FOOD SAFETY the background, the framework and the relevant recent developments
AVV. LUCIA RAGAGLINI AVV. GIUSEPPINA ROMANO
CONTENTS: INTRODUCTION
P.
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1.
BACKGROUND OF THE EUROPEAN LEGISLATION ON FOOD SAFETY
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2.
CURRENT EUROPEAN FRAMEWORK: REGULATION (EC) NO. 178/2002
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2.1.
THE PRINCIPLES AND PROVISIONS ON FOOD LAW
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2.2.
THE EUROPEAN FOOD SAFETY AUTHORITY (EFSA)
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2.3.
SAFETY PROCEDURES: TRACEABILITY
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2.4.
THE PRODUCER RESPONSIBILITY
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3.
THE SO-CALLED “HYGIENE PACKAGE”
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4.
FOOD SAFETY IN THE INTERNATIONAL CONTEXT
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5.
CURRENT ITALIAN FRAMEWORK ON FOOD SAFETY
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6.
THE LEGISLATION CONCERNING THE SECTOR
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7.
THE OFFENCES UNDER FOOD LAW
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7.1.
THE ELEMENTS OF THE OFFENCES
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7.2.
FOOD FRAUD CASES IN ITALY
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INTRODUCTION
The food safety issue, due to its central role in the everyday life of individuals, is the object of attention and regulation at multiple levels: national, supranational (i.e. European) and international. Therefore, as Italy is both member of the European Union and the International Community, the following illustration of the general regulatory framework governing this delicate subject takes into account various levels of intervention.
BACKGROUND OF THE EUROPEAN LEGISLATION ON FOOD SAFETY
1.
The European legislator began to pay increased attention to the issue of food safety in the aftermath of some serious incidents of food contamination, such as for example those related to BSE, the phenomenon of the so-called mad cow disease, dioxin and other incidents of food adulteration. The Green Paper published by the European Commission in 1997 on the “general principles of food law in the European Union” constitutes the first concrete action in this area. Through the Green Paper, the Commission sought to verify, by opening a debate at European level, the adequacy of the food safety legislation with respect to the need to protect the rights of consumers. Obviously, the underlying goal consisted in the improvement of protection and guarantee measures, in order to safeguard the health of individuals. The next step was the publication of the White Paper by the Commission in 2000, through which the guidelines set out in the Green Paper started taking shape. In particular, it stated: •
the need to make all the passages that form the chain of the product, from farm to table, traceable;
•
the need to broaden the scope of intervention of the legislator by extending safety (in addition to food) also to animal feed destined to become, in turn, food for individuals;
•
the need to create a separate entity, or a European Food Authority with specific responsibilities regarding the assessment of food safety risks;
•
the opportunity to confer the control of food safety risks on the European Commission.
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The preparatory process ended on January 28, 2002, with the adoption of Regulation (EC) No. 178/2002, as a result of the process of co-decision of the European Parliament and the Council. The main changes introduced by the said Regulation (as described in greater detail infra § 2) consist of three essential points (addressed separately below): •
the introduction and the ruling of the principles and provisions on food law, binding on all Member States;
•
establishment of the European Food Safety Authority (the “EFSA”);
•
determination of the procedures to be followed and complied with in the field of food safety.
2.
CURRENT EUROPEAN FRAMEWORK: REGULATION (EC) NO. 178/2002
2.1.
The principles and provisions on food law
The decision to regulate the food industry by means of a measure that has the nature of a regulation (and not a directive) is fully consistent with the need and urgency of introducing general safety requirements that are suitable to bind all States belonging to European Union to the same rules, avoiding, thus, the risk of uneven standards in such a delicate sector where the health and safety of consumers are directly concerned1. In essence, it was intended to unify the rules of the market and to determine the limits of its exercise, ensuring primary protection of food hygiene and as an additional effect, removing obstacles – that would otherwise be placed by national frameworks that differ considerably from one another – to the European trade. The nature of the legislation impacts not only on the direct applicability and the compulsory nature of the provisions set forth therein, but also on identifying the direct recipients: in fact, since it is a measure with a general scope, the provisions contained therein are applicable to any legal entity belonging to the European Union, and, therefore, not only to member States but also to individuals and legal entities – and, therefore, to farmers, agri-food businesses or other stakeholders in the sector — established in an EU country.
If, in fact, a directive rather than a regulation had been adopted, the member States would have been bound to the achievement of the objectives set out therein, but would retain full autonomy in the choice of the methods aimed at achieving the required results at European level, with the consequent risk of heterogeneous regulatory approaches in such a delicate sector.
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The main purpose of food law2 consists in reducing or eliminating the risk to health. To achieve this objective, it is necessary to perform in an objective and transparent way a preliminary risk analysis on the basis of scientific data. A foodstuff is risky if it causes damage to human health and/or cannot be destined for human consumption. The existence of the risk is determined in a process consisting of three linked stages: a) risk assessment, b) risk management, c) risk communication, consisting of exchange of information and opinions among members of the industry and consumers. The fulfillment of this crucial activity is based on the application of the precautionary principle. The use of this principle implies a prior assessment of the possible risk related to a particular product and the subsequent adoption of the most appropriate measures designed to eliminate it. The risk forecast is not based on definite and technical data but on evaluations of opportunities, where the scientific results are unable to define the scope of risk and therefore do not recognize as real but do not even exclude the existence of a danger to human health. Therefore, as a precautionary measure, action is taken to nullify the very possibility of danger.
2.2.
The European Food Safety Authority (“EFSA”)
The Regulation No. 178/2002, acknowledging the insufficiency of the system of scientific and technical assistance to respond to the severe contamination of feed and food, has established the European Food Safety Authority (the “EFSA”). Having its headquarters in Parma, the EFSA has an extended and general radius of action based on the “one door, one key” principle in order to centralize the powers to a single entity and thus to promote certainty and unambiguity of communications. In particular, the EFSA is entitled to: •
identify and assess all risks related to foodstuffs;
Broad and general concept including all “laws, regulations and administrative provisions governing food in general, and food safety in particular, whether at Community or national level; it covers any stage of production, processing and distribution of food, and also of feed produced for, or fed to, food-producing animals” (Article 3, No. 1 Regulation (EC) No. 178/2002). 2
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•
disseminate in a clear and understandable way information relating to food safety, promoting the exchange of news and communications3;
•
issue scientific and technical opinions in various fields involving food safety and if necessary provide technical support to the European Commission.
In doing so, the Authority aims to ensure the proper functioning of the internal market for food products.
2.3.
The procedures to follow to ensure food safety. In particular: the food traceability and
labeling Food traceability is the most useful procedure to identify feed, food and their ingredients, in respect of all raw materials used by the manufacturer as part of the food chain and thereby to reconstruct their path along the stages of production, processing and distribution of feed and food. That way, in the event of damages, it is easier to determine who is responsible. In fact, tracing enables to control the origin of the goods and to monitor the development up to the supply to the final consumer. This safety procedure, designed to protect human health, has also the effect of favoring manufacturers who are responsibly active in the field, as it enhances the activity and strengthens the positive results. More precisely, we refer to: •
“traceability” to define the description of the path followed by the product from “farm to fork”, throughout the entire food chain from harvest and production to distribution;
•
“retraceability” to define the reverse path by making use of the necessary information (tracks, notes) in order to go back over all the stages preceding the consumption of the product by consumers.
In fact, as far as the consumer is concerned the origin of a product is traceable through labeling. The food label contains all the necessary and appropriate information to find out the origin and the commercial In this regard, the existence of a rapid alert system, RASFF – Rapid Alert System for Food and Feed, aiming to disseminate in real time risks to public health caused by certain food or feed should be noted. It is a network of exchange of information with the participation of the European Commission, the EFSA and the Member States of the European Union. Thanks to the RASFF, foodstuff considered harmful shall be withdrawn in collaboration with the Carabinieri Department of Health and the Regional Councils; besides, in the case of an imminent and severe danger, in addition to the seizure, the information aimed at consumers shall be disseminated by means of media.
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characteristics of the product. The labeling as well has been the subject of a regulatory intervention at supranational level, in order to standardize the rules of application in all member States. The first intervention in the area was realized with the Directive 2000/13/EEC, and then replaced by the Regulation (EU) No. 1169/2011. This regulation sets out the requirements that manufacturers are obliged to follow in order to provide consumers in a simple and easily understandable way with necessary information. In particular, the Article 9 of the said Regulation provides that, from December 13, 20144, it shall be mandatory to indicate on the label of the product: a. the name of the food; b. the list of ingredients; c. any substance causing allergies or intolerances (peanuts, milk, mustard, fish, cereals containing gluten, etc.); d. the quantity of certain ingredients or categories of ingredients; e. the net quantity of the food; f.
the date of minimum durability or the ‘use by’ date;
g. any special storage conditions and/or conditions of use; h. the name or business name and address of the operator or the importer; i.
the country of origin or place of provenance for some type of meat, milk or when its omission might mislead the consumer;
j.
instructions for use where it would be difficult to make appropriate use of the food in the absence of such instructions;
k. with respect to beverages containing more than 1,2 % by volume of alcohol, the actual alcoholic strength by volume; l.
a nutrition declaration.
Certainly, the new requirements on labeling and especially indication of the country of origin or provenance where there is a risk of confusion for consumers, have the effect of strengthening the protection of Italian products, especially when there are illustrations and images on foodstuffs that mislead consumers into thinking that the product is Italian.
The Regulation will apply from December 13, 2014, except for Article 9, paragraph 1, letter l) on the nutrition declaration, which shall apply from December 13, 2016, and for Annex VI, PART B, which shall apply starting from January 1, 2014 on “Specific requirements concerning the designation of 'minced meat'”. 4
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Moreover, the same Regulation allows manufacturers to feature on the label of the product, in addition to the mandatory information, also voluntary information or indications that are likely to provide more clarification on the product and thus make it more attractive for the consumer. It is necessary, however, that such information is related to distinctive features of the product and is not ambiguous or confusing. A closer examination reveals that these innovative measures – introduced with the objective of protecting the primary interest of health – constitute a useful tool to stimulate competitiveness in the agricultural and food sector.
2.4.
The producer responsibility
The quality and the wholesomeness of food products depend directly on the rules of conduct laid down in terms of food hygiene by the subjects participating in the different stages that make up the chain. For this reason, the task of ensuring compliance with the provisions of food safety is incumbent on the food producer, i.e. on the subject – natural or legal person – that operates in the sector. In fact, through the adoption of measures of control and self-control, the risk of contamination caused by biological (such as, for example, viruses, bacteria, mould), physical (e.g. extraneous matters) or chemical (chemical substances such as, e.g., pesticides or detergents) factors can be eliminated or reduced. In a strictly legal sense, the liability of the food producer is governed by the Directive 85/374/EEC5, which regulates in general the liability for defective products. As a result, the threshold of responsibility on the food producer is significant in order to protect adequately a primary legal right, i.e. health and human life. The manufacturer, in fact, incurs an objective liability: the foodstuff, both in its natural and processed state6, implicates the assumption of liability by the manufacturer solely for the verification of the damage resulting from the defect of the product, regardless of the existence of intent or negligence, (in any case without prejudice to the right of the manufacturer to provide exonerating proof7).
In Italy the Directive was implemented first by the Presidential Decree No. 224 of 24.05.1988 (amended by Legislative Decree No. 25 of 2.02.2001), and subsequently by the Consumer Law (Legislative Decree No. 206/2005), Part IV, Title II, Articles 114-127. 6 In the past, the Directive included in its scope only processed agricultural products, excluding natural products of the soil, stock farming, fisheries and hunting; the expansion took place in 1999 with the Directive No. 34, which amended the Directive 85/374/EEC. 7 The exonerating proof that excludes the liability of the food producer, is as follows: “(a) that he did not put the product into circulation; (b) that, having regard to the circumstances, it is probable that the 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 into being afterwards; or 5
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In general, a product is defective when it is not safe or rather “when it does not provide the safety which a person is entitled to expect, taking all circumstances into account” 8. Hence, based on the provisions the food producer shall be committed to fulfill a safety obligation in favor of the consumer, i.e. the obligation to check with perseverance and diligence the entire production process and shall bear the legal consequences even if it has not intended or caused the offense.
3.
THE SO-CALLED “HYGIENE PACKAGE”
In addition to the Regulation No. 178/2002, the European legislator enacted further legislation to regulate particular areas of food law, namely the so-called hygiene package, consisting of the Regulation (EC) No. 852/2004 on the hygiene of foodstuffs, No. 853/2004 on the hygiene of foodstuffs of animal origin, No. 854/2004 on official controls on products of animal origin, No. 882/2004 on official controls performed to ensure the verification of compliance with feed and food law and animal health and animal welfare rules. These regulations make controls on food commodities and the application of hygiene rules by means of risk analysis system known as Hazard Analysis and Critical Control Points (“HACCP”) mandatory. The intervention of the legislator follows the same ratio of the Regulation No. 178/2002 to introduce a general framework, aimed at all manufacturers, whether organized in the form of food industry or manufacturer active in the production and distribution of unprocessed agricultural products, the so-called “primary producers” (who were excluded from the hygiene regulations under the former system). Thanks to this extension now, the entire agri-food chain is covered by the scope of the self-control obligations. These self-control obligations imply the observance of a good practice, aimed at ensuring that foodstuffs are produced under appropriate
(c) that the product was neither manufactured by him for sale or any form of distribution for economic purpose nor manufactured or distributed by him in the course of his business; (d) that the defect is due to compliance of the product with mandatory regulations issued by the public authorities; (e) that the state of scientific and technical knowledge at the time when he put the product into circulation was not such as to enable the existence of the defect to be discovered; (f) in the case of a manufacturer of a component, that the defect is attributable to the design of the product in which the component has been fitted or to the instructions given by the manufacturer of the product” (Article 7, Council Directive 85/374/ERC) 8 “A product is defective when it does not provide the safety which a person is entitled to expect, taking all circumstances into account, including: (a) the presentation of the product; (b) the use to which it could reasonably be expected that the product would be put; (c) the time when the product was put into circulation.” (Article 6, Council Directive 85/374/EEC).
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hygienic conditions, by adopting contaminants and/or disease control measures, and introducing the obligation to inform the competent authority if the existence of a threat to human health is to be feared.
4.
FOOD SAFETY IN THE INTERNATIONAL CONTEXT
The Codex Alimentarius At international level the safeguarding of food safety is implemented transversely by two organizations of the United Nations: the WHO, established to ensure the safeguarding of human health as a broad and general concept including physical and mental well-being, and the FAO, the objective of which is the reduction of chronic hunger between the populations and the development of the food and agriculture sectors. The “Codex Alimentarius”, a sort of consolidated text containing the standards of safety and quality of foodstuffs, rules of conduct developed with the primary purpose of preserving the health of consumers and transforming the food market in accordance with the principles of fairness and transparency, was published by means of a cooperation between the WTO and the FAO. On a legal level, the general practices and the principles of hygiene included in the Codex Alimentarius are not binding, but it is certainly recommended to make use of it. The Sanitary and Phytosanitary Agreement (the “SPS Agreement”) The SPS Agreement is aimed at enabling States belonging to the International Community to adopt the measures deemed necessary to protect human, animal or plant health within the territory, so that these measures do not constitute arbitrary, discriminatory or unjustified means to surreptitiously restrict the international trade. If a country participating in the WHO adopts a sanitary or phytosanitary measure that might adversely affect the international trade and is not compliant with the standards indicated by the SPS Agreement, it shall be summoned to justify its measure before a panel of the Dispute Settlement Body (“DSB”) and, where the measure is deemed unlawful even according to the Appellate Body, it shall remove the contested measure and shall compensate the country that suffered losses. In the event that the unsuccessful State refuses to comply, the “winner” Countries shall be authorized (by a new Panel) to implement retaliatory measures, corresponding to the loss suffered. 10
Scientific findings as the basis of administrative decisions are the heart of the SPS Agreement, because through the process of risk assessment they enable the States to deviate from international standards by adopting a more severe measure, and allow adjudication bodies to verify whether the measure is reasonable, necessary and, as will be seen, also proportionate. The suitability principle and the necessity principle require that the measure is adequate, effective and necessary to achieve the purpose with regard to which the measure was taken, in order to exclude alternative measures. This verification (“proportionality test”) is conducted on the basis of scientific assessments (according to Article 2.2 of the SPS Agreement).
5.
CURRENT ITALIAN FRAMEWORK ON FOOD SAFETY
At national level, the legal framework in the field of food safety is represented in the first place by Law No. 283 of 30 April 1962 “Amendments to Articles 242, 243, 247, 250 and 262 of the consolidated health laws, approved by the royal decree of 27 July 1934 No. 1265: Hygiene requirements for the production and sale of foodstuffs and beverages”, as well as by the Presidential Decree of 26 March 1980, No. 327 on the “implementation of Law 283/1962, as subsequently amended, relating to hygiene control of the production and sale of foodstuffs and beverages”. The scope of this legislation laying down the hygiene control on the production and sale of foodstuffs and beverages, apart from being slightly out of date, has been significantly reorganized over the years, as a result of multiple amending and abrogative interventions. The incompleteness of the national legislation on food safety can be explained by several factors. First, it should be considered that in our legal system the regulation of food belongs to the category of materials that fall within the concurrent legislative competence of the State and Regions, with the result that the State is responsible for the definition of the “frame” within the boundaries of which the Regions shall legislate. Second, the food safety issue has become, over time, increasingly extraterritorial and therefore requires a different approach by the legislature: on the one hand, the method of intervention should not focus only on subsequent verifications regarding the existence of the safety requirements but needs to determine ex-ante the necessary measures to prevent food safety risks (through the indication of rules of conduct and of verifications to be performed during food processing); on the other hand, there is a need to entrust that intervention to the European legislator in order to define binding and common rules for all member States that operate on the European market.
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In particular: the obtainment of the sanitary authorization for food businesses Article 2 of Law No. 283 of 1962 had made the exercise of activities in the food sector subject to a prior sanitary authorization that verified whether the health requirements provided by the laws and regulations were satisfied. The entry into force of the Regulation (EC) No. 852/2004 of the hygiene package replaced the said authorization Certified Declaration of Business Start-up (“SCIA”, formerly “DIA”), with a clear objective of simplification aimed at enabling food business operators to undertake activities with a simple communication and following the instructions provided by the relevant municipalities of destination. *** In conclusion, it should be emphasized that, due to the primacy of Union law over national law the key legal framework on the subject remains the Regulation (EC) No. 178/2002 on food law and the regulation package of 2004 relating to the rules on hygiene. The Italian legislation, at national and regional level, shall apply mutatis mutandis. Moreover, it should be added, that these legislative texts constitute the general framework in the sector, in addition to these there is also further detailed regulatory action (infra § 6), aimed at regulating specific aspects and areas, for which there is a constant and prolific regulatory activity.
6.
THE LEGISLATION CONCERNING THE SECTOR
The detailed legislation on foodstuffs is quite extensive; especially among the main references to the legislation the following can be found, in relation to: Additives, Flavorings, Enzymes (Regulation (EC) No. 1333/2008 as subsequently amended and supplemented, on food additives, Regulation (EC) No. 1334/2008 as subsequently amended and supplemented, relating to flavorings and ingredients with flavoring properties, Regulation (EC) No. 1332/2008 on food enzymes, Regulation (EU) No. 231/2012 as subsequently amended and supplemented, laying down specifications for food additives); Waters (Legislative Decree No. 31 of 2001 on the implementation of the Directive 98/83/EC on the quality of water intended for human consumption); Cocoa and Chocolate (Directive 2000/36/EC implemented in Italy with the Legislative Decree No. 178 of 2003); Meat (Regulation (EC) No. 1760/2000 on the system for the identification and registration of bovine animals and regarding the labeling of beef and beef products, as subsequently amended and supplemented, Regulation (EC) No. 2160/2003 on the control of salmonella and other specified food-borne zoonotic agents, Regulation 12
(EC) No. 2075/2005 as subsequently amended and supplemented laying down specific rules on official controls for the presence of Trichinella in meat, Regulation (EU) No. 1308/2013 establishing a common organization of markets in agricultural products and repealing Regulations (EEC) No. 922/72, (EEC) No. 234/79, (EC) No. 1037/2001 and (EC) No. 1234/2007, Regulation (EC) 119/2009 on the import of meat of wild leporidae, of certain wild mammals and farmed rabbit, Regulation (EC) 206/2010, as subsequently amended and supplemented - lists of third Countries, territories or parts thereof for import of animals and fresh meat and the veterinary certification requirements); Cereals and cereal products (Law No. 580 of 1967, as subsequently amended and supplemented on the regulation for the processing and marketing of cereals, flours, bread and pasta products, the Presidential Decree No. 187/2001 “Regulation for the revision of the legislation on the production and marketing of flours and pasta products; the Ministerial Decree of 22 July 2005 for the production and sale of certain confectionery products (such as panettone, pandoro, colomba, amaretto and savoyard); Food supplements (Legislative decree No. 169 of 2004 on the implementation of Directive 2002/46/EC on food supplements); Milk and milk products (Legislative Decree No. 175 of 2011 on the implementation of Directive 2007/61/EC on certain types of totally or partially dehydrated preserved milk for human consumption); Honey (Legislative Decree No. 179 of 2004 implementing Directive 2001/110/EC concerning the production and marketing of honey); Oil (Regulation (EU) No. 29/2012 containing marketing standards for olive oil, Law No. 9 of 2013 laying down rules on the quality and transparency of the supply chain of the virgin olive oil); Wines and vinegars, spirits (Law No. 1354 of 1962 on hygiene and health standards for the production and trade of beer, Regulation (EC) No. 110/2008 containing the definition, description, presentation, labeling and protection of geographical indications of spirits and repealing Regulation (EEC) 1576/89).
7.
THE OFFENSES UNDER FOOD LAW
As explained above the food law is organized through the introduction of standards articulated across various fields (EU and national). It is a “sensitive” sector requiring safety and safeguarding, exposed from time to time to unforeseen emergencies, linked to anxieties caused by the globalization of markets and risks. In such instances sanctioning rules, both criminal and administrative, characterized by a sanctioning gradualness of the safeguarding (ranging from crime, offense, decriminalized unlawful act, to administrative offense) act as a counterbalance. Food safety constitutes a functional interest (intermediate good) to health that, ultimately, is the protected asset, on the one hand, with cases regarding danger, on the other cases connected with the concept of risk. With reference to risk, it can be distinguished between cases dealing with the prevention of 13
known risks, and cases dealing with precaution and linked to unknown risks that given the current state of knowledge cannot be excluded (e.g., symbolic, the regulation on GMOs). Food safety serves as a functional interest to health, which is a fundamental asset having constitutional significance. In this regard, it should be pointed out that public health must be considered an autonomous legal right compared to the right of individuals to individual health, which is a genuine social and collective right. The safeguarding of public health in the food sector is therefore typically materialized through the configuration of crimes of danger, characterized by the anticipation of criminal protection to a time prior to the occurrence of damage. The danger to public health does not exist only if the foodstuffs lead to a danger for “the average consumer�, but also when the substance, even if harmless to the majority, adversely affects persons belonging to categories deserving special protection such as children, the bearers of particular diseases, the elderly, or those regularly taking certain medications. The system of sanctions regarding food fraud has three levels of protection. The first level consists of the rules provided by the Criminal Code, the laws protecting public safety with respect to fraud (Book II, Title VI, Chapter II), as well the rules that protect the public economy, industry and trade (Book II, Title VIII). The second level consists of the Law No. 283 of 1962 on the hygiene requirements of the production and sale of foodstuffs. The third level comprises the sector specific regulations concerning the storage of certain foodstuffs, rules providing for a series of administrative offenses (following the decriminalization carried out through the reform of 1999). In general, it should be noted that the administrative offenses succumb in any case to the criminal offenses. In addition, the decriminalized provisions identify behaviors that can easily be classified among the crimes identified in the Criminal Code (the first level of protection) or among the offenses identified in Law 283/1962. The food safety offenses are prosecuted ex officio. Moreover, offenses against the public safety are punished also as a result of negligence. Among these are: the poisoning of water or foodstuffs (Article 439 of the Italian Criminal Code), adulteration or counterfeiting of foodstuffs or other things that are detrimental to public health (Articles 440 and 441 of the Italian Criminal Code), the trade of counterfeited or altered or harmful foodstuffs (Articles 442 and 444 of the Italian Criminal Code). 14
In contrast, the offenses of trade fraud concern the sale of non-genuine foodstuffs as genuine (Article 516 of the Italian Criminal Code) and the counterfeiting of labels, including those indicating the geographical provenance or the designation of origin of agricultural products (Articles 517-517-quater of the Italian Criminal Code). All these offenses of trade fraud are offenses constituting a prerequisite for the application of the socalled administrative liability of companies, pursuant to Article 25 – bis No. 1 of Legislative Decree 231 of 2001 (as amended by law 99 of 2009). Law No. 99 of 2009 does not only aim at fighting effectively against counterfeiting, but also safeguards the accuracy of trade relations through the introduction of Article 25 – bis 1 in the text of the Legislative decree 231/2001 which provides the administrative responsibility of entities in the event of commission of certain offenses against industry and commerce. Counterfeits and alterations, even if they do not necessarily endanger the health of persons, undermine the good faith of the consumer that should be the right basis of every form of commercial relationship. Law 283/62 (in particular Articles 5 and 6) safeguards directly the hygiene, authenticity and integrity of the food and, in general, the safety and quality of food and indirectly the health of consumers. The model for safeguarding identified by the law in question is linked to the concept of risk as being potentially offensive and therefore deals with situations of mere disobedience: for example with reference to the exceeding of threshold limits or the mere failure to comply with regulations or administrative measures or authorization procedures. There are significant penalties contained in the Legislative decree 206 of 2005 the so-called Consumer Code, where it is determined that the case of misleading advertising about products that could endanger the health and safety of consumers is sanctioned by the Italian Competition and Trade Authority (the so-called “AGCM”) commensurate with the turnover of the food company; the AGCM, taking into account the gravity and duration of the infringement, provide for sanctions in any case not less than Euro 50.000,00 and for the publication of the measure, and thus produces serious consequents in terms of Company’s image. It is worth recalling the most recent and significant interventions of the legislator, that have introduced different sanctions both administrative and criminal. Special mention should be made of those concerning genetically modified organisms and those concerning controls on food safety. In detail: Legislative Decree 224/03, implementing the Directive 2001/18/EC on the deliberate release of genetically modified organisms into the environment; the Legislative Decree 169/04, implementing the Directive 2002/46/EC on food supplements; the Decree-Law 279/04 containing urgent measures to ensure the 15
co-existence of the three forms of agriculture – transgenic, conventional and organic; the Legislative Decree 70/05, that introduces the rules governing penalties for violations of the Regulations (EC) No. 1829/2003 and 1830/2003, respectively concerning genetically modified food and feed as well as the traceability and the labeling of GMOs; Legislative Decree 190/06, governing penalties for violations of the Regulation (EC) No. 178/2002 that determines the principles and requirements of food law, establishes the European Food Safety Authority and lays down procedures in the field; the Legislative Decree 193/07, implementing the Directive 2004/41/EC concerning controls in food safety and application of Community regulations in the same sector.
7.1.
The elements of the offenses
The most relevant cases of violation contained in the Italian Criminal Code include in particular those described below:
Article 439 of the Italian Criminal Code, Poisoning of water or foodstuffs. According to Article 439 of the Italian Criminal Code anyone who poisons, i.e. introduces substances that are lethal or toxic to humans, into waters or substances intended for human consumption before they are drawn or distributed for consumption is punishable by imprisonment of not less than fifteen years. The crime in question is punishable also for negligence under Article 452 of the Italian Criminal Code.
Article 440 of the Italian Criminal Code, Food adulteration and food counterfeiting. Pursuant to Article 440, first paragraph of the Italian Criminal anyone who “corrupts”, i.e. alters the natural composition of a substance intended for human consumption, making it thereby harmful, or “adulterates” it, or fraudulently alters the authenticity is punishable by imprisonment of between three and ten years. According to the second paragraph of this Article food “counterfeiting”, or the creation of a new foodstuff from scratch that is different from what it seems to be is a criminal offense.
Article 441 of the Italian Criminal Code, Adulteration or counterfeiting of other things damaging public health. Under Article 441 of the Italian Criminal Code anyone who adulterates or counterfeits (not foodstuffs, but) containers, wrappers or recipients used for foodstuffs in such a way that would endanger human health shall 16
be punished. In order for the conduct to constitute an offense, it is necessary that these wrappers, recipients or containers are intended for trade.
Article 442 of the Italian Criminal Code, Trading of counterfeited or adulterated foodstuffs. Article 442 of the Italian Criminal Code punishes the possession for trading, placing on the market or the distribution for consumption of adulterated, counterfeited or poisoned water or food, in such a way that would endanger human health.
Article 444 of the Italian Criminal Code, Trading of harmful foodstuffs. According to Article 444 of the Italian Criminal Code anyone who possesses for trading, places on the market or distributes for consumption food substances, not counterfeited or adulterated, but dangerous to public health, is punished with imprisonment from six months to three years. The danger to public health does not derive from the authenticity of the food, but from any subsequent alteration that made these foodstuffs harmful to public health.
Article 515 of the Italian Criminal Code, Fraudulent trading. Article 515 refers to cases, in which in the course of a commercial activity the buyer is delivered a product that is of different origin, provenance, quality or quantity, than the one stated or agreed (for example, if the merchant delivers raw ham to the buyer that is not from Parma as a specific product whose designation of origin is used under Article 1 of the Law No. 26/1190 exclusively to designate products with certain features and prerogatives, both commercial and formal). The penalty for fraudulent trading is imprisonment up to two years, or a fine up to Euro 2.065,00.
Article 516 of the Italian Criminal Code, Sale of non-genuine foodstuffs as genuine. According to Article 516 of the Italian Criminal Code anyone who offers non-genuine foodstuffs for sale as genuine is punished with imprisonment up to six months or a fine of up to Euro 1.032,00.
Article 517 of the Italian Criminal Code, Sale of industrial products with misleading signs. Anyone who offers for sale or puts into circulation intellectual work or industrial products, with names, trademarks or distinctive signs that are likely to mislead the buyer about the origin, provenance or quality of the 17
work or the product, thus leading the buyer to choose the respective product because he trusts in the quality of the brand, is punished with imprisonment up to one year or with a fine of up to Euro 20.000,00.
Article 517-bis of the Italian Criminal Code, Aggravating circumstance. The article in question stipulates that the penalties laid down in Articles 516 and 517 shall be increased if the facts provided therein concern food or drinks with a designation of origin or geographical designation or specific characters that are protected by the regulations in force. In these cases the Court in delivering its judgment may order, if the offense is particularly serious or in the event of recurrence, the closure of the establishment or the business in which the offense was committed for at least five days to not more than three months, or the revocation of the license, the authorization or the similar administrative measure allowing the conduct of commercial activity in the establishment or in the business itself.
Article 517-quater of the Italian Criminal Code, Counterfeiting of geographical indications and designations of origin of agricultural products. The provision in question punishes with imprisonment up to two years and a fine of up to Euro 20.000,00 anyone who counterfeits or otherwise alters geographical indications or designations of origin of agricultural products. The same penalty applies to anyone who, in order to obtain profit, introduces in the territory of the State, holds for sale, offers for sale directly to consumers, or, in any case, places on the market such goods with counterfeited indications or designations. With regard to criminal cases provided for by Law No. 283/1962, it should be noted that: •
Article 4 provides that anyone who produces, prepares, owns, sells or offers for sale substances intended for consumption, materials and articles intended to come into contact with foodstuffs, shall provide free samples of these substances to healthcare workers. Failure to comply constitutes an offense that is punished by monetary penalty;
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Article 5 prohibits to use in the production of food or beverage, to sell, to hold in order to sell or to give it to his employees, or to distribute for consumption, foodstuffs that: o have been deprived, even partly, of nutrients or are mixed with substances of lower quality or otherwise treated in a manner that changes its natural composition, except as provided by special laws or regulations; 18
o are in a poor state of preservation; o have microbial loads exceeding the limits established by regulations or ministerial orders; o are soiled, invaded by parasites, in an altered or harmful state, or subject to processing or treatments aimed at disguising a previously existing state of alteration; o have undergone the addition of any kind of unauthorized chemical additives; o contain residues of products used in agriculture for plant protection and in defense of stored foodstuffs, that are toxic to humans; •
Article 11 prohibits the manufacturing, holding for trade, placing on the market or use of kitchenware or tableware, containers or boxes to store foodstuffs, and any other object intended to come into direct contact with foodstuffs, that are: o of lead, zinc or alloys containing more than 10% lead with the exception of the pipes for drinking water; o internally tinplated with tin containing more than 1% lead; o internally coated with vitrified, varnished or enameled layers, which, placed in contact for 24 hours with a solution of 1% acetic acid, loosen lead at ordinary temperature; o
welded with tin-lead alloy, with a lead content greater than 10%, provided the crimps to be welded are realized to ensure the impenetrability of the solder alloy; and composed of material, in the composition of which there is more than three centigrams of arsenic per 100 grams of material;
o of plastic or any other product that may give flavors or odors that adversely affect the organoleptic properties and make foodstuffs harmful. •
Article 13 safeguards the “good faith of the consumer” and prohibits offering for sale or advertising through the press or by any other means, foodstuffs that have improper names or designations, advertising phrases, brands or quality or authenticity certificates whoever the issuer may be as well as illustrative drawings that surprise good faith or mislead purchasers as to the nature, substance, quality or the nutritional properties of foodstuffs or with medicinal properties.
In addition to these there are special provisions governing the production and preservation methods of the foodstuffs (supra § 6). The Most frequently encountered cases of food fraud to the detriment of consumers include false declarations of origin and/or characteristics of the product, misleading indications, noncorrespondence of products with the ingredients declaration or the failure to report “undesirable” ingredients, 19
amendments to the date of expiry or of preferable consumption.
7.2.
Food fraud cases in Italy
In this regard, it is interesting to analyze the 2013 report of the Department of the Central Inspectorate for quality protection and fraud repression of foodstuffs (“ICQRF”), belonging to the Ministry of agricultural, food and forestry policies, which delivers a picture of the food frauds that most frequently occur in Italy. The ICQRF, is a body responsible for monitoring the quality of agri-food products as well as for sanctioning the offenses occurred: in 2013 more than 300 crime reports were submitted to the Judicial Authority, more than 5.000 offenses were detected, 500 seizures for a total value of about Euro 37 million were performed. The ICQRF is particularly focused on regulated quality products (e.g., Wines, PDO, PGI products, products from organic production) in order to make Italian products both on the domestic and international market more reliable. In particular, it is interesting to note what the main offenses established in the course of 2013 are: •
With regard to wines: o adulteration of generic and from time to time DOC (controlled designation of origin) wines by sugaring and/or watering; o illicit holding of wine products, not supported by official documentation of the cellar; o marketing of DOC qualified wines with compositions not corresponding to the originally certified products; o production, sale or distribution of PDO and PGI wines that do not comply with the requirements established by the respective production regulations; o violations of the provisions on the description and presentation; o documentary violations, due to breach of the obligations to keep official cellar documentation.
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With regard to oils and fats o commercialization of oils obtained by blending with lampante and deodorized oil or seed oils as extra virgin olive oil;
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o extra virgin olive oils that have proven in organoleptic tests or in category analysis inferior to what is declared; o commercialization of products without the certification required and of uncertain origin as Italian extra virgin olive oil and organic product through the issuance of fraudulent documentation to certify the provenance; o violations of the rules on labeling and presentation of olive oils for omissions of mandatory indications, irregular use of optional references, misleading use of the designation of origin; o documentary violations for failure to keep records of loading and unloading or for keeping irregular records; o vegetable oils obtained from seeds that are different from what is declared and have lower economic value. •
With regard to cheeses: o commercialization of cheese of buffalo or sheep’s milk, both PDO and generic, obtained with partial use of cow's milk; o presence of fats other than those of the milk in mozzarella and scamorza; o use of preservatives in generic and even PDO cheese that are not permitted or not declared; o use of milk that does not fulfill the prescribed requirements of traceability stating the origin and provenance in the production of PDO cheeses; o misuse, imitation or evocation of a protected name to designate generic cheese; o irregularities in the labeling system of cheeses by omission of mandatory information and by using non-complying sales description, incorrect, non-transparent or misleading information for the consumer.
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With regard to cereals and cereal products: o commercialization of rice of varieties other than declared or with defects that exceed the tolerance of law; o commercialization of bread, dry pasta and flour having compositional characteristics that do not comply with the values required by law; o traditional bakery products containing fats other than butter; o commercialization, at a Chinese store, of dry pasta obtained with soft wheat flour and having irregular sales description; 21
o violations relating to the labeling system for omission of mandatory indications, improper use of the sales description, irregularities in ingredients listing, no indication of the characterizing ingredient, use of misleading phrases or products evoking protected designation. *** In conclusion, it should be pointed out that the measures outlined demonstrate a more and more vigilant and prudent action plan that produces the positive effect of protecting Italian products more and better and safeguarding the excellence of our Country's agri-food industry. Indeed, the compliance with food law requires the observance of rules of conduct that are particularly stringent. However, exactly this rigidity is a distinct strength of the Italian producers, which allows them to succeed more and more on the food market as well to build a worldwide trustworthiness. Lucia Ragaglini Giuseppina Romano
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