Opinion of the European Economic and Social Committee on the: Proposal for a Regulation of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings Proposal for a Regulation of the European Parliament and of the Council on food enzymes and amending Council Directive 83/417/EEC, Council Regulation (EC) No 1493/1999, Directive 2000/13/EC, and Council Directive 2001/112/EC Proposal for a Regulation of the European Parliament and of the Council on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1576/89, Council Regulation (EEC) No 1601/91, Regulation (EC) No 2232/96 and Directive 2000/13/EC Proposal for a Regulation of the European Parliament and of the Council on food additives COM(2006) 423 final — 2006/0143 (COD) — COM(2006) 425 final — 2006/0144 (COD) — COM(2006) 427 final — 2006/0147 (COD) — COM(2006) 428 final — 2006/0145 (COD)
Date: 2007-07-20
Institutions: European Economic and Social Committee
Subjects: ESC opinion, approximation of laws, consumer protection, enzyme, flavouring, food additive, foodstuff, foodstuffs legislation, public health

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Opinion of the European Economic and Social Committee on the:

— Proposal for a Regulation of the European Parliament and of the Council establishing a common

authorisation procedure for food additives, food enzymes and food flavourings

— Proposal for a Regulation of the European Parliament and of the Council on food enzymes and
amending Council Directive 83/417/EEC, Council Regulation (EC) No 1493/1999, Directive
2000/13/EC, and Council Directive 2001/112/EC

— Proposal for a Regulation of the European Parliament and of the Council on flavourings and
certain food ingredients with flavouring properties for use in and on foods and amending
Council Regulation (EEC) No 1576/89, Council Regulation (EEC) No 1601/91, Regulation (EC)
No 2232/96 and Directive 2000/13/EC

— Proposal for a Regulation of the European Parliament and of the Council on food additives

COM(2006) 423 final — 2006/0143 (COD)

COM(2006) 425 final — 2006/0144 (COD)

COM(2006) 427 final — 2006/0147 (COD)

COM(2006) 428 final — 2006/0145 (COD)

(2007/C 168/06)

On 11 September 2006 the Council decided to consult the European Economic and Social Committee,
under Articles 37 and 95 of the Treaty establishing the European Community, on the above-mentioned
proposals.

The Section for Agriculture, Rural Development and the Environment, which was responsible for preparing
the Committee's work on the subject, adopted its opinion on 21 March 2007. The rapporteur was
Mr Pezzini.

At its 435th plenary session held on 25 and 26 April 2007 (meeting of 25 April), the European Economic
and Social Committee adopted the following opinion by 127 votes in favour with four abstentions.

1. Conclusions and recommendations

are in many cases more burdensome than those laid down by
the Codex Alimentarius, potentially distorting competition to
the detriment of European companies, small ones in particular.

1.1
The Committee welcomes the package of proposals on
additives, enzymes and flavourings and on common authorisa-
tion procedures, in the context of an effective and competitive
that ensures a high level of protection for
internal market
human life and health.

The Committee believes that a series of clear and harmo-
1.2
nised rules on the way safety assessments are carried out, with
definite timeframes and reasonable costs, is of benefit to consu-
mers and producers alike, particularly small-scale producers.

1.3
The Committee welcomes the Commission's plan to
simplify and harmonise the additives, flavourings and enzymes
sectors and to promote consistency between them by adopting
a single common procedure for their approval.

1.4
In the Committee's view, while the possibility of a single
authorisation procedure for the entire EU may be of great
benefit to the single market in the medium to long term, consid-
eration must nevertheless be given to the impact of the new
regulations on imported products.

1.4.1
Europe is in constant competition on the global market
in terms both of exports and imports, and the rules proposed

The Committee welcomes

the choice of procedure,
1.5
namely that of submitting changes to the Community list to the
comitology process, providing that there are high levels of trans-
parency, constant dialogue with producers and consumers and
swift mechanisms for innovation and product development.

The Committee supports the bolstering of the work of
1.6
to
the EFSA (European Food Safety Authority),
promote transparent risk assessment based on scientific data
and objective reasoning, with a view to protecting consumers.

in order

1.7
The Committee recommends fleshing out the procedures
and human and financial resources available to the EFSA, with a
view to ensuring high quality,
transparent and independent
assessments, with full respect for confidentiality.

1.8
The Committee also believes it would be worthwhile
stepping up the monitoring done by Member States on the
consumption and use of additives, enzymes and flavourings, by
means of effective methodologies incorporating data supplied
by industry.

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1.9
The Committee is in favour of a periodical review of the
positive lists of additives, enzymes and flavourings, providing
this is based on an ongoing structured dialogue with consumers
and producers and does not generate an additional burden in
terms of time and money.

2.7
Harmonising procedures for flavourings and enzymes
will make for more streamline authorisation procedures, cutting
the cost of updating technical data sheets and of changing label-
ling.

2. Reasons

2.1
Scientific and technological advances offer better quality
food products thanks, not least, to the use of small quantities of
enzymes, flavouring and additives. These advances also provide
means of ensuring that such substances are not used inappropri-
ately.

2.2
In its White Paper on Food Safety, on which the
Committee issued an opinion (1), the Commission announced
its intention to update and flesh out existing legislation on addi-
tives and flavourings and to prepare specific provisions on
enzymes (White Paper — actions 11 and 13), in the context of
work to improve Community legislation on the basis of the
‘farm to table’ principle.

2.3
The Committee has always supported the objective of
securing the smooth running of the internal market, while also
ensuring a high level of protection for human life and health,
and has repeatedly supported the need to adopt a global and
integrated approach to food safety in the EU.

2.4
In the Committee's view, ‘The European food chain must
be legislated in its entirety — from “farm to table”. Each link in
the food chain must be as strong as the next and the Commis-
sion should assure reliable enforcement of Community legisla-
tion’ (2).

2.5
The adoption of a common procedure for the approval
of enzymes, flavourings and additives is a key innovation in the
Commission's package of proposals
and the Committee
welcomes the plan to simplify and harmonise these sectors. This
will do away with multiple authorisation procedures by indivi-
dual Member States, remove parallel authorisation systems and
considerably reduce administrative burdens and red tape.

2.6
Legislation on food additives has already been harmo-
nised at European level. Presently, there are around 330 food
additives permitted under the legislation, and requests to allow
additional additives or new uses of additives continue to
abound.

The current legal uncertainty resulting from differences
2.8
legislation on food enzymes is threatening to
in national
distort the market for food enzymes and increase the adminis-
trative and financial burden in the various Member States.
Furthermore, in the absence of a harmonisation initiative, there
will continue to be differences in protection levels, owing to the
differences between the Member States when it comes to risk
perception, safety assessment and legislation on food enzymes.

2.8.1
It should be noted that while the absence of EU-level
harmonised rules threatens to pose obstacles to the free move-
ment of goods and to trade in the industry, harmonisation —
both of safety assessments and of the authorisation of food
enzyme use — could entail a major investment, owing mainly
to the cost of authorisations, estimated to be in the order of
EUR 150-250 000 (3) per enzyme.

2.8.2
The food enzymes industry is continually developing
technologies and processes to innovate and improve food
production. It should not, however, underestimate the possible
chemical risks in terms of allergies, toxicity and residual micro-
biological
require ongoing
consumer safety assessments,
in particular regarding enzymes
from genetically modified organisms.

activity. These potential

risks

2.9
As regards legislation on flavourings and certain food
ingredients with flavouring properties destined for use in and
on food products, a more efficient authorisation procedure is
needed for
the management of a ‘positive list’ containing
approximately 2 600 flavouring products.

2.9.1
Harmonisation of the legislation on flavourings will
clearly put the European Union in a stronger position in nego-
tiations with third countries, as the flavourings will have to be
entered into the Codex Alimentarius system, not least in order
to prevent European companies, SMEs in particular, from being
penalised.

By creating a uniform and integrated market

for
2.9.2
flavourings in the EU, the European industry will be able to
maintain its leading position as a producer and developer of
flavourings.

2.9.3
required to meet
should not be underestimated.

On the other hand, the additional work that will be
the new standards on flavouring labelling

2.6.1
Sufficiently detailed information on the use and proper-
ties of the substances concerned is required when evaluating
these requests, particularly for decisions that relate to risk
management.

(1) See opinion CES 585/2000 of 26.5.2000, rapporteur: Mr Ataide

Ferreira. OJ C 204, 18.7.2000.

(2) See footnote 1.

2.10
The Committee believes that the European Food Safety
Authority should be given more resources and means and that
new procedures should be devised to ensure an independent,
transparent and high quality assessment of the safety of addi-
tives, enzymes and flavourings.

(3) See SEC(2006) 1044, point 3.3.

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The shift from decision-making based on co-decision
2.11
with the European Parliament
to the comitology procedure,
using committees for authorisations, will demand clear and
transparent criteria for the safety assessment of claimed benefits
to consumers.

2.12
As the Committee has already stressed in previous
opinions (4), in order to be able to evaluate progress on food
safety matters and to judge whether the new system is living up
to its expectations, there is a need for assessment criteria, such
as increased/decreased consumer confidence, the occurrence and
food crises, closer cooperation between stake-
handling of
holders, etc.

3.5
Common authorisation procedure The proposal
suggests introducing a common authorisation procedure for
food additives, food flavourings and food enzymes, based on
risk assessments conducted by the European Food Safety
Authority and a risk management system. The authorisation
stages involve the Member States and the Commission within
the framework of a regulatory committee procedure. The
proposal gives
the Commission the task of drafting and
‘positive lists’, one for each category of
updating various
substance concerned, on the basis of the EFSA's scientific assess-
ments. The inclusion of a substance on one of these lists means
that its use has been authorised on a general level and for all
operators on the Community market.

3. The Commission proposal

4. General comments

3.1
The package of proposals put forward by the Commis-
sion is designed to clarify existing legislation on food additives
and food flavourings and introduces new rules on enzymes. A
further proposal aims to establish common procedures for
authorisations in all
three sectors on the basis of scientific
opinions given by the European Food Safety Authority (EFSA).

3.2
Additives The new rules are designed to simplify and
pare down the authorisation system for food additives, currently
governed by Directive 89/107/EEC. Authorisations for the inclu-
sion of additives in the new positive list would be based on a
food safety risk assessment by the EFSA,
in accordance with
Regulation 178/2002/EC. There is also a proposal for a review
of the technical aspects of the current authorisation system and
new harmonised Community provisions are set out for additives
used in other additives.

3.3
Enzymes A new legislative framework is proposed for
the assessment, approval and monitoring of food enzymes and
for the establishment of a positive list of all enzymes with a
technological function in the final food, on the basis of a favour-
able scientific opinion from the EFSA. There are also provisions
for the labelling of food enzymes, with the exception of those
used as processing aids.

3.4
the
Flavourings Provision is made for a review of
general rules established by Directive 88/388/EEC, bringing
them up to date with technological and scientific developments.
The directive will be replaced by a new regulation, setting out
clearer rules on:

— maximum admissible levels of certain substances, in accord-

ance with opinions from the EFSA;

— a ‘Community list’ of

flavourings and source materials

approved for use in and on foods;

— tighter conditions for the use of flavourings and food ingre-

dients with flavouring properties;

For

the most part,

the
4.1
Commission's proposals, providing there are safeguards for the
efficiency and competitiveness of
the internal market and a
guaranteed high level of protection for human life and health.

the Committee welcomes

4.2
The Committee considers that the proposed instrument
— a regulation — will provide a better guarantee than would a
directive, as the latter would allow for differing interpretations
regarding the implementation of the rules.

4.3
The possibility of obtaining a single authorisation valid
for the entire European Union may, in the Committee's view, be
highly advantageous to the internal market in the medium to
long term.

Consideration must, however, be given to the impact of
4.3.1
the new regulations on imported products and to the fact that
Europe is a major importer competing on the global market, as
the Community rules are more burdensome
than those
currently set out in the Codex Alimentarius. The Codex should
therefore be amended, to prevent European companies from
being penalised.

The Commission's choice of the comitology procedure
4.4
for amending the Community list may prove to be a positive
step, both for industry and for civil society, on condition that
high levels of transparency are ensured and it remains possible
to keep step with innovation and the development of new and
improved products, not least in the fight against allergies.

4.5
The Committee welcomes the fact that the EFSA's risk
assessments are to be based on transparent procedures, scientific
data and objective reasoning.

— clear and uniform labelling rules.

(4) See Opinion CES 404/2001 of 28 March 2001, Rapporteur:

Mr Verhaeghe. OJ C 155, 29.5.2001.

The new responsibilities entrusted to the EFSA should be
4.6
matched by more robust procedures and human and financial
resources, with a view to ensuring high quality, transparent and
independent assessments, with full respect for confidentiality.

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5. Specific comments

5.1 Common authorisation procedure

5.2.2
The information provided in the labelling mentioned in
Article 20 must be clearly comprehensible and recognisable to
the general public and uniform throughout the Community.

The Committee believes

implementing
5.1.1
measures,
including the content, drafting and presentation of
the application, arrangements for checking the validity of appli-
cations and the type of information, as set out in Article 9,
should be included in the EFSA's opinion.

that

the

5.1.2
As regards updating the Community list, the deadlines
for the authorisation system should be shorter, cutting the time
taken by the Commission to issue its draft regulation from nine
to three months, so as to enable the entire examination and
approval cycle to be completed within 12 months.

5.1.3
Similarly, the possibility offered by Article 10 for the
EFSA or the Commission to extend the assessment period in
certain cases should not be open-ended. A maximum period
should be specified in the regulation.

5.1.4
The Committee believes that the common authorisa-
tion procedure should provide for a periodical review and
update of the lists, at a limited cost and effort and on the basis
of an ongoing structured dialogue with producers and consu-
mers.

Under no circumstances

5.1.5
should the Community
authorisation system be used to justify the creation of technical
barriers to trade. Costly tests and certification procedures for
imports and exports should not therefore be allowed.

5.2 Additives

The criteria of

5.2.1
‘advantages and benefits for the consumer’
further clarification.

‘reasonable technological need’ and
(Article 5) need

Brussels, 25 April 2007.

5.3 Enzymes

The Committee welcomes

5.3.1
food
enzymes with a technological function are covered by the regu-
lation and will be subject to approval before being added to the
Community's positive list.

the fact

that all

5.3.2
enzymes
consumer’ in the same way as for additives.

The Committee believes that the assessment criteria for
the

should include ‘advantages and benefits

for

5.3.3 With regard to labelling, the Committee would stress
the need for clarity and uniformity at Community level, without
the benefit of producers and
unnecessary complexities,
consumers alike.

for

The Committee believes that use of positive lists in
5.3.4
vertical
legislation should be avoided as that would create a
double authorisation system for the same enzymes. Previous
directives and regulations must be modified as soon as possible
in order to make uniform reference to the new regulation.

5.4 Flavourings

5.4.1
mirror those set out for additives,
benefits for the consumer’.

In the Committee's view, the assessment criteria should
including ‘advantages and

The Committee would underline the need for clearer
5.4.2
information for consumers, as set out in Article 14 regarding
the nature and origin of food flavourings.

The President

of the European Economic and Social Committee

Dimitris DIMITRIADIS