What should I consider when importing a product from a third country?
A product from a third country means that the product is manufactured outside the EU. Most importantly, you have to find out the legal requirements that apply for the product concerned. It could be requirements that the product itself has to fulfil regarding, e.g. different kinds of risks, such as chemical, mechanical or electrical risks. It could also concern how they should be marked, e.g. with symbols or warnings. Another aspect to consider is what kind of documentation should accompany the product and be made available to the authorities upon their request. In addition, you have to find out whether notification to competent authorities is mandatory. Such information can be obtained at the National Board of Trade or competent sector authority.
Information on whether the product is subject to any restrictions of import or fees, e.g. customs fees, VAT or other taxes, and how to declare your goods in customs, can be obtained at the Swedish customs.
The main responsibility for a product lies in principle with the manufacturer. The importer is, however, the person placing the product on the market and has therefore also far reaching obligations. If you place the product on the market under your own trade mark or modify the product in such a way that compliance with the applicable requirements may be affected, you are considered a manufacturer in legal terms.
What should I consider when importing a product from a country within the EU?
Within the EU, there is the principle of free movement of goods. If a product is lawfully marketed in a member state it should be considered lawfully marketed in all other member states. This principle is called mutual recognition which means that the customs authorities may not, without particular reason, stop a product from another EU country from entering the national border. Also the market surveillance authorities may not restrict the marketing of a product based on their own national technical rules without particular reasons, which have to be motivated and communicated according to agreed rules of procedure. If the product is subject to harmonised legislation (see below), the member states’ legislations for the product may not differ in any significant way.
As an importer you do not have as far reaching responsibilities as when you import from a third country (see above), but you still have obligations which are prescribed in the applicable legislative product acts.
What are my responsibilities as a distributor/retailer?
The manufacturer has the ultimate responsibility for the conformity of the product with all legal requirements, but as a distributor or a retailer you also have obligations, e.g. ensuring that the manufacturer has fulfilled all obligations of, for example, marking or documentation. You also have an obligation to cooperate with the market surveillance authorities. If you place a product on the market under your own trade mark or modify the product already placed on the market in such a way that compliance with the applicable requirements may be affected, you are considered a manufacturer in legal terms.
What does harmonised and non harmonised legislation mean?
When all member states in the EU have agreed upon common rules within an area, it is called harmonised legislation. Such legislation may take the form of Regulations or Directives. EU Regulations are directly applicable, i.e. directly considered national legislation and sometimes complemented by so called implementation acts. EU Directives have to be implemented in national law, normally in form of laws (adopted by Parliament), ordinances (adopted by Government) and regulations (adopted by public authorities). Where such agreements do not exist, within the so called non harmonised area, member states are free to choose between having their own national legislation and having no particular legislation at all. However, within the non harmonised area the principle of mutual recognition applies, i.e. the market surveillance authorities may not restrict the marketing of a product based on their own national technical rules without particular reasons, which have to be motivated and communicated according to agreed rules of procedure.
What is the New Approach or NLF?
A legislative method within the EU that restricts product requirements to essential requirements while technical details are specified in harmonised standards (see below). Other central components in this method are a set of modules for different conformity assessment procedures, i.e. how the manufacturer shall proceed to ensure that the product complies with the essential requirements, notified bodies, EU declaration of conformity, technical file and CE marking (see below). This legislative method was first used in 1985 and was complemented in 2008 by the so called Goods Package, which is also called the new legislative framework for the marketing of products (NLF) and also contains rules on accreditation. See the guidelines for the implementation of product legislation based on the New Approach.
The traditional, but less frequently used, legislative method where technical details are specified in the legal act is called the Old Approach. Product legislation drawn up in accordance to the old approach does not contain the components mentioned above.
What is CE marking?
A for numerous products mandatory marking implying that the manufacturer ensures that the product comply with all applicable legal requirements. Only those products for which are prescribed the CE marking may and should be marked.
What is an EU declaration of conformity?
A for numerous products mandatory document where the manufacturer ensures that the product complies with all legal requirements, specify which legislative acts are concerned and, when applicable, which harmonised standards have been used and which notified bodies have been involved. The document also contains the name and address of the manufacturer and information to identify the product, e.g. product or serial numbers.
What is a technical file?
A for numerous products mandatory documentation where the manufacturer describes how the product complies with legal requirements. Its content is specified in each individual legislative act, but as a common rule this documentation should contain information on the design, manufacture and operation of the product. It can, for example, include manufacturing drawings, test reports and descriptions of used material and quality systems.
Does the manual have to be in Swedish?
As a general rule the manual has to be in the official language of the country in which you intend to market the product, but there are exceptions.
What is a harmonised standard?
A technical specification, a document, specifying the technical requirements a product, process, service or system has to comply with, and that has been adopted by a recognized standardisation body. Standards can be national, European or international. A harmonised standard is a European standard adopted on the basis of a request made by the Commission for the application of Union harmonisation legislation and has been published in the Official Journal of the EU. The use of a relevant harmonised standard gives presumption of conformity with the legal requirements.
What is a notified body?
A conformity assessment body that in different ways should verify if products comply with specified requirements. A notified body shall provide services of conformity assessment according to the conditions prescribed in many legislative acts. Examples of such procedures are type examination, production control or quality assurance. All notified bodies are listed in NANDO, a database on the website of the European Commission. The reason why these conformity assessment bodies are called notified bodies is because they, after having been assessed and designated by a competent body in an EU member state, are notified to the European Commission. In Sweden, it is the Swedish Board for Accreditation and Conformity Assessment, Swedac, who is the competent body to assess, designate and notify such bodies. The process is similar to the accreditation process (see below).
What is accreditation?
An assessment of the competence of a body to fulfil the requirements to perform specific conformity assessments. The assessment of the competence of the body is performed by a national accreditation body in accordance with European and international standards. The Swedish accreditation body is the Swedish Board for Accreditation and Conformity Assessment, Swedac.
What is SOLVIT?
An informal network initiated by the European Commission, with a mission to solve obstacles to the free movement of goods, services, capital and persons, as an alternative to legal procedures. There is a SOLVIT centre in every EU member state through which companies and private individuals free of charge can obtain help with rapid and practical solutions to problems they experience in the internal market. SOLVIT only deals with complaints against public authorities and which have not been subject to legal procedures. SOLVIT does not deal with disputes between private individuals, between consumers and companies nor between companies. The Swedish National Board of Trade holds the Swedish Solvit center.
What is RAPEX?
A mandatory alert system that the market surveillance authorities in all EU member states use to inform each other of dangerous products and what measures have been taken by the public authorities to address the risks. The European Commission, who owns the system, publishes information every week about dangerous products that have been reported into the system. The reporting is performed via national contact points. The Swedish contact point is the Swedish Consumer Agency.
What is ICSMS?
A mandatory system that market surveillance authorities in all EU member states use to exchange information about products. It is above all an internal system for authorities. ICSMS is owned by the European Commission and Swedac is the national administrator for ICSMS in Sweden.