Abstract
The chapter analyses the gradual evolution in EU food law, turning to food and feed safety protection following the serious food crises of the 1990s. The comprehensive, integrated principles underlying the 1993 Green Paper and 2000 White Paper became a reality with Regulation (EC) No. 178/2002, which ascribes a crucial role to consumer protection, setting forth the principles of transparency, traceability, and responsibility of business operators; establishing a rapid alert system and crisis management plan; and, most importantly, establishing the European Food Safety Authority (EFSA). EFSA provides scientific opinions and scientific and technical assistance, establishes surveillance procedures, promotes cooperation among food safety organisations, and plays a crucial role in risk assessment and communication. EFSA’s first 10 years of activity has achieved a positive balance: despite the dramatic changes within the EU, it has successfully adapted itself. The need for the harmonisation of food hygiene requirements led to the adoption of the hygiene package and the HACCP system (Reg. 852/2004), as well as of specific hygiene rules applicable to products of animal origin (Reg. 853/2004). The conclusions drawn are encouraging: EU food law, by adopting harmonised vertical rules and regulations common to all operators, has committed to ensuring common, high quality standards. EU authorities’ capacity to promptly and effectively react to significant food crises has led to one of the most developed systems worldwide, one that is functional for operators and safe for consumers. Yet the need for rapid, repeated actions, is a constant challenge, which certainly cannot be considered complete.
Having worked as a food lawyer since the industry’s infancy, Giorgio Rusconi has gained significant experience in the field of food law, assisting Italian and foreign clients with food hygiene, labelling, additives, organic farming, geographical indications/destinations of origin, packaging, and responsibilities regarding food products and within the industry.
Giorgio handles client contracts, including those for stakeholders within the food chain, ensuring regulatory compliance and advising on issues of Italian and European law.
Aware of the needs of multinational companies, Giorgio maintains close relationships with experts in different countries and provides assistance and advice on markets nationally and beyond. With relationships built over the years with these and other foreign colleagues, Giorgio helped establish FLN—Food Lawyers’ Network Worldwide, in collaboration with Krell Weyland Grube, offering integrated legal services to multinationals in some 50 countries that are operating in the food industry.
To ensure that companies operating in the food industry have a wider range of services, Giorgio also works with a specialized laboratory capable of providing timely, individualized counter-analysis, as well as with a company specializing in the field of food audits.
He is the author, with Omar Cesana, of Guide to Food Law, which provides a broad and inclusive look at various aspects of food law in Italy.
In court, Giorgio handles all areas of civil litigation defense, centering on product liability and operators’ obligations in the food sector. He helps clients protect their interests in disputes before authorities, and represents entrepreneurs and managers of food-related operations before the criminal court.
In 1996 Giorgio obtained a Higher Diploma in Comparative Law at the International Faculty of Comparative Law of Strasbourg (France) on a scholarship offered by the European Commission. He graduated with a degree in law from Università degli Studi di Milano, was admitted to the bar in 2000, and in 2014 he was admitted to practice before the Supreme Court of Cassation. He speaks Italian, English, and French.
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Notes
- 1.
Document COM (97)176 final, of 30 April 1997.
- 2.
According to the Green Paper, within the Community every household then spent on average about 20 % of its disposable income on food and drink, with an estimated spending for 1996 for the consumption of food, drinks, and tobacco equal to approximately 500,000 million ECU, and an estimated production equal to 510,000 million ECU. Food and drink production and consumption between 1984 and 1992 had grown at a constant real rate equal to approximately 2–2.5 % a year.
- 3.
“[…] it is suggested that consideration be given to greater use of Regulations in appropriate cases, both in primary and in secondary Community legislation. However, legislation which is limited in scope to the harmonisation of general principles and criteria, such as legislation on the official control of foodstuffs, would continue to be adopted by means of a directive.”
- 4.
For which it proposes to examine the definition included in the Codex Alimentarius, pursuant to which “foodstuff means any substance or product, whether processed, partially processed or unprocessed, intended to be ingested by humans, with the exception of tobacco as defined by Directive 89/662/EEC, medicinal products as defined by Directive 65/65/EEC, and narcotic or psychotropic substances controlled by Member States pursuant to the relevant international conventions”.
- 5.
For which it proposes the following definition: “any operation the purpose of which is to supply foodstuffs to a third party, including supply for sale or any other form of transfer against payment or free of charge to a third party and storage with a view to supply to a third party, with the exception of supply for the purposes of scientific research conducted under the supervision of the Member States”.
- 6.
Whereas 66: “It is necessary and appropriate for the achievement of the basic objectives of this Regulation to provide for the approximation of the concepts, principles and procedures forming a common basis for food law in the Community and to establish a European Food Safety Authority. In accordance with the principle of proportionality as set out in Article 5 of the Treaty, this Regulation does not go beyond what is necessary in order to achieve the objectives pursued”.
- 7.
See Judgment of the Court of First Instance (Third Chamber) of 11 September 2002—Pfizer Animal Health SA v Council of the European Union—Case T-13/99: “A scientific risk assessment is commonly defined, at both the international level (see the provisional communication from the Codex Alimentarius Commission, cited at paragraph 147 above) and Community level (see the Communication on the Precautionary Principle, the Communication on Consumer Health and Food Safety and the green paper, cited at paragraphs 118 and 124 above), as a scientific process consisting of the identification and characterisation of a hazard, the assessment of exposure to the hazard and the characterisation of the risk. […]A scientific risk assessment carried out as thoroughly as possible on the basis of scientific advice founded on the principles of excellence, transparency and independence is an important procedural guarantee whose purpose is to ensure the scientific objectivity of the measures adopted and preclude any arbitrary measures”.
- 8.
The precautionary principle arises within international environmental law with the World Charter for Nature adopted by the United Nations General Assembly in 1982. Within the European Union, the principle is first mentioned (with reference to environmental protection only, though) in Article 174.2 of the EC Treaty, which, however, fails to give any definition of the same.
- 9.
See Judgment of the Court of 9 September 2003 Case C-236/01 (Monsanto Agricoltura Italia SpA and Others v Presidenza del Consiglio dei Ministri and Others): “[…] protective measures may be taken pursuant to Article 12 of Regulation No. 258/97 interpreted in the light of the precautionary principle even if it proves impossible to carry out as full a risk assessment as possible in the particular circumstances of a given case because of the inadequate nature of the available scientific data (see to that effect Pfizer Animal Health v Council, cited above, paragraphs 160 and 162, and Alpharma v Council, cited above, paragraphs 173 and 175). Such measures presuppose, in particular, that the risk assessment available to the national authorities provides specific evidence which, without precluding scientific uncertainty, makes it possible reasonably to conclude on the basis of the most reliable scientific evidence available and the most recent results of international research that the implementation of those measures is necessary in order to avoid novel foods which pose potential risks to human health being offered on the market […].”
- 10.
For an application of the precautionary principle, although in connection with the cosmetic sector, see the Judgment of the Court of First Instance (Third Chamber) of 16 July 1998—Laboratoires pharmaceutiques Bergaderm SA and Jean-Jacques Goupil v Commission of the European Communities—Case T-199/96, pursuant to which “…where there is uncertainty as to the existence or extent of risks to the health of consumers, the institutions may take protective measures without having to wait until the reality and the seriousness of those risks become fully apparent”.
- 11.
See Melkunie Case—Judgment of the European Court of Justice (Fifth Chamber) of 6 June 1984—Criminal proceedings against CMC Melkunie BV—C-97/83: “… According to a consistent line of decisions of the Court, it follows from Article 36 that a national measure which has, or may have, a restrictive effect on trade is compatible with the Treaty only in so far as it is necessary for the purpose of effectively protecting human life and health. The proviso in Article 36 cannot therefore apply where human life and health can be protected just as effectively by measures less restrictive of intra-Community trade. […] The data available at the present stage of scientific research do not make it possible to determine with certainty the precise number of nonpathogenic micro-organisms above which a pasteurised milk product becomes a source of danger to human health. In the absence of harmonisation in this field, it is for the member-States to determine, with due regard to the requirements of the free movement of goods, the level at which they wish to ensure that human life and health are protected. In those circumstances, national legislation seeking to ensure that at the time of consumption the milk product in question does not contain micro-organisms in a quantity which may constitute a risk merely to the health of some, particularly sensitive consumers, must be considered compatible with the requirements of Article 36”.
- 12.
See Whereas 59: “A system for rapid alert already exists in the framework of Council Directive 92/59/EEC of 29 June 1992 on general product safety. The scope of the existing system includes food and industrial products but not feed. Recent food crises have demonstrated the need to set up an improved and broadened rapid alert system covering food and feed. This revised system should be managed by the Commission and include as members of the network the Member States, the Commission and the Authority. The system should not cover the Community arrangements for the early exchange of information in the event of a radiological emergency as defined in Council Decision 87/600/Euratom.”
- 13.
Data drawn from the 2013 Annual Report on the Community Alert System of the Italian Ministry of Health, which has highlighted a drop of 8.7 % compared to the previous year of notifications forwarded through the alert system by Member States (the drop between 2012 and 2011 was 7.7 %). The analysis shows that Italy is the top Member State per number of notifications sent through the RASFF system, with 534 notifications. Regarding origin, Italy is the fourth Member State per number of received notifications, after Spain, Poland, and France.
- 14.
OJEC 1976 No. 136 p. 1, as amended.
- 15.
OJEC 1976 No. L 279 p. 35, as amended.
- 16.
Besides the committees described above, towards the end of the 1970s and in the early 1980s, other entities were set up, amongst which were the Scientific Committee on cosmetology (Decision 78/45/EEC of the Commission of 19 December 1977); the advisory Scientific Committee for the examination of toxicity and ecotoxicity of chemical compounds (Decision 78/618/EEC of the Commission of 28 June 1978); the Scientific Committee for pesticides (Decision 78/436/EEC of the Commission of 21 April 1978); and the veterinary Scientific Committee (Decision 81/651/EEC of the Commission of 30 July 1981.
- 17.
See White Paper on Food Safety, paragraph 25, where it is stated that “It has become evident that the existing system is handicapped by a lack of capacity and has struggled to cope with the increase in the demands placed upon it. Furthermore, the recent dioxin crisis could only be managed by delaying works in other areas and has shown the need to have a system which is able to respond rapidly and flexibly. This lack of capacity has led to delays which have consequences both for the Commission’s legislative programmes, and hence its ability to respond to consumer health problems, and for industry where commercial dossiers are involved. This situation will be exacerbated by the increased demands that will be placed on the scientific committees resulting, for example, from the proposed programme for reform of food legislation as set out later in this White Paper”.
- 18.
Article 29 of Regulation No. 178/2002.
- 19.
See Whereas 50 of Regulation No. 178/2002: “Improved identification of emerging risks may in the long term be a major preventive instrument at the disposal of the Member States and the Community in the exercise of its policies. It is therefore necessary to assign to the Authority an anticipatory task of collecting information and exercising vigilance and providing evaluation of and information on emerging risks with a view to their prevention”.
- 20.
See EFSA Website (http://www.efsa.europa.eu/en/10thanniversary/achievements.htm), which reads: “One area in which EFSA’s work has changed significantly over the past 10 years is the evaluation of regulated products such as food additives, GMOs, pesticides and health claims, which accounts for more than 60% of the Authority’s outputs . The resources committed to this work doubled between 2008 and 2010, from 20% to 40%”.
- 21.
See EFSA Website (http://www.efsa.europa.eu/en/10thanniversary/achievements.htm), where it also reads, “As outlined in the Strategic Plan 2009-2013 and the Science Strategy 2012-2016 (adopted in 2011), the Authority increasingly will focus on integrated multi-disciplinary advice in areas such as meat inspection, nutrition and animal welfare. It will continue to ensure it performs to the highest standards through the development of state-of-the-art, harmonised methodologies and the collection and analysis of quality data”.
- 22.
See by way of example, Directive 64/433/EEC of the Council of 26 June 1964 on health problems affecting intra-Community trade in fresh meat; Directive 89/362/EEC of the Commission of 26 May 1989 on general conditions of hygiene in milk production holdings; Directive 92/46/EEC of the Council of 16 June 1992, laying down the health rules for the production and placing on the market of raw milk, heat-treated milk, and milk-based products; Directive 89/437/EEC of the Council of 20 June 1989 on hygiene and health problems affecting the production and the placing on the market of egg products; Directive 91/492/EEC of the Council of 15 July 1991 laying down the health conditions for the production and the placing on the market of live bivalve molluscs; Directive 91/493/EEC of the Council of 22 July 1991 laying down the health conditions for the production and the placing on the market of fishery products; Directive 71/118/EEC of the Council of 15 February 1971 on health problems affecting trade in fresh poultry meat; Directive 91/495/EEC of the Council of 27 November 1990 concerning public health and animal health problems affecting the production and placing on the market of rabbit meat and farmed game meat; Directive 92/45/EEC of the Council of 16 June 1992 on public health and animal health problems relating to the killing of wild game and the placing on the market of wild-game meat; and Directive 94/65/EC of the Council of 14 December 1994 laying down the requirements for the production and placing on the market of minced meat and meat preparations.
- 23.
See Article 3 of Regulation No. 852/2004—“General obligation – Food business operators shall ensure that all stages of production, processing and distribution of food under their control satisfy the relevant hygiene requirements laid down in this Regulation”.
- 24.
In this respect, see Whereas 15: “The HACCP requirements should take account of the principles contained in the Codex Alimentarius. They should provide sufficient flexibility to be applicable in all situations, including in small businesses. In particular, it is necessary to recognise that, in certain food businesses, it is not possible to identify critical control points and that, in some cases, good hygienic practices can replace the monitoring of critical control points. Similarly, the requirement of establishing “critical limits” does not imply that it is necessary to fix a numerical limit in every case. In addition, the requirement of retaining documents needs to be flexible in order to avoid undue burdens for very small businesses”.
- 25.
The pre-existing rules were specifically abrogated by Directive No. 2004/41/EC of the European Parliament and of the Council of 21 April 2004, which abrogates some Directives governing the hygiene of foodstuffs and the health rules for the production and sale of certain products of animal origin intended for human consumption, amending Directives 89/662/EEC of the Council and 92/118/EEC, together with Decision 95/408/EC of the Council.
- 26.
The Regulation does not apply (Article 1) to the direct supply, by the producer, of small quantities of primary products to the final consumer or to local retail establishments directly supplying the final consumer; the direct supply, by the producer, of small quantities of meat from poultry and lagomorphs slaughtered on a farm to the final consumer or to local retail establishments directly supplying such meat to the final consumer as fresh meat; or to hunters who supply small quantities of wild game or wild game meat directly to the final consumer or to local retail establishments directly supplying the final consumer. Save for special cases, the Regulation does not apply to retail, either.
- 27.
Thus implementing and abiding by the general traceability rules pursuant to Regulation (EC) No. 178/2002.
- 28.
See Article 17 Regulation (EC) No. 178/2002, paragraph 2: “Member States shall enforce food law, and monitor and verify that the relevant requirements of food law are fulfilled by food and feed business operators at all stages of production, processing and distribution. For that purpose, they shall maintain a system of official controls and other activities as appropriate to the circumstances, including public communication on food and feed safety and risk, food and feed safety surveillance and other monitoring activities covering all stages of production, processing and distribution. Member States shall also lay down the rules on measures and penalties applicable to infringements of food and feed law. The measures and penalties provided for shall be effective, proportionate and dissuasive”. See also Whereas 6 of Regulation (EC) No. 882/2004: “The Member States should enforce feed and food law, animal health and animal welfare rules and monitor and verify that the relevant requirements thereof are fulfilled by business operators at all stages of production, processing and distribution. Official controls should be organised for that purpose”.
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Rusconi, G. (2016). Food Safety and Policy in the European Union. In: Steier, G., Patel, K. (eds) International Food Law and Policy. Springer, Cham. https://doi.org/10.1007/978-3-319-07542-6_20
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