On 21 March 2019, the German Environment Agency (UBA) published “evaluation criteria for plastics and other organic materials in contact with drinking water (KTW-BWGL)”. The KTW-BWGL is gradually replacing the previous KTW guidelines for organic materials. Since 21 March 2021 it is legally binding for plastics, organic coatings and lubricants. Due to the COVID-19 pandemic the UBA has extended the transitional period (Link to the document). Until 21 March 2023, manufacturers have the possibility to obtain a hygiene certificate without an initial inspection of the production facility according to the 1+ system. However, the formulations of the materials must comply with the new regulations in any case. In March 2022 elastomers and thermoplastic elastomers have also been included in the KTW-BWGL, with a transitional period until 01 March 2025. The TZW test centre is well prepared for the new requirements and accredited for the KTW-BWGL.
Drinking water must be protected against undesirable substances
According to the German Drinking Water Ordinance (Trinkwasserverordnung TrinkwV), materials used to construct or maintain systems for the extraction, treatment or distribution of drinking water and those in contact with drinking water must not:
- directly or indirectly reduce the protection to human health
- adversely change the odour or taste of the water, or
- allow substances to pass into drinking water in quantities beyond those which are unavoidable when complying with the generally accepted technical regulations.
These general requirements had formerly been specified for organic materials particularly in the guidelines of the German Environment Agency and in terms of microbial growth in the DVGW worksheet W 270. The German Environment Agency’s guidelines for organic materials are also summarised under the umbrella term “KTW guidelines”. It was not strictly mandatory to apply the KTW guidelines, however, product certifications in particular made them necessary. When certifying products for use with drinking water, certification bodies that are accredited for the drinking water sector, such as DVGW CERT GmbH, require evidence of hygienic safety, provided by the results of testing in line with the KTW guidelines. There was no specific requirement for certification that solely evaluated hygienic suitability.
New assessment criteria plus hygiene certificate for plastics
On 21 March 2019, the German Environment Agency published the “evaluation criteria for plastics and other organic materials in contact with drinking water (KTW-BWGL)” (Link to the document). The KTW-BWGL is gradually replacing the previous KTW guidelines for organic materials. Initially, only plastics, organic coatings and lubricants were within the scope of the KTW-BWGL. For these materials, the KTW-BWGL is legally binding since 21 March 2021. In March 2022, elastomers and thermoplastic elastomers have also been included in the KTW-BWGL, with a transitional period until 01 March 2025. The inclusion of silicones into the KTW-BWGL is planned; currently the silicone transitional recommendation applies to them. In addition to a general part, the KTW-BWGL contains a polymer-specific part with positive lists of those substances that may be used to produce the various organic materials.
At the same time as the publication of the KTW-BWGL, the German Environment Agency published the recommendation “conformity attestation of product hygiene suitability for drinking water” (Link to the document), which describes a procedure that can be used to demonstrate conformity and to receive a (hygiene) certificate. Relevant certification programs have been established by DVGW Cert GmbH based on this recommendation, which can be followed to obtain a certificate of conformity hygiene once compliance with all requirements is achieved (Link to the document CP 1000), (Link to the document CP 0800).
Pipes and equipment require KTW 1+ system
The new certification procedure can be used for components such as mechanical filter housing and for compound products containing components made from organic materials such as mechanical filters with all the individual components. Pipes and equipment such as fittings and valves are subject to the highest testing requirements according to the KTW-BWGL and certification according to the German Environment Agency’s recommendation. The reason behind this is that they comprise the vast proportion of the surface area in contact with drinking water in a drinking water distribution system. These products are classified as risk group P1 according to KTW-BWGL. Group P1 products or components must be certified according to the “1+ system”. The 1+ system involves:
- Initial inspection of the plant and sampling
- Type testing
- In-house production control (in-house monitoring) and
- Annual monitoring tests (third-party monitoring).
Previously, the KTW guidelines required only type testing. The awarded test certificate was then also used as evidence of conformity. Type testing is just one element in the new 1+ system, which also includes inspections and monitoring. The attestation of conformity is awarded by an accredited certification body based on testing and inspection reports.
From a practical perspective, type testing remains the same as before and is conducted according to DIN EN 12873-1 or, for microbial growth, according to DIN EN 16421, method 2 (identical to DVGW W 270 testing). The hygienic suitability of drinking water continues to be based on requirements on the formulation, basic and additional requirements, formulation-specific requirements on individual substances and a requirement concerning microbial growth.
Products with smaller surface areas in contact with drinking water are subject to simpler procedures to obtain the attestation of conformity: a type testing-based certification procedure for P2 products or a manufacturer’s self-declaration based on a KTW-BWGL test report for P3 products. The latter procedure omits the initial plant inspection and does not include any annual third-party monitoring.
TZW Test Centre is accredited for the new system
Product manufacturers are not obliged to obtain certification, however it is possible to acquire a certificate, as stated explicitly in section 17 of the German Drinking Water Ordinance, which attests to compliance with material requirements. A certificate issued by an accredited body is held in much higher esteem than other forms of conformity declarations. And this is increasingly the case when extensive testing and inspections are performed on the product and in the production site to obtain a certificate. These can only be performed by auditors and inspectors with appropriate qualifications – such as those who work at the TZW Test Centre.
The TZW Test Centre is already accredited as a test centre for testing according to KTW-BWGL. Furthermore it can provide inspectors commissioned by the certification body to perform specialist audits for the initial plant inspection and the annual monitoring tests. In addition, the testing capacities are currently being expanded.
