- Electrical
equipment prohibited from the market
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The Belgian Official Journal of 9 March 2004 published
two lists of electrical equipment
prohibited from the market. One concerns
111 devices not complying with the
"Low voltage" Directive - LVD:
73/23/EEC. The other concerns 27
products not complying with the EMC
Directive - 89/336/EEC. All products
were already prohibited in another EEA
Member State. Click
here to access the LVD list (Dutch
and French only);
Click
here to access the EMC list (Dutch
and French only). Our page on "Forbidden
& dangerous devices on the market"
gives a permanent link to such lists.
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- Re-writing
the low voltage Directive
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On 6 February 2004, the European
Commission issued the version 5 of the
draft revision of the "Low Voltage
Directive" (LVD) - 73/23/EEC. That
version has still some open wording.
Nevertheless, it will be submitted in
2004 to an extended impact analysis to
determine the economical social and
environmental effect of the proposed
changes. Indeed, the latter are rather
fundamental. If a good deal of those is
only a wording more in line with the
current wording of "New
approach" directives, some new
concepts were introduced:
- No lower limit in voltage: all
devices are covered from 0 Volt
upward;
- A risk analysis must be performed
for all electrical equipment
concerned. However, applying the
relevant harmonised standards will
satisfy this requirement;
- "Benign electrical
equipment" is defined as those
for which the risk analysis has
shown that they present negligible
hazards. A "Simple conformity
assessment procedure" is
defined for them;
- Extended list of hazards and
requirements to be considered,
including the principles of safety
integration, incorrect functioning,
various fields, and ergonomics;
- Extended labelling and instruction
for the installers and users.
Click
here to read the full text of the
draft - Version 5 (English only).
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- Weekly
updates of the RAPEX publicly
available
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The General Product Safety Directive
- GPSD - (2001/95/EC) has established
the legal basis for the Rapid Alert
System for Non-Food Products - RAPEX. Click
here to access our latest news on
the GPSD. The RAPEX concerns dangerous
consumer products. It is used by the EEA
members to rapidly exchange information
on such products. Now, the European
Commission makes that information publicly
available on its website. Updates are
usually done on a weekly basis. Two to
four products are generally added by
every update to the system. Click
here to access the RAPEX website
(English only). We permanently link
with the RAPEX website from our page on Forbidden
& Dangerous Devices.
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- Managing
the risks of active implantable
medical devices
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The Official Journal of the European
Union of 18 February 2004 publishes the
reference to the standard EN ISO
14971:2000/AC:2002 Medical devices -
Application of risk management to
medical devices in the framework of
the Directive 90/385/EEC on active
implantable medical devices. That
standard is since then considered as
"harmonised" and therefore
confers a presumption of conformity to
the directive when used for the design
and production of such devices.
The reference of that standard was
previously published on 31 July 2002 in
the framework of directives 93/42/EEC
concerning medical devices and 98/79/EC
on in vitro diagnostic medical devices. Read the
corresponding communication in: English,
français,
Nederlands
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- Revision
of the European directive on packaging
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The Official Journal of the European
Union of 18 February 2004 publishes the Directive
2004/12/EC of the European Parliament
and of the Council of 11 February 2004
amending Directive 94/62/EC on packaging
and packaging waste.
This revision completes the
definition of packaging by introducing
three new criteria. Examples are
supplied as Annex I to the Directive. It
also re-defines the obligations of the Member States regarding
prevention, and recovery and recycling of packaging waste. Further, it
introduces a revision process to be repeated every five years. This
Directive must be transposed into the national legislations by 18 August
2005. Read the full text of the Directive in: English,
français,
Nederlands
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- Amendments
of the Belgian General Regulation on
Electrical Installations - AREI/RGIE
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Since September 2003 we announce the coming publication of amendments
of the Belgian General Regulation on Electrical Installations -
AREI/RGIE. That publication has started. Four Royal Decrees have already
been published in the Belgian official journal of 17, 18, 24 and 26
February 2004.
Read the full text of the decrees (Dutch and French only):
| Articles |
Object |
Click |
| 28, 79, 80, 81, 82, 88, 94, 199, and
240 |
Terminology related to the earthing. |
Here |
| 57 |
Procedures of cutting, welding and
associated procedures using an electric arc. |
Here |
| 98 and 99 |
Prevention of electric shocks by
indirect contact at high voltage.
Prevention of electric shocks by indirect contact following
propagation of potential. |
Here
(540 kB) |
| 242 |
Discharge lamps which are not part of
public lighting installations and which are supplied by a
transformer, converter or inverter with a no-load rated output
voltage greater than 1 kV but not exceeding 10 kV. |
Here |
Seven Royal Decrees amending 54 other articles are still expected. To
access the draft decrees, read our news of: 24/9/2003
2/10/2003
23/10/2003
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- Clean
hot-water boilers for Belgium
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The Belgian Official Journal of 30 January 2004 has published the
Royal Decree of 8 January 2004 regulating the levels of nitrous oxide
(NOX) and carbon mono-oxide (CO) emissions for
central-heating boilers and burners fed with liquid or gaseous fuel with
a rated output of no more than 400 kW.
The decree specifies the maximum level of emissions for different
types of equipment and fuels. Before putting a new equipment on the
market, the manufacturer or its representative in the European Union
submits that equipment to a type-evaluation by a recognised body and
establishes a declaration of conformity (in Dutch, French and German) to
the maximum emission levels specified for its equipment. The production
is followed-up by a recognised body either by unannounced inspection
visits or by monitoring of its quality system (ISO 9001).
The decree will be applicable on 31 January 2005.
Click
here to read the Royal Decree (Dutch and French only).
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- A
new list of harmonised standards for
ATEX
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The Official Journal of the European Union of 24 January 2004
publishes the latest list of harmonised standards related to the
Directive 94/9/EC (ATEX).
It is good to know that products complying with the requirements of
an harmonised standard are presumed to comply with the corresponding
requirements of the Directive.
Read the full list of standards in: English,
français,
nederlands
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- Products
and services safety: upgrading the
guidance
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The Belgian transposition of the Directive 2001/95/EC has been
previously discussed. (Click here to read the
related news.) On 19 January 2004, the Product Safety Service of the
Belgian authorities has issued a revision of its former guidance
document.
Besides some details added in certain areas, the new document gives
now a road map to bring a safe product on the market.
Read the full text of the guidance in: français,
nederlands
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- Two
years guarantee for consumer goods in
Belgium?
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The Directive 1999/44/EC of the European Parliament and of the Council
of 25 May 1999 on certain aspects of the sale of consumer goods and
associated guarantees prescribes that all consumer goods are
guaranteed for a period of two years as from its delivery. This applies
to both new and second-hand goods. For the latter, the Member States may
allow that the supplier limits its guarantee in time but to not less
than one year.
This Directive had to be transposed in national legislations of all
EU Member States by 1 January 2002.
On 23 July 2003, Belgium was condemned by the European Court of
Justice for failing to transpose the Directive. It is still not done.
What are the consequences for the manufacturers supplying consumer goods
in Belgium and in the other EU member States and for the Belgian
consumers?
Suppliers of consumer goods must obey the law applicable where they
sell products. Therefore, manufacturers must offer a two years guarantee
for the consumer goods they supply in EU but outside of Belgium. In
Belgium, they may still limit their guarantee to one year for new
products and to nothing for second-hand goods.
Today, it remains difficult for the Belgian consumer to benefit from
the Directive. Of course, if he buys a good abroad in EU, the two years
guarantee will apply but with the burden to refer to foreign law and
supplier services. If he buys the good in Belgium and if he is refused a
guarantee of two years, he can act in court against Belgium that is
liable for not complying with its obligations within the EU treaties. He
will most probably win his case but when? and after which efforts?
Read the full text of the Directive in: English,
français,
nederlands
Read the full text of the judgement in: English,
français,
nederlands
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- Acoustical
noise from household appliances
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The Official Journal of the European Union of 16 January 2004
published the revised list of harmonised standards under the Council
Directive 86/594/EEC of 1 December 1986 on airborne noise emitted by
household appliances.
Read the list of standards in: English,
français, nederlands
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- Financing
the management of historical WEEE's
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The Official Journal of the European Union of 31 December 2003
published the Directive 2003/108/EC of the European Parliament and of
the Council of 8 December 2003 amending Directive 2002/96/EC on waste
electrical and electronic equipment (WEEE).
This amendment details how to finance the management of historical
WEEE from users other than private household. The initial provisions of
the Directive 2002/96/EC raised questions from the industry. Now, the
financing depends on replacement or not of the related equipment. If the
WEEE is replaced, the supplier of the new equipment takes care of the
WEEE. However, the Member States may stipulate that the user also be
made, partly or totally, responsible for the financing. If there is no
replacement, the financing is always provided by the user.
Read the full text of the Directive in: English,
français,
nederlands
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- Assuring
the safety of products and services
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The European Directive 2001/95/EC of the European Parliament and
of the Council of 3 December 2001 on general product safety - GPSD -
becomes strictly applicable on 15 January 2004 in the EEA
territory. It supersedes the initial directive of 1992.
The new Directive has a broader scope as it encompasses not only the
consumer products but all services rendered to consumers with such
products. A peculiarity is that this directive must be read in conjunction
with any directive covering a specific product. When such a directive
exists, the GPSD ceases to apply for the aspects covered by the specific
directive. This means that it still applies for what is not treated in
the specific directives.
This leads to an embarrassing question: What should be retained
from the GPSD in a particular case?
To help finding the appropriate answer, the EC (DG SANCO) has issued
a guidance document analysing the relation between the GPSD and the Toys
Directive (88/378/EEC), the low voltage directive (LVD: 73/23/EEC), the
directive on personal protective equipment (PPE: 96/58/EC) and the
cosmetics directive (76/768/EEC). There is however no guarantee that
this analysis is correct. Only the European Court of Justice may
interpret the Community law.
Click
here to read the guidance document (English only)
Considering that source and without any guarantee, our opinion
regarding directives in our activity area is as follows:
In Belgium, the GPSD has been transposed by the law of
9/2/1994 amended for the last time by the law of 18/12/2002. That
transposition has a much broader scope than the GPSD. Indeed, not only
it covers the consumer products and services but also products and
related services of the professional sphere. All products and
services are concerned.
Beside the fact that the scope is broader, the provisions of the
Belgian law are those of the GPSD. To clarify the application of the law
in the Belgian context, the authorities have issued a Q&R document.
Once again, that document is not legally binding but represents the
views of the authorities in that matter.
Read the Belgian Q&R document in: français,
nederlands
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- Harmonised
standards for the EMC
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The Official Journal of the European Union of 12 November 2003
published an updated list of harmonised standards relating to
electromagnetic compatibility - EMC.
It should be noted that many standards have been recently replaced,
the superseded standards loosing their applicability in 2004.
Access the list of EMC standards in: English,
français,
nederlands
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- New
standards for the medical devices
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The Official Journal of the European Union of 11 November 2003
published three new harmonised standards relating to medical devices.
These standards cover the biological evaluation and the clinical
investigation of medical devices, two crucial areas.
Clinical data are always requested to demonstrate the compliance of a
medical device with the regulation. Furthermore, clinical investigations
are requested for Class III devices and for implantable and long-term
invasive devices falling within Class IIa or IIb.
Access the list of new standards in: English,
français,
nederlands
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- The
"Cassis de Dijon" case
strikes again!
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On 4 November 2003, the Official Journal of the European Union
published the Commission interpretative communication on facilitating
the access of products to the markets of other Member States: the
practical application of mutual recognition (2003/C 265/02).
The principle of mutual recognition in the area of intra-Community
transfers of products is stated in articles 28 and 30 of the EC Treaty.
But what does it mean in practice? Of course, free movement is
guaranteed to products dully bearing the CE marking but what about those
other products that are allowed in a given country? Could they be freely
exported to another European country?
Since the ruling of the European Court of Justice in the "Cassis
de Dijon" Judgment of 20 February 1979, it is clear that, in
principle, a product which is legally marketed in a given Member State
of the European Economic Area (EEA) or in Turkey can be marketed in any
other country provided it provides an equivalent level of protection of
the various legitimate interests at stake.
Is this really clear? The communication of the Commission explains in
details what it means and how the principle of mutual recognition should
be applied.
Read the full text of the communication in: English,
français,
nederlands
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- ET
evaluates security firms
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Electro-Test - ET, our partner for the INCERT certification of
installers of alarm systems, has been recognised by M Patrick DEWAEL,
Belgian Minister of Interior, for the evaluation of security companies
wishing to be recognised in the framework of the law of 10 April 1990.
According to the law, security firms are firms offering to third
parties services of design, installation, maintenance, or repair of
alarm systems. Such firms must be evaluated and monitored by inspection
bodies recognised by the Minister of Interior, such as Electro-Test. In
that function, ET verifies that the security firms comply with the
requirements of the Royal Decree of 13 June 2002 on the recognition of
security firms. The latter include compliance with the Technical note
T015/2 (General requirements for the certification of security companies
and of installers of alarm systems) issued by the Belgian
Electrotechnical Committee (BEC). This note is also the basis for the
INCERT certification of security firms.
Click here for more details on
INCERT.
Click here to read the
notification of the Minister of Interior (Dutch and/or French).
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- Putting
cable reels on fire
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The 9 December 2003 issue of the Official Journal of the European
Union publishes the Commission opinion of 8 December 2003 within the
framework of Council Directive 73/23/EEC relating to electrical
equipment designed for use within certain voltage limits - Safety of
cable reels.
The Swedish authorities have noticed that electrical cable reels
complying with the EN 61242 standard could be set on fire when subject
to a maximum load and when the cable is not completely unrolled. In such
a case, the insulation material can melt and live parts may be
accessible. This is of course an intolerable risk and a non-compliance
with the essential requirements of the Directive.
After review of the problem, the EC concluded that:
- The EN 61242 is not regarded as giving a presumption of conformity
with regard to the risk of fire and electrical shock in cases of
foreseeable overload;
- Manufacturers may use thermal or current cut-outs or other
appropriate means to cover these risks;
- Member States should consider those risks in their market
surveillance activities.
We should also advise the owners of cable reels to examine whether
the latter are protected against overheating. If not, they should always
be used completely unrolled or replaced.
Read the full text of the Commission opinion in: English,
français,
nederlands
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- Protecting
workers against electromagnetic fields
- EMF
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On 20 October 2003, the European Commission announced that an
agreement has been found on a new Directive on the protection of workers
against electromagnetic fields.
The Directive targets hazards generated by power generation
installations, broadcasting antennae, mobile phone antennae, radar
installations, large furnaces and other industrial installations. It
also addresses risks incurred by workers exposed during long periods to
devices such as anti-theft gates used in shops.
The Directive concerns electromagnetic fields in the range of 0 Hz to
300 GHz. It addresses the risk to the health and safety of workers due
to known short-term adverse effects in the human body. It does not
address suggested long-term effects. The text fixes limits to be
observed to ensure protection against adverse effects.
Read the full text of the proposed Directive in: English,
nederlands
It should be noted that the protection of the population has been
dealt with by the European Council on 12 July 1999 in a Recommendation.
Read the full text of the Recommendation in: English,
français,
nederlands
Most of the scientific work done in that area is carried out in the
framework of the International Commission on Non-Ionizing Radiation
Protection - ICNIRP. Click here to visit
their website.
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- More
more draft
amendments of the Belgian General
Regulation on Electrical Installations
- RGIE/AREI
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The Official Journal of the European Union of 22 October 2003
references a new draft Royal Decree amending 8 articles of the Belgian
General Regulation on Electrical Installations - RGIE/AREI.
The standstill period during which the draft may not be adopted
extends till 2 January 2004. Comments or questions can be sent directly to
the Belgian authorities at: belnotif@mineco.fgov.be
The draft concerns measures to prevent fire in electrical
installations and to improve the behaviour of such installations during
fire. It also introduces the notion of "vital consumer" and of
"vital circuits". During fires, such circuits must remain
operational during at least 1 hour. For high rise buildings and
buildings accessible to the public, the material of the cables must not
produce toxic or opaque smokes when on fire.
Read the full text of the draft in: English,
français,
nederlands
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- Updating
the list of harmonised standards for
the EMC Directive
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The Official Journal of the European Union of 22 July 2003 published
an updated list of the harmonised standards giving a presumption of
conformity to the requirements of the EMC Directive (89/336/EC -
Electromagnetic compatibility).
It should be noted that the limit of validity of the superseded
standard EN 55022:1994 "Limits and methods of measurement of radio
disturbance characteristics of information technology equipment"
has been postponed till 1st August 2005 whilst the "new" EN
55022:1998 is already applicable. This gives some more time to get
acquainted with the technical solutions needed to apply the new
standard.
Click
here to access the dedicated webpage on the Europa website.
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- More
draft
amendments of the Belgian General
Regulation on Electrical Installations
- RGIE/AREI
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The Official Journal of the European Union of 1st October 2003
references six draft Royal Decrees amending 40 articles of the Belgian
General Regulation on Electrical Installations - RGIE/AREI.
The standstill period during which the drafts may not be adopted
extends till mid-December. Comments or questions can be sent directly to
the Belgian authorities at: belnotif@mineco.fgov.be
Click to read the drafts in:
| Draft |
Object |
EN |
FR |
NL |
| Art. 3, 22 to 27, 32, 40, 86, 88, 202, 203, 220 and
221 |
Introduction of the notion of very low
voltage. New rules for bathrooms. |
Here |
Ici |
Hier |
| Art. 90, 91 and 92 |
New rules for swimming pools, saunas,
fountains and other water pools. Use of very low voltages. |
Here |
Ici |
Hier |
| Art. 242 |
New rules for the installation of
discharge lamps. New protections against earth leakage and open
circuits. |
Here |
Ici |
Hier |
| Art. 15, 18, 66, 76, 77, 80, 94, 120, 169, 175, 181,
190, 199, 207, 236, 239, 240 and 260 |
Various linguistic corrections.
IPXX-B minimum for plugs.
New rules for high power connectors. |
NA |
Ici |
Hier |
| Art. 74 and 251 |
Conformity with HD 637.
Various prescriptions for high voltage installations. |
NA |
Ici |
Hier |
| Art. 29, 86, 207 and 227 |
Precisions regarding the IP code,
earthing cables and thermoplastic conduits. |
NA |
Ici |
Hier |
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- Draft
amendments of the Belgian General
Regulation on Electrical Installations
- RGIE/AREI
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The Official Journal of the European Union of 24 September 2003
references three draft Royal Decrees amending 15 articles of the Belgian
General Regulation on Electrical Installations - RGIE/AREI.
Two drafts concern the prevention of electric shocks by indirect
contact at high voltage or due to the propagation of the potential. The
third draft relates to the codification of people and to the conditions
of work in the vicinity of electrical installations.
Click to read the drafts in:
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- CEBEC
notified for the Medical Devices
Directive
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On 16 July 2003, the Belgian Minister of Public Health, Mr. Rudy
Demotte, confirmed that he will notify CEBEC to the European
Commission as a body recognised for performing the assessment procedures
foreseen by the art. 5 of the Royal Decree of 18 March 1999 transposing
the Directive 93/42/EEC on medical devices. This notification concerns
the annexes II (full quality assurance system), III (EC
type-examination), IV (EC verification), V (production quality
assurance) and VI (product quality assurance). It covers:
- Active medical devices but those emitting ionising radiations and
those designed to image in-vivo the dispersion of
radiopharmaceutical products
- Non invasive devices limited to those designed :
- to immobilise or to apply a force or pressure on the body or
parts of the body
- to stand patient bodies (beds...)
- for miscellaneous uses (stethoscopes, non invasive
electrodes...)
- Re-usable surgical instruments
It also concerns the verification of mechanical, electrical and
electromechanical aspects of medical devices of classes I, IIa and IIb
using ionising radiations according to the annexes III and IV but for
the nuclear aspects.
Click here to read the full text of
Minister Rudy Demotte letter (French only).
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CEBEC as the information source.
If in doubt, please contact CEBEC.
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