Document OV3b8Y3wjwyvJXrrZz2DbBQv

BAUM lined piping GMBH Pipes made of steel/PTFE-PFA Gewerbestrasse 25-29 D-75217 Birkenfeld-Grfenhausen Food Regulatory Declaration of Compliance This is to certify that the plastics: PTFE natural, PTFE black (with carbon), PFA natural, PFA black (with carbon) comply with the legal regulations as amended of the 1. German Consumer Goods Ordinance 2. Regulation (EC) No 1935/2004 on consumer goods in contact with foodstuffs 3. Regulation (EC) No 2023/2006 on good manufacturing practice for consumer goods in contact with foodstuffs 4. Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with foodstuffs. 5. Plastics in contact with foodstuffs, recommendations of the Federal Institute for Risk Assessment (BfR), ed. H. Wieczorek, Carl Heymanns Verlag KG Cologne, Berlin, Bonn, Munich. In accordance with the requirements of the abovementioned legal regulations, the plastics were tested by the laboratory TV SD Industrie Service GmbH (Chemical Analysis Department, Ridlerstrasse 65, 80339 Munich). The test reports are detailed under the test report numbers 20131928, 20154619 and 20156299. Specific limited substances: PTFE natural: Tetrafluoroethylene with SML = 0.05 mg/kg PTFE black (with carbon): Tetrafluoroethylene with SML = 0.05 mg/kg PFA natural and PFA black (with carbon): Tetrafluoroethylene with SML = 0.05 mg/kg and perfluoropropyl perfluorovinyl ether with SML = 0.05 mg/kg 1. Tests performed according to the Plastics Regulation 10/2011 for PTFE natural, PTFE black (with carbon), PFA natural: - Global migration with 3% acetic acid, 95% ethanol and isooctane. 10 days / 60C / 1dm:100 ml simulant - Sensory testing: 10 days / 60C / 1dm:100 ml drinking water - Migration of specific limited substances with 3% acetic acid, 95% ethanol and isooctane Test conditions: 10 days / 60C / 1dm:100 ml simulant - Colour fastness according to the recommendation of the Federal Institute for Risk Assessment (BfR) "Plastics in contact with foodstuffs" Part B II.IX. with water as a simulant BAUM lined piping GmbH, Zert.Zu.Be._1367_00-07/2019 Lebensmittelgerechte Konformittserklrung_en Created by Aydin Karadeniz, Created on 06.07.2019, Approved by Michael Leicht, Revision 0, Valid from 06.07.2019 Page 1 of 3 Result: The calculated total migration values of the third migration stages are below the limit value of 10 mg/dm2 stipulated by the Plastics Regulation 10/2011. The specific migration limits to be considered according to the documents are also complied with. The deviations compared with the reference samples as regards the parameters odour and taste are all within the tolerance range of the Foods, Consumer Goods and Feedstuffs Code (LFGB) requirement. No colourfastness of the tested materials was detected; as under test conditions, no tinting of the test strips in comparison to the reference strips occurred. This results in the suitability of the tested plastics for the following foodstuff groups: - aqueous foodstuffs - acidic foodstuffs - alcoholic foodstuffs - fatty foodstuffs The test at 60C for 10 days covers a long-term storage of more than 6 months at room temperature and below, including heating to 70C for up to 2 hours or heating to 100C for a period of up to 15 minutes. The application of 1 dm plastics to 100 ml foodstuffs simulant takes the most rigorous possible service conditions as the reference. 2. Tests performed pursuant to the Plastics Regulation 10/2011 for PTFE natural, PFA natural, PFA black (with carbon): - Global migration with food simulants A (10% ethanol), (3% acetic acid) and D2 (olive oil). Test conditions: 4 h / backflow / 1 dm : 38 ml (PTFE and PFA natural), 1 dm : 100 ml (PFA black with carbon) / simulant A and B1); 2h / 175C / 1 dm: 38 ml (PTFE and PFA natural), 1 dm : 100 ml (PFA black with carbon) / simulant D22) 3) - Sensory test with drinking water and butter Test conditions: 20 in / 100C / 1 dm: 38 ml (PTFE and PFA natural), 1 dm : 100 ml (PFA black with carbon) - Specific migration: Determination of the total content of tetrafluoroethylene and perfluoropropyl perfluorovinyl ether in the sample material by HS/GC-MSD.2) Subsequent calculation of the maximum possible migration of the substances from the finished plastic under the assumption of a total transition (see Note for guidance for petitioners presenting an application for the safety assessment of a substance to be used in food contact materials prior to its authorization from 30/07/2008). 1) The migration tests were carried out a total of three times in succession. At the end of each migration period, the simulant was emptied and replaced with a fresh one. 2) The analysis was subcontracted to an external accredited laboratory. 3) The evaluation was carried out on the test simulant of the first migration stage, as not enough sample material was available. The application of 1 dm plastic to 38 ml or 100 ml food simulant takes the most rigorous possible service conditions as the reference according to the customer specification, e.g. a thin tube. BAUM lined piping GmbH, Zert.Zu.Be._1367_00-07/2019 Lebensmittelgerechte Konformittserklrung_en Created by Aydin Karadeniz, Created on 06.07.2019, Approved by Michael Leicht, Revision 0, Valid from 06.07.2019 Page 2 of 3 Result: The total migration values determined of the third migration levels are below the limit to be observed according to the Plastics Regulation 10/2011 of 10 mg/dm2. The overall migration values determined with the simulant D2 were below the limit of 10 mg/dm in the first migration stage. Taking into account the previous empirical values in connection with multi-stage migration tests of plastics and the existing conditions of use of the tested plastics (pipelines through which food flows within a period of up to 30 seconds) it is unlikely that under these conditions the total migration value of 10 mg/dm is exceeded. Considering the possible applications of the plastics tested, it is still unlikely that the specific migration limits will be exceeded within the scope of the intended use. This was confirmed by calculations assuming a total transition. The deviations compared with the reference samples as regards the parameters odour and taste are all within the tolerance range of the requirement according to the LFGB (Foods, Consumer Goods and Feedstuffs Code). According to the recommendation of the Federal Institute for Risk Assessment (61. Communication on the Investigation of Plastics, Federal Health Bulletin 46 (2003)), there is a clear sensory deviation, insofar as test foods with an overall score of at least 3.0 have been assessed. The requirement according to Regulation (EU) No. 1935/2004, Article 3, paragraph 1c regarding the impairment of the organoleptic properties of foodstuffs was therefore fulfilled. This results in the suitability of the plastics tested (under the specific application of materials as pipe materials) for all types of foodstuffs. The check for global migration of 4 hours under backflow covers any food contact conditions with food simulants A and B at temperatures above 40C (standard test conditions OM 6; the test OM 6 also includes the food contact conditions described for OM 1, OM 2, OM 3, OM 4 and OM 5). Testing for global migration of 2 hours at 175C with simulant D2 covers high temperature applications with fatty foodstuffs (standard test conditions OM 7; the OM 7 test also covers the food contact conditions described for OM 1, OM 2, OM 3, OM 4 and OM 5). Date/Signature: 02/07/2019 Karadeniz (Quality Manager) The validity of this declaration expires in case of modification of the manufacturing formula as well as of the regulations BAUM lined piping GmbH, Zert.Zu.Be._1367_00-07/2019 Lebensmittelgerechte Konformittserklrung_en Created by Aydin Karadeniz, Created on 06.07.2019, Approved by Michael Leicht, Revision 0, Valid from 06.07.2019 Page 3 of 3