Specific migration testing – Irganox 1098

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.

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.

Specific migration of acetaldehyde [CAS: 75-07-0] from a plastic food contact material. Acetaldehyde is listed as FCM 128 with Ref No. 10060 in European Commission Regulation No 10/2011. Migration into food must not exceed the specific migration limit (SML) of 6 mg/kg.

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.

Test package for beeswax-coated wraps to evaluate suitability for food contact according to Regulation (EC) 1935/2004 (Article 3). The package is based on German BfR document "Beeswax cloths: what should you look out for?" The details of the analyses included are presented in the table below: Test parameter Test method Note Transfer of odor and flavor into food DIN 10955 Test performed with a model food Pesticide screening LC-MS, GC-MS Includes analysis of 715 substances Migration of mineral oil (MOSH/POSH & MOAH) hydrocarbons Online LC-GC-FID Simulant and conditions decided based on the intended use of the product Migration of primary aromatic amines LC-MS/MS Simulant and conditions decided based on the intended use of the product More information can be found in this FAQ document by BfR.

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.

Primary aromatic amines (PAA) are a class of compounds that are generated when residual isocyanate groups in food contact materials react with the water in foods. In addition, articles in which aniline, benzidine, or other PAAs have been used as precursors for pigments or as curing agents can be a source for restricted PAA. Certain PAAs are known carcinogens, and these are listed in entry 43 to Appendix 8 of Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and Council (known as the REACH Regulation). These PAAs are not allowed to migrate into food or food simulants. Primary aromatic amine testing is especially relevant for products that contain, for example, the following: Aromatic isocyanate groups containing SML substances, Polyurethane-based materials, Azo dyes, Recycled plastic. This test package includes the analysis of the following substances: Substance CAS number 2-Amino-4-nitrotoluene 99-55-8 2-Naphthylamine 91-59-8 2,4-Diaminoanisole 615-05-4 2,4-Toluenediamine 95-80-7 2,4,5-Trimethylaniline 137-17-7 3,3'-Dichlorobenzidine 91-94-1 3,3'-Dimethoxybenzidine 119-90-4 4,4ʹ-Diamino-3,3ʹ-dimethyldiphenylmethane, 838-88-0 3,3'-Dimethylbenzidine 119-93-7 4-Aminoazobenzene 60-09-3 4-Aminodiphenyl 92-67-1 4-Chloro-o-toluidine 95-69-2 4,4'-Diaminodiphenylmethane 101-77-9 4,4ʹ-Methylene-bis(2-chloroaniline) 101-14-4 4,4'-Oxydianiline 101-80-4 4,4'-Thiodianiline 139-65-1 Benzidine 92-87-5 o-Aminoazotoluene 97-56-3 o-Anisidine 90-04-0 o-Toluidine 95-53-4 p-Chloroaniline 106-47-8 p-Cresidine 120-71-8 1,2-Phenylenediamine 95-54-5 1,3-Phenylenediamine 108-45-2 1,4-Phenylenediamine 106-50-3 1,5-Diaminonaphthalene 2243-62-1 2-Aminobenzamide 88-68-6 2,4-Dimethylaniline 95-68-1 2,4'-Methylenedianiline 1208-52-2 2,5-Dimethoxy-4-chloroaniline 6358-64-1 2,6-Diaminotoluene 823-40-5 2,6-Dimethylaniline 87-62-7 3-Chloroaniline 108-42-9 4-Aminobenzamide 2835-68-9 4-Methylaminosulfonyl-p-cresidine 49564-57-0 4,4′-Diaminodiphenyl sulfone 80-08-0 5-Amino-6-methyl-2-benzimidazolone 67014-36-2 Aniline 62-53-3 4-Aminotoluene-3-sulfonic acid 88-44-8 N,N-Dimethylaniline 121-69-7 p-Toluidine 106-49-0 Sum of primary aromatic amines -

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 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.

Acrylamide (CAS: 79-06-1) is used in certain sizing and retention agents in the production of fiber-based food packaging. It is classified as a potential human carcinogen, and its migration into food is restricted under several EU and national regulations. A migration limit of 0.01 mg/kg was recently introduced for acrylamide release from paper- and board-based food contact materials by the latest version of German BfR recommendation XXXVI (October 2025). The same limit also applies to migration from plastic food contact materials under Regulation (EU) No 10/2011. Specific migration from plastics or rubber can be determined using several food simulants. Paper and board, for which conventional migration testing is not suitable, are analyzed using aqueous or solvent extractions (EN 645, EN 647, EN 15519).