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Thursday, December 06, 2012

ReDeco, Revista electrónica del Derecho del consumo y la alimentación, nº 29, 27-41


 
GMO and coexistence between conventional, organic and GM crop production in Italy*

 

Dr. A. Chiarabolli

 

1. INTRODUCTION

A Genetically Modified Organism (GMO) is “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”[1]. The technologies employed to produce a GMO belongs to the field known as biotechnology, and in particular the modern use of similar methods includes genetic engineering. The genes of an organism are changed during the genetic modification process and the DNA of the organism is recombined. The application of this technology in the European Union is strictly regulated.

EU legislation on GMOs, since the early 1990s, has two main objectives: to protect human health and environment[2] and to ensure free movement of safe gm products in the European Union. Today EU gm crop rules are probably the strictest[3] in the world and in particular the following conditions must be respected:

·         All gm products to be admitted to the EU market must be authorised using a centralised European Commission authorisation procedure[4] based on an independent risk assessment carried out by the European Food Safety Authority – EFSA[5]. Consequently all gm seeds must pass through the EU authorization process before cultivation[6];

·         Authorised gm food and feed are labelled[7] (threshold 0,9%) and traced in order to guarantee freedom of choice for consumers (informed choice). The labelling rules cover all authorised GMOs for their placing on the market, that is all products, including food and feed, containing or consisting of GMOs[8];

·         For non-approved GMOs the threshold is zero (zero tolerance)[9].

Agricultural systems can be divided into three general categories: a conventional production system, a biotech production system and an organic production system. The three agricultural models can coexist in the same geographical area, but it is largely accepted that a total isolation of gm material is impossible[10]. Consequently, in order to prevent an economic loss[11], conventional and organic growers aim to avoid a gm admixture in their production[12].

Europe already has a limited experience with GM crop commercial cultivation[13]. GM varieties may not be sold and planted in Member States until they are authorised and registered in the EU Common Catalogue of Varieties of Agricultural Plant Species or in the EU Common Catalogue of Varieties of Agricultural Vegetable Species[14]. In the EU, today, only three GM crops have been authorised for cultivation[15]:

·         Two GM maize products, of which only the insect-resistant Bt maize MON810 is cultivated in the EU area[16];

·         One GM potato[17].

 

Today coexistence is the weak point in European biotechnology legislation[18] and the coexistence debate is wide and difficult[19]. The starting point of the analysis is the view of the European Commission: coexistence is an economic problem and refers to the ability of growers to make a practical and free choice between conventional, organic and GM crop production, in compliance with the legal obligations for labelling and/or purity standards[20].

European growers should have the possibility to choose their preferred agricultural system because “no form of agriculture, be it conventional, organic or agriculture using genetically modified organisms (GMOs), should be excluded in the European Union” (Whereas 1 - Recommendation No.556/2003). On the basis of the choice of the European Commission an authorized GM seed is considered a safe seed[21] and therefore it can be grown throughout the EU. The coexistence rules should implement the necessary measures to avoid a GM admixture and consequently an economic loss for conventional or organic growers. The policy objective is to preserve the choice for producers to grow their preferred crops and for consumers to buy freely conventional, organic or GM products.

In the European Union the goal of avoiding GM admixture is particularly important. GM admixture must be adventitious[22] if the presence results from natural processes, like pollen transfer or cross pollination, and technically unavoidable[23] if the techniques to protect against admixture during certain farm activities do not exist or if the application of these techniques goes beyond economic flexibility. The EU “accepts” an adventitious or technically unavoidable presence of authorized GM material in non-GM food: it is established under the 0.9% level[24]. For EU unapproved GMOs, a zero tolerance is applied.

The European Commission adopted a conceptualization of coexistence relating to the economic consequences of the introduction of GM crops[25], and even then only when those economic consequences are directly linked with the de minimis non-GMO purity threshold which has been established for the labelling of products[26]. Coexistence measures have their focus on the economic impact, on the technical segregation measures and on the possible economic consequences of admixing GM and non-GM crops because environmental and health aspects of GM crop cultivation are to be addressed during the EU authorisation procedure. The European Commission coexistence approach on the one hand balances the freedom of economic initiative[27] and on the other tries to ensure a high level of protection of human and animal health and of the environment. In the European Union, coexistence regulation is a Member State’s specific task (subsidiarity principle): article 26a of Directive No.2001/18, as amended by Article 43 of Regulation No.1829/2003, states that “Member States may take appropriate measures to avoid the adventitious presence of GMOs in other products[28]. This means that Member States have to adopt their own national strategies in order to regulate coexistence of GM crops with conventional and organic agriculture[29].

 

In next paragraph the Italian approach to coexistence between conventional, organic and GM crops productions is described.

 

2. THE ITALIAN COEXISTENCE SYSTEM

As stated in the Special Eurobarometer Report Attitudes of European citizens towards the environment 2008” the 55% of Italians are against GMOs and the USDA GAIN Report FR 9043 of 17 June 2010 placed Italy in Group 1: Negative image and no cultivation. A research “Ricerche sugli OGM in agricoltura: Risultati” carried out in 2007 by the National Food and Nutrition Research Institute (Istituto Nazionale di Ricerca per gli Alimenti e la Nutrizione - INRAN) found that 82% of Italian farmers would refuse to grow GM crops on their land while 80% of consumers describe GM products as “less natural”. The USDA GAIN Report IT 1006 of 2 February 2010 noted that the average Italian regularly uses products such as insulin and cosmetics which are manufactured using biotechnology, because Italians generally support the medical and industrial applications of biotechnology more than agricultural biotechnology. According to this Report the Italian inconsistency of agricultural biotechnology support is problematic, for the USDA point of view, Italy is losing an important opportunity to modernize its agricultural production.

Italian consumers are sensitive to the potential risks that GM food may pose to human health and environment, in 2004 a SWG research about the Italian public opinion on GMOs showed that 75% of Italian consumers is contrary to use GM food and, in 2005, the percentage of Italians who perceive GM products as positive for environment and human beings was about 12%[30]. In Italy there have been many initiatives against GMOs[31] and among these it is interesting to remember the “Italia Europa – Liberi da Ogm coalition, which for the first time promoted and organised[32] a National Consultation[33] on the question “Do you want the agro-food sector, foodstuffs and their authenticity to be at the heart of development, which includes people and regions, health and quality, and that it be sustainable and innovative, based on biodiversity and GMO free?”. The poll was conducted via web or directly at the local site member organizations and the poll result was very clear[34]: Yes (99,43%)  and No (0,57%)[35]. On April 2012 a group of 200 Italian scientists wrote an appeal to President Napolitano and Prime Minister Monti asking that Italy be given the possibility to compete in agriculture (both scientifically and economically) by putting a stop to the anti GMO policy. They underlined that without GM feed the Made in Italy would not exist because Italy’s geographic indicators make extensive use of GM feed[36].

 

In Italy the competence for coexistence lies at regional level[37], infact as explained in the following pages, for the Italian Constitution (Art.117 Italian Constitution) the Environment Protection is a matter in which the State has an exclusive power and Agriculture, which is a matter not expressly covered by State legislation, falls within the legislative power of the Italian Regions.

In Italy a discussion about GM cultivation is purely theoretical because today in Italy there are not GM crops commercial cultivations and it is also impossible to start legal GM crops commercial cultivations[38].

The only EU approved GM variety (for cultivation) of interest to Italian farmers is GM maize[39]. EU Directive No.2001/18 has been implemented through Legislative Decree[40] No.244 of 8 July 2003 “Enforcement of Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms” (Attuazione della direttiva 2001/18/CE concernente l'emissione deliberata nell'ambiente di organismi geneticamente modificati)[41]. In the coexistence scenario Italy was one of the first Member States (after Denmark and Germany) to enact a coexistence legislation: in November 2004 Italy issued Law Decree[42] No.279 of 22 November 2004 “Concerning control measures in order to ensure the coexistence of genetically modified, conventional and organic crops” (Disposizioni urgenti per assicurare la coesistenza tra le forme di agricoltura transgenica, convenzionale e biologica)[43] which became Law No.5/2005 of 28 January 2005 “Conversion into Law, with modifications, of Law Decree No. 279 of 22 November 2004” (Conversione in legge, con modificazioni, del decreto-legge 22 novembre 2004, n. 279, recante disposizioni urgenti per assicurare la coesistenza tra le forme di agricoltura transgenica, convenzionale e biologica)[44]. It was a framework law to be completed by Regional implementing regulations. The law defined the minimum regulatory framework for coexistence of GM crops with conventional and organic agriculture[45] in order not to compromise the biodiversity of the natural environment and to guarantee freedom of enterprise, consumers' right of choice and the quality and genuineness of national agricultural production (art.1 para.1 law No.5/2005). It is important to underline that the law indicated that conventional, organic, and GM farming systems should coexist and the practice of one does not compromise the practice of the others. The introduction of GM crops must occur without the slightest prejudice to existing farms and without requiring changes in normal farming techniques and the implementation of the coexistence rules must ensure farmers, production chain operators and consumers the real possibility to choose among conventional, organic and transgenic products[46]; therefore, transgenic farming must be practiced as part of production chains which are separate from those of conventional and organic farming (art.2 law No.5/2005). The law established (art.7 Law No.5/2005) the creation of the “Advisory Committee for the Coexistence of Transgenic crops with Conventional and Organic crops” (Comitato consultivo in materia di coesistenza tra colture transgeniche, convenzionali e biologiche)[47] which should consist in coexistence qualified experts with documented independence. The Committee should propose the coexistence guidelines within 120 days from the entry into force of the coexistence law. Following the guidelines each Italian Region and Self Governing Province[48] would adopt a coexistence plan[49] that shall contain the technical rules for achieving coexistence, through the use of instruments which guarantee the collaboration of the local territorial agencies on the basis of the principles of subsidiarity, differentiation and proportionality (art.4 law No.5/2005). The final text of the law, after conversion of the Decree into Law, removed the first deadline by which each of the Italian Regions should approve their coexistence plans, initially set at the end of 2005 (31 December 2005), so there is not new deadline for the regional coexistence plans endorsement, and until regional rules were adopted transgenic crops would not be permitted in Italy (art.8 Law No.5/2005). In this way, the law established an indefinite moratorium over GM cultivation in Italy. In order to mitigate this effect, an agreement between the Ministry of Agriculture and the Regions fixed a new deadline. This agreement stated that the Ministry of Agriculture, Food and Rural Policies would have had six months after the approval of the law in order to issue the Ministerial Decree fixing the guidelines for the Regions (deadline 31 July 2005) and after then, the Regions would have one more year to establish their coexistence laws (deadline 31 July 2006) but today, as explained in the following pages, there are not neither Official Guidelines nor Regional coexistence laws. Farmers, and the other parties identified in the coexistence plan, are required to observe the measures specified in their farm coexistence plan and if a conventional or organic farmer will suffer a damage due to disrespect of coexistence measures by GM crop growers, the suffering farmer is entitled to compensation which shall be paid by whatever party has caused the damage (Art.5 Law No.5/2005)[50]. Farmers who fail to comply with the coexistence plan measures shall be fined a minimum of EUR 2.500,00 and a maximum of EUR 25.000,00 and farmers who will cultivate GM crops during the period of moratorium over GM cultivation[51] will be punished by imprisonment for one to two years or by a fine of Euro 5.000,00 to 50.000,00 (Art.6 Law No.5/2005).

In March 2006, after a Region Marche Appeal[52], with Judgment No.116/2006 of 17 March 2006 the Italian Constitutional Court (Corte Costituzionale) ruled that Law No.5/2005 was unconstitutional in consideration of the Regions’ exclusive right to establish the coexistence rules[53]. The Court upheld only the first two articles of law No.5/2005, which state the definition of transgenic, organic, and conventional farming and set out the principle of coexistence and the resulting freedom of choice for Italian consumers and Italian growers[54]. From a constitutional perspective the focus of the issue was the question of competence, recognizing that the Regions have exclusive right to determine the coexistence rules between the three types of cultivation: conventional, organic and transgenic. Coexistence of GM crops with conventional and organic agriculture is essentially related to the agricultural matter which is subject to regional rules as stated by the fourth paragraph of art.117 of the Italian Constitution, The Regions have legislative powers in all subject matters which are not expressly covered by State legislation[55]. It should be emphasized that Agriculture covers Food Production and Environment Protection (matter in which the State has an exclusive power). In the case of coexistence, the reference is clear to the Food Production and because agriculture is not included in the list of para.2 of art.117 Constitution and it is not referred to para.3 of art.117 Constitution, it must be regarded as covered in para.4 of art.117 Const., and therefore it falls within the legislative power of the Italian Regions[56], “Scelte del genere sono peraltro lesive della competenza legislativa delle Regioni nella materia agricoltura, dal momento che non può essere negato, in tale ambito, l'esercizio del potere legislativo da parte delle Regioni per disciplinare le modalità di applicazione del principio di coesistenza nei diversi territori regionali, notoriamente molto differenziati dal punto di vista morfologico e produttivo”[57]. As a consequence, Italian Regions and Self Governing Provinces are the only Authorities eligible to issue coexistence regulations.

Therefore the Ministry of Agriculture enacted the Ministerial Circular Letter of 31 March 2006 (Circolare 31 Marzo 2006 del Ministero delle Politiche Agricole e Forestali – “d.l. 279/2004, convertito con modificazioni in legge 5/2005 – sentenza Corte Costituzionale n.116/2006 – Coesistenza – Moratoria – Semina OGM), a kind of summary of coexistence legislation, establishing[58]:

·         a moratorium on GM crops planting until definition of the Regional coexistence plans, which have never been formally adopted;

·         the rules established with Ministerial Decree of the Agricultural Ministry 27/11/2003[59] will apply as to tolerance thresholds for seeds;

·         non compliance with the GM cultivation ban will be punished with the penalties established at art.1 para.5 of Legislative Decree No.212 of 24 April 2001[60], (anyone who grows GM seeds without the authorization of the Ministry of Agriculture, Food and Forestry Policies shall be punished with a penalty of from six months to three years or a fine up to € 51,700. The same penalty applies in case of revocation or suspension of the authorization).

In October 2006 the Ministry of Agriculture, Food and Forestry Policies  created a Technical Working Group[61] within the State-Regions Conference (Conferenza Stato-Regioni)[62], with the task to work out the general guidelines to be followed by the Regions when establishing their coexistence rules[63]. On 18 October 2007 the group published the “Coexistence Technical Guideline as a baseline for Regional Coexistence Measures” (Linee Guida per le normative regionali di coesistenza tra colture convenzionali, biologiche e geneticamente modificate) but the Region Presidents have not yet approved[64] the document creating a de facto moratorium on GM crops commercial cultivation in Italy[65]. The coexistence guidelines’ key points are[66]:

 

a) Authorization and Information System

Authorised GM crops may be cultivated only by GM crop growers who have previously received the official approval of the Region or Self Governing Province[67]. GM crop commercial cultivation is not allowed in Protected Areas, Natura 2000 Areas, Areas for the Protection and Conservation of Agronomic Biodiversity and Quality Production Areas. The GM crop grower has to send an Authorisation Notification to the Region or Self Governing Province[68] and he must necessarily notify the following data[69]: name and address of the GM crop grower; farm management coexistence plan (Piano di Gestione Aziendale - PGA)[70]; species and variety of the GM crops; location of the fields containing GM crops and the field size (ha)[71]; foreseen period of sowing; proof of having informed the neighbouring farmers about the intention to start a GM crop commercial cultivation[72]; proof of attendance of the coexistence training course (Patentino di Competenza - PC)[73]; and also in case of rented land the application has to contain a copy of the formal owner agreement. After obtaining authorisation for the GM cultivation the grower also has to notify to the Regional Agricultural Service the proof of the payment of the regional tariff per hectare for the GM crop cultivation[74] and also before sowing GM material the GM crop grower must take an insurance policy to cover any damage caused during GM crops commercial cultivation[75]. The Regions must organise a Regional Public Register[76] where anyone can find all the information about the authorised GM crops commercial cultivation[77].

 

b) GM seed sale

The GM seed seller shall be approved by the Region covering the area where the business is located.

 

c) Cultivation Measures

During GM crops commercial cultivation GM crop growers have to respect the provisions of the Farm Management Coexistence Plan[78]. GM crop grower must keep, for each GM cultivation site, a Register containing the following information[79]: data of the GM seeds suppliers; data of the service providers; data of all workers[80]; data of all vehicles, machineries, materials and stores used during GM crops commercial cultivation; farming operations performed; data of buyers of GM products. During GM crops commercial cultivation a GM crop grower necessarily has to respect the segregation measures: compulsory border rows with conventional/organic cultivation, isolation distances and possible additional border rows with a consequent reduction of the isolation distance. The guidelines foresee the following cultivation distances[81]: (for maize) 1000 meters as a distance to minimize the risk of GM admixture with the objective of ensuring an admixture rate  and 300 meters as a distance to minimize the risk of admixture with the objective of ensuring an admixture rate (0,9%)[82].

 

d) Control Activity and Liability Measures

The Authorities must set up a continuous monitoring activity to verify the effectiveness of measures and instruments adopted in order to develop a continuous assessment. In the case of GM admixture, Civil Liability rules will apply. A grower is excluded from any responsibility if he used certified non-GM seeds. The guidelines foresee the creation of a Regional Compensation Fund to compensate the damages resulting from the presence of GM material in other products or soils which cannot be compensated under civil liability rules[83]. The suffering farmer has to prove the economic damage suffered by the presence of GM material[84] and the Fund will compensate: the market price difference between conventional or organic product and GM product; test costs and indirect losses resulting from the change of market channels.

 

In January 2010 the State Council (Consiglio di Stato)[85] with judgment No.183 of 19 January 2010[86] instructed the Ministry of Agriculture, Food and Rural Policies to allow the planting of GM maize and stated that the Ministry should issue procedures for GM maize cultivation within 90 days from the communication of the decision or, if earlier, from the notification of the decision[87]. The Italian GM crop growers have the legitimate right to plant GM crops authorised at European level and listed in the Common Catalogue of Varieties and planting authorizations are not subject to the release of the coexistence regulations[88]. Given the economic profiles to be regulated by the regional coexistence plans and given that the coexistence plans are not within the environmental and health aspects, the granting of cultivation can not be conditioned by the prior adoption of the regional coexistence plans.

Then, in February 2010, the Regional Administrative Court of Lazio (Tribunale Amministrativo Regionale del Lazio – TAR LAZIO) with judgment No.2378/2010 of 17 February 2010, following an appeal by “Monsanto Agricultura Italy Spa” sanctioned the GM maize hybrids cultivation ban and the failure, by the Ministry of Agriculture, Food and Rural Policies, to register the GM maize applications in the National Register of Varieties of Agricultural Species. The ruling denied the legitimacy of the Ministry’s position that the issue of the permits would be conditional to the implementation by the Regional Coexistence Laws[89]. The Administrative Court also stated that the Ministry has to cover, even directly, the way to ensure, in the same territory, the coexistence between the different cultivations, under the power granted to the State by art.117 para.5 of the Italian Constitution[90] in the event of failure to implement the EU obligations concerning not only the need to avoid restrictions on the use and movement of GMOs, but also to safeguard biodiversity, to guarantee the freedom of private economic initiative, the freedom of consumer choice and the quality and uniqueness of the national food production.

Despite the ruling of the State Council, Italian GM crop growers have not been able to start a GM crops commercial cultivation; in fact, the joint Decree 19 March 2010 of the Ministry of Agriculture, Food and Rural Policies, Ministry of Health and Ministry of Environment rejected the authorisation for Silvano Dalla Libera to start a GM maize commercial cultivation. The Decree is very simple and it consists in only one article “The request to plant GM corn hybrids, including the Mon810 event, submitted by the Dalla Libera Silvano Farm on 08/14/2006 is rejected”[91]. For the Decree the coexistence between conventional, organic and GM crops is not possible in Italy, in view of the precautionary principle and in view of the fragmented structure of the local agriculture[92].

Finally, in June 2011, the Regional Administrative Court of Lazio (TAR LAZIO) with judgement No.5532/2011[93] annulled the Decree 19 March 2010 for violating national law and the Court noted that all GM cultivation regulations pending in the Ministry may not be stopped or suspended for specific political reasons[94] and consequently Italy, as others EU Member States, appears likely to invoke the safeguard clause to prevent the GM crops commercial cultivations authorised in the EU[95], infact Italy, as EU Member State, in principle, may not prohibit the cultivation of an authorised GM crops[96].

 














[*] Este artículo ha sido publicado como un adelanto del contenido del Liber Amicorum Luis González Vaqué, que se presentará en breve.

[1] Art.2 Directive No.2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms.


[2] “The regulatory framework must provide for a high level of protection for human health and the environment based on sound science and at the same time should also allow society to profit from the benefits of these new technologies…” (Source: European Commission  MEMO/01/42, 16 February 2001, Commissioner for Consumer Protection and Health).


[3] See Pollack M.A., Shaffer G.C., When Cooperation Fails, Oxford University Press, 2009 where the author notes that the EU regulatory system, despite its modifications over the past decade, remains a strict and precautionary system and also McHughen A., Introduction to the GM crops special issue on biosafety, food and GM regulation, in GM Crops and Food: Biotechnology in Agriculture and the Food Chain 3:1, 1–3; January/February 2012, Landes Bioscience.


[4] The EU rules established two different authorisation procedures (for a short summary of the procedures see the European Commission MEMO/10/58 of 13 July 2010):

1) Procedure relating to GM food and feed if those GMOs are to be used as source material in food and feed production (Under Regulation No.1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed). Reg. 1829 puts in place a centralised, uniform and transparent procedure for all applications for placing on the market of GMOs, whether they concern the genetic modified organisms or the food and feed derived therefrom.

2) Procedure relating the deliberate release of GMOs into the environment (Under Directive No.2001/18) for uses other than food/feed.


[5] Art.18 para.1 of Regulation 1829/2003 states that the EFSA should attempt to give its opinion within a period of 6 months from receipt of a valid application.


[6] Only authorised GMOs can be cultivated in the EU.


[7] Worldwide Biotechnology regulation can be divided into two different systems. The first one, typical in the USA, relies on the principle of substantial equivalence, a concept maintaining that a GM food should be considered the same as and as safe as a conventional food if it demonstrates the same characteristics and composition as the conventional food (Product School). The second one, typical in Europe, concentrates on the method of production, arguing that GMOs are produced by different technology (Process School). In the EU for all products consisting of or containing GMOs (threshold 0.9%), Regulation (EC) No.1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC requires that operators indicate on a label “This product contains genetically modified organisms” or “This product contains genetically modified [(name of organism(s)”. The Regulation does not require labelling for products produced with GMOs or products from animals fed with GM feed. In fact, according to European law, the meat, milk and eggs from animals which have been fed with genetically modified feed need not be identified specially. The GMO labelling requirement applies only to products which have been produced directly from genetically modified plants.


[8] Any presence of GM material (however small but more than 0.9%) would need to be labelled. 


[9] The European Commission on 24 June 2011 adopted the Regulation No. 619/2011 laying down the methods of sampling and analysis for the official control of feed as regards presence of genetically modified material for which an authorisation procedure is pending or the authorisation of which has expired. The new regulation sets at 0.1% the technical zero level  (in the Regulation, the technical zero is referred to as the Minimum Requited Performance Limit or MRPL). It is important to remember that the 0.1% threshold will only apply to imports of animal feed and not human food.


[10] Agriculture is an open process, which means that, in practice, a perfect segregation of different agricultural production types is not possible. See Easthman K. & Sweet J., Genetically modified organism: the significance of gene flow through pollen transfer, European Environment Agency Eds, 2002.


[11] See Rosso Grossman M., The coexistence of GM and other crops in the European Union, in KLP 16-3: 2007 and Rosso Grossman M., Coexistence of Genetically Modified, Conventional, and Organic Crops in the European Union: The Community Framework, in Cardwell M., Bodiguel L., The Regulation of GMOs: Comparative Approaches, Oxford University Press, 2010. See also Carpenter E., Impact of GM Crop in Biodiversity, in GM Crops and Food: Biotechnology in Agriculture and the Food Chain 2:1, 7–23; January/February/March 2011, Landes Bioscience.


[12] From a regulatory European standpoint, the key benchmark for distinguishing GM and non-GM product is the 0.9% food and feed labelling threshold for adventitious GM presence adopted by the EU.


[13] It is important to underline that in the EU, in the past 5 years,  public concern in the EU about GMOs has increased to 66%, up 4 points (Source: Organic farming dwarfs GM crop production in Europe, Friends of the Earth Europe, 2012 and European Commission, Eurobarometer 354: Food-related risks, November 2010).


[14] The Council Directive No.2002/53/EC of 13 June 2002 on the common catalogue of varieties of agricultural plant species and the Council Directive No.2002/55/EC of 13 June 2002 on marketing of vegetable created the legal basis for the establishment of the EU Common Catalogue of Varieties of Agricultural Plant Species and for the EU Common Catalogue of Varieties of Agricultural Vegetable Species.


[15] Source: European Commission IP/10/1181 Brussels, 27 September 2010.


[16] The big European Bt maize MON 810 grower is Spain. For an analysis see USDA, GAIN Report SP 1221 of 21 June 2012.  In 2011 in Spain 97,346 hectares were planted with Maize Mon 810 (Source: Organic farming dwarfs GM crop production in Europe, Friends of the Earth Europe, 2012). Six EU countries grow Bt maize: Spain, Portugal, the Czech Republic, Poland, Slovakia, Romania and Germany and, at the same time, six European countries have  banned the MON810 cultivations: France, Germany, Austria, Greece, Hungary and Luxemburg (Source: ISAAA Brief 42-2010, Executive Summary - Global Status of Commercialized Biotech/GM Crops: 2010).


[17] In 2011 the GM potato was planted on only 18 hectares in Sweden and Germany but the cultivation is banned in 3 EU Countries (Austria, Luxembourg and Hungary) because of the presence of an antibiotic resistance marker (ARM) gene (Source: Organic farming dwarfs GM crop production in Europe, Friends of the Earth Europe, 2012).


[18] With the Communication of 13 July 2010 on the freedom for Member States to decide on the cultivation of genetically modified crops the European Commission noted that, on the basis of the Council Conclusions of December 2008, the current legislative framework on Genetic modified organisms is comprehensive and complete but it is necessary to better implement the rules on GM crops commercial cultivations.


[19] In every Member State there is a different coexistence approach. “I am convinced that coexistence can be achieved by using appropriate measures that are well adapted to the different local conditions in the different regions. There is a need for feasible and pragmatic solutions” (Source: Commissioner Fisher Boel, Speech 27 June 2005).


[20] Whereas 3- Commission Recommendation No.556 of 23 July 2003 on guidelines for the development of national strategies and best practices to ensure the coexistence of genetically modified crops with conventional and organic farming.


[21] The seed is authorized and consequently the seed is safe and the coexistence measures must not be environmental or health risks management measures.


[22] The American Seed Trade Association defines the adventitious presence  as “the unintended or unintentional presence of another seed variety or genetic material, and/or trait(s) from another variety as a result of natural, mechanical, or human means” (Source: American Seed Trade Association, What is Adventitious Presence in Seed?, paper available in the internet site www.amseed.com).


[23] It implied a burden to demonstrate that the presence was truly unavoidable.


[24] The threshold plays a very important role in the European Biotechnology system (labelling threshold) and also in the coexistence scenario. The threshold defines the limit for compulsory labelling. An important question arises: is 0.9% the right level? It is important to remember, in this scenario, a recent research published in 2010 and carried out by Risgo L., Areal J.F., Sanvido O., Rodriguez.Cerezo E., Distances needed to limit cross-fertilization between GM and conventional maize in Europe, in Nature Biotechnology, 8, 2010, which shows that separating fields by 40 meters is sufficient to keep GM adventitious presence below the legal labelling threshold. The above distance (40 meters) is needed to keep cross fertilization below 0.5% with a probability higher than 90% and non GM maize pollen barriers have been proven to reduce cross-fertilization rates more effectively than an isolation of the same distance.


[25] Most significantly, the European Commission presents coexistence as an economic issue: coexistence measures are not designed to avoid environmental or health risks because these risks are addressed case by case in the European authorisation process (all environmental or health issues are dealt with in authorisation process or will be dealt with by safeguard clauses).


[26] Thijs F.M. Etty, Legal Brief On Coexistence – Best National Practices for Regulating the Cultivation of GMOs, 28 November 2007.


[27] A GM crop grower shall not be burdened with additional costs.


[28] And also para.2 art.26a defines that “The Commission shall gather and coordinate information based on studies at Community and national level, observe the developments regarding coexistence in the Member States and, on the basis of the information and observations, develop guidelines on the coexistence of genetically modified, conventional and organic crops”. Article 26a of Directive No.2001/18 must be read together with Article 22 of Directive No.2001/18 which provides that “Member States may not prohibit, restrict or impede the placing on the market of GMOs … which comply with the requirements of this Directive”.


[29] In this scenario it is important to recall the Directive 98/34/EC of the European Parliament and of the Council laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on information society services.


[30] See Gaskell G., Stares S., Allansdottir A., Allum N., Corchero C., Fischler C., Hampel J., Jackson J., Kronberger N., Mejlgaard N., Revuelta G., Schreiner C. , Torgersen H. and Wagner W., Europeans and Biotechnology in 2005: Patterns and Trends, 2006 and Harrison R.W., Boccaletti S., House L., Risk perceptions of urban and United States Consumers for Genetically Modified Foods, in AgBioForum, 7(4): 195-201, 2004. See also Gibson J., Markets in Tradition - Traditional Agricultural Communities in Italy and the Impact of GMOs, in SCRIPT-ed, Vol. 3, No. 3, 2006. Available at SSRN: http://ssrn.com/abstract=1128059.


[31] The initiatives of GreenPeace, Coldiretti, Friends of the Earth, the Italian GM Free Regions and Genetic Rights Council. There were also some actions pro GMOs as the initiatives of Confagricoltura or Assobiotech. In this scenario it is useful to remember that in November 2004 about 20 most significant Italian scientific societies working in the agronomic field and representing over 10.000 scientists signed and publicized a Consensus Document on "Food Safety and GMOs" where they noted that GMOs are governed by rules unparalleled elsewhere in the food industry and consequently they are more strictly controlled than any other food product. Authorised GM foods on the EU market have now passed a lot of safety tests and controls (see the rigid authorization process under the rules of Regulation 1829/2003) and have been properly authorized: therefore, on the basis of current knowledge, they should be considered safe for both human and animal consumption. The document concluded that all GMOs on the market are safe and any manichean approach should be laid aside and replaced by a rational approval, based on correct scientific information.


[32] From 15 September to 15 November 2007.


[33] The coalition called the initiative National Consultation but in reality it was very limited (about 3.000.000 voters).


[34] On the basis of 3.086.524 voters. The overwhelming victory of the votes against GM products was clear because the initiative came from and was supported by an anti-GM organization.


[35] Source: www.liberidaogm.org.


[36] Source: USDA, GAIN Report IT 1123 of 07 July 2012.


[37] As an EU Member State, Italy may not exclude any type of farming from its territory, nor may it prohibit the cultivation of GM crops of the varieties appearing in the Common Catalogue of Agricultural Varieties or in the Common Catalogue of Varieties of Vegetable Species.


[38] Source: Executive Summary ISAAA, Global Status of Commercialized Biotech/GM Crops: 2010, Brief 42:2011. Italy has never deposited a safeguard clause under article 23 of the EU Directive No.2001/18 and there is not a coexistence law in force. “For the past decade, Italy has maintained a de facto ban on the cultivation of biotech crops by failing to develop necessary regulations…” Source: USDA, GAIN Report IT 1127 of 06 July 2011. See also Bodiguel L., Cardwell M., Carretero Garcia A.,, Viti D., Coexistence of Genetically Modified, Conventional, and Organic Crops in the European Union: National Implementation, in Cardwell M., Bodiguel L., The Regulation of GMOs: Comparative Approaches, Oxford University Press, 2010 and Rosso Grossman M., The coexistence of Gm and other crops in the European Union, KLP 16-3: 2007.


[39] Source: USDA GAIN Report IT 7016, 19 July 2007.


[40] Art.76 of the Italian Constitution specifies the role of a Legislative Decree “The exercise of the legislative function may not be delegated to the Government unless principles and criteria have been established and then only for a limited time and for specified purposes” (Art.76 Constitution of the Italian Republic).


[41] The Decree acknowledges all principles contained in Directive 2001/18. It was published in the Official Journal of the Italian Republic No.194 of 22 August 2003.


[42] A Law Decree is an urgent temporary law promulgated by the Government and it is valid for 60 days. A Law Decree loses its effect if within 60 days, unless it is reissued, the two chambers of the Parliament fail to approve it and thus convert it into a law, as stated by Art.77 of the Italian Constitution.


[43] The Italian Coexistence Law-Decree. It was published in the Official Journal of the Italian Republic No.280 of 29 November 2004.


[44] It was published in the official Journal of the Italian Republic No. 22 of 28 January 2005. See also Barone A., Organismi geneticamente modificarti e rischi per la libertà economica: prime riflessioni sulla legge 28 gennaio 2005 n. 5, in Foro it., V, 2005;


[45] The law is general (a framework law) and it does not contain technical specifications but only the principles and objectives which need to be followed to protect consumers’ and growers’ freedom of choice. The implementation of coexistence rules must assure farmers, production chain operators and consumers the possibility to choose among conventional, organic and transgenic products. Also GM crops production must be practiced as a separate chain from those of conventional and organic farming (Art.2 para.3 Law No.5/2005). Field trials are out of the scope of this provision.


[46] The law guarantees the principle of freedom of choice for Italian farmers.


[47] The Advisory Committee should be instituted as part of the Ministry of Agriculture, Food and Forestry Policies (Ministero delle Politiche Agricole, Alimentari e Forestali).


[48] Trento and Bolzano.


[49] The Regional Plans will develop the technical rules for coexistence, identifying the best agricultural practices.


[50] The parties who fail to comply with the measures bear the burden of proof arising from their non compliance. GM crop growers will not be held liable for the economic loss if they have used certified seeds.


[51] It is the period before the competent Region has issued a Coexistence Law.


[52] The appeal, notified on 22 March 2005, focused on allocations of legislative competences. The complaints focused on a statutory provision which conferred to the State the power to legislate, even if the contamination problem concerned not only a matter of exclusive legislative competence of the Central State (protection of the environment, the ecosystem and cultural heritage), but also of concurrent competence between State and Regions (health protection) and exclusive competence of Regions (agriculture).


[53] For an analysis in italian language see, for example, Altili P., La coesistenza tra colture transgeniche e colture convenzionali nella sentenza della Corte Costituzionale n. 116 del 17 marzo 2006, in Diritto e Giurisprudenza agraria, alimentare e dell’ambiente, II, 2007; Motroni M., La disciplina degli OGM a metà tra ‹‹tutela dell'ambiente›› e ‹‹agricoltura››, ovvero della problematica 'coesistenza' di competenze legislative statali e regionali, in Federalismi.it, 18, 2006; Borghi P., Colture geneticamente modificate, ordinamenti e competenze: problemi di coesistenza, in Le Regioni, 5, 2006.


[54] “…sono da ritenersi non fondate le censure rivolte avverso gli artt. 1 e 2 del decreto-legge n. 279 del 2004, giacché tali disposizioni, nel fornire una definizione di colture transgeniche, biologiche e convenzionali, e nell'affermare il principio di coesistenza di tali colture, in forme tali da “tutelarne le peculiarità e le specificità produttive”, sono espressive della competenza esclusiva dello Stato nella materia “tutela dell'ambiente”, e della competenza concorrente nella materia “tutela della salute…” (Judgement No.116/2006 Italian Constitutional Court).


[55] “Legislative powers shall be vested in the State and the Regions in compliance with the Constitution and with the constraints deriving from EU legislation and international obligations. The State has exclusive legislative powers in the following matters… ……            s) protection of the environment, the ecosystem and cultural heritage.

Concurring legislation applies to the following subject matters: international and EU relations of the Regions; foreign trade; job protection and safety; education, subject to the autonomy of educational institutions and with the exception of vocational education and training; professions; scientific and technological research and innovation support for productive sectors; health protection; nutrition; sports; disaster relief; land-use planning; civil ports and airports; large transport and navigation networks; communications; national production, transport and distribution of energy; complementary and supplementary social security; harmonisation of public accounts and co-ordination of public finance and taxation system; enhancement of cultural and environmental properties, including the promotion and organisation of cultural activities; savings banks, rural banks, regional credit institutions; regional land and agricultural credit institutions. In the subject matters covered by concurring legislation legislative powers are vested in the Regions, except for the determination of the fundamental principles, which are laid down in State legislation.

The Regions have legislative powers in all subject matters which are not expressly covered by State legislation………….. (Art.117 Constitution of the Italian Republic). For the Italian Constitution the Environment Protection is a matter in which the State has an exclusive power and Agriculture, which is a matter not expressly covered by State legislation, falls within the legislative power of the Italian Regions. See Germanò A., Manuale di diritto agrario, Giappichelli, 2010, pag.36.


[56] Cultivation for GM production touches the heart Agriculture subject and it is a regional matter (la materia deve essere disciplinata in via residuale a livello regionale). See Tarchi R., Agricoltura e ambiente, in Rook Basile E. (a cura di), Dopo la modifica dell’art. 117 Cost.: problemi ed esperienze sulla competenza della materia agricoltura (Atti del Convegno IDAIC in Siena, 25-26 novembre 2005), Milano, 2006.


[57] Judgement No.116/2006. The power to adopt, by law, coexistence rules is attributed to Italian Regions because of the “nocciolo duro” of the matter agriculture, according to the Court, coincides with the production, for food, of plants and animals (Source: Motroni M., La disciplina degli OGM a metà tra ‹‹tutela dell'ambiente›› e ‹‹agricoltura››, ovvero della problematica 'coesistenza' di competenze legislative statali e regionali, in Federalismi.it, 18, 2006).


[58] See Martirano L., Divieto confermato alle colture transgeniche, in L’Informatore Agrario n.15 del 7/13 aprile 2006, pag. 9.


[59] Agricultural Ministry Ministerial Decree 2003 of November 2003 “Measures for control of maize and soybean seeds for the presence of GMO”. Under the Ministerial Circular disposition, GM crops commercial cultivations are not allowed in Italy until the adoption of regional laws that regulate coexistence between conventional, organic and GM crop production and the identification of appropriate solutions to manage coexistence between neighboring areas.


[60] Legislative Decree No.212 of 24 April 2001 “Implementation of Directives 98/95/EC and 98/96/EC on the marketing of seeds and on the common catalogue of varieties of agricultural plant species and on the specific controls” (The Decree was published in the Official Journal of the Italian Republic No.131 of 8 June 2001).


[61] Under the coordination of the Ministry of Agriculture, Food and Rural Policies.


[62] The State-Regions Conference on 11 September 2006 published the Dossier OGM where they noted the four possible following scenarios for the Italian Coexistence Approach: Scenario a) No measures of Regional Moratorium (High exposure to indiscriminate introduction of GM seeds in agriculture, taking advantage of regulatory gaps in regional and state legislations); Scenario b) Regional Moratorium (temporary or no expiry date); Scenario c) Review existing GMO legislations (rules notified to the European Commission under Directive 98/34 or rules not notified to the European Commission under Directive 98/34); Scenario d) National Moratorium about GM crops cultivation.


[63] General Guidelines to provide a basis for the regions to draw up detailed coexistence plans.


[64] See in Italian language: Bussinello O., Chiarello L., Vuoi produrre OGM? Paga la tassa, Italia Oggi, pag.29, 16/01/2010; Fornovo L., L’Italia sdogana gli OGM, La Stampa, pag,23, 17/01/2010; OGM le Regioni bloccano l’esame del documento sulla coesistenza, La Stampa, pag.26, 23/01/2010.


[65] The Guidelines are like a manual which will be useful (when officially approved) for the future regional coexistence laws. The State-Regions Conference has chosen, as a basic principle, the acceptance of coexistence among conventional or organic and GM crops cultivation but this choice does not appear to be shared by the Italian GM free Regions; in fact the Guidelines are not official because they are only a draft and they are not approved by the Presidents of the Italian Regions.


[66] It is important to remember that the Guidelines are only a draft measure because they are not yet approved. The Guidelines cover GM maize and GM rape commercial cultivation and GM soybean as a crop approved for animal feed. For maize two levels of tolerance will apply: under 0,01% (absence of GM admixture) and 0.9%. For soya one level will apply: under 0,01%. For a legal analysis see Paoloni L. (2008), Le linee guida per la coesistenza tra colture convenzionali, biologiche e geneticamente modificate, in Rivista di Diritto Alimentare, Anno II, n° 2, aprile-giugno 2008.


[67] Covering the area where the farm is located.


[68] By the end of November of the previous year and in any case at least 3 months before the date of sowing GM crops.


[69] Chapter 9 of the Coexistence Guidelines. 


[70] The PGA has to contain following information: techniques used for the separation of the fields, the conservation of seeds, sowing, harvesting, transport and storage of products; Activities during GM crops cultivation; destination of the products (Chapter 7 para e) of the Guidelines).


[71] Cadastral Reference of the Area.


[72] (Chapter 7 para b) of the Guidelines). A GM crop grower has to inform the nearest farms in conformity with procedures established by the Region or Self Governing Province.


[73] (Chapter 7 para d) of the Guidelines). GM crop growers must attend a Regional Training Course about coexistence rules.


[74] Chapter 7 para i) of the Guidelines.


[75] Chapter 7 para j) of the Guidelines. Today in Italy there is no such type of insurance and also in EU Member States there is no such type of insurance (Source: European Commission, Staff Working Document accompanying the Report from the Commission to the Council and to the European Parliament, on the coexistence of genetically modified crops with conventional and organic farming. Implementation of national measures on the coexistence of GM crops with conventional and organic farming, 2 April 2009).


[76] The Register is published in the internet web site of the Region.


[77] Chapter 10 of the Guidelines.


[78] Anyone mentioned in the Farm Coexistence Plan is meant to respect the coexistence measures. The Farm Coexistence Plan must be drafted on the basis of the Regional law.


[79] Chapter 7 para g) of the Guidelines.


[80] It is compulsory for GM workers as well to attend a GM training course.


[81] The cultivation distances established in the national Guidelines are general; in order to be effective and legal they must be established at regional level.


[82] Today the available researches made in Italy are based largely on simulations with mathematical models. In the Italian scenario it is important to remember the scientific study by the Documentation Centre on Agricultural Biotechnology (CEDAB) presented on 27 January 2006 during the Workshop Vegetalia. The research shows that in the Po Valley, under optimal conditions, the GM maize gene flow falls below the critical threshold of 0.9% at a distance from the source of pollen of 17.5 meters, and below 0.5% at a distance from the source of pollen of 30 meters. The results of the research involved about 40 hectares in different areas of Lombardy Region and they are in line with similar field trials conducted in Germany by the Institut für Pflanzenschutz und Pflanzenzüchtung of Halle and in Switzerland by the Institut für Pflanzenwissenschaften of Zurich. (Source: Comunicato stampa del CEDAB 27/01/2006 “Aree Cuscinetto di 20 metri limitano il flusso genico tra colture di mais contigue a valori inferiori allo 0,9% indicato dalla UE come soglia per la coesistenza tra colture ogm, convenzionali e biologiche – www.cedab.it).


[83] Chapter 12 of the Guidelines.


[84] With qualitative analysis (detection of the contaminant) and quantitative analysis (detection of the contaminant’s quantity).


[85] The highest Court of Appeals in Italy.


[86] The case was brought to the Council of State by farmer Silvano Dalla Libera, a member of Futuragra, a pro-biotech farming association. In April 2007 the Ministry of Agriculture rejected Dalla Libera’s request for legal authorization to start a GM maize commercial cultivation; therefore the farmer started a legal action. The claimant showed the impossibility to start a GM maize commercial cultivation in Italy due to the non adoption of the Regional Coexistence Plans.


[87] The Council’s ruling means that the Government can no longer delay the approval procedures. As a member of the European Union, Italy is required to allow biotech cultivation for the EU approved varieties. The Italian Minister of Agriculture, Food and Rural Policies referring to the Council decision, noted that “...the overwhelming majority of farmers don’t want genetically modified plants in their fields” (Source: Italian court gives GM go-ahead, in GMO-Compass news of 5 February 2010). See also United States Department of Agriculture GAIN Report IT 1016, 5 March 2010.


[88] The Ministry of Agriculture, Food and Rural Policies was obliged to release the GM crops cultivation authorization.


[89] And also after the establishment of the Regional Coexistence Management Plans.


[90] “Regarding the matters that lie within their field of competence, the Regions and the Autonomous Provinces of Trento and Bolzano participate in any decisions about the formation of community law. The regions and autonomous provinces also provide for the implementation and execution of international obligations and of the acts of the European Union in observance of procedures set by State law. State law establishes procedures for the State to act in substitution of the Regions whenever those should fail to fulfill their responsibilities in this respect”.


[91] Art.1 Joint Decree 19 March 2010 “La richiesta di messa in coltura di ibridi di mais geneticamente modificati, contenente l’evento MON 810, formulata dall’Azienda Dalla Libera Silvano con nota del 14/08/2006 è da considerarsi respinta”.


[92] The joint decree was drawn up by the Minister of Agriculture, Food and Rural Policies on 19 March 2010 after having acquired the Biotech Seed Commission (BSC)’s opinion of 18 March 2010 that was to ignore the EU obligations and to reject the request of the GM crop growers for the following reasons: the precautionary principle, lack of coexistence regulations, lack of research, and the need to safeguard the so-called Made in Italy brand. The Commission was established by Decree No.212/2001; it is an Advisory Body that consists of two members from the Ministry of Agriculture, two members from the Ministry of Health and two members from the Ministry of the Environment as well as the representatives from Basilicata, Emilia Romagna, Friuli Venezia Giulia, Lombardy, Tuscany and Veneto Regions. After the Decree the members of the Pro-Biotech Association Futuragra organised some pro biotech actions especially during August 2010 when, in Vivaro, a small town in Friuli Venezia Giulia Region, they illegally tried to plant GM maize to protest against the Italian rules about GM crops commercial cultivation.


[93] TAR Lazio Judgement No.5532 of 21 June 2011. The appeal was promoted by the biotech farmer Silvano Dalla Libera in 2010 against Decree 19 March 2010.


[94] The Court, again, notes that “È stato riconosciuto definitivamente in sede giurisdizionale che il procedimento di cui trattasi è di competenza esclusivamente statale e che l’amministrazione ministeriale, in caso di inerzia da parte delle regioni nell’adozione dei piani di coesistenza, debba attivare i propri poteri sostitutivi previsti dalla vigente normativa in materia di attuazione degli obblighi comunitari gravanti sulle regioni e non possa, pertanto, rifiutarsi di provvedere in caso di persistente inerzia di queste ultime”. It is very interesting to underline that TAR noted that the Decree was not notified to EU Commission as stated by the EU rules, “Il decreto è, altresì, illegittimo in quanto non è stato notificato agli organi della Commissione europea e, conseguentemente, gli organi comunitari non hanno potuto svolgere l’esame delle dette disposizioni nazionali adottate in deroga agli obblighi di armonizzazione di cui al richiamato par. 6 dell’articolo 95 del trattato CE”.


[95] The Italian Minister of Agriculture declared “After the decision of the Tar of Lazio I think we have reached the point which further complicates the current situation regarding Gmos, and I will avail myself of the right to ask the application of the safeguard clause. At this moment I instructed my offices to take all necessary measures in the EU to ask for the safeguard clause that would prevent the Gmo cultivation in the national territory” Source: The Minister of agriculture intervenes on the issue of the Gmo cultivation in Italy, Agricoltura Italiana on Line, 26 June 2011. The Italian Region Committee, in April 2012, formally requested (for the second time) that the Ministry of Agriculture invoke the safeguard clause to ban the GM crops commercial cultivations and the Committee justified the request on the need to protect italian organic production and Italian quality production as PDO and PGI (Source: USDA GAIN Report IT 1211, 16 April 2012). It useful to underline that the request does not provide any new or additional scientific information indicating the EU-approved biotech crops to be a risk to human health or the environment, as required by Directive 18/2001/EC (Source: USDA GAIN Report IT 1222, 5 July 2012).


[96] In fact as stated by the judgement of the European Court C-36/11 of 6 September 2012 “the cultivation of GMOs such as the MON 810 maize varieties cannot be made subject to a national authorisation procedure when the use and marketing of those varieties are authorised pursuant to Article 20 of Regulation No 1829/2003 and those varieties have been accepted for inclusion in the common catalogue provided for in Directive 2002/53; Article 26a of Directive 2001/18 does not entitle a Member State to prohibit in a general manner the cultivation on its territory of such GMOs pending the adoption of coexistence measures to avoid the unintended presence of GMOs in other crops”.

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