Step 3: User Instruction and Product Label
User Instruction
Requirements for user instructions or manuals may be formulated in the essential requirements of the applicable directives, or in the European harmonized standards. Below we go into the requirements of some of the main CE directives:
EMC Directive (2014/30/EU)
In article 7.7 and article 18 of the EMC Directive some requirements regarding the users manual can be found:
Article 7
(…)
7. Manufacturers shall ensure that the apparatus is accompanied by instructions and the information referred to in Article 18 in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned. Such instructions and information, as well as any labelling, shall be clear, understandable and intelligible.
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Article 18
1. Apparatus shall be accompanied by information on any specific precautions that must be taken when the apparatus is assembled, installed, maintained or used, in order to ensure that, when put into service, the apparatus is in conformity with the essential requirements set out in point 1 of Annex I.
2. Apparatus for which compliance with the essential requirements set out in point 1 of Annex I is not ensured in residential areas shall be accompanied by a clear indication of such restriction of use, where appropriate also on the packaging.
3. The information required to enable apparatus to be used in accordance with the intended purpose of the apparatus shall be included in the instructions accompanying the apparatus.
Other requirements may be found in the European harmonized standards that apply to your product. Therefore we recommend you refer to those standards as well.
Low Voltage Directive (2014/35/EU)
In article 6.7 of the Low Voltage Directive some requirements regarding the users manual can be found:
Article 6
(…)
7. Manufacturers shall ensure that the electrical equipment is accompanied by instructions and safety information in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned. Such instructions and safety information, as well as any labelling, shall be clear, understandable and intelligible.
(…)
Other requirements may be found in the European harmonized standards that apply to your product. Therefore we recommend you refer to those standards as well.
Machinery Directive (2006/42/EC)
The Machinery Directive has a number of clear requirements regarding instructions. The main provision regarding instructions is Article 1.7.4 of Annex I of the Machinery Directive. (Please note that information and warnings provided on labels will not be discussed here, but in SECTION B.8.)
The requirements regarding instructions are as follows:
1. All machinery must be accompanied by instructions in the official Community language or languages of the Member State in which it is placed on the market and/or put into service.
2. The instructions accompanying the machinery must be either ‘Original instructions’ or a ‘Translation of the original instructions’. A translated version of the instructions must always be accompanied with the text of the original instructions.
3. Maintenance instructions intended for use by specialized personnel mandated by the manufacturer or his authorized representative may be supplied in only one Community language that the specialized personnel understand.
4. The words Original instructions must appear on the language version(s) verified by the manufacturer or his authorized representative.
5. Where no Original instructions exist in the official language(s) of the country where the machinery is to be used, a translation into that/those language(s) must be provided by the manufacturer or his authorized representative or by the person bringing the machinery into the language area in question. The translations must bear the words Translation of the original instructions.
6. The contents of the instructions must cover not only the intended use of the machinery but also take into account any reasonably foreseeable misuse thereof.
7. In the case of machinery intended for use by non-professional operators, the wording and layout of the instructions for use must take into account the level of general education and acumen that can reasonably be expected from such operators.
8. Each instruction manual must contain, where applicable, at least the following information:
a. the business name and full address of the manufacturer and of his authorized representative;
b. the designation of the machinery as marked on the machinery itself, except for the serial number (see Article 1.7.3 of Annex I of the Machinery Directive);
c. the EC declaration of conformity, or a document setting out the contents of the EC declaration of conformity, showing the particulars of the machinery, not necessarily including the serial number and the signature;
d. a general description of the machinery;
e. the drawings, diagrams, descriptions and explanations necessary for the use, maintenance and repair of the machinery and for checking its correct functioning;
f. a description of the workstation(s) likely to be occupied by operators;
g. a description of the intended use of the machinery;
h. warnings concerning ways in which the machinery must not be used that experience has shown might occur;
i. assembly, installation and connection instructions, including drawings, diagrams and the means of attachment and the designation of the chassis or installation on which the machinery is to be mounted;
j. instructions relating to installation and assembly for reducing noise or vibration;
k. instructions for the putting into service and use of the machinery and, if necessary, instructions for the training of operators;
l. information about the residual risks that remain despite the inherent safe design measures, safeguarding and complementary protective measures adopted;
m. instructions on the protective measures to be taken by the user, including, where appropriate, the personal protective equipment to be provided;
n. the essential characteristics of tools which may be fitted to the machinery;
o. the conditions in which the machinery meets the requirement of stability during use, transportation, assembly, dismantling when out of service, testing or foreseeable breakdowns;
p. instructions with a view to ensuring that transport, handling and storage operations can be made safely, giving the mass of the machinery and of its various parts where these are regularly to be transported separately;
q. the operating method to be followed in the event of accident or breakdown; if a blockage is likely to occur, the operating method to be followed so as to enable the equipment to be safely unblocked;
r. the description of the adjustment and maintenance operations that should be carried out by the user and the preventive maintenance measures that should be observed;
s. instructions designed to enable adjustment and maintenance to be carried out safely, including the protective measures that should be taken during these operations;
t. the specifications of the spare parts to be used, when these affect the health and safety of operators;
u. the following information on airborne noise emissions:
? the A-weighted emission sound pressure level at workstations, where this exceeds 70 dB(A); where this level does not exceed 70 dB(A), this fact must be indicated,
? the peak C-weighted instantaneous sound pressure value at workstations, where this exceeds 63 Pa (130 dB in relation to 20 ?Pa),
? the A-weighted sound power level emitted by the machinery, where the A-weighted emission sound pressure level at workstations exceeds 80 dB(A).
These values must be either those actually measured for the machinery in question or those established on the basis of measurements taken for technically comparable machinery which is representative of the machinery to be produced.
In the case of very large machinery, instead of the A-weighted sound power level, the A-weighted emission sound pressure levels at specified positions around the machinery may be indicated.
Where the harmonized standards are not applied, sound levels must be measured using the most appropriate method for the machinery. Whenever sound emission values are indicated the uncertainties surrounding these values must be specified. The operating conditions of the machinery during measurement and the measuring methods used must be described.
Where the workstation(s) are undefined or cannot be defined, A-weighted sound pressure levels must be measured at a distance of 1 meter from the surface of the machinery and at a height of 1,6 meters from the floor or access platform. The position and value of the maximum sound pressure must be indicated.
Where specific Community Directives lay down other requirements for the measurement of sound pressure levels or sound power levels, those Directives must be applied and the corresponding provisions of this section shall not apply;
v. where machinery is likely to emit non-ionising radiation which may cause harm to persons, in particular persons with active or non-active implantable medical devices, information concerning the radiation emitted for the operator and exposed persons.
PLEASE NOTE: Sales literature describing the machinery must not contradict the instructions as regards health and safety aspects. Sales literature describing the performance characteristics of machinery must contain the same information on emissions as is contained in the instructions.
PLEASE NOTE 2: For certain categories of machinery, Annex I of the Machinery Directive may prescribe additional requirements regarding instructions. For example for foodstuffs machinery and machinery for cosmetics and pharmaceuticals (2.1.2), for portable hand-held and hand-guided machinery (2.2.1.1 and 2.2.2.2), for mobile machinery (3.6.3), and machinery for lifting purposes (4.4).
Currently, the ISO is developing a standard that will specifically provide guidance to machinery manufacturers how to make their machinery user manuals:
ISO/DIS 20607 Safety of machinery – Instruction handbook – General drafting principles
At this moment, this standard is not yet available, but we expect to be able to report its draft publication in the next few months. Let us know that you are interested, and we will notify you when there is news about this standard.
Product Label Requirements
For the safety of the users of your product it is essential that they have all the information they need to understand how they can use the product correctly and safely. For that reason, many of the CE marking directives and standards have specific provisions about the information or warnings that must be conveyed to users.
The information and warnings can be conveyed by means of a product label (or builders plate/warnings/engravings/product packaging) and a users manual (in some cases a users manual is nothing more than a one page leaflet).
The CE rules do not refer to the quality of the users manual or product label. You will not find any specifications about the exact content of a manual or label. Where provisions exist, they typically refer to information that has to be included in the users manual, the product label or both.
Information requirement for consumer products
If your product is a consumer product (used by consumers in stead of other companies), and if the CE Directives that apply have no provisions regarding the users manual or product label, your company is still bound by a provision in the General Product Safety Directive (2001/95/EC):
Article 5:
1. Within the limits of their respective activities, producers shall provide consumers with the relevant information to enable them to assess the risks inherent in a product throughout the normal or reasonably foreseeable period of its use, where such risks are not immediately obvious without adequate warnings, and to take precautions against those risks. The presence of warnings does not exempt any person from compliance with the other requirements laid down in this Directive.
And paragraph 3 of Article 1 of Decision 768/2008 of the European Council and of the European Parliament states:
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3. Economic operators shall be responsible for ensuring that all information they provide with regard to their products is accurate, complete and in compliance with Community rules applicable
Specific CE directives may have specific labeling requirements, so even when your product is not a consumer good, you may have to provide specific information or warnings.
What is a product label?
Product label is a very general term that can cover a lot of different forms. For the purpose of this section ‘product label’ will cover all of the following:
* builders plate
* warnings
* symbols
* engravings
* packaging (not the card board boxes)
* etc.
General Labeling Requirements
As we have seen when we discussed the obligations of economic operators, the following is required regarding labeling:
1. Products must bear a type number, serial number or batch number in order to allow its identification. Where the size or nature of the product does not allow the affixing of this information, it must be provided on the packaging or in a document accompanying the product.
2. Products must bear the manufacturers AND the importers name, registered trade name or registered trade mark and the address at which they can be contacted on the product. Where that is not possible, the information must be affixed to the product’s packaging or in a document accompanying the product. The address must indicate a single point at which the manufacturer can be contacted.
3. Products must be accompanied by instructions and safety information in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned. This means that the Member States are free to formulate requirement regarding the language on labels and manuals. Most countries do require all information to be translated in the country’s official language(s).
Specific Labeling Requirements:
EMC Directive (2014/30/EU)
In article 7 and article 9 of the EMC Directive some label requirements can be found:
Article 7
(…)
5. Manufacturers shall ensure that apparatus which they have placed on the market bear a type, batch or serial number or other element allowing their identification, or, where the size or nature of the apparatus does not allow it, that the required information is provided on the packaging or in a document accompanying the apparatus.
6. Manufacturers shall indicate, on the apparatus, their name, registered trade name or registered trade mark and the postal address at which they can be contacted or, where that is not possible, on its packaging or in a document accompanying the apparatus. The address shall indicate a single point at which the manufacturer can be contacted. The contact details shall be in a language easily understood by end-users and market surveillance authorities.
(…)
Article 9
(…)
3. Importers shall indicate on the apparatus their name, registered trade name or registered trade mark and the postal address at which they can be contacted or, where that is not possible, on its packaging or in a document accompanying the apparatus. The contact details shall be in a language easily understood by end-users and market surveillance authorities.
(…)
This means that if a product is importer from outside the EU, the name of the manufacturer and importer should be on the product label.
Other label requirements may be found in the European harmonized standards that apply to your product. Therefore we recommend you refer to those standards as well.
Low Voltage Directive (2014/35/EU)
In article 6, paragraph 6 the following is specified about product labeling:
6. Manufacturers shall indicate on the electrical equipment their name, registered trade name or registered trade mark and the postal address at which they can be contacted or, where that is not possible, on its packaging or in a document accompanying the electrical equipment. The address shall indicate a single point at which the manufacturer can be contacted. The contact details shall be in a language easily understood by end-users and market surveillance authorities.
Article 8 adds to that:
3. Importers shall indicate on the electrical equipment their name, registered trade name or registered trade mark and the postal address at which they can be contacted or, where that is not possible, on its packaging or in a document accompanying the electrical equipment. The contact details shall be in a language easily understood by end-users and market surveillance authorities.
This means that if a product is importer from outside the EU, the name of the manufacturer and importer should be on the product label.
In Annex I, section 1 to the Low Voltage Directive some label requirements can be found:
(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 electrical equipment, or, if this is not possible, on an accompanying document;
(…)
Other label requirements may be found in the European harmonized standards that apply to your product. Therefore we recommend you refer to those standards as well.
Machinery Directive (2006/42/EC)
The Machinery Directive has a few provisions regarding information and markings provided on the product label(s):
1. Information and warnings on the machinery should preferably be provided in the form of readily understandable symbols or pictograms. Any written or verbal information and warnings must be expressed in an official Community language or languages, which may be determined in accordance with the Treaty by the Member State in which the machinery is placed on the market and/or put into service and may be accompanied, on request, by versions in any other official Community language or languages understood by the operators. (See article 1.7.1. of Annex I of the Machinery Directive).
Please note that there are international standards that try to harmonize the use of graphical symbols, in order to come to a series of readily understandable symbols and pictograms: see ISO 7000 ‘Graphical Symbols for Use on Equipment, Index and Synopsis’ and ‘IEC 60417, Graphical Symbols for use on Equipment’.
2. The information needed to control machinery must be provided in a form that is unambiguous and easily understood. It must not be excessive to the extent of overloading the operator. Visual display units or any other interactive means of communication between the operator and the machine must be easily understood and easy to use.
3. All machinery must be marked visibly, legibly and indelibly with the following minimum particulars:
* the business name and full address of the manufacturer and, where applicable, his authorized representative,
* designation of the machinery,
* the CE Marking (see SECTION B.6.),
* designation of series or type,
* serial number, if any,
* the year of construction, that is the year in which the manufacturing process is completed.
It is prohibited to pre-date or post-date the machinery when affixing the CE Marking.
Furthermore, machinery designed and constructed for use in a potentially explosive atmosphere must be marked accordingly. (See ATEX Directive)
Machinery must also bear full information relevant to its type and essential for safe use. Such information should preferably be provided in the form of readily understandable symbols or pictograms, or else expressed in the official language(s) of the country in which the machinery is placed on the market or put into service.
Where a machine part must be handled during use with lifting equipment, its mass must be indicated legibly, indelibly and unambiguously.