Product requirements and labelling

As early as the design and development phase, it is important to identify the requirements that apply to your product in the countries you plan to export to in the future. There are several reasons why you should investigate product and labelling requirements as early as possible:

• Bring your product to market faster; save time and money by avoiding product adaptations to meet requirements at a later stage 
• Strengthen your position in tender processes and customer discussions
• Avoid delays in customs clearance and delivery by having the correct documentation in place
• Be prepared for potential market surveillance inspections

If your product does not meet the mandatory product or labelling requirements set by the authorities in the country where it is sold, it could ultimately be banned from sale and withdrawn from the market.

Product requirements may cover aspects such as the product's material composition, dimensions and design, how it is manufactured and how it can be recycled, its intended use and performance, including energy efficiency requirements. The more features a product has, such as WiFi, app connectivity and sensors, the more requirements it must meet. 

For some product categories, requirements may apply both to the product's technical design and to labelling on the product itself or its packaging. For example, packaging is subject to recycling requirements in all EU countries.

You may also need to have the product tested before placing it on the market.

In some industries, you may also be expected to follow certain standards, even when there are no mandatory requirements or regulations. End customers may also set their own requirements for how you develop the product before they enter into a sales contract.

Special requirements usually apply to products considered to pose a particular risk to health, the environment or safety. These include machinery, electrical household appliances, medical devices, chemicals, toys and food products.

The business that places the product on the market for the first time is responsible for ensuring that it meets the applicable market requirements.

If the manufacturer is based within the EEA, the manufacturer is responsible for ensuring that the products meet the requirements and are correctly labelled. If the manufacturer is based outside the EEA, responsibility lies with the manufacturer's representative in the EU or EEA, or, if the manufacturer does not have a representative in Europe, with the party importing the goods into the EEA.

As an importer, distributor or authorised representative responsible for selling imported goods in Norway, you need to ensure that you have a clear overview and documentation showing that the products in your portfolio comply with current product and labelling requirements.

The most critical point in the entire process is identifying the right regulations and requirements for your product. The regulations you need to follow will determine the steps you must take to meet the requirements. If you are unsure, now is the time to seek advice or consultation.

National

If you plan to sell in Norway, you can contact the authority responsible for your product area. The relevant regulatory authorities and agencies can provide information about current product and labelling requirements, enforce regulations and monitor goods once they have been placed on the market.

You can find an overview of the responsible authorities and their respective product areas on the Norwegian Government's website. 

The website of the Norwegian Product Contact Point can also help you identify the authority that can provide information about the regulations for your product area. If you are still unsure, contact the Norwegian Product Contact Point directly. 

Internationally

When selling internationally, a good starting point is to have a contact who understands the national regulations and the local language, and who can help you meet the product and labelling requirements in your export market. This could be an importer, distributor, local representative or agent.

You can also check our database for customs tariffs and documentation requirements. Please note that the information is not highly detailed or comprehensive in every area. Get free access to the database and user guide here. 

Another option is to contact a Notified Body (also known as a technical inspection body or independent third party in Norwegian). In some cases, you must involve a Notified Body before you can place your product on the market. The authorities in each country are responsible for appointing Notified Bodies and ensuring they have sufficient expertise in the relevant product area.

Accreditation forms part of the process for designating Notified Bodies. It officially recognises that an organisation has the competence and capability to assess and ensure that the product in question complies with the applicable requirements set out in the relevant legislation.

Find an overview of Notified Bodies on the European Commission's website. 

As a manufacturer, you are free to choose any Notified Body designated by the authorities as competent in your product area. The body you choose does not need to have a presence in your own country.

Product requirements and regulations can change quickly. Make sure you stay up to date with changes in the markets you export to.

Conformity assessment

The concept of ‘conformity assessment’ is central to identifying and verifying whether product requirements have been met. Conformity assessment is a process used to demonstrate that a product, service or system meets specified requirements.

Depending on the product's risk profile, the conformity assessment may be carried out by the company itself, the customer (for example, the importer or distributor), or an external party.

For some products considered low risk, the party placing the product on the market can carry out the conformity assessment. This involves assessing and testing the product and preparing the necessary documentation to show that it meets the specified requirements. As the party responsible for meeting the product requirements, you must also draw up a Declaration of Conformity confirming that the product meets all applicable requirements. You assume full legal responsibility if the product is subsequently found not to meet the requirements or to have been incorrectly labelled.

For products considered to pose a significant or high level of risk during use, such as medical devices and electrical household appliances, a Notified Body (a technical inspection body or independent third party) must carry out the conformity assessment. The applicable product regulations specify whether the conformity assessment requires a Notified Body.

Standards

If your product is subject to mandatory or voluntary requirements, there will usually be standards you can follow to demonstrate that it meets them. A standard provides a common set of instructions for how something should be produced to comply with applicable requirements or guidelines.

Standards Norway provides an overview of all standards available for both the European and global markets. You can purchase the standards on the Standards Norway website.

If you develop electrical and electronic products, you can use the AI assistant from the Norwegian Electrotechnical Committee (NEK) to identify relevant standards.

At the Competence Centre, you can take Standards Norway's introductory course on standards and standardisation. 

Testing

Regulations may require your product to be tested by an independent third party, often referred to as a Notified Body. The authorities designate Notified Bodies as qualified to carry out tests and assess products, services and processes against applicable regulations and requirements.

Even where this is not a regulatory requirement, you may want or need to use the laboratories and testing facilities of Notified Bodies to ensure that your product meets the relevant requirements and standards.

You can find an overview of Notified Bodies on the European Commission's website. 

As a manufacturer, you are free to choose any Notified Body appointed by the authorities with expertise in your product area. The Notified Body you choose does not need to have a presence in your country.

Certification

Certification is a process in which an independent third party provides written assurance that a product, system or process meets specified requirements or complies with European and international standards or other certification schemes.

This often means that the product, system or process must undergo testing and inspection to ensure it meets the requirements. Certification results in certificates or certification marks, which you may need to sell a product in a particular market. Authorities may require certification for certain goods or services to protect consumer safety, health or the environment. 

Customers may also require a product or service to be certified before making a purchase. Producers can also choose to initiate voluntary certification to demonstrate that they meet specific minimum requirements and thereby gain a competitive advantage in the market. 

There are a number of national, European and international certification schemes. Certifications are handled by accredited – in other words, officially recognised – certification bodies. You can find an overview of accredited Norwegian organisations on the Norwegian Accreditation website. 

A common technical framework

The EU has developed a common set of technical regulations for its internal market. These regulations apply nationally in all countries to products considered to pose a risk to users' health and safety or to the environment. These are known as harmonised product categories.

As Norway is part of the EU's internal market through the EEA Agreement, products intended for sale on the Norwegian market are also covered by this common regulatory framework. Harmonised rules are based on EU directives. Some of the most important are:

• The CE marking requirement applies to around ten product groups, including construction products, electrical products, machinery, toys and personal protective equipment. The CE mark relates to safety rather than the product's quality, function or performance.
• Chemicals are present in many products in one form or another. REACH and RoHS are fundamental and comprehensive regulations for identifying and regulating chemicals in products.
• There are also several regulations covering environmental and waste issues. These include the WEEE Directive, which covers producer responsibility and the recycling of waste electrical and electronic equipment, and the Ecodesign Directive, which aims to promote energy efficiency and reduce the environmental impact of energy-related products.

Find an overview of EU product and labelling requirements on Your Europe.

You can comply with the regulations by following the detailed technical specifications set out in what are known as harmonised standards. Find harmonised standards on the European Commission's website. 

You can contact the relevant Norwegian authority for guidance on the regulations that apply to your product category. Please note that the authorities cannot assess individual products for compliance with the applicable regulations.

If you are unsure whether your product meets the requirements, contact a Notified Body (technical inspection body) that can assist you with the conformity assessment.

If you would like information about the rules that apply to a specific product in a particular EU/EEA country, you can contact the country's national Product Contact Point. 

Products not covered by common technical regulations

Most products sold in the EEA market are not covered by common technical regulations. These are often referred to as ‘non-harmonised product categories’. They include goods considered safe and low-risk, such as clothing, footwear, furniture, semi-finished products and raw materials. The principle of mutual recognition applies to these products. This means that if a product is permitted to be marketed and is lawfully sold in one EEA country, you can freely market and sell it in other EEA countries without testing or inspection. Standards are also available for non-harmonised product categories, which you can choose to follow.

Exceptions to this principle may apply. National rules justified on health, environmental or safety grounds are permitted, provided they do not create hidden barriers to trade or distort competition in favour of certain businesses. If you want to find out whether the country where you plan to sell has national requirements for products that are not covered by common EU rules, you can contact the country's national Product Contact Point.

In addition to product requirements, you need to check which labelling requirements and certification schemes apply in the market you plan to export to. There are many different schemes across international markets. Some are mandatory for selling in the market, while others may be voluntary. Different certification schemes may apply to the same type of product, and requirements vary between markets. Radio equipment is one example. In the EU, this type of product must carry the CE marking, while in the US it will most likely need approval and labelling under the FCC scheme. The requirements of the two schemes are not necessarily the same.

See an overview of some of the most common labelling requirements in different markets.

Be prepared for product adaptations to meet different marking requirements and schemes to take time and incur costs. You may also face costs related to testing or certification.

The CE marking scheme in the EU and EEA

CE marking is an important part of EU product legislation and applies to a range of product categories, including construction products, electrical household appliances, machinery and toys. CE stands for Conformité Européenne, which in practice means that a product 'conforms to European directives' – in other words, that it complies with the health, environmental and safety requirements set out in European directives and regulations. Products considered to pose a certain level of risk to manufacturers or consumers must bear the CE marking.

In principle, CE marking is a manufacturer's self-declaration that the product meets essential health, environmental and safety requirements. In some cases, however, the product must be assessed by a Notified Body before the CE mark can be affixed.

The CE marking scheme applies throughout the EEA. Some countries outside the EU also accept CE-marked products, but the scheme is not mandatory in these countries.

Under mutual recognition agreements, some countries will accept that a range of CE-marked products comply with national standards if you provide a Declaration of Conformity. Please note that a Declaration of Conformity does not necessarily give your product automatic access to these non-EU countries, but it can provide a good basis for gaining acceptance in these markets.

Read more about CE marking on the European Commission's website and see the process here: CE marking step by step.

UKCA in the UK

As a result of the UK leaving the EU and the EU single market, the country is gradually moving away from the CE marking scheme. The equivalent marking scheme for products placed on the UK market is UKCA – United Kingdom Conformity Assessment. In addition to UKCA, there is a separate marking scheme for products sold in Northern Ireland.

As the marking scheme is in a transitional period, its requirements and guidance may be subject to ongoing changes and updates.

Make sure you read the latest information about UKCA and the equivalent scheme in Northern Ireland (UKNI) on the UK Government's websites. 

Mutual Recognition Agreements

A Mutual Recognition Agreement means that two countries with different accreditation or certification schemes recognise each other's conformity assessment procedures, making it easier to access their markets. 

When the EU negotiates mutual recognition agreements with non-EU countries, arrangements are also made for parallel negotiations with the EFTA countries Iceland, Liechtenstein, Switzerland and Norway. This means, for example, that a conformity assessment procedure under the CE marking scheme may, to some extent, be recognised in a country with which the EU has concluded a mutual recognition agreement.

You can find information about mutual recognition agreements on the EFTA website.

Voluntary and private labelling schemes

Voluntary certification schemes can also help you become more competitive. Examples include the EU's official environmental label, the EU Ecolabel, and the US government's energy efficiency certification, Energy Star.

There are also a number of private labelling schemes that can give you a competitive advantage in the market. Be aware that these often involve application, testing and certification costs, as well as annual fees for using the label.

You can find a simple overview of various voluntary and private labelling schemes on the Norwegian Consumer Council's website. 

Consequences of incorrect labelling

As the manufacturer or the party responsible for placing the product on the market, you must ensure that the product and its packaging are labelled correctly and safeguard consumer safety, health and the environment. If market surveillance authorities find that the product is incorrectly labelled, there will be consequences. The national authorities may ban its sale and withdraw it from the market. Other consequences may include claims for damages, financial penalties and, importantly, damage to your company's reputation, which may lead customers to choose other products on the market.

You should also be aware that importers and distributors in your export markets must notify the relevant national authorities if they discover that your product does not comply with applicable regulations or is incorrectly labelled.

Similarly, importers and distributors in Norway must report to the Norwegian authorities if a product in their portfolio fails to meet applicable product or labelling requirements.