ministry of health

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1. Competent Authorities

MINISTRY OF HEALTH

1. Please provide information on structure, responsibilities, staff resources and training of the Central Competent Authorities and co-ordination 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

YearScope of testingNumber of samples testedNumber of non-compliant samples

2011

Nitrates in processed cereal-based foods and baby foods for infants and young children 10 0

Lead and Cadmium - food supplements 40

Lead and Cadmium - processed cereal-based foods and baby foods for infants and young children 100

2012

Nitrates in processed cereal-based foods and baby foods for infants and young children30

Lead, cadmium - food supplements 40

2013



2014


Lead, Aluminium, Cadmium, Mercury in processed cereal-based foods and baby foods for infants and young children2

Table I. Contaminants control plans CPHD OLT

YearScope of testingNumber of samples testedNumber of non-compliant samples

2011

Nitrates in processed cereal-based foods and baby foods for infants and young children 6 0

Lead and Cadmium - processed cereal-based foods and baby foods for infants and young children 60

2012



2013



2014


Lead, Aluminium, Cadmium, Mercury in processed cereal-based foods and baby foods for infants and young children2

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 activitiesEstablishments visited for inspectionNo. of inspections carried outNo. of non-compliances foundNature of non-compliances (please list them here)

2012Primary producers000

Manufacturers000

Market controls (wholesalers, retailers, importers etc.)101Lack of notification at the Ministry of Health

2013 Primary producers000

Manufacturers000

Market controls (wholesalers, retailers, importers etc.)3700

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.

ContaminantCommodityCountry of originNo. of samples analysedNo. of non-compliant samples

2012201320122013

Nitrates

Mycotoxins

Aflatoxins0000

Ochratoxin A0000

Patulin0000

Deoxynivalenol0000

Zearalenone0000

Fumonisins0000

Metals

Lead3300

Cadmium3300

Mercury3300

Tin (inorganic)3300

3-MCPD0000

Dioxins and PCBs0000

PAHs benzo(a)pyrene0000

Table IV. Sampling of products imported from Third Countries


2012201320122013

Nitrates0000

Mycotoxins0000

Aflatoxins0000

Ochratoxin A0000

Patulin0000

Deoxynivalenol0000

Zearalenone0000

Fumonisins0000

Metals0

LeadFood supplementsUSA, China1 USA1 China00

CadmiumFood supplementsUSA, China1 USA1 China00

Mercury0000

Tin (inorganic)0000

3-MCPD0000


PAHs (benzo(a)pyrene)0000

CPHD OLT

Table II. Overview of inspections and sampling activitiesEstablishments visited for inspectionNo. of inspections carried outNo. of non-compliances foundNature of non-compliances (please list them here)

2012Primary producers000

Manufacturers000


2013 Primary producers000

Manufacturers000


Table III. Sampling of products of EU origin


20122013 20122013

Nitrates000300

Mycotoxins000000

Aflatoxins000000

Ochratoxin A000000

Patulin000000

Deoxynivalenol000000

Zearalenone000000

Fumonisins000000

Metals0012900

LeadBaby food

Cehia, Germania Romania 3300

Food supplementsRomania,

Germania

3300

CadmiumBaby food

Cehia, Germania

Romania3300

Food supplementsRomania,

Germania

3300

MercuryBaby foodCehia Germania Romania3000

Tin (inorganic)Baby foodCehia Germania Romania3300

3-MCPD000000


PAHs benzo(a)pyrene000000

Table IV. Sampling of products imported from Third Countries


2012201320122013

Nitrates0000

Mycotoxins0000

Aflatoxins0000

Ochratoxin A0000

Patulin0000

Deoxynivalenol0000

Zearalenone0000

Fumonisins0000

Metals0

LeadFood supplementsUSA1100

CadmiumFood supplementsUSA1100

Mercury0000

Tin (inorganic)0000

3-MCPD0000


PAHs (benzo(a)pyrene)0000

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

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