INTERNATIONAL REGULATORY LANDSCAPE
FOR FOOD ADDITIVES
Lynn Insall
Conference on Food Additives: Safety in Use and
Consumer Concerns
Nairobi, 24 June 2014
50 YEARS OF PROGRESS

Increase in global population

Increase in global prosperity

Major changes in world trade patterns

Major changes in food supply chains

“Global village”

People on the move

More travel, transport and trade
OVERVIEW OF ADDITIVES
REGULATION

European Union

USA

China

Codex Alimentarius
REGULATION IN THE EUROPEAN
UNION



Regulation 1331/2008, adopted December
2008
Establishes a common authorisation procedure
for food additives AND food enzymes and food
flavourings
Replaces previous framework legislation,
Directive 89/107/EEC, which set out criteria for
for authorisation of food additives, definitions,
general criteria for use, and labelling
requirements
THE EU “GLOBAL” REGULATION





Regulation (EC) No. 1333/2008
Replaces the previous specific Directives on
food colours, food sweeteners, and food
additives other than colours and sweeteners
Applicable from 20 January 2010
Previous Directives phased out from 1 June
2013
Annexes follow food categorisation system
ADDITIVES LEGISLATION IN THE
USA



Part of Federal Food, Drug and Cosmetic Act
(FFDCA)
Food Additives Amendment to FFDCA enacted
1958
Defines food additives as “safe” or “unsafe”,
excluding GRAS substances

Pre-market approval required

Uses food category system
THE SYSTEM IN CHINA




Additives controlled by National Food Safety
Standard GB2760-2011
Lists permitted additives and specifies
conditions of use
Uses hierarchical food categorisation system
China committed to establishing integrated
Food Safety standards systems by 2015, using
Codex standards as basis
CODEX GENERAL STANDARD
FOR FOOD ADDITIVES (GSFA)




Adopted as a Codex standard in 1995 –
CODEX STAN 192-1995
Intended to serve as a single authoritative
reference point for food additives
CIAA Categorisation System used as basis of
allocation of additives to foods
Still a “work in progress”
WHY DO WE NEED ADDITIVES
LEGISLATION?

Consumer safety

Prevention of food adulteration and fraud

Provision of consumer information

Avoidance of barriers to trade
MAJOR TRADING BLOCKS HAVE ADOPTED A
“HORIZONTAL” APPROACH TO REGULATING
FOOD ADDITIVES
THE “HORIZONTAL” APPROACH




EU Regulations and Codex GSFA rooted in
need to harmonise
“Vertical” commodity legislation and
compositional standards not readily adaptable
to control of food additives
Need for consumer protection requires
monitoring of intakes
Horizontal approach allows for adaptation if
changes in safety assessments or consumer
intake
COMMON PROVISIONS

Pre-market approval of additives - numbered

The need for a safety assessment

Safety assessments carried out by independent
scientific panels – EFSA and JECFA

Definitions

Safety in use – allocation of the ADI

Technological need

Use of additive must not mislead the consumer
CLASSES OF ADDITIVES



All “horizontal” systems recognise the many
classes of additives – Colours, Sweeteners,
Preservatives, Antioxidants, Emulsifiers,
Stabilisers etc. - though in some systems they
are treated differently
The use of some of these classes, and of
specific additives, can be controversial
Some countries and consumer groups seek to
restrict the use of certain additives or additive
classes
FOOD CATEGORISATION
SYSTEM





All regulatory schemes under discussion use a
form of food categorisation system
Key Food Categorisation System developed in
early 1990s by CIAA (now FoodDrinkEurope)
Intended to assist in allocation of additives to
foods, based on hierarchical system
Not adopted by the European Community in
first round of harmonisation
Taken up by Codex Alimentarius in the GSFA
WHY IS THIS IMPORTANT?




Provides transparent method for use of food
additives in “horizontal” system
Facilitates allocation of additives across foods
in which they are needed according to ADI
Facilitates enforcement of legislation
Assists in protecting consumer safety by intake
reviews
IS THE LEGISLATION FIT FOR
PURPOSE?


Consumer safety: all “horizontal” approaches
recognise the need for the safety assessment of
food additives. Some more up-to-date than
others
Trade: differences in national legislation were
seen as a barrier to trade in the European
Economic Community as far back as the 1960s;
Codex became the reference point for technical
issues in trade disputes under the WTO's
sanitary and phyto-sanitary agreements
INTO THE 21ST. CENTURY

CODEX first to provide on-line database
http://www.codexalimentarius.net/gsfaonline/addit
ives/search.html

EU followed suit, but not necessarily reliable
https://webgate.ec.europa.eu/sanco_foods/main/
?sector=FAD

Need to keep electronic databases updated
REQUIREMENTS FOR CHANGE?
There are three main requirements in change
management:

Money

Time

Goodwill
EVER CLOSER UNION?




Global trade requires a common approach in
order to minimise costs, disputes and
misunderstandings
Consumer safety must be protected
Laws and standards should recognise
differences in additive needs for geographical,
climatic and social reasons
Flexibility needed to encourage innovation
ROOM FOR IMPROVEMENT?





New EU Regulations easier to follow, more
adaptable than previous legislation
Programme of scientific re-evaluation will be
underway for some years
Any new scientific evidence has to be taken into
account
Codex: slow to adapt and under-resourced
Inconsistencies between vertical standards and
GSFA need to be resolved
TRANSITION TO THE FUTURE





Improved scientific co-operation
Maintain focus on consumer safety with
enhanced approaches to intake assessment
Respect consumer choice via information
Make greater use of technology, e.g. electronic
communications and “virtual” meetings
More goodwill
AN INTERNATIONAL APPROACH




Major trading blocks already have similar
approaches to horizontal additives legislation
Mutual recognition should apply where safety
standards are deemed equivalent
Codex GSFA should maintain its role in dispute
resolution under WTO rules
Codex partners should work together to resolve
remaining inconsistencies and and keep GSFA
up-to-date
FURTHER INFORMATION
Essential Guide to Food Additives (4th. Edition)
Edited by Mike Saltmarsh
RSC Publishing 2013
THANK YOU FOR YOUR ATTENTION
Lynn Insall
Milestone Consultancy Services
E-mail: milestone129@hotmail.co.uk