Introduction to the EU Regulatory system: for general products, and for construction and construction products Dr. Adam Pinney, CPR expert Adam Pinney.

Slides:



Advertisements
Similar presentations
Supplier’s Declaration of Conformity (SDoC)
Advertisements

General introduction to the New Approach and CE marking Contribution to workshop in Sofia, Bulgaria on 19 and 20 april 2006 by Annette Dragsdahl, Senior.
Standardisation, regulation, worldwide strategies 1 Modules of conformity assessment.
Market surveillance. Internal market Enforcement of Community legislation is an obligation on Member States: Article 10 of the EC Treaty requires Member.
Implementation of Voluntary Market Schemes Wayne Morris United States.
Workshop New Approach – Sofia, Bulgaria – 19/20 April Workshop on New Approach Directives for the Engineering Industry Focus on Directives Regulating.
S4: Market Surveillance Physikalisch-Technische Bundesanstalt Session 4: Market surveillance Peter Ulbig, Harry Stolz Belgrade, 31 October.
Hogan Lovells EU Product Safety and Market Surveillance Reforms How will this impact businesses – Lawyers' view BIICL seminar, 2 October.
European Commission Enterprise and Industry Market surveillance and automotive type-approval legislation - 28/06/2012 | ‹#› WP.29 Enforcement Working Group.
CE marking Catriona Blake Team Manager, Imaging, acute and community care.
Source: ec.europa.eu/CEmarking CE marking makes Europe’s market yours!
Low Voltage Directive New Approach. Directive Overview Guidelines on application and Recommendations Safety objectives Documentation LVD standardisation.
ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL European Commission Anna Solé Mena Policy Officer - European Commission DG Enterprise and Industry.
U D T Workshop on the Pressure Equipment Directive, Warsaw June 2004 INTERFACES BETWEEN NATIONAL LEGISLATION AND DIRECTIVE 97/23/EC SYSTEM OF ENSURING.
Best Practices in Wine Regulation Introduction to the World Wine Trade Group Robert G. Kalik World Wine Trade Group, USA.
Prof R T KennedyEMC & COMPLIANCE ENGINEERING 1 EET 422 EMC & COMPLIANCE ENGINEERING.
Market Surveillance Authorities intervention actions How the measures (corrective/repressive) are taken by the competent market surveillance authority.
Health and Consumers Directorate-General (DG SANCO) Howard Batho, Head of import and OIE sector Unit D1, Animal Health and Standing Committees.
Approximation of legislation to the internal market acquis An EU funded project managed by European Agency for Reconstruction Directive 89/106/EEC on Construction.
Presentation 4: How can I know if nanomaterials are used in my workplace?
Phare SL Implementation of Technical Regulations on Company Level Top Management Seminar Expert: Willem Wolf Chamber of Commerce and Industry,
1 MARKET SURVEILLANCE IN THE EUROPEAN UNION A coordinate approach for metrology Lucia Palmegiani Policy Officer, DG ENTR I.5 WELMEC, WG 5, Malta, 23 October.
European Commission Rita L’ABBATE Legal aspects linked to internal market DG Enterprise and Industry MARKET SURVEILLANCE COMMUNITY FRAMEWORK UNECE “MARS”
The New Approach and GPSD. Council Resolution of 7 May 1985 on a new approach to technical harmonization and standards [OJ C136 of June 1985] New Approach.
Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Business seminar on export to Europe Support to the Modernisation.
Slide 1 Recognition of Professional Qualifications in the European Single Market for Services Henri Olivier FEE Secretary General FEE (Fédération des Experts.
1 MARKET SURVEILLANCE IN SWEDEN UN-ECE MARS GROUP, Bratislava October 2010 Amina Makboul
Directorate General for Enterprise and Industry European Commission The New Legislative Framework - Market Surveillance UNECE “MARS” Group meeting Bratislava,
National Legislation on in- service inspections and the PED.
The New EU Legislative Framework for Harmonisation Legislation for products Richard Lawson Deputy Director, Technical Regulations Sustainable Development.
Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Training on standardisation Support to the Modernisation.
Workshop on Eurocodes: Training the trainers, Moscow, 9-10 December, European Legislation and Standardization: Benefits of International Cooperation.
Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Training on standardisation Support to the Modernisation.
European Commission REGULATORY MODEL OF THE EUROPEAN UNION Norbert ANSELMANN Head of Unit, ENTR G2, Standardisation Directorate.
Basic economic freedoms. 1. Free movement of goods The Community shall be based upon a customs union which shall cover all trade in goods and which shall.
The New Legislative Framework
Prof R T KennedyEMC & COMPLIANCE ENGINEERING 1 EET 422 EMC & COMPLIANCE ENGINEERING.
Prof R T KennedyEMC & COMPLIANCE ENGINEERING 1 EET 422 EMC & COMPLIANCE ENGINEERING.
EPHA Presentation Healthcare and social services treated equally as estate agents or advertising companies excluded from the Directive or Healthcare and.
CE Marking as Related to CPR Regulation (EU) No 305/2011
TAIEX GPSD Free Movement and Safety Vitomir Fister Beograd,
Engineering Environment Awareness
Conformity assessment in EU - 12 may Pascale MIENVILLE 1 Product Conformity Assessment Requirements for Access to the European Market CASCO/DEVCO.
High Level Symposium to Enhance Regulator Expertise on Good Regulatory Practices and the WTO Agreement on Technical Barriers to Trade.
Conformity assessment – some examples: cement, high pressure laminates, ceramic tiles.
Introduction to CE marking for construction products and how this relates to national construction regulations Dr. Adam Pinney, CPR expert Adam Pinney.
EU Certification Systems Dr. Friedrich Lüdeke, GLOBALG.A.P. Cairo, 12 June 2012.
Introduction to the CPR. Transition from CPD to CPR, key dates TAIEX Workshop INT MARKET CPR and CE marking, Baku, 23 and 24 February 2015.
Every employer must ensure, as far as is reasonable practicable, the health, safety and welfare of all his employees More specifically, employers must.
Workshop on conformity assessment procedures and certification of medical devices INT MARKT Kyiv, November 2011 Conformity assessment of medical.
ELA Forum The basis, objective and content of SNEL - EN81-80 The basis, objective and content of SNEL - EN81-80 Michael Savage.
Jacques McMillan Has Accreditation fulfilled the expectations? Jacques McMillan Former European.
Framework for Product Data Templates
EET 422 EMC & COMPLIANCE ENGINEERING
66 items – 70% of circulated products
The new “KEYMARK scheme for all Thermal Insulation”
Strategy for conformity of non-standard cryogenic equipment
EET 422 EMC & COMPLIANCE ENGINEERING
26/08/2018 EU PPE Regulation 2016/425 Henk Vanhoutte secretary general European Safety Federation European Safety Federation ivzw.
IECEx Industry Seminar Integrating IECEx and ATEX for Europe
EU legislation on Personal Protective Equipment (PPE)
Business seminar on export to Europe
Training on standardisation
Role of Industry Self-regulation in Phytosanitary Compliance
2.1. Monitoring of products placed on the market To verify the products comply with applicable directives EC declaration of conformity and technical.
INTERFACES BETWEEN NATIONAL LEGISLATION AND DIRECTIVE 97/23/EC
Seán Balfe Director, Sustainability and the Built Environment.
ESS approach and support for Declaration of Conformity (CE-marking) Fredrik Håkansson ESS Accelerator Collaboration Board Meeting Trieste
National Legislation in the Pressure Sector and the PED
General principles of the New Approach legislation
Presentation transcript:

Introduction to the EU Regulatory system: for general products, and for construction and construction products Dr. Adam Pinney, CPR expert Adam Pinney Consulting Ltd.

Two basic aims of the EU system: - Protection of citizens, domestic animals and the environment. - Free trade (free circulation of goods). Protection given by regulatory provisions = aspects of public interest. - Regulations cover: health, safety, (functionality), environment, Regulations do not cover: (functionality), quality, cost,.... Adam Pinney Consulting Ltd.

Brief history of the EU system The Treaty of Rome, 1957: Article 30: “Quantitative restrictions on imports and all measures having equivalent effect shall … be prohibited between Member States.” The Single European Act, 1986: Article 100a 3: “The Commission, in its proposals... concerning health, safety, environmental protection and consumer protection, will take as a base a high level of protection.” Article 129a 1: “The Community shall contribute to the attainment of a high level of consumer protection...” Adam Pinney Consulting Ltd.

Why free movement of goods? Barriers to trade harm all parties, including those imposing the barriers (“Theory of comparative advantage”, Ricardo, 1817). Hence the creation of Free Trade zones: EU and EFTA (the most advanced), NAFTA (North America), SAFTA (South Asia), USAN (South America). Adam Pinney Consulting Ltd.

What are technical barriers to trade? Requirements that restrict international trade: - different regulatory provisions, - compulsory national standards, - testing in the country of destination, - nationally imposed certification schemes, - additional technical requirements, - ‘devaluing’ non-national test results, Consequences of TBTs: different products/multiple assessment of products for different countries. Adam Pinney Consulting Ltd.

So wouldn’t it be fantastic if we had: A market based on the following principles: - a single regulatory framework allowing manufacturers to demonstrate satisfaction of national regulations, - a system of harmonised technical specifications, - an agreed system for showing the conformity of products, - an accepted conformity marking, - market surveillance, - no systematic intervention of the State CE marking is ALWAYS manufacturer’s declaration! Adam Pinney Consulting Ltd.

CE marking in general (excluding construction products) The CE marking poses and answers one simple question: - does this production meet regulatory requirements (= is this product ‘safe’)? The presence of the CE marking provides the answer “Yes, in principle”. Adam Pinney Consulting Ltd.

How does CE marking work? Directives set Essential Requirements on products = regulatory requirements identical in all Member States. Examples for electrical products: - Persons and domestic animals are protected against the danger of injury caused by direct or indirect contact. - The insulation must be suitable for foreseeable conditions. Examples for Personal Protective Equipment: - PPE must not adversely affect user hygiene or health. - PPE protecting part of the body against static compressive stress must be sufficient to prevent serious injury or chronic complaints. Compliance with (relevant) Essential Requirements is compulsory. Adam Pinney Consulting Ltd.

The route to CE marking Two routes to CE marking: - direct compliance with ERs (risk assessment), - compliance with a harmonised EN (EN remains voluntary). Manufacturer chooses the Attestation of Conformity (AoC) system, where the directive gives a choice. Manufacturer applies chosen AoC system (possibly involving a third party Notified Body). Manufacturer draws up and signs Declaration of Conformity (DoC). Signature of the DoC allows to be applied to the product. Adam Pinney Consulting Ltd.

CE marking of construction products Most regulatory requirements in Member States apply to construction works, not directly to construction products. Regulatory requirements on works are not the same throughout EU Member States! Adam Pinney Consulting Ltd.

Regulatory “envelope” Seven Basic Works Requirements (BWRs) in the CPR: 1)mechanical resistance and stability, 2)safety in case of fire, 3)hygiene, health and the environment, 4)safety and accessibility in use, 5)protection against noise, 6)energy economy and heat retention, 7)sustainable use of natural resources. Member States are limited in their regulations to the seven BWRs, but they are not obliged to regulate against all BWRs for all works or types of works, nor to regulate at the same level for all works.

CE marking of construction products The same question, “Does this product meet regulatory requirements?” cannot, in general, be asked or answered. The question for construction products is, therefore: “What are the performance levels of this product?” CE marking of a construction product therefore means: “You can presume that the declared performance levels of this product are correct.” The decision on whether a construction product allows the works to meet the applicable BWRs belongs to someone else: designer, architect, etc., not to the product manufacturer.

CE marking examples Construction product AnyCo Ltd, PO Box 21, Any Town CPR EN mm mineral wool for use in buildings Reaction to fire: Class A2-s1, d0, fully exposed Thermal conductivity: 0,04 W/mK Flexural tensile strength: NPD Electrical product

Some myths about CE marking CE marking applies only to products for export: Wrong! CE marking is required even for products made and sold in the same Member State. CE marking means “Fit for every purpose”: Wrong! CE marking is not a quality mark: To discuss! CE marking is applied equally to the highest performing products and to the lowest performing. CE marking means “Check everything”: Wrong! But this might be good advice! Adam Pinney Consulting Ltd.

The effects of the CPR The CPR does not (in general) introduce new regulatory requirements, either on construction works or on construction products. Manufacturers have always had to assess the performance of their products appropriately for their intended market(s). The CPR has, however, cut the ways of demonstrating product performance to one single route. Adam Pinney Consulting Ltd.

Conclusions for CE marked construction products CE marking of construction products is not the same as CE marking of any other products. CE marking does not mean “safe” or even “meets regulatory requirements”. CE marking of construction products can appear complicated, but in fact isn’t, once the basic principles and responsibilities are known! Adam Pinney Consulting Ltd.

My dream: Dr. Pinney, retired, having fun, temperature -12 o C... Adam Pinney Consulting Ltd.