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 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.

 

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 revised four times since then (datum of current revision in force 21 November 2018).

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 (Common Composition List of accepted metallic materials) 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.

 

Draft of the evaluation criteria for enamels and ceramic materials

In order to safeguard and specify safety requirements for materials that come into contact with drinking water, the UBA elaborates mandatory evaluation criteria, pursuant to § 17 Section 3 of the German Drinking Water Ordinance. In cooperation with a working group whose members were nominated by relevant industry associations like, among others, Deutscher Emailverband and Verband der keramischen Industrie, UBA had compiled two successive draft documents of evaluation criteria for enamels and ceramic materials which were made available to the public and to interested parties for discussion and annotation. By considering reasonable comments and petitions for inclusion of additional materials a revised document was elaborated. During the notification process that followed, further relevant comments and petitions were submitted. Thus, the document was revised once again.

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.

The evaluation criteria document is scheduled for publication in 2019.

 

Evaluation criteria for cementitious materials

The German Environment Agency currently elaborates an evaluation criteria document for cementitious materials.

 

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

The German Environment Agency has determined the „Evaluation criteria document for plastics and other organic materials in contact with drinking water“ with status as at  21 March 2019.

This document will be taking effect on 21 March 2021, that is after a two-year transition period following its issuing yet taken place.

The evaluation criteria shall replace the previous guidelines gradually. With its current status, the evaluation criteria document applies to plastics, organic coatings and lubricants.

For the transition period until the evaluation criteria document becomes mandatory, 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.

 

KTW-Guideline

The Guideline on the hygienic assessment of organic materials in contact with drinking water (KTW Guideline) was last updated on 7 March 2016.

The KTW Guideline is to be replaced by the evaluation criteria document for plastics and other organic materials in contact with drinking water and will be rejected effective from the date of mandatory governance of the evaluation criteria document on 21 March 2021. Test certificates relating to the KTW Guideline will become invalid after this date.

 

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:

 

Coating Guideline

The Guideline for hygienic assessment of organic coatings in contact with drinking water (Coating Guideline) was last updated on 16 March 2016.

The Coating Guideline is to be replaced by the evaluation criteria document for plastics and other organic materials in contact with drinking water and will be rejected effective from the date of mandatory governance of the evaluation criteria document on 21 March 2021. Test certificates relating to the Coating Guideline will become invalid after this date.

 

Elastomer Guideline

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

The positive list of starting substances for the production of elastomers in contact with drinking water as of 13 July 2018 has been supplemented by substances assessed since 2012. These will be considered for the transfer of the positive list to the polymer specific part of the evaluation criteria document for plastics and other organic materials in contact with drinking water.

For the management of positive lists of starting substances as part of guidelines or of the future mandatory evaluation criteria documents, the rules of procedure mentioned below apply.

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.

The UBA plans to transpose the Elastomer Guideline into mandatory evaluation criteria, pursuant to amended § 17 Section 3 of the German Drinking Water Ordinance. Transitional recommendations for hygienic assessment of silicones and thermoplastic elastomers have been issued which must be considered once the evaluation criteria document for plastics and other organic materials in contact with drinking water will have attained its mandatory status.

 

Lubricant Guideline

The Guideline for hygienic assessment of lubricants in contact with drinking water (Lubricant Guideline) was last updated on 16 March 2016.

The Lubricant Guideline is to be replaced by the evaluation criteria document for plastics and other organic materials in contact with drinking water and will be rejected effective from the date of mandatory governance of the evaluation criteria document on 21 March 2021. Test certificates relating to the Lubricant Guideline will become invalid after this date.

 

Thermoplastic elastomers

The UBA is in the process of drafting hygienic requirements for thermoplastic elastomers that come into contact with drinking water.

For the time period until completion of the respective regulation document, thermoplastic elastomers can 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.

 

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 supplemental recommendation can be used in conjunction with existing guidelines (KTW Guideline, Coating Guideline, Lubricant Guideline and Elastomer Guideline) and the 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 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 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 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 has been updated following a consultation procedure.

 

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 organic materials of the guidelines and the prospectively mandatory evaluation criteria documents, the following rules of procedure apply:

The rules of procedure applies to the positive list of the

  • Evaluation criteria for plastics and other organic materials in contact with drinking water, and the
  • Elastomer Guideline

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