Food safety

European Legal framework

• There are three basic types of EU legislation:

1. Regulations: like a national law with the difference that they are applicable in all EU countries.

2. Directives: set out general rules to be transferred into national law by each country as they deem

appropriate.

3. Decisions only deals with a particular issue and specifically mentioned persons or organizations.

• EC Regulation 178/2002, usually referred to as the General Food Law (GFL) : serves as a

foundational regulation in the field of food safety and consumer protection within the European

Union. It establishes key principles for food safety, traceability, transparency, and the responsibility

of food business operators.

These are the fundamental types of EU legislation, each serving different purposes and having

varying degrees of direct applicability in member states.

FOOD: EU Regulation 178/2002 art. 2 For the purposes of this Regulation, "food" (or "foodstuff")

means any substance or product, whether processed, partially processed or unprocessed, intended to

be, or reasonably expected to be ingested by humans. "Food" includes drink, chewing gum and any

substance, including water, intentionally incorporated into the food during its manufacture,

preparation or treatment. It includes water after the point of compliance.

Food" shall not include: (a) feed;(b) live animals unless they are prepared for placing on the market

for human consumption;(c) plants prior to harvesting;(d) medicinal products(e) cosmetics(f)

tobacco(g) narcotic(h) residues and contaminants.

(Notably, this definition focuses on the intended ingestion by consumers and doesn't encompass

sensory, nutritional, or quality aspects.)

To define a food three main requirements should be take in consideration:

• 1) foods should have hygienic-sanitary characteristics in agreement with law requirements

• 2) Organoleptic traits should correspond to the usual or traditional ones

• 3) Nutritional value is compliant or corresponding to the usual or traditional one

In particular, if a product is not manufactured under hygienic conditions following legal regulations,

it cannot be classified as food. Furthermore, it should exhibit sensory qualities characteristic of

traditionally produced food, reflecting both the quality standards of the product and the cultural

aspects associated with its consumption. Nutritional value, especially as indicated on the label,

plays a crucial role, and it should align with the product being sold.

Food is not edible if :

- There are some modification of sensory characteristics (color, smell, taste, texture).

- It can be dangerous for human health, even without manifesting alterations

- It is deprived, in part or completely, of its characteristic nutritional value (genuineness)

Food is unsafe if (reg. EU 178/2002):

-Unfit for human consumption: from a physiological point of view (depleted food, not regular in

terms of quality, food must be excluded from the market but it is not dangerous for the consumer.

(e.g. commercial fraud; putrefaction, deterioration or decay)

-Injurious to health: when, under normal conditions of intake, the food is able to determine, and in

fact determines, a damage to health: food borne pathogens.

a) not only to the probable immediate and/or short-term and/or long-term effects of that food on the

health of a person consuming it, but also on subsequent generations;

(b) to the probable cumulative toxic effects;

(c) to the particular health sensitivities of a specific category of consumers where the food is

intended for that category of consumers.

- such as illness and acute intoxication from substances like botulinum toxin. Additionally, it

addresses long-term health consequences, as observed in instances of chronic consumption of

mercury-contaminated tuna.

Special attention should be given to understanding the cumulative effects of toxic substances,

especially when assessing sensitive consumer groups like YOPIs (Young, Old, Pregnant, and

Immunodeficient consumers).

Commercial fraud vs Safety issues

Adulteration/dilution: addition of extraneous matter, e.g. addition of sand to food grains and water

to milk; MELAMINE

Adulteration – Unapproved enhancement: the use of prohibited dyes and preservatives, e.g.

colouring of spices SUDAN RED;

Substitution: whole or partial substitution of food components (replacing the described cheaper

product with undeclared alternatives); PUFFER FISH

Spoilage: Due to the spoilage of food HISTAMINE.

Some case explamples:

In the China milk powder scandal, which unfolded in 2008, infant formula and other dairy products

were found to be contaminated with melamine, an industrial chemical. This contamination led to the

hospitalization of thousands of infants and several deaths due to kidney problems. Melamine was

added to artificially inflate the apparent protein content of the products. The incident resulted in

widespread consumer panic, significant product recalls, and intensified global scrutiny of food

safety standards in China.

In the monkfish substitution fraud case, pufferfish, which contains the potent toxin Tetrodotoxin

(TTx), was fraudulently substituted for monkfish in various dishes. Tetrodotoxin is a deadly

neurotoxin, and its presence in the pufferfish can lead to severe poisoning, paralysis, and even death

when consumed. The substitution of monkfish with pufferfish put consumers at great risk, as

Tetrodotoxin is highly toxic. This incident highlighted the importance of robust food authentication

and safety measures to prevent such substitutions and protect public health.

In the case of adulteration with unapproved enhancement of paprika with Sudan Red, 10 paprika

spice products were found to be contaminated with Sudan Red, a synthetic red dye commonly used

in industrial applications but not approved for use in food. This adulteration was intended to

enhance the color of paprika. Sudan Red is a known carcinogen, and its presence in food products

posed serious health risks to consumers. The incident highlighted the significance of stringent food

safety regulations and monitoring to prevent unauthorized additives in food products and protect

public health.

The conversion of histidine into histamine in tuna meat is a natural process that can occur during

the fish's spoilage. Histamine is a toxin that can be harmful to human health if consumed in high

quantities. However, an interesting feature is that tuna contaminated with histamine during spoilage

does not always exhibit evident sensory alterations, such as changes in color, odor, or taste. This can

make it challenging to detect the toxicological hazard associated with consuming tuna contaminated

with histamine. The presence of histamine in seafood products is a food safety concern and requires

strict preventive and control measures to ensure the quality and safety of seafood products.

First, one of the main factors is the consumer, particularly the final consumer of a food product. To

define who the consumer is, we need to consider various categories of people. These include elderly

individuals, mothers, children, and immunocompromised individuals, such as transplant recipients

or those with chronic health issues. In addition to these categories, the risk level can vary depending

on factors like ethnicity and dietary preferences, which influence the types of foods consumed.

YOPI, or Young, Old, Pregnant, and Immunodeficient people, represent a portion of the

population (around 10-20%) considered at risk due to weakened immune systems. This group

includes individuals affected by conditions like obesity, diabetes, or organ transplants.

Additionally, evolving food consumption trends, such as the increased consumption of raw fish in

sushi or other fish products, can elevate the risk of certain foodborne diseases, including those

caused by parasites.

Consumers vs risk factors

The risk of contracting Foodborne Diseases (FD) depends on many factors: the type of food

consumed, the manipulations they undergo, the type of consumer. Situations at greater risk are

identified with the consumption of some raw products (such as fresh sausages, sweets with raw

eggs, uncleaned vegetables, etc.), probable cross-contamination (between contaminated food and

free food) and people suffering from chronic diseases, the elderly, the immunocompromised,

pregnant women and infants.

Food safety vs Food security:

Food Safety Actions: aimed to reduce the health risks deriving from the consumption of food and

increasing the "quality" of food.

Food Security Actions: aimed to produce food with and higher nutritional value. Eg: provide

adequate caloric doses and nutritional components.

Food safety a concept in evolution:

the set of activities aimed at ensuring the absence of risks or hazards for consumer in all the

ingredients, agricultural or industrial semi-fihished products, which constitute food or which are

destined to become food.

All the necessary measures to ensure the safety and healthiness of the food (Legislative Decree

155/97 not in force).àThe measures and conditions necessary to control the risks and ensure the

suitability for consumption of a food product taking into account the intended use. (Reg 178/2002)

Food safety is an entire system of managing the risk: actorsà Competent authorities; FBO;

consumers; EFSA ecc..

Assurance:

The concept of assurance, i.e. food safety and its management should be based on measures that

are in place to provide assurance that food is safe. Food safety depends on the conditions in which

food is produced and prepared, and not on the results of the end-product testing, which for many

contaminants cannot be a reliable method for food safety assurance.

Food hygiene: All conditions and measures necessary to ensure the safety and suitability of food at

all stages of the food chain (Codex Alimentarius).

Food hygiene is only a part of food safety. It is a subcategory of Food safety. Refers to an

individual set of practices for controlling one aspect. (e.g. GHP; GMP actors: FBO)

In simpler terms, food safety is the overarching goal that encompasses all aspects of food quality

and safety. Food hygiene is a specific set of practices within food safety that deals with cleanliness,

proper handling, and other critical factors to ensure the safety of food. Essentially, food hygiene is a

part of the broader framework of food safety, focusing on individual practices, while food safety

encompasses the entire system for ensuring food safety.

The hygienic status of a food depends on: This includes practices like Good Hygiene Practices

(GHP) and Good Manufacturing Practices (GMP) that food businesses and establishments

should adhere to.

✓hygienic status of added raw materials, ingredients and additives

✓general hygiene conditions of the plant, and of equipment, tools, surfaces

✓hygienic and sanitary conditions of those who manipulate food

✓hygienic conditions of storage of the product before sale and during marketing

✓sanitary conditions at the time of preparation for consumption

The intended use should be considered by the manufacturer in the design of the product as well as

in their information reported on labelling.

What is the most common place where we can

acquire a Food risk foodborne illness?

Home.

Households contribute the most to outbreaks (38.7%)

due to several factors. These include improper food

handling practices, inadequate cooking or storage

temperatures, cross-contamination, and a lack of

awareness about food safety standards. Unlike

regulated environments such as restaurants or

catering services, domestic kitchens often lack

formal food safety training and may not consistently

follow best practices for hygiene and sanitation, increasing the risk of foodborne illnesses.

Twenty years ago, several food crises had a profound impact, notably the mad cow disease incident

involving a prion-related foodborne illness. The world faced contamination problems like dioxin

in eggs as well. These events, combined with globalization, evolving lifestyles, and changes in food

consumption (e.g., ready-to-eat products with extended shelf lives), prompted a shift in the global

landscape. In response to these challenges, both people and governments recognized the necessity

for changes in European food legislation. As a result, the European food legislation underwent

significant modifications, notably after the mad cow disease crisis. This period also witnessed a

shifting global environment marked by lifestyle changes, increased product longevity, globalization,

and new European economic policies. In response to these challenges, comprehensive regulations

were developed. The foundation for these changes was established considering critical food crises

that began in Europe around 1996, including issues like BSE and dioxin contamination in food.

These crises unveiled a lack of consistency in how member states applied food safety regulations

and exposed deficiencies in the control system's organization. These factors led the European

Commission to undertake an extensive revision of food safety legislation. This revision produced

two crucial documents: the Green Paper, published in 1997, which outlined general principles of

European Union food legislation, and the White Paper on food safety, published in 2000. Concrete

results of this effort included Regulation (EC) 178/2002, establishing the general principles of food

safety and requiring traceability for all foods and animal feeds. Subsequently, the European

Commission engaged in comprehensive regulatory updates to reorganize the fragmented and varied

EU legislation concerning food hygiene. This process concluded in early 2004 with the publication

of the "Hygiene Package," consisting of four regulations (Regulation (EC) 852/2004, Regulation

(EC) 853/2004,). These regulations aimed to provide a comprehensive, integrated approach to food

safety based on risk analysis. They emphasized the importance of primary production and

heightened responsibility for industry operators (FBO). Each operator's awareness of monitoring

risks related to a specific phase of the production cycle, from production to distribution, became

essential.

The Hygiene Package also led to the repeal of numerous vertical and horizontal directives that

sometimes inconsistently regulated the food sector. Regulation (EC) 852/2004 serves as the

primary legislative act of the Hygiene Package, applying to all foods, including plant-based

products. A key guiding principle of the new food legislation is ensuring food safety throughout the

production chain and across different operators. Article 5 of Regulation (EC) 852/2004 requires

downstream operators to establish, implement, and maintain procedures based on the Hazard

Analysis Critical Control Point (HACCP) system for hygienic and sanitary self-control. HACCP

was already introduced in Europe in the early 1990s by Directive 93/43/EEC, transposed into Italian

law by Legislative Decree 155/97. In the Hygiene Package, HACCP is reaffirmed as the best tool

for preventing potential food-related risks. Regulation (EC) 853/2004 outlines specific sanitary and

hygiene requirements with more oriented measures for products of animal origin, while other

regulation (governs the implementation of official controls common to all foods and production

facilities.

Management of Food Safety:

1. Integrated approach, i.e. consideration of the risks and control measures along the entire

food chain, from primary production up to the point of consumption.

In today's rapidly evolving food industry, various challenges and emerging technologies are being

harnessed to implement this integrated approach effectively. For instance, remote inspection

techniques using hyperspectral imaging allow for the evaluation of food quality and safety from a

distance.

Innovative technologies are being employed to enhance food preservation methods, and the

Internet of Things (IoT) is utilized to create intelligent connections that can monitor various aspects

of the food supply chain. Moreover, new systems are being developed to reduce the reliance on

preservatives while ensuring food safety. This holistic approach aims to ensure that food is safe and

of high quality from the very beginning of its production all the way to the consumer's plate.

The actors in the food safety management

Shared responsibility, which is the recognition that all sectors, including consumers, have a

responsibility in ensuring food safety.

Consumers, Food Business operators, Governments.

Cooperation among the three actors for food safety: Provide all infrastructures and public

health services that are necessary for a good food safety management; Promulgate laws and

regulations; provide education.

Who is responsible for the safety and healthiness of the food product?

The primary responsibility lies with the producer and has an obligation to ensure that only healthy

and safe products, which are not dangerous to human health, are marketed.

The Food business Operator (FBO) Regulation (EC) 852/2004 Regulation CE 178/2002: FBO

means the natural or legal persons responsible for ensuring that the requirements of food law are

met within the food business under their control; Food business means any undertaking, whether for

profit or not and whether public or private, carrying out any of the activities related to any stage of

production, processing and distribution of food/Feed.

FBO:

- First line of defense : the implementation of codes of good practices, a set of general

principles and measures identified through past experience and with some adaptation

applicable to all categories of foods and products.

- Second line of defense is the application of the HACCP system (Hazard analysis critical

control points). During this process, hazards specific to a food and/or process are proactively

identified and control measures specific to the hazards in question are determined.

More clearly: The Food Business Operator (FBO) has a dual defense strategy for ensuring food

safety. The first line of defense involves the implementation of Good Manufacturing Practices

(GMP) and Good Hygiene Practices (GHP), which are guided by codes and guidelines. This

includes practices like pest management, sanitation, and adherence to best practices. These

principles and measures, derived from collective experience and adapted as needed, are broadly

applicable to all categories of food and pro