poster - approval scheme for products in contact with drinking water in portugal
TRANSCRIPT
INTRODUCTION
P.B.A. Gonçalves*, L.F.C. Simas **, M.C.A. Matos ***
* Project manager of the Water Quality Department at The Water and Waste Services Regulation Authority (ERSAR) ([email protected])
** Head of the Water Quality Department at ERSAR ([email protected])
*** Coordinator of the Water Quality Department at ERSAR ([email protected])
In a water supply system, the quality of the products (construction materials and treatment chemicals) used in contact with drinking water is particularly relevant given the possibility of organic
substances and/or heavy metals leaching from materials into water, in a very low level but for a continuous and long lasting period.
In this context, Article 10 of Council Directive 98/83/EC of 3 November 1998, on the quality of water intended for human consumption, establishes that Member States shall take all measures
necessary to ensure that products used in the preparation and distribution of water intended for human consumption, do not affect the quality of water and do not jeopardize the protection of human
health.
In order to comply with these requirements set into national law by Article 21 of Decree-Law 306/2007 of 27 August, The Water and Waste Services Regulation Authority (ERSAR) promoted the
creation of a national approval scheme for products in contact with drinking water, which was materialized in the form of the Regulation ERSAR “Portuguese Approval Scheme for products in contact
with water intended for human consumption”, as part of ERSAR regulatory powers.
This Regulation ERSAR is valid to all treatment chemicals and materials used in contact with drinking water, since the catchment to the consumer´s tap, applied either in new installations or in
renovations.
In 2008, ERSAR started this project by analysing the four approval schemes already
implemented at European level (Germany, France, Netherlands, United Kingdom).
The decision was to follow a product certification scheme, similar to the Dutch approval
scheme, also as supported in the document “The European acceptance scheme for
construction products in contact with drinking water” elaborated in 2004.
After a long period of study (2009-2013), the Regulation ERSAR for products in contact with
drinking water was created taking into account the current legal, scientific and technical
knowledge, supported by the experience of The Netherlands (Ministry of Housing, Spatial
Planning and the Environment and consultation of the certification body KIWA) and by a
national technical commission (Central government entities, Industry Associations,
Certification bodies, Laboratories and Technical centers).
Legal Framework
• Decree-Law 306/2007, 27th August (Portuguese law for drinking water quality);
• Directive 98/83/EC (quality of water intended for human consumption);
• Regulation (EU) 305/2011 (marketing of construction products);
• Regulation (EU) 528/2012 (market and use of biocides products);
• Regulation (EU) 1907/2006, (REACH);
• Regulation (EC) 764/2008 (national technical rules to products lawfully marketed in
another Member State);
• Regulation (EC) 765/2008 (accreditation and market surveillance);
• Regulation (EC) 1272/2008 (classification, labelling and packaging of substances);
Scientific and Technical Support
• European Standards (EN) developed by WG3 and WG9 of European Committee for
Standardisation (CEN) - CT 164;
• Work developed by the expert group of the 4MS Initiative (Germany, France, Netherlands,
UK), with which Portugal has been working since April 2012, on the Development of a
Common Approach to the Hygienic Approval of Products in Contact with Drinking Water.
The approval scheme
To avoid possible adverse effects on consumer’s health as a result of the migration to water
of harmful substances from the materials or products, the product approval process is based
on the conformity of the:
- Toxicological assessment of the chemical formulation;
- Migration tests assessing the effects on water quality.
The flowcharts on the right follow the operating rules of an accredited product certification
and the rules established for approval of low-risk products by ERSAR.
METHODS DISCUSSION
The Regulation ERSAR for products in contact with drinking water intends to simplify and make
faster the procurement process for water suppliers and for product suppliers, thus making it more
efficient: the selection of the appropriate products can be made just by consulting the list of
approved products, which have been evaluated by an independent and recognized entity
(certification body) and validated by ERSAR.
It is expected a reduction in the costs of product certification and trading to the suppliers, seeing
that for the approval of products the supplier may apply to only one recognized body, subsequently
undergoing the mutual recognition between Member States. Also, the standardisation of approval
criteria at the national level, will promote the adjustment of prices ensuring the same level of
health protection to all consumers.
Other than the level of human health protection, the main advantage is the harmonization of
national approval criteria to the criteria of the 4MS, anticipating the mutual recognition between
Member States advocated by EU legislation and promoting, insofar as possible, the free trade of
products within the internal market.
CONCLUSIONS
inspiring change
Acknowledgement: ERSAR would like to thank to all the stakeholders involved in this project (Central government entities, Industry Associations, Certification bodies, Laboratories and Technical centers, and the 4MS group)
References: Regulation ERSAR, public consultation documents in http://www.ersar.pt
4MS Initiative (Germany, France, Netherlands, UK), documents in http://www.umweltbundesamt.de/themen/wasser/trinkwasser/trinkwasser-verteilen/anerkennung-harmonisierung-4ms-initiative
Dutch Regulation “Materials and chemicals in the supply of drinking water and warm tap water”
Regulation (EU) 10/2011 (plastic materials in contact with food)
RESULTS The Regulation ERSAR laying down the conditions for the Portuguese Approval Scheme
for products in contact with water intended for human consumption comprises 30
articles with general and product approval provisions and 5 annexes for technical
specifications by type of material :
- Article 1 to 9: Competences and duties (ERSAR, certification bodies, economic operators,
water suppliers, technical commission);
- Article 10 to 13: Technical specifications;
- Article 14 to 18: Certification process;
- Article 19 to 21: Product approval process (and recognition of approved product);
- Article 22 to 30 : Transitional and final provisions;
- Annex A: Organic materials;
- Annex B: Cementitious materials;
- Annex C: Metallic materials;
- Annex D: Treatment chemicals;
- Annex D: Positive lists.
The document was put into public consultation from 22nd of May to 3rd of July 2014 and was
ready to be submitted to the EC notification process by August 2014. When the EC
notification process is concluded the Regulation will finally come into force in Portugal,
which should happen in the first semester of 2015, but considering a three year transitional
period for the mandatory use of approved products by the water suppliers.
A list of approved products under the Regulation ERSAR will be available at ERSAR’s
website (www.ersar.pt). This list comprises the products that are approved, banned or
removed from the list, with the indication of the conditions for the application, utilization and
eventual restrictions. The list will be updated whenever necessary or at least once per year.
www.iwahq.org
GENERAL PROCESS FOR
PRODUCT CERTIFICATION
GENERAL PROCESS FOR
LOW-RISK PRODUCT APPROVAL
It is also foreseen the recognition of products approved in another member-state. The process of
product recognition is subject by economic operator to ERSAR validation, which will approve the
product since it is found that the rules under which the product was approved are identical or
exceed the assessment criteria set out in Regulation ERSAR.
Approval scheme for products in contact
with drinking water in Portugal