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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.

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Presentation on theme: "Translation table from classification under Directive 67/548/EEC to classification under Regulation 1272/2008 (Annex VII of the CLP Regulation) - Practical."— Presentation transcript:

1 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

2 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

3 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

4 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

5 Annex VII – Translation Table When 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. © Bureau for Chemical Substances

6 Annex VII – Translation Table CLP 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 © Bureau for Chemical Substances

7 Annex VII – Translation Table The 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) © Bureau for Chemical Substances

8 Annex VII – Translation Table The 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. © Bureau for Chemical Substances

9 Annex VII – Translation Table Classification under Directive 67/548/EEC Physical state of the substance 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 35°C Flam. Liq. 3, H226 if flashpoint 23°C

10 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: 22 C, - boiling point: 57 C. © Bureau for Chemical Substances

11 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 possible Correct 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

12 Flammable liquid Transport classification Flammable liquid Classification according to CLP Flammable liquid Class 3; Packing groupIFlam. Liq. 1; H 224 Class 3; Packing group IIFlam. Liq. 2; H 225 Class 3; Packing group IIIFlam Liq. 3; H 226 Example: methanol – UN number 1230 – Class 3, packing group II – classification according to CLP: Flam. Liquid 2; H225

13 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 © Bureau for Chemical Substances

14 Annex VII – Translation Table Different criteria Example: Flammable substances and mixtures (DSD/DPD):Flash point 21°C and 50°C (CLP):Flash point 23°C and 60°C © Bureau for Chemical Substances

15 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 NumberDSD classificationCLP classification 611-013-00-1E; R2Expl. 1.3****; H202 609-068-00-1E; R2Expl. 1.1; H201 080-005-00-2E; R3Unst. Expl.; H200 080-006-00-8E; R3Expl. 1.1; H201

16 Annex VII – Translation Table ADR Classification CLP Classification Class 1 Division 1.1 Explosives Division 1.1 Class 1 Division 1.2 Explosives Division 1.2 Class 1 Division 1.3 Explosives Division 1.3 Class 1 Division 1.4 Explosives Division 1.4 Class 1 Division 1.5 Explosives Division 1.5 Class 1 Division 1.6 Explosives Division 1.6 © Bureau for Chemical Substances

17 Classification - Directive 67/548/EEC Physical state of the substance when relevant Classification – CLP RegulationNote Xn; R20gasAcute Tox. 4; H332(1) Xn; R20vapoursAcute Tox. 4; H332(1) Xn; R20dust/mistAcute Tox. 4; H332 Xn; R21Acute Tox. 4; H312(1) Xn; R22Acute Tox. 4; H302(1) T; R23gasAcute Tox. 3; H331(1) T; R23vapoursAcute Tox. 2; H331 T; R23dust/mistAcute Tox. 3; H331(1) T; R24Acute Tox. 3; H311(1) T; R25Acute Tox. 3; H301(1) T+; R26gasAcute Tox. 2; H330(1) T+; R26vapoursAcute Tox. 1; H330 T+; R26dust/mistAcute Tox. 2; H330(1) T; R27Acute Tox. 1; H310 T; R28Acute Tox. 2; H300(1) Acute toxicity– translation Table (Annex VII)

18 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

19 Acute toxicity – dermal EUT+;R27T;R24Xn; R21 LD 50 5050-200200-400400-10001000-2000 CLPCat. 1Cat. 2Cat. 3Cat. 4

20 Acute toxicity Acute toxicity – oral T+; R28T; R25Xn; R22 LD 50 25 200 2000 mg/kg Category 1Category 2Category 3Category 4 LD 50 5.0 50 300 2000 mg/kg Exposure routes Category 1Category 2Category 3Category 4 Oral (mg/kg bodyweight)ATE5,05 { "@context": "http://schema.org", "@type": "ImageObject", "contentUrl": "http://images.slideplayer.com/7/1649366/slides/slide_20.jpg", "name": "Acute toxicity Acute toxicity – oral T+; R28T; R25Xn; R22 LD 50 25 200 2000 mg/kg Category 1Category 2Category 3Category 4 LD 50 5.0 50 300 2000 mg/kg Exposure routes Category 1Category 2Category 3Category 4 Oral (mg/kg bodyweight)ATE5,05

21 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 : LD 50 = 120 mg/kg, Oral LD 50 rat : LD 50 = 210 mg/kg. What is the classification of these substance according to the CLP Regulation? © Bureau for Chemical Substances

22 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. © Bureau for Chemical Substances UE: C; R35 - CLP: Działanie żrące 1A (Skin Corr. 1A) UE: C; R34 - CLP: Działanie żrące 1B (Skin Corr. 1B) Note 2

23 Skin corrosion Corrosive in 1 of 3 animals Corrosive subcategory ExposureObservation Category 1 Corrosive 1A 3 mimutes 1 hour 1B >3 minutes 1 hour 14 days 1C >1 godzina 4 hours 14 days

24 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 LD 50 rat = 28 mg/kg, - flashpoint: Tz=57 C, What is the classification of these substance according to the CLP Regulation? © Bureau for Chemical Substances

25 Annex VII – Translation Table 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 Xn; R48/20STOT RE 2H373(3) Xn; R48/21STOT RE 2H373(3) Xn; R48/22STOT RE 2H373(3) T; R48/23STOT RE 1H372(3) T; R48/24STOT RE 1H372(3) T; R48/25STOT RE 1H372(3) Xn; R68/20STOT SE 2H371(3) Xn; R68/21STOT SE 2H371(3) Xn; R68/22STOT SE 2H371(3)

26 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

27 Annex VII – Translation Table Classification according to Directive 67/548/EEC Classification according to Regulation 1272/2008/WE N; R50Aquatic Acute 1 H400 N; R50/53Aquatic Acute 1 H400 Aquatic Chronic 1 H410 N; R51/53Aquatic Chronic 2 H411 R 52/53Aquatic Chronic 3 H412 R 53Aquatic Chronic 4 H413

28 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

29 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

30 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

31 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

32 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

33 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

34 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

35 Annex VII – Translation Table Directive 67/548/EEC CLP Regulation R1 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. © Bureau for Chemical Substances

36 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

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


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