Food flavourings regulatory framework in the EU:

Food flavourings regulatory framework in the EU: a taste of complexity?
By Elodie Lebastard, Food Law Manager, EAS Europe, 50 rue de l’Association, 1000 Brussels, Belgium,
www.eas.eu, +32 2 218 14 70, elodielebastard@eas.e

On 2 October 2012, the long-awaited new Union list of
permitted flavouring substances was published in the
Official Journal of the EU (Commission Implementing
Regulation (EU) No 872/2012 of 1 October 2012).
Long-awaited, because the evaluation and approval
process of flavouring substances has been running
– and will still be running – for many years. In fact,
the EU regulatory framework on flavourings has
become one of the most complex frameworks, both
from a regulatory and scientific point of view. Now
that the list is published, one could ask: is the EU
now done with the development of a harmonised set
of provisions on food flavourings? It is nowhere near
done.
Food flavourings are part of a broader group of socalled
“food improvement agents”, made up of food
additives, food enzymes and food flavourings, all of which
are linked through a common authorisation procedure
that places the European Food Safety Authority (EFSA)
as the reference for scientific assessment. ‘Flavourings’
specifically, mean:
– Products not intended to be consumed as such, which
are added to food in order to impart or modify odour
and/or taste;
– Products made or consisting of flavouring substances,
flavouring preparations, thermal process flavourings,
smoke flavourings, flavour precursors or other
flavourings or mixtures thereof.
In other words, the EU legislation defines several
types or categories of food flavourings. And besides
flavourings, the EU sectoral Regulation [Regulation (EC)
No 1334/2008] also defines and sets down harmonised
criteria and requirements for ‘food ingredients with
flavouring properties’ and ‘source materials’.
Food ingredients with flavouring properties
Certain types of flavourings and all food ingredients with
flavouring properties can be used in/on foods without an
evaluation and approval, provided they comply with the
general conditions for their use, namely:
– that they do not, on the basis of the available scientific
evidence, pose a safety risk to the health of the
consumer; and,
– that their use does not mislead the consumer.
But while food ingredients with flavouring properties do
not need to be evaluated and approved before use in the
EU market, this regulatory status is often not clear to food
companies, largely because national provisions and/or
practices are involved. A food ingredient with flavouring
properties means a food ingredient other than flavourings
which may be added to food for the main purpose of
adding flavour to it or modifying its flavour and which
contributes significantly to the presence in food of certain
naturally occurring undesirable substances.
Other flavourings
For all of the other flavourings defined in the legislation,
including all other flavouring substances and source
materials, there is a Union list of approved flavourings and
source materials for use in/on foods. In general, these
flavourings and source materials need to be authorised
through a common authorisation procedure for food
additives, enzymes and flavourings before they can be
used in foods.
The EU positive list of flavouring substances
The EU’s recently introduced positive list of flavouring
substances includes over 2,500 flavouring substances.
The scope of ‘flavouring substances’ is limited to
chemical substances with flavouring properties (including
natural flavouring substances).
The list becomes applicable in all 27 EU Member States
on 22 April 2013. Flavouring substances not included in
the EU list will be banned after an 18-month phasing out
period.
How the list of flavouring substances was
built up
The 27 EU Member States provided the European
Commission with a list of flavouring substances used
in/on foods marketed in their respective countries. A
‘Register’ containing the flavouring substances provided
by the Member States was created through Commission
Decision 1999/217/EC. The flavouring substances
authorised for use in food at the national level were
therefore already listed in this 1999 Register, which
contained around 2067 flavouring substances.
EFSA had the responsibility of evaluating a number of
flavouring substances used in the EU. It’s Panel on food
contact materials, enzymes, flavourings and processing
aids (CEF) has two main functions in relation to flavouring
substances:
• evaluating currently marketed flavouring substances,
• assessing applications for the authorisation of new
flavourings.

Food, category A substances of the Council of Europe,
certain substances from the Joint FAO/WHO Expert
Committee on Food Additives (JECFA).
Maximum levels for flavouring substances
The Regulation does not provide for maximum levels, as
it lists the flavouring substances that are compounds of
flavourings as such. References to levels suggested by
international associations are a way forward, but maximum
levels are left as the responsibility of the business using
Good Manufacturing Practices and following all relevant
EU Regulations.
Use of flavouring substances in foods for
infants and young children
Regulation (EU) No 872/2012 of 1 October 2012 introduces
a new EU-wide harmonised positive list of flavouring
substances in Annex I to the sectoral Regulation (EC) No
1334/2008 (part A of this list on flavourings and source
materials, which is limited to flavouring substances).
However, as laid down by Article 9 of Regulation
872/2012, EU Member States may apply national
provisions that are more restrictive than stipulated in Part
A of the Union list when it comes to the use of flavouring
substances in infant formulae, follow-on formulae,
processed cereal-based foods and baby foods, and
dietary Foods for Special Medical Purposes (FSMPs)
intended for infants and young children. Still, according to
this Article, those national measures must be essential to
ensure that consumers are adequately protected and must
be proportionate to the attainment of that objective.’
The use of flavourings in foods for infants and young
children therefore, is still not clearly laid out, as the EU list
of permitted flavouring substances does not provide legal
clarity and certainty for their use in foods for infants and
young children.
What is next?
Regulation 872/2012 will impact businesses in terms of the
sourcing of the raw materials, internal control processes
and certification, or relations with suppliers. Companies
would be well advised ensure that their suppliers are in line
with the implementation of this new regulation.
In terms of flavouring substances as such, a large
number of substances still need to be re-evaluated as
additional toxicological information is required to evaluate
their safety. Flavouring substances currently on the market
and for which the EFSA evaluation has not yet been
completed can continue to be used until a decision is
made.
Besides the remaining flavouring substances for which
data is required, EFSA also expects to receive a number of
applications related to new flavourings, many of which are
likely to be complex mixtures that may require a revised
risk assessment approach.
In the past, Member States had taken different
regulatory approaches, mainly opting not to regulate the
use of flavourings. While the regulatory framework is now
harmonised through EU legislation on food flavourings,
however, there are still areas that lack clarity and add
complexity for the food industry.
Since 2003 EFSA has evaluated the safety of thousands
of flavouring substances, and has published 170 scientific
opinions to date. It has not, however, had to evaluate
certain substances included in the Register that were
already deemed safe by other scientific bodies (such as
category 1 substances of the Scientific Committee for