2016 Market surveillance plan

Transcription

1 Myndigheten för samhällsskydd och beredskap [Swedish Civil Contingencies Agency] Ref. Ares(2016) /01/ (14) Version Supervision Unit Marianne Runhage marianne.runhage@msb.se 2016 Market surveillance plan in accordance with the requirements in Section 24(5) of the Ordinance (2010:1075) on flammable and explosive products and in Article 18(5) of Regulation (EC) No 765/2008 setting out the requirements for accreditation and market surveillance Produced in accordance with the guidelines for the production of market surveillance plans adopted by the Market Surveillance Council on 21 November 2014.

2 2 (14) Version Contents 2016 Market surveillance plan... 1 Contents Background and aims General goals for market surveillance Specific goals for market surveillance by the MSB Legal basis Horizontal legal documents The MSB s powers Interpretations and constraints Surveillance methods Reactive market surveillance Proactive market surveillance Other initiatives Principles for selecting products for surveillance Cooperation Costs/resources... 14

3 Version 3 (14) 1 Background and aims One of the fundamental principles of the EU is the free market. The free market involves economic operators themselves having the confidence and the responsibility to ensure that a product is safe and meets all applicable requirements. Any market surveillance takes place retrospectively. The responsibility for ensuring that available products comply with legislative requirements thus lies with economic operators, predominantly manufacturers/importers and, to some extent, distributors. In the event that the economic operators' own checks do not work in the distribution chain, defective and/or hazardous 1 products may also be identified by authorities and removed from the market if they are not rectified. Defective products may be found during the own checks carried out by economic operators on the quality of products in the distribution chain, by the customs authorities at the EU's external borders, or during checks by authorities to ensure that products meet all of the requirements, which is known as market surveillance. One of the commitments that Sweden has undertaken as an EU Member State is therefore to carry out market surveillance. This must be organised and carried out in a suitably efficient way and to a sufficient extent. In Sweden, this task is shared among a number of market surveillance authorities that are coordinated by the Market Surveillance Council, with SWEDAC (the Swedish Board for Accreditation and Conformity Assessment) performing the duties of the Secretariat. The Swedish legislation that regulates market surveillance by the authorities is divided up according to risk rather than product. A product may therefore be governed by several pieces of legislation and thus by several market surveillance authorities. It is therefore important to coordinate the market surveillance carried out by the authorities. This market surveillance plan has been produced in accordance with the guidelines adopted by the Market Surveillance Council on 21 November General goals for market surveillance Market surveillance 2 means all the activities carried out and measures taken by the authority responsible to ensure that products placed on the market meet the legal requirements. The aim of market surveillance is to protect the safety and health of employees, consumers and other users, as well as the environment. Market surveillance also aims to ensure equal competition conditions among economic operators and thus help prevent unfair competition. 1 Products that do not meet all the requirements are hazardous according to the definition in the Product Safety Act. 2 As defined in the Ordinance (2014:1039) on the market surveillance of goods and other similar supervision.

4 Version 4 (14) The impact of a measure increases if it is carried out collectively by a number of countries as the legislation follows national borders, while the products are covered by the principle of freedom of movement. 3 Specific goals for market surveillance by the MSB The MSB must carry out proactive and reactive market surveillance in collaboration and cooperation with other market surveillance authorities and with Swedish Customs. The goals for market surveillance in 2016 are as follows: results and experience from activities will have been reported in a national overview communicated to relevant parties; incoming market surveillance cases will have been processed on an ongoing basis (reactive market surveillance); proactive market surveillance will have been prioritised in line with the 2016 activity plan laid down in January 2016; within the framework of the Market Surveillance Council, the MSB will have attended meetings and performed other tasks arising from these meetings. Coordination will also have been carried out with other market surveillance authorities. The aim in 2017 and 2018 will continue to be to prioritise reactive market surveillance, methodological development and proactive market surveillance of product groups that are yet to be determined. 4 Legal basis 4.1 Horizontal legal documents The organisation of market surveillance and border checks by the Member States is regulated by Regulation (EC) No 765/2008 setting out the requirements for accreditation and market surveillance. Some definitions and concepts are defined in Decision 768/2008/EC, which also harmonises the way in which directives relating to goods are to be formulated. Ordinance (2014:1039) on market surveillance of goods and other similar supervision provides information concerning which Swedish authorities are to carry out market surveillance, as well as laying down general guidelines on how the surveillance and coordination are to be carried out. The Ordinance does not distinguish between harmonised and non-harmonised products. In the event that national technical rules apply to a good that is sold lawfully in another Member State, the order of precedence set out in Regulation (EC) No 764/2008 will apply. The MSB's powers are described in Section 4.2 below. The General Product Safety Directive (GPSD, 2001/95/EC) contains requirements for market surveillance. This Directive has been implemented in Sweden by means of the Product Safety Act (2004:451) and the Product Safety Ordinance (2004:469). The Act stipulates that goods and services sold to private individuals must be safe. According to Section 3 of the Product Safety Ordinance, any state authority that supervises compliance

5 Version 5 (14) with special provisions on product safety in relation to certain goods, services or risks pursuant to any other statute must also be the supervisory authority in accordance with the Product Safety Act. According to Section 9 of the Product Safety Ordinance, an authority with supervisory responsibility must: - establish, implement and follow up a programme for its supervision of various kinds of good, service and risk; - follow up scientific and technical knowledge on matters relating to product safety; and - regularly evaluate and review its supervisory activities. Provisions on CE marking may be found in Article 30 of Regulation (EC) No 765/2008 setting out the requirements for accreditation and market surveillance and in the Act (2011:791) on Accreditation and Technical Surveillance. 4.2 The MSB s powers The MSB s responsibility for market surveillance is regulated partly by Article 22 of the Act (2010:1011) on Flammable and Explosive Goods (LBE), Section 10(5) of the Ordinance (2006:311) on the Transportation of Hazardous Goods and Section 3 of the Product Safety Ordinance (2004:469). The MSB's market surveillance mandate thus covers: - products that are regulated by regulations adopted pursuant to the LBE, as well as the properties of flammable and explosive goods, such as ammunition; - transportable pressure equipment that is governed by regulations adopted pursuant to the Act (2006:263) on the Transportation of Hazardous Goods (LFG); - the application of the Product Safety Act to products included in this mandate in cases where a hazard has not been regulated or has been inadequately regulated or where a hazardous product has had to be withdrawn from the market or recalled from the consumer. The market surveillance carried out by the MSB is based on the following legal instruments:

6 6 (14) Version Horizontal regulations Act Product Safety Act (2004:451) [Produktsäkerhetslagen] (PSL) Ordinance/regulations EU Directive/Regulation Supervisory duties Scope/Product groups Directive 2001/95/EC on general Section 24 PSL The supervision shall be carried out by an authority Goods and services product safety (GPSD) determined by the government. Consumer protection Product Safety Ordinance Any state authority that supervises compliance with special (2004:469) provisions on product safety in relation to certain goods, services or [Produktsäkerhetsförordningen] risks pursuant to any other statute shall, however, also be the supervisory authority in accordance with the Product Safety Act and regulations issued pursuant to that Act. Ordinance (2014:1039) on the Market surveillance authorities, including the MSB, are designated. Products governed by sectoral legislation market surveillance of goods and The market surveillance covers both harmonised and non- other similar supervision Regulation (EC) No 765/2008 harmonised goods. Amongst other things, governs the Member States' organisation and Harmonised products setting out the requirements for implementation of market surveillance, dissemination of information accreditation and market and coordination with others, and checks on products from third surveillance relating to the countries (border checks). Regulation (EC) No 764/2008 on Governs communication with the counterpart where requirements are Products covered by national rules that mutual recognition stipulated after checks on goods which are subject to national have not been harmonised technical requirements but which are lawfully sold in another Member State. Only applies to products or aspects that are not Decision No 768/2008/EC establishing a common framework for the marketing of products Government Bill 2008/09:187 Directive 2006/123/EC on services with proposals for legislative in the internal market measures and practical arrangements for the Services Directive to start producing effects in Sweden.

7 7 (14) Version Sectoral regulations Act Ordinance/regulations EU Directive/Regulation Supervisory duties Scope/Product groups Act (2010:1011) on flammable and explosive goods Ordinance (2010:1075) on flammable and explosive goods Section 22. The Swedish Civil Contingencies Agency shall carry out market surveillance on: 1. the properties of flammable and explosive goods, and their placing on and availability on the market; and 2. products used for the handling of flammable and explosive goods in respect of which the authority has produced regulations. Market surveillance Section 23. The Swedish Civil Contingencies Agency shall be the market surveillance authority in relation to flammable and explosive goods and products used for the handling of flammable and explosive goods for which the authority has produced regulations, pursuant to Articles 19, 24(2), 26, 27(2), 28 and 29 of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93. Section 24. In accordance with Regulation (EC) No 765/2008 and in matters relating to flammable and explosive goods, the Swedish Civil Contingencies Agency shall: 1. inform the general public of the authority s activities pursuant to Article 17(2); 2. establish procedures in accordance with Article 18(2); 3. draw up market surveillance programmes, issue information about the programmes and make them available to the general public in accordance with Article 18(5); 4. perform the duties following from Articles and 23(2); and 5. cooperate with other parties in accordance with Article 24(4). Products in respect of which the MSB has produced regulations, irrespective of whether the user is a private individual or a trader, and properties of flammable and explosive goods, such as ammunition

8 8 (14) Version Sectoral regulations Act Ordinance/regulations EU Directive/Regulation Supervisory duties MSBFS (2010:4) concerning which goods are to be regarded as flammable or explosive goods SÄIFS (2000:6) on gas equipment SÄIFS (2000:4) on tanks, belltype gas holders, caverns, and pipes for flammable gases SÄIFS (2000:3) on flammable gases in loose containers SÄIFS (2000:2) on the handling of flammable liquids MSBFS (2014:5) on tanks and pipes for flammable liquids Directive 2009/142/EC of the European Parliament and of the Council of 30 November 2009 relating to appliances burning gaseous fuels The majority of the Directive's requirements, with the exception of protection against a) the discharge of combustion gases, which is transposed by the Swedish Chemicals Agency's regulations; b) burns from hot surfaces, which is transposed by the Swedish National Board of Housing, Building and Planning's regulations; c) electric shock injuries, which is transposed by the Electrical Safety Board's regulations. National rules, and also standard SS-EN 9994:2006, harmonised under the General Product Safety Directive 2001/95/EC (transposed by the Product Safety Act), must be applied to gas-fuelled cigarette lighters. Scope/Product groups The product group includes gas equipment for household use in the broad sense, such as for cooking, heating, cooling and laundry (e.g. LPG barbecues), and for camping, as well as sub-components for this equipment that are made available separately, e.g. controls and regulators. Also covers hoses for flammable gases, such as hoses from an LPG bottle to a barbecue. Covers small containers such as lighters. Covers some equipment for, and containers for the storage of, flammable liquids, such as kerosene and ethanol stoves (the latter are called flueless stoves), petrol cans, elements and explosion-proof vessels. The product group includes tanks and pipes that are covered by MSBFS (2014:5). Construction is checked by means of operational supervision by localauthority boards, and checks are carried out by accredited bodies.

9 9 (14) Version Sectoral regulations Ordinance/regulations EU Directive/Regulation Supervisory duties Scope/Product groups Act Explosive goods pursuant to MSBFS (2010:4) SÄIFS (1986:2) on the approval Ensuring that explosive goods with national approval meet the of explosive goods and SÄIFS stipulated requirements concerning which goods are to be regarded as (1989:16) with general flammable or explosive goods provisions on the approval of explosive goods and provisions on the approval of electric squibs SÄIFS (1997:4) on the surveillance and Council Directive 93/15/EEC The product group covers explosives on the harmonization of the placing on the market of provisions explosive goods for civil uses relating to the placing on the and electric squibs. MSBFS (2012:2) on identity labelling and registration of explosive goods for civil uses market and supervision of explosives for civil uses Commission Directive 2008/43/EC setting up, pursuant to Council Directive 93/15/EEC, a system for the identification and traceability of explosives for civil uses. Amended by Commission Directive 2012/4/EU. Explosives, with the exception of loose explosives, amongst other things MSBFS (2014:3) on Directive 2007/23/EC Repealed as of 1 July 2015, replaced by 2015:6 on - Fireworks; on pyrotechnic articles of the European Parliament and of the Council the making available of pyrotechnic articles and ammunition. - pyrotechnic articles (i.e. objects on the placing on the market of The following transitional provisions shall, however, apply: containing a pyrotechnic charge); on pyrotechnic articles - pyrotechnic stage effects; - rockets containing more than 75 grammes of explosive substance (net weight) may be supplied only to persons holding a permit to - other pyrotechnic articles. handle them; - approvals for pyrotechnic equipment for vehicles that have been issued in Sweden before 4 July 2013 shall be valid until they expire.

10 10 (14) Version - Approvals for pyrotechnic stage effects and other pyrotechnic articles that have been issued in Sweden before 4 July 2013 shall, however, be valid until 4 July 2017 at the latest. Ordinance/regulations EU Directive/Regulation Supervisory duties Scope/Product groups Sectoral regulations Act MSBFS (2015:6) on the making Directive 2013/29/EU of the In force as of 1 July 2015, except for Chapter 5, Sections 4 and 11, pyrotechnic articles (i.e. objects containing available of pyrotechnic articles European Parliament and of the with requirements for a register with registration numbers, etc. for a pyrotechnic charge), i.e.: and ammunition Council of 12 June 2013 on the manufactured or imported pyrotechnic articles - fireworks; harmonisation of the laws of the Covers certain exceptions to the approval requirement stipulated in - pyrotechnic stage effects, and Member States relating to the Section 12 LBE, categorisation of pyrotechnic articles, requirements - other pyrotechnic articles making available on the market of for a conformity assessment, a conformity declaration and marking, pyrotechnic articles (recast) and the economic operators' obligations Commission Implementing Directive 2014/58/EU of 16 April 2014 setting up, pursuant to Directive 2007/23/EC of the European Parliament and of the Council, a system for the traceability of pyrotechnic articles. SÄIFS 1992:2 on the approval of Repealed as of 3 July No new decisions have been made on The product group covers fireworks and fireworks and pyrotechnic stage the approval of unharmonised fireworks for consumers. Existing pyrotechnic articles that must be approved effects SRVFS 2007:2 on the detection of approvals shall, however, be valid until Traceability labelling before they are handled. Plastic explosives plastic explosives MSBFS (2010:8) on aerosol dispensers Directive 75/324/EEC of the European Parliament and of the Council of 20 May 1975 on the approximation of the laws of the Expires on 19 March Aerosol dispensers which contain mixtures and which are labelled in accordance with these rules may continue to be marketed and supplied until 1 June Aerosol dispensers with flammable gas as the propellant Member States relating to aerosol dispensers, as amended by

11 11 (14) Version Sectoral regulations Act LBE and Ordinance (2008:245) on chemical products Act (2006:263) on the Transportation of Hazardous Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March Ordinance/regulations EU Directive/Regulation Supervisory duties Scope/Product groups MSBFS (2014:1) on aerosol Directive 2008/47/EC amending, dispensers for the purposes of adapting to technical progress, Council Directive 75/324/EEC on the approximation of the laws of the Member States relating to aerosol dispensers Ordinance (2006:311) on the Transportation of Hazardous Goods MSBFS (2011:3) on Transportable Council Directive 1999/36/EC on Pressure Equipment transportable pressure equipment; Commission Directive 2002/50/EC amending, for the purposes of adapting to technical progress, Council Directive 1999/36/EC on transportable pressure equipment The MSB is responsible for market surveillance to ensure that the For the time being, aerosol dispensers with design, function and labelling of aerosol dispensers complies with flammable gas as the propellant. the requirements laid down by: - regulations issued by the Agency pursuant to the Act (2010:1011) on flammable and explosive goods (LBE). The supervision mandate is not yet clear with regard to aerosols that are not covered by the LBE. Section 10(5): Transportable pressure equipment (TPE) The MSB is responsible for supervision of transportable pressure equipment. Technical requirements for containers and accompanying labelling. TPED, e.g. gas bottles, tanks, etc. intended Labelling according to content is covered by the market surveillance for the transport of class 2 gases. duties of the Swedish Chemicals Agency. Recurring surveillance is carried out by accredited surveillance bodies, with the exception of single-use canisters.

12 Version 12 (14) 4.3 Interpretations and constraints In previous years, some points of confusion have been identified, and as a result the MSB's duties have been clarified and some constraints on them have been specified: - the MSB is responsible for emergency flares for use on land (pyrotechnic devices), while the Swedish Transport Agency is responsible for emergency flares for use at sea; - the MSB's rules cover stoves using flammable liquids as fuel by virtue of the SÄIFS 2000:2 regulations on the handling of flammable liquids, and the concept of stove has been interpreted by the MSB as covering products with power of 900 W or more; - the construction of lighters with gaseous fuels is governed by the Swedish National Inspectorate of Explosives and Flammables' regulations on flammable gases in loose containers, SÄIFS 2000:3. The MSB regulates construction requirements, and the Swedish Consumer Agency regulates child safety and toy-like products; - gas equipment used as tools, such as weed burners, Bunsen burners and LPG mosquito traps, is not covered by the Gas Equipment Directive, is not regulated by the MSB's regulations (SÄIFS 2000:6) on gas equipment, and falls outside the MSB's market surveillance mandate; - gas equipment regulated by SÄIFS 2000:6 is covered by the MSB's regulations even if fitted in a vehicle or craft; - some parts of the Gas Equipment Directive have been transposed by the regulations issued by the Swedish Chemicals Agency, the National Electrical Safety Board or the Swedish National Board of Housing, Building and Planning. 5 Surveillance methods 5.1 Reactive market surveillance Reactive market surveillance that is required, i.e. the surveillance of products which somebody believes do not meet all the applicable requirements, is carried out first of all. This involves handling cases within the whole of the MSB's market surveillance jurisdiction which are received through reports from private individuals, rival companies, other authorities, etc. or through the RAPEX system, the EU system for rapid information exchange concerning hazardous products. The surveillance is carried out predominantly through documentation checks and visual inspection. Technical testing may also be performed. 5.2 Proactive market surveillance Proactive market surveillance of products that the MSB has chosen to subject to surveillance is predominantly carried out by means of documentation checks

13 Version 13 (14) and visual inspection. Technical testing may also be performed. Decisions concerning testing will be taken as and when appropriate during the financial year. 5.3 Other initiatives For the time being, the MSB does not have any initiatives planned in collaboration with Swedish Customs in order to prevent the arrival of faulty products from third countries. The need may arise for us to intervene when we are alerted by Customs that certain goods have been blocked at the border, but this is not yet clear. No market surveillance is planned at trade fairs or exhibitions. 6 Principles for selecting products for surveillance Products throughout our area of responsibility may form the subject of reactive market surveillance; please see Section 5.1. They are selected for proactive market surveillance in a number of stages. Annual intelligence points to changes over time, e.g. if a certain product group has caused accidents or demonstrated failings; increased in use or found new user groups, whether the products have had a low priority for a long time, or if any legislation has been amended. Accident statistics are used as part of the intelligence wherever possible. Intelligence is used to prioritise product groups for proactive market surveillance. The products that are then selected will depend on the surveillance method that is used, e.g. on-site selection or virtual selection, selection of a certain sub-group or area of use, etc. In short, the following products are considered to require heightened surveillance: Fireworks for consumers since faulty products can cause severe harm to both people and property. Accidents occur every year, according to the statistics. There are now also some new, harmonised products in Sweden. Some of the labelling requirements appear in the regulations issued by KEMI, the Swedish Chemicals Agency. Gas equipment for consumers since the supply of such items has boomed recently. There are both sellers and buyers who are unfamiliar with LPG, and inspections of products have found failings, sometimes serious ones. Physical and visual inspections may be carried out by the MSB, and, once the products have been tested, any failings that are found may be addressed by means of regulations issued by KEMI, the Swedish National Board of Housing, Building and Planning, or the National Electrical Safety Board. Cigarette lighters which use a gaseous fuel are a very common product that may cause fires and severe injuries if the product does not comply with the requirements. There are indications that some non-compliant cigarette lighters are on the market. Aerosols. Market surveillance was carried out on this product group in 2015, but,

14 Version 14 (14) given the large number of products, it must be expected that many products with incorrect conformity labelling will still be found on the market. Single-use gas canisters (transportable pressure equipment) since economic operators sometimes mistakenly assume them to be aerosols. The MSB is responsible for surveillance of the canisters only; the contents are regulated by another authority. Flueless stoves which may cause fires or severe injury if they do not comply with the requirements. This product group is regulated nationally, but a mandate for harmonising the standards is currently being prepared. The following product types are considered to have a minor surveillance need: Explosive goods for civil uses, i.e. explosives employed predominantly by professional users in the mining and construction industries; Pyrotechnic articles for vehicles and fireworks for professional use; Transportable pressure equipment of the multiple-use type, where recurring surveillance is carried out by the surveillance body. 7 Cooperation There is a particular need for cooperation and coordination with other authorities which are responsible for surveillance of the same products as the MSB, e.g.: the Swedish authorities in whose legislation the Gas Appliances Directive has been transposed into Swedish law with the aim of imposing requirements concerning identified deficiencies of all kinds on the same occasion; counterpart authorities within the EU/EEA whose products coincide with the aim of increasing the impact of measures and harmonising the setting of requirements and priorities; Swedish Customs, with the aim of preventing the import of faulty products into Sweden. 8 Costs/resources One and a half FTEs are allocated to market surveillance. This work includes both operational work and reporting, as well as some administrative work, for example in connection with the Market Surveillance Council. Other cooperation may also take place nationally and, in exceptional cases, internationally. The cost of the MSB's market surveillance is estimated at approximately SEK This includes some travel costs. No funds have been reserved for technical testing for Technical testing may still be carried out as and when necessary through individual decisions taken during the financial year.