EU legal requirements for innovative food additives · PDF fileColours Directive Directive...

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

http://www.dsm.com/en_US/html/identity/home.htm

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



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


Common authorisation procedure (simplified chart)


• 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?


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


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


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


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



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


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)


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



Outcome of benchmark:

Application for authorisation of a substance as a

new food additive


Risk assessment Risk management

Authorisation


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


Risk assessment

Risk management Authorisation


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.


Risk assessment

Risk management

Authorisation


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


Outcome of scrutiny:

Publication of Regulation amending Annex II

in the OJEU

BUT…


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

[email protected]

Federation of European Specialty Food Ingredients Industries

http://www.elc-eu.org/



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