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Translation table from

classification under Directive


67/548/EEC to classification
under Regulation 1272/2008
(Annex VII of the CLP
Regulation) - Practical examples
Mariusz Godala
Belgrade
23-24 June 2011

Article 61(5) of CLP


Regulation
Where a substance
or mixture has been
classified in accordance with Directive
67/548/EEC or 1999/45/EC before
1 December 2010 or 1 June 2015
respectively, manufacturers, importers and
downstream users may amend the
classification of the substance or mixture
using the conversion table in Annex VII to
CLP Regulation.
Bureau for Chemical Substances

Annex VII Translation


Table
This Annex includes
a table to assist translation of a
classification made for a substance or a mixture
under Directive 67/548/EEC or Directive
1999/45/EC, respectively, into the corresponding
classification under CLP Regulation.
Whenever data for the substance or mixture are
available, an evaluation and classification shall be
done in accordance with Articles 9 to13 of CLP
Regulation.

Bureau for Chemical Substances

Annex VII Translation


Table
Although conceptually
similar, the coverage of CLP and
the DSD or DPD is different. In some places, there is a
good relationship between the category of danger and
corresponding R-phrases and hazard categories and
corresponding hazard statements but in others, the
relationship is less well defined.
Additionally CLP introduces new hazard classes
reflecting hazards that were not covered or only partly
covered by DSD and DPD.

Bureau for Chemical Substances

Annex VII Translation


When classifying inTable
accordance with CLP, the use

of the tables contained in Annex VII is optional.


They can only be used to translate an existing
classification provided that:
- the substance was classified according to the
DSD before 1st December 2010 or the mixture was
classified according to the DPD before 1st June
2015; and
- there is no data (scientific or technical
information) for the substance or mixture available
for an individual hazard class.
Bureau for Chemical Substances

Annex VII Translation


CLP introduces new Table
hazard classes reflecting hazards
-

that were not covered or only partly covered by DSD and


DPD:
gases under pressure,
flammable aerosols,
self-reactive substances
corrosive to metals

Bureau for Chemical Substances

Annex VII Translation


The hazard class gases under
pressure is a new hazard class that
Table
was not considered in DSD.
Gases that are classified in Annex VI of CLP have been identified with
the indication Press. Gas in the Classification column but without the
indication of the group and the corresponding hazard statement (H280 or
H281). The group depends on the physical state in which the gas is
packaged and therefore has to be assigned case-by-case (note U in Part
1 of Annex VI).
Example:
- hydrogen:
F+; R12 (DSD) Flamm. Gas 1; H220 Press. Gas 1 (Note U) (CLP)
- Boron trifluoride:
R14, T+; R26, C; R35 (DSD) Pres. Gas 1 (Note U), Acute Tox. 2; H330,
Skin Corr. 1A; H314 (CLP)
Bureau for Chemical Substances

Annex VII Translation


The hazard class corrosive to metals was not included in the DSD.
Table
Therefore, reclassification is not applicable. Only the substances and
mixtures presenting the health related property Skin corrosive were
included (Symbol C with R-phrases 34 or 35). These substances
generally present a significant potential for the corrosive to metals
property and should be considered for testing.
Example:
Hydroxylamine: (CLP) Unst. Expl. H200, Met. Corr. 1 H290, Acute Tox. 4 * H302, STOT RE 2
*H373, STOT SE 3 H335, Skin Irrit. 2 H315, Eye Dam. 1 H318, Skin Sens. 1 H317,
Aquatic Acute 1 H400
(DSD) R5 , Xn; R22-48/22, Xi; R37/38-41, R43, N; R50

Non-conformity with Table 3.1 for physical hazards


It is recommended to update the physical hazards of some entries in Table 3.2 in
a forthcoming adaptation totechnical progress. Until these entries are updated, the
physical hazards of the corresponding entries in both tables will not be in
conformity. These entries are indicated with reference in Table 3.2.
Bureau for Chemical Substances

Annex VII Translation


Classification under
Physical Table
Classification under CLP Regulation
Directive 67/548/EEC state of the
substance
when
relevant
R10

liquid

No direct translation possible.


Correct translation of R10, liquid is:
Flam. Liq. 1, H224 if flashpoint < 23C and initial
boiling point 35C
Flam. Liq. 2, H225 if flashpoint < 23C and initial
boiling point > 35C
Flam. Liq. 3, H226 if flashpoint 23C

Annex VII Translation


Table - example
Substance (liquid) classified according to Directive
67/548/EEC as flammable (R10). What will be the
classification of these substance according to CLP.
Additional information about the substance found in
Safety Data Sheet of :
- flashpoint: 22C,
- boiling point: 57C.

Bureau for Chemical Substances

Annex VII Translation


Table
Classification under Directive Physical state of
67/548/EEC
the substance
when relevant

Classification under CLP Regulation

R11

No direct translation possible


Correct translation of F; R11, liquid is:
Flam. Liq. 1, H224 if initial boiling point
35C
Flam. Liq. 2, H225 if initial boiling point
> 35C

liquid

Flammable liquid
Transport classification
Flammable liquid

Classification according to CLP


Flammable liquid

Class 3; Packing groupI

Flam. Liq. 1; H 224

Class 3; Packing group II

Flam. Liq. 2; H 225

Class 3; Packing group III

Flam Liq. 3; H 226

Example: methanol UN number 1230 Class 3, packing group II


classification according to CLP: Flam. Liquid 2; H225

Example
Mixture (liquid) is classified according to DPD Directive as
flammable (R10). What should be the classification of these
mixture according to CLP Regulation? During
reclassification used the information mentioned below:
a) information found in section 14 of SDS: UN number 1263
(Paints); Transport Class: 3; Packing group: III
b) information found in section 9 of SDS : boiling
temperature: 150C - 200C; Flashpoint: above 25C

Bureau for Chemical Substances

Annex VII Translation Table


Different criteria
Example: Flammable substances and mixtures
(DSD/DPD):Flash point 21C and 50C
(CLP):Flash point 23C and 60C

Bureau for Chemical Substances

Annex VII Translation Table


E; R2 - No direct translation possible.
E; R3 - No direct translation possible

Potential translation outcomes:


1) Explosive.
2) Organic peroxide
3) Flammable solid
Index Number
4) Oxidising solid
611-013-00-1
5) Self-reactive
6) No classification 609-068-00-1

DSD classification

CLP classification

E; R2

Expl. 1.3****; H202

E; R2

Expl. 1.1; H201

080-005-00-2

E; R3

Unst. Expl.; H200

080-006-00-8

E; R3

Expl. 1.1; H201

(**** - Correct classification for physical hazards could not be established


For some entries the correct classification for physical hazards could not be
established because sufficient data are not available for the application of
the classification criteria in this Regulation. The entry might be assigned to a
different (also higher) category or even another hazard class than indicated.
The correct classification shall be confirmed by testing).

Annex VII Translation Table


ADR Classification
Class 1 Division 1.1
Class 1 Division 1.2
Class 1 Division 1.3
Class 1 Division 1.4
Class 1 Division 1.5
Class 1 Division 1.6

CLP Classification
Explosives Division 1.1
Explosives Division 1.2
Explosives Division 1.3
Explosives Division 1.4
Explosives Division 1.5
Explosives Division 1.6

Bureau for Chemical Substances

Acute toxicity translation Table (Annex VII)


Classification
67/548/EEC

Directive

Physical state of
the substance
when relevant

Classification CLP Regulation

Note

Xn; R20

gas

Acute Tox. 4; H332

(1)

Xn; R20

vapours

Acute Tox. 4; H332

(1)

Xn; R20

dust/mist

Acute Tox. 4; H332

Xn; R21

Acute Tox. 4; H312

(1)

Xn; R22

Acute Tox. 4; H302

(1)
(1)

T; R23

gas

Acute Tox. 3; H331

T; R23

vapours

Acute Tox. 2; H331

T; R23

dust/mist

Acute Tox. 3; H331

(1)

T; R24

Acute Tox. 3; H311

(1)

T; R25

Acute Tox. 3; H301

(1)
(1)

T+; R26

gas

Acute Tox. 2; H330

T+; R26

vapours

Acute Tox. 1; H330

T+; R26

dust/mist

Acute Tox. 2; H330

T; R27

Acute Tox. 1; H310

T; R28

Acute Tox. 2; H300

(1)
(1)

Annex VII Translation Table


Note 1
For these classes it is possible to use the recommended
minimum classification as defined in section 1.2.1.1 in
Annex VI. Data or other information may be available to
indicate that re-classification in a more severe category is
appropriate.
This minimum classification should only be used if no
additional hazard information is available.

Bureau for Chemical Substances

Acute toxicity dermal


EU

T+;R27

T;R24

LD50

50

50-200

CLP

Cat. 1

Cat. 2

200-400

Xn; R21

400-1000

Cat. 3

1000-2000

Cat. 4

Acute toxicity
Exposure routes

Category 1

Category 2

Category 3

Category 4

Oral (mg/kg bodyweight)

ATE5,0

5<ATE50

50<ATE300

300<ATE2000

Dermal (mg/kg
bodyweight)

ATE50

50<ATE200

200<ATE1000

1000<ATE2000

Gases (ppm V)

ATE100

100<ATE500

500<ATE2500

2500<ATE20000

Vapours (mg/l)

ATE0,5

0,5<ATE2,0

2,0<ATE10

10,0<ATE20,0

Dust/mist (mg/l)

ATE0,05

0,05<ATE0,5

0,5<ATE1,0

1,0<ATE5,0

Acute toxicity oral


T+; R28
LD50

25

Category 1

LD50

T; R25

5.0

Xn; R22
200

Category 2

2000 mg/kg

Category 3

50

Category 4

300

2000 mg/kg

Example
Substance classified according to DSD as:
- Toxic with R phrase R24 (Toxic in contact with skin),
- Harmful with R phrase R22 (Harmful if swallowed).
Additional information about these substance:
Acute dermal toxicity : LD50= 120 mg/kg,
Oral LD50 rat : LD50= 210 mg/kg.
What is the classification of these substance according to
the CLP Regulation?

Bureau for Chemical Substances

Annex VII Translation Table


Note 2
It is recommended to classify in Category 1B even if it also
could be possible that 1C could be applicable for certain
cases. Going back to original data, may not result in a
possibility to distinguish between Category 1B or 1C, since
the exposure period has normally been up to 4 hours
according to Regulation (EC) No 440/2008. However, for the
future, when data are derived from tests following a
sequential approach as foreseen in the Regulation (EC) No
440/2008, Category 1C should be considered.
UE: C; R35 - CLP: Dziaanie rce 1A (Skin Corr. 1A)
UE: C; R34 - CLP: Dziaanie rce 1B (Skin Corr. 1B) Note 2

Bureau for Chemical Substances

Skin corrosion
Corrosive in 1 of 3 animals
Corrosive
subcategory

Exposure

Observation

Category 1 1A

3 mimutes

1 hour

Corrosive

1B

>3 minutes 1 hour

14 days

1C

>1 godzina 4 hours

14 days

Example
Substance (liquid) classified according to DSD as:
- Corrosive to skin with R phrase R34 (Causes burns),
- Toxic with R phrase R25 (Toxic if swallowed).
Additional information about these substance:
- A substance was tested on acute skin irritation / corrosion
according to OECD TG 404. A substance produced
destruction of skin tissue after 1hour 45 minutes after
application of the subtance on the skin of tested animals.
- Oral LD50 rat = 28 mg/kg,
- flashpoint: Tz=57C,
What is the classification of these substance according to
the CLP Regulation?
Bureau for Chemical Substances

Annex VII Translation Table


Xn; R48/20

STOT RE 2

H373

(3)

Xn; R48/21

STOT RE 2

H373

(3)

Xn; R48/22

STOT RE 2

H373

(3)

T; R48/23

STOT RE 1

H372

(3)

T; R48/24

STOT RE 1

H372

(3)

T; R48/25

STOT RE 1

H372

(3)

Xn; R68/20

STOT SE 2

H371

(3)

Xn; R68/21

STOT SE 2

H371

(3)

Xn; R68/22

STOT SE 2

H371

(3)

Note 3
The route of exposure could be added to the hazard statement if it is conclusively proven that no other routes of exposure cause the hazard.

Bureau for Chemical Substances

STOT - Example
CLP classification:
Carc 2 H351
Acute Tox. 4* H302
STOT RE 2* H373** (May cause damage to organs through
prolonged or repeated exposure)
Aquatic Chronic 1 H410
DSD classification:
Carc. cat. 3; R40
Xn; R22- 48/22 (Harmful: danger of serious damage to health
by prolonged exposure if swallowed)
N; R50/53

Annex VII Translation Table


Classification according to Directive
67/548/EEC

Classification according to Regulation


1272/2008/WE

N; R50
N; R50/53

Aquatic Acute 1 H400


Aquatic Acute 1 H400
Aquatic Chronic 1 H410

N; R51/53
R 52/53

Aquatic Chronic 2 H411


Aquatic Chronic 3 H412

R 53

Aquatic Chronic 4 H413

Annex VII Translation Table


DSD
. and the substance is not rapidly degradable
and/or the experimentally determined BCF 100
(or, if absent, the log Kow 3)

CLP
and the substance is not rapidly degradable and/or
the experimentally determined BCF 500 (or, if
absent, the log Kow 4)

Bureau for Chemical Substances

Annex VII Translation Table - Mixtures


Translation Table for mixture - attention is drawn to the fact that for
some hazards the DPD generic concentration limits, to be
applied for mixtures, are lowered under CLP. Lower generic
concentration limits are set for skin corrosion (R34 and R35),
severe eye damage and eye irritation (R41 and R36), skin irritancy
(R38) and reproductive toxicity (R60, R61, R62 and R63). Where
mixtures containing substances with risk phrases R34 or R41 have
been classified on basis of the hazards of individual ingredients,
the use of the translation table will lead to an under-classification
of the mixture.
Therefore, for mixtures with these R-phrases, the use of the
translation table may not be appropriate and re-classification may
be done by using the existing data.

Bureau for Chemical Substances

Annex VII Translation Table Mixtures


DPD: Mixtures containing 1-5% of R34 substances (and thus
not classified) CLP: Skin Irritant Category 2 - The generic
concentration limit is 1% in the CLP but the corresponding
limit is 5% in the DPD.
DPD: Mixtures containing 10 20% of R38 substances (and
thus not classified) CLP: Skin irritant Category 2
The generic concentration limit is 10% in the CLP but the
corresponding limit is 20% in the DPD.

Bureau for Chemical Substances

Annex VII Translation Table Mixtures


DPD: Mixtures containing 1-3% of R41 or R34 substances
(and thus not classified) CLP: Eye irritant Category 2 - The
lower generic concentration limit is 1% in the CLP but the
corresponding limit is 5% in the DPD.
DPD: Mixtures containing 3-5% of R41 or R34 substances
(and thus not classified) CLP: Serious eye damage
Category 1 - The generic concentration limit is 3% in the
CLP but the corresponding limit is 10% in the DPD.

Bureau for Chemical Substances

Annex VII Translation Table Mixtures


DPD: Mixtures containing 10 20% of R36 substances (and
thus not classified) CLP: Eye irritant Category 2 - The
generic concentration limit is 10% in the CLP but the
corresponding limit is 20% in the DPD.
DPD: Mixtures containing 3 - 5% of R62 or R63 substances
(and thus not classified) CLP: Reproductive toxicant,
Category 2 - The generic concentration limit is 3% in the
CLP but the corresponding limit is 5% in the DPD.

Bureau for Chemical Substances

Annex VII Translation Table Mixtures


DPD: Mixtures containing 0.3- 0.5% of R60 or R61
substances (and thus not classified) CLP:
Reproductive toxicant Category 1A/1B -The generic
concentration limit is 0.3% in the CLP but the
corresponding limit is 0.5% in the DPD.

Bureau for Chemical Substances

Example
Mixture consists of:
- 4,5% of substance classified according to DSD as corrosive
with R phrase R34 (C; R34)
- 6% of substance classified according to DSD as irritant with
R phrase R38 (Xi; R38)
What will be the classification of these mixture according to
CLP Regulation? During the reclassification use:
- translation table to reclassified the mixture,
- translation table to reclassified substances compounds of
the mixture. Then used the calculation methods to classified
mixture according to CLP Regulation.

Bureau for Chemical Substances

Annex VII Translation Table


Directive 67/548/EEC
R1
R6
R14
R18
R19
R44
R29
R31
R32
R66
R39-41

CLP Regulation
EUH001
EUH006
EUH014
EUH018
EUH019
EUH044
EUH029
EUH031
EUH032
EUH066
EUH070

Supplemental hazard statements shall be include in the section for


supplemental information on the label.

Bureau for Chemical Substances

Annex VII Translation Table


Pentane
DSD classification:
F+;R12 Xn;R65 R66 R67 N;R51/53
CLP classification
Flam. Liq. 2; H225 Asp. Tox. 1; H304 STOT SE 3;
H336 Aquatic Chronic 2; H411
Supplemental Hazard Stetement (Part of labelling
of substance not classification) EUH 066
Bureau for Chemical Substances

Thank you
for your attention!
mariusz.godala@chemikalia.gov.pl

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