3rd DRAFT DAO FOR GHS
DENR Administrative Order ______
Series of 2011
SUBJECT : Rules and Procedures for the Safety Data Sheet (SDS),
Labeling Requirements and Hazards Classification under
DENR Administrative Order No. 29, Series of 1992 of
Republic Act 6969 for the Adoption and Implementation
of the Globally Harmonized System (GHS)
Section I.
Legal Authority
Pursuant to the provisions of Republic Act 6969 under Section 4, Item C
“to inform and educate the populace regarding the hazards and risks attendant
to the manufacture, handling, storage, transportation, processing, distribution,
use and disposal of toxic chemical substances and other mixtures” as well as
to the Joint Administrative Order (JAO) among concerned government agencies
signed in 25 May 2009 on the adoption and implementation of Globally
Harmonized System (GHS) in labeling and re-labeling requirements, pertinent
rules and new regulations, procedures and requirements for industrial toxic
chemicals, are hereby promulgated.
Section II.
Objectives
These Rules aim to:
2.1
Develop and define the procedural guidelines and requirements to be
followed by the concerned stakeholders in the preparation and
submission of Safety Data Sheet (SDS) and labels of industrial toxic
chemicals and mixtures.
2.2
Strengthen the implementation of proper labeling and re-labeling
requirements of industrial toxic chemicals and mixtures.
2.3
Promote awareness on the adoption of concept and principles of the
Globally Harmonized system (GHS) for safe use and management of
industrial toxic chemicals and mixtures.
Section III.
Definitions
As used in these Rules
3.1 “CCO” is the acronym for Chemical Control Order that prohibit, limit, or
regulate the use, manufacture, import, transport, process, storage,
possession and wholesale of those priority chemicals that DENR
determined to be regulated, phased-out or banned because of the serious
risks that posed to public health, workplace, and in environment.
3.2 “Chemical” means any organic or inorganic substances of a particular
molecular identity including any element or uncombined chemical and
any combination of such substances, or any mixture of two and
excluding radioactive materials.
1
3.3
Chemical Substance refers to any organic or inorganic substance of a
particular molecular identity excluding radioactive materials but includes
– any element or uncombined chemical; and any combination of such
substances occurring in whole or in part as a result of chemical reaction
or occurring in nature
3.4 “Container” refers to any bottle, box, drums, cylinder, bag, barrel, vessel,
tank, among others that contains hazardous chemical substances and
mixtures.
3.5 “DAO 29” means Department Administrative Order on the Implementing
Rules and Regulations of Republic Act on Toxic Chemical Substances and
Nuclear and Hazardous Waste Control Act or otherwise known as “RA
6969”.
3.6 “DENR” refers to the Department of Environment and Natural
Resources
3.7
“EMB” refers to the Environmental Management Bureau
3.8
“GHS” is a system for standardizing and harmonizing the classification
and labeling of chemicals. It is logical and comprehensive approach to
▪ Defining health, physical and environmental hazards of chemicals
▪ Creating classification processes that use available data on
chemicals for comparison with the defined hazard criteria, and
▪ Communicating hazard information, as well as protective measures
on labels and Safety Data Sheets (SDS).
3.9
“Hazards” refer to the inherent characteristics of chemical substances
and mixtures that are existing in the workplace and in the environment
regardless of quantity that are potentially dangerous or which have the
capacity to harm i.e. its capacity to interfere with normal biological
processes, and its capacity to burn, explode, corrode, etc.
3.10 “Harmonization” refers to establishing a common and coherent basis
for classification and labeling of chemical hazards, and the appropriate
elements relevant to consumers, workers environmental
protection and mode of transport, can be selected/chosen.
3.11 IATA” refers to International Air Transport Association for the transport
of toxic chemicals in air.
3.12 “IMDG” refers to International Maritime Dangerous Goods for the
transport of chemical goods in ships.
3.13 “Label” refers to an appropriate group of written, printed or graphic
information elements that are affixed to, printed on, or attached to the
immediate container of a hazardous product, or to the outside packaging
of a hazardous product.
3.14 “Mixtures” refer to combination of two or more chemical substances with
no chemical reaction taking place.
3.15 New chemicals” refers to any chemical substances imported into or
manufactured in the country after December 31, 1993 and which are not
included in the Philippine Inventory of Chemicals and Chemical
Substances (PICCS) as nominated and published by the Department.
2
3.16 PCL” refers to the Priority Chemical List that consisted of existing and
new chemicals that DENR has determined to have potential risks to
public health, workplace and the environment.
3.17 “PMPIN” refers to Pre-Manufacture and Pre-Importation Notification which
is a process of review of notifications prior to manufacture and
importation activities of new chemicals or more chemical substances
undertaken by a Chemical Review Committee (CRC).
3.18
Precautionary statement is a phrase (and/or pictogram which
describes recommended measures that should be taken to minimize or
prevent adverse effects resulting from exposures to a hazardous product,
or improper storage or handling of hazardous product
3.19
Product Identifier refers to the name or number used for a
hazardous product on a label and on the SDS by which the substance or
mixture can be identified within the particular use and setting.
3.20 RA 6969” means Republic Act to control Toxic Substances and
Hazardous and Nuclear Wastes providing rules and guidance as well as
sanctions for violations thereof, and for other purposes.
3.21 Regulatory Permit/Clearance/Certification refers to the issuances made
by both the EMB from the Central and Regional Offices after review and
evaluation of documents by authorized representatives.
3.22 Safety Data Sheet (SDS) is a document prepared by the manufacturer
that contains important physical characteristics, ecological, health,
safety and toxicological information on chemical substances or mixtures
ingredients used at the workplace, transported, and utilized by
consumer.
3.23 “Toxic chemicals” are substances or mixtures that are harmful to the
environment and/or to human health in a short-term and long-term basis
if it is inhaled, swallowed, or absorbed through the skin.
3.24 “Worker” refers to any person exposed to toxic chemicals and mixtures,
e.g laboratory personnel, emergency responder, transporter, warehouse
staff, etc.
Section IV.
Scope and Coverage
These rules shall cover all chemical substances and mixtures manufactured,
imported, distributed, used, stored and transported in the Philippines. These
include chemicals and chemical substances under the priority chemical list,
chemical controlled order, high volume toxic chemicals, dangerous chemicals
regulated under IATA and IMDG and mixtures. These rules shall address the
classification, labeling and SDS requirements in order to convey information
about the chemical hazards as well as to protect the public and in the
environment from its potential health risks and effects.
3
Section V.
5.1
Transition of Implementation Period
Three (3) years of transition period after the effectivity of this Order shall
be provided for complete and strict compliance for the following:
5.1.1 CCO Chemicals
5.1.2 PCL Chemicals
5.2 Two years after the aforesaid transition period, this Order shall take effect
on the following :
5.2.1 High Volume Toxic Chemicals
5.3 A year after the aforesaid two periods, this Order shall take effect on:
5.3.1 Toxic Chemicals under the IATA and IMDG lists of dangerous
goods.
5.4 On the seventh year and thereafter, similar succession for their mixtures
shall be followed.
Section VI. General Procedures and Requirements
In addition to the general requirements under Title II of DAO 29 and the
pertinent DAOs for various controlled chemicals, the following rules have been
required for importers, distributors, manufacturers, users and transporters.
These procedures and requirements shall legally prescribe SDS and labelling of
toxic chemicals and mixtures. It hereby provides:
6.1 Preparation and Submission of SDS and labels.
6.1.1
All
chemical
importers,
manufacturers,
suppliers
and
distributors shall prepare the SDS and labels for all covered
industrial toxic chemical and mixtures which meet the harmonized
criteria for physical, health and environmental hazards under the
GHS following Annex 1 (guidelines for classification, labeling and
SDS preparation).
6.1.2
All chemical importers, manufacturers, suppliers and distributors
shall Submit SDS and labels when securing for permits, licenses,
clearances and certification using the GHS format together with a
notarized covering letter.
6.2 Screening, Review and Verification
6.2.1 SDS and labels submitted shall be initially screened by Chemical
Management staff and reviewed and verified by the GHS Review
Committee.
6.2.2 Information
sources
from
international
organizations
and
principal countries which are recognized to be reliable may be used
for verification1
1
Website addresses as GHS references in Annex 2
4
6.3 Inspection
6.3.1 The SDS of all chemicals used must be accessible and available to all
workers at all times.
6.3.2 All covered toxic chemicals and mixtures shall be labeled and marked
visibly
6.3.3 Appropriate pictograms, signal words, hazard and precautionary
statements must be placed at the storage facility/premise and on
transport.
Section VII.
Specific Requirements and Standards
The following hazard communication of all toxic chemicals and mixtures which
are expressed through labels and Safety Data Sheet (SDS) shall include various
detailed components and elements:
7.0 A. Labeling or Re-labeling Requirements
7.1A The importer, manufacturer, supplier and distributor shall ensure
that each container of chemical substances within the premise/
facility and in transport is labeled, tagged or marked
7.2A Labels shall clearly convey the hazards and risks and important
information about the chemical substances and mixtures by
including the following elements:
7.2.1A
7.2.2A
7.2.3A
7.2.4A
7.2.5A
7.2.6A
7.2.7A
Product Identifier
Supplier Identifier
Chemical Identity
Pictograms
Signal Words
Hazards Statement
Precautionary Statement
7.3A Product identifiers /declaration of ingredients
7.3.1A Name or number used for a hazardous product on a label or
in the SDS.
7.3.2A The substance or mixture can be identified within the
particular use setting.
7.3.3A UN number and proper shipping name also to be used on
the package when substance or mixture covered by the UN
RTDG
7.3.4A The labels for containers of hazardous chemical substances
and mixtures must clearly indicate the ingredients unless
covered by the CBI agreement.
7.4.A Supplier identification
7.4.1A
The name, address and telephone number of the
manufacturer or supplier of the substance or mixture shall be
provided on the label.
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7.5A Chemical Identity
7.5.1A The labels shall also include the chemical identity as
determined by International Union of Pure and Applied
Chemistry (IUPAC), by the Chemical Abstract Service (CAS)
Registry number or technical name.
7.6A Symbols, Pictograms (in white, red and black in colors) (Annex 3)
7.7A Signal word
7.7.1AWord that expresses the relative severity of hazard
(level of hazard) which warns the users of the potential
signal words used are “Danger and Warning”.
7.7.2A Use of signal word depends on the result of the
classification based on the criteria for GHS.
7.8A Hazard statements
7.8.1A A single harmonized statement for each hazard category2
within each hazard class.
7.8.2A Hazard statement depends on the result of Classification
based on the criteria for GHS.
7.9A Precautionary statements
7.9.1A Precautionary statements shall include prevention,
response in cases of accidental spillage and exposure, handling,
storage and disposal information.
7.0 B Safety Data Sheet (SDS) Requirements
7.1.B Identification of the substance or mixture and the manufacturer
and supplier.
7.1.1 B Name of the substance or mixture preparation
7.1.2 B Name, address and telephone number of the
manufacturer/supplier/undertaking
7.1.3 B Recommended use(s) of the chemical substance or
mixture
7.1.4 B Restrictions of use(s) of the chemical substance
or mixture
7.1.5B Emergency phone number of the manufacturer, importer or
supplier or distributor.
7.2 B Hazards identification
7.2.1 B Description of the hazards of the substance and
mixture.
7.2.2 B Appropriate signal word and hazard statements
7.2.3 B Precautionary statements associated with those hazards in this
section.
42 For example: Flammable liquid: Category 1 –“Extremely flammable liquid and vapour”; Category
2-“Highly flammable liquid and vapour”; Category 3-“Flammable liquid and vapour”; Category 4“Combustible liquid”.
6
7.2.4 B Hazard symbols may be provided as a pictograms or graphical
reproduction of the symbols in black and white background
with the meaning of the symbol.
7.30 B Composition and information on ingredients
7.3.1B
The identity of the chemical substance is being identified by its:
7.3.1.1B Chemical Abstract Service (CAS) Registered Number
7.3.1.2B IUPAC Name, technical name, etc
7.3.2 B Common Name/Trade Name/Brand Name/Code, etc
7.3.3 B Stabilizing additives and impurities which are classified and
which contribute to the classification of the substance.
7.3.4B The concentration ranges of all ingredients that are hazardous
and are above their cut-off levels.
7.40 B First-aid measures
7.4.1B
Description
of
necessary
and
preliminary
measures,
subdivided according to the different routes of exposure, i.e.
inhalation, skin and eye contact and ingestion.
7.4.2B Most important symptoms/effects: acute (immediate) and
chronic (delayed).
7.4.3 B Indication of immediate medical attention and special
treatment needed, if necessary.
7.50 B Fire-fighting measures
7.5.1 B Suitable and unsuitable media for fire extinguishing
7.5.2 B Specific hazards arising from chemical category (i.e. nature of
hazardous combustion products
7.5.3 B Appropriate Personal Protective Equipment (PPE) to be used.
7.5.4 B Precautions for firefighters
7.6 B Accidental release measures
7.6.1 B
Personal Protective Equipment (PPE), emergency
procedures and precautions.
7.6.2 B Methods and materials use for containment and
clean-up.
7.6.3 B Environmental Precautions
7.7 B Handling and storage
7.7.1 B Proper instructions on guidance and precautions on
safe handling of chemical substances and mixtures.
7.7.2 B Conditions for safe storage including incompatibilities.
7.8 B Exposure controls and personal protection
7.8.1 B Control parameters e.g. occupational exposure limit
values or biological limit values.
7.8.2 B Appropriate engineering controls.
7.8.3 B Individual protection measures, such as personal
protective equipment.
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7.9 B Physical and chemical properties
7.9.1B Appearance (physical state, colour etc)
7.9.2 B Odor
7.9.3 B Odor threshold
7.9.4 B pH
7.9.5 B Melting point and freezing point
7.9.6 B Initial boiling point and boiling range
7.9.7.B Flash point
7.9.8 B Evaporation rate
7.9.9 B Flammability (solid, gas)
7.9.10B Upper/lower flammability or explosive limits
7.9.11B Vapour pressure
7.9.12B Vapour density
7.9.13B Relative density
7.9.14B Solubility(ies)
7.9.15B Partition coefficient n-octanol/water
7.9.16B Auto-ignition temperature
7.9.17B Decomposition temperature
7.10 B Stability and Reactivity
7.10.1 B Chemical stability
7.10.2 B Possibility of hazardous reactions
7.10.3 B Conditions to avoid (e.g. static discharge, shock or
vibration)
7.10.4 B Incompatible materials
7.10.5 B Hazardous decomposition products.
7.10 B Toxicological information
7.11.1B Concise and complete description of the various
toxicological (health) effects and the available data
used to identify those effects.
7.11.2 B Information on the likely routes of exposure
(inhalation, ingestion, skin and eye contact)
7.11.3 B Symptoms related to the physical, chemical and
toxicological characteristics.
7.11.4 B Immediate effects (from short-term exposures)
and delayed effects (from long-term exposures).
7.11.5 B Numerical measures of toxicity (such as acute
toxicity estimates).
7.12 B Ecological information
7.12.1 B
7.12.2 B
7.12.3 B
7.12.4 B
7.12.5 B
Ecotoxicity (aquatic and terrestrial, where available)
Persistence and degradability
Bioaccumulative potential
Mobility in soil
Other adverse effects
7.13 B Disposal consideration
7.13.1 B Description of waste residues and information on
safe handling and methods of disposal, including the
disposal of any contaminated packaging.
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7.14 B Transport/Shipment information
7.14.1
7.14.2
7.14.3
7.14 4
7.14.5
7.14.6
B
B
B
B
B
B
UN number
UN Proper shipping name
Transport Hazard class(es)
Packing group, if applicable
Marine pollutant (Yes/No)
Special precautions which a user needs to be
Aware of or needs to comply with in connection
with transport or conveyance either within or
outside their premises
7.14.7 B Statement on the unavailability of relevant
information.
7.15 B National regulations and references
7.15.1 B Safety, health and environmental regulations specific
for the chemical substance or mixture in question.
7.15.2B Specify if the product is under Chemical Control
Order (CCO), Priority Chemical List (PCL) for local
chemical substance or mixtures.
7.16 B Other information
7.16.1 B Information on preparation and revision of the SDS,
i.e. date of revision, revision number, etc.
7.16.2 B Key/legend to abbreviations and acronyms used in
the SDS
7.16.3 B References/Purple Book
Section VIII. GHS REVIEW COMMITTEE
A collegial body comprised of multisectoral group from academe, industry,
concerned EMB-Regional Office, chemical management group, research and
development group and concerned government agencies shall be created
through a Special Order to form the GHS Review Committee. This body shall
review and evaluate the classification, appropriate chemical labeling and Safety
Data Sheet (SDS) in accordance with the adopted Globally Harmonized System
(GHS). Its composition with duties and responsibilities shall be approved prior
to its operation.
Section IX. Confidentiality of Business Information
Confidential Business Information (CBI) claims should be limited to the names
of chemicals and their concentrations in mixtures. The rules for CBI shall take
priority over the rules for product identification.
No disclosure of any information shall be done except for:
9.2.1 Instances when the provisions for CBI protection compromise the
health and safety of users.
9.2.2 Emergency situations.
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Section X. Revision of Requirements
The DENR in coordination with other concerned agencies may review, revise,
modify, update and supplement the requirements and procedures applicable to
these Rules particularly upon the applications of majority of industrialized
countries to the GHS concept and principles.
Section XI.
Monitoring Procedure
Compliance with the requirements established in this Administrative Order
shall be monitored regularly by the Department in collaboration with the GHS
Review Committee.
Section XII.
Penalty Clause
Any violations of the provisions specified in this Administrative Order will
subject those persons responsible thereof to administrative sanctions of Title V,
Chapter XI, Sections 41 of DAO 29, Series of 1992 and other existing pertinent
laws.
Section XIII.
Effectivity
This Order shall take effect thirty days (30) publication in two newspapers of
general circulation and submission of a copy hereof to the Office of the National
Registry of the University of the Philippines Law Center.
RAMON J.P. PAJE
Secretary
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ANNEX I - GUIDANCE FOR CLASSIFICATION, LABELING AND SDS
PREPARATION
(Preparation in progress)
11
ANNEX 2
SELECTED PCL CHEMICALS FOR LABELING
(As of 26 January 2011)
No. CAS No. PICCS Name
1. 106‐93‐4 1,2‐Dibromoethane 2. 95‐50‐1 0‐Dichlorobenzene 3. 106‐46‐7 1,4‐Dichlorobenzene 4. 107‐06‐2 1,2‐Dichloroethane 5. 122‐66‐7 1,2 Diphenylhydrazine 6. 108‐46‐3 3‐Hydroxyphenol 7. 7647‐18‐9 Antimony pentachloride 8. 7778‐39‐4 9. 22441‐45‐8 Arsenic pentachloride 10. 1303‐28‐2 Arsenic pentoxide 11. 7784‐34‐1 Arsenic trichloride 12. 1327‐53‐3 Arsenic trioxide 13. 7778‐39‐4 Arsenates 14. 1332‐21‐4 Asbestos 15. 71‐43‐2 Benzene 16. 13327‐32‐7 Beryllium hydroxide 17. 7787‐49‐7 Beryllium fluoride 18. 1304‐56‐9 Beryllium oxide 19. 13510‐49‐1 Beryllium sulfate 20. 543‐90‐8 Cadmium acetate 21. 10108‐64‐2 Cadmium chloride 22. 10325‐94‐7 Cadmium nitrate 23. 10124‐36‐4 Cadmium sulfate 24. 1306‐23‐6 Cadmium sulfide 25. 67‐66‐3 Chloroform 26. 76‐06‐2 Chloropicrin 27. 1327‐53‐3 Chromium nitrate 28. 1333‐82‐0 Chromium trioxide 29. 7789‐00‐6 Potassium Chromate 30. 7775‐11‐3 Sodium Chromate 31. 74‐90‐8 Hydrogen Cyanide 32. 143‐33‐9 Potassium Cyanide 33. 151‐50‐8 Sodium Cyanide 34. 64‐67‐5 Diethyl sulfate 35. 106‐93‐4 Ethylene dibromide 36. 75‐21‐8 Ethylene Oxide 37. 50‐00‐0 Formaldehyde 38. 111‐30‐8 Glutaraldehyde Arsenic Acid 12
39. 9002‐83‐9 Halons 40. 67‐72‐1 Hexachloroethane 41. 302‐01‐2 Hydrazine 42. 598‐63‐0 Lead carbonate 43. 1309‐60‐0 Lead dioxide 44. 15245‐44‐0 Lead styphnate 45. 1314‐91‐6 Lead telluride 46. 1314‐41‐6 Lead tetroxide 47. 1317‐36‐8 Lead (II) oxide 48. 10099‐74‐8 Lead (II) nitrate 49. 149‐30‐4 MBT (2‐Mercaptobenzothiazole) 50. 594‐42‐3 Mercaptan, Perchloromethyl 51. 7774‐29‐0 Mercury(II) iodide 52. 592‐85‐8 Mercury thiocyanate 53. 7439‐97‐6 Mercury metal 54. 7783‐34‐8 Mercuric nitrate monohydrate 55. 74‐87‐3 Methyl Chloride 56. 75‐09‐2 Methylenechloride 57. 87‐86‐5 Pentachlorophenol 58. 127‐18‐4 Perchloroethylene 59. 108‐95‐2 Phenic Acid 60. 75‐44‐5 Phosgene 61. 85‐44‐9 Phthalic Anhydride 62. 7782‐49‐2 Selenium 63. 79‐01‐6 Trichloroethylene 64. 75‐01‐4 Vinyl Chloride 13
ANNEX 3
Flammable subs.
Self reactive
Pyrophoric &
selfHeating
Explosives
PICTOGRA
Organic
peroxides
Self-reactive
bt
Compressed gas
(Gases under
Pressure)
Oxidizers
Organic peroxides
Acute
Toxicity
(Severe)
Corrosive to metal
Skin corrosion
Serious eye damage
Carcinogen
Respiratory Sensitive
Mutagenicity
Reproductive Toxicity
Target Organ Toxicity
Aspiration Hazard.
Irriitant (skin and eye)
Acute Toxicity (harmful)
Dermal Sensitizer
Target Organ toxicity
(narcotics or respiratory
Compressed gas
Oxidizing
Solids
Environmental
Hazard
14
Eye irritation
Acute
Toxicity
Skin
irritation
Eye irritation
Sensitization
(Dermal)
Target
Sensitization
(Respiratory)
Mutagenicity
Carcinogenicity
Reproductive
Toxicity
Target Organ
Toxicity
Aspiration Hazard.
Environmental
Hazard
15