REACH and CLP - CLASSIFICATION & LABELLING INVENTORY INTEGRITY

Transcription

1 REACH and CLP - CLASSIFICATION & LABELLING INVENTORY INTEGRITY Dr Stuart Longworth Sankey Safety Consultants Ltd Phone: stuart@sankeysc.com Chairman of the Chemical Hazards Communication Society (CHCS) SSC Ltd/CHCS 1

2 REACH The introduction of REACH brought about a huge change in the way that chemicals were considered Changes from Notification to: Registration [by manufacturer or importer], Evaluation and, if necessary, Authorisation or Banning [by EU authorities] Emphasis shifted from inherent Hazards to potential Risks during use SSC Ltd/CHCS 2

3 REACH Production of Chemical Safety Assessments Consideration of Down Stream uses Exposure Scenarios Production of Chemical Safety Reports and Risk Management Measures Changes to the layout of Safety Data Sheets SSC Ltd/CHCS 3

4 REACH All of this meant closer collaboration with: Competitors in SIEFs to prepare for registrations Suppliers to ensure use patterns covered Customers to find out about use patterns In other words discussions and information sharing up, down and across the supply chain This has cost implications both financially and in man power SSC Ltd/CHCS 4

5 REACH Ensuring continuity of supply ie are my suppliers going to register my raw materials? Ensuring suppliers are aware of all the uses for substances Ensuring correctness of structure of substance being registered Ensuring correctness of Safety Data Sheets SSC Ltd/CHCS 5

6 REACH & CLP Various deadlines were set up: Registration dependant upon tonnages 1,000 tpa + CMRs at > 1 tpa + R50/53 at > 10 tpa --- by 1 st December ,000 tpa --- by 1 st June tpa --- by 1 st June 2018 Classification & Labelling Inventory for ALL substances subject to registration or classified as dangerous under CLP or DSD when marketed as substances OR as ingredients in a mixture --- within 1 month of 1 st December 2010 or of date of placing on market if after SSC Ltd/CHCS 6

7 REACH & CLP The Classification & Labelling Inventory was set up under REACH From the preamble (the Whereas clauses): (113) The classification and labelling for any substance either subject to registration or covered by Article 1 of Directive 67/548/EEC [ie[ DSD] and placed on the market should therefore be notified to the Agency to be included in the inventory. TITLE XI CLASSIFICATION AND LABELLING INVENTORY CLP Deleted this Title It was replaced by CLP Chapter 2 SSC Ltd/CHCS 7

8 CLP CHAPTER 2 Classification and labelling inventory Article 39 Scope This Chapter shall apply to: (a) substances subject to registration in accordance with Regulation (EC) No 1907/2006 [ie[ REACH]; (b) substances within the scope of Article 1 which meet the criteria for classification as hazardous and are placed on the market either on their own or in a mixture above the concentration limits specified in this Regulation or Directive 1999/45/EC [ie[ DPD], where relevant, which results in the classification of the mixture as hazardous. SSC Ltd/CHCS 8

9 REACH Annex II Amendment The new Annex II of REACH makes changes to the layout of the SDS to take account of CLP and align more closely with GHS SDS layout Will comprise of 66 Sections and Sub-sections (if all relevant) It also applies various timescales for conversion to the new format 2 versions - one covering till , and one for onwards SSC Ltd/CHCS 9

10 SDS for Substances Already on the market: May apply the new Annex II before Need not replace SDS before New after SDS must comply with the new Annex II SSC Ltd/CHCS 10

11 SDS for Mixtures Already on the market: May apply the new Annex II (version A) before May apply the new Annex II (version B) before Need not replace SDS before New after SDS must comply with the new Annex II (version A) New after SDS must comply with the new Annex II (version B) SSC Ltd/CHCS 11

12 New SDS some changes Careful reading of the CLP regulations, the REACH Annex II Amendment regulations and the ECHA Guidance is necessary to ensure that all the correct elements are entered into the SDS in the correct places For both substances and mixtures in the Amended Annex II the label elements are moved from Section 15 to Section 2. When available Chemical Safety Report (CSR) extracts will have to be added as an Appendix SSC Ltd/CHCS 12

13 New SDS some changes CSR extracts are fairly easy for substances as they will come from the Registration process But for mixtures they raise all sorts of problems Do you add the CSR extracts for each ingredient substance? Do you combine & summarise them? The recommendation is the latter SSC Ltd/CHCS 13

14 New SDS some changes Substances - have to provide classification under DSD as well as CLP until Mixtures - have to provide classification under DPD as well as CLP until Also classification under DSD for ingredients in Section 3 Have to provide Registration Numbers when allocated (ingredients in mixtures without the last 4 digits) BUT - For imported mixtures, the full registration number shall be given. SSC Ltd/CHCS 14

15 New SDS some changes Mixtures - in Section 3 list ingredients in decreasing concentrations, either actual or range When using a range of percentages, the health and environmental hazards shall describe the effects of the highest concentration of each ingredient. (Section 3.2 (b)). This reads as if the classification to be quoted is that at the concentration used, not the intrinsic (100%) hazard as under DPD This has now been clarified by ECHA SSC Ltd/CHCS 15

16 New SDS some changes The Commission intended the provision to say e.g., that if the concentration of ingredient X is given as %, the hazard classification of the whole mixture, given in Section 2, should be calculated assuming that X is present in the mixture at 15% (even if the actual percentage is lower). But the hazard to be quoted in Section 3 IS the intrinsic hazard. This is as it was under DPD. However they acknowledged that the text isn't entirely clear on this point (in particular as a result of its positioning), and suggested the issue may also be addressed in guidance, so this may provide some further clarification when it's produced. SSC Ltd/CHCS 16

17 CLP CLP brought in the new methods of classification based upon the UN Global Harmonisation System (the Purple Book) CLP is the EU/EEA version of GHS but it does not take all the end points and added the class of Dangerous to the Ozone Layer. NB Ozone has been added to the 3 rd revision of GHS. SSC Ltd/CHCS 17

18 CLP Various deadlines were set up for classification: Substances --- by 1 st December 2010 Mixtures --- by 1 st June 2015 It also amended REACH to replace the word preparation by mixture SSC Ltd/CHCS 18

19 CLP After 1 st December, information on CLP classification should be placed in Section 16 for mixtures so classified on voluntary basis in advance of full implementation (i.e. actual labelling of the product) rather than Section 2 because Section 2 should be aligned with the actual label. If a substance or mixture is labelled according to the CLP, then it must be classified and packaged accordingly and the CLP classification takes precedence on the SDS SSC Ltd/CHCS 19

20 CLP The classification of Tier 1 registration substances will be harmonised and reported by the relevant SIEFs Other Tier substances will have to be self- classified until their SIEFs report Mixtures will also have to be self-classified as preparations were under the DPD SSC Ltd/CHCS 20

21 CLP Rules, criteria and methods of classification are set out for substances and for mixtures In some cases expert judgment is required to correctly classify, but there is no guidance on how to do this at the moment Comparison to similar, classified substances and mixtures is allowed this is known as the Bridging Principle CLP has more hazard classes that DSD/DPD SSC Ltd/CHCS 21

22 CLP A translation table is provided for translations from DSD to CLP, but not all end points can be translated directly and some not at all An example is shown on the next slide - SSC Ltd/CHCS 22

23 CLP Translation Table For Acetone the table gives the following results: DSD F; R11 Xi, R36 R66 R67 Eye irritant Cat 2; H319 EUH066 STOT SE3; H336 CLP No direct translation possible. Correct translation of F; R11, liquid is: Flam. Liq. 1, H224 if initial boiling point = 35ºC Flam. Liq. 2, H225 if initial boiling point > 35ºC SSC Ltd/CHCS 23

24 CLP Translation Table R11 = Highly flammable H224 = Extremely flammable liquid and vapour H225 = Highly flammable liquid and vapour R36 = Irritating to eyes H319 = Causes serious eye irritation R66 = Repeated exposure may cause skin dryness or cracking EUH066 = Repeated exposure may cause skin dryness or cracking R67 = Vapours may cause drowsiness and dizziness H336 = May cause drowsiness or dizziness SSC Ltd/CHCS 24

25 CLP Visible Changes There are going to be vast changes on labels and this is going to confuse users, especially on products sold to the general public We are going to see things like. SSC Ltd/CHCS 25

26 CLP Pictograms Signal Words: DANGER WARNING SSC Ltd/CHCS 26

27 CLP Hazard Statements Hazard (H) statements instead of Risk (R) phrases: Physical Hazard Statements: H200 to H taken into CLP Health Hazard Statements: Normal - H300 to H taken into CLP Modified H350i to H360Df 9 taken into CLP Environmental Hazard Statements: H400 to H413 5 taken into CLP EU Hazard Statements: EUH001 to H added into CLP SSC Ltd/CHCS 27

28 CLP Hazard Statements No combination H Statements yet Currently 83 in CLP cf 68 single + 57 combination R-phrasesR Some H Statements shorter than equivalent R-phrase, some longer A lot have a different emphasis e.g. R10 Flammable H226 Flammable liquid and vapour SSC Ltd/CHCS 28

29 CLP Precautionary Statements Precautionary (P) Statements instead of Safety (S) phrases: General Precautionary Statements: P101 to H103 3 taken into CLP Prevention Precautionary Statements: P201 to P taken into CLP + 2 listed combined Response Precautionary Statements: P301 to P taken into CLP + 24 listed combined Storage Precautionary Statements: P401 to P taken into CLP + 6 listed combined Disposal Precautionary Statements: P501 1 taken into CLP SSC Ltd/CHCS 29

30 CLP Precautionary Statements Currently 114 single + 32 combination in CLP cf 53 single + 20 combination S-phrasesS Can make own combined statements from listed singles, but CANNOT reword e.g. S7/8 Keep container tightly closed and dry P402+P404 Store in a dry place. Store in a closed container. SSC Ltd/CHCS 30

31 CLP Precautionary Statements Many P-statements P applied to hazard classes in the regulation e.g. Acute Toxicity Category 1 oral H300 (Fatal if swallowed) P264 Wash thoroughly after handling. P270 Do not eat, drink or smoke when using this product. P301+P310 IF SWALLOWED: Immediately call a POISON CENTER or doctor / physician. P321 Specific treatment (see on this label). P330 Rinse mouth. P405 Store locked up. P501 Dispose of contents / container to... You decide which are relevant and should be used, especially when present as an ingredient in a mixture. SSC Ltd/CHCS 31

32 CLP Down Stream Effects The new classifications are going to impact on all down stream legislation that is currently based upon R phrases Legislation such as COSHH COMAH Waste As all of this is based on EU Directives, before local legislation can be amended the EU has to update the current Directives. This is likely to take the form of new Regulations thus removing the necessity for them to be transposed into local Member State law. But we don t t yet know when this will happen. SSC Ltd/CHCS 32

33 CLI The Classification & Labelling Inventory set up under CLP is to be populated mainly by Industry notifications These will normally be done by the REACH-IT functions using IUCLID5 There are other possibilities for multiple notifications, etc SSC Ltd/CHCS 33

34 CLI The CLI & Annex VI of CLP are hoped, eventually, to provide authoritative classifications for all hazardous substances on the EU market BUT that depends on the substances being classified correctly Assuming that the classification procedures are followed correctly there is still one big problem. SSC Ltd/CHCS 34

35 CLI Is the substance being classified fully understood Is its structure fully known? Are there any impurities present? If so, what are they? Do they affect the classification? A couple of examples SSC Ltd/CHCS 35

36 CLI Classifications of a well known substance Supplier Previous (2007) Now A NC B R36 C R36/37/38 D R36/38 (26% aqueous soln) E - F - G - H - SSC Ltd/CHCS 36

37 CLI Classifications of a well known substance Supplier Previous (2007) Now A NC NC B R36 NC C R36/37/38 NC D R36/38 (26% aqueous soln) NC E - R36 F - NC G - R40 H - NC SSC Ltd/CHCS 37

38 CLI A hypothetical situation A manufacturer is part of a SIEF for Substance A and the Registration is proceeding correctly for December this year The substance is not classified as hazardous In order to prove sameness of their product they had XRD testing carried out This showed up to 5% of an impurity SSC Ltd/CHCS 38

39 CLI A hypothetical situation The impurity is a known substance (B) that has been classified in the 1 st ATP to the CLP as a Category 1 Carcinogen Panic all round!!! SSC Ltd/CHCS 39

40 CLI A hypothetical situation This raises all sorts of questions What to do about the classification of A? Still consider A to be and impure substance but the classification of B forward to A? Is this still the same substance as the rest within the SIEF? Prepare an amended registration? SSC Ltd/CHCS 40

41 CLI A hypothetical situation This raises all sorts of questions Withdraw from SIEF and go for a new registration? Consider that Substance A is Mixture A? If so does Substance B need to be registered and if so, when? SSC Ltd/CHCS 41

42 CLI A hypothetical situation This raises all sorts of questions What about the CLI Notification? Is Substance A notified as currently under its Registration? Is it notified separately with the classification carried over from B? Is the notification of A abandoned and B notified instead? SSC Ltd/CHCS 42

43 CLI All of these problems need to be sorted out before CLI notification takes place Otherwise we will be in the same position as currently where we can get different classifications depending on which supplier s s catalogue we consult SSC Ltd/CHCS 43