(1)30.3.2011 EN Official Journ alof the EuropeanUnion L 83/1
II 
(Non-legislative acts) 
REGULATIONS  
  
COMMISSION REGULATION (EU) No 286/2011
of 10 March 2011
amending, for the pu rposes 
of its adaptation to technical and scientific progress, Regu lation 
(EC) 
No 1272/2008 of the Eu ropean 
Parliament and of the Cou ncil 
on classification, labelling and packaging 
of substances 
and mixtu res
(Text with EEA relevance)
THE 
EUROPEAN 
COMMISSION,
Having regard to the Treaty on  the Functioning of the European 
Union,
Having 
regard 
to Regulation 
(EC) 
No 1272/2008 of the E uropean 
Parliamen t 
and 
of the Coun cil 
of 16 Decemb er 
2008 on 
classifi­
cation,
 labelling
 and
 packaging
 of substances
 and
 mixtures, 
amending 
and 
repealing 
Directives 67/548/E EC 
and 
1999/45/EC, 
and 
amending 
Regulation 
(EC) 
No 1907/2006
(1) OJ L 353, 31.12.2008, p. 1., and in particu­
lar 
Article 53 thereof,
Whereas:
(1) Regulation (EC) No 1272/2008 harmon ises the provision s 
and 
criteria for the classification  
and 
labelling 
of sub­
stances,
 mixtures an d
 certain specific articles within the 
European 
Union.
(2) That Regulation takes into account the Globally Harmon­
ised
 System of Classification an d
 Labelling
 of Chemicals 
(hereinafter 
referred to as ‘the GHS’) of the Un ited 
Nations 
(UN).(3) The classification  criteria an d labelling rules of the GHS are 
periodically 
reviewed at UN level. The third revised edition  
of 
the GHS was adopted in  
December 
2008 by 
the United 
Nations
 Committee of E xperts
 on the Tran sport
 of 
Dangerous 
Goods and 
on 
the Globally 
Harmonised 
System 
of Classification an d
 Labelling
 of Chemicals 
(UNCETDG/GHS).
 It
 contains
 amendments
 concerning,
 
inter 
alia, the provision s 
for the allocation  
of hazard state­
ments 
and 
for the lab elling 
of small pack aging, 
new 
sub-
categories
 for respiratory an d
 skin
 sensitisation,
 the 
revision 
of the classification  
criteria for lon g-term 
hazards 
(chronic 
toxicity) to the aquatic en vironment 
and 
a new 
hazard 
class for sub stances 
and 
mixtures hazardous to the 
ozone 
layer. It 
is therefore n ecessary 
to adapt the techn ical 
provisions 
and 
criteria in  
the Annexes 
to Regulation 
(EC) 
No 
1272/2008 to the third revised edition  
of the GHS.
(4) The GHS allows authorities to adopt supplemental lab el­
ling 
provisions 
to protect in dividuals 
already sen sitised 
to 
a specific chemical that may elicit a respon se 
at very low 
concentration. 
Requiremen ts 
should be 
introduced 
to add 
the name 
of such chemical on  
the label 
even 
if present 
at 
very low con centration 
in 
a mixture.
(5) The termin ology of differen t provision s in the An nexes 
and
 certain techn ical
 criteria should also b e
 amended
 to 
facilitate implemen tation
 by
 operators an d
 enforcement
 
authorities, to improve con sistency 
of the legal 
text and 
to 
enhance 
clarity.(1)
(2)L 83/2 EN Official Journ alof the EuropeanUnion 30.3.2011
(6) To ensure that suppliers of sub stances can adapt to the 
new
 classification ,
 labelling
 and
 packaging
 provision s
 
introduced 
by 
this Regulation, 
a transitional 
period should 
be 
foreseen 
and 
the application  
of this Reg ulation 
should 
be 
deferred. This should allow for the possib ility 
to apply 
the provision s 
laid down  
in 
this Regulation 
on 
a voluntary 
basis 
before 
the transitional 
period is over.
(7) The measures provided for in  this Regulation are in accor­
dance 
with the opin ion 
of the Committee estab lished 
pur­
suant 
to Article 133 of Reg ulation 
(EC) 
No 1907/2006 of 
the European 
Parliamen t 
and 
of the Coun cil
(1) OJ L 396, 30.12.2006, p. 1.,
HAS ADOPTE D THIS REGULATION:
Article 1
Regulation 
(EC) 
No 1272/2008 is amen ded 
as follows:
(1) Article 25(5) is deleted;
(2) the followin g 
new 
section 
(e) is inserted 
in 
Article 26(1):
‘(e)if the hazard pictog ram
 “GHS02” or “GHS06” applies, 
the use of the hazard pictog ram
 “GHS04” shall be
 
optional.
’;
(3) Annex 
I 
is amended 
in 
accordance 
with Annex 
I 
to this 
Regulation;
(4) Annex 
II 
is amended 
in 
accordance 
with Annex 
II 
to this 
Regulation;
(5)
 Annex
 III
 is amended
 in accordan ce
 with Annex
 III
 to this 
Regulation;
(6)
 Annex
 IV
 is amended
 in accordan ce
 with Annex
 IV
 to this 
Regulation;(7) Annex 
V is amen ded 
in 
accordance 
with Annex 
V to this 
Regulation;
(8)
 Annex
 VI is amen ded
 in accordan ce
 with Annex
 VI to this 
Regulation;
(9) Annex 
VII 
is amended 
in 
accordance 
with Annex 
VII 
to this 
Regulation.
Article 
2
Transitional provisions
1. By way of derog ation
 from the secon d
 paragraph
 of 
Article 3, sub stances 
and 
mixtures may, b efore 1 
December 
2012 
and 1 
June 
2015 respectively, b e 
classified, lab elled 
and 
packaged 
in accordance with Regulation (EC) No 1272/2008 as amen ded 
by this Regulation.
2.
 By way of derog ation
 from the secon d
 paragraph
 of 
Article 3, sub stances
 classified, lab elled
 and
 packaged in accor­
dance 
with Regulation 
(EC) 
No 1272/2008 an d 
placed on  
the 
market 
before 1 
December 
2012, are n ot 
required to b e 
relabelled 
and 
repackaged 
in 
accordance 
with this Reg ulation 
until 1 
Decem­
ber 
2014.
3. By way of derog ation
 from the secon d
 paragraph
 of 
Article 3, mixtures classified, lab elled 
and 
packaged 
in 
accordance 
with 
Directive 1999/45/E C 
of the European 
Parliamen t 
and 
of the 
Council
(2) OJ L 200, 30.7.1999, p. 1. or Regulation (EC) No 1272/2008 an d placed on  the 
market 
before 1 
June 
2015, are n ot 
required to b e 
relabelled 
and 
repackaged 
in 
accordance 
with this Reg ulation 
until 1 
June 
2017.
Article 3
This Regulation 
shall enter 
into 
force on 
the 20th day followin g 
its 
publication 
in 
the Official Journal of the European Union .
It 
shall apply in  
respect of sub stances 
from 1 Decemb er 
2012 and 
in 
respect of mixtures from 1 June 
2015.
This Regulation 
shall be 
binding 
in 
its entirety 
and 
directly applicab le 
in 
all Member 
States.
Done 
at Brussels, 10 March 2011.
For the Commission
The President
José Manuel BARROSO30.3.2011 EN Official Journ alof the EuropeanUnion L 83/3
ANNEX I
A. Part 1 of An nex 
I 
to Regulation 
(EC) 
No 1272/2008 is amen ded 
as follows:
(1) in 
section 
1.1.2.2.2, the Note un der 
Table 
1.1 is replaced b y 
the followin g:
‘
Note:
Generic 
cut-off values are in  
weight 
percentages 
except for g aseous 
mixtures for those hazard classes where the
generic 
cut-off values may b e 
best 
described 
in 
volume percen tages.
’;
(2) in 
section 
1.1.3.1, the b eginning 
of the first sen tence 
is replaced b y ‘If 
a tested mixture’;
(3) sections 
1.1.3.2, 1.1.3.3 an d 
1.1.3.4 are replaced b y 
the followin g:
‘
1.1.3.2. Batching
The hazard categ ory 
of a tested production  
batch 
of a mixture can  
be 
assumed to b e 
substantially 
equiva­
lent 
to that of an other 
untested 
production  
batch 
of the same commercial product, when  
produced b y
or 
under 
the control 
of the same supplier, un less 
there is reason  
to believe 
there is sig nificant 
variation
such that the hazard classification  
of the untested 
batch 
has changed. 
If 
the latter occurs, a n ew 
evalu­
ation 
is necessary.
1.1.3.3.
 Concentration of highly hazardous mixtures
In 
the case of the classification  
of mixtures covered b y 
sections 
3.1, 3.2, 3.3, 3.8, 3.9, 3.10 an d 
4.1, if a
tested mixture is classified in  
the highest 
hazard categ ory 
or sub-catego
ry, and 
the concentration 
of the
components 
of the tested mixture that are in  
that categ ory 
or sub-category 
is increased, 
the resultin g
untested 
mixture shall b e 
classified in  
that categ ory 
or sub-category 
without addition al 
testing.
1.1.3.4.
 Interpolation within one toxicity category
In 
the case of the classification  
of mixtures covered b y 
sections 
3.1, 3.2, 3.3, 3.8, 3.9, 3.10 an d 
4.1, for
three mixtures (A, B an d 
C) with iden tical 
components, 
where mixtures A an d 
B have been 
tested and
are 
in 
the same hazard categ ory, 
and 
where untested 
mixture C has the same hazardous compon ents 
as
mixture A an d 
B but 
has concentrations 
of those hazardous compon ents 
inter
mediate to the con cen­
trations 
in 
mixtures A an d 
B, then 
mixture C is assumed to b e 
in 
the same hazard categ ory 
as A and 
B.’;
(4) in 
section 
1.1.3.5, the last sen tence 
is replaced b y 
the followin g:
‘
If 
mixture (i) or (ii) is already classified b ased 
on 
test data, then  
the other mixture shall b e 
assigned 
the same haz­
ard category.
’;
(5) sections 
1.2, 1.2.1, 1.2.1.1, 1.2.1.2 an d 
1.2.1.3 are replaced b y 
the followin g:
‘
1.2. Labelling
1.2.1. General rules for the application of labels required by Article 31
1.2.1.1. Hazard pictog rams 
shall be 
in 
the shape of a square set at a poin t. 
1.2.1.2. Hazard 
pictograms 
as laid down  
in 
Annex 
V shall have a b lack 
symbol 
on 
a white background 
with a
red frame sufficien tly 
wide to be 
clearly visib le. 
1.2.1.3. Each 
hazard pictog ram 
shall cover at least on e 
fifteenth 
of the min imum 
surface area of the lab el 
dedi­
cated to the in formation 
required b y 
Article 17. The min imum 
area of each hazard pictog ram 
shall not
be 
less than 
1 cm2. L 83/4 EN Official Journ alof the EuropeanUnion 30.3.2011
1.2.1.4. The dimen sions of the lab el and of each pictog ram shall be as follows: 
Table 1.3
Minimum 
dimensions of labels and pictograms
Capacity of
the packageDimensions of the lab el (in millimetres)
for the information 
required b y 
Article 17Dimensions of each pictog ram
(in 
millimetres)
Not exceedin g
3 
litres:If possible, at least 52 × 74 Not smaller than  10 × 10
If 
possible, 
at least 16 × 16
Greater than
3 litres but 
not
exceeding
50 
litres:At least 74 × 105 At least 23 × 23
Greater than50 litres b
ut 
not
exceeding
500 
litres:At least 105 × 148 At least 32 × 32
Greater than500 litres:At least 148 × 210 At least 46 × 46’
(6) the in
troductory 
sentence 
in 
section 
1.5.2.1.3 is replaced b y 
the followin g:
‘
The pictog ram, 
the signal 
word, the hazard statemen t, 
and 
the precautionary statemen t 
linked 
to the hazard cat­
egories 
listed below 
may be 
omitted from the lab el 
elements 
required b y 
Article 17 where:’;
(7) in 
section 
1.5.2.2, poin t 
(b) 
is replaced b y 
the followin g:
‘
(b)The 
classification  
of the con tents 
of the solub le 
packaging 
is exclusively on e 
or more of the hazard categ o­
ries 
in 
1.5.2.1.1 (b ), 
1.5.2.1.2 (b ) 
or 1.5.2.1.3 (b ); 
and
’.
B. Part 2 of An nex 
I 
to Regulation 
(EC) 
No 1272/2008 is amen ded 
as follows:
(1) section 
2.1.4.1 is amen ded 
as follows:
(a) the footnote 
under 
Figure 
2.1.1 is replaced b y 
the followin g:
‘
(*)See UN Recommen dations
 on the Tran sport
 of Dangerous
 Goods, Model Regulation s,
 16th rev. ed,
sub-section 
2.1.2.’;
(b) Figure 
2.1.3 is replaced b y 
the followin g:’30.3.2011 EN Official Journ alof the EuropeanUnion L 83/5
‘Figure 2.1.3
Procedure 
for assignment to a division in the class of explosives (Class 1 for transport)’L 83/6 EN Official Journ alof the EuropeanUnion 30.3.2011
(c) Figure 2.1.4, is replaced b y the followin g:
‘
Figure 2.1.4
Procedure 
for the classification of ammoniu m 
nitrate emu lsion, 
suspensi
on or gel (ANE)30.3.2011 EN Official Journ alof the EuropeanUnion L 83/7
(2) in section   2.1.4.2, the Note is replaced b y the followin g:
‘
Note:
Neither a series 1 type (a) propag ation 
of detonation 
test nor 
a series 2 type (a) test of sen sitivity 
to detonative
shock 
is required if the exothermic decomposition  
energy 
of organic 
materials is less than  
800 J/g. 
For organic
substances 
and 
mixtures of org anic 
substances 
with a decomposition  
energ
y of 800 J/g  
or more, tests 1 (a)
and 
2 (a) need 
not 
be 
performed if the outcome of the b allistic 
mortar Mk .III
d test (F.1), or the b allistic 
mortar test
(F.2) or the BAM Trauzl test (F.3) with in itiation 
by 
a standard 
No 8 deton at
or (see Appen dix 
1 to the UN RTDG,
Manual 
of Tests an d 
Criteria) is “no
”. In 
this case, the results of test 1 (a) an d 
2 (a) are deemed to b e “
-”.’;
(3) in 
section 
2.2.2.1, the Note un der 
Table 
2.2.1 is replaced b y 
the followin g:
‘
Note:
Aerosols shall n ot 
be 
classified as flammab le 
gases; 
see section  
2.3.’;
(4) in 
section 
2.3.2.1, the Note is replaced b y 
the followin g 
notes:
‘
Note 1:
Flammable 
components 
do not 
cover pyrophoric, self-heatin g 
or water-reactive sub stances 
and 
mixtures b ecause
such 
components 
are never 
used as aerosol con tents.
Note 
2:
Flammable 
aerosols do n ot 
fall addition ally 
within 
the scope of section s 
2.2 (flammab le 
gases), 
2.6 (flammab le
liquids) 
or 2.7 (flammab le 
solids).’;
(5) in 
section 
2.3.2.2, the followin g 
Note is in serted 
at the end 
of the parag raph:
‘
Note:
Aerosols n ot
 submitted
 to the flammab ility
 classification procedures in this section shall b e
 classified as flam­
mable 
aerosols, Categ ory 
1.’;
(6) in 
section 
2.4.2.1, the Note un der 
Table 
2.4.1 is replaced b y 
the followin g:
‘
Note:
“Gases which cause or con tribute 
to the comb ustion 
of other material more than  
air does” mean  
pure gases 
or gas
mixtures
 with an oxidisin g
 power greater
 than 23,5 % as determin ed
 by
 a method specified in I SO
 10156 as
amended 
or 10156-2 as amen ded.
’;
(7) in 
section 
2.5.3, the followin g 
Note is in serted 
under 
Table 
2.5.2:
‘Note:
Pictogram 
GHS04 is n ot 
required for g ases 
under 
pressure where pictog ram 
GHS02 or pictog ram 
GHS06
appears.’;
(8) in 
section 
2.6.2.1 the followin g 
Note is in serted 
under 
Table 
2.6.1:
‘Note:Aerosols shall n
ot 
be 
classified as flammab le 
liquids; see section  
2.3.’;(*)
(**)L 83/8 EN Official Journ alof the EuropeanUnion 30.3.2011
(9) section  2.6.4.2 is amen ded as follows:
(a) the first parag raph 
is replaced b y 
the followin g:
‘
In 
the case of mixtures containing 
known 
flammable 
liquids in 
defined 
concentrations, 
although they may
contain
 non-volatile
 components
 e.g.
 polymers, additives, the flash poin t
 need
 not
 be
 determin ed
 experi­
mentally 
if the calculated flash poin t 
of the mixture, usin g 
the method g iv
en 
in 
2.6.4.3, is at least 5 ° C
greater 
than 
the relevan t 
classification  
criterion 
(23 °C 
and 
60 °C, 
respectively) an d 
provided that:
(*)To date, the calculation method has b een  validated for mixtures con taini ng  up to 6 volatile compo­
nents. 
These compon ents 
may be 
flammable 
liquids lik e 
hydrocarb ons, 
ethers, alcohols, esters (except
acrylates), an d 
water. It 
is however n ot 
yet validated for mixtures con taining 
halogenated 
sulphurous,
and/or 
phosphoric compoun ds 
as well as reactive acrylates.
(**)If the calculated flash poin t is less than  5 °C greater than the relevan t classification  criterion, the calcu­
lation 
method may n ot 
be 
used and 
the flash poin t 
should be 
determined 
experimen tally.
’;
(b) in 
point 
(b), 
the words ‘of the mixture’ shall b e 
added;
(10) in 
section 
2.6.4.4, Tab le 
2.6.3, the complete row ‘British Stan dard 
Institute, 
BS 2000 Part 170 as amen ded 
(iden­
tical 
to EN 
ISO 
13736)’ is deleted;
(11) section 
2.6.4.5 is replaced b y 
the followin g:
‘
2.6.4.5Liquids with a flash poin t 
of more than  
35 °C 
and 
not 
more than  
60 °C 
need 
not 
be 
classified in  
Cat­
egory 
3 if negative 
results have b een 
obtained 
in 
the sustain ed 
combustibi
lity test L.2, Part I II, 
section 
32
of the UN RTDG, Man ual 
of Tests an d 
Criteria.’;
(12) the followin g 
new 
section 
2.6.4.6 is in serted:
‘
2.6.4.6.Possible 
test methods for determin ing 
the initial 
boiling 
point of flammab le 
liquids are listed in
Table 
2.6.4.
Table 2.6.4
Methods for determining the initial boiling point of flammable liqu ids
European 
standards: EN 
ISO 
3405 as amen ded
Petroleum 
products — Determin ation 
of distillation  
characteristics at
atmospheric pressure
EN 
ISO 
3924 as amen ded
Petroleum 
products — Determin ation 
of boiling 
range 
distribution
— 
Gas chromatog raphy 
method
EN 
ISO 
4626 as amen ded
Volatile 
organic 
liquids — Determin ation 
of boiling 
range 
of organic
solvents 
used as raw materials
Regulation 
(EC)
No 
440/2008 (*)Method A.2 as describ ed 
in 
Part A of the An nex 
to Regulation 
(EC)
No 440/2008
(*)OJ L 142, 31.5.2008, p. 1.’
(13) in section   2.7.2.3, the Note un der Table 2.7.1 is replaced b y the followin g:
‘
Note 1:
The test shall b e 
performed on  
the substance 
or mixture in  
its physical form as presen ted. 
If, 
for example, for the
purposes of supply or tran sport, 
the same chemical is to b e 
presented 
in a physical form differen t 
from that which
was tested an d 
which is con sidered 
likely 
to materially alter its performan ce 
in 
a classification  
test, the sub stance
shall 
also be 
tested in 
the new 
form.
Note 2:
Aerosols shall n ot 
be 
classified as flammab le 
solids; see section  
2.3.’;30.3.2011 EN Official Journ alof the EuropeanUnion L 83/9
(14) in section   2.8.4.2, Fig ure 2.8.1, poin ts  7.4, 8.4 an d  9.4, the word ‘No’ is replaced b y ‘ None ’;
(15) section 
2.11.1.2 is replaced b y 
the followin g:
‘
2.11.1.2. Self-heatin g 
of a substance 
or a mixture is a process where the gradual reaction  
of that sub stance 
or
mixture with oxyg en 
(in 
the air) generates 
heat. If 
the rate of heat production  
exceeds the rate of heat
loss, then 
the temperature of the sub stance 
or mixture will rise which, after an  
induction 
time, may
lead to self-ig nition 
and 
combustion.
’;
(16) in 
section 
2.15.4.2, Fig ure 
2.15.1, poin ts 
7.4, 8.4 an d 
9.4, the word ‘No’ is replaced b y ‘
None
’.
C. Part 3 of An nex 
I 
to Regulation 
(EC) 
No 1272/2008 is amen ded 
as follows:
(1) section 
3.1.2.1 is replaced b y 
the followin g:
‘
3.1.2.1.Substances 
can 
be 
allocated to on e 
of four toxicity categ ories 
based on 
acute toxicity b y 
the oral, der­
mal or inhalation 
route accordin g 
to the numeric 
criteria shown  
in 
Table 
3.1.1. Acute toxicity values
are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity esti­
mates (ATE ). 
Explanatory 
notes 
are shown  
following 
Table 
3.1.1.
Table 3.1.1
Acute 
toxicity hazard categories and acu te 
toxicity estimates (ATE) defining the respective
categories
Exposure route Category 1 Category 2 Category 3 Category 4
Oral (mg/kg bodyweight)
A
T E  ≤  55 < ATE
≤  5 050 < ATE
≤ 300300 < ATE
≤ 2 000See:Note (a)
Note (b)
Dermal 
(mg/kg 
bodyweight)
A
T E  ≤  5 050 < ATE
≤ 200200 < ATE
≤ 1 0001 000 < ATE
≤ 2 000See:Note (a)Note (b
)
Gases 
(ppmV (*))
ATE 
≤ 100100 < ATE
≤ 500500 < ATE
≤ 2 5002 500 < ATE
≤ 20 000see:Note (a)Note (b
)
Note 
(c)
Vapours (mg /l)
ATE 
≤ 0,50,5 < ATE
≤ 2,02,0 < ATE
≤ 10,010,0 < ATE
≤ 20,0see:Note (a)Note (b
)
Note 
(c)
Note (d)
Dusts and 
mists (mg /l)
ATE 
≤ 0,050,05 < ATE
≤ 0,50,5 < ATE
≤ 1,01,0 < ATE
≤ 5,0see:Note (a)Note (b
)
Note 
(c)
(*)Gas concentrations are expressed in  parts per million  per volume (ppmV).
Notes to Table 3.1.1:
(a) The acute toxicity estimate (ATE ) 
for the classification  
of a subs
tanc
e is derived usin g
 the LD50/LC50
where availab le.
(b) The 
acute toxicity estimate (ATE ) 
for the classification  
of a substanc
e in 
a mixture is derived usin g:
—the 
LD50/LC50 where availab le,L 83/10 EN Official Journ alof the EuropeanUnion 30.3.2011
—the appropriate con version value from Tab le 3.1.2 that relates to the results of a ran ge test,
or
—the appropriate con version 
value from Tab le 
3.1.2 that relates to a classification  
category.
(c) Generic 
concentration 
limits for in halation 
toxicity in  
the table 
are based 
on 
4-hour testin g 
expo­
sures. Con version 
of existing 
inhalation 
toxicity data which have b een 
generated 
using 
a 1-hour
exposure can  
be 
carried out b y 
dividing 
by 
a factor of 2 for g ases 
and 
vapours an d 
4 for dusts an d
mists.
(d) For 
some substances 
the test atmosphere will n ot 
just be 
a vapour b ut 
will consist 
of a mixture of
liquid and 
vapour phases. For other sub stances 
the test atmosphere may consist of a vapour which
is near 
the gaseous 
phase. In 
these latter cases, classification  
shall be 
based on 
ppmV as follows:
Category
  1 (100 ppmV), Categ ory
  2 (500 ppmV), Categ ory
  3 (2 500  ppmV), Category  4
(20 000 ppmV).
The terms “dust”, “mist” and “
vapour” are defin ed 
as follows:
—dust: solid particles of a sub stance 
or mixture suspen ded 
in 
a gas 
(usually air),
—mist: liquid droplets of a sub stance 
or mixture suspen ded 
in 
a gas 
(usually air),
—vapour: the g aseous 
form of a sub stance 
or mixture released from its liquid or solid state.
Dust is generally
 formed b y
 mechanical
 processes. Mist is g enera
lly formed b y
 condensation
 of
supersaturated vapours or b y
 physical shearin g
 of liquids. Dusts an d
 mists gen era
lly have sizes
ranging 
from less than  
1 to about 
100 µm.’;
(2) section 
3.1.3.2 is replaced b y 
the followin g:
‘
3.1.3.2.For acute toxicity each route of exposure shall b e 
considered 
for the classification  
of mixtures, b ut 
only
one 
route of exposure is n eeded 
as long 
as this route is followed (estimated or tested) for all compo­
nents 
and 
there is no 
relevant 
evidence 
to suggest 
acute toxicity b y 
multiple routes. When  
there is rel­
evant
 evidence
 of toxicity b y
 multiple routes of exposure, classification is to b e
 conducted
 for all
appropriate routes of exposure. All availab le 
information 
shall be 
consi
dered. The pictog ram 
and 
signal
word 
used shall reflect the most severe hazard categ ory 
and 
all relevan t 
hazard statemen ts 
shall be 
used.’;
(3) in 
section 
3.1.3.3, poin ts 
(c) and 
(d) are added:
‘(c)If 
the converted 
acute toxicity poin t 
estimates for all compon ents 
of a mixture are within  
the same categ ory,
then 
the mixture should b e 
classified in  
that categ ory.
(d) When 
only 
range 
data (or acute toxicity hazard categ ory 
information) 
are availab le 
for compon en
ts in a mix­
ture, they may b e 
converted 
to point 
estimates in  
accordance 
with Table 
3.1.2 when  
calculating 
the classi­
fication 
of the new 
mixture usin g 
the formulas in  
sections 
3.1.3.6.1 an d 
3.1.3.6.2.3.’;
(4) section 
3.1.3.5.2 is replaced b y 
the followin g:
‘
3.1.3.5.2. If 
a tested mixture is diluted with a diluen t 
that has an  
equivalent 
or lower toxicity classification  
than
the least toxic orig inal 
components, 
and 
which is n ot 
expected to affect the toxicity of other compo­
nents,
 then the n ew
 diluted mixture may b e
 classified as equivalen t
 to the orig inal
 tested mixture.
Alternatively, 
the formula explain ed 
in 
section 
3.1.3.6.1 can  
be 
applied.’;
(5) section 
3.1.3.6.1, is amen ded 
as follows:
(a) point 
(c) is replaced b y 
the followin g:
‘
(c)ignore 
components 
if the data availab le 
are from a limit dose test (at the upper threshold for Categ ory 
4
for the appropriate route of exposure as provided in  
Table 
3.1.1) and 
do not 
show acute toxicity.’;’;30.3.2011 EN Official Journ alof the EuropeanUnion L 83/11
(b) the first sen tence beneath point  (c) is replaced b y the followin g:
‘
Components 
that fall within  
the scope of this section  
are considered 
to be 
components 
with a known 
acute
toxicity estimate (ATE ). 
See note 
(b) 
to Table 
3.1.1 and 
section 
3.1.3.3 for appropriate application  
of avail­
able 
data to the equation  
below, 
and 
section 
3.1.3.6.2.3.’;
(6) in 
section 
3.1.3.6.2.1, poin t 
(a), the footn ote 
is replaced b y 
the followin g:
‘
(1)When mixtures con tain components that do not have acute toxicity data for each route of exposure, acute
toxicity estimates may b e 
extrapolated from the availab le 
data and 
applied to the appropriate routes (see sec­
tion 
3.1.3.2). However, specific leg islation 
may require testin g 
for a specific route. I n 
those cases, classifica­
tion 
shall be 
performed for that route b ased 
upon 
the legal 
requiremen ts.
’;
(7) section 
3.1.3.6.2.2 is replaced b y 
the followin g:
‘
3.1.3.6.2.2. In 
the event 
that a compon ent 
without an y 
useable 
informati
on 
for classification  
is used in 
a mix­
ture at a con centration
 of 1 % or g reater,
 it is concluded
 that the mixture can not
 be
 attributed
 a
definitive 
acute toxicity estimate. I n 
this situation  
the mixture shall be classified b ased 
on 
the known
components 
only, 
with the addition al 
statement 
on 
the label 
and 
in 
the SDS that: “× percent 
of the
mixture con sists 
of compon ent(s) 
of unknown 
toxicity”.’;
(8) in 
section 
3.1.3.6.2.3, the title of Tab le 
3.1.2 is replaced b y 
the followin g:
‘
Conversion 
from experimen tally 
obtained 
acute toxicity ran ge 
values (or acute toxicity hazard categ ories) 
to acute
toxicity poin t 
estimates for use in  
the formulas for the classification  
of mixtures’;
(9) the followin g 
sentence 
is added to section  
3.1.4.1:
‘Without prejudice to Article 27, comb ined 
hazard statemen ts 
may be 
used in 
accordance 
with Annex 
III.
’;
(10) in 
Tables 
3.1.3, 3.2.5, 3.3.5, 3.4.4 an d 
3.8.4, the pictog ram 
with the exclamation  
mark 
is replaced b y 
the follow­
ing 
pictogram:
‘
(11) in 
section 
3.4.1.5 the words ‘at section  
3.4.4.’ are replaced b y ‘
in 
Annex 
II, 
section 
2.8.’;
(12) in 
section 
3.4.1.6 the word ‘and
’ is inserted 
after ‘Respiratory Sen s
itisation’;
(13) sections 
from 3.4.2 to 3.4.2.2.4.1 are replaced b y 
the followin g:
‘
3.4.2.  Classification criteria for substances
3.4.2.1.  Respiratory sensitisers
3.4.2.1.1.  Hazard categ ories
3.4.2.1.1.1.
 Respiratory sen sitisers
 shall be
 classified in Categ ory
  1 where data are n ot
 sufficien t
 for
sub-categorisation. 
3.4.2.1.1.2. Where 
data are sufficien t 
a refined 
evaluation  
according 
to 3.4.2.1.1.3 shall allow the allocation  
of
respiratory sen sitisers 
into 
sub-category 
1A, strong 
sensitisers, 
or sub-category 
1B for other respi­
ratory sen sitisers. Table 3.4.1
Hazard
category and su b-categories
for respiratory sensitisersL 83/12 EN Official Journ alof the EuropeanUnion 30.3.2011
3.4.2.1.1.3. Effects seen in either human s or animals will normally justify classification  in a weight of evidence
approach 
for respiratory sen sitisers. 
Substances 
may be 
allocated to on e 
of the two sub -
categor
ies 1A
or 1B usin g 
a weight 
of evidence 
approach in  
accordance 
with the criteria g i
ven 
in 
Table 
3.4.1 and
on 
the basis 
of reliable 
and 
good 
quality eviden ce 
from human  
cases or epidemiolog ical 
studies
and/or 
observations 
from appropriate studies in  
experimen tal 
animals. 
3.4.2.1.1.4. Substances 
shall be 
classified as respiratory sen sitisers 
in 
accordance 
with the criteria in  
Table 
3.4.1: 
 
      
Category Criteria
Category 1 Substances shall be classified as respiratory sen sitisers (Category 1) where
data are n ot 
sufficient 
for sub-categorisation 
in 
accordance 
with the fol­
lowing 
criteria:
(a) if there is eviden ce 
in 
humans 
that the sub stance 
can 
lead to specific
respiratory hypersen sitivity; 
and/or
(b) if 
there are positive results from an  
appropriate an imal 
test.
Sub-category 
1A: Substances
 showing 
a high 
frequency 
of occurren ce 
in 
humans; 
or a prob­
ability 
of occurren ce 
of a high 
sensitisation 
rate in 
humans 
based 
on 
ani­
mal 
or other tests (*). Severity of reaction  may also b e considered.
Sub-category
 1B: Substances
 showing
 a low to moderate frequen cy
 of occurren ce
 in
humans; 
or a probability 
of occurren ce 
of a low to moderate sen sitisation
rate 
in 
humans 
based 
on 
animal 
or other tests (*). Severity of reaction  may
also 
be 
considered.
(*)At presen t, recognised and validated an imal models for the testin g of respiratory hypersen sitivity are not avail­
able. 
Under 
certain 
circumstan ces, 
data from an imal 
studies may provide valuab le 
information 
in 
a weight 
of
evidence 
assessmen t.
3.4.2.1.2.  Human eviden ce
3.4.2.1.2.1. Evidence 
that a sub stance 
can 
lead to specific respiratory hypersen sitivity 
will normally 
be 
based 
on
human 
experience. 
In 
this context, 
hypersensitivity 
is normally 
seen 
as asthma, b ut 
other hypersen ­
sitivity 
reactions 
such as rhin itis/conjunctivitis 
and 
alveolitis are also con sidered. 
The condition 
will
have the clin ical 
character of an  
allergic 
reaction. 
However, immun ologi
cal mechan isms 
do not 
have
to be 
demonstrated. 
3.4.2.1.2.2. When 
considering 
the human  
evidence, 
it is necessary 
for a decision  
on 
classification  
to take 
into
account, 
in 
addition 
to the eviden ce 
from the cases: 
(a) the size of the population  
exposed;
(b) the 
extent 
of exposure.
The use of human  
data is discussed in  
sections 
1.1.1.3, 1.1.1.4 an d 
1.1.1.5.
3.4.2.1.2.3. The eviden ce 
referred to ab ove 
could be: 
(a) clinical 
history an d 
data from appropriate lun g 
function 
tests related to exposure to the sub ­
stance, 
confirmed 
by 
other supportive eviden ce 
which may in clude:
(i) in 
vivo immun ological 
test (e.g. 
skin 
prick 
test);
(ii) in 
vitro immun ological 
test (e.g. 
serological 
analysis);(*)
(**)30.3.2011 EN Official Journ alof the EuropeanUnion L 83/13
(iii) studies that in dicate other specific hypersen sitivity reactions where immun ological mecha­
nisms
 of action have n ot
 been
 proven,
 e.g.
 repeated low-level irritation ,
 pharmacolog i
­
cally mediated effects;
(iv) a chemical structure related to sub stances 
known 
to cause respiratory hypersen sitivity;
(b) data 
from one 
or more positive b ronchial 
challenge 
tests with the sub st
ance 
conducted 
accord­
ing 
to accepted g uidelines 
for the determin ation 
of a specific hypersen si
tivity reaction .
3.4.2.1.2.4.
 Clinical
 history shall in clude
 both
 medical an d
 occupational history to determin e
 a relation ship
between 
exposure to a specific sub stance 
and 
developmen t 
of respiratory hypersen sitivity. 
Relevant
information 
includes 
aggravating 
factors both 
in 
the home an d 
workplace, 
the onset 
and 
progress
of 
the disease, family history an d 
medical history of the patient in question . 
The medical history shall
also include 
a note 
of other allerg ic 
or airway disorders from childhood, an d 
smoking 
history. 
3.4.2.1.2.5. The results of positive b ronchial 
challenge 
tests are con si
dered to provide sufficient evidence for clas­
sification 
on 
their own . 
It 
is however recog nised 
that in 
practice man y 
of the examin ations 
listed
above 
will already have b een 
carried out. 
3.4.2.1.3.  Animal
 studies
3.4.2.1.3.1. Data from appropriate an imal 
studies which may b e 
indicative 
of the poten tial 
of a substance 
to
cause sensitisation 
by 
inhalation 
in 
humans
 may in clude:
(a)
 measuremen ts
 of Immunoglobulin
 E (IgE)
 and
 other specific immun ological
 parameters in
mice;
(b) specific 
pulmonary 
responses 
in 
guinea 
pigs.
3.4.2.2.
 Skin sensitisers
3.4.2.2.1.  Hazard categ ories
3.4.2.2.1.1. Skin 
sensitisers 
shall be 
classified in  
Category 
1 where data are n ot 
sufficient 
for sub-categorisation. 
3.4.2.2.1.2. Where 
data are sufficien t 
a refined 
evaluation  
according 
to section  
3.4.2.2.1.3 allows the allocation
of skin 
sensitisers 
into 
sub-category 
1A, stron g 
sensitisers, 
or sub-cat
egory 
1B for other sk in
sensitisers. 
3.4.2.2.1.3. Effects 
seen 
in 
either human s 
or animals 
will normally 
justify classification  
in 
a weight 
of evidence
approach 
for skin 
sensitisers 
as describ ed 
in 
section 
3.4.2.2.2. Sub stan
ces may b e 
allocated to on e
of 
the two sub -categories 
1A or 1B usin g 
a weight 
of evidence 
approach in  
accordance 
with the cri­
teria given 
in 
Table 
3.4.2 and 
on 
the basis 
of reliable 
and 
good 
quality eviden ce 
from human  
cases
or epidemiolog ical
 studies an d/or
 observations
 from appropriate studies in experimen tal
 animals
according 
to the guidance 
values provided in  
sections 
3.4.2.2.2.1 an d 
3.4.2.2.3.2 for sub -cat­
egory 
1A and 
in 
sections 
3.4.2.2.2.2 an d 
3.4.2.2.3.3 for sub -category 
1B. Table 3.4.2
Hazard
category and su b-categories
for skin sensitisersL 83/14 EN Official Journ alof the EuropeanUnion 30.3.2011
3.4.2.2.1.4. Substances shall be classified as sk in sensitisers in accordance with the criteria in  Table 3.4.2: 
 
      
Category Criteria
Category 1 Substances shall be classified as sk in sensitisers (Category 1) where data
are not 
sufficient 
for sub-categorisation 
in 
accordance 
with the followin g
criteria:
(a) if 
there is eviden ce 
in 
humans 
that the sub stance 
can 
lead to sen si­
tisation 
by 
skin 
contact 
in 
a substantial 
number 
of persons; 
or
(b) if 
there are positive results from an  
appropriate an imal 
test (see spe­
cific criteria in  
section 
3.4.2.2.4.1).
Sub-category 
1A: Substances 
showing 
a high 
frequency 
of occurren ce 
in 
humans 
and/or 
a
high
 potency
 in animals
 can be
 presumed to have the potential to pro­
duce significant 
sensitisation 
in 
humans. 
Severity of reaction  
may also be
considered.
Sub-category
 1B: Substances
 showing
 a low to moderate frequency of occurren ce
 in
humans 
and/or 
a low to moderate poten cy 
in 
animals 
can 
be 
presumed
to have the poten tial 
to produce sen sitisation 
in 
humans. 
Severity of reac­
tion 
may also b e 
considered.
3.4.2.2.2.
 Human eviden ce
3.4.2.2.2.1. Human 
evidence 
for sub-category 
1A can 
include: 
(a) positive 
responses 
at ≤ 500 µg /cm2 (HRIPT, HMT — in duction threshold);
(b) diagnostic 
patch test data where there is a relatively hig h 
and 
substan
tial incidence 
of reaction s
in 
a defined 
population  
in 
relation 
to relatively low exposure;
(c) other epidemiolog ical 
evidence 
where there is a relatively hig h 
and 
substantial 
incidence 
of
allergic 
contact 
dermatitis in  
relation 
to relatively low exposure.
3.4.2.2.2.2. Human 
evidence 
for sub-category 
1B can 
include: 
(a) positive 
responses 
at > 500 µg /cm2 
(HRIPT, 
HMT — in duction 
threshold);
(b) diagnostic 
patch test data where there is a relatively low b ut 
substant
ial incidence 
of reaction s
in 
a defined 
population  
in 
relation 
to relatively hig h 
exposure;
(c) other epidemiolog ical 
evidence 
where there is a relatively low b ut 
substantial 
incidence 
of aller­
gic 
contact 
dermatitis in  
relation 
to relatively hig h 
exposure.
The use of human  
data is discussed in  
sections 
1.1.1.3, 1.1.1.4 an d 
1.1.1.5.
3.4.2.2.3.  Animal
 studies
3.4.2.2.3.1. For Categ ory 
1, when 
an 
adjuvant 
type test method for sk in 
sensitisation  
is used, a respon se 
of at
least 30 % of the an imals
 is considered
 as positive. For a n on-adjuvant
 Guinea pig test method a
response 
of at least 15 % of the an imals 
is considered 
positive. For Categ or
y 1, a stimulation  
index
of 
three or more is con sidered 
a positive respon se 
in 
the local lymph n ode 
assay. Test methods for
skin 
sensitisation 
are describ ed 
in 
the OECD 
Guideline 
406 (the Guin ea 
Pig 
Maximisation  
test and
the 
Buehler guinea 
pig 
test) and 
Guideline 
429 (Local Lymph Node Assay). Other methods may b e
used 
provided that they are well-validated an d 
scientific 
justification  
is given. 
For example, the mouse
ear swellin g 
test (MEST) 
could be 
a reliable 
screening 
test to detect moderate to stron g 
sensitisers,
and 
could be 
used as a first stag e 
in 
the assessmen t 
of skin 
sensitisation 
potential. Table 3.4.3
nimal
test results
for sub-category
1A
Table 3.4.4
Animal
test results
for sub-category
1B30.3.2011 EN Official Journ alof the EuropeanUnion L 83/15
3.4.2.2.3.2. Animal test results for sub -category  1A can include data with values in dicated in Table 3.4.3 
 
     A
Assay Criteria
Local lymph n ode assay EC3 value ≤ 2 %
Guinea 
pig 
maximisation  
test ≥ 30 % respon ding 
at ≤ 0,1 % in tradermal 
induct
ion
dose or
≥ 60 % respon ding 
at > 0,1 % to ≤ 1 % in tradermal
induction 
dose
Buehler assay ≥ 15 % respon ding 
at ≤ 0,2 % topical in duction 
dose or
≥ 60 % respon ding 
at > 0,2 % to ≤ 20 % topical in duc­
tion 
dose
3.4.2.2.3.3. Animal 
test results for sub -category 
1B can 
include 
data with values in dicated 
in 
Table 
3.4.4 below: 
 
 
    
Assay Criteria
Local lymph n ode assay EC3 value > 2 %
Guinea 
pig 
maximisation  
test ≥ 30 % to < 60 % respon ding 
at > 0,1 % to ≤ 1 % in trad­
ermal 
induction 
dose or
≥ 30 % respon ding 
at > 1 % in tradermal 
induction 
dose
Buehler assay ≥ 15 % to < 60 % respon ding 
at > 0,2 % to ≤ 20 % topi­
cal induction 
dose or
≥ 15 % respon ding 
at > 20 % topical in duction 
dose
3.4.2.2.4.  Specific con siderations
3.4.2.2.4.1. For 
classification  
of a substance, 
evidence 
should include 
any 
or all of the followin g 
using 
a weight
of 
evidence 
approach: 
(a) positive data from patch testin g, 
normally 
obtained 
in 
more than  
one 
dermatolog y 
clinic;
(b) epidemiolog ical 
studies showin g 
allergic 
contact 
dermatitis caused b y 
the substance. 
Situations
in 
which a hig h 
proportion  
of those exposed exhib it 
characteristic symptoms are to b e 
looked
at 
with special con cern, 
even 
if the number 
of cases is small;
(c) positive data from appropriate an imal 
studies;
(d) positive data from experimen tal 
studies in 
man 
(see section  
1.3.2.4.7);
(e) well documen ted 
episodes of allerg ic 
contact 
dermatitis, n ormally 
obtained 
in 
more than  
one
dermatolog y 
clinic;
(f) severity 
of reaction  
may also b e 
considered.L 83/16 EN Official Journ alof the EuropeanUnion 30.3.2011
3.4.2.2.4.2. Evidence from animal studies is usually much more reliab le than evidence from human  exposure.
However, in  
cases where eviden ce 
is available 
from both 
sources, an d 
there is con flict 
between 
the
results, the quality an d
 reliability
 of the eviden ce
 from bo
th sources must b e
 assessed in order to
resolve the question  
of classification  
on 
a case-by-case 
basis. 
Normally, human  
data are n ot 
gener­
ated 
in 
controlled 
experimen ts 
with volun teers 
for the purpose of hazard classification  
but 
rather as
part of risk  
assessmen t 
to confirm 
lack 
of effects seen  
in 
animal 
tests. Consequen tly, 
positive human
data on 
skin 
sensitisation 
are usually derived from case-con trol 
or other, less defin ed 
studies. Evalu­
ation 
of human  
data must therefore b e 
carried out with caution  
as the frequen cy 
of cases reflect, in
addition to the in herent
 properties of the sub stances,
 factors such as the exposure situation ,
 bio
­
availability, 
individual 
predisposition  
and 
preventive 
measures tak en
. Negative 
human 
data should
not 
normally 
be 
used to negate 
positive results from an imal 
studies. For b o
th animal 
and 
human
data, consideration 
should be 
given 
to the impact of vehicle. 
3.4.2.2.4.3. If 
none 
of the abovementioned 
conditions 
are met, the sub sta
nce 
need 
not 
be 
classified as a sk in 
sen­
sitiser. 
However, a comb ination 
of two or more in dicators 
of skin 
sensitis
ation 
as listed b elow 
may
alter the decision . 
This shall b e 
considered 
on 
a case-by-case 
basis. 
(a) Isolated 
episodes of allerg ic 
contact 
dermatitis;
(b) epidemiolog ical 
studies of limited power, e.g . 
where chan ce, 
bias 
or confounders 
have not 
been
ruled 
out fully with reason able 
confidence;
(c) data 
from animal 
tests, performed accordin g 
to existing 
guidelines, 
which do n ot 
meet the cri­
teria for a positive result describ ed 
in 
section 
3.4.2.2.3, b ut 
which are sufficien tly 
close to the
limit to be 
considered 
significant;
(d) positive 
data from n on-standard 
methods;
(e) positive results from close structural an alogues.
3.4.2.2.4.4.
 Immunological
 contact
 urticaria
Substances
 meeting
 the criteria for classification as respiratory sen si
tisers may in addition cause
immunological 
contact 
urticaria. Con sideration 
should be 
given 
to classifyin g 
these substances 
also
as skin 
sensitisers. 
Substances 
which cause immun ological 
cont
act urticaria without meetin g 
the cri­
teria for respiratory sen sitisers 
should also b e 
considered 
for classification  
as skin 
sensitisers.
There 
is no 
recognised 
animal 
model availab le 
to identify 
substances 
which cause immun ological
contact 
urticaria. Therefore, classification  
will normally 
be 
based 
on 
human 
evidence 
which will b e
similar 
to that for sk in 
sensitisation.
(*)At presen t, recognised and validated an imal models for the testin g of respiratory hypersen sitiv­
ity 
are not 
available. 
Under 
certain 
circumstan ces, 
data from an imal 
studies may provide valu­
able 
information 
in 
a weight 
of evidence 
assessmen t.
(**)The mechan isms by which sub stances induce symptoms of asthma are n ot yet fully k nown. For
preventative 
measures, these sub stances 
are considered 
respiratory sensitisers. However, if on
the basis 
of the eviden ce, 
it can 
be 
demonstrated 
that these sub stances 
ind
uce symptoms of
asthma by 
irritation 
only 
in 
people with b ronchial 
hyper reactivity, they should n ot 
be 
consid­
ered 
as respiratory sen sitisers.
’;
(14) in 
section 
3.4.3.3.1 the referen ce 
to ‘Table 
3.4.3’ is replaced b y ‘
Table 
3.4.5’;
(15) section 
3.4.3.3.2 is amen ded 
as follows:
(a) the referen ce 
to ‘Table 
3.4.1’ is replaced b y ‘
Table 
3.4.5’;
(b) the 
reference 
to ‘Table 
3.4.3’ is replaced b y ‘
Table 
3.4.6’;30.3.2011 EN Official Journ alof the EuropeanUnion L 83/17
(c) Table 3.4.3 an d Notes 1, 2 an d  3 are replaced b y the followin g:
‘
Table 3.4.5
Generic concentration limits of components of a mixtu re 
classified as either respiratory
sensitisers or skin sensitisers that trigger classification of the mixture
Component classified as:Generic 
concentration 
limits trig gering 
classification  
of a mixture as:
Respiratory sen sitiser
Category 1Skin sensitiser
Category 1
Solid/liquid Gas All physical states
Respiratory sen sitiser
Category 
1≥ 1,0 % ≥ 0,2 %
Respiratory sen sitiser
Sub-category 
1A≥ 0,1 % ≥ 0,1 %
Respiratory sen sitiser
Sub-category 
1B≥ 1,0 % ≥ 0,2 %
Skin 
sensitiser
Category 
1≥ 1,0 %
Skin 
sensitiser
Sub-category 
1A≥ 0,1 %
Skin 
sensitiser
Sub-category 
1B≥ 1,0 %’
(d) a new 
Table 
3.4.6 is in serted 
after the n ew 
Table 
3.4.5:
‘Table 3.4.6
Concentration limits for elicitation of components of a mixtu re
Component classified as:Concentration 
limits for elicitation
Respiratory sen sitiser
Category 1Skin sensitiser
Category 1
Solid/liquid Gas All physical states
Respiratory sen sitiser
Category 
1≥ 0,1 % (Note 1) ≥ 0,1 % (Note 1)
Respiratory sen sitiser
Sub-category 
1A≥ 0,01 % (Note 1) ≥ 0,01 % (Note 1)
Respiratory sen sitiser
Sub-category 
1B≥ 0,1 % (Note 1) ≥ 0,1 % (Note 1)
Skin 
sensitiser
Category 
1≥ 0,1 % (Note 1)
Skin 
sensitiser
Sub-category 
1A≥ 0,01 % (Note 1)
Skin 
sensitiser
Sub-category 
1B≥ 0,1 % (Note 1)
Note 1:
This concentration
 limit for elicitation is used for the application of the special lab elling
 requiremen ts
 of
Annex 
II 
section 
2.8 to protect already sen sitised 
individuals. 
A SDS is required for the mixture con taining
a
 component
 above
 this concentration.
 For sens
itising substances with specific con centration
 limit lower
than 
0,1 %, the con centration 
limit for elicitation  
should be 
set at one 
tenth of the specific con centration
limit.
’;L 83/18 EN Official Journ alof the EuropeanUnion 30.3.2011
(16) section  3.4.4.1 is replaced b y the followin g:
‘
3.4.4.1.Label 
elements 
shall be 
used for sub stanc
es or mixtures meetin g 
the criteria for classification  
in 
this haz­
ard class in  
accordance 
with Table 
3.4.7.
Table 3.4.7
Respiratory or skin sensitisation label elements
ClassificationRespiratory sen sitisation Skin 
sensitisation
Category 1 and
sub-categories 
1A and 
1BCategory 1 and
sub-categories 
1A and 
1B
GHS pictog rams
Signal 
word Danger Warning
Hazard 
statementH334: 
May cause allerg y 
or
asthma symptoms or
breathing 
difficulties if
inhaledH317: 
May cause an  
allergic
skin 
reaction
Precaution ary 
statement
preventionP261
P285P261P272P280
Precaution
ary 
statement 
responseP304 
+ P341
P342 + P311P302 + P352P333 + P313
P321
P363
Precaution
ary 
statement 
storage
Precaution ary 
statement 
disposal P501 P501’
(17) in 
section 
3.8.3.4.5, the followin g 
sentence 
is added at the en d:
‘
Respiratory tract irritation  
and 
narcotic 
effects are to b e 
evaluated separately in  
accordance 
with the criteria g iven
in 
section 
3.8.2.2. When  
conducting 
classification s 
for these hazards, the con tribution 
of each compon ent 
should
be 
considered 
additive, un less 
there is eviden ce 
that the effects are n ot 
additive.’;
(18) in 
section 
3.9.1.2, the words ‘or mixture’ are added after the word ‘substance
’;
(19) the followin g 
section 
3.10.1.6.2a. is in serted:
‘
3.10.1.6.2a Although 
the definition 
of aspiration  
in 
section 
3.10.1.2 in cludes 
the entry 
of solids in to 
the res­
piratory system, classification  
according 
to point 
(b) 
in 
Table 
3.10.1 for Categ ory 
1 is intended 
to
apply to liquid sub stances 
and 
mixtures on ly.
’;
D. Part 4 of An nex 
I 
to Regulation 
(EC) 
No 1272/2008 is replaced b y 
the followin g 
text:
‘4.  PART 4: E NVIRONMENTAL 
HAZARDS
4.1.  Hazardou s 
to the aqu atic 
environment
4.1.1.  Definitions and general considerations
4.1.1.1.  Definitions
(a) “acute aquatic toxicity” mean s 
the intrinsic 
property of a sub stance 
to be 
injurious 
to an 
aquatic
organism 
in 
a short-term aquatic exposure to that sub stance.30.3.2011 EN Official Journ alof the EuropeanUnion L 83/19
(b) “acute (short-term) hazard” mean s for classification  purposes the hazard of a sub stance or mixture
caused by 
its acute toxicity to an  
organism 
during 
short-term aquatic exposure to that sub stance
or 
mixture.
(c) “availability 
of a substance
” means 
the extent 
to which this sub stance 
becomes 
a soluble 
or disag­
gregate 
species. For metal availab ility, 
the extent 
to which the metal ion  
portion 
of a metal (M° )
compoun d 
can 
disaggregate 
from the rest of the compoun d 
(molecule).
(d) “bioavailability
” or “biological 
availability
” means 
the extent 
to which a sub stance 
is taken 
up by
an
 organism,
 and
 distributed
 to an area within the org anism.
 It
 is depen den
t upon physico-
chemical properties of the sub stance, 
anatomy 
and 
physiolog y 
of the org an
ism, pharmacok inet­
ics, 
and 
route of exposure. Availab ility 
is not 
a prerequisite for b ioavai
lability.
(e) “
bioaccumulation
” means 
the net 
result of uptak e, 
transformation 
and 
elimination 
of a substance
in 
an 
organism 
due to all routes of exposure (i.e. air, water, sedimen t/soi
l and 
food).
(f) “bioconcentration
” means 
the net 
result of uptak e, 
transformation 
and elimin ation 
of a substance
in 
an 
organism 
due to waterb orne 
exposure.
(g) “
chronic 
aquatic toxicity” mean s 
the intrinsic 
property of a sub stanc
e to cause adverse effects to
aquatic org anisms 
during 
aquatic exposures which are determin ed 
in 
relation 
to the life-cycle of
the organism.
(h) “
degradation
” means 
the decomposition  
of organic 
molecules to smaller molecules an d 
eventually
to 
carbon 
dioxide, water an d 
salts.
(i) “ECx” means the effect con centration associated with x% respon se.
(j) “
long-term 
hazard” mean s 
for classification  
purposes the hazard of a sub stance 
or mixture caused
by 
its chronic 
toxicity followin g 
long-term 
exposure in  
the aquatic en vir
onment.
(k) “
no 
observed 
effect con centration 
(NOEC)
” means 
the test con centrati
on 
immediately b elow 
the
lowest tested con centration 
with statistically sig nificant 
adverse effect. The NOE C 
has no 
statisti­
cally significant 
adverse effect compared to the con trol.
4.1.1.2.
 Basic elements
4.1.1.2.0. Hazardous to the aquatic en vironment 
is differen tiated 
into: 
—acute 
aquatic hazard,
—long-term 
aquatic hazard.
4.1.1.2.1. The basic 
elements 
used for classification  
for aquatic en viro
nmental 
hazards are: 
—acute aquatic toxicity,
—chronic 
aquatic toxicity,
—potential 
for or actual b ioaccumulation, 
and
—degradation 
(biotic 
or abiotic) 
for organic 
chemicals.
4.1.1.2.2. Preferably 
data shall b e 
derived usin g 
the standardised 
test methods referred to in  
Article 8(3). I n 
prac­
tice data from other stan dardised 
test methods such as n ational 
methods shall also b e 
used where they
are considered 
as equivalen t. 
Where valid data are availab le 
from non-sta
ndard 
testing 
and 
from non-
testing 
methods, these shall b e 
considered 
in 
classification  
provided they fulfil the requiremen ts 
speci­
fied in 
section 
1 of Annex 
XI 
to Regulation 
(EC) 
No 1907/2006. I n 
general, 
bo
th freshwater an d 
marine
species 
toxicity data are con sidered 
suitable 
for use in 
classification  
provided the test methods used are
equivalent. 
Where such data are n ot 
available 
classification  
shall be 
bas
ed on 
the best 
available 
data. See
also Part 1 of An nex 
I 
to Regulation 
(EC) 
No 1272/2008. L 83/20 EN Official Journ alof the EuropeanUnion 30.3.2011
4.1.1.3.  Other considerations
4.1.1.3.1. Classification  
of substances 
and 
mixtures for en vironmental 
hazards requires the iden tification 
of the
hazards they presen t 
to the aquatic en vironment. 
The aquatic en vironment 
is considered 
in 
terms of the
aquatic org anisms 
that live in  
the water, an d 
the aquatic ecosystem of which they are part. The b asis,
therefore, 
of the iden tification 
of acute (short-term) an d 
long-term 
hazards is the aquatic toxicity of the
substance 
or mixture, althoug h 
this shall b e 
modified b y 
taking 
account 
of further in formation 
on 
the
degradation 
and 
bioaccumulation 
behaviour, 
if appropriate. 
4.1.1.3.2. While the classification  
system applies to all sub stances 
and 
mixtures, it is recog nised 
that for special
cases (e.g. 
metals) the E uropean 
Chemicals Ag ency 
has issued g uidance. 
4.1.2.
 Classification criteria for substances
4.1.2.1. The system for classification  
recognises 
that the in trinsic 
hazard to aquatic org anisms 
is represen ted 
by
both 
the acute an d 
long-term 
hazard of a sub stance. 
For the lon g-term 
hazard, separate hazard categ o­
ries 
are defined 
representing 
a gradation 
in 
the level of hazard iden tifie
d. The lowest of the availab le 
tox­
icity values b etween 
and 
within 
the differen t 
trophic levels (fish, crustacean , 
algae/aquatic 
plants) 
shall
normally
 be
 used to defin e
 the appropriate hazard category(ies). There are circumstan ces,
 however,
when 
a weight 
of evidence 
approach is appropriate. 
4.1.2.2. The core classification  
system for sub stances 
consists 
of one 
acute hazard classification  
category 
and
three 
long-term 
hazard classification  
categories. 
The acute an d 
the long
-term hazard classification  
cat­
egories 
are applied in dependently. 
4.1.2.3. The 
criteria for classification  
of a substance 
in category Acute 1 are defin ed 
on 
the basis 
of acute aquatic
toxicity data on ly
 (EC50 or LC50). The criteria for classification of a sub stance into the categ ories
Chronic 
1 to 3 follow a tiered approach where the first step is to see if availab le 
information 
on 
chronic
toxicity 
merits lon g-term 
hazard classification . 
In 
absence 
of adequate chron ic 
toxicity data, the sub se­
quent 
step is to comb ine 
two types of in formation, 
i.e. acute aquatic toxicity data an d 
environmental
fate 
data (degradability 
and 
bioaccumulation 
data) (see fig ure 
4.1.1). 30.3.2011 EN Official Journ alof the EuropeanUnion L 83/21
Figure 4.1.1
Categories for su bstances 
long-term 
hazardou s 
to the aqu atic 
environment
4.1.2.4. The system also in troduces 
a “safety net
” classification  
(referred to as categ ory 
Chronic 
4) for use when
the data availab le 
do not 
allow classification  
under 
the formal criteria for acute 1 or chron ic 
1 to 3 but
there 
are nevertheless 
some grounds 
for concern 
(see example in  
Table 
4.1.0).
4.1.2.5. Substances
 with acute toxicities b elow
 1 mg/l
 or chron ic
 toxicities below 0,1 mg/l (if n on-rapidly
degradable) 
and 
0,01 mg/l 
(if rapidly deg radable) 
contribute 
as compon en
ts of a mixture to the toxicity
of the mixture even  
at a low con centration 
and 
shall normally 
be 
given 
increased 
weight 
in 
applying
the 
summation  
of classification  
approach (see n ote 
1 of Table 
4.1.0 and 
section 
4.1.3.5.5). 
4.1.2.6. The criteria for classifyin g 
and 
categorising 
substances 
as “hazardous to the aquatic en vironment
” are
summarised in  
Table 
4.1.0.
Table 4.1.0
Classification categories for hazardou s 
to the aqu atic 
environment
(a) Acute (short-term) aquatic hazard
Category Acu te 
1: (Note 1)
96 hr LC50 (for fish) ≤ 1 mg/l and/or
48 
hr EC50 (for crustacea) ≤ 1 mg/l and/or
72 
or 96 hr E rC50 (for algae or other aquatic
plants)≤ 1 mg/l. (Note 2)
(b) Long-term 
aquatic hazard
(i) Non-rapidly 
degradable 
substances 
(Note 3) for which there are adequate chron ic 
toxicity
data availab le
Category 
Chronic 1: (Note 1)
Chronic 
NOEC 
or ECx (for fish) ≤ 0,1 mg/l and/or
Chronic 
NOEC 
or ECx (for crustacea) ≤ 0,1 mg/l and/orL 83/22 EN Official Journ alof the EuropeanUnion 30.3.2011
Chronic NOEC or ECx (for algae or other
aquatic plan ts)≤0,1  mg/l.
Category 
Chronic 2:
Chronic 
NOEC 
or ECx (for fish) > 0,1 to ≤ 1 mg /l and/or
Chronic 
NOEC 
or ECx (for crustacea) > 0,1 to ≤ 1 mg /l and/or
Chronic 
NOEC 
or ECx (for algae or other
aquatic plan ts)> 0,1 to ≤ 1 mg /l.
(ii) Rapidly 
degradable 
substances 
(Note 3) for which there are adequate chron ic 
toxicity data
available
Category 
Chronic 1: (Note 1)
Chronic 
NOEC 
or ECx (for fish) ≤ 0,01 mg /l and/or
Chronic 
NOEC 
or ECx (for crustacea) ≤ 0,01 mg /l and/or
Chronic 
NOEC 
or ECx (for algae or other
aquatic plan ts)≤ 0,01 mg/l.
Category 
Chronic 2:
Chronic 
NOEC 
or ECx (for fish) > 0,01 to ≤ 0,1 mg /l and/or
Chronic 
NOEC 
or ECx (for crustacea) > 0,01 to ≤ 0,1 mg /l and/or
Chronic 
NOEC 
or ECx (for algae or other
aquatic plan ts)> 0,01 to ≤ 0,1 mg /l.
Category 
Chronic 3:
Chronic 
NOEC 
or ECx (for fish) > 0,1 to ≤ 1 mg /l and/or
Chronic 
NOEC 
or ECx (for crustacea) > 0,1 to ≤ 1 mg /l and/or
Chronic 
NOEC 
or ECx (for algae or other
aquatic plan ts)> 0,1 to ≤ 1 mg /l.
(iii) Substances 
for which adequate chron ic 
toxicity data are n ot 
available
Category Chronic 1: (Note 1)
96 hr LC50 (for fish) ≤ 1 mg/l and/or
48 
hr EC50 (for crustacea) ≤ 1 mg/l and/or
72 
or 96 hr E rC50 (for algae or other aquatic
plants)≤ 1 mg/l. (Note 2)
and 
the substance 
is not 
rapidly deg radable 
and/or 
the experimen tally 
determined 
BCF
≥ 500 (or, if ab sent, 
the log 
Kow≥ 4). (Note 3).
Category Chronic 2:96 hr LC
50 (for fish) > 1 to ≤10 mg /l and/or
48 
hr EC50 (for crustacea) > 1 to ≤10 mg /l and/or
72 
or 96 hr E rC50 (for algae or other aquatic
plants)> 1 to ≤10 mg /l (Note 2)
and 
the substance 
is not 
rapidly deg radable 
and/or 
the experimen tally 
determined 
BCF
≥ 500 (or, if ab sent, 
the log 
Kow≥ 4). (Note 3).
Category Chronic 3:
96 hr LC50 (for fish) > 10 to ≤ 100 mg /l and/or
48 
hr EC50 (for crustacea) > 10 to ≤ 100 mg /l and/or
72 
or 96 hr E rC50 (for algae or other aquatic
plants)> 10 to ≤ 100 mg /l. (Note 2)
and 
the substance 
is not 
rapidly deg radable 
and/or 
the experimen tally 
determined 
BCF
≥ 500 (or, if ab sent, 
the log 
Kow≥ 4). (Note 3).
“Safety net
” classification
Category Chronic 4Cases when
 
data do not 
allow classification  
under 
the above 
criteria but 
there are n ever­
theless 
some grounds 
for concern. 
This includes, 
for example, poorly solub le 
substances
for 
which no 
acute toxicity is recorded at levels up to the water solub ility 
(note 
4), and
which 
are not 
rapidly deg radable 
in 
accordance 
with section  
4.1.2.9.5 an d 
have an 
experi­
mentally 
determined 
BCF ≥ 500 (or, if ab sent, 
a log 
Kow ≥ 4), indicating a potential to
bioaccumulate, 
which will b e 
classified in  
this category 
unless 
other scien tific 
evidence
exists 
showing 
classification  
to be 
unnecessary. 
Such eviden ce 
includes 
chronic 
toxicity
NOECs 
> water solub ility 
or > 1 mg /l, 
or other eviden ce 
of rapid deg radation 
in 
the envi­
ronment 
than 
the ones 
provided b y 
any 
of the methods listed in  
section 
4.1.2.9.5.30.3.2011 EN Official Journ alof the EuropeanUnion L 83/23
Note 1:
When 
classifying 
substances 
as Acute Categ ory 
1 and/or 
Chronic 
Category 
1 it is necessary 
at the same
time to in dicate 
the appropriate M-factor(s) (see Tab le 
4.1.3).
Note 2:
Classification  
shall be 
based 
on 
the ErC50 [= EC50 (growth rate)]. In circumstan ces where the b asis of
the EC50 is not specified or n o ErC50 is recorded, classification  shall be based on the lowest E C50
available.
Note 
3:
When 
no 
useful data on  
degradability 
are availab le, 
either experimen tall
y determin ed 
or estimated data,
the substance 
should be 
regarded 
as not 
rapidly deg radable.
Note 
4:
“No acute toxicity” is tak en 
to mean 
that the L(E )C50(s) is/are ab ove the water solub ility. Also for poorly
soluble 
substances, 
(water solub ility 
< 1 mg/l), 
where there is eviden ce 
that the acute test does n ot 
pro­
vide a true measure of the in trinsic 
toxicity.
4.1.2.7.  Aquatic toxicity
4.1.2.7.1. Acute aquatic toxicity is n ormally 
determined 
using 
a fish 96-hour LC50, a crustacea species 48-hour
EC50 and/or an algal  species 72- or 96-hour E C50. These species cover a ran ge of trophic levels an d
taxa 
and 
are considered 
as surrogate 
for all aquatic org anisms. 
Data on 
other species (e.g . 
Lemna 
spp.)
shall also b e 
considered 
if the test methodolog y 
is suitable. 
The aquatic plan t 
growth 
inhibition 
tests are
normally
 considered
 as chron ic
 tests but
 the EC50s are treated as acute values for classification pur­
poses (see n ote 
2). 
4.1.2.7.2. For determin ing 
chronic 
aquatic toxicity for classification  
purposes data g enerated 
according 
to the stan ­
dardised 
test methods referred to in  
Article 8(3) shall b e 
accepted, as well as results ob tained 
from other
validated an d 
internationally 
accepted test methods. The NOE Cs 
or other equivalen t 
ECx (e.g. EC10) shall
be 
used. 
4.1.2.8.  Bioaccumulation
4.1.2.8.1. Bioaccumulation  
of substances 
within 
aquatic org anisms 
can 
give 
rise to toxic effects over lon ger 
time
scales even  
when 
actual water con centrations 
are low. For org anic 
substan
ces the poten tial 
for bioac­
cumulation
 shall normally
 be
 determin ed
 by
 using
 the octan ol/water
 partition coefficien t,
 usually
reported as a log  
Kow. The relation ship between the log Kow of an organic substance and its biocon­
centration 
as measured b y 
the bioconcentration 
factor (BCF) in  
fish has con siderable 
scientific 
literature
support. Usin g 
a cut-off value of log  
Kow ≥ 4 is intended to identify only those sub stances with a real
potential 
to bioconcentrate. 
While this represen ts 
a potential 
to bioacc
umulate, an  
experimentally deter­
mined 
BCF provides a b etter 
measure an d 
shall be 
used in 
preference 
if available. 
A BCF in 
fish of ≥ 500
is indicative 
of the poten tial 
to bioconcentrate 
for classification  
purposes. Some relation ships 
can 
be
observed
 between
 chronic
 toxicity an d
 bioaccumulation
 potential,
 as toxicity is related to the b ody
burden. 
4.1.2.9.
 Rapid degradability of organic substances
4.1.2.9.1. Substances 
that rapidly deg rade 
can 
be 
quickly 
removed from the en vironment. 
While effects of such
substances 
can 
occur, particularly in  
the event 
of a spillag e 
or acciden t, 
they are localised an d 
of short
duration. 
In 
the absence 
of rapid deg radati
on 
in 
the environment 
a substan
ce in 
the water has the poten ­
tial 
to exert toxicity over a wide temporal an d 
spatial scale. 
4.1.2.9.2. One
 way of demon strating
 rapid deg radation
 utilises the b iode
gradation
 screening
 tests desig ned
 to
determine 
whether an  
organic 
substance 
is “readily biodegradable
”. Where such data are n ot 
available,
a 
BOD(5 days)/COD ratio ≥ 0,5 is con sidered 
as indicative 
of rapid deg radat
ion. 
Thus, a sub sta
nce which
passes this screen ing 
test is con sidered 
likely 
to biodegrade “
rapidly” in  
the aquatic en vironment, 
and 
is
thus unlikely 
to be 
persistent. 
However, a fail in  
the screen ing 
test does n ot 
necessarily 
mean 
that the
substance 
will not 
degrade 
rapidly in 
the environment. 
Other eviden ce 
of rapid deg radation 
in 
the envi­
ronment 
may therefore also b e 
considered 
and 
are of particular importan ce 
where the sub stances 
are
inhibitory 
to microb ial 
activity at the con centration 
levels used in  
standard testin g. 
Thus, a further clas­
sification 
criterion 
is included 
which allows the use of data to show that the sub stance 
did actually
degrade 
biotically 
or abiotically 
in 
the aquatic en vironment 
by 
> 70 % in  
28 days. Thus, if deg radation
is 
demonstrated 
under 
environmentally 
realistic con ditions, 
then 
the criterion  
of “rapid deg radability
” is
met.(*)L 83/24 EN Official Journ alof the EuropeanUnion 30.3.2011
4.1.2.9.3. Many degradation data are availab le in the form of deg radation half-lives an d these can be used in  defin­
ing 
rapid degradation 
provided that ultimate b iodegradation 
of the sub st
ance, 
i.e. full min eralisation, 
is
achieved. Primary b iodegradation
 does not
 normally
 suffice in the assessmen t
 of rapid degradability
unless 
it can 
be 
demonstrated 
that the deg radation 
products do n ot 
fulfil the criteria for classification  
as
hazardous to the aquatic en vironment. 
4.1.2.9.4. The 
criteria used reflect the fact that en vironmental 
degrada
tion 
may be 
biotic 
or abiotic. 
Hydrolysis can
be 
considered 
if the hydrolysis products do n ot 
fulfil the criteria for classification  
as hazardous to the
aquatic en vironment. 
4.1.2.9.5. Substances 
are considered 
rapidly deg radable 
in 
the environm
ent 
if one 
of the followin g 
criteria holds
true: 
(a) if, in 
28-day ready b iodegradation 
studies, at least the followin g 
levels of deg radation 
are achieved:
(i) tests based 
on 
dissolved org anic 
carbon: 
70 %;
(ii) tests based 
on 
oxygen 
depletion 
or carbon 
dioxide generation: 
60 % of theoretical maximum.
These levels of b iodegradation 
must be 
achieved within  
10 days of the start of deg radation 
which
point 
is taken 
as the time when  
10 % of the sub stance 
has been 
degraded, 
unles
s the substance 
is
identified 
as an 
UVCB or as a complex, multi-con stituent 
substance 
with structurally similar con ­
stituents. 
In 
this case, an d 
where there is sufficien t 
justification , 
the 10-day win dow 
condition 
may
be 
waived an d 
the pass level applied at 28 days; or
(b) if, 
in 
those cases where on ly 
BOD and 
COD data are availab le, 
when 
the ratio of BOD5/COD is
≥ 0,5; or
(c) if other con vincing 
scientific 
evidence 
is availab le 
to demon strate 
that the sub stance 
can 
be
degraded 
(biotically 
and/or 
abiotically) 
in 
the aquatic en vironment 
to a level > 70 % within  
a
28-day period.
4.1.2.10.  Inorganic compounds and metals
4.1.2.10.1. For inorganic 
compoun ds 
and 
metals, the con cept 
of degradabi
lity as applied to org anic 
compoun ds
has 
limited or n o 
meaning. 
Rather, such sub stances 
may be 
transformed 
by 
no
rmal environmental 
pro­
cesses to either in crease 
or decrease the b ioavailability 
of the toxic species. E qually 
the use of b ioaccu­
mulation 
data shall b e 
treated with care .
(*)Specific g uidance has been issued by the European Chemicals Ag ency on how these data for such
substances 
may be 
used in 
meeting 
the requiremen ts 
of the classification  
criteria.
4.1.2.10.2. Poorly solub le 
inorganic 
compoun ds 
and 
metals may b e 
acutely or chron ically 
toxic in 
the aquatic en vi­
ronment 
depending 
on 
the intrinsic 
toxicity of the b ioavailable 
inorgani
c species an d 
the rate an d
amount 
of this species which en ter 
solution. 
All eviden ce 
must be 
weighed 
in 
a classification  
decision.
This 
would be 
especially true for metals showin g 
borderline 
results in 
the Transformation/Dissolution
Protocol. 
4.1.3.
 Classification criteria for mixtures
4.1.3.1. The classification  
system for mixtures covers all classification  
categories 
which are used for sub stances,
i.e. 
categories 
Acute 1 an d 
Chronic 
1 to 4. In 
order to mak e 
use of all available data for purposes of
classifying 
the aquatic en vironmental 
hazards of the mixture, the followin g 
is applied where appropriate: 
The “relevant 
components
” of a mixture are those which are classified “Acute 1”or “Chronic 
1” and
present 
in 
a concentration 
of 0,1 % (w/w) or g reater, 
and 
those which are classified “Chronic 
2”, “Chronic
3
” or “Chronic 
4” and 
present 
in 
a concentration 
of 1 % (w/w) or g reater, 
unle
ss there is a presumption
(such as in  
the case of hig hly 
toxic compon ents 
(see section  
4.1.3.5.5.5)) that a compon ent 
present 
in
a lower con centration 
can 
still be 
relevant 
for classifyin g 
the mixture for aquatic en vironmental 
haz­
ards. Generally, 
for substances 
classified as “Acute 1” or “Chronic 
1” the con centration 
to be 
taken 
into
account 
is (0,1/M) %. (For explan ation 
M-factor see section  
4.1.3.5.5.5.)30.3.2011 EN Official Journ alof the EuropeanUnion L 83/25
4.1.3.2. The approach for classification  of aquatic en vironmental hazards is tiered, an d is dependent upon the
type of information 
available 
for the mixture itself an d
 for its compon ent
s. Figure 
4.1.2 outlin es 
the pro­
cess to be 
followed. 
Elements 
of the tiered approach in clude: 
—classification  
based 
on 
tested mixtures,
—classification  
based 
on 
bridging 
principles,
—the 
use of “summation  
of classified compon ents
” and/or 
an “
additivity formula”.
Figure 4.1.2
Tiered approach to classification of mixtu res 
for acute 
and long- term 
aquatic environmental
hazards
4.1.3.3.  Classification of mixtures when toxicity data are available for the complete mixture
4.1.3.3.1. When 
the mixture as a whole has b een 
tested to determin e 
its aquatic toxicity, this in formation 
can 
be
used 
for classifyin g 
the mixture accordin g 
to the criteria that have b een 
agreed 
for substances. 
The clas­
sification is n ormally
 based
 on the data for fish, crustacea an d
 algae/pla
nts
 (see section s
 4.1.2.7.1
and 
4.1.2.7.2). When  
adequate acute or chron ic 
toxicity data for the mixture as a whole are lack ing,
“
bridging 
principles
” or “summation  
method” should b e 
applied (see section s 
4.1.3.4 an d 
4.1.3.5).
4.1.3.3.2. The long-term 
hazard classification  
of mixtures requires addition al 
information 
on 
degradability 
and 
in
certain cases b ioaccumulation.
 Degradability
 and
 bioaccum
ulation tests for mixtures are n ot
 used as
they are usually difficult to in terpret, 
and 
such tests may b e 
meaningful 
only 
for single 
substances. 
4.1.3.3.3.
 Classification for categ ory
 Acute 1
(a) When 
there are adequate acute toxicity test data (LC50 or EC50) available for the mixture as a whole
showing 
L(E)C50 ≤ 1 mg/l:
Classify 
mixture as Acute 1 in  
accordance 
with poin t 
(a) of Tab le 
4.1.0.L 83/26 EN Official Journ alof the EuropeanUnion 30.3.2011
(b) When  there are acute toxicity test data (LC50(s) or EC50(s)) availab le for the mixture as a whole
showing 
L(E)C50(s) > 1 mg /l for normally all trophic levels:
No 
need 
to classify for acute hazard.
4.1.3.3.4.  Classification for categ ories
 Chron ic
 1, 2 and  3
(a) When 
there are adequate chron ic 
toxicity data (E Cxx or NOEC) available for the mixture as a whole
showing 
ECx or NOEC of the tested mixture ≤ 1mg /l:
(i) Classify 
the mixture as Chron ic 
1, 2 or 3 in  
accordance 
with poin t 
(b)(ii
) of Table 
4.1.0 as
rapidly deg radable 
if the availab le 
information 
allows the con clusion 
that all relevan t 
com­
ponents 
of the mixture are rapidly deg radable;
(ii)
 Classify the mixture as Chron ic
 1 or 2 in all other cases in accordan ce
 with poin t
 (b)(i)
 of
Table 
4.1.0 as n on-rapidly 
degradable;
(b) When 
there are adequate chron ic 
toxicity data (E Cx or NOEC) available for the mixture as a whole
showing 
ECx(s) or NOE C(s) of the tested mixture > 1 mg /l for normally all trophic levels:
No 
need 
to classify for lon g-term 
hazard in 
categories 
Chronic 
1, 2 or 3.
4.1.3.3.5.  Classification for categ ory
 Chron ic
 4
If 
there are n evertheless 
reasons 
for concern:
Classify 
the mixture as Chron ic 
4 (safety n et 
classification ) 
in 
accordance with Tab le 
4.1.0.
4.1.3.4.  Classification of mixtures when toxicity data are not available for the complete mixture: bridging principles
4.1.3.4.1. Where the mixture itself has n ot 
been 
tested to determin e 
its aquatic en vironmental 
hazard, but 
there
are sufficien t 
data on 
the individual 
components 
and 
similar tested mixtures to adequately characterise
the hazards of the mixture, this data shall b e 
used in 
accordance 
with the b r
idging 
rules set out in  
sec­
tion 1.1.3. However, in relation to application of the b ridging
 rule for dilution ,
 sections 4.1.3.4.2
and 
4.1.3.4.3 shall b e 
used. 
4.1.3.4.2. Dilution: 
if a mixture is formed b y 
diluting 
another tested mixture or a sub stance 
classified for its aquatic
environmental 
hazard with a diluen t 
which has an  
equivalent 
or lower aquatic hazard classification  
than
the least toxic orig inal 
component 
and 
which is n ot 
expected to affect the aquatic hazards of other com­
ponents, 
then 
the resultin g 
mixture may b e 
classified as equivalen t 
to the orig inal 
tested mixture or sub ­
stance. 
Alternatively, 
the method explain ed 
in 
section 
4.1.3.5 may b e 
applied. 
4.1.3.4.3. If 
a mixture is formed b y 
diluting 
another 
classified mixture or sub stance 
with water or other totally
non-toxic 
material, the toxicity of the mixture can  
be 
calculated from the orig inal 
mixture or sub stance. 
4.1.3.5.
 Classification of mixtures when toxicity data are available for some or all components of the mixture
4.1.3.5.1. The classification of a mixture is b ased
 on summation of the concen tration
 of its classified compo­
nents. 
The percen tage 
of compon ents 
classified as “Acute” or “Chronic
” is fed straig ht 
in 
to the sum­
mation 
method. Details of the summation  
method are describ ed 
in 
section 
4.1.3.5.5.∑Ci
L(E)C50m=∑
nCi
L(E)C50i
∑Ci+∑Cj
EqNOECm=∑
nCi
NOECi+∑
nCj
0,1×NOE Cj30.3.2011 EN Official Journ alof the EuropeanUnion L 83/27
4.1.3.5.2. Mixtures can b e  made of a comb ination  of both  components  that are classified (as Acute 1 an d/or
Chronic 
1, 2, 3, 4) an d 
others for which adequate toxicity test data is availab le. 
When 
adequate toxicity
data are availab le 
for more than  
one 
component 
in 
the mixture, the comb ined 
toxicity of those com­
ponents 
is calculated usin g 
the followin g 
additivity formulas (a) or (b ), 
depending 
on 
the nature 
of the
toxicity data: 
(a) Based on 
acute aquatic toxicity:
where:
Ci =concentration of compon ent i (weight percentage);
L(E)C50i =(mg/l) LC50 or EC50 for compon ent i;
η =number 
of compon ents, 
and 
i is running 
from 1 to n ;
L(E)C50m =L(E) C50 of the part of the mixture with test data.
The calculated toxicity may b e 
used to assig n 
that portion  
of the mixture an  
acute hazard categ ory
which 
is then 
subsequently 
used in 
applying 
the summation  
method;
(b) Based 
on 
chronic 
aquatic toxicity:
where:C
i =concentration of compon ent i (weight percentage) covering the rapidly deg rad­
able 
components;
Cj =concentration 
of compon ent 
j (weight 
percentage) 
covering 
the non- 
rapidly
degradable 
components;
NOECi =NOEC 
(or other recog nised 
measures for chron ic 
toxicity) for compon ent 
i
covering 
the rapidly deg radable 
components, 
in 
mg/l;
NOECj =NOEC 
(or other recog nised 
measures for chron ic 
toxicity) for compon ent 
j
covering 
the non-rapidly 
degradable 
components, 
in 
mg/l;
n =number 
of compon ents, 
and 
i and 
j are running 
from 1 to n ;
EqNOECm =Equivalent 
NOEC 
of the part of the mixture with test data.
The equivalen t 
toxicity thus reflects the fact that n on-rapidly 
degrading 
substances 
are classified
one 
hazard categ ory 
level more “severe” than  
rapidly deg rading 
substance
s.
The calculated equivalen t 
toxicity may b e 
used to assig n 
that portion  
of the mixture a lon g-term
hazard 
category, 
in 
accordance 
with the criteria for rapidly deg radable 
substances 
(point 
(b)(ii) 
of
Table 
4.1.0), which is then  
subsequently 
used in 
applying 
the summation  
method.
4.1.3.5.3. When 
applying 
the additivity formula for part of the mixture, it is preferab le 
to calculate the toxicity of
this part of the mixture usin g 
for each sub stance 
toxicity values that relate to the same taxon omic 
group
(i.e. 
fish, crustacean , 
algae 
or equivalen t) 
and 
then 
to use the hig hest 
toxicity (lowest value) ob tained 
(i.e.
use the most sen sitive 
of the three taxon omic 
groups). 
However, when  
toxicity data for each compo­
nent 
are not 
available 
in 
the same taxon omic 
group, 
the toxicity value of each compon ent 
is selected in
the same man ner 
that toxicity values are selected for the classification  
of substances, 
i.e. the hig her 
tox­
icity (from the most sen sitive 
test organism) 
is used. The calculated acute an d 
chronic 
toxicity is then
used to assess whether this part of the mixture shall b e 
classified as Acute 1 an d/or 
Chronic 
1, 2 or 3
using 
the same criteria describ ed 
for substances. L 83/28 EN Official Journ alof the EuropeanUnion 30.3.2011
4.1.3.5.4. If a mixture is classified in  more than  one way, the method yieldin g the more con servative result shall
be 
used. 
4.1.3.5.5.  Summation method
4.1.3.5.5.1.  Rationale
4.1.3.5.5.1.1. In 
case of the sub stance 
classification  
categories 
Chronic 1 to Chron ic 
3, the underlying 
toxicity criteria
differ by 
a factor of 10 in  
moving 
from one 
category 
to another. 
Substances 
with a classification  
in 
a
high 
toxicity band 
therefore con tribute 
to the classification  
of a mixture in  
a lower band. 
The calcula­
tion 
of these classification  
categories 
therefore n eeds 
to consider 
the contribution 
of any 
substance 
clas­
sified as Chron ic 
1, 2 or 3. 
4.1.3.5.5.1.2. When 
a mixture con tains 
components 
classified as Acute 1 or Chron ic 
1, attention 
must be 
paid to the
fact that such compon ents, 
when 
their acute toxicity is b elow 
1 mg/l 
and/or 
chronic 
toxicity is b elow
0,1 
mg/l 
(if non 
rapidly deg radable) 
and 
0,01 mg/l 
(if rapidly deg radable) 
contribute 
to the toxicity of
the mixture even  
at a low con centration. 
Active ingredients 
in 
pesticides often  
possess such high aquatic
toxicity but 
also some other sub stances 
like 
organometallic 
compoun ds. 
Under 
these circumstan ces 
the
application  
of the normal 
generic 
concentration 
limits leads to an  “
under
-classification ” of the mixture.
Therefore, multiplyin g 
factors shall b e 
applied to accoun t 
for highly 
toxic compon ents, 
as describ ed 
in
section 
4.1.3.5.5.5.
4.1.3.5.5.2.  Classification procedure
4.1.3.5.5.2.1. In 
general 
a more severe classification  
for mixtures overrides a less severe classification , 
e.g. 
a classifi­
cation 
with Chron ic 
1 overrides a classification  
with Chron ic 
2. As a con se
quence, 
in 
this example, the
classification  
procedure is already completed if the result of the classification  
is Chroni
c 1. A more severe
classification  
than 
Chronic 
1 is not 
possible. 
Therefore it is n ot 
necessa
ry to undergo 
the further clas­
sification 
procedure. 
4.1.3.5.5.3.  Classification for category Acute 1
4.1.3.5.5.3.1. First all compon ents 
classified as Acute 1 are con sidered. 
If 
the sum of the con centrations 
(in 
%) of these
components 
multiplied b y 
their correspon ding 
M-factors is g reater 
than 
25 % the whole mixture is clas­
sified as Acute 1. 
4.1.3.5.5.3.2. The classification  
of mixtures for acute hazards b ased 
on 
this summation  
of classified compon ents 
is
summarised in  
Table 
4.1.1. 
Table 4.1.1
Classification of a mixtu re 
for acute 
hazards, based on su mmation 
of classified components
Sum of compon ents classified as: Mixture is classified as:
Acute  1  ×  M   (a) ≥ 25 % Acute 1
(a)For explan ation of the M-factor, see 4.1.3.5.5.5.
4.1.3.5.5.4.  Classification for the categories Chronic 1, 2, 3 and  4
4.1.3.5.5.4.1. First all compon ents 
classified as Chron ic 
1 are consider
ed. If 
the sum of the con centrations 
(in 
%) of
these compon ents 
multiplied b y 
their correspondin g 
M-factors is equal to or g reater 
than 
25 %, the mix­
ture is classified as Chron ic 
1. If 
the result of the calculation  
is a classification  
of the mixture as Chron ic
1, 
the classification  
procedure is completed. 
4.1.3.5.5.4.2. In 
cases where the mixture is n ot 
classified as Chron ic 
1, classification  
of the mixture as Chron ic 
2 is
considered. 
A mixture is classified as Chron ic 
2 if 10 times the sum of the con centrations 
(in 
%) of all
components
 classified as Chron ic
 1 multiplied b y
 their correspon ding
 M-factors plus the sum of the
concentrations 
(in 
%) of all compon ents 
classified as Chron ic 
2 is equal to or g reater 
than 
25 %. If 
the
result of the calculation  
is classification  
of the mixture as Chron ic 
2, the classification  
process is
completed. 30.3.2011 EN Official Journ alof the EuropeanUnion L 83/29
4.1.3.5.5.4.3. In cases where the mixture is n ot classified either as Chron ic 1 or Chron ic 2, classification  of the mix­
ture as Chron ic 
3 is considered. 
A mixture is classified as Chron ic 
3 if 100 times the sum of the con ­
centrations 
(in 
%) of all compon ents 
classified as Chron ic
 1 multiplied b y 
their correspon ding 
M-factors
plus 10 times the sum of the con centrations 
(in 
%) of all compon ents 
classified with Chron ic 
2 plus the
sum of the con centrations 
(in 
%) of all compon ents 
classified as Chron ic 
3 is  ≥  2 5  % .  
4.1.3.5.5.4.4. If 
the mixture is still n ot 
classified in  
Chronic 
1, 2 or 3, classification  
of the mixture as Chron ic 
4 shall
be 
considered. 
A mixture is classified as Chron ic 
4 if the sum of the con cent
rations 
(in 
%) of compo­
nents 
classified as Chron ic 
1, 2, 3 an d 
4 is equal to or g reater 
than 
25 %. 
4.1.3.5.5.4.5. The classification  
of mixtures for lon g-term 
hazards, b a
sed on 
this summation  
of the con centrations 
of
classified compon ents, 
is summarised in  
Table 
4.1.2. 
Table 4.1.2
Classification of a mixtu re 
for long-term 
hazards, based on su mmation 
of the concentrations
of classified components
Sum of compon ents classified as: Mixture is classified as:
Chronic  1  ×  M  (a) ≥ 25 % Chronic 1
(M × 10 × Chron ic 
1) + Chron ic
 2  ≥  2 5   % Chronic 
2
(M × 100 × Chron ic 
1) + (10 × Chron ic 
2) + Chron ic
 3  ≥  2 5   % Chronic 
3
Chronic 
1 + Chron i
c 2 + Chron i
c 3 + Chron ic
 4  ≥  2 5   % Chronic 
4
(a)For explan ation of the M-factor, see 4.1.3.5.5.5.
4.1.3.5.5.5.  Mixtures with highly toxic components
4.1.3.5.5.5.1. Acute 1 an d
 Chronic
 1 compon ents
 with toxicities b elow
 1 mg/l an d/or
 chronic
 toxicities b elow
0,1 
mg/l 
(if non-rapidly 
degradable) 
and 
0,01 mg/l 
(if rapidly deg radable
) contribute 
to the toxicity of
the mixture even  
at a low con centration 
and 
shall normally 
be 
given 
increas
ed weight 
in 
applying 
the
summation of classification approach. When a mixture con tains
 component
s classified as Acute or
Chronic 
1, one 
of the followin g 
shall be 
applied: 
—the tiered approach describ ed 
in 
sections 
4.1.3.5.5.3 an d 
4.1.3.5.5.4 usin g
 a weighted 
sum by 
mul­
tiplying 
the concentrations 
of Acute 1 an d 
Chronic 
1 compon ents 
by 
a factor, in stead 
of merely
adding 
up the percen tages. 
This mean s 
that the con centration 
of “Acute 1” in  
the left column  
of
Table 
4.1.1 and 
the concentration 
of “Chronic 
1” in 
the left column  
of Table 
4.1.2 are multiplied
by 
the appropriate multiplyin g 
factor. The multiplyin g 
factors to b e 
applied to these compon ents
are 
defined 
using 
the toxicity value, as summarised in  
Table 
4.1.3. Therefore, in  
order to classify a
mixture con taining 
Acute/Chron ic 
1 compon ents, 
the classifier n eeds 
to be informed 
of the value
of the M-factor in  
order to apply the summation  
method,
—the additivity formula (see section  
4.1.3.5.2) provided that toxicity data are availab le 
for all hig hly
toxic
 components
 in the mixture an d
 there is con vincing
 evidence
 that all other compon ents,
including 
those for which specific acute an d/or 
chronic 
toxicity data are n ot 
available, 
are of low
or no 
toxicity an d 
do not 
significantly 
contribute 
to the environmental 
hazard of the mixture.L 83/30 EN Official Journ alof the EuropeanUnion 30.3.2011
Table 4.1.3
Multiplying 
factors for highly toxic components of mixtu res
Acute toxicity M factor Chronic toxicity M factor
L(E)C50 value mg/l NOEC value mg/lNRD
 (a)
componentsRD  (b)
components
0,1 < L(E)C50 ≤ 1 1 0,01 < NOE C ≤ 0,1 1 —
0,01 < L(E )C50 ≤ 0,1 10 0,001 < NOE C ≤ 0,01 10 1
0,001 < L(E )C50 ≤ 0,01 100 0,0001 < NOE C ≤ 0,001 100 10
0,0001 < L(E )C50 ≤ 0,001 1 000 0,00001 < NOE C
≤ 
0,00011 000 100
0,00001 < L(E )C50 ≤ 0,0001 10 000 0,000001 < NOE C
≤ 
0,0000110 000 1 000
(continue 
in 
factor 10 in tervals) (continue 
in 
factor 10 in tervals)
(a)Non-rapidly degradable.
(b)Rapidly deg radable.
4.1.3.6.  Classification of mixtures with components without any useable information
4.1.3.6.1. In 
the event 
that no 
useable 
information 
on 
acute and/or 
long-t
erm aquatic hazard is availab le 
for one
or
 more relevan t
 components,
 it is concluded
 that the mixture can not
 be
 attributed
 to one
 or more
definitive 
hazard categ ory(ies). 
In 
this situation  
the mixture shall b e 
classified b ased 
on 
the known 
com­
ponents 
only, 
with the addition al 
statement 
on 
the label 
and 
in 
the SDS that: “Contains 
x % of compo­
nents 
with unknown 
hazards to the aquatic en vironment
”.
4.1.4.  Hazard communication
4.1.4.1. Label 
elements 
shall be 
used for sub stances
 or mixtures meetin g 
the criteria for classification  
in 
this haz­
ard class in  
accordance 
with Table 
4.1.4. 
Table 4.1.4
Label elements for hazardou s 
to the aqu atic 
environment
ACUTE AQUATI C HAZARD
Acute 
1
GHS pictog ram
Signal 
word Warning
Hazard 
statement H400: 
Very toxic to aquatic life
Precaution ary 
statement 
prevention P273
Precaution ary 
statement 
response P391
Precaution ary 
statement 
storage
Precaution ary 
statement 
disposal P501(*)30.3.2011 EN Official Journ alof the EuropeanUnion L 83/31
LONG-TE RM AQUATI C HAZARD
Chronic 
1 Chronic 
2 Chronic 
3 Chronic 
4
GHS pictog rams No pictogram
is 
usedNo pictog ram
is 
used
Signal 
word Warning No 
signal 
word
is usedNo signal 
word
is usedNo signal 
word
is used
Hazard statemen tH410: 
Very toxic
to aquatic life
with long 
lasting
effectsH411: 
Toxic to
aquatic life with
long 
lasting
effectsH412: 
Harmful
to aquatic life
with long 
lasting
effectsH413: 
May cause
long 
lasting
harmful 
effects
to aquatic life
Precaution ary
statement
preventionP273 P273 P273 P273
Precaution ary
statement
responseP391 P391
Precaution ary
statement 
storage
Precaution ary
statement 
disposalP501 P501 P501 P501’
E. Part 
5 of Annex 
I 
to Regulation 
(EC) 
No 1272/2008 is replaced b y 
the followin g 
text:
‘5. PART 5: ADDI TIONAL 
HAZARDS
5.1. Hazardou s 
to the ozone layer
5.1.1. Definitions and general considerations
5.1.1.1. Ozone 
depleting 
potential 
(ODP) is an  
integrative 
quantity, 
distinct 
for each halocarb on 
source species, that
represents
 the exten t
 of ozone
 depletion in the stratosphere expected from the halocarb on
 on a mass-for-
mass basis 
relative to CFC-11. The formal defin ition 
of ODP is the ratio of in tegrated 
perturbations 
to total
ozone, 
for a differen tial 
mass emission  
of a particular compoun d 
relative to an  
equal emission  
of CFC-11. 
Substance 
hazardous to the ozon e 
layer mean s 
a substance 
which, on  
the basi
s of the availab le 
evidence 
con­
cerning 
its properties an d 
its predicted or ob served 
environmental 
fate and 
behaviour 
may presen t 
a danger
to 
the structure an d/or 
the functioning 
of the stratospheric ozon e 
layer. This in cludes 
substances 
which are
listed in 
Annex 
I 
to Regulation 
(EC) 
No 1005/2009 of the E uropean 
Parliament an d 
of the Coun cil 
of 16 Sep­
tember 
2009 on 
substances 
that deplete the ozon e 
layer.
5.1.2. Classification criteria for substances
5.1.2.1. A substance 
shall be 
classified as hazardous to the ozon e 
layer (Categ ory 
1) if the availab le 
evidence 
concern­
ing 
its properties an d 
its predicted or ob served 
environmental 
fate and 
be
haviour in dicate 
that it may presen t
a 
danger 
to the structure an d/or 
the functioning 
of the stratospheric ozone layer. L 83/32 EN Official Journ alof the EuropeanUnion 30.3.2011
5.1.3. Classification criteria for mixtures
5.1.3.1. Mixtures shall b e 
classified as hazardous to the ozon e 
layer (Categ ory 
1) on 
the basis 
of the individual 
con­
centration 
of the sub stance(s) 
contained 
therein 
that are also classified as hazardous to the ozon e 
layer (Cat­
egory 
1), in 
accordance 
with Table 
5.1. 
Table 5.1
Generic concentration limits for su bstances 
(in a mixtu re), 
classified as hazardou s 
to the ozone
layer (Category 1), that trigger classification of the mixtu re 
as hazardou s 
to the ozone layer
(Category 1)
Classification  of the sub stance Classification  of the mixture
Hazardous to the ozon e layer (Categ ory 1) C ≥ 0,1 %
5.1.4. Hazard communication
5.1.4.1. Label 
elements 
shall be 
used for sub stances 
or mixtures meetin g 
the criteria for classification  
in 
this hazard
class in 
accordance 
with Table 
5.2. 
Table 5.2
Label elements for hazardou s 
to the ozone layer
Symbol/pictogram
Signal 
word Warning
Hazard 
statementH420: 
Harms pub lic 
health and 
the environment 
by 
destroying 
ozone
in 
the upper atmosphere
Precaution ary 
statements P502
(*)OJ L 286, 31.10.2009, p. 1.’.30.3.2011 EN Official Journ alof the EuropeanUnion L 83/33
ANNEX II
Annex 
II 
to Regulation 
(EC) 
No 1272/2008 is amen ded 
as follows:
(1) Part 2 is amen ded 
as follows:
(a) section 
2.8 is replaced b y 
the followin g:
‘
2.8. Mixtures 
containing at least one sensitising su bstance
The 
label 
on 
the packaging 
of mixtures n ot 
classified as sen sitising 
but 
containing 
at least on e 
substance
classified 
as sensitising 
and 
present 
in 
a concentration 
equal to or g reat
er than 
that specified in  
Table 
3.4.6
of Annex 
I 
shall bear 
the statemen t:
EUH208 
— “Contains 
(name 
of sensitising 
substance). 
May produce an  
allergic reaction ”.
Mixtures classified as sen sitising 
containing 
other substan c
e(s) classified as sen sitising 
(in 
addition 
to the one
that 
leads to the classification  
of the mixture) an d 
present 
in 
a concentra
tion 
equal to or g reater 
than 
that
specified in  
Table 
3.4.6 of An nex 
I 
shall bear 
the name(s) 
of that/those substan ce(s) 
on 
the label.
’;
(b) in 
section 
2.10, the first in dent 
is replaced b y 
the followin g:
‘
—≥ 0,1 % of a sub stance 
classified as sk in 
sensitiser 
category 
1, 1B, respiratory sen sitiser 
category 
1, 1B, or car­
cinogenic 
category 
2, or
— ≥ 0,01 % of a sub stance 
classified as sk in 
sensitiser 
category 
1A, respiratory sen sitiser 
category 
1A, or
— ≥ one 
tenth 
of the specific con centration 
limit for a sub stance 
classified as sk in 
sensitiser 
or respiratory sen ­
sitiser 
with specific con centration 
limit lower than  
0,1 %, or’;
(2) in 
Part 3, section  
3.2.2.1, is replaced b y 
the followin g:
‘
3.2.2.1. This provision  
does not 
apply to aerosols which are on ly 
classified an d 
labelled 
as “flammab le 
aerosols, Cat­
egory 
1” or “flammab le 
aerosols, Categ ory 
2”. It 
does not 
apply either to tran sportable 
gas 
receptacles.’.L 83/34 EN Official Journ alof the EuropeanUnion 30.3.2011
ANNEX III
Annex 
III 
to Regulation 
(EC) 
No 1272/2008 is amen ded 
as follows:
(1) Part 1 shall b e 
amended 
as follows:
(a) the introductory 
sentence 
is replaced b y 
the followin g:
‘
The hazard statemen ts 
shall be 
applied in  
accordance 
with Parts 2, 3, 4 an d 
5 of Annex 
I.
In 
selecting 
the hazard statemen ts 
in 
accordance 
with Articles 21 an d 
27, suppliers may use the comb ined 
hazard
statements 
provided for in  
this Annex.
In 
accordance 
with Article 27 the followin g 
principles 
of preceden ce 
for hazard statemen ts 
may apply to lab elling:
(a) if 
the hazard statemen t 
H410 “Very toxic to aquatic life with lon g 
lasting 
effects” is assig ned, 
the statemen t
H400 “
Very toxic to aquatic life” may b e 
omitted;
(b) if 
the statemen t 
H314 “Causes severe sk in 
burns 
and 
eye damag e
” is assign ed, 
the statemen t 
H318 “Causes
serious eye damag e
” may be 
omitted.
In 
order to in dicate 
the route of admin istration 
or exposure the comb ined 
hazard statemen ts 
in 
Table 
1.2 may b e
used.
’;
(b) in 
Table 
1.1, the footn ote 
to code H200 is deleted;
(c) Table 
1.2 is amen ded 
as follows:
(i) in 
Code H317, the title of the 3rd column is replaced b y the followin g:
‘
3.4 — Sen sitisation 
— Skin, 
hazard categ ory 
1, 1A, 1B’;
(ii) in 
Code H334, the title of the 3rd column is replaced b y the followin g:
‘
3.4 — Sen sitisation 
— Respiratory, hazard categ ory 
1, 1A, 1B’;
(iii) the followin g 
combined 
hazard statemen ts 
are added to the Tab le 
after Code H373:
H300
+
H310Language 3.1 
— Acute toxicity (oral) an d 
acute toxicity (dermal), hazard categ ory 
1, 2
‘BG Смъртоносен при поглъ щане или при к онтакт с кожата
ESMortal 
en 
caso de in gestión 
o en 
contacto 
con 
la piel
CSPři požití n ebo 
při styku 
s kůží 
může způsob it 
smrt
DA Livsfarlig 
ved indtagelse 
eller hudk ontakt
DELebensgefahr 
bei 
Verschluck en 
oder Hautk ontakt
ETAllaneelamisel 
või nahale 
sattumisel surmav
ELΘανατηφόρο 
σε 
περίπτωση 
κατάποσης 
ή σε 
επαφή 
με 
το 
δέρμα
ENFatal 
if swallowed or in  
contact 
with skin
FRMortel 
par ingestion 
ou par con tact 
cutané
GAÁbhar 
marfach é seo má shlog tar 
é nó 
má theagmhaíonn 
leis an 
gcraiceann
ITMortale 
in 
caso di in gestion
e o a contatto 
con 
la pelle
LVVar izraisīt n āvi, 
ja norīts 
vai saskaras 
ar ādu
LTMirtina 
prarijus arb a 
susilietus su oda
HULenyelve 
vagy 
bőrrel 
érintkezve 
halálos
MTFatali jekk 
tinbela’ 
jew tmiss mal-ġ ilda
NLDodelijk 
bij 
inslikken 
en 
bij 
contact 
met de huidH300
+
H310Language
3.1 — Acute toxicity (oral) an d
acute toxicity (dermal), hazard categ ory
1, 230.3.2011 EN Official Journ alof the EuropeanUnion L 83/35
PLGrozi śmiercią po połk nięciu lub w kontakcie ze skórą
PTMortal 
por ingestão 
ou contacto 
com a pele
ROMortal în 
caz de înghiţire 
sau în 
contact 
cu pielea
SKPri požití aleb o 
styku 
s kožou 
môže spôsob iť 
smrť
SLSmrtno 
pri zaužitju ali v stik u 
s kožo
FITappavaa 
nieltynä 
tai joutuessaan  
iholle
SVDödligt 
vid förtärin g 
eller vid hudk ontakt
H300
+
H330Language 3.1 
— Acute toxicity (oral) an d 
acute toxicity (in halation), 
hazard categ ory 
1, 2
BGСмъртоносен при поглъ щане или при вдишван е
ESMortal 
en 
caso de in gestión 
o inhalación
CSPři 
požití nebo 
při vdechován í 
může způsob it 
smrt
DA Livsfarlig 
ved indtagelse 
eller indånding
DELebensgefahr 
bei 
Verschluck en 
oder Einatmen
ETAllaneelamisel 
või sissehin gamisel 
surmav
ELΘανατηφόρο 
σε 
περίπτωση 
κατάποσης 
ή σε 
περίπτωση 
εισπνοής
ENFatal 
if swallowed or if in haled
FRMortel 
par ingestion 
ou par inhalation
GAÁbhar 
marfach é seo má shlog tar 
nó 
má ionanálaítear 
é
ITMortale 
se ingerito 
o inalato
LVVar 
izraisīt nāvi, 
ja norīts 
vai iekļūst 
elpceļos
LTMirtina 
prarijus arb a 
įkvėpus
HULenyelve 
vagy 
belélegezve 
halálos
MTFatali jekk 
tinbela’ 
jew tittieħed b in-nifs
NLDodelijk 
bij 
inslikken 
en 
bij 
inademing
PLGrozi 
śmiercią po połk nięciu 
lub 
w następstwie 
wdychania
PTMortal 
por ingestão 
ou inalação
ROMortal 
în 
caz de înghiţire 
sau inhalare
SKPri 
požití aleb o 
vdýchnutí 
môže spôsob iť 
smrť
SLSmrtno 
pri zaužitju ali vdihavan ju
FITappavaa 
nieltynä 
tai hengitettynä
SVDödligt 
vid förtärin g 
eller inandning
H310
+
H330Language 3.1 
— Acute toxicity (dermal) an d 
acute toxicity (in halation), 
hazard categ ory 
1, 2
BGСмъртоносен при контакт с кожата или при вдишван е
ESMortal 
en 
contacto 
con 
la piel o si se in hala
CSPři 
styku 
s kůží 
nebo 
při vdechován í 
může způsob it 
smrt
DA Livsfarlig 
ved hudkontakt 
eller indånding
DELebensgefahr 
bei 
Hautkontakt 
oder Einatmen
ETNahale 
sattumisel või sissehin gamisel 
surmav
ELΘανατηφόρο 
σε 
επαφή 
με 
το 
δέρμα 
ή σε 
περίπτωση 
εισπνοήςH310
+
H330Language
3.1 — Acute toxicity (dermal) an d
acute toxicity (in halation),
hazard categ ory
1, 2L 83/36 EN Official Journ alof the EuropeanUnion 30.3.2011
ENFatal in contact with skin or if inhaled
FRMortel 
par contact 
cutané 
ou par inhalation
GAÁbhar 
marfach é seo má theag mhaíonn 
leis an 
gcraiceann 
nó 
má ionanálaíte
ar é
ITMortale 
a contatto 
con 
la pelle o in  
caso di in alazione
LVVar 
izraisīt nāvi, 
ja saskaras 
ar ādu vai n onāk 
elpceļos
LTMirtina 
susilietus su oda arb a 
įkvėpus
HUBőrrel 
érintkezve 
vagy 
belélegezve 
halálos
MTFatali f’kuntatt 
mal-ġilda 
jew jekk 
tittieħed b in-nifs
NLDodelijk 
bij 
contact 
met de huid en  
bij 
inademing
PLGrozi 
śmiercią w k ontakcie 
ze skórą 
lub 
w następstwie 
wdychania
PTMortal 
por contacto 
com a pele ou in alação
ROMortal 
în 
contact 
cu pielea sau prin  
inhalare
SKPri 
styku 
s kožou 
alebo 
pri vdýchn utí 
môže spôsob iť 
smrť
SLSmrtno 
v stiku 
s kožo 
ali pri vdihavan ju
FITappavaa 
joutuessaan  
iholle tai hen gitettynä
SVDödligt 
vid hudkontakt 
eller inandning
H300 +
H310 +
H330Language3.1 — Acute toxicity (oral), acute toxicity (dermal) an d acute toxicity (in halation),
hazard 
category 
1, 2
BGСмъртоносен при поглъ щане, при контакт с кожата или при вдишван е
ESMortal 
en 
caso de in gestión, 
contacto 
con 
la piel o in halación
CSPři 
požití, při styk u 
s kůží 
nebo 
při vdechován í 
může způsob it 
smrt
DA Livsfarlig 
ved indtagelse, 
hudkontakt 
eller indånding
DELebensgefahr 
bei 
Verschluck en, 
Hautkontakt 
oder Einatmen
ETAllaneelamisel, 
nahale 
sattumisel või sissehin gamisel 
surmav
ELΘανατηφόρο 
σε 
περίπτωση 
κατάποσης, 
σε 
επαφή 
με 
το 
δέρμα 
ή σε 
περίπτωση 
εισπνοής
ENFatal 
if swallowed, in  
contact 
with skin 
or if inhaled
FRMortel 
par ingestion, 
par contact 
cutané 
ou par inhalation
GAÁbhar
 marfach é seo má shlog tar,
 má theag mhaíonn
 leis an gcraiceann
 nó
 má
ionanálaítear 
é
ITMortale 
se ingerito, 
a contatto 
con 
la pelle o se in alato
LVVar 
izraisīt nāvi, 
ja norīts, 
saskaras 
ar ādu vai iek ļūst 
elpceļos
LTMirtina 
prarijus, susilietus su oda arb a 
įkvėpus
HULenyelve, 
bőrrel 
érintkezve 
vagy 
belélegezve 
halálos
MTFatali jekk 
tinbela’, 
tmiss mal-ġ ilda 
jew tittieħed b in-nifs
NLDodelijk 
bij 
inslikken, 
bij 
contact 
met de huid en  
bij 
inademing
PLGrozi 
śmiercią po połk nięciu, 
w kontakcie 
ze skó
rą lub 
w następstwie 
wdychania
PTMortal 
por ingestão, 
contacto 
com a pele ou in alação
ROMortal 
în 
caz de înghiţire, 
în 
contact 
cu pielea sau prin  
inhalareH300 +
H310 +
H330Language3.1— Acute toxicity (oral), acute toxicity (dermal) an dacute toxicity (in halation),
hazard
category
1, 230.3.2011 EN Official Journ alof the EuropeanUnion L 83/37
SKPri požití, pri styk u s kožou alebo pri vdýchn utí môže spôsob iť smrť
SLSmrtno 
pri zaužitju, v stik u 
s kožo 
ali pri vdihavan ju
FITappavaa 
nieltynä, 
joutuessaan  
iholle tai hen gitettynä
SVDödligt 
vid förtärin g, 
hudkontakt 
eller inandning
H301
+
H311Language 3.1 
— Acute toxicity (oral) an d 
acute toxicity (dermal), hazard categ ory 
3
BGТоксичен при поглъ щане или при к онтакт с кожата
ESTóxico 
en 
caso de in gestión 
o en 
contacto 
con 
la piel
CSToxický 
při požití a při styk u 
s kůží
DA Giftig 
ved indtagelse 
eller hudk ontakt
DEGiftig 
bei 
Verschluck en 
oder Hautk ontakt
ETAllaneelamisel 
või nahale 
sattumisel mürg ine
ELΤοξικό 
σε 
περίπτωση 
κατάποσης 
ή σε 
επαφή 
με 
το 
δέρμα
ENToxic 
if swallowed or in  
contact 
with skin
FRToxique 
par ingestion 
ou par con tact 
cutané
GAÁbhar 
tocsaineach 
má shlogtar 
é nó 
má theagmhaíonn 
leis an 
gcraiceann
ITTossico 
se ingerit
o o a contatto 
con 
la pelle
LVToksisks, 
ja norīts 
vai saskaras 
ar ādu
LTToksiška 
prarijus arb a 
susilietus su oda
HULenyelve 
vagy 
bőrrel 
érintkezve 
mérgező
MTTossika 
jekk 
tinbela’ 
jew tmiss mal-ġ ilda
NLGiftig 
bij 
inslikken 
en 
bij 
contact 
met de huid
PLDziała tok sycznie 
po połknięciu 
lub 
w kontakcie 
ze skórą
PTTóxico 
por ingestão 
ou contacto 
com a pele
ROToxic în 
caz de înghiţire 
sau în 
contact 
cu pielea
SKToxický 
pri požití a pri styk u 
s kožou
SLStrupeno 
pri zaužitju ali v stik u 
s kožo
FIMyrkyllistä 
nieltynä 
tai joutuessaan  
iholle
SVGiftigt 
vid förtärin g 
eller hudk ontakt
H301
+
H331Language 3.1 
— Acute toxicity (oral) an d 
acute toxicity (in halation), 
hazard categ ory 
3
BGТоксичен при поглъ щане или при вдишван е
ESTóxico 
en 
caso de in gestión 
o inhalación
CSToxický 
při požití a při vdechován í
DA Giftig 
ved indtagelse 
eller indånding
DEGiftig 
bei 
Verschluck en 
oder Einatmen
ETAllaneelamisel 
või sissehin gamisel 
mürgine
ELΤοξικό 
σε 
περίπτωση 
κατάποσης 
ή σε 
περίπτωση 
εισπνοής
ENToxic 
if swallowed or if in haled
FRToxique 
par ingestion 
ou par inhalation
GAÁbhar 
tocsaineach 
má shlogtar 
nó 
má ionanálaítear 
éH301
+
H331Language
3.1 — Acute toxicity (oral) an d
acute toxicity (in halation),
hazard categ ory
3L 83/38 EN Official Journ alof the EuropeanUnion 30.3.2011
ITTossico se ingerito o inalato
LVToksisks, 
ja norīts 
vai iekļūst 
elpceļos
LTToksiška 
prarijus arb a 
įkvėpus
HULenyelve 
vagy 
belélegezve 
mérgező
MTTossika 
jekk 
tinbela’ 
jew tittieħed b in-nifs
NLGiftig 
bij 
inslikken 
en 
bij 
inademing
PLDziała 
toksycznie 
po połknięciu 
lub 
w następstwie 
wdychania
PTTóxico 
por ingestão 
ou inalação
ROToxic 
în 
caz de înghiţire 
sau prin 
inhalare
SKToxický 
pri požití aleb o 
vdýchnutí
SLStrupeno 
pri zaužitju ali vdihavan ju
FIMyrkyllistä 
nieltynä 
tai hengitettynä
SVGiftigt 
vid förtärin g 
eller inandning
H311
+
H331Language 3.1 
— Acute toxicity (dermal) an d 
acute toxicity (in halation), 
hazard categ ory 
3
BGТоксичен при контакт с кожата или при вдишван е
ESTóxico 
en 
contacto 
con 
la piel o si se in hala
CSToxický 
při styku 
s kůží 
a při vdechován í
DA Livsfarlig 
ved hudkontakt 
eller indånding
DEGiftig 
bei 
Hautkontakt 
oder Einatmen
ETNahale 
sattumisel või sissehin gamisel 
mürgine
ELΤοξικό 
σε 
επαφή 
με 
το 
δέρμα 
ή σε 
περίπτωση 
εισπνοής
ENToxic 
in 
contact 
with skin 
or if inhaled
FRToxique 
par contact 
cutané 
ou par inhalation
GAÁbhar 
tocsaineach 
má theagmhaíonn 
leis an 
gcraiceann 
nó 
má ionanálaíte
ar é
ITTossico 
a contatto 
con 
la pelle o se in alato
LVToksisks 
saskarē 
ar ādu vai ja iek ļūst 
elpceļos
LTToksiška 
susilietus su oda arb a 
įkvėpus
HUBőrrel 
érintkezve 
vagy 
belélegezve 
mérgező
MTTossika 
jekk 
tmiss mal-ġ ilda 
jew tittieħeb  
bin-nifs
NLGiftig 
bij 
contact 
met de huid en  
bij 
inademing
PLDziała 
toksycznie 
w kontakcie 
ze skórą 
lub 
w następstwie 
wdychania
PTTóxico 
em contacto 
com a pele ou por in alação
ROToxic 
în 
contact 
cu pielea sau prin  
inhalare
SKToxický 
pri styku 
s kožou 
alebo 
pri vdýchn utí
SLStrupeno 
v stiku 
s kožo 
ali pri vdihavan ju
FIMyrkyllistä 
joutuessaan  
iholle tai hen gitettynä
SVGiftigt 
vid hudkontakt 
eller förtärin g30.3.2011 EN Official Journ alof the EuropeanUnion L 83/39
H301 +
H311 +
H331Language3.1 — Acute toxicity (oral), acute toxicity (dermal) an d acute toxicity (in halation),
hazard 
category 
3
BGТоксичен при поглъ щане, при контакт с кожата или при вдишван е
ESTóxico 
en 
caso de in gestión, 
contacto 
con 
la piel o in halación
CSToxický 
při požití, při styk u 
s kůží 
a při vdechován í
DA Giftig 
ved indtagelse, 
hudkontakt 
eller indånding
DEGiftig 
bei 
Verschluck en, 
Hautkontakt 
oder Einatmen
ETAllaneelamisel, 
nahale 
sattumisel või sissehin gamisel 
mürgine
ELΤοξικό 
σε 
περίπτωση 
κατάποσης, 
σε 
επαφή 
με 
το 
δέρμα 
ή σε 
περίπτωση 
κατάπο
σης
ENToxic 
if swallowed, in  
contact 
with skin 
or if inhaled
FRToxique 
par ingestion, 
par contact 
cutané 
ou par inhalation
GA Ábhar
 tocsaineach
 má shlog tar,
 má theag mhaíonn
 leis an gcraicean n
 nó má
ionanálaítear 
é
ITTossico 
se ingerito, 
a contatto 
con 
la pelle o se in alato
LVToksisks, 
ja norīts, 
saskaras 
ar ādu vai iek ļūst 
elpceļos
LTToksiška 
prarijus, susilietus su oda arb a 
įkvėpus
HULenyelve, 
bőrrel 
érintkezve 
vagy 
belélegezve 
mérgező
MTTossika 
jekk 
tinbela’, 
tmiss mal-ġ ilda 
jew tittieħed b in-nifs
NLGiftig 
bij 
inslikken, 
bij 
contact 
met de huid en  
bij 
inademing
PLDziała
 toksycznie
 po połk nięciu,
 w kontakcie
 ze skórą
 lub w n a
stępstwie
wdychania
PTTóxico 
por ingestão, 
contacto 
com a pele ou in alação
ROToxic 
în 
caz de înghiţire, 
în 
contact 
cu pielea sau prin  
inhalare
SKToxický 
pri požití, styk u 
s kožou 
alebo 
pri vdýchn utí
SLStrupeno 
pri zaužitju, v stik u 
s kožo 
ali pri vdihavan ju
FIMyrkyllistä 
nieltynä, 
joutuessaan  
iholle tai hen gitettynä
SVGiftigt 
vid förtärin g, 
hudkontakt 
eller inandning
H302
+
H312Language 3.1 
— Acute toxicity (oral) an d 
acute toxicity (dermal), hazard categ ory 
4
BGВреден при поглъ щане или при к онтакт с кожата
ESNocivo 
en 
caso de in gestión 
o en 
contacto 
con 
la piel
CSZdraví škodlivý 
při požití a při styk u 
s kůží
DA Livsfarlig 
ved indtagelse 
eller hudk ontakt
DEGesundheitsschädlich 
bei 
Verschluck en 
oder Hautk ontakt
ETAllaneelamisel 
või nahale 
sattumisel k ahjulik
ELΕπιβλαβές 
σε 
περίπτωση 
κατάποσης 
ή σε 
επαφή 
με 
το 
δέρμα
ENHarmful 
if swallowed or in  
contact 
with skin
FRNocif 
en 
cas d’ingestion 
ou de con tact 
cutané
GAÁbhar 
dochrach má shlog tar 
é nó 
má theagmhaíonn 
leis an 
gcraiceann
ITNocivo 
se ingerit
o o a contatto 
con 
la pelle
LVKaitīgs, 
ja norīts 
vai saskaras 
ar ādu
LTKenksminga 
prarijus arb a 
susilietus su oda
HULenyelve 
vagy 
bőrrel 
érintkezve 
ártalmas
MTTagħmel 
ħsara jekk 
tinbela’ 
jew jekk 
tmiss mal-ġ ilda
NLSchadelijk  
bij 
inslikken 
en 
bij 
contact 
met de huidH302
+
H312Language
3.1 — Acute toxicity (oral) an d
acute toxicity (dermal), hazard categ ory
4L 83/40 EN Official Journ alof the EuropeanUnion 30.3.2011
PLDziała szk odliwie po połknięciu lub w kontakcie ze skórą
PTNocivo 
por ingestão 
ou contacto 
com a pele
RONociv în 
caz de înghiţire 
sau în 
contact 
cu pielea
SKZdraviu šk odlivý 
pri požití aleb o 
pri styku 
s kožou
SLZdravju 
škodljivo 
pri zaužitju ali v stik u 
s kožo
FIHaitallista 
nieltynä 
tai joutuessaan  
iholle
SVSkadligt 
vid förtärin g 
eller hudk ontakt
H302
+
H332Language 3.1 
— Acute toxicity (oral) an d 
acute toxicity (in halation), 
hazard categ ory 
4
BGВреден при поглъ щане или при вдишван е
ESNocivo 
en 
caso de in gestión 
o inhalación
CSZdraví 
škodlivý 
při požití a při vdechován í
DA Farlig 
ved indtagelse 
eller indånding
DEGesundheitsschädlich 
bei 
Verschluck en 
oder Einatmen
ETAllaneelamisel 
või sissehin gamisel 
kahjulik
ELΕπιβλαβές 
σε 
περίπτωση 
κατάποσης 
ή σε 
περίπτωση 
εισπνοής
ENHarmful 
if swallowed or if in haled
FRNocif 
en 
cas d’ingestion 
ou d’inhalation
GAÁbhar 
dochrach má shlog tar 
nó 
má ionanálaítear 
é
ITNocivo 
se ingerito 
o inalato
LVKaitīgs, 
ja norīts 
vai iekļūst 
elpceļos
LTKenksminga 
prarijus arb a 
įkvėpus
HULenyelve 
vagy 
belélegezve 
ártalmas
MTTagħmel 
ħsara jekk 
tinbela’ 
jew tittieħed b in-nifs
NLSchadelijk  
bij 
inslikken 
en 
bij 
inademing
PLDziała 
szkodliwie 
po połknięciu 
lub 
w następstwie 
wdychania
PTNocivo 
por ingestão 
ou inalação
RONociv 
în 
caz de înghiţire 
sau inhalare
SKZdraviu 
škodlivý 
pri požití aleb o 
vdýchnutí
SLZdravju 
škodljivo 
pri zaužitju in  
vdihavanju
FIHaitallista 
nieltynä 
tai hengitettynä
SVSkadligt 
vid förtärin g 
eller inandning
H312
+
H332Language 3.1 
— Acute toxicity (dermal) an d 
acute toxicity (in halation), 
hazard categ ory 
4
BGВреден при контакт с кожата или при вдишван е
ESNocivo 
en 
contacto 
con 
la piel o si se in hala
CSZdraví 
škodlivý 
při styku 
s kůží 
a při vdechován í
DA Farlig 
ved hudkontakt 
eller indånding
DEGesundheitsschädlich 
bei 
Hautkontakt 
oder Einatmen
ETNahale 
sattumisel või sissehin gamisel 
kahjulik
ELΕπιβλαβές 
σε 
επαφή 
με 
το 
δέρμα 
ή σε 
περίπτωση 
εισπνοήςH312
+
H332Language
3.1 — Acute toxicity (dermal) an d
acute toxicity (in halation),
hazard categ ory
430.3.2011 EN Official Journ alof the EuropeanUnion L 83/41
ENHarmful in contact with skin or if inhaled
FRNocif 
en 
cas de con tact 
cutané 
ou d’inhalation
GAÁbhar 
dochrach má theag mhaíonn 
leis an 
gcraiceann 
nó 
má ionanálaítear 
é
ITNocivo 
a contatto 
con 
la pelle o se in alato
LVKaitīgs 
saskarē 
ar ādu vai ja iek ļūst 
elpceļos
LTKenksminga 
susilietus su oda arb a 
įkvėpus
HUBőrrel 
érintkezve 
vagy 
belélegezve 
ártalmas
MTTagħmel 
ħsara jekk 
tmiss mal-ġ ilda 
jew jekk 
tittieħed b in-nifs
NLSchadelijk  
bij 
contact 
met de huid en  
bij 
inademing
PLDziała 
szkodliwie 
w kontakcie 
ze skórą 
lub 
w następstwie 
wdychania
PTNocivo 
em contacto 
com a pele ou por in alação
RONociv 
în 
contact 
cu pielea sau prin  
inhalare
SKZdraviu 
škodlivý 
pri styku 
s kožou 
alebo 
pri vdýchn utí
SLZdravju 
škodljivo 
v stiku 
s kožo 
in 
pri vdihavan ju
FIHaitallista 
joutuessaan  
iholle tai hen gitettynä
SVSkadligt 
vid hudkontakt 
eller inandning
H302 +
H312 +
H332Language3.1 — Acute toxicity (oral), acute toxicity (dermal) an d acute toxicity (in halation),
hazard 
category 
4
BGВреден при поглъ щане, при контакт с кожата или при вдишван е
ESNocivo 
en 
caso de in gestión, 
contacto 
con 
la piel o in halación
CSZdraví 
škodlivý 
při požití, při styk u 
s kůží 
a při vdechován í
DA Farlig 
ved indånding, 
hudkontakt 
eller indånding
DEGesundheitsschädlich 
bei 
Verschluck en, 
Hautkontakt 
oder Einatmen
ETAllaneelamisel, 
nahale 
sattumisel või sissehin gamisel 
kahjulik
ELΕπιβλαβές 
σε 
περίπτωση 
κατάποσης, 
σε 
επαφή 
με 
το 
δέρμα 
ή σε 
περίπτωση 
εισ
πνοής
ENHarmful 
if swallowed, in  
contact 
with skin 
or if inhaled
FRNocif 
en 
cas d’ingestion, 
de contact 
cutané 
ou d’inhalation
GAÁbhar
 dochrach má shlog tar,
 má theag mhaíonn
 leis an g craiceann
 nó
 má
ionanálaítear 
é
ITNocivo 
se ingerito, 
a contatto 
con 
la pelle o se in alato
LVKaitīgs, 
ja norīts, 
saskaras 
ar ādu vai n onāk 
elpceļos
LTKenksminga 
prarijus, susilietus su oda arb a 
įkvėpus
HULenyelve, 
bőrrel 
érintkezve 
vagy 
belélegezve 
ártalmas
MTTagħmel 
il-ħsara jek k 
tinbela’, 
tmiss mal-ġ ilda 
jew tittiħed b in-nifs
NLSchadelijk  
bij 
inslikken, 
bij 
contact 
met de huid en  
bij 
inademing
PLDziała
 szkodliwie
 po połk nięciu,
 w kontakcie
 ze skórą
 lub w następstwie
wdychania
PTNocivo 
por ingestão, 
contacto 
com a pele ou in alação
RONociv 
în 
caz de înghiţire, 
în 
contact 
cu pielea sau prin  
inhalare
SKZdraviu 
škodlivý 
pri požití, styk u 
s kožou 
alebo 
pri vdýchn utí
SLZdravju 
škodljivo 
pri zaužitju, v stik u 
s kožo 
ali pri vdihavan ju
FIHaitallista 
nieltynä, 
joutuessaan  
iholle tai hen gitettynä
SVSkadligt 
vid förtärin g, 
hudkontakt 
eller inandning
’L 83/42 EN Official Journ alof the EuropeanUnion 30.3.2011
(d) Table 1.3 is amen ded as follows:
(i) the followin g 
new 
hazard statemen t 
is added to the Tab le 
after Code H413:
‘H420 Language 5.1– Hazardous to the ozon e layer — hazard categ ory 1
BGВреди на обществен ото здраве и н а околната среда, като разрушава озон а във висо­
ките 
слоеве на 
атмосферата
ESCausa 
daños 
a la salud púb lica 
y el medio amb iente 
al destruir el ozon o 
en 
la
atmósfera superior
CSPoškozuje 
veřejné 
zdraví a životn í 
prostředí tím, že n ičí 
ozon 
ve svrchních
vrstvách atmosféry
DA Skader 
folkesundheden 
og 
miljøet ved at ødelæg ge 
ozon 
i den 
øvre atmosfære
DESchädigt
 die öffen tliche
 Gesundheit
 und
 die Umwelt durch Ozon a
bb
au in der
äußeren 
Atmosphäre
ETKahjustab
 rahvatervist ja k eskkonda,
 hävitades k õrgatmosfääris
 asuvat osoon i
­
kihti
ELΒλάπτει 
τη 
δημόσια 
υγεία 
και 
το 
περιβάλλον 
καταστρέφοντας 
το 
όζον στην 
ανώτερη
ατμόσφαιρα
ENHarms
 public
 health an d
 the environment
 by
 destroyin g
 ozone
 in the upper
atmosphere
FRNuit à la san té 
publique 
et à l’environnement 
en 
détruisant 
l’ozone 
dans 
la haute
atmosphère
GADéanann 
an 
t-ábhar 
seo díobháil 
don 
tsláinte 
phoiblí 
agus 
don 
chomhshaol trí
ózón 
san 
atmaisféar uachtarach a scriosadh
ITNuoce 
alla salute pub blica 
e all’ambiente 
distruggendo 
l’ozono 
dello strato supe­
riore dell’atmosfera
LVBīstams sab iedrības 
veselībai 
un 
videi, jo izn īcina 
ozonu 
atmosfēras aug šējā 
slānī
LTKenkia
 visuomen ės
 sveikatai
 ir aplinkai,
 nes
 naikina
 ozono
 sluoksnį
 viršutinėje
atmosferoje
HUKárosítja 
a közegészséget 
és a környezetet, 
mert a lég kör 
felső réteg ei
ben 
lebontja
az 
ózont
MTTagħmel
 ħsara lis-saħħa tal-pub bliku
 u lill-amb jent
 billi
 teqred l-oż onu
fl-atmosfera 
ta’ fuq
NLSchadelijk  
voor de volk sgezondheid 
en 
het milieu door afb raak 
van 
ozon 
in  d e
bovenste 
lagen 
van 
de atmosfeer
PLSzkodliwe 
dla zdrowia pub licznego 
i środowisk a 
w związku 
z niszczącym 
odd­
ziaływaniem 
na 
ozon 
w górnej 
warstwie atmosfery
PTPrejudica a saúde púb lica
 e  o  a mbiente 
ao destruir o ozon o 
na 
alta atmosfera
RODăunează 
sănătăţii 
publice
 și mediului în conjurător 
prin 
distrugerea 
ozonului 
în
atmosfera superioară
SKPoškodzuje 
verejné 
zdravie a životn é 
prostredie tým, že n ičí 
ozón 
vo vrchných
vrstvách 
atmosféry
SLŠkodljivo 
za javno 
zdravje in  
okolje 
zaradi uničevanja 
ozona 
v zgornji 
atmosferi
FIVahingoittaa
 kansanterveyttä
 ja ympäristöä tuhoamalla otsonia ylemmässä
ilmakehässä
SVSkadar 
folkhälsan 
och miljön  
genom 
förstöring 
av ozonet 
i övre delen  
av atmos­
fären’
(2) in 
Part 2, Tab le 
2.3 is deleted;
(3) Part 3 is amen ded 
as follows:
(a) in 
the title the words ‘substances 
and
’ are deleted;
(b) in 
Code EUH201/201A, 
first column , 
all referen ces 
to ‘201/201A’ are deleted;
(c) in 
Code EUH209/209A, 
first column , 
all referen ces 
to ‘209/209A’ are deleted.30.3.2011 EN Official Journ alof the EuropeanUnion L 83/43
ANNEX IV
Annex 
IV 
to Regulation 
(EC) 
No 1272/2008 is amen ded 
as follows:
(1) Part 1 is amen ded 
as follows:
(a) Table 
6.2 is amen ded 
as follows:
(i) Code P261 is replaced b y 
the followin g:
‘
P261Avoid breathing
dust/fume/g as/mist/
vapours/spray.Acute 
toxicity — in hala­
tion 
(section 
3.1)3, 4 Manufacturer/supplier 
to
specify applicab le 
condi­
tions.
’Respiratory sen sitisation 
(section 
3.4)1, 1A, 1B
Skin 
sensitisation 
(section 
3.4)1, 1A, 1B
Specific targ et 
organ 
toxic­
ity — single 
exposure; 
respiratory tract irritation  
(section 
3.8)3
Specific targ et 
organ 
toxic­
ity — single 
exposure; 
narcosis 
(section 
3.8)3
(ii) Code P272 is replaced b y 
the followin g:
‘
P272Contaminated 
work
clothing 
should not 
be
allowed 
out of the
workplace.Skin 
sensitisation
(section 
3.4)1, 1A, 1B’
(iii) Code P280 is replaced b y 
the followin g:
‘
P280Wear protective
gloves/protective
clothing/eye
protection /
face 
protection .Explosives
(section 
2.1)Divisions
1.1, 
1.2,
1.3, 1.4,
1.5Manufacturer/supplier 
to
specify type of equipmen t.
—Specify 
face protection.
Flammable 
liquids 
(section 
2.6)1, 2, 3 Manufacturer/supplier 
to 
specify type of equipmen t.
—Specify 
protective gloves 
and eye/face protection.Flammable 
solids 
(section 
2.7)1, 2
Self-reactive sub stances 
and 
mixtures 
(section 
2.8)Types A, 
B, C, D, E , 
F
Pyrophoric 
liquids 
(section 
2.9)1
Pyrophoric solids 
(section 
2.10)1
Self-heatin g 
substances 
and 
mixtures 
(section 
2.11)1, 2
Substances 
and 
mixtures 
which, in 
contact 
with 
water, emit flammab le 
gases 
(section 
2.12)1, 2, 3
Oxidising 
liquids 
(section 
2.13)1, 2, 3L 83/44 EN Official Journ alof the EuropeanUnion 30.3.2011
Oxidising solids 
(section 
2.14)1, 2, 3
Organic 
peroxides 
(section 
2.15)Types A, 
B, C, D, E , 
F
Acute 
toxicity — dermal 
(section 
3.1)1, 2, 3, 4 Manufacturer/supplier 
to 
specify type of equipmen t.
—Specify 
protective 
gloves/clothing.
Skin 
corrosion  
(section 
3.2)1A, 1B, 
1CManufacturer/supplier 
to 
specify type of equipmen t.
—Specify 
protective 
gloves/clothing and 
eye/face protection.
Skin 
irritation 
(section 
3.2)2Manufacturer/supplier 
to 
specify type of equipmen t.
—Specify 
protective gloves.Skin 
sensitisation 
(section 
3.4)1, 1A, 1B
Severe eye damag e 
(section 
3.3)1Manufacturer/supplier 
to 
specify type of equipmen t.
—Specify 
eye/face protec­
tion.’Eye 
irritation 
(section 
3.3)2
(iv) Code P285 is replaced b y 
the followin g:
‘
P285In 
case of inadequate 
ventilation 
wear respi­
ratory protection .Respiratory 
sensitisation 
(section 
3.4)1, 1A, 1B Manufacturer/supplier 
to 
specify equipmen t.
’
(v) Code P273 is amen ded 
as follows:
—in 
column 
3, row 2, the words ‘chronic 
aquatic hazard (section  
4.1)’ are replaced b y ‘
long-term 
aquatic 
hazard (section  
4.1)’, 
—the last row is deleted;
(b) Table 
6.3 is amen ded 
as follows:
(i) Code P302 is replaced b y 
the followin g:
‘
P302IF 
ON SKIN: Pyrophoric 
liquids 
(section 
2.9)1
Acute toxicity — dermal (section
 
3.1)1, 2, 3, 4
Skin 
irritation 
(section 
3.2)2
Skin 
sensitisation 
(section 
3.4)1, 1A, 1B’30.3.2011 EN Official Journ alof the EuropeanUnion L 83/45
(ii) Code P304 is replaced b y the followin g:
‘
P304IF 
INHALED: Acute 
toxicity — in hala­
tion 
(section 
3.1)1, 2, 3, 4
Skin 
corrosion  
(section 
3.2)1A, 1B, 
1C
Respiratory sen sitisation 
(section 
3.4)1, 1A, 1B
Specific targ et 
organ 
tox­
icity — sin gle 
exposure; 
respiratory tract irritation  
(section 
3.8)3
Specific targ et 
organ 
tox­
icity — sin gle 
exposure; 
narcosis 
(section 
3.8)3’
(iii) Code P311 is replaced b y 
the followin g:
‘
P311Call a POI SON 
CEN­
TRE 
or 
doctor/physician .Acute 
toxicity — in hala­
tion 
(section 
3.1)3
Respiratory sen sitisation 
(section 
3.4)1, 1A, 1B
Specific targ et 
organ 
tox­
icity — sin gle 
exposure 
(section 
3.8)1, 2’
(iv) Code P313 is replaced b y 
the followin g:
‘
P313Get medical 
advice/atten tion.Skin 
irritation 
(section 
3.2)2, 3
Eye 
irritation 
(section 
3.3) 2
Skin 
sensitisation 
(section 
3.4)1, 1A, 1B
Germ cell mutag enicity 
(section 
3.5)1A, 1B, 2
Carcinogenicity 
(section 
3.6)1A, 1B, 2
Reproductive toxicity (section
 
3.7)1A, 1B, 2
Reproductive toxicity — effects on
 
or via lactation  
(section 
3.7)Additional 
category
’
(v) Code P321 is replaced b y 
the followin g:
‘
P321Specific treatmen t 
(see 
… on 
this label).Acute 
toxicity — oral 
(section 
3.1)1, 2, 3 … Reference 
to supple­
mental 
first aid 
instruction.
— if 
immediate administra­
tion of antidote is required.
Acute toxicity — in
hala­
tion 
(section 
3.1)3… Reference 
to supple­
mental 
first aid 
instruction.
— if 
immediate specific 
measures are required.L 83/46 EN Official Journ alof the EuropeanUnion 30.3.2011
Specific targ et organ tox­
icity 
— single 
exposure 
(section 
3.8)1… Reference to supple­
mental 
first aid 
instruction.
— if 
immediate measures 
are required.
Skin 
sensitisation 
(section 
3.4)1, 1A, 1B … Reference 
to supple­
mental 
first aid 
instruction.
— manufacturer/supplier 
may 
specify a cleansing 
agent if appropriate.’Skin 
corrosion  
(section 
3.2)1A, 1B, 
1C
Skin 
irritation 
(section 
3.2)2
(vi) Code P333 is replaced b y 
the followin g:
‘
P333If 
skin 
irritation 
or 
rash occurs:Skin 
sensitisation 
(section 
3.4)1, 1A, 1B’
(vii) Code P341 is replaced b y 
the followin g:
‘
P341If 
breathing 
is diffi­
cult, remove victim to fresh air an
d 
keep 
at 
rest in 
a position  
comfortab le 
for 
breathing.Respiratory 
sensitisation 
(section 
3.4)1, 1A, 1B’
(viii) Code P342 is replaced b y 
the followin g:
‘
P342If 
experiencing 
respi­
ratory symptoms:Respiratory sen sitisation 
(section 
3.4)1, 1A, 1B’
(ix) Code P352 is replaced b y 
the followin g:
‘
P352Wash with plen ty 
of 
soap and 
water.Acute toxicity — dermal (section
 
3.1)3, 4
Skin 
irritation 
(section 
3.2)2
Skin 
sensitisation 
(section 
3.4)1, 1A, 1B’
(x) Code P363 is replaced b y 
the followin g:
‘
P363Wash con taminated 
clothing 
before 
reuse.Acute toxicity — dermal (section
 
3.1)1, 2, 3, 4
Skin 
corrosion  
(section 
3.2)1A, 1B, 
1C
Skin 
sensitisation 
(section 
3.4)1, 1A, 1B’30.3.2011 EN Official Journ alof the EuropeanUnion L 83/47
(xi) Code P302 + P352 is replaced b y the followin g:
‘
P302 + 
P352IF 
ON SKIN: 
Wash 
with plenty 
of soap 
and 
water.Acute toxicity — dermal 
(section 
3.1)3, 4
Skin 
irritation 
(section 
3.2)2
Skin 
sensitisation 
(section 
3.4)1, 1A, 1B’
(xii) Code P304 + P341 is replaced b y 
the followin g:
‘
P304 + 
P341IF 
INHALED: 
If 
breathing 
is difficult, 
remove victim to fresh air an
d 
keep 
at 
rest in 
a position  
comfortab le 
for 
breathing.Respiratory 
sensitisation 
(section 
3.4)1, 1A, 1B’
(xiii) Code P333 + P313 is replaced b y 
the followin g:
‘
P333 + 
P313If 
skin 
irritation 
or 
rash occurs: Get medical advice/atten
tion.Skin 
sensitisation 
(section 
3.4)1, 1A, 1B’
(xiv) Code P342 + P311 is replaced b y 
the followin g:
‘
P342 + 
P311If 
experiencing 
respi­
ratory symptoms: Call a POI
SON 
CEN­
TRE 
or 
doctor/physician .Respiratory 
sensitisation 
(section 
3.4)1, 1A, 1B’
(xv) in 
Code P391, column  
3, row 2, the words ‘chronic 
aquatic hazard (section  
4.1)’ are replaced b y ‘
long-term 
aquatic 
hazard (section  
4.1)’;
(c) Table 
6.5 is replaced b y 
the followin g:
‘
Table 6.5
Precautionary 
statements — D isposal
CodeDisposal precaution ary 
statementsHazard classHazard 
categoryConditions for use
(1) (2) (3) (4) (5)
P501Dispose of con
tents/container 
to 
…Explosives (section 2.1) Unstable 
explosives 
and 
Divisions 
1.1, 
1.2, 
1.3, 1.4, 1.5… in accordance with 
local/regional/national/ 
international 
regulation 
(to 
be 
specified).
Flammable 
liquids (sec­
tion 
2.6)1, 2, 3CodeDisposal precaution ary
statementsHazard classHazard
categoryConditions for use
(1) (2) (3) (4) (5)L 83/48 EN Official Journ alof the EuropeanUnion 30.3.2011
Self-reactive sub stances and 
mixtures 
(section 
2.8)Types A, B, 
C, D, E, 
F
Substances 
and 
mixtures 
which, in 
contact 
with 
water, emit flammab le 
gases 
(section 
2.12)1, 2, 3
Oxidising 
liquids 
(section 
2.13)1, 2, 3
Oxidising 
solids 
(section 
2.14)1, 2, 3
Organic 
peroxides 
(section 
2.15)Types A, B, 
C, D, E, 
F
Acute toxicity — oral 
(section 
3.1)1, 2, 3, 4
Acute toxicity — dermal (section
 
3.1)1, 2, 3, 4
Acute toxicity — in halation 
(section 
3.1)1, 2
Skin 
corrosion  
(section 
3.2)1A, 1B, 1C
Respiratory sen sitisation 
(section 
3.4)1, 1A, 1B
Skin 
sensitisation 
(section 
3.4)1, 1A, 1B
Germ cell mutag enicity 
(section 
3.5)1A, 1B, 2
Carcinogenicity 
(section 
3.6)1A, 1B, 2
Reproductive toxicity (section
 
3.7)1A, 1B, 2
Specific targ et 
organ 
toxicity 
— single 
exposure 
(section 
3.8)1, 2
Specific targ et 
organ 
toxicity 
— single 
exposure; 
respiratory tract irritation  
(section 
3.8)3
Specific targ et 
organ 
toxicity 
— single 
exposure; 
narcosis 
(section 
3.8)3
Specific targ et 
organ 
toxicity 
— repeated 
exposure (section  
3.9)1, 2
Aspiration  
hazard 
(section 
3.10)1
Hazardous to the aquatic en
vironment 
— acute 
aquatic hazard(section  
4.1)1
Hazardous to the aquatic 
environment 
— long-term 
aquatic 
hazard (section  
4.1)1, 2, 3, 4CodeDisposal precaution ary
statementsHazard classHazard
categoryConditions for use
(1) (2) (3) (4) (5)30.3.2011 EN Official Journ alof the EuropeanUnion L 83/49
P502Refer to 
manufacturer/supplier 
for 
information 
on 
recovery/recyclin gHazardous to the ozon e 
layer 
(section 
5.1)1’
(2) in 
Part 2, Tab le 
1.5, the followin g 
precaution ary 
statement 
is added after Code P501:
‘P502 Language
BG Обърнете  се към  производителя/доставчик а  за информ ация относн о  възст ановяването/  
рециклирането
ESPedir 
información 
al fabricante 
o proveedor sob re 
su recuperación  
o reciclado
CS Informujte 
se u výrob ce 
nebo 
dodavatele o reg eneraci 
nebo 
recyklaci
DA Indhent 
oplysninger 
om genvinding/genanvendelse 
hos producen ten/leverandøren
DE Informationen
 zur Wiederverwen dung/Wiederverwertung
 beim
 Hersteller/Lieferan ten
 
erfragen
ETHankida 
valmistajalt/tarn ijalt 
teavet kemikaali 
taaskasutamise/ringlussevõtu 
kohta
ELΑπευθυνθείτε 
στον 
παραγωγό/προμηθευτή 
για 
την 
ανάκτηση/ανακύκλωση
ENRefer 
to manufacturer/supplier 
for information 
on 
recovery/recycling
FR Se reporter au fab ricant/fournisseur 
pour des in formations 
concernant 
la récupération /le 
recyclage
GA Féach 
an 
fhaisnéis 
ón 
monaróir/soláthróir 
maidir le haisg habháil/ath
chúrsáil
ITChiedere 
informazioni 
al produttore o forn itore 
per il recupero/riciclag gio
LV Informācija 
par rekuperāciju/pārstrādi 
saņemama 
pie ražotāja/pieg ādātāja
LT Kreiptis
 į gamintoją
 (tiekėją)
 informacijai
 apie šių medžiag ų
 ar preparatų panaudojimą
 
arba 
perdirbimą 
gauti
HU A
 gyártó/szállító
 határozza meg a haszn osításra
 és újrafeldolg ozásra 
vonatkozó
 
információkat
MT Irreferi 
għall-manifattur/fornitur 
rigward 
informazzjoni 
dwar l-irk upru/riċiklaġġ
NL Raadpleeg  
fabrikant/leverancier 
voor informatie 
over terug winning/recycling
PL Przestrzeg ać 
wskazówek 
producenta 
lub 
dostawcy dotyczących odzysk u 
lub 
wtórnego 
wykorzystania
PT Solicitar 
ao fabricante/fornecedor 
informações 
relativas à recuperação/reciclag em
RO Adresaţi-vă 
producătorului pen tru 
informaţii 
privind 
recuperarea/reciclarea
SK Informujte 
sa u výrob cu 
alebo 
dodávateľ a 
o regenerácii 
alebo 
recykláci
i
SL Za podatk e 
glede 
obnovitve/reciklaže 
se obrnite 
na 
proizvajalca/dob a
vitelja
FIHanki 
valmistajalta/toimittajalta tietoja uudelleen käytöstä/kier
rätyksestä
SV Rådfråga 
tillverkare/leverantör 
om återvin ning/återanvändning
’’;
’;
L 83/50 EN Official Journ alof the EuropeanUnion 30.3.2011
ANNEX V
Annex 
V to Regulation 
(EC) 
No 1272/2008 is amen ded 
as follows:
(1) the first sen tence 
is replaced b y 
the followin g:
‘
The hazard pictog rams 
for each hazard class, differen tiation 
of a hazard class an d 
hazard categ ory 
shall satisfy the pro­
visions 
of this An nex 
and 
Annex 
I, 
section 
1.2 and 
conform 
in 
terms of symb ol
s and 
general 
format, to the specimen s
shown.
’;
(2) Part 2, section  
2.3 is amen ded 
as follows:
(a) in 
column 
1, the pictog ram 
GHS07 is replaced b y 
the followin g 
pictogram
:
‘GHS07
(b) in 
column 
2, the words ‘Skin 
sensitisation, 
hazard categ ory 
1’ are replaced b y ‘
Skin 
sensitisation, 
hazard categ o­
ries 
1, 1A, 1B’;
(3) in 
Part 2, section  
2.4, column  
2, the words ‘Respiratory sen sitisation
, hazard categ ory 
1’ are replaced b y ‘
Respiratory
sensitisation, 
hazard categ ories 
1, 1A, 1B’;
(4) in 
Part 3, the pictog ram 
GHS09 is replaced b y 
the followin g 
pictogram:
‘
GHS09
(5) the 
following 
new 
Part 4 is added:
‘4. PART 4: ADDI TIONAL 
HAZARDS
4.1. Symbol: 
exclamation mark
Pictogram Hazard class and hazard categ ory
(1) (2)
GHS07 Section 5.1
Hazardous to the ozon e 
layer, hazard categ ory 
1’30.3.2011 EN Official Journ alof the EuropeanUnion L 83/51
ANNEX VI
Annex 
VI 
to Regulation 
(EC) 
No 1272/2008 is amen ded 
as follows:
(1) Part 1 is amen ded 
as follows:
(a) Table 
1.1 is amen ded 
as follows:
(i) in the Hazard Class Respiratory/sk in
 sensitisation,
 the Categ ory
 Code ‘Resp. Sen s.
 1’ is replaced b y
 ‘Resp. 
Sens. 
1, 1A, 1B’ an d 
the Category 
Code ‘Skin 
Sens. 
1’ is replaced b y ‘
Skin. 
Sens. 
1, 1A, 1B’;
(ii) in 
the Hazard Class Hazardous for the ozon e 
layer, the Categ ory 
Code ‘Ozone
’ is replaced b y ‘
Ozone 
1’;
(b) in 
section 
1.1.2.3, the last parag raph 
is replaced b y 
the followin g:
‘
In 
case an 
M-factor has b een 
harmonised 
for substances 
classified as hazardous to the aquatic en vironment 
in 
the
categories 
Aquatic Acute 1 or Aquatic Chron ic 
1, this M-factor is g iven 
in 
Table 
3.1 in 
the same column  
as the
specific con centration 
limits. In 
case an 
M-factor for Aquatic Acute 1 an d 
an 
M-factor for Aquatic Chron ic 
1 have
been 
harmonised, 
each M-factor shall b e 
listed in 
the same lin e 
as its correspon ding 
differentiation. 
Where a sin gle
M-factor 
is given 
in 
Table 
3.1 and 
the substance 
is classified as Aquatic Acute 1 an d 
Aquatic Chron ic 
1, this
M-factor shall b e 
used by 
the manufacturer, 
importer or down stream 
user for the classification  
of a mixture con ­
taining 
this substance 
for acute an d 
long-term 
aquatic hazards usin g 
the summation  
method. Where n o 
M-factor
is given
 in Table
 3.1, M-factor(s) b ased
 on availab le
 data for the sub stanc
e shall be
 set by
 the manufacturer,
importer 
or downstream 
user. For the settin g 
and 
use of M-factors, see section  
4.1.3.5.5.5 of An nex 
I.
’;
(c) in 
section 
1.1.3.1, ‘Note H (Tab le 
3.1)’ and ‘
Note H (Tab le 
3.2)’ are deleted;
(d) section 
1.1.4.4 is deleted;
(2) Part 3, is amen ded 
as follows:
(a) the first two parag raphs 
are replaced b y 
the followin g:
‘
Table 
3.1: List of harmon ised 
classification  
and 
labelling 
of hazardous sub stances.
Table
 3.2: The list of harmon ised
 classification an d
 labell
ing
 of hazardous sub stances
 from An nex
  I to
Directive 67/548/E EC.
’;
(b) in 
Tables 
3.1 and 
3.2, last column , 
all the referen ces 
to Note ‘H’ are deleted;L 83/52 EN Official Journ alof the EuropeanUnion 30.3.2011(c) in Table 3.1, entries 602-002-00-2, 602-008-00-5, 602-013-00-2 and 602-084-00-X are replaced by the following:
‘Index NoInternational chemical
identificationEC No CAS NoClassification Labelling
Specific conc. limits,
M-factorsNotesHazard class and
category code(s)Hazard statement
code(s)Pictogram, signal
word code(s)Hazard
statement
code(s)Supplementary
hazard
statement
code(s)
602-002-00-2 bromomethane;
methylbromide200-813-2 74-83-9 Press. Gas
Muta. 2
Acute Tox. 3 *Acute Tox. 3 *STOT RE 2 *Eye Irrit. 2STOT SE 3Skin Irrit. 2
Aquatic Acute 1
Ozone 1H341H331H301H373**H319H335H315
H400
H420GHS04GHS06GHS08GHS09DgrH341H331H301H373 **H319H335H315H400
H420U
602-008-00-5 carbon tetrachloride;
tetrachloromethane200-262-8 56-23-5 Carc. 2
Acute Tox. 3 *
Acute Tox. 3 *Acute Tox. 3 *STOT RE 1AquaticChronic 3Ozone 1H351H331H311H301H372**H412H420GHS06GHS08DgrH351H331H311H301H372 **H412H420*S T O T  R E  1 ;H372:  C  ≥  1  %S T O T  R E  2 ;H373: 0,2 % ≤ C<  1  %
602-013-00-2 1,1,1-trichloroethane;
methyl chloroform200-756-3 71-55-6 Acute Tox. 4 *
Ozone 1H332H420GHS07WngH332H420F’
602-084-00-X 1,1-dichloro-1-
fluoroethane404-080-1 1717-00-6 Aquatic
Chronic 3Ozone 1H412H420GHS07 Wng— H412H42030.3.2011 EN Official Journ alof the EuropeanUnion L 83/53
ANNEX VII
Annex 
VII 
to Regulation 
(EC) 
No 1272/2008 is amen ded 
as follows:
 in 
Table 
1.1, last row, the hazard statemen t ‘
EUH059
’ is replaced b y ‘
H420’.