Additives: - Discovering the new EU positive lists of food additives

and preparing for EFSA’s re-evaluation system - Getting ready for a changing environment

Maryse Hervé – Secretary General ELC Fi Masterclass – Legislation & Regulation in F&B

Paris 28 November 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 membersCorporate members

ECU

INEC

ELC at a glance (cont’d)

Specialty ingredients are valuable – not just for the food industry but for everybody who enjoys tasty, safe, affordable food and choice.

Manufactured food has a place in today’s health balanced

diet. The ingredients used are there for a reason. With their

technological, nutritional and health related functions, they help deliver tasty, safe, affordable food and food choices, hence they are an integral part of our food supply. To name but a few: vitamins, minerals, enzymes, specific

proteins, fibres, additives, specific carbohydrates, cultures etc.

ELC at a glance (cont’d)

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.

I - Setting the scene: the new EU legislative framework for FA II - From the lab to the Community lists of FA

Risk assessment Risk management Authorisation

III - Re-evaluation of FA

Today’s agenda

I - 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)

• EFSA Technical guidance

• Early 2012

• EFSA General guidance directly inspired from the 2001 SCF guidelines

• EC Practical Guidance

• Sept 2011

• EC General guidance

Reg. (EU) 234/2011 implementing Reg.

(EC) 1331/2008

EC guidance for applicants on the

submission of applications for FA,

FE and FF

EFSA guidance to explain the

technical, exposure and toxicological data required to

establish the safety of food additives

2009 EFSA guidelines on data requirements for the evaluation of FA applications

Common Authorisation Procedure

• Adoption Feb 2012 • Application from 1

December 2012 (Reg.)

• How manufacturers of TTS shall make available information to allow the safe use by consumers

• 2012?

• Additives in additives, enzymes, flavourings & nutrients

• Application 2 December 2011

• Community list of FA permitted per food category

• Application from 1 June 2013 (Annex II)

Regulation (EU)

1129/2011 on Annex II

Regulation (EU)

1130/2011 on Annex

III

Regulation on

specifications

TTS guidance

The new EU legislative framework for FA (cont’d)

Food Additives Regulation

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 (1st: steviol glycosides – Reg. (EU) 1131/2011)

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

II - From the lab to the Community list of food additives

Sou

rce:

La

Pro

venc

e

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

Outcome of Risk Assessment:

EFSA opinion

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.

Risk assessment Risk management

Authorisation

From the lab to the Community list of FA

Authorisation

Proposed Regulation submitted to scrutiny of EP/Council

Favourable opinion of EC and MS may not be enough to guarantee the authorisation - role of the EP is important The thrombin case

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

III - Re-evaluation

« Learning by doing » process for EFSA, EC & industry

Re-evaluation

Re-evaluation programme set in Regulation (EU) 257/2010

Applies to all FA permitted in the EU before 20 Jan. 2009

Ambitious deadlines total completion by 31.12.2020

Risk assessment by EFSA

Risk management measures by EC

2004 2015 2012 2016 2018 2020

Re-evaluation

Start colours

End Asparta

me

End certain priority MAD

End colours

End all MAD

End sweeteners

End certain priority MAD

2009 2013-14?

Start Sweeteners?

Start MAD

Anticipated in 2011

Re-evaluation

Risk assessment EFSA calls for data published on EFSA’s website

Procedure to provide the requested information is defined in the

calls for data Currently a two-steps procedure

Registration of the contact details of the interested party and description of the information available

[Within (3-6) months after call for data is issued] Submission to EFSA of the data selected by EFSA [20 working days to provide hard and/or electronic copies of data upon

request]

Re-evaluation

Risk assessment (cont’d) Information sought

Use patterns (intake, actual levels of use (typical & maximum), exposure assessments if available)

Purity, including particle size and particle size distribution if relevant Production method Analytical methods available for determination in foods Toxicokinetics and toxicity (subchronic toxicity, genotoxicity and

carcinogenicity, reproduction and environmental toxicity, allergenicity etc) and any information relevant to their safety assessment

Re-evaluation

Risk assessment (cont’d) Learning from the re-evaluation of colours Progressive improvement

A certain standardisation of the procedure Some interaction with the interested parties, in particular in step 2 of

the procedure Some dialogue with industry in the framework of general meetings

(i.e. on the procedure in general, not on a given FA) Some flexibility

If data gathered is insufficient new call If request for new tox study that the industry commits to perform in

a certain timeframe

Still room for improvement (coordinated input from IP, limitation of conservative approach to intake assessments etc)

Risk management (on the basis of EFSA opinion) Withdrawal of authorisation

Restrictions of use

Maintenance of the same authorisation

Possible impact on specifications

Re-evaluation

To conclude: The EU Food Additives legislation is complex

It has far-reaching consequences since FA are used in almost all processed foods & beverages

To apply for a new FA authorisation/extension of use of a permitted FA

new rules shall be taken into account (new guidances, new FCS, new Annex III etc)

To maintain a FA on the market robust dossier for the re-evaluation

Thank you for your attention

www.elc-eu.org elc@ecco-eu.com

Federation of European Specialty Food Ingredients Industries