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28.6.2012 Official
Journal
of
the
European
Union L
168/21
COMMISSION IMPLEMENTING REGULATION (EU) No 562/2012
of 27 June 2012
amending Commission Regulation (EU) No 234/2011 with regard to specific data required for risk
assessment of food enzymes
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
to be supplied provided that the potential consumption
under normal use does not lead to an intake of any
components which is larger than can be expected from
Having regard to the Treaty on the Functioning of the European
normal consumption of the source as such, and provided
Union,
that satisfactory chemical and microbiological specifi
cations can be established.
Having regard to Regulation (EC) No 1331/2008 of the
European Parliament and of the Council of 16 December
(5) The
European
Food
Safety
Authority
("the Authority")
2008 establishing a common authorisation procedure for
has also indicated in its guidance on data requirements
food additives, food enzymes and food flavourings ( 1 ), and in
for the evaluation of food enzyme applications ( 5 ) that
particular Article 9(1) thereof,
the justification for not supplying toxicological data for
food enzymes from edible parts of animals and non
genetically modified plants may include a documented
After consulting the European Food Safety Authority,
history on the safety of the source of the food
enzymes, the composition and the properties of the
food enzyme as well as its use in food which demon
Whereas:
strates no adverse effects on human health when
consumed in a comparable way, supported by any
existing toxicological studies. Therefore, the enzyme
(1) Pursuant
to
Article
5(2)
of
Commission
Regulation
(EU)
application for food enzymes from such edible sources
No 234/2011 of 10 March 2011 implementing Regu
should not be required to include toxicological data.
lation (EC) No 1331/2008 of the European Parliament
and of the Council of 16 December 2008 establishing a
common authorisation procedure for food additives, food
enzymes and food flavourings (
(6)
The concept of Qualified Presumption of Safety (here

2 ), the application dossier
shall include all the available data relevant for the
inafter referred to as "QPS") ( 6 ) was established by the
purpose of the risk assessment.
Authority as a tool for the assessment of the safety of
micro-organisms that are introduced into the food chain
either directly or as a source of additives or food
enzymes. This concept means that, where a strain of
(2) Pursuant
to
Article
8(1)
of
Regulation
(EU)
No
234/2011
concerning specific data required for risk assessment of
micro-organism is assigned to a QPS group and
food enzymes, information shall be provided on the
satisfies the qualifications specified, the Authority does
biological and toxicological data.
not need to carry out any further safety assessment of

the production strain. Therefore, if the micro-organism
used in the production of a food enzyme has a status of
QPS according to the most recent list of QPS recom
(3) A
number
of
food
enzymes
currently
placed
on
the
Union market have been evaluated and authorised
mended biological agents adopted by the Authority, the
under national provisions in France and Denmark in
enzyme application should not be required to include
accordance with the guidelines for the presentation of
toxicological data. However, if residues, impurities, degra
data on food enzymes of the Scientific Committee on
dation products linked to the total enzyme production
Food ("the SCF") set out in opinion expressed on
process (production, recovery and purification) could give
11 April 1991 (published in 1992) (
rise for concern the Authority, pursuant to Article 6(1) of

3 ). A few food
enzymes (e.g. chymosin, invertase and urease) have also
Regulation (EC) No 1331/2008, may request additional
been evaluated by the SCF (
data for risk assessment, including toxicological data.

4 ).
(4) With
regard
to
the
toxicological
properties
of
enzyme (7) Pursuant
to
Article
6(a)
of
Regulation
(EC)
No
preparations, the SCF guidelines indicated that food
1332/2008 of the European Parliament and of the
enzymes which are derived from edible parts of (non
Council of 16 December 2008 on food enzymes ( 7 ) a
genetically modified) plants and animals are generally
food enzyme may be included in the Union list only if
considered as posing no health problems. According to
it does not, on the basis of the scientific evidence
the guidelines no special documentation for safety needs
available, pose a safety concern to the health of the
consumer at the level of use proposed. The reduction
( 1 ) OJ 354, 31.12.2008, p. 1.
( 2 ) OJ L 64, 11.3.2011, p. 15.
( 5 ) http://www.efsa.europa.eu/en/efsajournal/pub/1305.htm
( 3 ) http://ec.europa.eu/food/fs/sc/scf/reports/scf_reports_27.pdf
( 6 ) http://www.efsa.europa.eu/en/efsajournal/doc/587.pdf
( 4 ) http://ec.europa.eu/food/fs/sc/scf/reports_en.html
( 7 ) OJ L 354, 31.12.2008, p. 7.

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L 168/22
EN
Official Journal of the European Union
28.6.2012
of data required for risk assessment in relation to food
contained use of genetically modified micro-organ
enzymes obtained from edible parts of non genetically
isms ( 2 ). However, as regards food enzymes obtained
modified animals and plants, and from micro-organisms
from genetically modified micro-organisms through the
that have a status of QPS does not have a negative
use of techniques listed in Annex II, Part A, point 4 of
impact on the quality of the risk assessment based on
Directive 2009/41/EC, the derogation from submitting
the SCF and the Authority’s guidance.
toxicological data should apply if the parent strains of
the micro-organisms have a status of QPS ( 3 ).
(8) With
regard
to
grouping
of
specified
food
enzymes
in (14) Regulation (EU) No 234/2011 should therefore be
one application, the Authority has already indicated in its
amended accordingly.
guidance on data requirements for the evaluation of food
enzyme applications that specified food enzymes with
(15) The
measures
provided
for
in
this
Regulation
are
in
the same catalytic activity, produced by the same
accordance with the opinion of the Standing
micro-organism strain and by the substantially same
Committee on the Food Chain and Animal Health,
manufacturing process may be grouped in one appli
cation, even if as a rule each individual food enzyme
must be assessed.
HAS ADOPTED THIS REGULATION:
Article 1
(9) It
is
appropriate
that
food
enzymes
obtained
from
edible Regulation (EU) No 234/2011 is amended as follows:
parts of plants or animals which have the same catalytic
activity and which are processed from the same source
(e.g. at species level) and with a substantially same
(1) The following Article 1a is inserted:
production process may be grouped under one appli
cation.
"Article 1a
Definitions
(10) It
is
also
appropriate
that
food
enzymes
obtained
from
For the purposes of this Regulation the following definitions
micro-organisms which have a status of QPS or from
shall apply:
micro-organisms which have been used in the production
of food enzymes that have been evaluated and authorised
(a) "Status of Qualified Presumption of Safety" means the
by the competent authorities in France or Denmark in
safety status assigned by the Authority to selected
accordance with the SCF guidelines of 1992 may be
groups of micro-organisms on the basis of an
grouped under one application under the same
assessment showing no safety concerns.
conditions.
(b) "SCF guidelines of 1992" means the guidelines for the
presentation of data on food enzymes set out in the
(11) Pursuant to Article 6(1) of Regulation (EC) No
opinion expressed by the Scientific Committee for
1331/2008, during the risk assessment the Authority
Food on 11 April 1991 ( 1 ).
may request additional information in duly justified cases.
___________
( 1 ) http://ec.europa.eu/food/fs/sc/scf/reports/scf_reports_27.
(12) The establishment of the Union list of food enzymes
pdf".
should take place smoothly and should not disturb the
existing food enzyme market. The derogation from
submitting toxicological data and the possibility of
(2) In Article 8 the following paragraphs 3, 4, 5 and 6 are
grouping dossiers will reduce the burden on applicants
added:
and in particular on small and medium size enterprises.
"3. By
way
of
derogation
from
point
(l)
of
paragraph
1
the dossier submitted in support of an application for the
(13) The
derogation
from
submitting
toxicological
data
and
safety evaluation of a food enzyme does not need to include
the possibility of grouping dossiers should not apply to
toxicological data if the food enzyme in question is
food enzymes which are produced from genetically
obtained from:
modified plants or animals as defined in point 5 of
Article 2 of Regulation (EC) No 1829/2003 of the
European Parliament and of the Council of 22 September
(a) edible parts of plants or animals intended to be or
2003 on genetically modified food and feed (
reasonably expected to be ingested by humans; or

1 ) nor to
food enzymes which are produced from or produced
with genetically modified micro-organisms as defined in
(b) micro-organisms having the status of Qualified
Article 2(b) of Directive 2009/41/EC of the European
Presumption of Safety.
Parliament and of the Council of 6 May 2009 on the
( 2 ) OJ L 125, 21.5.2009, p. 75.
( 1 ) OJ L 268, 18.10.2003, p. 1
( 3 ) http://www.efsa.europa.eu/en/efsajournal/doc/587.pdf. See page 13

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EN
28.6.2012 Official
Journal
of
the
European
Union L
168/23
4. Paragraph
3
shall
not
apply
where
the
plants
or
(c) micro-organisms which have been used in the
animals concerned are genetically modified organisms as
production of food enzymes that have been evaluated
defined in point 5 of Article 2 of Regulation (EC) No
and authorised by the competent authorities in either
1829/2003 or where the micro-organism concerned is a
France or Denmark in accordance with the SCF
genetically modified micro-organism as defined in
guidelines of 1992.
Article 2 (b) of Directive 2009/41/EC
( 1 ). However,
paragraph 3, point (b) shall apply to micro-organisms
6. Paragraph
5
shall
not
apply
where
the
plants
or
where genetic modification is obtained through the use of
animals concerned are genetically modified organisms as
the techniques/methods listed in Annex II, Part A, point 4
defined in point 5 of Article 2 of Regulation (EC) No
of Directive 2009/41/EC.
1829/2003 or where the micro-organism concerned is a
genetically modified micro-organism as defined in
5. Food
enzymes
may
be
grouped
under
one
application
Article 2 (b) of Directive 2009/41/EC.
provided that they have the same catalytic activity, are
processed from the same source material (e.g. at species
___________
level) and with a substantially same production process,
( 1 ) OJ L 125, 21.5.2009, p. 75".
and have been obtained from:
(a) edible parts of plants or animals intended to be or
Article 2
reasonably expected to be ingested by humans; or
This Regulation shall enter into force on the twentieth day
(b) micro-organisms having the status of Qualified
following that of its publication in the Official Journal of the
Presumption of Safety; or
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 27 June 2012.
For the Commission
The President
José Manuel BARROSO

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