External Review of Progress in
F.Y. Republic of Macedonia
Towards Sustainable Optimal
Iodine Nutrition
Skopje, 19-23 May 2003
Report by the Team of Experts
nominated by the Network for Sustained
Elimination of Iodine Deficiency
WHO logo
UNICEF logo
ICCIDD logo
Table of Contents
EXECUTIVE SUMMARY .................................................................................................................................. 3
KEY PEOPLE ENCOUNTERED DURING VISIT ......................................................................................... 5
1
MACEDONIA: BACKGROUND INFORMATION AND STATISTICS ....................................... 6
2
HISTORY OF IDD IN MACEDONIA ................................................................................................ 8
3
CURRENT IDD STATUS ................................................................................................................... 10
3.1
3.2
3.3
DETERMINATION OF THYROID VOLUME BY ULTRASONOGRAPHY ....................................................... 11
SCREENING OF NEONATAL TSH ........................................................................................................ 12
URINARY IODINE EXCRETION IN PREGNANT AND BREAST-FEEDING WOMEN ................................... 13
4
EDUCATIONAL AND INFORMATIVE ACTIVITIES ................................................................. 14
5
NATIONAL SALT SUPPLY AND SALT IODIZATION ............................................................... 15
5.1
SALT SUPPLY ..................................................................................................................................... 15
5.2
SALT MONITORING ............................................................................................................................. 15
5.2.1
Quality Control of Iodised Salt..................................................................................................... 15
5.2.2
Governmental control at product level ......................................................................................... 15
5.2.3
Quality control at the retail stage ................................................................................................ 16
5.2.4
Quality control of iodized salt at household level ........................................................................ 17
5.2.5
Questionnaire on the awareness of and use of iodised salt .......................................................... 18
5.3
FACILITIES FOR IODINE MEASUREMENT ............................................................................................ 19
6
FINAL STATEMENT AND RECOMMENDATIONS .................................................................... 20
ANNEX 1 AGENDA OF ACTIVITIES .......................................................................................................... 22
ANNEX 2 MEMBERS OF THE MACEDONIAN COMMITTEE FOR IODINE DEFICIENCY ............ 28
ANNEX 3 PROTOCOL OF THE OF THE WORK OF THE NATIONAL COMMITTEE FOR IODINE
DEFICIENCY .................................................................................................................................................... 30
ANNEX 4 SALT LEGISLATION .................................................................................................................... 35
Tables and Figures
Tab.
Tab.
Tab.
Tab.
Tab.
Tab.
1
2
3
4
5
6
Summary of surveys and iodine prophylactic measures in Macedonia ................. 10
Thyroid volume measured by ultrasound .............................................................. 12
UIE in pregnant and breastfeeding women (2001) ................................................ 13
Iodine concentration after storage under various conditions ................................. 16
Level of iodization of household salt samples ....................................................... 17
Permitted additives to salt for human consumption ............................................... 36
Fig. 1
Urinary iodine excretion in schoolchildren (2002) ................................................. 11
2
Executive Summary
This document reports the findings of a team of experts on the status of iodine
nutrition in Macedonia. The team, nominated on behalf of the Network for Sustained
Elimination of Iodine Deficiency, spent five days visiting Ministries, schools, salt production
and distribution points and the consumer association. The visit was coordinated by the
Macedonian National Committee for Iodine Deficiency together with the Macedonian
UNICEF and WHO offices. The expert team members also had the task of reviewing the
documentation provided by the Head of the Macedonian Committee for Iodine Deficiency on
work performed by the national committee in recent years. Details of the visit agenda are
given in Annex 1.
According to data available from the beginning of 1950s, there were around 200,000
people with goiter in Macedonia. This was one of the reasons for the Yugoslav government
to pass a law in 1956, which obliged all salt producers and importers to add 10 mg potassium
iodide per kg of salt.
In 1998 a National Committee for Iodine Deficiency (ID) was set up to manage the
task of eliminating ID disorders in the country. New regulations on iodization of the salt with
20-30 mg of iodine per kg of salt were enacted and went into effect in October 1999 (see
Annex 4, on Rule Book on the quality of the edible salt). The latest survey, performed in
2002, showed an adequate supply of iodine, as assessed both by thyroid volume and urinary
iodine (UI) excretion. In particular, the median of UI excretion was 198 µg/L.
A neonatal TSH screening program, covering only part of the neonates, detected
487/11,109 (4.3%) TSH values above 5 U/ml. This figure satisfies the ICCIDD/WHO
criteria of iodine sufficiency, although the number of total screened children is still too small.
A survey in 1999 on pregnant and breast-feeding women showed adequate UI
excretion when criteria for the general population are used. However, it may be that higher
values would be desirable in pregnancy and during lactation.
A number of actions have been undertaken in the field of Educational and
Informative activities. In particular the problem of ID has been inserted in several university
curricula, informative material has been printed and distributed by the UNICEF office and
the Ministry of Education and Science in Skopje, consumer information activities on ID were
carried out in cooperation with the Consumer’s Association and finally the problem of ID
was publicized through mass media.
Macedonia does not produce salt and satisfies its needs by importing from Bosnia,
Bulgaria, Greece, Egypt and Austria. The team of experts inspected the Izvor iodization plant
which treats salt imported from Egypt with the spray method, and found the procedure
appropriate to requirements.
All salt for human consumption is iodised: this includes table salt, salt used for food
production and salt as a carrier of additives, i.e. nutritious substance (see annex 4 article 2).
Quality control of iodization is performed satisfactorily at several levels:
 At and by the iodisation plants in the country
 Government control at the product/importation level
 Control at the retail stage
3
 Control of iodized salt at household level
In addition to the iodisation plant Izvor, facilities for iodine measurement were
inspected at 3 sites: Institute of Pathophysiology and Nuclear Medicine, the Republic
Institute for Health Protection, Veterinary Institute, all of which were found to use
appropriate methods.
The team found that the efforts of the National Committee for Iodine Deficiency had
succeeded in tackling a historically significant problem, bringing iodine intake into the range
of iodine sufficiency. A well structured program of salt monitoring was found in the country,
thus ensuring that the current status of iodine sufficiency will be maintained in the future.
In order to sustain USI in the future, the team made the following recommendations:
-
-
Surveys in schoolchildren using the same methodology should be performed every 2
to 3 years.
Screening of neonatal TSH should be extended to all newborns.
To continue to produce and import only iodised salt so that the use of iodised salt
remains compulsory for all edible salt according to the rule book (see annex 4). Clear
sanctions for non-compliance should be defined for producers, importers, and
iodisation plants alike.
Control of iodised salt at the border, at the iodization plants, in the food industry
sector, and at the consumer level must be continued.
Education and information on ID at the level of the consumers and key personalities
must be continued and reinforced.
Expert Team
Team Leader :
Paolo Vitti
Associate Professor of Endocrinology
University of Pisa, Italy
ICCIDD Director and
Deputy Regional Coordinator for West Central Europe
Team members:
Hans Bürgi
Professor Emeritus Dr. Med
Solothurn, Switzerland
ICCIDD Director
Klaas Kaaskooper
Commercial Director, Frisia Zout B. V.
The Netherlands, part of esco european salt company
Hannover, Germany
Member of EU salt, formerly ESPA
Cynthia Baker
Former Head of Consumer Office
Tuscan Regional Government
Former Representative for Regional Governments on the
Italian National Consumer Council, Florence, Italy
4
Key people encountered during visit
Ministries
Mr. Redzep Selmani
Dr. Donka Maneva
Dr. Borislav Josifovski
Dr Shemsi Musa
Dr. Vera Menkovska
Dr Bozin Petreski
Dr. Nevzat Elezi
Antigona Ciriviri
Vesna Dancevska
Dr Blagoja Aleksoski
Dr. Lence Kolevska
Dr. Biliana Culeva
Minister for Health, Ministry of Health
Ministry of Health
Ministry of Health
Director of Health and Sanitary Inspectorate
Ministry of Health, National Health and Sanitary Inspectorate
Border Sanitary and Health Inspector
Ministry of Health, National Health and Sanitary Inspectorate
State market Inspectorate
Ministry of Agriculture, Forestry and Water Economy
Director, Republic Institute for Health Protection
Republic Institute for Health Protection
Republic Institute for Health Protection, Head of Laboratory
Non Governmental Organizations , Others
Debora Comini
Nora Sabani MD
Katerina Venovska MD
Marija Kisman MD
Marijana Loncar Velkova
Kalco Mitev
Prof. Mihail Danev
Vadin Asani
Goranco Angelevski
Dr. Marika Petrovska
UNICEF Head of Macedonia Office
UNICEF Officer
UNICEF Assistant
WHO Liaison Officer
President of Consumers Organization of Macedonia
Consumers Organization of Macedonia
Veterinary Institute of Skopje
Izvor Salt plant
Izvor Salt plant
Macedonian Radio and Television
Medical staff
Prof. Borislav Karanfilski
Dr. Mirjana Kochova
Dr. Stojance Stefanoski
President of the National Iodine Deficiency Committee
Clinic of Child's Diseases
Director, Mother and Child Health Protection Institute
Dr Nadica Janeva
Dr Biljana Ancevska
Stojanoska
Vice-President, Mother and Child Health Protection Institute
Pediatrician, President, Center for Family, Motherhood and
Childhood Support
Mother and Child Health Protection Institute
Institute of Pathophysiology and Nuclear Medicine
Institute of Pathophysiology and Nuclear Medicine
Prof. Olivija Vaskova
Prof. Svetlana Micevska
Ristevska
Dr. Suzana Loparska
Dr. Verka Miloscevska
Vukosava Bubalova
Institute of Pathophysiology and Nuclear Medicine
Institute of Pathophysiology and Nuclear Medicine
Institute of Pathophysiology and Nuclear Medicine
5
1 Macedonia: Background information and statistics
The Republika Makedonija is located in South-eastern Europe and covers a total area
of 25,333 square kilometers. It borders with Greece to the south for 262 kilometers, Albania
to the southwest (191 km.), Bulgaria northeast (165 km.) and Serbia and Montenegro to the
north for 232 km. The Kosovo region is only a two-hour’s drive from Skopje, Macedonia’s
capital and largest city.
According to 2002 estimates, the population of Macedonia is 2,054,800 with almost
550,000 living in the Skopje area. Other important cities are Bitola (84,000 people), Prilep
(70,000) and Kumanovo (69,000). Ohrid (43,000) is the religious and cultural centre of the
country. Though previous administrative divisions continue to exist, recent reform measures
for greater decentralization will provide for 123 municipalities.
Population growth rate was around 0.41% with infant mortality at 11.9 deaths per
1,000 live births and life expectancy at 74.26 years (72.01 for men and 76.68 for women).
66% of the population are Macedonians, 22.7 % Albanian, 4% Turkish, 2.2% Rom, 2.1%
Serb and 2.4% other ethnic groups. 67 % of the population belongs to the Macedonian
Orthodox Church while 30% is Muslim.
Macedonia’s territory is prevalently mountainous with deep basins and valleys. Its
highest point is Golem Korab at 2,753 meters; the lowest the Vardar River (50 m.). Its
southwest border with Albania and Greece cuts through two large lakes (Lake Ohrid and
Lake Prespa) with a third smaller lake shared with Greece to the southeast. The Vardar river
bisects the country, but the Republic is land-locked with absolutely no access to the sea.
Many areas are highly seismic; in 1963 an earthquake destroyed more than 80 % of Skopje
with many deaths.
Natural resources include chromium, lead, zinc, manganese, tungsten, nickel, lowgrade iron ore, asbestos, sulfur and timber. About 23.6% of the land is arable with grains,
tobacco, cotton, citrus fruits and vegetables as major agricultural products.
In September 1991, when the disintegration of the Socialist Federal Republic of
Yugoslavia had become evident, a referendum was held in Macedonia; 95% of the voters
who went to the polls voted in favor of an autonomous, independent and sovereign republic.
The new constitution, which strengthened minority rights considerably, was approved by
Parliament on November 17th, but international recognition of the Former Yugoslav Republic
of Macedonia (F.Y.R.O.M.) was delayed by Greece’s opposition to the new state’s use of
what the Greeks considered a Hellenic name and symbol. In 1995 Greece’s trade blockade
was lifted and relations were normalized.
The Republic of Macedonia is a parliamentary democracy. A unicameral Assembly is
elected every four years with 120 seats: all by percentage-based party lists. Chief of State is
the President elected by popular vote for five years. The current President, Boris Trajkovski
was elected on second-round ballot in 1999, while the Prime Minister, Branko Crvenkoski
(SDSM), was elected by Parliament in October 2002. The current cabinet is a coalition of the
SDSM (Social-Democratic Alliance of Macedonia), LDP (Liberal Democratic Party) and
DUI (Democratic Union for Integration).
The flag of Macedonia is a rising yellow sun with eight rays extending to the edges of
the red field.
6
Prior to independence in 1991, Macedonia was considered the least developed of the
Yugoslav republics, producing a mere 5% of the total federal output of goods and services.
The end of central transfers and a de facto free trade area, UN sanctions on Yugoslavia, one
of its major trade partners and the Greek embargo hindered economic growth until 1996.
Subsequently GDP rose each year through 2000, but in 2001 the economy shrank 4.6% due
to decreased trade, intermittent border closures, increased deficit spending on security and
investor uncertainty linked for the most part with the Albanian insurgency.
In 2002 growth recovered moderately but unemployment at one-third of the
workforce (some say 40%) made development difficult. In 2002 GDP/real growth rate was
3.8% with GDP per capita at $5,000 (purchasing power parity). In 2001 the GDP
composition by sector was as follows: agriculture 11%, industry 31% and services 58%. In
2001 24% of the population was below poverty line with inflation (consumer prices) in 2002
estimated at 4%. Industrial production growth was –5%.
Economic aid amounted to about $150 million in 2001. Budget revenues in 2001
were about $850 million with expenditures at $950 million. Military expenditures in 2002
were estimated at around $200 million (6% of GDP).
Exports in 2002 amounted to about $ 1 billion f.o.b. (principal products: food,
beverages, tobacco, manufactured goods, iron and steel) while imports (machinery and
equipment, chemicals, fuels, food products) were $ 1.6 billion. In 2001 principal trade
partners were Germany (12.6%), Greece (10%), Yugoslavia (Serbia and Montenegro 9 %),
Russia (8.3%), Slovenia (7%).
The country’s currency is the Macedonian Denar (MKD).
1997 data estimated about 408,000 main-line and 12,362 mobile telephones in use,
510,000 televisions and 31 TV broadcasting stations. By 2001 there were over 100,000
Internet users.
7
2 History Of IDD In Macedonia
Much of the data from the past demonstrate that Macedonia was an iodine deficient
area with a high prevalence of goiter in certain districts. According to data available from the
beginning of the 1950s, there were around 200,000 people with goiter in Macedonia. This
was one of the reasons for the Yugoslav government to pass a law in 1956, which obliged all
salt producers and importers to add 10 mg potassium iodide (corresponding to 7.5 mg of
iodine) per kg of salt.
This law resulted in a significant reduction of the prevalence of goiter. However,
complete eradication of iodine deficiency and goiter in Macedonia was not achieved, even
after 30-40 years of iodine prophylaxis. Many clinical and epidemiological data showed that
the thyroid pathology in Macedonia had the characteristics of an iodine deficient area with a
persisting high prevalence of goiter. In the 1990s, around 1,000 new patients with goiter were
registered each year in Macedonia, and in certain places 60% of the primary schoolchildren
had goiter. A preliminary survey in schoolchildren performed in 1992 showed mean urinary
iodine (UI) excretion of 87 µg/L in Skopje (n= 258) and 105 µg/L in Kocani (n=40) both
non-goitrous areas, and in 4 villages with endemic goiter the UI ranged from 46 to 84 µg/L
(n= 271).
An agreement was reached between the UNICEF Office in Skopje and the Institute of
Pathophysiology and Nuclear Medicine of the Medical University of Skopje in 1994, and a
survey using WHO/UNICEF and ICCIDD methods covering the whole territory was
undertaken 1995-96, financed by the UNICEF Office in Skopje. The survey adopted WHO,
UNICEF and ICCIDD methods, criteria and standards. A total of 11,486 children aged 7 to
15 from 115 schools were checked for goiter by palpation. The volume of the thyroid gland
was measured in a total of 2,487 children by ultrasonography. UI excretion was measured in
3,380 children. Goiter was detected in 18.7% (range 7.8-29.8%). The thyroid gland volume
measured by ultrasound was higher than that found in children from iodine sufficient
countries. The median UI excretion for the whole country was 117 g.
In 1998 a National Committee for Iodine Deficiency was set up to manage the task of
eliminating IDD in the country. The Ministry of Health invited relevant institutions and
organizations to recommend members for the national committee. The Minister of Health
reviewed the suggested members and appointed the committee. This committee included a
wide range of competencies including medical, representatives from various national
Ministries, International Organizations such as UNICEF, WHO and ICCIDD, the salt
industry, and other interested parties (see Annex 2). At the first meeting, chaired by the
Minister of Health, members voted a president and Prof. Borislav Karanfilski was
unanimously elected. The regulations for the operation of the committee are described in
Annex 3.
On the basis of the fact that ID was not yet defeated, it was thought that a new
regulation, establishing an increase of the level of the iodization to 20 to 30 mg of iodine per
kg of salt, should be enacted in September 1999 in order to achieve eradication of iodine
deficiency in Macedonia.
8
The situation of the iodine deficiency in Macedonia was monitored through
epidemiological surveys carried out in 1998/99 and 1999/2000, the latter immediately after
the enactment of the new regulation. These surveys showed, as it could be expected, that the
situation had not changed and that iodine deficiency in Macedonia was continuing, with mild
worsening of the situation in 1998/99.
With the end of the communist economy, the primary responsibility for salt iodization
processes and plants and salt quality matters was taken on by salt producers, importers and
salt iodization plants, with substantial secondary controls at governmental level.
The new regulations on iodization of the salt with 20-30 mg of iodine per kg of salt
were enacted and went into effect in October 1999 (see Annex 4, on Rule Book on the
quality of the edible salt). In order to check on the effects of the new regulations, new
surveys were conducted in 2000, 2001 and 2002. The last survey, in particular, revealed
satisfactory iodine nutrition, proof that the iodine prophylaxis program enacted in Macedonia
is successful.
The success of the iodine prophylaxis program in Macedonia was made possible
through the partnership of several agencies: Ministry of Health, the WHO and UNICEF
offices in Skopje, the Institute of Pathophysiology and Nuclear Medicine, the Republic
Institute for Health Protection, the Institute for Mother and Child Health Care, the State
Health and Sanitary Inspectorate, the Republic Market Inspectorate, the Veterinary Institute,
salt producers and consumer organizations, all of them united in the National IDD
Committee, chaired by Prof. Borislav Karanfilski.
9
3 Current IDD Status
Tab. 1 gives a summary of reported goiter prevalence and other data from 1956 to
date. Surveys performed since 1995/1996 have been carried out using the sampling and
methodology guidelines provided by WHO-ICCIDD.
Tab. 1
Summary of surveys and iodine prophylactic measures in Macedonia
Date and site
Number
Median
UI (µg/L)
1956
Goiter
%
Comments on salt
iodization
20
7.5 ppm as KI, compulsory by
Yugoslavian legislation
1992, Skopje
258
87
low
1992, Kocani
40
105
low
1992, 4 villages
271
46-84
60
1995-96,
2380 (UIE)
nationwide*
11486 (pal)
1998, nationwide
117
1132
79.7
1142
116.7
1211
154.1
2001, nationwide
929
164.5
2002, nationwide
1216
1999 Sept-Oct,
nationwide
2000 Sept-Oct,
nationwide
198.5
Recommendation by Rep Inst
of Health Protection:5-25 ppm
iodine as KI (1993)
18.7
(7.8-29.8)
8.3
New regulation: 20-30 ppm as
KIO3, enacted October 1999
19
5.8
* The Survey in 1995/6 was performed on schoolchildren from 115 schools (66 urban and 49
rural areas) and the subsequent surveys were performed on schoolchildren from 30 schools (20
urban and 10 rural areas) chosen according to the method of proportionality with the number of
inhabitants (proportional to population sampling, PPS). The choice of about 40 children from
each school was made randomly and there were approximately the same number of children
from both sexes
The latest study shows an adequate supply of iodine, as assessed both by thyroid volume (Tab.
2) and UI excretion (Fig. 1). In particular, the median of UI excretion was 198 µg/L, with <
2.4% below 5 0 µg/L. It is also worth noting that 12% of the values were above 300 µg/L,
indicating that indeed iodine intake is at the upper limit of the recommended level.
10
Urinary excretion (2002) n=1216
Median = 198.5 MV=206.8 SD=95.8
160
150
140
115
Number of samples
120
103
100
106
96
91
78
80
82
79
65
60
51
50
40
40
24
20
13
3
0
20
40
60
80
100
120
140
160
180
200
220
240
260
280
300
>300
Iodine in the Urine(g/l)
Fig. 1
Urinary iodine excretion in schoolchildren (2002)
3.1 Determination of thyroid volume by ultrasonography
In 2002, thyroid gland volume was determined by ultrasonography in 535 children: 283 boys
and 252 girls. Although the medians of thyroid volumes measured in 2002 still moderately
exceeded the new provisional WHO/ICCIDD reference values for iodine sufficient populations
(last column of the table), they show a 15% reduction with respect to the thyroid volumes
measured in 1995-96 in children of the corresponding age.
11
Tab. 2
Thyroid volume measured by ultrasound
NUMBER
MEDIAN
VOLUME
(ml)
(ml)
(ml)
MEDIAN
REFERENCE
VOLUME
BOYS/GIRLS
(ml)
3.45
0.90
2.4/2.4
3.96
1.03
2.6/2.8
4.43
1.24
2.9/3.1
4.88
1.47
3.2/3.6
2002
29
3.24
1995/96
285
4.10
2002
265
3.83
1995/96
316
4.7
2002
199
4.25
1995/96
308
5.1
2002
42
4.90
1995/96
336
5.3
MEAN
VOLUME
SD
7 years
8 years
9 years
10 years
The results (median thyroid volumes moderately above latest international standards) are
compatible with recently corrected iodine deficiency. A survey in 2006 will become of crucial
interest. In 2006, seven-year olds will have never been exposed to iodine deficiency. Should
their thyroid volumes then still significantly exceed the WHO/ICCIDD standards, the presence
of dietary goitrogens should be seriously taken into account
3.2 Screening of Neonatal TSH
Neonatal screening for hypothyroidism was established in April 16, 2002 at six
nurseries in Macedonia covering about 30% of total newborn population.
The screening was introduced with the help of the International Newborn Screening
Society (INSN), and with the support of Kinderspitall in Zurich (Dr Torresani) and the
International Fund for Child health (Dr Foley).
Measurement of TSH on spot samples is carried out using the DELFIA kit at the
genetic laboratory at the Pediatric Clinic, Medical Faculty in Skopje, under the supervision of
Prof Dr M. Kocova. The cut-off value is 15 U/ml.
After 13 months, 11,109 newborn children were screened. Six children with
congenital hypothyroidism were detected and treatment was started before day 15 of life.
487 newborns had values of TSH above 5 U/ml. This represents 4.3 % of all tested children.
This figure satisfies the ICCIDD/WHO criteria of iodine sufficiency, although the number of
total screened children is still too small. These data thus need to be extended.
12
3.3 Urinary Iodine Excretion in Pregnant and Breast-Feeding Women
A survey in 2001 covered women from 10 dispensaries located across the country. The
results are given in Tab. 3 and show adequate UI excretion (140µg/l) when criteria for the
general population are used. However, in 25 % of the surveyed pregnant and lactating women,
UI was below 100µg/l. Based on this observation, the national ID committee recommended
supplementation for pregnant and lactating women with 100 µg iodine tablets per day. This issue
should be investigated in further studies.
The results of the determination of urinary iodine excretion among pregnant and
breastfeeding women are shown in Tab. 3
Tab. 3
UIE in pregnant and breastfeeding women (2001)
Pregnant women
Total
Breast
feeding
women
Pregnant
& breastfeeding
women
First
Second
Third
trimester
trimester
trimester
78
140
164
382
108
490
150
158
130.4
141
139
140
< 20
-
1(0.7%)
1(0.6%)
2(0.5%)
-
2(0.4%)
20-49
-
8(5.07%)
7(4.3%)
15(3.9%)
5(4.7%)
20(4.1%)
24(22.2%)
103(21.0%)
8(7.4%)
37(7.6%)
Number of
examinees
Median (µg/l)
50-99
> 300
17(21.8%) 24(17.1%) 38(23.2%) 79(20.7%)
3(3.9%)
19(13.6%)
7(4.3%)
13
29(7.6%)
4 Educational and Informative Activities
In 2000 and 2001 the National IDD committee recommended the following population
targets in Macedonia: general policy makers, and in particular health policy makers, health
workers, managers in salt production and trade, non-governmental organizations and
households.
By 2002, in its activity report, the Committee had undertaken a number of actions in
this direction:

An agreement was reached with the Institute of Pathophysiology and Nuclear Medicine
of the Faculty of Medicine in Skopje to extend the curriculum unit on the
Pathophysiology of the thyroid gland to include the problem of iodine deficiency. This
extended curriculum will be taught to medicine, dentistry and pharmacy students, and
will deal with the consequences and prevention of iodine deficiency, with a particular
emphasis on the situation in Macedonia.

An agreement was reached with the Pedagogical Office within the Ministry of Education
and Science to produce an informative text concerning iodine deficiency (reasons,
consequences, possibilities and conditions in Macedonia). The material, printed by the
UNICEF office in Skopje, was sent to all the primary and secondary schools in
Macedonia, together with a letter from the Ministry of Education and Science.

The past year saw a broad and fruitful cooperation with the Consumers’ Association of
Macedonia, with frequent contacts and idea and information exchange. The Consumers’
Association included IDD in its plan of action and it carried out various activities to
inform consumers throughout the country about iodine deficiency, its consequences on
health as well advice on purchasing, storing and using iodized salt at the household
level.

Iodine deficiency was dealt with in leading daily newspapers and weekly magazines such
as “Dnevnik”, “Vecher”, “Makedonija Denes”, as well as in TV programs broadcasted on
the Macedonian Radio and Television Network, Kanal 5 and Telma.

Medical doctors, dentists and other medical workers were informed on the current status
of iodine deficiency in Macedonia through publications in various medical journals:
“Makedonski Medicinski Pregled”, ICCIDD Newsletter, Journal of Pediatric
Endocrinology and Metabolism”, “Vox Medici”.

Collaboration mainly via the chairman of the national committee with the two inland
iodization companies resulted in their awareness of the importance of salt iodization
Current efforts aim at introducing consumer information into school curricula on how
iodized salt should be purchased, stored and used. Both a new monograph and a pamphlet,
targeted at the general population will be produced containing basic information on iodine
deficiency.
14
5 National Salt Supply and Salt Iodization
5.1 Salt supply
Macedonia does not produce salt and satisfies its needs by importing from other
countries, in particular from Bosnia, Bulgaria, Greece, Egypt and Austria. According to the State
Health and Sanitary Inspectorate, during 2002 Macedonia imported about 16,400 tons of salt for
human consumption. Although there is no official data, it is known that a part of it is re-exported
and that the amount consumed in the country is around 10,000 tons. If the imported amount of
salt is divided by the number of inhabitants of Macedonia (according to the results from the 2002
census: 2,038,059), the approximate yearly sales of salt per capita is about 5 kg, i.e. 14 g per
day. In the year 2002 there were over 50 importers of salt for human consumption. 60% of salt is
imported already iodized, and 40% is iodized in 2 Macedonian plants: “Izvor” in Skopje covers
about 80% of in-country iodisation and “Solbit” in Bitola that covers about 20%.
All salt for human consumption is iodized: this includes table salt, as an additional
raw material in food production and salt as a carrier of additives, i.e. nutritious substance (see
Annex 4 article 2).
The team of experts inspected the Izvor plant and spoke with the manager and owner.
The plant iodizes salt imported from Egypt employing the spray method, and the team found the
procedure appropriate to requirements. Potassium iodate is imported through Greek channels at
market prices. In addition to the legislative regulations (see annex 4) plant management was
aware of the importance of salt iodization and collaboration with the chairman of the
Macedonian IDD committee was evident. The Izvor plant packaged 20% of its salt in 0,5 and 1
kg packages, 35% in 5 and 10 Kg packages, and 45% in 25 kg packages. The plant was equipped
with a small laboratory in which regular iodine checks are performed by titration. As a control
measure, some samples are also submitted to the Veterinary Institute (see section on facilities for
iodine measurements).
5.2 Salt monitoring
The legislative Rule Book regulates the packaging of salt (see Annex 4). The team
inspected packages at the iodization plant and in points of sale, and all were packaged in
compliance with the rules.
5.2.1
Quality Control of Iodised Salt
As said before the primary responsible parties are producers, importers and processing
plants, who should satisfy them selves to comply with the rule book for edible salt (annex 4).
5.2.2
Governmental control at product level
Quality control of iodized salt carried out by more than a hundred inspectors trained in
the field and employed by the Ministry of Health (104 inspectors) and the Ministry of Economy
and Trade (160 inspectors). Controls take place at different levels: at the border for the salt that
is imported as iodized and then at the distribution level. The imported iodized salt is packaged in
0.5 kg to 50 kg packages. Importers of iodized salt must register in advance for importation and
15
include an invoice specifying quantity and quality and a laboratory certificate from the country
of origin. A control takes place at the border and is organized in such a way that the results of
iodine concentration measurements in the salt are available within 2-3 hours. 12 government
laboratories are equipped country-wide to run these tests. 825 spot controls were done in 2002,
of which only 20 samples did not meet requirements. In addition, in-country random analyses
were performed on 310 samples of which 37 had too little iodine and 12 too much. For the salt
that is iodized in-country at the Bitola and Skopje plants, analogous spot controls are made on
site. The Ministry of Economy, in collaboration with the Ministry of Health established a rule
book in 1999 on the quality of edible salt (see Annex 4). In particular, the rule book specifies
that the edible salt must be enriched with no less than 20 and no more than 30 mg of iodine in
the form of potassium iodate per kg salt. An additional advantage of this rule book over normal
legislation is its flexibility, permitting quick adaptation of the level of iodization to changing
needs should salt intake decrease.
Prof. Mihail Danev, Director of the Veterinary Institute, pointed out that iodine
deficiency in livestock is not a problem in the country. The salt for animal feeding must also be
iodized at 20 to 30 ppm (see Annex 4). However, he considers salt intake by farm animals as too
variable to provide a reliable iodine supply through salt. Livestock iodine intake is therefore met
mainly through food concentrate additives and not by iodized salt. Incidentally, he mentioned
that the country is selenium deficient.
5.2.3
Quality control at the retail stage
Samples of table salt, produced in the Tuzla Salt Factory, with date of production
17.03.2002 and expiry date after three years, were analyzed by the State institute for health
protection. Iodine content was measured before and after different storage conditions.
Test results are shown in Tab. 4 and confirmed the high stability of iodate. Similar
results were obtained when the salt was kept at higher temperatures, in the presence of light, in
open containers, and at increased humidity.
Tab. 4
Iodine concentration after storage under various conditions
Room temperature in
presence of light, closed
package
Room temperature, presence
of light, partially closed
Room temperature, presence
of light, completely open
May
28,56
26,45
29,09
26,45
28,04
26,45
27,50
25,92
26,97
June
30,68
30,68
33,32
26,45
26,72
26,45
27,50
25,92
26,45
Iodine mg/kg
July
August
34,38
29,62
33,85
35,44
33,85
28,04
26,45
28,04
26,72
29,62
26,45
29,09
26,97
27,50
25,92
26,45
26,97
26,97
September October
26,45
27,51
25,39
26,45
24,86
26,98
26,97
26,97
29,09
26,97
28,03
26,97
25,92
25,92
24,86
26,45
25,39
24,86
In conclusion, iodized salt producers and importers are able to meet the nation’s needs.
They are producing 100% of salt as iodized, and even export it. Salt iodization is self sustained
with no government subsidies. Salt producers and importers are aware of IDD and of the
regulations on iodized salt. Laboratory facilities for the official iodate titration method are
16
available at the plant site. Some producers also use an external laboratory for control.
Government quality control is extensive and performed by qualified laboratories. Iodate salt is
packaged and labeled properly and the price is considered affordable by Macedonian standards
(15 to 27 denars per kg, i.e. 0.30 to 0.45 Euros). Appropriate experiments have established that
the salt iodine content is stable.
5.2.4
Quality control of iodized salt at household level
In 2002, the expert team from the State Institute for Health Protection tested table salt
samples from the households of pupils who were examined as part of the iodine status
survey.
The tests involved households of pupils from 30 primary schools from 16 regions in
the Republic of Macedonia. 21 of the schools were in urban and 9 in rural areas. 418 samples
were tested, 291 of which were taken from urban and 127 from rural areas. The standard
ICCIDD UNICEF method was used to measure iodine in table salt.
Of the 418 salt samples, 65.5% had the required iodine content (20 to 30mg/kg),
19.5% had a lower content, and 15% were over-iodized (Table 2).
Tab. 5
Level of iodization of household salt samples
Town
Berovo
Bitola
Veles
Vinica
Gostivar
Debar
Kavadarci
Kichevo
Kumanovo
Negotino
Prilep
Resen
Skopje
Struga
Strumica
Tetovo
TOTAL
< 20
mg/kg
20-30
Mg/kg
> 30
mg/kg
13,33
33,33
7,69
0,00
40,00
38,46
10,00
9,09
12,82
33,33
16,00
23,53
7,38
31,82
9,09
54,29
19,62
86,67
53,33
76,92
85,71
50,00
61,54
90,00
81,82
69,23
66,67
52,00
70,59
68,03
45,45
86,36
45,71
65,55
0,00
13,33
15,38
14,29
10,00
0,00
0,00
9,09
17,95
0,00
32,00
5,88
24,59
22,73
4,55
0,00
14,83
The data of Tab. 5 show that 80% of households use salt with a sufficient iodine content.
The 20 % of samples that were outside the indicated range were still quite close to the required
content.
17
5.2.5
Questionnaire on the awareness of and use of iodised salt
In 2002, the national IDD committee in cooperation with the UNICEF office in Skopje,
submitted a questionnaire, based on the WHO, UNICEF and ICCIDD guidelines to 951 patients
who came for a medical examination at the Institute of Pathological Physiology and Nuclear
Medicine of Skopje.





















The surveyed group ranged from 10 –79 yr from all Macedonian regions.
85% were living in urban, and 15 % in rural areas.
The occupational breakdown was as follows: housewives (21%), senior citizens (18%),
pupils and students (4%), professionals with university education (5%), high school
education (27%), primary education (27%), no answer (16%).
The number of family members varied from 1 –12 (MV=4).
The families’ monthly salary ranged from 200 to 80 000 denars (MV=14 033), income
per capita 50 to 16 000 denars (MV=4,034).
Majority of the surveyed purchase salt in local shops (62%), followed by supermarkets
(30.3%), other points of sale (4.3%) and no answer (3.4%).
92% purchase iodized salt, 2.4% non-iodized, and 5.6% didn’t know what kind of salt
they were buying.
The largest part of the households buy salt produced in Tuzla (50,4%), 11% from
Alkaloid, 11.4% from various producers and 27.2 % with no answer.
The salt prices reported varied as follows: 10 to 20 denars (45%), 21 to 30 denars (31%),
31 to 50 denars (4.8%), no answer (19.2%).
To the question what kind of packages of salt they bought, 5% answered that they bought
salt in ½ kg packages, 90.6% as 1kg packages, 2.8% above 1 kg, and no answer – 1.6%.
88.8% buy one package at a time, 6.6% buy several packages and no answer 4.6%.
On the question whether they check the expiry date of the salt they buy, 71.4% answered
yes, 25.3% with no, and 3.3% gave no answer.
As to packing material, 81.7% of the surveyed bought their salt is cardboard cartons ,
17.3% in a plastic bags, glass jars or boxes, and 1% gave no answer.
To the question of how long did a package last in their households, the answers ranged
from 0.1 to 12 months. If a calculation is made for the amount of salt used per family
member, we get the MV=257 grams (from 20 to 2,500 grams) or 8.6 grams per day.
Concerning the salt storage conditions, 92.3% answered that they stored it in the kitchen,
4.7% in a storeroom, 1.2% in the cellar, 1.8% did not answer.
20% of the surveyed kept the salt in its original package, 45% in a closed container, 4%
in an open container, 20% had various ways of keeping it, and 1% didn’t answer.
95.6% kept the salt at room temperature, 0.6% in the fridge, 1% other, 2.8% no answer.
Concerning the humidity of the storage place, 725 answered that there was no humidity,
23.8% mildly humid, 0.6% very humid and no answer 2.6%.
78.8% keep the salt in a dark place, 17.6% in direct light, and 3.6% gave no answer.
When asked when the salt was added to their food: 38% replied at the beginning of
cooking, 52.8% at end of cooking, 7% said it depended on the kind of food, and 2.2% no
answer.
Regarding the consequences of iodine deficiency: 13% answered they didn’t know any,
4% knew but didn’t list them, 12% knew what goiter was, 17% answered that the
18




consequences were thyroid diseases, 12.2% listed other diseases, and 41.6% gave no
answer.
When asked who advised them to use iodated salt: 16% answered the doctor, 7% the
school, 12% the media, 20% various other sources and 45% didn’t answer.
When asked whether they always used iodated salt in their diet: 85% replied yes, 7,1%
no and 7.9 % no answer.
27% of the surveyed had domestic animals, 70% didn’t, and 3% did not answer.
62% gave iodated salt to their domestic animals, 29% gave them non-iodized salt, and
9% provided no answer.
The survey suggests that the Macedonian population stores and uses iodized salt
correctly and is informed about iodine, although people do not know what the consequences of
iodine deficiency are.
5.3 Facilities for Iodine Measurement
As well as the Izvor plant small but effective test facility, the team of experts visited 3
laboratories:
-
At the Institute of Pathophysiology and Nuclear Medicine: the laboratory uses the
standard WHO-ICCIDD method for urinary iodine (UI); it is properly equipped and is
operated by qualified personnel. It uses adequate internal quality controls, as well as
external control exchanging samples with the Department of Clinical Biology of
CHU Saint-Pierre in Bruxelles. The results of some of these external controls were
inspected by the team and found adequate.
-
At the Republic Institute for Health Protection: this laboratory is equipped to perform
titration of iodate in salt by the thiosulfate titration method, with starch as indicator.
The equipment and staff are excellent.
-
At the Veterinary Institute: this laboratory has excellent equipment for the
determination of several trace elements in food. With regards to iodine in salt, it uses
the above mentioned thiosulfate titration method.
The rapid colorimetric test kits for salt iodine are not used in the country. 12
laboratories with facilities for measuring iodine in salt are available in Macedonia, and are
able to give results of salt iodization in 2 hours.
19
6 Final Statement And Recommendations
The team of experts nominated by ICCIDD, UNICEF, WHO and the Network for
Sustained Elimination of IDD, in agreement with the government of Macedonia is pleased to
draw and release the following conclusions after a week of assessment in the country:
Iodine deficiency in Macedonia has been eradicated thanks to the joint effort of all the
institutions, agencies and civil groups involved with particular reference to the Ministry of
Health, the Ministry of Education and Science, the Ministry of Economy, the WHO and
UNICEF offices in Skopje, the Institute of Pathophysiology and Nuclear Medicine, the
Republic Institute for Health Protection, the Institute for Mother and Child Health Care, the
State Health and Sanitary Inspectorate, the State Market Inspectorate, the Veterinary
Institute, salt producers and consumer organizations, all of them united in the National ID
Committee, chaired by Prof. Borislav Karanfilski.
Iodine Deficiency has been defeated in Macedonia through USI, defined by rules
enacted in 1999, thanks to the Ministry of Economy, the Ministry of Health and the National
IDD Committee.
The methodology of assessment of ID that we had the opportunity to verify directly in
the field during surveys in schoolchildren, as well as the control of the level of iodization of
edible salt through Health and Market Inspectors are perfectly adequate.
In order to sustain USI in the future, the team would like to make the following
recommendations:
-
-
Surveys in schoolchildren using the same methodology should be performed every 2
to 3 years
Screening of neonatal TSH should be extended to all newborns
To continue to produce and import only iodized salt so that the use of iodized salt
remains compulsory for all edible salt according to the rule book (see annex 4). Clear
sanctions for non-compliance should be defined for producers, importers, and
iodization plants alike.
Control of iodized salt at the border, at the iodization plants, in the food industry
sector, and at the consumer level must be continued.
Education and information on ID at the level of the consumers and key personalities
must be continued and reinforced
It would be of interest to clarify the following points with further studies:
-
-
Establish in a placebo-controlled study whether thyroid volume increases during
pregnancy and whether an eventual increase is preventable by additional iodine
tablets.
Measure iodine in samples of breast milk
Measure excretion of sodium as a parameter of sodium chloride intake in the
population, preferably on 24 hour urine collections
Monitor incidence of thyroid diseases with particular emphasis to possible cases of
iodine-induced thyroid disease
Quantify the amounts of salt destined to the food industry
20
-
Have periodical independent surveys done by consumer or other civic organization on
the availability, packaging, labeling, pricing, positioning and retail outlets of iodized
salt.
21
Annex 1 Agenda of Activities
Day 1
- Meeting with heads of UNICEF and WHO
Nora Sabani UNICEF officer and Debora Comini Head of the UNICEF office.
The agenda of the mission was discussed in detail, including whether the mission was
expected to do direct testing or only assess the existing data, what activities were required to
test salt quality (where the salt comes from, different types and brands of salt available,
iodization factory in Macedonia) and to assess the distribution to end-users as well as the
amount and quality of consumer information. Dr Comini expressed their great interest in
discussing and working out recommendations for future activities with particular reference to
monitoring and sustainable ID prophylaxis. The discussion revealed that 30-40% of salt is
iodized within Macedonia and 60% is imported as iodized salt. List of the distributing
companies, the brands available on the market (4 or 5) and samples of each were arranged to
have been made available during this mission. A visit to a warehouse was also programmed.
Marija Kisman MD, WHO Liaison Officer, Skopje
Dr Kisma, an epidemiologist and expert in mental health, provided background information
on special WHO programs for Central and Eastern Europe, called EUOHELP focused on
long-term activities. The program was established in the early 1990s and is concerned
predominantly with in-country activities (as opposed to the more traditional international
WHO activities). The Macedonian office was one of the last set up in eastern Europe in 1996.
There are actually 2 WHO offices in Macedonia, the international office for emergency
actions and the Liaison Office for the Development of in-country activities. This office works
in close collaboration with the Ministry of Health and is mainly dedicated to micronutrients,
child health and infant mortality issues.
22
- Ministry of Health
Meeting with Redzep Selmani, Minister for Health
During this meeting, Paolo Vitti underlined the success of the Macedonian campaign for
elimination of IDD, and expressed his opinion that it could be a point of reference for other
countries. The Minister appreciated these observations, and Prof Karanfilski presented a brief
overview of the Macedonian efforts to eradicate IDD since the 1950s.
Meeting with Prof Borislav Karanfilski, President of the Macedonian National IDD
Committee and members of the IDD Committee
After an extensive introduction made by Prof. Karanfilski on the chronology of the
campaign to eliminate IDD in Macedonia, various members of the ID committee presented
data on the current situation of ID, the kinds of thyroid diseases which are treated at the
Institute of Pathology and Nuclear Medicine of Skopje, and more specific issues relating to
neonatal TSH screening and iodine supplementation in pregnant and lactating women. All
these arguments are detailed in the chapter on Current IDD Status
List of present Iodine Deficiency Committee members at the session held on 19th May 2003
1. Prof. Dr. Borislav Karanfilski, President of the National Iodine Deficiency Committee
2. Dr. Donka Maneva, Ministry of Health, secretary of National ID Committee
3. Dr. Mirjana Kochova, Clinic of Child's Diseases
4. Dr. Katerina Venovska, UNICEF Skopje Office
5. Dr. Stojance Stefanoski, Mother and Child Health Protection Institute
6. Vukosava Bubalova, Institute of Pathophisiology and Nuclear Medicine
7. Dr. Vera Menkovska, Ministry of Health, National Health and Sanitary Inspectorate
8. Dr. Borislav Josifovski, Ministry of Health
9. Dr. Nevzat Elezi, Ministry of Health, National Health and Sanitary Inspectorate
10. Vesna Dancevska, Ministry of Agriculture, Forestry and Water Economy
11. Kalco Mitev, Organization of Consumers of Macedonia
12. Antigona Ciriviri, National Health and Sanitary Inspectorate
13. Dr. Marika Petrovska, Macedonian Radio and Television
14. Dr. Suzana Loparska, Institute of Pathophisiology and Nuclear Medicine
15. Prof. Dr. Svetlana Micevska Ristevksa, Institute of Pathophisiology and Nuclear
Medicine
16. Prof. Dr. Olivija Vaskova, Institute of Pathophisiology and Nuclear Medicine
Day 2
- Visit to the Institute for Mother and Child Health Care
Dr. Stojance Stefanoski - President
Dr Nadica Janeva - Vice President
Dr Biljana Ancevska Stojanoska,
The team discussed in detail the matter of iodine supplementation of women during
pregnancy and lactation. The Macedonian IDD committee had raised the question whether
iodine supplementation during pregnancy was desirable, the UI excretion values in pregnant
women being lower than the values found in the general population (see ). After an in-depth
discussion, it was agreed that a pilot controlled study was needed to measure thyroid volume
changes during pregnancy and iodine content in breast milk in 2 groups of women either
supplemented or not with 100 µg/day of iodine during pregnancy
23
- Visit to the Institute of Pathophysiology and Nuclear Medicine.
Dr Olivija Vaskova reviewed the activity of this Institute, the largest in the country and the
referral center for thyroid diseases in Macedonia. The staff consists of 43 people, 40% of
whom with a university degree, 12 doctors, 5 with PhDs, 2 physicists and 2 pharmacists.
They perform 24,000 check-ups per year, 9-10,000 nuclear medicine in vivo diagnostic
exams and about 70,000 lab analyses
-Visit to the UI determination Laboratory.
The laboratory equipment was inspected. The methodology and protocols of UI
determination was reviewed (See Annex 4)
-Meeting with the work group for the National IDD project carried out by the Institute. The
methodology for the field survey on schoolchildren (including goiter assessment by palpation
and thyroid ultrasound) was supervised during a field survey with the physicians directly in
charge. The methodology and periodicity of surveys were discussed in detail (see
Recommendations Chapter)
- Lectures were delivered by Prof. Hans Bürgi (Thyrotoxicosis in Switzerland after the
increase of iodine in the salt from 7.5 to 15 ppm) and Prof. Paolo Vitti (Epidemiology and
Pathogenesis of IDD)
- Meeting with Macedonian Consumer Organization
Mrs. Marijana Loncar Velkova discussed the specific role that the Consumer Organization in
Macedonia is playing in current and future IDD activities. These activities are carried out in
close collaboration with the IDD National Committee and the Institute for the Advancement
of Household (see Annex)
Day 3
- Meeting at the Institute of Health
Dr Shemsi Musa, Director of Health and Sanitary Inspectorate, Dr. Bozin Petreski, State
Sanitary and Health Inspector for Border Survey, Dr Nevzat Elezi, Manager of Department
of Border Inspectorate.
The discussion centered on the importation and processing of salt in the country.
- The total amount of salt imported for human use in 2002 was 16,400 tons. 825 salt samples
were taken for analysis. About half is imported as boiled salt, and then processed in
Macedonia. Much goes into the food industry and is then exported. What remains in the
country is about 9,000 -10,000 tons, part of it is used in the food industry and part for
household use. Estimated consumption pro capita (from the questionnaire) is 8-9 g/day (See
Chapter). Only 20 samples out of 825 did not comply to the Macedonian rules (567 tons). 47
samples were also analyzed for traces of radionuclides , and were all negative. Non-iodized
salt is packaged in 50 kg bags, while the iodized is packaged in 0.5 and 1 kg bags. The Lab in
Skopje analyzed 310 samples from supermarkets, restaurants. 61 were not correct, 37 hypo,
12 hyper and 12 impure.
- Meeting at the Republic Institute for Health Protection
Dr Blagoja Aleksoski, Director
An outline of iodine prophylaxis program in Macedonia was given. The IDD Committee was
established in 1998. Comments were made on salt iodization regulation, level (20-30 mg/kg)
and type (K iodate), controls at the consumer level.
24
Dr. Lence Kolevska, Republic Institute for Health Protection. This Institution takes care of
special subgroups of the population such as students, workers etc. Nutrition status is
monitored according to the Ministry of Health. Iodine nutrition is studied in cooperation with
the Institute of Pathophysiology and Nuclear Medicine. Data related to individual salt intake
were discussed in detail.
Dr. Pharm. Biliana Culeva, Chemist and Chief of the laboratory of the Republic Institute for
Health Protection. A detailed discussion was conducted on the method of iodine
determination in salt samples. The titration method is used as advised by UNICEF and the
European Salt Producers Association (ESPA) using sodium thiosulphate and starch as
indicator. The laboratory was visited.
- Visit to the Veterinary Institute of Skopje
Prof. Mihail Danev
This Institute carries out quality control of foods on the market in Macedonia, both home
produced and imported. Tested are performed for the presence of pesticides, toxins,
radioactive elements, and anabolic substances. For salt control, the same titration method
used at the Republic Institute for Health Protection is applied.
- Visit to the salt plant in Skopje
Mr. Vadin Asani and Mr. Goranco Angelevski
Production capacity is 5 tons/hr. Class A raw materials come from Egypt. In 2002, this plant
produced about 8,000 tons of salt, 6.7 of which was iodized, 4 for Macedonia and the rest for
exportation. 18-20% was in 1 kg packages, 40-45% in 25 kg packages. The iodization
process involves first the washing, then centrifugation, heating and drying with hot air at
100-120°C, then grinding and iodization with a solution of potassium iodate sprayed while
the salt is being conveyed on a moving belt then collected and mixed to render iodine
concentration homogeneous , then bagged.
25
Day 4
- Surveys of school children in Grescnica and Ohrid
Surveys were performed on schoolchildren of primary school in the village of Grescnica near
Kicevo (40 children were examined) and in the city of Ohrid (40 children). The local MD
personnel who carried out the survey were: Prof Karanfilski, Prof. Olivija Vaskova, Svetlana
Micevska Ristevska, Dr Suzana Loparska and Laboratory Technician Verka Miloscevska.
The methodology of the clinical examination and thyroid ultrasonography were assessed and
found to be appropriate.
Thyroid volumes of all 80 children examined were within the normal range according to the
ICCIDD standards. 1 case with a hypoechoic gland suggestive of thyroiditis was found in
Gresnika.
26
Day 5
- UNICEF
Meeting with Debora Comini Head of Office of United Nations Children. The activities
carried out during the mission were briefly reviewed.
- WHO
Meeting with Marija Kisman MD, WHO Liaison Officer, Skopje. Review of IDD data and
discussion of the recommendations delivered by the team of experts.
- Ministry of Health
Meeting with Redzep Selmani, Minister of Health. At the end of the mission, the team
confirmed to the Minister that Macedonia has achieved iodine sufficiency. The Minister
promised to give his support to sustaining the monitoring program.
- Press conference with the Expert team , Ministry and UNICEF staff, together with the
Macedonian IDD Committee.
- Lunch with all participants involved in country review visit.
27
Annex 2 Members of the Macedonian Committee for
Iodine Deficiency
REPUBLIKA MAKEDONIJA
MINISTERSTVO ZA ZDRAVSTVO
Br. 09-6263
26.12.1997 god.
S k o p j e
On the basis of the article 60 paragraph 2 of the Low for Health Protection ("Official Gazette
of RM", no 38/91 and 55/95), the Ministry of Health of R. of Macedonia is bringing the
following
DECISION
For the establishment of National Committee for Iodine Deficiency
National Committee for iodine deficiency is established in the Republic of Macedonia with
the following composition:
I.
From the Institute of Pathophysiology and Nuclear Medicine – Skopje:
1.
Prof. Dr. Borislav Karanfilski
2.
Doc. Dr. Olivija Vaskova
II.
From the Republic Institute for Health Protection – Skopje
1. Prim. Dr. Lence Kolevska
III.
From the Ministry of Health – Skopje
1. Prim. Dr. Violeta Malinska-Petrusevska
2. Prim. Dr. Donka Maneva
IV.
From the Ministry of Economy
1. Nikolina Kaeva
V.
From the Ministry of Agriculture, Forestry and Water Economy – Skopje
1. Vesna Dancevska
VI.
From the Ministry of Education and physical Culture – Skopje
1. Jelica Gerovska
VII.
From the Clinic for Child's Diseases – Skopje
1. Prof. Dr. Mirjana Kocova
VIII.
From the Clinic for Endocrinology and metabolic Diseases – Skopje
1. Prof. Dr. Cedomir Dimitrovski
28
IX.
From the Mother and Child Health Protection Institute at the Skopje Health Home
1. Prim. Dr. Stojanco Stefanovski
X.
From the Republic Sanitary and Health Inspectorate – Skopje
1. Dr. Dimce Petreski
XI.
From the Republic Market Inspectorate – Skopje
1. Dipl. Ing. Techn. Antigona Ciriviri
XII.
From UNICEF Skopje Office
1. Dr. Katerina Venovska
XIII.
From the World Health Liaision Office – Skopje
1. Dr. Marija Kisman
XIV.
From AD "Alkaloid" – Skopje
1. Dr. Petre Lubarovski
XV.
From AD "Zito Bitola" – Bitola
1. Dipl. Ing. Techn. Vera Zlatevska
XVI.
From the Macedonian Radio and Television – Skopje
1. Dr. Marika Petrovska
The Committee will work on the base of the manner outlined with the Protocol and Programme of
work, in accordance to the recommendations and directions from the World Health Organization,
UNICEF and International Council for Control of Iodine Deficiency Disorders.
The Committee will regularly inform the Ministry of Health for its work.
MINISTER
Doc. Dr. Petar M. Ilievski
29
Annex 3 Protocol of the of the work of the National
Committee for Iodine Deficiency
1. GENERAL PROVISIONS
Article 1
This Protocol regulates the internal organization and the manner of work of the National
Committee for Iodine Deficiency (hereinafter: Committee), the manner of realization of the
relations and the cooperation of the Committee with WHO, UNICEF, national authorities and
other organizations, as well as other issues of importance for the work and the organization
of the Committee.
Article 2
For the purpose of realization of its functions and tasks the Committee adopts
programmes and plans for its work.
Article 3
The Committee works and decides at its sessions.
The work of the Committee is of public nature.
The Committee informs the public about its work through the press and other mass media.
2. PRESIDENT, MEMBERS OF THE COMMITTEE AND SECRETARY OF THE
COMMITTEE
2.1. President of the Committee
Article 4
-
The President of the Committee:
represents the Committee;
convenes sessions of the Committee and chairs them;
signs the documents adopted by the Committee;
sees to the implementation of the Committee conclusions;
sees to the implementation of the programme and plans of work of the Committee;
informs the Minister of Health about the work of the Committee;
performs other activities relating to the functions and the tasks of the Committee
established with this Protocol.
2.2. Members of the Committee
Article 5
The Members of the Committee have the right and duty with respect to the functions
and tasks of the Committee:
- to attend the sessions of the Committee;
- to propose review of certain issues;
- to present initiatives for drafting materials and documents;
- to be acquainted with the preparation of certain materials;
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-
to be familiar with the possible solutions and alternatives upon particular issues;
to perform other activities.
Every Member of the Committee has the right to seek that Committee take stand upon
an issue of relevance for the implementation of the Committee functions and tasks.
Article 6
The Member of the Committee has the right and duty in compliance with the attitude
of the Committee to represent the Committee at sessions of organs and organizations and at
public, cultural and other manifestations relating to the Committee functions and tasks.
Article 7
The Committee gives directives and establishes the positions of the work of the
Member of the Committee which will be determined by it to represent it.
Every Member of the Committee is personally responsible for its work and for the
work of the Committee in accordance with his rights and duties.
The Member of the Committee is responsible for the implementation of the positions
of the Committee and has the duty to inform the Committee on the execution of all activities
entrusted to him.
2.3. Secretary of the Committee
Article 8
The Secretary of the Committee in compliance with the instructions of the President
of the Committee shall see to:
- the preparation of the sessions of the Committee;
- drafting of the materials from the sessions of the Committee;
- provision and forwarding of the materials necessary for the work of the Committee;
- forwarding of the conclusions and other materials of the Committee to the other
Members of the Committee, as well as to other organs and organizations for which
they are intended;
- other activities relating to the organization of the work of the Committee, the
technical preparation of the materials and the forwarding of the same.
3. SESSIONS OF THE COMMITTEE
3.1. Drafting materials for the sessions
Article 9
The material to be reviewed at the sessions is prepared and forwarded in a manner
provided for in this Protocol.
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The proposal for review of the materials at the session of the Committee shall be
submitted by the Committee President and Members.
The proposals for review of the materials by other organs, organizations, cultural,
scientific and expert staff shall be forwarded at latest five days prior to the session, to the
Secretary of the Committee.
3.2. Convening the sessions and establishing the agenda
Article 10
The sessions of the Committee shall be convened by the President of the Committee
as well as upon the initiative of a Member of the Committee.
Article 11
The proposal for the agenda shall be established by the President of the Committee.
The President of the Committee shall adjourn the review of the material if the same
has not been prepared in accordance with this Protocol.
The Secretary of the Committee shall inform the proponent of the reasons owing to
which the review of the material shall be adjourned.
Article 12
The President shall inform the member about the time and place of the organization
of the session, three days prior to its being held, at latest, together with the forwarding of the
material for the session.
3.3. Work and decision-making at the sessions of the Committee
Article 13
The President of the Committee shall open the session.
After establishing the agenda which shall be proposed by the President of the
Committee, the adoption of the minutes from the previous session shall be approached.
The Members of the Committee have the right to give objections to the minutes.
The Minutes shall be signed by the President and the Secretary of the Committee.
Article 14
The Committee works according to the established agenda.
For each item of the agenda a discussion shall be open.
At the beginning of the discussion, the proponent of the material shall give short oral
rationale of the material.
Article 15
After the completion of the discussion upon each issue, the Committee shall adopt a
conclusion.
The conclusions shall be formulated by the President of the Committee.
Article 16
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For the purpose of provision of quorum for the work at the sessions of the Committee
the presence of two thirds of the Members of the Committee shall be necessary.
The Committee shall adopt conclusions with a majority of the total number of the
Members attending the session.
3.4. Minutes of the Session
Article 17
Minutes shall be kept on the work of the Session of the Committee.
The Minutes shall contain the agenda of the session, the names of the Chairperson,
the attending and the absent Members of the Committee, as well as other invited individuals.
Every person attending the session has the right to request that his statements and
proposals be inserted in the Minutes.
The Secretary of the Committee shall see to the keeping of the Minutes.
4. PROCEDURE FOR SUBMISSION OF RESIGNATION AND FOR RAISING THE
ISSUE OF CONFIDENCE
Article 18
Each Member of the Committee may submit a resignation.
The resignation shall be submitted to the President of the Committee with a written
rationalized request.
The Committee shall inform the Minister of Health on the submitted written request
for resignation, with a proposal for appointing another member instead of the resigning
member.
The resigning member has the duty to finalize the initiated activities relating to the
work of the Committee which are of pressing nature.
5. ACTS OF THE COMMITTEE
Article 19
For the purpose of realization of its functions and tasks, the Committee adopts
programmes, plans and conclusions.
The acts of the Committee shall be signed by the President of the Committee.
6. COOPERATION OF THE COMMITTEE WITH ORGANS AND ORGANIZATIONS
Article 20
The Committee cooperates with organs and organization on particular issues within
its area of responsibility through:
- mutual exchange of opinions, experiences, information and materials on the issues of
common interest;
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-
forwarding of positions, proposals and opinions on issues in the field of responsibility
of the Committee;
participation of representatives of the Committee at sessions of organs, organizations,
that is participation of their authorized persons at sessions of the Committee
7. PUBLIC CHARACTER OF THE WORK OF THE COMMITTEE
Article 20
The President of the Committee shall see to the public character of the work of the
Committee.
The procedure, the manner and the contents of the public information shall be done in
accordance with the Minister of Health.
Article 20
This Protocol enters into force with the day of its adoption.
PRESIDENT OF THE COMMITTEE
Prof. Ph.D. Borislav Karanfilski
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Annex 4 Salt Legislation
On the basis of article 86 of the Act on Standardization ("Off. Reg. of RM" no. 23/95), the
Minister of Economy, in collaboration with the Minister of Health, brought the following
RULE BOOK
ON THE QUALITY OF THE EDIBLE SALT
Article 1
This rulebook stipulates the norms that, with respect to the quality and composition
having an impact on the biological value, the edible salt ("the salt") should satisfy in the
production and trade.
Article 2
For the purposes of this rule book, salt means a product which is used for direct
human consumption, as table salt, as an additional raw material in the food production or as a
carrier of additives, i.e. nutritious substances.
Article 3
3.1 The salt is a crystal product consisting mainly of sodium chloride.
3.2 Subject to the origin and the manner of preparation, one can distinguish:
a) boiled salt
- obtained by evaporation of natural salt water;
b) stone salt
- obtained by processing salt ores;
c) sea salt
- obtained by evaporation of seawater.
Article 4
The salt obtained as a by-product in the chemical industry, as well as the salt of other
origin, except the one of article 3, paragraph 2 hereof, can not be declared and marketed as
salt in the sense of this rule book.
Article 5
1.
2.
3.
4.
5.
6.
The salt intended for sale should meet the following norms:
The sodium chloride contents should not be less than 97% counting on dry substance,
excluding the additives, i.e. the nutritious substances.
The moisture contents should not exceed 7%.
It should be white, should have no odour and should not contain ingredients that are
prohibited by this rulebook.
It should not contain more than 0,05% mineral ingredients non-soluble in hydrochloric
acid.
The salt granulation should be such, that at least 90% of the salt be able to pass through a
sieve having square openings of 3 mm side.
It should be iodinated with kalium iodate (KJO3), so as to contain neither less than 20 mg
iodine per 1 kg salt, nor more than 30 mg iodine per kg salt.
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Article 6
Under the name "fine table salt" there can be marketed a finely crystallized or finely
grounded salt being entirely white.
The fine table salt intended for sale shall satisfy the norms provided for in article 5
hereof, provided that it should not contain more than 0,5% moisture and that at least 90% of
the particles should pass through a sieve having square openings of 0,5 mm.
Article 7
Subject to the origin and the procedure of preparation, the salt, except the sodium
chloride, may also contain in various quantities the following mineral ingredients, namely:
calcium, kalium, magnesium and sodium sulfate, carbonate and bromide, as well as calcium,
kalium and magnesium chloride.
Article 8
The salt may be used as a carrier of various additives, in preparation of admixtures
intended for the food industry (ex. marinating salt) and of preparations enriched with
nutritious substances (vitamins, minerals) intended as food additives.
Article 9
The following additives may be used in the technological process for salt production:
Tab. 6
Permitted additives to salt for human consumption
Type of additive
Maximum level in the final product
Anticlodding and impregnating ingredients:
calcium or magnesium carbonate;
magnesium oxide;
calcium (III) phosphate;
20 g/kg individually or
silicium dioxide, amorphous;
in combination
calcium, magnesium, sodium-alumine or sodiumcalcium-alumine silicates;
 aluminum, calcium, magnesium, kalium or
sodium salts of the myristic or stearic acid
2. Crystal modifiers:
10 mg/kg individually or
in combination
 calcium, kalium or sodium;
(expressed
as [Fe(CN)6]3-)
 ferrocyanide
3. Emulgators:
10 mg/kg
 polysorbate 80
4. Auxiliary ingredients:
10 mg/kg
(as a residue)
 dimethylpolysiloxan
The kalium and sodium ferrocyanide, in the sense of additives mentioned in
paragraph 1, may be used in maximum quantity of 20 mg/kg, in the procedure for obtaining
stone salt.
All additives that are mentioned in paragraph 1 of this article should satisfy the norms
that are enforceable for the use thereof in the food industry.
1.





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Article 10
The salt intended for sale is packed in a polystyrene, paper or other suitable package,
which shall not influence the composition, i.e. the biological value of the salt.
The table salt intended for the retail market should be packed in the original package
of not more than 1 kg.
Article 11
The salt being marketed in manufacturer's (the wrapper) original packages should
have a declaration containing the following information:
1. Name of the article: "cooking salt", "table salt", or "fine table salt". In cases where the
salt contains one or more ferrocyanide salts, added during the process of preparation
(crystallization), the one of the terms quoted in paragraph 2 of article 3 should be added
to the basic name of the article.
The name of the article should also indicate the origin, i.e. the manner of obtaining the
salt (article 3): sea salt, stone salt, boiled salt.
In cases where the salt is used as a carrier of one or more components, included by
technological, nutritious or health reasons, and the salt being marketed as such, the package
should clearly indicate ex. "fluorinated salt", "iodinated salt", "iron enriched salt", "vitamin
enriched salt" etc.
2. Visible indication of the substance the salt has been iodinated with, the quantity, date of
iodination and expiry date.
3. List of additives declaring all additives included in the product. The additives shall be
declared by indicating the functional group of the additive (ex. anticlodding substance)
and the specific name of the additive or the numerical designation of the additive.
In case the salt contains greater number of nutritious components (vitamins, minerals etc.),
the list of those additives follows the descending order per volume.
4. Net weight in grams or kilograms.
5. Name and address of the firm or the organization manufacturing, importing or packing
the article.
6. Name of the country of origin of the article.
In case the edible salt intended for marketing has been finally processed in another country
with the aim of improving its quality, such country should be indicated as the country of
origin.
4. Instructions on manner and conditions to store the article.
The declaration indicated on the package of the article should be clear, unerasable and
readily legible for the consumers, under normal conditions for supply and use.
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Article 12
By entering of this rulebook into force, the following provisions should cease: the
provisions of articles 61, 62, 63 and 64 of the rules on quality of coffee and coffee
substitutes, tea, spices, soup concentrates, baking yeast, baking powder, pudding powder, diet
products and additives ("Official Register of SFRY" no. 22/63, 2/64, 25/65, 50/66, 10/67,
54/67, 15/68, 53/69, 27/71, 8/75, 58/77, 60/77, 13/78, 20/80, 41/80, 45/81, 52/86 and 33/89).
Article 13
This rulebook enters into force the eighth day from the day of publishing thereof in
the "Official Register of the Republic of Macedonia".
No. 09-6208/2
24 September 1999
Skopje
Minister of Health,
Dr Dragan Danilovski (sign.)
No.124416/2
24 September 1999
Skopje
Minister of Economy,
Mihailo Tolevski (sign.)
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