REPUBLIC OF ALBANIA

MINISTRY OF AGRICULTURE, FOOD AND CONSUMERS’ PROTECTION

AND

NATIONAL FOOD AUTHORITY

CONSOLIDATION OF THE FOOD SAFETY SYSTEM IN ALBANIA

Assessment of the Law on Food No.9863/2008

November 2014

IPA 2009 – Ref. EuropeAid/129820/C/SER/AL

Consolidation of the Food Safety System in Albania
An EU-funded Project managed by the Delegation of the European Union
in Albania

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TABLE OF CONTENT

I. INTRODUCTION 3
THE MAIN OBJECTIVE OF THE ASSESSMENT 3
THE METHODOLOGY OF THE ASSESSMENT 3

II. SUMMARY FINDINGS 4

III. THE MAIN DEFICIENCIES ASSESSED 5

A) DEFINITIONS IN FOOD LAW 5
B) LEGAL BASIS FOR SPECIFIC LEGISLATION 5
C) THE FUNCTION OF COMPETENT AUTHORITIES 5
D) RISK ANALYSIS PROCESS 5
E) THE SYSTEM OF REGISTRATION AND APPROVAL OF ESTABLISHMENTS 6
F) TRACEABILITY 7
G) EXPORTS AND IMPORTS 7
H) OFFICIAL CONTROL/INSPECTION 8
I) GENERAL LEGAL TECHNIQUE 9

IV. RECOMMENDATIONS 10

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I.Introduction

This assessment provides a general and comprehensive view on the standing legal situation in the
area of food safety in Albania with specific emphasis in the compliance of the Law no. 9863/2008
“On Food” with the relevant dispositions of the respective acquis. The legal expert assessed the
provisions of the Food law in terms of:

- Compliance with the EU acquis in the sector of food safety (as listed below)
- Legal, Procedural and Administrative arrangements needed for the implementation of the
Law on food as amended.

The scope of the assessment is to identify the main legal gaps hindering the proper implementation
of food safety system in Albania. For this purpose, the analysis of the Food Law in force is carried
out not only with regard to legal obligations arising for Food Business Operators, but it includes
some general shortcomings in procedural and administrative aspects with relevance to public
institutions organization. The assessment is focused in the area of food safety, but due to several
EU guiding principles, such as Traceability, it also extends to a certain aspects of Animal Health and
Plant Health protection.

List of EU acquis consulted for the assessment purposes:

- REGULATION (EC) No 178/2002 General Food Law; OJ 32002R0178

- REGULATION (EC) No 852/2004 on the hygiene of foodstuffs; OJ 32004R0852
- REGULATION (EC) No 853/2004 laying down specific hygiene rules for food of animal origin,
OJ 32004R0853
- REGULATION (EC) No 882/2004 on official controls performed to ensure the verification of
compliance with feed and food law, animal health and animal welfare rules; OJ
32004R0882
- REGULATION (EC) No 854/2004 laying down specific rules for the organization of official
controls on products of animal origin intended for human consumption; OJ 32004R0853

The main objective of the assessment

- To compare the level of harmonization and approximation of the Law No. 9863/2008 “On
Food” as amended, to the particular EU acquis related to Food and Feed Hygiene (see
above)
- To identify the potential legal gaps in drafting amendment of the Law No. 9863/2008 “On
Food” as amended;
- To provide some of the main steps to be taken in order to address the identified gaps;

The methodology of the assessment

- The assessment was conducted based on previous legal gap analysis performed by the
project as well as by identifying topics of the acquis on food safety missing or not properly
addressed in this Law and by-laws in force, in this area.

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II.Summary Findings

Main findings could be summarized as follows:

- Provision of Regulation 882/2004 transposed through the draft amendments are inadequate
especially as it concerns import and export conditions;
- Provisions of Regulation 882/2004 related to official controls are also inadequate;
- Provisions for materials and articles in contact with food is missing;
- Provisions related to the approval and registrations of establishments have to be regulated
according to the EU regulations requirements;
- No adequate legal basis for adoption of secondary legislation;
- Fines and penalties have to be thoroughly incorporated in the Food Law since the Albanian
legal system does not allow of introducing them through secondary legislation.

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III. The main deficiencies assessed

a) Definitions in Food Law

Several definitions provided by the REGULATION (EC) No 178/2002, refer to other EU Directives and
Regulations, which transposition into the Albanian corpus of law remain unknown, therefore the
transposition of such definitions can not be considered as compliant to those provided by the
acquis. The importance of clear and precise definitions is undisputable for every piece of legislation.
Without clear definitions chances for creation of legal loopholes, inconsistency and legal
uncertainty is very high. Scope of the legal act will be also unclear and ambiguous.

b) Legal basis for specific legislation

There are missing provisions, legal basis, for specific legislation to be developed e.g. pesticide
residues (MRLs), flavourings, PARNUTS, additives, materials and articles intended to come in
contact with food, measures necessary to ensure the uniform implementation of official controls on
the introduction of feed and food shall be laid down e.g. imports:

- free zones or free warehouses;

- feed and food ordered remotely (for example, by mail, by telephone or via the internet) and
delivered to the consumer;
- feed intended for pets or horses and food carried by passengers and crew of international
means of transport;

c) The function of competent authorities

The main functions regarding food safety are provided to the National Food Authority (hereafter
referred as NFA), but there are still some uncertainties as regards the official control of food safety
as far as it concerns the animal health, which somehow is divided between, NFA, the Veterinary
Sector in the Ministry and Local Government Authorities. The function of competent authorities has
to be defined very clearly. Bodies included in the system of official controls in food and feed should
be strictly stipulated in law to avoid possible conflict of competence.

d) Risk analysis process

Risk assessment, under art 4/1, is carried out by the Scientific Commission on risk assessments and
scientific panels whilst risk management is performed by the Ministry and NFA. Official food control
is performed by inspections responsible for food and feed of the NFA, except when otherwise is
expressly provided in this law. The Scientific commission for Risk Assessment and Scientific Panels
are established by NFA, the members and the chairman are appointed by the Minister.
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EU has adopted the approach of a clear separation of risk management from risk assessment.
Alternatively, if the both functions are under the same roof, a mechanisms within the relevant
institutions (Competent Authorities - CA) it has to be established ensuring the transparency and the
independency of the risk assessor from risk manager (avoidance of conflict of interest).

Food law provisions do not separate the risk assessment from risk management as required by EC
Regulation 178/2002 (EU) art. 6.2. This encompasses establishment of a risk assessment institution
independent from the managerial functions and possible influences. If risk management
considerations (for example, the economic effects of a particular control action for a particular
chemical) are seen to affect the choice of inference options, the credibility of the assessment inside
and outside the NFA can be compromised, and the risk management decision itself may lose
legitimacy.

e) The system of registration and approval of establishments

The system of registration and approval of establishments has to be clearly defined. It is somehow
confusing procedure (Food law, art. 19) related to determining of which establishments have to be
approved and which have to register only. It is unclear whether or not also establishments
conducting activities like, retail, establishments engaged in primary production of food and related
activities, sale of small quantities of primary products at the place of production, that are otherwise
obliged only to register according to EC rules, have to obtained an approval according to the EC
requirements/procedure.

The provision referring to the law on licensing is rather confused, poorly worded and not sufficient
given the purpose. It should be noted that the law on licenses provides for three “big” categories of
licenses depending on the licensing procedures: Group I, Group II and Group III. Without entering in
to much details on the distinctive criteria for each of the groups, it should be noted that “Group I”
licenses are based on self declaration of the applicants (that fulfills the licensing criteria and
promises that will observe the mandatory legal conditions for the respective activity). In poorer
terms the “Group I” licenses are rather a form of “registration” if referred to the Acquis
terminology. Group II licenses are a form of approval, based on the self-declaration of the
applicants and on the demonstration by the applicant that complies with the licenses criteria by
submitting proving documents. In both cases Group I+II the only institution involved in the formal
decision-making (granting/refusing the license) is the National Licensing Center. Whilst Group III
licenses, provides for the involvement of the relevant competent authority/authorities (NFA in our
case). The competent authority verifies the fulfillment of the licensing conditions though a
documentary check, an in-site inspection, or else. The law on licenses, provides that the assignment
of a certain specific license to one of the groups (whether group II, II or III) and by consequence to
the related licensing procedure, is determined/decided by a decree of government (example:
license “X” belong to the group III)

It should be, also noted, that in accordance with the Acquis, certain type of establishments (animal
origin products) have to “approved” following an in site inspection. The wording of the proposed

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art. 19, is not sufficient to make this point which is specific for the food law and should be explicitly
provided therein.

The main guiding principle, when referring to the law on licenses, is to refer to that law where a full
compliance is found in the provision of such a law (law on licenses) and provide for explicit
exceptions (special provisions), when necessary and justified by the specificity of the regulated area
(food safety in this cases). In poorer terms the reference to the law on licenses should be much
more complete and should provide for exceptional provisions if deemed necessary in our specific
case.

The same argument is valid for the art. 21 “Fees for licensing and registration”. The law on licenses
provide that the only fee applicable with the license application is the NLC fee (a fee of less than 1
EUR), unless other wise provided by special law. The food law should provide for the payment of a
fee in case of the like “approval procedure”, in order to cover the “cost” of in-site inspection, when
applicable. Further- more the same law provides that other applicable fees/taxes are payable after
the approval of the license but prior to the issuance of its “title” (the administrative act of
approval). Given these provisions there is a risk, in our case (approval like procedure licenses), that
the applicant is going to pay the fee only if the license was granted and not when the approval is
refused. Instead we want to cover the costs of the in site inspection any way (even in case of
refusal), for this very reason specific provision that make the preliminary payment of the fee
covering the inspection cost, a condition for consideration should explicitly worded.

f) Traceability

A fully implemented identification and registration of all food-producing animals in Albania is not
yet in place. FVO report of September 2010 said: “Traceability (to the farm of origin) of samples
taken at slaughter cannot be assured because not all animals are identified and for those already
identified…”. In addition to this gap, a proper system that ensures the Traceability from one FBO to
the other does not exist as far as it is not regulated by normative acts and respective administrative
procedures.

It is necessary also to establish procedures and guidelines for traceability. This goes not only to food
produced and marketed, but also on use of PPP (farmers) purchased and used at the farms.

g) Exports and imports

Articles on rules on exports and imports have to be introduced in the Food law. The provisions,
among others, of the Regulation 882/2004 on official control related to import into the Community
have to be incorporated properly into the national legislation, and the legal basis for this specific
legislation to be developed, is missing in the Food Law.

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 h) Official Control/Inspection

The official control is an “inspection” under the meaning of the horizontal law on inspection. The
law on inspections provides a full set of provisions applicable at any kind of inspection. It provides
the principles of inspection; the principles and general rules of organization and functioning of
inspection state authorities; the status of the inspectors, including the obligation for their periodical
training and certification; the rules and principles of planning the inspections; the rights of
inspectors and auxiliary staff, including the right to enter wherever the activity is carried out, to
take photos and make registration, to take samples and submit them to tests, etc; as well as the
obligations of the inspected subject; detailed inspection procedures, covering from “the
authorization” of a concrete inspection; the notification of the inspection, as well as the procedures
on the application of administrative sanctions or administrative measure and legal remedies
(appeal procedures) etc.

Based on the philosophy of the law on inspection and of the concept paper on the inspection
reform in Albania, the inspection procedure from A to Z should be unified as much as possible
except when not possible and justified. In other terms every special law dealing (regulating) with
specific inspection function (such as the law on food), should be amended accordingly to be made
consistent and compliant with the horizontal law. The amendments should ensure that every
provision which is not specific to a certain inspection function and which is covered (regulated) by
the horizontal law on inspection is abolished. The special law should limit to contain provisions
which are: a- very specific to the given inspection function; b- which are not covered by the
horizontal law on inspection (because of being very specific) and c- which derogates from the rules
laid done by the horizontal law on inspection. Further more during the drafting process any
exception or different provisions should be weight to figure out whether such exception: a) is
justified and b) even though if justified does not contravene the “general principles” of the
Horizontal law on inspections.

The provisions of Regulation 882/2004 should be observed, especially:

- That MS shall organise the official controls on the basis of the multi-annual national control
plan drawn up in accordance with Articles 41 to 43 and in the light of potential risks. The
controls shall cover all aspects of feed and food law.

- Satisfactory results of checks on goods shall neither affect the duty of feed and food
business operators to ensure that feed and food comply with feed and food law from the
moment of release for free circulation nor prevent further official controls on the feed or
food concerned from being carried out (art. 14. 3 – food of animal origin)

- Satisfactory results of checks referred to in paragraph 3 shall neither affect the duty of feed
and food business operators to ensure that feed and food comply with feed and food law
from the moment of release for free circulation nor prevent further official controls on the
feed or food concerned from being carried out.(15.4 – 882 – food of non-animal origin)

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 - A list of feed and food of non-animal origin that is, on the basis of known or emerging risk,
to be subject to an increased level of official controls at the point of entry into territories
referred to in Annex I shall be drawn up and updated (15.5)

- Article 16 Types of checks on feed and food of non-animal origin

The official controls referred to in Article 15(1) shall include at least a systematic
documentary check, a random identity check and, as appropriate, a physical check

- Physical checks shall be carried out at a frequency depending on diff criteria 16.2

- Article 19 Action following official controls on feed and food 882

- The feed or food business operator responsible for the consignment or its representative
shall be liable for the costs incurred by competent authorities for the activities referred to in
Articles 18, 19, 20 and 21.

i) General legal technique

From the legal technique point of view the draft amendment is poorly written, and generally does
not comply with the rules laid dawn in the “Legal Drafting Manual“ and best practice in legal
drafting Albanian. Some of the most common deficiencies consist in:

a) the use of the “terms” is sometimes inconsistent and confusing. Different wording is used
for describing the same terms/concepts and certain terms are uses thoroughly in the text,
but are not defined although are not terms of common use. These inconsistencies make the
text difficult to read and rather confusing.

b) some of the paragraphs are also too long and difficult to read.

c) the text if full with paragraphs which are rather statements of intention and do not
constitute legal norms (do not have normative -general, abstract and binding character); this
is the case of for instance art. 11. Other paragraphs despite might constitute legal norms are
badly shaped as to sound as policy intention too.

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IV.Recommendations

The food law has transposed the main corpus of the food safety acquis, but this assessment showed
that there exist some mayor concerns related to:

 the functioning of the NFA and its role as the Competent Authority in the Food Safety
System in Albania. The approach of a clear separation of risk management from risk
assessment remain not clear. Alternatively, if the both functions are under the same roof,
mechanisms within the relevant institutions (Competent Authorities - CA) it has to be
established ensuring the transparency and the independency of the risk assessor from risk
manager (avoidance of conflict of interest).

 the importance of a clear understanding of principles, techniques and functioning of official

controls as regulated in EU Regulation 882/2004 have to be integrated into Albanian legal
system in a manner that will allow for an institutional set up compliant to that of the EU.

Therefore it is recommendable that:

Regulation 882/2004 on official controls should be adopted as a separate law or (if this solution is
not workable at the moment) to be adopted in twofold way: legal basis in the Food law (major
substantial provisions), while others by secondary legislation/regulations: CoM and/or the
Ministry depending of legal nature of a provision/norm.

Provisions related to the approval and registrations of establishments have to be regulated

according to the EU regulations requirements.

The obligations introducing system of adequate and regular trainings of staff needs to be
established in the Food law or legal acts to be adopted based on the Food law provisions.

The transitional periods of a new Food Law or adopted amendment of Food Law should be granted
taking into account the level of preparedness of food businesses and capacity of competent
authorities.

In the framework and for the purpose of pursuing the Project’s ToR – in particular as regards (i)
import conditions and import controls, and (ii) operational criteria of the competent authority and
qualifications of staff performing official controls – and respecting MoAFCP’s policy and expressed
wish for a limited and targeted revision of the Law on Food No.9863/2008, the following additional
amendments are proposed:

1. In Article 1, point 53, replace the descriptive and indirect definition of the competent authority
for the BIPs inferred by reference to general legislation and, instead, nominate this authority
clearly and unambiguously.

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2. In article 7 (amending article 16 of Food Law No.9863/2008), insert new paragraphs 8 and 9, with
the following text, respectively:

‘ 8. The conditions governing import of consignments of food and feed into, or transit through, the
territory of Albania will be laid down in a Decision of the Council of Ministers upon a proposal
by the Ministry of Agriculture, Food and Consumer Protection.

9. The organization and content of official controls applied on consignments of food and feed
imported into, or transiting through, the territory of Albania, as well as the appropriate
follow-up measures, will be laid down in an Order of the Minister of Agriculture, Food and
Consumer Protection. ‘

3. In article 36 (amending article 62 of Food Law No.9863/2008), insert new paragraph 7 with the
following text:

‘ 7. The operational criteria of the National Food Authority, as well as the qualifications of staff
involved in official food and feed controls, will be laid down in an Order of the Minister of
Agriculture, Food and Consumer Protection.

Furthermore, it is recommended that the main provisions of Regulation No.882/2004 governing the
organization, content and follow-up measures of official controls on food and feed, which are
currently missing, may be adopted by an Order of the Minister of Agriculture, Food and Consumer
Protection. ‘

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