EUROPEAN COMMISSION

ENTERPRISE DIRECTORATE-GENERAL

Single Market, regulatory environment, Industries under vertical legislation

Conformity and standardisation, new approach, industries under new approach

Brussels, 7 September 2000

M/305 EN

STANDARDISATION MANDATE ADDRESSED TO CEN, CENELEC AND ETSI

IN THE FIELD OF ELECTROTECHNOLOGY, INFORMATION TECHNOLOGY
AND TELECOMMUNICATIONS

Title

Harmonised standards covering protection from electromagnetic fields (0 Hz to 300 GHz)

generated by apparatus included in the scope of either the Low Voltage Directive 73/23/EEC 1 ,
(LVD) or the Radio Equipment and Telecommunications Terminal Equipment (R&TTE)
Directive 1999/5/EC 2 .

Purpose

Drafting of European Standards defining the requirements to protect human beings from
hazardous effects, which may be caused by exposure to electromagnetic fields, emitted by
electrical apparatus. The standards must relate to the apparatus as the LVD and the R&TTE
Directive relates to apparatus. The standards are intended to become harmonised standards
giving a presumption of conformity to articles 2 of Directive 73/23/EEC and articles 3.1.a of
1999/5/EC.

1. INTRODUCTION

During a number of years there has been ongoing research in the field of determining the
influence of exposure of human body to electromagnetic fields and efforts to establish
reproducible and reliable measurement and calculation methods for the physical quantities
describing the electromagnetic field.

1 Council Directive 73/23/EEC of 19 February 1973 on the harmonization of the laws of Member States
relating to electrical equipment designed for use within certain voltage limits (Official Journal L 77 of 26
March 1973) as amended.

2 Council Directive 99/5/EC of 9 March 1999 on radio equipment and telecommunications terminal
equipment and the mutual recognition of their conformity (Official Journal L 91 of 7 April 1999).

Rue de la Loi 200, B-1049 Bruxelles/Wetstraat 200, B-1049 Brussel - Belgium - Office: SC 15 - 3/04.
Telephone: direct line (+32-2)2992843, switchboard 299.11.11. Fax: 2966273.
Telex: COMEU B 21877. Telegraphic address: COMEUR Brussels.

X.400: G=Jan; S=Roed; O=DG-Enterprise/D/1; P=CEC; A=RTT; C=BE Internet: [email protected]

 Electrical apparatus mainly creates the electromagnetic fields. A majority of these
apparatus falls under the scope of the Directives 73/23/EEC, the Low Voltage Directive
and 1999/5/EC, the R&TTE Directive.

Risks, caused by these phenomena are covered by the Low Voltage Directive (see
justification below). The R&TTE Directive extends the applicability of the safety
objectives and requirements of the LVD to equipment, which is in its scope but not in the
scope of the LVD. It further enables a single conformity assessment for all requirements.

In July 1999 a Council Recommendation 1999/519/EC 3 on the limitation of exposure of

the general public to electromagnetic fields (0 Hz to 300 GHz) was adopted.

The present mandate is an update of the previously issued mandate M/032 and takes into
account the change of directive for Telecommunication Terminal Equipment from
91/263/EEC to the Radio Equipment & Telecommunications Terminal Equipment
Directive 99/5/EC. The scope of the mandate is broader and now covers the products
covered by the Directive 73/23/EEC.

2. JUSTIFICATION

2.1. Legal Basis

This standardisation mandate falls within the framework of the Low Voltage
Directive and the R&TTE Directive and refers to products covered by these
directives, as defined in article 1 of the LVD and article 2 of the R&TTE Directive.

Article 2 of Directive 73/23/EEC stipulates that the Member States take all
appropriate measures to ensure that electrical equipment may be placed on the
market only if, having been constructed in accordance with good engineering
practice in safety matters in force in the Community, it does not endanger the safety
of persons, domestic animals or property when properly installed and maintained
and used in applications for which it was made.

The principal elements of the safety objectives are listed in Annex I of Directive
73/23/EEC. In this case clause 2b is applicable:

Measures of a technical nature should be prescribed in accordance with point

1 (of Annex I of Directive 73/23/EEC), in order to ensure that temperatures,
arcs or radiation which would cause a danger, are not produced.

Article 3 of Directive 1999/5/EC stipulates that the following essential requirements

are applicable to all apparatus:

3 Council Recommendation 1999/519/EC of 12 July 1999 on the limitation of exposure of the general public
to electromagnetic fields (0 Hz to 300 GHz) (Official Journal L 197 of 30 July 1999).

2
 (a) the protection of the health and the safety of the user and any other
person, including the objectives with respect to safety requirements contained
in Directive 73/23/EEC, but with no voltage limit applying.

In the preamble of Recommendation 1999/519/EC it is stated that whereas

“(12) In order to assess compliance with the basic restrictions provided in this
recommendation, the national and European bodies for standardisation (e.g.
CENELEC, CEN) should be encouraged to develop standards within the
framework of Community legislation for the purposes of the design and
testing of equipment;”

2.2. Status of the original mandate

Under the first version of this mandate (M/0324 ) CEN, CENELEC and ETSI were
entrusted to develop standards covering the so-called thermal effects of
radiocommunications equipment operating in the most commonly used frequency
ranges, notably including the frequency ranges used by GSM. In addition to M/032
the 3 bodies were entrusted with a programming mandate to assess the need to
develop harmonised standards covering other effects (M/0335 ). Progress of work
under these mandates has not been satisfactory.

The present mandate confirms the need for harmonised standards as requested by
M/032 for the effects referred to in Council Recommendation 1999/519/EC and
the dangers referred to in Directive 73/23/EEC and incorporates the objectives of
M/033, which hereby is withdrawn.

3. DESCRIPTION OF THE M ANDATE

The European Commission requests CEN, CENELEC and ETSI to prepare and adopt
the harmonised standards covering the aspects of emission of electromagnetic fields from 0
Hz to 300 GHz emitted by equipment covered by Directives 1999/5/EC and 73/23/EEC.

Harmonised standards should describe the test methods, test equipment and calculation
methods needed in order to specify product requirements, limiting the emission of EMF.
They should take into account the reference levels and basic restrictions in Council
recommendation 1999/519/EC to allow presumption of conformity to article 2 of
Directive 73/23/EEC and article 3.1 (a) of 1999/5/EC, taking due account of the
international standardisation and current technical practice in this sector.

4 Mandate M/032, Safety requirements for mobile communication equipment; Thermal aspects of EMR of
11. October 1993. Other references are BC-T-302, SOGT 93/18 Rev.4 and SOGITS Nº 682 Rev. 4

5 Mandate M/033, Work programme for safety requirements on athermal effects for mobile
communication equipment exposing humans to EMR of 12 October 1993. Other references are BC-T-303,
SOGT 93/19 Rev.3 and SOGITS Nº 683 Rev. 3

3
 Council Recommendation 1999/519/EC specifies limit values for exposure to
electromagnetic fields that can be produced by several apparatus. The CEN/CENELEC
Resolution “Standardization policy in the area covered by article 118a of the EU Treaty”
underlines that the right to set such limit values for occupational exposure must be reserved
for the political decision-making process. The compliance of a product with the emission
limits given in the harmonised standards asked for in this mandate, will ensure that the
measured EMF exposure of the human body originating from this apparatus, will not under
normal use exceed the limits given in the Council recommendation.

In all matters relating to the health aspects and biological effects of electromagnetic fields,
the standard bodies should seek the advice of ICNIRP and relevant services of the
European Commission.

All relevant interested parties at regional and international level should contribute to the
execution of the mandate.

In order to provide a comprehensive solution, the package of standard shall consist of:

− Basic and Generic standards , containing assessment methods (measurement and

calculation procedures) for EMF emission and defining limits in accordance with the values
provided in Council Recommendation 1999/519/EC.
If necessary they shall also describe the test equipment to be used.
In case of emission from sources with multiple frequencies, the calculation of reference
levels using the formulae’s in Annex IV of 1999/519/EC shall be used.
In certain situations, where the emission from the products is highly localised on the human
body, the use of generic measurement standards may not be appropriate. In such cases
respect of the basic restriction should be addressed directly in product standards or product
family standards. This shall be explained in the generic standards.

In case of products likely to emit very weak EMF, a description of simpler and less
accurate measurement methods and/or measurement equipment can be made, providing the
uncertainties by using such equipment or measurement method are fully taken into account.

− Product – or product-family standards, applying the applicable tests from the basic and
generic standards to specific products or product groups, and specifying specific measuring
and calculation methods and limits where appropriate, in accordance with the normal
condition of use.
In case of products likely to emit very weak EMF, a description of simpler and less
accurate measurement methods and/or measurement equipment can be made, providing the
uncertainties by using such equipment or measurement method are fully taken into account.

Standards must also address the issue of providing all necessary information to accompany
the products with regard to safe use (also if special precautions is needed during
repair/maintenance).

4
4. EXECUTION OF THE M ANDATE

4.1. Designation of the mandate

The Commission hereby entrusts to CEN, CENELEC and ETSI the described
mandate.

4.2. Starting phase

In order to ensure transparency in the work to be carried out, CEN, CENELEC

and ETSI will provide by the end March 2001 with the following information:

- A programme with the standards that will cover the mandate and the target dates
for public enquiry and for adoption.

- An indication of aspects to be modified and/or supplemented.

As a matter of urgency CEN, CENELEC and ETSI shall complete the harmonised
standard covering mobile GSM handsets, covered by the original mandate by
December 2000.

4.3. Implementation of the programme

CEN, CENELEC and ETSI shall implement the submitted programme.

4.4. Progress reports

The formal cooperation between CENELEC and the Commission is ensured

through the normal procedures in the Directive 98/34/EC Committee.

CEN, CENELEC and ETSI are at regular intervals to inform the Commission,
which in turn will inform the Directive 98/34/EC Committee and where it concerns
equipment within the scope of the R&TTE Directive its standing Committee
(TCAM), of any new draft standard which might be covered by this mandate,
together with the characteristics of the standard as referred to above.

4.5. Transposition of standards

The European standards adopted are to be transposed into national standards and
the conflicting national standards are to be withdrawn from the catalogues of the
national standards organisations of Member States before the date of withdrawal
specified in the relevant harmonised standards. In this context it should be
mentioned that the R&TTE Directive does not request transposition of standards
into national standards in order to give a presumption of conformity with its essential
requirements.

5
 4.6. International co-operation

It goes without saying that CEN, CENELEC and ETSI must co-operate with
ICNIRP 6 to ensure that the standards on measurement and testing are properly
aligned with the Council Recommendation 1999/519/EC and avoid any duplication
of work. EMF standards are of international and interregional interest. CEN,
CENELEC and ETSI are therefore also advised to co-ordinate their activities with
the other international standardisation bodies concerned.

4.7. Standstill

Accepting the standardisation programme by the European standards bodies will

open the standstill period referred to in Article 7 of the Directive 98/34/EC 7

6 The International Commission on Non Ionizing Radiation Protection.

7 Council Directive 98/34/EC of 22 June 1998, laying down a procedure for the provision of information in
the field of technical standards and regulations (Official Journal L 204 of 21.07.98) (former Directive
83/189/EEC).