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1.

COMPETENT AUTHORITIES
MINISTRY OF HEALTH
1.1.

Please provide information on structure, responsibilities, staff


resources and training of the Central Competent Authorities and coordination bodies responsible for controls of contaminants in food
within the context of this audit.
Please also provide this information for the regional Competent
Authorities which will be visited during the course of the audit.

Structure and responsabilities:


According to the Governmental Decision no 144/2010 regarding the organising and
functioning of the Ministry of Health, there is one directorate with responsibilities in
the field of food safety and nutrition: the Public Health and Control in Public Health
Directorate.
The main responsibilities in the field of food safety are:
- developing of legal acts in the field of food safety;
- carrying out monitoring and control of food safety in accordance with national public
health programs of the Ministry of Health;
- carrying out official food control according to the annual plans of CPHD as well as
control thematic actions initiated at the central level, (PHCPHD MH) and in case of
complaints from population;
- co-ordinating the activity of inspectors from the County Public Health Control
Departments (CPHCD). CPHCD checks the compliance of food products and food
contact materials, the health status of the employees in food establishments and
carries out official controls to ensure compliance with public health rules at all stages
of production, processing, distribution and food supply to the final consumer of the
food products for which the MH is competent authority:
- food additives, flavouring and enzymes,
- natural mineral waters, bottled waters
- foodstuffs with ionising radiation treatment,
- food suplements,
- foodstuffs with special nutritional destination,
- evaluation of iodine level from iodate salt for the human consumption,
- novel food
Other responsabilities according to the national legislation:
- health and nutritional claims;
food products with addition of vitamins and minerals and of certain other
substances;

control of compliance with the rules of food preparation, according to


nutritional regulations in hospitals, school premises (including after school), social
assistance, school camps and premises which organize activities similar those of
school camps;
control of compliance with the rules regarding the distribution in schools and
kindergartens of dairy and bakery products and fruits (fruits school scheme
programe);
- RASFF notification (Rapid Alert System for Food and Feed) and taking the
necessary measures for food categories in the fields of competence;
According to the Governmental Decision no. 1414/2009 regarding the establishing,
organising and functioning of the National Institute of Public Health at regional level a
National Public Health Institute with 6 regional public health centres in Bucharest,
Iasi, Cluj-Napoca, Timisoara, Targu - Mures and Sibiu was set up.
The responsibilities of the County Public Health Directorates are established by the
Ministerial Order no. 1078/ 2010 for organising and functioning of the CPHDs and the
Ministerial Order no 824/2006 regarding the Norms for functioning and organizing of
the sanitary state inspection.
HUMAN RESOURCES:
central level MH PHCPHD 3;
- NIPH 19;
- county level CPHDs - 426;
-

COUNTY PUBLIC HEALTH DIRECTORATES (CPHDs) OF CONSTANTA and OLT


STRUCTURE: there are 2 departments with responsibilities in food safety
control at county level: Department of Control in Public Health and Department of
Public Health.
The CPHD structure includes also the Laboratory of Diagnosis and Public Health
Investigation.
RESPONSABILITIES
- coordinating and implementing at county level the national health programmes
associated to food risk factors;
- reporting these data to the NIPH;
- official control of foodstuffs: imposing the observing by individuals or legal entities of
the hygiene and public health norms; identifies dangers to the public health; apply
sanctions in case of unconformities;
HUMAN RESOURCES staff with responsibilities on food safety:
-

a. CPHD CONSTANTA:
21 sanitary inspectors Department of Control in Public Health;
3 specialists Department of Public Health
10 specialists - Laboratory of Diagnosis and Public Health Investigation.

b. CPHD OLT:
2 sanitary inspectors Department of Control in Public Health;
2 specialists Department of Public Health;
3 specialists - Laboratory of Diagnosis and Public Health Investigation;
2.1 For the two regions to be visited during the course of the audit please
outline the mechanism(s) used to establish control/monitoring plan(s) for
contaminants in food. On what basis are the priorities decided? Indicate the
rules pertaining to the monitoring of food contaminants. Please provide this
information for the two regions separately.
Mechanism(s) used to establish control/monitoring plan(s) for contaminants in
food:

1. Annually, Ministry of Health develops health programs with a component of food


safety.
Public Health Programme is coordinated by the Public Health and Control in
Public health Directorate from Ministry of Health;
The National Institute of Public Health elaborates methodologies for the food
component of the public health program. CPHDs take samples of the food
categories for which the Ministry of Health is responsible, according to the
methodologies of the NIPH.
2. PHCPHD of the Ministry of Health initiates at national level thematic actions for
controls of different food categories.
There were organised 2 thematic actions on foods with special destination
purposes (2012 and 2013) no. 56733/ 06.11.2012 and no. 72196/25.11.2013 with
sampling only in case of suspicion. There were no unconformities found.
2.2 For the two regions to be visited during the course of the audit please
list separately in Table I below control/monitoring plans for contaminants in
food (except those organised to comply with the requirements of Council
Directive 96/23), planned and implemented since 2011. Please explain how the
results are collated, analysed and used.

Table I. Contaminants control plans CPHD CONSTANTA


Year

Scope of testing

Number of samples Number of nontested


compliant samples

2011

Nitrates in processed cerealbased foods and baby foods for


infants and young children

10

Lead and Cadmium - food


supplements

2012

2013

2014

Lead
and
Cadmium
processed cereal-based foods
and baby foods for infants and
young children

10

Nitrates in processed cerealbased foods and baby foods for


infants and young children

Lead, cadmium
supplements

food

Nitrates in processed cerealbased foods and baby foods for


infants and young children

Lead, cadmium
supplements

food

Nitrates in processed cerealbased foods and baby foods for


infants and young children

Lead, Aluminium, Cadmium,


Mercury in processed cerealbased foods and baby foods for
infants and young children

Table I. Contaminants control plans CPHD OLT


Year

Scope of testing

2011

Nitrates in processed cerealbased foods and baby foods for


infants and young children

2012

Number of samples Number of nontested


compliant samples
6

Lead
and
Cadmium
processed cereal-based foods
and baby foods for infants and
young children

Nitrates in processed cerealbased foods and baby foods for


infants and young children

Lead, cadmium
supplements

food

2013

2014

Nitrates in processed cerealbased foods and baby foods for


infants and young children

Lead, cadmium
supplements

food

Nitrates in processed cerealbased foods and baby foods for


infants and young children

Lead, Aluminium, Cadmium,


Mercury in processed cerealbased foods and baby foods for
infants and young children

2.3 For the two regions to be visited during the course of the audit
please provide the administrative provisions, guidance for sampling (if
different from those listed in point 1.2 above), and operational
instructions on official controls or checklists issued for the control of
contaminants in food.

ADMINISTRATIVE PROVISIONS:

Ministerial Order no. 1078/2010 regarding the organizing and functioning of


counties public health directorates;
a. CPHD CONSTANTA:
Sampling is performed in accordance with:
1. Operational Procedure OP-CAMS-03 on sampling during the actions of
sanitary inspection in the CPHD Constanta;
2. The procedures developed by the PHCPHD of the Ministry of Health:
- General procedure for sampling in food - PG 001;
- Specific procedure for control actions on foods for particular nutritional uses
and sampling - PS 002;

b. CPHD OLT:
Sampling is performed in accordance with the procedures developed by the
PHCPHD of the Ministry of Health:
- General procedure for sampling in food - PG 001;
- Specific procedure for control actions on foods for particular nutritional uses
and sampling - PS 002;

2.5 Please provide, for the two regions to be visited during the course of the
audit separately, an overview of 2012 and 2013 inspections and sampling
activities undertaken during routine official controls covering contaminants
in food by completing the Tables II-IV below.

CPHD CONSTANTA
Table II. Overview of inspections and sampling activities
Establishments
inspection
2012

2013

visited

for

No.
of No. of nonNature of non-compliances
inspections complianc
(please list them here)
carried out
es found

Primary producers

Manufacturers

Market
controls
(wholesalers, retailers,
importers etc.)

10

Lack of notification at the Ministry


of Health

Primary producers

Manufacturers

Market
controls
(wholesalers, retailers,
importers etc.)

37

Table III. Sampling of products of EU origin

Samples of baby food were collected in order to determine the content in Lead,
Cadmium, Mercury, Tin and Aluminium. All the samples complied with the rules.

Contaminant

Nitrates
Mycotoxins

Commodity

Country
of origin

No. of
analysed
2012

samples No.
of
noncompliant samples
2013

2012

2013

Contaminant

Commodity

Country
of origin

No. of
analysed

samples No.
of
noncompliant samples

2012

2013

2012

2013

Aflatoxins

Ochratoxin A

Patulin

Deoxynivale
nol

Zearalenone

Fumonisins

Lead

Cadmium

Mercury

Tin
(inorganic)

3-MCPD

Metals

Dioxins
PCBs

and

PAHs
benzo(a)pyre
ne

Table IV. Sampling of products imported from Third Countries

No. of
analysed
Contaminant

Commodity

Country
of origin

samples No.
of
noncompliant samples

2012

2013

2012

2013

Nitrates

Mycotoxins

Aflatoxins

Ochratoxin A

Patulin

Deoxynivaleno
l

Zearalenone

Fumonisins

Metals

Lead

Food
supplements

USA,
China

1 USA

1 China

Cadmium

Food
supplements

USA,
China

1 USA

1 China

Mercury

Tin
(inorganic)

3-MCPD

and

PAHs
(benzo(a)pyre
ne)

Dioxins
PCBs

CPHD OLT
Table II. Overview of inspections and sampling activities
Establishments
inspection
2012

2013

visited

for

No.
of No. of nonNature of non-compliances
inspections compliances
(please list them here)
carried out
found

Primary producers

Manufacturers

Market
controls
(wholesalers, retailers,
importers etc.)

Primary producers

Manufacturers

Market
controls
(wholesalers, retailers,
importers etc.)

Table III. Sampling of products of EU origin

Contaminant

Commodity

Country of
origin

No. of samples analysed


2012

No. of
samples

2013

non-compliant

2012

2013

Nitrates

Mycotoxins

Aflatoxins

Ochratoxin A

Patulin

Deoxynivalen

Zearalenone

Fumonisins

12

Baby food

Cehia,
Germania

ol

Metals
Lead

Contaminant

Commodity

Country of
origin

No. of samples analysed


2012

No. of
samples

2013

non-compliant

2012

2013

Romania
Food
supplements

Romania,

Baby food

Cehia,
Germania

Germania

Romania
Cadmium

Food
supplements

Romania,

Baby food

Cehia
Germania
Romania

Baby food

Cehia
Germania
Romania

and 0

PAHs
0
benzo(a)pyrene

Mercury

Tin
(inorganic)
3-MCPD
Dioxins
PCBs

Germania

Table IV. Sampling of products imported from Third Countries

No. of
analysed
Contaminant

Commodity

Country
of origin

samples No.
of
noncompliant samples

2012

2013

2012

2013

Nitrates

Mycotoxins

Aflatoxins

Ochratoxin A

Patulin

Deoxynivaleno
l

Zearalenone

Fumonisins

Metals

Lead

Food
supplements

USA

Cadmium

Food
supplements

USA

Mercury

Tin
(inorganic)

3-MCPD

and

PAHs
(benzo(a)pyre
ne)

Dioxins
PCBs

2.7 Please present administrative provisions and guidance issued


regarding actions that can be taken in case of non-compliance. On the
basis of the controls carried out in 2012 and 2013, please explain what
enforcement measures have been taken in relation to non-compliant foodstuffs
(if any).
GD no 857/2011 establishing and sanctioning of contraventions to the public
health rules includes provisions regarding the actions which can be taken in
case of non-compliance.
Ordinance no 2/2001 regarding the legal regime of contraventions