Rights, obligations and rules for the production of goods

NSAI (National Standards Authority of Ireland) is Ireland’s official standards body.

NSAI aims to inspire consumer confidence and create the infrastructure for products and services to be recognised and relied on, all over the world.

NSAI is a Notified Body (NB) under the following EU directives and regulations only:

• 90/385/EEC Active implantable medical devices
• 93/42/EEC Medical devices
• 98/79/EC In vitro diagnostic medical devices
• Regulation (EU) No 305/2011 - Construction products
• Regulation (EU) 2017/745 on medical devices
• 2014/31/EU Non-automatic weighing instruments
• 2014/32/EU Measuring Instruments Directive

Many products require CE marking before they can be sold in the EU. CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU.

It is not a quality indicator or a certification mark.

10 Steps to CE Marking

Step 1

Identify the Directive/s that is/are applicable to your product. You can download these directives free of charge from the EU website: www.europa-cemarking.org.

If your product does not fall under any of these Directives, 'CE' marking is not possible at present.

However, all products must comply with the provisions of the General Product Safety Directive 2009/95/EC as transposed into Irish law by S.I. No. 199/2004.

Further information is also available on the Competition and Consumer Protection Commission website.

You may wish to demonstrate that your manufacturing and/or sales and distribution activities comply with best practice, therefore you may consider Certification by NSAI to ISO9001:2015.

Step 2

Identify the conformity assessment procedure that must be taken. This could be self-declaration, involve testing, inspection or quality system assessment from a Notified Body or a combination of these. The conformity assessment procedure will differ depending on your product and the Directive in respect of which you will be CE Marking.

Step 3

Determine the date by which you must take action. This will be the date that the Directive comes into force. The majority of Directives are already in force. In these cases, it is an offence to place a product on the market without CE Marking because it indicates a presumption of conformity with all relevant legislation.

Step 4

Identify if there are any Harmonized European Standards applicable to your product. These are not always mandatory for manufacturers although there is a presumption that conformity to these standards will give conformity to the relevant part of the Directive. Whenever possible or appropriate, manufacturers should follow harmonised standards.

Step 5

Ensure the product complies with all the essential requirements of the Directive(s). Take appropriate measures to comply or identify existing data and test reports.

Step 6

Identify whether independent assessment of your conformity to the Directive, or some aspects of it, is required from a Notified Body. This will be stated in the Directive and is dependent upon the product you are CE Marking. You must not affix CE Marking to your product until all necessary certifications have been obtained from the Notified Body. A list of Notified Bodies and the directives they are notified for can be found on the NANDO Website.

Step 7

Maintain technical documentation required by the Directive(s). Your technical documentation should support your compliance with the requirements of the Directive. It is essential to retain this documentation.

Step 8

Prepare the Declaration of Conformity and the required supporting evidence. The Declaration of Conformity along with the Technical Documentation should be available to Competent Authorities (EU Members) upon request.

Step 9

Check that no other purely national requirements exist in the countries where the product will be sold. These may include national standards, labelling or packaging requirements.

Step 10

Affix CE Marking on your product and/or its packaging and accompanying literature as stated in the Directive.

For more information, you can access the European Commission, Enterprise and Industry CE Marking & Download.

EU-wide standards and technical specifications exist for a number of product categories. You must ensure your products comply with any relevant EU rules before they can be traded freely in the EU.

Where no EU-wide rules exist, different specifications might apply in different EU countries. In such cases, you must only comply with the rules valid in your EU country.

What product requirements are

EU law sets essential requirements to ensure products traded in the EU meet high health, safety, and environmental standards.

Requirements can cover:

• the product itself: for example flammability, electrical properties or hygiene
• the product's manufacturing process
• the product's performance: for example, its energy efficiency

In most cases, the law defines the results to be achieved or the hazards to be dealt with, but it does not specify technical solutions.

Sometimes harmonised standards can help you demonstrate conformity with the law.

Where to find EU product requirements

Currently, most of the product rules are harmonised in the EU. This means that the same rules apply in all EU countries. Rules are applied to product groups, such as toys, or product characteristics, such as electromagnetic compatibility.

You can check the requirements for your product in the Trade Helpdesk database.

The Trade Helpdesk database offers information on the:

• rules and regulations for your product
• competent authorities you can contact for specific product requirements
• VAT and excise duty rates applied to your product in the EU country of sale

The Trade Helpdesk database is structured around custom codes: to view requirements for your product you will first have to identify its customs code. If you do not know the customs code, you can search for it with your product's name with the built-in search engine.

Where to find national product requirements

There are also product rules that are not harmonised in the EU, this means specifications might differ in each EU country. In such cases, you must only comply with the rules applicable in the EU country where you intend to place your product on the market.

If your products meet these requirements in your EU country, other EU countries cannot:

• forbid the sale of your products
• oblige you to modify them
• make you undertake additional testing

unless they can prove that your products do not fulfil your country's technical and quality requirements and do not offer a similar level of safety. This is known as the principle of mutual recognition.

If you are facing a problem related to the product rules in another EU country being incompatible with the mutual recognition principle, you may request assistance from SOLVIT.

National rules

The governments of EU countries are obliged to publish their national rules. You can read more about national rules and the ‘mutual recognition' principle in the TRIS database for non-harmonised product rules.

In particular, the requirements under national rules might differ for the:

• size/dimensions
• weight
• composition
• labelling
• packaging
• testing

To find out which technical rules apply to specific products in each EU country or the details of competent authorities within that EU country you can contact the Product Contact Points.

Restrictions based on national rules

If your products pose a risk to the public interest, based on the laws in place in other EU countries that affect:

• health and life of humans, animals or plants
• environmental protection
• public security or public morality

you may not be allowed to export them freely.

Your products could be banned if the EU country you want to export to can prove that its own technical requirements are essential or mandatory, and your products are not equivalent in terms of the level of safety sought.

To find out which national rules apply to specific products in each EU country or the details of competent authorities within that country you can contact the Product Contact Points.

Standards are voluntary guidelines that provide technical specifications for certain goods, services and processes. By following EU standards, you can be sure that your company and the products you make meet any applicable legal requirements. And because standards enhance quality, safety and reliability, following them can give consumers more confidence in your products and services.

Standards in Europe

In principle, a product authorised for sale in one EU country is authorised for all EU countries. In practice, the authorities in another EU target country might ask for additional information before authorising you to sell your products. A mutual recognition declaration can help you provide that information.

This voluntary self-declaration allows producers, importers and distributors to show to authorities that their goods comply with the rules in another EU country, where are already being sold.

The declaration covers all ‘non-harmonised' goods of any type – meaning goods that are not covered by EU-wide legislation, which sets common requirements. It can be also used for agricultural goods.

How a mutual recognition declaration can help you

If there is no prior authorisation procedure for your product, you are free to begin selling it in another EU country. Authorities in that country do have the right, however, at any time, to decide to assess goods you have begun selling. They will inform you in writing:

• what goods of yours will be assessed
• what technical rules or authorisation procedures apply to them
• whether you can use the mutual recognition declaration to demonstrate that your goods are already authorised for sale in another EU country

During the assessment period, you can still sell your products freely. You will only have to stop if you receive an administrative decision restricting or denying access to the market for the products concerned.

How to write a mutual recognition declaration

The declaration consists of two parts, described in detail in the EU regulation. There are 3 possibilities regarding the drafting:

• the producer (or their authorised representative) fills out Parts I and II
• the producer (or representative) fills out Part I, and the importer/distributor fills out Part II
• the importer/distributor fills out Parts I and II (if they can supply evidence supporting the information in the declaration)

Part I – information about the goods

Part I describes the goods and any applicable rules in the EU country where they are already being sold. It must contain:

1. A number or other reference marker that uniquely identifies the goods or type of goods

2. Name and address of the producer, importer or distributor filling out Part I of the declaration

3. Description of the (type of) goods, sufficient to enable them to be identified for traceability reasons. This can include a photograph.

4. Declaration that the goods:

have already been lawfully sold in EU country X (give the title and official publication reference of the relevant rules and/or authorisation decision); or

are not subject to any relevant rules in EU country X

5. Reference information for any conformity‑assessment procedure or test undergone by the goods (including the name and address of the assessment body)

6. Any other documentation showing the goods have already been lawfully sold in EU country

Signature of the producer, importer or distributor identified in point 2 above:

Signed for and on behalf of:

(place and date):

(name, function) (signature)

Part II – information about the selling of the goods

Part II focuses on the selling of the goods. It must contain:

7.1 EU country in which the goods are already sold (as indicated in 4.1)

7.2 Date on which the goods were first sold in that country. For example, you can prove this by attaching an invoice.

8. Any additional information that can help the authorities assess whether the goods are already being lawfully sold in EU country X.

9. Signature of the producer, importer or distributor who has filled out Part II

Signed for and on behalf of:

(place and date):

(name, function) (signature)

Language regime

The mutual recognition declaration must be drafted in one of the official EU languages. National authorities can require you to translate it into the language of their choice.

If you supply any hazardous chemicals within the EEA, you must abide by the Classification, Labelling and Packaging Regulation. It complements the REACH Regulation and ensures that the hazards of chemicals are clearly communicated to workers and consumers through pictograms and standard statements on labels and safety data sheets.

The new system for classification, labelling and packaging (CLP) took effect on 1 June 2015. All businesses supplying hazardous chemicals anywhere within the European Economic Area (EEA) must comply.

If you are a newcomer to EU laws on chemicals, have a look at the guide to chemical safety for small and medium-sized businesses. You should take account of the processes associated with REACH and of legislation on biocides and pesticides, if applicable, when planning CLP procedures.

Hazardous chemicals

Before placing chemical substances or mixtures of such substances on the market, you must:

• establish any risk they may pose to human health and the environment and classify them according to the hazards you identify
• label and package hazardous chemicals using the standardised system set out in the Classification, Labelling and Packaging (CLP) Regulation so that workers and consumers know about their effects before they handle them

If you place a hazardous substance on the market (whether on its own or mixed with other substances), you must notify its classification and labelling to the Classification and Labelling Inventory set up by the European Chemicals Agency (ECHA). Notifications are free of charge and ​must be completed within one month of placing the substance/mixture on the market for the first time. If you are an importer, the deadline is counted from the day when a substance (or mixture of substances) enters EU customs territory.

How to classify, label and package chemicals

As of​ June 2015,​ you must follow 2 rules:

• classify, label and package chemical substances in line with the new CLP system and inform your users of the classification
• label and package mixtures of substances in line with the new CLP system only

How to comply with CLP (Classification, Labelling and Packaging) Regulation

The CLP Regulation applies to a wide range of companies:

• manufacturers
• importers and re-importers of substances or mixtures
• producers of specific articles
• formulators and distributors
• retailers

Your obligations depend on your role in the supply chain.

More information.

E-commerce and off-premises selling offers many advantages, but it also entails certain obligations under EU rules.

Transactions subject to these EU rules are sales and service contracts to consumers when you don't meet your customer face-to-face; for example contractual agreements by internet, telephone (with or without human interaction), email, fax or standard letter and contracts when you conclude a contract with customers outside your usual business premises.

E-commerce, distance and off-premises rules do not cover transactions in the following areas:

• social and healthcare services
• gambling
• financial, insurance and investment products
• residential real estate and rental accommodation
• package travel, timeshare and certain holiday services that are subject to specific rules
• passenger transport (apart from some specific rules)
• contracts established by certain public office holders, such as notaries
• food and drink supplied by regular delivery to a customer's home or workplace
• products sold in vending machines

In some EU countries the following rules do not apply to off-premises contracts for a value of less than EUR 50.

Learn more.

Information to be given to customers in advance

Wherever you buy a product or service in the EU the trader must provide you with clear, correct and understandable information about the product or service before you buy.

This contract information should include:

• email address of the trader
• any delivery restrictions in certain countries
• the right to cancel your order within 14 days
• available after-sales services
• dispute resolution mechanisms
• trade register number of the trader
• professional title and VAT details of the trader (if applicable)
• professional association to which the trader belongs (if applicable)

For these purchases, you should bear in mind that you do not have to pay any delivery costs or other charges which you weren't informed about in advance.

Contracts must be written in plain and understandable language and cannot contain unfair contract terms.

In some EU countries, the right to receive confirmation for your order, to cancel it and other legal requirements do not apply to door-to-door purchases of less than EUR 50.

Confirmation of the contract in writing

When you have purchased something elsewhere than an actual shop – for example, online, by phone or by catalogue – you must receive written confirmation of your transaction. The confirmation must be on paper or in a durable format such as e-mail or a message to your personal account on the trader's website – provided it is something you can store and which the trader cannot unilaterally change.

Digital content

Specific information requirements apply when you buy digital content online, for example when you download or stream music or video. Before you make your purchase, you must also be informed how the content operates with relevant hardware/software (interoperability) and about its functionalities, including whether any geographical restrictions apply to the use of the content and if private copies are allowed.

After-sales communication by telephone

Traders who provide after-sales telephone lines for consumers must make sure that calls are charged at the basic rate. It is forbidden for traders to require consumers to use premium-rate telephone lines to make enquiries or complaints about their purchase or contract.

Buying from non-EU online traders

Your consumer rights under EU rules normally also apply to purchases from non-EU online traders targeting consumers in the EU. However, you may have difficulties in asserting your rights with traders based outside the EU.

Withdrawal from a contract

Under EU rules, a trader must repair, replace, reduce the price or give you a refund if goods you bought turn out to be faulty or do not look or work as advertised.

If you bought a product or a service online or outside of a shop (by telephone, mail order, from a door-to-door salesperson), you also have the right to cancel and return your order within 14 days, for any reason and without a justification.

If you're not sure which situation applies to you, you can also try this consumer rights tool to help you understand your rights when you shop in the EU.

More information about:

• guarantees for faulty goods
• your right to cancel and return an order

Delivering of the goods and other specific obligations

If you don't collect your purchase straight away or have ordered it for delivery at home the trader should deliver it to you within 30 days – unless you specifically agreed on a different delivery time.

Delivery costs

You must always be clearly informed of the total price for your purchase, including delivery and other related costs.

A trader may charge you a different price to deliver items to another EU country. This can be justified, as postal charges are not the same in all EU countries. Before you buy your goods, the trader must inform you about which cross-border delivery options are available to you and how much they cost.

You must give your explicit consent to any additional costs, for example if the trader wishes to offer you express delivery, or gift wrapping. Using a pre-ticked box on the trader's website does not constitute such consent and you would be entitled to reimbursement of any payment which has been collected in this way.

The trader is responsible for any damage to your goods from the time they are dispatched until you receive them.

Therefore, if when you receive something that you ordered, you discover your goods are faulty or don't work as they should, you are entitled to ask for them to be repaired, replaced, or, where neither is possible, you can ask for a price reduction or refund.

Remember that you always have a 2-year minimum guarantee at no cost, regardless of whether you bought your goods in an actual shop or elsewhere, for example online, by catalogue or by phone. Find out more about guarantees and returns.

Missing delivery

If you don't receive your goods within 30 days, or within the agreed time, you should remind the trader giving them an additional, reasonable time limit to deliver. For example, if the trader has informed you that your delivery is delayed by a week because of problems with his suppliers you should consider giving him that extra week.

If the trader still doesn't deliver within the extended deadline then you're entitled to terminate your contract and be reimbursed as soon as possible. You don't have to give the trader extra time if they refuse to deliver or when an agreed delivery period is essential, for example, if you need the goods for a specific event, such as a dress for a wedding, and you have informed the trader of this in advance.

Consumer rights and guarantees

EU consumer protection rules ensure that when you buy goods and services in the EU you have clear information on the product or service you're buying, its price, shipping and delivery costs as well as on your rights when things go wrong.

Try this easy to use tool to help you understand your rights when you buy in the EU.

After-sale responsibilities

Under EU rules, a trader must repair, replace, reduce the price or give you a refund if goods you bought turn out to be faulty or do not look or work as advertised.

If you bought a product or a service online or outside of a shop (by telephone, mail order, from a door-to-door salesperson), you also have the right to cancel and return your order within 14 days, for any reason and without a justification.

Means of redress for an injured party

Have you ever had problems with an item or a service purchased in another EU country? Regardless of whether you made your purchase online or offline there are several ways in which you can seek redress:

• informal dispute resolution: you might first wish to explore ways of settling your dispute directly with the trader, or with the help of a consumer organisation in your country
• out-of-court procedures: you can try to solve your problem through alternative or online dispute resolution
• formal legal action: a small claims procedure and payment order can help you recover money from a trader in another EU country

Certification and Labels

Many products must bear the CE marking before they can be sold in the EU. CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU.

It is not a quality indicator or a certification mark.

EMAs

By monitoring and systematically improving the environmental performance of your business, you can help to reduce your energy consumption, make sure that the resources you use protect the environment, and improve your reputation. As a company, you can request registration under the EU's Eco-management and Audit Scheme (EMAS).

Learn more.

Energy labels

Energy labels show how the appliances you sell or manufacture rank on a scale from A to G according to its energy consumption. Class A (green) is the most energy efficient and Class G (red) the least. Currently - once most appliances of a given type reach Class A - up to 3 further classes can be added to the scale; A+, A++ and A+++.

Due to improved energy efficiency in many products, more and more appliances are ranked within the A+, A++ and A+++ grades. This has proven to be confusing for consumers so from 2021 onwards, these rankings will be phased out for the following product groups:

• fridges
• dishwashers
• washing machines
• TVs
• lamps

The new grading system will use only the A to G rankings (without A+, A++ and A+++).

Learn more.

Eco-design

There are certain products that must comply with minimum requirements related to energy efficiency. These are called ecodesign requirements and the aim is to reduce the negative environmental impact throughout the product's lifecycle.

Before you place this type of product on the EU market you must ensure that they comply with these rules.

The product types currently covered by these rules are those that use energy (boilers, computers, household appliances and so on).

Learn more.

EU eco-label

If you manufacture products which you believe have outstanding environmental features, they might qualify to use the EU Ecolabel. Today, over 37 000 products sold on the EU market bear the EU Ecolabel, meaning that they comply with rigorous ecological criteria.

EU Ecolabel criteria are defined for a wide range of product groups. Check whether they exist for your product.

Learn more.

The WEEE label indicates that the product should not be discarded as unsorted waste but must be sent to separate collection facilities for recovery and recycling. The WEEE marking must appear on any electrical and electronic equipment placed on the EU market.

With a few exceptions, most electrical and electronic equipment sold in the EU must bear a specific marking.

Learn more.

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