Regulation

178/2002
• Sally O’Neill
 • In 2002 European Commission issued a
White Paper on Food Safety
• Reform of food law
– ‘Regulation (EC) No 178/2002 of the
European Parliament and of the
Council of 28 January 2002 laying
down the general principle and
Regulation requirements of food law, establishing
the European Food Safety Authority

178/2002 and laying down procedures in

matters of food safety’
– Abbreviated to GLF – General Food
Law
– Came into force 21/02/02
– Enacted into UK law after Brexit
>>>now know a Regulation 178/2002
 Point to be aware of
– 178 superseded the Food Safety Act 1990
definition of food >>> beware when
reading copies of the FSA 90
– 178s definition now applies
– Food Safety & Hygiene (England) Regs 2013
• Enable the enforcement of Articles 14,
16, 18 & 19 in EC Reg 178/2002
• Offence to contravene these articles is
Reg 19 of FH&H regs
 Regulation 178/2002
• Article 1 – aim & scope
– High level of protection of human health and consumers’
interest in relation to food
– Establish EFSA
– Applies to all stages of production, processing and
distribution of food & feed.
• Except primary production for domestic use
• Domestic activities and consumption

• Article 2 – definition of food

• Article 3 – other definitions

 Article 2 – definition of food

• ‘Food’ includes drink, chewing gum and any

substance, including water, intentionally
incorporated into the food during its
manufacture, preparation or treatment.
 Article 2 – definition of food
• Food is not >
• Animal feed
• Live animals unless they are prepared for placing
on the market for human consumption
• Plants prior to harvesting
• Medicine
• Cosmetics
• Chewing Tobacco and tobacco products
• Narcotics
 Definition of food business operator

• Article 3.3

“FBO means the natural or legal persons

responsible for ensuring that the
requirements of the food law are met within
the food business under their control”
NB – this differs from the FSA 90 definition and
terminology
Definition of placing on the market
• Article 3.8
• ‘placing on the market’ means the holding of
food or feed for the purpose of sale, including
offering for sale or any other form of transfer,
whether free of charge or not, and the sale,
distribution, and other forms of transfer
themselves.
 (EC) Regulation 178/2002 Article 5
• Article 5 – General Objectives of this
legislation
– Protection of
• Human life & health
• Consumer interests
• Fair practices in trade
• Animal health & welfare, plant health & environment
• Free movement of food products
 (EC) Regulation 178/2002 Article 6
• Article 6 – Risk Analysis
– Based on risk analysis

• Risk assessment shall be based on the available scientific

evidence and undertaken in an independent, objective
and transparent.

• Risk management takes into account results of RA, Other

legitimate factors (OLFs) and precautionary principle >>
ensure the high
• level of health protection until proven otherwise.
 Risk Analysis
• https://www.youtube.com/watch?v=KSluc9igx
kA
 Regulation 178/2002 Article 7
• Article 7 – Precautionary Principle
– If possible harmful effects on health are identified, but
scientific uncertainty persists
• Provisional risk management measures may be taken
• Pending further research
• Proportionate
• No more restrictive to trade than required
• With regard to technical and economic feasibility and other
legitimate factors
• Measures shall be reviewed within a reasonable time
 EFSA
• ‘The [EFSA]Authority should be an
independent scientific source of advice,
information and risk communication in order
to improve consumer confidence;’

Regulation(EC) No 178/2002
Preliminary remarks (35)
 Tasks of the EFSA
• Scientific Evaluation of Risks
• Collection of Scientific data
• Safety evaluations of industrial proposals (substances
or processes)
• Identification of emerging risks
– Rapid alert system
– Networking with other organisations
• Scientific support to the commission
• Direct communication to the public and other
interested parties
 Article 8
• It shall aim at the prevention of:

• (a) fraudulent or deceptive practices;

• (b) the adulteration of food;
• (c) any other practices which may mislead the
consumer.
 Article 9 & 10
• Public consultation (9)with relevant bodies -
unless laws are needed at such a time that its
not possible

• Public (10) information will be made available

to the public where possible --- show how
decision making process worked.
 Article 11, 12, 13.
Article 11 – food & feed imported into the community
 Imports shall comply with EU law

Article 12 – food & feed exported from the community

 Exports shall comply with EU laws
 In the case of exporting or re-exporting food, as it is not allowed into EU
the competent authorities of the destination country must have expressly
agreed for the food to be exported or re-exported, after having been fully
informed as to why the food could not be placed on the market in the
Community.

Article 13 – international standards

 Contribute to development
 Promote international organisations
 Contribute to agreements
 Special attention to needs of developing countries
 Promote consistency
 Article 14 Food Safety Requirements

1. “Food shall not be placed on the market if it is

unsafe.

2. Food shall be deemed to be unsafe if it is considered

to be:

(a) injurious to health;

(b) unfit for human consumption.”
 Article 14 – Food Safety Requirements
• Not confined to food place on the market by FBOs

• Offence could be committed from

– A one off sale or transfer of food
– Food supplied free of charge

• Article 1(3) provides exemptions for

– Private domestic use or private domestic
consumption
 Article 14 sub para 3 (a)- (b)
3. “In determining whether any food is unsafe, regard shall
be had:

(a) to the normal conditions of use of the food by the consumer

and at each stage of production, processing and distribution,
and

(b) to 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.”
 Article 14(4) sub paragraph (a) – (c)

4. “In determining whether any food is injurious to health, regard

shall be had:

(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.”
 Example: patulin
• patulin is found in apples and apple products such as juices,
jams, and ciders. Fungal growth leading to patulin production
is most common on damaged fruits. The EU has set a
maximum limits of 50μg/kg pertaining to fruit juices and
drinks, while solid apple products have a limit of 25μg/kg
 Article 14(5)
5. “In determining whether any food is unfit for
human consumption, regard shall be had to
whether the food is unacceptable for human
consumption according to its intended use, for
reasons of contamination, whether by
extraneous matter or otherwise, or through
putrefaction, deterioration or decay.”
Mouldy cheese
 Batch, lot or consignment
• Article 14(6) Reg EC 178/2002

“any food which is unsafe forms part of a batch, lot or

consignment of food of the same class or description, it shall
be presumed that all the food in that batch, lot or
consignment is also unsafe, unless following a detailed
assessment there is no evidence that the rest of the batch, lot
or consignment is unsafe”

• Detailed assessment can displace the presumption.

 Boxes containing
mouldy oranges,
probably caused by
storage in damp
packaging. The vendor's
intention was to
remove decomposing
fruit, wipe the
remainder and offer
them for retail sale.
 Article 16 – presentation of food
• Creates a further offence than those in the
FSA (S14 & S15).

• Deals with
– Labelling, presenting and advertising of food and
feed such as to not mislead the customer.
– Shape, appearance, packing, packing materials,
display and information.
 Article 18 - Traceability
• Para 1
“Traceability of food, feed, food-producing animals,
and any other substance intended to be , or
expected to be incorporated into a food or feed
shall be established at all stages of production,
processing and distribution”
 Article 18 - Traceability
• Businesses required to
– Identify their suppliers of food, food producing animals
and any other substance intended or expected to be
incorporated into food.
– Businesses they supply
– Provide this information to the competent authority on
demand.

– “One step forward one step back”

Article 18 - Traceability
• Purpose of traceability
– Assist in targeted and accurate withdrawals
– Information to control officials
– Avoid wider distribution

• Applies to
– Primary producers
– Manufacturers
– Retailers
– Transporters
– Distributors
– Food brokers
– Caterers
– Businesses importing from third countries
 Article 18 - Traceability
• Traceability records

– Address of customer or supplier

– Nature & quantity of product
– Date of transaction & delivery
• All the above probably available in accounting records

• Helpful to have batch number & durability.

 Article 19 – Withdrawal, recall &
notification of food
• Article 19(1)
– Food businesses operator must withdraw food
from the market where it considers or has reason
to believe that a food which it has imported,
produced, processed, manufactures or distributed
does not comply with Article 14, and the food has
left the immediate control of the initial food
business.
 Article 19 – Withdrawal, recall &
notification of food
• Withdraw
– Remove product from the supply chain

• Recall
– Remove product from supply chain &
customers
 Article 19 – Withdrawal, recall &
notification of food
• Article 19(3)
– FBO shall immediately inform the competent authorities if
it considers or has reason to believe it has placed a food on
the market which is injurious to health.

– Inform authorities of actions taken to reduce risk.

– Should not prevent any person cooperating with the

competent authorities.
• Where food has not left the immediate control
of the initial food business operator

– No withdrawal required
– If food considered Injurious to Health they must
still notify the competent authorities immediately.
What happens when the competent
authorities are told?
 Alert Systems
• IN EU they share data via Rapid Alert System for
Food & Feed (RASFF)
– Alerts notification – immediate action
– Information notification – product not reached the
market so no action
– News notification – info of interest to member states
– http://ec.europa.eu/avservices/video/player.cfm?ref=I
063048
- Hopefully we will have access again with any trade deal
New iRASFF introduced if it relates to FOOD FRAUD –
cross border cooperation beyond just EU and EEA
 Alert Systems
• TRACES – TRAde Control and Expert Systems.

– Central database established April 2004.

– Traceability of animals across borders within the EU and from third

countries.

– In the event of disease outbreak TRACES ensures identification of affected

animals and that authorities take appropriate measures.
– EU based but used by 90 Countries - information on the movements of
their consignments and by significantly speeding up administrative
procedures

– UK businesses can use the system for Imports to EU

 Break

We break here to look at some case studies before

moving on to enforcement