ANNEX: II SAFETY DATA SHEET (SDS) TEMPLATE

SECTION 2: Hazards identification

2.1 Classification of the substance or mixture

Signal Word(s): Hazard Statements: Pictograms: Delete pictograms that don’t apply! Precautionary Statements: Description of other hazards: Section 3: Composition/ Information on Ingredients For Substances (a) Chemical name (b) Common name and synonyms (c) CAS number and other unique identifiers (d) Impurities and stabilizing additives which are themselves classified and which contribute to the classification of the substance For Mixtures In addition to the information required for substances: (a) The chemical name and concentration (exact percentage) of all ingredients which are classified as health hazards in accordance with WAC 296-901-14008 and (1) are present above their cut-off/concentration limits; or (2) present a health risk below the cut-off/concentration limits. (b) The concentration (exact percentage) must be specified. Chemical Name Synonym CAS# Conc. Section 4: First-Aid Measures (a) Description of necessary measures, subdivided according to the different routes of exposure, i.e., inhalation, skin and eye contact, and ingestion (b) Most important symptoms/effects, acute and delayed (c) Indication of immediate medical attention and special treatment needed, if necessary After skin contact: After eye contact: After inhalation: After swallowing: Section 5: Fire-Fighting Measures (a) Suitable (and unsuitable) extinguishing media (b) Specific hazards arising from the chemical (e.g., nature of any hazardous combustion products) (c) Special protective equipment and precautions for fire-fighters Suitable extinguishing agents: Special protective equipment for firefighters: Section 6: Accidental Release Measures (a) Personal precautions, protective equipment, and emergency procedures (b) Methods and materials for containment and cleaning up Personal precautions: Measures for environmental protection: Measures for cleaning/collecting: Section 7: Handling and Storage (a) Precautions for safe handling (b) Conditions for safe storage, including any incompatibilities Handling: Storage: Section 8: Exposure Controls/Personal Protection (a) DOSH permissible exposure limit (PEL), American Conference of Governmental Industrial Hygienists (ACGIH) Threshold Limit Value (TLV), and any other exposure limit used or recommended by the chemical manufacturer, importer, or employer preparing the safety data sheet, where available (b) Appropriate engineering controls (c) Individual protection measures, such as personal protective equipment Chemical Name OSHA PEL OSHA PEL ACGIH OEL ACGIH OEL (ceiling) (TWA) (STEL) General protective and hygienic measures: Breathing equipment: Protection of hands: Eye protection: Section 9: Physical and Chemical Properties (a) Appearance (physical state, color, etc.) (b) Odor (c) Odor threshold (d) pH (e) Melting point/freezing point (f) Initial boiling point and boiling range (g) Flash point (h) Evaporation rate (i) Flammability (solid, gas) (j) Upper/lower flammability or explosive limits (k) Vapor pressure (l) Vapor density (m) Relative density (n) Solubility(ies) (o) Partition coefficient: n-octanol/water (p) Auto-ignition temperature (q) Decomposition temperature (r) Viscosity Form: Odor: Odor threshold: pH: Melting point/melting range: Boiling point/boiling range: Flash point: Evaporation rate: Flammability: Upper/lower flammability or explosive limits: Auto ignition temperature: Danger of explosion: Vapor pressure: Vapor density: Relative density: Solubility in/Miscibility with water: Section 10: Stability and Reactivity (a) Reactivity (b) Chemical stability (c) Possibility of hazardous reactions (d) Conditions to avoid (e.g., static discharge, shock, or vibration) (e) Incompatible materials (f) Hazardous decomposition products Reactivity: Chemical stability: Conditions to avoid: Incompatible materials: Hazardous decomposition products: Section 11: Toxicological Information Description of the various toxicological (health) effects and the available data used to identify those effects, including: (a) Information on the likely routes of exposure (inhalation, ingestion, skin and eye contact) (b) Symptoms related to the physical, chemical and toxicological Characteristics (c) Delayed and immediate effects and also chronic effects from short and long-term exposure (d) Numerical measures of toxicity (such as acute toxicity estimates) (e) Whether the hazardous chemical is listed in the National Toxicology Program (NTP) Report on Carcinogens (latest edition) or has been found to be a potential carcinogen in the International Agency for Research on Cancer (IARC) Monographs (latest edition), or by DOSH Acute toxicity: Potential routes of exposure/potential health effects Skin: Eye: Inhalation: Ingestion: Carcinogenic effects: Mutagenic effects: Reproductive toxicity: Sensitization: Target organs: Section 12: Ecological Information (non-mandatory) (a) Ecotoxicity (aquatic and terrestrial, where available) (b) Persistence and degradability (c) Bioaccumulative potential (d) Mobility in soil (e) Other adverse effects (such as hazardous to the ozone layer) Ecotoxicity: Mobility: Biodegradation: Bioaccumulation: Section 13: Disposal Considerations (non-mandatory) Description of waste residues and information on their safe handling and methods of disposal, including the disposal of any contaminated packaging Section 14: Transport Information (non-mandatory) (a) UN number (b) UN proper shipping name (c) Transport hazard class(es) (d) Packing group, if applicable (e) Environmental hazards (e.g., Marine pollutant (Yes/No)); (f) Transport in bulk (according to Annex II of MARPOL 73/78 and the IBC Code) (g) 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 DOT regulations: ● Hazard class: ● Land transport ADR/RID (cross-border): ● ADR/RID class: ● Maritime transport IMDG: Air transport ICAO-TI and IATA-DGR: ● ICAO/IATA Class: Section 15: Regulatory Information (non-mandatory) Safety, health and environmental regulations specific for the product in question US Federal Regulations SARA Section 355 (extremely hazardous substances): SARA Section 313 (specific toxic chemical listings): Clean Air Act, Section 112 Hazardous Air Pollutants (HAPs): TSCA (Toxic Substances Control Act): Etc. Section 16: Other Information The date of preparation of the SDS or the last change to it SDS date of preparation/update: Doc No: DD/CHCR/FORM/007 Revision No: 002 Effective Date: …../05/2025 ANNEX III: Application form for new registration of public health laboratory chemical products 1. ADMINISTRATIVE INFORMATION 1.1 Name(s) and complete physical address(es) of the manufacturer(s) Company name: ……………………………………………… Physical address: …………………………………………………. Postal address: ……………………………………………………. Country: …………………………………………………………... Telephone: ………………………………………………………... Telefax: …………………………………………………………... E­mail: ………………………………………………………….... 1.2 Particulars of Applicant/ Registrant Name: ……………………………………………………………… Physical Address: …………………………………………………. Postal Address: ……………………………………………………. Country: …………………………………………………………… Phone: ……………….………………. Fax: ……………………. Email: ……………………………………………………………. Status of applicant (tick where appropriate): Manufacturer: Importer: Exporter: Other: 1.3 Particulars of Local Technical Representative/ Distributor (if applicable) Name: ………………………………………………………………….. Physical Address: ……………………………………………………… Postal Address: ………………………………………………………… Country: ……………………………………………………………… Phone: ……………………………………………………………….. Fax:……………………………………………………………………. Email:………………………………………………………… 1.4 Marketing Authorisation 1.4.1 Have you applied for Marketing Authorization of public health laboratory chemical product containing the same chemical substance (s) in the Rwanda FDA? Yes ☐ No ☐ If Yes state: …………………………………………………………………… Product name (s): ……………………………………………………………. CAS number………………………. EC number: ………………………….. Rwanda FDA, P.O.Box:1948 Kigali-Rwanda, Email: info@rwandafda.gov.rw Website: www.rwandafda.gov.rw, Toll Free:9707 Other reference number (EINES, ELINCS/ NLP): …………………………… .. Strength/percentage Purity: …………………………………………………………………… Product form (s): ……………………………………………………………… Use(s): ………………………………………………………………… 1.4.2 Have you applied for Marketing Authorization of public health laboratory chemical product containing the same formulation with different excipients/composition/mixture (s) in the Rwanda FDA? Yes ☐ No ☐ If Yes state: …………………………………………………………………… Product name (s): …………………………………………………………….. CAS number………………………. EC number: ………………………….. Other reference number (EINES, ELINCS/ NLP): …………………………….. Strength/percentage purity: …………………………………………………………………… product form (s): ……………………………………………………………… Use(s): …………………………………………………………………. Short description of difference……………………………………………… ………………………………………………………………………………… 1.4.3. Product Marketing Authorisation in the country of manufacture of the same public health laboratory chemical product. Product name: …………………………………………………………………. CAS number………………………. EC number: ………………………….. Other reference number (EINES, ELINCS/ NLP): …………………………….. Authorised Country: ……………………………………………………………. Date of authorisation (dd­mm­yyyy): …………………………………………… Authorisation number: …………………………………………………………… If not registered/licensed state reasons: …………………………………………… Date of refusal (dd­mm­yyyy): ………………………………………………….... Reason for Refusal: ………………………………………………………… 1.4.4. Product Marketing Authorisation in the country of manufacture of the same public health laboratory chemical product. (Withdrawn by applicant after authorisation) Withdrawn Country: ……………………………………………………………… Date of withdrawal: (dd-mm-yyyy): ……………………………………………… Product name: ……………………………………………………………………. CAS number………………………. EC number: ………………………….. Other reference number (EINES, ELINCS/ NLP): …………………………….. Reason for withdrawal: …………………………………………………………… Rwanda FDA, P.O.Box:1948 Kigali-Rwanda, Email: info@rwandafda.gov.rw Website: www.rwandafda.gov.rw, Toll Free:9707 1.4.5. Product Marketing Authorisation in the country of manufacture of the same public health laboratory chemical product. (Suspended/revoked/banned by competent authority) Suspended/revoked/banned Country: ……………………………………………………… Date of suspension/revocation/ban (dd­mm­yyyy): …………………………………… Product name: ……………………………………………………………………. CAS number………………………. EC number: ………………………….. Other reference number (EINES, ELINCS/ NLP): …………………………….. Reason for suspension/revocation/ban: ……………………………………………….. 2. Product information 2.1 Proprietary name of the product and Brand name (exactly as shown on label): ………………………….. 2.2 Name and strength/purity of chemical substance(s)…………………………………………. CAS number………………………. EC number: ………………………….. Other reference number (EINES, ELINCS/ NLP): …………………………….. 2.3 a. Class of laboratory chemical product Hazard Class and category Specify Acute toxicity, category 1,2, and 3 Acute toxicity, category 4 Skin corrosion/irritation, category 1, sub-categories: 1A, 1B, 1C and Category 2 category 1: Sub-category: 1A…., 1B….., 1C…. Category 2 Serious damage to eyes/eye irritation, category 1 and 2 Category 1 Category 2 Respiratory/skin sensitization Germ cell mutagenicity category 1A and 1B category 1A category 1B Germ cell mutagenicity category 2 Carcinogenicity category 1A, 1B and 2 category 1A category 1B category 2 Reproductive toxicity, category 1A, 1B, 2 and effects on or via lactation category 1A category 1B Rwanda FDA, P.O.Box:1948 Kigali-Rwanda, Email: info@rwandafda.gov.rw Website: www.rwandafda.gov.rw, Toll Free:9707 category 2 Specific target organ toxicity (STOT)-Single exposure, category 1 and 2 category 1 category 2 Specific target organ toxicity (STOT)-Repeated exposure, category 1 and 2 category 1 category 2 Aspiration Hazard Hazardous to the aquatic environment-Acute, category 1 Hazardous to the aquatic environment-Chronic, category 1 Hazardous to the aquatic environment-Chronic, category 1, 2,3 and 4 category 1 category 2 category 3 category 4 Hazardous for the ozone layer 2.4 Packing type: 2.5 Intended use: 2.6 Pack size: 2.7 Visual description: 2.8 Proposed shelf life: 2.9 Proposed shelf life (dilution if any): 2.10 Proposed shelf life (after first opening container): 2.11 Proposed storage conditions: 2.12 Proposed storage conditions after first opening: 2.13 Other sister products registered or applied for registration 2.14 Distribution category: ☐ Institutional ☐ Industrial ☐ General public. ☐ Other……………… 2.15 Country of (origin) manufacture: 2.16 Qualitative and Quantitative composition (chemical substance (s) and excipient(s) No Name of Quantity/unit (ml, g)/ Reasons of inclusion Manufact ingredient batch urer and/or Supplier’s full address 1 2 3 4 Etc 2.17 Submitted Spectral data (if applicable): Rwanda FDA, P.O.Box:1948 Kigali-Rwanda, Email: info@rwandafda.gov.rw Website: www.rwandafda.gov.rw, Toll Free:9707 Ultra-violet: Yes ☐ No ☐ Infra-red: Yes ☐ No ☐ Nuclear magnetic resonance: Yes ☐ No ☐ Mass spectrum: Yes ☐ No ☐ 2.18 Do you hold Marketing Authorization (s) of this product from other regulatory authorities? Yes  No  If yes state; Market Authorization Number: Market Authorization issuance date: Name of Regulatory Authority issued the Market Authorization: Country: 3 Type of Formulation 3.1. Solids ☐Powder ☐Wettable Powder ☐Soluble Powder ☐tablet ☐ Pellet ☐Cake ☐ Other (specify) 3.2. Liquids ☐ Emulsifiable Concentrate ☐ Flowable Concentrate 3.3. Other ☐Suspension ☐Gel ☐Aerosol ☐Emulsion ☐ ☐Gaseous ☐Powder: ☐ Paste ☐Others (Specify)………………………………… 4. LABELLING 4.1. Brief description of the type and properties of packaging material and the seal and its liner (if any) and provide justification for the suitability of the packaging material and the seal and its liner used. ………………………………………………………………………………………………… 4.2. Recommended storage conditions (where applicable) including any relevant information after the product is opened for use or reconstituted: ………………………………………………………………………………………………… 4.3.Mode of use …………………………………………………………………………………………………… ……………… 5. Declaration by the Applicant/ Registrant I, the undersigned certify that all the information in this form and accompanying documentation is correct, complete and true to the best of my knowledge. Rwanda FDA, P.O.Box:1948 Kigali-Rwanda, Email: info@rwandafda.gov.rw Website: www.rwandafda.gov.rw, Toll Free:9707 I also agree that I shall carry out vigilance to monitor the safety of the product in the market and provide safety update reports to Rwanda Food and Drugs Authority. It is hereby confirmed that fees have been paid according to the Rwanda Food and Drugs Authority fees and regulation. I understand that if any information given here above is found false or incorrect, I will be reliable for appropriate action under the provisions of the Rwanda Food and Drugs Authority regulation. Name: …………………………………… Position in the company: ………………… Signature: ………………………………… Official stamp: ……………………………. Date: ………………………………………. Rwanda FDA, P.O.Box:1948 Kigali-Rwanda, Email: info@rwandafda.gov.rw Website: www.rwandafda.gov.rw, Toll Free:9707 Doc No: DD/CHCR/FORM/005 Revision No: 001 Effective Date: …../05/2025 Annex IV: Application form for renew of registration of cosmetic, vector control products, public health antiseptic and disinfectant and public health laboratory chemical products 1. Product information 1.1 Registration number……………………………………………………………. 1.2 Date of issue of current Market Authorization……………………………………. 1.3 Date of expiry of current registration………………………………………….. 1.4 Brand Name of Product: ……………………………………………………… 1.5 Product category:……………………………………………………………… 1.6 Physical description.…………………………………………………………….. 1.7 Product Form: ….………………………………………………………………….. 1.8 Name and Strength of the Active ingredient(s):……………………………………. 1.9 Intended use of the product…………………………………………………………. 1.10 Are there any changes since product was registered? No Yes If yes, give descriptions of the changes and if such variation was approved by Rwanda FDA …………………………………………………………………………………………….. ………………………………………………………………………………………… 2. Are there any reported adverse reactions? No Yes If yes, give descriptions of the adverse reactions and if were reported to Rwanda FDA …………………………………………………………………………………………….. 3. Particulars of Applicant/ Registrant Name of company: ……………………………………………………………………………. Physical Address: ………………………………………………………………… Postal Address: ………………………………………………………………… Country: …………………………………………………………………………… Phone: ………………..………………. Rwanda FDA, P.O.Box:1948 Kigali-Rwanda, Email: info@rwandafda.gov.rw Website: www.rwandafda.gov.rw, Toll Free:9707 Fax: …………………………………… Email: ……………………………………………………………………………. Status of applicant (tick where appropriate) Manufacturer Importer Other If other, please specify:………………………………………………………………… 4. Particulars of manufacturer Name: ……………………………………………………………………………. Physical Address: ………………………………………………………………… Post Adress:……………………………………………………………………. Country…………………………………………………………………………… Phone: ……………………Fax: ……………………Email: …………………… 5. Particulars of Local Technical Representative (if applicable) Name: ………………………………………………………………… Physical Address: ………………………………………………………………… Postal Address: …………………………………………………………………… Phone Number……………… Fax: ……………………Email: ……………… Declaration by the Applicant I……………………………………………………………..undersigned certify that all the information filled on this form and accompanying documentation are correct, complete and true to the best of my knowledge. I also agree that I shall carry out vigilance to monitor the safety of the product on the market and provide safety update reports to Rwanda FDA. It is hereby confirmed that fees have been paid according to the Rwanda FDA fees and regulation. I understand that if any information given here above is found false or incorrect, I will be reliable for appropriate action under the provisions of the Rwanda FDA regulations. Name:……………………………………………………………………………. Position:…………………………………………………………………………. Signature:………………………………………………………………………… Officials Stamp:……………………………………………………………………. Date:………………………………………………………………………………… Rwanda FDA, P.O.Box:1948 Kigali-Rwanda, Email: info@rwandafda.gov.rw Website: www.rwandafda.gov.rw, Toll Free:9707

Hazard statements

symbol(s) and precautionary statement(s) in accordance with WAC 296-901-14012. (Hazard symbols may be provided as graphical reproductions in black and white or the name of the symbol, e.g., flame, skull and crossbones) (c) Describe any hazards not otherwise classified that have been identified during the classification process (d) Where an ingredient with unknown acute toxicity is used in a mixture at a concentration ≥ 1% and the mixture is not classified based on testing of the mixture as a whole, a statement that X% of the mixture consists of ingredient(s) of unknown acute toxicity is required Hazard Classification

Signal word

Hazard Statements Pictograms Delete pictograms that don’t apply!

Precautionary statements

Description of other hazards