Transcript New Regulation on food additives (Reg. (EC) No 1333/2008)

Directorate-General for
Health & Consumers
Food Additives – the EU Regulatory Framework
Jiri Sochor
Unit E3: Chemicals, contaminants and pesticides
Vilnius, 18 October 2011
This presentation expresses the views of the author and does
not, in any case, bind the European Commission
Food Improvement Agents
Regulation (EC) No 1331/2008 establishing a common
authorisation procedure for food additives, food enzymes
and flavourings.
Regulation (EC) No 1332/2008 on food enzymes and
amending Council Directive 83/417/EEC, Council Regulation
(EC) No 1493/1999, Directive 2000/13/EC, Council
Directive 2001/112/EC and Regulation (EC) No 258/97
Regulation (EC) No 1333/2008 on food additives
Regulation (EC) No 1334/2008 on flavourings and
certain food ingredients with flavouring properties amending
Council Regulation (EEC) no 1601/91, Regulations (EC) No
2232/96 and (EC) No 110/2008 and Directive 2000/13/EC
This presentation expresses the views of the author and does
not, in any case, bind the European Commission
Legal framework for food additives
Fully harmonized sector
Framework Regulation (EC) No 1333/2008

Annexes to specific Directives for 3 groups of additives still apply
 Positive lists of additives authorised to the exclusion of all others
+ conditions of use

Dir. 94/36: Roughly 30
Colours authorised
Ex. E 160d (lycopene),
E 129 (allura red)…


Dir. 95/2: Roughly
300 additives other
than Colours and
Ex. E 950 (Acesulfame
Sweeteners
K), E 951
Ex. E 260 (acetic
(Aspartame)…
acid), 220 (sulphur
This presentation expresses the views of the author and does
dioxide)…
not, in any case, bind the European Commission
Dir. 94/35: Roughly 15
Sweeteners
Regulation (EC) No 1333/2008 on
food additives
Replaces Directive 89/107/EEC
Most provisions have applied since 20/01/2010
One single Regulation on food additives: colours,
sweeteners and miscellaneous additives
Comitology: Simpler regulatory procedure for
additive authorisation (changes due to Lisbon Treaty)
to set up a re-evaluation programme for existing
food additives.
Deadlines for EFSA and the Commission with regard
to new authorisations
General conditions of use of food additives
Conditions of use:
Does not pose a safety concern to the health
of the consumer at the level of use proposed
Reasonable technological need for their use
which cannot be achieved by other
economically and technologically practicable
means
Does not mislead the consumer
Advantages and benefits for the consumer
Additional conditions for colours
restore the original appearance of food of which
the colour has been affected by processing,
storage, packaging and distribution, whereby
visual acceptability may have been impaired
make food more visually appealing
give colour to food otherwise colourless
Additional conditions for sweeteners
replace sugars for the production of energyreduced food (*), non-cariogenic food or food
with no added sugars
replace sugars where this permits an increase
in the shelf-life of the food
produce food intended for particular nutritional
use
Establishment of EU lists
Food additives in Annex II shall be listed on the basis of
the categories of food to which they may be added.
Food additives which are permitted for use in foods under
Directives 94/35/EC, 94/36/EC and 95/2/EC and their
conditions of use shall be entered in Annex II to this
Regulation after a review of their compliance with Articles
6, 7 and 8 thereof.
The review shall not include a new risk assessment by
the Authority.
The review was to be completed by 20 January 2011.
Food additives and uses which are no longer needed shall
not be entered in Annex II.
This presentation expresses the views of the author and does
not, in any case, bind the European Commission
Food categorisation system
0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
All foodstuffs
Dairy
Fats and Oils
Edible Ice
Fruit and Vegetables
Confectionery
Cereals and Cereal Products
Bakery Wares
Meat and Meat Products
Fish and Fish Products
Eggs and Egg Products
Sugars and Table Top Sweeteners
Salt, Spices, Seasonings, Sauces etc.
PARNUTS
Beverages
Snacks
Desserts
Food Supplements
Processed foodstuffs no belonging to 1 - 17
This presentation expresses the views of the author and does
not, in any case, bind the European Commission
Category 14 beverages
14.1
Non-alcoholic beverages
14.1.1
Waters (inc Natural mineral
waters, source waters, table waters and soda
waters)
14.1.2 Fruit and vegetable juices
14.1.3 Fruit and vegetable nectars
14.1.4 Flavoured drinks
14.1.5 Coffee, coffee substitutes, tea, herbal
infusions, and other hot cereal and grain
beverages, excluding cocoa
This presentation expresses the views of the author and does
not, in any case, bind the European Commission
Category 14 beverages
14.2
Alcoholic beverages, including
alcohol-free and low-alcoholic
counterparts
14.2.1 Beer and malt beverages
14.2.2 Grape wines
14.2.3 Cider and perry,
14.2.3.1
14.2.3.2
Cider and perry, including aromatised products
Cidre Bouché,
14.2.4 Fruit wines and made wine
14.2.5 Mead
This presentation expresses the views of the author and does
not, in any case, bind the European Commission
Category 14 beverages
14.2
Alcoholic beverages, including alcohol-free
and low-alcoholic counterparts
14.2.6
Distilled spirituous beverages
14.2.6.1 Spirit drinks as defined in Reg 110/2008
14.2.6.2 Spirituous beverages containing less than 15 % of
alcohol
14.2.7 Aromatized wine based products as defined in
Regulation (EEC) No 1601/91
14.2.7.1
14.2.7.2
14.2.7.3
14.2.8
Aromatized wines
Aromatized wine based drinks
aromatized wine based products
mixtures
This presentation expresses the views of the author and does
not, in any case, bind the European Commission
State of play EU list
(Annex II to Regulation (EC) No 1333/2008)
One single list
Additives listed on the basis of the categories of
food to which they may be added
Positive opinion at the SCoFCAH, on 4 April
2011
3 Months scrutiny EP start on 15 July 2011
Expected adoption and publication 11/11/11
Date of application 1 June 2013
Food additives database
See:
Food Improvement Agents website
See:
Food Additives Database
COMMISSION REGULATION (EU) No 257/2010,
re-evaluation programme.
New risk assessment by EFSA
All food additives which were authorised
before 20 January 2009
Re-evaluation programme
Colours completed by 31.12.2015
Some “southampton colours” voted 9.09.2011
Further work will start during 2012
Sweeteners completed by 31.12.2020
All others completed by 31.12.2018
This presentation expresses the views of the author and does
not, in any case, bind the European Commission
Regulation (EC) No 1331/2008 establishing a common
authorisation procedure for food additives, food enzymes
and food flavourings
Lays down the procedural arrangements for
updating the lists of substances the marketing
of which is only authorised when included in a
Union list.
‘Updating the Union list’ means:
(a) adding a substance to the list;
(b) removing a substance from the list;
(c) adding, removing or changing conditions,
specifications or restrictions associated with the
presence of a substance
This presentation expresses the views of the author and does
not, in any case, bind the European Commission
Timing for an authorisation
Opinion of EFSA: nine months
Proposal of the Commission at the Standing
Committee: nine months
Regulatory procedure with scrutiny: 2 months
Time needed for adoption by the Commission
and publication in the official journal
This presentation expresses the views of the author and does
not, in any case, bind the European Commission
Food Additives-Implementation
Implementing measures
Deadline
Programme for re-evaluation, REGULATION (EU) No 257/2010
25.03.2010
Implementing measure, REGULATION (EU) No 234/2011
10.03.2011
Practical Guidance for applicants
11.09.2011
Review of current authorisations
07.04.2011
New Regulation on specifications
04.07.2011
Regulation of additives in additives, enzymes and nutrients.
07.04.2011
Specifications for new substances
Ongoing
Request for new additives/extension of uses
Ongoing
Revisions following re-evaluation by EFSA
Ongoing
Guidance for appropriate information for table top sweeteners
Guidance on common methodology
gathering
intake
Thisfor
presentation
expresses
thedata
views of the author and does
not, in any case, bind the European Commission
Better Training for Safer Food
Starting in 2012
12 x 3-day training
540 overall No of participants
Content: legislation, authorisation
procedure, RA, RM, RC, understanding the EU
list, specifications, monitoring, national control
plan, inspections, laboratory analysis
This presentation expresses the views of the author and does
not, in any case, bind the European Commission
Thank you for your attention