Agricultural law in Italy: overview
A Q&A guide to agricultural law in Italy by Ferdinando Albisinni, Studio Legale Albisinni.
The Q&A gives a high level overview of agricultural law, including acquiring agricultural companies and co-operatives, competition law, land ownership and usage rights, pricing and tender processes, tax and financing, crop seed business, importing crop seeds, commercial crop production and distribution, plant variety right protection, GM crops, GM foods, importing animals, gene patents, and product liability.
To compare answers across multiple jurisdictions, visit the Agriculture Country Q&A tool.
This Q&A is part of the Agricultural Law Global Guide. For a full list of jurisdictional Q&As visit www.practicallaw.com/agriculture-guide.
The World Trade Organization.
The Food and Agriculture Organization of the United Nations.
The International Plant Protection Convention.
The Office International des Epizooties, also known as the World Animal Health Organization.
World Trade Organization (WTO)
Italy ratified the General Agreement on Tariffs and Trade in 1950 (now part of the WTO framework). It also ratified in 1994 the Marrakech Agreements, including GATT 1994.
Food and Agriculture Organization of the United Nations (FAO)
Italy has been a member of the FAO from the second session held in 1946.
International Plant Protection Convention (IPPC)
Italy ratified the IPPC in 1955.
Office International des Epizooties (IOE)/World Animal Health Organization
Italy is a founding member of the IOE, created in Paris in 1924.
Key national legislation
Article 2135, Civil Code. Legislative Decree 228/2001 partly amended and modified Article 2135 of the Civil Code, which includes key agricultural definitions of:
An agricultural undertaking.
Associated activities performed by an agricultural undertaking.
Article 44 of the Constitution. This was enacted in 1948, and created a special private ownership regime for agricultural land, to ensure the rational use of natural resources and equitable social relationships. In particular, it:
Imposes certain obligations and restrictions on the private ownership of land.
Restricts the size of holdings according to the region and agricultural zone.
Encourages and imposes land reclamation, the conversion of certain large estates (latifundia) and the reorganisation of farm units.
Assists small and medium-sized holdings.
Makes special provisions for mountain areas.
Measures include a:
Right of first refusal for farmers in case of a land sale (see Question 8) and a privileged building regime.
A privileged tax regime for farmers in case of land acquisition, and for owners of land in mountain areas.
The EU Common Agricultural Policy (CAP) largely leads economic, financial and regulatory decisions in all EU member states.
As an EU member state, Italy must apply EU regulations and directives dealing with biotech technologies and GMO crops. The new Directive 2015/412/EU on restricting or prohibiting the cultivation of genetically modified organisms (Cultivation of GMO Directive) gives member states the power to adopt measures restricting or prohibiting the cultivation in all or part of its territory of GMOs, or of a group of GMOs. Italy prohibits any cultivation of GMOs in its territory due to the large public opposition to them (see Question 26).
Acquisition of agricultural companies
There is a specific regime for agricultural undertakings, irrespective of:
The dimension and legal form of the business, including capital companies.
The nationality of the farmer or of the managers and shareholders of the company.
Agricultural undertakings benefit from (Civil Code):
Exclusion from the usual bankruptcy rules.
A special tax regime.
Favourable pension contributions.
Special rules for the direct sale of agricultural products.
Law No 3 of 24 January 2012 has introduced special procedures to help manage the financial crisis, by allowing agricultural holdings to negotiate general agreements with their creditors.
Legislative Decrees 226, 227 and 228 of 2001, and 99 of 2004 (known as the orientation and modernisation of agriculture, forestry and fisheries decrees), widened the area of associated activities allowed to farmers. This included:
Sale of services (not just goods).
Transformation and sale of transformed products, obtained using only up to 50% of raw vegetable or animal components produced in the farm.
They also kept the advantages of the agricultural undertaking, as regulated by Article 2135 of the Civil Code.
Under Article 2 of Legislative Decree 99/2004, a company is qualified as agricultural if it:
Has the word "agricolo" in its name.
Has agricultural activity (as defined in Article 2135 of the Civil Code, therefore including associated activities) as the only area of activity in its bye-laws.
Is registered as such in the public register of companies.
No relevance is given to the nationality of shareholders and of administrators.
The introduction of this new type of agricultural company, entitled to the same benefits as individual farmers, has encouraged investment in the agricultural sector in the last decade by undertakings from other sectors. While the number of individual farmers has continued to decrease, in-line with a long term trend, the number of agricultural companies has increased significantly.
An agricultural company can also acquire the status of "professional farmer", on condition that one of the members of its board is a farmer. A person qualifies as a professional farmer if he spends at least 50% of his labour time and gets at least 50% of his labour income from agricultural activity. These conditions are reduced to 25% if the farmer operates in mountainous or disadvantaged areas. Professional farmers are entitled to tax and finance privileges (see Question 12).
Even if it does not qualify as a professional farmer, an agricultural company is recognised as an active farmer under Article 9 of EU Regulation No 1307/2013 establishing rules for direct payment to farmers. It is therefore entitled to the benefit of direct payment under the CAP.
Co-operatives are widely used in the agricultural sector. Their range of activities has been widened by the Legislative Decrees 226, 227 and 228 of 2001.
Agricultural co-operatives are considered farmers, and subject to the legal privileged regime (see Question 1), even if they do not directly perform an activity of cultivation or breeding, but mainly transform products of their members or mainly provide to them products and services to be used in their agricultural activities (Article 1.2, Legislative Decree No 228/2001).
Agricultural co-operatives are fully open to foreign members.
Italian anti-trust law is regulated by Law 287/1990, which largely reproduces EU competition principles and rules.
The Italian Anti-trust Authority (whose decisions are published at www.agcm.it) applies the relevant European regulations, based on Article 42 of the Treaty on the Functioning of the European Union (TFEU) (under Regulation 1308/2013).
Articles 101 to 106 of the TFEU and their implementing provisions apply to all agreements, decisions and practices referred to in Article 101(1) and Article 102 of the TFEU which relate to the production of, or trade in, agricultural products (Article 206, Regulation 1308/2013).
The Anti-trust Authority, in a well-known case regarding the consortium of producers of protected designation of origin (PDO) cheese Grana Padano, concluded that the acts of the consortium regarding quality and financial contributions were capable of restricting competition among producers, and were therefore illegal under national and EU rules (Case I569, Decision 13300, 2004).
There is a specific exception for farmers and farmers' organisations, under Article 209.1(2) of Regulation No 1308/2013. Farmers and farmers' organisations benefit from a specific regime, which favours collective agreements regarding agricultural products. Only agreements, decisions and concerted practices regarding the determination of prices remain prohibited in general terms.
Regulation No 1308/2013 on the Common Organisation of Markets in agricultural products (at Article 168) gives member states powers to decide that deliveries of agricultural products must be covered by a written contract between the parties, including price, quantity and quality, and time of delivery. Italy had already introduced in 2012 (Article 62, Decree Law No 1 of 24 January 2012):
The obligation to adopt written contracts for food and agricultural products, with specification of terms, qualities, quantities, prices, forms of delivery and of payment.
Penalties for the abuse of a dominant position in the agri-food market.
Powers to the Anti-trust Authority to enforce these rules (see Decision No 7195 of 17 July 2013 of the Regional Administrative Tribunal of Lazio).
Production quotas are also being reformed. Until recently, the CAP limited (directly or indirectly) quantities of agricultural production, such as milk quotas and planting rights for wine grapevines. Regulation 261/2012 and Regulation 1308/2013 abolish these production quotas at the end of a transition period.
Acquisition of agricultural land
Sale and transfer of usage rights and ownership
Usage rights to agricultural land.
Ownership of agricultural land.
Usage rights are normally transferred by a contract of lease, regulated by the Civil Code and Law No 203 of 3 May 1982 (see Question 10).
There is no general legal restriction on the acquisition of agricultural land (or usage rights) by a foreign (or foreign invested) party and the transfer of such land and rights by foreign investors to other parties (whether Italian or foreign).
Ownership of agricultural land
Ownership of agricultural land can be freely transferred by sale or gift (in writing before a public notary), inheritance, usucaption, and judicial decision.
There are some restrictions on the acquisition of certain land by certain foreign persons (see Question 7).
There are no compulsory tendering or prior approval procedures by public authorities required for the sale or purchase of agricultural land. However, there is a right of first refusal if the land is rented to a direct farmer, or if bordering land is owned by a direct farmer working on it. In both cases, the seller must notify the tenant or neighbour in advance of the terms and conditions of the sale, including:
The name of the buyer.
Terms of payment.
Any other conditions of the sale.
The tenant or neighbour have 30 days to decide whether they want to buy the land at those conditions. If previous notice is not given before the sale, the tenant or neighbour have the right, within one year of the sale, to claim in court for judicial transfer of the land ownership.
The general maximum term applicable to lease contracts is 30 years (Article 1573, Civil Code), except for a lease of land to be afforested where the term is up to 99 years (Article 1629, Civil Code).
Law No 203/1982 introduced a complex systemic regulation of all agricultural leases, fixing a normal minimal duration of 15 years, and a fixed amount of rent to be established by administrative commission operating on a local basis. However, Article 45 of Law No 203/1982 allows parties to execute a lease for a shorter term and for a rent higher than that fixed by administrative commission, if the contract is executed with the assistance of trade unions of farmers. Leases under Article 45 are now usual, while leases under the complex compulsory model dictated by other articles of Law No 203/1982 are now rare.
Private autonomy has been further increased by two decisions of the Constitutional Court. They declared contrary to the Constitution and therefore illegal and ineffective the provisions of Law No 203/1982 which fixed agricultural rents through administrative procedures (Constitutional Court Decisions No 318 of 5 July 2002, and No 315 of 28 October 2004). Parties are free to determine the amount of rent, even if not assisted by trade unions of farmers.
Expropriation of agricultural land is regulated by the same general rules regarding expropriation of any real estate. Article 42.3 of the Constitution establishes that private real ownership can only be expropriated in cases established by law, for reasons of general interest and with payment of compensation.
The present expropriation rules are set out in Consolidated Text, D.P.R. No 327 of 8 June 2001. Law No 244 of 24 December 2007 modified Article 37 of D.P.R. No 327/2001, recognising an indemnity for expropriation of land with building potential (including agricultural land situated in areas subject to building development) which is equal to the commercial value of the property.
Tax and financing
Sale and transfer of land ownership is subject to registration tax (regulated by D.P.R. No 131 of 26 April 1986). This tax is paid at the moment of sale in the hands of the public notary who legalises the sale contract and transfers the tax to the Registry Office.
The taxable basis is the current value of the land (Article 43, DPR No 131/1986). From 1 January 2016, the normal tax rate is 15% (article 1 comma 905 of Law No 208 of 28 December 2015), and not 12% as it was before (in any case, at least EUR1,000), reduced to:
A fixed amount of EUR490 plus 1% for cadastral tax if the buyer is a direct farmer (see Question 8) or a professional farmer (see Question 4, Agricultural companies) enrolled in the registries of agricultural pension funds.
9% plus 1% for cadastral tax if the direct farmer or the professional farmer is not entitled to benefit from the fixed taxation above.
Both the seller and the buyer are jointly obliged to pay the registration tax, but it is usual in the sale contract for the buyer to agree to pay all the taxes and fees of the notary.
There is a national law on national parks and green protected areas (Law No 394 of 6 December 1991, as amended) and regional laws, but investment in these areas is not generally incentivised. On a local basis, some regions grant financial incentives for investment in those areas with specific programmes, but there is no provision such as reduction of tax or land use fee.
To get financing by banks or other institutions, a mortgage must usually be granted by signing a written mortgage deed before a public notary (Article 2821, Civil Code). The mortgage is registered in the official register of land property, for a value which is usually twice the loan amount including interest for the entire loan term.
This registration does not prevent the assessment of a bank loan for an amount which can cover 70% to 80% of the land value, as long as the total guarantee registered may be even higher than the price paid for the land.
The mortgage deed is subject to a tax of 2%. The mortgage is registered for a term of 20 years. Before the end of this period the creditor, if still not paid, must request a renewal for an equal term of 20 years, otherwise the mortgage will become ineffective (Article 2847, Civil Code).
The security guaranteed by the mortgage can be transferred to another creditor, who succeeds to all rights deriving from the mortgage, subject to registration of the transfer of the security and of the mortgage in the official register of land property (Articles 1260 and 2843, Civil Code). The mortgage cannot be transferred to a property different from the original one, but can be cancelled by consent of both parties or by a court order on request of the interested party (Articles 2882 to 2888, Civil Code).
Crop seed business
Legislation and regulatory authorities
Crop seed business in Italy is regulated by Law No 1096 of 25 November 1971, as amended by EU directives.
Authorisation to produce and import crop seed is given by regional authorities (Article 19, Legislative Decree 214/ 2005), on the basis of the national register of approved seeds maintained by the Ministry for Agricultural Policies. A national authorisation is not required to import new plant species or varieties if they are approved by the EU (see Question 16, Import of new plant species or varieties and crop growing technologies).
The National Centre of study and certification of seeds (CRA-SCS, www.scs.entecra.it/) has been authorised by the Ministry of Agricultural Policies to operate as the national authority to verify seeds and issue authorisations.
Directive No 2002/53 of 13 June 2002, on the common catalogue of varieties of agricultural plant species, has been implemented by Legislative Decree 308/2003.
Directive No 2008/62 of 20 June 2008, providing for certain derogations for agricultural landraces and varieties naturally adapted to local and regional conditions and threatened by genetic erosion, and marketing of related seed and seed potatoes, was implemented by Legislative Decree 149/2009.
Import/export control measures
Imports. The national phytosanitary import requirements Italy are directly based on the plant health regime of the EU. The EU Plant Health Directive lists harmful organisms which are:
Banned outright from introduction into the EU common market (Part A).
Banned from introduction into protected zones (as defined in the Directive) (Part B).
The Plant Health Directive requires varieties to have a "plant passport", in order to sell the crop seeds in the EU. A plant passport proves that the plant varieties comply with all relevant phytosanitary requirements applicable in the EU, and will be issued if the plant variety:
Is free of the harmful organisms referred to in Annex I, Part A of the Plant Health Directive.
Is free of the organisms referred to in Annex II, Part A of the Plant Health Directive.
Complies with the special requirements in Annex IV, Part A, Section II of the Plant Health Directive.
Exports. A separate phytosanitary regime applies to the export of crop seeds. The exact requirements depend on the country of destination.
Since Italy is a WTO member, restrictions on the import of plant (materials) need to be based on international standards or justified on a scientific basis under the WTO Agreement on Sanitary and Phytosanitary measures. The international phytosanitary (plant health) standards are developed by the Secretariat of the IPCC (see www.ippc.int/standards).
The Ministry of Agricultural Policies is the official contact point for the IPPC. In principle, Italy implements the IPPC and its standards.
Import of new plant species or varieties and import of crop growing technologies.
Set up of R&D centres and use of test plots of new crops.
Crop seed production.
Commercial crop production.
Distribution of seeds or crops (wholesale/retail/e-commerce).
Import of new plant species or varieties and crop growing technologies
A national authorisation is not required to import new plant species or varieties if they are approved by the EU.
The import and sale of plant varieties and seeds not on the EU register is subject to previous approval of the variety by the Minister of Agricultural Policies, which maintains a register of approved varieties, including some still not on the EU's list.
Under Article 19 of Law No 1096 of 1971 the registration can be requested by the breeder of the variety that should grant the purity of variety.
The Ministry of Agricultural Policies has established specific requirements for the registration of each crop species.
The requirements for registration can be found online at www.scs.entecra.it/prove%20iscrizioni/indice.html
For registration, a basic registration package is required to be submitted by applicants. The application must include:
Name of the applicant.
A reference seed sample.
A description of the variety.
Details of the pedigree and history of development of the variety.
Botanical and common name of the taxon.
The performance of tests is managed by a technical group that evaluates the technical documentation provided by the breeder.
Set up of R&D centres and use of test plots of new crops
A national authorisation is not required to set up R&D centres and use test plots of new crops if they are set up according to EU law.
At the EU level the marketing of seeds and plant propagating material is regulated by a number of directives and regulations which cover the most important plant species on the EU market. These include:
Directive 66/401/EEC - marketing of fodder plant seed.
Directive 92/33/EEC - marketing of vegetable material, other than seed.
Directive 66/402/EEC - marketing of cereal seed.
Directive 1998/56/EC - marketing of propagating material of ornamental plants.
Directive 1999/105/EC - marketing of forest reproductive material.
Directive 2000/29/EC - on protective measures against the introduction into the EU of organisms harmful to plants or plant products and against their spread within the EU.
Directive 2002/53/EC - common catalogue of agricultural plant species.
Directive 2002/54/EC - marketing of beet seed.
Directive 2002/55/EC - marketing of vegetable seed.
Directive 2002/56/EC - marketing of seed potatoes.
Directive 2002/57/EC - marketing of seed of oil and fibre plants.
Regulation (EC) No 217/2006 - marketing of seed not satisfying the requirements in respect of the minimum germination.
Directive 2008/72/EC - marketing of material for the propagation of the vine.
Directive 2008/90/EC - marketing of fruit propagating material and fruit plants for fruit production.
The two basic pillars of the regulation are:
Registration of varieties/material.
Certification/inspection of lots before marketing.
Furthermore, there are specific requirements for the production and marketing, depending on the plant species and their marketing categories (pre-basic, basic, certified and standard material).
Crop seed production
A national authorisation is not required to carry out crop seed production, if it is approved by the EU. The procedure is briefly explained above (see above, Set up of R&D centres and use of test plots of new crops).
Commercial crop production
A national authorisation is not required to carry out commercial crop production, if it is approved by the EU. The procedure is briefly explained above (see above, Set up of R&D centres and use of test plots of new crops).
Distribution of seeds or crops
A national authorisation is not required to distribute seeds or crops, if it is approved by the EU. The procedure is briefly explained above (see above, Set up of R&D centres and use of test plots of new crops).
Packaging and labelling are regulated by D.P.R. No 1065 of 8 August 1973, which imposes packaging which cannot be resealed after opening and detailed rules for labelling, with a duty to expressly indicate any GMO seeds.
The EU legislation requires GM seed varieties to be approved and authorised in the EU before they are marketed in the EU. Authorisation is only granted if a positive scientific assessment has concluded that no unacceptable risks to the environment or human health are likely to appear.
All GM seeds have to be labelled as such.
Production and marketing of seed are activities governed by national and EU legislation.
For vegetable seeds the legislation established the category of certification standards, which belongs to the whole amount of seeds marketed.
The seed products can only be placed on the market if packaged in pouches or sealed packs (each unit must contain products of the same species) and bear on the outside the card of the manufacturer and, when required, the card of a national body for the seed certification.
The card of the national seeds certifies that the check has been carried by the same, and that the product complies with the rules and assumes different colours, depending on the category:
White for basic seed.
Blue for certified seed of the first generation after basic seed.
Red for certified seed of subsequent generations.
Brown for commercial seed.
This area of regulation has been harmonised by EU directives (see Question 16).
Plant variety rights (PVR)
The application procedure, regulated by Regulation 2100/94 and Regulation 874/2009, is centralised at EU level. An application for a Community PVR must be filed at the Community Plant Variety Office, directly or through a national agency, indicating (Article 50, Regulation No 2100/94):
A request for the grant of a Community PVR.
Identification of the botanical taxon.
Information identifying the applicant or, where appropriate, the joint applicants.
The name of the breeder and an assurance that, to the best of the applicant's knowledge, no further persons have been involved in the breeding, or discovery and development, of the variety. If the applicant is not the breeder, or not the only breeder, he must provide relevant documentary evidence of how the entitlement to the Community PVR came into his possession.
A provisional designation for the variety.
A technical description of the variety.
The geographic origin of the variety.
The credentials of any procedural representative.
Details of any previous commercialisation of the variety.
Details of any other application made in respect of the variety.
The EU Plant Variety Office updates and maintains an official register of applications and an official register of Community PVR (at www.cpvo.europa.eu/main/en).
Requirements for protection.
Extent of the protection.
Restrictions on the rights of the PVR holder.
Requirements for protection
To obtain exclusive rights, varieties must be:
Distinct, uniform, and stable.
Designated by a name in accordance with the Regulation.
Extent of the protection
The breeder is entitled to the exclusive PVR, and the holder has the exclusive right, for 25 years, in relation to variety constituents, or harvested material of the protected variety, to authorise:
Production or reproduction (multiplication).
Conditioning for the purpose of propagation.
Offering for sale.
Selling or other marketing.
Exporting from the Community.
Importing into the Community.
Stocking for any of the purposes in the bullet points above.
The holder can make his authorisation subject to conditions and limitations (Article 13.2, Regulation No 2100/94).
These provisions apply also to varieties (Article 13(5) Regulation No 2100/94):
Essentially derived from the variety in respect of which the Community PVR has been granted, where this variety is not itself an essentially derived variety.
Not distinct in accordance with Article 7 from the protected variety.
Whose production requires the repeated use of the protected variety.
Restrictions on the rights of the holder
There are some exceptions to the PVR holder's exclusive rights. Under Article 15 of Regulation No 2100/94, a Community PVR does not extend to acts:
Done privately and for non-commercial purposes.
Done for experimental purposes.
Done for the purpose of breeding, or discovering and developing other varieties.
Referred to in Article 13(2) to (4) of Regulation No 2100/94, in respect of such other varieties, except where Article 13(5) applies, or where the other variety or the material of this variety is protected by a property right not containing a comparable provision.
Whose prohibition would violate provisions in Articles 13(8), 14 or 29 of Regulation No 2100/94.
In all these cases, the prior consent of the PVR holder and payment of royalties are not required, both by small and large farmers.
A more significant exception is farmers' privilege, regulated by Article 14 of Regulation No 2100/94. Farmers can use propagating materials of a protected plant variety on their own holding, but they cannot share the harvest or such propagating materials with other farmers.
The prior consent of the PVR holder is not required. Small farmers do not have to pay royalties to the PVR holder. Others farmers must pay equitable remuneration (sensibly lower than the amount normally charged) to the PVR holder, as established by indications adopted by the European Commission (Article 14.3, Regulation 2100/94).
Under Article 107 of the Industrial Property Code (Legislative Decree No. 30 of 10 February 2005) the holder can prevent anyone doing the following acts to propagating material without authority:
Production or reproduction.
Selling or other marketing.
Conditioning for the purpose of propagation.
Offering for sale.
Stocking (for any of the purposes mentioned above).
Remedies for infringement are available as for other proprietary rights, such as a trade mark and patents. A breeder who considers that his right has been infringed is able to take action against the infringer through the civil courts.
The right of being the breeder of a new plant variety may be claimed by the breeder himself, and after his death, by his spouse and descendants to the second degree (in their absence or after their death, by parents and other ascendants and in their absence, or after death also, by relatives up to the fourth degree inclusive).
The ECJ has confirmed the principles and limitations of the farmer's privilege (see Question 22, Farmer's privilege) (10 April 2003, Case C-305/00, Schulin, and 11 March 2004, Case C-182/01, Saatgut-Treuhandverwaltungsgesellschaft).
Genetically modified (GM) crops
Italy is subject to the same EU legislation on GM crops applicable in all EU member states. However, this legislation has been applied in Italy in a much more restrictive way, due to public opinion being largely against GM crops.
Legislative Decree No 224/2003 (as amended) implemented Directive 2001/18/EC of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and Directive No 2009/41/EC of 6 May 2009 on the contained use of genetically modified micro-organisms .
The National Committee for Biosafety and Biotechnologies includes leading scientists who advise the government and ensure permanent monitoring in this area (Legislative Decree 224/ 2003).
The Minister of Health controls and authorises the contained use of GMO. The authority competent to authorise the release into the environment of GMOs is the Minister of Environment, acting with the Ministers of Health, Labour and Social Policies, Agricultural Policies, Economic Activities, University and Scientific Research.
Violation of rules on previous authorisation are subject to criminal sanctions (imprisonment up to three years) and fines (up to EUR51,700).
In Italy, pressure of public opinion has induced the government to adopt a very restrictive attitude, even with reference to products already authorised by the European Commission, and no GMO crops can be cultivated in Italy.
In this uncertain and still largely unstable legal framework, judicial decisions and regulatory provisions at national and regional level indicate the current approach in Italy (see Question 31).
Some Italian regions have adopted regional laws prohibiting cultivation of GMO seeds in their territory. Among others, Friuli Venezia Giulia and Valle d'Aosta introduced temporary bans, until the adoption of a general plan for transgenic, conventional and organic cultivation. This plan is foreseen by a national law of 2004, but is still far from approval.
At EU level, due to different approaches adopted in member states, there has been an increasing trend to allow member states to decide autonomously whether to authorise the cultivation in their territory of GMO crops, even if previously authorised by the European Commission and enrolled in the EU registry.
The new Cultivation of GMO Directive gave member states the power to adopt measures restricting or prohibiting the cultivation in all or part of its territory of a GMO, or of a group of GMOs. Italy has prohibited the cultivation of GMOs on its territory.
The EU has introduced rules on GMO food and feed. The main EU regulations on GMO food directly applied in Italy are:
Regulation 258/97, concerning novel foods and novel food ingredients is now repealed and substituted by Regulation 2015/2283/EU on novel foods (Novel Foods Regulation), which shall apply from 1 January 2018, except for some articles applicable 31 December 2015. Those regulations impose detailed rules requiring previous authorisation before putting GM products on the market and labelling. Even for authorised products, an EU member state can provisionally restrict or prohibit the use and/or sale of a GMO or a GM product in its territory (Article 12, Regulation 258/97). A safeguard is also provided by Article 54 of Regulation 178/2002 and Article 34 of Regulation 1829/2003.
Regulation 1829/2003 on GM food and feed.
Regulation 1830/2003 concerning the traceability and labelling of GMO and the traceability of food and feed products produced from GMO.
The procedure for authorisation of GMO food and feed starts at national level, then goes through the scientific opinion of the European Food Safety Authority (EFSA) (www.efsa.europa.eu) and the final decision of the European Commission.
The Italian authority competent to control GMO food and feed is the Ministry of Health. It publishes a report each year on the implementation of the National Plan of Official Control on GMOs in food and feed (at www.salute.gov.it/imgs/C_17_pubblicazioni_1987_allegato.pdf). No GMO food or feed has been authorised by the Ministry of Health.
Violations of Italian rules on prohibition of cultivation of GMOs are punished by imprisonment from six months to three years, or fines up to EUR50,000 (Law 116/2014 4).
In 2000 a Prime Minister's Decree dated 4 August 2000 suspended, on a cautionary basis, the marketing and use of four transgenic maize products of the Monsanto Company, previously authorised by the European Commission. The Regional Administrative Tribunal of Lazio, on the basis of an ECJ judgment (Case C-236/01, Monsanto) accepted the Monsanto petition and repealed the Decree, holding that the Decree, even if admissible in theory, was based only on hypothetical considerations and lacked evidence of a specific and effective danger (T.A.R. Lazio, Decision 14477, 29 November 2004).
The ECJ has stated that the cultivation of GMO cannot be made subject to a national authorisation procedure when the use and marketing of those varieties are authorised at EU level (Decision of 6 September 2012, Case C- 36/11) rejecting arguments from the Italian government.
A similar case was discussed before the Regional Administrative Tribunal of Lazio and the Council of State. The Council of State (Decision No 183, 19 January 2010) affirmed that, without any scientific evidence contesting EU authorisation, the Italian government cannot impose a national ban.
Even after this decision, the Italian government has strongly disapproved of GMO seeds in cultivation. In particular in 2013, the Minister of Health adopted a Ministerial Decree (12 July 2013, in G.U.R.I. 10 August 2013, No 187) prohibiting on a cautionary and temporary basis the cultivation of maize Monsanto MON 810, until the adoption of EU measures under Article 54.3 of Regulation 178/2002, and in any case for no longer than 18 months. Some farmers, who intended to use this maize for cultivation, filed two actions before the Regional Administrative Tribunal of Lazio for the annulment of the Ministerial Decree and damages (Cases 9965/2013 and 10302/2013). The Administrative Tribunal (No 4410/2014 and No 4411/2014) rejected the claims, stating that national authorities still have power to adopt temporary measures on a cautionary basis. The Council of State, in a hearing of 12 June 2014, refused to suspend these decisions. Now, Cultivation of GMO Directive has confirmed the power of member states to prohibit the cultivation of GMOs.
EU legislation (Directive 91/496, implemented in Italy by Legislative Decree 93 of 3 March 1993 and with Ministerial Decree 30 June 1993) regulates the organisation of veterinary checks on animals entering the Community from third countries. Those checks are carried out by member states at any EU border, on all imported living animals or animal genetic material. Documentation must show the origin, destination and characteristics of the animals. The checks include, in particular:
A documentary check.
An identification check.
A clinical examination of the animals, to ensure they conform to the information provided in the accompanying certificate or document, and that they are clinically healthy.
If all conditions for importation are met and no danger appears from the checks, the official vet at the border issues a certificate of importation.
The Italian Central Veterinary Authority is the Ministry of Health. The IOE delegate is the Department for Veterinary Public Health Food Safety and Collegial Bodies for Health Protection, which publish guidelines and information on controls (www.iss.it/spva/).
Official checks on imported food and feed are performed in accordance with Regulation No 882 of 29 April 2004.
The Ministry of Health is also the central authority for food and feed, and acts as the contact point in the Rapid Alert System, under Article 50 of Regulation No 178 of 28 January 2002.
Italy, with Decree Law No 3 of 10 January 2006, admitted patentability of biotechnological inventions, with a set of specific provisions separate from the general patent legislation. Later, with Legislative Decree No 131 of 13 August 2010, those provisions have been introduced into the Industrial Property Code, introducing a new Section IV-bis expressly referred to as Biotechnological inventions (Article 81-bis-ter-quarter-quinquies-sexies-septies-octies) and new Article 170-bis and 170-ter).
On the basis of these rules, the following can be patented:
Biomaterial isolated from its natural environment.
A technical proceeding to obtain, modify or use biomaterial.
A new use of biomaterial or of a related proceeding.
With specific reference to vegetables or animals, any invention characterised by the use of a specific gene, as far as this invention is not limited, from a technical point of view, to obtaining simply a new variety of plants or of animal species.
The following cannot be patented:
The human body.
Any invention contrary to human dignity, public order, morality and health, and environmental protection.
In any case, an application for an invention which refers to or uses biomaterial of human origin must be accompanied by the express consent of the person from whom the biomaterial has been obtained. Any application regarding or using GMOs must be accompanied by an express declaration of compliance with EU and national rules regarding GMOs.
An application for biotechnological patents is examined by the Patent Office with the assistance of the National Committee for Biosafety and Biotechnologies (see Question 26).
Sale and marketing of animals obtained through biotechnologies is regulated by a Decree of the Minister of Agricultural Policies, adopted together with the Health and Economic Development Ministers.
The origin of biocomponents must be expressly declared.
Violation of these legal provisions is punished with fines (up to EUR1 million, in case of use of biomaterial of human origin, and up to EUR100,000 in other cases).
See Question 33.
See Question 33.
Agricultural safety and product liability
Italy, as an EU member state, applies EU standards.
The international standards for food safety are set out in the Codex Alimentarius of the FAO. Codex Alimentarius recommendations are taken into consideration when adopting EU standards, but they are not directly binding (Article 13, Regulation No 178/2002 and Article 75, Regulation No 1308/2013).
Directive No 374 of 25 July 1985 introduced the general principle of strict liability for a producer.
Producer means any of the following:
The manufacturer of a finished product.
The producer of any raw material or the manufacturer of a component part.
Any person who, by putting his name, trade mark or other distinguishing feature on the product, represents himself as a producer.
Without prejudice to the liability of a producer outside the EU, any person who imports into the EU a product for sale, hire, leasing or any form of distribution in the course of his business.
Strict liability applies to producers of any sort of goods, including agricultural products.
A product is defective when it does not provide the safety which a person is entitled to expect, taking all circumstances into account (Article 117, Legislative Decree No 206/2005, known as the Consumer Code).
Producers, importers, distributors and sellers of agricultural and food products are subject, in addition to the special strict liability rules, to general rules on negligence.
Under the general provision of Article 2043 of the Civil Code, any person causing damage by fault or intentionally must compensate the damage, but in this case the damaged person must prove, not only the damage, but the existence of fault or intention.
In both cases (strict liability and negligence) the key issue is to establish under which conditions a food product is considered not defective. Useful indications are in the food safety requirements established by Article 14 of Regulation No 178/2002, which states that food is deemed unsafe if it is considered to be injurious to health and unfit for human consumption. In determining whether food is unsafe, regard will be had to:
The normal conditions of use of the food by the consumer and at each stage of production, processing and distribution.
The information provided to the consumer, including information on the label, or other information generally available to the consumer concerning the avoidance of specific adverse health effects from a particular food or category of foods.
On this basis, safety or defectiveness of food depends on its substantive material characteristics and its presentation. Therefore compliance with mandatory regulations and previous EU approval (as is the case for novel foods) may play a significant role as a legal defence against claims for damages, both in cases of strict liability and negligence.
However, in any case in which a food or feed business operator (which includes farmers, as per Regulation No 178/2002) considers or has reason to believe that a food which he has imported, produced, processed, manufactured or distributed does not comply with food safety requirements, as known at that moment, he must immediately initiate procedures to withdraw the food from the market, even if the food was produced in compliance with mandatory regulations previously in force. In other words, compliance with mandatory regulations may operate as a defence against claims for damages, but does not exclude the duty of food and feed business operators to continue to monitor the actual safety of the products, even after their production or distribution.
Criminal liability may also apply to producers and distributors, in case of fraud or of marketing or sale of unsafe food and agricultural products (Articles 438 to 448, and 515 to 518, Criminal Code).
The producer is not liable if he proves any of the following (Article 118, Legislative Decree No 206/2005):
That he did not put the product into circulation.
The defect which caused the damage did not exist at the time when the product was put into circulation.
The product was not manufactured by him for sale or any form of distribution for economic purpose, nor manufactured or distributed by him in the course of his business.
The defect is due to compliance of the product with mandatory regulations.
The state of scientific and technical knowledge at the time when he put the product into circulation was not such as to consider the product as defective.
In the case of a manufacturer of a component, that the defect is entirely attributable to the design of the product in which the component has been fitted, or to the instructions given by the manufacturer of the product.
Current Italian legislation on strict liability is included in Articles 114 to 127 of the Consumer Code (Legislative Decree No 206, 6 September 2005). The damage which is compensated is:
Damage caused by death or personal injury.
Damage to, or destruction of, any item of property other than the defective product itself, with a minimum claim threshold of EUR370.
Damage which can be compensated by an Italian civil court includes:
Moral damages (which includes personal pain, damages in the areas of family and friendship relations, and loss of reasonable expectations in social life).
Loss of value.
Loss of revenue.
Punitive damages are not awarded.
Description. The website provides free access to the Official Journal of the European Union; EU legislation; preparatory acts; EU case-law; international agreements; and other public documents.
Description. This website is managed by the national mint on behalf of the Italian government. The website provides free access to Italian legislation but it is not updated daily.
Italian Ministry of Agriculture, Food and Forestry
Description. Official website of the Italian Ministry of Agriculture, Food and Forestry, responsible for policy and regulations on food, feed, and rural issues. The website contains guidance on Italian law and some information on the department of the Ministry.
Summary: agricultural law in Italy
Acquisition of a domestic agricultural company
National security review
Foreign acquisition of agricultural land
Agricultural land ownership?
Agricultural land usage rights (maximum term)?
Allowed (maximum 30/99 years)
Mortgage/pledge of agricultural land?
Foreign investment incentives?
Foreign investment in crop business
Import of foreign plant varieties?
Generally permitted (the plant variety should obtain national or EU approval)
Production of crop seed?
Generally permitted (the plant variety should obtain national or EU approval)
Commercial crop production?
Generally permitted (the plant variety should obtain national or EU approval)
Distribution of crop seeds?
Generally permitted (the plant variety should obtain national or EU approval)
Plant variety right?
Patent on plant genetic sequence?
Patent on livestock genes?
Exemption from breeder rights to a protected plant variety
R&D for scientific purpose
Prior consent breeder
Royalty payment obligation
Third parties breeding rights?
Required with exceptions
Farmer rights to harvest protected plant varieties?
Allowed subject to some conditions
Import of GM seeds?
Import of GM crops?
Testing of GM seeds?
Local production of GM seeds
Local production of GM crops?
Import of animal genetic material?
Import of new animal breeds?
Food product liability
Market-entry approval is a legal defence?
Article 2043, Civil Code
Consumer Code applicable if the producer is located outside the EU
Article 2043, Civil Code
Consumer Code applicable if the producer is located outside the EU
Article 2043, Civil Code
Ferdinando Albisinni, Partner
Studio Legale Albisinni
T +39 0632 16171
F +39 0632 10986
Professional qualifications. Lawyer, the Bar of Rome since 1974, admitted to the Supreme Court; expert of the Italian Federation of Consortia of quality wine producers; consultant to companies and producer groups in the food and agriculture sectors
Areas of practice. Food law; agricultural law; intellectual property law; competition law; consumer law; business and corporate law.
Non-professional qualifications. BA in Law University of Rome La Sapienza; full professor of European Food and Agricultural Law at the University of Viterbo, Director of the European Food Law Centre; Scientific director of the Journal of Food Law.
Languages. English; Italian
- Member of AgroFood Legal network.
- National Secretary of the Italian Food Law Association.
- Director of the Advanced Master in European Food Law, Tuscia University, Viterbo.
- Member of the Italian delegation to the O.I.V. – Organisation International de Vine, Paris.
- Ordinary Member of the Academy of Georgofili, Florence.
- Member of the Italian Association of Comparative Law.
- Member of the Institute of Comparative and International Agricultural Law.
- Board member of EFLA, the European Food Law Association
- European and Global Food Law, F. Albisinni, L. Costato (eds.), Wolters Kluwer, Second edition, Padoa, 2016.
- El derecho alimentario como acicate de la innovaciòn del Derecho europeo, in A. Leticia Bourgues (ed.), UE: Sociologìa y Derecho Alimentarios, Cizur Meno, Thomson Reuters, 2013, p. 111-146.
- Agricultural and food law as innovation engine of European law: the new scenario, in V. Rodriguez Fuentes (ed.), From agricultural to food law, Wageningen Academic Publisher, 2014, p. 19-45.
- Food Law and innovation in European Law, in A.A. V.V. Studi in onore di Luigi Costato Vol, II, Jovene, Naples, 2014.
- Transparency, crisis and innovation in EU Food Law, in Resnick Program for Food Law –UCLA –Harvard Food Law and Policy Conference, 24 October 2014.