Training of Employees in the Framework of Monitoring and Estimation of Materials in Contact with...

Post on 11-Jan-2016

220 views 0 download

Tags:

Transcript of Training of Employees in the Framework of Monitoring and Estimation of Materials in Contact with...

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 - KEN@DIBt.de

Construction Products Directive CPD

CE Marking of Construction Products

Mr. K. Endrullat

Deutsches Institut für Bautechnik

Berlin, June 2009

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

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 - KEN@DIBt.de

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 - KEN@DIBt.de

Free European Market

New Approach Directives Other Directives

Essential Requirements Requirements

Technical Specifications

Harmonised Standards European Technical Approvals

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

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 - KEN@DIBt.de

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 - KEN@DIBt.de

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 - KEN@DIBt.de

Countries requiring the CE marking

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

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 - KEN@DIBt.de

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 - KEN@DIBt.de

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 - KEN@DIBt.de

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 - KEN@DIBt.de

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

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 - KEN@DIBt.de

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 - KEN@DIBt.de

Example DoorE

xam

ple

Doo

rK. Endrullat – Berlin – June 2009 - KEN@DIBt.de

Exa

mpl

e D

oor

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

Exa

mpl

e D

oor

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

Exa

mpl

e D

oor

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

Exa

mpl

e D

oor

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

Exa

mpl

e D

oor

Example Door

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

Example AnchorE

xam

ple

Anc

hor

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

Exa

mpl

e A

ncho

r

Example Anchor

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

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 - KEN@DIBt.de

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 - KEN@DIBt.de

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 - KEN@DIBt.de

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 - KEN@DIBt.de

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 - KEN@DIBt.de

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 - KEN@DIBt.de

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 - KEN@DIBt.de

CPD attestation of conformity levelsand Notified Bodies

FCP = Factory Production Control

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

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 - KEN@DIBt.de

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 - KEN@DIBt.de

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 - KEN@DIBt.de

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 - KEN@DIBt.de

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 - KEN@DIBt.de

CE mark sticker arefree available on the market

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

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 - KEN@DIBt.de

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

Bathroom Tap

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

National DVGW mark! No CE mark!

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

No access fordeclaration documents!

No relevant marking!

Kitchen Tap

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

Electrical Water Heater

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

CE mark withoutany specifications!

Other voluntary marks!

No CE mark relatedtechnical informations!

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

Inside the package onlyrepeating information

on marking.Declaration documents

are missing!

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

Electrical Water Heater

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

CE mark withoutany specifications!

Other voluntary marks!

Distance between other marks and CE mark!

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

Electrical Water Heater

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

CE mark withoutany specifications!

Other voluntary marks!

Distance between other marks and CE mark!

No access fordeclaration documents!

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

Kitchen Tap

No CE mark!National quality mark!

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

Kitchen Tap

National quality mark!No CE mark!

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

Electrical Water Heater

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

Other voluntary marks!

CE mark withoutany specifications!

Distance between other marks and CE mark!

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

Electrical Water HeaterOther voluntary marks!

CE mark withoutany specifications!

Distance between other marks and CE mark!

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

National legal markbased on

building regulations.Noise emmission

only!

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

Electrical Water Heater

Marking on product itself!

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

Other voluntary marks!

CE mark withoutany specifications!

Distance between other marks and CE mark!

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

Electrical Water Heater

Other voluntary marks!

CE mark withoutany specification!

Distance between other marks and CE mark!

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

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 - KEN@DIBt.de

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 - KEN@DIBt.de

Useful URL

I thank you for your attention!

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

RETURN

EXIT

KEN@DIBt.de

Klick for Backup Informations!

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 - KEN@DIBt.de

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 - KEN@DIBt.de

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 - KEN@DIBt.de

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

K. Endrullat – Berlin – June 2009 - KEN@DIBt.de

RETURN

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 - KEN@DIBt.de

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 - KEN@DIBt.de

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 - KEN@DIBt.de

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 - KEN@DIBt.de

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 - KEN@DIBt.de

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 - KEN@DIBt.de

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 - KEN@DIBt.de