Product Safety and Market Surveillance Package: Safer products and more fair play in the internal market
The European Commission proposed on 13 February 2013 (see press release) to improve product safety in the EU by strengthening market surveillance in the Member States. This will benefit consumers and will protect businesses from unfair competition. Today, if market surveillance is ‘softer’ in some parts of the EU than others, weak spots are created which threaten the public interest and create unfair trading conditions. Furthermore, much of the risk derives from products entering the Union from third countries. There must be effective market surveillance along the entire length of the Union’s external borders. Therefore, the new package of new enforcement rules will help national market surveillance authorities to cooperate much better to ensure equal level playing field for businesses and safer products for consumers. To this end national authorities should also improve cooperation with their colleagues in other Member States, which will avoid double work as test results can be exchanged.
The package consists of:
- A communication outlining the various elements of the package (COM(2013)74 )
- A proposal for a Regulation on market surveillance of products (COM(2013)75 )
- A multi-annual plan for market surveillance of products (COM(2013)76 )
- A report on the implementation of Regulation (EC) No 765/2008 (COM(2013)77 )
- A proposal for a Regulation on consumer product safety (COM(2013)78 )
- A Commission staff working document on accreditation (SWD(2013)35)
- A Commission staff working document on market surveillance (SWD(2013)36)
- Impact assessment and annexes (SWD(2013)33 and SWD(2013)33 Annexes)
- Executive summary of the impact assessment (SWD(2013) 34)
See also information on Health and consumers site http://ec.europa.eu/consumers/safety/product_safety_legislation/product_safety_and_market_surveillance_package/index_en.htm.
The objective of market surveillance is to ensure that products placed on the market do not endanger health, safety or any other aspect of protection of public interests.
In practice, market surveillance includes any necessary action (e.g. bans, withdrawals, recalls) to stop the circulation of products that do not comply with all the requirements set out in the relevant EU harmonisation legislation, to bring the products into compliance and to apply sanctions.
Market surveillance is vital to the smooth functioning of the Single Market. It is essential in protecting European consumers and workers against risks presented by non-compliant products. In addition, market surveillance helps to protect responsible businesses from unfair competition by unscrupulous economic operators who ignore the rules or cut corners.
The organisation of market surveillance at national level
EU legislation lays down specific requirements for the organisation of market surveillance. However, in accordance with the subsidiarity principle, market surveillance is organised and carried out at national level. Member States are responsible for surveillance activities on their own territory.
The EU requirements
Regulation (EC) 765/2008 sets out the requirements for accreditation and market surveillance relating to the marketing of products.
The Regulation sets out clear obligations for market surveillance authorities, stipulating that they must have the necessary powers, resources and knowledge to properly perform their functions. The Regulation requires procedures to be put in place for following up complaints, monitoring accidents, verifying that corrective action has been taken and gathering scientific and technical knowledge concerning safety issues. In addition, Member States must establish, implement and periodically update national market surveillance programmes and review and assess the functioning of their surveillance activities at least every four years.
Regulation (EC) 765/2008 also defines market surveillance measures to be taken by the surveillance authorities. These include: organising random and spot checks; obtaining all necessary documentation from manufacturer to evaluate product conformity; when justified, entering manufacturers' premises and taking samples for testing, and in extreme cases destroying products. If authorities find products presenting a risk, they must alert other potential users of those products to reduce the risk of further injury or harm. Products which present a serious risk, requiring rapid reaction, must be recalled from the market or measures must be taken in order to ensure that they do not reach the market.
The Regulation includes clear obligations for Member States to ensure cooperation at national level among different authorities, at international level with other EU Member States and with the European Commission and any relevant Commission agencies.
List of national market surveillance authorities
Member States have provided the following information about national market surveillance authorities operating in their respective territories.
- Belgium: FR, NL
- Cyprus, Market surveillance system
- Czech Republic, Market surveillance system
- United Kingdom
National market surveillance programmes
Member States have provided the following market surveillance programmes.
- Austria - programme 2014 DE / EN
- programme 2014 FR / NL / EN
- programme 2015 FR / NL
- programme 2014 BG / EN
- programme 2015 BG
- Croatia - programme 2014
- Cyprus - programme 2014
- Czech Republic - Annual report 2013
- Denmark - programme 2014 DA / EN
- Estonia - programme 2014 ET / EN
- Finland - programme 2014 - sectoral programmes 2014 [3 MB] (Annex)
- France - programme 2014 FR / EN
- Construction EN / DE
- Cosmetic/chemical requirements for toys/tobacco 2014 EN / DE
- Electromagnetic and Telecommunication 2014-2017 EN / DE
- Energy labelling/automotive/tyres 2014 EN / DE
- Energy related products 2014 EN / DE
- Metrolgoy EN / DE
- Medical products 2014-2017 EN / DE ( Annex EN - DE)
- Product safety 2014-2017 EN / DE
- Greece - programme 2014
- Hungary - programme 2014
- Ireland - programme 2014-2015
- Chemical substances 2013 EN / IT
- Civil explosives 2013 EN / IT
- Imported products 2013 EN / IT
- Maritime equipment 2013 EN / IT
- Products related to fire prevention 2013 EN / IT
- Pyrotechnical products 2013 EN / IT
- Radio and telecommunications equipment 2013 EN / IT
- Rail 2013 EN / IT
- Recreational crafts 2013 EN / IT
- Tobacco products 2013 EN / IT
- Various products - Guardia di Finanza 2013 EN / IT
- Various products - Ministero Salute 2013 EN / IT
- Various products - Ministero Svilupppo Economico 2013 EN / IT
- Latvia - programme 2014
- Luxembourg - programme 2014 FR - sectorial programme 2014 EN
- Malta - programme 2014
- Netherlands - programme 2013-2014 NL / EN
- Poland - programme 2014
- Portugal - programme 2012-2013
- Romania - Information 2012 - General description
- Slovakia - programme 2013-2014 - programme 2014-2015
- Slovenia - programme 2014 - sectorial programme 2014
- Spain - programme 2014 (AECOSAN) - programme 2014 (Ministry of Industry, Energy and Tourism)
- Sweden - programme 2014 SV / EN
- Agricultural transportation 2013 and marine equipment 2013
- Chemicals 2014
- Construction products, hot-water boilers and lifts 2014
- Electrical equipment 2014-2016
- Electronic communications networks and services 2014
- Energy 2014
- Explosives for civil use and appliances burning gaseous fuels 2014 (annex 1, annex 2)
- Toys 2014-2016
- Medical devices and cosmetic products 2014
- Metrology 2013
- Personal protective equipment, machinery and pressure equipment 2014-2016
- Radio equipment 2013-2015
- United Kingdom - programme 2014-2015 and sectoral programme 2013-2014
- Iceland - programme 2014
- Building 2014
- Civil protection 2014
- Consumer 2014
- Environment 2014
- Food safety - agriculture 2014
- Food safety - cosmetics 2014
- Health 2014
- Labour inspection 2014
- Marine 2014
- Medicines 2014
- Metrology 2014
- Petroleum safety 2014
- Post- and telecommunications 2014
- Road users and vehicles 2014
- Water resources and energy 2014
- Turkey - programme 2014
Reviews and assessments of market surveillance activities
Member States have provided the following reports on the functioning of market surveillance activities carried out in the 2010-2013 period.
- Austria EN / DE
- Belgium - FR and NL
- Bulgaria EN /BG
- Croatia EN / HR
- Cyprus EN / EL
- Czech Republic EN / CS
- Denmark EN / DA
- Estonia EN / ET
- Finland EN
- France EN / FR
- Germany EN / DE
- Greece EN / EL
- Hungary EN / HU
- Ireland EN
- Italy EN / IT
- Latvia EN / LV
- Lithuania EN / LT
- Luxembourg EN / FR
- Malta EN
- Netherlands EN / NL
- Poland EN / PL
- Portugal EN / PT
- Romania - Not available
- Slovakia EN / SK
- Slovenia - SL
- Spain - Not available
- Sweden EN / SV
- United Kingdom - Not available
Information and cooperation at EU level
Information exchange and effective cross-border co-operation between market surveillance authorities in different Member States is essential to ensure efficient, comprehensive and consistent market surveillance in the Single Market.
The following tools allow the pooling of information and cooperation at EU level:
- Exchange of information - Rapid Information System (RAPEX):
If a surveillance authority spots a product which presents a risk and could have an effect outside the territory of its Member State, the information is transmitted to all EU Member States using the Rapid Information System (RAPEX). RAPEX is an alert system that facilitates the rapid exchange of information among Member States and the European Commission.
RAPEX was initially established under Directive 2001/95/EC on General product safety (GPSD) for consumer goods and its scope was subsequently extended by Regulation (EC) 765/2008 to include all harmonised goods. Thus, since 1 January 2010 it has been used to notify serious risks presented by consumer and professional products.
Every Friday, the Commission publishes a weekly overview of products presenting a serious risk (RAPEX notifications) or non-serious risk as reported by the national authorities.
See the latest notifications by clicking on the following link: http://ec.europa.eu/consumers/dyna/rapex/rapex_archives_en.cfm
- General information support system:
The European Commission has developed a system for information exchange (the ICSMS - information and communication system market surveillance) which will include best practices, results of joint actions, details of non-compliant products and information on national market surveillance programmes, etc. This system will also reflect RAPEX notifications.
The public section of the system can be accessed by clicking on the following link: https://webgate.ec.europa.eu/icsms/App/index.jsp.
- Safeguard procedures:
Most Union product harmonisation legislation contains a safeguard procedure which obliges Member States to communicate any measures they take which restrict the free movement of a product on the basis that it presents a risk or is otherwise non-compliant. The safeguard procedure allows other Member States to express their views on the measures taken and ultimately enables the European Commission to evaluate the grounds for the national measures and decide whether they are justified.
- Administrative Co-operation Groups:
The European Commission has created and facilitates discussions within Directive-specific Administrative Co-operation Groups (AdCos), composed of market surveillance experts. These groups enable national market surveillance experts to meet, share information and co-operate on practical matters related to the implementation of specific Directives.
Additional tools for market surveillance
Decision 768/2008/EC on a common framework for the marketing of products contains provisions on market surveillance, including obligations of economic operators, and traceability and safeguard mechanisms.
Directive 2001/95/EC on General product safety (GPSD) on the safety of consumer products.