Materials and objects in contact with water, products and processes used for treating water for public distribution

Materials and objects used in permanent facilities for the supply, treatment and production of water intended for human consumption:

When in contact with water intended for human consumption, some materials and objects may cause a deterioration of the organoleptic, physical-chemical or microbiological characteristics of the water. Thus the water may not comply with the quality requirements stipulated by the French Public Health Code and might even adversely affect the health of consumers. Consequently, the safety of materials and objects used in permanent facilities for the supply, treatment and production of water intended for human consumption must be assessed.

In France the marketing of such materials and objects on the one hand and their use in facilities for  producing, distributing and treating water, on the other, are regulated by the French Public Health Code (Regulatory provisions of Articles R. 1321-48 and 49 and decrees for their application.)

The proof of compliance with health regulations governing materials and objects used in permanent facilities for the supply, treatment and production of water intended for human consumption depends on the following:

• the nature of the materials (organic materials, materials made from hydraulic binders or from metal, etc.) and
• their uses (pipes, tanks, joints and couplings, accessories, etc).

The assessment of compliance with health legislation is based on formulation conformity or composition regulations with regard to positive reference lists, migration tests and compliance with acceptability criteria defined in the regulations.

On the European level, even though regulations governing the quality of water intended for human consumption (Directive no. 98/83/EC of 3 November 1998 (cf. Article 10)) and the quality of building products(Regulation no. 305/2011/EC of 9 March 2011 (cf. Requirement 3 in Annex I)) define requirements for the safety of the materials and objects used in permanent facilities for production, treatment and distribution, they are not precise enough to enable a standardised European regulatory system. France, Germany, the United Kingdom and the Netherlands are currently collaborating in this field (the work by the so-called 4MS - Member States), with the ultimate objective of adopting common or directly comparable practices ( Signature, in December 2010, of a declaration of intention by the respective competent authorities of the 4MS)

The role of ANSES

In this context, the Agency has been mandated to:

• provide scientific and technical support, particularly in emergencies, to the joint Member States group:
  • before meetings in order to define the French position on the various items on the agenda, to be defended within the working group;
  • writing reports for the group on the common approach to be adopted for assessing materials;
  • drawing up positive lists of authorised substances for the organic materials.

• respond to national requests for assessments of materials and objects used in permanent facilities for the supply, treatment and production of water intended for human consumption, which involves:
  • drawing up or revising guidelines for assessing the safety of different classes of materials: organic materials (plastics, elastomers, epoxydic resins, etc), metal materials (metal coatings, alloys, solders, etc), mineral materials (enamels, ceramics, glasses, etc), and hydraulic binders (concrete, mortar) and "assembled products" or "accessories" (bathroom taps and pipes, meters, pumps, etc);
  • evaluating requests for listing of a new material (metal materials or hydraulic binders) in Annexes I and II of the Order of 29 May 1997 as amended), concerning the conditions for using materials and objects which are in contact with water intended for human consumption;
  • evaluating applications for the marketing of bituminous coatings;
  • evaluating requests for listing of new substances on the positive reference lists for organic materials.

Expert groups have conducted research on organic materials (Guidelines for assessing the safety of lubricants and adhesives, positive lists of substances used in the manufacture of materials, evaluation of exposure and health risks associated with bisphenol A in WIHC, authorisations for bituminous paints, etc.) and metallic materials (guidelines for the evaluation of metals and alloys for listing in the Order of 29 May 1997, as amended), listing of new metal coatings (tin-nickel, tin, etc).

Systems, processes and products for treating collectively distributed water intended for human consumption:

Water intended for human consumption must be on tap at all times for consumers and must permanently satisfy the quality criteria defined in the regulations. However water resources do not always meet these criteria and generally require treatment in order to comply before being delivered to consumers' taps.

Water is treated in successive stages (treatment system) in a plant. These treatment stages are intended to inactivate or filter out microorganisms (viruses, parasites and bacteria) and toxic or undesirable substances whether they be natural (fluorine, arsenic, calcium, etc) or man-made (pesticides, nitrates, drug residues, etc). Each stage of a system is effective in its own right and the succession of several stages increases overall effectiveness. This is known as the multiple barrier effect.

The treatments vary greatly. They may be based on chemical reactions, on the activity of microorganisms, on physical processes or a combination of the three types. They involve different products and media (sand, filtering membranes, ion exchange resins, for example), and have to be adapted to enable the specific quality of water authorised by the Ministry of Health.

The products and processes used that have been investigated for several years on a large scale correspond to authorised groups or uses covered by the regulations (Article R. 1321-50-IV of the Public Health Code (CSP), Circular no.2000/166 of 28 March 2000 concerning products and processes for treating water intended for human consumption and the Order of 17 August 2007 as amended concerning the drawing up of an application for permission to market a product or process for treating water intended for human consumption, listed in Article R.1321-50-IV of the Public Health Code.)

Those products and processes which are not on the authorised lists are considered to be "innovative" and ANSES evaluates their safety and effectiveness on a case-by-case basis. The Agency has published a great number of specific Opinions and the experience gained in processing these dossiers has enabled it to establish guidelines for assessing the treatment of water, by means of:

• ultraviolet lamps;
• filtering membranes (micro-, ultra-, nano-filtration or reverse osmosis);
• ion exchange resins;
• orthophosphates;
• filtering media covered with metal oxides.

Some of the products used for disinfecting water or facilities in contact with water fall under the European Directive 98/8/EC concerning the placing of biocidal products on the market. ANSES has published guidelines for drawing up applications for authorisation of treatments for controlling Legionella bacteria in water distribution supplies and in particular for conducting efficacy tests.

ANSES also evaluates treatment systems which use diversified water resources such as for the desalinisation of seawater.

Additional home water treatments

Home water treatment devices (water softeners, reverse osmosis units, jug or cartridge filters) are often used for convenience reasons such as to improve the taste of water or to reduce scaling in household appliances.  The effectiveness, settings and safety of these devices are not monitored and can cause a deterioration of the water quality due to the release of toxic or undesirable substances or the development of micro-organisms.

Within the framework of an internal request, work on the assessment of the safety and effectiveness of water filter jugs has been undertaken by the Agency.

Materials and objects intended to come into contact with foodstuffs (MCDA)

Bottles of spring water or natural mineral water, as well as large reusable containers are subject to the regulations governing materials intended to come into contact with foodstuffs.