Evaluation Criteria and Guidelines

Table of Contents

 

Introduction

Pursuant to the 2nd amendment of the German Drinking Water Ordinance (TrinkwV), since December 2012 the German Environment Agency (Umweltbundesamt – UBA ) has been tasked with stipulating mandatory evaluation criteria for materials and substances that come into contact with drinking water. The guidelines and recommendations issued heretofore by the UBA were less legally binding. These guidelines and recommendations will successively be implemented in the mandatory evaluation criteria in the next years.

According to § 17 Section 3 of the TrinkwV, evaluation criteria documents become legally binding two years after they have been issued by UBA. After this date, for construction and maintenance of facilities for the abstraction, treatment and distribution of drinking water only materials that fulfill the requirements of these evaluation criteria must be used.

For certification (attestation of conformity) of products in contact with drinking water according to the evaluation criteria the German Environment Agency has set up a recommendation. An explanatory document adressing questions and answers (FAQ) in relation to the implementation of these regulatory documents can be found righthand within the Documents navigation box, which will be amended if required.

 

Evaluation criteria for metallic materials

The evaluation criteria document for metallic materials used for products in contact with drinking water became mandatory on 10 April 2017 and has been recast in the meantime (date of recasting in force 14 May 2020).
The valid version is dated 25 May 2021

The evaluation criteria document comprises a positive list of metallic materials hygienically suitable for contact with drinking water. The German Environment Agency evaluates metallic materials in collaboration with relevant authorities of other EU member states that cooperate within the voluntary 4MS collaboration (4MS-Initiative, started by four EU member states Germany, France, Netherlands and Great Britain). Metallic materials having been assessed this way are included in the 4MS Composition List as well.

The below mentioned rules of procedure govern the positive list of metallic materials used for products in contact with drinking water contained in the evaluation criteria document.

Currently product testing according to DIN EN 16058 may be necessary to verify hygienic suitability for drinking water of some products, which do not fall within the scope of the evaluation criteria document for metallic materials. For this testing and the corresponding assessment, the following, currently non-binding, information has been prepared:

 

Evaluation criteria for enamels and ceramic materials

The German Environmental Agency has determined and published the „Evaluation criteria document for enamels and ceramic materials in contact with drinking water” (BWGL enamel/ceramics) on 12th September 2019. Following a transitional period of two years pursuant to § 17(3) TrinkwV, this document is mandatory from 12th September 2021. The BWGL enamel/ceramics has been amended once in between and is provided in its recent current version of 6th August 2021:

To help with the process of consideration of new materials in the evaluation criteria document for enamels and ceramic materials, UBA has published an information.

 

Evaluation criteria for cementitious materials

The German Environment Agency does not intend to define an evaluation criteria document for cementitious materials in contact with drinking water in anticipation of an European regulation. According to the revision of the European Drinking Water Directive being in progress, European positive lists for materials in contact with drinking water will be defined in the future.

 

Evaluation criteria for plastics and other organic materials in contact with drinking water

For plastics and other organic materials (coatings, lubricants, elastomers and thermoplastic elastomers) in contact with drinking water the following evaluation criteria document applies:

The translation of the document into English is expected in the second quarter of 2022.

The document has been amended three times so far. Amendments can be reviewed from official documents of the German Federal Gazette at:

For the transition from UBA guidelines to KTW evaluation criteria the German Environment Agency has set up the following transitional regulation:

One prerequisite for being tested according to the evaluation criteria document is that starting substances to be employed are evaluated and listed in the respective polymer-specific positive list. The German Environment Agency evaluates drinking water hygienic suitability of starting substances for organic materials in cooperation with the German Federal Institute for Risk Assessment (Bundesinstitut für Risikobewertung, BfR) and in collaboration with relevant authorities of other EU member states. Starting substances that have been positively evaluated within the voluntary 4MS Initiative collaboration (initiated by four EU member states Germany, France, Netherlands and Great Britain) will also be included in the 4MS-Core List (List of confirmed substances).

For the management of positive lists of starting substances for organic materials of the evaluation criteria documents, the rules of procedure mentioned below apply.

 

Transitional regulation for silicones

Silicones hitherto have been regulated within the KTW Guideline and are not yet covered by the Evaluation criteria document for plastics and other organic materials in contact with drinking water. For this reason, the following transitional recommendation applies:

 

Elastomer Guideline

The valid version of the Elastomer Guideline dates from 16 March 2016.

The valid positive list of the starting substances is included in Annex ED of the KTW evaluation criteria document.

For some materials the formula-specific requirements concerning migration into drinking water can be computed mathematically by using the Modelling Guideline, rather than being substantiated analytically.

The De Minimis Guideline can additionally be used as a basis for formulation assessment for substances that are used in small amounts and that have specific technological functions.

UBA has transposed the Elastomer Guideline and the TPE transitional regulation into the KTW evaluation criteria document.

 

Thermoplastic elastomers

Hitherto thermoplastic elastomers could be assessed using the transitional recommendation for hygienic assessment of thermoplastic elastomers (TPE Transitional Recommendation).

The document version currently valid dates from 11 March 2019.

By having transposed the Elastomer Guideline and the TPE transitional regulation into the KTW evaluation criteria document, UBA has also rearranged hygienic assessment of thermoplastic elastomers.

 

De Minimis Guideline

The recommendation titled: “Assessment of substances with a specific technological function and low required quantities relating to the formulation review in accordance with the guidelines of the German Environment Agency on the hygienic assessment of organic materials in contact with drinking water (De Minimis Guideline)” was published in the 2012 issue of Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz (55:150-151).

The valid version of the De Minimis guideline  dates from 18 April 2011.

This guideline can be used in conjunction with the still existing documents Elastomer Guideline and transitional recommendation for TPE to evaluate formulations for manufacturing organic materials in contact with drinking water.

 

Modelling Guideline

The Guideline for the Mathematical Estimate of the Migration of Individual Substances from Organic Material in Drinking Water (Modelling Guideline) was published in the August 2009 issue of Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz (52:1105-1112).

The valid version is the one dated 7 October 2008.

The Modelling Guideline enables the testing of formulation and substance-specific requirements pursuant to the Evaluation criteria for plastics and other organic materials in contact with drinking water, the KTW Guideline, Coating Guideline, Lubricant Guideline and Elastomer Guideline, as well as to the transitional recommendation for thermoplastic elastomers, using mathematical modelling. Following this, experimental testing concerning these requirements is not necessary.

 

Recommendation for attestation of conformity of product hygiene suitability for drinking water

The German Environment Agency has published the „Recommendation for attestation of conformity of product hygiene suitability for drinking water“:

The German Environmental Agency is mandated to publish evaluation criteria documents for drinking water contact materials pursuant to § 17 Section 3 of the German Drinking Water Ordinance. These legally binding evaluation criteria do not include determinations regarding to the manner of attestation of conformity for products intended to come into contact with drinking water. As endorsement to evaluation criteria documents, the German Environment Agency in cooperation with expert groups and after having passed a hearing process have prepared a recommendation for attestation of conformity of product hygiene suitability for drinking water. 

The recommendation for attestation of conformity of product hygiene suitability for drinking water had been amended before in April and July 2020 (1st and 2nd amendment, respectively) and has been updated in July 2021 by the current 3rd amendment.

Explanations for implementation of this recommendation in certification processes for products in contact with drinking water following evaluation criteria are provided in an FAQ document, see navigation box 'Documents'.

 

Rules of procedure of the German Environment Agency for the management of the positive list of metallic materials suitable for use in contact with drinking water

For the management of the positive list of metallic materials hygienically suitable for the contact with drinking water as implemented in the evaluation criteria document for metallic materials in contact with drinking water, the following rules of procedure apply:

 

Rules of procedure for the management of the positive list of starting substances for organic materials in contact with drinking water

For the management of positive lists of starting substances for Evaluation criteria for plastics and other organic materials in contact with drinking water, the following rules of procedure apply:

The appendixes can be downloaded separately:

  • Annex 1: Application for inclusion of a starting material in a positive list of evaluation criteria in accordance with §17 TrinkwV
  • Annex 2: Additional application form for the inclusion of a not completely assessed substance
  • Annex 3: Additional application form for the inclusion of a substance which is already assessed by EFSA
  • Annex 4: Additional application form for the inclusion of a substance which is already assessed by another authority or international organization
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