Beeswax wraps - compliance testing package for Reg. (EC) 1935/2004

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).

Specific migration of mineral oil hydrocarbons (MOH), including mineral oil saturated hydrocarbons (MOSH) with polyolefin oligomeric hydrocarbons (POSH) and mineral oil aromatic hydrocarbons (MOAH) from food contact materials (FCM) into a food simulant. Analysis is possible with food simulants 10%, 20%, 50%, and 95% ethanol, 3% acetic acid, iso-octane, olive oil, and Tenax. The price includes testing with one simulant. The results are reported as the concentrations of fractions of MOSH/POSH and MOAH, with grouping based on the number of carbon atoms in the substances. The reported fractions are listed in the table below: MOSH/POSH (C10-C50), total MOAH (C10-C50), total MOSH/POSH (≥C10-≤C16) MOAH (≥C10-≤C16) MOSH/POSH (>C16-≤C20) MOAH (>C16-≤C25) MOSH/POSH (>C20-≤C25) MOAH (>C25-≤C35) MOSH/POSH (>C25-≤C35) MOAH (>C35-≤C50) MOSH/POSH (>C35-≤C40) MOSH/POSH (>C40-≤C50) POSH are not part of MOH but can be present in polyolefin plastics, such as polyethylene (PE) and polypropylene (PP). MOSH and POSH have very similar structures and they tend to elute together in chromatography. Thus in polyolefin plastics and materials with polyolefin layers, it is usually impossible to separate MOSH and POSH with normal analysis techniques. The analysis includes a compliance assessment according to the following references: MOSH fraction: in-house risk assessment POSH fraction: Plastics Europe documentation Polyolefin oligomers: research project for risk assessment. MOAH fraction: Standing Committee on Plants, Animals, Food and Feed Section Novel Food and Toxicological Safety of the Food Chain 19 October 2022

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 package for silicone elastomers intended for food contact: Test parameter Limit Test method Regulatory reference Volatile content 0.5% Bestimmung von flüchtigen Verbindungen in Bedarfsgegenständen aus Silikon (version 02, 09/2023) BfR recommendation XV Residual peroxides Not detected 58. Mitteilung zur Untersuchung von Kunststoffen: Bundesgesundheitsblatt 40, (1997) BfR recommendation XV Release of odor and flavor No deterioration of organoleptic properties DIN 10955:2024 Regulation (EC) 1935/2004 Upon request, analysis of cyclosiloxanes can be included in the test package. Cyclosiloxanes are known impurities in silicone articles, and their concentrations must be very low for products to be eligible for sustainability labels, such as the Nordic Swan Ecolabel.

As there is no harmonized EU regulation for using wood in food contact applications, compliance should be assessed based on other resources, such as the national legislation of member states. This test package is based on the requirements of French Information note n°2012-93 (Note d'information n° 2012-93) for coated and non-coated wood intended for food contact. The following analyses are included in the displayed price: Test parameter Test method/standard Method of extraction or preparation Transfer of odor and flavor into food DIN 10955 Water extract or contact with model food Heavy metals in water extract (Pb, Cd, Hg) ICP-MS Cold or hot water extract (EN 645 / EN 647) Formaldehyde in water extract EN 1541 Cold or hot water extract (EN 645 / EN 647) Polychlorinated biphenyls (PCB28, PCB52, PCB101, PCB118, PCB153, PCB180) GC-MS In-house method Pentachlorophenol (PCP) content GC-MS CEN/TR 14823 In addition to the tests listed above, a pesticide screening should be performed for wood treated with antifungal substances (so-called "anti-blue" protection). The analysis covers 715 substances and is available for an additional cost of 298 EUR. In most cases, this test package is sufficient to establish food contact compliance of non-coated wood or articles thereof. If the wood has been coated with a lacquer or varnish, has been painted, or contains adhesives, complementary testing could be required (e.g., migration of primary aromatic amines, migration of mineral oil (MOSH/POSH and MOAH hydrocarbons). Our experts are happy to support you by reviewing the documentation of the coating material and/or the adhesive to determine the full scope of required testing.

Specific migration testing to measure the transfer of 1,6-hexamethylene-bis[3-(3,5-di- tert-butyl-4-hydroxyphenyl) propionamide] into food. The substance is better known by the trade name Irganox 1098 [CAS: 23128-74-7]. Irganox 1098 is listed as FCM 631 with Ref No. 59120 in Regulation (EU) No 10/2011 on plastic food contact materials. The specific migration limit (SML) for the substance is 45 mg/kg of food.

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).

Accredited laboratory analysis for determining the specific migration of 1,3-butadiene [CAS: 106-99-0] from plastic and rubber-based materials intended for food contact. The compound is listed in Regulation (EU) No 10/2011 on plastic food contact materials with FCM substance number 223 and Reference number 13630. The specific migration limit (SML) for butadiene is ND, which means that there must not be detectable migration into food with a detection limit of 0.01 mg/kg. In addition, the concentration of butadiene in the final product must not exceed 1 mg/kg. According to German BfR Recommendation XXI, the above restrictions also apply to materials based on natural and synthetic rubber, such as nitrile gloves.

Determination of the specific migration of 9,9-bis(methoxymethyl)fluorene [CAS: 182121-12-6 ] from a plastic material intended for food contact. The substance is listed under FCM No. 779 and Ref No. 39815 in European Commission Regulation No 10/2011. The specific migration limit (SML) is 0.05 mg/kg of food. 9,​9-​bis(methoxymethyl)​​fluorene is used in the preparation of polypropylene by heterogeneous Ziegler-Natta catalysts.

Specific migration of vinyl acetate [CAS: 108-05-4] from a sample or material intended for food contact. Vinyl acetate is listed with FCM 231 and Ref No. 10120 in European Commission Regulation No 10/2011 with an SML value of 12 mg/kg of food.