NATIONAL MARKET SURVEILLANCE PROGRAMME Poland

Transcription

1 NATIONAL MARKET SURVEILLANCE PROGRAMME 2017 Poland Warsaw, December 2016

2 Contents 1. ORGANISATION AND INFRASTRUCTURE OF THE MARKET SURVEILLANCE SYSTEM Identification and responsibilities of national market surveillance authorities Coordination and cooperation mechanisms between national market surveillance authorities Cooperation between national market surveillance authorities and the customs services Rapid alert system (RAPEX) ICSMS information system General description of market surveillance activities and relevant procedures General framework of cooperation with other Member States and nonmember states Evaluation of market surveillance actions and reporting Horizontal activities planned for the relevant period MARKET SURVEILLANCE IN SPECIFIC SECTORS Sector 1 Medical devices (including in vitro diagnostic medical devices and active implantable medical devices) Responsible authority and contact details Market surveillance procedures and strategy Report from activities carried out under the previous planning period Sector 2 - Cosmetics Responsible authority and contact details Market surveillance procedures and strategy Report from activities carried out under the previous planning period Sector 3 - Toys Responsible authority and contact details: Market surveillance procedures and strategy Report from activities carried out under the previous planning period Sector 4 - Personal protective equipment Responsible authority and contact details: Market surveillance procedures and strategy Report from activities carried out under the previous planning period Sector 5 - Construction products Responsible authority and contact details: Market surveillance procedures and strategy Report from activities carried out under the previous planning period Sector 7 - Simple pressure vessels and pressure equipment Responsible authority and contact details Market surveillance procedures and strategy Report from activities carried out under the previous planning period Sector 8 - Transportable pressure equipment

3 Responsible authority and contact details Market surveillance procedures and strategy Report from activities carried out under the previous planning period Sector 9 - Machinery Responsible authority and contact details Market surveillance procedures and strategy Report from activities carried out under the previous planning period Sector 10 - Lifts Responsible authority and contact details Market surveillance procedures and strategy Report from activities carried out under the previous planning period Sector 11 - Cableways Responsible authority and contact details Market surveillance procedures and strategy Report from activities carried out under the previous planning period Sector 12 - Noise emissions for outdoor equipment Responsible authority and contact details Market surveillance procedures and strategy Report from activities carried out under the previous planning period Sector 13 - Equipment and protective systems intended for use in potentially explosive atmospheres Responsible authority and contact details Market surveillance procedures and strategy Report from activities carried out under the previous planning period Sector 14 - Pyrotechnics Responsible authority and contact details Market surveillance procedures and strategy Report from activities carried out under the previous planning period Sector 15 - Explosives for civil uses Responsible authority and contact details Market surveillance procedures and strategy Report from activities carried out under the previous planning period Sector 16 - Appliances burning gaseous fuels Responsible authority and contact details Market surveillance procedures and strategy Report from activities carried out under the previous planning period Sector 17 - Measuring instruments, non-automatic weighing instruments and pre-packaged products Responsible authority and contact details Market surveillance procedures and strategy Report from activities carried out under the previous planning 3

4 period Sector 18 - Electrical equipment under EMC Responsible authority and contact details Market surveillance procedures and strategy Report from activities carried out under the previous planning period Sector 19 - Radio and telecom equipment under RTTE Responsible authority and contact details: Market surveillance procedures and strategy Report from activities carried out under the previous planning period Sector 20 - Electrical appliances and equipment under LVD Responsible authority and contact details Market surveillance procedures and strategy Report from activities carried out under the previous planning period Sector 21 - Electrical and electronic equipment under RoHS and WEEE and batteries Responsible authority and contact details Market surveillance procedures and strategy Report from activities carried out under the previous planning period /A Sector 22A - Chemical substances under REACH and Classification and Labelling Regulations /A.1. Responsible authority and contact details /A.2. Market surveillance procedures and strategy /A.3. Report from activities carried out under the previous planning period /B Sector 22B - Other chemicals (detergents, paints, persistent organic pollutants, fluorinated greenhouse gases, ozone depleting substances, etc.) /B.1. Responsible authority and contact details /B.2. Market surveillance procedures and strategy /B.3. Report from activities carried out under the previous planning period Sector 23 - Efficiency requirements for hot-boilers fired with liquid or gaseous fuels Responsible authority and contact details: Market surveillance procedures and strategy Report from activities carried out under the previous planning period Sector 24 - Tyre labelling Responsible authority and contact details Market surveillance procedures and strategy Report from activities carried out under the previous planning period Sector 25 - Recreational crafts Responsible authority and contact details Market surveillance procedures and strategy Report from activities carried out under the previous planning 4

5 period Sector 26 Marine equipment Responsible authority and contact details Market surveillance procedures and strategy Report from activities carried out under the previous planning period Sector 27 - Motor vehicles Responsible authority and contact details Market surveillance procedures and strategy Report from activities carried out under the previous planning period Sector 29 Fertilisers Responsible authority and contact details Market surveillance procedures and strategy Report from activities carried out under the previous planning period Sector 31 - Biocides Responsible authority and contact details Market surveillance procedures and strategy Report from activities carried out under the previous planning period Sector 32 - Textile labelling Responsible authority and contact details Market surveillance procedures and strategy Report from activities carried out under the previous planning period Sector 34 - Railway interoperability Responsible authority and contact details Market surveillance procedures and strategy Report from activities carried out under the previous planning period

6 1. ORGANISATION AND INFRASTRUCTURE OF THE MARKET SURVEILLANCE SYSTEM 1.1. Identification and responsibilities of national market surveillance authorities The Polish market surveillance system, particularly for products subject to CE marking, is governed by the Act of 13 April 2016 on conformity assessment and market surveillance systems (Journal of Laws, item 542, as amended, hereinafter: USOZiNR), which introduces a total of 13 EU sectoral directives and includes product groups such as: toys, electrical equipment, pressure equipment or pyrotechnics, as well as recreational crafts, jet skis and measuring instruments. The current legal provisions of 30 August 2002 on the conformity assessment system (Journal of Laws (Dziennik Ustaw) 2016, item 655, as amended, further: ACAS) remain in effect for 11 product groups, including machinery, aerosol products, appliances burning gaseous fuels (e.g. camping stoves) or personal protective equipment (e.g. cycle helmets, protective gloves). This system does not apply to: - medical devices which are subject to supervision by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, - cosmetics which are subject to supervision by the Chief Sanitary Inspector and, in terms of marking, adulteration and legality of trade, the Trade Inspection, - fertilisers which are subject to supervision by the Chief Inspector of Agricultural and Food Quality, - chemical substances, chemicals, tyre labelling, biocides, textile product labelling which are subject to supervision by the Trade Inspection. The rules governing the above-mentioned areas are indicated in Part 2. Market surveillance in specific sectors. Furthermore, the national market surveillance system is also governed by the provisions 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 (OJ L 218, , p. 30, hereinafter: Regulation 765/2008/EC). The competencies of different market surveillance authorities within the national system are detailed in the following separate provisions: Market surveillance Legal act authority Provincial inspectors of the Trade Inspection Act of 15 December 2000 (codified Trade Inspection reporting text: Journal of Laws 2016, item 1059) to the President of the Office of Competition and Consumer Protection (further: IH Inspekcja Handlowa) National Labour Inspection authorities (further: PIP Państwowa Inspekcja Pracy) President of the Office of Electronic Communications (further: President of the UKE Urząd Komunikacji Elektronicznej) Environmental Protection Inspection authorities (further: National Labour Inspection Act of 13 April 2007 (codified text: Journal of Laws 2015, item 640, as amended) Telecommunications Law Act of 16 July 2004 (codified text: Journal of Laws 2016, item 1489) Environmental Protection Inspection Act of 20 July 1991 (Journal of Laws 2013, item 686, as amended) 6

7 IOŚ Inspekcja Ochrony Środowiska) President of the Office of Rail Transport (further: President of the UTK Urząd Transportu Kolejowego) - Rail Transport Act of 28 March 2003 (codified text: Journal of Laws 2016, item 1727) - Act of 19 August 2011 on transport of dangerous goods (codified text: Journal of Laws 2016, item 1834) building control authorities Construction Products Act of 16 April 2004 (codified text: Journal of Laws 2016, item 1570) President of the State Mining Authority (further: President of the WUG Wyższy Urząd Górniczy) directors of maritime offices (further: UM Urząd Morski) provincial road transport inspectors (further: ITD inspektor transportu drogowego) President of the Central Office of Measures and directors of the District Offices of Measures President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (further: URPL Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych) Chief Inspector of Agricultural and Food Geological and Mining Law Act of 9 June 2011 (codified text: Journal of Laws 2016, item 1131, as amended) - Act of 21 March 1991 on the maritime territory of the Republic of Poland and on the maritime administration (codified text: Journal of Laws 2013, item 934, as amended) - Marine Equipment Act of 20 April 2004 (Journal of Laws 2004, No 93, item 899, as amended) Act of 19 August 2011 on transport of dangerous goods (Journal of Laws 2016, item 1834) Measures Act of 11 May 2001 (Journal of Laws 2016, item 884) Medical Devices Act of 20 May 2010 (codified text: Journal of Laws 2015, item 876, as amended) Act of 21 December 2000 on the commercial quality of agricultural and food products (Journal of Laws 2016, item 1604, as amended) Quality Chief Sanitary Inspector State Sanitary Inspection Act of 14 March 1985 (codified text: Journal of Laws 2015, item 1412, as amended) The list of Polish market surveillance authorities, including their areas of responsibility and contact details, is available at the European Commission s website: /pdf. It is difficult to specify resources at the disposal of national market surveillance authorities (including budget or staff expressed as full-time equivalent units), as inspectors are also involved in the performance of other statutory tasks (e.g. trade inspectors check fuel quality or price marking of goods, whereas labour inspectors check compliance with labour provisions and provisions on the legality of employment and 7

8 other paid work). In 2016, market surveillance authorities had at their disposal an estimated budget of EUR and a total of full-time equivalent units 2. This document provides information on activities planned from 1 January to 31 December Activities of all market surveillance authorities extend to the entire national territory. The 2016 National Market Surveillance Programme, following its approval by the Polish Cabinet s Committee for European Affairs (KSE), was sent by to the European Commission and to the other Member States on 18 January Coordination and cooperation mechanisms between national market surveillance authorities The President of the Office of Competition and Consumer Protection (further: President of the UOKiK Urząd Ochrony Konkurencji i Konsumentów) is the authority responsible for monitoring and coordinating the national market surveillance system in Poland (in accordance with Article 18(1) of Regulation No 765/2008/EC) and for carrying out administrative proceedings with the aim of imposing obligations on economic operators who place on the market consumer goods posing a risk or goods which do not conform to the requirements applicable to the following sectors: 2, 3, 4, 7, 9, 14, 16, 20, 21, 22, 23, 24, 27, 32. The market surveillance tasks of the President of the UOKiK include cooperating with the Customs Service and national market surveillance authorities, planning inspections to be carried out by the Trade Inspection, responding to complaints and signals of negative phenomena coming from the market, conducting EUlevel cooperation with market surveillance authorities from other Member States and with the European Commission, preparing periodic reports on the findings of inspections, training IH inspectors responsible for carrying out inspections, and keeping public registers to inform the public on goods which do not comply with requirements or which pose a risk. The President of the UOKiK also plays the role of a national contact point under the European Union s RAPEX and ICSMS systems. Complaints lodged with the President of the UOKiK are, insofar as possible, factored in when planning inspections or the President of the UOKiK instructs the competent market surveillance authority to investigate the matter. Coordination and cooperation at the national level take place during regular meetings of the Market Surveillance Steering Committee. It is a platform for information and opinion exchange among the representatives of the state administration involved in the performance of market surveillance tasks. It is also tasked with supporting the President of the UOKiK in his role as a monitoring authority. The Committee has been meeting at least once a year since 2004, i.e. since the market surveillance system was implemented in Poland. The representatives of market surveillance authorities 3, the Ministry of Finance (representing the Customs Service) and the Ministry of Development (responsible for legislative matters as part of the national market surveillance system) participate in the Committee s meetings. The most recent meeting took place on 13 July 2016 at the headquarters of the UOKiK. Market surveillance authorities report annually to the President of the UOKiK on the inspections they have carried out. Based on these reports, the President of the UOKiK 1 These figures do not include the, Maritime Offices, the Agricultural and Food Quality Inspection, the Road Transport Inspection, and the State Labour Inspection and the State Sanitary Inspection. 2 These figures do not include the Agricultural and Food Quality Inspection, the, the State Labour Inspection and the State Sanitary Inspection. 3 Chief Inspectorate of Environmental Protection, Chief Labour Inspectorate, Chief Inspectorate of Road Transport, Central Office of Measures, General Office of Building Control, Office of Electronic Communications, Office of Competition and Consumer Protection, Office of Rail Transport, Maritime Offices, State Mining Authority. 8

9 draws up each year a report on the functioning of the national market surveillance system, which is approved by KSE. Since 2012, the reports have been published on the UOKiK website: Cooperation between national market surveillance authorities and the customs services The framework for cooperation between Customs and market surveillance authorities is laid down in Articles 27 to 29 of Regulation 765/2008/EC. These provisions are applied directly by Customs authorities. Collaboration between Customs and market surveillance authorities takes place both at the central and local levels (on the part of the Customs Service, the responsibility for collaboration rests on product safety coordinators, who have been appointed at each of the sixteen customs chambers). The collaboration includes mainly: passing information on negative phenomena identified by market surveillance authorities as requiring increased efforts, regular dialogue and experience sharing: o at the Steering Committee s forum, o collaboration on preparing Poland s position on new EU legislative proposals, joint actions, including collaboration on international projects (e.g. PROSAFE-led projects 4 ). In view of the opportunity to finance the participation of representatives of Customs authorities in project initiation and closure meetings from Customs2020, it is planned that Polish customs authorities will be involved in the projects in which Polish market surveillance authorities will participate. Customs authorities also receive support from market surveillance authorities on: training for customs officers, preparing new or updating existing checklists for different product groups, engaging in the work of Expert Working Group led by DG TAXUD. In 2017, the Customs Service will continue its market surveillance operations in accordance with, inter alia, the Customs Action Strategy, one of whose strategic goals is to increase market security and protection, including through disclosure of goods which do not conform to harmonisation requirements and separate provisions. Sectoral areas of Customs authorities operations will depend on both the operational priorities identified by market surveillance authorities and on the characteristics of trade in goods. Furthermore, in connection with the findings from the meeting of the representatives of the customs authorities and market surveillance authorities in the countries of the Visegrad group, held on October in Poronin, Poland, it is likely that inspections will be carried out in 2017 as part of joint action regarding toys made from soft plastic (phthalate content control). It is envisaged that the project will be implemented during the period September-October Rapid alert system (RAPEX) The President of the UOKiK manages data collected in the EU rapid alert system 4 9

10 (RAPEX) at the national level. Acting as a RAPEX Polish Contact Point (hereinafter: PCP RAPEX), the President of the UOKiK has the right to enter, approve and send notifications to the European Commission. Notifications published in the system are created using information submitted by economic operators (voluntary notifications of remedial actions) and received from other market surveillance authorities (legal measures applied against products posing a serious risk). Market surveillance authorities provide PCP RAPEX with information about the actions taken, which serves as the basis for notifications and for responding to notifications from other Member States. As things currently stand, the RAPEX accounts of the Customs Service and market surveillance authorities (other than the UOKiK) have a functionality that allows them only to browse notifications. PCP RAPEX coordinates the operation of the system at the national level by ordering the competent market surveillance authorities to carry out an inspection in the event where the occurrence of a dangerous product on the Polish territory is reported ICSMS information system The Office of Competition and Consumer Protection has been the national administrator of ICSMS since The national ICSMS administrator is responsible for coordinating actions, collaborating with contact points established within other national market surveillance authorities, ongoing liaising with the Commission in matters relating to the system s technical operation, registering new users in the system and ensuring the consistency of Polish translation. The national administrator also participates in meetings of the Expert Group on the Internal Market for Products (ICSMS). It also provides training for the system s users at the national level. In addition to the UOKiK, the national ICSMS network is formed by 11 market surveillance authorities (Office of Electronic Communications, Chief Inspectorate of Environmental Protection, Chief Inspectorate of Road Transport, Central Office of Measures, Maritime Office in Gdynia, Maritime Office in Słupsk, Maritime Office in Szczecin,, President of the Office of Rail Transport, General Office of Building Control, Chief Sanitary Inspectorate). According to national regulations, these authorities enter data into the system on the actions taken and measures adopted General description of market surveillance activities and relevant procedures Ensuring safety and protecting the health and lives of consumers and users is a continuous process. In meeting their responsibilities, market surveillance authorities take measures aimed at the effective elimination from the market of products that may potentially represent serious risks and that do not comply with current requirements. The authorities, as far as they have the necessary financial and human resources, do their best to ensure that the measures they take address all areas of their competence. It should be taken into consideration, however, that planned measures are only targeted at the areas which were found by the risk analysis to pose the highest threat of risks. However, products that fall outside the scope of the activities planned in a given year are also subject to inspections if the authority receives credible complaints or signals from the market that there may be a serious risk to the health or lives of consumers and users in a specific area. No separate market surveillance strategic documents are in place for different sectors. The tasks within the market surveillance system are carried out in accordance with the annual inspection plans prepared by different market surveillance authorities. The priorities and principles of operation of the UOKiK and IH in relation to ensuring 10

11 product safety are defined in the strategic guidance documents entitled The action lines of the Trade Inspection for and Consumer policy for The Trade Inspection carries out its inspections on the basis of detailed quarterly inspection programmes prepared by the President of the UOKiK. Products may also be inspected as part of intervention actions undertaken at the request of the President of the UOKiK in response to reports from consumers or information published in the media or provided by industry organisations. In addition, provincial IH inspectors may take action on their own initiative if they deem it necessary, depending on the specifics of the region in which they operate, e.g. in response to complaints submitted directly to the IH. During an inspection, an IH inspector may take samples of products free of charge for laboratory testing. The inspector is authorised to verify documents related to the conformity assessment procedure. If, during inspections, a product is found not to comply with formal requirements but the non-compliance does not create any serious risks and is relatively easy to remedy (e.g. by adding marking or warnings or attaching a label), the inspector enables the inspected party to take remedial measures. If the economic operator did not voluntarily take remedial measures within the designated time limit or did not withdraw disputed products from the market, the inspection file is sent to the entity in charge of the proceedings (the President of the UOKiK in the case of the Trade Inspection) with a request to initiate proceedings (Article 75(4) USOZiNR or Article 40k(3) ACAS). For products subject to USOZiNR regulations, in accordance with Article 84(2) USOZiNR, if it is found that a product does not comply with the requirements and the party to the proceedings has not presented proof confirming the rectification of the nonconformity of the product with the requirements, withdrawal of the product from the market or from use, recovery of the product, destruction of the product or notification of users of the nonconformities found, the market surveillance authority carrying out the proceedings may by way of a decision: order the rectification of the nonconformity, order the withdrawal of the product from the market or from use, prohibit the product from being made accessible, order the recovery of the product, order the destruction of the product, order the notification of consumers or other users of the nonconformities found, outlining the time frame and method for such notifications. In terms of products subject to ACAS regulations, if no remedial measures are taken within the designated time limit, the authority in charge of the proceedings may, by means of a decision under Article 41c(3) ACAS may apply similar legal measures (in other words, order the withdrawal of the product from the market, prohibit the product from being made available, restrict the availability of the product, or instruct the party to the proceedings to notify consumers or users of the product about the matters in respect of which non-compliance was found within the time limit and in the manner specified by that authority. Decisions issued by the market surveillance authorities that impose obligations on commercial entities, in accordance with Article 61(3) USOZiNR, form a basis for entering the product in the register of goods which do not conform to requirements or pose a risk. The register is kept by the President of the UOKiK and is made available to the public via the UOKiK website ( Furthermore, the legal measures adopted and information about the actions taken are sent to the European Union systems RAPEX and ICSMS (depending on the level and scope of risk) General framework of cooperation with other Member States and nonmember states 11

12 Within the scope of their competence, market surveillance authorities take an active part in EU initiatives and international control projects concerning safety of products. This is motivated by the fact that ensuring a high level of safety for consumers on the single market would not be possible without close collaboration with partners from other Member States. The President of the UOKiK has become actively involved in the work of PROSAFE, an organisation whose goal is to share the market surveillance experience and best practice, particularly to facilitate information sharing among market surveillance authorities in this field. Since 2010, a representative of the UOKiK has been a member of the Board of Directors of PROSAFE, while UOKiK and the Trade Inspection regularly participate in joint actions managed by PROSAFE. Representatives of market surveillance authorities participate also in the meetings of Administrative Co-operation Groups (ADCO) concerned with the directives falling within their sphere of competence. The representatives of the UOKiK as a monitoring body attend meetings of the expert group on the internal market for products market surveillance group (IMP-MSG). The Trade Inspection and UOKiK participate each year in the officer exchange programme financed by the European Commission in the field of market surveillance and safety of non-food products, as well as receiving foreign delegations and visiting market surveillance authorities in other Member States Evaluation of market surveillance actions and reporting Inspections are typically carried out in the areas that exhibit a high ratio of detected irregularities and pose a serious and direct threat to human life and health and the environment. Market surveillance authorities are committed to regularly inspecting the areas involving products that are offered on a mass scale or intended for particularly vulnerable groups of consumers, the areas where serious irregularities have been detected in the past, and the newly regulated areas that yet need to be probed. Insofar as possible, inspections are carried out at producers, importers and wholesalers in order to target the highest level of the distribution chain. Retail outlets, which are the most easily available to consumers, are also subject to detailed inspections. Entities to be inspected are largely selected at random. However, outlets in which irregularities have been detected in past inspections or against which complaints have been made are also taken into account in the selection process. Complaints made directly to a given authority trigger ad hoc inspections or are factored in when planning own actions. Furthermore, the systematic collaboration of market surveillance authorities with the Customs Service has contributed to increasing the system s effectiveness. This collaboration has made it possible to detect irregularities even before products are placed on the common EU market. The Customs Service focuses its activity on the areas where the most irregularities were detected in the previous years. The system s effectiveness is monitored on an ongoing basis and presented in annual reports on the operation of the national market surveillance system, which are prepared by the President of the UOKiK. This effectiveness is measured using statistical data on actions and measures taken by the national market surveillance authorities and the Customs Service. The effectiveness of the national market surveillance system is also discussed on an annual basis during meetings of the Market Surveillance Steering Committee. 12

13 1.9. Horizontal activities planned for the relevant period In 2017, the UOKiK will continue its activities related to Joint Action 2014 on the control of pyrotechnics and power tools and EEPLIANT In 2016 it signed up to the Joint Action 2015 project control of toy safety (chemical properties) and developing a risk assessment methodology. UOKiK is also planning to sign up to JA2016 (safety actions: electrical toys, consumer power tools, household appliances, as well as actions aimed at reviewing the system in effect in a given country, improving its operation and exchanging best practices between market surveillance authorities CIMS: Continuous Improvement in Market Surveillance). Representatives of the following market surveillance authorities will take part in 2017 in meetings of the ADCO groups in the following areas: 1) UOKiK: safety of toys, safety of electrical equipment, safety of pyrotechnic products, eco-design and energy labelling. 2) UKE: electromagnetic compatibility, radio equipment. 3) PIP: machinery, lifts, personal protective equipment and pressure equipment and simple pressure vessels. 4) GINB [Chief Inspectorate of Building Control]: construction products. 5) WUG: explosives, machinery. 6) GIOŚ [Chief Inspectorate of Environmental Protection]: Noise. 2. MARKET SURVEILLANCE IN SPECIFIC SECTORS 2.1. Sector 1 Medical devices (including in vitro diagnostic medical devices and active implantable medical devices) Responsible authority and contact details Surveillance of medical devices in the Republic of Poland is carried out by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Al. Jerozolimskie 181C, Warszawa Tel Fax incydenty@urpl.gov.pl Market surveillance procedures and strategy The President of the Office plans and carries out their activities based on the surveillance plan for the market of medical devices, using the legal provisions laid down in the Medical Devices Act of 20 May The 2017 priorities include actions regarding medical devices for which the name, labelling, usage instructions, promotional materials or presentation may be misleading in terms of the properties and effects of the device by assigning it properties, functions and effects that it does not have or by falsely suggesting uses or properties other than those declared when carrying out a conformity assessment procedure. Furthermore, the 13

14 inspections of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products particularly focus on products that have been wrongly classed as medical devices when they should be classed as medical products, or products that contain, as an integral part thereof, a substance which, when used separately, would be classed as a medical product and which may have a different effect on the human body when used as a medical device, as well as products that have wrongly not been classified as class III medical devices in accordance with Rule 13 outlined in appendix IX to Directive 93/42/EEC Report from activities carried out under the previous planning period The activities carried out by the President of the Office by 25 November 2016 as part of surveillance of the medical devices market included: - initiating 63 administrative procedures, - issuing 25 opinions on medical devices conformity to applicable requirements at the request of Customs authorities, - filing five notifications of a suspected offence related to the trade in noncompliant medical devices to the police and the public prosecutor Sector 2 - Cosmetics Responsible authority and contact details Market surveillance tasks in the field of cosmetics are carried out by the Chief Sanitary Inspector and in respect of the marking and adulteration of, and the legality of trade in, cosmetics the Trade Inspection authorities reporting to the President of the UOKiK. Chief Sanitary Inspectorate ul. Wspólna 65, Warszawa Tel , Fax inpektorat@gis.gov.pl Office of Competition and Consumer Protection Plac Powstańców Warszawy 1, Warszawa Trade Inspection Department Tel Fax uokik@uokik.gov.pl, dih@uokik.gov.pl Market surveillance procedures and strategy Activities are carried out under the Cosmetics Act of 30 March 2001 (Journal of Laws 2013, item 475). State Sanitary Inspection In 2017, the actions of the State Health Inspection authorities will focus on the inspection of cosmetic product information files, especially products with special reference 5 Council Directive 93/42/EEC of 14 June 1993 on Medical Devices (OJ 169, , p. 1) 14

15 to the use of a substance in nano-form, collection of products for laboratory tests in the form of chemical and microbiological analyses, as well as inspections of tooth whiteners and checks of compliance with the provisions of Commission Regulation (EU) 2016/1198 of 22 July 2016 amending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (OJ L 198, , p. 10). 15

16 Trade Inspection As part of its checks on cosmetics, the Trade Inspection commissions product tests at the Specialist Laboratory of Fuels and Domestic Detergents in Bydgoszcz, which is a unit of the Office of Competition and Consumer Protection. Laboratory tests of cosmetics will mainly be concerned with checking the conformity of net filling volume with the producer s declaration Report from activities carried out under the previous planning period State Sanitary Inspection Information on the activities of the State Sanitary Inspection in a given calendar year is provided in The state sanitary condition (Stan sanitarny kraju), a document published annually on the website of the Chief Sanitary Inspectorate ( Publications section). Trade Inspection In the first quarter of 2016, the Trade Inspection carried out nationwide checks on the marketing and labelling of cosmetic products. The checks covered manufacturers, importers, wholesalers and retailers, in particular those selling goods in bulk. Marketing claims were also checked. Of the 403 batches checked for claims, 30 batches, i.e. 7.4 %, were challenged. Checks covered 73 enterprises offering cosmetic products. 410 product batches were checked. 63 batches, i.e % of all those checked, were called into question Sector 3 - Toys Responsible authority and contact details: Market surveillance tasks in the field of toys are carried out by the Trade Inspection authorities reporting to the President of the UOKiK. Office of Competition and Consumer Protection Plac Powstańców Warszawy 1, Warszawa Market Surveillance Department Tel Fax uokik@uokik.gov.pl, dnr@uokik.gov.pl Market surveillance procedures and strategy The 2017 plan of inspections foresees checks of toys from all categories, especially toys for children aged under 36 months made from plastic in terms of the presence of unauthorised substances. Plans are also in place to carry out laboratory tests of toys. These will be carried out by the Specialist Testing Laboratory of Toys in Lublin and the Specialist Laboratory of Textile Products and Instrumental Analysis in Łódź, both of which are units of the Office of Competition and Consumer Protection Report from activities carried out under the previous planning period. 86 administrative proceedings concerning toys which did not conform to the essential requirements were initiated by 1 December Six decisions were issued imposing 16

17 obligations on operators responsible for placing non-conforming toys on the market (withdrawal of the toys from the market). 20 notifications regarding toys presenting a serious threat were entered in RAPEX and information on five toys was recorded in the national register of products non-conforming with requirements or constituting a threat Sector 4 - Personal protective equipment Responsible authority and contact details: Market surveillance tasks in the field of personal protective equipment are carried out by the National Labour Inspection authorities for products intended for use by employers, the Trade Inspection authorities reporting to the President of the UOKiK for products intended for consumers and by the President of the for products intended for use in mines. Chief Labour Inspectorate ul. Barska 28/30, Warszawa Surveillance and Control Department Tel Fax kancelaria@gip.pip.gov.pl Office of Competition and Consumer Protection Plac Powstańców Warszawy 1, Warszawa Market Surveillance Department Tel Fax uokik@uokik.gov.pl, dnr@uokik.gov.pl ul. Poniatowskiego 31, Katowice Electrical Power and Mechanical Systems Department Tel Fax wug@wug.gov.pl Market surveillance procedures and strategy National Labour Inspection In 2017, the National Labour Inspection is planning: 17

18 a) proactive inspections of a selected group of personal protective equipment based on the assessment of risk to worker safety and health. These inspections will particularly focus on respiratory protective equipment, b) reactive inspections these will be carried out in response to complaints and reports on the presence on the national market of personal protective equipment used at work that may not conform to regulatory requirements. Trade Inspection The 2017 plan of inspections foresees checks of selected personal protective equipment - reflective clothing, ear defenders, helmets and ski goggles. Laboratory tests are also planned at accredited external laboratories. The President of the WUG applies the procedures laid down in the Geological and Mining Law Act of 9 June Inspections at mining plants will comprise checks on products and supporting documents. Where it is suspected that a product does not conform to the requirements, a risk assessment will be carried out. Actions will be taken in accordance with the procedure applicable to the detection of a non-compliant product in a mining plant Report from activities carried out under the previous planning period. National Labour Inspection Information about inspections in a given calendar year can be found in the annual publication Report on actions taken by the National Labour Inspection ( Trade Inspection By 1 December 2016, inspection findings resulted in the initiation of 15 administrative proceedings on non-compliance of personal protective equipment with the essential requirements. No decision was issued that would impose any obligations on operators responsible for placing products on the market. Assumptions underlying the existing plan of inspections are carried out on an ongoing basis Sector 5 - Construction products Responsible authority and contact details: The General Inspector of Building Control and 16 provincial inspectors of building control are the authorities responsible for matters relating to construction products. General Office of Building Control ul. Krucza 38/42, Warszawa Construction Products Department Fax esp@gunb.gov.pl, dwb@gunb.gov.pl 18

19 Market surveillance procedures and strategy In 2017, inspections are planned to focus on products identified through risk assessment, particularly in terms of their impact on the safety of building structures, environmental protection and energy efficiency, as well as on those where the need for inspection is prompted by the knowledge of the local market of construction products in different provinces Report from activities carried out under the previous planning period A total of inspections were carried out by 15 November 2016, covering construction products. Irregularities were found in 38 % of products checked. As a result, 583 administrative proceedings were initiated that led to the issuance of 226 rulings restricting trade in the products concerned. In 2016, building control authorities issued 29 opinions, including 23 negative opinions, at the request of Customs authorities Sector 7 - Simple pressure vessels and pressure equipment Responsible authority and contact details Market surveillance tasks in the field of simple pressure vessels and pressure equipment are carried out by the National Labour Inspection authorities for products intended for use by employers, the Trade Inspection authorities reporting to the President of the UOKiK for products intended for consumers and by the President of the for products intended for use in mines. Chief Labour Inspectorate ul. Barska 28/30, Warszawa Surveillance and Control Department Tel Fax kancelaria@gip.pip.gov.pl ul. Poniatowskiego 31, Katowice Electrical Power and Mechanical Systems Department Tel Fax wug@wug.gov.pl Office of Competition and Consumer Protection Plac Powstańców Warszawy 1, Warszawa Market Surveillance Department Tel Fax uokik@uokik.gov.pl, dnr@uokik.gov.pl 19

20 Market surveillance procedures and strategy National Labour Inspection In 2017, the National Labour Inspection is planning to conduct inspections of selected simple pressure vessels and pressure equipment. Inspections will be carried out in particular in response to complaints and reports on the presence on the national market of products used in the workplace that may not conform to requirements. The President of the WUG applies the procedures laid down in the Geological and Mining Law Act of 9 June Trade Inspection No actions are planned in Intervention operations are permitted, e.g. upon receipt of complaints Report from activities carried out under the previous planning period. National Labour Inspection Information about inspections in a given calendar year can be found in the annual publication Report on actions taken by the National Labour Inspection ( Assumptions underlying the existing plan of inspections are carried out on an ongoing basis. Trade Inspection The findings of inspections carried out by 1 December 2016 did not give rise to any administrative proceedings on non-compliant products Sector 8 - Transportable pressure equipment Responsible authority and contact details Market surveillance activities in the field of transportable pressure equipment are carried out by the President of the Office of Rail Transport and the provincial road transport inspectors. Office of Rail Transport Al. Jerozolimskie 134, Warszawa Surveillance Department Tel Fax utk@utk.gov.pl Chief Inspectorate of Road Transport Al. Jerozolimskie 94, Warszawa 20

21 Inspection Surveillance Office Tel Fax Market surveillance procedures and strategy Office of Rail Transport Strengthening the safety surveillance of the railway system in Poland by stepping up audit and control measures related to its operation has been identified by the President of the UTK as a priority for inspections of transportable pressure equipment are planned for Road Transport Inspection Control activities of the Road Transport Inspection are governed by the Act of 19 August 2011 on transport of dangerous goods and on the European Agreement concerning the International Carriage of Dangerous Goods by Road (ADR). These tasks are carried out as part of routine checks on vehicles carrying dangerous goods and on-the-spot checks at the premises of enterprises engaged in the transport of dangerous goods by road Report from activities carried out under the previous planning period Office of Rail Transport One inspection was carried out on five products. No irregularities were found. Road Transport Inspection Assumptions underlying the existing plan of inspections are carried out on an ongoing basis Sector 9 - Machinery Responsible authority and contact details Market surveillance tasks in the field of machinery are carried out by the President of the for products intended for use in mines, the National Labour Inspection authorities for products intended for use by employers and the Trade Inspection authorities reporting to the President of the UOKiK for products intended for consumers. Chief Labour Inspectorate ul. Barska 28/30, Warszawa Surveillance and Control Department Tel Fax kancelaria@gip.pip.gov.pl 21

22 Office of Competition and Consumer Protection Plac Powstańców Warszawy 1, Warszawa Market Surveillance Department Tel Fax ul. Poniatowskiego 31, Katowice Electrical Power and Mechanical Systems Department Tel Fax Market surveillance procedures and strategy National Labour Inspection In 2017, the National Labour Inspection is planning: a) proactive inspections of a selected machinery group that presents a serious accident risk, in particular inspections of machinery for working wood. b) reactive inspections these will be carried out in response to complaints and reports on the presence on the national market of machines used at work that may not conform to regulatory requirements. Trade Inspection The 2017 plan of inspections foresees checks on consumer power tools, fuel-powered tools and gardening machinery. The President of the WUG prepares and carries out their activities based on the annual plan of inspections, using the procedures laid down in the Geological and Mining Law Act of 9 June Report from activities carried out under the previous planning period. National Labour Inspection Information about inspections in a given calendar year can be found in the annual publication Report on actions taken by the National Labour Inspection ( Trade Inspection Two administrative proceedings on non-conforming machines were initiated by 1 December 2016; both were discontinued. Two notifications were entered into the RAPEX system on machines posing a serious threat. Assumptions underlying the existing plan of inspections are carried out on an ongoing basis. 22