1. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Working Group for Chapter 28 – Consumer and Health Protection Bilateral screening: Chapter 28 PRESENTATION OF MONTENEGRO Brussels, 15-16 April 2013

2. Chapter 28: Consumer and Health Protection GENERAL PRODUCT SAFETY Nada Đurđić Coordinator in Market Inspectorate Administration for Inspection Affairs nada.djurdjic@ti.gov.me M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Chapter 28: CONSUMER AND HEALTH PROTECTION

3. Chapter 28:Consumer and health protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union  Relevant Acquis  National legislation  The conformity relation  Institutional framework  Administrative capacity  The implementation of market surveillance  Realized results  Planned activities Chapter 28: CONSUMER AND HEALTH PROTECTION Content

4. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Relevant Acquis  Directive 2001/95/EC on general product safety  Directive 87/357/EEZ on misleading products Chapter 28: CONSUMER AND HEALTH PROTECTION

5. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union National legislation  The Law on general product safety(“OG MNE”, no.48 /2008) Directive 2001/95/EC on general product safety is transposed in this Law  Regulation on the Way of Exchanging Information on Products that Pose a Risk (“OG MNE”no. 13/2010) includes operation and cooperation of the competent authorities in the national and international level for exchanging of information on dangerous products  Instructions for the forms of notification on products posing a risk (“OG MNE”,no.60/2010) which is used by the authority in the procedure of notification on products posing the risk  The rulebook on the contents of notifications of dangerous product (“OG MNE”no 30/2010) relating to the actions undertake by producers and distributors toward the relevant inspectorates  The rulebook on establishing the List of Montenegrin standards in the area of general product safety (“OG MNE”, no 74/2010) apter 28: CONSUMER AND HEALTH PROTECTION

6. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Scope of the Law The Law contains: I- General provisions II -The safety requirements and criteria III –The obligation of producers and distributors IV - Informing and exchange of information V –Supervision VI – Offences VII-Tranzitional and final provision Chapter 28: CONSUMER AND HEALTH PROTECTION

7. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union I General provisions This chapter declares:  The subject of the law This Law shall regulate the requirements that must be met by the products placed on the market, obligations of producers and distributors, manner of providing information and exchange of information about product risks.  Application of the Law a/ This Law shall apply to the products whose safety is not regulated by separate regulations. b/ This Law shall not apply to used products delivered as antiques, and to the products that must be repaired or reconditioned prior to their use, provided that the deliverer informs thereof the person to whom the product is delivered in writing.  Definitions For the purpose of this Law, the meanings of the some terms are given such as produsts, safe product,dangerous product, misleading product, producer, distributor, party concerned, serious risk, preventing distribution and sale, recall,RAPEX Chapter 28: CONSUMER AND HEALTH PROTECTION

8. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union II The safety requirements and criteria This chapter declares:  The safety requirements a/ prescribed the obligation that the producer shall be obliged to place only safe products on the market b/ When assessing the safety of a product, in particular shall be taken into account: the characteristics of the product, the effect on other products, labelling of the product the categories of consumers c/ It shall be prohibited to produce, import, export or place on the market misleading products.  Standard Conformity Criteria a/ A product shall be presumed safe as far as the risks or risk categories are concerned, if it conforms to the applicable standards in Montenegro adopted on the basis of the European standards, the List of which have been published in the Official Gazette of Montenegro. b/ The Ministry competent for standardization activities shall be publish the List of the standards Chapter 28: CONSUMER AND HEALTH PROTECTION

9. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union The safety requirements and criteria /2  Criteria for risk assesment In case of absence of the standards the safety of products shall be assesed on the basis of the following : Montenegrin standards adopted on the basis of the relevant European standards, and have not existed on the mandatory list, other standards, EC Commission recommendations, product safety codes of good practice, the state of the art and technology and reasonable consumer expectations  Protective Clause Competent inspection body may take appropriate measures prescribed by this Law, if, on the basis of obtained evidence, it establishes that a product is not safe, although the product is in conformity with the safety requirements or safety criteria Chapter 28: CONSUMER AND HEALTH PROTECTION

10. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union III Obligations of Producers and Distributors This chapter declares:  Obligations of Producers a/to place the safe products on the market b/ to provide consumers and other users, in writing, with the relevant information and instructions necessary for risk assessment when using products throughout the entire foreseen or usual duration, if such risks are not obvious without an adequate warning. c/ to assess risks and take adequate measures (warnings to the consumers and other users about risks which the products might pose; additional labeling of data, sample testing of marketed products preventing distribution and sale, recall...  Obligations of Distributors a/ to ensure the supply of safe products. b/ must not supply products which it knows or should have known, on the basis of available information or its professional knowledge and experience, do not comply with the safety requirements. c/ to participate in monitoring the safety of products placed on the market. Chapter 28: CONSUMER AND HEALTH PROTECTION

11. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Joint Obligations of Producers and Distributors  Joint Obligations of Producers and Distributors a/ Producers and distributors shall be obliged to inform a competent inspection body with no delay and in writing,if -they know or should have known based on available information and professional knowledge and experience that a certain product placed on the market is dangerous, or - they assess that a certain product placed on the market poses a serious risk(on the prescribed form). b/ Producers and distributors shall be obliged, at the request of a competent inspection body, to cooperate in implementing the measures aimed at preventing the risks associated with the products that they deliver or have delivered. Chapter 28: CONSUMER AND HEALTH PROTECTION

12. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union IV Informing and exchange of information This chapter declares:  Transparency of Information a/ Information relating to risks to consumers and other users’ health and safety that may be posed by products which are available to the authority shall be the information of public interest. b/ The competent bodies shall be obliged to submit the information about the risks at the request of the parties concerned c/ The information about the risks shall be available to the public, even if they are determined as business secret by another law.  Exchange of Information a/ Exchange of information about the risks shall be done among the competent bodies of Montenegro, as well as between the bodies of Montenegro and the EC b/ The exchange of information with the EC shall be done through the RAPEX system. The Government of Montenegro shall determine the bodies competent for the exchange of information and more detailed procedure regarding the exchange and contents of information with adoption of the Regulation Chapter 28: CONSUMER AND HEALTH PROTECTION

13. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union V Supervision  Competencies of Inspection Bodies It is established the competencies of inspection Bodies in supervision of implementation of this Law Measures taken by Inspection Bodies a/ prescribed the authorisation for competent inspection Body for evry products, as well as: - for any product associated with risks in certain conditions - for any product associated with risks for certain persons, - for any product that could be dangerous - for any dangerous product b/ the measures are taken against producers and distributors, against traders and other persons, when necessary to do in supervision. c/ Appeal against the decision on measures shall be submitted within eight days from the day of decision submission. The appeal shall not postpone the enforcement of the decision. - Chapter 28: CONSUMER AND HEALTH PROTECTION

14. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Obligations of a Customs Authority  Obligations of a Customs Authority a/ A customs authority shall, in a customs procedure, postpone for three days the release of the product and immediately inform thereof a competent inspection body, if it establishes that: Products show certain characteristics that cause a reasonable doubt that they could pose a serious risk products are not accompanied with the prescribed documents or that they are not marked in a prescribed manner. b/ If a competent inspection body does not take the prescribed measures within three business days, or does not inform a customs authority about taking the measures within that deadline, a customs authority shall release the product  Precautionary Principle Prescribe the obligation for inspection bodies that they shall be obliged to act in a manner proportional to the seriousness of the risks and with due care when taking the prescribed measures Chapter 28: CONSUMER AND HEALTH PROTECTION

15. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Offences and transitional and final provision  VI Offences It is prescribed a pecuniary fine for offence of a business organization or entrepreneur and responsible person of the legal entity or physical person,if: - place on the market a product that is not safe produce, import, export or place on the market misleading products - fail to provide consumers and other users with relevant information and instruction for risk assessment fail to assess the risk depanding on the characteristics of the product and fail to take measures fail to pass on the information about the risks involved with the product, fail to keep, provide and submit the documentation necessary for tracing the origin of product.. fail to inform a competent inspection body that the product they have placed on the market is dangerous,ei to pose a risk  VII TRANSITIONAL AND FINAL PROVISION Deadline for Adoption of Regulations Coming into Effect Chapter 28: CONSUMER AND HEALTH PROTECTION

16. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Noncompliance of the Law with the Directive 2001/95/EC This Law shall not apply if there is separate regulation about the products, there is not the necessary restrictions, only on the special regulations which are harmonized with EU law recall and withdrawall are define as the same measure, not as the two(very different measures from wich only recall are treated as final tool) the safety criteria are not transposed entirely,-there is no comformity criteria with the regulation (the law prescribed that existance of any nonharmonized act prevents the aplication of the Law) all obligations of producers and distributors are not transposed The precautionary Principle is not traken properly as the key principal in performing the market surveillance The obligations of the authority are not transposed to encourage the voluntary activities of producers and distributors Chapter 28: CONSUMER AND HEALTH PROTECTION

17. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Institutional framework Chapter 28: CONSUMER AND HEALTH PROTECTION The Ministry of Economy - Department of Infrastructure Quality The Administration for Inspection Affairs – over the competent The Custom Authority Contact Point – MI The Ministry of Transport and Maritime Affairs Coordination Body for Market Surveillance Web - TI The Ministry of Interior Market Inspection, Healthcare and Sanitary Inspection, Phytosanitary Inspection, Environmental Inspection, Termoenergetic Inspection, Electro energetic Inspection, the Inspection of Electronic Communication and Postal Services, Metrological Inspection, Labor Inspection etc/ authorized inspections The List of responsibility for market surveillance, according to the group of products, adopted by the Governement on April, 25 2012 System for rapid exchange of information on national level Formed by the Decision of the Government, the composition and tasks

18. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Administrative Capacities  Authorized inspection of the Administration of Inspection Affairs  Authorized inspection of The Ministry of Transport and Maritime Affairs...... 10  Authorized inspection of The Ministry of the Interior Affairs................................... 8 Chapter 28: CONSUMER AND HEALTH PROTECTION Market Inspection50 Healthcare and Sanitary Inspection37 Phytosanitary Inspection17 Environmental Inspection7 Termoenergetic Inspection1 Electroenergetic Inspection1 Inspection for Electronic Communications and Postal Services1 Metrological Inspection1

19. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union The implementation of market surveillance  Proactive surveillance  Reactive surveillance The aim: Protection of the safety and health of consumers, particularly children as the most vulnerable category. Chapter 28: CONSUMER AND HEALTH PROTECTION

20. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Proactive surveillance / 1 2011 2012 2013 Planned activities by types of product 5 17 17 Focus is given to products for children Surveillance is implemented in accordance with: The Law on General Product Safety (“ O.G. ME “ no. 48/08.), Valid standards for the controlled product types (in accordance with Article 5 and 6 LGSP) Separate regulations Procedural laws The Law on Inspection surveillance (“O. G. ME" no. 39/03 and “O. G. ME"br.76/09 and 57/11) The Law on Market Inspection (O.G. ME 53/11). Chapter 28: CONSUMER AND HEALTH PROTECTION

21. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Proactive surveillance / 2 Preparation of conducting surveillance: Drafting checklist for inspections, Obtained data on importers, Monitoring of market Various suppliers (retailers, wholesales, importers) Appointment of inspectors for surveillance It is held working meeting with all inspectors who participate in conducting surveillance Chapter 28: CONSUMER AND HEALTH PROTECTION

22. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Proactive surveillance /3  Inspection review:  Inspection review conducted through: Administrative checking the accompanying documentation, Visual control of the product Risk assessment, on the base of which to take measures in relation to the established level of risk posed by the product. For this control was not planned to take samples for laboratory analysis.  Within the ORF project was performed sampling of goods (high chair). Sample sent to laboratory examination.  Inspections are carried out through targeted control Chapter 28: CONSUMER AND HEALTH PROTECTION

23. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Reactive surveillance This form of surveillance is conducted: By monitoring information on dangerous products from the RAPEX and other databases (Croatia and Bosnia and Herzegovina), By notification from manufacturers / distributors By notification from the Customs Administration By consumer complaints, information from the media Chapter 28: CONSUMER AND HEALTH PROTECTION

24. M O N T E N E G R O Negotiating Team for the Accession of the Montenegro to the European Union Chapter 28: Consumer and Health Protection A Realized results 2011 2012Total Total inspection controls performed 1.1053.5114616 I Proactive surveillance 272 696 968 II Reactive surveillance 8332.8153648 1By RAPEX reports 8062.689 3495 2By notification from Customs Administration 1 2 3 3By notification from manufacturers / distributor 1 1 2 4By information from other sources 25 50

25. Chapter 28: CONSUMER AND HEALTH PROTECTION M O N T E N E G R O. Chapter 28: Consumer and Health Protection B Results accomplished in the proactive surveillance by product 20112012Total ITotal found dangerous products11.10712.53023.637 1Dangerous products with serious risk 6.1609.56115.721 2Dangerous products that are not a with serious risk 4.9472.969 7.916 Undertaken measures: IIIndication to supplier: 1Order withdrawal and permanently ban selling 6.1609.75015.910 2Order temporary withdrawal from the market 4.9472.780 7.727 3Recall 12 20 32

26. Chapter 28: CONSUMER AND HEALTH PROTECTION M O N T E N E G R O Negotiating Team for the Accession of the Montenegro to the European Union Chapter 28: Consumer and Health Protection C Accomplished results in reactive surveillance 20112012Total I Total found dangerous products 98 118 216 1By RAPEX report 15 14 29 2By notification from the Customs Administration 36 5 41 3By notification from manufacturers / distributors 47 - 4By information from other sources - 99 Undertaken measures IIndication to supplier 1Order withdrawal and permanently banned sales 98 31 129 2Temporary withdrawal of goods from circulation - 87 3Recall 1 - 1

27. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of the Montenegro to the European Union D The structure of dangerous products in a proactive surveillance 20112012Total IDangerous products with serious risk 6.1609.56115.721 1Child appealing lamps 414 - 2Baby walkers 314 - 3Cable reels for hausehold and similar purposes 45 - 4Misleading products 11 291 302 5Lighting chains 5.3767.75813.134 6High chairs for children - 159 7Baby cots/cribs and cradles - 2 2 8City, tracking and mountain bikes - 1 1 9Children's clothing -1.148 10Toys - 202

28. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of the Montenegro to the European Union E The structure of dangerous products in a proactive surveillance 20112012Total IDangerous products that are not with serious risk4.9472.9697.916 1 Lighting chains 4.9472.0196.966 2 Baby high chairs - 20 3 City, trekking and mountain bikes - 210 4 Children's clothing - 215 5 Ladders - 316 6 Plant nutrition products - 83 7 Plant protection products - 106

29. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of the Montenegro to the European Union F The structure of dangerous products in reactive surveillance Source of information 20112012Total I Dangerous products with serious risk 98 19 117 1Child appealing lamps By notification from theCustoms Administration 36 - 2Helmets for motorcyclists by RAPEX reports 15 - 3Hairdryers By notification from the manufacturers / suppliers 47 - 4Ladders by RAPEX reports - 14 5Baby walkersBy notification from theCustoms Administration - 5 5

30. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of the Montenegro to the European Union G The structure of dangerous products in reactive surveillance Source of information20112012Total I Dangerous products that are not with serious risk - 99 1Toys Other sources (consumers complaints) - 30 2Cosmetics Other sources (consumers complaints) - 21 3Medicines Other sources (consumers complaints) - 4 4 4Medical devices Other sources (consumers complaints) - 32 5Color for hairOther sources (consumers complaints) - 12

31. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Informing about the dangerous product  For all dangerous products found, inspectors promptly informed contact point about prescribed procedure used.  Information about found dangerous consumer products were published on the website of TI www.ti.gov.me. www.ti.gov.me Chapter 28: CONSUMER AND HEALTH PROTECTION

32. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of the Montenegro to the European Union Example of the product recall published in the daily newspaper

33. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of the Montenegro to the European Union Example of the product recall published in the daily newspaper

34. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of the Montenegro to the European Union Example of the product recall published in the daily newspaper

35. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of the Montenegro to the European Union Lighting chains / examples of dangerous products found

36. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of the Montenegro to the European Union Children's clothing / examples of dangerous products found

37. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of the Montenegro to the European Union Baby high chair / examples of dangerous products found Chapter 28: CONSUMER AND HEALTH PROTECTION

38. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Acting on consumer complaints Duty inspector Answering machine By: telephone: 20/230-529,230-921,230-481 fax : 20/230 - 486 Web : www.ti.gov.me submitting a written application orally– direct arrival to market inspectorate, Cooperation with Institute for standardization of Montenegro Cooperation with bussines Over Chamber of commerce of Montenegro Over Montenegrin employers federation By direct training through the seminars Through preventive action in supervision Chapter 28: CONSUMER AND HEALTH PROTECTION

39. Chapter 28: Consumer and Health Protection M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Planned activities  Harmonization of national legislation with EU in the area of safety of products Working version of the Law on general safety of products Working version of the Law on market surveillance  Administration for inspectoral affairs will continue through competent inspections and with other competent authorities to carry out surveillance in this area in line with current legislation and EU good practice. Chapter 28: CONSUMER AND HEALTH PROTECTION

40. Thank you for your attention. QUESTIONS