Harmonised product area
Harmonisation entails the unification of different legal systems that are not independent of each other. This means that individual EU Member States have no autonomous competence and may not supplement or annul Community rules by adopting more or less stringent domestic standards. The main objectives are to provide active support to the economy in its efforts to achieve global competitiveness, exert a positive impact on product quality and ensure consumer safety.
Technical requirements for products
International trade is closely linked to a large number of technical requirements for products and their related services and standards, mainly in terms of safety. This is an important part of economic policy, enabling countries to develop and make progress, and is closely linked to economic growth, employment and continuous development.
When trade is relaxed, it is essential to ensure adequate protection of human, animal and plant health, the safety of consumers and other users, and the environment. Products on the single market must meet high safety criteria and comply with environmental protection requirements. The system that ensures this is comprised of several elements. Technical or quality requirements for products, production processes or test methods are defined in the standards. Standardisation is a tool that helps the industry ensure that products are capable, safe and interoperable. Conformity assessment procedures conducted before a product is placed on the market are used by manufacturers to certify that their products comply with the applicable requirements. Accreditation is the last level of public oversight in the European conformity assessment system and is designed to ensure that conformity assessment bodies are appropriately qualified to provide their services.
The legal framework for the rules governing the free movement of technical non-food products is defined by the Technical Requirements for Products and Conformity Assessment Act. It provides the legal basis for the transposition of EU Directives into Slovenian law. The Act regulates the conditions for the placing on the market or putting into service of products, the technical requirements applying to products, conformity assessment procedures, the requirements and procedures for designating conformity assessment bodies, and the documents that must accompany products when they are placed on the market.
Product safety and CE marking
CE marking is the principal indicator of product conformity. It certifies that the product complies with the essential requirements relating to consumer, health and environmental protection as laid down in EU legislation. The labelling of products in accordance with the legislation protects the public interest by requiring products to be safe, as legislative mechanisms support and facilitate the free movement of goods within the EU. The single European market brings benefits to consumers, and those consumers expect the products they purchase to be safe. Under the legislation, manufacturers must provide a declaration of conformity that confirms that their products are safe. Importers must also make checks to ensure that the manufacturer has implemented all measures required by the legislation, while distributors must be able to determine and decide which products conform to and meet the safety requirements. By affixing a CE marking to a product, the manufacturer assumes responsibility for ensuring that the product conforms with all the legal requirements for obtaining the CE marking and for ensuring its conformity throughout the European Economic Area (EEA, which, in addition to the 28 EU Member States, includes Iceland, Norway and Liechtenstein) and in Turkey. The same applies to products that have been manufactured outside the EU and are intended for sale in the EEA and Turkey. By using the CE marking, the manufacturer confirms that the product complies with all the relevant health and safety requirements set out in the applicable directive or, where the directive so provides, that they have had the product tested by a notified conformity assessment body.
Manufacturers must ensure that their products comply with the relevant safety requirements, which they do by assessing potential risks and testing samples of the product. Safety checks for products that automatically pose a higher risk (e.g. heaters or chainsaws) may not be performed by the manufacturers of the products themselves. In such cases, safety verification must be carried out by an independent organisation appointed by the competent national authority, which is why all European countries have established market surveillance authorities whose role is to monitor the market and protect consumers from unsafe products to the greatest extent possible. They do this by inspecting manufacturers, importers and distributors, inspecting and testing products, and taking action in the event of non-compliance with the rules. These measures include recalling unsafe products and removing them from shop shelves, destroying dangerous goods and imposing fines or other sanctions. National authorities also inform each other of the measures taken with regard to dangerous products via the rapid alert system, which enables other European countries to take similar measures. The competent national authorities are also required to follow up on consumer complaints regarding product safety problems.
Standards are among the key factors that drive the transfer of innovation to the economy and the progress of the single market. They are a very important tool for strengthening European competitiveness, facilitating technical development, promoting global trade and contributing to social prosperity, health, safety and environmental protection. Standards help businesses to rationalise production and services, because they can provide technical specifications and other precise criteria that are often used as rules, instructions, test procedures or definitions. As the currently established state of the art, they also lay the foundations for future development.
The Slovenian Institute for Standardization (SIST) is the national body responsible for preparing, adopting and issuing standards and other standardisation deliverables. It represents Slovenian interests in international organisations, including the International Organization for Standardization (ISO), the International Electrotechnical Commission (IEC) and the International Telecommunications Union (ITU), as well as various European organisations (the European Committee for Standardisation [CEN], the European Committee for Electrotechnical Standardisation [CENELEC] and the European Telecommunications Standards Institute [ETSI]). Through working via its technical committees, it also ensures that Slovenia enjoys equal standing in European and international standardisation activities.
The Joint Initiative on Standardisation contains ambitious roadmaps and actions in specific areas of standardisation with a view to strengthening economic competitiveness within the EU and, more broadly, within the global standardisation environment. The signatories to the initiative are the European Commission, all EU and EFTA Member States, European standardisation organisations (CEN, CENELEC and ETSI), national standardisation bodies, and European industry (as represented by various associations, including small and medium-sized enterprises, and social stakeholders representing consumers and environmental interests).
Accreditation is an impartial and independent professional process whereby the national accreditation service formally certifies, by means of an accreditation document, the competence of bodies to carry out specific conformity assessment tasks. Those bodies include calibration and testing laboratories, certification and control bodies, bodies responsible for verifying and auditing schemes involving environmental management systems and bodies responsible for reviewing greenhouse gas emission reports.
Accreditation serves to improve the quality of products and services, helps the economy to compete globally and contributes to the promotion of international trade. The accreditation system ensures that goods can move freely and accompanied by internationally recognised documents from accredited bodies.
Conformity assessment bodies
Conformity assessment bodies are undertakings designated by ministerial decision to carry out conformity assessment activities such as calibration, testing, certification and control. The designation of a conformity assessment body is subject to accreditation to the relevant standards in relation to a product, service area, task or activity. Conformity assessment bodies must comply on an ongoing basis with the requirements for designation laid down in regulations or by decision.
Conformity assessment bodies become notified bodies when they are notified by the ministry to the European Commission and other EU Member States via the New Approach Notified and Designated Organisations Information System (NANDO). Notification is a key process because it opens up the EU internal market to companies, allowing them to provide conformity assessment services on an equal footing with the notified bodies of other EU Member States.
The designation and notification procedures are specific to each area – for example, in the field of construction products the designated body is a body authorised to carry out third-party tasks in the process of assessing and verifying the stability of the properties and characteristics of a specific product. For those construction products for which harmonised standards do not (or do not yet) exist, the manufacturer may obtain a European technical assessment based on a European assessment document.