How To Write The Harmonised Chemical Safety Plan

Transcription

1 Classification, labelling and packaging according to CLP Studiedag LAB 3th October 2013 Dr Saskia Walraedt Sr Advisor Projectleider VLARIP 1

2 Content Introduction to CLP General principles on classification of mixtures Using harmonised classification and labelling Action plan 2

3 Abbreviations ATE : acute toxicity estimate ATP: adaptation to technical progress C&L: classification and labelling CLP : classification, labelling and packaging CMR : carcinogenic, mutagenic, reprotoxic DPD : Dangerous product directive DSD : dangerous substance directive DU : downstream user EC: European Commission ECHA : European Chemicals Agency GCL : generic concentration limit GHS: Globally Harmonised System LC: lethal concentration MS : member states NOEC : no observed effect concentration OJ: official journal RAC : Risk Assessment Committee REACH : registration, evaluation, authorisation and restriction of chemicals SCL : specific concentration limit STOT SE : specific target organ toxicity single exposure STOT RE : specific target organ toxicity repeated exposure

4 CLP the basics European implementation of the Globally Harmonised System (GHS), developed by UN But also EU specific List of EU harmonised classifications (annex VI) Notification of dangerous mixtures to national anti-poison centres Notification of the classification & labeling of substances to ECHA for the C&L inventory Regular updates via ATP Extension of the Annex VI list Adaption to the biannual revision of GHS

5 GHS vs CLP GHS (VN) CLP (EU ) Binding? no yes, EU regulation Classification yes yes GHS + EUH Labelling yes yes SDS yes no, REACH Packaging no yes Notification poison centres no yes Notification C&L no yes 5

6 CLP - a living regulation Extension of Annex VI list of harmonised classifications 1 ste ATP to CLP : inclusion of 30st en31st ATP to DSD Consolidated version: 3 e ATP First new harmonised classifications added :0010:NL:PDF 5 e ATP Notification to WTO expected Q EiF 20 d after publication in OJ The provisions will apply from 1 st January

7 CLP- a living regulation Adoption to the biannual revision of GHS 2 de ATP (regulation 286/2010) Adoption to 3th revision of GHS 4 e ATP (regulation 487/2013) Adoption to 4th revision GHS 7

8 Adaptation to revisions of GHS New classifications New test methods Changes to H statements Changes to P statements Impact on own classifications, labelling, SDS, software. 8

9 overgangsbepalingen CLP mbt indeling MENGSELS STOFFEN indeling volgens EU 67/548 verplicht indeling volgens EU 1999/45 verplicht indeling volgens CLP optie indeling volgens EU 67/548 verplicht indeling volgens CLP verplicht* indeling volgens EU 67/548 verplicht* indeling volgens CLP optie indeling volgens EU 1999/45 verplicht indeling volgens CLP verplicht indeling volgens CLP verplicht * Zowel indeling volgens CLP als volgens EU 67/548 te vermelden in SDS overgangsbepalingen CLP mbt etikettering MENGSELS STOFFEN etikettering volgens EU 67/548 verplicht etikettering volgens EU 1999/45 verplicht etikettering volgens EU67/548 of CLP (afh. van de indeling) 1 etiket! etikettering volgens CLP verplicht etikettering volgens EU 67/548 optie* etikettering volgens CLP verplicht etikettering volgens CLP verplicht etikettering volgens EU67/548 of CLP (afh. van de indeling) 1 etiket! etikettering volgens EU 67/548 optie* * Indien al op de martkt met EU-etiket voor de deadline

10 CLP for mixtures where to start 1/6/2015 knowled -ge CLP? CLP C&L ingredients Estimating C&L own mixture Reformulation and approvals Finalising C&L, modif. SDS Notification poison centres Labelling and packaging 10

11 CLP how it works Notification poison centre Collecting data Verification against criteria classification Labelling Packaging Notification C&L

12 Collecting data for own mixtures Fysical properties : classification on mixtures Human tox : no animal testing for C&L! aquatoxicity : based on aquatox data of ingredients Original concentration of a substance Max deviation < of = 2,5% ca 30% 2,5 < C < of = 10% ca 20% 10 < C < of = 25% ca 10% 25 < C < of = 100% ca 5% 12

13 For substances For mixtures DATA Use available data DATA Use available information on the mixture Use data of comparable mixtures ANNEX VI Check Annex VI tabel 3.1 for harmonised C&L Componente n Use information on C&L of substances to classify the mixture Conversio n table Use the conversion table (annex VII) for each substance not on annex VI and for which no data are available Conversietabel Use conversion table (annex VII) on DPD classification of the mixture till 1/6/

14 Fysische gevaren DPD Explosive Oxidising Flammable, highly flammable, extremely flammable CLP : No 1-to-1 conversion possible Physical state important Many new classes CLP Explosive Flammable gas Chem unstable gases Aerosols Oxidising gas Pressurised gas Flammable liquid Flammable solid Self react Pyroforic liq Pyroforic solid Self heating Water reacting Oxidising liquid Oxidising solid Organic peroxides Metal corrosives 14

15 Flammable Liquids CLP GHS danger warning warning Cat. 1 V p < 23 C & T k < 35 C Cat. 2 V p < 23 C & T k > 35 C Cat C < V p < 60 C Cat C < V p < 93 C F +,,R12 V p <0 & T k < 35 C R10 93 C flashpoint F,,R11 DSD/DPD 15

16 Humane tox DPD Harmful, toxic, very toxic Corrosive Irritant Sensitizer CMR CLP New classes New concept for calcution acute tox of mixtures based on ATE More stringent CLP Acute tox oral Acute tox dermal Acute tox inhalation Skin corr or irr Eye damage or irr Resp sensitiser Skin sensitiser CMR STOT SE STOT RE Asp tox 16

17 Acute toxicity estimate : ATE New! ATE = acute toxicity estimate To calculate acute tox of mixtures If available ATE = LC50 If LC50 not available and only category known, use ATE of table 3,1,2 17

18 ATE 18

19 Acute toxicity for mixtures When data available on all substances New! 100 ATEmix Ci n ATEi (Formule ) ATE mix = 100 / ( n Ci / ATEi) met Ci = concentration of substance i (% w/w of % v/v) i = the individual substances 1 to n n = number of substances ATEi = acute toxicity estimate for substancei 19

20 Tabel : determining acute tox category Blootstellingsroute Oraal (mg/kg lichaamsgewicht) Dermaal (mg/kg lichaamsgewicht) Categorie 1 Categorie 2 Categorie 3 Categorie 4 ATE 5 5 < ATE < ATE < ATE 2000 ATE 50 Gases (ppmv 1 ) ATE < ATE < ATE < ATE < ATE 2500 Dampen (mg/l) ATE < ATE < ATE 10.0 Stofdeeltjes en nevels (mg/l) ATE < ATE < ATE < ATE < ATE < ATE < ATE

21 Acute toxicity If acute tox is not known for all substances Substance with unknown acute tox 10 % Formule Substance with unknown acute tox > 10 % New! ATE mix = (100 ( C unknown if > 10 %) ) / ( Ci / ATEi) n 21

22 Generic concentration limits (GCL) DPD DPD Conc limit CLP CLP conc. limit Corr C, R34 10% Skin corr 1B en 1C 5% Corr C, R35 5% Skin corr 1A 3% Irr Xi, R38 20% Skin irr cat. 2 10% Irr XI, R36 20% Eye irr 2A 10% Irr Xi, R 41 10% Eye dam 1 3% Repr R60 of R61 0,5% Repr 1 0,3% Repr R62 of R63 5% Repr 2 3% 22

23 environment DPD Aq tox acute Aq tox chronic Ozone depletion CLP Aq Tox Acute Aq tox Chronic Ozone depletion New calculation rules New concept of M-factor for class 1 substances Use of EC50 and NOEC values Biodegradability taken into account 23

24 Annex VI : for which substances? Only for substances or groups of substances Group 1 : CMR cat 1A,1B or 2 respiratory sensitisers cat 1 When EU considers that harmonisation is required To be submitted by the MS (or industry) Attention :for all other hazards : self classification required!

25 Annex VI : for which substances? Group 2: Voor plant protection products and biocides Only to be submitted by MS For all end points

26 Specific concentration limits (SCL) In annex VI or Determined by registrant, importer or DU based on data To be indicated in section 3 of SDS Always check first if SCL available Priority : SCL > GCL, indepent of SCL value higher or lower than GCL value

27 opleiding REACH en CLP 27

28 ATP s adapting Annex VI Public consultati on Registry of Intentions RAC advise Follow up as soon as substance on RoI Impact own business? Reformulation required? To be adopted even if still on DPD! (before 6/2015) EC decision ATP in OJ 28

29 CLP for mixtures where to start 1/6/2015 knowled -ge CLP? CLP C&L ingredients Estimating C&L own mixture Reformulation and approvals Finalising C&L, modif. SDS Notification poison centres Labelling and packaging 29

30 CLP pictograms EXPLOSIEF ONTVLAMBAAR OXIDEREND GASSEN ONDER DRUK GHS01 GHS02 GHS03 GHS04! CORROSIEF GHS05 GEVAARLIJK VOOR HET AQUATISCH MILIEU GHS09 GIFTIG GHS06 IRRITEREND, SENSIBILISEREND, SCHADELIJK GHS07 LANGE TERMIJN GEZONDHEIDSGEVAARLIJK GHS08 ghs/pictograms.html 30h

31 Labelling Hazard statements Precautionary statements Max 6 statements How to select? Use priority guidelines ECHA guidance Avoid duplicates Consider at least 1 P statement per hazard Selling to industrial users/ professional/consumers? 31

32 Multiple languages OK but keep it readable! 32

33 CLP for mixtures where to start 1/6/2015 knowled -ge CLP? CLP C&L ingredients Estimating C&L own mixture Reformulation and approvals Finalising C&L, modif. SDS Notification poison centres Labelling and packaging 33

34 Notification to Be poison centre 1. According EU directives and regulations Gevaarlijke preparaten (KB 11/01/ vervangen door KB van 17/07/2002) art. 17 DPD CLP (art 45) Pesticides (KB 28/02/1994) Biocides (KB 5/09/2001) 2. Additional nationale regulations Cosmetics (KB 15/10/1997) 34

35 Melding anti-gifcentrum : 0&lang=nl pag. 35 Opleidingscyclus CLP voor experten 2013

36 CLP for mixtures where to start 1/6/2015 knowled -ge CLP? CLP C&L ingredients Estimating C&L own mixture Reformulation and approvals Finalising C&L, modif. SDS Notification poison centres Labelling and packaging 36

37 Logistics Consumer market? Other packaging may be required! New software labelling? New color printer or preprinted label? Warehouse organisation : Mixtures which were previously not classified may become CLP classified! E.g. flammables, irritating Packaging requirements For consumer products : tactile warnings and child proof caps? If ADR labelling required : Inner label : CLP, outer label : ADR and CLP optionally Single packaging : CLP picto may be omitted if = ADR labels 37

38 CLP for mixtures a team effort EHS classification impact? IT dept software impact? Logistics dpt labelling and packaging impact? R&D dpt reformulation required? Marketing/sales dpt commercial impact? 38

39 Conversion to CLP CLP training, build a CLP team Allow time Plan budget Discuss with suppliers (of mixtures) Inform internally (sales, purchasing, production, warehouse ) and externally (customers and suppliers)

40 More info on ECHA website Opleidingscyclus CLP voor experten

41 ECHA guidance Opleidingscyclus CLP voor experten

42 Usefull links ation/index_en.htm

43 Belgian helpdesk CLP Federale overheidsdienst (FOD) Volksgezondheid, Veiligheid van de Voedselketen en Leefmilieu Eurostation II Victor Hortaplein, 40 bus Brussel Contact Center : +32 (0) [email protected] calsubstances/index.htm 43

44 Conclusions Regular changes to the classification of mixtures possible, even before switching to CLP new data from the REACH registrations of the substances new harmonised classifications Make an action plan for the conversion of own production to CLP Follow up on the adaptation of other legislations, i.e. SEVESO, VLAREM

45 Disclaimer Alle gegevens op dit document worden door essenscia vzw/essenscia vlaanderen met de grootste zorgvuldigheid samengesteld. Voor deze informatie worden enkel betrouwbare bronnen aangewend. Ondermeer door de snelle evolutie van de behandelde materie blijft de mogelijkheid bestaan dat de gegevens toch niet volledig accuraat zijn, daarom wijst essenscia vzw/essenscia vlaanderen elke aansprakelijkheid voor fouten of onvolkomenheden af.