Overall migration testing – simulant A (10% ethanol)

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 (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 (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 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).

General compliance testing package for single-use plastic food contact materials (FCMs) by regulation (EU) 10/2011 and (EC) 1935/2004, article 3. This testing package includes the following tests: Overall migration testing for all food types (simulants A, B, and D2), Sensory testing (odor and taste) according to DIN 10955, Specific migration of ammonium ion and elements listed in Annex II of EU 10/2011, Specific migration of non-intentionally added substances (NIAS) to simulant D2e (95% ethanol) with GC-MS screening analysis. When relevant, this general testing package can be combined with additional tests and test packages, such as: Specific migration tests of substances with specific migration limitations (SMLs), Specific migration of primary aromatic amines (PAAs), Extended screening analyses of non-intentionally added substances (NIAS).

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).

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).

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 A, B, and C are assigned for foods that have a hydrophilic character and can extract hydrophilic substances. Food simulant B shall be used for foods with a pH below 4.5. In order 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 the higher end to repeated-use materials.

Overall migration (OM) is the sum of all the non-volatile compounds that migrate from a food contact material into food. This test with simulant D2e is suitable for contact materials for which simulant D2 (olive oil) is not suitable. 95% ethanol is also a suitable simulant for materials that are intended for the storage of ethyl alcohol. The contact temperature with simulant D2e is not allowed to exceed 60 °C. In addition, this 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. Please contact the method expert for support if needed. To comply with Regulation (EU) No 10/2011, the overall migration must not exceed 10 mg/dm2 (or 60 mg/kg). The test is intended for repeat-use articles and materials and is thus repeated three times for the same article/sample. The compliance is evaluated from the 3rd migration.