Translation table from classification under Directive 67/548/EEC to classification under Regulation...

Translation table from classification under Directive 67/548/EEC to classification under Regulation 1272/2008 (Annex VII of the CLP

Regulation) - Practical examples

Mariusz GodalaBelgrade23-24 June 2011

Article 61(5) of CLP RegulationWhere 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 TableThis 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.


Annex VII – Translation TableAlthough 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.


Annex VII – Translation TableWhen classifying in 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.


Annex VII – Translation TableCLP introduces new 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


Annex VII – Translation TableThe hazard class “gases under pressure” is a new hazard class that 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)


Annex VII – Translation TableThe hazard class ‘corrosive to metals’ was not included in the DSD. 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.⊗


Annex VII – Translation TableClassification under Directive 67/548/EEC

Physical state of thesubstance when relevant

Classification under CLP Regulation

R10 liquid No direct translation possible.Correct translation of R10, liquid is:— Flam. Liq. 1, H224 if flashpoint < 23°C and initial boiling point ≤ 35°C— Flam. Liq. 2, H225 if flashpoint < 23°C and initial boiling point > 35°C— Flam. Liq. 3, H226 if flashpoint ≥ 23°C

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.


Annex VII – Translation Table

Classification under Directive 67/548/EEC

Physical state of the substance when relevant

Classification under CLP Regulation

R11 liquid No direct translation possibleCorrect translation of F; R11, liquid is:— Flam. Liq. 1, H224 if initial boiling point ≤ 35°C— Flam. Liq. 2, H225 if initial boiling point > 35°C

Flammable liquid

Transport classificationFlammable liquid

Classification according to CLPFlammable 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: 150°C - 200°C; Flashpoint: above 25°C



Different criteria

Example: Flammable substances and mixtures

(DSD/DPD):Flash point ≥ 21°C and ≤ 50°C

(CLP):Flash point ≥ 23°C and ≤ 60°C


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

4) Oxidising solid

5) Self-reactive

6) No classification

(**** - 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).

Index Number DSD classification CLP classification

611-013-00-1 E; R2 Expl. 1.3****; H202

609-068-00-1 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

Annex VII – Translation TableADR Classification CLP ClassificationClass 1 Division 1.1 Explosives Division 1.1

Class 1 Division 1.2 Explosives Division 1.2






Classification - Directive 67/548/EEC

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)

T; R23 gas Acute Tox. 3; H331 (1)

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)

T+; R26 gas Acute Tox. 2; H330 (1)

T+; R26 vapours Acute Tox. 1; H330

T+; R26 dust/mist Acute Tox. 2; H330 (1)

T; R27 Acute Tox. 1; H310

T; R28 Acute Tox. 2; H300 (1)

Acute toxicity– translation Table (Annex VII)


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.


Acute toxicity – dermal

EU T+;R27 T;R24 Xn; R21

LD50 ≤50 50-200 200-400 400-1000 1000-2000

CLP Cat. 1 Cat. 2 Cat. 3 Cat. 4

Acute toxicity

Acute toxicity – oral

T+; R28 T; R25 Xn; R22

LD50 25 200 2000 mg/kg

Category 1 Category 2 Category 3 Category 4

LD50 5.0 50 300 2000 mg/kg

Exposure routes Category 1 Category 2 Category 3 Category 4

Oral (mg/kg bodyweight) ATE≤5,0 5<ATE≤50 50<ATE≤300 300<ATE≤2000

Dermal (mg/kg bodyweight)

ATE≤50 50<ATE≤200 200<ATE≤1000 1000<ATE≤2000

Gases (ppm V) ATE≤100 100<ATE≤500 500<ATE≤2500 2500<ATE≤20000

Vapours (mg/l) ATE≤0,5 0,5<ATE≤2,0 2,0<ATE≤10 10,0<ATE≤20,0

Dust/mist (mg/l) ATE≤0,05 0,05<ATE≤0,5 0,5<ATE≤1,0 1,0<ATE≤5,0

ExampleSubstance 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?


Annex VII – Translation TableNote 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: Działanie żrące 1A (Skin Corr. 1A) UE: C; R34 - CLP: Działanie żrące 1B (Skin Corr. 1B) Note 2

Skin corrosion

Corrosive in ≥1 of 3 animals

Corrosive subcategory

Exposure Observation

Category 1Corrosive

1A ≤ 3 mimutes ≤ 1 hour

1B >3 minutes ≤ 1 hour ≤ 14 days

1C >1 godzina ≤ 4 hours ≤ 14 days

ExampleSubstance (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?



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.


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)

STOT - ExampleCLP classification:Carc 2 H351Acute 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; R40Xn; R22- 48/22 (Harmful: danger of serious damage to health

by prolonged exposure if swallowed)N; R50/53


Classification according to Directive 67/548/EEC

Classification according to Regulation 1272/2008/WE

N; R50 Aquatic Acute 1 H400N; R50/53 Aquatic Acute 1 H400

Aquatic Chronic 1 H410N; R51/53 Aquatic Chronic 2 H411R 52/53 Aquatic Chronic 3 H412R 53 Aquatic Chronic 4 H413


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)


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.



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.



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.



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.



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.


ExampleMixture 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.


Annex VII – Translation TableDirective 67/548/EEC CLP RegulationR1 EUH001

R6 EUH006

R14 EUH014

R18 EUH018

R19 EUH019

R44 EUH044

R29 EUH029

R31 EUH031

R32 EUH032

R66 EUH066

R39-41 EUH070

Supplemental hazard statements shall be include in the section for supplemental information on the label.



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


Thank you for your attention!

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