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Market surveillance for products ensures that products on the market conform to applicable laws and regulations. This helps to foster trust among consumers buying products or financial services and protects consumers and professionals from harm from non-compliant products. It also helps companies that comply to stay in business and avoid losing market share to rogue traders. [1]
In the European Union, individual member states are responsible for market surveillance but EU harmonisation legislation is considered necessary to guarantee the free movement of products within the Union, [2] and any action undertaken regarding product safety for consumer products and other precautions for professional products is done under the auspices of the European Commission regulations. [3] EU Regulation (EC) No 765/2008 applies to consumer products and regulation 2017/625 applies to food products. At the European Union level, three Directorates General are in charge: Health and consumers, Enterprise, [4] and Customs.
Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products had the effect of amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011. [2] Provision has been made for operational cooperation between UK and EU market surveillance authorities within the proposed EU–UK Trade and Cooperation Agreement of 2020. [5] Market surveillance in the EU for (consumer) products was further strengthened by the introduction of Regulation (EU) 2023/988 on general product safety (GPSR), that included rules on accident reporting to authorities by manufacturers as well as reinforced market surveillance rules. [6]
The European Free Trade Alliance is putting efforts in market surveillance. [7]
For consumer goods, an information system about dangerous goods has been set up, called RAPEX. [8] Every week, products that were voluntarily recalled or banned by authorities are listed. RAPEX is one element of the General Product Safety Directive (GPSD) that ensures a high level of protection of consumers by stating key safety elements. [9]
The Administrative Cooperation Group. Representatives of Member States meet to exchange information and discuss implementation issues. The European Commission is also present. ADCO groups discuss specific laws like PED [10] or EMC Electro Magnetic Compatibility [11] and also LVD. [12]
Within Europe most products are required to bear a CE mark. This is a self-certification achieved by complying with the appropriate Directive. The mark ensures that a product is safe from a variety of hazards. A specific individual bears legal responsibility for the mark and the compliance of the product.
European industry is asking for more market surveillance, from companies [13] or industry associations. [14] Market surveillance and border controls are essential to fulfill policy goals such as health and safety, environmental protection and level playing fields among economic operators.
If market surveillance fails, non-compliant products circulate and pose risks to end-users. Moreover, lawful manufacturers face unfair competition from rogue traders who do not invest in product compliance and traceability, who add between 2% and 25% to product costs (depending on product category). It is estimated that a high percentage of cases of non-compliance in certain product categories discredit all products of this kind, even the compliant ones. [15]
An industry support platform was launched in 2011. Its web-platform is designed to serve as a resource database of technical documents from European machinery industries. Information is available by sector and is made available in multiple languages. In addition, the website is enriched with testimonials and any other relevant information market surveillance.
European machinery industries that link in this initiative show firm commitment to help improve market surveillance for capital goods. This voluntary initiative can be seen as complementary to governmental efforts under the EU's new legislative framework for the marketing of products. It testifies to the commitment of industry to help maintain high levels of health, safety and environmental standards and ensures a level playing field in the single market. [16]
European customs are now more involved in market surveillance. Regulation 768/2008 offers guidelines for more efficient protocols for products entering the European market. [17]
The lack of market surveillance has been pointed out by many players in Europe. [18] At the European Parliament many voiced concern about the risk posed to the single market because of the lack of market surveillance. [19] Compliance is easy to check for products such as clothes, but industrial products may be difficult to check due to lack of time or lack of knowledge.
The Waste Electrical and Electronic Equipment Directive is a European Community Directive, numbered 2012/19/EU, concerned with waste electrical and electronic equipment (WEEE). Together with the RoHS Directive 2011/65/EU, it became European Law in February 2003. The WEEE Directive set collection, recycling and recovery targets for all types of electrical goods, with a minimum rate of 4 kilograms (9 lb) per head of population per annum recovered for recycling by 2009. The RoHS Directive set restrictions upon European manufacturers as to the material content of new electronic equipment placed on the market.
The Restriction of Hazardous Substances Directive 2002/95/EC, short for Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment, was adopted in February 2003 by the European Union.
The European Committee for Standardization is a public standards organization whose mission is to foster the economy of the European Single Market and the wider European continent in global trading, the welfare of European citizens and the environment by providing an efficient infrastructure to interested parties for the development, maintenance and distribution of coherent sets of standards and specifications.
The presence of the logo on commercial products indicates that the manufacturer or importer affirms the goods' conformity with European health, safety, and environmental protection standards. It is not a quality indicator or a certification mark. The CE marking is required for goods sold in the European Economic Area (EEA); goods sold elsewhere may also carry the mark.
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is a European Union regulation dating from 18 December 2006, amended on 16 December 2008 by Regulation (EC) No 1272/2008. REACH addresses the production and use of chemical substances, and their potential impacts on both human health and the environment. Its 849 pages took seven years to pass, and it has been described as the most complex legislation in the Union's history and the most important in 20 years. It is the strictest law to date regulating chemical substances and will affect industries throughout the world. REACH entered into force on 1 June 2007, with a phased implementation over the next decade. The regulation also established the European Chemicals Agency, which manages the technical, scientific and administrative aspects of REACH.
Type approval or certificate of conformity is granted to a product that meets a minimum set of regulatory, technical and safety requirements. Generally, type approval is required before a product is allowed to be sold in a particular country, so the requirements for a given product will vary around the world. Processes and certifications known as type approval in English are often called homologation, or some cognate expression, in other European languages.
European Standards, sometimes called Euronorm, are technical standards which have been ratified by one of the three European Standards Organizations (ESO): European Committee for Standardization (CEN), European Committee for Electrotechnical Standardization (CENELEC), or European Telecommunications Standards Institute (ETSI). All ENs are designed and created by all standards organizations and interested parties through a transparent, open, and consensual process.
The Principles of Good Laboratory Practice (GLP) establish rules and criteria for a quality system that oversees the organizational processes and conditions in which non-clinical health and environmental safety studies are planned, conducted, monitored, recorded, reported, and archived. These principles apply to the non-clinical safety testing of substances found in various products to ensure the quality and integrity of the safety data submitted to regulatory authorities globally.
Toy safety is the practice of ensuring that toys, especially those made for children, are safe, usually through the application of set safety standards. In many countries, commercial toys must be able to pass safety tests in order to be sold. In the U.S., some toys must meet national standards, while other toys may not have to meet a defined safety standard. In countries where standards exist, they exist in order to prevent accidents, but there have still been some high-profile product recalls after such problems have occurred. The danger is often not due to faulty design; usage and chance both play a role in injury and death incidents as well.
The General Product Safety Regulations 2005 is a 2005 statutory instrument of the Parliament of the United Kingdom that demands that "No producer shall [supply or] place a [consumer] product on the market unless the product is a safe product" and provides broad enforcement powers. The regulations implemented European Union directive 2001/95/EC and revoked the General Product Safety Regulations 1994. The regulations also repealed section 10 of the Consumer Protection Act 1987 which had previously imposed a more limited general safety requirement.
A European Authorised Representative (E.A.R.) serves as a legal entity designated by non European Union (EU) manufacturers, to represent them in the EU and ensure their compliance with the European Directives. The CE certificate and declaration of conformity can only be issued by a company located in the European Union.
The Ecodesign Directive of the European Union establishes a framework to set mandatory ecological requirements for energy-using and energy-related products sold in all 27 member states. Its scope currently covers more than 40 product groups, which are responsible for around 40% of all EU greenhouse gas emissions.
Regulation No. 305/2011 of the European Parliament and of the Council of the European Union is a regulation of 9 March 2011 which lays down harmonised conditions for the marketing of construction products and replaces Construction Products Directive (89/106/EEC). This EU regulation is designed to simplify and clarify the existing framework for the placing on the market of construction products. It replaced the earlier (1989) Construction Products Directive (89/106/EEC).
The Rapid Exchange of Information System (RAPEX) is the European Union rapid alert system for unsafe consumer products and consumer protection. RAPEX does not encompass food and pharmaceutical products and drugs. It does cover products such as clothing, shoes, cosmetics, jewelry or toys with potentially harmful ingredients or quality or even products with technical faults, electrical appliances that present an electric shock or ignition hazard.
The European Materials Handling Federation, is the association representing material handling, lifting and storage equipment manufacturers in Europe.
The Machinery Directive, Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 is a European Union directive concerning machinery and certain parts of machinery. Its main intent is to ensure a common safety level in machinery placed on the market or put in service in all member states and to ensure freedom of movement within the European Union by stating that "member states shall not prohibit, restrict or impede the placing on the market and/or putting into service in their territory of machinery which complies with [the] Directive".
EC Regulation 1223/2009 on cosmetics sets binding requirements for cosmetic products that have been made available on the market within the European Union. Manufacturers of products that fall under the category or cosmetics are required to abide by this regulation as they prepare their initial release of products and while continuing to sell said products within the Member States of the EU.
Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. It repealed Directive 93/42/EEC on Medical Devices (MDD), and Directive 90/385/EEC, which concerns active implantable medical device.
Regulation (EU) 2019/1020 is a regulation of the European Union on market surveillance and compliance of products. It aims to protect customers’ health and safety, the environment, and other public interests.
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