FAQ
The Federal Environment Agency has drawn up a recommendation for the certification (confirmation of conformity) of products in contact with drinking water in accordance with the evaluation criteria. An explanatory document with questions and answers on the implementation of these regulatory documents in certification procedures can be found on the website of the Federal Environment Agency in the navigation area Documents:
Notified Bodies
1. A conformity assessment body shall be established under national law and have legal personality.
2. A conformity assessment body shall be a third-party body independent of the manufacturer’s, the importer’s or the authorized representative’s organization or the products it assesses. 3. A conformity assessment body shall be accredited by a national accreditation body in accordance with Regulation (EC) No 765/2008.
The accreditation shall be based on international standard EN ISO/IEC 17065:2017.
4. The accreditation certificate shall attest that the conformity assessment body is competent to perform the conformity assessment procedures referred to in Article 2 of this Regulation. 5. A conformity assessment body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, importer, supplier, purchaser, owner or user of products which they assess, nor the authorised representative of any of those parties.
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2. A conformity assessment body shall be a third-party body independent of the manufacturer’s, the importer’s or the authorized representative’s organization or the products it assesses. 3. A conformity assessment body shall be accredited by a national accreditation body in accordance with Regulation (EC) No 765/2008.
The accreditation shall be based on international standard EN ISO/IEC 17065:2017.
4. The accreditation certificate shall attest that the conformity assessment body is competent to perform the conformity assessment procedures referred to in Article 2 of this Regulation. 5. A conformity assessment body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, importer, supplier, purchaser, owner or user of products which they assess, nor the authorised representative of any of those parties.
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Formulation Review
A formulation review requires a full composition diclosure of the product to be evaluated down to the positive list level of starting substances. A table layout and supporting information can be found in Annex 1 to UBA Recommendation.
1. In the table, the manufacturer shall enter all formulation components, including additional formulation components of the preparation, such as solvents and impurities.
2. A current data safety sheet or technical data sheet for the starting materials or preparation can generally provide information on starting material purity and on the other substances contained in the formulation.
3. If the manufacturer does not possess complete formulation details, the supplier shall submit the respective information (supplier contact details required).
4. For products with several layers, the composition of each layer must be disclosed for assessment of the product formulation.
5. The declaration of formulation is integral part of required information the manufacturer must provide to the certification body in order to have the formulation evaluated.
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1. In the table, the manufacturer shall enter all formulation components, including additional formulation components of the preparation, such as solvents and impurities.
2. A current data safety sheet or technical data sheet for the starting materials or preparation can generally provide information on starting material purity and on the other substances contained in the formulation.
3. If the manufacturer does not possess complete formulation details, the supplier shall submit the respective information (supplier contact details required).
4. For products with several layers, the composition of each layer must be disclosed for assessment of the product formulation.
5. The declaration of formulation is integral part of required information the manufacturer must provide to the certification body in order to have the formulation evaluated.
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How does the certification of drinking water contact materials work?
Certification according to EN ISO/IEC 17065 confirms that materials and products intended for contact with drinking water meet the applicable legal and technical standards in Germany. This certification is carried out by an independent, accredited body and provides official recognition of compliance under the German Drinking Water Ordinance.
Unlike a self-declaration, which is issued by the manufacturer based on internal assessments or outsourced testing, a formal certification is conducted by an accredited third party. This ensures objectivity and credibility, as the certification process includes independent review and documented procedures.
Within this system, testing laboratories and certification bodies have different roles. Testing laboratories, accredited under ISO/IEC 17025, are responsible for conducting product tests such as migration testing or testing for microbial growth. The certification body, on the other hand, is responsible for reviewing the formulation, setting up a testing plan, reviewing the results of testing, making the final conformity decision, and issuing the certificate.
The certification process involves several structured steps. It begins with an application, followed by a formal application review. Then comes the evaluation phase, where technical data and the formulation are assessed based on which test results are generated. This is followed by an internal review conducted by someone not involved in the evaluation. If everything is in order, a certification decision is made, and a certificate is issued. Inspections and surveillance tests follow to ensure continued compliance over time.
During evaluation, several factors are considered, including risk-based assessments, product formulation reviews, and migration testing for parameters such as total organic carbon (TOC), taste, odor, turbidity, and color. Material specific tests may also be required for certain materials like rubber or multilayer structures, and formulation specific test will be conducted.
In cases where non-conformities are identified, the client is informed and given the opportunity to correct them. Once the necessary improvements are made, the evaluation may be repeated to confirm compliance.
The final certification decision is made by a qualified individual or committee who were not involved in the product evaluation itself, ensuring impartiality. A certificate is only issued after a positive decision and the signing of a certification agreement between the certification body and the client.
This certification process offers a reliable and legally recognized pathway to demonstrate that drinking water contact materials are safe, compliant, and fit for use.
Unlike a self-declaration, which is issued by the manufacturer based on internal assessments or outsourced testing, a formal certification is conducted by an accredited third party. This ensures objectivity and credibility, as the certification process includes independent review and documented procedures.
Within this system, testing laboratories and certification bodies have different roles. Testing laboratories, accredited under ISO/IEC 17025, are responsible for conducting product tests such as migration testing or testing for microbial growth. The certification body, on the other hand, is responsible for reviewing the formulation, setting up a testing plan, reviewing the results of testing, making the final conformity decision, and issuing the certificate.
The certification process involves several structured steps. It begins with an application, followed by a formal application review. Then comes the evaluation phase, where technical data and the formulation are assessed based on which test results are generated. This is followed by an internal review conducted by someone not involved in the evaluation. If everything is in order, a certification decision is made, and a certificate is issued. Inspections and surveillance tests follow to ensure continued compliance over time.
During evaluation, several factors are considered, including risk-based assessments, product formulation reviews, and migration testing for parameters such as total organic carbon (TOC), taste, odor, turbidity, and color. Material specific tests may also be required for certain materials like rubber or multilayer structures, and formulation specific test will be conducted.
In cases where non-conformities are identified, the client is informed and given the opportunity to correct them. Once the necessary improvements are made, the evaluation may be repeated to confirm compliance.
The final certification decision is made by a qualified individual or committee who were not involved in the product evaluation itself, ensuring impartiality. A certificate is only issued after a positive decision and the signing of a certification agreement between the certification body and the client.
This certification process offers a reliable and legally recognized pathway to demonstrate that drinking water contact materials are safe, compliant, and fit for use.