PRODUCT SAFETYPRODUCT SAFETY

Marko BaretićMarko Baretić

Faculty of LawFaculty of Law

University of ZagrebUniversity of Zagreb

BASIC CONCEPTSBASIC CONCEPTS

Why to regulate safety?Why to regulate safety? How much safety?How much safety? What to regulate?What to regulate? Who should regulate?Who should regulate? How to regulate?How to regulate? How to control?How to control? Who should control?Who should control?

WHY TO REGULATE WHY TO REGULATE SAFETY?SAFETY?

Consumer safety - first objective of Consumer safety - first objective of consumer protection policyconsumer protection policy

Perils to consumersPerils to consumers• New and sophisticated products New and sophisticated products • Competitive marketsCompetitive markets• Mass-production Mass-production

Preventive function of the safety Preventive function of the safety regulationregulation

HOW MUCH SAFETY?HOW MUCH SAFETY?

Absolute safety or optimal safety?Absolute safety or optimal safety? No risk or acceptable risk?No risk or acceptable risk? Optimal safety – acceptable risk Optimal safety – acceptable risk

systemsystem• Elements of product regulation:Elements of product regulation:

Safety, performance, efficiency,Safety, performance, efficiency, quality, quality, priceprice

• Risk-utility testRisk-utility test Acceptability of the product assessed Acceptability of the product assessed

against its utilityagainst its utility

WHAT TO REGULATE?WHAT TO REGULATE?

(Producers)(Producers) Design of the productDesign of the product Manufacturing/performance processManufacturing/performance process Instructions, warnings and Instructions, warnings and

informationinformation

WHO SHOULD REGULATE?WHO SHOULD REGULATE?

Private regulationPrivate regulation• Individual manufacturerIndividual manufacturer• Manufacturers’ associations Manufacturers’ associations • Private regulatorsPrivate regulators

Public regulationPublic regulation• Government (politicians)Government (politicians)• Regulatory agencies (technocrats, Regulatory agencies (technocrats,

experts)experts)

HOW TO REGULATE?HOW TO REGULATE?

Compulsory regulationCompulsory regulation• laws, regulations, administrative laws, regulations, administrative

provisionsprovisions Voluntary regulationVoluntary regulation

• standardsstandards Mixed regulationMixed regulation

• compulsory laws supplemented by compulsory laws supplemented by voluntary standards voluntary standards

HOW TO CONTROL?HOW TO CONTROL?

Pre-market controlPre-market control• Imposition of safety requirementsImposition of safety requirements• Approval to market the productApproval to market the product

Post-market controlPost-market control• Conformity assessment after the Conformity assessment after the

product is put on the marketproduct is put on the market

WHO SHOULD CONTROL?WHO SHOULD CONTROL?

Conformity assessment Conformity assessment • self-declaration by the manufacturerself-declaration by the manufacturer• quality assessment procedures quality assessment procedures

supervised and controlled by a third supervised and controlled by a third partyparty

• third party certificationthird party certification

EUROPEAN MODELEUROPEAN MODEL

““Old approach”Old approach”• 1969 – 1969 – General Programme for the elimination General Programme for the elimination

of technical barriers to trade that result from of technical barriers to trade that result from disparities between the provisions laid down by disparities between the provisions laid down by lalaww, regulation or administrative action in , regulation or administrative action in MMember ember SStatestates

““New approach”New approach”• 1985 – 1985 – Council resolution on the New Approach Council resolution on the New Approach

to Technical Harmonisation and Standardsto Technical Harmonisation and Standards

OLD APPROACHOLD APPROACH

OverambitiousOverambitious• Sought to set out in details all the performance Sought to set out in details all the performance

objectives and design and manufacture objectives and design and manufacture specifications for the products coveredspecifications for the products covered

• Long-lasting and expensiveLong-lasting and expensive In 18 months only 1 measure instead of 124 In 18 months only 1 measure instead of 124

envisaged envisaged

• Detailed regulation to inflexibleDetailed regulation to inflexible• Flaws in style and content of the resulting Flaws in style and content of the resulting

legislationlegislation

NEW APPROACHNEW APPROACH

Distinction is drawn between:Distinction is drawn between:• Essential safety requirementsEssential safety requirements

Imposed by harmonising legislation Imposed by harmonising legislation (regulations and directives)(regulations and directives)

• Design/Manufacturing Design/Manufacturing specificationsspecifications

Set out by voluntary standardsSet out by voluntary standards Safety is achieved through the Safety is achieved through the

synergy of mandatory legislation and synergy of mandatory legislation and voluntary standardsvoluntary standards

ESSENTIAL SAFETY ESSENTIAL SAFETY REQUIREMENTSREQUIREMENTS

They are safety objectives which must be They are safety objectives which must be met met

A directive should contain a description of A directive should contain a description of the safety which products covered by it the safety which products covered by it must satisfymust satisfy

It should be worded precisely enoughIt should be worded precisely enough Sometimes vague objectives:Sometimes vague objectives:

• to minimise risks to minimise risks • to reduce risks as far as possible to reduce risks as far as possible • to insure temperatures do not cause burningto insure temperatures do not cause burning

STANDARDSSTANDARDS

Technical specification approved by a Technical specification approved by a recognised standardisation body for recognised standardisation body for repeated and continuous application repeated and continuous application with which compliance is not with which compliance is not compuslorcompusloryy and which is adopted by and which is adopted by an international, regional or national an international, regional or national ststaandardisation body and made ndardisation body and made available to the publicavailable to the public

STANDARDSSTANDARDS

Detailed technical (design and Detailed technical (design and manufacturing) specificationsmanufacturing) specifications

Define how to reach the level of Define how to reach the level of safety envisaged by essential safety safety envisaged by essential safety requirements requirements in a manner in a manner acceptable to industryacceptable to industry

Voluntary in natureVoluntary in nature Produced by professional public and Produced by professional public and

independent standardisation bodiesindependent standardisation bodies

STANDARDSSTANDARDS InternationalInternational

• ISOISO International Organisation for Standards International Organisation for Standards

Regional (European)Regional (European)• ENEN

European Committee for Standardisation (CEN)European Committee for Standardisation (CEN) European Committee for Electrotechnical European Committee for Electrotechnical

Standardisation (CENELEC)Standardisation (CENELEC) European Telecommunication Standards Institute European Telecommunication Standards Institute

(ETSI)(ETSI) NationalNational

• HRNHRN Hrvatski zavod za norme (HZN)Hrvatski zavod za norme (HZN)

DISTINCTIONDISTINCTION

ESSENTIAL SAFETY ESSENTIAL SAFETY REQUIREMENTSREQUIREMENTS

ggenerally definedenerally defined created by the created by the

politicianspoliticians

set out in the set out in the regulations or regulations or directivesdirectives

mandatory mandatory

TECHNICAL TECHNICAL SPECIFICATIONSSPECIFICATIONS

very detailedvery detailed created by created by

technocrats technocrats (experts)(experts)

set out in set out in standardsstandards

voluntaryvoluntary

SYNERGY OF REGULATION AND SYNERGY OF REGULATION AND STANDARDSSTANDARDS

Regulation determines what level of Regulation determines what level of safety must be achievedsafety must be achieved

Standards define how to achieve Standards define how to achieve required level of safetyrequired level of safety

Products conforming to the Products conforming to the harmonised standards harmonised standards are are presumedpresumed to conform to the to conform to the essential requirementsessential requirements

CONFORMITY ASSESSMENTCONFORMITY ASSESSMENT

Council Resolution on a Global Council Resolution on a Global Approach to Conformity Assessment Approach to Conformity Assessment of 1989of 1989

Conformity Assessment and CE Conformity Assessment and CE Marking Decision of 1993Marking Decision of 1993

establishment of European establishment of European Organisation for Testing and Organisation for Testing and Certification (EOTC) in 1990Certification (EOTC) in 1990

CONFORMITY ASSESSMENTCONFORMITY ASSESSMENT

Three basic categories:Three basic categories:• Self-declarationSelf-declaration• Quality assessment procedures Quality assessment procedures

supervised and controlled by a third supervised and controlled by a third party party

• Third party certificationThird party certification

SELF DECLARATIONSELF DECLARATION Voluntary conformity assessmentVoluntary conformity assessment Dominant conformity assessment mechanismDominant conformity assessment mechanism The manufacturer must:The manufacturer must:

• establish technical documentation that covers establish technical documentation that covers conformity assessment of the design, manufacture and conformity assessment of the design, manufacture and operation of the productoperation of the product

• affix the CE marking to each product and draw up a affix the CE marking to each product and draw up a written declaration of conformitywritten declaration of conformity

CE (CE (CConformité onformité EEuropéene)uropéene)• The mark signifies that the product confirms to new The mark signifies that the product confirms to new

approach directivesapproach directives• The mark DOES NOT signify that the product has been The mark DOES NOT signify that the product has been

tested or previously approved by third partytested or previously approved by third party

QUALITY ASSESSMENT QUALITY ASSESSMENT PROCEDUREPROCEDURE

Manufacturer ensures and declares that Manufacturer ensures and declares that the products are in conformity with the products are in conformity with technical documentation and essential technical documentation and essential safety requirementssafety requirements

Manufacturer affixes CE marking and Manufacturer affixes CE marking and draws up a written declarationdraws up a written declaration

The manufacturer must operate an The manufacturer must operate an approved quality system for production, approved quality system for production, final product inspection and testing which final product inspection and testing which is subject to monitoringis subject to monitoring

The quality system must be under The quality system must be under surveillance of a notified bodysurveillance of a notified body

THIRD PARTY CERTIFICATIONTHIRD PARTY CERTIFICATION

Manufacturer establishes technical Manufacturer establishes technical documentation to enable conformity documentation to enable conformity assessment concerning the design, assessment concerning the design, manufacture and operation of the productmanufacture and operation of the product

Manufacturer lodges an application with a Manufacturer lodges an application with a notified bodynotified body

If the “type” or actual product is in If the “type” or actual product is in conformity with technical documentation conformity with technical documentation and essential safety requirements, notified and essential safety requirements, notified body issues a certificate body issues a certificate

PRODUCT SAFETY SYSTEMPRODUCT SAFETY SYSTEM General product safetyGeneral product safety

• Directive 2001/95/EC on general product safetyDirective 2001/95/EC on general product safety Specific product safetySpecific product safety

• ToysToys (Directive 2009/48, Directive 2005/84/EC) (Directive 2009/48, Directive 2005/84/EC)• Pyrotechnic articlesPyrotechnic articles (Directive 2007/23/EC) (Directive 2007/23/EC)• MachineryMachinery (Directive 2006/42/EC) (Directive 2006/42/EC)• Cableway installationsCableway installations (2000/9/EC) (2000/9/EC)• Medicinal productsMedicinal products (Directive 93/42/EEC, Directive 2002/98/EC, (Directive 93/42/EEC, Directive 2002/98/EC,

Directive 2004/33/EC, Directive 2005/62/EC, Directive 2004/23/EC, Directive 2004/33/EC, Directive 2005/62/EC, Directive 2004/23/EC, Directive 2006/17/EC, Directive 2005/62/EC, Directive 2001/83/EC, Directive 2006/17/EC, Directive 2005/62/EC, Directive 2001/83/EC, Directive 2004/27/EC, Regulation 1394/2007, Regulation 726/2004, Directive 2004/27/EC, Regulation 1394/2007, Regulation 726/2004, Regulation 1901/2006)Regulation 1901/2006)

• Pressure equipmentPressure equipment (Directive 97/23/EC, Directive 2009/105/EC) (Directive 97/23/EC, Directive 2009/105/EC)• Appliances burning gaseous fuelsAppliances burning gaseous fuels (Directive 2009/142/EC) (Directive 2009/142/EC)• Electrical equipmentElectrical equipment (Directive 2006/95/EC) (Directive 2006/95/EC)• Telecommunications equipmentTelecommunications equipment (Directive 1999/5/EC) (Directive 1999/5/EC)• Passenger shipsPassenger ships (Directive 98/18/EC) (Directive 98/18/EC)• AirplanesAirplanes (Regulation 1592/2002, Regulation 1702/2003) (Regulation 1592/2002, Regulation 1702/2003)

GENERAL PRODUCT SAFETYGENERAL PRODUCT SAFETY

The system applies iThe system applies iff no specific no specific provisions on product safety existprovisions on product safety exist

If specific product safety system If specific product safety system does exist, the general system does exist, the general system applies to the aspects and risks or applies to the aspects and risks or categories of risks not covered by categories of risks not covered by specific systemspecific system

CONCEPT OF SAFE PRODUCTCONCEPT OF SAFE PRODUCT

A product whichA product which• under normal or reasonably foreseeable under normal or reasonably foreseeable

conditionsconditions of use including duration and, of use including duration and, where applicable, putting into service, where applicable, putting into service, installation and maintenance requirements, installation and maintenance requirements,

• does not present any risk or only does not present any risk or only minimum risksminimum risks compatible and consistent compatible and consistent with a high level of protection for the safety with a high level of protection for the safety and health of personsand health of persons

CONCEPT OF SAFE PRODUCTCONCEPT OF SAFE PRODUCT

When determining whether the product is safe, When determining whether the product is safe, following shall be taken into account:following shall be taken into account:• the characteristics of the productthe characteristics of the product, including its , including its

composition, packaging, instructions for assembly andcomposition, packaging, instructions for assembly and for installation and maintenancefor installation and maintenance

• the effect on other productsthe effect on other products, where it is reasonably , where it is reasonably foreseeable that it will be use with other productsforeseeable that it will be use with other products

• the presentation of the productthe presentation of the product, the labelling, any , the labelling, any warnings and instructions for its use and disposal and warnings and instructions for its use and disposal and any other indication or information regarding the any other indication or information regarding the productproduct

• the categories of consumers at riskthe categories of consumers at risk when using the when using the product, in particular children and elderlyproduct, in particular children and elderly

CONCEPT OF SAFE PRODUCTCONCEPT OF SAFE PRODUCT

The feasibility of obtaining higher The feasibility of obtaining higher levels of safety or the availability of levels of safety or the availability of other products presenting a lesser other products presenting a lesser

degree of risk degree of risk shall not shall not constitute grounds for constitute grounds for consideringconsidering a product to be a product to be “dangerous”“dangerous”

ASSESSMENT OF SAFETYASSESSMENT OF SAFETY It is It is presumedpresumed that the product is safe when it that the product is safe when it

conforms to:conforms to:

• voluntary national standards transposing European standardsvoluntary national standards transposing European standards

If there are no such standards, the safety shall be assessed If there are no such standards, the safety shall be assessed by taking into account by taking into account

• standards drawn up istandards drawn up inn the MS the MS• Commission recommendations setting guidelines on product Commission recommendations setting guidelines on product

safety assessmentsafety assessment• product safety codes of good practice in force in the sector product safety codes of good practice in force in the sector

concernedconcerned• the state of the art and technologythe state of the art and technology• reasonable consumer expectations concerning safetyreasonable consumer expectations concerning safety

RESPOSIBLE PERSONSRESPOSIBLE PERSONS

ProducerProducer• manufacturermanufacturer and anyone presenting himself and anyone presenting himself

as the manufacturer by putting his name, trade as the manufacturer by putting his name, trade mark or other distinctive mark on the productmark or other distinctive mark on the product

• manufacturer’s representativemanufacturer’s representative, when the , when the manufacturer is not established within EUmanufacturer is not established within EU

• importerimporter if there is no representative if there is no representative established in the EUestablished in the EU

• other professionalsother professionals in the supply chain, in the supply chain, insofar as their activities may affect the safety insofar as their activities may affect the safety of the productof the product

OBLIGATIONS OF THE OBLIGATIONS OF THE PRODUCERPRODUCER

To place only safe products on the To place only safe products on the marketmarket

To inform consumers and other users on To inform consumers and other users on risks which the products might poserisks which the products might pose

To take appropriate action including, if To take appropriate action including, if necessary to avoid the risks, withdrawal necessary to avoid the risks, withdrawal from the market, adequately and from the market, adequately and effectively warning consumers or recall effectively warning consumers or recall from consumersfrom consumers• Recall shall be taken as a last resort, where Recall shall be taken as a last resort, where

other measures would not suffice to prevent other measures would not suffice to prevent the risksthe risks

OBLIGATIONS OF THE MSOBLIGATIONS OF THE MS

To insure that producers and To insure that producers and distributors comply with their safety distributors comply with their safety obligationsobligations

To nominate authorities competent To nominate authorities competent to monitor the compliance of to monitor the compliance of products with safety requirements products with safety requirements

To define tasks, powers, organisation To define tasks, powers, organisation and cooperation arrangements of the and cooperation arrangements of the competent authoritiescompetent authorities

ETITLEMENTS OF COMPETENT ETITLEMENTS OF COMPETENT AUTORITIESAUTORITIES

For any product:For any product:• to organise appropriate checks, even after product being to organise appropriate checks, even after product being

placed on the marketplaced on the market• to require all necessary informationto require all necessary information• to take samples of products and subject them to safety checksto take samples of products and subject them to safety checks

For any product which could pose the risk:For any product which could pose the risk:• to require that product be marketed with suitable warningsto require that product be marketed with suitable warnings• to make its marketing subject to prior conditionsto make its marketing subject to prior conditions

For any product that could be dangerous:For any product that could be dangerous:• to temporarily ban the supply, for the period needed for safety to temporarily ban the supply, for the period needed for safety

evaluations, checks and controlsevaluations, checks and controls For any dangerous product:For any dangerous product:

• to ban marketingto ban marketing• to order and organise withdrawal from the marketto order and organise withdrawal from the market• to order recall from consumers and the destruction of the to order recall from consumers and the destruction of the

productproduct

EXCHANGE OF INFORMATION EXCHANGE OF INFORMATION AND RAPID INTERVENTIONAND RAPID INTERVENTION

When a MS takes measures When a MS takes measures restricting placing on the market of restricting placing on the market of the products it shall notify other MSthe products it shall notify other MS

RAPEXRAPEX (Rapid alert system for (Rapid alert system for dangerous consumer products)dangerous consumer products)

http://ec.europa.eu/consumers/safety/rapex/alerts/main/index.cfm?event=main.listNotifications