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http://economie.fgov.be Maureen Logghe FPS Economy International Strategy Regulating the free movement of goods

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Page 1: Regulating the free movement of goods - EU FUNDS Funds Programmes/Other Programmes... · Technical specifications in harmonized standards ... Civil explosives 2014/28/EC Simple Pressure

http://economie.fgov.be

Maureen Logghe

FPS Economy

International Strategy

Regulating the free

movement of goods

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http://economie.fgov.be

Structure of this presentation

Hierarchy of legislation

Treaty of the functioning of the European Union

Mutual recognition

Old and New Appraoch

New Legislative framework

765/2008

Market Surveillance

Harmonized legislation

2001/95

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Hierarchy of legislation

Primary legislation

– Treaty

Secondary legislation

– Regulations

– Directives

– Decisions and recommendations

– …

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Hierarchy of legislation

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Treaty on the functioning of the European Union

Art 26 Internal market

The Union shall adopt measures with the aim of

establishing or ensuring the functioning of the

internal market, in accordance with the relevant

provisions of the Treaties

The internal market shall comprise an area

without internal frontiers in which the free

movement of goods, persons, services and

capital is ensured in accordance with the

provisions of the Treaties

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Treaty on the functioning of the European Union

Art 28 free movement of goods

The Union shall comprise a customs union which

shall cover all trade in goods and which shall

involve the prohibition between Member States

of customs duties on imports and exports and of

all charges having equivalent effect, and the

adoption of a common customs tariff in their

relations with third countries

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Treaty on the functioning of the European Union

Art 34-37 Quantitative restrictions

Quantitative restrictions on imports/exports and

all measures having equivalent effect shall be

prohibited between Member States

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Treaty on the functioning of the European Union

Art 114 approximation of laws

The European Parliament and the Council shall,

acting in accordance with the ordinary legislative

procedure and after consulting the Economic and

Social Committee, adopt the measures for the

approximation of the provisions laid down by law,

regulation or administrative action in Member

States which have as their object the establishment

and functioning of the internal market.

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Treaty on the functioning of the European Union

Art 114

The Commission, concerning health, safety,

environmental protection and consumer

protection, will take as a base a high level of

protection, taking account in particular of any

new development based on scientific facts.

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Treaty on the functioning of the European Union

Art 114

If, after the adoption of a harmonisation measure

a Member State deems it necessary to maintain

national provisions on grounds of major needs

referred to in Article 36, or relating to the

protection of the environment or the working

environment, it shall notify the Commission of

these provisions as well as the grounds for

maintaining them

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Treaty on the functioning of the European Union

Information =

http://bookshop.europa.eu/is-

bin/INTERSHOP.enfinity/WFS/EU-Bookshop-

Site/en_GB/-/EUR/ViewPublication-

Start?PublicationKey=NB3109160

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Mutual recognition

Basis =

Regulation 764/2008

Case law of the European Court of Justice

120/78 the ‘Cassis de Dijon’ case

Aim =

ensuring the free movement of goods within the internal

market

a Member State may not prohibit the sale on its territory

of products which are lawfully marketed in another

Member State, even where those products were

manufactured in accordance with technical rules different

from those to which domestic products are subject

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Mutual recognition

Mutual recongition =

applies to products which are not subject to

Community harmonisation legislation, or to aspects

of products falling outside the scope of such

legislation

http://ec.europa.eu/growth/single-

market/goods/free-movement-sectors/mutual-

recognition/products-list/index_en.htm

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Mutual recognition

Applies to administrative decisions addressed to

economic operators, on the basis of a technical

rule, in respect of any product lawfully marketed in

another Member State, where the direct or indirect

effect of that decision is the prohibition,

modification, additional testing or withdrawal of the

product

Any authority intending to take such a decision

must follow the procedural requirements set out in

the Regulation

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MUTUAL RECOGNITION FOR GOODS Next steps

Action Plan and revision of the Mutual Recognition Regulation

Inception impact assessment

Public consultation

Stakeholders event 17.06.2016

Revision of the Mutual Recognition Regulation

Evaluation of the Mutual Recognition Regulation

Impact assessment

Action plan

Revision of the Mutual Recognition Regulation

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Old approach

Old =

detailed texts containing all the necessary

technical and administrative requirements

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New approach

Principle of new approach:

Essential requirements

Technical specifications in harmonized

standards

– Presumption of conformity

– voluntary

Conformity assessment procedures

– Competence of 3rd parties - EN ISO/IEC 17000

– Notified bodies

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New legislative framework

New legislative framework:

Regulation (EC) No 765/2008

– Lex specialis

Decision No 768/2008/EC

– sui generis

– Toolbox for new legislation

[Regulation (EC) No 764/2008]

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New legislative framework

REGULATION 765/2008

• Accreditation

• Market surveillance

- Internal

- Imported products

- General principles

• Financing elements

DECISION 768/2008

• Definitions/obligations

for economic operators

• Notified bodies

• Conformity assessment

procedures

• Safeguard mechanisms

• Marking

http://ec.europa.eu/growth/single-market/goods/new-

legislative-framework/index_en.htm

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New legislative framework

Harmonization legislation =

is designed to ensure free movement of products

that comply with the high level of protection laid

down in the applicable legislation

Tool =

Free movement clause in harmonization

legislation

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http://economie.fgov.be

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General information - directives aligned with 768/2008

Toys 2009/48/EC

RoHS 2 2011/65/EC

Pyrotechnic Articles

2013/29/EC

Recreational crafts and per-

sonal watercraft 2013/53/EC

Radio Equipment 2014/53/EC

Pressure Equipment

2014/68/EC

Marine Equipment 2014/90/EC

Civil explosives 2014/28/EC

Simple Pressure Vessels

2014/29/EC

EMC 2014/30/EC

Non-automatic weighing

instruments 2014/31/EC

Measuring Instruments 2014/32/EC

Lifts Directive 2014/33/EC

ATEX Directive 2014/34/EC

Low Voltage 2014/35/EC

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Focus on Regulation (EC) No 765/2008

Chapter I General provisions

Chapter II Accreditation

Chapter III Community market surveillance framework and controls of products entering the community market

Chapter IV CE marking

Chapter VI Final provisions

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Chapter III

SECTION 1 General provisions (Art. 15-16)

SECTION 2 Community market surveillance

framework (Art. 17-26)

SECTION 3 Controls of products entering

the Community market (Art. 27-

29)

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General provision - scope 765/2008

- products covered by Community

harmonisation legislation

- in so far as there are no specific

provisions with the same objective in

Community harmonisation legislation

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scope 765/2008

Scope

non-food and non-agricultural products

industrial products

products whether for use by consumers or

professionals

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Excluded from the scope: Food and Feed

Regulation (EC) No 178/2002 laying down the

general principles and requirements of food law

(General Food Law Regulation).

Information =

http://ec.europa.eu/food/safety/general_food_la

w/index_en.htm

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scope 765/2008

Regulation 765/2008 shall not prevent MSA

from taking more specific measures as

provided for in Directive 2001/95/EC

(GPSD)

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http://economie.fgov.be

Regulation 765/2008 : requirements market surveillance

communicating

existence, responsibilities and contact details of

national market surveillance authorities

annual market surveillance programme

• to other Member States and the Commission

• available to the public

– a better cooperation between authorities

– a higher level of transparency

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http://economie.fgov.be

national market surveillance programme is available on website FPS Economy

• listing of all market surveillance authorities

• announcing planning for market surveillance (annual)

http://economie.fgov.be/fr/spf/Matrice_strategique/programme_national_surveillance_marche/

BELGIUM

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periodically review and assess the functioning of

their surveillance activities

– detect problems early and make changes faster

– detect good practices

– learn from each other

available to the public

Regulation 765/2008 : requirements market surveillance

review and self-assessment

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establish adequate procedures to follow up

scientific and technical knowledge concerning

safety issues

– impossible to follow up for all sectors and all possible

safety issues in case of small MS

– sharing knowledge between MS?

– “buy” knowledge from laboratories and research

institutes?

Regulation 765/2008 : requirements market surveillance

knowledge

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assistance for market surveillance on an adequate

scale (bilateral cooperation)

– economic operators which do not cooperate can be

forced to cooperate via their “home authority”

– linguistic difficulties

– interesting for small MS

Regulation 765/2008 : requirements market surveillance

cooperation between MS

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appropriate checks on the characteristics of products

by Customs on an adequate scale

– efficient controls at the border stop non conforming

products to enter the community market

– the earlier in the supply chain a non conforming product is

stopped, the easier and the more efficient

Regulation 765/2008 : requirements market surveillance

Customs

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before this regulation: market surveillance was only

a few lines in each directive

now: market surveillance is a theme as such with a

high visibility

transparency on market surveillance activities will

put pressure on less active MS

think “national” think “Europe”

cooperation and exchange of information between

authorities are the key to success

Regulation 765/2008 : requirements market surveillance

Conclusions

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Evolution in practical difficulties

for market surveillance authorities

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15 to 10 years ago

most products were not accompanied by test reports

– results of tests by market surveillance authorities were not

contested

– easy for market surveillance authorities to convince the

economic operators to take corrective actions

– market surveillance through visual inspection and

requesting test reports

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nowadays (1)

importers and distributors (chain stores) ask

manufacturers more often for test reports

test reports exist, but the products do not pass the

test carried out by / for market surveillance

authorities

difficult to convince an importer or distributor that there

is a problem

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causes: • only partial tests have been carried out

• test reports correspond to other products

• poor production quality

• interpretation of the standards differ between laboratories – Which one is right ?

– Can we accept both interpretations ?

market surveillance authorities need more (technical)

knowledge on a higher level

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nowadays (2)

Market surveillance authorities have to deal with the

information (over)flow

f. e. : the “explosion” of RAPEX notifications

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issues :

– market surveillance authorities have to deal with a mass

of information on non compliant products

– market surveillance authorities need more (technical)

knowledge

solutions :

– market surveillance authorities have more obligations

and better tools

– cooperation and exchange of information between

authorities on a European level

conclusions

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market surveillance authorities cooperate in Joint

Actions and Rapid Advice Forum (coordinated by

Prosafe)

AdCo-meetings (Administrative Cooperation): exchange

of information, views & interpretations, discussions …

Ad hoc bilateral cooperation between market

surveillance authorities (directly or via ICSMS) ~ ‘home

authority principle’

risk assessment tool : New RAPEX Guidelines

conclusions – todays best practices

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Market surveillance – EU cooperation

http://economie.fgov.be

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Administrative co-operation between the authorities of the

Member States in ‘AdCo’-groups

Exchange of information on risk assessment, dangerous

products, test methods,....

Establishments and execution of joint surveillance and

testing projects

Exchange of expertise in training activities

Co-operation with regard to the tracing, withdrawal and

recall of dangerous products

Market Surveillance - EU Co-operation

http://economie.fgov.be

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CIRCABC

Communication and Information Resource Centre

Administrator (CIRCA)

Formal network

It is mainly a database administrated by the European

Commission

There are also restricted areas within the database and

can be accessed by authorised officials only

Market Surveillance - EU Co-operation - Networks

http://economie.fgov.be

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Europe Network Formal : CIRCABC

Market Surveillance - EU Co-operation

http://economie.fgov.be

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Market Surveillance - EU Co-operation - Networks

ICSMS : Internet Supported Information and Communications System for Market Surveillance

http://economie.fgov.be

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Market Surveillance - EU Co-operation - Networks

Rapid Alert System for dangerous non-food products

http://economie.fgov.be

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Market Surveillance - EU Co-operation - Networks

PROSAFE

http://economie.fgov.be

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http://economie.fgov.be

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Belgian participation PROSAFE Joint Actions (JA)

JA 2008 cords & drawstrings

JA 2008 & 2009 sunbeds & solarium services

JA 2009 child appealing appliances

JA 2010 visibility clothing & accessories

JA 2010 ladders

JA 2011 fireworks

JA 2012 toys, high chairs

JA 2013 cots, steps

JA 2014 fireworks II, acoustic toys, safety barriers

JA 2015 plasticized toys, soothers & soother holders,

playground safety, power tools II …

… to be continued …

http://economie.fgov.be

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Belgian participation PROSAFE

Horizontal topics: – risk assessment

– home authority principle

– E-learning (f.e. toys)

– Rapid Advice Forum

http://economie.fgov.be

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Belgian Customs and Market

surveillance 55

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56

Main legislation:

• Regulation (EEC) No 2913/92 (Community Customs Code) and Regulation (EEC) No 2454/93 (Implementing provisions to Community Customs Code)

• Regulation (EC) No 765/2008, setting out the requirements for

accreditation and market surveillance relating to the marketing of products

More information: http://ec.europa.eu/taxation_customs/resources/documents/common/publications/info_docs/customs/product_safety/guidelines_en.pdf

I) Legal base

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Main missions:

* Administer and watch the border of the EU in order to:

– ensure security EU citizens

– protect financial interests (EU, Member States)

– protect EU economy >< unfair & illegal trade + promote legal economic activity

– trade facilitation

II) Overall situation: large number of missions of C&E

administration

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STEP1: Priority

Decided during common meetings C&E / MSA

Principle:

•MSA = stakeholder owner of the priority (decides)

•C&E takes part to the decision (inputs used by C&E: control capacity, customs statistical, hits, feedback of the controls via checklists)

STEP2: Analysis

Is made together with STEP 1 (during the common meetings)

Based on “likelihood” and “impact”. Likelihood = evaluation of the probabilities that it happens. Impact = evaluation of the consequences.

III) Description of the process

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STEP3: Profiling

Decided during common meetings C&E / MSA

Principle:

Information sheet (if exist) for the product in the EU guidelines

+ Information on the product (available in the MSA)

+ Information on the movement of the product (cross-border; C&E)

Elements for the profiling

E.g.: information sheet on skates, roller skates, online skates, skateboards, scooters and toy bicycles for children: NC codes = 95030010, 95067030, 95069990, 87120030 (A3)

N.B: other elements in the information sheets are more relevant for the controls by C&E (check lists) & by the MSA

III) Description of the process

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Targeting & selection for PLDA declarations

1) Lodging of the declaration

2) Automatic system of selection (risk assessment)

3) Refining of the selection (by the CRC)

60

III) Description of the process

Customs broker declaration

PLDA server

( validation tests inside the system, MRN, …)

Green Orange Red

control

Release (no control)

Filter (SEDA)

Final assessment (selection team)

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61

STEP6: Control by C&E administration

• Control required: • physical check (always, sometimes scanning) >< documentary checks

• Control modalities, measures to be taken: • instructions for controls: in selection instrument & in checklist (if any)

• Name of a contact person (or a contact department) in the competent authority (e.g.: environmental authorities, MSA)

• Feedback of the controls: direct link with the reasons of the control (ref. selection profile)

Results of the control: acceptance, refusal or suspension

IV) Description of the process

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Control by the customs

1) Control of the products / documents

2) Relaase or contact with MSA

62

III) Description of the process

Control (based on check list or instructions in the SPS record)

OK Not OK

Contact MSA for a control

Release (no control by MSA)

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63

STEP7: Control by MSA

(See other presentations)

STEP8: Results of the controls, consequences & feedback

Once control performed => results are communicated to C&E administration

Consequences:

Consignment (decision of MSA):

if conform release for free circulation authorised

If NOT decision of modification of the goods in appropriate

manner, destruction of the goods, render them inoperable,…

Future selections: depending on the results = adaptation (or not) of priorities and profiling

III) Description of the process

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When does union harmonization legislation apply?

when the product is placed on the market and to

any subsequent operation which constitutes

making available until it reaches the end-user.

to all forms of selling

to newly manufactured products but also to used

and second-hand products imported from a third

country when they enter the Union market for the

first time

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When does union harmonization legislation apply?

Making available and placing on the market

– A product is made available on the market when

supplied for distribution, consumption or use on the

Union market in the course of a commercial activity,

whether in return for payment or free of charge.

– The concept of making available refers to each

individual product.

– A product is placed on the market when it is made

available for the first time on the Union market.

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When does union harmonization legislation apply?

Putting into service

– Putting into service takes place at the moment of first

use within the Union by the end user for the purposes

for which it was intended.

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When does union harmonization legislation apply?

Simultaneous application

– Essential and other requirements laid down in Union

harmonisation legislation may overlap or complement

each other, depending on the hazards covered by

these requirements that are related to the product in

question.

– The making available or putting into service can only

take place when the product complies with the

provisions of all applicable Union harmonisation

legislation at the time of its placing on the market.

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When does union harmonization legislation apply?

Intended use/misuse

– Intended use means either the use for which a

product is intended in accordance with the information

provided by the person placing it on the market, or the

ordinary use as determined by the design and

construction of the product.

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When does union harmonization legislation apply?

Geographical application

– the Member States of the EU and to certain European

territories to the extent necessary to give effect to the

arrangements set out in the Accession Treaty of the

relevant Member States.

– The Agreement on the European Economic Area is

established between the European Union and

Iceland, Liechtenstein and Norway – EEA EFTA

– The Customs Union Agreement between the EU and

Turkey aims to ensure the free movement of products

between the EU and Turkey

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General product safety directive

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GPSD Chapter I

Objective – Scope – Definitions

Article 1

− To ensure that products placed on the

market are safe

To which products does it apply?

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Article 1 Objective – Scope (cont´d)

− Applies to all new and second hand

products for consumers (for personal use)

− Applies also to products that have

migrated from professional to consumer

user, either through

- the distribution of new products or

- resale of second-hand products

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Article 1 Objective – Scope (cont´d)

− Products include all goods placed on the

market, including during the provision of

a service

− “Supply” includes selling, leasing, hiring,

lending and part exchanging

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Article 1 Objective – Scope (cont´d)

Does not apply to products

− for use in the workplace by employees or

− for those which are to be exported

outside the EU

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Article 1 Objective – Scope (cont´d)

Where safety related requirements for a

product are dealt with by other directives

(such as CE marking directives), their

requirements shall take precedence over the

corresponding GPSD requirements.

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Article 1 Objective – Scope (cont´d)

What is safe product?

It is a product which poses

- no threat or only a reduced threat in

accordance with the nature of its use and

- which is acceptable in view of maintaining

a high level of protection

for the health and safety of persons

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Reg 765/2008 vs GPSD 2001/95/EC

GPSD set up RAPEX

– Extended by 765/2008 to harmonized industrial products

and all risks

GPSD foresees temporary decisions

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Reg 765/2008 vs General product safety directive

2001/95/EC

http://ec.europa.eu/consumers/archive/safety/prod_legis/docs/20100324_guidance_gspd_reg_en.pdf

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http://economie.fgov.be

EC = European Commisison

FPS = Federal Public Service

TFEU = treaty on the functioning of the European

Union

Abbreviations

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http://economie.fgov.be

Interesting link

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Market surveillance in Belgium http://economie.fgov.be

Consolidated legislation

Interpretation on legislation

Reports on market surveillance campaigns

Interesting documents

economie.fgov.be/veiligheid

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Market surveillance in Belgium http://economie.fgov.be

Maureen Logghe

Office of the President

International strategy

City Atrium C

Vooruitgangstraat 50

1210 Brussel

T +32 (0) 2 277 87 96

[email protected]

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http://economie.fgov.be

Questions?

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http://economie.fgov.be

Thanks for your attention !