ANNEX-1 EXEMPTIONS FROM ARTICLES 7 AND 8. 1-The following substances which occur in nature, if they are not chemically modified.
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1 ANNEX-1 EXEMPTIONS FROM ARTICLES 7 AND 8 1-The following substances which occur in nature, if they are not chemically modified. Minerals, ores, ore concentrates, cement clinker, natural gas, liquefied petroleum gas, natural gas condensate, process gases and components thereof, crude oil, coal, coke. 2-Basic elemental substances for which hazards and risks are already well known: hydrogen, oxygen, noble gases (argon, helium, neon, xenon), nitrogen. 3- Substances with below given EC numbers and CAS numbers: EINECS Number Name/Group CAS Number D-glucitol C6H14O Ascorbic acid C6H8O Glucose C6H12O Fructose C6H12O L-lysine C6H14N2O Palmitic acid, pure C16H32O Stearic acid, pure C18H36O Sucrose, pure C12H22O α-tocopheryl acetate C31H52O Galactose C6H12O DL-methionine C5H11NO2S Lactose C12H22O D-mannitol C6H14O Sucrose, pure C12H22O Oleic acid, pure C18H34O Glycerol stearate, pure C21H42O Carbon dioxide CO
2 Calcium pantothenate, D-form C9H17NO5.1/2Ca Lauric acid, pure C12H24O2 Potassium oleate C18H34O2K DL-phenylalanine C9H11NO Sodium gluconate C6H12O7.Na Sodium stearate, pure C18H36O2.Na Limestone A noncombustible solid characteristic of sedimentary rock. It consists primarily of calcium carbonate Sorbitan oleate C24H44O Calcium distearate, pure C18H36O2.1/2Ca Krypton Kr Neon Ne Argon Ar Helium He Xenon Xe Carbon C Nitrogen N Water, distilled, conductivity or of similar purity H2O Graphite C Sunflower oil the fatty acids linoleic, and oleic. (Helianthus annuus, Compositae). Soybean oil the fatty acids linoleic, oleic, palmitic and stearic (Soja hispida, Leguminosae)
3 Safflower oil the fatty acid linoleic (Carthamus tinctorius, Compositae). Linseed oil the fatty acids linoleic, linolenic and oleic(linum usitatissimum, Linaceae). Corn oil the fatty acids linoleic, oleic, palmitic and stearic. (Zea mays, Gramineae). Castor Oil the fatty acid ricinoleic (Ricinus communis,euphorbiaceae). Rape oil the fatty acids erucic, linoleic and oleic(brassica napus, Cruciferae) Lecithins The complex combination of diglycerides of fatty acids linked to the choline ester of phosphoric acid Syrups, hydrolyzed starch A complex combination obtained by the hydrolysis of cornstarch by the action of acids or enzymes. It consists primarily of d-glucose, maltose and maltodextrins Tallow, hydrogenated Dextrin Starch High-polymeric carbohydrate material usually derived from cereal grains such as corn, wheat and sorghum, and from roots and tubers such as potatoes and tapioca. Includes starch which has been pregelatinised by
4 heating in the presence of water Maltodextrin Vitamin A Sodium D-gluconate C6H12O7.xNa D-glucitol monostearate C24H48O Fatty acids, coco, Me esters Fatty acids, tallow, Me esters Fatty acids, castor-oil Fatty acids, tallow Cellulose pulp Fatty acids, C12-18 C12-C18 alkyl carboxylic acid Fatty acids C16-18 C16-C18 alkyl carboxylic acid Fatty acids, C8-18 and C18-unsaturated. C8-C18 and C18 unsaturated alkyl carboxylic acid Fatty acids, C14-18 and C16-18-unsaturated. C14-C18 and C16-C18 unsaturated alkyl carboxylic acid Fatty acids, C16-C18 and C18-unsaturated. C16-C18 and C18 unsaturated alkyl carboxylic acid Glycerides, C16-18 and C18-unsaturated. This substance is identified by SDA Substance Name: C16-C18 and C18 unsaturated trialkyl glyceride and SDA Reporting Number: Fatty acids, C14-18 and C16-18-unsaturated., Me esters C14-C18 and C16-C18 unsaturated alkyl carboxylic acid methyl ester Fatty acids, C6-12 C6-C12 alkyl carboxylic acid
5 Fatty acids, C14-22 and C16-22 unsaturated. C14-C22 and C16-C22 unsaturated alkyl carboxylic acid Syrups, corn, dehydrated Glycerides, tallow mono-, di- and tri-, hydrogenated Fatty acids, C14-22 Fatty acids, linseed-oil Glycerides, C16-18 and C18-unsaturated, mono- and di- C16-C18 and C18 unsaturated alkyl and C16-C18 and C18 unsaturated dialkyl glyceride Glycerides, C Fatty acids, C12-14 Fatty acids, C12-18 and C18-unsaturated. Fatty acids, rape-oil, erucic acid-low Polymers
6 ANNEX-2 INFORMATION REFERRED TO IN ARTICLE 7 1. General information 1.1. Name of substance 1.2. EC No 1.3. CAS No 1.4. Synonyms 1.5. Purity 1.6. Impurities 1.7. Molecular formula 1.8. Structural formula 1.9. Type of substance Physical state Please indicate who is submitting the data set Quantity produced or imported, greater than tonnes per year Indicate if the substance has been produced during the last 12 months Indicate if the substance has been imported during the last 12 months Classification and labelling Use pattern Has the complete data set already been submitted by another manufacturer or importer? Specify if you are acting on behalf of another concerned manufacturer or importer Other remarks: (e. g. options for disposal) 2. Physical-chemical data 2.1. Melting point 2.2. Boiling point 2.3. Density 2.4. Vapour pressure 2.5. Partition coefficient (log10 POW) 2.6. Water solubility 2.7. Flash point 2.8. Auto flammability 2.9. Flammability Explosive properties Oxidizing properties Other data and remarks 3. Environmental fate and pathways 3.1. Stability Photodegradation Stability in water Stability in soil 3.2. Monitoring data (environment) 3.3. Transport and distribution between environmental compartments including estimated environmental concentrations and distribution pathways Transport Distribution among environmental compartments
7 3.4. Biodegradation 3.5. Bioaccumulation 3.6. Other remarks 4. Ecotoxicity 4.1. Toxicity to fish 4.2. Toxicity to daphnia and other aquatic invertebrates 4.3. Toxicity to algae 4.4. Toxicity to bacteria 4.5. Toxicity to terrestrial organisms 4.6. Toxicity to soil dwelling organisms 4.7. Other remarks 5. Toxicity 5.1. Acute toxicity Acute oral toxicity Acute inhalation toxicity Acute dermal toxicity Acute toxicity (other routes of administration) 5.2. Corrosiveness and irritation Skin irritation Eye irritation 5.3. Sensitization 5.4. Repeated dose toxicity 5.5. Genetic toxicity in vitro 5.6. Genetic toxicity in vivo 5.7. Carcinogenicity 5.8. Toxicity to reproduction 5.9. Other relevant information Experience with human exposure 6. List of references
8 ANNEX-3 INFORMATION REFERRED TO IN ARTICLE 8 (1) 1. General information 1.1. Name of substance 1.2. EC No 1.3. CAS No 1.4. Synonyms 1.5. Purity 1.6. Impurities 1.7. Molecular formula 1.8. Structural formula 1.9. Type of substance Physical state Please indicate who is submitting the data set Quantity produced or imported exceeding 1 tonnes per year but not greater than tonnes Indicate if the substance has been produced during the last 12 months Indicate if the substance has been imported during the last 12 months Classification and labelling Use pattern Other remarks
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