Current Amendments of Annex I, Annex XIII to the REACH Legal Text and The 2 nd ATP to CLP

Transcription

1 Current Amendments of Annex I, Annex XIII to the REACH Legal Text and The 2 nd ATP to CLP

2 Agenda 1. Updates of REACh legal text Location of updated documents Overview of update history 2. Annex I - General provisions for assessing substances and preparing of CSR Background Deadline Important updates 3. Annex XIII Criteria for identification of PBT and vpvb substances Background Deadline Key information 4. The 2 nd ATP to CLP Background Appointed dates for reclassification PC, Tox and Ecotox Labelling and H-statements

3 1. Updates of REACH legal text Where can you find the documents

4 1. Updates of REACH legal text

5 1. Updates of REACH legal text Official publications of legal text:

6 1. Updates of REACH legal text Overview of amendments of REACH legal text Legislation Amending as regards Annexes IV and V exemption (EC) No 987/2008 (EC) No. 1272/2008 C&L Amending as regards Annex XI waiving (EC) No 134/2009 A general amendment regarding Annex II (EC) No 453/2010 Date of in force 12. October January February June 2010 Key information Replacement of Annexes VI and V with modifications of exemption list in the Annex VI and exemption categories in the Annex V Adaptation of GHS in EU Effective dates: 1. December 2010 for Substance 1. June 2015 for mixtures Specification of the section 3.2: Justification and documentation requirement for exposure base waiving Safety Data Sheets related update. Effective dates: 01. December 2010 for substance 01. June 2015 for mixture Update dates: 01. December 2012 for substance 01. June 2017 for mixture

7 1. Updates of REACH legal text Overview of amendments of REACH legal text cont d Four amendments as regards Annex XVII- restriction (EC) No 552/2009 (EC) No 276/2010 (EC) No 207/2011 (EC) No 366/2011 Amendments as regards Annex XIV Substance subject to authorisation (EC) No 143/2011 Amending as regards Annex I (EC) No. 252/2011 Amending as regards Annex XIII (EC) No 253/2011 Legislation 21. February April 2011 Date of in force (1) 29. June 2009 (2) 4. April 2010 (3) 6. March 2011 (4) 5. May March 2011 Key information (1) Replacement of Annex XVII with revised restriction list (58 entries) (2) Modification of entry 3, addition of entry 59 (3) Deletion of entries 44 and 53 (4) addition of entry 60 6 substances are assigned as PBT or vpvb, or T, which may need to be subject to authorisation Assessing of substance and preparing of the CSR Effective date: 05. May 2011 Identification of PBT, vpvb Effective date: 19. March 2011

8 2. Updates of Annex I Provision for conducting a Chemical Safety Assessment and preparing of CSR Background Annex I is amended to adapt to the criteria for classification and other relevant provisions laid down in the CLP (EC 1272/2008) Important dates Publication date : 16. March 2011 Date of entry into force: 5 April 2011 Effective date: 5 May 2011 Deadline for updating of CSR Registrations submitted prior to 5 May 2011, the CSR shall be updated by 30. November 2012 free of charge

9 2. Updates of Annex I Provision for conducting a Chemical Safety Assessment and preparing of CSR Important updates 1. Chemical Safety Assessment shall include steps 5 and 6 if a substance or mixture fulfil the criteria of - physical hazards of all classes and categories EXCEPT Flammable aerosols Gases under pressure Self reactive of Type C&D, E&F and G Self-heating Oxidising liquids Category 3 Oxidising solids Category 3 Organic peroxides Type G

10 2. Updates of Annex I Provision for conducting a Chemical Safety Assessment and preparing of CSR Important updates cont d 1. Chemical Safety Assessment shall include steps 5 and 6 if a substance or mixture fulfil the criteria of - Health Hazards of all classes and categories EXCEPT Reproductive toxicity: adverse effect on or via lactation STOT SE Cat. 3: narcotic effect - Environmental Hazards of all classes and categories - Hazardous to the ozone layer A summary of all the relevant information used in addressing the points above shall be presented under the relevant heading of the Chemical Safety Report.

11 2. Updates of Annex I Provision for conducting a Chemical Safety Assessment and preparing of CSR Important updates cont d 2. Specific Concentration Limits (SCL) and M-Factor shall be presented if available; Application of Specific Concentration Limits (SCL) and M-Factor, which are not included in the Annex VI (harmonised classification and labelling), need to be justified. 3. Updates of PBT and vpvb assessment steps 1 and 2 4. Changes in CSR Format Irritation: deletion of subtitles Sensitisation: deletion of subtitles Mutagenicity replaced by Germ cell mutagenicity Toxicity for reproduction: deletion of subtitles

12 2. Updates of Annex XIII Identification and assessment of PBT, vpvb Background Annex XIII is amended/completed based on the review carried out by Commission pursuant to Article 138 (5) of REACH and to adapt to the criteria for classification and other relevant provisions laid down in the CLP (EC 1272/2008) Important dates Publication date : 16. March 2011 Date of entry into force: 19. March 2011 Effective date: 19. March 2011 Deadline for updating of Registration Registrations submitted prior to 19 March 2011 shall be updated by 19. March 2013 free of charge

13 2. Updates of Annex XIII Identification and assessment of PBT, vpvb Key information 1. General technical issues - Application of weight-of-evidence approach - Considering of constituents with PBT or vpvb properties - Considering of transformation and degradation products - Application of all relevant information available, not limited by the data requirement corresponding to the tonnage band - By positive screening assessment, additional information or testing may needed, unless implementation or recommendation of sufficient risks management measures (RMM) or operational condition established

14 2. Updates of Annex XIII Identification and assessment of PBT, vpvb Key information 1. Amended sections - Section 2: Screening and assessment of P. vp, B. vb and T Section 3: Information relevant for screening and assessment of P. vp, B. vb and T -..

15 4. 2 nd ATP to the EC 1272/2008 (CLP) Where can you find the document

16 4. 2 nd ATP to the EC 1272/2008 (CLP) Overview of updates to CLP Legislation Entry into force Key information EC No. 1272/2008 C&L 20. January 2009 Adaptation of GHS in EU Effective dates: 1. December 2010 for Substance 1. June 2015 for mixtures CLP related fee 25. May 2010 Fee for name change Fee for HCL dossier 1 st ATP 25. September 2009 Replacement of Harmonised Classification (Tab 3.1 and Tab 3.2) to Annex VI Effective data: 01. December nd ATP 20. April 2011 Adapting the technical provisions and criteria in the Annexes to Regulation (EC) No 1272/2008 to the third revised edition of the GHS. Effective dates: 1 December 2012 for Substance 1 June 2015 for mixtures ATP: Adaptation to Technical and scientific Progress

17 4. 2 nd ATP to the EC 1272/2008 (CLP) Background Adaptation of the technical provisions and criteria in the Annexes (I to VII) to Regulation (EC) No 1272/2008 to (CLP) the third revised edition of the GHS. Important dates Publication date : 30. March 2011 Date of entry into force: 19 April 2011 Effective date: 1 December 2012 for substances 1 June 2015 for mixture Nevertheless, the 2nd ATP can be applied prior to the effective dates on a voluntary basis

18 4. 2 nd ATP to the EC 1272/2008 (CLP) Appointed dates for reclassification Substances, classified, labelled and packed according to CLP and on the market prior to the 1 st December 2012, DO NOT need to be reclassified before 1. December 2014 Mixtures, classified, labelled and packed according to DPD/CLP and on the market prior to the 1 st June 2015, DO NOT need not be reclassified before 1. June 2017

19 4. 2 nd ATP to the EC 1272/2008 (CLP) Changes relevant for classification Physical Hazards 1. Physical hazards Flammable aerosols: Explicit clarification that flammable aerosols shall not be classified as flammable gasses, flammable liquids or flammable solids (additionally). - Health hazards Sensitisation : The classification of sensitising substances in category 1 shall now be divided in the sub-categories 1A and 1B, as long as the data are sufficient for such a classification. * Cat.1 shall be applied when data are not sufficient for sub-categorisation

20 4. 2 nd ATP to the EC 1272/2008 (CLP) Changes relevant for classification Health Hazards Sensitisation : The classification of sensitising substances in category 1 shall now be divided in the sub-categories 1A and 1B, as long as the data are sufficient for such a classification. * Cat.1 shall be applied when data are not sufficient for sub-categorisation

21 Hazard category and sub-categories for respiratory sensitisers 4. 2 nd ATP to the EC 1272/2008 (CLP) Respiratory Sensitiser:

22 Hazard category and sub-categories for respiratory sensitisers 4. 2 nd ATP to the EC 1272/2008 (CLP) Skin Sensitiser:

23 Hazard category and sub-categories for respiratory sensitisers 4. 2 nd ATP to the EC 1272/2008 (CLP) Skin Sensitiser:

24 Hazard category and sub-categories for respiratory sensitisers 4. 2 nd ATP to the EC 1272/2008 (CLP) Skin Sensitiser:

25 Hazard category and sub-categories for respiratory sensitisers 4. 2 nd ATP to the EC 1272/2008 (CLP) Generic concentration limits (GCL) for Respiratory/Skin Sensitisers:

26 4. 2 nd ATP to the EC 1272/2008 (CLP) This concentration limit for elicitation is used for the application of the special labelling requirements (EUH208) of Annex II section 2.8 to protect already sensitised individuals.

27 Hazard category and sub-categories for respiratory sensitisers 4. 2 nd ATP to the EC 1272/2008 (CLP) Changes relevant for classification Environmental Hazards The whole system for classification of chronic aquatic toxicity has now been aligned to the UN-GHS system. The consequence is that chronic aquatic toxicity will be classified predominately based on chronic toxicity data, such as NOEC values or ECx for chronic toxicity, rather than based on acute and fate data as before. According to the current CLP classification criteria for chronic toxicity, a substance, that is readily biodegradable and has low potential for bioaccumulation, does not need to be classified, though NOECs < 1 mg/l. Now, available chronic toxicity data needs to be considered for classification. An expert statement based declassification, for example low potential for bioaccumulation, should only be applied in absence of adequate chronic toxicity data. Hence, classification of chronic aquatic toxicity is more demanding and a higher number of substances will be in need to be classified for chronic toxicity.

28 4. 2 nd ATP to the EC 1272/2008 (CLP) Categories for substances long-term hazardous to the aquatic environment The criteria for classification of a substance in category Acute 1 are defined on the basis of acute aquatictoxicity data only (EC50 or LC50). The criteria for classification of a substance into the categories Chronic 1 to 3 follow a tiered approach: Are there adequate chronic toxicity data available for all three trophic levels? yes Classify according to the criteria given in Table (b) (i) or (b)(ii) depending on information on rapid degradation No

29 4. 2 nd ATP to the EC 1272/2008 (CLP) No Are there adequate chronic toxicity data available for one or two trophic levels? No yes Assess both: a) According to the criteria given in Table (b) (i) or (b)(ii) (depending on information on rapid degradation), and b) (if for the other level(s) adequate acute toxicity data are available) according to the criteria given in Table (b) (iii) and classify according to the most stringent outcome Are there adequate acute toxicity data available? yes Classify according to the criteria given in Table (b) (iii)

30 4. 2 nd ATP to the EC 1272/2008 (CLP) Classification categories aquatic acute toxicity Table a)

31 4. 2 nd ATP to the EC 1272/2008 (CLP) Classification categories aquatic chronic toxicity (I) Table b)i)

32 4. 2 nd ATP to the EC 1272/2008 (CLP) Classification categories aquatic chronic toxicity (II) Table b)ii)

33 4. 2 nd ATP to the EC 1272/2008 (CLP) Classification categories aquatic chronic toxicity (III)

34 4. 2 nd ATP to the EC 1272/2008 (CLP) Classification categories aquatic chronic toxicity (IV) Table 4.1.0

35 4. 2 nd ATP to the EC 1272/2008 (CLP) Changes relevant for classification Hazardous to the ozone layer - Definition The formal Ozone Depleting Potential (ODP) is the ratio of integrated perturbations to total ozone, for a differential mass emission of a particular compound relative to an equal emission of CFC-11. Substance hazardous to the ozone layer includes substances which are listed in Annex I to Regulation (EC) No 1005/2009, issued on 16. September New symbol, signal word H- and P-statements

36 4. 2 nd ATP to the EC 1272/2008 (CLP) Changes relevant for labelling 1. As Hazardous to the Ozone Layer is now an official UN-GHS class an exclamation mark has been added to the labelling. 2. If the hazard pictogram 'GHS02' or 'GHS06' applies, the use of the hazard pictogram 'GHS04' shall be optional. 3. Last but no least the layout of two pictograms has changed: exclamation mark and environmental hazards. GHS09

37 4. 2 nd ATP to the EC 1272/2008 (CLP) Amendment of mixtures containing at least one sensitising substance In the first CLP the EUH208 had only to be given in case of mixtures not classified as sensitising, but containing a sensitising substance above a specified value. Now EUH208 (Contains (name of sensitising substance). May produce an allergic reaction) has to be given on the label irrespectively of the classification of the mixture as sensitising or not in case sensitising substance above the relevant concentration limit is present.

38 4. 2 nd ATP to the EC 1272/2008 (CLP) Combined hazard statements for acute toxicity H300 + H310 H300 + H330 H310 + H330 H300 + H310 + H330 H301 + H311 H301 + H331 H311 + H331 H301 + H311 + H331 H302 + H312 H302 + H332 H312 + H332 H302 + H312 + H332 Fatal if swallowed or in contact with skin Fatal if swallowed or if inhaled Fatal in contact with skin or if inhaled Fatal if swallowed, in contact with skin or if inhaled Toxic if swallowed or in contact with skin Toxic if swallowed or if inhaled Toxic in contact with skin or if inhaled Toxic if swallowed, in contact with skin or if inhaled Harmful if swallowed or in contact with skin Harmful if swallowed or if inhaled Harmful in contact with skin or if inhaled Harmful if swallowed, in contact with skin or if inhaled

39 4. 2 nd ATP to the EC 1272/2008 (CLP) New P-statement P502 - Refer to manufacturer/supplier for information on recovery/recycling