draft ghs dao

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DRAFT GHS DAO
DENR Administrative Order ______
Series of 2007
SUBJECT: Rules and Procedures for the (Material) Safety Data
Sheet (MSDS) and Labeling Requirements Under
the DENR Administrative Order No. 29, Series of
1992 of Republic Act 6969. for the Implementation
of the 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 chemical substances and other mixtures”
as well as to labeling and re-labeling requirements of chemicals and
chemical substances and mixtures and other unregulated chemicals,
pertinent rules and new regulations, procedures and requirements for
chemicals and chemical substances, are hereby promulgated.
Section II.
Objectives
These Rules aim to:
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) of all industrial chemicals.
Strengthen the implementation of proper labeling and re-labeling
requirements of regulated all chemical substances and mixtures.
Promote awareness on the adoption of concept and principles of the Globally
Harmonized system (GHS for safe use and management of chemicals.
Section III.
Definitions
As used in these Rules:
3.1
Container refers to any bottle, box, drum, cylinder, bag, barrel, vessel,
tank, among others that contains hazardous chemical substances and
mixtures.
3.2
“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,
otherwise known as “RA 6969”.
3.3
“DENR” refers to the Department of Environment and Natural
Resources
1
3.4
“Chemical substance” means any organic or inorganic substance 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.
3.5
EMB refers to the Environmental Management Bureau
3.6
GHS
is
an
acronym
for
Globally Harmonized System of
Classification and Labeling of Chemicals. The 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).
3.7
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.
3.8
Harmonization refers to establishing a common and coherent basis for
hazards classification and communication of chemicals, and the
appropriate elements relevant to means of transport, consumers,
workers and environmental protection can be selected/chosen.
3.9
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.
3.10 “Mixtures” refer to combination of two or more chemical substances
with no chemical reaction taking place.
3.11 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
3.12 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.
2
3.13 Regulatory Permit/Clearance/Certification refers to the issuances
made by both the EMB from the Central and Regional Offices after
review and evaluation of authorized representatives.
3.14 Safety Data Sheet (SDS) is a document that provides important
physical
characteristics,
ecological,
health,
safety
and
toxicological information on chemical substances or mixtures
ingredients used at the workplace, transported, and utilized by
consumer.
3.15 “Toxic substances” are chemical substances or mixtures that
may be 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.
3.16 “Worker” refers to any person exposed to chemical substances and
mixtures, e.g,
laboratory personnel, emergency responder,
transporter, warehouse staff, etc.
Section IV.
Scope and Coverage
These Rules cover all chemicals and chemical substances and mixtures. It
addresses the proper preparation, submission and use of SDS and labels 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.
Pharmaceuticals, food additives, cosmetics and pesticide residues in food
are not covered at the point of intentional intake but will be covered where
workers may be exposed and in transport.
Section V. Exemptions
5.1
The rules excludes the submission and review on the following
requirements for:
5.1.1 Chemical hazards
test methods.
classification
and
establishing
uniform
5.1.2 Actual
testing
of chemical substances or mixtures to
address health outcomes
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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 are
required for importers, distributors, manufacturers, users and transporters.
These procedures and requirements shall
legally prescribe SDS and
labeling of hazardous chemicals. It hereby provides:
6.1 Preparation and Submission of SDS
6.1.1
Any
chemical
importer,
manufacturer,
supplier
and
distributor shall prepare the SDS for all chemical
substances and mixtures which meet the harmonized
criteria for physical, health and environmental hazards
under the GHS.
6.1.2 Any prepared SDS shall consider the available scientific
evidences in determining the hazards and reflecting the
scientific data/information in the SDS as provided in Annex 11.
6.1.3 Any chemical importer, manufacturer, distributor and supplier
must ensure that the SDS information prepared must be
clearly written in English.
6.1.4
Updating of SDS should be done whenever there are changes in
chemical
components,
toxicological
and
environmental
information and other relevant information.
6.1.5
Submit SDS using the GHS format together with a notarized
covering letter.
6.2 Screening, Review and Verification
1
6.2.1
SDS of specific chemical substance and mixture shall be
screened, reviewed and verified by all concerned agencies in
accordance with the sixteen (16) sections of the GHS.
6.2.2
All SDS must be easily understood, legible, disseminated and
provided to all manufacturers, distributors, transporters and
users.
6.2.3
In case of uncertainty or doubt on the veracity of the veracity of
the SDS, verification and confirmation shall be made by
concerned agencies with the assistance of industry partners.
6.2.3
Information sources from international organizations and
principal countries which are recognized to be reliable may be
used for verification2.
US, Canada, Japan, Australia Reference Materials in Annex 1
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6.2 Inspection
6.3.1
The SDS of all chemicals used must be accessible and
available to all workers at all times.
6.3.2
Visible labels and marks shall be made in all containers of
hazardous chemical substances and mixtures.
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 chemical substances and
mixtures which are expressed through labels and Safety Data Sheet (SDS)
shall include various detailed components and elements:
7.A Labeling or Re-labeling Requirements
7.A.1
7.A.2
The importer, manufacturer and distributor shall ensure that
each container of hazardous chemical substances within the
premise/facility and in transport is labeled, tagged or marked
within 6 months upon arrival or produced.
Labels shall clearly convey the hazards and important
information about the chemical substances and mixtures by
including the following elements:
7.A.2.1
7.A.2.2
7.A.2.3
7.A.2.4
7.A.2.5
7.A.2.6
Product Identifier
Supplier Identifier
Chemical Identity
Signal Words
Hazards Statement
Precautionary Statement
7.A.3 Symbols, Pictograms and Color2
7.A.4 Signal word
7.A.4.1
Word that expresses the relative severity of hazard
(level of hazard) which warns the users of the potential
hazard. Signal words used are “Danger and Warning”
7.A.4.2 Use of signal word depends on the result of the
classification based on the GHS criteria.
7.A.5 Hazard Statements
2
Examples of Pictograms in Annex 2
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7.A.5.1
A single harmonized statement for each hazard
category within each hazard class
7.A.5.2 Hazard
statement
depends
on the result of
Classification based on the GHS criteria.
7.A.6 Precautionary Statements
7.A.6.1 Precautionary statements shall include prevention,
response in cases of accidental spillage and exposure,
storage and disposal information.
7.A.6.2 Consideration should be given to select precautionary
statements for each target audience such as worker,
commercial user, consumer, among others.
7.A.7 Product identifiers /declaration of ingredients
7.A.7.1
Name or number used for a hazardous product on a
label or in the SDS.
7.A.7.2 The substance or mixture can be identified within the
particular use setting.
7.A.7.3 UN number and proper shipping name also to be used
on the package when substance or mixture covered by
the UN RTDG
7.A.7.4 The labels
for
containers of hazardous
chemical substances and mixtures must clearly
indicate the ingredients.
7.A.8 Chemical Identity
7.A.8.1 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.A.9 Supplier Identification
7.A.9.1 The name, address and telephone number of the
manufacturer or supplier of the substance or mixture
shall be provided on the label.
7.B Safety Data Sheet (SDS) Requirements
7.B.1 Identification of the Substance or Mixture and the Supplier.
7.B.1.1 Name of the substance or mixture preparation
7.B.1.2 Name, address and telephone number of the
company/supplier/undertaking
7.B.1.3 Recommended use(s) of the chemical substance or
mixture
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7.B.1.4 Restrictions of use(s) of the chemical substance
or mixture
7.B.1.5 Emergency phone number
7.B.2 Hazards Identification
7.B.2.1 Description of the hazards of the substance/ mixture.
7.B.2.2 Appropriate signal word and hazard statements
7.B.2.3 Precautionary statements associated with those
hazards in this section.
7.B.2.4 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.B.3 Composition and Information on Ingredients
7.B.3.1 The identity of the chemical substance is being
identified by its:
7.B3.1.1 Chemical Abstract Service (CAS) Registered
Number
7.B3.1.2 IUPAC Name, technical name, etc
7.B.3.2 Common Name/Trade Name/Brand Name/Code, etc
7.B.3.3 Stabilizing
additives and impurities which are
classified and which contribute to the classification of
the substance.
7.B.3.3 The concentration ranges of all ingredients that are
hazardous and are above their cut-off levels.
7.B.4 First-aid Measures
7.B.4.1 Description of necessary and preliminary measures,
subdivided according to the different routes of
exposure, i.e. inhalation, skin and eye contact and
ingestion.
7.B.4.2 Most important symptoms/effects: acute (immediate)
and chronic (delayed).
7.B.4.3 Indication of immediate medical attention and special
treatment needed, if necessary.
7.B.5 Fire-fighting Measures
7.B.5.1 Suitable and unsuitable media for fire extinguishing
7.B.5.2 Specific hazards arising from chemical category, i.e.,
nature of hazardous combustion products.
7.B.5.3 Appropriate Personal Protective Equipment (PPE) to be
used.
7.B.5.4 Precautions for firefighters
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7.B.6 Accidental Release Measures
7.B.6.1 Personal
Protective Equipment (PPE), emergency
procedures and precautions.
7.B.6.2 Methods and materials use for containment and cleanup.
7.B.6.3 Environmental Precautions
7.B.7
Handling and Storage
7.B.7.1 Proper instructions on guidance and precautions on
safe handling of chemical substances and mixtures.
7.B7.2 Conditions for safe storage including incompatibilities.
7.B.8
Exposure Controls and Personal Protection

7.B.8.1 Control parameters e.g. occupational exposure limit
values or biological limit values.
7.B.8.2 Appropriate engineering controls.
7.B.8.3 Individual protection measures, such as personal
protective equipment.
7.B.9 Physical and chemical properties
7.B.9.1
7.B.9.2
7.B.9.3
7.B.9.4
7.B.9.5
7.B.9.6
7.B.9.7
7.B.9.8
7.B.9.9
7.B.9.10
7.B.9.11
7.B.9.12
7.B.9.13
7.B.9.14
7.B.9.15
7.B.9.16
7.B.9.17
Appearance (physical state, colour etc)
Odor
Odor threshold
pH
Melting point and freezing point
Initial boiling point and boiling range
Flash point
Evaporation rate
Flammability (solid, gas)
Upper/lower flammability or explosive limits
Vapour pressure
Vapour density
Relative density
Solubility(ies)
Partition coefficient n-octanol/water:
Auto-ignition temperature
Decomposition temperature
7.B.10 Stability and Reactivity
7.B.10.1 Chemical stability
7.B.10.2 Possibility of hazardous reactions
7.B.10.3 Conditions to avoid, e.g., static discharge, shock or
vibration.
7.B.10.4 Incompatible materials
7.B.10.5 Hazardous decomposition products.
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7.B.11 Toxicological information
7.B.11.1 Concise and complete description of the various
toxicological (health) effects and the available data
used to identify those effects.
7.B.11.2 Information on the
likely routes of exposure
(inhalation, ingestion, skin and eye contact)
7.B.11.3 Symptoms related to the physical, chemical and
toxicological characteristics.
7.B.11.4 Immediate effects (from short-term
exposures)
and delayed effects (from long-term exposures).
7.B.11.5 Numerical measures of toxicity (such as acute
toxicity estimates).
7.B.12 Ecological Information
7.B.12.1
7.B.12.2
7.B.12.3
7.B.12.4
7.B.12.5
Ecotoxicity (aquatic and terrestrial, where available)
Persistence and degradability
Bioaccumulative potential
Mobility in soil
Other adverse effects
7.B.13 Disposal consideration
7.B.13.1 Description of waste residues and information on
safe handling and methods of disposal, including the
disposal of any contaminated packaging.
7.B.14 Transport/Shipment information
7.B.14.1
7.B.14.2
7.B.14.3
7.B.14 4
7.B.14.5
7.B.14.6
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.B.14.7 Statement on the unavailability of
relevant
information.
7.B.15 National Regulations and References
7.B.15.1 Safety, health and environmental regulations specific
for the chemical substance or mixture in question.
7.B.15.2 Specify if the product is under Chemical Control
Order (CCO), Priority Chemical List (PCL) for local
chemical substance or mixtures.
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7.B.16 Other information
7.B.16.1 Information on preparation and revision of the SDS,
i.e., date of revision, revision number, etc.
7.B.16.2 Key/legend to abbreviations and acronyms used in
the SDS
7.B.16.3 References/Purple Book
Section VIII. Institutional Arrangements3
The DENR in collaboration with the concerned agencies and entities (Annex
4) shall promote and initiate public awareness, information, dissemination,
training on preparing, using and applying the SDS and the labels. The
delineation of tasks corresponds to the highlights of the various thrusts and
commitments of concerned government agencies and partners with regards
to chemical labeling and submission of the SDS.
The DENR may promulgate such other guidelines, rules and regulations as
may, from time to time be deemed necessary or appropriate under the
circumstances in order to ensure the continuing implementation of the
aforesaid activities.
Section IX. Confidentiality of Information
9.1
Confidential Business Information (CBI) claims should be limited to
the names of chemicals and their concentrations in mixtures. The
rules for CBI is a priority over the rules for product
identification.
9.2
No disclosure of any information shall be done except for:
9.2.1 The provisions for CBI protection compromise the health
and safety of users.
9.2.2 Emergency situations.
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
In complying with the requirements established in this Administrative Order
shall be monitored regularly by the Department and the other concerned
agencies according to their thrusts and mandates.
3
Delineation of Duties and Responsibilities of concerned stakeholders in Annex 3.
10
Section XII.
Penalty Clause
Any violations of the provisions specified in this Administrative Order will
subject those persons responsible therefore 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) after completion of 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.
Section XIV.
Transition Period
Two years of transition period after the effectivity of this Order shall be
provided for complete and strict compliance for chemical substances and
mixtures4.
ANGELO T. REYES
Secretary
TWG/ Draft GHS DAO rev2 as of 02-23-07
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ANNEX 3
DELINEATION OF DUTIES AND RESPONSIBILITIES
OF CONCERNED AGENCIES/INSTITUTIONS/ENTITIES
(This includes the agency mandate/thrust and the required tasks/activities
to implement GHS. The defined roles/duties/responsibilities in accordance
with the mandate can be agreed to address the cross cutting issues and
shall be served as the basis of each agency/entity)
AGENCY
DEPARTMENT OF AGRICULTURE
Fertilizer and Pesticides Authority
MANDATE/THRUST
PD 1144 Creation of Fertilizer
Pesticide Authority (FPA)
GHS
RESPONSIBILITY
and
Article V of the FPA Rules and
Regulations No.1, Series of
1977, in particular Sections 1 to
4,6 and 8 of PD 1144.
DEPARTMENT OF ENVIRONMENT Republic Act 6969 ”Toxic
AND NATURAL RESOURCES
Substances and Hazardous and
Nuclear Waste Control Act of
1990.”
Environmental Management Bureau
Specify the basic requirements for a
pesticide label including the prescribed
statements, language, FPA control
number, precautionary measures
Develop training and guidance
materials adoptable to the needs of
agricultural workers.
Section 4, Item C of RA 6969
mandated “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”
E.O 192 – Creation of the EMB To formulate, review and draft relevant
and delegated by the Secretary policies and procedural guidelines for
of the DENR
GHS implementation.
Sections 17,18, and 19 of the
DENR DAO No. 92-29
(Philippine
Inventory
of
Chemicals
and
Chemical
Substances, Priority Chemical
List.
Section 20 of the DENR DAO
No. 92-29 (Chemical Control
Order) on the Labeling and Relabeling Requirements.
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Initiate and assist in the GHS
dissemination and capability building
for the concerned stakeholders in
cooperation with SPIK.
AGENCY
MANDATE/THRUST
GHS
RESPONSIBILITY
DEPARTMENT OF FINANCE
Bureau of Customs
DEPARTMENT OF HEALTH
PD 881Empowering the Secretary of
Health to Regulate the Labeling,
Sale and Distribution of
Household Hazardous
Substances
Bureau of Food and Drugs
Administrative Order # 311Series 1977Labeling Requirements
Hazardous Substances .
Monitors the entry of all kinds of
importation of chemical substances,
mixtures and products
Develop framework of activities in
support to the implementation of GHS
Provide technical assistance to
concerned government agencies
of related
to
health/toxicological
concerns on GHS for hazardous
household substances
Participate in trainings/meetings and
other related activities
Prepare and conduct research studies
related to the implementation of GHS
DEPARTMENT OF INTERIOR AND
LOCAL GOVERNMENT
Bureau of Fire Protection
PD 1185 “The Fire Code of the
Philippines”
Responsible to develop emergency
and contingency preparedness and
responses.
DEPARTMENT OF LABOR AND
Consider the establishment of
EMPLOYMENT
incentive programs, training, SDS and
labeling for GHS implementation.
Facilitate GHS implementation through
formulation of pertinent laws, policies
and regulations in consultation with
industry associations, trade unions,
civil society groups (TUCP) and
international groups (ILO).
Occupational Health and Safety Industrial Chemicals
Develop information materials and
Center (OSHC)
Rule 1070 –Occupational Health training modules for capability building
& Environmental Control
and workers’ protection program.
Conduct awareness raising program
and skills program for employees,
workers,
government
(labor
inspectors).
Conduct research studies on Risk
Assessment of chemicals
Provide technical inputs in policy
formulation and network
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AGENCY
MANDATE/THRUST
Bureau of Working Standards
Rule 1090 – Handling of
Hazardous Substances All
containers with hazardous
substance shall be properly
labeled.
DEPARTRMENT OF TRANSPORT
AND COMMUNICATION
GHS
RESPONSIBILITY
Formulate/develop and prescribe
standard guidelines/ measures on
general labor concerns including
occupational safety and health
Perform
policy
and
program
development and advisory function for
the administration and enforcement of
labor standards including OSH
Technical supervision over the 15
labor inspectorate – enforcement in
the regions
Develop training modules for GHS for
trainers, drivers, licensing agencies
and cargo handlers.
Performs enforcement function/issues
policies and rules and regulations
Philippine Coast Guard
PD 601 Revised Coast Guard Law
MARINA
Philippine Merchant Marine Issues policies, rules and regulations
Rules and Regulations on and pertinent permits to carry
Carriage of Dangerous Goods
dangerous goods/cargoes.
CPA
Philippine Port Authority
Land Transportation Office/LTFRB
International
Air
Association (IATA)
Goods Regulations
Transport
Dangerous
DEPARTMENT OF TRADE AND RA 7394 –
INDUSTRY
Consumer Act of the Philippines
Board of Investments
Bureau of Product Standards
Philippine National Police
Aviation Security Group
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Oversee/monitor the handling of
dangerous goods/cargoes inside the
port.
Responsible for ensuring the safe
operation of the road transport system
in issuance of drivers’ license and
registration of all motor vehicles and
franchise to PUJ, respectively..
Provides procedures for the shipper
and the operators by which articles
and substances with hazardous
properties can be safely transported
by air on all commercial air transport.
Conduct information and education
campaign for GHS awareness raising
Oversee the implementation of GHS
starting 2008.
Participate in trainings, meetings and
other related activities
Preparation of label standards for
chemical substances and mixture for
consumer
Ensure the clear differences of risk
and hazard based labeling for
consumer products.
Monitoring
and
emergency
preparedness
ANNEX 2
PICTOGRAMS
Flammable subs.
Self reactive
Pyrophoric & selfHeating
substances
Organic peroxides
Explosives
Organic
peroxides
Self-reactive
substances
Compressed gas
Oxidizing
Solids
Acute
Toxicity
Corrosive to metal
Skin corrosion
Serious eye damage
Eye irritation
Acute
Toxicity
Skin
irritation
Eye irritation
Sensitization
(Dermal)
Target
Organ
toxicity
Sensitization
(Respiratory)
Mutagenicity
Carcinogenicity
Reproductive
Toxicity
Target Organ
Toxicity
Aspiration Hazard.
Environmental
Hazard
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