(1) General conditions
a) The essential characteristics, the recognition and observance of which
will ensure that electrical equipment will be used safely and in applications
for which it was made, shall be marked on the equipment, or, if this is
not possible, on an accompanying notice.
b) The manufacturer’s brand name or trade mark should be clearly printed
on the electrical equipment or, where that is not possible, on the packaging.
c) The electrical equipment, together with its component parts, should be
made in such a way as to ensure that it can be safely and properly assembled
and connected.
d) The electrical equipment should be so designed and manufactured as to
ensure that protection against the hazards set out in points 2 and 3 of
this Annex is assured providing that the equipment is used in applications
for which it was made and is adequately maintained.
(2) Protection against hazards arising from the electrical equipment
Measures of a technical nature should be prescribed in accordance with point
1, in order to ensure:
a) that persons and domestic animals are adequately protected against danger
of physical injury or other harm which might be caused by electrical contact
(direct or indirect);
b) that temperatures, arcs or radiation which would cause a danger are not
produced;
c) that persons, domestic animals and property are adequately protected
against non-electrical dangers caused by the electrical equipment which
are revealed by experience;
d) that the insulation must be suitable for foreseeable conditions.
(3) Protection against hazards which may be caused by external influences
on the electrical equipment
Technical measures are to be laid down in accordance with point 1, in order
to ensure:
a) that the electrical equipment meets the expected mechanical requirements
in such a way that persons, domestic animals and property are not endangered;
b) that the electrical equipment shall be resistant to non-mechanical influences
in expected environmental conditions, in such a way that persons, domestic
animals and property are not endangered;
c) that the electrical equipment shall not endanger persons, domestic animals
and property in foreseeable conditions of overload.
Originally, EU Member
States were to take appropriate measures to implement the legislation on
a country by country basis, with designated country marks indicating conformity
to European harmonized standards in accordance with the directive. In 1993
the original directive was amended (93/68/EEC) and converted to the EU-wide
New Approach Directive format. The CE mark has been mandatory since January
1, 1997.
Simple Pressure Vessels
Directive
The Simple Pressure Vessels Directive (77/804/EEC) was adopted on June 25,
1987. It was implemented for voluntary compliance on July 1, 1990, amended
September 17, 1990 (90/488/EEC), and became mandatory on July 1, 1992. Since
that date, a CE mark and EC Declaration of Conformity have been required
in order to sell a simple pressure vessel in the European Union.
The scope of the directive, defined in Article 1, is set forth below:
1. This directive
applies to simple pressure vessels manufactured in series.
2. For the purposes of this directive, “simple pressure vessel” means
any welded vessel subjected to an internal gauge pressure greater than
0.5 bar which is intended to contain air or nitrogen and which is not
intended to be fired.
- Moreover, the parts
and assemblies contributing to the strength of the vessel under pressure
shall be made either of non-alloy quality steel or of non-alloy aluminum
or non-age hardening aluminum alloys.
- The vessels shall
be made of either a cylindrical part of circular cross-section closed
by outwardly dished and/or flat ends which revolve around the same axis
as the cylindrical part; or two dished ends revolving around the same
axis;
- the maximum working
pressure of the vessel shall not exceed 30 bar and the product of that
pressure and the capacity of the vessel (PS.V) shall not exceed 10,000
bar/liter; the minimum working temperature must be no lower than 50
degrees C and the maximum working temperature shall not be higher than
300 degrees C for steel and 100 degrees C for aluminum or aluminum alloy
vessels.
Excluded from the directive
are vessels designed specifically for nuclear use, propulsion of ships or
aircraft and fire extinguishers.
The conformity assessment
procedures are set forth in Article 3 and are listed below:
1. Vessels in respect
of which the product of PS and V exceed 50 bar/liter must satisfy the
essential safety requirements set out in Annex I.
2. Vessels in respect of which the product of PS and V is 50 bar/liter
or less must be manufactured in accordance with sound engineering practice
in one of the Member States and bear markings as laid down in section
1 of Annex II, with the exception of the CE marking referred to in Article
16.
Vessels must have a
CE mark in addition to the markings laid down in section 1 of Annex II.
If a machine also contains a simple pressure vessel as defined by this directive,
the CE mark must indicate which directives have been satisfied; this information
must be provided in the Declaration of Conformity that accompanies each
machine.
Gas Appliances Directive
The scope of the Directive is set forth below:
1. This directive
shall apply to:
- appliances burning
gaseous fuels used for cooking, heating, hot water production, refrigeration,
lighting or washing and having, where applicable, a normal water temperature
not to exceed 105 degrees C, hereinafter referred to as “appliances.”
Forced draught burners and heating bodies to be equipped with such burners
will also be considered as appliances.
- safety devices,
controlling devices or regulating devices and sub-assemblies, other
than forced draught burners and heating bodies to be equipped with such
burners separately marketed for trade use and designed to be incorporated
into an appliance burning gaseous fuel or assembled to constitute such
an appliance, hereinafter referred to as “fittings.”
2. Appliances specifically
designed for use in industrial processes carried out on industrial premises
are excluded from the scope in paragraph 1.
3. For the purposes of this directive, “gaseous fuel” means any fuel which
is in a gaseous state at a temperature of 15 degrees C under a pressure
of 1 bar.
4. For the purposes of this directive, an appliance is said to be “normally
used” when it is:
- correctly installed
and regularly serviced in accordance with the manufacturer’s instructions;
- used with a normal
variation in the gas quality and a normal fluctuation in the supply
pressure; and
- used in accordance
with its intended purpose or in a way which can be reasonably foreseen.
Article 3 stipulates
that appliances and fittings must satisfy the essential requirements which
apply to them as defined in Annex I, Essential Requirements. The general
conditions for the essential requirements are listed below:
1.1. Appliances must
be so designed and built as to operate safely and present no danger to
persons, domestic animals or property when normally used as defined in
Article 1(4) of this directive.
1.2. When placed on the market, all appliances must: be accompanied by
technical instructions intended for the installer; be accompanied by instructions
for use and servicing, intended for the user; bear appropriate warning
notices, which must also appear on the packaging.
The instructions and
warning notices must be in the official language or languages of the Member
States of destination.
1.2.1. The technical instructions intended for the installer must contain
all the instructions for installation, adjustment and servicing required
to ensure that those operations are correctly performed and that the appliance
may be used safely. In particular, the instructions must specify: the
type of gas used; the gas supply pressure used; the flow of fresh air
required for the combustion air supply; to avoid the formation of dangerous
unburned gas mixtures for appliances not fitted with the device referred
to in point 3.2.3; the conditions for the dispersal of combustion products;
for forced draught burners and heating bodies intended to be equipped
with such burners, their characteristics, the requirements for assembly,
to assist compliance with the essential requirements applicable to finished
appliances and, where appropriate, the list of combinations recommended
by the manufacturer.
1.2.2. The instructions for use and servicing intended for the user must
contain all the information required for safe use, and must in particular
draw the user’s attention to any restrictions on use.
1.2.3. The warning notices on the appliance and its packaging must clearly
state the type of gas used, the gas supply pressure and any restrictions
on use, in particular the restrictions whereby the appliance must be installed
only in areas where there is sufficient ventilation.
1.3. Fittings intended to be part of an appliance must be so designed
and built as to fulfill correctly their intended purpose when incorporated
in accordance with the instructions for installation.
The instructions for
installation, adjustment, operation and maintenance must be provided with
the fittings concerned.
The conformity assessment procedures are set forth in Article 8. Once compliance
has been completed, the CE mark can be affixed and a Declaration of Conformity
can be signed. As noted earlier, if more than one directive is required,
the CE mark must indicate this fact in the Declaration of Conformity that
accompanies each machine.
Telecommunications
Terminal Equipment (TTE) Directive
The Telecommunications Terminal Equipment Directive was adopted on April
29, 1991 and implemented into law without a transition period on November
6, 1992.
The scope of the directive is set forth in Article 1.
1. This directive
shall apply to terminal equipment.
2. For the purpose of this directive:
- “public telecommunications
network” means the public telecommunications infrastructure which permits
the conveyance of signals between defined network termination points
by wire, by microwave, by optical means or by other electromagnetic
means;
- “terminal equipment”
means equipment intended to be connected to the public telecommunications
network, i.e.:
(a) to be connected directly to the termination of a public telecommunications
network; or
(b) to interwork with a public telecommunications network being connected
directly or indirectly to the termination of a public telecommunications
network in order to send or receive information.
The system of connections
may be wire, radio, optical or other electromagnetic system.
- “technical specification”
means a specification contained in a document which lays down the characteristics
required of a product such as levels of quality, performance, safety
or dimensions, including the requirements applicable to the product
as regards terminology, symbols, testing and test methods, packaging,
marking and labeling;
- “standard” means
a technical specification adopted by a recognized standards body for
repeated or continuous application, compliance with which is not compulsory.
3. The intended purpose
of the equipment shall be declared by the manufacturer or supplier of
the equipment. However, terminal equipment within the meaning of paragraph
2 which makes use of a system of communication employing the radio frequency
spectrum is presumed to be intended for connection to the public telecommunications
network.
The requirements of
the TTE Directive are set forth in Article 4:
Terminal equipment shall satisfy the following essential requirements:
(a) user safety, in
so far as this requirement is not covered by Directive 73/23/EEC;
(b) safety of employees of public telecommunications networks operators,
in so far as this requirement is not covered by Directive 73/23/EEC;
(c) electromagnetic compatibility requirements in so far as they are specific
to terminal equipment;
(d) protection of the public telecommunications network from harm;
(e) effective use of the radio frequency spectrum, where appropriate;
(f) interworking of terminal equipment with public telecommunications
network equipment for the purpose of establishing, modifying, charging
for, holding and clearing real or virtual connection;
(g) interworking of terminal equipment via the public telecommunications
network, in justified cases. The cases where terminal equipment supports:
(i) reserved service according to Community law; or
(ii) a service which the Council has decided that there should be Community-wide
availability, are considered as justified cases and the requirements concerning
this interworking are determined in accordance with the procedure provided
for in Article 14.
The preceding describes
the technical requirements that terminal equipment must meet and which must
be specified in EU harmonized technical standards.
The conformity assessment options are set forth in Article 9, and the criteria
are described in Annexes I – IV. Common Technical Requirements (CTRs) have
been developed or are being developed to implement the directive. CTRs have
their own implementation dates.
Anything directly or indirectly able to connect to, or interwork with, the
public telecommunications network via wire, radio, optical or other magnetic
systems is considered telecom equipment. If a machine contains hardware
or software that allows it to connect to any other computer or machine via
the public telecommunications network, the entire machine is subject to
the TTE Directive.
If, however, the machine contains a personal computer where the PC is considered
Information Technology Equipment (ITE), and if an approved TTE modem is
installed in the machine PC, the machine PC remains ITE equipment. Either
way, a machine which is connected to the telecom network or the installed
modem that facilitates connection with the telecom network must have a CE
mark and be accompanied by a Declaration of Conformity.
As noted in the Council Decision of July 22, 1993, Annex I (B) (c): Where
the industrial products are subject to other directives concerning other
aspects and which also provide for the affixing of the CE marking, the latter
must indicate that the products are also presumed to conform to the provisions
of those other directives.
However, where one or more of these directives allow the manufacturer, during
a transitional period, to choose which arrangements to apply, the CE marking
indicates conformity to the provisions only of those directives applied
by the manufacturer. In this case, particulars of the directives applied,
as published in the Official Journal of the European Communities, must be
given in the documents, notices or instructions accompanying the products
or, when appropriate, on the data plate.
EU Environmental
Directives
In addition to the related New Approach Directives discussed in the preceding
section, several EU environmental directives should be reviewed to determine
their potential impact upon manufacturers. These directives range from the
use of batteries and accumulators, to how products are packaged and transported,
to any hazardous waste presented by use of the product, to disposal of the
product itself. How the directives are implemented will have an impact on
how manufacturers and distributors comply with the directive requirements.
A few examples should help illustrate this point:
First, if a manufacturer uses batteries and/or accumulators, instructions
will have to be provided on how the spent batteries and accumulators are
to be disposed. Further, in several countries, disposal is a manufacturer’s
obligation, and it will be necessary to participate in a disposal system.
Finally, products will have to be so constructed that batteries can be removed
for disposal separate from the product itself. This applies to all products.
Second, all packaging, including transport packaging and packaging
waste are covered by an EU directive. Participation in national recycling
programs by manufacturers and/or distributors will be mandatory. Further,
there are no exceptions. During the final debates before passage, the medical
device industry asked for an exemption from the directives; their request
was denied. Since the EU directive was strongly influenced by an earlier
German packaging and packaging waste ordinance, an examination of the German
law will provide guidance for the EU law.
Third, a newly adopted German Electronic Waste Ordinance should be
given close scrutiny since German legislation often becomes EU legislation.
This new German ordinance requires that manufacturers participate in a recycling
program which breaks down all electronic equipment for disposal in appropriate
categories.
Fourth, an examination should be given to the EU’s new Eco Audit
and Management Scheme (EMAS). Environmental issues are a large part of new
legislation and therefore should be incorporated into policy decisions.
ISO/TC 207 is in the final stages of creating DIS/ISO 14000. This standard
will most likely be a framework for the final EU environmental legislation
blended with the EU’s EMAS scheme. In addition, it is quickly gaining worldwide
acceptance, with as much notoriety as the ISO 9000 series.
A brief summary of the aforementioned programs follows.
EU Hazardous Waste
Directive
The EU Hazardous Waste Directive covers the controlled management of hazardous
waste, excluding domestic waste. The definitions for hazardous wastes are
based on a list of substances drawn up on the basis of Annexes I and II
and one or more properties listed in Annex III such as: explosive, oxidizing,
flammable, irritant, toxic, carcinogenic, corrosive, infectious tertogenic,
mutagenic, exonoxic.
The Hazardous Waste Directive was implemented in December 1993. The directive
includes the following requirements:
- Each Member State
must develop a waste management plan, including methods for recovery and
disposal;
- Waste has to be properly
packaged and labeled by companies for collection, transport and temporary
storage;
- The competent authority
for each Member State must be identified and records about dumping and
storage sites must be maintained;
- EC Commission must
be informed about recovery and/or disposal facilities, including the names
and addresses of these facilities;
- The mixing of different
kinds of waste is prohibited;
- Transferred waste
must be labeled in accordance with section A of Annex I;
- Manufacturers must
participate in the program in accordance with Member State law.
Batteries and Accumulators
Directive
The purpose of the directive is for the recovery and disposal of batteries
containing dangerous substances. These are listed in Annex I; the exclusions
to the directive are listed in Annex II of the directive.
Batteries and accumulators are defined as the source of electrical energy
converted by chemical energy. Spent batteries are those that are not reusable.
Collection is defined as the gathering, sorting and grouping of spent batteries.
A deposit system is when a seller pays a sum which is refunded when batteries
are returned.
The purpose of the directive is to create a separate collection system for
batteries for recovery or disposal, reduce the heavy-metal content and encourage
recycling. Manufacturers must participate in Member State disposal systems
and make certain that spent batteries can be removed and disposed of separately.
The directive’s primary requirement is to prohibit the marketing of alkaline
manganese batteries containing .05% or .025% of mercury.
EU Packaging and
Packaging Waste Directive
The purpose of this directive is to harmonize the management of packaging
waste (packaging used industrially, commercially or in the household); to
promote the return, recovery and reuse of packaging waste; and to replace
EC Directive 85/339.
- The directive covers
all packaging and packaging waste whether industrial, commercial or household;
primary (sales packaging), secondary (group packaging) or tertiary (transport
packaging).
- The directive defines
packaging, used packaging, packaging waste, packaging waste management,
prevention, recovery, recycling and disposal.
- The directive sets
EU Member State targets regarding the recovery of packaging waste at no
later than five years from implementation of the directive into national
law:
- 65 percent by weight
should be removed from the waste stream for recovery;
- 45 percent by weight
of packaging material should be removed for recycling and must be recycled;
- Greece, Ireland and
Portugal are allowed a later deadline (not to exceed December 21, 2005)
but must reach at least 25 percent recovery in the first five years.
- EU Member States
are instructed to provide for the return of all used packaging and/or
packaging waste from the consumer, waste stream or final user to channel
it to appropriate uses, and to ensure that used packaging or packaging
waste is reused, recovered and/or recycled.
- The packaging and
packaging waste return and management systems are to be designed in such
a way that there are no barriers to trade or distortions of competition
for imported products.
- Within five years
from implementation into national law, all packaging shall comply with
the marking provisions of Article 6 and Annex I of the directive. Markings
are to be appropriately durable and any Community rules for eco-labeling
for packaging are to be harmonized with this directive.
- EU Member States
are instructed to take all appropriate measures to ensure that only packaging
that complies with the “essential requirements” of this directive may
be placed on the market.
- Manufacturers must
participate in the program in accordance with Member State law.
Electronic Waste
Ordinance (Electronik – Schrott – Verordnung)
This directive’s purpose is to reduce the waste of used electronic equipment
(e.g. computer hardware, television sets, VCRs, faxes, etc.) by requiring
dismantling and/or repair of used equipment.
The scope of the directive includes ITE, entertainment, household, laboratory,
medical, bank and measurement equipment. Distributors are defined as everyone
who puts equipment on the market. End users include everyone using such
equipment.
Reuse has the highest priority followed by reduction of waste by recycling.
The purpose is to promote “clean” or “low waste” technology.
The directive includes the following requirements:
- Distributors (manufacturers)
must take back the equipment for free;
- Distributors (manufacturers)
are responsible for recycling and disposal;
- Recycling and disposal
facilities have to be approved by the government;
- Methods of treatment
must be reported to the government.
Worker Safety Directives
& Regulations
For companies manufacturing machines to be used in a plant setting, EU regulations
governing worker safety will have an impact upon machine use and, by extension,
have an impact on machine safety. Manufacturers should study prospective
buyers and users of machines to determine what worker safety laws may be
unique to their type of machines.
An example of a worker safety law is the June 12, 1989 directive to “Encourage
Improvements in the Safety and Health of Workers at Work” (89/391/EEC).
Article 5 states that, The employer shall have a duty to ensure the safety
and health of workers in every aspect related to work. The machine environment
will certainly be an aspect of this requirement.
It mandates that employers must hire external help if they lack competent
personnel within their plant to ensure work place safety. The general obligations
for employers, defined in Article 6 of the directive, are listed below:
1. Within the context
of responsibility, the employer shall take the measures necessary for
the safety and health protection of workers, including prevention of occupational
risks and provision of information and training, as well as provision
of the necessary organizations and means. The employer shall be alert
to the need to adjust these measures to take account of changing circumstances
and aim to improve existing conditions.
2. The employer shall implement the measures referred to in the first
subparagraph of paragraph 1 on the basis of the following general principles
of prevention:
(a) avoiding risks;
(b) evaluating the risks which cannot be avoided;
(c) combining the risks at source;
(d) adapting the work to the individual, especially as regards the design
of work places, the choice of work equipment and the choice of working
and production methods, with a view, in particular, to alleviating monotonous
work and work at a predetermined work-rate and to reducing their effects
on health;
(e) adapting to technical progress;
(f) replacing the dangerous with the non-dangerous or the less dangerous;
(g) developing a coherent overall prevention policy which covers technology,
organization of work, working conditions, social relationships and the
influence of factors related to the working environment;
(h) giving collective protective measures priority over individual protective
measures;
(i) giving appropriate instructions to the workers.
The directive goes on
to instruct employers to:
- evaluate worker
health and safety risks;
- develop preventive
measures to assure improved protection at all levels of plant operations;
• evaluate worker capabilities regarding health and safety;
- develop strategies
for introducing new technologies;
- take steps to ensure
that only workers who have received adequate instructions may have access
to areas where there is a serious and specific danger.
In addition to the preceding
sections, Article 9 stipulates various obligations for all employers.
1. The employer shall:
a) be in possession
of an assessment of the risks to safety and health at work, including
those facing groups of workers exposed to particular risks;
b) decide on the protective measures to be taken and, if necessary,
the protective equipment to be used;
c) keep a list of occupational accidents resulting in a worker being
unfit for work for more than three working days;
d) draw up, for the responsible authorities and in accordance with national
laws and/or practices, reports on occupational accidents suffered by
his workers.
2. Member States shall
define, in the light of the nature of the activities and size of the undertakings,
the obligations to be met by the different categories of undertakings
in respect of the drawing-up of the documents provided for in paragraph
1 and when preparing the documents provided for in paragraph 1.
Article II spells out
the requirement for worker consultation. Finally, Article 16 indicates that
this directive will serve as a parent directive for other worker safety
directives, and Article 18 indicates that “Member States shall communicate
to the Commission the texts of the provisions which they have already adopted
or adopt in the field covered by the directive.”
The significance of Directive 89/391/EEC is twofold. This directive is the
EU equivalent of the U.S. Occupational Safety and Health Act (OSHA). One
method by which this directive is being enforced is through Member State
laws such as the UK’s. The Provision and Use of Work Equipment Regulations
required employers to purchase only CE marked electrical apparatus to safeguard
the safety of their employees after January 1, 1996. Similar regulations
have been adopted by Germany, France and other EU Member States. In addition
to enforcement by the UK authorities, several large EU labor unions are
monitoring manufacturer compliance to see that only CE marked apparatus
is purchased, in accordance with Article 11.
Obligation of Employers
Directive 89/655/EEC establishes the obligation of employers and is the
second individual directive within the meaning of Article 16 (1) of 89/391/EEC.
Article 1 “lays down minimum safety and health requirements for the
use of work equipment by workers at work.”
Article 3 states that the employers shall take the measures necessary
to ensure that the work equipment made available to workers in the undertaking
and/or establishment is suitable for the work to be carried out or properly
adapted for that purpose and may be used by workers without impairment to
their safety or health.
In selecting the work equipment which he proposes to use, the employer shall
pay attention to the specific working conditions and characteristics and
to the hazards which exist in the undertaking and/or establishment, in particular
at the workplace, for the safety and health of the workers, and/or any additional
hazards posed by the use of work equipment in question.
Article 4 sets forth rules concerning work equipment. Without prejudice
to Article 3, the employer must obtain and/or use:
(a) work equipment
which, if provided to workers in the undertaking and/or establishment
for the first time after December 31, 1992, complies with:
(i) the provisions of any relevant community directive which is applicable;
(ii) the minimum requirements laid down in the annex, to the extent that
no other community directive is applicable, or is so only partially.
This directive provides
the legal teeth that have been used by EU Member States to mandate that
only properly CE marked electrical products can be used in the workplace.
