Approval and Harmonization – 4MS Initiative | Umweltbundesamt

Four EU Member States France, Germany, the Netherlands and the United Kingdom (4MS) announced in January 2011 that they have formalised arrangements to work together on this important aspect of the regulatory frameworks they have in place to ensure the hygienic safety of drinking water. Since the formalisation of this work the membership of the 4MS-Initiative is as follows:

Members States may join the 4MS-Initiative according to the document Procedure for new countries to join the 4MS-Initiative linked here.

Background to the Common Approach

In 1998 work started on the design and development of a single European scheme for the hygienic assessment of products in contact with drinking water - the European Acceptance Scheme (EAS). The aims were to remove barriers to trade by creating a universal approval scheme and to design assessment systems that would respond to the growing awareness of the need to manage drinking water quality from source to tap. This work was being carried out under the auspices of the European Commission (DG Enterprise), but in 2006 the Commission withdrew its support for the EAS. Work was to proceed on a more limited “harmonisation” project under the Construction Products Directive, but this would not achieve the full aims of the EAS.

France, Germany, the Netherlands and the United Kingdom Great Britain had been strong supporters of the EAS ideas. In 2007 they agreed to pursue a common approach to product assessment with the intention of achieving the hygienic safety aims of the EAS in their countries. They still support a European arrangement and provide active input to achieve this.

Basis for a Common Approach

The 4MS intend to adopt common, or directly comparable, practices for:

• The acceptance of the constituents used in materials in contact with drinking water
• The testing of materials
• The use of common test methods and setting acceptance levels
• The specification of tests to be applied to products
• Reviewing factory production control and setting audit testing requirements
• Assessing the capabilities of certification and testing bodies

Publication of Common Approaches

The Common Approaches for the regulation of different materials in contact with drinking water were published by the 4MSI. Some of the Common Approaches still have a draft status.

• Part C of the Common Approach for organic materials
• Common Approach for enamels and ceramic materials
• Common Approach for approval and certification

The Common Approaches serve as proposals for national regulations and now have been submitted to the European Commission as substantive proposals for the development of implementing acts and delegating acts under the new Article 11 of the revised Drinking Water Directive (Directive (EU) 2020/2184) adopted on 16 December 2020. To this end, the Common Approaches have been transferred to the structure of the implementing acts referred to in Article 11(2) of the Drinking Water Directive.

There will be no further work on the Common Approaches. The only exceptions are the positive lists (Part B of respective material-specific documents), which are still being updated until a European list is available.

Information

On 5th of November 2020 a webinar was held. The purpose of this informative meeting was to communicate especially to industrial representatives the draft documents and to put these documents up for discussion. Presentations and recordings of talks may be downloaded here .