Food additives and their regulation

how many additives are permitted for use in the EU

300 - found on FSAI website

What are food additives

substances added to foods to perform specific technological functions

what are the functions of food addtives

preserving, inhibiting the growth of pathogens or adding colour or sweetness to enhance flavour for interest and variety

what role does food additves play in consumer demand

consumers want convenience alongside higher standards of safety and wholesoemness at affordable prices

What is in the food improvements agents package

4 regualtions

- regulation 1331/2008 - common authorisation porcedure

- regulation 1332/2008 on food enzyme

- regulation 1333/2008 on food additives

- 1334/2008 on food flavourings

is the food additives legisaltion harmonised

yes

what is harmonisation

essential aspect of the internal market contributing to the hea;th and wellbeing of the EU citizens and to the free movement of safe and wholesome food

what does reg no. 231/2012 entail

laying down specifications/purity criteria for food additives

what does reg. no 1331/2008 detail

establishing a common authorisation procedure for food additives, food enzyme and flavourings

what does reg. 257/2010 detail

setting up a programme for the re-evaluation of approved food additives

what does reg 1333/2008 detail

- one single regulation on food additives

- directly applicable in all member states - enforced in ireland by SI 330 of 2015

- introduction of comitolgy with scrutiny by EP

- SINGLE REGULATORY PROCEDURE FOR ADDITIVE AUTHORISATION

What is detailed in reg 1333/2008/EC-article 1

a) community list of approved food additives as set out in annexes II and III

B) conditions of use of food additives

c) rules on labelling of additives sold as such

what is the definition of food additve according to article 3

- not normally consumed as a food in itself

- not normally used as a characterisitc ingredient of food

- intentionally added for a technological purpose

- becomes directly or indirectly a component of the food

what are the conditions of use

- present no health hazard at the level of use proposed

- technological need

- do not mislead the consumer

- must have advantages for consumer

- specific conditions for colours and sweeteners

Details of the union list of food additives authorised in food

- list and conditions of use in Annex II

- established by reg 1129/2011

- in force since june 1st 2013

- over 100 amendements made

how many different categories of food system

18

pg. 15

what food is in category 14

beverages, non-alcoholic beverages

what is the food additive database

up to date list of food additves

- can search by additve or food category

details of Annex III of additives regulation

- list of permitted additives in additives, enzymes and flavourings

- carriers in nutrient and other substances

what are labelling requirements detailed under

reg 1169/2011

- must be labelled with their category and functional class

what warnings must be born for polyols

excessive consumption may induce laxative effects

What warnings must be added with aspartame

contains a source of phenylalanine

what must sulphur dioxide and sulphites must be labelled as

must be declared as product name not with E number

what warning must be carried with food colours

may have an adverse effect on activity and attention in children

what did regulation 231/2012 adopt on Dec 1st 2012

adopted revised specfications in one single list

what is the common authorisation procedure

- EFSA opinion (9 months) will be followed by a risk management decision taken by commission (9 months)

- scrutiny by the european parliament and EC (3 months)

- time needed for translation, adoption by the commission and publication in the offical journal

- includes procedural arrangements for updating the community lists

what is the re-evaluation programme

- evaluate all additives approved before 20th Jan 2009

what is the formal evaluation programme on food additives

regulation 257/2010

- criteria

- procedure

- order of priority

re-evaluation mandate

EC - single mandate covering all food additives to be re-evaluated and interested parties call for data

How many were included in the re-evaluation programme programme under reg. 257/2010

317

88 still to be evaluated

what does authorisation and safety assessment of food additives - what does this process involve

- application by industry to EC to include a new additive in the list

- commission requets EFSA to evaluate the safety of the additive

- EFSA opinion on safety - comprehensive report

- safety, conditions of use and MPL in foods discussed by government experts

- agreement on these

what is an authorised food additive

- a food additve that is included in the positive list

- indentified in list by name and E-number

- identified on the label of a foodstuff by their category/functional calss and name or E-number

details for assessing the safety of food additives

- decsions underpinned by risk assessment

- dossier assessed by EFSA

- Committee of independent scientists with expertise in toxicology, food chemsitry and exposure assessment

- Scientific Committee on food previously carried out this assessment

how is an assessment of the safety of a food additives carried out

- information on chemistry of additives, specifications and intended use

- toxicoligical studies covering toxicity, genotoxicity, carcinogenicity and effects on reproduction

- information on human effect if available

what is an ADI

An estimate of the amount of food additive expressed on a body weight bassi that can be ingested daily over a lifestime without appreciable health risk

How is an ADI established

by applying a safety factor to the concentration of the additive used in the toxicological studies found to produce no health effects in the animals

- NOAEL / UF = ADI

What is NOAEL

Highest administered level of the test compound which does not affect the physiological status of the test animals after long term exposure

how is uncertainty factor applied

species difference (10) X interindividual variability (10) = 100

estimations of likely exposures to humans are usually what

very conservative

what was the last colour evaluated

titanium dioxide

when did EFSA publish their opinion on this colour in September 2016

Sept 2016

- 4 new studies

- have published 3 opinions since

what country banned titanium dioxide

E 171 banned from Jan 2020

why is titanium dioxide concluded unsafe

- could not exclude genotixicty concerns

- could not establish a safe level of daily intake of the additive

what are the transitional measures for titanium dioxide

- foods produced with titanium oxide prior to 7 feb 2022