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EU legal requirements
for innovative food additives
Maryse Hervé – Secretary General ELC
EFFL Conference « Regulation of Innovations » – Berlin 6&7 October 2011
Federation of EU Specialty Food Ingredients Industries
The ELC is the voice of the Specialty Food Ingredients Industries in
Europe. We aim to create a safe and suitable regulatory
environment and represent the industry with EU-decision-makers.
It is our objective to ensure that all stakeholders – from
manufacturers and retailers to regulatory authorities and consumers
– are correctly informed of the use and safety of specialty food
ingredients and their advantages.
ELC at a glance
ELC at a glance (cont’d)
More than 200 EU companies represented either by direct membership
or through a member association
ELC membership (2011)
20
21
Association members
Corporate members
ECU
INEC
ELC at a glance (cont’d)
With their technological, nutritional and health related functions,
specialty food ingredients typically make food tasty, pleasant to
eat, safe, healthy and affordable.
To name but a few: vitamins, minerals, enzymes, specific
proteins, fibres, additives, specific carbohydrates, cultures etc.
3-8 % of EU specialty food ingredients manufacturers’ turnover is
dedicated to R&D, depending on the sectors. Overall the average
investment is between 4-5 % of revenue.
The specialty food ingredients industry represents around € 35
billion of the global food ingredients market – of which 40 %
(around €15 billion) is in Europe.
Setting the scene: the new EU legislative framework for FA
From the lab to the Community lists of FA
Criteria for FA qualification
Risk assessment
Risk management
Authorisation
Today’s agenda
Setting the scene: the new EU legislative framework for FA
The new EU legislative framework for FA (cont’d)
Directive 89/107/EEC
Framework Directive
Directive 94/35/EC
Sweeteners Directive
Directive 94/36/EC
Colours Directive
Directive 95/2/EC
MAD Directive
Specifications Dir 2008/60/EC
Specifications Dir 2008/128/EC
Specifications Dir 2008/84/EC
Regulation (EC) 1331/2008
Common authorisation
procedure for FA, FE & FF
Regulation (EC) 1333/2008
Food Additives
Regulation (EC) …/2011
Specifications
9 months
Application
EFSA Opinion
Commission
Draft Regulation
SCFCAH
9 months
3 months
Council
EP
Not adopted
Adopted
or no opinion
Commission
Publication –
Community list
= Total minimum
24 months
2 months scrutiny
The new EU legislative framework for FA (cont’d)
Common authorisation procedure (simplified chart)
The new EU legislative framework for FA (cont’d)
• Reg. (EU) 234/2011
implementing Reg. (EC)
1331/2008
General guidance
• 2009 EFSA guidelines on data
requirements for the
evaluation of FA applications
General guidance
directly inspired from the
2001 SCF guidelines
• EFSA technical guidance
to explain the technical,
exposure and toxicological
data required to establish
the safety of food additives
Common Authorisation Procedure
• EC practical guidance
for applicants on the
submission of applications
for FA, FE and FF
Adoption
end 2011 –
early 2012
Sept. 2011
• Reg. on Annex II –
Community list of FA
permitted per food
category
• Table-top sweeteners
Guidance on how
manufacturers of TTS
shall make available
information to allow the
safe use by consumers
• Regulation on
specifications
for food additives
• Reg. on Annex III
Additives in additives,
enzymes, flavourings &
nutrients
Food Additives Regulation
Adoption
Oct-Nov
2011
Adoption
end 2011
2012?
The new EU legislative framework for FA (cont’d)
Adoption
Oct-Nov
2011
Application
20 days after
publication (Reg.)
Application
from 1 Dec.
2012 (Reg.)
Application
from 1 April
2013 (Annex II)
Annex II
Consolidation in a single Community list of all current
authorisations spread over the 3 former vertical Directives (no
mechanical transfer – a few new authorisations included – minimal
“cleaning” exercise)
Composed of 5 parts:
• A: general provisions
• B: list of all permitted food additives
• C: definitions of groups of food additives
• D: food categories
• E: authorised food additives and conditions of use in food categories
Express authorisations in a more transparent, clear and
coherent manner, i.e. list of additives permitted per
category/subcategory
The new EU legislative framework for FA (cont’d)
Annex II (cont’d)
New food additives/extensions of use of permitted food
additives will be permitted via amendments to the Regulation
establishing Annex II (first one: steviol glycosides)
New applications shall take into account the new FCS
A list of descriptors of main food categories will be available to
facilitate interpretation BUT it is not part of the Regulation (i.e.
not legally binding)
In principle a specific Regulation for each new FA authorisation
Speed up the procedure comparing to former « omnibus »
approach
Confine potential EP rejection
However unclear how the pending authorisations will be
treated
The new EU legislative framework for FA (cont’d)
Annex III
Composed of 6 parts:
Carriers in food additives
Food additives other than carriers in food additives (NEW)
Food additives including carriers in food enzymes (NEW)
Food additives including carriers in food flavourings
Food additives in nutrients Section A : FA in nutrients except nutrients for use in foodstuffs
for infants and young children (NEW)
Section B: FA in nutrients for use in foodstuffs for infants and
young children
Definitions of groups of FA for the purpose of the 5 other
parts
The new EU legislative framework for FA (cont’d)
Conditions for inclusion and use of FA in Community lists (Art. 6 & 7 of Reg. (EC) 1333/2008)
Only if it meets the following conditions and, where relevant,
other legitimate factors, including environmental factors:
(a) it does not, on the basis of the scientific evidence available,
pose a safety concern to the health of the consumer at the
level of use proposed
(b) there is a reasonable technological need that cannot be
achieved by other economically practicable means; and
(c ) its use does not mislead the consumer
In addition, it must have advantages and benefits for the
consumer
Additional specific conditions are laid down for sweeteners and
colours
The new EU legislative framework for FA (cont’d)
The new EU legislative framework for FA (cont’d)
Misleading the consumer includes, but is not limited to, issues
related to the nature, freshness, quality of ingredients used, the
naturalness of a product or of the production process, or the
nutritional quality of the product, including its fruit and vegetable
content.
Other legitimate factors include societal, economic, traditional,
ethical and environmental factors, the precautionery principle and
the feasibility of controls. Whereas (7) Reg. (EC) 1333/2008
?
06.5 Noodles
group I Additives
group II Colours at quantum
satis
quantum
satis
E 338 -
452
Phosphoric acid -
phosphates - di - tri-
and polyphosphates
2000 (1) (4)
E 426 Soybean
hemicellulose
10000 only pre-packaged ready to eat oriental
noodles intended for retail sale
(1): The additives may be added individually or in combination
(4): The maximum level is expressed as P2O5
06.6 Batters
Group I Additives
Group II Colours at quantum
satis
quantum
satis
Group III Food colours with
combined maximum
limit
500 only batters for coating
E 160b Annatto, Bixin,
Norbixin
20 only batters for coating
From the lab to the Community list of food additives
Sourc
e:
La P
rovence
Criteria for FA qualification Risk assessment
Risk management
Authorisation
From the lab to the Community list of FA
Food additive - Definition unchanged
« Food additive » shall mean any substance not normally consumed
as a food in itself and not normally used as a characteristic ingredient
of food, wether or not it has nutritive value, the intentional addition of
which to food for a technological purpose in the manufacture,
processing, preparation, treatment, packaging, transport or storage of
such food results, or may be reasonably expected to result, in it or its
by-products becoming directly or indirectly a component of such
foods»
List of a number of substances that are not considered to be food
additives: e.g. caseinates and casein, inulin, chewing gum bases etc.
Art. 3.2. (a) Reg. (EC) 1333/2008
Criteria for FA qualification
Benchmark against:
Novel Foods (Reg. (EC) 258/97)
Novelty / intended use
Processing aids - Definition unchanged
« Processing aid» shall mean any substance which:
(i) is not consumed as a food by itself;
(ii) is intentionally used in the processing of raw materials,
foods or their ingredients, to fulfil a certain technological
purpose during treatment or processing; and
(iii) may result in the unintentional but technologically
unavoidable presence in the final product of residues of the
substance or its derivatives provided they do not present any
health risk and do not have any technological effect on the final
product. Art. 3.2. (b) Reg. (EC) 1333/2008
Criteria for FA qualification (cont’d)
Benchmark against (cont’d):
Art. 12 Reg. (EC) 1333/2008 - Change in the production process
or starting materials of a food additive already included in a
Community list
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, or there is a change in particle size, for
example through nanotechnology, the food additive prepared by
those new methods or materials shall be considered as a different
additive and a next entry in the Community lists or a change in the
specifications shall be required before it can be placed on the
market.
« Regular » ingredient (not submitted to pre-market
authorisation)
Criteria for FA qualification (cont’d)
Specific points for consideration:
If the substance is produced from a GM source
The source shall be covered by an authorisation in
accordance with Reg. (EC) 1829/2003
If food additives (including carriers) are used in this food
additive (not blends)
Compliance with the lists established in Annex III
shall be checked. If necessary, an amendment to Annex
III shall be requested
Criteria for FA qualification (cont’d)
Criteria for FA qualification (cont’d)
Outcome of benchmark:
Application for authorisation of a substance as a
new food additive
Criteria for FA qualification
Risk assessment Risk management
Authorisation
From the lab to the Community list of FA
Risk assessment
Application prepared according to EFSA & EC (new) guidances
« Light » application in case of requests for extension of use of a
permitted FA
If numerical ADI calculation of impact on intake exposure is
essential
R.A. by EFSA (ANS Panel + other Panels as relevant)
Focus: safety of the food additive
Risk assessment (cont’d)
A « consumer oriented » public summary (EC practical guidance)
The target group of a public summary is a non-professional public. The structure
and content of the public summary shall be elaborated accordingly. The
document should be less extensive comparing to the summary of the dossier
and should indicate what added value brings the authorisation for consumers. A
scientific /professional terminology shall be avoided if possible.
Outcome of Risk Assessment:
EFSA opinion
Criteria for FA qualification
Risk assessment
Risk management Authorisation
From the lab to the Community list of FA
Risk management
EC/MS
Working Party of Governmental Experts
SCFCAH
Basis: EFSA opinion
Focus:
Safety at the levels of use considered (below ADI)
Technological need
Not misleading the consumer
Benefits for the consumers
Other legitimate factors
Risk management (cont’d)
Outcome of Risk Management:
Draft Regulation amending Annex II
It defines the food categories where the additive is
permitted, and the permitted levels of use.
Criteria for FA qualification
Risk assessment
Risk management
Authorisation
From the lab to the Community list of FA
Authorisation
Proposed Regulation submitted to scrutiny of EP/Council
EP focus (in practice)
• Not misleading the consumer
• Benefits for the consumer
• Other legitimate factors
Authorisation (cont’d)
Favourable opinion of EC and MS may not be enough to
guarantee the authorisation role of the EP is important
The thrombin case (2010) • Bovine and/or porcine thrombin to be used with fibrinogen in pre-packed
meat preparations and pre-packed meat products intended for the final
consumer
• SCFCAH: positive vote on the proposed Directive
• EP: Adoption of a Motion for a Resolution to oppose the proposed Directive
• Thrombin/fibrinogen was part of an « omnibus » Directive all other
authorisations automatically rejected
• Re-submission to the SCFCAH and EP a « sanitised » Directive
Authorisation (cont’d)
Outcome of scrutiny:
Publication of Regulation amending Annex II
in the OJEU
BUT…
Authorisation (cont’d)
Even if a food additive authorisation is not time-limited:
The authorisation may be withdrawn/restricted on the basis of
new scientific or technical information that might affect the
assessment of the safety of the food additive
The food additive is submitted to a re-evaluation according to a
programme set in Regulation (EU) 257/2010
Legal requirements for
innovative food additives:
• Hurdles race that requires
a thorough preparation
• No certainty until the very
last step (scrutiny)
Ultimately, market reality
(big challenge: consumers
mistrust/clean labels)
Thank you for your attention
www.elc-eu.org
Federation of European Specialty Food Ingredients Industries