Annex 1

MEMO

Subject: Opinion on the Draft law “On Food “submitted to the Parliament for enactment
by the Council of Ministers.

From: Project –Europe aid/122779/C/SER/AL “Establishment of the National Food

Authority”

Date: 30 October, 2007

Why a new law “On food”?

One of the main objectives of the Albanian Government is the protection of the consumers and
the guarantee of Food Safety. This objective is foreseen as such in the Government Program,
National Strategy for Development and Integration, National Plan for the approximation of
legislation and implementation of the Stabilization and Association Agreement as well as other
strategic documents.

This objective is not only the main priority of the government foreseen as such in the strategic
documents of Albania, but it is also one of the most important obligations, deriving from the
contractual agreements that Albania has signed with international partners, where can be
evidenced the Stabilization and Association of Agreement (SAA).

The obligations foreseen by this agreement on Food Safety, as one of the elements consumer’s
protection are:

Article 76 (SAA):
The Parties shall cooperate in order to align the standards of consumer protection in Albania to those of
the Community. Effective consumer protection is necessary in order to ensure that the market economy
functions properly, and this protection will depend on the development of an administrative
infrastructure in order to ensure market surveillance and law enforcement in this field.

To that end, and in view of their common interests, the Parties shall encourage and ensure:
 a policy of active consumer protection, in accordance with Community law;
 the harmonisation of legislation of consumer protection in Albania on that in force in the
Community;
 effective legal protection for consumers in order to improve the quality of consumer
goods and maintain appropriate safety standards;
  monitoring of rules by competent authorities and providing access to justice in case of
disputes.

Article 70(3) SAA:

During the first stage as defined in Article 6, approximation shall focus on fundamental elements
of the Internal Market acquis as well as on other important areas such as competition, ….
consumer protection, data protection,….

Which is the goal of this Law?

The goal of the Food Law aims at insuring the protection of human health and the protection of
consumers inters, insuring the free movement of agriculture products and the promotion of
international standards through the adjustment of all phases of the production, processing and
distribution of food and feed, based mainly in risk analyses performed through scientific
instruments.

The Draft Law should guarantee also direct consultations either public or through
representative organizations which should not reframe only to information but they have to
guarantee the involvement of all groups of inters, for any possible risk identified from the
competent authority.

Which are the principles where the Food Law should be based?

The Food Law is a normative framework act, which adoptee the regulation of European
Parliament and Council nr.178, dated 28th January 2002 that lay down the main principles of
this law. In respect to this principles and requirements the draft food law should insure that:

 Food must not be placed on the market if it is unsafe, i.e. if it is harmful to health and/or
unfit for consumption.
 Feed must not be placed on the market or given to any food-producing animal if it is
unsafe. Feed is deemed to be unsafe if it has an adverse effect on human or animal
health.
 At all stages of the food production chain, business operators must ensure that food and
feed satisfies the requirements of food law and that those requirements are being
adhered to.
 The traceability of food, feed, food-producing animals and all substances incorporated
into foodstuffs must be established at all stages of production, processing and
distribution.
 If an operator considers that a food or feed product which has been imported,
produced, processed, manufactured or distributed is harmful to human or animal
 health, steps must be taken immediately to withdraw the product from the market and
to inform the competent authorities accordingly. In cases where a product may have
reached consumers, the operator must inform them and recall the products already
supplied.

By scrutinizing the principles and requirements of this law it is easy to understand that it aims
at insuring food safety in the market and as result it insure the free movement of food and feed
in area were the same principles are respected(referring to EU market.)

To guarantee effectiveness of this law, European Community and Members States , have
established appropriate institutions, which by the structural form and organigrame are
different, but without any exception, they all supervise and guarantee consumer protection,
insuring their independence and avoiding possible conflict of inters with the producers, other
economic operators in the field of agriculture and food, as well as different state or private
institutions which protect or represent their inters through sartorial policy.

Which are the main problems of the Law “ On Food” , proposed for enactment by the
Council of Ministers?

Main Problems:

The article 3, point 7, of the draft –law, foresee that the definition ‘’Competent Authority
“shall mean the institutions of risk managements, such as the Ministry of Agriculture, Food and
Consumer Protection, Ministry of Health and National Food Authority.

In the regulation 178/2002(EU regulation which is adopted) is foreseen the establishment of

European Food Safety Authority as a competent authority, independent from other community
institutions in the field of food safety. In the point 58 of the “whereas” of this regulation is
foreseen the obligation for the cooperation of this institution with the competent authority of
a third country which has an agreement with European Community and Member States as
regard the Food Safety area.

A part from the difficulties of the functioning and the co ordinations between some National
Competent Authorities is evident the impossibility of theirs representative of their
representation with shared competences, in these community institution as an obligation
deriving from SAA.
Article 61, of the draft Law foresees the establishment of the National Food Authority
depending from the Minister of Ministry of Agriculture, Food and Consumer Protection.

The dependency of NFA exists in some EU Member countries in the form of the dependency
from the Council of Ministers, Ministry of Health or Ministry of Consumer Protection and Public
Health. The dependency foreseen in this draft law would be impossible to function effectively
because:

- As foresee by the legislation in force and different strategic documents the Ministry of
Agriculture, Food and Consumer Protection is responsible for policymaking and their
execution in relation to sustainable development of agriculture production and for
supporting the increase of the competition in internal and international market;

While

- The Competent Food Authority must have all executive competencies related to risk
management and communication on food safety as well as the competencies in regard
to the coordination of the institution responsible for risk evaluation.

As result coming from the establishment of the dependency proposed in the draft Law
(considering the legislation in force) will be created the possibility for violation of one of basic
principle of the community acquis (obligation from SAA), that of avoiding the conflict of interest
between the producers or others economic operators with consumers.

Article 19, of the draft law determine that the procedure for “application, approval and
registration” of the businesses of the primary food production, businesses for the production,
processing and food conservation and businesses for preparation, processing and food
treatment, will be competences of the Ministry of Agriculture, Food and Consumer Protection.

The regulation Nr. 178/2002 foresees that these competences are crucial for the proper
functioning of a National Food Authority. Pulling out these competences from NFA would
transform it into an Agency, which main function would be scientific and not in any case
executive. This provision is incompliant with the provisions and principles of the Regulation
178/2002.

Article 6, point 2 of the draft law, stipulate that risk management will be performed by the
Competent Authority, which in the definition included in this draft law, include three
institution, meanwhile the Regulation 178/2002 stipulate the existence of only one institution
responsible for the food safety, leading so to incompliance of the draft law with the regulation.
Article 10, of the law do not transpose the article 15 of the Regulation 178/2002 “requirements
of feed safety” leading to a legal vacuum as regards feed safety (these requirements are
included in the Regulation 178/202, because the management of the risk coming from feed is
obligation of the Competent Food Authority).

Article 12 of this draft law, “the evaluation of the food safety” is an additional provision, not
foreseen by the Regulation No. 178/2002 and it deforms the principles enforced by this
Regulation.

Article 13 of this law “restrictive measure” is an additional provision, not foreseen by the
Regulation No. 178/2002. This article foresees the evaluation of food safety, in a form not
foreseen in the Regulation No. 178/2002, which stipulates clear competences of Food Authority
in the risk management.

Article 18 of this draft law is an additional provision, not foreseen by the Regulation No.
178/2002 or other Community normative acts (where is foreseen the sanitary certificate), The
provisions of this article can constitute possible discrimination between national and EU
economic operator, which is considered as an administrative barrier to the free movement of
products, in contradiction to what is foreseen in article 26 of the SAA (article 13 of the Interim
Agreement), (administrative barrier can be considered the provisions of articles 16 and 17 of
the draft law)

In the draft law is also foreseen “the definition of Origin or Geographic Indication” and “ the
laboratory procedures” which goes beyond the possibility to cover these issues by a single act
and can be ruled by others normative acts.

Secondary problems:

In article 3 of the draft law, point 31, the definition on “novel food” provided by this draft law is
not compliant with the definition of the Regulation 258/1997/EC, because the categories
defining novel foods are missing. For this reason, there cannot be compliance between the two
acts.

In article 3 of the draft law, point 32, the definition for “genetically modified organisms” given
by this draft law, does not comply with the definition provided by the Directive 2001/18 EC. For
this reason, there cannot be compliance between the two acts.

In article 3 of the draft law, point 37, the definition on “package” provided by this draft law is
not used as such in the other articles of the draft law, but it is used as “packaging”. The
Definition “Package” is not foreseen as such in the Directive 2000/13 EC, which article 3 has
been transposed in article 36 of the draft law. The article 36 of the draft law is the only article
where it is used the definition “Packaging” and not the definition “Package”.

In article 3 of the draft law, point 38, the definition on “pre -packaging” given by this draft law,
does not comply with the definition provided by the Directive 2003/13 EC. For this reason,
there cannot be compliance between the two acts.

Article 26 of the draft law, “requirements for the system o self-control”, must be harmonized
with the Regulation 852/2004, of European Union.

Article 27, point 2, of the draft law “the novel food categories”, is not foreseen by the
Regulation 258/1997. This definition used in this article can create trade barriers with
equivalent effect to quantity restriction.

Article 30, point 3, of the draft law for the impediment of imports for food and feed products,
comports possible discrimination between national and EU economic operators and as such can
constitute a violation to the provisions of SAA.

Article 40, 41, 42, and 43, of the draft law, settle the official controls and for this reason should
be considered the harmonization with Regulation no. 882/2004.

Article 45 of the draft law, “activities of the authorized laboratories for the control” should be
revised in order to foresee that all authorized laboratories for the control must be accredited.
This comply the accreditation procedure from an accreditation body. This article must comply
with accredited laboratories according to the national standard of the certification and
accreditation foreseen also in SAA provisions.

Evaluation of the draft law “On Food “

The model propose for the National Food Authority proposed in this draft law, is a merge of
one Agency with the MAFCP, including evaluation of the risk (article 4), risk management
(article 39, 62) and risk communication (article 5). The draft law proposed does not provide to
the National Food Authority the competences to implement his functions such as risk
management, risk communication and the coordination of the independent institutions in risk
assessment, which compose the fundamental functions deriving for this Authority by the
Regulation 178/2002. To ensure the proper adoption of this regulation it would be necessary to
guarantee the independency in the functioning of the Authority.