Additives in Food and Feed- The Work of EFSA -

G E N K PhDGeorge E. N. Kass, PhDDeputy Head,

Food Ingredients and Packaging

New Challenges in Food Safety Review in Japan & the EUTokyo, 2 July 2013

Additives in FoodAdditives in Food

Food Additives in the EU: LegislationsLegislations

In order to be placed on the EU market, In order to be placed on the EU market, food additives need to undergo an authorisation procedure

1994: Several directives for several subgroups of food additivesFood colours (~30)  (94/36/EC)Other than food colours & sweeteners (~300)  (95/2/EC)Sweeteners  (~15) (94/35/EC)

2008: H i ti b t bli hi th i ti d2008: Harmonisation by establishing a common authorisation procedure(Regulation (EC) No 1333/2008)

2011 H i i b bli hi U i Li f d f d2011: Harmonisation by establishing a Union List of approved food additives

(Commission Regulation (EU) No 1129/2011)

2011: Harmonisation of content, drafting and presentation of an

application (Commission Regulation (EU) No 234/2011) 3

Food Additives in the EU: DefinitionsDefinitions

Regulation (EC) No 1333/2008Regulation (EC) No 1333/2008

‘Food dditi e e b t n e th t e not no m ll on med food ‘Food additives are substances that are not normally consumed as food itself but are added to food intentionally for a technological purpose described in this Regulation, such as the preservation of food.’

Are Not considered as Food Additives in the EU:Flavouring substances (e g salt flavours)Flavouring substances (e.g. salt, flavours)Nutritional supplements (e.g. vitamins and minerals)Substances used for a technological function (e.g. food enzymes)Processing aids

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Food Additives in the EU: Conditions

Regulation (EC) No 1333/2008Regulation (EC) No 1333/2008

Food dditi e m t be fe hen ed Food additives must be safe when used There must be a technological need for their useTheir use must not mislead the consumer They must be of benefit to the consumerThey must be of benefit to the consumer

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The Food Additive Evaluation Process in the EU

ApplicantApplicant

in the EU

Application

Dossier

RequestEuropean European CommissionCommission

European Parliament

CommissionCommission

Member States Assessment byPanel

Opinion

LegislationLegislation

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Risk Assessment Process

Highlights of the 2012 Guidance DocumentHighlights of the 2012 Guidance Document

To replace the 2001 guidance document by the Scientific Committee for Food

Combines recent developments in risk assessment with other considerationsCombines recent developments in risk assessment with other considerations such as use and animal welfare.

The use of a tiered approach that balances data requirements against risk.

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Consists of three tiers

Tiered Toxicity Testing Framework for Food Additives

TIER 2

TIER 1**

Absorption

Genotoxicity

Approach to Tier 3 studies‐ Consideration of all available 

d

Approach to Tier 3 studies‐ Consideration of all available 

d

TIER 2

ADME

Genotoxicity 

Genotoxicity ‐ in vitro testing

‐ genotoxic impurities 

Extended 90‐day t t d

TIER 3**TIER 3**

data 

‐ Case‐by‐case approach 

‐ Equivocal findings

data 

‐ Case‐by‐case approach 

‐ Equivocal findings

‐ in vivo testing

Chronic/Carc‐ stand‐alone or combined

Reproductive

tox study‐ repro endpoints

‐ endocrine activity

‐ other (immune, neuro)

TIER 3**

Toxicokinetics

‐ PBK modelling, volunteer studies

TIER 3**

Toxicokinetics

‐ PBK modelling, volunteer studies

Reproductive1. EOGRT study (rat ‐ various endpoints) 

‐ repro & developmental

‐ immunotoxicity, neurotoxicity

2. Pre‐natal developmental tox (rabbit)

Triggers for Tier 2Absorption/Systemic exposure

GI toxicity

Triggers for Tier 2Absorption/Systemic exposure

GI toxicityCarcinogenicity

‐ 2nd species (?) 

Repro

Carcinogenicity

‐ 2nd species (?) 

ReproTriggers for Tier 3

Bioaccumulation/slow excretionTriggers for Tier 3

Bioaccumulation/slow excretion

p ( )GI toxicity

Subchronic toxicity

(+ve) in vitro genetox

GI toxicity

Subchronic toxicity

(+ve) in vitro genetox

* Minimal dataset ‐ Applicable to all compounds

‐ F2 generation

‐ developmental immuno‐ & neurotox

Specialised studies

‐ immunotox neurotox endocrine

‐ F2 generation

‐ developmental immuno‐ & neurotox

Specialised studies

‐ immunotox neurotox endocrine

(+ve) in vivo genetox

Chronic/carc

EOGRTS toxicity 

Developmental toxicity (rabbit)

(+ve) in vivo genetox

Chronic/carc

EOGRTS toxicity 

Developmental toxicity (rabbit)

** Additional studies ‐ Only if triggered 

immunotox, neurotox, endocrineimmunotox, neurotox, endocrine

The Food Additives Re-evaluation ProgrammeProgramme

Regulation (EU) No 257/2010 (re‐evaluation programme)

- Re-evaluation of all food additives that were permitted before 20.01.2009 p

Re‐evaluation finalised by 2020Food colours 2015- Food colours 2015

- FA other than food colours & sweeteners 2015, 2016 & 2018- Sweeteners 2020

E ti A t 2013- Exception: Aspartame 2013

Priority criteriaL t l ti i tifi id i d h EC» Last evaluation, new scientific evidence, increased human exposure, EC request, emerging concern.

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Re-evaluation of food additives

Challenges faced by EFSA and ANS Panel in the re-evaluation of food additives programme

No dossiers

Scientific information and data available highly variable inScientific information and data available highly variable in terms of quality and quantity.

Highly variable response to EFSA’s public call for data( ) (o Range from full dossiers (e.g. aspartame) to zero information (e.g.

orphan food additives)

Consequence: major data gaps for many food additives

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Distribution of activities: recent and ongoing (2010-2014)and ongoing (2010 2014)

~26~15

~55

(extension of use, refined exposure assessment, etc…)exposure assessment, etc )

Additives in FeedAdditives in Feed

Feed Additives in the EU

In order to be placed on the EU market feed additives needIn order to be placed on the EU market, feed additives need

to undergo an authorisation procedure as established in

the Regulation (EC) No 1831/2003

All feed additives authorised under Directive 70/524

Application required before 8 11 2010

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70/524(and amino acids authorised under Directive

82/471)

8.11.2010

Feed Additives in the EU

Feed Additives: Substances, micro-organisms or , gpreparations, other than feed material and premixtures intentionally added to feed or water in order to:

Favourably affect the characteristics of feed, animal y ,products and the colour of ornamental fish and birds

Satisfy the nutritional needs of animals

Favourably affect the environmental consequences of animal production

Favourably affect animal production, performance or welfare

Have a coccidiostat or histomonostatic effect14

Feed Additives in the EU

Regulatory Guidelines: Regulation 429/2008

EFSA G id Ad i i t ti / T h i lList and the characteristics of studies and information on the additive to be submitted in the

dossier

EFSA Guidance: Administrative / Technical

dossier

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Food and Feed Additives in the EU:Challenges and Opportunities for EFSAChallenges and Opportunities for EFSA

Challenges for EFSA1. Evaluation and authorisation under different legislations

2. Information submitted by industry

Dossiers for new applications for both feed and food additives

Public call for data for re-evaluations for food additives vs dossiers for feed additives

3. Different requirements

Food additivesFood additives

Safety for the consumer

Feed additives

Safety for target species and the consumer (for target species intended for consumption)

Safety for the operator

Efficacy

O i iOpportunities1. Many substances used both as food and feed additives

2. ANS and FEEDAP Panels

Co-ordination of work between the two Panels

Harmonisation of the scientific approaches used

To avoid divergences

To increase efficiency

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Thank you very much for your attentionThank you very much for your attention

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