1. LABELLING Mariana Mihalcea Udrea
NATIONAL ENVIRONMEMTAL PROTECTION AGENCY
BUCHAREST, SPLAIUL INDEPENDENTEI, 294, ROMANIA 1
22/04/2017

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
22/04/2017

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
22/04/2017

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
22/04/2017

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
22/04/2017

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
22/04/2017

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
22/04/2017

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
22/04/2017

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
22/04/2017

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
22/04/2017

11. Location of information on the CLP hazard label
CLP requirement (Article 32)
Decision left to the discretion
of the supplier
The hazard pictograms, signal word, hazard statements and precautionary statements shall be kept together on the label.
The supplier is free to choose the arrangement of the pictograms.
Hazard statements shall be grouped together on the label while the order of the hazard statements can be chosen freely..
The supplier may choose whether these groups are to be presented on the left, on the right or elsewhere on the label.
Precautionary statements shall be grouped together on the label while the order of the hazard statements can be chosen freely.
The supplier may choose whether these groups are to be presented on the left, on the right or elsewhere on the label.
In case more than one language is used on the
label, the hazard and precautionary statements of
the same language shall be grouped together on
the label.
Where the supplier may choose whether to
accomplish this using fold-out labels, tie-on tags or on an outer packaging,
Any supplemental information as referred to in Article 25 shall be included in the section for
supplemental labelling
The supplier may choose how to visibly separate
this section from the section containing the label
Elements and may also decide to place this information in more than one location on the label.
NATIONAL ENVIRONMEMTAL PROTECTION AGENCY
22/04/2017

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
22/04/2017

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 of Annex I) ≥0,1 %
shall bear the statement:
EUH208 — ‘Contains (name of sensitising substance). May produce an allergic reaction’.
NATIONAL ENVIRONMEMTAL PROTECTION AGENCY
22/04/2017

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
22/04/2017

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
22/04/2017

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
22/04/2017

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
22/04/2017

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
22/04/2017

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
22/04/2017

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
22/04/2017

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
22/04/2017

22. Minimum dimensions of labels and pictograms under CLP
Capacity of the package
Dimensions of the label
(in millimetres)
Dimensions of the
pictogram (in
millimetres)
Maximum 3 litres:
If possible at least52 × 74
Not small than 10 × 10
If possible at least, 16 × 16
> 3 litres but ≤ 50 litres
At least 74 x 105
At least 23 x 23
> 50 litres but ≤ 500 litres
At least 105 x 148
At least 32 x 32
> 500 litres
At least 148 x 210
At least 46 x 46
the label size and the size of the pictograms should remain proportional to the size of the packaging
NATIONAL ENVIRONMEMTAL PROTECTION AGENCY
22/04/2017

23. Pictograms GHS01 GHS06 GHS02 GHS07 GHS03 GHS04 GHS08 GHS05 GHS09 .
NATIONAL ENVIRONMEMTAL PROTECTION AGENCY
22/04/2017

24. Pictograms
The pictograms are provided free of charge for download from the website 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
22/04/2017

25. Pictograms
For physical and health hazards / if the label carries the pictogram GHS02 or GHS06 then GHS04 is optional : or
GHS GHS GHS04
mandatory mandatory optional
For health hazards, if the label carries the pictogram GHS06 then GHS07 shall not appear:
GHS GHS07 .
NATIONAL ENVIRONMEMTAL PROTECTION AGENCY
22/04/2017

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
22/04/2017

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
22/04/2017

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
22/04/2017

29. Obligatory supplemental labelling information pursuant to CLP Articles 25 and 32
1. Physical proprieties
EUH 001
Explosive when dry
EUH 006
Explosive with or without contact with air
EUH 014
Reacts violently with water
EUH 018
In use, may form flammable/ explosive vapor-air mixture
EUH 019
May form explosive peroxides
EUH 044
Risk of explosion if heated under confinement
NATIONAL ENVIRONMEMTAL PROTECTION AGENCY
22/04/2017

30. 2.Health proprieties Contact with water liberates toxic gas
EUH 029
Contact with water liberates toxic gas
EUH 031
Contact with acids liberates toxic gas
EUH 032
Contact with acids liberates very toxic gas
EUH 066
Repeated exposure may cause skin dryness or cracking
EUH 070
Toxic by eye contact
EUH 071
Corrosive to the respiratory tract
NATIONAL ENVIRONMEMTAL PROTECTION AGENCY
22/04/2017

31. 2. Health proprieties – certain mixtures
EUH 201
Contains lead. Should not be used on surfaces liable
to be chewed or sucked by children
EUH 201A
Warning! Contains lead. (for packaging content less
than 125 ml)
EUH 202
Cyanoacrylate. Danger. Bonds skin and eyes in seconds. Keep out of the reach of children.
EUH 203
Contains chromium (VI). May produce an allergic reaction
EUH 204
Contains isocyanates. May produce an allergic reaction
EUH 205
Contains epoxy constituents. May produce
an allergic reaction (M <700)
EUH 206
Warning! Do not use together with other products. May release dangerous gases (chlorine) (public use)
NATIONAL ENVIRONMEMTAL PROTECTION AGENCY
22/04/2017

32. supplemental labelling information
EUH 207
Warning! Contains cadmium. Dangerous fumes
are formed during use. See information supplied by the
manufacturer. Comply with the safety instructions.
EUH 208
Contains (name of sensitizing substance). May
produce an allergic reaction
EUH 209/209A
Can become highly flammable in use / Can become flammable in use
EUH 210
Safety Data Sheet available on request (not for public use)
EUH 401
To avoid risks to human health and the environment, comply with the instructions for use
NATIONAL ENVIRONMEMTAL PROTECTION AGENCY
22/04/2017

33. 3. Proprieties that can affect environment`
EUH 059
Hazardous to the ozone layer
NATIONAL ENVIRONMEMTAL PROTECTION AGENCY
22/04/2017

34. Hazard statements “H”
The suppliers have to select precautionary statements according to CLP Art.21 provisions and considering Parts of Annex I, as well
H2xx – physical hazard
H3xx - health hazard
H4xx – environmental hazard
NATIONAL ENVIRONMEMTAL PROTECTION AGENCY
22/04/2017

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
22/04/2017

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
22/04/2017

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
22/04/2017

38. Interaction between the CLP and the transport labelling rules
NATIONAL ENVIRONMEMTAL PROTECTION AGENCY
22/04/2017

39. Derogations from labelling requirements for special cases (Art
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
22/04/2017

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
22/04/2017

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
22/04/2017

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
22/04/2017

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
22/04/2017

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
22/04/2017

45. Thank you for attention !
NATIONAL ENVIRONMEMTAL PROTECTION AGENCY
22/04/2017