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 3 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 4 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 5 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 6 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 7 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. 8 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. 9 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 11 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. 12 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 13 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 14 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 15