New Legal FrameworkCarlo Casati

Milan, 1 April 2016

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• New Legislative Framework• Market Surveillance• Conformity Assessment• CE Marking

Summary

New Legislative Framework (NLF)

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• Primary legislation• Founding Treaties• Constitution

• Secondary legislation• Jurisprudence

• Sentences of the Court of Justice

• Sentences of the Court of First Instance

European Union Law (Aquis)

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• Regulations: these are binding in their entirety and directly applicable in all Member States;

• Directives: these bind the Member States as to the results to be achieved; they have to be transposed into the national legal framework and thus leave margin for manoeuvre as to the form and means of implementation;

• Decisions: these are fully binding on those to whom they are addressed;

• Recommendations and opinions: these are non-binding, declaratory instruments.

European Union Legal instruments

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To improve the internal market for goods and strengthen the conditions for placing a wide range of products on the EU Market, the New Legislative Framework was adopted in 2008• improves market surveillance rules to better protect both

consumers and professionals from unsafe products, including those imported from outside the EU;

• sets clear and transparent rules for the accreditation of conformity assessment bodies;

• boosts the quality of and confidence in the conformity assessment of products through stronger and clearer rules on the requirements for the notification of conformity assessment bodies;

• clarifies the meaning of CE marking and enhances its credibility;• establishes a common legal framework for industrial products in

the form of a toolbox of measures for use in future legislation.

New Legislative Framework

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• Regulation (EC) 765/2008 setting out the requirements for accreditation and the market surveillance of products;

• Decision 768/2008 on a common framework for the marketing of products, which includes reference provisions to be incorporated whenever product legislation is revised. In effect, it is a template for future product harmonisation legislation;

• Regulation (EC) 764/2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another EU country.

The package consists of:

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• Low Voltage Directive - 2014/35/EU;• Electromagnetic Compatibility Directive: 2014/30/EU;• ATEX Directive - 2014/34/EU;• Lifts Directive - 2014/33/EU;• Simple Pressure Vessels Directive - 2014/29/EU;• Measuring Instruments Directive - 2014/32/EU;• Non-automatic Weighing Instruments Directive - 2014/31/

EU;

• Civil Explosives Directive - 2014/28/EU.

Alignment of product legislation

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• In addition, aligned legislation has also been adopted in the areas of Pyrotechnic Articles (Directive 2013/29/EU), Toy Safety (2009/48/EU), Restriction of Hazardous Substances in Electrical and Electronic Equipment (2011/65/EU), Recreational Craft (2013/53/EU), Radio Equipment (2014/53/EU), Pressure Equipment (2014/68/EU) and Marine Equipment (2014/90/EU). Further aligning proposals are pending on Medical Devices, Gas Appliances, Cableways, and Personal Protective Equipment.

Alignment of product legislation

Market Surveillance

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Market surveillance for products

• Member States have to take appropriate measures to prevent the placing on the market and use of non-compliant products.

• Market surveillance activities may be organized differently depending on the nature of the product and may range from control of formal requirements to profound laboratory examinations.

• All economic operators have a role and obligations in market surveillance.

• One major task for market surveillance authorities is to keep the public informed against potential risks (RAPEX)

• Non-compliant products are subject to corrective measures, bans withdrawals or recalls.

• The level of the sanctions is determined at national level

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Manufacturer• The manufacturer is any natural or legal person who manufactures a

product or has a product designed or manufactured, and places it on the market under his own name or trademark.

• The manufacturer is responsible for the conformity assessment of the product and is subject to a series of obligations including traceability requirements.

• When placing a product on the Union market, the responsibilities of a manufacturer are the same whether he is established outside the European Union or in a Member State.

• The manufacturer must cooperate with the competent national authorities in charge of market surveillance in case of a product presenting a risk or being non-compliant.

Economic Operators

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Authorised representative• Irrespectively of whether he is established in the EU or not, the

manufacturer may appoint an authorised representative in the Union to act on his behalf in carrying out certain tasks.

Importer• The importer is a natural or legal person established in the Union

who places a product from a third country on the EU market.• His obligations build on the obligation of the manufacturer.Distributor• The distributor is a natural or a legal person in the supply chain,

other than the manufacturer or the importer, who makes a product available on the market.

• Distributors are subject to specific obligations and have a key role to play in the context of market surveillance.

Economic Operators

Conformity Assessment

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Single Market and European Standardisation

Single Market

Technical Harmonization

CEN European Committee for StandardizationCENELEC European Committee for Electro-technical StandardizationETSI European Telecommunication Standard Institute

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Conformity Assessment and Global Approach

Global Approach

Technical Requirements

Module Conformity Assessment

• Not only rules (technical harmonisation) must be shared but also how to assess them

• Global Approach:• Module Conformity

Assessment• Notified Bodies• CE marking

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Conformity Assessment Modules

There are eight modules. Some of them have variants.

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Technical Innovation and New Approach

New Approach

Essential Requirements

Module Conformity Assessment

• Innovative products can not be subjected by technical standards, as they have long development times.

• The new approach completes the global approach keeping the rules for conformity assessment but replacing technical regulation with essential requirement.

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Presumption of Conformity

Conformity

Presumptionof Conformity

Essential Requirements(must)

Harmonised standards(possibility)

Ceases if:The harmonised standard expiresThe contrary is proved

• The conformity of a product may be demonstrated not only by harmonised standards but also by other technical specifications.

• Other technical specifications however do not benefit from the presumption of conformity.

Why standards are used or not used ?

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Use

d • Presumption of conformity through standards requires often less resources (time, money, competence, …) than proving essential requirements.

• Standards are worldwide recognised, may be used commercially. N

ot U

sed • By means of technical

documentation the conformity of a product family can be derived (this is not possible for global approach and standard based product certification).

• No specific standards are available

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Why standards are not used ?

Regulation 765/2008 promotes a uniformly rigorous approach to accreditation across EU countries. The main principles of accreditation are:• one accreditation body per EU country (it is

possible however to use another country’s national accreditation body);

• accreditation is a public sector activity and a not-for-profit activity;

• there is no competition between national accreditation bodies;

• stakeholders are represented;• accreditation is the preferred means of

demonstrating technical capacity of notified bodies in the regulated area.

Nando(New Approach Notified

and Designated Organisations)

Information System

CE Marking

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CE Marking

What does the CE marking on a product indicate?By affixing the CE marking to a product, the manufacturer declares on his sole responsibility that the product is in conformity with the essential requirements of the applicable Union harmonisation legislation providing for its affixing and that the relevant conformity assessment procedures have been fulfilled. Products bearing the CE marking are presumed to be in compliance with the applicable Union harmonisation legislation and hence benefit from free circulation in the European Market.What is a manufacturer’s Declaration of Conformity?The EU Declaration of Conformity (EU DoC) is a document in which the manufacturer, or his authorised representative within the European Economic Area (EEA), indicates that the product meets all the necessary requirements of the Union harmonisation legislation applicable to the specific product. The EU DoC must be signed by an individual working for the manufacturer or his authorised representative, and the employee’s function shall also be indicated. Whether a Notified Body has been involved or not, the manufacturer must draw up and sign the EE Declaration of Conformity.

CE marking

• Legal tool• Mainly based on new legislative

framework directives• Fulfilment of essential requirements

• Presumption of conformity if compliance to harmonised standards

• Application of conformity assessment procedures

• Asserted by technical documentation & UE declaration of conformity.

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