new approach directives

OFFICE OF COMPETITION AND CONSUMER PROTECTION
POLISH ENTERPRISE
IN THE EUROPEAN UNION
Products subject to conformity
assessment and CE marking
WARSAW 2005
Publication financed with the support from European Union under
PHARE project PL2002/000-605.02.01 “Market Surveillance – Technical
Assistance, Lot 1: New Approach Directives”
OFFICE OF COMPETITION AND CONSUMER PROTECTION
pl. Powstańców Warszawy 1
00-950 Warsaw
ph. (+48 22) 55 60 800
e-mail: [email protected]
www.uokik.gov.pl
© Copyright by Office of Competition and Consumer Protection
Warsaw 2005
ISBN 83-60257-02-7
Volume 1500
Project Consultant:
13, Mazowiecka Str., 00-052 Warsaw
ph. (+48 22) 826 10 47, 827 07 72
fax. (+48 22) 826 69 91
e-mail: [email protected]
www.twigger.medianet.pl
The contents of this publication is the sole responsibility of Office of Competition
and Consumer Protection and can in no way be taken to reflect the views of the
European Union.
NOTE
This publication provides an overall review and it discusses only key
elements of New Approach directives and their transposition into
the Polish legislation. Yet it should be noted that it neither informs
about all requirements for products and all manufacturer obligations
related to conformity assessment, nor it thoroughly discusses the
New Approach directives-related market surveillance organisation.
Addressing all these details and options in such concise text is
impossible because of the large number of New Approach directives
and the variety of diverse product aspects.
Therefore this brochure can serve as auxiliary material only. For
effective dealing with practical issues some familiarisation with the
relevant legal acts may be necessary.
All references to the legal acts in this publication are as of
August 1, 2005.
TABLE OF CONTENTS
What is the new and global approach? ..................................................... 7
New approach directives – what issues
do they regulate?........................................................................................... 9
Basic definitions used in new approach directives.............................. 10
Placing on the market and putting into service ......................................................... 10
Manufacturer ..................................................................................................................................... 11
Authorised representative ..........................................................................................................12
Importer .................................................................................................................................................12
Distributor .............................................................................................................................................13
User / employer .................................................................................................................................14
Conformity assessment – how product conformity
with essential requirements is verified ................................................... 15
Marking products covered by new approach directives ..................... 19
Role of CE marking ..........................................................................................................................19
Affixing of CE marking...................................................................................................................20
Market surveillance and control of product conformity with essential
requirements ................................................................................................ 21
Product control ..................................................................................................................................22
Annex. Polish legal acts implementing new approach
Directives covered by the occp monitoring system ............................. 24
POLISH ENTERPRISE IN THE EUROPEAN UNION
WHAT IS THE NEW AND GLOBAL APPROACH?
Development of a single market for goods and services within the
European Union is one of the European integration’s major achievements. One of the basic obstacles to free movement of goods are technical standards – they represent a barrier to trade since standards
effective in various countries differ between themselves. Manufacturers must therefore adjust their products to each country specific
requirements. It was quite common in the past that even in the EU
products were manufactured in a few dozen variants, each destined
for different market, which – of course – generated extra costs and
hindered the products free circulation.
In the initial phase of elimination of obstacles to Community trade
an emphasis was laid on setting Community-wide requirements for
products (which is today referred to as the “old approach” to technical harmonisation), and on the rule of mutual recognition, which assumes the right for free circulation throughout the single market of
any product that meets legal requirements and standards of the country of its manufacturing and has been legally placed on that market.
In the 1980 the effects of the harmonisation process were assessed
and a change in the approach to the removal of technical barriers decided upon. A so called “new approach” to the technical harmonisation was then adopted. The rule that a product may be placed on
the market only when and if it meets essential requirements provided
for in certain directives (so called “New Approach directives”) is a basic principle of new approach. On the other hand any product that is
compliant with the directives might be sold at any and all EU markets.
Applying of the technical standards remained voluntary, and a manufacturer is vested with the right to apply any technical solution as far as
a product meets the essential requirements provided for in the directives.
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OFFICE OF COMPETITION AND CONSUMER PROTECTION
Setting up uniform conditions of a credible assessment of product
conformity with the essential requirements was a significant element
of the barrier removal within the EU. The so called “global approach
to conformity assessment” defines main elements of testing and certification, rules of appointing bodies that participate in conformity
assessment procedure, as well as unifies rules of affixing and applying
of CE marking. In most cases New Approach directives also take into
account rules of the global approach to conformity assessment.
The New and Global Approach rules apply to some sectors of
economy only. The industries to which some common detailed requirements had applied prior to the New Approach adoption and
mutual recognition was in place, or where experts were unable to
identify all product-related risks are excluded. The New and Global Approach does not concern, for instance, food, chemicals (also
cosmetics), medicines, and cars. Despite the small number of New
Approach directives (over 20), products thereby covered account for
a large number of all commodities offered on the market. The European Commission experts estimate the annual sales of the products
covered by New Approach directives at over EUR 1.5 billion.
This publication, mainly due to the Polish legal conditions1, refers
only to those directives that at the same time include elements of both
concepts: the New Approach to technical harmonisation and the Global Approach to conformity assessment, for simplicity’s sake they are
called the “New Approach directives”. There are 26 such directives as of
now. Because of specific provisions of the three directives on medical
devices2 (they are transposed into the Polish law differently than the directives implemented by the Conformity Assessment Act3) they are not
discussed in this booklet in order to avoid description of many distinct
features specific to these provisions. A complete list of the directives
referred to in this publication is presented in the Annex.
1
Pursuant to Article 3a of the Conformity Assessment Act, the control system
provided for in the Act covers compliance with the essential requirements of the
New Approach directives only, the notion of “Global Approach directives” does not
appear at all in Conformity Assessment Act.
2
Directive 90/385 on active implantable medical devices (implants), Directive
93/42 on medical devices, Directive 98/79 on in vitro diagnostic medical devices.
3
The August 30, 2002 Act (J. of L. 2004 No 204, Item 2087 and 2005 No 64, Item
565), hereinafter referred to as the “Conformity Assessment Act”.
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POLISH ENTERPRISE IN THE EUROPEAN UNION
NEW APPROACH DIRECTIVES – WHAT ISSUES DO
THEY REGULATE?
New Approach directives refer either to a product group (such as toys,
machines, elevators) or to a type of risk and/or phenomenon (noise
emission, electromagnetic compatibility). Therefore a product may be
covered by several directives – in such situation it must meet requirements provided for in all relevant directives. A manufacturer, while
analysing product features and the risks thereby posed, must assess
whether the product falls into the scope of one directive, or several
directives.
In the European Union directives do not bind directly – the Member States are obliged to transpose them into their respective national
legislations. In Poland the most important legal act in this regard is
the Conformity Assessment Act which identifies the system basis,
whereas the essential requirements provided for in each directive are
specified in regulations issued on the basis of the Conformity Assessment Act and some other Acts (including the acts on construction
products, explosives for civil uses, marine equipment, railway transport, etc.). No provisions of the Conformity Assessment Act apply to
medical devices, food products and animal feed.
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OFFICE OF COMPETITION AND CONSUMER PROTECTION
BASIC DEFINITIONS USED IN NEW APPROACH
DIRECTIVES
Placing on the market and putting into service
In the European Commission opinion presented in the Guide4, placing on the market shall be deemed effective once a product is made
available at the Community market for the first time. This is considered to take place when a product after its manufacture is transferred
or offered for transfer with the intention of distribution or use on
the Community market. This covers either a physical handover of
a product or a transfer of its ownership rights. “Placing on the market” refers to each individual product, not to a type product, and
whether it was manufactured as an individual unit (on a one – off
basis) or in series. A product may be made available for payment or
free of charge, by means of a variety of legal actions such as sale, loan,
rent, lease, or gift.
Most New Approach directives differentiate between “placing on
the market” and “putting into service”, which is considered using the
product in the Community for the first time.
Most products have been placed on the market before putting
them into service – their conformity must be assessed prior to placing
them on the market. Yet some products have not been placed on the
Guide to implementation of directives based on the New Approach and the Global
Approach – the original version drawn up by the European Commission and
published in 2000 in Luxembourg by The Office for Official Publications of the
European Communities, available in electronic format on www.europa.eu.int/
comm/enterprise/newapproach/newapproach.htm (hereinafter referred to as the
Guide).
4
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POLISH ENTERPRISE IN THE EUROPEAN UNION
market – such as those manufactured on a customer order and delivered to the customer directly by the manufacturer – in such circumstances the directives require that their conformity is assessed prior to
putting them into service.
In the Polish Act on Conformity Assessment the definitions of
“placing on the market” and “putting into service” are combined and,
pursuant to the Article 5 Point 2, there is only one term used – “placing on the market”, which means transfer of a product for the first
time to the user, consumer, or distributor by the manufacturer, his
authorised representative, or importer. Therefore this definition covers product delivery to a distributor (thus the product is placed on
the market) as well as its handover to an user (and then the product
may not be placed on the market but it is directly transferred from its
manufacturer to its user – thus it is put into service).
Manufacturer
Most New Approach directives do not define “manufacturer”, even
if the manufacturer is responsible for product conformity with essential requirements. The European Commission Guide explains that
manufacturer is any natural or legal person, who has designed and
manufactured a product with a view to placing it on the European
Union market under his own name or brand. When subcontractors
are hired, a manufacturer should retain control over the product, as
the manufacturer is the only one responsible for the conformity assessment of the product. Subcontracting of the entire work or any
part thereof does not release a manufacturer from responsibility for
the product.
The directives provide for different scopes and types of manufacturer responsibilities. These depend mainly on product-specific
risks. In some cases manufacturer himself may carry out a conformity assessment procedure, in other cases a third party (notified body)
controls product or manufacturing process. It is also a manufacturer’s
obligation to issue a declaration of conformity, to develop technical
documentation of the product, and to attach specific information or
documents to the product.
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OFFICE OF COMPETITION AND CONSUMER PROTECTION
Most New Approach directives provide for a requirement to mark
product with its manufacturer’s name.
Authorised representative
An authorised representative is a person established in the European
Union, appointed by a manufacturer to act on the manufacturer’s behalf in carrying out conformity assessment. An authorised representative ensures (instead of the manufacturer) that the product meets
essential requirements – for instance, affixes the CE marking to the
product, draws up EC declaration of conformity, as well as keeps it
on file. Transfer of manufacturer tasks to an authorised representative
must be done in writing and should identify the scope of the tasks and
rights transferred.
An authorised representative performs tasks in relation with
product conformity assessment and cannot be confused with other
entities that represent the manufacturer – for instance with legal
counsellor, trade representative, or exclusive distributor.
An authorised representative is defined by Article 5 Point 5 of the
Conformity Assessment Act and this definition corresponds to the
meaning of the term provided for in New Approach directives.
Importer
An importer is a person that places a product on the Community
customs area. A feature that differentiates importer from an authorised representative is that importer has not been appointed by
a manufacturer to act on the manufacturer’s behalf – and as such is
not authorised to carry out conformity assessment procedures in lieu
thereof.
The Conformity Assessment Act does not define the importer.
However importer is mentioned in Article 5 Point 2 in the context
of “placing on the market”. Pursuant to this provision first transfer of
a product to a user, consumer, or distributor by an importer equals
placing the product on the market. Therefore importer shall be held
responsible if he has placed on the market a product that does not
meet essential requirements. It should be however underlined that,
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POLISH ENTERPRISE IN THE EUROPEAN UNION
as a rule, importer can not individually (without the manufacturer’s
authorisation) perform any conformity assessment activity (affix the
CE marking, or issue EC declaration of conformity, in particular).
However some directives (e.g. the Machinery Directive) provide for
exceptions to this rule.
Distributor
A distributor is to be considered as any natural or legal person in
the supply chain, who takes subsequent commercial actions after the
product has been placed on the European Union market.
No special obligations are imposed on distributors by New Approach directives. Accordingly, the Polish Act on Conformity Assessment only orders a distributor to co-operate with market surveillance
authorities to an extent necessary to establish whether the product
meets essential requirements.
A distributor cannot be obliged to make EC declaration of conformity and/or technical documentation available, unless he acts
as the authorised representative at the same time. Yet a distributor
should, within the framework of co-operation with market surveillance authorities, identify the manufacturer, importer, or person, who
has delivered the product to the distributor. It happens in practice
that distributor keeps copies of conformity assessment documents
(e.g. EC declaration of conformity) or is able to get hold of such documents easily, owing to which the market surveillance authority may
quickly and effectively verify whether the product complies with essential requirements.
Distributor is not responsible for product, still the distributor should have basic knowledge of legal requirements concerning
the products that he trades in – the distributor should know which
products are subject to the CE marking, what information should be
thereto attached, in which language the user manual should be drawn
up, etc. Distributor cannot sell any product that he identifies or supposes to identify as non-compliant with effective legal regulations.
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OFFICE OF COMPETITION AND CONSUMER PROTECTION
User / employer
There are two categories of users of products covered by New Approach directives: consumers, who use products for their own needs,
and employers, who supply workplaces with products, for which essential requirements have been determined. In most cases a consumer may at his own risk and responsibility buy a product that does not
meet essential requirements – for instance may bring from outside
the European Union a refrigerator or an iron, at manufacturing of
which the Community requirements have been neglected. An exception is a case, when some provisions other than New Approach directives provide for rules of the products usage (e.g. yacht registration
regulations that require compliance with the directive). However, employers do not enjoy such “liberty” at purchasing products, as they are
obliged to ensure that all products used at the workplace (both appliances and personal protective equipment provided by the employer)
are essential requirement-compliant. Yet the employer obligations
with regard to conformity with requirements of the products used by
the employees are not provided for in New Approach directives but in
labour law provisions or regulations on work safety and hygiene.
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POLISH ENTERPRISE IN THE EUROPEAN UNION
CONFORMITY ASSESSMENT – HOW PRODUCT
CONFORMITY WITH ESSENTIAL REQUIREMENTS
IS VERIFIED
It is the manufacturer obligation to ensure that products thereby
manufactured comply with the requirements determined in New Approach directives. The requirements concern the risk that products
may pose because of their features. Some also concern the materials,
of which a product should be manufactured and its engineering mode
and manufacturing process. The directives often specify examples of
the risks that may be posed by some specific types of product to enable the manufacturer to eliminate them.
Essential requirements are mandatory, yet their format is specific
– they indicate the purpose to be achieved by the product manufacture but they include no detailed engineering or technological solutions to be applied in its designing and/or manufacturing. Therefore
a manufacturer may choose how to meet the essential requirements
determined in the relevant directive.
While designing and/or manufacturing a product the manufacturer may voluntarily use harmonised standards developed by
European standardisation bodies, application of which establishes
a presumption of conformity with the directives to the extent of the
standard scope. Harmonised standards specify detailed and concrete
engineering solutions or parameters that a product or a raw material used to manufacture the product must meet. Standards, however, do not always regulate all product-related aspects: for instance
a standard may determine only flammability-related requirements,
so another standard has to be applied with respect to mechanical resistance. However, applying harmonised standards is not mandatory
15
OFFICE OF COMPETITION AND CONSUMER PROTECTION
– a manufacturer may himself develop technical solutions to ensure
the product conformity with the requirements of the directive.
Applying harmonised standard provides a product with a presumption of its conformity with the provisions of the directive, but
it does not prevent an inspection of the product or even calling into
question product conformity by a market surveillance authority. Neither it releases the manufacturer from responsibility for the product
and/or damages caused by its use.
Each New Approach directive specifies details of assessment of
product conformity with essential requirements. Conformity assessment procedures are called “modules”. There are eight basic modules
(marked with letters from A to H) and their eight variants and combinations: Aa 1, Aa 2, C bis 1, C bis 2, D bis, E bis, F bis, H bis).
Basic conformity assessment procedures
Module
A
B
C
D
16
Conformity assessment procedure
Internal production control. This module does not require
a notified body to take action.
EC type-examination.
This module is not executed alone – it must be followed
by a module providing for assessment in the production
phase. A notified body participates in the examination
and issues the EC-type examination certificate.
Conformity to type.
Follows module B. Used in order to ensure product conformity to the type as described in the EC-type examination certificate issued according to module B. Module C
does not require a notified body to take action.
Production quality assurance.
Follows module B. Derives from quality assurance standard EN ISO 9002 with the intervention of a notified body
responsible for approving and controlling the quality system for production, final product inspection and testing
set up by the manufacturer.
POLISH ENTERPRISE IN THE EUROPEAN UNION
E
Product quality assurance.
Follows module B. Derives from quality assurance standard EN ISO 9003, with the intervention of a notified body
responsible for approving and controlling the quality system for final product inspection and testing set up by the
manufacturer.
F
Product verification.
Follows module B. A notified body controls conformity to
the type as described in the EC type-examination certificate issued according to module B, and issues a certificate
of conformity.
G
Unit verification.
Each individual product is examined by a notified body,
which issues a certificate of conformity.
H
Full quality assurance.
Derives from quality assurance standard EN ISO 9001,
with the intervention of a notified body responsible for
approving and controlling the quality system for design,
manufacture, final product inspection and testing set up
by the manufacturer.
Another manufacturer obligation is to draw up technical documentation that includes test results and data confirming the product conformity to the relevant requirements. It should be kept on file for ten
years since the date of the last product manufacture (some directives
provide for shorter periods). Technical documentation should be
drawn up in one of the European Union’s official languages5 – the
document types and details that should be referred to therein are provided for in the relevant directives. Each piece of technical documentation, however, should include details of the product design, manufacture, and operation of the product.
In Poland authority responsible for inspection may request for translation into
Polish of any document drawn up in a foreign language.
5
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OFFICE OF COMPETITION AND CONSUMER PROTECTION
Moreover, manufacturer (or his authorised representative) is also
obliged to draw up EC declaration of conformity (with exception of
the Toy Safety Directive 88/378/EEC). It is hence declared that the
product conforms to essential requirements. The document should
indicate details sufficient to identify:
• product,
• relevant directive,
• manufacturer,
• notified body, if involved in conformity assessment procedure,
• harmonised standards and other documents referred to in conformity assessment procedure.
Details of the information which should be part of EC declaration
of conformity are provided for in the relevant New Approach directives.
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POLISH ENTERPRISE IN THE EUROPEAN UNION
MARKING PRODUCTS COVERED BY NEW
APPROACH DIRECTIVES
Role of CE marking
The CE marking is manufacturer’s declaration that the product has
been subject to conformity assessment procedure and meets essential
requirements. No product which should be CE marked – as it is required under most New Approach directives – can be placed on the
market without it. The CE marking format is strictly specified by the
relevant directives:
The following three directives do not require CE marking to be
affixed: Directive 94/62/EC on packaging and packaging waste and
two directives on interoperability of trans-European rail system:
96/48/EC and 2001/16/EC, whereas Directive 96/98/EC on marine
equipment provides for another marking which is affixed subject to
the same rules and for the same purpose, i.e. as an evidence of product conformity to the essential requirements:
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OFFICE OF COMPETITION AND CONSUMER PROTECTION
Marine equipment conformity marking
Affixing of conformity marking is mandatory with respect to
all products, which are so required by the relevant directives; while
it is prohibited to affix it to any product that is not subject to New
Approach directives, as no essential requirements were established
for it.
Affixing of CE marking
The CE marking may be affixed to product or a plate attached thereto,
such as a brand or data plate. Only exceptionally, and because of technical reasons, another location may be permitted, such as packaging
or documents attached to product. CE marking may be neither omitted nor moved on aesthetic grounds, for example.
The CE marking must be affixed visibly (5 mm minimum height,
although there are some exceptions to this rule) and legibly (easily
accessible, apparent and indelible).
It should be remembered that CE marking confirms product conformity to essential requirements provided for by New Approach directives and it is irrelevant to the product origin or quality.
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POLISH ENTERPRISE IN THE EUROPEAN UNION
MARKET SURVEILLANCE AND CONTROL OF
PRODUCT CONFORMITY WITH ESSENTIAL
REQUIREMENTS
Inspection of products that are subject to conformity assessment procedure is an issue of particular importance for users of products that
may pose a threat to human health and life, as well as property, or
the environment. Market surveillance protects not only interests of
product users, but also those of manufacturers, by levelling off market conditions for everybody. An effective inspection system prohibits unfair businesses from “savings” on product safety or conformity
assessment related tests.
Market surveillance acts pursuant to the proportionality rule. It
assumes that any action undertaken should be adequate to the type of
the risk posed by product or whether product non-compliance with
essential requirements is substantial or not. No means exceeding what
is necessary to ensure public health and safety may be applied.
The Polish system of market surveillance for products subject to
conformity assessment procedures consists of the President of the
OCCP (Office of Competition and Consumer Protection [= Urząd
Ochrony Konkurencji i Konsumentów], who monitors the entire system operation, and of the following specialised authorities (inspectorates):
• Trade Inspection [= Inspekcja Handlowa],
• The National Labour Inspectorate [= Państwowa Inspekcja
Pracy],
• Environmental Protection Inspectorate [= Inspekcja Ochrony
Środowiska],
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OFFICE OF COMPETITION AND CONSUMER PROTECTION
• Railway Transport Bureau [= Urząd Transportu Kolejowego],
• Office of Telecommunications and Post Regulation [= Urząd Regulacji Telekomunikacji i Poczty,
• State Mining Authority [= Wyższy Urząd Górniczy],
• Maritime Offices [= Urzędy Morskie],
• construction surveillance authorities [= organy nadzoru budowlanego],
as well as customs authorities that co-operate with all inspectorates
and help to detect and disable import from third (non-EU) countries
of product that is non-compliant with essential requirements.
The task of the inspectorates is to control whether product that
is placed on the market complies with essential requirements, and to
adopt measures against non-compliant product. The President of the
OCCP is responsible for the proper performance of the whole system.
Product control
Subject to control may be a product, product marking, and technical documentation. EC declaration of conformity is a document of
utmost importance for market surveillance authorities.
When inspection findings indicate product non-compliance with
essential requirements, a specialised authority shall take administrative proceeding. The proceeding should not last over four months.
In the course of such proceeding the relevant inspectorate may allow
the non-compliance to be eliminated voluntarily by the person responsible for the product. Only when such person fails to co-operate,
statutory enforcement measure may be implemented. A specialised
authority may:
• order product withdrawal from the market, as well as its recall
from users,
• limit or prohibit further product transfer to users, consumers, and
distributors,
• order to inform consumers or users of the product about noncompliance discovered (specifying date and manner of such information),
• order product destruction.
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POLISH ENTERPRISE IN THE EUROPEAN UNION
The measure is chosen depending on type of the product noncompliance with essential requirements and risks thereby posed (proportionality rule).
Any decision to implement a measure, and the name of the product subject thereto, are entered to a register of products non-complying with essential requirements that is maintained by the OCCP
President. It gathers data enabling product identification, details of
non-compliance, measures implemented and risks posed.
The register is publicly available, also on the OCCP website:
www.uokik.gov.pl.
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OFFICE OF COMPETITION AND CONSUMER PROTECTION
ANNEX
POLISH LEGAL ACTS IMPLEMENTING
NEW APPROACH DIRECTIVES COVERED
BY THE OCCP MONITORING SYSTEM
1. General provisions:the August 30, 2002 Act (J. of L. 2004 No 204, Item
2087 and 2005 No 64, Item 565)
2. Detailed regulations:
1
2
3
24
Directive
Act
Directive-implementing regulation
73/23
Low voltage
electrical equipment (LVD)
The Conformity
Assessment Act
The March 12, 2003 Regulation
of Minister for Economy, Labour & Social
Policy on essential requirements for electrical equipment
J.of L. No 49, Item 414
87/404
Simple pressure
vessels
The Conformity
Assessment Act
The May 12, 2003 Regulation
of Minister for Economy, Labour & Social
Policy on essential requirements for simple
pressure vessels
J.of L. No 98, Item 898
88/378
Toy safety
(TOYS)
The Conformity
Assessment Act
The November 14, 2003 Regulation
of Minister for Economy, Labour & Social
Policy on essential requirements for toys
J.of L. No 210, Item 2045
POLISH ENTERPRISE IN THE EUROPEAN UNION
4
Directive
Act
89/106
Construction
products
The April 16, 2004 Construction Products Act
J.of L. No 92, Item 881
89/336
Electromagnetic
compatibility
(EMC)
The Conformity
Assessment Act
5
Directive-implementing regulation
The April 2, 2003 Regulation
of Minister for Infrastructure
on assessment of apparatus conformity with
essential requirements of electromagnetic
compatibility and conformity marking
J.of L. 2003 No 90, Item 848
The Telecommu- The July 16, 2004 Telecommunication Act
J.of L. No 171, Item 1800 and No 273, Item
nication Act
2703
The Conformity
Assessment Act
6
89/686
Personal protective equipment
(PPE)
The March 31, 2003 Regulation
of Minister for Economy, Labour & Social
Policy on essential requirements for
personal protective equipment
J.of L. No 80, Item 725
The Conformity
Assessment Act
7
90/384
Non-automatic
weighing instruments
The December 11, 2003 Regulation
of Minister for Economy, Labour & Social
Policy on essential requirements for
non-automatic weighing instruments that
are subject to conformity assessment
J.of L. 2004 No 4, Item 23
90/396
The Conformity
Appliances burn- Assessment Act
ing gaseous fuels
The April 15, 2003 Regulation
of Minister for Economy, Labour & Social
Policy on essential requirements for
appliances burning gaseous fuels
J.of L. No 91, Item 859
8
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OFFICE OF COMPETITION AND CONSUMER PROTECTION
Directive
9
Act
92/42
The Conformity
Efficiency reAssessment Act
quirements for
new hot-water
boilers fired with
liquid or gaseous
fuel
93/15
Explosives for
10
civil uses
The May 12, 2003 Regulation
of Minister for Economy, Labour & Social
Policy on essential efficiency requirements
for new hot-water boilers fired with liquid
or gaseous fuel
J.of L. No 97, Item 881
The June 21, 2002 Explosives for Civil Uses Act
J.of L. No 117, Item 1007 and No 238, Item 2019, and in 2004
No 222, Item 2249
94/9
The Conformity
Equipment and Assessment Act
protective systems intended for
11
use in potentially
explosive atmospheres (ATEX)
The July 28, 2003 Regulation
of Minister for Economy, Labour & Social
Policy on essential requirements for equipment and protective systems intended for
use in potentially explosive atmospheres
J.of L. No 143, Item 1393
94/25
The Conformity
Recreational craft Assessment Act
The November 19, 2004 Regulation
of Minister for Economy, Labour & Social
Policy on essential requirements for recreational craft
J.of L. No 258, Item 2584
12
94/62
Packaging and
13
packaging waste
95/16
Lift (elevators)
14
26
Directive-implementing regulation
The May 11, 2001 Packaging and Packaging Waste Act
J.of L. No 63, Item 638, 2003 No 7, Item 78, and in 2004 No 11,
Item 97 and No 96, Item 959
The Conformity
Assessment Act
The May 22, 2003 Regulation
of Minister for Economy, Labour & Social
Policy on essential requirements for lifts and
their safety components
J.of L. No 117, Item 1107
POLISH ENTERPRISE IN THE EUROPEAN UNION
Directive
96/48
Interoperability
of the transEuropean high
speed railway
15 system
Act
The March 28, 2003 Railway Transport Act
J.of L. No 86 Item 789, No 170, Item 1652 and No 203,
Item 1966, and in 2004 No 92, Item 883, No 96, Item 959,
No 97, Item 962, and No 173, Item 1808
The June 29, 2004 Regulation of Minister for Infrastructure
on essential requirements relating to railway interoperability
and conformity assessments procedures for the trans-European
high speed railway system
J.of L. No 162, Item 1697
96/57
The Conformity
Energy efficiency Assessment Act
requirements
16 for household
refrigerators &
freezers
17
Directive-implementing regulation
The December 2, 2003 Regulation
of Minister for Economy, Labour & Social
Policy on essential energy efficiency
requirements for household refrigerators &
freezers
J.of L. No 219, Item 2157
96/98
Marine equipment
The Marine
Equipment Act
- The April 20, 2004 Marine Equipment Act
J.of L. No 93, Item 899
- The April 30, 2004 Regulation
of Minister for Infrastructure on
requirements for marine equipment
J.of L. No 103, Item 1091
97/23
Pressure equipment
The Conformity
Assessment Act
The May 8, 2003 Regulation
of Minister for Economy, Labour & Social
Policy on essential requirements for
pressure equipment and pressure equipment
combinations
J.of L. No 99, Item 912, and in 2004 No 175,
Item 1818
18
98/37
The Conformity
Machinery safety Assessment Act
19 (MD)
The April 10, 2003 Regulation
of Minister for Economy, Labour & Social
Policy on essential requirements for
machinery and safety components
J.of L. No 91, Item 858
27
OFFICE OF COMPETITION AND CONSUMER PROTECTION
Directive
Act
Directive-implementing regulation
99/5
The Telecommu- - The July 16, 2004 Telecommunication Act
Radio equipment nication Act
J.of L. No 171, Item 1800 and No 273,
& telecommuniItem 2703
cations terminal equipment
The Conformity - The April 15, 2004 Regulation
(RTTE)
of Minister for Infrastructure
Assessment Act
20
on conformity assessment of
telecommunications terminal equipment
to be connected to the mains and of radio
equipment with essential requirements
and of its conformity marking
J.of L. No 73, Item 659
28
2000/9
Cableway installations designed
21
to carry persons
The Conformity
Assessment Act
The December 11, 2003 Regulation
of Minister for Infrastructure on essential
requirements for cableway installations
designed to carry persons
J.of L. 2004 No 15, Item 130
2000/14
Noise emissions
for outdoor
22 equipment
The Conformity
Assessment Act
The July 2, 2003 Regulation of Minister
of Economy, Labour & Social Policy on
essential requirements relating to noise
emissions to the environment by outdoor
equipment
J.of L. No 138, Item 1316
2001/16
Interoperability
of the trans-Eu23
ropean conventional rail system
The March 28, 2003 Railway Transport Act
J.of L. No 86, Item 789, No 170, Item 1652 and No 203,
Item 1966, and in 2004 No 92, Item 883, No 96, Item 959,
No 97, Item 962, and No 173, Item 1808