Abstract
Italy belongs to the European Union, therefore European rules concerning GMO have been applied in Italy. In particular, Regulation No. 1829/2003 requires that no-one can introduce a GMO destined for human consumption into the market unless both authorisation has been granted for the product and the conditions of the authorisation are respected. Italian public opinion fully shares EU worries about GMOs and the Government has been the mouthpiece for concerned citizens in two cases: in 2000, on a cautionary basis a decree suspended the marketing and utilisation of three Monsanto transgenic maize products; in 2013, a decree banned the cultivation of MON810 maize varieties deriving from genetically modified seed all over Italy. The formulation and implementation of government policies pertaining to certain subjects – as in the case of GMOs – involve complex interaction between scientific and technological questions. Therefore the juridical bodies entrusted with drawing up the legal aspects of the rules often need to consult with scientific experts who are in possession of in-depth knowledge on the subject, or they may need to call upon advanced technical analyses. On the basis of the information thereby acquired, one of the distinct opinions on the matter at hand will be selected, and will thus become the legally binding rule.
In contrast to the technocratic character of many of the current Community rules, there is a desire for greater openness of the decision-making processes to all components of society. This would allow a broader base of opinion to make a contribution to formation of the rules and to an improvement in the quality of the decisions. In other words, the overall framework of the European Union is experiencing a demand for critical revision of the system of European governance, in the direction of its democratisation.
An Italian translation of this article was published in Rivista di Diritto Agrario, Volume XCIII/2 under the title “Biotecnologie e sicurezza alimentare”
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Notes
- 1.
In Guce C 407, 28.12.1998.
- 2.
Freedom of enterprise is also guaranteed by Art. 41 of the Italian Constitution, according to which “economic initiative is free”.
- 3.
Pursuant to Directive 90/220 the standard procedure to be adopted when foodstuffs containing GMOs or constituted by or starting from GMOs were going to be introduced onto the market began with an “application” notified to the national authority that was the competent organ for the market on which the GMO products were to be launched. The notification was followed by an assessment carried out by the competent national authority, and then the application was transmitted to the Commission which, in turn, “sent it on” to the other Member States in order to allow them to put forward their observations. At the end of the 60-day period, if no objections had been raised, the Member State – or the Commission in the case of objections – made a decision with regard to the authorisation. If, due to the absence of objections, it was not necessary for the Commission to make a decision, the Member State that had set the procedure in motion, i.e. the Member State to which the applicant had submitted the request, could not refuse its “written consent” (i.e. the authorisation), but it had to complete the procedure by taking into account its own original favourable evaluation and the positive communication by the Commission (Court of Justice 231 March 2000, C-6/99, Greenpeace France). With regard to the novel foods regarded as equivalent to conventional foods, Regulation No. 258/97 provided for a simplified procedure: the notification would be sent directly to the Commission, which then transmitted a copy to the Member States and limited itself to publishing, every year, a summary of these notifications in the Official Gazette of the European Union. Once the introduction of the novel foods onto the market had been authorised, the foods in question could circulate freely in the Community market; however, Article 23 of Directive 2001/18, as had been the case earlier with Article 12 of Regulation n. 258/97, required what is known as the safeguard clause, on the basis of which “where a Member State (…) has detailed grounds for considering that a GMO as or in a product which has been properly notified and has received written consent under this Directive constitutes a risk to human health or the environment” this Member State “may provisionally restrict or prohibit the use and/or sale of that GMO as or in a product on its territory”. The safeguard clause is also invoked by Article 54 of Regulation No. 178/2002 on food safety and by Article 34 of Regulation No. 1829/2003.
- 4.
The Italian Ministerial decree states that the French Minister of Agriculture had already, in March 2012, as a cautionary measure, forbidden the sowing of a crop of MON810 maize (but then this decree was nullified by the French Conseil d’Etat, 1st August, 2013), and the Commission had not felt any duty to intervene in the form of an extension, modification or repeal of the previous authorisation. Furthermore, the Italian decree mentions the study conducted by the Federal Institute of Technology of Zurich, which claims that the Cry1Ab toxin increases the mortality of ladybird larvae.
- 5.
It should be kept in mind that Article 2 of Directive 2001/18/EC dated 12 March 2001 defines the “organism” as “any biological entity capable of replication or of transferring genetic material”, and defines the “genetically modified organism” as “an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination”.
There are three promises associated with these novel foods: (1) greater quantities of food, which will make it possible to feed the enormous and increasing world population; (2) healthier food, because the production of GMOs is subject to strict controls; (3) food obtained from less polluting agriculture, because GM plants require a lower level of herbicides and pesticides.
While these are the definite and certain advantages, the disadvantages are not so certain. But it is known that: (A) between the end of 1998 and the beginning of 1999 a British geneticist, Arpad Pusztai, who reared mice on genetically modified potatoes, noted that the immune system of the experimental mice appeared to be damaged; however, the British Royal Society defined his work as unconvincing; (B) the entomologist John Losey of Cornell University published an article in the 20 May 1999 issue of the American journal Nature, detailing his experiments on the Monarch butterfly (a butterfly having orange wings striped with black, which performs an amazing migration every year from the mountains of Mexico to the region that extends from the North-West of the USA up to southern Canada, and then returns to Mexico) reared on Asclepiadaceae dusted with BT maize; Losey noted that butterflies reared on this diet ate less, grew more slowly and had a higher mortality rate; (C) at the end of the 1980s an American company that produces food supplements by using the amino acid known as tryptophan sought to increase its production of the supplements by inserting certain genes into bacteria in order to obtain a greater quantity of enzymes, which it then purified so as to market the food supplements: all this was done without the need to apply for an authorisation from the Food and Drug Administration (FDA) since the method of producing tryptophan (with the use of “normal” bacteria or with the use of genetically modified bacteria) was regarded as irrelevant, due to application of the American principle of substantial equivalence, given that tryptophan had been on the market for years without any reports of toxic effects. But in the case of the genetic modification, the GM food supplements caused the death of 37 people and severe infirmity in over 1500 persons; (D) the September 19th, 2012, number of the journal “Le Nouvel Observateur” published an article by the French biologist Gilles-Eric Séralini presenting the results of his research concerning mice reared on Monsanto’s maize NK 603: Séralini found that after 725 days on this diet the mice had developed tumours, whereas Monsanto had declared that after 90 days on the genetically modified maize diet the mice continued to enjoy good health.
- 6.
The ethical question was taken to the Court of Justice by Holland. The Court noted, however, that the definition of GMO expressly makes mention of “the exception of human beings” (Article 2, Directive 2001/18/EC of 12 March 2001, quoted supra, note 4).
- 7.
The spectre of mad cow disease, which cows had contracted through consumption of animal meal, and the suspicion that cows suffering from this affliction had succeeded in transmitting Creutzfeldt-Jacob disease to man, raises primeval fears among consumers who do not wish to eat foodstuffs deriving from genetically modified agricultural products or who, at the very least, want to know what they are eating.
- 8.
The precautionary principle first arose as a principle designed to safeguard the environment: this approach is found, first of all, in the Declaration on Environment and Development (Conference of Rio de Janeiro, 3–14 June 1992) which states (in principle 15) that: “where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation”; it is then found in the Cartagena Protocol on Biosafety (Convention on biological diversity, 2002), which states that the “lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding the extent of the potential adverse effects of a living modified organism on the conservation and sustainable use of biological diversity in the Party of import, taking also into account risks to human health, shall not prevent that Party from taking a decision, as appropriate, with regard to the import of the living modified organism in question (…), in order to avoid or minimize such potential adverse effects”; furthermore, in article 191.2 of the Treaty on the Functioning of the European Union (TFUE) (previously Article 174 of the Treaty of Rome) in which it is stated that “Union policy on the environment shall (…) shall be based on the precautionary principle and on the principles that preventive action should be taken, that environmental damage should as a priority be rectified at source and that the polluter should pay”. Only later was the precautionary principle extended to food safety, first of all in the Sanitary and Phytosanitary Measures Agreement (attached to the Treaty of Marrakech 1994), according to which Sanitary or Phytosanitary Measures (…) shall be deemed to be necessary to protect human, animal or plant life or health (article 3.2); and subsequently in Article 7 of Regulation n. 178/2002 on food safety.
- 9.
See article 2.4 of the TBT Agreement: “Where technical regulations are required and relevant international standards exist (…) Members shall use them, or the relevant parts of them, as a basis for their regulations except when such international standards or relevant parts would be an ineffective or inappropriate means for the fulfilment of the legitimate objectives pursued, for instance because of fundamental climatic or geographical factors or fundamental technological problems”.
- 10.
See Article 2.4 of the TBT Agreement: “With a view to harmonizing technical regulations on as wide a basis as possible, Members shall play a full part, within the limits of their resources, in the preparation by appropriate international standardising bodies of international standards for products for which they either have adopted, or expect to adopt, technical regulations”.
- 11.
Cf. the WTO Report on hormone-containing meat, with reference to Community Directives 81/602 dated 31 July 1961 and 85/649 dated 31 December 1985, which forbade the use of hormones in feeds destined to bovines, and which justify this prohibition by reference to the danger of tumours that may arise in those who eat meat from bovines whose growth has been enhanced by a diet “rich” in hormones. The European Union’s prohibition on the importing of bovine meat obtained from animals fed with hormones led to a clash between the European Union and the United States of America; the dispute was brought to an end, with what was effectively a defeat of the European Union, by the WTO Panel of August 1997, partially corrected by the Appeal Organ of the WTO of 16 January 1998.
- 12.
Cf. European Communities – Measures Affecting Asbestos and Asbestos-Containing Products dated 12 March 2001.
- 13.
Cf. European Communities – Trade Description of Sardines dated 26 September 2002, which, in point 208 of the decision, states: “Furthermore, like Articles 5.1 and 5.5 of the SPS Agreement, Article 2.4 is a ‘central provision’ of the TBT Agreement, and it cannot just be assumed that such a central provision does not apply to existing measures”.
- 14.
Article 2.5 of the TBT Agreement continues: “…it shall be rebuttably presumed not to create an unnecessary obstacle to international trade”.
- 15.
Article 2.2 of the TBT Agreement asserts that the national technical rules cannot be “more trade-restrictive than necessary to fulfil a legitimate objective”; it thus indicates the national security requirements, the prevention of deceptive practices; protection of human health or safety, animal or plant life or health, or environment as “legitimate objectives”; finally it identifies as “relevant elements of consideration” the available scientific and technical information, the related processing technology or the intended end-uses of products.
- 16.
In this regard it is useful to recall the case of the Land of Upper Austria, which intended to ban genetically modified crops throughout its territory, by appealing to Art. 95.5 (which was in force at that time) of the Treaty of Rome, which stated that when there is a harmonised Community rule (as was the case for the Directive on the deliberate emission of GMOs into the environment), a Member State which believes it is necessary, on the basis of new scientific evidence, to introduce measures for the protection of the environment (or of the workplace) must notify the Commission in this regard. More specifically, the Land of Upper Austria had submitted to the Commission a draft bill of a ruling that would forbid the utilisation of biotechnology in agriculture; in submitting its draft, the Land of Upper Austria invoked the provisions laid out in Art. 95.5 of the Treaty of Rome (now Art. 114 of the TFUE). First the Commission, then the Court of First Instance (Sentence dated 5 October 2005, T-366/03, Austria v. Commission) and then the Court of Justice (Sentence 13 September 2007, C-439/05 and C-454/05, Austria v. Commission) rejected the request for authorisation, because it had not been demonstrated that the territory of the Land of Upper Austria contained special or exceptional ecosystems such as would have required a purpose-instituted risk assessment and such as would thus have warranted the prohibition on GM crops, given, also, that the justifications adduced pertaining to the limited surface area of farms in the Land in question and to their special vocation of organic farming had been rejected as insufficient.
- 17.
The same conclusion is probably reached if, on the assumption that the regional formulas are technical rules, it is pointed out that the various laws of those Italian Regions that have declared their territories to be GMO-free were not notified to the Commission, as should obligatorily have been done – under pain of absence of force of the technical rule – pursuant to Directive 98/34 dated 22 June 1998.
- 18.
In addition to (a) foods and food ingredients containing or consisting of genetically modified organisms; (b) foods and food ingredients produced from, but not containing, genetically modified organisms, the following are also novel foods: (c) foods and food ingredients with a new or intentionally modified primary molecular structure; (d) foods and food ingredients consisting of or isolated from microorganisms, fungi or algae; (e) foods and food ingredients consisting of or isolated from plants and food ingredients isolated from animals, except for foods and food ingredients obtained by traditional propagating or breeding practices and having a history of safe food use; (f) foods and food ingredients which have undergone a production process not currently used, where that process gives rise to significant changes in the composition or structure of the foods or food ingredients which affect their nutritional value, metabolism or level of undesirable substances (Article 1.2). The novel foods must not present a danger for the consumer, mislead the consumer, differ from foods or food ingredients which they are intended to replace to such an extent that their normal consumption would be nutritionally disadvantageous for the consumer (article 3.1).
- 19.
In 2008 the Commission formulated a proposal for modification of Regulation 258/1997 on novel foods; the proposal, among other things, clarified the definition of “novel food” taking into account the new technologies that have an impact on foodstuffs. The proposal was not adopted because the Council and the European Parliament failed to reach an agreement during the dispute settlement procedure, after the Parliament had proposed various amendments both during the first reading (25 March 2009) and the second reading (7 July 2010).
- 20.
The discrimen between the standard and the simplified procedure – the latter being characterised by mere notification to the Commission – was given by the equivalence of the novel food to the product already existing in nature. The recognised equivalence between novel food and the corresponding conventional food was held to be sufficient evidence that the novel food, precisely because it was equivalent to the conventional food, would be “safe” just as the conventional foodstuff was safe. Once the equivalence had been ascertained, the obligation to indicate on the label that the new food consisted of or contained GMOs was no longer imposed. The labelling obligation was also lifted when the novel food, although produced by starting from GMOs, non no longer contained any GMOs.
- 21.
The European Union intends to take action with regard to Regulation No. 258/97, including the “residual” parts that remain after the interventions of Regulations 1829 and 1830 of 2003. In particular, the Community aims, through the proposed modification put forward on 14 January 2008 [COM (2007) 0872 def.], to replace the earlier distinct procedures – maintained for the other novel foods – by a single centralised assessment procedure, and at the same time to give a single definition of “novel food” as one that “is not found to have been used to a significant extent for human consumption within the Community prior to 15 May 1997”. Such a definition seeks to gather together in a single definition all four of the previous definitions, which were governed by Regulation No. 258/97 on novel foods after the “transfer” of the rules on genetically modified foods into Regulation No. 1829/2003. This unified definition would make it possible to include any foodstuffs that new technological processes, such as cloning, nanotechnology and nanoscience, could potentially create. Thus the proposal for modification of Regulation 258/1997 on novel foods aims to clarify the definition of “novel food” taking into account the new technologies that have an impact on foodstuffs. As mentioned earlier in note 19, the proposal was not adopted because the Council and the European Parliament failed to reach an agreement during the dispute settlement procedure, after the Parliament had proposed various amendments both during the first reading (25 March 2009) and the second reading (7 July 2010).
- 22.
On the rules governing this scientific Committee see, Regulation No. 182/2011 dated 6 February 2011.
- 23.
By means of Regulation No. 258/97 dated 27 January 1997, the European Union declared that the new products and new food ingredients must bear a label indicating the presence of GMOs. Regulations Nos. 1829/2003 and 1830/2003, both dated 18 October 2003, reiterated this obligation. Therefore, probably due to concerns about the risk of so-called “mad cow disease”, and also responding to demands stemming from consumer organisations and the media, the European Union has introduced a series of provisions, all of which are designed to ensure full achievement of the right to adequate information, according to two distinct channels: one concerns the labelling of all food products (Directives 79/112 and 2000/13), while the other deals with the labelling of specific GM foods (Regulations Nos. 258/97, 49 and 50/2000; Directive 2000/18; Regulation No. 1829/2003).
The contrast between Community Law and the legal system in force in the United States, Canada and Argentina is very clear-cut. On account of the principle, maintained by these three countries, of substantial equivalence between traditional agricultural products and genetically modified agricultural products, labels indicating the presence of GMOs in the products cannot be admitted.
- 24.
This is a breach that is punished as a criminal offence, by arrest for a period ranging from 6 months to 3 years, or with a fine up to euro 51,700 (fifty-one thousand seven hundred) (Article 35.1, Decreto legislativo 224/2003).
- 25.
This is a breach that is punished as a criminal offence, by arrest for a period ranging from 6 months to 2 years, or with a fine up to euro 51,700 (fifty-one thousand seven hundred) (Article 34.2, Decreto legislativo 224/2003).
- 26.
This is a breach that results in a fine ranging from euro 7,800 (seven thousand eight hundred) to euro 46,500 (forty-six thousand five hundred) (Article 35.5, Decreto legislativo 224/2003).
- 27.
This is a breach that is punished as a criminal offense, by arrest for up to 2 years, or with a fine up to euro 51,700 (fifty-one thousand seven hundred), in the first case (Article 35.6, Decreto legislativo 224/2003), while in the second case there is a fine ranging from euro 7,800 (seven thousand eight hundred) to euro 46,500 (forty-six thousand five hundred) (Article 35.8, Decreto legislativo 224/2003).
- 28.
Section 402 A of Restatement (Second) of Torts of 1965 introduces the rule of strict liability in tort into the United States legal system; that is to say, it introduces the rule of the objective liability of producers for any harm caused by their defective products.
- 29.
On this subject see above all the work of the German sociologist, Ulrich Beck.
- 30.
Article 9 of the Directive 2001/18: “Consultation of and information to the public. 1. Member States shall, without prejudice to the provisions of Articles 7 and 25, consult the public and, where appropriate, groups on the proposed deliberate release. In doing so, Member States shall lay down arrangements for this consultation, including a reasonable time period, in order to give the public or groups the opportunity to express an opinion.// 2. Without prejudice to the provisions of Article 25: – Member States shall make available to the public information on all part B releases of GMOs in their territory; – the Commission shall make available to the public the information contained in the system of exchange of information pursuant to Article 11”.
- 31.
Article 24 of the Directive 2001/18: “Information to the public. 1. Without prejudice to Article 25, upon receipt of a notification in accordance with Article 13(1), the Commission shall immediately make available to the public the summary referred to in Article 13(2)(h). The Commission shall also make available to the public assessment reports in the case referred to in Article 14(3)(a). The public may make comments to the Commission within 30 days. The Commission shall immediately forward the comments to the competent authorities.// 2. Without prejudice to Article 25, for all GMOs which have received written consent for placing on the market or whose placing on the market was rejected as or in products under this Directive, the assessment reports carried out for these GMOs and the opinion(s) of the Scientific Committees consulted shall be made available to the public. For each product, the GMO or GMOs contained therein and the use or uses shall be clearly specified”.
- 32.
Article 9 of the Regulation n. 178/2002: “Public consultation. There shall be open and transparent public consultation, directly or through representative bodies, during the preparation, evaluation and revision of food law, except where the urgency of the matter does not allow it”.
Article 10 of the Regulation n. 178/2002: “Public information. Without prejudice to the applicable provisions of Community and national law on access to documents, where there are reasonable grounds to suspect that a food or feed may present a risk for human or animal health, then, depending on the nature, seriousness and extent of that risk, public authorities shall take appropriate steps to inform the general public of the nature of the risk to health, identifying to the fullest extent possible the food or feed, or type of food or feed, the risk that it may present, and the measures which are taken or about to be taken to prevent, reduce or eliminate that risk”..
- 33.
Article 11 of the Treaty on the European Union: “1. The institutions shall, by appropriate means, give citizens and representative associations the opportunity to make known and publicly exchange their views in all areas of Union action.// 2. The institutions shall maintain an open, transparent and regular dialogue with representative associations and civil society.// 3. The European Commission shall carry out broad consultations with parties concerned in order to ensure that the Union’s actions are coherent and transparent.// 4. Not less than one million citizens who are nationals of a significant number of Member States may take the initiative of inviting the European Commission, within the framework of its powers, to submit any appropriate proposal on matters where citizens consider that a legal act of the Union is required for the purpose of implementing the Treaties.// The procedures and conditions required for such a citizens’ initiative shall be determined in accordance with the first paragraph of Article 24 of the Treaty on the Functioning of the European Union”.
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Germanò, A., Basile, E.R. (2016). Genetic Technology and Food Security: Country Report – Italy. In: Norer, R. (eds) Genetic Technology and Food Safety. Ius Comparatum - Global Studies in Comparative Law, vol 14. Springer, Cham. https://doi.org/10.1007/978-3-319-23995-8_6
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