UPDATE ON FOOD ENZYME
DOSSIERS
Rafael Perez Berbejal
European Commission, DG Health and Consumers,
Unit E3 Chemicals, contaminants and pesticides
EFSA-info sessions on applications
27 May 2014
Health and
Consumers
C t t off the
Content
th presentation
t ti
1. Type of food enzyme applications
p
on the food enzyme
y
dossiers
2. Update
3. Applicability checks: Main issues
4 Confidentiality: Main issues
4.
Health and
Consumers
This presentation expresses the views of
the author and does not, in any case,
bind the European Commission
2
1 Type of applications
1-Type
• Generic (joint) dossiers: Non-GM
Non GM microorganisms
¾ Enzymes produced by QPS microorganisms
¾ Enzymes already evaluated in FR/DK
¾ Enzymes obtained from animal-plant sources
• Producer-specific
P od ce specific dossiers
dossie s
¾ Enzymes produced by GM microorganisms
¾ Enzymes
E
ffor which
hi h no joint
j i t dossier
d
i is
i possible
ibl
Health and
Consumers
This presentation expresses the views of
the author and does not, in any case,
bind the European Commission
3
Health and
Consumers
4
2-Update
p
on the food enzyme
y
dossiers
Year
Number of
dossiers
submitted
GMM
Valid
dossiers
2012
5
4
5
2013
28
19
18
7 more info
are requested
3 in process
2014
13 (26 May
2014)
10
7 in process
Health and
Consumers
This presentation expresses the views of
the author and does not, in any case,
bind the European Commission
5
2-Update
2
Update on the food enzyme
dossiers
• 46 enzymes: 43 obtained by microorganisms
and 6 of them are QPS
• 29 enzymes are authorised
h i d either
i h in
i DK
DK, FR or
both
• The remaining 17 have not yet been evaluated
in the EU
Health and
Consumers
This presentation expresses the views of
the author and does not, in any case,
bind the European Commission
6
2-Update
p
on the food enzyme
y
dossiers: Forecast of applications
Year
Number of
expected
dossiers
Number of
received
dossiers
Discrepancy
2012
4
5
+1
2013
53
28
-25
2014
199
13 (until 26
May)
y)
-
March 2015
26
-
-
Health and
Consumers
This presentation expresses the views of
the author and does not, in any case,
bind the European Commission
7
3 Applicability
3A li bilit checks:
h k M
Main
i iissues
Very few dossiers have been sent back to the
applicant as some data were missing:
¾ Description
D
i i
off the
h different
diff
food
f d processing.
i
No
N
information on the key steps and on the time and
temperatures used.
used
¾ Dietary exposure assessment. No data provided
¾ Why the use would not mislead the consumer.
consumer
Not enough information supporting this point.
Health and
Consumers
This presentation expresses the views of
the author and does not, in any case,
bind the European Commission
8
4 Confidentiality
4-Confidentiality
Regulated by Article 12 of CAP Regulation
Information that cannot be regarded as confidential:
¾The name and address of the applicant
¾The name and a clear description of the substance
¾The jjustification of the use of the substance in or
on specific foodstuffs or food categories
¾Information
o at o that
t at is
s relevant
e e a t to the
t e assessment
assess e t of
o
the safety of the substance
¾Where applicable, the analysis method(s)
Health and
Consumers
This presentation expresses the views of
the author and does not, in any case,
bind the European Commission
9
4 Confidentiality
4-Confidentiality
Article 12 of CAP Regulation
¾Art 12.2. Applicants shall indicate which of the
info provided should be treated as confidential.
confidential
Verifiable justification must be given
¾Art. 12.3. The COM shall decide after consulting
pp
which info can remain
with the applicants
confidential and shall notify applicants and the MS
accordingly
Health and
Consumers
This presentation expresses the views of
the author and does not, in any case,
bind the European Commission
10
4 C fid ti lit
4-Confidentiality
By means of a Commission Decision, the COM has
delegated to the Director-General of DGSANCO the
adoption on its behalf of
adoption,
¾ Decisions determining, in accordance with Article
12(3) of Reg 1331/2008
Health and
Consumers
This presentation expresses the views of
the author and does not, in any case,
bind the European Commission
11
4-Confidentiality
Examples of information claimed as confidential
which are not in line with Art 12 of CAP
¾The properties of the food enzyme
¾Measured enzymatic activity (e.g. activity of the
enzyme/mg TOS)
¾Reaction and Fate in Food
¾Case of need and proposed conditions of use
¾Proposed normal, recommended and maximum
use levels
¾Dietary exposure assessment
¾Characterisation of the batch used for toxicity
This presentation expresses the views of 12
the author and does not, in any case,
tests
Health and
Consumers
bind the European Commission
4 C fid ti lit
4-Confidentiality
Examples of information claimed as confidential
which may be in line with Art 12 of CAP
¾A i
¾Amino-acid
id sequence off enzymes produced
d
d by
b
GMMs
¾Genetic stability of the production strain
¾The GMM dossier
¾M
¾Manufacturing
f t i
process
Confidential treatment will be given on a caseby case basis
by-case
Health and
Consumers
This presentation expresses the views of
the author and does not, in any case,
bind the European Commission
13
QUESTIONS?
European Commission, DG Health and Consumers Website
http://ec.europa.eu/food/food/fAEF/index_en.htm
Rafael PEREZ BERBEJAL (email: rafael.perez-berbejal@ec.europa.eu)
Health and
Consumers
14