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 M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union ELECTROMAGNETIC FIELD Chapter 28: CONSUMER AND HEALTH PROTECTION Slavojka Šuković Advisor Ministry of Health slavojka.sukovic@mzd.gov.me

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 Contents  Relevant Acquis  National Legislation  Institutional Framework Chapter 28: CONSUMER AND HEALTH PROTECTION

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 2004/40/EC of the European Parliament and of the Council of 29 April 2004 on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields) (18th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)  31999H0519 (EUR-Lex: 15.30) Council Recommendation as of 12 July 1999 on the restriction of exposure of the general public to electromagnetic fields (0 Hz to 300 GHz) (OJ L 199, 30.7.1999, p. 59–70) 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 Transposition  Directive 2004/40/EC (electromagnetic fields) is partly transposed in the Rulebook on limit values ​​of the parameters of electromagnetic fields in order to limit the exposure of the population to electromagnetic radiation (“OG of Montenegro”, No. 15/10)(exposure limits for electromagnetic fileds) and in the Proposal of the Law on Non-Ionising Radiation Protectio, which is in Parliament procedure for adoption.  EU Reccomendation 1999/519 on electromagnetic fileds are fully transposed within Rulebook on limit values ​​of the parameters of electromagnetic fields in order to limit the exposure of the population to electromagnetic radiation (“OG of Montenegro”, No. 15/10)  The full transposition with the directive 2004/40/EC is expected to be done by developing of eighteen rulebooks on the basis on the Law on Non-Ionising Radiation Protection (Proposal) by July of 2015 Chapter 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  The Rulebook on limit values ​​of the parameters of electromagnetic fields in order to restrict the exposure of the population to electromagnetic radiation (“OG of Montenegro”, No. 15/10 as of 23rd March 2010) prescribes limit values of electromagnetic fields’ parameters in order to restrict the impact of long-term exposure of population to high frequency electromagnetic fields (9 kHz - 300 GHz), including population whose professional involvement includes exposure to these fields. Chapter 28: CONSUMER AND HEALTH PROTECTION National Legislation

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 The Rulebook on Limit Values of Electromagnetic Fields’ Parameters in Order to Restrict the Exposure of the Population to Electromagnetic Radiation  The Rulebook shall be applicable to radio stations which are being imported, traded in market and used in Montenegro.  The Rulebook shall not be applicable to radio stations in the systems of directed microwave terrestrial and satellite links, to fixed stations of effective radiated power less than 10 W and amateur radio stations of effective radiated power less than 100W. 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 The Rulebook Contents  The values of ​​measured or calculated parameters of the electromagnetic field generated by radio stations are compared with the reference levels given in Table 2 in order to determine whether the basic restrictions have been met.  If the reference levels have been met, the basic restrictions are considered to be fulfilled.  If the values ​​of measured or calculated parameters of the electromagnetic field generated by radio stations are over the reference levels shown in the Table, it is necessary to check the fulfillment. In the case of localized exposure to electromagnetic fields, such as with mobile radio stations leaned against the head, the basic restrictions given in Table 1 shall be met.  In the case of simultaneous exposure to electromagnetic fields’ effects radiating from multiple sources and different frequencies, meeting the basic restrictions is conditioned not only by fulfillment of the reference levels from the Table 2, but also by meeting additional requirements.  Measurements of electromagnetic field parameters in Table 2 shall be performed by the Agency or the entity authorized by the Agency.  Measurements and calculations of values in Table 2 shall be carried out in accordance with the methods and procedures set forth in relevant regulations and standards limiting the strength of electromagnetic fields. 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 Basic Restrictions which shall be met by all the radio stations (Table1) Chapter 28: CONSUMER AND HEALTH PROTECTION Frequency [f] Current density in head and torso J (mA/m 2 ) Specific absorption rate (SAR) in W / kg Power density S (W/m 2 ) concentrated throughout the body concentrated in the head and torso concentrated in the limbs General public exposure 9kHz-100kHzf/500---- 100kHz-10MHzf/5000.0824- 10MHz-10GHz-0.0824- 10GHz-300GHz----10 Occupational exposure 9kHz-100kHzf/100---- 100kHz-10MHzf/1000.41020- 10MHz-10GHz-0.41020- 10GHz-300GHz----50

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 Basic restrictions which shall be met by all the radio stations (Clarification of Table 1)  f is frequency expressed in Hz.  Due to electrical inhomogenity of a human body, an average value of the current density is taken over the cross-sectional area of ​​1 cm2, which is in normal position to the current direction.  For the frequency range of 9 kHz to 100 kHz, the peak value of current density is obtained by multiplying the mean square value by 200,5.  For the frequency range of 9 kHz to 100 kHz, in the case of pulsed magnetic fields, the maximum current density associated with an impulse is calculated on the basis of the rise and fall time interval, and the maximum change rate of magnetic induction (V). The induced current density can be compared with the corresponding basic restriction.  All values ​​of specific absorbed power (SAR) are averaged during any time interval of 6 (six) minutes. 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 Clarification of Table 1 (sequel)  Averaging of specific absorbed power (SAR), concentrated in the head and body or limbs, is done on any part of tissue weighing 10 g. The value of maximum specific absorbed power (SAR) obtained in this way shall be used for exposure assessment.  For pulses of duration tp, the equivalent frequency applied in the basic restrictions is determined according to the formula f = 1 / (2TP). In addition, for the frequency range from 300 MHz to 10 GHz and for localized exposure of the head, additional basic restriction is recommended, whereby the value of the specific absorbed energy (SA) shall not exceed 10 MJ/kg in the case of occupational exposure, and 2 mJ/kg for general public exposure, taken as the mean value for 10 g of tissue.  Power density must be averaged on each 20 cm2 of exposed tissue during the time interval of 68/f1.05 minutes (f is expressed in GHz) in order to compensate for progressively weaker penetration at higher frequencies.  The maximum values ​​of power density, averaged over an area of ​​1 cm2, shall not exceed the values ​​in this Table more than 20 times. 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 Reference Levels of Electromagnetic Field Parameters, Derived from Relevant Basic Restrictions for the Most Critical Practical Case of Exposure (Table 2) Chapter 28: CONSUMER AND HEALTH PROTECTION Frequency [f] Electric field strength E (V/m) Magnetic Field Strength H (A/m) Magnetic flux density B (mT) Power density (of the equivalent direct wave) S ekv (W/m 2 ) General public exposure 9 - 150 kHz8756.25- 0.15-1 MHz870.73/f0.92/f- 1-10 MHz87/f 0.5 0.73/f0.92/f- 10-400 MHz280.0730.0922 400-2000 MHz1.375 f 0.5 0.0037 f 0.5 0.0046 f 0.5 f/200 2-300 GHz610.160.2010 Occupational exposure 9-65 kHz61024.430.7- 0.065-1 MHz6101.6/f2.0/f- 1-10 MHz610/f1.6/f2.0/f- 10-400 MHz610.160.210 400-2000 MHz3 f 0.5 0.008 f 0.5 0.01 f 0.5 f/40 2-300 GHz1370.360.4550

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 Clarification of Table 2:  f is expressed in units as specified in the table for certain ranges.  In the frequency range of 100 kHz to 10 GHz values ​​for Sekv, E2, H2 i V2 are averaged during any time interval of 6 (six) minutes.  For the frequency range of 9 kHz to 100 kHz, the peak value of the current density is obtained by multiplying the mean square value by 20,5.  For the frequency range of 100 kHz to 10 MHz, the peak values of the field strength (E and N) have been obtained by interpolation, from 1.5-declining value at 100 kHz to 32-decreasing values ​​at 10 MHz. For frequencies above 10 MHz it is recommended that the peak value of the power density, averaged for the duration of the pulse, shall not exceed 1000 times larger limit value, and the peak values of the field strength (E and N) shall not exceed 32 times larger value of the reference levels given in this Table.  For the frequency range from 10 GHz to 300 GHz values ​​for Sekv, E2 N2 and V2 are averaged during any time interval of 68/f1,05 minutes (f is expressed in GHz) 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 Reference Standards and Regulations 1.Recommendation of the European Union Council 1999/519/ES on restricted exposure of population to electromagnetic fields (0 Hz to 300 GHz) 2.ICNIRP 1998 - Instructions for restricted exposure to time-varying electric, magnetic and electromagnetic fields (up to 300 HGZ) 3.ICNIRP Declaration on ICNIRP 1998 (September 2009) 4.EN 50364/2001 - Restriction of human exposure to electromagnetic fields from devices operating in the frequency range of 0 Hz to 10 GHz, used in Electronic Article Surveillance (EAS), radio frequency identification (RFID) and similar applications 5.EN 50360/2001 – Standard displaying compliance of mobile phones with the basic restrictions related to human exposure to electromagnetic fields (300 MHz - 3 GHz) 6.EN 50371/2002 – Standard displaying compliance of low power electrical and electronic devices with basic restrictions related to human exposure to electromagnetic fields (10 MHz to 300 GHz) 7.EN 50385/2002 - Product standard displaying compliance of radio base stations and fixed terminal stations for wireless telecommunication systems with the basic restrictions related to human exposure to electromagnetic fields (110 MHz-40 GHz) 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 Institutional Framework Ministry of Sustainable Development and Tourism Agency for Environmental Protection Inspection Directorate 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 Monitoring and Inspection Inspection and monitoring is performed by Environmental inspection Chapter 28: CONSUMER AND HEALTH PROTECTION

17. Thank you for your attention. QUESTIONS?