Annex 1.

Comments and suggestions for the draft food law

Prepared by: EuropeAid Project/122779/C/SER/AL “Establishment of National Food Authority”

Object: Presenting some comments and suggestions for the draft food law in compliant with the
obligations of ASA, EU legislation and best practices applied by member countries of EU.

Aiming fulfillment of Term of Reference, approved by European Commission and Albanian Government,
where is underline that: institutional framework and administrative food safety in Albania, to be
compliant with approximation process of acquis in this sector. Building up an effective and independent
structure, able to assure implementation of national legislation on food safety field, to approximate, and
also for distributes the necessary information to the government, consumer and food producers”.

The Project’s staff submits below comments and suggestions aiming improvement of draft food law.

Main objectives decided by Community Legislation according to food safety are:

 Life and health human protection and consumer interest with special attention for health
animal protection, plants and environment.
 Free movement of food in market.
 Adopting the national standard

Community Legislation, according to necessary administrative standards for the food safety detemine
that the last ones should guaranty in independent manner:

 Accomplishment of risk assessment

 Accomplishment of risk communication
 Accomplishment of risk management.

Based in these objectives and allocations, brings out these important issues.

Article 3, point 7, based in draft law is- “Competent Authority” shall mean risk management
institutions, namely Ministry of Agriculture, Food and Consumer Protection, Ministry of Health and
National Food Authority .

In this way, functioning of risk management is shared between 3 institutions by making more difficult
than currently, his implementation in the practice. By sharing the functioning of risk management
between these institutions, not only create dependence between them which is difficult to be
administrated in emergency cases, but might create possibilities for the interests crossing of the
consumer protection with other interests promoted by these institutions.

In this point exists another problem. In Ordinance 178/2002 is determined the obligation of the
collaboration of Competent Authority of non member country (as it is foreseen in draft law would have
been 3), with European Authority of the Food Safety, which is an independent institution from European
Commission, fact which make impossible the representation of these “Authorities” with functions of the
risk management shared between them, in this Communitarian institution.

For the solution of this problem we would suggest the foreseen of one institution as Competent
Authority in the implementation of the risk management.

Article 3, point 7 in this draft law is: “Competent Authority” shall mean risk management institutions,
namely Ministry of Agriculture, Food and Consumer Protection, Ministry of Health and National Food
Authority .

Suggestions:

“Competent Authority”- risk management institution, concretely, National Food Authority.

In the case when it is seen as necessary the foreseen of Ministry of Agriculture, food and Consumer
Protection, in this definition, would have been:

“Competent Authority”- Institution of risk management, concretely, Minister of Agriculture, Food and
Consumer Protection and National Food Authority.

In the second case needs to be improved specially, article 6:

Article 6

1. Risk management shall ensure that the preventive and control measures taken with the objective of
preventing, eliminating and reducing risks to human health connected with food consumption, be based
on the results of risk assessment.

2. Risk management shall be performed by the Competent Authority.

Suggestion: To be add as point 3: functioning and proper tasks of the Ministry of Agriculture Food and
Consumer Protection shall be determined by decision of the Ministers Council.

In this context should be align after all the articles where is repeated or is reflected this definition.

2. The second problem has to do with the Functional Independence of the National Food Authority.

One important issue that needs to be discussed is also the independence of the National Food Authority.
According to the national doctrine, functional independence (not administrative one) of one institution
is performed by:

a) Independent budget
b) Independent nominations
c) Independent decision making.
In the articles, 16,17,19,20,23,25,26,43,44,45,50,54,61 and 62 is avoided independence in
decision making of NFA. This independence, in Ordinance Nr. 178/2002, makes the main issue
for the performance of the functions of the National Food Authority. Her avoidance will change
the Authority in one Agency mostly with scientific functions without any executive function.
 For the solution of this problem we would suggest, creation and determination of independent
decision making of NFA, with administrative dependence from Minister of Agriculture, Food and
Consumer Protection, as political responsible from consumer.

Issuing a normative act, Minister of Agriculture, Food and Consumer Protection has full
competencies proposed by NFA.

Minister of Agriculture, Food and Consumer Protection has full competencies according with the
adaption of communitarian policies and legislation for the food safety.

In all articles above we suggest to be adding the determination....

3. Other suggestions.

Article 3, point 17 is: “Stage of production, processing and distribution” shall mean any stage, including
import and raw materials in food production, including storage, transport, selling or supply of final
consumer, where relevant importation, production, storage, transport, distribution, selling and supply
with feed.

Suggestion from ENFA Project: after the word “distribution”, to be adding word “donation”, selling and
supply with feed.

Article 13 is: The restrictive measures for placing the food and feed on the market and the request for
withdrawing of them from the market, if there are scientific arguments that food or feed is unsafe, shall
be adopted by the Minister of Agriculture, Food and Consumer Protection

Suggestion from ENFA Project: shall be determined, in every case proposed by NFA and adopted by
Minister of Agriculture, Food and Consumer Protection.

Article 16 the Title is: Supervision of food safety of imported food

Suggestion from ENFA : To be substitute the word “ supervision” with “ control” of food safety of
imported food.

Article 16 point 3: The border inspection posts shall be determined by ordinance of Minister of
Agriculture, Food and Consumer Protection.

Suggestion from ENFA: The border inspection posts shall be proposed by NFA and determined by
ordinance of Minister of Agriculture, Food and Consumer Protection.

Article 17 point 3: The border inspector of food and feed control for the purpose of verifying the safety
of imported food shall reserve the right to take samples without payment and have them examined in
authorized laboratories according to the compiled plan by Ministry of Agriculture, Food and Consumer
Protection. The rules for sampling will be determined with the directive of Minister of Agriculture, Food
and Consumer Protection.
Suggestion from ENFA:.....performing of the analyses, based on the plan designed by NFA and
proposed by Minister of Agriculture Food and Consumer Protection.

Article 17 point 4: The expenses of sampling and laboratory analysis fee shall be covered by the
importer. The tariffs for sampling and laboratory analysis shall be determined with the ordinance of
Minister of Agriculture, Food and Consumer Protection

Suggestion from ENFA: The tariffs shall be determined by propose of NFA and by a common ordinance
of Minister of Agriculture, Food and Consumer Protection.

Article 18, the title is: Import certificates

ENFA suggestion: certificate of imported food. (To be adding word food)

Article 19 point 4; The Regional Directorate of Agriculture and Food, after the analysis of documentation
for registration must send an official paper to the Ministry of Agriculture, Food and Consumer
Protection, when is asked to register the establishment in the Register Book of the Ministry of
Agriculture, Food and Consumer Protection. The application documents needed for registration of
establishments are determined by ordinance of the Minister of Agriculture, Food and Consumer
Protection.

ENFA suggestion: Regional directorates of agriculture and food in districts to be substitute by regional
directorates of NFA. Also to be substitute the word “scrutinizing of documentation” with word
“verification of documentation” for registering.

Article 19, point 6. The activities of establishments subject to the procedure of approval cannot begin
without authorization. The Ministry of Agriculture, Food and Consumer Protection shall approve only
those establishments submitted to an evaluation control for the purpose of meeting the conditions.

ENFA suggestion: to be substitute word “Agriculture “Ministry” by word Agriculture Minister, Food and
Consumer Protection.

Article 19, point 7; Ministry of Agriculture, Food and Consumer Protection in the end of registration
procedure in its register issue officially a registration number to every establishment according to
paragraph 1 and 2 of this article.

ENFA suggestion: Ministry of Agriculture, Food and Consumer Protection, deliver to NFA list of food
business operators registered in her register book.

Article 19, point 10: The Ministry of Agriculture, Food and Consumer Protection erase the food business
operator registered in the Register Book with request of food business operator and in the cases when
food business operator has stopped meeting the conditions according requirements of this law. The
unregistered of establishment should be known for food business operators and regional directorate of
Agriculture and Food.
ENFA suggestion: By NFA proposes, Ministry of Agriculture, Food and Consumer Protection, might erase
establishments with…….

Article 19, point 12: Food business operator shall begin their production and marketing activity after
obtaining the technical – technological, hygiene-sanitary and veterinary permission by the NFA. The
procedures for obtaining the technical – technological, hygiene-sanitary and veterinary permission shall
be determined by ordinance of the Minister of Agriculture, Food and Consumer Protection and Minister
of Health.

ENFA suggestion: Explaining first the independence of NFA and executive dependence by Minister of
Agriculture, Food and Consumer Protection. “Turns down” responsibility of Minister of Health.

Article 20 starts: The Ministry of Agriculture, Food and Consumer Protection may temporarily and
permanently prohibit the establishment’s activity foreseen in article 19 of this law in the following cases:

a) When during the inspectorial supervision it is established that the establishment had not been fulfil
the requirements of this law;

b) When such a procedure is crucial and effective in order to ensure the safety of food.

ENFA suggestion: Word “ Ministry” to be substitute by word “ Minister” of Agriculture Food and
Consumer Protection proposed by NFA, might prohibit temporary or decisively……

Article 21: The expenses for the procedure of establishment’s approval

ENFA suggestion: Word “Expenses” to be substitute by word “tariffs” for procedure approve and after
to be adding the word “registration” of establishment.

Article 23, point 1,2,3,4,5: Point 1 The food business operators on the level of primary production must
ensure systematic implementation of general and specific conditions of food hygiene. These conditions
are determined by a directive of the Minister of Agriculture, Food and Consumer Protection.

Point 2 The food business operators in the production, processing and transport of food must ensure
systematic implementation of general and specific conditions of food hygiene which are
determined by ordinance of the Minister of Agriculture, Food and Consumer Protection

Point 3 The food business operators on the level of distribution terminals must ensure systematic
implementation of specific conditions of food hygiene, which are determined by a joint directive of the
Minister of Agriculture, Food and Consumer Protection and Minister of Health.

ENFA suggestion: it is not necessary that all determined conditions in this article to be allocated by a
joint directive of Minister of Agriculture, Food and Consumer Protection, but shall be proposed
by NFA and arranged by common decisions or ordinances, because they have to do only with
technical procedures.
Article 23, point 4: The food business operators that prepare, process, treat and refrigerate store food
in retail space must ensure systematic implementation of specific hygiene conditions determined by
joint directive of the Minister of Agriculture, Food and Consumer Protection and Minister of Health.

ENFA suggestion: Based on EU Ordinance 178/2002, the responsibility should be linked with one
institution.

Other suggestion: Also shall be taken off the point 5 of this article because it is included in other articles.

Article 25, point 5: The food placed on the market or most likely to be placed on the market must be
labelled or identified in some other way through provided documentation or other information in order
to ensure the traceability. The requirements for traceability are determined with Decision of Council of
Ministers with proposal of the Minister of Agriculture, Food and Consumer Protection.

ENFA suggestion: Traceability requests shall be determined by NFA, which propose to the Minister of
Agriculture, Food and Consumer Protection to issue the right regulations.

Article 26, point 1 (c) : to establish the critical limits at critical control points

ENFA suggestion: Word “Establish” to be substitute by “implements” the effective procedures.

Article 26, point 3: initial harmonization verification of the HACCP plan for objects from paragraph 1 of
this article shall be carried out by the Ministry of Agriculture, Food and Consumer Protection

ENFA suggestion: Initial verification for the suitability of HACCP plans, for objects determined at point 1
of this article to be accomplished by NFA and also the same for point 5, 6, and 7 of this article.
Because the controls issue should be implement by NFA.

Article 28, point 2: The conditions and the procedures for issuing the approval set out in paragraph 1 of
this article shall be provided by ordinance of the Minister of Agriculture, Food and consumer Protection.

ENFA suggestion: conditions and procedures for the licenses should be allocated proposed by NFA.

Article 30, point 1: If there is any scientific discrepancies regarding the harmful effect of novel foods on
the people’s health, especially food and food ingredients containing genetically modified organisms or
consisting of them, the Minister of Health in agreement with the Minister of Agriculture, Food and
Consumer Protection can temporarily prohibit the placement of such food on the market for the
purpose of preventing or decreasing the possibility of negative influences on the health of the people.

ENFA suggestion: to be substitute Minister of Health and Minister of Agriculture, Food and Consumer
Protection, with “by propose of NFA” and the same for the point 2 of this article. Whereas for
the point 3 to be Council of Ministers with propose of Minister of Agriculture, Food and
Consumer Protection, without Ministry of Health. (According EU regulation where is allocated
one institution)

Chapter VIII: THE INDICATION OF THE TRADITIONAL REPUTATION OF FOOD

Chapter IX: THE INDICATION OF THE TRADITIONAL REPUTATION OF FOOD

ENFA suggestion: since these two chapters has nothing to do with NFA activity, is suggested that these
two chapters to be managed by Ministry of Agriculture, Food and Consumer Protection.

Article 37, point 2,3 : Point 2 The advertising of the food or feed shall be done only when the Ministry of
Agriculture, Food and Consumer Protection has approved their production and marketing.

Point 3: The manner of packaging, advertising and presentation of the food shall be determined by the
ordinance of the Minister of Agriculture, Food and Consumer Protection.

ENFA suggestion: Minister of Agriculture, Food and Consumer Protection with a propose by NFA, might
prohibit publishing and trade of food products when is approved that the publishing and trade
of food productions is creating confusion to the consumers, based on criteria determined by
legislation on power.

Article 42, point 3: The sampling procedure shall be determined with the ordinance of the Minister of
Agriculture, Food and Consumer Protection.

ENFA suggestion: The procedures of taking samples are determined by NFA instruction.

Article 43 point 7: The tasks, responsibilities of inspectors of food and feed control, annual inspection
program and reporting shall be determined by the directive of the Minister of Agriculture, Food and
Consumer Protection

ENFA suggestion: The tasks and the responsibilities of food control inspectorate and feed, annual plan
of inspection and reporting are determined by NFA instruction.

Article 44 point 3: The tariffs of the performed analyses of food produced in the Republic of Albania
shall be covered by the Ministry of Agriculture, Food and Consumer Protection and NFA. In the cases
when the food does not meet compulsory requirements based on this law and/or the information
specified on the label, the food business operator who either produces and/or places the food on the
market shall cover the tariffs.

ENFA suggestion: Tariffs of the performed analyses of the food produced in the Republic of Albania
shall be covered by NFA budget. In cases when food doesn’t fulfill the compulsory demands
based in this law and also/ or the information specified on label, the food business operator who
either produce and/ or place the food in the market shall cover the tariffs.

Article 44, point 4: The list of testing laboratories which states the type of laboratories and the analyses
they are authorized to perform shall be approved by the ordinance of the Minister of Agriculture, Food
and Consumer Protection and shall be published in the Official Gazette once a year.

ENFA suggestion: The list of testing labs authorized which states the type of lab and analyses that are
authorized to accomplish, is approved by ordinance of Minister of Agriculture Food and
 Consumer Protection after the propose of NFA and shall be published in official bulletin once
year.

Article 45 point 2: The authorized control laboratories to perform the basic activities must meet the
requirements determined by the Decision of Council of Ministers with the proposal of the Minister of
Agriculture, Food and Consumer Protection.

ENFA suggestion: the authorized control laboratories to perform the basic activities, must meet the
requirement determined by NFA approved by Ordinance of Minister of Agriculture, Food and
Consumer Protection.

Article 45 point 5: the Minister of Agriculture, Food and Consumer Protection with ordinance can
determine special conditions that must be met by the control laboratories from letters b) and c) of
paragraph 1 of this article.

ENFA suggestion: The NFA with ordinance can determine special conditions that must be met by the
control laboratories from letters b) and c) of paragraph 1 of this article.

Article 45 point 6: The procedures of assessment and authorization of control laboratories according to
paragraph 1 of this article shall be determined by the ordinance of the Minister of Agriculture, Food and
Consumer Protection.

ENFA suggestion: The procedures of assessment and authorization of control laboratories according to
paragraph 1 of this article shall be determined by the ordinance National Food Authority.

Article 46 point 3 (a): The reference laboratories shall: a) Carry out risk assessment

ENFA suggestion: To be deleted point a). Risk assessment shall be performed by Scientific Council of
NFA.

Article 47 point 1: When is established that the food presents a serious hazard for the health of the
people or the environment and that such a risk cannot be eliminated in a satisfactory way, the Minister
of Agriculture, Food and Consumer Protection and Minister of Health depending on the gravity of the
situation can order one or more measure from paragraphs 2 and 3 of this article.

ENFA suggestion: When is established that the food presents a serious hazard for the health of the
people or the environment and that such a risk cannot be eliminated in a satisfactory way, with
ordinance by National Food Authority depending on the gravity of the situation, Minister of Agriculture
Food and Consumer Protection can order one or more measure from paragraphs 2 and 3 of this article.

Article 48 point 1: NFA in cooperation with Ministry of Agriculture, Food and Consumer Protection and
Ministry of Health shall construct a general plan for dealing with a crisis in the field of food safety.

ENFA suggestion: NFA in cooperation with Ministry of Agriculture, Food and Consumer Protection and
Ministry of Health shall construct a general plan for dealing with a crisis in the field of food safety and
shall inform the Ministry of Health.
Article 48 point 2, last paragraph: This plan shall determines the types of risk originating from food
which can directly or indirectly be hazardous for the health of the people and which are not likely to be
eliminated or reduced to an acceptable level through the application of provisions of this law.

ENFA suggestion: This plan determines communication strategy of NFA.

Article 50 point 1: When there are grounds for suspicion that the feed is unsafe, the Ministry of
Agriculture, Food and Consumer Protection shall take measures of restricting the marketing of the feed,
its withdrawal from the market respectively.

ENFA suggestion: When there are grounds for suspicion that the feed is unsafe, by propose of NFA, the
Minister of Agriculture, Food and Consumer Protection shall take measures of restricting the marketing
of the feed, its withdrawal from the market respectively.

Article 54 point 3: The conditions and the procedures for issuing the approval set out in paragraph 1 of
this article shall be provided by an common ordinance of the Minister of Agriculture, Food and
Consumer Protection and Minister of Environment, Forestry and Water Management.

ENFA suggestion: The conditions and the procedures for issuing the approval set out in paragraph 1 of
this article shall be provided by an common ordinance of the Minister of Agriculture, Food and
Consumer Protection and Minister of Environment, Forestry and Water Management, by propose of
NFA.

Article 54 point 6: The Council of Ministers with proposal of the Minister of Agriculture, Food and
Consumer Protection and Minister of Health may temporarily or permanently prohibit the import of
feeds containing genetically modified organisms in case of lack of the relevant scientific information and
knowledge about the possible extent of the negative consequences to human life and health.

ENFA suggestion: The Council of Ministers with proposal of the Minister of Agriculture, Food and
Consumer Protection and National Food Authority (NFA) may temporarily or permanently prohibit the
import of feeds containing genetically modified organisms in case of lack of the relevant scientific
information and knowledge about the possible extent of the negative consequences to human life and
health.

Article 56 point 2: The manner of the feed labelling, including them contain or consist GMOs, shall be
determined by the Decision of Council of Ministers with the proposal of the Minister of Agriculture,
Food and Consumer Protection.

ENFA suggestion: The manner of the feed labelling, including them contain or consist GMOs, shall be
determined by the Decision of Council of Ministers with the proposal of the Minister of Agriculture,
Food and Consumer Protection and National Food Authority.

Article 57 point 5: The tasks, responsibilities of inspectors of food and feed control, annual inspection
program and reporting shall be determined by the ordinance of the Minister of Agriculture, Food and
Consumer Protection.
ENFA suggestion: The tasks, responsibilities of inspectors of food and feed control, annual inspection
program and reporting shall be determined by the ordinance of the Minister of Agriculture, Food and
Consumer Protection by propose of National Food Authority.

Article 59 point 1: Laboratory analyses of the samples from article 58 of this law, taken for the purpose
of feed official control, shall be carried out by laboratories authorized by the Minister of Agriculture,
Food and Consumer Protection.

ENFA suggestion: Laboratory analyses of the samples from article 58 of this law, taken for the purpose
of feed official control, shall be carried out by laboratories authorized by the Minister of Agriculture,
Food and Consumer Protection by propose of National Food Authority.

Article 59 point 9: The reference laboratories shall: a) analyse risk assessment

ENFA suggestion: To be deleted point a). Risk assessment shall be performed by Scientific Council of
NFA.

Article 59 point 10: The list of reference laboratories where are specified the analyses they are
authorized to perform as reference laboratories shall be approved by directive of the Minister of
Agriculture, Food and Consumer Protection and shall be published in the Official Bulletin once a year.

ENFA suggestion: The list of reference laboratories where are specified the analyses they are
authorized to perform as reference laboratories by propose of NFA and shall be approved by directive
of the Minister of Agriculture, Food and Consumer Protection and shall be published in the Official
Bulletin once a year.

Article 61 point 2: NFA is legal public person with the head office in Tirana.

ENFA suggestion: NFA is legal public person with the head office in Tirana and Regional Directorates,
which perform competencies given by this law in independent manner.

Article 61 point 6: NFA can, with previous authorization of the Minister of Agriculture, Food and
Consumer Protection, depute to the other legal public persons performing the activities according the
scope of NFA.

ENFA suggestion: NFA, depute to other legal public persons performing the activities according to NFA’s
scope

Article 61 to be adding another point as point 7, with this suggestion:

The structure of organization and functioning of NFA shall be approved by ordinance of Prime minister.

Article 62 point 1 (b): In cooperation of Public Health Institute, Institute of Food Safety and Veterinary
and other legal persons enforce monitoring of food and feed safety.

ENFA suggestion: In cooperation of Public Health Institute, Institute of Food Safety and Veterinary and
other public institutions implement monitoring of food and feed safety.
Article 62 point 2 (a): inform on the risks and offers professional and scientific opinions to the Ministry
of Agriculture, Food and Consumer Protection, Ministry of Health, the food and feed business operators,
the consumers and other legal persons concerning the hazards and safety of food and feed.

ENFA suggestion: inform on the risks and offers professional and scientific opinions to the Ministry of
Agriculture, Food and Consumer Protection, other public or private institutions, the food and feed
business operators, the consumers and other legal persons concerning the hazards and safety of food
and feed.

Article 62 point 3: Within the frame of risk management, NFA shall together with the Ministry of
Agriculture, Food and Consumer Protection and Ministry of Health coordinate the activities of
paragraphs 1 and 2 regarding the official control of food and feed safety and the development of
regulations in the field of food and feed.

ENFA suggestion: Within the frame of risk management, NFA collaborate with the Ministry of
Agriculture, Food and Consumer Protection to coordinate the activities of paragraphs 1 and 2 regarding
the official control of food and feed safety and the development of regulations in the field of food and
feed.

Article 62 point II: Apart from performing the activities from paragraph I of this article, the NFA shall
also:

a) develop standards, guide book for Good Production Practices, guide books for the application of
the HACCP system and guide books for Good Laboratory Practice;

ENFA suggestion: Develop standards, booklet for Good Agriculture Production Practices, Good
Production Practice, Good Hygiene Practice, for the application of the HACCP system and guide books
for Good Laboratory Practice.

Article 63 is: NFA is composed of:

- Management Board
- Director and his staff
- Scientific Committee and Scientific Panels
- Inspectorates and respective laboratories.

ENFA suggestion:

- Board
- General Director
- Scientific Committee
- Consultative Committee
- Inspectorates
- Respective Laboratories.
Article 64 point 1: i) Head of the Association of the Heads of Municipalities, j) five professors of the
food and feed areas, veterinary and plant protection sector representing Universities.

ENFA suggestion: To be deleted point i), and j) shall be: four professors of the food and feed fields,
veterinary and plant protection sector representing Universities.

Article 64 point 2: The functions represented in the board by the institutions and members of point i
and k of this article, are appointed with a decision of the Council of Ministers upon the proposal of the
Minister of Agriculture, Food and Consumer Protection.

ENFA suggestion: The member mentioned of the point I and K shall be proposed by civil society and
shall be approved by Parliament of Albania.

Article 64 point 4: The Chairmen of the Management Board shall be proposed by the members of the
Board and is appointed by the Minister of Agriculture, Food and Consumer Protection for the period of
two years.

ENFA suggestion: The Chairmen of the Management Board shall be proposed by the members of the
Board and is appointed by Management Board for a period of two years.

Article 67: The inspectorate of food and feed control, animal health and plant protection as well as their
respective laboratories form part of NFA. These inspectorates perform their activities in district,
municipality and commune level, in compliance with the respective duties foreseen in this law, law “On
veterinary service” and law “On plant protection service”.

ENFA suggestion: All inspectorates responsible for food and feed control, animal health and plant
protection and respective labs are part of NFA. These inspectorates perform their activities in district,
municipality and commune level, in compliance with the respective duties foreseen in this law, law on
veterinary service and law on plant protection service.

Article71 point 2: Minister of Agriculture, Food and Consumer Protection and Minister of Health with a
common ordinance shall approve the new destination of the food that can be reused.

ENFA suggestion: Minister of Agriculture, Food and Consumer Protection by propose of NFA set the
new destination of the food that can be reused.