Product information relevant to consumers - Guidelines for standard developers

This Guide provides standardization committees with the information necessary to develop product information requirements in as uniform and complete manner as possible. It concentrates on safety information, but also contains other kinds of information.
Some European Directives have specific requirements for product information relating to consumer safety or the safety of employees. Compliance with this Guide may not meet these requirements.
This Guide can be consulted where:
   products are not (yet) covered by standards and/or codes of good practice;
   products are covered by standards without product information requirements;
   more in-depth guidance on product information is sought.

Informacija o izdelku, pomembna za uporabnika - Smernice za pripravo standardov

Ta priročnik odborom za standardizacijo podaja informacije, ki so nujne za razvoj zahtev glede informacij o proizvodih na čim enotnejši in celovitejši način. Osredotoča se na varnostne informacije, a vsebuje tudi druge vrste informacij.
Nekatere evropske direktive imajo posebne zahteve glede informacij o proizvodih v povezavi z varnostjo potrošnikov ali zaposlenih. S skladnostjo s tem priročnikom te zahteve morda ne bodo izpolnjene.
Ta priročnik je mogoče uporabiti, kadar:
proizvodi (še) niso zajeti s standardi in/ali kodeksi dobre prakse;
so proizvodi zajeti s standardi brez zahtev glede informacij o proizvodih;
se zahteva več poglobljenih smernic glede informacij o proizvodih.

General Information

Status
Published
Publication Date
11-Oct-2016
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
03-Jun-2016
Due Date
08-Aug-2016
Completion Date
12-Oct-2016

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SLOVENSKI STANDARD
SIST-V CEN/CLC Guide 11:2016
01-november-2016
Informacija o izdelku, pomembna za uporabnika - Smernice za pripravo
standardov
Product information relevant to consumers - Guidelines for standard developers
Ta slovenski standard je istoveten z: CEN/CLC Guide 11:2012
ICS:
01.120 Standardizacija. Splošna Standardization. General
pravila rules
SIST-V CEN/CLC Guide 11:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-V CEN/CLC Guide 11:2016







CEN-CENELEC
GUIDE
11







Product information relevant to
consumers — Guidelines for
standard developers
Edition 2, 2012-10-31



CEN-CENELEC Guide 11 was adopted by the CEN Technical Board through Decision 22/2012 and by the CENELEC
Technical Board through Decision D142/016.

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European Committee for Standardization
Tel: +32 2 550 08 11
Fax: +32 2 550 08 19

European Committee for Electrotechnical Standardization
Tel: +32 2 519 68 71
Fax: +32 2 550 08 19


Avenue Marnix 17
1000 Brussels – Belgium


www.cen.eu

www.cenelec.eu

www.cencenelec.eu

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Guidelines for standards developers

Contents
Foreword . 4
Introduction . 5
1 Scope . 6
2 References and bibliography . 6
3 Terms and definitions . 6
4 Principles of development of product information . 8
4.1 Principles of safety . 8
4.2 Risk assessment . 9
4.3 Authorship of the product information . 9
4.4 Principles for communicating information . 9
4.4.1 General aspects . 10
4.4.2 Communicating of the consumer's questions . 10
4.4.3 Communicating of several functions . 10
4.4.4 Communicating of complex information . 10
4.4.5 Communicating to specific groups . 10
5 Content of product information . 10
5.1 Purchase information . 10
5.1.1 General . 10
5.1.2 Handling . 11
5.1.3 Storage and unpacking . 11
5.1.4 Product traceability . 12
5.2 Instructions for use . 12
5.2.1 Assembly and / or installation. 12
5.2.2 Operation . 12
5.2.3 Other information . 12
5.3 After sales information . 13
6 Presentation of product information . 13
6.1 General . 13
6.2 Media . 14
6.3 Location . 14
6.4 Understandability . 14
6.4.1 Comprehensibility . 14
6.4.2 Readability. 15
6.4.3 Legibility . 15
6.4.4 Language . 15
6.5 Durability of the instruction for use . 16
7 Guidelines for the development of safety sentences and symbols . 16
7.1 Warnings . 16
7.2 Safety signs. 17
8 Testing and evaluation . 17
Annex A Examples of warning sentences . 18
Annex B Overview of criteria and guidelines for a legible presentation of safety sentences and
symbols . 19
Annex C Stages of risk assessment . 20
Annex D Contents for standards . 21
D.1 General . 21
D.2 Markings . 21
D.3 Purchase information . 21
D.4 Instructions for use . 21
Annex E Checklist . 22

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Foreword
CEN (the European Committee for Standardization) and CENELEC (the European Committee for
Electrotechnical Standardization) form part of the specialised system for European standardization. National
bodies that are members of CEN or CENELEC participate in the development of European Standards through
technical committees established by the respective organisation to deal with particular fields of technical activity.
Other European organisations, governmental and non-governmental, in liaison with CEN and/or CENELEC, also
take part in the work.
European Standards are drafted in accordance with the rules given in the CEN-CENELEC Internal Regulations,
Parts 2 and 3.
Draft Guides adopted by the responsible Committee or Group are circulated to national bodies for voting.
Publication as a Guide requires approval by simple majority of the national bodies casting a vote.
Edition 1 of this guide was prepared by CEN/BT WG 124 ‘Safety of consumers and children — Product
information’, the secretariat of which is held by NEN. Subsequently, the Guide was adopted by the CENELEC
Technical Board in Decisions D125/C013 and D125/C014.
The present Edition 2 of CEN-CENELEC Guide 11 results from an editorial exercise, where dated references
have been updated or replaced by undated ones whenever possible. It has been adopted by the CEN Technical
Board in Decision 22/2012, and by the CENELEC Technical Board in Decision D142/016.
This document has been prepared under Mandate M/292 given to CEN, CENELEC and ETSI by the European
Commission and the European Free Trade Association.
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Introduction
The primary purpose of this Guide is to assist Technical Committees, or Working Groups, responsible for drafting
standards to identify the essential characteristics of information of significance to the consumers of products. The
Guide may also assist those responsible for providing product information. This Guide will be of value to those
seeking to meet their obligations to provide consumers with adequate information to ensure them to use a
product safely. This Guide could also be used by standard writers for services.
Technical Committees have the best competence to decide if and how to address aspects regarding product
information in their standards. Not every standard is affected (e.g. test method standards).
This Guide is one of several on aspects of consumer information. The CEN Working Group responsible for its
creation has identified, in the References, those documents, which it believes contain material of fundamental
importance to the production of effective product information.
Guidance on the general informational needs of people with disabilities and older people can be found in CEN-
CENELEC Guide 6. Specific guidance for standards writers to address the issues of child safety in standards can
be found in CEN-CENELEC Guide 14.
It is important to emphasise that this Guide does not contain original material. Its purpose is to draw selectively
from key documents and to present essential material in a concise and easily accessible form. Interested parties
may find specific guidance on a number of related themes in the documents listed in the references. Cross-
references have only been included when the quoted list is not complete.
This Guide is relevant to all methods by which products are offered to consumers, including distance selling and
sales by electronic mail. While this Guide is aimed at products used by consumers, standard writers for products
aimed at the professional user should consider this Guide in case of possible use by consumers, such as
migration products, e.g. in the do-it-yourself market.
Information for consumers is a vital part of any product. Improving the quality of information increases
consumers’ ability to make a reasoned choice at the point of purchase. It helps to minimise risk of incorrect or
inappropriate purchases or contracts. Consumer uncertainties are reduced and consumer satisfaction is
increased. Those who supply a high standard of consumer information enhance their commercial reputation, and
save time and money by reducing enquiries and complaints.
There is considerable scope for further standardization in the field of consumer information in terms of individual
products, and even more so for groups of products.
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1 Scope
This Guide provides standardization committees with the information necessary to develop product information
requirements in as uniform and complete manner as possible. It concentrates on safety information, but also
contains other kinds of information.
Some European Directives have specific requirements for product information relating to consumer safety or the
safety of employees. Compliance with this Guide may not meet these requirements.
This Guide can be consulted where:
 products are not (yet) covered by standards and/or codes of good practice;
 products are covered by standards without product information requirements;
 more in-depth guidance on product information is sought.
2 References and bibliography
EN-ISO 12100, Safety of machinery — General principles for design – Risk assessment and risk reduction
(ISO 12100)
EN 82079-1:2012, Preparation of instructions for use — Structuring, content and presentation — Part 1: General
principles and detailed requirements (IEC 82079-1:2012)

CEN/TR 13387:2004, Child use and care articles — Safety guidelines
ISO 3864-1, Graphical symbols — Safety colours and safety signs — Part 1: Design principles for safety signs
and safety markings
ISO 3864-2, Graphical symbols — Safety colours and safety signs — Part 2: Design principles for product safety
labels
ISO 7000, Graphical symbols for use on equipment — Registered symbols
CEN-CENELEC Guide 6:2002, Guidelines for standards developers to address the needs of older persons and
persons with disabilities
CEN-CENELEC Guide 14, Child safety — Guidance for its inclusion in Standards
ISO/IEC Guide 14:2003, Purchase information on goods and services intended for consumers
ISO/IEC Guide 37, Instructions for use of products of consumer interest
ISO/IEC Guide 41, Packaging — Recommendations for addressing consumer needs
ISO/IEC Guide 50, Safety aspects — Guidelines for child safety
ISO/IEC Guide 71, Guidelines for standards developers to address the needs of older persons and persons with
disabilities

ISO/IEC Guide 51:1999, Safety aspects — Guidelines for their inclusion in standards
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

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Table 3.1 —
Alphabetical list of terms and definitions


Term or definition Subclause

After sales information 3.5
Harm 3.10
Hazard 3.9
Instruction for use 3.4
Marking 3.2
Producer 3.11
Product information 3.1
Purchase information 3.3
Residual risk 3.8
Risk 3.6
Risk assessment 3.7

3.1 Product information
Texts and images may accompany or be associated with a specific product. This includes labels, certification
marks, markings, leaflets, manuals and brochures. Product information consists of three different categories, see
Figure 3.1.


Figure 3.1 — Categories of product information

3.2 Marking
Marking is a kind of product information permanently attached to the product or, if the packaging creates the risk,
to its packaging; all markings belong to one of the categories ‘purchase information’ and ‘instructions for use’, or
both.
3.3 Purchase information
Information that will allow an informed choice before the purchase of a product (including mail order catalogues,
telesales and e-business).
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Instructions for use
3.4
Information supplied to enable the consumer to assemble, install, operate, store, maintain, repair, and dispose of
the product.
3.5 After sales information
Any information that is not accompanying the product such as information on updates, recalls, and maintenance.
3.6 Risk
Combination of the probability of occurrence of harm and the severity of that harm.
3.7 Risk assessment
Overall process comprising a risk analysis and risk evaluation.
3.8 Residual risk
Risk remaining after protective measures have been taken.
3.9 Hazard
A potential source of harm.
NOTE The term hazard can be qualified in order to define its origin (e.g. mechanical hazard, electrical hazard) or the
nature of the potential harm (e.g. electric shock hazard, cutting hazard, toxic hazard, fire hazard).
3.10 Harm
Physical injury or damage to the health of people.
3.11 Producer
The definition of producer depends on whether the manufacturer is established in the community and whether
other professionals in the supply chain affect the safety properties of a product. Therefore, the following
definitions for producer are used (GPSD):
 the manufacturer of the product, when he is established in the community and any other person presenting
himself as the manufacturer by affixing to the product his name, trade mark or other distinctive mark, or the
person who reconditions the product;
 the manufacturer’s representative, when the manufacturer is not established in the community or, if there is
no representative established in the community, the importer of the product;
 other professionals in the supply chain, in so far as their activities may affect the safety properties of a
product placed on the market.
4 Principles of development of product information
Product information is an integral part of the delivery of the product.
4.1 Principles of safety
Product information requirements in standards have a direct impact on safety. Product information should
contribute to avoiding risks to the person, or damage to the product. However, product information is not
intended to compensate for design deficiencies. It does not in itself make a product safer, but it is a means for
the producer to communicate with the buyer and/or consumer. It can contribute to avoid unsafe interactions of
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people with the product. Therefore, reasonable foreseeable misuse and risks of the product should be made
explicit and adequate warnings be given.
4.2 Risk assessment
Risk assessment should be carried out to determine the risks of a product (procedure described in
ISO/IEC Guide 51 and in Annex C). The product should be designed in such a way that as many hazards as
possible are eliminated. The residual risk should be described in the product information including all necessary
references to personal protective equipment.
NOTE In some cases specific sector guides to determine risk assessment are available, e.g. CEN/TR 13387:2004.
All products posing a potential residual risk to the consumer shall be accompanied by appropriate, clear, and
legible warnings of such risks. Where specific skills, experience, knowledge, or additional equipment or clothing
is required for safe use, warnings should be given at the point of sale, on retail packaging, and on the product.
However, risks associated in the use of products that are obvious for the consumer, just because they are part of
their functions, should not be mentioned (is it useful to warn people that they can cut themselves with a knife?).
This could result in such a multiplication of useless warnings that the consumer would not even pay attention to
the necessary ones. Over-marking with consumer information should be avoided, as this would detract from
safety warnings. The difficult part is defining what is obvious. For instance, every consumer knows that an oven
will become hot, but most consumers expect that the outside of the oven is just a little bit warm and not so hot
that you can get burned. However, most ovens get so hot that you can get burned. Do you need a warning or
not? Furthermore, everyone knows that you need special skills to ride a bicycle otherwise you can fall and get
hurt. Do bicycles need a warning? ‘Warning: Wear a helmet when riding your bike, you could fall and hurt
yourself’.
Warnings, which relate to the skills, experience or age of the consumer, should appear on the product, on its
retail packaging and be clearly legible at the point of sale.
4.3 Authorship of the product information
The preparation of instructions should be an integral part of the product development process, rather than an
exercise carried out when everything else has been done. According to the guidelines on product information, it
is preferable not to use people who are too close to the product to see it from the consumers point of view to
write instructions. Producers are responsible for adequate quality of the product information and ensure that
qualified persons will write the information.
4.4 Principles for communicating information
 the product information shall be expressed concisely and precisely and aim at a given target group;
 the product information shall be imparted to the target group in an understandable and useful way;
 recognised methods and means like typography, layout and printing procedures shall be used to enhance
the readability;
 relevant laws, regulations and standards concerning product liability, copyright, etc. shall be given
prominence.
Consumer information should be clearly distinguishable from that intended to promote the product
(EN 82079-1:2012).
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4.4.1 General aspects
Effective communication of information is most likely when authors apply the principle of 'First Read Then Act'.
Instructions for use should follow the likely sequence of actions to be taken by the consumer.
4.4.2 Communicating the consumer's questions
The instructions for use of a product should anticipate the consumer’s questions ‘Where? Who? What? When?
How? Why?’ and provide answers to them.
4.4.3 Communicating several functions
Instructions for use of a product intended to perform several different and independent functions should start with
a basic or normal function and deal later with other functions.
4.4.4 Communicating complex information
Where complex-operating procedures shall be followed for safe and correct use of the product, the instructions
should enable and encourage the consumer to follow a continuous learning and understanding process.
Particularly useful means of promoting this process include illustrations, tables and flow-charts.
4.4.5 Communicating to specific groups
Parts of the information that are directed only to a specific group of persons (e.g. for installation, repair) should
be given separately and in the format selected to be the most appropriate for the specific group. This information
should be marked.
5 Content of product information
A useful distinction between information necessary for all products, product specific information, and information
for specific tasks (e.g. maintenance for unskilled persons, maintenance for skilled persons) should be made.
5.1 Purchase information
The principle should be that a consumer can get all essential information concerning a pre-packaged product
without opening a package. That information will allow an informed choice before the purchase of a product.
5.1.1 General
Normally, the minimum contents of purchase information should characterise the essential features of the
product. The purchase information should include items of the following list, where relevant
(ISO/IEC Guide 14:2003):
a) conditions and any limitations for use;
1) description of the type of consumer or non-consumer;
2) for example if usage is restricted to skilled persons only, and typical staffing requirements for normal
operation;
3) for example a pregnant woman is not allowed in a rollercoaster;
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4) additional parts that are available for certain environments (e.g. guard devices, accessories);
5) intended use of the product, the main function and the range of applications including compatibility with
devices designed specifically for persons with disabilities;
6) limitations of use under climatic conditions of operation and storage (for example temperature limits,
restriction of usage in explosive atmospheres, humidity, outdoor operation);
7) type of personal protective equipment.
b) identification of the product;
c) product characteristics such as contents or size;
d) need for special (professional) installation
e) type of resource needed;
f) additional parts that are available for certain environments (e.g. guard devices, accessories);
g) indication of what is included with the product (e.g. personal protective equipment);
h) residual risk;
i) environmental issues (e.g. water, waste, noise);
j) warranties and guarantees.
5.1.2 Handling
Instructions on handling and transportation where relevant should include:
 dimensions, mass value(s), position of the centre(s) of gravity;
 indications for transport handling (e.g. drawings indicating gripping points for lifting the product);
 details of the measures to be taken to protect and preserve the product during transit.
5.1.3 Storage and unpacking
Instructions on storage and unpacking where relevant should include:
 packaging or inventory checklist;
 packaging, repackaging and unpacking instructions, including details of the measures to be taken to protect
and preserve the product during storage;
 storage conditions of the product;
 disposal of packaging.
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5.1.4 Product traceability
General principle: The product shall be traceable. The information on the product (if the product is too small, on
the packaging) could include:
 name and address or trademark of producer of the product (including country code);
 product identification by reference designation, serial number, batch number (if applicable), name model
and/or type.
5.2 Instructions for use
Information for safe operations /intended use of the product should be in accordance with the results of the risk
assessment. Where applicable, special protective measures should be given (e.g. adult supervision, wearing
special clothing).
NOTE Warnings directed to children should be avoided.
More information about warning sentences and symbols are mentioned in Clause 7.
5.2.1 Assembly and / or installation
Instructions for assembly and / or installation of the product should include, where relevant (EN 82079-1:2012):
 inventory of parts;
 special skills or tools required.
5.2.2 Operation
Instructions on operation should include information for (EN 82079-1:2012):
 restrictions on use (e.g. not in wet areas);
 need for personal protective equipment;
 warning about hazards;
 operation / operational life;
 maintenance / cleaning;
 repair;
 disposal.
5.2.3 Other information
Other information covers the following subjects:
 environment (e.g. disposal of waste material, recycling);
 service maintenance;
 training mat
...

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