Classification of Directives. Product legislation.

The scope of various Directives explain Low Voltage Directive (LVD), EMC Directive, R Energy using Products EuP, RoHS, Machinery Directive, Noise Emission, Pressure Equipment Construction Products (CPD) www.agoria.be Classification of Directives Product legislation Machinery Directive Low Voltage EUP PED WEEE EMC RoHS Lifts REACH ATEX IPPC Emissie motoren Noise Emission Environmental legislation ATEX arbeidsmiddelenrichtlijn Fysische agentia: geluid trillingen EMF - optische radiatie Social legislation 2 1

Low Voltage Directive (LVD) Jo Boullart www.agoria.be Low Voltage Directive > Title > Directive 2006/95/EC of the European Parliament and of the Council of 12 December 2006 on the harmonisation of the laws of Member States relating to electrical equipment designed for use within certain voltage limits 4 2

Low Voltage Directive > Scope > Electrical equipment designed for use with a voltage rating [50 1000] Volt AC or [75 1500] Volt DC > Not covered : > Equipment mentioned in Annex II Electrical equipment for use in explosive atmospheres Electrical equipment for radiology and medical purposes Electrical parts for goods and passenger lifts Electricity meters Plugs and socket outlets for domestic use Electric fence controllers Specialised electrical equipment for use on ships, aircraft or railways > LVD does not apply to electrical installations (Installation rules are not subject of EU harmonised legislation) 5 Low Voltage Directive > Essential requirements > Electrical equipment constructed in accordance with good engineering practice > Electrical equipment does not endanger the safety of persons, domestic animals or property when properly installed. > Principle elements of the safety objectives (Annex I) : General conditions (indication of the manufacturer, instructions for use) Protection against hazards arising from the technical equipment (physical injury or other harm, e.g. temperature, arcs, radiation, nonelectrical hazards) Protection against hazards caused by external influences on the electrical equipment (e.g. mechanical or non-mechanical influences, overload, functional safety) 6 3

Low Voltage Directive > Conformity assessment procedure > Internal production control > Procedure whereby the manufacturer ensures and declares that the electrical equipment satisfies the requirements of the Directive (Module A) > Technical documentation General description of equipment, conceptual design and manufacturing drawings, descriptions and explanations to understand these, list of standards applied in full or in part, results of design calculations, test reports > EC declaration of conformity > CE marking 7 Low Voltage Directive > Standardisation > Large system of European electrotechnical standards based on international standards ( > 600) > Example : EN 60950-1 Information technology equipment Safety Part 1 : General requirements Reduction of risk of injury or damage due to» Electric shock» Energy related hazards» Fire» Heat related hazards» Mechanical hazards» Radiation» Chemical hazards 8 4

Electromagnetic Compatibility Directive (EMC) Jo Boullart www.agoria.be EMC Directive > Title > Directive 2004/108/EC of the European Parliament and of the Council of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility and repealing Directive 89/336/EEC 10 5

EMC Directive > Scope > Equipment > Apparatus Electrical and electronic appliance Component (component intended for incorporation by the end user) > Fixed installations > Not covered Many appliances or components assembled and installed at a predefined location > R&TTE equipment (Directive 1999/5/EC) > Aeronautical equipment > EMC benign equipment 11 EMC Directive > Essential requirements > Protection requirements : Emission, Immunity > Specific requirements for fixed installations > Installation and intended use of components» Application of good engineering practices & respecting the information on the intended use of its components» Good engineering practices shall be documented & documentation shall be held by the responsible person(s) as long as the installation is in operation 12 6

EMC Directive > Conformity assessment procedure Equipment type EMC Assessment (Application of HS is equivalent to carrying out EMC assessment) No conformity assessment procedure Technical Documentation Optional report from notified body D.o.C Name & address of manufacturer importer Information allowing identification apparatus, e.g. Type : xxx-yyy S/N : 123456 13 EMC Directive > Standardisation > Large system of European electro technical standards based on international standards ( > 150) 14 7

Radio & Telecommunications Terminal Equipment Directive (R&TTE) Jo Boullart www.agoria.be R&TTE Directive > Title > Directive 1999/5/EC of the European Parliament and of the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity 16 8

R&TTE Directive > Scope > Telecommunications terminal equipment > Radio equipment (i.e. equipment capable of communication by emission and/or reception of radio waves) 17 R&TTE Directive > Essential requirements > Health and safety > Incl. safety objectives of LVD but with no voltage limit > Electromagnetic compatibility > Protection requirements as in 2004/108/EC > Spectrum use > Effective use as to avoid harmful interference > Possibility to define some additional public interest requirements > End-to end interworking, no network harm, privacy protection, avoidance fraud, access emergency services, features for disabled > Note : Does not harmonise spectrum use 18 9

19 R&TTE Directive > Standardisation > Harmonised standards for wide range of applications > Standards for IMT-2000, GSM, DECT, 2.4 GHz RLAN, 5 GHz RLAN, Fixed radio links, Satellite earth stations, Land-mobile radio, RFID, Medical implants, Road transport & traffic telematics > Generic short range devices > EN 300 220 : Devices between 25 MHz and 1 GHz > EN 300 330 : Inductive devices & devices operating below 25 MHz > EN 300 440 : Devices between 1 GHz and 40 GHz 20 10

Energy related Products Directive (ErP) Jo Boullart www.agoria.be ErP Directive > Title > Directive 2009/125/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for the setting of ecodesign requirements for energy-related products > Note : ErP Directive is a recast of the framework directive on Energy-using Products (EuP 2005/32/EC) 22 11

ErP Directive > Scope > Energy-related products > Any good that has an impact on energy consumption during use which is placed on the market and/or put into service, and includes parts intended to be incorporated into energy-related products covered by this Directive which are placed on the market and/or put into service as individual parts for end-users and of which the environmental performance can be assessed independently 23 ErP Directive > Essential requirements > Framework Directive : No binding requirements for specific products > Selection criteria (significant volume of sales, significant environmental impact, significant improvement potential) & procedures > Requirements in implementation measures > Published implementation measures > Focus on energy efficiency > Examples : lighting (e.g. phase-out of incandescent light bulbs), standby power consumption, external power supplies, electrical motors, simple set top boxes > Implementation measures in preparation or under study for more than 25 product groups 24 12

ErP Directive > Conformity assessment procedure > Internal production control > Procedure whereby the manufacturer ensures and declares that the electrical equipment satisfies the requirements of the Directive (Module A) > Technical documentation General description of equipment, conceptual design and manufacturing drawings, descriptions and explanations to understand these, list of standards applied in full or in part, results of design calculations, test reports > EC declaration of conformity > CE marking 25 ErP Directive > Standardisation > Standardisation mandates > M/341 : Programming of standardisation work in the field of eco-design of Energy using Products (EuP) Identification EuP relevant standardisation documents Identification of standardisation gaps Standardisation programmes based on gaps and priorities > M/439 : Standby and off mode power consumption measurement for energy using products (EuPs) 26 13

Restriction of Hazardous Substances (RoHS) Maxime Soldati www.agoria.be RoHS Directive > Title > Directive 2002/95/EC of the European Parliament and of the Council of 27 January 2003 on the restriction of the use of certain hazardous substances in electrical and electronic equipment 28 14

RoHS Directive > Scope > Electrical and electronic equipment > Falling in WEEE categories (except cat. 8 medical devices - and 9 monitoring and control instruments -) Large household appliances, small household appliances, IT and telecommunications equipment, consumer equipment, lighting equipment, electrical and electronic tools, toys, leisure and sports equipment, automatic dispensers > Electric light bulbs, luminaries in households > Note : In ongoing RoHS Revision discussions, EP and Council seem to favour open scope 29 RoHS Directive > Requirements > Equipment may not contain lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB), polybrominated diphenyl ethers (PBDE) > Maximum concentration values by weight in homogeneous materials 0,1 % for lead, mercury, hexavalent chromium, PBB, PBDE 0,01 % for cadmium > Some applications are exempted from the obligations, e.g. lead in glass of cathode ray tubes > Note : In ongoing RoHS Revision discussions, EP seems to be split over additional substance bans 30 15

RoHS Directive > Conformity assessment procedure > No conformity assessment procedure specified > In many cases process based approach making use of materials declarations > Proposal revision RoHS Directive : Module A new approach 31 RoHS Directive > Standardisation > Main activities in electro technical environmental standardisation committees (IEC and CLC TC111) > IEC 62321 : Determination of levels of six regulated substances > IEC 62474 : Material declaration for electrical and electronic equipment (standard in preparation) > IEC TS 62476 : Guidance for assessing compliance of finished goods with respect to restriction of use of hazardous substances (standard in preparation) > IEC 63430 : Environmental conscious design for electrical and electronic products 32 16

Machinery Directive Jo Boullart www.agoria.be Machinery Directive > Title > The new Machinery Directive, 2006/42/EC, is not fundamentally different from the old directive, 98/37/EC. > It is meant to clarify definitions and lay clear boundaries with regard to other Directives. > The Machinery Directive is not the principal reason for various new standards or for adaptations to standards. These changes come about to comply with current product requirements. 34 17

Machinery Directive > Scope a) machinery b) interchangeable equipment c) safety components d) lifting accessories e) chains, ropes and webbing f) removable mechanical transmission devices a) to f): Machinery g) partly completed machinery 35 Machinery Directive > Explanations > Definition of machinery > Demarcation with the LVD > Demarcation with the Lifts Directive > Relationship with other directives 36 18

Clarification of the definition of machinery > An assembly > fitted with or intended to be fitted with a drive system > other than directly applied human or animal effort > consisting of linked parts or components, at least one of which moves > joined together for a specific application > An assembly referred to in the first indent, missing only the components to connect it on site or to sources of energy and motion; > An assembly referred to in the first and second indents, ready to be installed and able to function as it stands only if mounted on a means of transport, or installed in a building or a structure; > Assemblies of machinery referred to in the first, second and third indents or partly completed machinery referred to in point (g) which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole; > An assembly of linked parts or components, at least one of which moves and which are joined together, intended for lifting loads and whose only power source is directly applied human effort. 37 Clear demarcation with the Low Voltage Directive > Current Machinery Directive: if the risks are primarily of an electrical nature, the machinery will fall exclusively within the scope of the Low Voltage Directive, 73/23/EEC. > New Machinery Directive: demarcation based on the type of product: The new Machinery Directive does NOT apply to the following product categories: > Electrical and electronic products falling within the scope of Directive 73/23/EEC (amendment 2006/95/EC) on the harmonisation of the laws of Member States relating to electrical equipment designed for use within certain voltage limits: household appliances intended for domestic use; audio and video equipment; information technology equipment; ordinary office machinery; low-voltage switchgear and control gear; electric motors. > the following types of high-voltage electrical equipment: switch gear and control gear; transformers. 38 19

Clear demarcation with the Low Voltage Directive Important! > The Low Voltage Directive applies as from 50 V AC but, for example, 24-V machinery with an integrated 230-V transformer falls under the definitions of the Low Voltage Directive. 39 Machinery Directive > Relationship with other Directives > Where, for machinery, the hazards referred to in Annex I are wholly or partly covered more specifically by other Community Directives, this Directive shall not apply, or shall cease to apply, to that machinery in respect of such hazards from the date of implementation of those other Directives. > Important! All documentation and administrative matters must still be dealt with as per the provisions of the Machinery Directive. > Example: Noise Emission Directive 2000/14/EC 40 20

Machinery Directive > Essential requirements > The Machinery Directive defines only the essential health and safety requirements of general application, supplemented by a number of more specific requirements for certain categories of machinery. The essential health and safety requirements are grouped together based on the risks which they address (Annex 1). > The manufacturer of machinery must ensure that a risk assessment is carried out in order to determine the risks which apply to the machinery. The machinery must then be designed and constructed taking into account the results of the risk assessment. 41 Machinery Directive > Objectives > Obtain an acceptable level of residual risk > To achieve this, it makes sense to use harmonised standards which ensure a greater presumption of conformity. > Residual risks are principally covered by the Use of Work Equipment Directive. 42 21

Legal cover for the risks Machinery Directive:... compulsory risk assessment Manufacturer, placing on the market Law on well-being at work (Codex):... dynamic risk assessment system (quality of the work, well-being of the employee) Employer, use on the shop floor Use of Work Equipment Directive:... take account of the residual risks 43 Machinery Directive > Clarified or new definitions > placing on the market : making available for the first time in the Community machinery or partly completed machinery with a view to distribution or use, whether for reward or free of charge. > putting into service : the first use, for its intended purpose, in the Community, of machinery covered by this Directive. 44 22

Technical construction file: for internal use (covers you in case of an accident) > The limits of your machinery (as per ISO 14121-1); > Standards and the risks they cover; > Instruction manual; > Technical file: > completed checklist with assessed risk, > discussion of risks related to the limits, > assessments of uncovered risks, > design plans, ( It [the technical file] must cover the design, manufacture and operation of the machinery to the extent necessary for this assessment ) > Copy of the EC declaration of conformity for this machinery and for machinery incorporated into this machinery; > The declaration of incorporation for included partly completed machinery and the relevant assembly instructions for such machinery; > Must be drafted in one or more official Community languages; > The requirements for a technical file for partly completed machinery are to a great extent comparable with those for complete machinery. 45 Harmonized standards Type A Basic safety Standards Safety of machines; ISO12100-1 ISO12100-2 Principles for risk assesement: ISO14121-1 ISO14121-2 Type B1 Group safety standards Higher-level safety aspects Type B2 Standards Generally handled safety-related devices Positioning Safetyrelevanances against equipment machine Safety clear- Electrical Safety Of protective equipment to parts of accessing dangerous locations machines vices with and of latching de- approach speed control of human body systems with the upper without limbs tumbler priso13855 (EN999) EN 954-1 ISO13857 EN60204 EN1088 Two-hand circuit Emergency switching-off device, functional Light barriers aspects, design guidelines EN574 ISO13850 IEC61496 Type C Standards - Specialist standards Specific requirements on specific machines Elevators EN 81-1 Food preparation machines pren 1672-1 Woodworking machines Presses + shears EN692 EN1870 EN693 Printing and paper machines EN1010-4 Injection molding machines EN201 Cable railways EN1709 etc. 46 23

Wich kind of standards exists? > A-norms : Main standards, used for all kinds of machinery (main design principles, user manual, terminology,...) > B-norms : Standards regarding techniques (B1) and compontents (B2) wich can be used for several types of machinery. > B1 : safety distances, noise, > B2 : emergency stops, 2 hand control, light barriers, > C-norms : Standards for specific kind of machinery 47 Some commissions Main: CEN/TC 114 & ISO/TC 199 Safety of machinery CEN/TC 122 & ISO/TC 159 Ergonomics CEN/TC 211 & ISO/TC 043 Acoustics CEN/TC 231 & ISO/TC 108 Mechanical vibration and shock CEN/TC 305 Potentially explosive atmospheres - Explosion prevention and protection 48 24

Some commissions Specific machinery: CEN/TC 143 CEN/TC 214 CEN/TC 144 CEN/TC 146 CEN/TC 153 CEN/TC 151 CEN/TC 197 CEN/TC 232 CEN/TC 198 CEN/TC 186 CEN/TC 098 CEN/TC 147 CEN/TC 397 Machine tools - Safety Textile machinery and machinery for dry-cleaning and industrial laundry Tractors and machinery for agriculture and forestry Packaging machines - Safety Food processing machinery - Safety and hygiene specifications Construction equipment and building material machines - Safety Pumps Compressors - Safety Printing and paper machinery - Safety Industrial thermo processing - Safety Lifting platforms Cranes - Safety Project Committee - Bailing presses - Safety requirements 49 Risk analysis and assessment > Are there C Standards? Apply them first to minimise risks inherent to the type of machinery. > If the C Standard refers to other specific standards: use them as well if applicable. The C Standard takes precedence over these A-B Standards. > Apply the general standards for the remaining aspects if they exist for the type of machinery in question. > A last check for residual risks: > go through the list of health and safety risks in the Machinery Directive; > assess the risks (apply ISO 14121-1 to do this). 50 25

Conformity assessment procedure Machinery not included in Annex IV ( Module A, no real changes) Module A = self-certification Machine design and construction in accordance with essential health & safety requirements Compilation of the technical file for the type (Annex VII, A) + measures for conformity of machinery with file For type Ensure availability of technical file and provide required information (instruction manual, etc.) EC declaration of conformity for each machine (Annex II, A) For each machine Affix the CE marking on each machine 51 Conformity assessment procedure Machinery not included in Annex IV: technical construction file Main changes > Clear reference to the core of the file, namely documentation on the risk assessment with: > a list with the essential health and safety requirements; > a description of the protective measures... and when applicable information on the residual risks of the machinery. > Rules regarding the incorporation of partly completed machinery and completed machinery: > where appropriate, the declaration of incorporation for included partly completed machinery and the relevant assembly instructions for such machinery ; > where appropriate, copies of the EC declaration of conformity of machinery or other products incorporated into the machinery. > The express request to include a copy of the EC declaration of conformity in the file. 52 26

Conformity assessment procedure Machinery included in Annex IV New Machinery Directive technical construction file YES Conformity with harmonised standards NO For type or or Module A: self-certification EC type-examination by notified body Full quality assurance by notified body EC type-examination by notified body Full quality assurance by notified body or CE marking EC declaration of conformity For each machine 53 Conformity assessment procedure Machinery included in Annex IV ( Module A, no real changes) > Important! > Not all harmonised standards cover all the relevant requirements in the Directive. This can be verified in the Scope section of the standard and in the informative annex addressing the relationship between the standard s requirements and those of the Directive (generally called Annex ZA). 54 27

Conformity assessment procedure The EC declaration of conformity: new items The EC declaration of conformity must contain the following particulars: 1. Business name and full address of the manufacturer and, where appropriate, his authorised representative. 2. Name and address of the person authorised to compile the technical file, who must be established in the Community. 3. Description and identification of the machinery, including generic denomination, function, model, type, serial number and commercial name. 4. A sentence expressly declaring that the machinery fulfils all the relevant provisions of this Directive and where appropriate, a similar sentence declaring the conformity with other Directives and/or relevant provisions with which the machinery complies. These references must be those of the texts published in the Official Journal of the European Union. 5. Where appropriate, the name, address and identification number of the notified body which carried out the EC typeexamination referred to in Annex IX and the number of the EC type-examination certificate. 6. Where appropriate, the name, address and identification number of the notified body which approved the full quality assurance system referred to in Annex X. 7. Where appropriate, a reference to the harmonised standards used. 8. where appropriate, the reference to other technical standards and specifications used; 9. The place and date of the declaration. 10. The identity and signature of the person empowered to draw up the declaration on behalf of the manufacturer or his authorised representative. 55 Conformity assessment procedure The CE marking: new items > The CE conformity marking shall consist of the initials CE taking the following form: If the CE marking is reduced or enlarged the proportions shown in the above drawing must be respected. The various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5 mm. The minimum dimension may be waived for small-scale machinery. The CE marking must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative, using the same technique. Where the full quality assurance procedure has been applied, the CE marking must be followed by the identification number of the notified body. 56 28

Conformity assessment procedure The instructions: new items With regard to the language of the instructions, a distinction will now be made between: > Original instructions : this indication applies to all the language version(s) of the instructions verified by the manufacturer or his authorised representative (and it appears on these versions); > Translation of the original instructions : this indication applies for all other translations (provided by the manufacturer or his authorised representative or by the person bringing the machinery into the language area in question). All machinery must be accompanied by: > either original instructions in the official Community language or languages of the Member State in which it is placed on the market and/or put into service; > or with original instructions in another language, in which case these must be accompanied by a translation of the original instructions in the official Community language or languages of the Member State in which it is placed on the market and/or put into service. 57 Conformity assessment procedure The instructions: new items > New provision: The contents of the instructions must cover not only the intended use of the machinery but also take into account any reasonably foreseeable misuse thereof. > The list describing the contents of the instructions has been restructured and broadened with the explicit mentioning of a number of additional points such as: > the business name and full address of the manufacturer, designation of the machinery, copy of the declaration of conformity (not necessarily including the serial number and the signature), a general description of the machinery, etc.; > information about the residual risks, on the protective measures to be taken (including Personal Protective Equipment), the operating method to be followed so as to enable the equipment to be safely unblocked, etc.; > instructions designed to enable adjustment and maintenance to be carried out safely; > the specifications of the spare parts to be used; > etc. 58 29

Conformity assessment procedure The instructions: new items > New provisions regarding noise > Whenever sound emission values are indicated the uncertainties surrounding these values must be specified. > Where specific Community Directives lay down other requirements for the measurement of sound pressure levels or sound power levels, those Directives must be applied and the corresponding provisions of this section shall not apply. 59 Conformity assessment procedure Partly completed machinery: current Directive > Obligation for the final manufacturer to apply the Machinery Directive to the final machinery, so also to the partly completed machinery described in Annex II, B. > The final manufacturer bears all the risk! > How can we solve this problem? Requirements can only be set out contractually For example: > Require that the subcontractor create files; > Hold these files yourself; > Inspect these files on the subcontractor s premises. > Require that the subcontractor carry out a risk assessment; > Include a contractual obligation stating that if problems occur, the subcontractor will make available all calculation notes etc. 60 30

Conformity assessment procedure Partly completed machinery: new Directive > The manufacturer of the partly completed machine must cover his responsibility (procedure set out in Article 13). > Article 13 Procedure for partly completed machinery > The manufacturer must prepare: a) the relevant technical documentation as described in Annex VII, part B (this documentation is comparable to that for normal machinery, but there are no instructions to be included, only a copy of the assembly instructions); b) The assembly instructions as described in Annex VI ( contain a description of the conditions which must be met with a view to correct incorporation in the final machinery, so as not to compromise safety and health. ); c) A declaration of incorporation as described in Annex II, section 1(B); basis is still prohibited to use until an EC declaration of conformity is available for the final machinery ; Indicate which essential requirements of this Directive have been applied and fulfilled. > The assembly instructions and the declaration of incorporation shall accompany the partly completed machinery until it is incorporated into the final machinery and shall then form part of the technical file for that machinery. 61 TIPS: language for the instructions > Consumer product : language spoken in the consumer s area, work equipment : language of the operator. > There must be a physical set of instructions on CD-ROM or on paper. > The Use of Work Equipment Directive clearly states that a set of instructions must be available on paper and that this is the employer s responsibility! > In addition to providing instructions on paper in the language of the operator, the following is also allowed: > either a CD-ROM with at least one version in one original language; > or a link to a website for download. > The party responsible for carrying out the translation can be agreed upon contractually. 62 31

TIPS: compulsory delivery of spare parts > There are no special laws in Europe which make it obligatory to offer spare parts. > For consumer goods, Directive 1999/44/EC does state that a two-year guarantee must be associated with the product. In other words, this means that the manufacturer can keep a stock of spare parts to repair a product, but he can also offer an equivalent product. > It is possible to make contractual agreements regarding the delivery of spare parts during the normal lifetime of a product. 63 TIPS: keeping the technical construction file > Minimum of 13 years > The European Product Liability Directive provides for a 10-year period after the sale of the last product, after which liability expires. > Legal action can extend this period by three years. 64 32

TIPS: liability for importers > In Belgium, importers are also liable and they must submit the technical construction file if this is requested by the government! > Generally speaking, only the risk analysis is requested. > A new European Regulation clarifies the liability issues affecting importers. 65 Machinery Directive > Standardisation > http://ec.europa.eu/entreprise > http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/refli st.html 66 33

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69 Noise Emission Directive (Noise) Jo Boullart www.agoria.be 35

Noise Emission Directive > Title > Directive 2000/14/EC on the approximation of the laws of the Member States relating to the noise emission in the environment by equipment for use outdoors 71 Noise Emission Directive > Scope > Harmonisation of the requirements for the noise emission by equipment for use outdoors in order to prevent obstacles to the free movement of such equipment > Reducing permissible noise levels to protect health and well-being of citizens as well as protection of the environment > Provide information on the noise emitted by such equipment 72 36

Noise Emission Directive > Essential requirements > Marking*: visibly, legibly and indelibly affixing on the equipment of the CE marking defined in Decision 93/465/EEC accompanied by the indication of the guaranteed sound power level > Permissible noise levels**: depending on power or size of the equipment > * for all equipment subjected to 2000/14/EC > ** for a list of equipment subjected to 2000/14/EC 73 Noise Emission Directive 74 37

Noise Emission Directive > Conformity assessment procedure > Subjected to noise limits: > Internal control of production with assessment of the technical documentation and periodical checking > Full quality assurance > Only marking: > Internal control of production 75 Noise Emission Directive > Standardisation > Basic noise emission standard: EN ISO 3744:1995 76 38

Pressure Equipment Directive (PED) Dirk De Moor www.agoria.be Pressure Equipment Directive > Title > Directive 97/23/EC of the European Parliament and of the Council of 29 May 1997 on the approximation of the laws of the Member States concerning pressure equipment 78 39

Pressure Equipment Directive > Scope > This Directive applies to the design, manufacture and conformity assessment of pressure equipment and assemblies with a maximum allowable pressure PS greater than 0,5 bar. > Types of pressure equipment > Vessels > Piping > Safety accessories > Pressure accessories > Assemblies 79 Pressure Equipment Directive > Essential requirements > General > Eliminate or reduce hazards, apply appropriate protection measures against hazards, inform users of residual hazards > Design > A proper design taking all relevant factors into account in order to ensure that the equipment will be safe throughout its intended life > Manufacture > Manufacturing procedures (joining, NDT, heat treatment) > Final assessment > Marking and labelling > Operating instructions > Materials > Complying with harmonized standards > European approval of pressure equipment materials > Particular material appraisal 80 40

Conformity assessment procedure 81 Pressure Equipment Directive > Standardisation > Harmonised standards > Material standards EN 10025: Hot-rolled products of non-alloy structural steels EN 10028: Flat products made of steel for pressure purposes EN 10216: Seamless tubes for pressure purposes EN 10217: Welded tubes for pressure purposes EN 10222: Steel forgings for pressure purposes 82 41

Pressure Equipment Directive > Standardisation > Harmonised standards > Product standards EN 13445: Unfired pressure vessels EN 12952: Water-tube boilers and auxilliary installations EN 12953: Shell boilers EN 13480: Metallic industrial piping EN 764: Pressure Equipment 83 Construction Products Directive (CPD) Maxime Soldati www.agoria.be 42

Construction Products Directive > Directive 89/106/EEC of 21 December 1988, amended by Directive 93/68/EEC of 22 July 1993 > Scope: > Eliminate technical barriers to trade for construction products. > How to do: > Put on the market ONLY products fit for the intended use CE marking 85 Bouwproducten Richtlijn (CPD) > Scope CE-marking? > Abolishing unjustified technical barriers > European market > Safe and environmental friendly products 86 43

Construction Products Directive > Scope > Free circulation of construction products. > Construction products? Products produced for incorporation in construction works Installation & parts (heating, ventilation, HVAC, ) 87 Construction Products Directive > Essential requirements > NOT directed on products BUT on the works as a whole! > Specific requirements > Mechanical resistance & stability > Safety in case of fire > Hygiene, health & environment > Safety in use > Protection against noise > Energy economy and heat retention 88 44

Construction Products Directive > Harmonized standards > NOT every new standard is harmonized > Approved by European standardization organization en referenced in the Official Journal of EU > Link > http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseactio n=cpd.hs (594) > http://www.cen.eu/esearch/ > European Technical Agreement (ETA) > Declaration delivered by EOTA members 89 Construction Products Directive > European Technical Agreement (ETA) > ETA forms recognition of the serviceability of a product NOT covered by hen but that is to receive a CE mark for an intended use. > Compulsory preliminary step before putting on the European market products not covered by EN, > Confirms serviceability of the product (manufacturer s responsibility) > Defines production inspection provisions and possibly supervised by a notified body. > Declaration delivered by EOTA members 90 45

Construction Products Directive > Declaration of conformity > Annex III of CPD > Manufacturer s responsibility for putting the CE marking > Composition > Initial test (information on CE marking) > Supervision of production in the factory > Certification of the product > Annex ZA of the hen or appropriate section of the Guidance Paper for European Technical Agreements 91 Construction Products Directive > Conformity system 92 46

Construction Products Directive > CE marking in 6 steps 1. Determining of the text applicable tot the products. 2. Respecting the essential requirements. 3. Conformity assessment procedure. > Certification organizations, manufacturer, testing laboratories, inspection bodies. 4. Affixing the CE marking. 5. Declaration of conformity. > Declaration and technical file. 6. Effect of the CE marking. > Free movement of products within European market 93 The Future > Revision of the Construction Products Directive Construction Products Regulation 94 47

Coinstruction Products Regulation (CPR) > Regulation (EN = Verordening, FR = Règlement) > Binding in its entirety > Applicable for all (Member States, citizens,..) > Directly applicable > National authorities should not convert regulation into national law 95 Coinstruction Products Regulation (CPR) > Changes > Evaluation of the definition of construction. > Several articles of the CPD are bound to each other (difficult review). > Discussion on CE marking and performance of products. > Discussion about the way an ETA must be written > Discussion about the EAD (European Assessment Document) and harmonized standards related to privacy. 96 48

Coinstruction Products Regulation (CPR) > Schedule > Revision of the CPD would be ready within 18 months (without additionally problems) 97 Construction Products Directive > Title > Directive 89/106/EEC of 21 December 1988, amended by Directive 93/68/EEC of 22 July 1993 to eliminate technical barriers to trade for construction products. > How to do? request Member States to take all necessary measures that only products, which are fit for the intended use, may be put on the market. 98 49

Construction Products Directive > Scope > Abolishing unjustified technical barriers fit for intended use in the free movement of Construction products > Mandatory > Construction products? Products produced for incorporation in construction works Installations & parts (heating, HVAC, sanitary, electrical, ) 99 Construction Products Directive > Essential requirements > CPD requirements are not directed on products BUT on the works as a whole > Specific requirements for the works > Mechanical resistance & stability > Safety in case of fire > Hygiene, health & environment > Safety in use > Protection against noise > Energy economy and heat retention Requirements subjected to normal maintenance must be satisfied for an economically reasonable working life 100 50

Construction Products Directive > Interpretative documents Link between essential requirements & product specifications Facilitate correct application of directive > Concrete forms to the essentials requirements and detail them > Correlation between requirements to works & the product characteristics > Lay down products characteristics & their classes 101 Construction Products Directive > Other important Directives > General Product Directive (2001/95/CE) No risk under normal conditions of use Applicable for new, used & reconditioned > Product Liability Directive (85/374/EEC) Protection against health or property damage > Information Directive (98/34/EC) Notify draft technical regulations & standards 102 51

Construction Products Directive > Useful Link > http://ec.europa.eu/enterprise/newapproach/nando/index.cf m?fuseaction=cpd.hs 103 Thank you for your attention www.agoria.be 52