Materials intended for use in contact with drinking water have to meet specific requirements for the protection of human health. In Germany, these requirements are laid down in the Drinking Water Ordinance and are legally binding. Where elastomer products are concerned, their hygienic assessment can alternatively be based on the Federal Environment Agency (UBA) Elastomer Guideline, which mainly addresses the evaluation of starting substances and their migration. This paper discusses the specific requirements and the principles of the assessment.
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References
1.
Ordinance on the quality of water intended for human consumption (Drinking Water Ordinance – Trinkwasserverordnung – TrinkwV 2001)
2.
Guideline for hygienic assessment of elastomers in contact with drinking water (Elastomer Guideline – Elastomerleitlinie), UBA Recommendation, 22.12.2011
3.
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 Authorisation, EFSA document, 30.07.2008
4.
Rules of Procedure of the Federal Environment Agency for maintaining the positive lists of starting substances for organic materials in contact with drinking water, UBA Rules of Procedure (Geschäftsordnung), 06.02.2014
5.
DIN EN 12873-1: 2004–04, Influence of materials on water intended for human consumption – Influence due to migration – Part 1: Test method for non-metallic and non-cementitious factory made products; German version EN 12873-1:2003
6.
Guideline for the Mathematical Estimate of the Migration of Individual Substances from Organic Material in Drinking Water (Modelling Guideline – Modellierungsleitlinie), UBA Recommendation, 07.10.2008
7.
Approval and Harmonisation – 4MS Initiative, UBA publication, 08.08.2013
