Food Law – Dr.

Luca Leone (Italy Semester)

Lesson 1- The Eu Food Law and policy

Food law at national level against food alteration, food fraud and dangerous foods. Food law
is linked to Food safety and legal innovation.

EEC Treaty – 1958 (European Economic Community)

Aim: create a common market, approach the economic policies of member states,
harmonious development of economic activities, continuous and balanced expansion,
increased stability, and raising of standard living conditions.

The four freedoms of the EEC: free movement of capital, goods, services and people among
the EU.
European Food law was mainly focused on the creation of an international market (1960s)
for food products in the EU. Two stages:
- Focus on harmonization of national product standards through vertical directives.
Ended with the Case of Dijon Liquor.
- Harmonization through horizontal directives. The BSE crisis made it clear that the
existing body of EU food law needed some alterations.

From the 1990s a series of food crisis resulted in a breakdown of consumer confidence in
public authorities, industry and science.

1997- Green Paper Approach

Focused on these principles:

- Separation of the responsibility for legislation, scientific advice and inspection
- More transparency and information throughout the decision-making-process and
inspection

Three instruments are crucial for an effective consumer health policy: scientific advice, risk
analysis and risk control.

Goals of the Green Paper Approach

- High level of protection in public health, safety and the consumer
- Free movements of goods in the international market
- Ensuring the legislation is based on scientific evidence and risk assessment
- Competitiveness of the European industry and increase export
- Place the primary responsibility of safe food on the industry, suppliers and
producers.

2000- White Paper Approach

Eu Food Policy states that all food standards must be set to protect and promote health.
Comprehensive and integrated approach à covering the whole food chain and all food
sectors and defining the role of the stakeholders in the food chain.

Three pillars of Food Safety

1. Risk assessment – scientific advice, data gathering and analysis

2. Risk management – regulatory and control aspects
3. Risk communication – consumer information

Lesson 2: General Objectives of the food and feed law

- Guarantee a high level of protection of human life and health and the protection of
consumers’ interests. Fair practices in food trade: animal health and welfare, plant
health and the environment

- Ensure free movement of food and feed manufactured and marketed in the Union,
in accordance with the General Food Law Regulation

- Facilitate global trade of safe feed and safe

FOOD SAFETY Requirements (ART 14 GFL)

A food is unsafe when it is considered to injure human health and unfit for human
consumption.
To ensure a safe product for the consumer:
- Conditions of use
- Label information or any other important information must be listed

In determing whether any food is injurious to health regard must be had:

- Short and long term effects of consumption
- Any toxic effects
- Health sensitivities
Is the food unacceptable for human consumption because of contamination, putrefaction,
deterioration or decay.

Responsibility in Food Safety

Everyone working in the food industry is responsible for their hygiene in the process they
put out. Safety must be ensured from farm to fork involving each category of food. Food
chain integrated approach. All are responsible but not liable for anyone’s fault.

ART 17 GFL
Member states shall enforce food law and monitor and verify that the requirements are
being fulfilled by food and feed business operators through all stages.
Operators shall have a system of official controls. Measures and penalties are applied when
rules are violated.

When an operator considers a food as not in compliance with the food safety requirements,
the operator must:

1. Withdraw the food from the market

2. Inform the national authority in charge
3. Inform consumers why the food product was taken off the market
4. Recall the product from consumers that were already supplied to

TRACEABILITY (ART 3(15) GFL)

The ability to trace and follow a food product through all stages from farm to fork. It is an
incident management tool.

Goals
Downwards: possible for operators and control authorities to retrieve information required
for market withdrawal and recall procedure.
Upwards: search for the cause of non-compliance, to find the cause and fix it and to identify
the responsibilities.
Subjects are all operator in the food chain.

Everybody in the food chain must be able to identify their suppliers and business operators.
WHO supplied WHAT and WHO received WHICH product.

Lesson 3 – Dealing with RISKS: Governance of Food Safety in Europe

There are three types of general risks:

- Risk with known impact and known probabilities (aspestos- cancerous)
- Uncertainty known impact and unknown probabilities (antibiotics in our food)
- Ignorance unknown impact and unknown probabilities (nanometals)

ART 3 – REGL No 178/2992

‘risk’: meaning the probabilities of a severe health effect on human health, the severity of
that effect consequential to a hazard.

‘risk assessment’: scientifically based process of four steps: hazard identification, hazard
characteristics, risk characteristics and exposure assessment.

‘hazard’: physical, chemical or biological agent in or around food with the potential to cause
harm.

Risk analysis is science based and confronted with two tasks: identifying risks or excluding
risks.
ART 6 - GFL
EFSA is charged with risk assessment. Risk assessment shall be based on the available
scientific evidence and undertaken in an independent, objective and transparent manner.

The European Commission, Member state authorities and the European Parliament are
responsible for risk management. Risk management shall take into account the results of
the risk assessment.

Precautionary Principle (PP) was introduced in 1992 as the precautionary approach by the
Rio Declaration on Environment and Development.

The precautionary principle is a principle of environmental and health policy; according to it,
conceivable burdens or damage to the environment or human health should be avoided or
reduced as far as possible in advance. It thus serves to prevent risks and hazards.

Precaution is used: (basically step one, two is EFSA, three is European Commission, Member
state authorities and the European Parliament)

1. To assign responsibility for providing scientific data needed for risk assessment (EFSA
beauftragen) basically to commission EFSA
2. To choose the risk management option after risk assessment has shown the
existence of a risk.
3. As a basis for risk management in cases where risk assessment is unproved (not
enough scientific data)

The PP is used when there is a suspicion but no proof.

2000- Communication of the European Commission on PP

Article 174(2) of the EC Treaty specifies that Community policy on the environment shall be
based on the precautionary principle.
Lesson 4 – EFSA (European Food Safety Authoristation)

EFSA is the European reference body for risk assessment on food and feed safety.

Mission:
Contributing to a high level of protection of human health and life; taking into account
animal welfare; plant welfare and the environment in the operation of the internal market.
Providing independent information on these fields and communicating risks.

Structure of EFSA: management board, advisory forum, executive director and EFSA staff
and scientific committee and panels.

How does EFSA work?

EFSA receives a question from the EU Commission, Parliament or member states and EFSAS
scientists evaluate and collect scientific data and the information is then adopted and
communicated back to the EU Commission, Parliament or member states.

Tasks:
1. Providing the EU institutions with reliable scientific opinions
2. Ensuring that the information provided is quick, reliable, objective and
comprehensive
3. Providing scientific and technical assistance to the community
4. Expressing independently its own conclusion and orientations

EFSA’s opinion do not have legally binding nature but they are likely to influence effects.

Risk communication: the exchange of information and opinions concerning risk and risk
related factors among risk assessors, risk managers, consumers and other interested parties.

Goals of food safety risk communication:

- Provide consumers with information to protect their health from any risk
- Facilitate dialogue and understanding among all interested stakeholders
- To reduce the risk of food safety hazards
- Improve overall effectiveness of the risk analysis process

Risk communicators must inform the public when a food presents a serious risk. The risk
information needs to address who is at risk.

EFSA DATA:
EFSA has access to data from the member states, private companies, other EU and
international bodies, scientific literature and public sources.
The ownership of these data remains with their originator. Contractual agreements among.

(Case study: Glyphosate)

RASFF (Europäisches Schnellwarnsystem für Lebensmittel und Futtermittel)

The Rapid Alert System for Food and Feed (RASFF) was put in place to provide food and
feed control authorities with an effective tool to exchange information about measures
taken responding to serious risks detected in relation to food or feed.

Why? - To be able to take quick action and to avoid food safety risks before harming
consumers.

Members of RAFFS are the 27 member states, EFSA, EEA, European Commission and third
countries or international organizations special agreement.
If a food is unsafe the RASFF must immediately take that product off the market and inform
competent authorities.

Process: The members of RAFFS get some serious information from EFSA (ex) which then
gets handed over to the European Commission who verify this information and immediate
transmit it to other members of the network. They use a common template.

There are four different RAFFS notifications:

Alert: food contains serious risks, rapid action is needed

Information notification: does not require rapid action as the risk is not considered serious
or the product is not yet on the market.
Border refection notification: concerns a shipment of food that was not allowed across the
border due to risk to human/animal/environmal.
News: interesting information for the food/feed control authorities

(Case study: Egg Scandal)

Lesson 5 – Regulating Food Information

Transparency

Public consultation:
The principle of transparency requires that any information addressed to the public or to
the data subject be concise, easily accessible and easy to understand, and that clear and
plain language and, additionally, where appropriate, visualisation be used.

Public information:
Where there are reasonable grounds to suspect that a food or feed may present a risk for
human or animal health, then, depending on the nature, seriousness and extent of that risk,
public authorities shall take appropriate steps to inform the general public of the nature of
the risk to health, identifying to the fullest extent possible.

Presentation:
the labelling, advertising and presentation of food or feed, including their shape,
appearance or packaging, the packaging materials used, setting in which they are displayed,
and the information which is made available about them through whatever medium, shall
not mislead consumers.

Information reaches the consumer over the label. Labelling is now used to create
transparency in the market.

Food information shall not be misleading, particularly:

• as to the characteristics of the food

• by attributing to the food effects or properties which it does not possess;
• by suggesting that the food possesses special characteristics when in fact all similar foods
possess such characteristics,
• By attributing to any food the property of preventing, treating or curing a human disease

Unintentional presence in food of substances or products causing allergies or intolerances

Requires the indication of any ingredient or processing aid causing allergies or intolerances
if they are voluntary used in the manufacture or preparation of a food and if they are still
present in the finished product, even if in an altered form.

EFSA’s tool
- The EFSA tool is structured as a decision tree with a series of questions to be
answered by food business operators to help them decide whether a ‘use by’ or
‘best before’ date is required.
- Questions range from whether date marking requirements for a food category are
already regulated by legislation, whether a product undergoes any treatment to
eliminate hazards, and whether it is handled again before packaging, its
characteristics and storage conditions.
- Experts also reviewed the factors that need to be considered by food business
operators to set a shelf-life date.
 - This includes the period of time during which a foodstuff remains safe and/or of a
suitable quality for consumption while the packaging is intact and it is stored as
instructed.

Gluten-free: only allowed to be labeled when there is no more than 20mg/kg of gluten
‘very low gluten’: no more than 100mg/kg

Article 26(3) of Regulation (EU) No 1169/2011 requires that where the origin of a food is
given and is different from the one of its primary ingredient, the origin of the primary
ingredient shall be given or at least indicated as being different to the origin of the food.

“Primary ingredient” means one or more ingredient(s) of a food that represent over half of
that food, or which is usually associated with the name of the food for which a quantitative
indication is typically required.

Nutrition information

The mandatory nutrition declaration shall include:

(a) energy value; and
(b) the amounts of fat, saturates, carbohydrate, sugars, protein and salt.

The content of the mandatory nutrition declaration may be supplemented with an

indication of the amounts of: (a) mono- unsaturates; (b) polyunsaturates; (c) polyols; (d)
starch; (e) fibre; (f) vitamins or minerals.

Front-of-pack nutrition labelling is simplified nutrition information provided on the front of

food packaging aiming to help consumers with their food choices. Voluntary (ex. Nutria
score)

Open data is data that anyone can access, use and share. Governments, businesses and
individuals can use open data to bring about social, economic and environmental benefits.

Principles of Open Data: complete, primary, timely, accessible, license-free, machine

processable, non-discriminatory, non-proprietary.

Which reasons should incentivize the use of Open Data in the food sector?
à providing the consumer with an active role in the decisions and choices of purchasing
and consumption
àIt helps regulators to identify areas where food standards are not being complied with
à it drives sector changes in response this increased consumer choice.
Lesson 6 – Novel foods

Food that had not been consumed to a significant degree by humans in the EU before 15
May 1997, when the first Regulation on novel food came into force.
'Novel Food' can be newly developed, innovative food, food produced using new
technologies and production processes, as well as food which is or has been traditionally
eaten outside of the EU.
Examples of Novel Food include new sources of vitamin K or extracts from existing food,
agricultural products from third countries (chia seeds, noni fruit juice), or food derived from
new production processes (UV-treated food (milk, bread, mushrooms and yeast).

As of 1 January 2018, the new Regulation (EU) 2015/2283 on novel foods (the new
Regulation) is applicable.

The new Regulation improves conditions so that food businesses can easily bring new and
innovative foods to the EU market, while maintaining a high level of food safety for
European consumers.
Expanded categories of Novel Foods: The Novel Food definition describes the various
situations of:
o foods originating from plants, animals, microorganisms, cell cultures,
minerals, etc.,
o specific categories of foods (insects, vitamins, minerals, food supplements,
etc.),
o foods resulting from production processes and practices, and state of the art
technologies (e.g. intentionally modified or new molecular structure,
nanomaterials)

The underlying principles underpinning Novel Food in the European Union are that Novel
Foods must be:
1. Safe for consumers
2. Properly labelled, so as not to mislead consumers
3. If novel food is intended to replace another food, it must not be nutritionally
disadvantageous for the consumer.
4. Pre-market authorisation of Novel Foods on the basis of an evaluation in line with
the above principles is necessary.
5. A simplified, centralised authorisation procedure manged by the European
Commission using an online application submission system.
6. Centralised, safety evaluation of the Novel Foods will be carried out by the
European Food Safety Authority (EFSA). The European Commission consults EFSA
on the applications and bases its authorisation decisions on the outcome of the EFSA's
evaluation.
7. Establishment of a Union list of authorised Novel Foods: This is a positive list
containing all authorised novel foods.

Entomography – eating insects

PROS
Edible insects may have superior health benefits due to their high levels of nutrients.
• A reduction of greenhouse gas emissions which contribute to climate change.
• A potential solution to world hunger and food insecurity.
• A stable income to farmers in developing countries
• Less space required

CONS
• some doubts about their compliance with food safety standards: microbial hazards, allergy hazards
but also parasitical and chemical hazards could derive from the ingestion of insects.
• environmental risk of insect farming is also expected to be comparable to other animal production
systems

EFSA concludes that when non-processed insects are fed with currently permitted feed
materials, the potential occurrence of microbiological hazards is expected to be similar to
that associated with other non-processed sources of protein.

The EU strategy for nanotechnology

Definition: food which has been cultivated, produced, processed or packaged using
nanotechnology techniques or tools. Food to which manufactured nanomaterials have been
added.

Scientific Uncertainty

Currently, there are significant knowledge gaps as to the exposure of nanomaterials in the
human body, methods to detect and measure nanomaterials in food and feed, the
nanomaterials’ toxicity and fate in the environment as well as about the present use of
nanomaterials in the food and feed area

CONCERNS OVER CONSUMER SAFETY: 'nanomaterials are similar to normal

chemicals/substances in that some may be toxic and some may not'.
Responsible approach:

In sum, the main directions of the safe, integrated and responsible approach were

i) to boost networking infrastructures for research and development of the sector,

ii) to develop a better integration between research and its ethical dimension,
iii) to involve all stakeholders in the development of nanotechnologies and their regulation,
iv) to apply the current regulatory framework by checking its adequacy.

The Code of Conduct for Responsible Research and Innovation in Nanosciences and
Nanotechnologies

- Reccomendation is a soft law document

- Code as a source of normativity created to address and fill all existing and emerging
regulatory gaps
- Ruled- and value-based tool
- Broad stakeholder involvement and early public intervention

Principles: meaning, excellence, sustainability, innovation, precaution, accountability and

inclusiveness

Critics

- lack of correlation between the principles and the guidelines that weakens the
dimension of their practicability.
- some guidelines are not well formulated and seem to lead to unintended
consequences or not to the intended ones.
- absence of 'criteria and indicators to clarify how to apply it'
- it seems unrealistic to require all N&N researchers to "launch and coordinate"
nanotoxicology research‘
- the language of the Commission limited the comprehensibility of the code
- there was no official platform providing information about the code

In 2008 first review of the regulatory aspects of nanomaterials. In 2009 Parliament adopted
a critical resolution with which it asked the Commission for a strategy change in EU policy.

EC versus PC

European Commission 2004: no need for new regulations, regulations already exist,
normalizing the new

European Parliament 2009: current legislation is not sufficient, improving implementation of

current regulation, addressing nanometals within the scope of legislation on food.

The EU legal framework on Nanofood

Food additives, enzymes and flavourings

They must undergo a common (EU-wide) assessment and authorisation prior marketing, for
which Regulation (EC) 1331/2008 lays down the common procedure
Food enzymes: “a food enzyme already included in the Community list under this Regulation
which is prepared by production methods or using starting materials significantly different
from those included in the risk assessment of the Authority, or different from those covered
by the authorization and the specifications under this Regulation, should be submitted for
evaluation by the Authority” (Reg. No 1332/2008, Whereas 12).

Food additives: “Changes in the production process or starting materials of a food additive
already included in a Community list,” states:

“When a food additive is already included in a Community list and there is a significant
change in its production methods or in the starting materials used etc., shall be considered
as a different additive and a new entry in the Community lists or a change in the
specifications shall be required before it can be placed on the market.”

Art. 2:

(f) ‘engineered nanomaterial’ means any intentionally produced material that has one or
more dimensions of the order of 100 nm or less or that is composed of discrete functional
parts, either internally or at the surface, many of which have one or more dimensions of the
order of 100 nm or less, including structures, agglomerates or aggregates, which may have a
size above the order of 100 nm but retain properties that are characteristic of the
nanoscale.

Properties that are characteristic of the nanoscale include:

(i) those related to the large specific surface area of the materials considered; and/or
(ii) specific physico-chemical properties that are different from those of the non-nanoform
of the same material.
Lesson 7 – Deailing with GMOs

GMO: A Genetically Modified Organism is any organism whose genetic material has been
altered using genetic engineering techniques (use of bio technology)

We use biotechnology to change negative characteristics, to produce more and to make

products more resistant.

Possible risks:

• Intensification of the use of chemicals

• Genetic drift
• Development of resistances
• Insect damage
• Genetic erosion

The legal framework aims to:

Precautionary Principle: imposes a pre-market authorization for any GMO to be placed on

the market and a post-market environmental monitoring for any authorized GMO. à
implemented by risk assessment and risk management.

GMOs, the pre-market authorization

1. authorisations are valid throughout the EU and may be for: cultivation or/and
marketing of food and feed and derived products
2. in both cases, an application for authorization must be submitted to a
national competent authority, by submitting a dossier with experimental data
and a risk assessment.
3. If the authorisation concerns the marketing, the procedure is more complex
and centralized: the examination of the application, and therefore the
scientific risk assessment, in this case is always carried out by EFSA.
4. Within three months from EFSA’s opinion, the Commission prepares a draft
implementing decision granting or refusing authorisation. It may diverge
from EFSA’s opinion, but it must then justify its position
5. Authorisations are valid for a maximum of 10 years (renewable)

Requirements to gain authorization: the Gmo must not;

- have adverse effects on human health, animal health or the environment;
- mislead the consumer
- differ from the food which it is intended to replace to such an extent that its normal
consumption would be nutritionally disadvantageous for the consumer

GMOs Labelling: pre-packaged food/feed products must indicate ‘genetically modified’.

Shall not be labelled as GMO if: it contains less than 0,9% GM contamination.

5 categories of GMOs have been authorized: maize (only one authorized for cultivation),
cotton, soybean, oilseed rape and sugar beet. The EU imports are mainly GM feed but very
little GM food.

Coexistence with conventional and organic agriculture

- The objective of coexistence is to avoid unintended presence of GMOs in other products

- Consumer's choice is possible with a functioning traceability and labelling system, and an
agricultural sector producing the different types of products

Is coexistence possible?
All phases of production should be separated, costs are very high.

The development of new Plant breeding techniques

Is it therefore necessary to rethink the definition of GMOs?

The consequences are important:

- Authorization, Monitoring, Risk assessment, Traceability, Labelling

Lesson 8 – The ‘ethical’ Organic Food
Regulation (EU) 2018/848

Organic farming is an overall system of farm management and food production that
respects natural life cycles. It minimizes the human impact on the environment and
operates as naturally as possible, in accordance with objectives and principles including the
following:

- Chemical pesticides and synthetic fertilizers are banned, antibiotics and other substances
are severely restricted;
-Genetically modified organisms (GMOs) are banned;
-Crops are rotated so that soil and on-site resources are used efficiently;
- On-site resources are put to good use, such as manure for fertilizer or feed produced on
the farm;
- Disease-resistant plant and animal species adapted to the local environment are used;
- Livestock are raised in a free-range, open-air environment and are fed with organic fodder;
- Animal husbandry practices are tailored to the various livestock species.

ORGANIC - summary

Organic 1.0 was started by our numerous pioneers, who observed the problems with the
direction that agriculture was taking at the end of the 19th century and the beginning of the
20th century and saw the need for a radical change.

Organic 2.0 started in the 1970s when the writings and agricultural systems developed by
our pioneers were codified into standards and then later into legally-mandated regulatory
systems.

Organic 3.0 is about bringing organic out of its current niche into the mainstream and
positioning organic systems as part of the multiple solutions needed to solve the
tremendous challenges faced by our planet and our species.

Organic 1.0

“Organic 1.0” was started by numerous pioneers, who observed the problems of
industrialized conventional agriculture at the end of the 19th century and the beginning of
the 20th century and saw the need for a radical change.

The modern form of organic agriculture was developed in Europe (mainly in German-
speaking countries), the Anglo-Saxon area of influence, and Japan since the early 19th century

The visionary pioneers of the organic movement showed the holistic and healthy relationships
between how we live, eat, and farm, our health and the health of the planet.

Ethical principles, the pioneers – achievements of IFOAM: principle of health, ecology,

fairness and care.

The pioneers:

1970s – ‘Know your Farmer, Know your Food’

 - Global movements have concerns with pollution and the health of the Earth’s
environment
- There is an increase in focus toward organic farming
- The market for organic agriculture products is born, and ‘Organic 1.0’ makes room for
Organic 2.0

Organic 2.0 – from the 1970s

Organic 2.0 started in the 1970s when the writings and agricultural systems developed by
our pioneers were codified into standards and then later into legally-mandated regulatory
systems.

It marks a time where awareness of organic farming increased considerably and the market
for organic produce grew significantly. There is more and more evidence highlighting the
positive impacts of organic on a range of important issues including consumer health,
biodiversity, animal welfare and the improved livelihoods of producers.

Despite increasing success, certified organic agriculture has not reached 1% of global
agricultural land. At the same time there is increasing awareness that organic can be a
solution to global challenges such as soil contamination, loss of biodiversity and climate
change. It is time to position organic as a modern, innovative system that can bring true
sustainability to food and farming systems.

By the 1980s, as the landscape was becoming more complex with the advent of novel
technologies – from biotechnology to ICT – organics evolved differently in the EU countries
and the US.

Organic 2.0: Value Chain (market development, trade) and codification (standards and
regulations)

By 1990 organic markets are growing by 20% . In 2010 a new EU organic logo – replacing
the previous one – was launched symbolising the unique set of legal organic rules valid all
over the EU. The use of the 'organic leaf' is obligatory for pre-packed EU products and
optional for imported products.

At the end of 2011, the European Commission decided to review the organic legislative
framework. Regulation EU, 2018/848: The new regulation on organic food will apply from 1
January 2021.

Objectives:
1. Long term fertility of soild
2. Non-toxis environment
3. Short distribution channels and local production in various areas of the Union
4. The preservation of rare and native breeds in danger of extinction
5. The development of organic plant breeding activities

General principles:
- preserving natural landscape
- wide variety of high quality food
- ensuring the integrity of organic production through all stages
- no use of external inputs
- biological process
- animal welfare
-no engineering nanomaterials

Precautionary measures:
- avoid risks of contamination
- an official investigation to ensure the organic product à if the product turns out not to be
produced by organic regulation, the production will be decertified.
- mixed farms are allowed (conventional and organic farming) as long as the farming
activities are clearly separated
- not allowed to be labelled organic if contamination was deliberate or caused by
irresponsible food business operators.

Conversion period:
when a farmer wishes to produce organic products it has to go through a conversion period
during which it must be fully managed according to organic production rules, but during this
stage it cannot yet be called organic. It can only sell its products as organic once the
conversion period has elapsed and checked.

Big DATA

In the flourishing ag sector, the process of digitalisation driven by big data is strongly serving
farmers’ interests, operations and needs. ICT technologies such as cloud computing, drones,
sensors, global positioning systems and Internet of Things (IoT) allow users to collect
weather data, map crop yields, track seed varieties, and, at the same time, share all
captured data and interpret them with big-data techniques.

Legal approach of Big Data

EU Code of Conduct on agriculture data sharing: to maximise the potential of data sharing
from farm to farm products within the agri-food chain, this process must be conducted
under fair and transparent measures, ensuring data is handled in a safe and appropriate
manner.

The EU conduct on agriculture by contractial agreement: the conduct constitutes that a

document that will look at general principles for sharing agricultural data within the agro-
food chain.

ORGANIC 3.0

“Organic 3.0” is the third phase of the organic movement – the next paradigm.

• It is about bringing organic out of its current niche into the mainstream and positioning
organic systems as part of the multiple solutions needed to solve the tremendous
challenges faced by our planet and our species.
• “Organic 3.0” is about developing a new collective vision for the organic sector and like-
minded movements such as agroecology, fair trade, slow food, and others, to actively
engage with major global issues.

(Simple explanation from video:)

Undeterred by the rise of industrial agriculture organic pioneers had already started looking
for alternatives. A way of farming in harmony with nature, not against it. This marks a time
we call organic 1.0. These efforts led to the codification of standards and rules that
established organic in 87 countries supported by over two point four million producers and
an ever-growing number of consumers, a development we see as organic 2.0.

This is the start of realizing the full potential of organic agriculture. Now we are shaping a
vision for organic 3.0 —> it’s time to talk more about the relationship of consumers and
producers, the choices we all make from field to fork and what it means for people and the
planet. Organic 3.0 centers around six features:
- A culture of innovation enables people to adopt leading-edge solutions to deal with
major social and environmental challenges.
- Continuous improvement; means making organic agriculture better and inspiring
improvements in all agricultural practices.
- Ensuring transparent integrity; beyond labels and explores new tools to build trust at
all levels.
- Inclusive of wider sustainability interests; involves building alliances with those also
working for the establishment of sustainable food and farming systems
- Empowerment from farm to consumer; focuses on moving from food chains to food
systems, from certified products to a way of life addressing all aspects of
sustainability
- True value and cost accounting; reflects the real cost of producing our food and the
cost of healthy biodiversity and the environment more than the actual price we pay
in the supermarkets

àIn organic 3.0 is about bringing true sustainability to our food and to our farming systems.
Lesson 9 – Animal welfare

Organic farming
'preventive measures at every stage of production, preparation and distribution, where
appropriate to avoid negative effects on animal health.’

The new rule aims at avoiding or keeping to a minimum any suffering, pain or distress at all
stages of animal lives. The EU organic logo à symbol embeds high standard of animal
welfare.

In February 2019, the Court ruled that Halal meat from animals slaughtered by religious
ritual without having first been stunned cannot be labelled organic, as it fails to observe the
highest animal welfare standards.

On 24 September 2012, OABA sent to the Minister for Agriculture an application requesting
that he take measures to end the advertising and marketing of minced beef patties under
the ‘Tendre France’ brand, certified ‘halal’ and bearing the ‘ organic farming’ indication

‘Must EU law be interpreted as permitting or prohibiting the use of the European “organic
farming” label in relation to products derived from animals which have been slaughtered in
accordance with religious rites without first being stunned, where such slaughter is
conducted in accordance with the requirements laid down by Regulation [No 1099/2009]?’

The defendants:
- No regulation explicitly preclude a derogation
- No incompatibility between the certification halal and organic farming
- Freedom to practice one’s religion
- The principle of consumer confidence was not infringed

The CJEU (court of justice of the EU)

The EU legislation on organic farming highlights observance of enhanced standards with

regard to animal welfare in all locations and at all stages of production where it is possible
further to improve that welfare.

Regulation No 1099/2009 contributes to ‘improving the protection of animals at the time of

slaughter’ and encourages ‘ stunning methods [that] can lead to death while avoiding pain
and minimising distress or suffering for the animals’

Methods of slaughter prescribed by religious rites that are carried out without pre-stunning
and that are permitted by Regulation No 1099/2009 are not tantamount, in terms of
ensuring a high level of animal welfare at the time of killing, to slaughter with pre-stunning.
Regulation No 834/2007 lays down the objective of ‘maintaining and justifying consumer
confidence in products labelled as organic’. In that regard, it is important to ensure that
consumers are reassured that products bearing the Organic logo of the EU have actually
been obtained in observance of the highest standards, in particular in the area of animal
welfare.
à Regulation No 834/2007 must be interpreted as NOT authorizing the placing of the
Organic logo of the EU on products derived from animals which have been slaughtered in
accordance with religious rites without first being stunned.

EFSA developed a set of indicators – “animal-based measures” – to be included in its welfare

assessments. EFSA published three scientific opinions on the use of animal- based measures
for animal welfare assessment. The opinions covered pigs, dairy cows, and broilers.

Definition of animal welfare

"Animal welfare" means how an animal is coping with the conditions in which it lives.
An animal is in a good state of welfare if (as indicated by scientific evidence) it is healthy,
comfortable, well nourished, safe, able to express innate behaviour, and if it is not suffering
from unpleasant states such as pain, fear, and distress . . . .

Kant – can they suffer?

3 Rs by Russel & Burch 1959: human experimentation

Replacement
Animals should be replaced in experiments

Refinement
If animal experiments can not be avoided protocols should be refined to minimize any
adverse effects for each individual animal. Appropriate anaesthesia and analgesia should be
used for any surgical intervention. Humane endpoints should be used whenever possible.
Staff should be well trained, and housing should be of a high standard with appropriate
environmental enrichment. Animals should be protected from pathogens.

Reduction
The number of animals should be reduced to the minimum consistent with achieving the
scientific objectives of the study, recognizing that important biological effects may be
missed if too few animals are used. Alternatively, methods should be found to obtain more
information from each experiment, thus speeding up the pace of research.

The Brambell Report, December 1965

1. Freedom from Hunger and Thirst - by ready access to fresh water and a diet to maintain
full health and vigour.
2. Freedom from Discomfort - by providing an appropriate environment including shelter
and a comfortable resting area.
3. Freedom from Pain, Injury or Disease - by prevention or rapid diagnosis and treatment.
4. Freedom to Express Normal Behaviour - by providing sufficient space, proper facilities and
company of the animal's own kind.
5. Freedom from Fear and Distress - by ensuring conditions and treatment which avoid
mental suffering.
Animal welfare
(D.M. Broom, K.G. Johnson, Stress and Animal Welfare, 1993) The quality of life can be
measured through biological, physiological and behavioral indicators.

Peter Singer: All sentient beings have the interest not to suffer
Tom Regan: if humans have natural rights, then animals have rights as well

Starting point - economics:

method to optimize animal production/experimentation by balancing scientific/economic
needs and animal well-being

Towards ethical concern:

animals can be used only if their quality of life is respected
(3Rs, Five Freedoms, etc.)

The agribusiness food domain

The outcome of the BSE crisis made animal welfare one of the 'legitimate factors' essential
for EU food safety policy – albeit in close connection with animal health – 'for the health
protection of consumers and the promotion of fair practices in food trade.'

• From here, the agricultural product quality policy came to identify welfare among the
'most stringent farming requirements' for high quality foodstuffs.

Legal Framework – Article 13 TFEU

European member states shall pay full attention to welfare requirements of animals, while
respecting the legislative or administrative provisions and customs of the member states
relating in particular to religious rites, cultural traditions and regional heritage.

Council Directive 98/58/EC concerning the protection of animals kept for farming purposes
transposes into EU law the Council of Europe Convention.

• Responsibility is placed on owners and keepers of animals to ensure the welfare of

animals under their care and prevent unnecessary pain, suffering or injury.

• Animals to be cared for by sufficient numbers of appropriately trained workers.

• About breeding methods, cause suffering or injury to any of the animals concerned must
not be practiced

• regular inspection, rapid treatment for sick animals, recording of veterinary treatment and
mortality, general provisions with regard to livestock buildings, outdoor shelter, feed and
water.

The 2003 reform of the CAP (Common Agricultural Policy)

• It introduced compulsory cross-compliance, which makes the payment of subsidies
conditional on respect of animal welfare standards, as well as environment, public and
animal health standards.

• Cross-compliance with animal welfare legislation could apply to all areas of livestock
farming, not only to those receiving presently direct aid.

• However only three Directives have been included in cross- compliance, Directive on the
protection of farm animals, Directive on the protection of calves and Directive on the
protection of pigs.

• Member states have to set up indicators to control cross- compliance.

The Rural Development Regulation (2005)

• It included new measures to improve farm animal welfare (not obliged)

• An animal welfare payment: Farmers may receive subsidies for the extra costs this causes.
• Meeting standards: farmers can be paid to adapt to new, more demanding legal
standards.

Transgenic and cloned animals

Shall be considered unpatentable: (a) processes for cloning human beings; (b) processes for
modifying the germ line genetic identity of human beings; (c) uses of human embryos for
industrial or commercial purposes; (d) processes for modifying the genetic identity of
animals which are likely to cause them suffering without any substantial medical benefit to
man or animal, and also animals resulting from such processes».

BBFAW: The Business Benchmark, on Farm Animal Welfare publicly ranks the world’s
leading food companies on their farm animal welfare management etc.
EggTrack: companies commitment to purchase 100% cage free eggs by 2025.

GLOBAL Highlights

• 63% of the 210 companies tracked this year have made progress towards their
commitments.
• Since 2016, the number of companies with GLOBAL cage-free commitments has grown
from five to at least 37 (including global giants like Unilever, Nestlé and Compass Group).
• Danone increased its global cage-free sourcing from 43% to 88%.

• McDonald’s are reporting 100% cage-free shell eggs in Europe, they do not yet have a
global cage- free commitment.
• Barilla is the ONLY company to have met a global cage-free commitment, which it did in
2019.
Introduction to an independent animal welfare label. More and more consumers find it
important to high animal standards in production of animal-based foods. Label
Contributes to transparency and openness in the entire production chain.

EU Platform on Animal Welfare

In 2017 the Commission established the expert group 'Platform on Animal Welfare' with the
aim to develop and exchange of coordinated actions on animal welfare with a particular
focus on:

1. better application of EU rules on animal welfare, through exchanges of information

and best practices and the direct involvement of stakeholders,
2. the development and use of voluntary commitments by businesses to further
improve animal welfare,
3. the promotion of EU animal welfare standards to valorise the market value of the
Union's products at the global level.

The new Veterinary Medicines Regulation

(Regulation (EU) 2019/6) will modernise the existing rules on the authorisation and use of
veterinary medicines in the EU when it becomes applicable on 28 January 2022.

The main objectives of the new Regulation are to:

- simplify the regulatory environment and reduce administrative burden for
pharmaceutical companies developing veterinary medicines, for example through
streamlined pharmacovigilance rules;

- stimulate the development of innovative veterinary medicines, including products

for small markets (minor use and minor species);

- improve the functioning of the internal market for veterinary medicines;

- strengthen EU action to fight antimicrobial resistance through specific measures

ensuring prudent and responsible use of antimicrobials in animals, including
reserving certain antimicrobials for the treatment of infections in people.