Workshop on Classification and Workshop on Classification and ppLabelling System of Dangerous Labelling System of Dangerous

Ch i lCh i lChemicalsChemicals

TAIEX

Zagreb, 29-30 October 2009Zagreb, 29 30 October 2009

Contribution by Hermann Goetsch

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Labelling and packagingLabelling and packagingLabelling and packagingLabelling and packagingLLegal requirements, selection of egal requirements, selection of

precautionary statements, precautionary statements, practical examplespractical examples

Hermann GötschHermann Götsch Senior Legal Adviser, Chemicals Policy Unit, Federal Ministry of

Agriculture, Forestry, Environment and Water Management, g , y, g ,Vienna, Austria

Member of Austrian Delegation for UNECEGHSg

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Obligations for Classification, Labelling,Obligations for Classification, Labelling,Obligations for Classification, Labelling, Obligations for Classification, Labelling, Packaging, Art. 4 to 35 CLPPackaging, Art. 4 to 35 CLP

• Classify into Hazard classes, - categories, - divisions– Substances/mixtures meeting classification criteria

Notion of differentiation of hazard classes– Notion of differentiation of hazard classes– Hazard classes described in Annex I to CLP-Regulation

• General obligation to classify, label and packM f t i t d t h t l if l b l d k b f– Manufacturers, importers, downstream users have to classify, label and pack before placing a hazardous substance/mixture on market (Art. 4/1 CLP)

– Obligation for manufacturer, importer, downstream user to classify substances for REACH purposes (Art. 4/2 CLP)p p ( )

– Obligation for distributor to classify, package and label if relabelled/repackaged or change of label/package, otherwise they can use classification of suppliers (Art. 4/5 and 6 CLP)Labelling and correct packaging always necessary requirement for placing on the– Labelling and correct packaging always necessary requirement for placing on the market (Art. 4/10 CLP)

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Hazard Label (Art 17Hazard Label (Art 17 –– 34 CLP)34 CLP)Hazard Label (Art. 17 Hazard Label (Art. 17 –– 34 CLP)34 CLP)Provisions concerning the Label ContentsProvisions concerning the Label Contents

– General rules• Labelling elements:

Supplier detail; quantity in package; product identifiers; hazard– Supplier detail; quantity in package; product identifiers; hazard pictograms; signal words; hazard statements; precautionary statements; supplemental information

• Use of languagesg g– Special rules and exemptions for the general rules for labelling

(LPG, Aerosol dispensers, metals, etc.), Annex II (EUH001, etc)– Principles of precedence for labelling of substances andPrinciples of precedence for labelling of substances and

mixtures classified for multiple hazard classes– Updating information on labels

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Application of LabelsApplication of LabelsApplication of LabelsApplication of Labels

– General rules for the application of labels (Art. 31 CLP)31 CLP)

– Location of information on the label (Art. 32 CLP)CLP)

– Labelling of outer, inner packages and single packages according to transport rules and CLP (Art. 33 CLP)

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Packaging (Art 35 CLP)Packaging (Art 35 CLP)Packaging (Art. 35 CLP)Packaging (Art. 35 CLP)Requirements in principle similar to Directives– Requirements in principle similar to Directives 67/548/EEC and 1999/45/ECChild resistant fastenings and tactile warnings– Child resistant fastenings and tactile warnings for certain hazard classes/categoriesCertain design elements/expressions/forms– Certain design elements/expressions/forms forbidden for packages for the general publicCertain specific provisions in Annex II Part 5– Certain specific provisions in Annex II, Part 5 (currently only applying to wet cement and concrete, unpacked)concrete, unpacked)

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P i l E lP i l E lPractical Example: Practical Example: Attribution of Precautionary StatementsAttribution of Precautionary Statementsyy

P ti St t t fPrecautionary Statements for:2,2-dibromo-2-nitroethanol,

Index No. 609-056-00-6 EC N 412 380 9EC No. 412-380-9,

CAS No. 69094-18-4

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I f ti i A VI CLPI f ti i A VI CLPInformation in Annex VI CLPInformation in Annex VI CLP(Part 3, Table 1)(Part 3, Table 1)(Part 3, Table 1)(Part 3, Table 1)

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I f i i A VI CLPI f i i A VI CLPInformation in Annex VI CLPInformation in Annex VI CLP(Part 3 Table 2)(Part 3 Table 2)(Part 3, Table 2)(Part 3, Table 2)

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Classification and Labelling:Classification and Labelling:Classification

E l 1 1 H201

Labelling

Expl. 1.1, H201Carc. 2, H351Acute Tox. 4 *, H302

Pictograms:GHS01GHS08

STOT RE 2 *, H373**Skin Corr. 1A, H314Skin Sens. 1, H317

GHS05GHS07GHS09

Aquatic Acute 1, H400Aquatic Chronic 1, H 410

GHS09Signal Word: DangerHazard Statements:

H201H201H351H302

H373 **H373 **H314H317

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H410*

Choice of precautionary statements (not for Choice of precautionary statements (not for p y (p y (the general public):the general public):

Applicable provisions (1):Article 22 CLP-Regulation:Precautionary statementsPrecautionary statements1. The label shall include the relevant precautionary statements.2. The precautionary statements shall be selected from those set out in

the tables in Parts 2 to 5 of Annex I indicating the label elements forthe tables in Parts 2 to 5 of Annex I indicating the label elements for each hazard class.

3. The precautionary statements shall be selected in accordance with the criteria laid down in Part 1 of Annex IV taking into account the t e c te a a d do a t o e ta g to accou t t ehazard statements and the intended or identified use or uses of the substance or the mixture.

4. The precautionary statements shall be worded in accordance with P t 2 f A IVPart 2 of Annex IV.

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Applicable provisions (2):

Article 28 CLP Regulation:Article 28 CLP-Regulation:

Principles of precedence for precautionary statements1 Wh th l ti f th ti t t t lt i t i1. Where the selection of the precautionary statements results in certain precautionary statements being clearly redundant or unnecessary given the specific substance, mixture or packaging, such statements shall be omitted from the label.2. Where the substance or mixture is supplied to the general public, one precautionary statement addressing the disposal of that substance or p y g pmixture as well as the disposal of packaging shall appear on the label, unless not required under Article 22. In all other cases, a precautionary statement addressing disposal shall not be required where it is clear thatstatement addressing disposal shall not be required, where it is clear that the disposal of the substance or mixture or the packaging does not present a hazard to human health or the environment.3 Not more than six precautionary statements shall appear on the label3. Not more than six precautionary statements shall appear on the label, unless necessary to reflect the nature and the severity of the hazards.

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Applicable provisions (3):Applicable provisions (3):

•Annex V Part I and Part II of CLP-RegulationAnnex V, Part I and Part II of CLP-Regulation (attribution of precautionary statements, wording of precautionary statements)precautionary statements)

•Annex VI Part 3 of CLP-Regulation (classification andAnnex VI, Part 3 of CLP Regulation (classification and labelling information for “harmonised” substances)

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Step 1:pIdentification of precautionary statements to be attributed:• Expl. 1.1: P 210, 230, 240, 250, 280, 370+380, 372, 373,

401 501401, 501• Carc. 2: P 201, 202, 281, 308+313, 405, 501• Acute Tox 4 (H 302): P 264 270 301+312 330 501• Acute Tox. 4 (H 302): P 264, 270, 301+312, 330, 501• STOT Re 2 (H 373): P 260, 314, 501• Skin Corr 1A: P 260, 264, 280, 301+330+333, 303+361+353,

363, 304+340, 310, 321, 305+351+338, 405, 501• Skin Sens 1: P 261, 272, 280, 302+352, 333+313, 321, 363,

501501• Aquatic Acute 1: P 273, 391, 501• Aquatic Chronic 1: P 273 391 501Aquatic Chronic 1: P 273, 391, 501

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Step 2:

Precautionary statements summation:

• Prevention: P 201, 202, 210, 230, 240, 250, 260, 261, 264, 270, 272, 273, 280, 281 (overall: 14)270, 272, 273, 280, 281 (overall: 14)

• Response: P 301+312, 301+330+333, 302+352, 303+361+353, 304+340, 305+351+338, 308+313, 333+313, 370+380, 310, 314, 321, 330, 363, 372, 373, 391 (overall: 17)

• Storage: P 401 405 (overall: 2)• Storage: P 401, 405 (overall: 2)• Disposal: P 501 (overall: 1)

Altogether: theoretically 34 precautionary statements

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Step 3:Step 3:

Reduction of phrases (according to Art. 28 CLP, includingReduction of phrases (according to Art. 28 CLP, including practical considerations):

• Delete 201 (no more information than 202), delete 261 (same meaning as 260), delete 281 (same meaning as 280);

• Delete 301+312, 302-352, 314, 321, 330, 363, 372, 373, 391, 308+313, 333+313 (Duplications, information partly not suitable because of higher danger (corrosion explosion etc )suitable because of higher danger (corrosion, explosion, etc.).

• Combine wording of 401 and 405; • Keep 501 (disposal clearly may present a hazard).Keep 501 (disposal clearly may present a hazard).

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Result:

19 sentences necessary to reflect the ynature and the severity of all the

hazards present:hazards present:

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Remaining precautionary statements:Remaining precautionary statements:

(1) Prevention:(1) Prevention:

P 202: Do not handle until all safety precautions have been read and understood.P 202: Do not handle until all safety precautions have been read and understood.P 210: Keep away from heat/sparks/open flames/hot surfaces. — No smoking.P 230: Keep wetted with …P 240: Ground/bond container and receiving equipment.g q pP 250: Do not subject to grinding/shock/…/friction.P 260: Do not breathe dust/fume/gas/mist/vapours/spray.P 264: Wash … thoroughly after handling.P 270: Do not eat, drink or smoke when using this product.P 272: Contaminated work clothing should not be allowed out of the workplace.P 273: Avoid release to the environmentP 280: Wear protective gloves/protective clothing/eye protection/face protection.

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(2) Response:

P 310 (do be combined with P 307): If exposed, immediately call a POISON CENTER or doctor/physicianp y

P 301+330+331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.P 303+361+353: IF ON SKIN (or hair): Remove/Take off immediately all contaminated

clothing. Rinse skin with water/shower.P 304+340: IF INHALED: Remove victim to fresh air and keep at rest in a position

comfortable for breathing.P 305+351+338: IF IN EYES: Rinse cautiously with water for several minutes. Remove

contact lenses, if present and easy to do. Continue rinsing.P 370+380: In case of fire: Evacuate area.

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(3) Storage:(3) Storage:

P 401, 405: Store locked up and in accordance with rules on explosives

(4) Disposal:

P 501: Dispose of contents/container to hazardous waste site in accordance with hazardous waste act (HWC No. . . .).( )

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For comparison: S-phrases necessary according to directive 67/548/EEC (not for the general public):

S 23-26-36/37/39-45-60-61:S 23: Do not breathe gas/fumes/vapour/sprayS 26: In case of contact with eyes, rinse immediately with plenty of water and

seek medical advice.S 36/37/39: Wear suitable protective clothing, gloves and eye/face protection.S 45: In case of accident or if you feel unwell, seek medical advice immediately

(show the label where possible)(show the label where possible).S 60: This material and its container must be disposed of as hazardous waste.S 61: Avoid release to the environment. Refer to special instructions/Safety

data sheetsdata sheets.

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ConclusionsConclusions

New statements give more and more specific information but tend to be too specific andinformation, but tend to be too specific and

numerous, sometimes lengthy, maybe difficult di l ll kto display on small packages

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Appendix: General Recommendations:Appendix: General Recommendations:Ad t ti i th L l F kAd t ti i th L l F kAdaptations in the Legal Framework: Adaptations in the Legal Framework:

• EU-Deadlines for Application should be kept: – December 1, 2010 (substances)– June 1, 2015 (mixtures)

• No major changes regarding enforcement and duties forNo major changes regarding enforcement and duties for Competent Authorities necessary

ll i ifi i d i• Overall no significant impacts expected – CLP is more or less a „deep“ technical adaptation of classification/labelling criteria, but considerable practical implications

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Appendix: General Recommendations: Appendix: General Recommendations: S ti f CLPS ti f CLP Vi l tiVi l tiSanctions for CLPSanctions for CLP--Violations Violations

• All offences regarding CLP-duties should be declared „administrative offences“

• Placing on the market (including importation) without proper classification labelling and packaging should be anproper classification, labelling and packaging should be an offence which leads to a considerable fine

• In severe cases, substances or mixtures not complying with CLP-requirements should be seized from the market (e.g. when child resistant fastenings are missing)when child-resistant fastenings are missing)

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Thank you very much for your kindThank you very much for your kindThank you very much for your kind Thank you very much for your kind attention !attention !

hermann.goetsch@lebensministerium.atg @

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