LFGB vs FDA testing standard for silicone products, What is the difference?

1. LFGB vs FDA testing standard for silicone products, What is the difference? LFGB (Lebensmittel-, Bedarfsgegenstände-und Futtermittelgesetzbuch, or “ "food, tobacco products cosmetics and other commodity management laws"), is the most important basic legal document in German food hygiene management. The specific LFGB standard is:German Food, Articles of Daily Use and Feed Code of September 1,2005(LFGB), Section 30 & 31 with amendments and Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004. LFGB test requested, including extractable components, sensorial examination odour and taste test, Lead and Cadmium, Volatile organic matter(VOM) and Polycyclic aromatic hydrocarbons(PAHs) Content. Test Requested German Food, Articles of Daily Use and Feed Code of September 1,2005(LFGB), Section 30 & 31 with amendments and BfR recommendation -Extractable Components German Food, Articles of Daily Use and Feed Code of September 1,2005(LFGB), Section 30 & 31 with amendments-Sensorial examination odour and taste test German Food, Articles of Daily Use and Feed Code of September 1,2005(LFGB), Section 30 & 31 with amendments and BfR recommendation -Lead and Cadmium German Food, Articles of Daily Use and Feed Code of September 1,2005(LFGB), Section 30 & 31 with amendments and BfR recommendation -Volatile organic matter(VOM) Polycyclic aromatic hydrocarbons (PAHs) Content Conclusion PASS PASS PASS PASS PASS

2. German Food, Articles of Daily Use and Feed Code of September 1,2005(LFGB), Section 30 & 31 with amendments and BfR recommendation -Extractable Components Test Method: With reference to 61. Mitteilung über die Untersuchung von Kunststoffen, Bundesgesundheitsbl 46 (2003) 362. Simulant Used Time Temperature Max.Permissible Limit 0.5%(w/w) 0.5%(w/w) Result of 001 Comment Distilled Water 3% Acetic Acid (W/V) Aqueous Solution 10% Ethanol (V/V) Aqueous Solution 4.0hr(s) 100℃ 4.0hr(s) 100℃ <0.1%(w/w) <0.1%(w/w) PASS PASS 4.0hr(s) 100℃ 0.5%(w/w) <0.1%(w/w) PASS Notes: %w/w = percentage of weight by weight German Food, Articles of Daily Use and Feed Code of September 1,2005(LFGB), Section 30 & 31 with amendments-Sensorial examination odour and taste test Test Method: With reference to DIN10955:2004,direct contact method. No.of panelist:6 Test Item(s) Test media Test Temperature (℃) Test time (hr) Sensorial examination odour (Point scale) Sensorial examination taste (Point scale) Comments Limit - - - 2.5 2.5 001 Distilled water 100 4 1.0 1.0 PASS Notes: Intensity scale(rounded at 0.5): 0 - no perceptible difference, 1 -just perceptible difference, 2 -slight difference, 3 -marked difference, 4 -strong difference German Food, Articles of Daily Use and Feed Code of September 1,2005(LFGB), Section 30 & 31 with amendments and BfR recommendation -Lead and Cadmium Test Method: Microwave digestion (GZTC CHEM- TOP-004-01), analysis was performed by ICP-OES. Test Items(s) Limit Unit MDL 001

3. Cadmium (Cd) Comment Lead (Pb) Comment mg/kg 2 ND PASS ND PASS ★ mg/kg 2 ★ Notes: 1.mg/kg =milligram per kilogram of sample 3.ND=Not Detected(less than MDL) 2.MDL=Method Detection Limit 4.★=Absent German Food, Articles of Daily Use and Feed Code of September 1,2005(LFGB), Section 30 & 31 with amendments and BfR recommendation -Volatile organic matter(VOM) Test Method: With reference to 61. Mitteilung über die Untersuchung von Kunststoffen, Bundesgesundheitsbl 46 (2003) 362. Test Items(s) Test Temperature Test Time Volatile organic matter (VOM) Comment Limit - - 0.5 Unit ℃ hr(s) %(w/w) MDL - - 0.1 001 200 4.0 ND PASS Notes: 1. %w/w = percentage of weight by weight 3.ND=Not Detected(less than MDL) 2.MDL=Method Detection Limit Polycyclic aromatic hydrocarbons (PAHs) Content Test Method: GC-MS. With reference to AfPS GS 2014:01 PAK, analysis was performed by Test Item(s): Sum of 18 PAHs. Sum of 7 PAHs Acenaphthylene, Acenaphthene, Fluorene, Phenanthrene, Pyrene, Anthracene, Fluoranthene. Naphthalene(NAP CAS NO. 91-20-3). Acenaphthylene(ANY, CAS NO.208-96-8). Acenaphthene(ANA, CAS NO.83-32-9). Fluorene(FLU, CAS NO.86-73-7). Phenanthrene(PHE, CAS NO.85-01-8). Anthracene(ANT, CAS NO.120-12-7). Fluoranthene(FLT, CAS NO.206-44-0). Pyrene(PYR, CAS NO.129-00-0). Benzo(a)anthracene(BaA, CAS NO.56-55-3). Chrysene(CHR, CAS NO. 218-01-9). Benzo(b)fluoranthene(BbF, CAS NO.205-99-2). Benzo(j)fluoranthene(BjF, CAS NO.205-82-3). Benzo(k)fluoranthene(BkF, CAS NO.207-08-9). Benzo(a)pyrene(BaP, CAS NO.50-32-8). Benzo(e)pyrene(BeP, CAS NO.192-97-2). Indeno( 1,2,3-c,d)pyrene(IPY,

4. CAS NO.193-39-5). Dibenzo(a,h)anthracene(DBA, CAS NO.53-70-3). Benzo(g,h,i)perylene(BPE, CAS NO.191-24-2) FDA testing (Food & Drug Administration Standard) is the minimum safety standard for food-contact silicone products in the US & Australia. The specific standards is: United States Federal Code, Part 21, Food and Drugs (21 CFR). FDA test requested Test Requested FDA 21 CFR 177.2600-Total extractive residues Conclusion PASS FDA21 CFR 177.2600-Total extractive residues Test Method: With reference to US FDA 21 CFR 177.2600. Simulant Used Time Temperature Max.Permissible Limit 20mg/sq.in Result of 002 <0.5mg/sq.in Comment Distilled Water 7.0hr(s) Reflux PASS temperature Succeeding Extraction n-Hexane 2.0hr(s) Reflux 1mg/sq.in <0.5mg/sq.in PASS temperature 7.0hr(s) Reflux 175mg/sq.in 9.2mg/sq.in PASS temperature Succeeding Extraction 2.0hr(s) Reflux 4mg/sq.in <0.5mg/sq.in PASS temperature In summary... LFGB silicone pass more strict testing and is therefore more expensive, while FDA silicone is more widely used, but silicone that has passed LFGB testing is definitely safer. Different countries have different standards for food-contact silicone products. LFGB is standard mainly for Europe, while FDA (Food and Drug Administration) is standard in America(though different country has their own FDA standard, but US FDA is internationally applied.) Our baby suction bowls, Baby self-feeding spoon, Silicone Baby Plate, Silicone teether,and other silicone baby items are produced with LFGB silicone. We also can custom products with FDA approved silicone or silicone with LFGB certification based on customer's requirement.