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BESTÄTIGUNG Die zur Herstellung von Bedarfsgegenständen mit Lebensmittelkontakt verwendete Elastomermischung mit der DMH-Bezeichnung : DMH333 EPDM FDA Materialnummer : 333 Basispolymer : EPDM Farbe : schwarz Härte (Shore A) : 85 ± 5 Dichte (g/cm3) : 1,19 ± 0,03 Entspricht in der Zusammensetzung der Wirkstoffe:
• der Positive List für wässrige Lebensmittel nach dem § 177.2600, CFR 21, „Rubber
Articles Intended For Repeated Use“, der Food and Drug Administration (FDA), USA.
Es liegt in der Verantwortung des Herstellers des Endproduktes sein Fertigteil zu prüfen und sicherzustellen, dass zulässige Grenzwerte wie Globalmigration und zutreffende Gesetze eingehalten werden (siehe FDA – Regelwerke: Grenzwerte und Einsatzbedingungen) Traboch, den 19.05.2016 DMH Dichtungs- und Maschinenhandels GmbH Die o.g. Mitteilung geben wir nach bestem Wissen. Sie gilt jedoch nur als unverbindlicher Hinweis, und befreit Sie nicht von der eigenen Prüfung der von uns gelieferten Produkte auf ihre Eignung für die beabsichtigten Verfahren und Zwecke. Anwendung, Verwendung und Verarbeitung der Produkte erfolgt außerhalb unserer Kontrollmöglichkeiten und liegen daher ausschließlich in Ihrem Verantwortungsbereich. Sollte dennoch eine Haftung in Frage kommen so ist diese für alle Schäden auf den Wert der von uns gelieferten und von Ihnen eingesetzten Ware begrenzt. Diese Mitteilung unterliegt nicht dem Änderungsdienst.
CERTIFICATE The used elastomer DMH-Notation : DMH333 EPDM FDA Material Number : 333 Base polymer : EPDM Colour : black Hardness (Shore A) : 85 ± 5 Density (g/cm³) : 1,19 ± 0,03 Complies in the composition of the active components with:
• the positive list after the § 177.2600, CFR 21, ‘Rubber Articles Intended For Repeated
Use’, of the Food and Drug Administration (FDA), USA.
It is the responsibility of the manufacturer of the finished part to examine and ensure that permissible limits, such as global migration and appropriate laws are observed (see FDA - Rules and Regulations: Limits and conditions of use)
Traboch, 19.05.2016 DMH Dichtungs- und Maschinenhandels GmbH We are giving this message to the best of our knowledge. It is only a non-binding advice, and does not exempt you from testing our product for their suitability for the intended processes and purposes. Application, use and processing of the products are beyond our control and, therefore, entirely on your own responsibility. However, should a case of liability come into consideration, it is limited to all damages to the value of the goods which we delivered and you used. This message is no subject to the updating service.
Declaration: Regulation EU No 1935/2004 Regulation EU No 2023/2006
The materials and applications listed below are referred to in the above regulations under Article 5 Annex 1, They are therefore not new, and are not ‘active’ or ‘intelligent’ materials or substances, and no application for new substances under Articles 8 and 23 of the regulation is being sought. Therefore under Article 16 of the regulation this letter constitutes a Declaration of Compliance that the list below complies with the requirements of the regulation and we can provide the appropriate evidence of compliance as laid out in the Regulation. Product: DMH333 EPDM FDA Description: Sealing material (EPDM) DMH-Notation : DMH333 EPDM FDA Material Number : 333 Base polymer : EPDM Colour : black Hardness (Shore A) : 85 + 5 Density (g/cm³) : 1,18 ± 0,03
DMH confirms that the above-mentioned materials are produced conform to the EC Regulation 1935/2004 and - under normal or foreseeable conditions of use - releases no constituents to food in quantities which could endanger human health or cause an unacceptable change in the final product. FDA 177.2600 has been used to demonstrate the compliance with the EU1935/2004 regulation. These compounds have been manufactured under procedures “Good manufacturing practice” as laid out in regulation EU 2023/2006
Traboch, 02.07.2018 DMH Dichtungs- und Maschinenhandels GmbH We are giving this message to the best of our knowledge. It is only a non-binding advice, and does not exempt you from testing our product for their suitability for the intended processes and purposes. Application, use and processing of the products are beyond our
control and, therefore, entirely on your own responsibility. However, should a case of liability come into consideration, it is limited to all damages to the value of the goods which we delivered and you used. This message is no subject to the updating service.