Residual peroxides in silicone

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

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

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.

Content of 15 polycyclic aromatic hydrocarbons (PAHs) in plastic and rubber and products made from them (e.g., toys, kitchenware) according to AfPS GS 2019:01 PAK. If PAH levels are sufficiently low, the product may be granted a GS mark (a voluntary German product safety label). The test package includes the following substances: Naphthalene [CAS: 91-20-3], Acenaphthylene [CAS: 208-96-8] , Acenaphthene [CAS: 83-32-9] , Fluorene [CAS: 86-73-7] , Phenanthrene [CAS: 85-01-8] , Anthracene [CAS: 120-12-7] , Fluoranthene [CAS: 206-44-0] , Pyrene [CAS: 129-00-0] , Benzo(a)anthracene [CAS: 56-55-3] , Chrysene [CAS: 218-01-9] , Benzo(b)fluoranthene [CAS: 205-99-2] , Benzo(k)fluoranthene [CAS: 207-08-9] , Benzo(j)fluoranthene [CAS: 205-82-3] , Benzo(e)pyrene [CAS: 192-97-2] , Benzo(a)pyrene [benzo(def)chrysene] [CAS: 50-32- 8] , Indeno(1,2,3-cd)pyrene [CAS: 193-39-5] , Dibenzo(a,h)anthracene [CAS: 53-70-3] , Benzo(g,h,i)perylene [CAS: 191-24-2].

We offer two extended analysis packages for phthalates and plasticizers in various matrices using the GC-MS technique. The first package covers 22 compounds with reporting limits significantly lower than the industry standard of 0.001%: Substance name Abbreviation CAS No Reporting limit (LOD) (wt%) Dimethyl phthalate DMP 131-11-3 0.00005 Diethyl phthalate DEP 84-66-2 0.00005 Triethyl citrate TEC 77-93-0 0.00025 Diallyl phthalate DAP 131-17-9 0.00005 Dipropyl phthalate DPrP 131-16-8 0.00005 Diisobutyl phthalate DIBP 84-69-5 0.00005 Dibutyl phthalate DBP 84-74-2 0.00005 Di-n-pentyl phthalate DPP 131-18-0 0.00005 Di-n-hexyl phthalate DHXP 84-75-3 0.00005 Dibutyl sebacate DBS 109-43-3 0.00005 Acetyl tributyl citrate ATBC 77-90-7 0.00005 Benzyl butyl phthalate BBP 85-68-7 0.00005 Diethylhexyl adipate DEHA 103-23-1 0.00005 Dicyclohexyl phthalate DCHP 84-61-7 0.00005 Di-2-ethylhexyl phthalate DEHP 117-81-7 0.00005 Di-n-octyl phthalate DNOP 117-84-0 0.00005 DINCH DINCH 166412-78-8 0.00005 Di-2-ethylhexyl sebacate - 122-62-3 0.00005 Dioctyl terephthalate DOTP 6422-86-2 0.00005 Diisononyl phthalate DINP 28553-12-0 0.00025 Diisodecyl phthalate DIDP 26761-40-0 0.00025 Phthalic anhydride - 85-44-9 0.00005 The other package covers 43 compounds with a detection limit of 0.001%. The full list of target substances is available upon request. Please let us know which option you are interested in when requesting a quote.

We offer bisphenol A (BPA) content determination for various matrices, including: Consumer goods made from plastic, elastomers, and rubber, Toys and childcare articles, Food packaging (plastic, paper, multi-materials), Food (herbs, spices, nuts, coffee, etc.). Extraction is possible with various techniques, including: Exhaustive solvent extraction after cutting or cryogrinding of the sample, Cold water extract (EN 645), hot water extract (EN 647), or solvent extract (EN 15519) from packaging containing recycled fibers for compliance according to German BfR recommendation XXXVI, Acetonitrile extract of food contact materials for compliance according to French regulation LOI n° 2012-1442, Release into aqueous simulant from child care articles for compliance according to EN 14372 and EN 14350, Release into aqueous simulant from toys for compliance according to Toy Safety Directive 2009/48/EC. For food contact materials, we also offer a low LOD method that meets the 1 μg/kg detection limit specified in Commission Regulation (EU) 2024/3190. Our experts are happy to provide a quote for BPA testing with this method.

Analysis package for quantifying the following bisphenol compounds: bisphenol A (BPA) [CAS: 80-05-7], bisphenol B (BPB) [CAS: 77-40-7], bisphenol F (BPF) [CAS: 620-92-8], bisphenol S (BPS) [CAS: 80-09-1], bisphenol AF (BPAF) [CAS: 1478-61-1]. Testing is primarily intended for: Analyzing recycled PE, PP and LDPE intended for cosmetic packaging according to CosPaTox guidelines, Evaluating the compliance of plastics, paper, and board according to food contact regulations (by modeling migration based on the content). If the analysis is intended for food contact compliance, a method with a lower LOQ (0.05 mg/kg) can be used. Please let us know the goal of the analysis when requesting a quote.

Cyclosiloxanes are the primary building blocks of siloxane polymers and, ultimately, silicone rubber. Hence, cyclosiloxanes can remain in the final silicone article as residual impurities. Several cyclosiloxanes (D4, D5, D6; see table below) are considered harmful to the environment and human health. These three substances are listed in the REACH Candidate List of substances of very high concern (SVHC). Substance Abbreviation CAS N:o Octamethylcyclotetrasiloxane D4 556-67-2 Decamethylcyclopentasiloxane D5 541-02-6 Dodecamethylcyclohexasiloxane D6 540-97-6 The Nordic Swan Ecolabel criteria for greaseproof paper sets the limit values for D4, D5, and D6 impurities in silicone coating as 400 ppm per substance and 1000 ppm for the sum of D4, D5, and D6. In addition to the restricted substances listed above, this analysis package includes the quantification of cyclosiloxanes D3, D7, and D8.

Analysis of PAH compounds in plastic, rubber, paper, board, and products made from these raw materials (e.g., textiles, toys, packaging materials) as required by the REACH Regulation. Test package includes the following substances: Benzo(a)pyrene [benzo(def)chrysene] [CAS: 50-32-8] , Benzo(e)pyrene [CAS: 192-97-2] , Benzo(a)anthracene [CAS: 56-55-3] , Chrysene [CAS: 218-01-9] , Benzo(b)fluoranthene [CAS: 205-99-2] , Benzo(j)fluoranthene [CAS: 205-82-3] , Benzo(k)fluoranthene [CAS: 207-08-9], Dibenzo(a,h)anthracene [CAS: 53-70-3].

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.