The Article analyses on an operative ground the recently adopted reforms in the field of Official Controls on Foodstuffs in order to highlight some shortage of coherence within EU Food Law. Being aimed at pursuing a number of different objectives, a high level of protection of human life and health, the protection of consumers’ interests, including fair practices in food trade, modern EU Food Law is a very impressive set of rules covering a large number of aspects of the food business and the activities of public authorities; at the same time such a big picture may risk being shattered by a decoupling based overview where the whole scope of Food Law is not properly understood by the Competent Authorities and the Food Business Operator gets addicted to an esoteric legal system.

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What do Food Safety and Fair Trade Stand for?
Reconciling the Twofold Objective of EU Food
Law
Daniele Pisanello*
The Article analyses on an operative ground the recently adopted reforms in the field of
Official Controls on Foodstuffs in order to highlight some shortage of coherence within
EU Food Law. Being aimed at pursuing a number of different objectives, a high level of
protection of human life and health, the protection of consumers’ interests, including fair
practices in food trade, modern EU Food Law is a very impressive set of rules covering
a large number of aspects of the food business and the activities of public authorities;
at the same time such a big picture may risk being shattered by a decoupling based
overview where the whole scope of Food Law is not properly understood by the
Competent Authorities and the Food Business Operator gets addicted to an esoteric legal
system.
I. EU Food Law: main features Food and Feed (RASFF) and the intensive training
and contents programme, managed by the Commission Services,
are other two successful tools of the EU Food Law.
Due to its close connection with foodstuffs, Euro- Reg. EC No 178/021 (hereinafter, also General Food
pean Food Law falls within the general category of Law, GFL) gave rise to a number of innovations: i)
EC product-laws (pharmaceutical, cosmetics, toys, general principles of Food Law (Risk Analysis, Pre-
machineries et cetera). However, Food Law has cautionary Principle, Protection of consumers’ inter-
some peculiarity the others have not: unlike other ests and principles of transparency); ii) general
product laws, Food Law is based upon general prin- framework on risk assessment and risk manage-
ciples specifically governing the food market; sec- ment and the establishment of an Independent
ondly, the complex regulatory organization and the Authority dealing with risk assessment (The Euro-
establishment of an Independent Authority under- pean Food Safety Authority, EFSA); iii) new and
pin the distinction of Food Law from the other general obligations for food business operators
product regulations (pharmaceutical market and (safety requirements, traceability and crisis man-
the EMEA-European Medicines Agency excluded). agement tools, product presentation); iv) general
Since its very beginning, European legal acts outline on food control within the Single Market,
in the domain of food trade called for more inte- including importing and exporting food. Such a
gration and mutual cooperation and assistance general set of rules have to be integrated with a
between public authorities. EEC regulation on food number of sectoral items of legislation laying down
trade was intended as a tool for the free circulation rules for specific products (baby foods, supple-
of foods in the Community. Over the time the pro-
tection of consumers’ rights and the fair practices
* Independent Food Lawyer, website: www.alimentarialex.eu;
emerged as specific objectives of the European contacts: danielepisanello@alimentarialex.eu.
Community. 1 Regulation EC No 178/2002 of the European Parliament and of
As of today, European Food Safety has a well the Council of 28 January 2002 laying down the general princi-
ples and requirements of food law, establishing the European
planned strategy involving Community and Natio- Food Safety Authority and laying down procedures in matters of
nal Levels; additionally the Rapid Alert System for food safety, (OJ L 31, 1.2.2002, p. 1).

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EFFL 5 | 2009 What do Food Safety and Fair Trade Stand for? 321
ments, products of animal origin et cetera) or One of the key concepts in the EU Food Law is that
aspects (Food Hygiene, for example); specific prod- Food Business Operators (hereinafter, FBOs) at all
uct safety and quality requirements; presentation stages of production, processing and distribution
rules (labelling and promotion); other aspects. within the business “are responsible for ensuring the
One of the groundbreaking tools lies on the defi- fulfilment of food law which are relevant to their
nition of Food Law. Nomen est omen! activities”. As Article 17 of GFL requires, FBOs are
Food Law within the EU Single Market means called on to ensure that foods satisfy the require-
“the laws, regulations and administrative provisions ments of food law which are relevant to their activi-
governing food in general, and food safety in particu- ties and shall verify that such requirements are met.
lar, whether at Community or national levels; it cov- What are these requirements about? What being
ers any stage of production, processing and distribu- responsible exactly means?
tion of food, and also of feed produced for, or fed to, In the light of articles 3 (1) and 5 of GFL, there
food-producing animals” (Article 3 of GFL). Two ele- should be no doubt that FBOs are obliged to comply
ments are clearly highlighted by the mentioned pro- both with safety and other rules governing its food-
vision: i) “food in general” and ii) “food safety” in stuff and food producing process. It should be
particular. Such a two-fold objective is confirmed by undisputed that the general conformity duty, as
Article 5 of GFL according to which: “food law shall ruled by Article 17 GFL, relates to safety require-
pursue one or more of the general objectives of a ments (Articles 14, 18 and 19 of GFL)3 and presen-
high level of protection of human life and health and tation requirements (Article 16 of GFL)4 as well.
the protection of consumers’ interests, including fair In order to assess the meaning of FBO’s responsi-
practices in food trade, taking account of, where bility, it should be considered that, according to GFL
appropriate, the protection of animal health and wel- and Reg. No. 882/045, a number of legal conse-
fare, plant health and the environment” (Article 5, quences for the FBO can be addressed when a lack
par. 1, of GFL)2. of compliance with Food Law is detected.
It is important to bear in mind that such a defini- A first set of consequences affects the market
tion applies to all legal acts or measures governing access: the Competent Authority (CA) has the
foodstuffs adopted at both the Community and power to determine whether a food is marketable or
national levels. Consequently, public authorities not. This would be the case of Border Inspection
and private operators should pay attention to both Posts6 for food entering EC customs or the case
elements: safety management and the other legal of inconsistency with microbiological criteria ad-
issues enclosed in the definition of Food Law, dressed by Reg. EC No 2073/057.
namely: protection of consumers interests, fair Other consequences relate to a number of legal
practices and, where appropriate, the protection of issues linked to the detection of breaches to food
animal health and welfare, plant health and the law: i) administrative fines and/or criminal of-
environment. fences, in the form of criminal prosecution, if so
2 Art. 5, par. 2, of GFL recalls the rule of free movement of goods: established for safety purposes are traceability and safety manage-
“Food law shall aim to achieve the free movement in the Commu- ment under Art. 18 and 19 GFL respectively.
nity of food and feed manufactured or marketed according to the
4 Article 16 of GFL reads: “Without prejudice to more specific pro-
general principles and requirements in this Chapter”. The role of
visions of food law, the labelling, advertising and presentation of
International standards setting organizations is enclosed in the last food or feed, including their shape, appearance or packaging, the
part of the disposition, paragraph 3: “Where international stan- packaging materials used, the manner in which they are arranged
dards exist or their completion is imminent, they shall be taken and the setting in which they are displayed, and the information
into consideration in the development or adaptation of food law, which is made available about them through whatever medium,
except where such standards or relevant parts would be an inef- shall not mislead consumers”.
fective or inappropriate means for the fulfilment of the legitimate
objectives of food law or where there is a scientific justification, or 5 Regulation EC No 882/2004 of the European Parliament and of the
where they would result in a different level of protection from the council of 29 April 2004 on official controls performed to ensure
one determined as appropriate in the Community”. It is to note the verification of compliance with feed and food law, animal
that GFL does not name Codex Alimentarius nor other Interna- health and animal welfare rules (OJ L 191, 28.5.2004, p. 1).
tional setting standard organisations which are expressly quoted in 6 See Council Directive EC No 97/78 of 18 December 1997 laying
the WTO legal framework by Sanitary and Phitosanitary Agree- down the principles governing the organisation of veterinary
ment. On the contrary, Codex Alimentarius standards are recalled checks on products entering the Community from third countries
by Reg. EC No 852/04 as regards to HACCP procedures (see Arti- (OJ L 24, 30.1.1998, p. 9).
cles 8, 9 and recitals 15 and 18 of the mentioned Regulation).
7 Commission Regulation EC No 2073/2005 of 15 November 2005
3 Article 14 of GFL is about the general safety requirements by pro- on microbiological criteria for foodstuffs, (OJ L 338, 22.12.2005,
viding for the definition of unsafe products. Other requirements p. 1).

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provided for by national laws; ii) compulsory orders a person is entitled to expect, taking all circum-
in accordance to Reg. EC No 882/04, Article 54; iii) stances into account, including: (a) the presentation
increased charges and expenses as consequent to of the product; (b) the use to which it could reason-
additional control activities or depending on higher ably be expected that the product would be put; (c)
frequency in routine control on the FBO (the less the time when the product was put into circulation”.
the compliance, the more the controls and the From a logical point of view, the safety which is
costs); iv) last but not least, claims filed by clients or expected should be gathered from the legal stan-
consumers regarding lack of conformity of the dards at least. Food regulations introduce standards
traded foods. aimed at assuring a high level of safe consumption
It has to be borne in mind that it is for Member by assessing safety performance of products, bind-
States to determine penalties for the breaches to ing procedures on FBOs et cetera. Are the standards
food law as recently ruled by EC Court of Justice in addressed by Food Law such to give meaning to
the Lidl Italia Case.8 From the point of view of crim- the definition of “defect” as relevant under the
inal law (or administrative fines), the relation Dir. EEC No 85/374? According to Article 21 of Reg.
between Food Law and the final punitive decision EC No 178/02 the answer is negative. The paradox is
depends on the role of the fault within each that a product, deemed safe under the meaning of
National legal order. For example, where criminal GFL, may be held as grounds for a civil suit (prod-
prosecution is based on the fault, an EC oriented uct-liability).
judicial approach should require a careful evalua- Notwithstanding the radical separation of the
tion of the degree of FBO’s consistency with two mentioned pieces of legislation, product liabil-
hygiene rules (HACCP and Good Manufacturing ity law and Food Law may be affected by some
Practices) and food safety management standards cross-contamination hypothesis.
(traceability and crisis management). Such evalua- Firstly, the identification of the producer: as
tion should be the basis for assessing the fault and, everybody knows, for a number of food products
consequently, compliance with European food regu- the indication of the “genuine” producer is manda-
lations should be intended as the main ground tory; this is the case for products of animal origin
upon which acquittal or conviction should be based. which must bear a health mark or an identification
On the contrary, where legal order provides for mark which relate to the producer.
no fault liability system, as it is the case for civil Secondly, EU Food Law may impact the defence
action under the product liability regime, compli- claims as ruled by Article 7 of Dir. EEC No 85/374.9
ance with food law has a minor role. From this
point of view, it is to be remembered that art. 21
8 As ruled by Judgment of the Court (Second Chamber) 23 Novem-
GFL establishes that the provisions of Chapter II ber 2006 (Reference for a preliminary ruling from the Giudice di
(General Food Law, articles 4 to 20) “shall be without pace di Monselice), in Case C-315/05, Lidl Italia Srl v Comune di
Arcole (VR) with notes of A. Alemanno, La Jurisprudence de la
prejudice to Council Directive 85/374/EEC of 25 July Cour de justice et du Tribunal de première instance, Arret Lidl
1985 on the approximation of the laws, regulations Italia, Revue du Droit de l’Union Europeenne, 2006, p. 895, in
addition: D. Pisanello, La disciplina dell’etichettatura à la croisée
and administrative provisions of the Member States des chemins, Diritto comunitario e degli scambi internazionali,
concerning liability for defective products”. In other 2006, p. 677 and B. Klaus and A. Meyer, The Liability of the
Distributors in the Event of Infringements of Food Law – Case
words, food, even if processed consistently with the involving Lidl Italia: the Judgments of the European Court of Justice
best safety practices, may be challenged as defective and the Giudice di Pace of Monselice, Italy, EFFL, 2008, p. 407.
where it is assumed as the cause of damage or 9 The producer shall not be liable as a result of the Directive if he
proves: (a) that he did not put the product into circulation; or (b)
injury to the consumer. that, having regard to the circumstances, it is probable that the
Article 21 GFL is clearly oriented to avoid any defect which caused the damage did not exist at the time when the
product was put into circulation by him or that this defect came
interference of the business compliance with Food into being afterwards; or (c) that the product was neither manufac-
Law on the civil trail held to settle a product liability tured by him for sale or any form of distribution for economic pur-
pose nor manufactured or distributed by him in the course of his
claim under the Directive EEC No 85/374. As a con- business; or (d) that the defect is due to compliance of the product
sequence, product safety standards seem to have with mandatory regulations issued by the public authorities; or (e)
that the state of scientific and technical knowledge at the time
different meaning according to the several pieces of when he put the product into circulation was not such as to enable
legislation considered from time to time. Under the the existence of the defect to be discovered; or (f) in the case of a
manufacturer of a component, that the defect is attributable to the
meaning of Article 6 of Dir. 85/374 a product is design of the product in which the component has been fitted or to
defective “when it does not provide the safety which the instructions given by the manufacturer of the product.

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An interesting point relates to the defence claim in order to assess whether the defect which caused
under Article 7 (a) according to which producer lia- the damage did not exist at the time when the prod-
bility is excluded where the manufacturer proved uct was put into circulation or that this defect came
that he did not put the product into circulation. The into being afterwards.
question is to consider whether the food recall,
launched under the meaning of Article 19 of GFL,
may give rise to considering such a recalled product II. Modern EU Food Law and challenges
“out of the market”. Additionally, where a producer for the System of Official Control
ordered the withdrawal, by alerting all the clients
supplied with the defective/unsafe batch, is he to be Adoption of Reg. EC No 178/02 gave grounds for
held liable under the Dir. EEC No 85/374 for the sole important reforms in the field of system of official
finding that one of his clients failed to withdraw controls on food market. As previously clarified, the
100 % of recalled products? main responsibility for the compliance to the food
Traceability and product control, as applied by law is with the Food Business Operator. In this con-
the food industry, may play a role in the view of text competent authorities, at both national or Com-
Article 7(b) defence claim. The producer shall not munity levels, are charged with the duty of verifica-
be held liable if he proves that “having regard to the tion of such fulfilment and, where a lack of compli-
circumstances, it is probable that the defect which ance is detected, to adopt the necessary and appro-
caused the damage did not exist at the time when the priate measures, in terms of monitoring and recov-
product was put into circulation by him or that this ery measures.
defect came into being afterwards”. This is the case A number of authorities are entitled to carry out
for a number of contamination or tampering cases. control activities on foods. Firstly, Member States
In these cases, traceability and product control may are requested to enforce Food Law and to organize
help the defendant: Article 7 (b) is clearly relating to the official control on their territories accordingly
the probable assumption (not a certainty) that the to principles, rules and requirements including spe-
defect, as claimed by the plaintiff, was not origi- cific procedures as regards to multi-annual control
nated within the producer process. The effective- plans, crisis management, financing, recovery meas-
ness of such a defence will depend greatly on the ures and penalties,10 as addressed by EU laws,
judge’s interpretation of the burden of proof and notably the Reg. EC No 882/04 and Reg. EC No.
notably what degree of probability he will require 854/04, and other specific acts.11
Under the meaning of Reg. EC No 882/04, the
10 Other principles, requirements and rules are relating to official European Community level is also involved as
certification, reference laboratories, administrative assistance and
cooperation. regards controlling Member States (Article 45 of
11 The main EC legal acts providing the legal framework for the offi- Reg. EC No 882/04); Controls in Third Countries
cial controls performed to ensure the verification of compliance (Article 46 of Reg. EC No 882/04); Safeguard Mea-
are: Reg. EC No 882/04 on official controls performed to ensure
the verification of compliance with feed and food law, animal sures (Article 56 of Reg. EC No 882/04); Import
health and animal welfare rules; Reg. EC No 854/04 on specific Conditions (Article 47 of Reg. EC No 882/04); and
rules for the organisation of official controls on products of animal
origin intended for human consumption; Dir. EC No 02/99 on Training of Control Staff (Article 51 of Reg. EC No
animal health rules governing the production, processing, distri- 882/04). Another important target for the Commu-
bution and introduction of products of animal origin for human
consumption. Further legislation in the field of food control nity is to develop a comprehensive, integrated
should consider the specific rules on certain aspects or products approach to the operation of controls in order to
(for example Veterinary law, microbiological criteria (Reg. EC No
2073/05), safety requirements for contact-materials (Reg. EC No have a global and uniform approach with regard to
1935/04), Implementing rules listed under Reg. EC No 882/04, official controls by means of broad guidelines
Annex VIII and those rules still in force by virtue of the transitional
provision Article 61 Reg. EC No 882/04; in addition: specific rules drawn up at Community level, promoting coherent
for Intra-Community control; contingency plans as referred to national strategies, and identify risk-based priorities
Article 55 of Reg. EC No 178/02; specific rules on Import Condi-
tions (for example: Dir. EC No 97/78 on principles governing the and the most effective control procedures.
organisation of veterinary checks on products entering the EU General requirements for official control on food-
from third countries; specific rules on an animal welfare and oth-
ers. Recently, the Commission Regulation (EC) No 669/2009 of 24
stuffs are addressed today by the mentioned Reg.
July 2009 introduced implementing rules to Regulation EC No EC No 882/04. Its scope results in it being consid-
882/2004 as regards the increased level of official controls on
imports of certain feed and food of non-animal origin and amend-
ered as the twin-regulation to GFL (Reg. EC No
ing Decision 2006/504/EC. 178/02). Reg. EC No 882/04 contains the General

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obligations Member States have to comply with in such programmes are designed to meet require-
carrying out official control of food. ments of feed and food law, animal health and ani-
With reference to the organisation of the official mal welfare rules. Ad hoc controls should be carried
control by Member States, Reg. EC No 882/04 out in the case of suspicion of non-compliance.
requires official controls are carried out regularly, Additionally ad hoc controls could be carried out at
on a risk basis and with the appropriate frequency any time, even where there is no suspicion of non-
(Article 3 of Reg. No. 882/04). Risk and Risk Analy- compliance.
sis are confirmed as marking rules for the whole EU Compliance with the principle of risk analysis,
Food Law. Article 6, par. 1, of GFL establishes that, with appropriateness and other requirements15
in order to achieve the general objective of a high should be assured by means of the Multi-Annual
level of protection of human health and life, food National Control Plan (MANCP) which is intended
law is “based on risk analysis except where this is not by Reg. No 882/04 as the main implementing meas-
appropriate to the circumstances or the nature of the ure of the obligation addressed by Article 17, par. 2
measure”. As a result, risk analysis plays as the basic of GFL.16 According to Articles 41 and 42 of the
standard the role as the law-making process12 but it Reg. EC No. 882/04, Member States are required to
also has an increasing role in the control of verifica- prepare and implement a single integrated multi-
tion of compliance process.13 Reg. EC No 834/2007, annual national control plan and to provide the
laying down the organic production and labelling of Commission with an up-to-date copy upon request.
organic products,14 gives confirmation to this as- Every year, Member States are required to submit to
sumption where it arranges that “the nature and fre- the Commission a report indicating any amend-
quency of the controls shall be determined on the ment of the MANCPs, the results of controls and
basis of an assessment of the risk of occurrence of ir- audits17, the type and number of cases of non-com-
regularities and infringements as regards compliance pliance and the actions taking to ensure effective
with the requirements laid down in this Regulation”. operation and enforcement (Article 44).
Secondly, official control must be carried out reg- Building capability in complying with require-
ularly and consistently with an “appropriate fre- ments relating to food control activities also
quency of control” (i.e. according to an adequate depends on the financial resources available. It is to
planning). The frequency should be regular and be noted that Reg. EC No 882/04 contains provi-
proportionate to the risk, taking into account the sions laying down financing of official controls
results of the checks carried out by feed and food (Articles 26 to 29) reflecting the rationale of EU
business operators under HACCP based control pro- Food Law: the greater the compliance, the lower the
grammes or quality assurance programmes, where fees and the charges on Food Business Operator.
12 See A. Alemanno, Trade in Food, Regulatory and Judicial business operators at all stages of production, processing and
Approaches in the EC and the WTO, London, Cameron and May, distribution. For that purpose, they shall maintain a system of
2007. official controls and other activities as appropriate to the circum-
stances, including public communication on food and feed
13 See D. Pisanello, Obblighi di sicurezza alimentare nel mercato
unico europeo tra gestione del rischio e responsabilità d’impresa, safety and risk, food and feed safety surveillance and other
Diritto Comunitario e degli Scambi Internazionali, 4/2008. monitoring activities covering all stages of production, process-
ing and distribution. Member States shall also lay down the rules
14 Council Regulation (EC) No 834/2007 of 28 June 2007 on on measures and penalties applicable to infringements of food
organic production and labelling of organic products and repeal- and feed law. The measures and penalties provided for shall be
ing Regulation (EEC) No 2092/91, OJ L 189, 20.7.2007. effective, proportionate and dissuasive”. Article 41 Reg. EC No
15 Other requirements are: no discriminatory checks; same care in 882/04 reads: “In order to ensure the effective implementation of
checking compliance with no regard to final market (see Article Article 17(2) of Regulation (EC) No 178/2002, of animal health
4 of Reg. EC No 882/04), no prior warning golden rule (audit is and animal welfare rules and of Article 45 of this Regulation,
excepted) and appropriate measures to be adopted with refer- each Member State shall prepare a single integrated multi-annual
ence to a “non compliance” (Article 54 of Reg. EC No 882/04); national control plan”.
Adequate financial resources (Articles 26 to 28) and Appropriate 17 Audit is a control technique introduced into the European frame-
training activities. A number of general standards in enforcing work of Official Control on Foods by Reg. EC No 882/04 and
EU law on official control are addressed with specific reference Reg. EC No 854/04. Audit means a systematic and independent
to these tools: Transparency and Confidentiality; Control and examination to determine whether activities and related results
verification procedures (investigation, methods and techniques, comply with planned arrangements and whether these arrange-
sampling and analysis, reporting, follow-up, necessary actions,
ments are implemented effectively and are suitable to achieve
Penalties, Contingency plans).
objectives. Other appropriate techniques for official control pur-
16 Article 17, par. 2, of Regulation EC No 178/02 reads: “Member pose include: routine surveillance checks and more intensive
States shall enforce food law, and monitor and verify that the controls such as inspections, verifications, sampling and the test-
relevant requirements of food law are fulfilled by food and feed ing of samples.

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Indeed Article 27.6 of Reg. EC No 882/04 reads: there is a significant degree of variation in the
“When, in view of own-check and tracing systems enforcement of the financing provisions of the Reg.
implemented by the feed or food business as well as EC No 882/04 by the Member States and a signifi-
of the level of compliance found during official con- cant lack of clarity and transparency of the various
trols, for a certain type of feed or food or activities, national fee systems as currently implemented. As a
official controls are carried out with a reduced fre- result, direct comparison of actual fee levels across
quency or to take account of the criteria referred to the EU (and between sectors) is extremely diffi-
in paragraph 5(b) to (d), Member States may set the cult.19 On the basis of the findings reported by the
official control fee below the minimum rates referred study Commission is near to launch discussion on a
to in paragraph 4(b), provided that the Member State range of policy options (“full subsidiarity”, which
concerned provides the Commission with a report would imply the repeal of most of the constraints
specifying: (a) the type of feed or food or activity laid down in the existing legal framework, as
concerned; (b) the controls performed in the feed regards, in particular, the calculation of the fees and
and food business concerned; and (c) the method for the scope of the mandatory fees; Member States
calculating the reduction of the fee”. The same rule is would be free to decide on the best way to finance
the reason for Article 28 of Reg. EC No 882/04, lay- their official control services; “full harmonisation”,
ing down expenses arising from additional official with fees fixed at the same level across the whole
controls: “when the detection of non-compliance European Union and for all the sectors concerned
leads to official controls that exceed the competent (identified by Community legislation).
authority’s normal control activities, the competent On operative grounds, Member States have to
authority shall charge the operators responsible for designate and confer competencies to one or more
the non-compliance, or may charge the operator own- authorities complying with the standards addressed
ing or keeping the goods at the time when the addi- by the UE.
tional official controls are carried out, for the Designated National Competent Authorities
expenses arising from the additional official con- (CAs) are obliged to perform official controls con-
trols”. It is to be borne in mind that “normal control sistently with compulsory standards consisting of
activities” are the routine control activities required the following: Effectiveness and appropriateness of
under Community or national law and, in particu- the performed controls; Experience and qualifica-
lar, those described in the Multi-Annual National tion; Appropriate and properly maintained facili-
Control Plan (MANCP). It results that activities ties and equipments; No conflict of interests; Legal
exceeding normal control activities include the tak- powers to carry out the control and to take the nec-
ing and analysis of samples as well as other controls essary measures in case of non compliance (i. e.
that are required to check the extent of a problem, measures under Article 54 of Reg. No 882/04 and
to verify whether corrective action has been taken, penalties if so provided by national legal frame-
or to detect and/or substantiate non-compliance. work); Adequate planning and documented proce-
The financial rules on official control are a very dures; Periodical examination whether activities
complex issue so that the Commission called for an and related results comply with planned arrange-
external evaluation aimed at providing a better ments; Multi-annual Control Planning (Article 41);
understanding of the functioning of the inspection Efficient and effective coordination and cooperation
fees systems as currently implemented by the Mem- between the units and CAs.
ber States on the basis of the relevant provisions of In conferring competence to the internal author-
the Reg. EC No 882/04.18 The study established that ity or authorities, Member States should not ignore
the scope of the Reg. 882/04 which is clearly high-
18 See European Commission Directorate General for Health and lighted by Article 1: “general rules for the perform-
Consumers, “Study on fees or charges collected by the Member
States to cover the costs occasioned by official controls”, Frame- ance of official controls to verify compliance with
work Contract for evaluation and evaluation related services – Lot rules aiming, in particular, at: (a) preventing, elimi-
3: Food Chain (awarded through tender no 2004/S 243-208899).
nating or reducing to acceptable levels risks to
19 The study results also suggest that, due to the very broad definition
of cost categories in Annex VI to the Regulation EC No 882/04 and
humans and animals, either directly or through the
to the reported lack of transparency of the calculation methods, it environment; and (b) guaranteeing fair practices in
is quite unclear whether cost-based fees truly reflect actual costs
incurred by the competent authorities of the Member States for the
feed and food trade and protecting consumer inter-
performance of the inspections for which the fees are collected. ests, including feed and food labelling and other

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forms of consumer information” (art. 1 of Reg. EC No vide the FBO concerned, or a representative, with
882/04). In other words, implementation of Reg. EC written notification of its decision concerning the
No 882/04 should not be exclusively devoted to the action to be taken together with the reasons for the
food safety and hygiene rules. decision. Additionally CA must inform FBO con-
Article 1 of Reg. No 882/04 is not a novelty ex se: cerned on rights of appeal against such decisions
the previous Directive (Directive EEC No. 89/397 on and on the applicable procedure and time limits.
the official control of foodstuffs) had a similar provi-
sion on the scope of the law.20 The really huge differ-
ence with respect to earlier legal system lies in the III. Denying the obvious: what do fair
powers the CAs are entitled to vis-à-vis non compli- trade and consumer information
ance. Unlike Directive No 89/397, Reg. 882/04 expres-
sis verbis requires, inter alia, CAs to address “admin-
stand for?
istrative actions”, effective, dissuasive and propor- Food safety, consumer protection and fair practice
tionate, in order to resolve the non compliance. are the main objectives of EU Food Law. As above
Legal meaning of “non compliance” is something mentioned, Regulation EC No 882/04 lays down
clear: all breaches of compliance “with rules aiming, general rules for the performance of official con-
in particular, at: (a) preventing, eliminating or re- trols to verify compliance with Food Law and in
ducing to acceptable levels risks to humans and ani- particular with “rules aiming, in particular, at: (a)
mals, either directly or through the environment; preventing, eliminating or reducing to acceptable
and (b) guaranteeing fair practices in feed and food levels risks to humans and animals, either directly or
trade and protecting consumer interests, including through the environment; and (b) guaranteeing fair
feed and food labelling and other forms of con- practices in feed and food trade and protecting con-
sumer information” (Article 1 of Reg. No 882/04). sumer interests, including feed and food labelling
Such situations should be subject to recovery meas- and other forms of consumer information” (Article 1
ures accordingly to Article 54 of Reg. No 882/04. of Reg. EC No 882/04).
According to Article 54 of Reg. 882/04, when the Undoubtedly such regulations apply to all foods
CA identifies non-compliance, it shall take action to marketed within the Single Market and that its pro-
ensure that the operator remedies the situation. De- visions cover all the aspects relevant under a legal
cisions on which actions are to be taken with regard perspective. For example, the compliance with rules
to the nature of the non-compliance and that opera- on organic production or the regulation on pro-
tor’s past record with regard to non-compliance. Arti- tected designation of origin for foodstuffs undoubt-
cle 54 provides for a not exhaustive list of actions to edly fall within the definition and the scope of Reg.
be addressed, where appropriate. Such a list includ- EC No 882/04.
es the following measures: (a) the imposition of san- Let’s take an example. Some Food Business Oper-
itation procedures or any other action deemed nec- ators put into the market of one Member States
essary to ensure the safety of feed or food or compli- meat products labelled with claims and trade name
ance with feed or food law, animal health or animal which correspond to a protected designation of
welfare rules; (b) the restriction or prohibition of the origin registered under the meaning of Reg. EEC
placing on the market, import or export of feed, food No 2081/92 (repealed by Reg. EC No 510/06). Such
or animals; (c) monitoring and, if necessary, order- products are not permitted to bear such designation
ing the recall, withdrawal and/or destruction of feed of origin because they do not meet the legal require-
or food; (d) the authorisation to use feed or food ments. Consequently such business is in breach of
for purposes other than those for which they were the legal rights conferred by Reg. EC No 510/06.
originally intended; (e) the suspension of operation Quid iuris: are the National Competent Authorities,
or closure of all or part of the business concerned designated under the meaning of Reg. EC No. 882/04,
for an appropriate period of time; (f) the suspension
or withdrawal of the establishment’s approval; (g)
20 According to Article 1 Dir. EEC No 89/397, ‘official control of
the measures referred to in Article 19 on consign- foodstuffs’ consisted in inspections by the competent authorities
ments from third countries; (h) any other measure of the compliance of foodstuffs “with provisions aimed at
preventing risks to public health, guaranteeing fair commercial
the competent authority deems appropriate. Some transactions or protecting consumer interests, including provi-
rights are granted to FBO: indeed the CA must pro- sions on consumer information”.

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EFFL 5 | 2009 What do Food Safety and Fair Trade Stand for? 327
obliged to proceed against such unlawful business migiano Reggiano” and obligation on the Federal
practice? Further, given that such products are not Republic of Germany to proceed against infringe-
properly labelled, are National CAs compelled to ad- ments of Article 13(1) of Regulation No 2081/92.
dress recovery measures in order to prevent unlawful The previous two question were a sequel of an ear-
product being offered to the consumer? lier case23, where the third one represented the
The answer should be the affirmative: CAs must flawless core of the judgement.
address recovery measures under the meaning of The Commission tried to contend that the Fed-
Article 54 of Reg. 882/04. For example the CA may eral Republic of Germany was bound to take action
give instructions to modify the labels in order to against the unlawful business but its arguments
delete any reference to the protected designation of were based on Articles 10 and 13 of Regulation No
origin and suspend the offer to the consumer unless 2081/92. According to the Commission, Member
the mandatory instructions are fulfilled. State intervention should include administrative
Surprisingly, the affirmative answer was not the and penal measures such as to enable the objectives
decision set out by the Court of Justice of the Euro- referred to in that regulation concerning the protec-
pean Communities in the Case C-132/05 (Commis- tion of designations of origin to be achieved. Prod-
sion v. Germany).21 ucts which do not comply with the requirements of
In the judgement of 26 February 2008, the Court the regulation should be not marketed.
ruled on the Commission request to declare that, by Caution: no reference to Reg. EC No. 882/04 was
formally refusing to proceed against the use, on its submitted by the Commission application nor by
territory, of the name “Parmesan” on the labelling of the Czech Republic and Italian Republic which sup-
products which do not comply with the require- ported the applicant.
ments of the specification for the protected designa- As defendant, Germany claimed that numerous
tion of origin (PDO) “Parmigiano Reggiano”, thereby legislative provisions enabling action to be taken
favouring the appropriation of the reputation of the against the unlawful use of a PDO, in particular the
genuine, Community-wide protected product, the Law against unfair competition (Gesetz gegen den
Federal Republic of Germany has failed to fulfil its unlauteren Wettbewerb) of 7 June 1909 and the Law
obligations under Article 13(1)(b) of Council Regu- on trade marks and other distinctive signs (Gesetz
lation (EEC) No 2081/92 of 14 July 1992 on the pro- über den Schutz von Marken und sonstigen Kenn-
tection of geographical indications and designa- zeichen) of 25 October 1994 have been adopted. In
tions of origin for agricultural products and food- the view of the Germany defence, by granting those
stuffs.22 civil law rights, the Federal Republic of Germany has
In this case, three questions were discussed by taken all the measures necessary to guarantee full ap-
the Court: extension of legal protection of com- plication of Article 13(1) of Regulation No 2081/92.
pound designations, infringement of the PDO “Par- According to the Federal Republic of Germany, it
is not necessary for the public authorities to take
administrative action on their own initiative against
21 Court of Justice of the European Communities, Judgment of 26
February 2008, in the Case C-132/05 (Commission v. Germany), infringements of rights granted by Regulation on
hereinafter Parmesan case with notes of C. Hauer, Using the protection of protected designation of origin for
Designation ‘Parmesan’ for Hard Cheese (Grated Cheese) of
Non-Italian Origin Judgment of the ECJ of 26 February 2008 in foodstuffs.
case C-132/05 (Commission of the European Communities vs. According to the Court: “the Commission has not
Federal Republic of Germany), EFFL, 2008, p. 387; in addition
D. Pisanello, Denominazioni di origine ed indicazioni geogra- demonstrated that the Federal Republic of Germany
fiche protette tra diritto industriale e diritto alimentare: il caso has failed to comply with the obligations under Reg-
Parmesan II, Contratto-Impresa/Europa, 2008, p. 389.
ulation No 2081/92, and it has not furnished proof
22 OJ 1992 L 208, p. 1. Reg. EEC No 2081/92 has been repealed by
Council Regulation (EC) No 510/2006 of 20 March 2006 on the
that measures such as those referred to in paragraph
protection of geographical indications and designations of origin 63 above were not taken or were not such as to pro-
for agricultural products and foodstuffs (OJ L 93, 31.3.2006,
p. 12). On the subject: F. Capelli, Protection of the Designations
tect the PDO ‘Parmigiano Reggiano”.24 So the action
of Origin and the Geographical Indications of Agricultural was dismissed.
Products – The New Community Regulation No. 510/2006 and
the Italian “Sanctioning” Decree, EFFL, 2006 p. 137.
In so ruling, the Court entered in an interpreta-
23 See Judgment of the Court of Justice of European Communities,
tion of the “control of verification of compliance”
25 June 2002, case C-66/00 (Bigi). which is totally restricted to the Reg. 2081/92 and
24 See paragraph 69 of the Parmesan Case Judgment. inconsistent with the general legal framework of

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328 What do Food Safety and Fair Trade Stand for? EFFL 5| 2009
EU rules on official control for foodstuffs. The main of 14 July 1992 on certificates of specific character
reason of complaint claims that the judgement was for agricultural products and foodstuffs contain spe-
based on an incorrect meaning of “control of verifi- cific measures for the verification of compliance
cation”. Indeed, by following Germany suggestions, with the requirements contained therein. The require-
the Court mixed up the system of control of compli- ments of this Regulation should be flexible enough so
ance (with the rules on fair practice and protection as to take account of the specificity of these areas”.
of consumer interests) for the national structure for The mentioned language is clearly oriented to
accreditation and control as ruled by Article 10 of include the legislation on the protection of geo-
Regulation No 2081/92.25 It is evident that verifica- graphical indications and designations of origin for
tion of compliance with the registered specification, agricultural products and foodstuffs in the scope of
carried out in order to obtain the right to use the Reg. EC No 882/04 even if in a flexible way. So, what
protected designation of origin, is something differ- flexibility should mean in this case? Flexibility may
ent to the verification of compliance of a product affect the multi-annual planning of control activi-
with food regulations, included rules governing the ties as well as the training of civil servants involved
lawful use of a designation of origin. in carrying out official control but, in accordance
Additionally such a judgement seems to be not with the reasons above expressed, it seems quite
consistent with the rationale of Reg. EC No 510/06 undisputable that Article 54 of Reg. EC No 882/04
on the protection of geographical indications and should be applied to situations of breach to rights
designations of origin for agricultural products and conferred by the Regulation on the protection of
foodstuffs26 according to which “The designations geographical indications and designations of origin
of origin and geographical indications protected on for agricultural products and foodstuffs or on
Community territory should be subject to a monitor- organic production.
ing system of official controls, based on a system of Of course, Reg. EC No 882/04 (which entered in
checks in line with Regulation (EC) No 882/2004 of force on 1 January 2006) and Reg. EC No 510/06
the European Parliament and of the Council of 29 (which entered in force 31 March 2006) did not
April 2004 on official controls performed to ensure apply ratione temporis to the facts of the proceeding
the verification of compliance with feed and food but this is not a sufficient reason to accept the ratio
law, animal health and animal welfare rules, includ- decidendi applied by the Judgment on the Parmesan
ing a system of checks to ensure compliance with the case as regards to the obligation for Member states
specification of the agricultural products and food- to proceed against the use of geographical name
stuffs concerned” (see recital 16). registered under EU Food Law.
It is to be noted that Reg. No. 882/04 expressly It is to be hoped that a second case will be filed in
recalls the legislation related to the protection of order to clarify the relationships between “food law
designation of origin and organic foods under the in general” and the obligations of Public Authorities
recital 9: “Council Regulations (EEC) No 2092/91 of to prosecute against unlawful marketing practices.
24 June 1991 on organic production of agricultural
products and indications referring thereto on agri-
cultural products and foodstuffs, (EEC) No 2081/92
25 See paragraphs 73–77 of the Parmesan Case Judgment.
of 14 July 1992 on the protection of geographical
26 Council Regulation EC No 510/2006 of 20 March 2006 on the
indications and designations of origin for agricul- protection of geographical indications and designations of origin
tural products and foodstuffs, and (EEC) No 2082/92 for agricultural products and foodstuffs (OJ L 93, 31.3.2006, p. 12).