欧盟Eurlex法规详细信息

30.3.2011
EN
Official Journal of the European Union
L 83/1
II
(Non-legislative acts)
REGULATIONS

COMMISSION REGULATION (EU) No 286/2011
of 10March 2011
amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC)
No1272/2008 of the European Parliament and of the Council on classification, labelling and packaging
of substances and mixtures
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(3)
The classification criteria and 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 Experts on the Transport of
Having regard to the Treaty on the Functioning of the European
Dangerous Goods and on the Globally Harmonised System
Union,
of Classification and Labelling of Chemicals
(UNCETDG/GHS). It contains amendments concerning,
inter alia, the provisions for the allocation of hazard state
ments and for the labelling of small packaging, new sub-
categories for respiratory and skin sensitisation, the
Having regard to Regulation (EC) No1272/2008 of the European
revision of the classification criteria for long-term hazards
Parliament and of the Council of 16December 2008 on classifi
(chronic toxicity) to the aquatic environment and a new
cation, labelling and packaging of substances and mixtures,
hazard class for substances and mixtures hazardous to the
amending and repealing Directives 67/548/EEC and1999/45/EC,
ozone layer. It is therefore necessary to adapt the technical
and amending Regulation (EC) No1907/2006 (1), and in particu
provisions and criteria in the Annexes to Regulation (EC)
lar Article53 thereof,
No1272/2008 to the third revised edition of the GHS.
Whereas:
(4)
The GHS allows authorities to adopt supplemental label
ling provisions to protect individuals already sensitised to
(1)
Regulation (EC) No1272/2008 harmonises the provisions
a specific chemical that may elicit a response at very low
and criteria for the classification and labelling of sub
concentration. Requirements should be introduced to add
stances, mixtures and certain specific articles within the
the name of such chemical on the label even if present at
European Union.
very low concentration in a mixture.
(2)
That Regulation takes into account the Globally Harmon
ised System of Classification and Labelling of Chemicals
(hereinafter referred to as ‘the GHS’) of the United Nations
(5)
The terminology of different provisions in the Annexes
(UN).
and certain technical criteria should also be amended to
facilitate implementation by operators and enforcement
authorities, to improve consistency of the legal text and to
(1) OJL353, 31.12.2008, p.1.
enhance clarity.

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L 83/2
EN
Official Journal of the European Union
30.3.2011
(6)
To
ensure that suppliers of substances can adapt to the
(7) An
nex V is amended in accordance with Annex V to this
n
ew classification, labelling and packaging provisions
Regulation;
in
troduced

by this Regulation, a transitional period should
b
e foreseen

and the application of this Regulation should
(8) An
nex VI is amended in accordance with Annex VI to this
b
e deferred. This should allow for the possibility to apply
Regulation;
the
provisions laid down in this Regulation on a voluntary
b
asis

before the transitional period is over.
(9) An
nexVII is amended in accordance with AnnexVII to this
Regulation.
(7)
The

measures provided for in this Regulation are in accor
dan
ce
with the opinion of the Committee established pur
suan
t to Article133 of Regulation (EC) No1907/2006 of
Article

2
the
E uropean Parliament and of the Council (1),
Transitional provisions
HAS ADOPTED THIS REGULATION:
1.
By way of derogation from the second paragraph of
Article

3, substances and mixtures may, before 1December 2012
an
d
1June 2015 respectively, be classified, labelled and packaged
Article

1
in accordance with Regulation (EC) No1272/2008 as amended
b
y this Regulation.
Regulation (EC) No1272/2008 is amended as follows:
2.
By way of derogation from the second paragraph of
Article

3, substances classified, labelled and packaged in accor
(1) Article25(5) is deleted;
dan
ce with Regulation (EC) No 1272/2008 and placed on the
mark

et before 1December 2012, are not required to be relabelled
(2) the following new section(e) is inserted in Article26(1):
an
d repackaged in accordance with this Regulation until 1Decem
b
er 2014.
‘(e) if the
hazard pictogram “GHS02” or “GHS06” applies,
the
use of the hazard pictogram “GHS04” shall be
3.
By way of derogation from the second paragraph of
optional.’;
Article

3, mixtures classified, labelled and packaged in accordance
with
Directive

1999/45/EC of the European Parliament and of the
(3) An
nex I is amended in accordance with Annex I to this
Council (2) or
Regulation (EC) No1272/2008 and placed on the
Regulation;
mark
et before 1June 2015, are not required to be relabelled and
repack

aged in accordance with this Regulation until 1June 2017.
(4) An
nex II is amended in accordance with Annex II to this
Regulation;
Article

3
(5) An
nex III is amended in accordance with Annex III to this
This
Regulation shall enter into force on the 20th day following
Regulation;
its
pub
lication

in the Official Journal of the European Union.
(6) An
nex IV is amended in accordance with Annex IV to this
I
t shall
apply in respect of substances from 1December 2012 and
Regulation;
in
respect

of mixtures from 1June 2015.
This

Regulation shall be binding in its entirety and directly applicable in all Member States.
Don
e at Brussels, 10March 2011.
For

the Commission
The President
José Manuel BARROSO
(1) OJL396, 30.12.2006, p.1.
(2) OJL200, 30.7.1999, p.1.

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30.3.2011
EN
Official Journal of the European Union
L 83/3
ANNEXI
A. Part
1 of AnnexI to Regulation (EC) No1272/2008 is amended as follows:
(1) in
section1.1.2.2.2, the Note under Table 1.1 is replaced by the following:
‘Note:
Gen
eric cut-off values are in weight percentages except for gaseous mixtures for those hazard classes where the
g
eneric cut-off values may be best described in volume percentages.’;
(2) in
section
1.1.3.1, the beginning of the first sentence is replaced by ‘If a tested mixture’;
(3) section

s1.1.3.2, 1.1.3.3 and1.1.3.4are replaced by the following:
‘1.1.3.2.

Batching
The
hazard

category of a tested production batch of a mixture can be assumed to be substantially equiva
len
t to
that of another untested production batch of the same commercial product, when produced by
or
un
der
the control of the same supplier, unless there is reason to believe there is significant variation
such
that
the hazard classification of the untested batch has changed. If the latter occurs, a new evalu
ation is necessary.
1.1.3.3.

Concentration

of highly hazardous mixtures
I n the
case
of
the
classification of mixtures covered by sections3.1, 3.2, 3.3, 3.8, 3.9, 3.10 and4.1, if a
tested
mixture is classified in the highest hazard category or sub-category, and the concentration of the
compon
ents of the tested mixture that are in that category or sub-category is increased, the resulting
un
tested mixture shall be classified in that category or sub-category without additional testing.
1.1.3.4.

Interpolation

within one toxicity category
I n the
case
of
the
classification of mixtures covered by sections3.1, 3.2, 3.3, 3.8, 3.9, 3.10 and4.1, for
three
mixtures (A, B andC) with identical components, where mixtures A and B have been tested and
are
in the same hazard category, and where untested mixture C has the same hazardous components as
mixture

A and B but has concentrations of those hazardous components intermediate to the concen
tration
s in mixtures A and B, then mixture C is assumed to be in the same hazard category as A and B.’;
(4) in
section1.1.3.5, the last sentence is replaced by the following:
‘I f mixture

(i) or(ii) is already classified based on test data, then the other mixture shall be assigned the same haz
ard category.’;
(5) section

s1.2, 1.2.1, 1.2.1.1, 1.2.1.2 and1.2.1.3are replaced by the following:
‘1.2.


Labelling
1.2.1.


General

rules for the application of labels required by Article31
1.2.1.1. Hazard
pictograms shall be in the shape of a square set at a point.
1.2.1.2. Hazard
pictograms as laid down in AnnexV shall have a black symbol on a white background with a
red frame sufficiently wide to be clearly visible.
1.2.1.3. E ach
hazard

pictogram shall cover at least one fifteenth of the minimum surface area of the label dedi
cated
to the information required by Article17. The minimum area of each hazard pictogram shall not
b e less than 1cm2.

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L 83/4
EN
Official Journal of the European Union
30.3.2011
1.2.1.4. The
dimen

sions of the label and of each pictogram shall be as follows:
Table 1.3

Minimum dimensions of labels and pictograms
Capacity

of
Dimen

sions of the label (in millimetres)
Dimen

sions of each pictogram
the package
for
the information required by Article 17
(in millimetres)
Not exceeding
If possible, at least 52 × 74
Not

smaller than 10 × 10
3litres:
If possible, at least 16 × 16
Greater

than
At least 74 × 105
At least 23 × 23
3litres but not
exceeding
50litres:
Greater

than
At least 105 × 148
At least 32 × 32
50litres but not
exceeding
500litres:
Greater

than
At least 148 × 210
At least 46 × 46’
500litres:
(6) the
introductory sentence in section1.5.2.1.3 is replaced by the following:
‘The
pictog

ram, the signal word, the hazard statement, and the precautionary statement linked to the hazard cat
eg
ories listed below may be omitted from the label elements required by Article17 where:’;
(7) in
section1.5.2.2, point(b) is replaced by the following:
‘(b) The
classification

of the contents of the soluble packaging is exclusively one or more of the hazard catego
ries

in 1.5.2.1.1 (b), 1.5.2.1.2 (b) or1.5.2.1.3 (b); and’.
B. Part
2 of AnnexI to Regulation (EC) No1272/2008 is amended as follows:
(1) section2.1.4.1 is amended as follows:
(a) the
footnote under Figure 2.1.1 is replaced by the following:
‘(*) See
UN Recommendations on the Transport of Dangerous Goods, Model Regulations, 16th rev. ed,
sub-section2.1.2.’;
(b) Fig
ure 2.1.3 is replaced by the following:

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30.3.2011
EN
Official Journal of the European Union
L 83/5
‘Figure 2.1.3
Procedu

re for assignment to a division in the class of explosives (Class 1 for transport)
’

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L 83/6
EN
Official Journal of the European Union
30.3.2011
(c) Fig
ure 2.1.4, is replaced by the following:
‘Figure 2.1.4
Procedu

re for the classification of ammonium nitrate emulsion, suspension or gel (ANE)
’

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30.3.2011
EN
Official Journal of the European Union
L 83/7
(2) in
section2.1.4.2, the Note is replaced by the following:
‘Note:
Neither
a series 1 type (a) propagation of detonation test nor a series 2 type (a) test of sensitivity to detonative
shock
is required if the exothermic decomposition energy of organic materials is less than 800 J/g. For organic
sub
stan
ces and mixtures of organic substances with a decomposition energy of 800 J/g or more, tests 1 (a)
an
d 2
(a)
n
eed not be performed if the outcome of the ballistic mortar Mk.IIId test (F.1), or the ballistic mortar test
(F.2)
or
the BAM Trauzl test (F.3) with initiation by a standard No8 detonator (see Appendix1 to the UN RTDG,
Man
ual
of
Tests
andCriteria) is “no”. In this case, the results of test 1 (a) and2 (a) are deemed to be “-”.’;
(3) in
section2.2.2.1, the Note under Table 2.2.1 is replaced by the following:
‘Note:
Aerosols shall not be classified as flammable gases; see section2.3.’;
(4) in
section2.3.2.1, the Note is replaced by the following notes:
‘Note 1:
Flammab

le components do not cover pyrophoric, self-heating or water-reactive substances and mixtures because
such components are never used as aerosol contents.
Note 2:
Flammab

le aerosols do not fall additionally within the scope of sections2.2 (flammable gases), 2.6 (flammable
liquids) or2.7 (flammable solids).’;
(5) in
section

2.3.2.2, the following Note is inserted at the end of the paragraph:
‘Note:
Aerosols

not submitted to the flammability classification procedures in this section shall be classified as flam
mable aerosols, Category1.’;
(6) in
section2.4.2.1, the Note under Table 2.4.1 is replaced by the following:
‘Note:
“
Gases

which cause or contribute to the combustion of other material more than air does” mean pure gases or gas
mixtures

with an oxidising power greater than 23,5% as determined by a method specified in ISO 10156 as
amended or10156-2 as amended.’;
(7) in
section2.5.3, the following Note is inserted under Table 2.5.2:
‘Note:
Pictogram GHS04 is not required for gases under pressure where pictogram GHS02 or pictogram GHS06
appears.’;
(8) in
section2.6.2.1 the following Note is inserted under Table 2.6.1:
‘Note:
Aerosols shall not be classified as flammable liquids; see section2.3.’;

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L 83/8
EN
Official Journal of the European Union
30.3.2011
(9) section2.6.4.2 is amended as follows:
(a) the
first paragraph is replaced by the following:
‘I
n the
case of mixtures (*) containing known flammable liquids in defined concentrations, although they may
con
tain non-volatile components e.g. polymers, additives, the flash point need not be determined experi
men
tally

if the calculated flash point of the mixture, using the method given in 2.6.4.3, is at least 5°C (**)
g
reater
than the relevant classification criterion (23°C and60°C, respectively) and provided that:
(*) To
date, the calculation method has been validated for mixtures containing up to6 volatile compo
n
ents. These components may be flammable liquids like hydrocarbons, ethers, alcohols, esters (except
acrylates),

and water. It is however not yet validated for mixtures containing halogenated sulphurous,
and/or phosphoric compounds as well as reactive acrylates.
(**) I f the
calculated

flash point is less than 5°C greater than the relevant classification criterion, the calcu
lation

method may not be used and the flash point should be determined experimentally.’;
(b) in
poin

t(b), the words ‘of the mixture’ shall be added;
(10) in
section

2.6.4.4, Table 2.6.3, the complete row ‘British Standard Institute, BS 2000 Part 170 as amended (iden
tical

to EN ISO 13736)’ is deleted;
(11) section

2.6.4.5 is replaced by the following:
‘2.6.4.5 Liquids
with a flash point of more than 35°C and not more than 60°C need not be classified in Cat
eg
ory3 if negative results have been obtained in the sustained combustibility test L.2, Part III, section32
of
the
UN RTDG, Manual of Tests and Criteria.’;
(12) the following new section2.6.4.6 is inserted:
‘2.6.4.6. Possib

le test methods for determining the initial boiling point of flammable liquids are listed in
Table 2.6.4.
Table 2.6.4

Methods for determining the initial boiling point of flammable liquids
European standards:
EN ISO 3405 as amended
Petroleum

products — Determination of distillation characteristics at
atmospheric pressure
EN ISO 3924 as amended
Petroleum

products — Determination of boiling range distribution
— Gas chromatography method
EN ISO 4626 as amended
Volatile

organic liquids — Determination of boiling range of organic
solvents used as raw materials
Regulation (EC)
Method

A.2 as described in Part A of the Annex to Regulation (EC)
No

440/2008(*)
No 440/2008
(*
) OJ L 142, 31.5.2008, p. 1.’
(13) in
section2.7.2.3, the Note under Table 2.7.1 is replaced by the following:
‘Note 1:
The
test

shall be performed on the substance or mixture in its physical form as presented. If, for example, for the
purposes

of supply or transport, the same chemical is to be presented in a physical form different from that which
was
tested

and which is considered likely to materially alter its performance in a classification test, the substance
shall
also be tested in the new form.
Note 2:
Aerosols shall not be classified as flammable solids; see section2.3.’;

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30.3.2011
EN
Official Journal of the European Union
L 83/9
(14) in
section

2.8.4.2, Figure 2.8.1, points7.4, 8.4 and9.4, the word ‘No’ is replaced by ‘None’;
(15) section

2.11.1.2 is replaced by the following:
‘2.11.1.2. Self-heatin
g of a substance or a mixture is a process where the gradual reaction of that substance or
mixture
with
oxygen (in the air) generates heat. If the rate of heat production exceeds the rate of heat
loss,
then
the temperature of the substance or mixture will rise which, after an induction time, may
lead

to self-ignition and combustion.’;
(16) in
section

2.15.4.2, Figure 2.15.1, points7.4, 8.4 and9.4, the word ‘No’ is replaced by ‘None’.
C. Part
3 of AnnexI to Regulation (EC) No1272/2008 is amended as follows:
(1) section

3.1.2.1 is replaced by the following:
‘3.1.2.1. Sub
stan
ces can be allocated to one of four toxicity categories based on acute toxicity by the oral, der
mal
or inhalation route according 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 acute toxicity estimates (ATE) defining the respective
categories
E
xposure route
Categ

ory 1
Categ

ory 2
Categ

ory 3
Category 4
Oral (mg/kg bodyweight)
See:
Note (a)
ATE ≤ 5
5 < ATE
50 < ATE
300 < ATE
≤ 50
≤
300
≤
2000
Note (b)
Dermal (mg/kg bodyweight)
See:
Note (a)
ATE ≤ 50
50 < ATE
200 < ATE
1000 < ATE
≤
200
≤
1000
≤
2000
Note (b)
Gases (ppmV(*))
see:
Note (a)
ATE ≤ 100
100 < ATE
500 < ATE
2500 < ATE
≤ 500
≤
2500
≤
20000
Note (b)
Note (c)
Vapours (mg/l)
see:
Note (a)
Note (b)
ATE ≤ 0,5
0,5 < ATE
2,0 < ATE
10,0 < ATE
≤ 2,0
≤ 10,0
≤
20,0
Note (c)
Note (d)
Dusts

and mists (mg/l)
see:
Note (a)
ATE ≤ 0,05
0,05 < ATE
0,5 < ATE
1,0 < ATE
≤ 0,5
≤ 1,0
≤ 5,0
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 substance is derived using the LD50/LC50
where available.
(b) The
acute

toxicity estimate (ATE) for the classification of a substance in a mixture is derived using:
— the LD50/LC50 where available,

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L 83/10
EN
Official Journal of the European Union
30.3.2011
— the
appropriate

conversion value from Table 3.1.2 that relates to the results of a range test,
or
— the
appropriate conversion value from Table 3.1.2 that relates to a classification category.
(c) Gen
eric concentration limits for inhalation toxicity in the table are based on 4-hour testing expo
sures.

Conversion of existing inhalation toxicity data which have been generated using a 1-hour
exposure
can be carried out by dividing by a factor of 2 for gases and vapours and4 for dusts and
mists.
(d) For
some

substances the test atmosphere will not just be a vapour but will consist of a mixture of
liquid
and vapour phases. For other substances the test atmosphere may consist of a vapour which
is
n ear the gaseous phase. In these latter cases, classification shall be based on ppmV as follows:
Categ
ory 1 (100 ppmV), Category 2 (500 ppmV), Category 3 (2500 ppmV), Category 4
(20000 ppmV).
The
terms

“dust”, “mist” and “vapour” are defined as follows:
— dust:
solid particles of a substance or mixture suspended in a gas (usually air),
— mist:
liquid droplets of a substance or mixture suspended in a gas (usually air),
— vapour:

the gaseous form of a substance or mixture released from its liquid or solid state.
Dust

is generally formed by mechanical processes. Mist is generally formed by condensation of
supersaturated

vapours or by physical shearing of liquids. Dusts and mists generally have sizes
ran
g ing from less than 1 to about 100m.’;
(2) section

3.1.3.2 is replaced by the following:
‘3.1.3.2. For
acute
toxicity each route of exposure shall be considered for the classification of mixtures, but only
on
e route
of exposure is needed as long as this route is followed (estimated ortested) for all compo
n
en
ts and there is no relevant evidence to suggest acute toxicity by multiple routes. When there is rel
evan
t evidence of toxicity by multiple routes of exposure, classification is to be conducted for all
appropriate

routes of exposure. All available information shall be considered. The pictogram and signal
word
used shall reflect the most severe hazard category and all relevant hazard statements shall be used.’;
(3) in
section3.1.3.3, points(c) and(d) are added:
‘(c) I f the
con
verted acute toxicity point estimates for all components of a mixture are within the same category,
then
the mixture should be classified in that category.
(d) When

only range data (or acute toxicity hazard categoryinformation) are available for components in a mix
ture,
they may be converted to point estimates in accordance with Table 3.1.2 when calculating the classi
fication
of the new mixture using the formulas in sections3.1.3.6.1 and3.1.3.6.2.3.’;
(4) section

3.1.3.5.2 is replaced by the following:
‘3.1.3.5.2. I f a
tested
mixture is diluted with a diluent that has an equivalent or lower toxicity classification than
the
least toxic original components, and which is not expected to affect the toxicity of other compo
n
en
ts, then the new diluted mixture may be classified as equivalent to the original tested mixture.
Altern

atively, the formula explained in section3.1.3.6.1 can be applied.’;
(5) section

3.1.3.6.1, is amended as follows:
(a) poin

t(c) is replaced by the following:
‘(c) ig
n ore
components if the data available are from a limit dose test (at the upper threshold for Category4
for
the
appropriate route of exposure as provided in Table 3.1.1) and do not show acute toxicity.’;

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30.3.2011
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Official Journal of the European Union
L 83/11
(b) the
first sentence beneath point(c) is replaced by the following:
‘Compon
ents 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 section3.1.3.3 for appropriate application of avail
ab
le data to the equation below, and section3.1.3.6.2.3.’;
(6) in
section

3.1.3.6.2.1, point(a), the footnote is replaced by the following:
‘(1) When
mixtures contain components that do not have acute toxicity data for each route of exposure, acute
toxicity
estimates may be extrapolated from the available data and applied to the appropriate routes (see sec
tion
3.1.3.2).

However, specific legislation may require testing for a specific route. In those cases, classifica
tion
shall

be performed for that route based upon the legal requirements.’;
(7) section

3.1.3.6.2.2 is replaced by the following:
‘3.1.3.6.2.2. I n the
event that a component without any useable information for classification is used in a mix
ture
at
a concentration of 1% or greater, it is concluded that the mixture cannot be attributed a
defin
itive acute toxicity estimate. In this situation the mixture shall be classified based on the known
compon
en
ts on
ly, with the additional statement on the label and in the SDS that: “× percent of the
mixture

consists of component(s) of unknown toxicity”.’;
(8) in
section
3.1.3.6.2.3, the title of Table 3.1.2 is replaced by the following:
‘Conversion from experimentally obtained acute toxicity range values (or acute toxicity hazard categories) to acute
toxicity

point estimates for use in the formulas for the classification of mixtures’;
(9) the
following sentence is added to section3.1.4.1:
‘Without prejudice to Article27, combined hazard statements may be used in accordance with AnnexIII.’;
(10) in
Tab
les
3.1.3,

3.2.5, 3.3.5, 3.4.4 and3.8.4, the pictogram with the exclamation mark is replaced by the follow
ing pictogram:
‘
’;
(11) in
section

3.4.1.5 the words ‘at section3.4.4.’ are replaced by ‘in AnnexII, section2.8.’;
(12) in
section

3.4.1.6 the word ‘and’ is inserted after ‘Respiratory Sensitisation’;
(13) section

s from 3.4.2 to3.4.2.2.4.1are replaced by the following:
‘3.4.2.


Classification criteria for substances
3.4.2.1.


Respiratory sensitisers
3.4.2.1.1.


H a z a r d c a t e g o r i e s
3.4.2.1.1.1. Respiratory

sensitisers shall be classified in Category 1 where data are not sufficient for
sub-categorisation.
3.4.2.1.1.2. Where
data

are sufficient a refined evaluation according to3.4.2.1.1.3 shall allow the allocation of
respiratory sensitisers into sub-category1A, strong sensitisers, or sub-category1B for other respi
ratory sensitisers.

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L 83/12
EN
Official Journal of the European Union
30.3.2011
3.4.2.1.1.3. E ffects
seen in either humans or animals will normally justify classification in a weight of evidence
approach
for
respiratory sensitisers. Substances may be allocated to one of the two sub-categories1A
or
1B
usin
g a weight of evidence approach in accordance with the criteria given in Table 3.4.1 and
on
the
b asis of reliable and good quality evidence from human cases or epidemiological studies
an
d/or observations from appropriate studies in experimental animals.
3.4.2.1.1.4. Sub
stan
ces shall be classified as respiratory sensitisers in accordance with the criteria in Table 3.4.1:

Table 3.4.1

Hazard category and sub-categories for respiratory sensitisers
Category
Criteria
Categ

ory 1
Sub
stances shall be classified as respiratory sensitisers (Category 1) where
data
are
not sufficient for sub-categorisation in accordance with the fol
lowing criteria:
(a)
if there
is evidence in humans that the substance can lead to specific
respiratory

hypersensitivity; and/or
(b
) if there are positive results from an appropriate animal test.
Sub-category 1A:
Sub
stan

ces showing a high frequency of occurrence in humans; or a prob
ab
ility
of
occurrence of a high sensitisation rate in humans based on ani
mal
or
other tests(*). Severity of reaction may also be considered.
Sub-category 1B:
Sub
st ances showing a low to moderate frequency of occurrence in
human
s;
or
a probability of occurrence of a low to moderate sensitisation
rate
in
humans based on animal or other tests(*). Severity of reaction may
also be considered.
(*
) At
presen
t, recognised and validated animal models for the testing of respiratory hypersensitivity are not avail
ab
le.
Un
der certain circumstances, data from animal studies may provide valuable information in a weight of
evidence assessment.
3.4.2.1.2.


H u m a n e v i d e n c e
3.4.2.1.2.1. E viden
ce
that
a substance can lead to specific respiratory hypersensitivity will normally be based on
human

experience. In this context, hypersensitivity is normally seen as asthma, but other hypersen
sitivity
reactions such as rhinitis/conjunctivitis and alveolitis are also considered. The condition will
have
the
clinical character of an allergic reaction. However, immunological mechanisms do not have
to be demonstrated.
3.4.2.1.2.2. When
con
sidering the human evidence, it is necessary for a decision on classification to take into
accoun
t, in addition to the evidence from the cases:
(a) the
size of the population exposed;
(b) the
extent of exposure.
The
use

of human data is discussed in sections1.1.1.3, 1.1.1.4 and1.1.1.5.
3.4.2.1.2.3. The
evidence referred to above could be:
(a) clin
ical
history

and data from appropriate lung function tests related to exposure to the sub
stan

ce, confirmed by other supportive evidence which may include:
(i) in
vivo immunological test (e.g. skin prick test);
(ii) in
vitro

immunological test (e.g. serological analysis);

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30.3.2011
EN
Official Journal of the European Union
L 83/13
(iii) studies

that indicate other specific hypersensitivity reactions where immunological mecha
n
isms

of action have not been proven, e.g. repeated low-level irritation, pharmacologi
cally mediated effects;
(iv) a chemical structure related to substances known to cause respiratory hypersensitivity;
(b) data
from one or more positive bronchial challenge tests with the substance conducted accord
in
g to accepted guidelines for the determination of a specific hypersensitivity reaction.
3.4.2.1.2.4. Clin
ical history shall include both medical and occupational history to determine a relationship
b
etween

exposure to a specific substance and development of respiratory hypersensitivity. Relevant
in
formation

includes aggravating factors both in the home and workplace, the onset and progress
of
the
disease, family history and medical history of the patient in question. The medical history shall
also
in
clude a note of other allergic or airway disorders from childhood, and smoking history.
3.4.2.1.2.5. The

results of positive bronchial challenge tests are considered to provide sufficient evidence for clas
sification
on their own. It is however recognised that in practice many of the examinations listed
ab
ove will already have been carried out.
3.4.2.1.3.


A n i m a l s t u d i e s
3.4.2.1.3.1. Data
from

appropriate animal studies (*) which may be indicative of the potential of a substance to
cause sensitisation by inhalation in humans (**) may include:
(a) measuremen

ts of Immunoglobulin E (IgE) and other specific immunological parameters in
mice;
(b) specific pulmonary responses in guinea pigs.
3.4.2.2.


Skin sensitisers
3.4.2.2.1.


H a z a r d c a t e g o r i e s
3.4.2.2.1.1. Sk
in sensitisers shall be classified in Category1 where data are not sufficient for sub-categorisation.
3.4.2.2.1.2. Where
data are sufficient a refined evaluation according to section3.4.2.2.1.3 allows the allocation
of skin sensitisers into sub-category 1A, strong sensitisers, or sub-category 1B for other skin
sensitisers.
3.4.2.2.1.3. E ffects

seen in either humans or animals will normally justify classification in a weight of evidence
approach

for skin sensitisers as described in section3.4.2.2.2. Substances may be allocated to one
of
the
two sub-categories1A or1B using 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 evidence from human cases
or
epidemiological studies and/or observations from appropriate studies in experimental animals
accordin

g to the guidance values provided in sections 3.4.2.2.2.1 and 3.4.2.2.3.2 for sub-cat
eg
ory
1A and in sections3.4.2.2.2.2 and3.4.2.2.3.3 for sub-category1B.

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L 83/14
EN
Official Journal of the European Union
30.3.2011
3.4.2.2.1.4. Sub
stan
ces

shall be classified as skin sensitisers in accordance with the criteria in Table 3.4.2:

Table 3.4.2

Hazard category and sub-categories for skin sensitisers
Category
Criteria
Categ

ory 1
Sub
stances shall be classified as skin sensitisers (Category 1) where data
are
n ot
sufficient for sub-categorisation in accordance with the following
criteria:
(a)
if there
is evidence in humans that the substance can lead to sensi
tisation
b y skin contact in a substantial number of persons; or
(b
) if there are positive results from an appropriate animal test (see spe
cific
criteria in section 3.4.2.2.4.1).
Sub-category 1A:
Sub
stan
ces showing a high frequency of occurrence in humans and/or a
hig
h
potency in animals can be presumed to have the potential to pro
duce
sig
nificant sensitisation in humans. Severity of reaction may also be
considered.
Sub-category 1B:
Sub
st ances showing a low to moderate frequency of occurrence in
human
s
and/or a low to moderate potency in animals can be presumed
to
have
the potential to produce sensitisation in humans. Severity of reac
tion
may also be considered.
3.4.2.2.2.


H u m a n e v i d e n c e
3.4.2.2.2.1. Human
evidence for sub-category1A can include:
(a) positive

responses at ≤ 500 g/cm2 (HRIPT, HMT — induction threshold);
(b) diag
n ostic
patch test data where there is a relatively high and substantial incidence of reactions
in
a
defined population in relation to relatively low exposure;
(c) other
epidemiolog

ical evidence where there is a relatively high and substantial incidence of
allerg

ic contact dermatitis in relation to relatively low exposure.
3.4.2.2.2.2. Human
evidence for sub-category1B can include:
(a) positive

responses at > 500 g/cm2 (HRIPT, HMT — induction threshold);
(b) diag
n ostic
patch test data where there is a relatively low but substantial incidence of reactions
in
a defined population in relation to relatively high exposure;
(c) other
epidemiolog

ical evidence where there is a relatively low but substantial incidence of aller
g
ic contact dermatitis in relation to relatively high exposure.
The
use
of human data is discussed in sections1.1.1.3, 1.1.1.4 and1.1.1.5.
3.4.2.2.3.


A n i m a l s t u d i e s
3.4.2.2.3.1. For
Categ
ory
1, when an adjuvant type test method for skin sensitisation is used, a response of at
least
30
%
of the animals is considered as positive. For a non-adjuvant Guinea pig test method a
respon
se
of
at least 15% of the animals is considered positive. For Category1, a stimulation index
of
three
or
more is considered a positive response in the local lymph node assay. Test methods for
sk
in sen
sitisation are described in the OECD Guideline 406 (the Guinea Pig Maximisation test and
the
Buehler guinea pig test) and Guideline 429 (Local Lymph Node Assay). Other methods may be
used
provided

that they are well-validated and scientific justification is given. For example, the mouse
ear
swellin

g test (MEST) could be a reliable screening test to detect moderate to strong sensitisers,
an
d could
be used as a first stage in the assessment of skin sensitisation potential.

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30.3.2011
EN
Official Journal of the European Union
L 83/15
3.4.2.2.3.2. An
imal
test
results for sub-category1A can include data with values indicated in Table 3.4.3

Table 3.4.3

nimal
A
test results for sub-category 1A
Assay
Criteria
Local lymph node assay
E
C3 value ≤ 2%
Guin
ea pig maximisation test
≥
30
% responding at ≤ 0,1% intradermal induction
dose

or
≥
60
% responding at > 0,1% to ≤ 1% intradermal
induction dose
Buehler assay
≥
15
% responding at ≤ 0,2% topical induction dose or
≥
60
% responding at > 0,2% to ≤ 20% topical induc
tion dose
3.4.2.2.3.3. An
imal
test
results for sub-category1B can include data with values indicated in Table 3.4.4 below:

Table 3.4.4

Animal test results for sub-category 1B
Assay
Criteria
Local lymph node assay
E
C3 value > 2%
Guin
ea pig maximisation test
≥
30
% to < 60% responding at > 0,1% to ≤ 1% intrad
ermal

induction dose or
≥
30
% responding at > 1% intradermal induction dose
Buehler assay
≥
15
% to < 60% responding at > 0,2% to ≤ 20% topi
cal
induction dose or
≥
15
% responding at > 20% topical induction dose
3.4.2.2.4.


S p e c i f i c c o n s i d e r a t i o n s
3.4.2.2.4.1. For
classification

of a substance, evidence should include any or all of the following using a weight
of evidence approach:
(a) positive

data from patch testing, normally obtained in more than one dermatology clinic;
(b) epidemiolog

ical studies showing allergic contact dermatitis caused by the substance. Situations
in
which

a high proportion of those exposed exhibit characteristic symptoms are to be looked
at
with

special concern, even if the number of cases is small;
(c) positive

data from appropriate animal studies;
(d) positive

data from experimental studies in man (see section1.3.2.4.7);
(e) well
documen

ted episodes of allergic contact dermatitis, normally obtained in more than one
dermatology clinic;
(f) severity

of reaction may also be considered.

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L 83/16
EN
Official Journal of the European Union
30.3.2011
3.4.2.2.4.2. E viden

ce from animal studies is usually much more reliable than evidence from human exposure.
However,

in cases where evidence is available from both sources, and there is conflict between the
results,
the quality and reliability of the evidence from both sources must be assessed in order to
resolve
the question of classification on a case-by-case basis. Normally, human data are not gener
ated
in controlled experiments with volunteers for the purpose of hazard classification but rather as
part
of risk assessment to confirm lack of effects seen in animal tests. Consequently, positive human
data

on skin sensitisation are usually derived from case-control or other, less defined studies. Evalu
ation
of
human data must therefore be carried out with caution as the frequency of cases reflect, in
addition
to the inherent properties of the substances, factors such as the exposure situation, bio
availab

ility, individual predisposition and preventive measures taken. Negative human data should
n
ot
normally be used to negate positive results from animal studies. For both animal and human
data,
consideration should be given to the impact of vehicle.
3.4.2.2.4.3. I f n
on
e of the abovementioned conditions are met, the substance need not be classified as a skin sen
sitiser.
However, a combination of two or more indicators of skin sensitisation as listed below may
alter
the decision. This shall be considered on a case-by-case basis.
(a) I solated

episodes of allergic contact dermatitis;
(b) epidemiolog

ical studies of limited power, e.g. where chance, bias or confounders have not been
ruled

out fully with reasonable confidence;
(c) data
from animal tests, performed according to existing guidelines, which do not meet the cri
teria
for a positive result described in section3.4.2.2.3, but which are sufficiently close to the
limit to be considered significant;
(d) positive data from non-standard methods;
(e) positive

results from close structural analogues.
3.4.2.2.4.4.

I m m u n o l o g i c a l c o n t a c t u r t i c a r i a
Sub
stances meeting the criteria for classification as respiratory sensitisers may in addition cause
immun

ological contact urticaria. Consideration should be given to classifying these substances also
as
skin sensitisers. Substances which cause immunological contact urticaria without meeting the cri
teria

for respiratory sensitisers should also be considered for classification as skin sensitisers.
There

is no recognised animal model available to identify substances which cause immunological
con
tact urticaria. Therefore, classification will normally be based on human evidence which will be
similar

to that for skin sensitisation.
(*) At
presen

t, recognised and validated animal models for the testing of respiratory hypersensitiv
ity
are
not available. Under certain circumstances, data from animal studies may provide valu
ab
le information in a weight of evidence assessment.
(**) The

mechanisms by which substances induce symptoms of asthma are not yet fully known. For
preven

tative measures, these substances are considered respiratory sensitisers. However, if on
the
b asis
of the evidence, it can be demonstrated that these substances induce symptoms of
asthma

by irritation only in people with bronchial hyper reactivity, they should not be consid
ered as respiratory sensitisers.’;
(14) in
section
3.4.3.3.1 the reference to ‘Table 3.4.3’ is replaced by ‘Table 3.4.5’;
(15) section

3.4.3.3.2 is amended as follows:
(a) the
referen

ce to ‘Table 3.4.1’ is replaced by ‘Table 3.4.5’;
(b) the
referen

ce to ‘Table 3.4.3’ is replaced by ‘Table 3.4.6’;

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30.3.2011
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Official Journal of the European Union
L 83/17
(c) Tab
le 3.4.3

and Notes 1, 2 and3are replaced by the following:

‘Table 3.4.5

Generic concentration limits of components of a mixture classified as either respiratory
sensitisers

or skin sensitisers that trigger classification of the mixture
Gen
eric concentration limits triggering classification of a mixture as:
Component classified as:
Respiratory sensitiser
Skin sensitiser
Categ

ory 1
Categ

ory 1
Solid/liquid
Gas
All physical states
Respiratory sensitiser
≥ 1,0%
≥ 0,2%
Categ

ory 1
Respiratory sensitiser
≥ 0,1%
≥ 0,1%
Sub-category 1A
Respiratory sensitiser
≥ 1,0%
≥ 0,2%
Sub-category 1B
Skin sensitiser
≥ 1,0%
Categ

ory 1
Skin sensitiser
≥ 0,1%
Sub-category 1A
Skin sensitiser
≥ 1,0%’
Sub-category 1B
(d) a n
ew
Table 3.4.6 is inserted after the new Table 3.4.5:

‘Table 3.4.6

Concentration limits for elicitation of components of a mixture
Concentration limits for elicitation
Component classified as:
Respiratory sensitiser
Skin sensitiser
Categ

ory 1
Categ

ory 1
Solid/liquid
Gas
All physical states
Respiratory sensitiser
≥ 0,1% (Note 1)
≥ 0,1% (Note 1)
Categ

ory 1
Respiratory sensitiser
≥ 0,01% (Note 1)
≥ 0,01% (Note 1)
Sub-category 1A
Respiratory sensitiser
≥ 0,1% (Note 1)
≥ 0,1% (Note 1)
Sub-category 1B
Skin sensitiser
≥ 0,1% (Note 1)
Categ

ory 1
Skin sensitiser
≥ 0,01% (Note 1)
Sub-category 1A
Skin sensitiser
≥ 0,1% (Note 1)
Sub-category 1B
Note 1:
This
concentration limit for elicitation is used for the application of the special labelling requirements of
An
nexII section2.8 to protect already sensitised individuals. A SDS is required for the mixture containing
a
compon

ent above this concentration. For sensitising substances with specific concentration limit lower
than
0,1%, the concentration limit for elicitation should be set at one tenth of the specific concentration
limit.’;

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L 83/18
EN
Official Journal of the European Union
30.3.2011
(16) section

3.4.4.1 is replaced by the following:
‘3.4.4.1. Lab
el elements shall be used for substances or mixtures meeting 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
Respiratory sensitisation
Skin sensitisation
Classification
Categ
ory 1 and
Categ
ory 1 and
sub
-categories 1A and 1B
sub
-categories 1A and 1B
GHS pictograms
Signal word
Danger
Warning
H334:

May cause allergy or
Hazard statement
asthma symptoms or
H317:

May cause an allergic
breathing difficulties if
skin reaction
inhaled
P261
Precautionary statement
P261
prevention
P272
P285
P280
P302 + P352
P304 + P341
Precautionary statement response
P333 + P313
P342 + P311
P321
P363
Precautionary statement storage
Precautionary statement disposal
P501
P501’
(17) in
section

3.8.3.4.5, the following sentence is added at the end:
‘Respiratory

tract irritation and narcotic effects are to be evaluated separately in accordance with the criteria given
in
section
3.8.2.2. When conducting classifications for these hazards, the contribution of each component should
b
e con
sidered additive, unless there is evidence that the effects are not additive.’;
(18) in
section
3.9.1.2, the words ‘or mixture’ are added after the word ‘substance’;
(19) the
following section3.10.1.6.2a. is inserted:
‘3.10.1.6.2a Althoug
h the definition of aspiration in section3.10.1.2 includes the entry of solids into the res
piratory

system, classification according to point(b) in Table 3.10.1 for Category1 is intended to
apply

to liquid substances and mixtures only.’;
D. Part
4 of AnnexI to Regulation (EC) No1272/2008 is replaced by the following text:
‘4.

PART

4: ENVIRONMENTAL HAZARDS
4.1.

Hazardou

s to the aquatic environment
4.1.1.


Definitions

and general considerations
4.1.1.1.


Definitions
(a) “ acute
aquatic toxicity” means the intrinsic property of a substance to be injurious to an aquatic
org
anism in a short-term aquatic exposure to that substance.

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30.3.2011
EN
Official Journal of the European Union
L 83/19
(b) “ acute
(short-term) hazard” means for classification purposes the hazard of a substance or mixture
caused

by its acute toxicity to an organism during short-term aquatic exposure to that substance
or mixture.
(c) “ availab
ility of a substance” means the extent to which this substance becomes a soluble or disag
g
reg
ate
species. For metal availability, the extent to which the metal ion portion of a metal (M°)
compoun

d can disaggregate from the rest of the compound (molecule).
(d) “ b ioavailab

ility” or “biological availability” means the extent to which a substance is taken up by
an
org
anism, and distributed to an area within the organism. It is dependent upon physico-
chemical
properties of the substance, anatomy and physiology of the organism, pharmacokinet
ics,
an
d route of exposure. Availability is not a prerequisite for bioavailability.
(e) “ b ioaccumulation

” means the net result of uptake, transformation and elimination of a substance
in
an
org
anism due to all routes of exposure (i.e. air, water, sediment/soil andfood).
(f) “ b iocon
centration” means the net result of uptake, transformation and elimination of a substance
in
an organism due to waterborne exposure.
(g) “ chron
ic aquatic toxicity” means the intrinsic property of a substance to cause adverse effects to
aquatic

organisms during aquatic exposures which are determined in relation to the life-cycle of
the organism.
(h) “ deg
radation” means the decomposition of organic molecules to smaller molecules and eventually
to
carbon dioxide, water and salts.
(i) “ ECx” means the effect concentration associated with x% response.
(j) “ lon
g-term hazard” means for classification purposes the hazard of a substance or mixture caused
b
y its chronic toxicity following long-term exposure in the aquatic environment.
(k) “ n o observed effect concentration (NOEC)” means the test concentration immediately below the
lowest tested concentration with statistically significant adverse effect. The NOEC has no statisti
cally

significant adverse effect compared to the control.
4.1.1.2.


Basic elements
4.1.1.2.0.
Hazardous

to the aquatic environment is differentiated into:
— acute aquatic hazard,
— long-term aquatic hazard.
4.1.1.2.1.
The basic elements used for classification for aquatic environmental hazards are:
— acute aquatic toxicity,
— chronic aquatic toxicity,
— poten

tial for or actual bioaccumulation, and
— degradation (biotic orabiotic) for organic chemicals.
4.1.1.2.2.
Preferab

ly data shall be derived using the standardised test methods referred to in Article8(3). In prac
tice
data from other standardised test methods such as national methods shall also be used where they
are
considered as equivalent. Where valid data are available from non-standard testing and from non-
testin
g methods, these shall be considered in classification provided they fulfil the requirements speci
fied
in
section1 of AnnexXI to Regulation (EC) No1907/2006. In general, both freshwater and marine
species

toxicity data are considered suitable for use in classification provided the test methods used are
equivalen

t. Where such data are not available classification shall be based on the best available data. See
also
Part 1 of AnnexI to Regulation (EC) No1272/2008.

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L 83/20
EN
Official Journal of the European Union
30.3.2011
4.1.1.3.


Other considerations
4.1.1.3.1.
Classification

of substances and mixtures for environmental hazards requires the identification of the
hazards
they present to the aquatic environment. The aquatic environment is considered in terms of the
aquatic
organisms that live in the water, and the aquatic ecosystem of which they are part. The basis,
therefore,
of
the identification of acute (short-term) and long-term hazards is the aquatic toxicity of the
sub
stan
ce or mixture, although this shall be modified by taking account of further information on the
deg
radation and bioaccumulation behaviour, if appropriate.
4.1.1.3.2.
While
the classification system applies to all substances and mixtures, it is recognised that for special
cases

(e.g. metals) the European Chemicals Agency has issued guidance.
4.1.2.


Classification criteria for substances
4.1.2.1.
The
system for classification recognises that the intrinsic hazard to aquatic organisms is represented by
b
oth
the
acute

and long-term hazard of a substance. For the long-term hazard, separate hazard catego
ries
are
defin

ed representing a gradation in the level of hazard identified. The lowest of the available tox
icity
values between and within the different trophic levels (fish, crustacean, algae/aquatic plants) shall
n
ormally

be used to define the appropriate hazard category(ies). There are circumstances, however,
when
a weight of evidence approach is appropriate.
4.1.2.2.
The
core classification system for substances consists of one acute hazard classification category and
three
long-term hazard classification categories. The acute and the long-term hazard classification cat
egories are applied independently.
4.1.2.3.
The
criteria

for classification of a substance in category Acute 1are defined on the basis of acute aquatic
toxicity
data only (EC50 or LC50). The criteria for classification of a substance into the categories
Chron
ic
1 to3 follow a tiered approach where the first step is to see if available information on chronic
toxicity

merits long-term hazard classification. In absence of adequate chronic toxicity data, the subse
quen
t step is to combine two types of information, i.e. acute aquatic toxicity data and environmental
fate
data (degradability and bioaccumulation data) (see figure 4.1.1).

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30.3.2011
EN
Official Journal of the European Union
L 83/21
Figure 4.1.1
Categories for substances long-term hazardous to the aquatic environment
4.1.2.4.
The
system also introduces a “safety net” classification (referred to as category Chronic 4) for use when
the
data
available do not allow classification under the formal criteria for acute 1 or chronic 1 to3 but
there are nevertheless some grounds for concern (see example in Table 4.1.0).
4.1.2.5.
Sub
stances with acute toxicities below 1mg/l or chronic toxicities below 0,1mg/l (if non-rapidly
deg
radab

le) and0,01mg/l (if rapidly degradable) contribute as components of a mixture to the toxicity
of
the
mixture even at a low concentration and shall normally be given increased weight in applying
the
summation

of classification approach (see note 1 of Table 4.1.0 and section4.1.3.5.5).
4.1.2.6.
The
criteria for classifying and categorising substances as “hazardous to the aquatic environment” are
summarised in Table 4.1.0.
Table 4.1.0

Classification categories for hazardous to the aquatic environment
(a) Acute (short-term) aquatic hazard
Category Acute 1: (Note 1)
96
hr LC

50 (for fish)
≤ 1mg/l and/or
48hr EC

50 (for crustacea)
≤ 1mg/l and/or
72
or 96hr ErC

50 (for algae or other aquatic
≤ 1mg/l. (Note 2)
plants)
(b) Long-term aquatic hazard

(i) Non-rapidly degradable substances (Note 3) for which there are adequate chronic toxicity
data available
Category Chronic 1: (Note 1)
Chron

ic NOEC or EC

x (for fish)
≤ 0,1mg/l and/or
Chronic NOEC or EC

x (for crustacea)
≤ 0,1mg/l and/or

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L 83/22
EN
Official Journal of the European Union
30.3.2011
Chron

ic NOEC or ECx (for algae or other
≤0,1mg/l.
aquatic plants)
Category Chronic 2:
Chron

ic NOEC or EC

x (for fish)
> 0,1 to ≤ 1mg/l and/or
Chronic NOEC or EC

x (for crustacea)
> 0,1 to ≤ 1mg/l and/or
Chron

ic NOEC or EC

x (for algae or other
> 0,1 to ≤ 1mg/l.
aquatic plants)

(ii) Rapidly degradable substances (Note 3) for which there are adequate chronic toxicity data
available
Category Chronic 1: (Note 1)
Chron

ic NOEC or EC

x (for fish)
≤ 0,01mg/l and/or
Chronic NOEC or EC

x (for crustacea)
≤ 0,01mg/l and/or
Chron

ic NOEC or ECx (for algae or other
≤ 0,01mg/l.
aquatic plants)
Category Chronic 2:
Chron

ic NOEC or EC

x (for fish)
> 0,01 to ≤ 0,1mg/l and/or
Chronic NOEC or EC

x (for crustacea)
> 0,01 to ≤ 0,1mg/l and/or
Chron

ic NOEC or ECx (for algae or other
> 0,01 to ≤ 0,1mg/l.
aquatic plants)
Category Chronic 3:
Chron

ic NOEC or EC

x (for fish)
> 0,1 to ≤ 1mg/l and/or
Chronic NOEC or EC

x (for crustacea)
> 0,1 to ≤ 1mg/l and/or
Chron

ic NOEC or EC

x (for algae or other
> 0,1 to ≤ 1mg/l.
aquatic plants)
(iii) Substances for which adequate chronic toxicity data are not available
Category Chronic 1: (Note 1)
96
hr LC

50 (for fish)
≤ 1mg/l and/or
48hr EC

50 (for crustacea)
≤ 1mg/l and/or
72
or 96hr ErC

50 (for algae or other aquatic
≤ 1mg/l. (Note 2)
plants)
an
d the substance is not rapidly degradable and/or the experimentally determined BCF
≥
500

(or, if absent, the log Kow≥ 4). (Note 3).
Category Chronic 2:
96
hr LC

50 (for fish)
> 1 to ≤10mg/l and/or
48hr EC

50 (for crustacea)
> 1 to ≤10mg/l and/or
72
or 96hr ErC

50 (for algae or other aquatic
> 1 to ≤10mg/l (Note 2)
plants)
an
d the substance is not rapidly degradable and/or the experimentally determined BCF
≥
500

(or, if absent, the log Kow≥ 4). (Note 3).
Category Chronic 3:
96
hr LC

50 (for fish)
> 10 to ≤ 100mg/l and/or
48hr EC

50 (for crustacea)
> 10 to ≤ 100mg/l and/or
72
or 96hr ErC50 (for algae or other aquatic
> 10 to ≤ 100mg/l. (Note 2)
plants)
an
d the substance is not rapidly degradable and/or the experimentally determined BCF
≥
500

(or, if absent, the log Kow≥ 4). (Note 3).
“Safety net” classification
Category Chronic 4
Cases
when data do not allow classification under the above criteria but there are never
theless some grounds for concern. This includes, for example, poorly soluble substances
for
which no acute toxicity is recorded at levels up to the water solubility (note 4), and
which

are not rapidly degradable in accordance with section 4.1.2.9.5 and have an experi
men
tally determined BCF ≥ 500 (or, if absent, a log Kow ≥ 4), indicating a potential to
b
ioaccumulate, which will be classified in this category unless other scientific evidence
exists showing classification to be unnecessary. Such evidence includes chronic toxicity
NOE
Cs > water solubility or > 1mg/l, or other evidence of rapid degradation in the envi
ron
men
t than the ones provided by any of the methods listed in section 4.1.2.9.5.

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30.3.2011
EN
Official Journal of the European Union
L 83/23
Note 1:
When
classifying substances as Acute Category1 and/or Chronic Category1 it is necessary at the same
time

to indicate the appropriate M-factor(s) (see Table 4.1.3).
Note 2:
Classification

shall be based on the ErC50 [= EC50 (growth rate)]. In circumstances where the basis of
the
EC50 is not specified or no ErC50 is recorded, classification shall be based on the lowest EC50
available.
Note 3:
When

no useful data on degradability are available, either experimentally determined or estimated data,
the substance should be regarded as not rapidly degradable.
Note 4:
“
No
acute toxicity” is taken to mean that the L(E)C50(s) is/are above the water solubility. Also for poorly
solub
le substances, (water solubility < 1mg/l), where there is evidence that the acute test does not pro
vide
a true measure of the intrinsic toxicity.
4.1.2.7.


Aquatic toxicity
4.1.2.7.1.
Acute
aquatic toxicity is normally determined using a fish 96-hour LC50, a crustacea species 48-hour
E
C
50 and/or an algal species 72- or 96-hour EC50. These species cover a range of trophic levels and
taxa
and are considered as surrogate for all aquatic organisms. Data on other species (e.g. Lemna spp.)
shall
also be considered if the test methodology is suitable. The aquatic plant growth inhibition tests are
n
ormally considered as chronic tests but the EC50s are treated as acute values for classification pur
poses (see note 2).
4.1.2.7.2.
For
determining chronic aquatic toxicity for classification purposes data generated according to the stan
dardised test methods referred to in Article8(3) shall be accepted, as well as results obtained from other
validated

and internationally accepted test methods. The NOECs or other equivalent ECx (e.g. EC10) shall
be used.
4.1.2.8.


Bioaccumulation
4.1.2.8.1.
Bioaccumulation

of substances within aquatic organisms can give rise to toxic effects over longer time
scales

even when actual water concentrations are low. For organic substances the potential for bioac
cumulation

shall normally be determined by using the octanol/water partition coefficient, usually
reported
as a log Kow. The relationship between the log Kow of an organic substance and its biocon
cen
tration as measured by the bioconcentration factor (BCF) in fish has considerable scientific literature
support.
Using a cut-off value of log Kow ≥ 4 is intended to identify only those substances with a real
poten
tial to bioconcentrate. While this represents a potential to bioaccumulate, an experimentally deter
min
ed
BCF provides a better measure and shall be used in preference if available. A BCF in fish of ≥ 500
is
indicative of the potential to bioconcentrate for classification purposes. Some relationships can be
ob
served between chronic toxicity and bioaccumulation potential, as toxicity is related to the body
burden.
4.1.2.9.


Rapid

degradability of organic substances
4.1.2.9.1.
Sub
stances that rapidly degrade can be quickly removed from the environment. While effects of such
sub
stan
ces
can occur, particularly in the event of a spillage or accident, they are localised and of short
duration
. In the absence of rapid degradation in the environment a substance in the water has the poten
tial
to exert toxicity over a wide temporal and spatial scale.
4.1.2.9.2.
On
e way of demonstrating rapid degradation utilises the biodegradation screening tests designed to
determin

e whether an organic substance is “readily biodegradable”. Where such data are not available,
a
BOD(5

days)/COD ratio ≥ 0,5 is considered as indicative of rapid degradation. Thus, a substance which
passes
this screening test is considered likely to biodegrade “rapidly” in the aquatic environment, and is
thus
un
likely to be persistent. However, a fail in the screening test does not necessarily mean that the
sub
stan

ce will not degrade rapidly in the environment. Other evidence of rapid degradation in the envi
ron
men
t may therefore also be considered and are of particular importance where the substances are
in
hib
itory to microbial activity at the concentration levels used in standard testing. Thus, a further clas
sification
criterion is included which allows the use of data to show that the substance did actually
deg
rade biotically or abiotically in the aquatic environment by > 70% in 28 days. Thus, if degradation
is
demon

strated under environmentally realistic conditions, then the criterion of “rapid degradability” is
met.

---

L 83/24
EN
Official Journal of the European Union
30.3.2011
4.1.2.9.3.
Man
y degradation data are available in the form of degradation half-lives and these can be used in defin
in
g rapid degradation provided that ultimate biodegradation of the substance, i.e. full mineralisation, is
achieved.

Primary biodegradation does not normally suffice in the assessment of rapid degradability
un
less
it can be demonstrated that the degradation products do not fulfil the criteria for classification as
hazardous

to the aquatic environment.
4.1.2.9.4.
The
criteria used reflect the fact that environmental degradation may be biotic or abiotic. Hydrolysis can
b
e con
sidered if the hydrolysis products do not fulfil the criteria for classification as hazardous to the
aquatic environment.
4.1.2.9.5.
Sub
stan
ces are considered rapidly degradable in the environment if one of the following criteria holds
true:
(a) if,
in 28-day ready biodegradation studies, at least the following levels of degradation are achieved:
(i) tests

based on dissolved organic carbon: 70%;
(ii) tests
based on oxygen depletion or carbon dioxide generation: 60% of theoretical maximum.
These
levels of biodegradation must be achieved within 10 days of the start of degradation which
poin
t is taken as the time when 10% of the substance has been degraded, unless the substance is
iden
tified as an UVCB or as a complex, multi-constituent substance with structurally similar con
stituen
ts. In this case, and where there is sufficient justification, the 10-day window condition may
b
e waived and the pass level applied at 28 days; or
(b) if,
in those

cases where only BOD and COD data are available, when the ratio of BOD5/COD is
≥ 0,5; or
(c) if
other convincing scientific evidence is available to demonstrate that the substance can be
deg
raded

(biotically and/or abiotically) in the aquatic environment to a level > 70% within a
28-day

period.
4.1.2.10.


Inorganic

compounds and metals
4.1.2.10.1.
For
inorganic compounds and metals, the concept of degradability as applied to organic compounds
has limited or no meaning. Rather, such substances may be transformed by normal environmental pro
cesses
to either increase or decrease the bioavailability of the toxic species. Equally the use of bioaccu
mulation data shall be treated with care (*).
(*) Specific
guidance has been issued by the European Chemicals Agency on how these data for such
sub
stan

ces may be used in meeting the requirements of the classification criteria.
4.1.2.10.2.
Poorly

soluble inorganic compounds and metals may be acutely or chronically toxic in the aquatic envi
ron
men
t depending on the intrinsic toxicity of the bioavailable inorganic species and the rate and
amoun

t of this species which enter solution. All evidence must be weighed in a classification decision.
This

would be especially true for metals showing 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 substances,
i.e.
categ
ories Acute 1 and Chronic 1 to4. In order to make use of all available data for purposes of
classifyin

g the aquatic environmental hazards of the mixture, the following is applied where appropriate:
The
“ relevan
t components” of a mixture are those which are classified “Acute 1”or “Chronic 1” and
presen
t in a concentration of 0,1% (w/w) or greater, and those which are classified “Chronic 2”, “Chronic
3
” or
“ Chron
ic 4” and present in a concentration of 1% (w/w) or greater, unless there is a presumption
(such
as in the case of highly toxic components (see section4.1.3.5.5.5)) that a component present in
a
lower

concentration can still be relevant for classifying the mixture for aquatic environmental haz
ards.
Gen
erally, for substances classified as “Acute 1” or “Chronic 1” the concentration to be taken into
account is (0,1/M)%. (For explanation M-factor see section4.1.3.5.5.5.)

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30.3.2011
EN
Official Journal of the European Union
L 83/25
4.1.3.2.
The
approach

for classification of aquatic environmental hazards is tiered, and is dependent upon the
type
of
in formation

available for the mixture itself and for its components. Figure 4.1.2 outlines the pro
cess
to be followed.
E
lemen
ts of the tiered approach include:
— classification

based on tested mixtures,
— classification

based on bridging principles,
— the
use
of
“summation of classified components” and/or an “additivity formula”.

Figure 4.1.2

Ti red
e
app oa
rl h
c to c assification of mixtures 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 been tested to determine its aquatic toxicity, this information can be
used
for
classifyin

g the mixture according to the criteria that have been agreed for substances. The clas
sification
is normally based on the data for fish, crustacea and algae/plants (see sections 4.1.2.7.1
an
d
4.1.2.7.2).

When adequate acute or chronic toxicity data for the mixture as a whole are lacking,
“
b ridg
in g principles” or “summation method” should be applied (see sections4.1.3.4 and4.1.3.5).
4.1.3.3.2.
The
lon
g-term hazard classification of mixtures requires additional information on degradability and in
certain
cases

bioaccumulation. Degradability and bioaccumulation tests for mixtures are not used as
they
are
usually

difficult to interpret, and such tests may be meaningful only for single substances.
4.1.3.3.3.


C
l a s s i f i c a t i o n f o r c a t e g o r y A c u t e 1
(a) When
there
are
adequate acute toxicity test data (LC50 orEC50) available for the mixture as a whole
showin

g L(E)C50 ≤ 1mg/l:
Classify
mixture as Acute 1 in accordance with point(a) of Table 4.1.0.

---

L 83/26
EN
Official Journal of the European Union
30.3.2011
(b) When
there are acute toxicity test data (LC50(s) or EC50(s)) available for the mixture as a whole
showin

g L(E)C50(s) > 1mg/l for normally all trophic levels:
No need to classify for acute hazard.
4.1.3.3.4.


C
l a s s i f i c a t i o n f o r c a t e g o r i e s C h r o n i c 1 , 2 a n d 3
(a) When
there are adequate chronic toxicity data (ECxx orNOEC) available for the mixture as a whole
showin

g ECx or NOEC of the tested mixture ≤ 1mg/l:
(i) Classify
the mixture as Chronic 1, 2 or3 in accordance with point(b)(ii) of Table 4.1.0 as
rapidly
degradable if the available information allows the conclusion that all relevant com
pon
ents of the mixture are rapidly degradable;
(ii) Classify
the mixture as Chronic 1 or2 in all other cases in accordance with point(b)(i) of
Table 4.1.0 as non-rapidly degradable;
(b) When
there are adequate chronic toxicity data (ECx orNOEC) available for the mixture as a whole
showin
g ECx(s) or NOEC(s) of the tested mixture > 1mg/l for normally all trophic levels:
No
need to classify for long-term hazard in categories Chronic 1, 2 or3.
4.1.3.3.5.


C l a s s i f i c a t i o n f o r c a t e g o r y C h r o n i c 4
I
f there are nevertheless reasons for concern:
Classify

the mixture as Chronic 4 (safety net classification) in accordance with Table 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 not been tested to determine its aquatic environmental hazard, but there
are
sufficient data on the individual components and similar tested mixtures to adequately characterise
the
hazards

of the mixture, this data shall be used in accordance with the bridging rules set out in sec
tion
1.1.3. However, in relation to application of the bridging rule for dilution, sections 4.1.3.4.2
and4.1.3.4.3 shall be used.
4.1.3.4.2.
Dilution

: if a mixture is formed by diluting another tested mixture or a substance classified for its aquatic
en
viron
mental hazard with a diluent which has an equivalent or lower aquatic hazard classification than
the
least toxic original component and which is not expected to affect the aquatic hazards of other com
pon
ents, then the resulting mixture may be classified as equivalent to the original tested mixture or sub
stan
ce. Alternatively, the method explained in section4.1.3.5may be applied.
4.1.3.4.3.
I
f a mixture is formed by diluting another classified mixture or substance with water or other totally
n
on
-toxic

material, the toxicity of the mixture can be calculated from the original mixture or substance.
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 based on summation of the concentration of its classified compo
n
en
ts.
The percentage of components classified as “Acute” or “Chronic” is fed straight in to the sum
mation

method. Details of the summation method are described in section4.1.3.5.5.

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30.3.2011
EN
Official Journal of the European Union
L 83/27
4.1.3.5.2.
Mixtures
can be made of a combination of both components that are classified (as Acute 1 and/or
Chron

ic 1, 2, 3, 4) and others for which adequate toxicity test data is available. When adequate toxicity
data
are
available for more than one component in the mixture, the combined toxicity of those com
pon
en
ts
is calculated using the following additivity formulas (a) or(b), depending on the nature of the
toxicity data:
(a) Based

on acute aquatic toxicity:
∑ Ci
Ci
= ∑
L(E)C
L(E)C

50m
n
50i
where:
C

i
= con
centration of component i (weight percentage);
L(E)C50i
= (mg

/l) LC50 or EC50 for component i;
η
= n umb
er of components, andi is running from 1 to n;
L(E)C

50m
= L(E
) C50 of the part of the mixture with test data.
The
calculated

toxicity may be used to assign that portion of the mixture an acute hazard category
which

is then subsequently used in applying the summation method;
(b) Based

on chronic aquatic toxicity:
∑ Ci + ∑ Cj
Ci
Cj
= ∑
+ ∑
EqNOECm
NOECi
0,1 × NOECj

n
n
where:
C

i
= con
centration of component i (weight percentage) covering the rapidly degrad
able components;
Cj
= con
cen
tration of component j (weight percentage) covering the non- rapidly
degradable components;
NOECi
= NOE

C (or other recognised measures for chronic toxicity) for component i
coverin

g the rapidly degradable components, in mg/l;
NOECj
= NOE

C (or other recognised measures for chronic toxicity) for component j
coverin

g the non-rapidly degradable components, in mg/l;
n
= n umb
er
of components, andi and j are running from 1 to n;
EqNOECm
= E quivalen
t NOEC of the part of the mixture with test data.
The
equivalent toxicity thus reflects the fact that non-rapidly degrading substances are classified
on
e hazard category level more “severe” than rapidly degrading substances.
The
calculated

equivalent toxicity may be used to assign that portion of the mixture a long-term
hazard

category, in accordance with the criteria for rapidly degradable substances (point(b)(ii) of
Tab
le 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 preferable to calculate the toxicity of
this
part
of the mixture using for each substance toxicity values that relate to the same taxonomic group
(i.e.
fish,
crustacean, algae orequivalent) and then to use the highest toxicity (lowest value) obtained (i.e.
use
the
most sensitive of the three taxonomic groups). However, when toxicity data for each compo
n
en
t are not available in the same taxonomic group, the toxicity value of each component is selected in
the
same

manner that toxicity values are selected for the classification of substances, i.e. the higher tox
icity
(from the most sensitive test organism) is used. The calculated acute and chronic toxicity is then
used
to
assess

whether this part of the mixture shall be classified as Acute 1 and/or Chronic 1, 2 or3
usin

g the same criteria described for substances.

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L 83/28
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Official Journal of the European Union
30.3.2011
4.1.3.5.4.
I
f a mixture

is classified in more than one way, the method yielding the more conservative result shall
be used.
4.1.3.5.5.


S u m m a t i o n m e t h o d
4.1.3.5.5.1.


R a t i o n a l e
4.1.3.5.5.1.1. I n case
of the substance classification categories Chronic 1 to Chronic 3, the underlying toxicity criteria
differ
b y a factor of 10 in moving from one category to another. Substances with a classification in a
hig
h
toxicity

band therefore contribute to the classification of a mixture in a lower band. The calcula
tion
of these

classification categories therefore needs to consider the contribution of any substance clas
sified

as Chronic 1, 2 or3.
4.1.3.5.5.1.2. When
a mixture contains components classified as Acute 1 or Chronic 1, attention must be paid to the
fact
that

such components, when their acute toxicity is below 1mg/l and/or chronic toxicity is below
0,1
mg/l (if non rapidly degradable) and0,01mg/l (if rapidly degradable) contribute to the toxicity of
the
mixture

even at a low concentration. Active ingredients in pesticides often possess such high aquatic
toxicity
but also some other substances like organometallic compounds. Under these circumstances the
application
of the normal generic concentration limits leads to an “under-classification” of the mixture.
Therefore, multiplying factors shall be applied to account for highly toxic components, as described in
section4.1.3.5.5.5.
4.1.3.5.5.2.


C l a s s i f i c a t i o n p r o c e d u r e
4.1.3.5.5.2.1. I n g eneral a more severe classification for mixtures overrides a less severe classification, e.g. a classifi
cation
with Chronic 1 overrides a classification with Chronic 2. As a consequence, in this example, the
classification

procedure is already completed if the result of the classification is Chronic 1. A more severe
classification

than Chronic 1 is not possible. Therefore it is not necessary to undergo the further clas
sification procedure.
4.1.3.5.5.3.


C
l a s s i f i c a t i o n f o r c a t e g o r y A c u t e 1
4.1.3.5.5.3.1. First
all
compon

ents classified as Acute 1are considered. If the sum of the concentrations (in%) of these
compon

ents multiplied by their corresponding M-factors is greater 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 based on this summation of classified components is
summarised in Table 4.1.1.
Table 4.1.1

Classification of a mi