LABELLING Mariana Mihalcea Udrea NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

1. LABELLING Mariana Mihalcea Udrea NATIONAL ENVIRONMEMTAL PROTECTION AGENCY BUCHAREST, SPLAIUL INDEPENDENTEI, 294, ROMANIA +4021 202 47 91 +40 746 248 466 m.mihalcea@anpm.ro 1

2. Purpose and scope of CLP on labelling • to ensure a high level of protection of human health and the environment by: • the rules on labelling and packaging for hazardous substances and mixtures • providing an obligation for suppliers • Suppliers must label a substance or mixture contained in packaging according to CLP before placing it on the market either when: • A substance is classified as hazardous. • A mixture contains one or more substances classified as hazardous above a certain threshold. • For manufacturers and importers of substances to notify the ECHA of such classifications and label elements if these have not been submitted as part of a registration dossier under Regulation (EC) No 1907/2006; NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

3. Overview rules The supplier shall ensure that a hazardous substance or mixture is labelled in accordance with Title III of the CLP Regulation before placing it on the market. The contact details of one / several suppliers must be included on the label. There can be more than one supplier of the same substance or mixture in the supply chain, e.g. in case a mixture has been supplied by the formulator to a distributor who would supply it to third parties as well. CLP Article 17 does not specify whether the contact details of both suppliers are needed in such cases. Nor does it specify whether the contact details of one particular supplier have precedence. NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

4. Elements of the CLP label -Art.17 Substance or mixture classified as hazardous and contained in packaging shall bear a label including the following elements: • Name, address and telephone number of the supplier(s); • The nominal quantity of the substance or mixture in the package where this is being made available to the general public, unless this quantity is specified elsewhere on the package; • Product identifiers, (Art.18); • Hazard pictograms, (Art.19); • The relevant signal word, (Art.20); • Hazard statements, (Art.21); • Appropriate precautionary statements, (Art.22); • A section for supplemental information, (Art.25). NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

5. Product identifiers • For substances shall consist of at least the following: • name and an identification number of substance included in Part 3 of Annex VI, or • name and an identification number as given C&L Inventory, or • number provided by the CAS together with the name set out in the nomenclature provided by the IUPAC, or the CAS number together with another international chemical name NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

6. Product identifiers For mixture shall consist of both of the following: • the trade name or the designation of the mixture; • the identity of all substances in the mixture that contribute to the classification of the mixture as regards acute toxicity, skin corrosion or serious eye damage, germ cell mutagenicity, carcinogenicity, reproductive toxicity, respiratory or skin sensitisation, specific target organ toxicity (STOT) or aspiration hazard. (unless more than four names are needed to reflect the nature and the severity of the hazards; the substances primarily responsible for the major health hazards which have given rise to the classification and the choice of the corresponding hazard statements) NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

7. Label updating (Art.30) • The label is updated, without undue delay, following any change to the classification and labelling of substance or mixture, where the new hazard is more severe or where new supplemental labelling elements are required under Article 25, taking into account the nature of the change as regards the protection of human health and the environment. • Suppliers shall cooperate in accordance with Article 4(9) to complete the changes to the labelling without undue delay. • Where labelling changes are required other than those referred to before, the supplier shall ensure that the label is updated within 18 months. • The supplier of a substance or a mixture within the scope of Regulation 1107/2009 or Regulation 528/2012 shall update the label in accordance with those Regulations NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

8. CLP Relabelled exemption A mixture that is already placed on the market before 1 June 2015 does not need to be relabelled before 1 June 2017. Once a product is in a warehouse, labelled and ready to use by final user, it is placed on the market . This applies not only to a distributor, but any supplier up the supply chain. In the case of a manufacturer’s warehouse, a sales contract should be available to claim that the product has already been made available to the customer before 1 June 2015. NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

9. General rules for the application of labels (Art.31) • Labels shall be firmly affixed to one or more surfaces of the packaging immediately containing the substance or mixture and shall be readable horizontally when the package is set down normally. • The colour and presentation of any label shall be such that the hazard pictogram stands out clearly. • The label elements shall be clearly and indelibly marked. They shall stand out clearly from the background and be of such size and spacing as to be easily read. • A physical label is not required when the label elements are shown clearly on the packaging itself NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

10. General rules for selection of “P” In selecting the precautionary statements in accordance with Articles 22 and 28(3), suppliers may combine the Precautionary Statements, having regard to clarity and comprehensibility of the precautionary advice. Annex IV - Part 1: Criteria for the selection of precautionary statements NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

11. Location of information on the CLP hazard label NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

12. Specific rules for labelling of certain mixtures Mixtures containing lead The label on the packaging of paints and varnishes containing lead in quantities exceeding 0,15 % (expressed as weight of metal) of the total weight of the mixture, as determined in accordance with ISO standard 6503, shall bear the following statement: EUH201 — ‘Contains lead. Should not be used on surfaces liable to be chewed or sucked by children’ In the case of packages the contents of which are less than 125 ml, the statement may be as follows: EUH201A — ‘Warning! Contains lead’ NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

13. Specific labelling rules The label on the packaging of mixtures not classified as sensitising but containing at least one substance classified as sensitising and present in a concentration equal to or greater than (that specified in Table 3.4.6 of Annex I) ≥0,1 % shall bear the statement: EUH208 — ‘Contains (name of sensitising substance). May produce an allergic reaction’. NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

14. Specific labelling rules Liquid mixtures containing halogenated hydrocarbons For liquid mixtures which show no flashpoint or a flashpoint higher than 60 ⁰ C but not more than 93 ⁰ C and contain a halogenated hydrocarbon and more than 5 % highly flammable or flammable substances, the label on the packaging shall bear one of the following statements, depending on whether the substances referred to above are highly flammable or flammable: EUH209 — ‘Can become highly flammable in use’ or EUH209A — ‘Can become flammable in use’ NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

15. Mixtures not intended for the general public For mixtures not classified as hazardous but which contain: • ≥ 0,1 % of a substance classified as skin sensitizer category 1, 1B, respiratory sensitizer category 1, 1B, or carcinogenic category 2, or • ≥ 0,01 % of a substance classified as skin sensitizer category 1A, respiratory sensitizer category 1A, or • ≥ one tenth of the specific concentration limit for a substance classified as skin sensitizer or respiratory sensitizer with specific concentration limit lower than 0,1 %, or • ≥ 0,1 % of a substance classified as toxic to reproduction categories 1A, 1B or 2, or with effects on or via lactation; or • at least one substance in an individual concentration of ≥ 1 % by weight for non-gaseous mixtures and ≥ 0,2 % by volume for gaseous mixtures either: — classified with other health or environmental hazards; or — for which there are Community workplace exposure limits the label on the packaging shall bear the statement: EUH210 — ‘Safety data sheet available on request’. NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

16. Principles of precedence for hazard statements (Art.27) • If a substance or mixture is classified within several hazard classes or differentiations of a hazard class, all hazard statements resulting from the classification shall appear on the label, unless there is evident duplication or redundancy. NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

17. Principles of precedence for precautionary statements (Art.28) • 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. • Where the substance or mixture is supplied to the general public, one precautionary statement addressing the disposal of that substance or mixture 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 that the disposal of the substance or mixture or the packaging does not present a hazard to human health or the environment. • Not more than six precautionary statements shall appear on the label, unless necessary to reflect the nature and the severity of the hazards. NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

18. Derogations from labelling requirements for special cases The specific provisions on labelling laid down in section 1.3 of Annex I shall apply in respect of the following: (a) transportable gas cylinders; (b) gas containers intended for propane, butane or liquefied petroleum gas; (c) aerosols and containers fitted with a sealed spray attachment and containing substances or mixtures classified as presenting an aspiration hazard; (d) metals in massive form, alloys, mixtures containing polymers, mixtures containing elastomers; (e) explosives, as referred to in section 2.1 of Annex I, placed on the market with a view to obtaining an explosive or pyrotechnic effect. NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

19. Supplemental information on the label shall be included in the section for supplemental information on the label where a substance or mixture classified as hazardous has: physical properties: • Unstable at the room temperature, • Reacts violently with water, • Flammable or occurs flammability • Explozive, etc or health properties: • Liberates toxic gas in contact with water or with acids • Repeated exposure may cause skin dryness or cracking • Toxic by eye contact • Corrosive to the respiratory Tract NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

20. Supplemental information on the label shall be included in the section for supplemental information on the label where a substance or mixture classified as hazardous falls within the scope of Directive 91/414/EEC / Regulation 1107/2009. Label elements resulting from other Community acts pursuant to Article 32(6): - authorisation number (REACH Reg.1907/2006) - listing of specified constituents such as anionic surfactants, oxygen bleaching agents, enzymes, disinfectants, optical brighteners and perfumes (Detergent Reg. 648/2004) - flammability labelling (aerosol dispenser Directive 75/234) - content of volatile organic compound(VOC Directive 2004/42) NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

21. information on the label Statements such as ‘non-toxic’, ‘non-harmful’, ‘non-polluting’, ‘ecological’ or any other statements indicating that the substance or mixture is not hazardous or any other statements that are inconsistent with the classification of that substance or mixture shall not appear on the label or packaging of any substance or mixture. NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

22. Minimum dimensions of labels and pictograms under CLP the label size and the size of the pictograms should remain proportional to the size of the packaging NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

23. Pictograms GHS01 GHS06 GHS02 GHS07 GHS03 GHS04GHS08 GHS05 GHS09 . NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

24. Pictograms The pictograms are provided free of charge for download from the website http://www.unece.org/trans/danger/publi/ghs/pictograms.html An example pictogram is the exclamation mark (pictogram GHS07), which is assigned to various health hazard classes and categories of lower severity GHS07 For physical hazards- For substances and mixtures classified for more than one hazard, GHS01 mandatory GHS02 optional GHS03 optional if the hazard pictogram ‘GHS01’ applies, the use of the hazard pictograms ‘GHS02’ and ‘GHS03’ shall be optional, except in cases where more than one of these hazard pictograms are compulsory; namely for substances and mixtures classified as self-reactive Type B or as organic peroxide Type B NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

25. Pictograms For physical and health hazards / if the label carries the pictogram GHS02 or GHS06 then GHS04 is optional : or GHS02 GHS06 GHS04 mandatorymandatoryoptional For health hazards, if the label carries the pictogram GHS06 then GHS07 shall not appear: GHS06 GHS07 . NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

26. Pictograms For health hazards, if the label carries the pictogram GHS05 (corrosion), then GHS07 (exclamation mark) shall not be used for skin or eye irritation … GHS05 GHS07 … but still has to be used for other hazards if the label carries the pictogram GHS08 (health hazard) for respiratory sensitisation, then GHS07 shall not be used for skin sensitisation or for skin or eye irritation … … but still has to be used for other hazards. NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

27. Pictograms For health hazards, In case a substance or mixture is assigned the supplemental hazard statement EUH071 (“Corrosive to the respiratory tract”), a corrosivity pictogram (GHS05) may be assigned. In that case the pictogram GHS07 for STOT, single exposure, category 3 (respiratory tract irritation) can be omitted from the label, as well as the hazard statement H335 (“May cause respiratory irritation”)sensitisation or for skin or eye irritation … GHS05 GHS07 ( STOT SE cat3 ) For substances and mixtures that have to be labelled both in accordance with the CLP Regulation and with the rules on the transport of dangerous goods, the CLP pictograms may be omitted from the label where a similar transport pictogram appears, NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

28. Signal words A signal word indicates the relative level of severity of a particular hazard in accordance with the classification of the hazardous substance or mixture: • more severe hazards require the signal word ‘danger’ • less severe hazards require the signal word ‘warning’ • Where a substance or mixture is classified for more than one hazard, the label shall only bear one single signal word. • In such cases, the signal word ‘danger’ takes precedence. • the label shall include the hazard pictogram corresponding to the most severe hazard category for each relevant hazard class. NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

29. Obligatory supplemental labelling information pursuant to CLP Articles 25 and 32 • 1. Physical proprieties NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

30. 2.Health proprieties NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

31. 2. Health proprieties – certain mixtures NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

32. supplemental labelling information NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

33. 3. Proprieties that can affect environment ` NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

34. Hazard statements “H” The suppliers have to select precautionary statements according to CLP Art.21 provisions and considering Parts. 2-5 of Annex I, as well H2xx – physical hazard H3xx - health hazard H4xx – environmental hazard NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

35. Precautionary statements “P” The suppliers have to select precautionary statements according to CLP Art.22 and 28 provisions and considering Part.1 of Annex IV, as well. Suppliers: • manufacturers or importers of substances, • importers of mixtures; • downstream users of substances or mixtures (including formulators), • distributors (including retailers) of substances or mixtures, and • producers or importers of explosive articles as defined in Part 2.1 of Annex I to CLP P1xx – general P2xx - prevention P3xx – response P4xx – storage P5xx – disposal NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

36. Exemptions from the labelling requirements derogations for packaging which is so small or in such a shape or form or that it is impossible to meet the requirements of Art. 31: label elements may be provided either on: • fold-out labels, / tie-on tags - shall meet the same performance standards as a normal label • outer packaging NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

37. Interaction between the CLP and the transport labelling rules • CLP labelling is normally required on every inner and intermediate layer of the packaging of a substance or mixture; it may also appear on an outer packaging. • Transport labelling will have to appear on the outer packaging of hazardous substances and mixtures if these are “dangerous goods” according to the rules on the transport of dangerous goods. • Single packages need to carry both the CLP label elements and the transport labelling, except for the CLP hazard pictograms where these are already covered by equivalent transport pictogram reflecting the same hazard. NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

38. Interaction between the CLP and the transport labelling rules NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

39. Derogations from labelling requirements for special cases (Art.23) for: • Transportable gas cylinders, with a water capacity of less than or equal to 150 litres: format and dimensions following the prescriptions of the current edition of Standard ISO 7225 relating to ‘Gas cylinders — Precautionary labels’ • Gas containers intended for propane, butane or liquefied petroleum gas (LPG) • Aerosols and containers fitted with a sealed spray attachment and containing substances or mixtures classified as presenting an aspiration hazard • Metals in massive form, alloys, mixtures containing polymers, mixtures containing elastomers • Explosives placed on the market with a view to obtaining an explosive or pyrotechnic effect NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

40. Labelling of packages where the contents do not exceed 125 ml The hazard statements and the precautionary statements linked to the hazard categories listed below may be omitted from the label elements required by Article 17 where: • the contents of the package do not exceed 125 ml; and • the substance or mixture is classified in one or more of the following hazard categories: 1) Oxidising gases of category 1; 2) Gases under pressure; 3) Flammable liquids of category 2 or 3; 4) Flammable solids of category 1 or 2; 5) Self-reactive substances or mixtures Types C to F; 6) Self-heating substances or mixtures of category 2; 7) Substances and mixtures which, in contact with water, emit flammable gases of categories 1, 2 or 3; NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

41. Labelling of packages where the contents do not exceed 125 ml 8) Oxidising liquids of category 2 or 3; 9) Oxidising solids of category 2 or 3; 10) Organic peroxides Types C to F; 11) Acute toxicity of category 4, if the substances or mixtures are not supplied to the general public; 12) Skin irritation of category 2; 13) Eye irritation of category 2; 14) Specific target organ toxicity — single exposure of category 2 or 3, if the substance or mixture is not supplied to the general public; 15) Specific target organ toxicity — repeated exposure of category 2, if the substance or mixture is not supplied to the general public; 16) Hazardous to the aquatic environment — Acute of category 1; 17) Hazardous to the aquatic environment — Chronic of category 1 or 2. NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

42. Labelling exemptions The precautionary statements linked to the hazard categories listed below may be omitted from the label elements required by Article 17 where: (a) the contents of the package do not exceed 125 ml; and (b) the substance or mixture is classified in one or more of the following hazard categories: 1) Flammable gases of category 2; 2) Reproductive toxicity: effects on or via lactation; 3) Hazardous to the aquatic environment — Chronic of category 3 or 4. NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

43. Labelling exemptions The pictogram, the signal word, the hazard statement, and the precautionary statement linked to the hazard categories listed below may be omitted from the label elements required by Article 17 where: (a) the contents of the package do not exceed 125 ml; and (b) the substance or mixture is classified in one or more of the following hazard categories: 1) Corrosive to metals. NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

44. Labelling exemptions Labelling of soluble packaging for single use The label elements required by Article 17 may be omitted where: a) The content of each soluble packaging does not exceed a volume of 25 ml; (b) The classification of the contents of the soluble packaging is exclusively one or more of the hazard categories presented previous 4 slides and (c) The soluble packaging is contained within outer packaging that fully meets the requirements of Article 17 The before provisions shall not apply to substances or mixtures within the scope of Regulation 1107/2009 or Regulation 528/2012. NATIONAL ENVIRONMEMTAL PROTECTION AGENCY

45. Thank you for attention ! NATIONAL ENVIRONMEMTAL PROTECTION AGENCY