Declaration of conformity VEGABAR 82

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Claribel Briggs
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1 Declaration of conformity acc. to VO (EG) 1935/2004 and VO (EU) 10/2011 as well as acc. to FDA and USP Class VI as well as ADI-free Document ID: 47480

2 Editing status:

3 CFR FDA stands for Food and Drug Administration, a U.S. authority. Among other things, this authority issues a regulation on the use of product-contacting materials in the pharmaceutical, food and beverage and cosmetics industries (Code of Federal Regulations CFR). We meet these basic requirements by implementing sensor variants made of materials whose composition corresponds to the relevant 21 CFR's 177. For materials for which 21 CFR's 177 are not applicable, we refer to the current state of knowledge of independent experts from the pharmaceutical and food sectors or to statements of the Public Health Service of the Food and Drug Administration. EG 1935/2004 Regulation (EC) No. 1935/2004 of is aimed at ensuring a high level of protection of human health as well as the safety of consumers, respecting articles and materials intended to come into contact with food. Along with this regulation, individual measures can be implemented. For plastics, this is for example regulation (EU) no. 10/2011. The special focus of the regulation is on compliance with good manufacturing practice. We understand the principal aspect of good manufacturing practice to be making sure that parts with potential food contact are designed so that, at least under foreseeable conditions, the migration of constituent substances is largely avoided or does not occur in quantities that would endanger human health or bring about unacceptable changes in composition or organoleptic properties. GMP EG 2023/2006 Under the second aspect of good manufacturing practice (GMP) acc. to EG 2023/2006 of , we understand ensuring the traceability of components and products potentially coming into contact with foodstuffs throughout all stages of manufacturing and sales. This is guaranteed by our quality management system according to ISO 9001 and ISO USP The USP (US Pharmacopial Convention) is a non-commercial organisation for development and formulation of requirements and standards for the identity, quality and purity of drugs as well as food components and supplements. If confirmations of the supplier for plastics or elastomers on USP Class VI are available, the we confirm this for the respective concerned versions. ADI-free Free from substances with animal origin or substances associated with TSE (Transmissible Spongioform Encephalopathy) or BSE (Bovine Spongioform Encephalopathy). If confirmations of the supplier are available that plastics or elastomers are ADI-free, the we confirm this for the respective concerned versions. Notes on proper use The conformity declaration contains no information on additional hygienic aspects or cleanability, e.g. absence of gaps and undercuts, surface quality. If hygienic design is required, we recommend our instrument versions, for which conformity with "3A or EHEDG" is also confirmed. To ensure that there is no unintentional contamination to the process through transport, installation or mounting, a rinsing with a suitable cleaning medium (e.g. drinking water) is required before the first contact with the foodstuff. The seal of Klingersil C-4400 supplied as a standard feature with the threaded version, is not part of this conformity declaration and must be removed before installing into the process. 3

4 In the process, damages on the seal represent a hygienic risk. To avoid this, the seals must be checked regularly on damages and appropriate measures must be taken (e.g. exchange), if necessary. 4

5 Issue date: Issued by: VEGA Grieshaber KG Am Hohenstein Schiltach We hereby declare that the materials in contact with the medium of the variants listed below comply with Regulation (EC) No. 1935/2004 as well as the requirements of the Food Drug Administration or are made of stainless steel alloys (e.g. 316L) which have proven themselves over many years in the pharmaceutical and food sectors and are thus suitable for contact with foodstuffs. The requirement acc. to VO (EC) 10/2011 is not applicable because no plastic parts are used in the below listed versions which are in contact with the foodstuff. Thread A4 / F9 / C3 / LF / NX YD / EA / DF / CS / C4 N9 / C5 / DS / CX / C6 CW / CT / CZ / C9 / CU DW / C2 / AQ / AK / AL B82. * * AN / AM / AO / AP / AF AH / AG / AI / AJ / C8 DA / DG / DM A / DO DC / DR / C7 / DB / DD DU / DE / DH / DQ / DN DI / DT / DL / DK / DP DJ / S5 / R7 / S4 / LX QQ / RC / QB / RA / DE Z9 D / F 5

6 Flange AB / AA / AC / AD / EI EJ / EK / EL / FI /A2 FJ / BX / DX / N7 / BD CL / A3 / BY / B3 / DZ A8 / CK / D7 / D9 / NA B2 / BC / CN / BU / D3 NC / F7 / BQ / Q2 / BO FW / BP / D2 / B5 / NW A7 / BE / F2 / A4 / CE BS / FT / CC / FU / CD FQ / FV / A6 / D8 / N8 CR / D4 / D5 / CQ / CH B82. * * F8 / BW / BL / CI / FN F3 / CA / BT / BG H F4 / CB / F5 / B6 / FM B4 / FO / F6 / BB / FP BA / B9 / B7 / CF / BV CG / D6 / CP / EG / EI EJ / EK / EL / EV / QS QK / QL / T8 / TH / C4 Q3 / ST / PA / TP / RQ SU / QR / CH / SV / JV L3 / RD / QH / JQ / BT QP / BH / K5 / QG / B6 FM / B4 / FO / F6 / BB FP / BA / B9 / B7 / CF BV / CG / D6 D / F Clamp B82. * * AV / AT / AZ / AR / AX AW / AS / TD / PE / TE PC / TF / Q8 D / F Varivent B82. * * FR / FS / TO D / F Cone B82. * * EN / EO / EM / EP D / F 6

7 Neumo BioControl B82. * * FG / FD / FE / FH / QY D / F Collar socket B82. * * ES / EZ / E2 / NB / E3 E5 / LN / EZ / SE / SD D / F Hygienic fitting/saddle flange B82. * * EU / ES / ET C / AC SM / EI / EJ / EK / EL AD / TG / SR / AY / TB E8 / TW D / F SMS B82. * * FA / FB / FC D / F Others B82. * * GB / FF / PS / EG / SI PB / TN / E7 / FK / E6 DY / EW / EX / EY D / F Others with single seal in front B82. * * EW / C3 / DC S F For the measuring cell seal materials "A" and "B", the supplier only confirms compliance with FDA 21 CFR (a-d) and the absence of animal substances associated with BSE or TSE. The traceability of the wetted parts and materials according to VO (EG) 2023/2006 (GMP) is guaranteed by our QM system from procurement to production and assembly up to placing on the market. The following table lists the seal versions and the associated statements of conformity from our seal suppliers. Sealing feature Seal material Standard D, E EPDM (A+P 75.5/KW75F) EC 1935/2004 FDA 21 CFR (a-f) 3-A Standard Klasse 2 NSF (Standard 51) for food till 100 C USP class VI, <87>; and <88> (121 C) ADI free resp. TSE/BSE related substances 7

8 Sealing feature Seal material Standard F, G FFKM (Perlast G75S) EG1935/2004 FDA 21 CFR (e,f) P FKM(V70SW) EG1935/2004 Q EPDM(E70Q) EG1935/2004 USP <87>; USP <88> Class VI (70 C 3-A Standard Klasse 1 ADI free resp. TSE/BSE related substances FDA 21 CFR (e,f) USP <87>; USP <88> Class VI (70 C) 3-A Standard Klasse 1 ADI free resp. TSE/BSE related substances FDA 21 CFR (e,f) USP <87>; USP <88> Class VI (70 C 3-A Sanitary Standard Class 2 ADI free resp. TSE/BSE related substances O FFKM (Fluoraz SD890) FDA 21 CFR (e,f) USP Class VI ADI free resp. TSE/BSE related substances A, B FKM(VP2/A) FDA 21 CFR (a-d) This declaration is based on the following certificates: ADI free resp. TSE/BSE related substances Official statements of the seal suppliers for the following measuring cells and O-ring seals: EPDM (E70Q), FKM (V70SW), EPDM (A+P 75.5/KW 75 F), FEPM (Fluoraz SD890) and FFKM (Perlast G75S) for conformity with the FDA requirements as well as their conformity with EG regulation 1935/2004 to USP Class and ADI-free with regard to substances that are associated with TSE, BSE test certificate H Bg of Hygieneinstitut Gelsenkirchen for suitability of the measuring cell ceramic according to the requirements of FDA/CFSAN as well as directive 84/500/EWG Test certificate H Bg of the Hygieneinstitut for the suitability of the measuring point ceramics according to Directive 84/500/EEC including amending Directive 2005/31EC and thus Regulation (EU) 1935/2004 8

9 Notes 9

10 Notes 10

11 Notes 11

12 Printing date: All statements concerning scope of delivery, application, practical use and operating conditions of the sensors and processing systems correspond to the information available at the time of printing. Subject to change without prior notice VEGA Grieshaber KG, Schiltach/Germany 2018 VEGA Grieshaber KG Am Hohenstein Schiltach Germany Phone Fax

Declaration of conformity Adapter

Declaration of conformity Adapter Declaration of conformity acc. to VO (EG) 1935/2004 and VO (EU) 10/2011 as well as acc. to FDA Document ID: 34466 Editing status: 2017-05-19 2 CFR FDA stands for Food and Drug Administration, a U.S. authority.