Food and animal safety in Italy

Food safety, certification programmes, animal safety and disease

List the main applicable enacted legislation for primary processors of live animals.

Some of the legal instruments listed in our discussion on the legal regime applicable to food in general, and meat and poultry in particular, including Regulation (EC) No. 178/2002, Regulations (EC) No. 852/2004, 853/2004 and 854/2004, Directive 2002/99/EC and Regulation (EC) 882/2004, are relevant, as they form the legal background to a primary processor’s activities. In addition to these general rules, Council Directive 98/58/EC concerning the protection of animals kept for farming purposes lays down the minimum standards for the protection of all farmed animals. This Directive was implemented in Italy by Legislative Decree No. 146/2001. In addition to this framework, specific directives define requirements for the protection of individual animals (eg, the welfare of pigs is assured by Directive 2008/120/EC, while Council Directive 2007/43/CE lays down minimum rules for the protection of chickens kept for meat production).

Furthermore, processors of live animals are subject to Regulation (EC) No. 1/2005 on the protection of animals during transport and related operations and Regulation (EC) No. 1099/2009 on the protection of animals at the time of killing.

At national level, Italy adopted and implemented the strategy of ‘safety from farm to table’; the Ministry of Health (MOH) is responsible for ensuring application of the European Regulations, including compliance with the general principles contained under General Food Law (ie, Regulation (EC) No. 178/2002 adopted on 28 January 2002).

In this regard, Legislative Decree No. 158/2006, which implements Directive 2003/74/CE in Italy, concerns the prohibition of the use of certain substances having a hormonal or thyrostatic action, the prohibition of beta-agonists in the production of animals, and control measures on certain substances and their residues in live animals and their products. For this purpose, the National Residue Monitoring Plan (NRMP) has been implemented to monitor breeding animals and the primary processing of animal origin products. The aim of the Plan is to reveal cases of illegal administration of prohibited substances and misuse of authorised substances, and to verify the conformity of residues of veterinary drugs, pesticides and contaminants to the environment with the maximum residue limits set out by EU and national laws.

Legislative Decree No. 181/2010 implemented in Italy by Directive 2007/43/EC, which establishes minimum standards for the protection of chickens kept for meat production, and Ministerial Decree of 4 February 2013 implemented the provisions on the protection of chickens kept for meat production, pursuant to articles 3, 4 ,6 and 8 of Legislative Decree No. 181/2010.

Legislative Decree No. 126/2011 implemented in Italy Directive 2008/119/EC, which establishes the minimum standards for the protection of calves; Legislative Decree No. 122/2011  implemented in Italy Directive 2008/120/EC, which establishes the minimum standards for the protection of pigs; and Legislative Decree of 267/2003 implemented Directives 1999/74/EC and 2002/4/EC in Italy, for the protection of laying hens and the registration of related breeding establishments.

Describe food safety regulations for meat and poultry products, and all other food products in your jurisdiction.

Food safety regulations are mainly based on Regulation (EC) No. 178/2002, whose penalties framework was implemented by Legislative Decree No. 190/06; and Regulations (EC) Nos. 852/2004,853/2004, 854/2004, 882/2004 (Safety package) which was implemented in Italy, mainly, by Legislative Decree No. 193/07. Regulation (EC) No. 178/2002 essentially prohibits the placing onto the market foods that could be injurious to human health or otherwise unfit for consumption. On this basis, it establishes several rules covering all stages of food and feed production and distribution. These obligations must be followed by all businesses intervening at any stage of the food chain; they concern the traceability of food, feed and food-producing animals. The Regulation also prescribes an obligation to withdraw food or feed from the market or recall products already supplied if these are considered to be harmful to health.

Regulation (EC) No. 853/2004, specifically for meat and poultry products, was implemented in Italy through an applicative Guideline issued by the MOH, and adopted by each region, and pertains to the ‘preparation of self-control plans for the identification and management of hazards in environments handling food of animal origin pursuant to EU Regulation 853/2004’.

This Guideline, in line with the Hazard analysis and critical control points principles provided in the Codex Alimentarius Commission’s Committee on Food Hygiene, indicates the criteria based on which should be drafted:

• the manuals of correct operating practices elaborated by the trade associations of the food industry sector; and
• the preparation of the self-control plan by food business operators.

Such manuals are not mandatory; however, their implementation is recommended by the MOH.

The Guideline provides three different level of regulation: prerequisites; HACCP; and main chemical and physical biological hazards.

As said, the purpose is to guarantee safety throughout the food chain, specifically, regarding the traceability of food, feed and food-producing animals, as well as the withdrawal of food or feed from the market, or the recall the products already supplied, if these are considered to be harmful to health.

The MOH is the supervisory authority at national level and its policies will be implemented at local level through the health local authorities (ASL) of the regions, and the autonomous provinces of Trento and Bolzano.

The general rule is that each food business operator shall notify the competent local authority of the establishment’s location via a declaration of commencement of activity.

In this case, the authorisation’s holder shall send notification to the municipality and ASL of where the activity is located, and the existence, opening, variation of ownership or activity of the termination of each activity subject to ASL registration.

What enforcement can take place in relation to food safety? What penalties may apply?

The main Italian law dealing with food safety is Legislative Decree No. 193/07, which implements Directive 2004/41/EC, European Regulations Nos. 852, 853, 854, 882/2004, and Directive 2002/99.

Legislative Decree No. 193/07 defines the necessary measures to guarantee the safety of food products, while article 6 provides penalties in the case of infringement of food safety rules. Depending on the type of infringement, except where the facts constitute a serious offence, the law provides penalties ranging from a minimum of €250 up to a maximum of €150,000, or as alternative to the highest penalties, the law provides for imprisonment from six months up to one year.

Legislative Decree No. 190/2006 provides the penalties that apply in the case of a violation of Regulation (EU) No. 178/2002 (eg, traceability, food integrity, withdrawn from the market). Finally, Legislative Decree No. 231/2017 provides penalties in the case of violation of the provisions of Regulation (EU) No. 1169/2011, concerning food labelling and consumer information.

Generally, except where the facts constitute a serious offence, the actual penalty depends on the severity of the infringement.

Describe any certification programmes and regulations for genetically modified foods and organic foods.

Genetically modified (GM) foods have been subject to a specific regulatory framework since 2004. The EU framework now consists of several regulations of the Council and the European Parliament, regulations of the Commission and directives. Before GM foods can be placed on the market, they need to be approved based on a double safety assessment. First, they need an authorisation for the deliberate release into the environment according to the criteria laid down in Directive 2001/18, and second, an authorisation for use in food or feed according to the criteria laid down in Regulation 1829/2003 and Regulation 641/2004, which provides detailed rules for the implementation of Regulation 1829/2003; third, such food and/or feed should be compliant with the labelling and traceability regulation laid down in Regulation 1830/2003 as well as with Directive 90/219/EEC, as amended by Directive 98/81/EC, related to research and industrial work activities involving GM under the condition of containment.

Each application for the introduction of a new GM food to the market is reviewed on a case-by-case basis, including a detailed consideration of the potential for toxic, nutritional and allergenic effects, by the European Food Safety Authority. Currently, a number of GM varieties are allowed in the EU for the following crops: maize, soybean, rapeseed, cotton, sugar beet and potato. To date, no GM animals are allowed in the European Union. Of note, to date only one commercial GM crop has been authorised for commercial cultivation in the EU, namely MON 810 maize. A number of member states, including Italy, have prohibited the cultivation of MON 810.

Legislative Decree No. 227/2016, implementing Directive (EU) 2015/412 which modified Directive 2001/18, provides the possibility to limit or prohibit the cultivation of GM organisms on Italian territory.

Penalties are provided in Legislative Decree No. 70 of 21 July 2005 ‘sanctioning provisions for violations of Regulation (EC) No. 1829/2003 and Regulation (EC) No. 1830/2003, relating to genetically modified food and feed’.

Organic products are notably subject to compliance with the requirements defined under Regulation (ECC) 2092/91 as amended and integrated into Regulation (EC) No. 834/2007 on organic production and labelling of organic products (which will be replaced as of 1 January 2021 by Regulation (EU) No. 2018/848). The legislation on organic production defines a framework in which the protection of the environment and of biodiversity is promoted and the interests of consumers are protected by means of clear and reliable information. The rules on organic production apply along the whole product life cycle, and entail – among others – the prohibition of the use of genetically modified organisms, prohibition on the use of ionising radiation, limits on the use of artificial fertilisers, herbicides and pesticides prohibition on the use of hormones, and restriction on the use of antibiotics.

In Italy, the organic certificate (BIO Certificate) and the relative control of the compliance of cultivation methods and procedure are carried out by private controlling bodies, authorised in accordance with a ministerial decree.

Such control bodies will provide administrative control (notifications of production activity with organic methods, annual production programmes, field notebooks, raw materials sheets, etc);inspection (visits to farms and processing industries);and analytical control (laboratory analysis searching for pesticide residues, synthetic chemicals and GMOs, in both the field in soil samples and plant parts, and in the finished product).

There are two other food certifications – DOP (protected designation of origin) Reg. Ce 628/2008 and IGP (protected geographic indication) Reg. Ce 1898/2006.

The DOP is a name of a region, a specific place or, in exceptional cases, a country, that serves to designate an agricultural or food product: originating from that region, specific place or country; whose quality or characteristics are essentially or exclusively due to the geographical environment, including natural and human factors; whose production, transformation and processing take place within the specific geographical area.

The IGP is a name of a region, a specific place or, in exceptional cases, a country, which serves to designate an agricultural product or foodstuff: originating in that region, in that specific place or in that country; a specific quality, reputation or other characteristics can be attributed to geographical origin; whose production or processing takes place in the specific geographical area.

Both certifications should be linked with a specific territory; however, for IGP the link with territory is not exclusive. It suffices that one part of the production occurs in the territory.

The proceeding for registration as a DOP or IGP provides an initial valuation on national level by the Regions and the Ministry of Agriculture and Forestry, and a second one at Community level at the relevant Commission’s offices. If both valuations are successful, the denomination will be part of a special register held and updated by the Commission. The denominations registered as DOP or IGP are legally protected against any direct or indirect commercial use, imitation, evocation or usurpation of the same name, as well as against any other practice that may mislead the consumer about the true origin of the product.

What are the food labelling requirements, including the applicable enacted legislation, enforcement and penalties?

The main EU set of rules relating to food labelling is Regulation (EU) No. 1169/2011 on the provision of food information to consumers (FIC). This regulation provides general rules on food and nutrition labelling, including the rules on the mandatory nutrition declaration that has been in force since 13 December 2016. This regulation provides that in the case of prepacked foods, the following food information must appear directly on the package or on a label attached to the package:

• the name of the food;
• the list of ingredients;
• an indication of the allergens present in the product, even if in an altered form;
• the quantity of certain ingredients or categories of ingredients (QUID – see below);
• the net quantity of the food;
• the date of minimum durability or the ‘use by’ date;
• any special storage conditions and/or conditions of use;
• the name or business name and address of the food business establishment responsible for placing the food on the market;
• the country of origin or place of provenance in certain cases;
• instructions for use where it would be difficult to make appropriate use of the food in the absence of such instructions;
• with respect to beverages containing more than 1.2 per cent by volume of alcohol, the actual alcoholic strength by volume; and
• a nutrition declaration.

Specific categories of products are subject to more detailed requirements. Examples include chocolate and honey. Further requirements are laid down in other legislation such as, for example, Regulation (EC) No. 1924/2006 on nutrition and health claims.

Mandatory food information must appear in a language that is easily understood by the consumers. In this sense, Italian laws require that the mandatory food information has to appear in Italian and, as recommended, the quantity indication given in both millilitres and grams. According to Legislative Decree No. 145/2017 (adopted, among others, pursuant to articles 39(2) and 45 of Regulation (EU) No. 1169/2011), it is necessary, in principle, to indicate the address where the product is manufactured, or if different, where it is packaged. This obligation does not apply (i) if the place where the product is manufactured or packaged coincides with the address of the importer in the EU; or (ii) if the place where the product is manufactured or where it is packaged is indicated within the product’s brand placed on its packaging.

Enforcement and penalties are defined at national level.

The Ministry of Agricultural, Food and Forestry Policies, Department of Quality, Safety and Combating Food Fraud, is in charge of market surveillance and enforcement of labelling rules.

The sanctions related to non-compliance with labelling requirements are defined by Legislative Decree No. 231/2007, which provides pecuniary sanctions from a minimum of €500 up to a maximum of €40,000.

List the main applicable enacted legislation regarding health of food animals, including transportation and disease outbreak and management.

Legislation regarding health of food animals is both European and domestic.

Legislation, at the European level, includes:

• Directive (EC) 64/432, as modified by Directive (EC) 97/12 on animal health problems affecting intra-Community trade in bovine animals and swine (transposed in Italy by the Legislative Decree No. 196/1999);
• Directive (EC) 98/58 on the protection of animals kept for farming purposes (implemented, in Italy, by Legislative Decree No. 146/2001);
• Directive (EC) 2008/119/CE on the minimum protection requirements for bovine animals (implemented, in Italy, by Legislative Decree No. 126/2011);
• Directive (EC) 2008/120 on the minimum protection requirements for pork (implemented in Italy by Legislative Decree No. 122/2012);
• Directive (EC) 2007/43 on the minimum protection requirements for chicken (implemented in Italy by Legislative Decree No. 181/2010 and Ministerial Decree of 4 February 2013);
• Directive (EC) 1999/74 on the protection of laying hens (implemented in Italy by Legislative Decree No. 267/2003);
• Directive (EC) 91/68 on animal health conditions governing intra-Community trade in ovine and caprine animals (transposed in Italy by Legislative Decree No. 193/2005 laying down animal health rules for the import and trade of sheep and goats); and
• Regulation (EC) No. 21/2004 establishing a system for the identification and registration of ovine and caprine animals.

Regarding animal transportation, this is regulated by Regulation (EC) No. 1/2005 (protection of animals during transport applies to the transport of live vertebrate animals in connection with an economic activity).

Regarding possible diseases and their management, the MOH provides controls, plans and programmes based on, inter alia, the Directive (CEE) 82/894, as modified by the Commission Implementing Regulation (EC) 2012/737, which also provides the Animal Disease Notification System, as well as Presidential Decree (DPR) No. 320/1954 (Veterinary Police Regulations), which lists the infectious diseases that should be immediately reported to the authorities).

What are the restrictions on the movement of animals within your country?

In accordance with Regulation (EC) No. 1/2005, transporters of animals over 65km in connection with an economic activity are required to hold a transporter authorisation. For all journeys exceeding 65km, all drivers of road vehicles carrying domestic equine, cattle, sheep, goats, poultry or pigs must have a certificate of professional competence issued following comprehensive training on animals in transport and sanctioned by the successful completion of an examination by an independent body authorised by the competent authorities. To obtain this authorisation, the applicant must demonstrate in particular that he or she has sufficient and appropriate personnel, equipment and operational procedures. These authorisations are valid for five years and follow a harmonised European format. They are recorded in a publicly accessible electronic database.

The MOH, on 14 December 2007, provided an explanatory note related to the implementation of the mentioned regulation, which, among other things, specified that transport vehicles that reach the final destination in Italy without travelling more than 12 hours may be exempted from the required certificate for long journeys (pursuant to article 18, paragraph 4 of Regulation (EC) No. 1/2005).

Where would one find the regulations related to livestock slaughtering?

Regulation (EC) No. 1099/2009 on the protection of animals at the time of killing lays down rules for the killing of animals bred or kept for the production of food, wool, skin, fur or other products, and the killing of animals for depopulation. The Regulation introduces a series of new, directly applicable operational requirements for the construction, layout and equipment of slaughterhouses.

The Regulation also permits EU member states to maintain existing national rules in force at the time the Regulation came into force, where they provide greater protection for animals at the time of killing than those in the Regulation, and provides a derogation to allow religious slaughter without prior stunning.

In Italy, the MOH, together with the National Reference Centre on Animal Welfare, developed a manual of good practices consisting of summary sheets on the animal species bred (see www.salute.gov.it/portale/temi/p2_6.jsp?id=2085&area=sanitaAnimale&menu=benessere).

Outline the regulatory regime for pesticides in your jurisdiction.

Biocides control viruses, bacteria, fungi, insects and animals. Safeguards are crucial to ensure safety to people, the environment or animals.

At European level, two regulatory schemes concern pesticides:

• Biocidal Product Regulation (Regulation (EU) No. 528/2012) (BPR), and its supporting legislation such as the Biocides Review Regulation (Regulation (EU) No. 1062/2014). The BPR cover a diverse group of products, including disinfectants, pest control products and preservatives.
• Regulation (EC) No. 1107/2009 provides rules concerning the placing of plant protection products on the market.

In Italy, Directive 2009/128 establishing a framework for Community action to achieve the sustainable use of pesticides, implemented in Italy by Legislative Decree No. 150/2012. This Directive aims at reducing the risks and impact of pesticide use on human health and the environment, and promoting the use of integrated pest management and alternative approaches or techniques such as non-chemical alternatives to pesticides.

The Ministerial Decree of 22 January 2014, in accordance with article 6 of the mentioned Legislative Decree, adopted the National Action Plan for the Sustainable Use of Plant Protection Products, which is periodically updated.

Law stated date

Give the date on which the information above is accurate.

Correct on 19 December 2019.