. We offer OM testing with simulant D1 for both single-use articles (lower displayed price) and repeated-use articles (higher displayed price). According to Regulation (EU) No 10/2011, food simulants D1 and D2 are assigned for testing migration into foods that have a lipophilic character and are capable of extracting lipophilic substances. Food simulant D1 shall be used for alcoholic foods with alcohol content above 20%, milk and dairy products, and oil-in-water emulsions. To comply with Regulation (EU) No 10/2011, migration must not exceed the overall migration limit (OML) of 10 mg/dm2 (or 60 mg/kg).