Guidelines and Evaluation Criteria

Drinking water supplied by the water works or one’s own well comes into contact with a number of materials on its way to the tap. Hygiene standards for materials help safeguard against any possible impairments of the drinking water by chemical substances or microbial contamination.

Introduction

Pursuant to the amended German Drinking Water Ordinance, since December 2012 the 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 coming years.

Draft evaluation criteria for enamels and ceramic materials

In the interest of fleshing out  the safety requirements for materials that come into contact with drinking water, the UBA elaborates mandatory evaluation criteria, pursuant to § 17 Par. 3 of the German Drinking Water Ordinance 2001. In cooperation with a working group whose members were recommended by the relevant industry associations and other stakeholders, UBA had compiled a second draft in German of the evaluation criteria for enamel and ceramic materials. In the following you can find the first draft of 2013 in English:

The evaluation criteria are scheduled for finalization end 2016. Pursuant to § 17 Par. 3 of the German Drinking Water Ordinance 2001, they will become valid two years after publication. As from the effective date of these evaluation criteria, all owners and operators of drinking water extraction, purification facilities and distribution installations will be required to exclusively use enamels and ceramic materials that meet the requirements of these evaluation criteria; whereby this applies to newly constructed installations and repair operations for existing installations.

Evaluation criteria for metallic materials

The Federal Environment Agency published  the evaluation criteria for metallic materials used for products in contact with drinking water:

The document took effect on 10 April 2015, which marks the start of the two-year transitional phase in accordance with Section 17 Para 3 Drinking Water Ordinance (TrinkwV 2001) and ends on 10 April 2017. The 1st revision of the evaluation criteria document for metallic materials was published on 28 April 2016 updates the positive list of metallic materials suitable for contact with drinking water.

Within the 1st revision of the evaluation criteria document the material CC752S* was substituted by the material CC770S. The designation CC770S serves for a better labeling of the accepted material as the accepted chemical composition does not correspond completely to the composition of the material CC752S. Until now this was marked with the *-sign. In the same process the range of the minimal lead content was reduced. The accepted chemical composition of the material CC752S* is minimal adjusted regarding the copper content. The up to now listed chemical composition of the material CC752S* can be used until the positive list will get mandatory on 10 April 2017. Decisive for the accordance with the positive list is the chemical composition of the material.

During the notification process of the 1st revision of the evaluation criteria for metallic materials the Federal Environment Agency has cooperated with the responsible authorities in other EU Member States and added other metallic materials to the 4MS Common Composition List of accepted metallic materials.

The 4MS Composition List was revised on 07March 2016 and includes materials which are not yet in the positive list of the evaluation criteria document.

The 4MS Common Approach:  “Acceptance of metallic materials used for products in contact with drinking water was revised on 07 March 2016. It is planned to transfer the modifications also in the German evaluation criteria document for metallic materials. This will require initiation of another notification procedure at the EU Commission about the relevant changes.

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

KTW-Guideline

The Guideline for Hygienic Assessment of Organic Materials in Contact with Drinking Water (KTW Guideline), was notified to the European Commission under no. 2013/470/D, pursuant toDirective 98/34/EEC.

The valid version was issued on 7 March 2016.

The KTW-Guideline contains test protocols and safety requirements for plastics and silicones that come into contact with drinking water.

The below-mentioned rules of procedure govern the positive list of starting substances used for organic materials in contact with drinking water contained in guidelines resp. the prospective evaluation criteria.

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 formula testing for substances that are used in small amounts and that have specific technological functions.

The UBA plans to transpose the KTW-Guideline into mandatory evaluation criteria, pursuant to § 17 Par. 3 of the German Drinking Water Ordinance 2001.

Separate guidelines have been elaborated for coatings, lubricants and elastomers. A transitional recommendation for hygienic assessment of thermoplastic elastomers (TPE- Übergangsempfehlung) has also been issued.

Coating Guideline

The Guideline for Hygienic Assessment of Organic Coatings in Contact with Drinking Water  (Coatings Guideline) was notified to the European Commission under no. 20013/472/D, pursuant to Directive 98/34/EEC. The valid version was issued 16 March 2016.

The Coating Guideline, which contains test protocols and safety requirements for organic coating systems, is an expanded version of the previous Epoxidharzleitlinie (Epoxy Resin Guideline).

The coating guideline doesn’t contain a list of products anymore.

The below-mentioned rules of procedure govern the positive list of starting substances used for organic materials in contact with drinking water contained in guidelines resp. the prospective the evaluation criteria.

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 formula testing for substances that are used in small amounts and that have specific technological functions.

The UBA plans to transpose the Coating Guideline into mandatory evaluation criteria, pursuant to § 17 Par. 3 of the German Drinking Water Ordinance 2001.

Elastomer Guideline

The Elastomer Guideline was notified to the European Commission under no. 2013/471/D, pursuant to Directive 98/34/EEC.

The valid version was published 16 March 2016.

The below-mentioned rules of procedure govern the positive list of starting substances used for organic materials in contact with drinking water contained in guidelines resp. the prospective the evaluation criteria.

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 formula testing 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 § 17 Par. 3 of the German Drinking Water Ordinance 2001. Requirements to silicones are contained in the KTW-Guideline. A transitional recommendation for hygienic assessment of thermoplastic elastomers (TPE- Übergangsempfehlung) has also been issued.

Lubricant Guideline

The Guideline for the Hygienic Assessment of Lubricants in Contact with Drinking Water (Lubricant Guideline) was notified to the European Commission under no. 2013/473/D, pursuant to Directive 98/34/EEC.

The valid version was published 16 March2016.

The Lubricant Guideline contains test protocols and safety requirements for sanitary lubricants.

The Lubricant Guideline doesn’t contain a list of products anymore.

The below-mentioned rules of procedure govern the positive list of starting substances used for organic materials in contact with drinking water contained in guidelines resp. the prospective the evaluation criteria.

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 Minis Guideline  can additionally be used as a basis for formula testing for substances that are used in small amounts and that have specific technological functions.

The UBA plans to transpose the Lubricant Guideline into mandatory evaluation criteria, pursuant to § 17 Par. 3 of the German Drinking Water Ordinance 2001.

Thermoplastic elastomers

The UBA is in the process of drafting hygienic requirements for thermoplastic elastomers that come into contact with drinking water. Meanwhile, thermoplastic elastomers can be assessed using the transitional recommendation for hygienic assessment of thermoplastic elastomers (TPE-Übergangsempfehlung).

The valid version of this document is the one dated 9 May 2014.

UBA will examine, whether separate mandatory evaluation criteria will be necessary for 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 Federal 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) and was notified to the European Commission under no. 2011/280/D, pursuant to Directive 98/34/EEC.

The valid version is the one dated 18 April 2011.

This recommendation can be used in conjunction with the existing guidelines (KTW Guideline, Coating Guideline, Lubricant Guideline and Elastomer Guideline) and the transitional recommendation for TPE.

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) and was notified to the European Commission under no. 2009/40/D, pursuant to Directive 98/34/EEC.

The valid version is the one dated 7 October 2008.

The Modelling Guideline enables the testing of formula and substance specific requirements pursuant to the KTW Guideline, Coating Guideline, Lubricant Guideline and Elastomer Guideline, as well as the transitional recommendation for thermoplastic elastomers, using mathematical modelling. Following this, experimental testing concerning these requirements is not necessary.

Rules of Procedure for the management of the positive list of metallic materials which are hygienically suitable for contact with drinking water

For the management of the positive list of metallic materials which are hygienically suitable for the contact with drinking water of the evaluation criteria for metallic materials in contact with drinking water the following rules of procedure applies:

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 the positive lists of starting substances for organic materials of the Guidelines resp. the prospective evaluation criteria the following rules of procedure applies:

The rule of procedure applies to the positive list of the following Guidelines:

  • KTW-Guideline
  • Coating Guideline
  • Elastomer Guideline
  • Lubricant Guideline

The appendixes can be downloaded separately:

 

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