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Training of Employees
in the Framework of Monitoring and Estimation
of Materials in Contact with
Drinking Water
during Treatment, Storage and Distribution
K. Endrullat – Berlin – June 2009 - [email protected]
Construction Products Directive CPD
CE Marking of Construction Products
Mr. K. Endrullat
Deutsches Institut für Bautechnik
Berlin, June 2009
K. Endrullat – Berlin – June 2009 - [email protected]
Free Movement of Goods
CE Mark
Attestation of Conformity
European Directives
Mutual Recognition
Notified Bodies
Market Surveillance
Mis-use or Fake of CE Marks
Samples
Useful URLs
K. Endrullat – Berlin – June 2009 - [email protected]
Free movement of goods is a cornerstone of the single market. The mechanisms in place to achieve this aim are based on prevention of new barriers to trade, mutual recognition and technical harmonisation.
Drinking water products put into the market
K. Endrullat – Berlin – June 2009 - [email protected]
Free European Market
New Approach Directives Other Directives
Essential Requirements Requirements
Technical Specifications
Harmonised Standards European Technical Approvals
K. Endrullat – Berlin – June 2009 - [email protected]
Why is this economic approach of importanceto drinking water inspections?
Products in contact with drinking water (DWP = Drinking Water Products)are mainly construction products.
DWP are also subjects of other European directives.
Legal differences between puting DWP into the market and
DWP are already installed and in use.
Inspectors are responsible to act if misuse of DWP marking and declaration is obvious.
K. Endrullat – Berlin – June 2009 - [email protected]
Free Movement of Goods
CE Mark
Attestation of Conformity
European Directives
Mutual Recognition
Notified Bodies
Market Surveillance
Mis-use or Fake of CE Marks
Samples
Useful URLs
K. Endrullat – Berlin – June 2009 - [email protected]
CE marking is a "passport" enabling a product to be legally placed on the market in any Member State. However, this does not necessarily mean that the product will be suitable for all end uses in all Member States.
The CE marking (also known as CE mark) is a mandatory conformity mark on many products placed on the single market in the European Economic Area (EEA). The CE marking certifies that a product has met EU consumer safety, health or environmental requirements.
K. Endrullat – Berlin – June 2009 - [email protected]
Testing Product
Harmonised Standards European Technical Approval
Attestation of Conformity
CE Marking
Product Placed on the Market or Put into Service
K. Endrullat – Berlin – June 2009 - [email protected]
HOW:
VisiblyLegiblyIndelibly
Affixing of the CE marking
The CE marking must be affixed by the manufacturer, or by the authorised representative established within the Community.
If the CE marking is reduced or enlarged the proportions must be respected.
WHERE:
on the product itself, oron a label attached to it, oron its packaging, oron accompanying commercial documents
K. Endrullat – Berlin – June 2009 - [email protected]
CE marking and other marks
The CE Marking is the only marking indicating conformity with the relevant European directives
CE Marking must replace national mandatory conformity markings having the same scope
CE Marking is neither a mark of origin, nor a quality mark
Manufacturer may affix different marks to a product
A product may bear additional markings and marks, provided that they:
fulfil a different function from that of the CE marking,
are not liable to cause confusion with it, and
do not reduce its legibility and visibility.
K. Endrullat – Berlin – June 2009 - [email protected]
CE logo
Commission notified body number
Manufacturers address
Last two digits of year of affixing CE marking
Number of the EC certificate of conformity
Product standard and data.
YYY for product identification like trade mark.
Classification.
NPD for product data not in standard, not proofed or not avaiable (NPD = no performance determined)
K. Endrullat – Berlin – June 2009 - [email protected]
K. Endrullat – Berlin – June 2009 - [email protected]
K. Endrullat – Berlin – June 2009 - [email protected]
Free Movement of Goods
CE Mark
Attestation of Conformity
European Directives
Mutual Recognition
Notified Bodies
Market Surveillance
Mis-use or Fake of CE Marks
Samples
Useful URLs
K. Endrullat – Berlin – June 2009 - [email protected]
Declaration of Conformity
To permit the use of a CE mark on a product, proof that the item meets the relevant requirements must be documented. Sometimes this is achieved using an external test house which evaluates the product and its documentation. Often it is achieved by a company-internal self-certification process. In any case the responsible organization (manufacturer, representative, importer) has to issue a EC-Declaration of Conformity (EC-DoC) indicating its identity (location, etc.), the list of European Directives it is declaring compliance with, a list of standards the product complies with, and a legally binding signature on behalf of the organization. The EC-DoC underlines the sole responsibility of the manufacturer. When parts of the certification process for the CE marking are performed by 3rd party test houses or certification bodies then it is mandatory that the CE symbol also includes a number identifying the 'Notified Body'.
K. Endrullat – Berlin – June 2009 - [email protected]
Plastic Pipes and Fittings Situation
CPD (89/106/EEC): Construction Product Directive
Mandate 131:Pipes, tanks and ancillaries not in contact with water intended for
human consumption
Harmonised EN by CEN/TC 155: European standardisation committee “Plastics pipes and fittings”hEN:
Soil and waste dischargeNon-pressure underground drainagePressure piping systemsHot and cold water supply
K. Endrullat – Berlin – June 2009 - [email protected]
Free Movement of Goods
CE Mark
Attestation of Conformity
European Directives
Mutual Recognition
Notified Bodies
Market Surveillance
Mis-use or Fake of CE Marks
Samples
Useful URLs
K. Endrullat – Berlin – June 2009 - [email protected]
New Approach Directives are Based on the Following Principles:
Harmonisation is limited to essential requirements.
Only products fulfilling the essential requirements may be placed on the market and put into service.
Harmonised standards, the reference numbers of which have been published in the Official Journal and which have been transposed into national standards, are presumed to conform to the corresponding essential requirements.
Application of harmonised standards or other technical specifications remains voluntary, and manufacturers are free to choose any technical solution that provides compliance with the essential requirements.
Manufacturers may choose between different conformity assessment procedures provided for in the applicable directive.
K. Endrullat – Berlin – June 2009 - [email protected]
Directive reference
90/396/EEC Appliances burning gaseous fuels
89/106/EEC Construction products
2004/108/EC Electromagnetic compatibility
2006/95/EC Low voltage equipment
98/37/EC Machinery safety
2004/22/EEC Measuring instruments
93/42/EEC Medical devices: General
92/42/EEC New hot-water boilers fired with liquid or gaseous fluids
89/686/EEC Personal protective equipment
97/23/EC Pressure equipment
87/404/EEC Simple pressure vessels
K. Endrullat – Berlin – June 2009 - [email protected]
Free Movement of Goods
CE Mark
Attestation of Conformity
European Directives
Mutual Recognition
Notified Bodies
Market Surveillance
Mis-use or Fake of CE Marks
Samples
Useful URLs
K. Endrullat – Berlin – June 2009 - [email protected]
Mutual Recognition
Products legally manufactured or marketed in one country should in principle move freely throughout the Community, where such products meet equivalent levels of protection to those imposed by the Member State of exportation and where they are marketed in the territory of the exporting country.
Barriers to trade, which result from differences between national legislations, may only be accepted, if national measures: are necessary to satisfy mandatory requirements (such as health, safety, consumer protection and environmental protection).
K. Endrullat – Berlin – June 2009 - [email protected]
Free Movement of Goods
CE Mark
Attestation of Conformity
European Directives
Mutual Recognition
Notified Bodies
Market Surveillance
Mis-use or Fake of CE Marks
Samples
Useful URLs
K. Endrullat – Berlin – June 2009 - [email protected]
CPD attestation of conformity levelsand Notified Bodies
FCP = Factory Production Control
K. Endrullat – Berlin – June 2009 - [email protected]
Principles of Notified Bodies
Notified by member states
Notification Information are sent to the Commission for publishing
Withdrawel of notification by the member state are possible
Accreditation organisation will control the competence of the notified body
Notified bodies will test or certify
K. Endrullat – Berlin – June 2009 - [email protected]
Free Movement of Goods
CE Mark
Attestation of Conformity
European Directives
Mutual Recognition
Notified Bodies
Market Surveillance
Mis-use or Fake of CE Marks
Samples
Useful URLs
K. Endrullat – Berlin – June 2009 - [email protected]
Principles of Market Surveillance
Market surveillance is an essential tool for the enforcement of New Approach directives.
The purpose of market surveillance is to ensure that the provisions of applicable directives are complied with across the Community.
It helps to eliminate unfair competition.
Member States must nominate or establish authorities to be responsible for market surveillance.
Notified bodies should, basically, be excluded from the responsibility of market surveillance activities to avoid conflicts of interests.
National surveillance authorities shall monitor the market.
They shall take action up to use safegard clause of directive.
Not in force now but will come in near future!
K. Endrullat – Berlin – June 2009 - [email protected]
Free Movement of Goods
CE Mark
Attestation of Conformity
European Directives
Mutual Recognition
Notified Bodies
Market Surveillance
Mis-use or Fake of CE Marks
Samples
Useful URLs
K. Endrullat – Berlin – June 2009 - [email protected]
Mis-use or Fake of CE Marks or Rumor about confusing CE marks
Some products are said to have a CE mark that stands for China Export, which is not confirming to European specifications. The two letters are close together, not spaced as in the European conformance mark.
However, the "China Export" mark doesn't exist. Some products may be conforming but not displaying the logotype correctly and others may illegally put the correct mark on a non-conforming item.
K. Endrullat – Berlin – June 2009 - [email protected]
CE mark sticker arefree available on the market
K. Endrullat – Berlin – June 2009 - [email protected]
K. Endrullat – Berlin – June 2009 - [email protected]
K. Endrullat – Berlin – June 2009 - [email protected]
Free Movement of Goods
CE Mark
Attestation of Conformity
European Directives
Mutual Recognition
Notified Bodies
Market Surveillance
Mis-use or Fake of CE Marks
Samples
Useful URLs
K. Endrullat – Berlin – June 2009 - [email protected]
K. Endrullat – Berlin – June 2009 - [email protected]
K. Endrullat – Berlin – June 2009 - [email protected]
K. Endrullat – Berlin – June 2009 - [email protected]
K. Endrullat – Berlin – June 2009 - [email protected]
K. Endrullat – Berlin – June 2009 - [email protected]
K. Endrullat – Berlin – June 2009 - [email protected]
No access fordeclaration documents!
No relevant marking!
Kitchen Tap
K. Endrullat – Berlin – June 2009 - [email protected]
CE mark withoutany specifications!
Other voluntary marks!
No CE mark relatedtechnical informations!
K. Endrullat – Berlin – June 2009 - [email protected]
Inside the package onlyrepeating information
on marking.Declaration documents
are missing!
K. Endrullat – Berlin – June 2009 - [email protected]
CE mark withoutany specifications!
Other voluntary marks!
Distance between other marks and CE mark!
K. Endrullat – Berlin – June 2009 - [email protected]
CE mark withoutany specifications!
Other voluntary marks!
Distance between other marks and CE mark!
No access fordeclaration documents!
K. Endrullat – Berlin – June 2009 - [email protected]
Other voluntary marks!
CE mark withoutany specifications!
Distance between other marks and CE mark!
K. Endrullat – Berlin – June 2009 - [email protected]
Electrical Water HeaterOther voluntary marks!
CE mark withoutany specifications!
Distance between other marks and CE mark!
K. Endrullat – Berlin – June 2009 - [email protected]
National legal markbased on
building regulations.Noise emmission
only!
K. Endrullat – Berlin – June 2009 - [email protected]
Electrical Water Heater
Marking on product itself!
K. Endrullat – Berlin – June 2009 - [email protected]
Other voluntary marks!
CE mark withoutany specifications!
Distance between other marks and CE mark!
K. Endrullat – Berlin – June 2009 - [email protected]
Electrical Water Heater
Other voluntary marks!
CE mark withoutany specification!
Distance between other marks and CE mark!
K. Endrullat – Berlin – June 2009 - [email protected]
Free Movement of Goods
CE Mark
Attestation of Conformity
European Directives
Mutual Recognition
Notified Bodies
Market Surveillance
Mis-use or Fake of CE Marks
Samples
Useful URLs
K. Endrullat – Berlin – June 2009 - [email protected]
Guide to the Implementation of Directives Based on New Approach and Global Approachhttp://ec.europa.eu/enterprise/newapproach/legislation/guide/index.htmEuropean Directives:http://www.newapproach.org/Directives/DirectiveList.asphttp://ec.europa.eu/enterprise/newapproach/legislation/directives/table1.htmhttp://ec.europa.eu/enterprise/newapproach/legislation/directives/table2.htmhttp://ec.europa.eu/enterprise/newapproach/legislation/directives/table3.htmhttp://ec.europa.eu/enterprise/newapproach/legislation/directives/table4.htmNew Approach:http://ec.europa.eu/enterprise/newapproach/index_en.htmNotified Bodies:http://ec.europa.eu/enterprise/newapproach/nando/Mutual Recognition Agreements:http://ec.europa.eu/enterprise/international/index_en.htmHarmonised Standards:http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/whatsnew.htmlhttp://ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist.htmlStandardisation, Mandates Database:http://ec.europa.eu/enterprise/standards_policy/mandates/database/CEN* Standards Search:http://www.cen.eu/esearch/CEN List of Sectors:http://www.cen.eu/cenorm/sectors/sectors/index.aspCEN Technical Committees, Workshops and Other Bodies:http://www.cen.eu/cenorm/sectors/technicalcommitteesworkshops/centechnicalcommittees/index.asp
*CEN: European Committee for Standardization (Comité Européen de Normalisation in French)
K. Endrullat – Berlin – June 2009 - [email protected]
Useful URL
Legislative harmonisation is limited to essential requirements that products placed on the Community market must meet, if they are to benefit from free movement within the Community.
The technical specifications of products meeting the essential requirements set out in the directives are laid down in harmonised standards.
Application of harmonised or other standards remains voluntary, and the manufacturer may always apply other technical specifications to meet the requirements.
Products manufactured in compliance with harmonised standards benefit from a presumption of conformity with the corresponding essential requirements.
RETURN
K. Endrullat – Berlin – June 2009 - [email protected]
Principles of CE marking
The CE marking symbolises the conformity of the product with the applicable Community requirements imposed on the manufacturer.
The CE marking affixed to products is a declaration by the person responsible that:
the product conforms to all applicable Community provisions,
and
the appropriate conformity assessment procedures have been completed.
K. Endrullat – Berlin – June 2009 - [email protected]
Products to be CE marked
The CE marking must be affixed before any product subject to it is placed on the market and put into service, save where specific directives require otherwise.
Where products are subject to several directives, which all provide for the affixing of the CE marking, the marking indicates that the products are presumed to conform to the provisions of all these directives.
A product may not be CE marked, unless it is covered by a directive providing for its affixing.
RETURN
K. Endrullat – Berlin – June 2009 - [email protected]
K. Endrullat – Berlin – June 2009 - [email protected]
K. Endrullat – Berlin – June 2009 - [email protected]
K. Endrullat – Berlin – June 2009 - [email protected]
National technical regulations are subject to the provisions of Articles 28 and 30 of the Treaty establishing the European Community (the EC Treaty), which prohibit quantitative restrictions or measures having equivalent effect. Case law of the European Court of Justice, especially case 120/78 (the ‘Cassis de Dijon’ case), provides the key elements for mutual recognition. The effect of this case law is as follows.
Products legally manufactured or marketed in one country should in principle move freely throughout the Community, where such products meet equivalent levels of protection to those imposed by the Member State of exportation and where they are marketed in the territory of the exporting country.
In the absence of Community measures, Member States are free to legislate on their territory.
Barriers to trade, which result from differences between national legislations, may only be accepted, if national measures: are necessary to satisfy mandatory requirements (such as health, safety, consumer protection and environmental protection); serve a legitimate purpose justifying the breach of the principle of free movement of goods; and can be justified with regard to the legitimate purpose and are proportionate with the aims..
Mutual Recognition
RETURN
K. Endrullat – Berlin – June 2009 - [email protected]
Principles of notification
Notified bodies carry out the tasks pertaining to the conformity assessment procedures referred to in the applicable New Approach directives when a third party is required.
Member States are responsible for their notification. They may choose the bodies they notify from the bodies under their jurisdiction which comply with the requirements of the directives and the principles laid down in Decision 93/465/EEC.
The assessment of the body seeking notification determines if it is technically competent and capable of carrying out the conformity assessment procedures in question, and if it can demonstrate the necessary level of independence, impartiality and integrity.
Further, the competence of the notified body should be subject to surveillance, which is carried out at regular intervals and follows the practice established by the accreditation organisations.
The EN 45000 series of standards and accreditation are important instruments to help in establishing conformity with the requirements of the applicable directive.
K. Endrullat – Berlin – June 2009 - [email protected]
Notified bodies and conformity assessment
The primary task of a notified body is to provide services for conformity assessment on the conditions set out in the directives. This is a service to the manufacturers in an area of public interest.
Notified bodies are free to offer their conformity assessment services, within their scope of notification, to any economic operator established either inside or outside the Community.
They may carry out these activities also on the territory of other Member States or of third countries.
Manufacturers are free to choose any notified body that has been designated to carry out the conformity assessment procedure in question according to the applicable directive.
K. Endrullat – Berlin – June 2009 - [email protected]
Notification procedure and withdrawal of notification
Notification is an act to inform the Commission and the other Member States that a body, which fulfils the requirements, has been designated to carry out conformity assessment according to a directive.
The Commission publishes a list of notified bodies in the Official Journal of the European Communities for information purposes. The list is constantly updated and can be obtained directly from the Commission services.
Withdrawal of notification takes place when the notified body ceases to fulfil the requirements or its obligations. Withdrawal is the responsibility of the notifying Member State. It can also be the end result of an infringement procedure.
RETURN
K. Endrullat – Berlin – June 2009 - [email protected]
Principles of market surveillance
Market surveillance is an essential tool for the enforcement of New Approach directives.
The purpose of market surveillance is to ensure that the provisions of applicable directives are complied with across the Community. Citizens are entitled to an equivalent level of protection throughout the single market, regardless of the origin of the product.
Further, market surveillance is important for the interest of economic operators, because it helps to eliminate unfair competition.
Member States must nominate or establish authorities to be responsible for market surveillance. These authorities need to have the necessary resources and powers for their surveillance activities, ensure technical competence and professional integrity of their personnel, and act in an independent and non-discriminatory way respecting the principle of proportionality.
Notified bodies should, basically, be excluded from the responsibility of market surveillance activities. This is to avoid conflicts of interest.
K. Endrullat – Berlin – June 2009 - [email protected]
Market surveillance activities
Market surveillance involves two main stages:
national surveillance authorities shall monitor that products placed on the market comply with the provisions of the applicable national legislation transposing the New Approach directives;
subsequently, when necessary, they shall take action to establish conformity. Although market surveillance operations cannot take place
during the design and product stages, efficient enforcement usually requires that surveillance authorities act in collaboration with manufacturers and suppliers in order to prevent the placing on the market of non-compliant products.
K. Endrullat – Berlin – June 2009 - [email protected]
Safeguard clause procedure
New Approach directives include a form of safeguard clause, which obliges Member States to restrict or forbid the placing on the market and the putting into service of dangerous – or, according to some directives, otherwise non-compliant – products, or to have them withdrawn from the market. As a general rule, this safeguard clause procedure is restricted to products which are:
covered by New Approach directives;CE marked; andascertained by the Member State to present a substantial hazard, even if the products are correctly constructed, installed and maintained, and used according to their intended purpose.
This safeguard clause procedure shall be applied to national measures which:
restrict or forbid the placing on the market of a product, or have a product withdrawn from the market;relate to all products belonging to the same batch or series; andhave binding legal effects.
RETURN
K. Endrullat – Berlin – June 2009 - [email protected]