User instructions are generally used to provide useful information to consumers and users in general, such as how to install, properly use, or dispose of products. User instructions can also include battery replacement instructions, warning texts, and more.
Instructions are mandatory for a wide range of products sold in the European Union. Hence, failing to create a sufficient user instruction document could result in fines, product recalls, and other issues.
In this guide, we explain what importers, manufacturers, and Amazon sellers must know about creating user instructions for electronics, toys, and other products.
Content Overview
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Which products require user instructions in the European Union?
Many regulations and directives set requirements for user instructions. Whether a product requires user instructions depends on what regulations and directives affect it.
Here are some examples of product categories for which, in general, user instructions are required:
- Electronic products
- Toys
- Machinery
- Personal protective equipment
- Food contact materials
- Cosmetics
- Medical devices
General Product Safety Regulation
The General Product Safety Regulation contains labelling, documentation and other requirements affecting consumer products. It requires that covered products come with clear instructions and safety information, unless they can be used safely without the provision of such instructions. The instructions must be written in a language easily understood by the consumer.
Here are some examples of products that may require user instructions:
- Foldaway beds for domestic use
- Children’s cots and folding cots
- Cribs
- Mattresses for cots and cribs
- Strength training benches
Article 10(7): Manufacturers shall ensure that their product is accompanied by clear instructions and safety information in a language which can be easily understood by consumers, as determined by the Member State in which the product is made available on the market. That requirement shall not apply where the product can be used safely and as intended by the manufacturer without such instructions and safety information.
Electronics
There are a number of directives and regulations that affect electronic products. Most of them contain a requirement for instructions and safety information to be provided for users of the product.
Here are some examples of electronic products that require instructions:
- Lighting products
- Wireless products
- Game consoles
- Refrigerators
- Electronic displays
Here is a list of regulations and directives that require covered products to come with instructions:
- Low Voltage Directive (LVD)
- Electromagnetic Compatibility (EMC) Directive
- Radio Equipment Directive
- Ecodesign Directive
- Energy Labelling Regulation
- WEEE Directive
Note that we could not find any requirements for the provision of instructions in the RoHS Directive.
Low Voltage Directive, 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.
EMC Directive, 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.
Radio Equipment Directive, Article 10(8): Manufacturers shall ensure that the radio equipment is accompanied by instructions and safety information. Instructions shall include the information required to use radio equipment in accordance with its intended use. Such information shall include, where applicable, a description of accessories and components, including software, which allow the radio equipment to operate as intended. Such instructions and safety information, as well as any labelling, shall be clear, understandable and intelligible. […]
WEEE Directive, Article 14(5): Member States may require that some or all of the information referred to in paragraphs 2, 3 and 4 shall be provided by producers and/or distributors, e.g. in the instructions for use, at the point of sale and through public awareness campaigns.
Regulations that implement the Ecodesign Directive and the Energy Labelling Regulation may contain requirements for user instructions. Here are some examples:
Commission Regulation (EU) 2019/2020 on ecodesign requirements for light sources and separate control gears, Article 4(2): Manufacturers, importers or authorised representatives of containing products shall provide information about the replaceability or non-replaceability of light sources and control gears by end-users or qualified persons without permanent damage to the containing product. Such information shall be available on a free-access website. For products sold directly to end-users, this information shall be on the packaging, at least in the form of a pictogram, and in the user instructions.
Commission Delegated Regulation (EU) 2019/2015 on energy labelling of light sources, Annex V: 2. Information to be displayed in the documentation for a containing product
If a light source is placed on the market as a part in a containing product, the technical documentation for the containing product shall clearly identify the contained light source(s), including the energy efficiency class.
If a light source is placed on the market as a part in a containing product, the following text shall be displayed, clearly legible, in the user manual or booklet of instructions: […]
Batteries Regulation
The Batteries Regulation is a CE marking regulation that affects different types of batteries and products containing batteries. Among its many requirements, it requires that covered products come with readable instructions and safety information.
Additionally, products that are designed to use portable batteries must come with instructions and safety information on the use, removal and replacement of such batteries. The instructions must be made available online for users and must be in languages which can be easily understood by users.
Here are some examples of covered products:
- Button cell batteries
- AA batteries
- Batteries for Electric bicycles
- Batteries for Electric scooters
Article 11(1): […] Any natural or legal person that places on the market products incorporating portable batteries shall ensure that those products are accompanied with instructions and safety information on the use, removal and replacement of the batteries. Those instructions and that safety information shall be made available permanently online, on a publicly available website, in an easily understandable way for end-users.
Toy Safety Directive
The Toy Safety Directive requires that toys intended to be used by children under 14 years of age must be accompanied by instructions and safety information. It must be provided in a language that is easily understood by consumers.
The user instructions, if necessary, should also contain warning symbols and statements that indicate the hazards and accidents that may arise during the use of the toys, such as age warnings, choking warnings, adult supervision warnings, and allergy warnings.
Here are some examples of toys for which specific warnings are required:
- Activity toys
- Chemical toys
- Roller skates, skateboards, toy bicycles
- Aquatic toys
- Toys in food
Article 4(7): Manufacturers shall ensure that the toy is accompanied by instructions and safety information in a language or languages easily understood by consumers, as determined by the Member State concerned.
Personal Protective Equipment Regulation
The Personal Protective Equipment Regulation mandates that personal protective equipment sold in the EU must include user instructions that contain detailed information for storage, use, cleaning, maintenance, servicing, and disinfection of the products.
Annex II of the regulation lists additional information that may be included in the instructions, such as:
a. Class of protection suitable for the level of risk and limits of use, when applicable
b. Date of obsolescence of the product or some of its components, when applicable
c. Type of packaging that is suitable for transportation, when applicable
Also, markings, symbols, or warning statements must be included in the manufacturer’s instructions and product packaging, when the PPE is too small to accommodate all necessary marking.
Here are some examples of personal protective equipment:
- Hearing protectors
- Respiratory protective devices
- Industrial safety helmets
- Protective clothing for users of hand-held chainsaws
Article 8(7): Manufacturers shall ensure that the PPE is accompanied by the instructions and information set out in point 1.4 of Annex II 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, intelligible and legible.
Construction Products Regulation
The Construction Product Regulation requires that construction products must be accompanied by instructions and safety information.
Here are some examples of construction products
- Doors
- Windows
- Sanitary appliances
- Floorings
- Space heating appliances
Article 11(6): When making a construction product available on the market, manufacturers shall ensure that the product is accompanied by instructions and safety information in a language determined by the Member State concerned which can be easily understood by users.
Medical Devices Regulation
The Medical Devices Regulation requires that covered products include instructions for use, which should contain the device’s intended purpose, proper use, and precautions be taken when using the device.
Product examples include:
- Surgical gloves
- Electronic thermometer
- Electronic blood pressure measuring equipment
- Long term corrective contact lenses
Annex I, Chapter III, 23.1: […] Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user, or any other person, as appropriate. Such information may appear on the device itself, on the packaging or in the instructions for use, and shall, if the manufacturer has a website, be made available and kept up to date on the website, taking into account the following: […]
Machinery Regulation
The Machinery Regulation contains requirements affecting machinery, partly completed machinery, and the following related products:
- Interchangeable equipment
- Safety components
- Lifting accessories
- Chains, ropes and webbing
- Removable mechanical transmission devices
Among its many requirements, the regulation requires user instructions to be provided for the machinery and related products supplied. Here are some examples of covered products:
- Electrically power assisted cycles
- Robotic battery powered electrical lawnmowers
- Garden blowers
- Vegetable cutting machines
- Compression power tools
Article 10(7): Manufacturers shall ensure that the machinery or related products are accompanied by the instructions for use and the information set out in Annex III. The instructions may be provided in a digital format. Such instructions and information shall clearly describe the product model to which they correspond.
Cosmetic Products Regulation
The Cosmetic Products Regulation contains labelling, documentation, and testing requirements affecting cosmetic products. It also requires that instructions for use and disposal be provided with the cosmetic product.
Here are some examples of cosmetic products:
- Eyelash colouring products
- Tooth whitening products
- Eye products
- Shower gels
- Face, hand, and lip products
Article 3: A cosmetic product made available on the market shall be safe for human health when used under normal or reasonably foreseeable conditions of use, taking account, in particular, of the following:
(a) presentation including conformity with Directive 87/357/EEC;
(b) labelling;
(c) instructions for use and disposal;
(d) any other indication or information provided by the responsible person defined in Article 4.
The provision of warnings shall not exempt persons defined in Articles 2 and 4 from compliance with the other requirements laid down in this Regulation.
EU Food Contact Materials Framework Regulation
The EU Food Contact Materials Framework Regulation contains labelling, documentation, and testing requirements affecting food contact materials. Under this regulation, specific measures are developed for certain food contact materials.
The regulation requires that user instructions be provided for the food contact product (if necessary). Here are some examples of food contact materials:
- Cork
- Glass
- Metals and alloys
- Plastics
- Wood
Article 15(1): Without prejudice to the specific measures referred to in Article 5, materials and articles, which are not yet in contact with food when placed on the market, shall be accompanied by:
(a) the words ‘for food contact’, or a specific indication as to their use, such as coffee machine, wine bottle, soup spoon, or the symbol reproduced in Annex II;
and
(b) if necessary, special instructions to be observed for safe and appropriate use; […]
Are user instructions required for CE-marked products?
Yes, instructions are generally required for CE-marked products. However, there are exceptions like the RoHS Directive which does not contain such a requirement.
By following the instructions, consumers can use the product as the manufacturer intended and avoid certain risks associated with the mishandling of the product.
Are user instructions required for other (non-CE) products?
Due to the General Product Safety Regulation, the Cosmetic Products Regulation, and the Food Contact Materials Framework Regulation, virtually all non-food products must come with instructions.
Non-CE marking regulations cover many products that pose risks to the users if mishandled. For instance, baby strollers must be assembled and operated as the manufacturer intended otherwise the user may risk having the product breakdown resulting in physical injury to the child occupant.
Standards
Some standards contain requirements for product user instructions. Below we provide examples of such standards. Note that there may be more standards that contain requirements for user instructions.
| Standard | Description |
| IEC/IEEE 82079-1 – Preparation of information for use (instructions for use) of products Part 1: Principles and general requirements | This standard contains general principles and detailed requirements for user instructions relating to a wide range of product categories. |
| ISO/IEEE DIS 82079-2 – Preparation of information for use (instructions for use) of products Part 2: Assembly of self-assembly products | This standard covers self-assembly products and contains information relating to the user instructions for such products. However, the standard is currently under development. |
| IEC/AWI 82079-3 – Preparation of information for use (instructions for use) of products
Part 3: Specific provisions for complex systems |
This standard contains requirements for user instructions relating to complex systems. Complex systems refer to an assembly of linked parts, components and subsystems which are brought together for a specific purpose. |
| ISO 21600 – Technical product documentation (TPD) — General requirements of mechanical product digital manuals | This standard contains requirements for mechanical product digital manuals. For instance, it contains guidance on topics such as provisions for repair and maintenance found in user instructions. |
| ISO 20607:2019
Safety of machinery — Instruction handbook — General drafting principles |
This is a standard that contains requirements for the preparation of instructions for machinery. It specifically focuses on the content of the instructions related to product safety. |
User instructions examples
In this section, we provide examples of information covered in user instructions. All the examples provided in this section are based on the user instruction requirements of EU regulations and directives.
Table of contents
We could not find an example of a requirement for a table of contents to be featured in user instructions. However, it is important to include the table to make the context of the user instructions more easily accessible to consumers.
Product and company information
Many regulations require product information for traceability purposes and company information to be featured on a product. However, where that is not possible, this information may be included in documents accompanying the product like user instructions. An example of such regulation is the EMC Directive.
Intended use
Some products require to be used in a specific manner or purpose to avoid possible malfunctioning of the product or physical injury to the user. This is the reason why user instructions should come with information about the product’s intended use or purpose.
Both the EMC Directive and the PPE Regulation are examples of legislation that require user instructions to contain information about the intended use of the product.
List of components and accessories
Some user instructions must disclose the list of components and accessories that come with products. For example, the Radio Equipment Directive requires radio equipment to come with ’ user instructions that contain descriptions of accessories and components so that the user can ultimately operate the product as intended.
Safety warnings and compliance marks
Some user instructions feature safety warnings and other compliance marks to alert the consumer of the hazards related to the product and the precautions that should be taken.
For example, under the Toy Safety Directive, toys that are unsuitable for younger children typically come with user instructions that disclose the hazards that come with them.
Assembly, installation and use instructions
Some user instructions should come with information on assembly, installation and use as without such information it could result in physical injury to the user or damage to the product.
For example, under the Machinery Regulation, machinery products designed to be mounted or installed on another item should come with such instructions.
Maintenance and cleaning instructions
Some user instructions should come with maintenance and cleaning instructions. For instance, under the Machinery Regulation certain machinery products are required to come with user instructions detailing the type of inspections and maintenance required.
Additionally, the user instructions for machinery or related products for foodstuffs, cosmetics or pharmaceutical products must disclose the methods for cleaning, disinfecting and rinsing the product.
Disposal and recycling instructions
The user instructions for some products should come with a section that explains how the user should dispose of or recycle the product. For example, the WEEE Directive provides some examples of information that may be required to be included in the user instruction for electronic products:
- Information on disposal practices of WEEE
- Return and collection systems available to consumers
- Risks concerning hazardous substances in EEE
Other Information
Some regulations may require additional information to be shown in the user instructions.
Language Requirements
Many regulations require that instructions be provided in languages that are easily understood by consumers. This is determined by the Member States to which the product is sold.
For example, the General Product Safety Regulation contains the language requirement for user instructions:
General Product Safety Regulation, Article 10(7): Manufacturers shall ensure that their product is accompanied by clear instructions and safety information in a language which can be easily understood by consumers, as determined by the Member State in which the product is made available on the market. That requirement shall not apply where the product can be used safely and as intended by the manufacturer without such instructions and safety information.
Very interesting article! Thank you so much!
Do you think that refrigerators fall under the scope of application of the EU Machinery Directive, and consequently they need to be sold accompanied by an instruction manual in the language of the consumer?
Thank you!
Hi Fredrik, I had a question regarding the language requirements. “User instructions must be written in language or languages which could be understood by the consumers of the destined market.” For the Netherlands, must we have dutch translated user manuals or will english suffice given english is so widely used in NL?
Hi Ash,
I think the directives and regulations only mention language requirements in the context of the official national languages.
Thank you for the extensive information. I have 2 questions, is this information still valid these days? 2: we sell electronical office devices (keyboards & mice). Our US partner is switching from printed user manuals accompanying the product to putting them online, accessible through a QR-code on a small product card in the box of the device.
I get from the information above that that is also allowed in Europe.
For keyboards and mice, what else is mandatory in Europe to mention on the ‘product card’?
Thank you for your time!
Hello Esther,
Several directives state that instructions must be provided on accompanying documentation.
Hi,
Nice article. Can you tell me which directive lists the mentioned IEC IEEE 82079-1 standard. Anyway it has an EN version, so probably it’s harmonised, but it doesn’t include that typical chapter what tells which requirement of which directive is fulfilled by following the standard.
You haven’t mentioned but the Machinery Directive lists the EN ISO 20607:2019 standard. It’s about Safety of machinery – Instruction handbook – General drafting principles.
Interesting read! Do you know if for electronic equipment you need to include a printed manual incl safety instructions, or is it allowed to point to an online PDF manual & safety precautions via a small leaflet with QR code?
Hello Peter,
This is written in the Low Voltage Directive
“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.”
It’s not certain that they will accept a QR code as it cannot be assumed that everyone has access to the internet at all times. Also, it just seems like an unnecessary risk to me as the common practice is to provide a printed manual.