4-Member States Regulators Group EAS - History and Background, Current Status

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1 4-Member States Regulators Group EAS - History and Background, Current Status Joanna Hunt (Inspector), DWI Brussels, May 2015

2 Regulations EU Drinking Water Directive (Art 10) EU Construction Products Directive (superseded) EU Construction Products Regulation EU Biocidal Products Regulation National Legislative transposition, where required

3 Formulation of EAS A step back in time Initiated by European Commission Context: Construction Products Directive and Drinking Water Directive 1998: Feasibility study (EC, France, Germany, Netherlands and UK) 1999: Start of development of European Acceptance Scheme (EAS) through Expert Group Construction Products in contact with Drinking Water (EG-CPDW) Joint EAS research programme 2001: Mandate M136 to CEN (revised in 2006 and 2010) 2002: Commission Decision on Attestation of Conformity (2002/359/EC) 2002: Conference CEN-EAS. Almost a reality? 2003: Seminar on revision of Drinking Water Directive 2005: EAS Proposal

4 A step back in time (2) Key elements of a single approval scheme Scope: all products between source and tap Control of performance of substances and materials Lists of acceptable substances (PL, CL and ACL) health based Full formulation information provided by manufacturers Product testing (initial type testing) Product standards, supporting test standards (CEN) Harmonised pass/fail criteria Auditing Pre-certificate audit of factory production control systems Post-certificate auditing of systems and products (including audit testing)

5 A step back in time (3) Why was the EAS proposal rejected? Lack of an adequate legal basis for such a scheme, the CPD provided a basis for harmonised test methods but not the setting of common requirements for all MS Lack of organisation and resources for the central operation of a single scheme operating at European level The EAS could not cover from source to tap (under the CPD it was described as only covering products after the last point of treatment (usually disinfection) to tap)

6 The formation of the 4MS Started in To support DG Enterprise (now DG Growth) in formulating guidance for standardisation work under Mandate M To work on convergence of the 4 national approval schemes (4MS Common Approach) Who are they? Regulators and technical advisors from UK, France, Germany, the Netherlands and Portugal Aim work towards a common approach/mutual recognition of approval 1. Formulate tools that can be used to assist approval processes that are common 2. Provide regulatory assistance to the Commission when requested 3. Combine resources

7 Declaration of Intent Formalisation of co-operation: Declaration of Intent, signed by the 4MS (January 2011) DoI is not a legally binding instrument (multilateral treaty) Mutual commitment to harmonise national requirements and approval schemes (common approach) Confirms the aims of the 4MS Signatories Objectives Areas of Cooperation Benefits Organisation

8 DoI signatories

9 Objectives of the DoI To establish convergence of the operations of national approval systems for materials and products in contact with drinking water To promote approval systems providing high uniform levels of consumer protection To promote optimum use of regulatory and scientific resources To collaborate in supporting developments at EU level aimed at creating consistent practice

10 Areas of Cooperation Development of common principles, leading to mutual recognition EAS proposal + 4NAS + new developments = hnas Maintenance of common building blocks (e.g. Positive Lists) All aspects of the operation of national approval systems Implementation of common elements of practice Co-ordination of inputs to activities and discussions at the EU level with respect to impacts of products and substances on drinking water quality

11 Benefits of the DoI Sharing of (scarce) government resources Mutual recognition (single market) Reduced testing and certification costs for manufacturer Better products and better protection of human health 4MS Group: not a closed shop, Portugal joined in 2012 Other MSs are invited to use results of the common approach Other MSs may become a Signatory to the Declaration The Signatories will work with services of the EC to achieve harmonisation of testing and approval of products in contact with drinking water

12 Organisation of DoI Joint Management Committee Task: Implementation of the Declaration of Intent Membership: regulators representing the Signatories, advised by national experts Reports to Signatories (annual report, work programme,...) Technical subgroups, including Group of Toxicologists

13 Current situation These next slides are aimed at providing an update of the current situation. Organics Positive List Bianca will cover Metallics Composition List Thomas will cover Positive List Cementitious Materials Test methods

14 Positive List Cementitious Background Materials work started in the Commission in the Sub Group Non Metallic Materials (SGNMM), this work has been reviewed and amended for the 4MS Outline of document split into parts Part A CONTROL of (PRIMARY) SUBSTANCES Part B CONTROL of (GENERIC) CONSTITUENTS Part C - APPROVAL of MANUFACTURERS CONSTITUENT PRODUCTS Part D - FINAL PRODUCT TESTING & APPROVAL Positive List

15 Test Methods This work has been split into three sections Test methods for organic materials Test methods for metallic materials Test methods for cementitious materials These test methods have come from the common approach work carried out at the very beginning of the 4MS work (2008) and are the EN test methods developed by CEN

16 Test Methods Organic Materials Odour & Flavour EN1420 (under revision) using EN1622 Enhanced Microbial Growth Assessment New EN16421 Appearance EN13052 Cytotoxicity GCMS New EN15768 TOC Specific determinands Leachate preparation EN12873 (all parts)

17 Enhanced Microbial Growth

18 Why 3 methods? Examples of why 3 methods are needed Multilayered components biomass method suitable O-rings (small components) MDOD or ATP methods suitable Greases and lubricants MDOD suitable Product standards will specify the most suitable method

19 Cytotoxicity Currently no CEN method Only countries in the 4MS carrying out this analysis are UK and France Discussion yet to be completed

20 Cementitious Test Methods Factory made products Odour & Flavour EN using EN1622 Enhanced Microbial Growth Assessment EN16421 Colour EN using EN ISO 7887 Turbidity EN using EN ISO 7020 Metals EN using EN11885 or equivalent GCMS EN using EN15768 TOC EN using EN1484 Specific determinands

21 Cementitious Test Methods (2) Site applied materials and constituents (currently under development) Odour & Flavour EN using EN1622 Enhanced Microbial Growth Assessment EN16421 Colour EN using EN ISO 7887 Turbidity EN using EN ISO 7020 Metals EN using EN11885 or equivalent GCMS EN using EN TOC EN using EN1484 Specific determinands

22 What does all this mean? Tools for the assessment of products in contact with drinking water are under development The aim of the 4MS is to use the same test methods One test report suitable for any of the 4MS for use to approve products Aim to move towards mutual recognition of products approved across the 4MS Reduced cost to manufacturer and no reduction in the protection of the consumer They do not mean products made from listed ingredients do not need testing

23 Summary We ve looked at the history 1998 to 2005 Work carried out from 2007 to 2015 Declaration of Intent Tools for product/component approval Additional information:- Comparison of 4MS processes - 4MS Initiative -