Dangerous Substances and Preparations Regulations, 2002 (L.N. No. 221 of 2002)

B 3261 Suppliment tal-Gazzetta tal-Gvern ta' Malta, Nru. 17,267, 30 ta' Lulju, 2002 TaqsimaB L.N. 221 of2002 PRODUCTSAFETYAC~2001 (ACT NO. V OF 2001) The Dangerous Substances and Preparations Regulations, 2002 IN exercise of the powers conferred by Section 38 of the Product Safety Act, 2001, the Minister for Economic Services, on the advice of the Malta Standards Authority, has made the following regulations: 1.1 The title of these regulations is the Dangerous Substances Citation and and Preparations Regulations, 2002. commencement. 1.2 These regulations shall come into effect as from: (a) 30th July 2002, in the case of preparations not within the scope of Directive 91/414/EEC or Directive 98/8/EC; and (b) 30th July 2004, in the case of preparations within the scope of Directive 91/414/EEC or Directive 98/8/EC. Applicability 2.1 These regulations shall apply to: the classification, packaging and labelling of dangerous preparations, and to those preparations which may present hazards, whether or not they are classified as dangerous within the meaning of these Regulations, when such preparations are placed on the market. 2.2 These regulations shall apply to preparations which: contain at least one dangerous substance within the meaning of Article 2, and are considered dangerous within the meaning of Article 5, 6or7. 2.3 The specific provisions set out: in Article 9 and defined in the Fourth Schedule, B 3262 in Article 10 and defined in the Fifth Schedule, and in Article 14 shall also apply to preparations which are not considered dangerous within the meaning of Articles 5, 6 or 7 but may nevertheless present a specific hazard. 2.4 Without prejudice to other provisions implementing the requirements of Directive 91/414/EEC, the articles on classification, packaging, labelling and safety data sheets of these regulations. shall apply to plant protection products. 2.5 These regulations shall not apply to the following preparations in the finished state, intended for the final user: · (a) medicinal products for human or veterinary use, as defined in the Act; (b) cosmetic products as defined.in the Cosmetic Products Order, 2000; ( c) mixtures of substances which, in the form of waste, are covered by provisions implementing the requirements of Directives 75/442/EEC and 78/319/EEC; ( d) foodstuffs; ( e) animal feedingstuffs; (f) preparations containing radioactive substances as defined by Directive 80/836/Euratom; (g) medical devices which are invasive or used in direct physical contact with the human body in so far as other measures lay down provisions for the classification and labelling of dangerous substances and preparations which ensure the same level of information provision and protection as these regulations. 2.6 These regulations shall not apply to: the carriage of dangerous preparations by rail, road, inland waterway, sea or air, ~ preparations in transit which are under customs supervision, provided they do not undergo any treatment or processing. B 3263 3.1 In these regulations, the following definitions shall apply, Definitions unless the context otherwise requires: (a) "substances'' means chemical elements and their compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the products and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition; (b) "preparations" means mixtures or solutions composed of two or more substances; ( c) "polymer" means a substance consisting of molecules characterised by the sequence of one or more types of monomer units and comprising a simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant and consists of less than a simple weight majority of molecules of the same molecular weight. Such molecules must be distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units. In the context of this definition a "monomer unit" means the reacted form of a monomer in a polymer; ( d) "placing on the market" means making available to third parties. Importation into customs territory shall be deemed to be placing on the market for the purposes of these regulations; ( e) "scientific research and development" means scientific experimentation, analysis or chemical research carried out under controlled conditions; it includes the determination of intrinsic properties, performance and efficacy as well as scientific investigation related to product development; (f) "process-orientated research and development" means the further development of a substance in the course of which pilot plant or production trials are used to test the fields of application of the substance; (g) "Einecs" means the European Inventory of Existing Commercial Chemical Substances. This inventory contains the definitive list of all chemical substances deemed to be on the market within the European Community on 18 September 1981. B 3264 3.2 The following are ~'dangerous" within the meaning of these Regulations: (a) explosive substances and preparations: solid, liquid, pasty or gelatinous substances and preparations which may also react exothermically without atmospheric oxygen thereby quickly evolving gases, and whjch, under defined test conditions, detonate, quickly deflagrate or upon heating explode when partially confined; (b) oxidising substances and preparations: substances and preparations which give rise to a highly exothermic reaction in contact with other substances, particularly flammable substances; ( c) extremely flammable substances and preparations: liquid substances and preparations having an extremely low flash-point and a low boiling-point and gaseous substances and preparations which are flammable in contact with air at ambient temperature and. pressure; (d) highly flammable substances·and preparations: substances and preparations which .may become hot and finally catch fire in contact with air at ambient temperature without any application of energy, or solid substances and preparatioris which may readily. catch fire after brief contact with a source of ignition and which continue to bum or to be consumed after removal of the source of ignition, or liquid substances and preparations having a very low flash-point, or substances and preparations which, in contact with water or damp air; evolve extremely flammable gases in dangerous quantities; (e) flammable substances and prepa,rations: liquid substances and preparations having a low flash-point; (t) . very toxic substances· and preparations: substances and ,preparations which in very low quantities cause death or acute or .chronic damage to health when inhaled, swallowed or absorbed vfa"the skin; (g) toxic substances and preparations: substances and preparations which in low quantities cause death or acute or chronic damage to health when inhaled, swallowed or absorbed via the skin; (h) harmful substances and preparations: substances and preparations which may cause death or acute or chronic damage to health when inhaled, swallowed or absorbed via the skin; (i) corrosive substances and preparations: substances and preparations which may, on contact with living tissues, destroy them; (j) irritant substances and preparations: non-corrosive substances and preparations which, through immediate, prolonged or repeated contact with the skin or mucous membrane, may cause inflammation; (k) sensitising substances and preparations: substances and preparations which, if they are inhaled or if they penetrate the skin, are capable of eliciting a reaction of hypersensitisation such that on further exposure to the substance of preparation, characteristic adverse effects are produced; (1) carcinogenic substances and preparations: substances or preparations which, if they are inhaled or ingested or if they penetrate the skin, may induce cancer or increase its incidence; (m) mutagenic substances and preparations: substances and preparations which, if they are inhaled or ingested or if they penetrate the skin, may induce heritable genetic defects or increase their incidence; (n) substances and preparations which are toxic for reproduction: substances and preparations which, if they are inhaled or ingested or if they penetrate the skin, may produce, or increase the incidence of, non-heritable adverse effects in the progeny and/ or an impairment of male or female reproductive functions or capacity; (o) substances and preparations which are dangerous for the environment: substances and preparations which, were they to enter the environment, would or could present an immediate or delayed danger for one or more components of the environment. B 3265 B 3266 Detennination of dangerous properties of preparations 3.3 IDirective 67/548/EEct shall mean Directive 67/548/EEC of the European Community or equivalent provisions. 4.1 The evaluation of the hazards of a preparation shall be based on the determination of: physico-chemical properties, properties affecting health, environmental properties. These different properties shall be determined in accordance with the provisions laid down in paragraphs 6, 7 · and 8. Where laboratory tests are conducted, they shall be carried out on the preparation as placed on the market. 4.2 Where the determination of dangerous properties is carried out in accordance with paragraphs 6~ 7 and 8, all dangerous substances within the meaning of paragraph 3.2 and in particular those which: are listed in Annex I to Directive 67 /548/EEC, are listed in Elincs in accordance with Article 21 of Directive 67 /548/EEC, are classified and labelled provisionally by the person responsible for the placing on the market in accordance with Article 6 of Directive 67 /548/EEC, are classified and labelled in accordance with Article 7 of Directive 67 /548/EEC and are not yet included in Elincs, are covered by Article 8 of Directive 67 /548/EEC, are classified and labelled in accordance with Article 13 of Directive 67 /548/EEC, shall be taken into consideration in accordance with the provisions laid down in the method used. 4.3 For preparations covered by these regulations, dangerous substances as referred to in paragraph 3.2 which are classified as dangerous on the basis of their health and/or environmental effects, whether they are present as impurities or additives, shall be taken into consideration when their concentrations are equal to, or greater than, those defined in the following table unless lower values are given in Annex I to Directive 67 /548/EEC, or in Part B of the Second Schedule to these Regulations or in Part B of the Third Schedule thereto, unless otherwise specified in the Fifth Schedule to these Regulations. Category of danger of the substance Very toxic Toxic Carcinogenic Category 1 or 2 Mutagenic Category 1 or 2 Toxic for reproduction Category 1 or 2 Harmful Corrosive Irritant Sensitising Carcinogenic Category 3 Mutagenic Category 3 Toxic for reproduction Category 3 Concentration to take into consideration for gaseous preparations % vol/vol (0.02 (0.02 ( 0.02 (0.02 ( 0.02 ( 0.2 (0.02 ( 0.2 ( 0.2 ( 0.2 ( 0.2 ( 0.2 other preparations %w/w ( 0.1 ( 0.1 ( 0.1 ( 0.1 ( 0.1 ( 1 ( 1 ( 1 ( 1 ( 1 ( 1 ( 1 Dangerous for the environment N ( 0.1 Dangerous for the environment ozone ( 0.1 ( 0.1 Dangerous for the environment ( 1 B 3267 5.1 The classification of dangerous preparations according to the General Principles , , f d , d hall be th of Classification degree and spec1f1c nature o the hazar s mvolve s based on e and Labelling definitions of categories of danger laid down in paragraph 3.2. 5.2 The general principles of the classification and labelling of preparations shall be applied in accordance with the criteria laid down in Annex VI to Directive 67/548/EEC, save where alternative criteria referred to in Paragraphs 6, 7, 8 or 11 and the relevant Schedules of these regulations are applied. B 3268 Evaluation of the hazards deriving from physico chemical properties 6.1 The hazards of a preparation deriving from its physico chemical properties shall be assessed by determining, by means of the methods specified in Part Aof Annex V to Directive 67 /548/EEC, the ., physico-chemical properties of the preparation necessary for appropriate classification and labelling in accordance with the criteria laid down in Annex VI to that Directive. 6.2 By way of derogation from paragraph 6.1: the determination of the explosive, oxidising, extremely flammable, highly flammable, or flammable properties is not necessary provided that: none of the constituents possesses such properties and· that, on the basis of the information available to the manufacturer, the preparation is unlikely to present hazards · of this kind, in the event of a change in the composition of a preparation of known composition, scientific evidence indicates that a reassessment of the hazards will not lead to a change in classification, preparations placed on the market in the form of aerosols satisfy the provisions of Article 9a of Directive 75/ 324/EEC. 6.3 For certain cases for which the methods laid down in Part A of Annex V to Directive 67/548/EEC are not appropriate, alternative calculation methods are laid down in Part B of the First Schedule to these Regulations. 6.4 Certain exemptions from the application of the methods laid down in Part A of Annex V to Directive 67 /548/EEC are referred to in Part A of the First Schedule to these Regulations. 6.5 The hazards deriving from the physico-chemical properties of a preparation covered by Directive 91/414/EEC or equivalent provisions shall · be assessed· by determining the physico-chemical · properties of the preparation necessary for appropriate classification in accordance with the criteria set out in Annex VI to Directive· 67/548/ EEC. These properties shall be determined by means of the methods laid down in Part A of Annex V to Directive 67 /548/EEC unless other internationally recognised methods are acceptable in accordance with the provisions of Annexes II and m to Directive 91/414/EEC. B 3269 7 .1 The health hazards of a preparation shall be assessed by one Evaluation of health • hazards or more of the followmg procedures: (a) by a conventional method described in the Second Schedule; (b) by determining the toxicological properties of the preparation necessary for appropriate classification in accordance with the criteria in Annex VI to Directive 67/548/EEC. These properties shall be determined by means of the methods laid down in Part B of Annex V to Directive 67 /548/EEC, unless, in the case of plant protection products, other internationally recognised methods are acceptable in accordance with the provisions of Annexes II and III to Directive 91/414/EEC. 7.2 Without prejudice to the requirements of Directive 91/414/ EEC or equivalent provisions, only where it can be scientifically demonstrated by the person responsible for placing the preparation on the market that the toxicological properties of the preparation cannot correctly be determined by the method outlined in paragraph l(a), or on the basis of existing test results on animals, the methods outlined in paragraph 7 .1 (b) may be used, provided they are justified or specifically authorised under Article 12 of Directive 86/609/EEC. 7 .2.1 When a toxicological property is established by the methods outlined in paragraph 7 .1 (b) to obtain new data, the test shall be conducted in compliance with the principles of good laboratory practice provided for in Council Directive 87/18/EEC of 18 December 1986 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances and the provisions of Directive 86/609/EEC, in particular Articles 7 and 12 thereof. 7.2.2 Subject to the provisions of paragraph 7.3, where a toxicological property has been established on the basis of both the methods outlined in paragraphs 7.l(a) and (b), the results from the methods outlined in paragraph 7 .1 (b) shall be used for classifying the preparation, except in the case of carcinogenic, mutagenic or toxic effects for reproduction for which only the method outlined in 7.l(a) shall be used. 7 .2.3 Any of the toxicological properties of the preparation which are not assessed by the method outlined in paragraph 7 .1 (b) shall be assessed in accordance with the method outlined in paragraph 7.l(a). B 3270 7 .3 Furthermore, where it can be demonstrated: by epidemiological studies, by scientifically valid case studies as specified by Annex VI to Directive 67/548/EEC or by statistically backed experience, such as the assessment of data from poison information units or concerning occupational diseases, that toxicological effects on man differ from those suggested by the application of the methods outlined in paragraph 7.1, then the preparation shall be classified according to its effects on man, that, owing to effects such as potentiation, a conventional assessment would underestimate the toxicological hazard, those effects shall be taken into account in classifying the preparation, that, owing to effects such as antagonism, a conventional assessment would overestimate the toxicological hazard, those effects shall be taken into account in classifying the preparation. 7 .4 · For preparations of a known composition, with the exception of those covered by Directive 91/414/EEC or equivalent provisions, classified in accordance with paragraph 7.1 (b ), a new evaluation of health hazard by the methods outlined in either paragraph 7.l(a) or (b) shall be performed whenever: changes of composition of the initial concentration, as a weight/weight or volume/volume percentage, of one or more of the dangerous constituents are introduced by the manufacturer, in accordance with the following table: Initial concentration range Permitted variation in initial of the constituent concentration of the constituent S2.5% ±30% >2.5S 10% ±20% > 10S25 % ±10% >25S 100% ±5% changes of composition involving the substitution or addition of one or more constituents, which may or may not be dangerous within the meaning of the definitions set out in Article 3.2, are introduced by the manufacturer. This new evaluation will apply unless there is valid scientific justification for considering that a re-evaluation of the hazard will not result in a change of classification. B 3271 8.1 The hazards of a preparation for the environment shall be Ev~uation of , envuonmental assessed by one or more of the following procedures: hazards (a) by a conventional method described in the Third Schedule to these regulations; . (b) by determining the hazardous properties of the preparation for the environment necessary for appropriate classification in accordance with the criteria set out in Annex VI to Directive 67 /548/EEC. These properties shall be determined by means of the methods laid down in Part C of Annex V to Directive 67 /548/EEC unless, in the case of plant protection products, other internationally recognised methods are acceptable in accordance with the provisions of Annexes II and III to Directive 91/414/EEC. Without prejudice to the testing requirements set out in Directive 91/414/EEC, the conditions for application of the test methods are described in Part C of the Third Schedule to these regulations. 8.2 Where an ecotoxicological property is established by one of the methods outlined in paragraph 8.l(b) to obtain new data, the test shall be conducted in compliance with the principles of good laboratory practice provided for in Directive 87/18/EEC and with the provisions of Directive 86/609/EEC. Where the environmental hazards have been assessed in compliance with both the procedures mentioned above, the results of the methods referred to in paragraph 8.l(b) shall be used for classifying the preparation. 8.3 For preparations of a known composition, with the exception of those covered by Directive 91/414/EEC or equivalent provisions, classified in accordance with the method outlined in paragraph 8.l(b), a new evaluation·of environmental hazard either by the method outlined in paragraph 8.l(a) or that outlined in paragraph 8.l(b) shall be performed whenever: changes of composition of the initial concentration, as a weight/weight or volume/volume percentage, of one or more of the dangerous constituents are introduced by the manufacturer, in accordance with the following table: Initial concentration range Permitted variation in initial of the constituent concentration of the constituent $;2.5% ±30% >2.5% $; 10 % ±20% > 10% ~25 % ±10% >25% ~ 100 % ±5% B 3272 Prohibition of marketing Packaging changes of composition involving the substitution or addition of one or more constituents, which may or may not be dangerous within the meaning of the definitions set out in paragraph 3.2, are introduced by the manufacturer. This new evaluation will apply unless there is valid scientific justification for considering that a re-evaluation of the hazard will not result in a change of classification. 9.1 Preparations covered by these regulations cannot be placed on the market unless they comply with it. 9.2 In order to ensure compliance with these regulations, the Director may request information on the composition of the preparation and any other pertinent information from any person responsible for placing the preparation on the market. 9.3 The Director shall take all necessary measures to ensure that those responsible for placing the preparation on the market hold at his disposal: the data used for the classification and labelling of the preparation, any pertinent information relating to packaging requirements in accordance with paragraph 10.1.3, including the test certificate issued in accordance with Part A of Annex IX to Directive 67/548/EEC, the data used for establishing the safety data sheet, in accordance with paragraph 15. 10.1 Preparations within the meaning of paragraph 2.2 and preparations covered by the Fourth Schedule pursuant to paragraph 2.3 cannot be placed on the market unless their packaging satisfies the following requirements: it shall be so designed and constructed that its contents cannot escape; this requirement shall not apply where special safety devices are prescribed, the materials constituting the packaging and fastenings must not be susceptible to adverse attack by the contents, or liable to form dangerous compounds with the contents, packaging and fastenings must be strong and solid throughout to ensure that they will not loosen and will safely meet the normal stresses and strains of handling, containers fitted with replaceable fastening devices shall be so designed that the packaging can be refastened repeatedly without the contents escaping; 10.2 Containers which contain preparations within the meaning of paragraph 2.2 and preparations covered by the Fourth Schedule pursuant to paragraph 2.3 offered or sold to the general public must not have: either a shape and/or graphic decoration likely to attract or arouse the active curiosity of children or to mislead consumers, or a presentation and/or a designation used for foodstuffs or animal feedingstuffs or medicinal or cosmetic products. 10.3 Containers which contain certain preparations offered or sold to the general public covered by the Fourth Schedule to these regulations must: be fitted with child-resistant fastenings, and/or carry a tactile warning of danger. The devices must conform to the technical specifications given in Parts A and B of Annex IX to Directive 67/548/EEC. 10.4 The packaging of preparations shall be deemed to satisfy the requirements of paragraphs 10.1 to 10.3 if it complies with the requirements for carriage of dangerous goods by rail, road, inland waterway, sea or air. B 3273 11.1 Preparations within the meaning of paragraph 2.2 cannot Labelling be placed on the market unless the labelling on their packaging satisfies all the requirements of paragraph 11.2 and the specific provisions of Part A and B of the Fifth Schedule; Preparations within the meaning of paragraph 2.3 as defined in Parts B and C of the Fifth Schedule cannot be placed on the market unless the labelli!l g on their packaging satisfies the requirements of paragraphs 11.2.1 and 11.2.2 and the specific provisions of Parts B and C of the Fifth Schedule. B 3274 11.1.1 With respect to plant protection products subject to Directive 91/414/EEC. or equivalent provisions, the labelling requirements in accordance with these Regulations shall be accompanied by the following wording: ''To avoid risks to man and the environment, comply with the instructions for use." This labelling shall be without prejudice to the information required in accordance with Article 16 of, and Annex V to, Directive 91/414/EEC. 11.2 The following information shall be clearly and indelibly marked on any package: 11.2.1 the trade name or designation of the preparation; 11.2.2 the name, full address and telephone number of the person established in Malta or the European Community who is responsible for placing the preparation on the market, whether it be the manufacturer, the importer or the distributor; 11.2.3 the chemical name of the substance or substances present in the preparation in accordance with the following detailed rules: for preparations classified T +, T, Xn in accordance with paragraph 7, only the substances T +, T, Xn present in concentrations equal to, or greater than, the lowest limit (limit Xn) for each of them laid down in Annex I to Directive 67 /548/EEC or, failing that, Part B of the Second Schedule to these regulations have to be taken into consideration; for preparations classified C in accordance with paragraph 7, only C substances present in concentrations equal to, or greater than, the lowest limit (limit Xi) laid down in Annex I to Directive 67 /548/EEC or, failing that, Part B of the Second Schedule ~o these regulations have to be taken into consideration; the name of the substances which have given rise to the classification of the preparation in one or more of the following danger categories: carcinogen category 1, 2 or 3, mutagen category 1, 2 or 3, toxic for reproduction category 1, 2 or 3, very toxic, toxic or harmful due to non-lethal effects after a single exposure, toxic or harmful due to severe effects after repeated or prolonged exposure, sensitising; shall be mentioned on the label. The chemical name shall be one of the designations listed in Annex I to Directive 67 /548/EEC or an internationally recognised chemical nomenclature if no corresponding designation is yet listed in that Annex. As a consequence of the above provisions the name of any substance which led to the classification of the preparation in the following danger categories: explosive, oxidising, extremely flammable, highly flammable, flammable, irritant, dangerous for the environment, need not be mentioned on the label unless the substance has to be mentioned pursuant· to the first, second or third indents of paragraph 11.2.3. As a general rule, a maximum of four chemical names shall suffice to identify the substances primarily responsible for the major health hazards which have given rise to the classification and the choice of the corresponding phrases referring to the risk involved. In some cases, more than four chemical names may be necessary. 11.2.4. The danger symbol(s) and indication(s) of danger. The danger symbols, where specified in these Regulations, and indications of the dangers involved in the use of the preparation, shall be in accordance with the wording of Annexes II and VI to Directive B 3275 B 3276 67 /548/EEC and shall be applied in accordance with the evaluation of the hazards carried out in accordance with the First, Second and Third Schedules to these Regulations. Where more than one danger symbol must be assigned to a preparation the obligation to apply the symbol: T shall make the symbols C and X optional unless otherwise specified in Annex I to Directive 67 /548/EEC, C shall make the symbol X optional, E shall make the symbols F and O optional, X0 shall make the symbol Xi optional. The symbol(s) shall be printed in black on an orange-yellow background. 11.2.5. The risk phrases (R phrases) The indications concerning special risks (R phrases) shall comply with the wording in Annexes ill and VI to Directive 67 /548/EEC and shall be assigned in accordance with the results of the hazard evaluation carried out in accordance with the First, Second and Third Schedules to these regulations. As a general rule, a maximum of six R phrases shall suffice to describe the risks; for this purpose, the combined phrases listed in Annex III to Directive 67/548/EEC shall be regarded as single phrases. However, if the preparation falls within more than one danger category, those standard phrases shall cover all the principal hazards associated with the preparation. In some cases more than six R phrases may be necessary. The standard phrases "extremely flammable" or "highly flammable" need not be used where they describe an indication of danger used in accordance with paragraph 11.2.4. 11.2.6. The safety advice (S phrases) The indications giving safety advice (S phrases) shall comply with the wording in the Fourth Schedule and with Annex VI to Directive 67 / 548/EEC and shall be assigned in accordance with the results of the hazard evaluation carried out in accordance with the First, Second and Third Schedules to these regulations. As a general rule, a maximum of six S phrases shall suffice to formulate the most appropriate safety advice; for this purpose the combined phrases listed in Annex IV to Directive 67 /548/EEC shall be regarded as single phrases. However, in some cases more than six S phrases may be necessary. Where it is physically impossible to include the advice on the label or package itself, the package shall be accompanied by safety advice on the use of the preparation. 11.2. 7 The nominal quantity (nominal mass or nominal volume) of the contents in the case of preparations offered or sold to the general public. 11.3 For certain preparations classified as dangerous within the meaning of paragraph 8, by way of derogation from paragraphs 11.2.4, 11.2.5, and 11.2.6, exemptions to certain provisions on environmental labelling or specific provisions in relation to environmental labelling may be determined in accordance with the procedure referred to in Article 20 of Directive 1999/45/EC, where it can be demonstrated that there would be a reduction in the environmental impact. These exemptions or specific provisions are defined and laid down in Part A or B of the Fifth Schedule. 11.4 If the contents of the package do not exceed 125 ml: in the case of preparations that are classified as highly flammable, oxidising, irritant, with the exception of those assigned R4 l, or dangerous for the environment and assigned the N symbol it shall not be necessary to indicate the R phrases or the S phrases, in the case of preparations that are classified as flammable or dangerous for the environment and not assigned the N symbol it shall be necessary to indicate the R phrases but it shall not be necessary to indicate the S phrases. 11.5 Without prejudice to Article 16(4) of Directive 91/414/EC or equivalent provisions, indications such as "non-toxic", "non-harmful", "non-polluting", "ecological" or any other statement indicating that the preparation is not dangerous or likely to lead to underestimation of the dangers of the preparation in question shall not appear on the packaging or labelling of any preparation subject to these regulations. B 3277 12.1 Where the particulars required by paragraph 11 appear on a Implementation of label, that label shall be firmly affixed to one or more surfaces of the ~~!!:~ packaging so that those particulars can be read horizontally when the B 3278 package is set down normally. The dimensions of the label are laid down in Annex VI to Directive 67 /548/EEC and the label is intended solely for provision of the information required by this Directive and if necessary of any supplementary health or safety information. 12.2 A label shall not be required when the particulars are clearly shown on the package itself, as specified in paragraph 12.1. 12.3 The colour and presentation of the label - or, in the case of paragraph 12.2, of the package - shall be such that the danger symbol and its background stand out clearly from it. 12.4 The information required on the label under paragraph 11 shall stand out clearly from its background and shall be of such size and spacing as to be easily read. Any specific provisions regarding the presentation and format of this information laid down in Annex VI to Directive 67 /548/EEC shall be applicable. 12.5 Preparations covered by these regulations must be labelled in at least one of the official languages of Malta. 12.6 For the purposes of these Regulations, labelling requirements shall be dee~ed to be satisfied: (a) in the case of an outer package containing one or more inner packages, if the outer package is labelled in accordance with international rules on the transport of dangerous goods and the inner package or packages are labelled in accordance with these regulations; (b) in the case of a single package: if such a package is labelled in accordance with international rules on the transport of dangerous goods and with paragraphs 11.2.1, 11.2.2, 11.2.3, 11.2.5 and 11.2. 6; for preparations classified according to paragraph 8, the provisions of paragraph 11.2.4 shall additionally apply with respect to the property in question when it has not been so identified on the label, or where appropriate, for particular types of packaging such as mobile gas cylinders, if the specific requirements referred to in Annex VI to Directive 67 /548/EEC are complied with. B 3279 13.1 Paragraphs 10, 11 and 12 shall not apply to explosives placed Exempti~ns from th k 'th . b . . l . , the labellmg and on e mar et w1 a view to o tammg an exp os1ve or pyrotechnic packaging effect. requirements 13.2 For certain dangerous preparations within the meaning of paragraphs 6, 7 or 8 defined in the Seventh Schedule which, in the form in which they are placed on the market, do not present any physico chemical risk, or risk to health or to the environment, paragraphs 10, 11 and 12 shall not apply. 13.3 The Director may also, on the advice of the Malta Standards Authority: (a) permit the labelling required by paragraph 11 to be applied in some other appropriate manner on packages which are either too small or otherwise unsuitable for labelling in accordance with Article 12.1 and 12.2; (b) by way of derogation from paragraphs 11 and 12 permit the packaging of dangerous preparations which are classified as harmful, extremely flammable, highly flammable, flammable, irritant or oxidising to be unlabelled or to be labelled in some other way, if they contain such small quantities that there is no reason to fear any danger to persons handling such preparations or to other persons; (c) by way of derogation from paragraphs 11 and 12, for preparations classified according to paragraph 8, permit the packaging of dangerous preparations to be unlabelled or labelled in some other way if they contain such small quantities that there is no reason to fear any dangers to the environment; (d) by way of derogation from paragraphs 11 and 12 permit the packaging of dangerous preparations which are not mentioned in (b) or ( c) above to be labelled in some other appropriate way, if the packages are too small for the labelling provided for in paragraphs 11 and 12 and there is no reason to fear any danger to persons handling such preparations or to other persons. Where this paragraph is applied, the use of symbols, indications of danger, risk (R) phrases or safety (S) phrases different to those laid down in these Regulations shall not be permitted. 14.1 Any advertisement for a preparation within the meaning of Distance Selling these regulations which enables a member of the general public to conclude a contract for purchase without first having sight of the label B 3280 for that preparation must make mention of the type or types of hazard indicated on the label. This requirement is without prejudice to the provisions of the Consumer Affairs Act on the protection of consumers in respect of distance contracts. Safety Data Sheet 15.1 The safety data sheet information is principally intended Confidentiality of Chemical Names for use by professional users and must enable them to take the necessary measures as regards the protection of health, safety and the environment at the place of work. 15.2 The person responsible for placing on the market a preparation within the meaning of paragraph 2.2 shall provide a safety data sheet. 15.3 The person responsible for placing on the market a preparation shall provide on request of a professional user a safety data sheet providing proportionate information for preparations not classified as dangerous within the meaning of paragraphs 6, 7 and 8 but containing in an individual concentration of ( 1 % by weight for non-gaseous preparations and ( 0,2 % by volume for gaseous preparations at least: one substance posing health or environmental hazards, or one substance for which there are workplace exposure limits established by the European Community. 15.4 The safety data sheet and its supply must comply with the provisions of Directive 91/155/EEC or equivalent provisions. 15.5 The safety data sheet may be supplied on paper or electronically, provided that the addressee has the necessary means of receiving it. 16.1 Where the person responsible for placing the preparation on the market can demonstrate that the disclosure on the label or safety data sheet of the chemical identity of a substance which is exclusively classified as: irritant with the exception of those assigned R41 or irritant in combination with one or more of the other properties mentioned in the fourth indent of paragraph 11.2.3, or harmful or harmful in combination with one or more of the properties mentioned in the fourth indent of paragraph 11.2.3 presenting acute lethal effects alone will put at risk the confidential nature of his intellectual property, he may, in accordance with the provisions of the Sixth Schedule be permitted to refer to that substance either by means of a name that identifies the most important functional chemical groups or by means of an alternative name. This procedure may not be applied where the substance concerned has been assigned an exposure limit by the European Community. Where the person responsible for placing a preparation on the market wishes to take advantage of confidentiality provisions, he shall make a request to the Director. This request must be made in accordance with the provisions of the Sixth Schedule and must provide the information required in the form in Part A of that Schedule. The Director may nevertheless request further information from the person responsible for placing the preparation on the market if such information appears necessary in order to evaluate the validity of the request. The Director, when receiving a request for confidentiality shall notify the applicant of his decision. The Director shall recognise a decision pursuant to a request for confidentiality taken by the competent authority of a Member State of the European Community, provided that a copy of such decision has been duly forwarded to him by the person responsible for placing the preparation on the Maltese market. Confidential information brought to the attention of the Director shall be treated in accordance with Article 19(4) of Directive 67/548/ EEC. B 3281 17 ,1 These regulations shall apply without prejudice to other Safety of Workers requirements deemed necessary to ensure that workers are protected when using the dangerous preparations in question, provided that this does not mean that the classification, packaging, and labelling of dangerous preparations are modified in a way not provided for in these regulations. 18.1 Where the Director has detailed evidence that a preparation, Safeguard Clause although satisfying the provisions of these regulations, constitutes a hazard for man or the environment on grounds relating to the provisions of these Regulations, he may, on the advice of the Directorate responsible for chemicals withi.n the Malta Standards Authority, provisionally prohibit the placing on the market of that preparation or subject it to special conditions. B 3282 Repeal of Regulations L.N. 163 of 2001. 19.1 The Dangerous Substances and Preparations Regulations, 2001 are hereby repealed and any reference to those regulations shall be construed as a reference to these regulations. B 3283 FIRST SCHEDULE Methods for the evahmtion of physico-chcmical properties of preparations in accordance with paragraph 6 PART A !:\emptions to test methods of Annex V - Part A to Directive 67/548/EEC Sl!c 2.2.5 of Annex VI lo Directive 67/548/EEC. PARTB Alternative calculation methods B.1. Non-~aseous preparations 1. Method for the determination of oxidising properties of preparations containing organic peroxides. Sec point 2.2.2.1 of Annex VI to Directive 67/548/EEC. 13.2. Gaseous preparations 1. Method for the determination of oxidising properties See 9.1.1.2 uf Annex VI to Directive 67/548/EEC. 2. Method for the determination of flammability properties See 9.1.1.1 of Annex VI to Directive 67 /548/EEC. B 3284 SECOND SCHEDULE Methods for the evaluation of health haza1·ds of preparations in accordance with paragraph 7 lntroduc:tio11 An assessment must be made for all the health effects corresponding to the health effects of substances contained in a preparation. This conventional method described in Parts A and B of this Schedule is a calculation method which is applicable to all preparations and which takes into consideration all the health hazards of substances contained in the preparation. For that purpose the dangerous health effects have been subdivided into: I. acute lethal effects; 2. non-lethal irreversible effects after a single exposure; 3. severe effects after repeated or prolonged exposure; 4. corrosive effects, irritant effects; 5. sensitising effects; 6. carcinogenic effects, mutagcnic effects, toxic effects for reproduction. The health effects of a preparation arc to be assessed in accordance with paragraph 7 .1 (a) by the conventional method described in parts A and B of this Schedule using individual concentration limits. (a) where the dangerous substances listed in Annex I to Directive 67 /548/EEC are assigned concentration limits necessary for the application of the method of assessment described in part A of this Schedule, these concentration limits must be used; (b) where the dangerous substances do not appear in Annex I to Directive 67 /548/EEC or appear there without the concentration limits necessary for the application of the method of evaluation described in part A of this Schedule, the concentration limits must be assigned in accordance with the specifications in part B of this Schedule. The procedure for classification is set out in Part A of this Schedule. The classification of the substance(s) and the resulting classification of the preparation are expressed: either by a symbol and one or more risk phrases, or by categories (category 1, category 2 or category 3) also assigned risk phrases when substances and preparations are shown to be carcinogenic, mutagenic or toxic for reproduction. Therefore it is important to consider, in addition to the symbol, all the phrases denoting specific risks which are assigned to each substance under consideration. The systematic assessment of all the dangerous health effects is expressed by means of concentration limits, expressed as a weight/weight percentage except for gaseous B 3285 preparations where they arc expressed as a volume/volume percentage and in conjunction with the classification of the substance. Where they are not given in Annex I to Directive 67/548/EEC, the concentration limits to be taken into account for the application of this conventional method are those set out in Part B of this Schedulc. PART A Procedure for evaluation of health hazards The evaluation proceeds stepwise as follows: 1. 11ie following preparations are to be classified as very toxic: 1.1. owing to their acute lethal effects and assigned the symbol "T+", the indication of danger "very toxic" and the risk phrases R26, R27 or R28; 1.1.1 preparations containing one or more substances classified as very toxic that produce such effects, in individual concentrations equal to or greater than: (a) either the concentration specified in Annex I to Directive 67 /548/EEC for the substance or substances under consideration, or (b) the concentration specified at point 1 in Part B of this Schedule (Table I and I A) where the substance or substances do not appear in Annex I to Directive 67 /548/EEC or appear in it without concentration limits; 1. 1.2. preparations containing more than one substance classified as very toxic in lower individual concentrations than the limits specified under 1.1.l(a) or (b) if: where: PT+ is the percentage by weight or by volume of each very toxic substance in the preparation, L-r+ is the very toxic limit specified for each very toxic substance, expressed as a percentage by weight or by volume; 1.2. owing to their non-lethal irreversible effects after a single exposure and assigned the symbol "T", the indication of danger "very toxic" and the risk phrase R39/route of exposure. Preparations containing at least one dangerous substance that produces such effects in individual concentrations equal to or greater than: (a) either the concentration specified in Annex I to Directive 67 /548/EEC for the substance or substances under consideration, or B 3286 (b) the concentration specified at point 2 in Part B of this Schedule (Table II and II /\) where the substance or substances do not appear in Annex l to Directive 67/548/EEC or appear in it without concentration limits. 2. 71w j<Jllowi11g preparations shall be classified as toxic: 2.1. owing to their acute lethal effects and assigned the symbol "T", the indication of danger "toxic" and the risk phrases R23, R24 or R2S; 2.1.1 preparations containing one or more substances classified as very toxic or toxic that produce such effects in individual concentrations equal to or greater than: (a) either the concentration specified in Annex I to Directive 67 /548/EEC for the substance or substances under consideration, or (b) the concentration specified at point 1 in Part B of this Schedule (Table I and I A) where the substance or substances do not appear in Annex I to Directive 67 /548/EEC or appear in it without concentration limits; 2.1.2 preparations containing more than one substance classified as very toxic or toxic in lower individual concentrations than the limits specified under 2. l.1 (a) or (b) if: where: PT+ is the percentage by weight or by volume of each very toxic substance in the preparation, PT is the percentage by weight or by volume of each toxic substance in the preparation, LT is the respective toxic limit specified for each very toxic or toxic substance, expressed as a percentage by weight or by volume; 2.2. owing to their non-lethal irreversible effects after a single exposure and assigned the symbol "T", the indication of danger "toxic" and the risk phrase R39/route of exposure. Preparations containing at least one dangerous substance classified as very toxic or toxic that produce such effects in individual concentrations equal to or greater than: (a) either the concentration specified in Annex I to Directive 67 /548/EEC for the substance or substances under consideration, or (b) the concentration specified at point 2 in Part B of this Schedule (Table II and II A) where the substance or substances do not appear in Annex I to Directive 67 /548/EEC or appear in it· without concentration limits; B 3287 2.3. owing to their long-tenn effects and assigned the symbol "T", the indication of danger "toxic" and the risk phrase R48/routc of exposure. Preparations containing at least one dangerous substance that produces such eff ccts in individual concentrations equal to or greater than: (a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under considemtion, or (b) the concentration specified at point 3 in Part B of this Schedule (Table Ill and Ill A) where the substance or substances do not appear in Annex I to Directive 67 /548/EEC or appear in it without concentration limits. 3. The following preparations shall be classified as harmful: 3.1. owing to their acute lethal effects and assigned the symbol "Xn" and the indication of danger "harmful" and the risk phrases R20, R21 or R22; 3 .1.1. preparations containing one or more substances classified as very toxic, toxic or hannful and that produce such effects in individual concentrations equal to or greater than: (a) either the concentration specified in Annex I to Directive 67 /548/EEC for the substance or substances under consideration, or (b) the concentration specified at point 1 in Part B of this Schedule (Table I and I A) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits. 3 .1.2 preparations containing more than one substance classified as very toxic, toxic or harmful in lower individual concentrations than the limits specified under 3.1.l(a) or (b) if: ~(PT+ PT Pxn J l ~ -+-+- ~ Lxn Lxn Lxn where: Pr+ is the percentage by weight or by volume of each very toxic substance in the preparation, Pr is the percentage by weight or by volume of each toxic substance in the preparation, Px11 is the percentage by weight or by volume of each hannful substance in the preparation, Lxn is the respective hannful limit specified for each very toxic, toxic or hannful substance, expressed as percentage by weight or by volume; 3 .2. owing to their acute effects to the lungs if swallowed and assigned the symbol "X1111 , and the indication of danger "hannful" and the risk phrase R65. Preparations classified as hannful according to the criteria specified in paragraph 3.2.3 of Annex VI to Directive 67/548/EEC. In applying the B 3288 conventional method according to the above paragraph 3 .1 no account shall be taken of the classification of a substance as R.65; 3J. owing to their non-lethal irreversible effects after a single exposure and assigned the symbol "X11 ", the indication of danger "harmful" and the risk phrase R68/routc or exposure. Preparations containing at !cast one dangerous substance classified as very toxic, toxic or harmful that produces such effects in individual concentrations equal to or greater than: (a) either the concentration specified in Annex I to Directive 67 /548/EEC for the substance or substances under consideration, or (b) the concentration specified at point 2 in Part B of this Schedule (Table II and II A) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits; 3 A owing to their long-term effects and assigned the symbol "Xn", the indication of danger "harmful" and the risk phrase R.48/route of exposure. Preparations containing al least one dangerous substance classified as toxic or harmful that produces such effects in individual concentrations equal to or greater than: (a) either the concentration specified in Annex I to Directive 67 /548/EEC for the substance or substances under consideration, or (b) the concentration specified at point 3 in Part B of this Schedule (Table III and III A) where the substance or substances do not appear in Annex I to Directive 67 /548/EEC or appear in it without concentration limits. 4. The following preparations are to be classified as corrosive 4.1. and assigned the symbol "C", the indication of danger "corrosive" and the risk phrase R35; 4.1.1 preparations containing one or more substances classified as corrosive to which is assigned the phrase R35 in individual concentrations equal to or greater than: (a) either the concentration specified in Annex I to Directive 67 /548/EEC for the substance or substances under consideration, or (b) the concentration specified at point 4 in Part B of this Schedule (Table IV and IV A) where the substance or substances do not appear in Annex I to Directive 67 /548/EEC or appear in it without concentration limits. 4.1.2 preparations containing more than one substance classified as corrosive to which is assigned phrase R35 in lower individual concentrations than the limits specified under 4.1.l(a) or (b) if: B 3289 where: Pc.R3:i is the percentage by weight or by volume of each corrosive substance which is assigned phrase R35 in the preparation, Lt·.R.1s is the corrosive limit R35 specified for each corrosive substance to which is assigned phrase R35, expressed as a percentage by weight or by volume; 4.2. and assigned the symbol "C", the indication of danger "corrosive" and the risk phrase R.34; 4.2.1 preparations contammg one or more substances classified as corrosive to which is assigned the phrase R.35 or R34 in individual concentrations equal to or greater than: (a) either the concentration specified in Annex I to Directive 67 /548/EEC for the substance or substances under consideration, or (b) the concentration specified at point 4 in Part B of this Schedule (Table IV and IV A) where the substance or substances do not appear in Annex I to Directive 67 /548/EEC or appear in it without concentration limits; 4.2.2 preparations containing more than one of the substances classified as corrosive to which is assigned the phrase R35 or R.34 in lower individual concentrations than the limits specified under 4.2.l(a) or (b) if: where: Pc,,m is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R35 in the preparation, Pc.R34 is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R34 in the preparation, Lc,R34 is the respective corrosive limit R34 specified for each corrosive substance to which is assigned phrase R35 or R34, expressed as a percentage by weight or by volume. 5. The following preparations are to be classified as irritants: 5 .1. liable to cause serious eye damage and assigned the symbol "Xi'', the indication of danger "irritant" and the risk phrase R41; 5.1.1. preparations containing one or more substances classified as irritant to which is assigned phrase R41 in individual concentrations equal to or greater than: (a) either the concentration specified in Annex I to Directive 67 /548/EEC for the substance or substances under consideration, or B 3290 (b) the com:cntration specified at point ➔ in Part 8 of this Schedule (Table IV and IV A) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits; 5.1.2 pn.:parations containing more than one of the substances classified as irritant and to which is assigned phrase R41, or classified as corrosive and to which is assigned phrase R35 or R34, in lower individual concentrations than the limits specified under 5 .1.1 (a) or (b) if: where: Pc.R:15 is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R35 in the preparation, Pc.int is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R34 in the prepamtion, l\:i,IW is the percentage by weight or by volume· of each irritant substance to which is assigned phrase R4 l in the preparation, Lxi,IW is the respective irritant limit R41 specified for each corrosive substance to which is assigned phrase R35 or R34 or irritant substance to which is assigned phrase R41, expressed ·as percentage by weight or by volume; 5 .1. irritant to eyes and assigned the symbol "Xi", the indication of danger "irritant" and the risk phrase R36; 5 .1.1 preparations containing one or more substances classified as corrosive to which is assigned phrase R35 or R34 or as irritant and to which is assigned phrase R.41 or R.36 in individual concentrations equal to or greater than: (a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or (b) the concentration specified at point 4 in Part B of this Schedule (Table IV and IV A) where the substance or substances do not appear in Annex I to Directive 67 /548/EEC or appear in it without concentration limits; 5 .2.2 preparations containing more than one substance classified as irritant to which is assigned phrase R41 or R36, or as corrosive and to which is assigned phrase R35 or R34, in lower individual concentrations than the limits specified under 5.2.l(a) or (b) if: where: Pc.R3s is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R35 in the preparation, Pc.R34 is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R34 in the preparation, B 3291 I\, R-11 is the pcrcrntagc by weight or hy volume of each irritant substance to which is assigned phrase R.41 in the preparation, P,i,JUc, is the percentage by weight or by volume of each irritant substance to which is assigned phrase R.36 in the preparation, Lxi,1U1, is the respective irritant limit R36 specified for each corrosive substance to which is assigned phrase R35 or R34 or irritant substance to which is assigned phrase R41, or R36 expressed as percentage by weight or by volume; 5 J. irritant to skin and assigned the symbol "X1 ", the indication of danger "irritant" and the risk phrase R.38; 5 J. I preparations containing one or more substances classified as irritant and to which is assigned phrase R38 or as corrosive and to which is assigned phrase R35 or R34 in individual concentrations equal to or greater than: (a) either the concentration specified in Annex I to Directive 67 /548/EEC for the substance or substances under consideration, or (b) the concentration specified at point 4 in Part B of this Schedule (Table IV and IV A) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits; 5 .3 .2 preparations containing more than one of the substances classified as irritant and to which is assigned phrase R38, or as corrosive and to which is assigned phrase R35 or R34 in lower individual concentrations than the limits specified under 5.3.l(a) or (b) if: where: Pc,R35 is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R35 in the preparation, Pc,R:14 is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R34 in the preparation, Pxi,R38 is the percentage by weight or by volume of each irritant substance to which is assigned phrase R38 in the preparation, Lxi,R'.\B is the respective irritant limit R38 specified for each corrosive substance to which is assigned phrase R35 or R34 or irritant substance to which is assigned phrase R38, expressed as percentage by weight or by volume; 5.4. irritant to respiratory system and assigned the symbol 11Xi", the indication of danger "irritant" and the risk phrase R37; 5 .4.1 preparations containing one or more substances classified as irritant and to which is assigned phrase R37 in individual concentrations equal to or greater than: B 3292 (a) either thl.'. L"nncentration specified in Annex I to Directive 67/548/EEC for the substam:e or substam:cs u1H.kr consideration, or (h) the conL"entration spedfh:d al point ➔ in Part l3 of this Schedule (Table IV and IV A) where the substance or the substances do not appear in Annex I to Directive 6 7 /5-t8/EEC or app1.'ar in it without concentration limits; 5 A.2 pn:parations containing more than one substance classified as irritant and to whil.:h is assigned phrase R37 in lower individual concentrations than the limits specified under 5A.l(a) or (b) if: where: 1\:i.im is the percentage by weight or by volume of each irritant substance to which is assigned phrase R.37 in the preparation, Lxi.lm is the irritant limit R37 specified for each irritant substance to which is assigned phrase R37, expressed as percentage by weight or by volume; 5 A.>. gaseous preparations containing more than one of the substances classified as irritant to which is assigned phrase R37 or as corrosive and to which is assigned phrase R35 or R34 in lower individual concentrations than the limits specified under 5 .4.1 (a) or (b) if: whcrc: Pc.1m is the percentage by volume of each corrosive substance to which is assigned phrase R35 in the preparation, l\:.1rn is the percentage by volume of each corrosive substance to which is assigned phrase R34 in the preparation, Pc.R37 is the percentage by volume of each irritant substance to which is assigned phrase R37 in the preparation; Lxi.R37 is the respective irritant limit R37 specified for each gaseous corrosive substance to which is assigned phrase R35 or R34 or gaseous irritant substance to which is assigned phrase R37, expressed as percentage by weight or by volume. 6. The following preparations are to be classified as sensitising: 6.1 by skin contact and assigned the symbol "Xi", the indication of danger "irritant" and the risk phrase R43. Preparations containing at least one substance classified as sensitising and to which is assigned phrase R43 that produces such effects in individual concentrations equal to or greater than: (a) either the concentration specified in Annex I to Direcuve 67/548/EEC for the substance or substances under consideration, or B 3293 (b) the concentration spccifkd at point 5 in Part B of this Schedule (Table V and V A) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits; 6.2 by inhalation and assigned the symbol "Xn", the indicatidn of danger "harmful" and the risk phrase R42. preparations containing at least one substance classified as sensitising to which is assigned phrase R42 that produces such cff ects in individual concentrations equal to or greater than: (a) either the concentration specified in Annex I to Directive 67 /548/EEC for the substance or substances under consideration, or (b) the concentration specified at point 5 in Part B of this Schedule (Table V and V A) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits. 7. 11ze following preparations are to be classified as carcinogenic: 7. I those of category 1 or 2 which arc assigned the symbol "T" and the phrase R45 or R49. preparations contammg at !east one substance producing such effects, classified as carcinogenic and to which is assigned phrase R45 or R49 which denotes carcinogenic substances in category 1 and category 2, in individual concentrations equal to or greater than: (a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or (b) the concentration specified at point 6 in Part B of this Schedule (Table VI and VI A) where the substance or substances do not appear in Annex I to Directive 67 /548/EEC or appear in it without concentration limits; 7.2 those of category 3 which are assigned the symbol 11X0 11 and the phrase R40. preparations containing at least one substance producing such effects classified as carcinogenic and to which is assigned phrase R40 which denotes carcinogenic substances in category 3, in individual concentrations equal to or greater than: (a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or (b) the concentration specified at point 6 in Part B of this Schedule (Table VI and VI A) where the substance or substances do not appear in Annex I to Directive 67 /548/EEC or appear in it without concentration limits. B 3294 8. 17ze following preparations are to be classij1cd as mutagenic: 8. l those of category l or 2 which are assigned the symbol "T" and the phrase R46. preparations containing at least one substance producing such effects, classified as mutagcnic and to which is assigned phrase R46 which denotes mutagenic substances in category 1 and category 2, in individual concentrations equal to or greater than: (a) either the concentmtion specified in Annex I to Directive 67 /548/EEC for the substance or substances under consideration, or (b) the concentration specified at point 6 in Part B of this Schedule (Table VI and YI A) where the substance or substances do not appear in Annex I to Directive 67 /548/EEC or appear in it without concentration limits; 8.2 those of category 3 which are assigned the symbol "Xn" and the phrase R68. preparations containing at least one substance, producing such effects, classified as mutagcnic and to which is assigned phrase R68 which denotes mutagenic substances in category 3, in individual concentrations equal to or greater than: (a) either the concentration specified in Annex I to Directive 67 /548/EEC for the substance or substances under consideration, or (b) the concentration specified at point 6 in Part B of this Schedule (Table VI and YI A) where the substance or substances do not appear in Annex I to Directive 67 /548/EEC or appear in it without concentration limits. 9. The following preparations are to be classified as toxic for reproduction: 9 .1 those of category 1 or 2 which are assigned the symbol "T" and the phrase R60 (fertility). preparations contammg at least one substance producing such effects, classified as toxic for reproduction and to which is assigned phrase R60 which denotes substances toxic for reproduction of category 1 and category 2, in individual concentrations equal to or greater than: (a) either the concentration specified in Annex I to Directive 67 /548/EEC for the substance or substances under consideration, or (b) the concentration specified at point 6 in Part B of this Schedule (Table VI and VI A) where the substance or substances do not appear in Annex I to Directive 67 /548/EEC or appear in it without concentration limits; 9 .2 those of category 3 which are assigned the symbol "Xn" and the phrase R62 (fertility). preparations containing at least one substance producing such effects, classified as toxic for reproduction and to which is assigned phrase R62 which B 3295 denotes substances toxic for reproduction of category 3, in individual com:cntrations equal to or greater than: (a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or (b) the concentration specified at point 6 in Part B of this Schedule (Table VI and Yl A) where the substance or substances do not appear in Annex I to Directive 67 /548/EEC or appear in it without concentration limits; 9.3 those of catego ry 1 or:! which arc assigned the symbol "T" and the phrase R61 (development). preparations containing at least one substance producing such effects, classified as toxic for reproduction and to which is assigned phrase R61 which denotes substances toxic for reproduction of category 1 and category 2, in individual concentrations equal to or greater than: (a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or (b) the concentration specified at point 6 in Part B of this Schedule (Table VI and YI A) where the substance or substances do not appear in Annex I to Directive 67 /548/EEC or appear in it without concentration limits; 9.4 those of category 3 which are assigned the symbol "Xn" and the phrase R63 (development). preparations containing at least one substance producing such effects, classified as toxic for reproduction and to which is assigned phrase R63 which denotes substances toxic for reproduction of category 3, in individual concentrations equal to or greater than: (a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or (b) the concentration specified at point 6 in Part B of this Schedule (Table VI and VI A) where the substance or substances do not appear in Annex I to Directive 67 /548/EEC or appear in it without concentration limits. PARTB Concentration limits to be used in evaluation of health hazards For each health effect, the first table (Tables I to VI) sets out the concentration limits (expressed as a weight/weight percentage) to be used for non-gaseous preparations and the second table (Tables I A to VI A) sets out the concentration limits (expressed as a volume/volume percentage) to be used for gaseous preparations. These concentration limits are used in the absence of specific concentration limits for the substance under consideration in Annex I to Directive 67 /548/EEC. B 3296 I. Arnie lethal ej}'ects I .I Non-gaseous preparations The concentration limits fixed in Table I, expressed as a weight/weight percentage, determine the classification of the preparation in relation to the individual concentration of the substancc(s) present whose classification is also shown. Table I Cl:1ssifkation of the Classification of the preparation substance T• T x. T' with R26, R27, R28 concentration ~ 7 % l ';'~, 0.1 % S concentration < 7 % S concentration < 1 % --. T with R23, R24, R25 concentration ~ 25 % 3% S concentration S 25 % ~" with R20, R2 l, R22 concentration ~ 25 % The R phrases denoting risk are to be assigned to the preparation in accordance with the following criteria: the label shall include one or more of the abovementioned R phrases according to the classification used, in general, the R phrases selected should be those applicable to the substancc(s) present in the concentration which gives rise to the most severe classification. 1.2 Gaseous preparations The concentration limits expressed as a volume/volume percentage in Table I A below determine the classification of the gaseous preparations in relation to the individual concentration of the gas(es) present whose classification is also shown. Table I A Classification of the Classification of the gaseous preparation substance r T x. (gas) T' with R26, R27, R28 concentration ~ 1 % 0.2% 0.02% S concentration< 1 % S concentration< 0.2 % T with R23, R24, R25 concentration ~ 5 % 05% s concentration S 5- % Xn with R20, R21, R22 concentration .!: 5 % The R phrases denoting risk shall be assigned to the preparation in accordance with the following criteria: the label shall include one or more of the abovementioned R phrases according to the classification used, ) 2.1 B 3297 in general, the R phrases selected should be those applicable to the substanci.:(s) pri.:si.:nt in the concentration which gives rise to the most severe dassification. No11-lethal irreversible effects after u single exposure Non-gaseous preparations For substances that produce non-lethal irreversible effects after a single exposure (R39/route of exposure, R68/route of exposure), the individual concentration limits specified in Table II, expressed as a weight/weight percentage, determine, when appropriate, the classification of the preparation. Table II Classification of the Classification of the preparation substance T• T x. T-'~ith-1~39/route of ·-·-· concentration 2: 10 % 1% 0.1 % expnsure R39 (*) obligatory s concentration < 10 % S concentration < 1 % R39 (*) obligatory R68 (*) obligatory T with R39/route of concentration 2: 10 % 1% cxposun: R39 (*) obligatory s concentration s 10 % ~ R68 (*) obligatory X11 with R68/routc of concentration 2:. IO % exposure R68 (*) obligatory (*) In order to indicate the route of administration/exposure (route of exposure) the combined R phrases listed under points 3.2.1, 3.2.2 and 3.2.3 of the labelling guide (Annex VI to Directive 67/548/EEC) arc to be used. 2.2. Gaseous preparations For gases that produce non-lethal irreversible effects after a single exposure (R39/route of exposure, R68/route of exposure), the individual concentration limits specified in Table II A, expressed as a volume/volume percentage, determine, when appropriate, the classification of the preparation. Table II A Classification of the Classification of the ~aseous prepararion substance (gas) T T x. r+ with R39/route of concentration 2: 1 % 0.2% 0.02% exposure R39 (*) obligatory s concentration < 1 % S concentration< 0.2 R39 (*) obligatory % R68 (*) obligatory T with R39/route of concentration ~ 5 % 0.5 % exposure R39 (*) obligatory S concentration S 5 % R68 (*) obligatory Xn with R68/routc of concentration ;:: 5 % exposure R68 (*) obligatory (*) In order to indicate the route of administration/exposure (route of exposure) the combined R phrases listed under points 3.2.1, 3.2.2 and 3.2.3 of the labelling guide (Annex VI to Directive 67/548/EEC) are to be used. B 3298 3. Sc,·en· cj]t'Cls ajicr rcpearcd or prolonged exposure 3. I Non-gaseous preparations '--·· For substances that produce severe effects after repeated or prolonged exposure (R 48/route of exposure), the individual concentration limits specified in Table 111, expressed as a weight/weight percentage, determine, when appropriate, the classification of the preparation. Table Ill Classifi1:;11ion of the substance Classification of the preparation T Xn T wi1h R48/routc of exposure concentration~ IO % 1 % $ concentration < 10 % "-- --·~-·-· R48 (*) obligatory R48 ("') obligatory X" wilh R48/route of exposure concentration ~ 10 % R48 ("') obligatory (*) In order to indicate the route of administration/exposure (rou1c of exposure) the combined R phrases listed under poinls 3.::?.I, 3.2.2 and 3.2.3 of the lahdling guide (Annex VI to Directive 6 7 '548/EEC) arc 10 he used. 3.2. Gaseous preparations For gases that produce severe eff ccts after repeated or prolonged exposure (R48/route of exposure), the individual concentmtion limits specified in Table Ill A below, expressed as a volume/volume percentage, determine, when appropriate, the classification of the prepamtion. Table III A Classification of the substance Classification of the preparation T Xn T with R48/routc of exposure concentration ~ 5 % 0 .5 % $ concentration < 5 % R48 (*) oblhiatorv R48 (*) oblhtatorv X0 with R48/routc of exposure concentration ~ 5 % R48 ("') obligatory (*) In order to indicate the route of administration/exposure (route of exposure) the combined R phrases listed under points 3.2.1, 3.2.2 and 3.2.3 of the labelling guide (Annex VI to Directive 67.'548/EEC) arc to be used. 4. Corrosive and irritant effects including serious damage to the eye 4.1 Non-gaseous preparations For substances that produce corrosive effects (R34, R35) or irritant effects (R36, R37, R38, R41), the individual concentration limits specified in Table IV, expressed as a weight/weight percentage, determine, when appropriate, the classification of the preparation. B 3299 Table IV ·-·-·---~- ( 'lassii'i~·:1tillll nf -~-'1?s~~~~1t i\2~1~r thl:Jl! 9), 1ration the suh,tanct: C with !US C with R3·+ X, with R41 X; with R36, R37, R38 Cw1th R35 conccnlralllln? 51:;, ~ 5 % l *) 1%:s ll) r;;, com:cnlration < c onccntration < 5 R35 obligatory 10% % R34 obligatory ~~---- R36/38 obligatory C with 1U4 concentration ? IO%(*) 5 % ~ 10% concentration < R34 obligatory 10 % R36/38 obli1rntorv X; wi1h R41 concentration 2: 5%:s 10% concentration < R4 l obligatory 10% R36 obligatory X, with R36, R37, concentration ~ R38 20% R36,R37,R38 are obligatory in the light of the concentration present if they apply to the substances under consideration (*) According lo the labelling guide (Annex VI to Directive 67/548/EEC), corrosive substances assigned risk phrases R35 or R34 must also be considered as being assigned phrase R41. Consequently, if the preparation contains corrosive substances with R35 or R34 below the concentration limits for a classifica 1ion of the preparation as corrosive, such substances can contribute lo a classification of the preparation as irritant with R4 l or irritant with R36, Nii: Simple application of the conventional method to preparations containing substances classified as corrosive or irritant may result in under-classification or over-classification of the hazard, if other relevant factors (e.g. pH of the preparation) are not taken into account. Therefore, in classifying for corrosivity, consider the advice given in paragraph 3.2.5 of Annex VI to Directive 67/548/EEC and in the second and third indents of regulation 7 J of these Regulations. 4.2. Gaseous preparations For gases that produce such effects (R34, R35 or R36, R37, R38, R41), the individual concentration limits specified in Table IV A below, expressed as a volume/volume percentage determine, when appropriate, the classification of the preparation, Table IV A Classification of Classification of the gaseous preparation the substance C with R35 C with R34 Xi with R41 X; with R36, R37, (gas) R38 Cwith R35 concentration 2: 1 02% S 02 % (*) 0.02 %$ % concentration < 1 concentration < R35 obligatory % 0.2% R34 obli gatorv R36/38 obli2atory C with R34 concentration ~ 5 5 % (*) 05 % s tfc1 concentration < 5 B 3300 Classification of Classilkation of the l!aseous oreparation the substance Cwith R35 Cwith R34 X; with R41 X; with R36, R37, (gas) R38 R34 obligatory % R36/38 oblil!atory X; with R41 concentration ~ 5 0.5 %S % concentration < 5 R41 obligatory % R36 obli1wtorv X; with R36, R37, concentration ~ 5 R38 % R36,R37,R38 obligatory as annrooriatc (") According to the labelling guide (Annex VI to Directive 67/548/EEC), corrosive substances assigned risk phrases R35 or R34 must also be considered as being assigned phrase R41. Consequently, if the preparation contains corrosive substances with R35 or R34 below the concentration limits for a classification of the preparation as corrosive, such substances can contribute to a classification of the preparation as irritant with R41 or irritant with R36. NB: Simple application of the conventional method to preparations containing substances classffied as corrosive or irritant may result in under-classification or over-classification of the hazard, if other relevant factors (e.g. pH of the preparation) arc not taken into account. Therefore, in classifying for corrosivity, consider the advice given in paragraph 3.2.5 of Annex VI to Directive 67/548/EEC and in the second and third indents of re2ulation 7 3 of these Re2ulations. 5. Sensitising effects 5 .1 Non-gaseous preparations preparations that produce such effects are classified as sensitising and assigned: the symbol Xn and phrase R42 if this effect can be produced by inhalation, the symbol Xi and phrase R43 if this effect can be produced through contact with the skin. The individual concentration limits specified in Table V, expressed as a weight/weight percentage, determine, when appropriate, the classification of the preparation. Table V aassification of the substance aassification of the oreoaration Sensitisin2 with R42 Sensitisine with R43 Sensitising with R42 concentration :2: 1 % R42 obli2atorv Sensitising with R43 concentration ~ 1 % R43 obliitatorv 5 .2. Gaseous preparations Gaseous preparations that produce such effects are classified as sensitising and assigned: B 3301 'the symbol X11 and phrase R42 if this effect can be produced by inhalation, the symbol X, and phrase R--+:i if this effect can be produced through contact with the skin. The individual concentration limits specified in Table V A below, expressed as a volume/Volume percentage, determine, when appropriate, the classification of the preparation. Tabk VA Cla~siri.:a1inn of the substance Classifiea1ion of the gaseous preparation ... (gas) ~-·--·· Sensitising with R42 Sensitising with R43 S1:nsi1ising with R42 concentration~ 0.2 % R42 obligatory S-:nsitisinl,\ with R43 concentration~ 0.2 % R43 obligatory 6. Carcinogenic/mutagenic/toxic ejfects for reproductfon (). I Non-gaseous preparations For substances which produce such effects, the concentration limits laid down in Table VI, expressed as a weight/weight percentage, shall determine, where appropriate, the classification of the preparation. The following symbol and risk phrases are assigned: Carcinogenic categories 1 and 2: Carcinogenic category 3: Mutagcnic categories 1 and 2: Mutagenic category 3: Toxic for reproduction fertility categories 1 and 2: Toxic for reproduction development categories 1 and 2: Toxic for reproduction fertility category 3: Toxic for reproduction development category 3: Table VI T; R45 or R49 Xn; R40 T; R46 Xn; R68 T; R60 T;R61 Xn; R62 Xn; R63 Classification of the substance Classification of the preparation Categories 1 and 2 Category 3 carcinogenic substances of concentration~ 0.1 % category 1 or 2 with R45 or R49 carcinogenic R45, R49 obligatory as aooropriate carcinogenic substances of concentration~ 1 % category 3 with R40 carcinogenic R40 obligatory mutagenic substances of concentration ~ 0.1 % category l or 2 with R46 mutagenic R46 obligatorv B 3302 Classificalion or the suhstancc Classification nf 1hc preparation Catel!ories I and 2 Category 3 mutagenic substances of concentration 2: I % category 3 with R68 mutagenic R68 oblil!atory substances 'toxic for concentration 2: 0.5 % reproduction' of category I or 2 toxic for reproduction with R60 (fertility) (fertility) R60 obligatory suhsiances 'toxic for concentration 2: 5 % reproduction' of category 3 with toxic for reproduction R62 (fertility) (fertility) R62 obligatory substances 'toxic for concentration 2: 0.5 % reproduction' of category I or 2 toxic for reproduction wi1h R61 (development) (dcvclopmenl) R61 obligatory substances 'toxic for concentration 2: 5 % n:pmduction' of category 3 with toxic for reproduction R63 ( development) (development) R63 obligatory 6.2. Gaseous preparations For gases which produce such effects, the concentration limits laid down in Table VI A, expressed as a volume/volume percentage, shall determine, where appropriate, the classification of the preparation. The following symbol and risk phrases are assigned: Carcinogenic categories 1 and 2: Carcinogenic category 3: Mutagenic categories 1 and 2: Mutagenic category 3: Toxic for reproduction fertility categories 1 and 2: Toxic for reproduction development categories 1 and 2: Toxic for reproduction fertility category 3: Toxic for reproduction development category 3: Table VIA T; R45 or R49 X 0 ; R40 T;R46 Xn; R68 T;R60 T;R61 X0 ; R62 Xn; R63 aassification of the substance Classification of the preparation Categories 1 and 2 Catee;ory 3 carcinogenic substances of concentration 2: 0.1 % category l or 2 with R45 or R49 carcinogenic R45, R49 obligatory as appropriate carcinogenic substances of concentration 2: 1 % category 3 with R40 carcinogenic R40 oblie:atorv mutagcnic substances of concentration 2: 0.1 % category 1 or 2 with R46 mutagenic R46 obligatory mutagenic substances of concentration ~ 1 % category 3 with R68 mutagenic R68 obligatory B 3303 Classification of the substance Classification of the preparation Catel!orics 1 and 2 Cate2orv 3 substances 'toxic for concentration 2: 05 % reproduction' of category 1 or 2 toxic for reproduction with R60 (fcnility) (fertility) R60 obli11atorv substances 'toxic for concentration 2: 1 % reproduction' of category 3 with toxic for reproduction R62 (fertility) (fertility) R62 obligatory substances 'toxic for concentration 2: 0.2 % reproduction' of category 1 or 2 toxic for reproduction with R6 l (development) (development) R61 obli2atorv substances 'toxic for concentration 2: 1 % reproduction' of category 3 with toxic for reproduction R63 (development) (development) R63 oblhiatorv B 3304 THIRD SCHEDULE Methods for the evaluation of the environmental hazards of preparations in accordance with paragraph 8 Introduction The systematic assessment of all the dangerous properties for the environment is expressed by means of concentration limits, expressed as a weight/weight percentage except for gaseous preparations where they are expressed as a volume/volume percentage and in conjunction with the classification of a substance. Part A gives the calculation procedure according to paragraph 8.l(a) and gives the R phrases to be assigned to the classification of the preparation. Part B gives the concentration limits to be used when applying the conventional method and relevant symbols and R phrases for classification. In accordance with paragraph 8.1 (a) the environmental hazards of a preparation shall be assessed by the conventional method described in parts A and B of this Schedule, using individual concentration limits. (a) Where the dangerous substances listed in Annex 1 to Directive 67/548/EEC are assigned concentration limits necessary for the application of the method of assessment described in Part A of this Schedule, these concentration limits must be used. (b) Where the dangerous substances do not appear in Annex I to Directive 67 /548/EEC or appear there without the concentration limits necessary for the application of the method of evaluation described in Part A of this Schedule, the concentration limits shall be assigned in accordance with the specification in Part B of this Schedule. Part C gives the test methods for the evaluation of the hazards for the aquatic environment. PART A Procedure for the evaluation of environmental hazards (a) Aquatic environment I. Conventional method for the evaluation of hazards to the aquatic environment The conventional method for the evaluation of hazards to the aquatic environment takes into account all the hazards that a preparation may entail for this medium according to the following specifications. B 3305 The following preparations are to be classified as dangerous for tlie enviromne11t: 1. and assigned the symbol "N", the indication of danger "dangerous for the environment" and the risk phrases RSO and R53 (RS0-53): 1.1. preparations containing one or more substances classified as dangerous to the environment and to which is assigned phrases RS0-53 in individual concentrations equal to or greater than: (a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or (b) the concentration specified in Part B of this Schedule (Table 1) where the substance or substances do not appear in Annex I to Directive 67 /548/EEC or appear in it without concentration limits; 1.2 preparations containing more than one substance classified as dangerous for the environment and to which is assigned phrases R50-53 in lower individual concentrations than the limits specified under 1.1.l(a) or (b) if: L(:N,RS0-53 J 21 N ,H50-53 where: PN,R5o 53 is the percentage by weight of each substance dangerous for the environment to which is assigned phrases RS0-53 in the preparation, LN,R.'io-s3 is the limit RS0-53 for each substance dangerous for the environment to which is assigned the phrases RS0-53, expressed as percentage by weight 2. and assigned the symbol "N", the indication of danger "dangerous for the environment" and the risk phrases R51 and R53 (RSl-53) unless the preparation is already classified according to 1.1 above; 2 .1. preparations containing one or more than one substance classified as dangerous to the environment and to which is assigned phrases RS0-53 or RS 1-53 in individual concentrations equal to or greater than: (a) either the concentration specified in Annex I to Directive 67 /548/EEC for the substance or substances under consideration, or (b) the concentration specified in Part B of this Schedule (Table 1) where the substance or substances do not appear in Annex I to Directive 67 /548/EEC or appear in it without concentration limits; 2.2 preparations containing more than one of the substances classified as dangerous for the environment and to which is assigned phrases R50-53 or R51-53 in lower individual concentrations than the limits specified under 1.2. (a) or (b) if: B 3306 where: PN,RS0-53 is the percentage by weight of each substance dangerous for the environment to which is assigned phrases RS0-53 in the preparation, PN,1t~1-s3 is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R51-53 in the preparation, LN,R.'il-53 is the respective limit R51-53 for each substance dangerous for the environment to which is assigned phrases RS0-53 or RSl-53, expressed as percentage by weight 3. and assigned the risk phrases R52 and R53 (R52-53) unless the preparation is already classified according to 1.1 or 1.2 above; 3.1 preparations containing one or more than one substance classified as dangerous to the environment and to which is assigned phrases RS0-53 or RS 1-53 or R52-53 in individual concentrations equal to or greater than: (a) either the concentration specified in Annex I to Directive 67 /548/EEC for the substance or substances under consideration, or (b) the concentration specified in Part B of this Schedule (Table 1) where the substance or substances do not appear in Annex I to Directive 67 /548/EEC or appear in it without concentration limits; 3.2 preparations containing more than one of the substances classified as dangerous for the environment and to which is assigned phrases RSl-53 or RS0-53 or R52-53 in lower individual concentrations than the limits specified under 1.3.l(a) or (b) if: where: PN,R.'io-s3 is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R50-53 in the preparation, PN,R5J-S3 is the percentage by weight of each substance dangerous for the environment to which is assigned phrases RSl-53 in the preparation, Pas2.53 is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R52-53 in the preparation, Las2.5j is the respective limit R52-53 for each substance dangerous for the environment to which is assigned phrases RS0-53 or RSl-53 or R52-53, expressed as percentage by weight; 4. and assigned the symbol "N", the indication of danger "dangerous for the environment 11 and the risk phrase R50 unless the preparation is already classified according to I.1 above: B 3307 LI preparations contammg one or more than one substance classified as dangerous 10 the environment and lo which is assigned phrase R50 in individual concentrations equal to or greater than: (a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or (b) the concentration specified in Part B of this Schedule (Table 2) where the substance or substances do not appear in Annex l to Directive 67/548/EEC or appear in it without concentration limits; 4 .2 preparations containing more than one substance classified as dangerous for the environment and to which is assigned phrase R50 in lower individual concentrations than the limits specified under 1.4.l(a) or (b) if: I(:N.i/50) ~ 1 N ,/(SO :, where: PN.R5o is the pcn.:entage by weight of each substance dangerous for the environment to ,vhich is assigned phrase R50 in the preparation, LN.R'>o is the limit RSO for each substance dangerous for the environment to which is assigned phrase RSO, expressed as percentage by weight. 4.3. preparations containing one or more than one of the substances classified as dangerous for the environment and to which is assigned phrase R50 not meeting the criteria under l.4.1 or l.4.2 and containing one or more than one substance classified as dangerous for the environment and to which is assigned phrases RS0-53 if: where: PN,R.'iO is the percentage by weight of each substance dangerous for the environment to which is assigned phrase RSO in the preparation, PN,R.'iO-.'iJ is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R50-53 in the preparation, LN,R5o is the perspective limit R50 for each substance dangerous for the environment to which is assigned phrases RSO or RS0-53, expressed as percentage by weight; 5. and assigned the risk phrase R52 unless the preparation is already classified according to 1.1, 1.2, I.3, orl.4 above: 5.1 preparations containing one or more than one substance classified as dangerous to the environment and to which is assigned phrase R52 in individual concentrations equal to or greater than: (a) either the concentration specified in Annex I to Directive 67 /548/EEC for the substance or substances under consideration, or B 3308 (h) the concentration specified in Part B of this Schedule (Table 3) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits; 5 .2 preparations containing more than one substance classified as dangerous for the environment and to which is assigned phrase R52 in lower individual concentrations than the limits specified under 1.5.1 (a) or (b) if: where: Pim is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R52 in the preparation, LR:12 is the limit R.52 for each substance dangerous for the environment to which is assigned phrase R52, expressed as percentage by weight; 6. and assigned the risk phrase R53 unless the preparation is already classified according to I.I, 1.2, or 1.3 above: 6.1 preparations containing one or more than one substance classified as dangerous to the environment and to which is assigned phrase R53 in individual concentrations equal to or greater than: (a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consid(:ration, or (b) the concentration specified in Part B of this Schedule (Table 4) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits; 6.2 preparations containing more than one substance classified as dangerous for the environment and to which is assigned phrase R53 in lower individual concentrations than the limits specified under 1.6.l(a) or (b) if: where: PR.53 is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R53 in the preparation, LR53 is the limit R53 for each substance dangerous for the environment to which is assigned phrase R53, expressed as percentage by weight; 6.3. preparations containing one or more than one of the substances classified as dangerous for the environment and to which is assigned phrase R53 not meeting the criteria under 1.6.2 and containing one or more than one substance classified as dangerous for the environment and to which is assigned phrases R50-53 or RSl-53 or R52-53 if: B 3309 l, /' /' /' - I' l L ~ + N.H~0--5.1 + N,H51·5.1 + H51--.1.1 :::: 1 L l l L HS) H5.1 H5.l H5.l where: PR.'\.1 is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R53 in the preparation, PN.lt'io-5:i is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R50-53 in the preparation, PN,R5t-53 is the percentage by weight of each substance dangerous for the environment lo which is assigned phrase R51-53 in the preparation, PRs2-s:i is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R52-53 in the preparation, LRsJ is the respective limit R53 for each substance dangerous for the environment to which is assigned phrase R53 or RS0-53 or RSl-53 or R52-53, expressed as percentage by weight. (h) Non-aquatic: environment (I) OZONE LAYER l. Conventional method for the evaluation of preparations dangerous for the ozone layer The following preparations are to classified as dangerous for the environment: 1. and assigned the symbol "N", the indication of danger "dangerous for the environment" and the risk phrase R59; 1.1 preparations containing one or more substances classified as dangerous to the environment and to which is assigned the symbol "N" and the risk phrase R59 in individual concentrations equal to or greater than: (a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or (b) the concentration specified in Part B of this Schedule (Table 5) where the substance or substances do not appear in Annex I to Directive 67 /548/EEC or appear in it without concentration limits; 2. and assigned the risk phrase R59: 2.1 preparations containing one or more substances classified.as dangerous to the environment and to which is assigned R59 in individual concentrations equal to or greater than: (a) either the concentration specified in Annex I to Directive 67 /548/EEC for the substance or substances under consideration, or (b) the concentration specified in Part B of this Schedule (Table 5) where the substance or substances do not appear in Annex I to Directive 67 /548/EEC or appear in it without concentration limits; B 3310 (2) TERRESTRIAL ENVIRONMENT I. Evaluation of prcpa rations dangerous for the terrestrial environment Classification of preparations using the risk phrases below will follow after the detailed criteria for use of the phrases have been incorporated in Annex VI to Directive 67 /548/EEC. R54 R55 R56 R57 R58 Toxic to flora Toxic to fauna Toxic to soil organisms Toxic to bees May cause long-term adverse effects in the environment. PARTB Concentration limits to be used for the evaluation of environmental hazards I. For the aquatic environment The concentration limits fixed in the following tables, expressed as a weight/weight percentage, determine the classification of the preparation in relation to the individual concentration of the substance(s) present whose classification is also shown. Table 1 Acute aquatic toxicity and long-term adverse effects Classification of the Classification of the preparation substance N,R50-53 N,R5 l-53 R52-53 N.R50-53 C,,>25% 2.5 % s C., < 25 % 0.25 % s C.. < 25 % N,R5l-53 c,, 2: 25 % 25 % .$ C.. < 25 % R52-53 C,,2:25% ~ Table 2 Acute aquatic toxicity Classification of the substance Classification of the preparation N,R50 N,R50 C..2':25% N,R50-53 Cr,~25 % B 3311 T.1blc 3 Ac111atic toxicity Classific,11 inn nf the substance Classil'il:ation of the preparation R52 R52 ~---~----· R52 C,,225% Table 4 Long-term adverse effects Classifica1ion of the substance Classification of the preparation R53 R53 R53 C,,225% N, RS0-53 C,,225% N, RS 1-53 C0 2 25 % R52-53 C,,225% II. For the ,ion-aquatic environment The concentration limits fixed in the following tables, expressed as weight/weight percentage or, for gaseous preparations as a volume/volume percentage, determine the classification of the preparation in relation to the individual concentration of the substance(s) present whose classification is also shown. Table 5 Dangerous for the owne layer Classification of the substance Classification of the preparation N,R59 N with R59 C20.l % Classification of the substance Classification of the preparation R59 R59 C~0.1 % PARTC Test methods for the evaluation of the hazards for the aquatic environment Normally, the classification of a preparation is made on the basis of the conventional method. However, for the determination of the acute aquatic toxicity, there may be cases for which it is appropriate to carry out tests on the preparation. B 3312 The result of these tests o.n the preparation may only modify the classification concerning acute aquatic toxicity which would have been obtained by the application of the conventional method. If such tcsts arc chosen by the person responsible for the placing on the market, it must be ensured that the quality criteria of the test methods in Part C of Annex V to Directive 67 /548/EEC have been complied with. Furthermore, the tests arc to be carried out on all three species in conformity with the criteria of Annex VI to Directive 67/548/EEC (algae, daphnia and fish), unless the highest hazard classification relating to acute aquatic toxicity has been assigned to the preparation after testing on one of the species or a test result was already available before Directive 1999/45/EC entered into force. B 3313 FOURTH SCHEDULE Special provisions for containers containing preparations offered or sold to the general public PARTA Containers to be fitted with child-resistant fastenings 1. Containers of whatever capacity, containing preparations offered or sold to the general public and labelled as very toxic, toxic or corrosive in accordance with paragraph 11 and under the conditions laid down in paragraph 7 of these Regulations, are to fitted with child-resistant fastenings. 2. Containers of whatever capacity containing preparations presenting an aspiration hazard (Xn, R65) and classified and labelled according to paragraph 3.2.3 of Annex VI to Directive 67 /548/EEC with the exception of preparations placed on the market in the form of aerosols or in a container fitted with a sealed spray attachment. 3. Containers of whatever capacity, having at least one of the substances mentioned below in a concentration equal to or greater than the maximum individual concentration specified. No 1 2 Identification of the substance Concentration limit CAS Reg No Name Einecs No 67-56-1 Methanol 2006596 ~3% 75-09-2 Dichloromethane 2008389 ~1% which are offered or sold to the general public are to be fitted with child resistant fastenings. PARTB Containers to be fitted with a tactile warning of danger Containers of whatever capacity, containing preparations offered or sold to the general public and labelled as very toxic, toxic, corrosive, harmful, extremely flammable or highly flammable in accordance with paragraph 11 and under the conditions laid down in paragraphs 6 and 7 of these Regulations, are to carry a tactile warning of danger. This provision does not apply to aerosols classified and labelled only as extremely flammable or highly flammable. B 3314 Flfl'll SCHEDULE Special provisions concerning the labelling of certain preparations /\. For preparations dassificd as dangerous within the meaning of paragraphs 6, 7 and 8 1. Preparations sold to the general public 1.l The labels on packages containing such preparations, in addition to the specific safety advice, must bear the relevant safety advice Sl, S2, S45 or S46 in accordance with the criteria laid down in Annex VI to Directive 6 7 /548/EEC. 1.2 When such preparations arc classified as very toxic (T), toxic (T) or corrosive (C) and where it is physically impossible to give such information on the package itself, packages containing such preparations must be accompanied by precise and easily understandable instructions for use including, where appropriate, instructions for the destruction of the empty package. 2. Preparations intended for use by spraying The package label containing such preparations must compulsorily bear the safety advice S23 accompanied by safety advice S38 or S51 assigned to it in accordance with the criteria laid down in Annex VI to Directive 67 /548/EEC. 3. Preparations containing a substance assigned phrase R33: Danger of cumulative effects When a preparation contains at least one substance assigned the phrase R33, the label of the preparation must carry the wording of this phrase as set out in Annex III to Directive 67 /548/EEC, when the concentration of this substance present in the preparation is equal to or higher than 1 %, unless different values are set in Annex I to Directive 67 /548/EEC. 4. Preparations containing a substance assigned phrase R64: May cause harm to breastfed babies When a preparation contains at least one substance assigned phrase R64, the label of the preparation must carry the wording of this phrase as set out in Annex III to Directive 67 /548/EEC, when the concentration of this substance present in the preparation is equal to or higher than 1 %, unless different values are set in Annex I to Directive 67 /548/EEC. B. For preparations irrespective of their classification within the meaning of Articles 5, 6 and 7 1. Preparations containing lead 1.1 Paint and varnishes B 3315 L1bcls of packages of paints and varnishes containing lead in quantities exceeding 0, 15 % (expressed as weight of metal) of the total weight of the preparation, as determined in accordance with ISO standard 6503/1984, must show the following particulars: 11 Contains lead. Should not be used on surfaces liable to be chewed or sucked by children". In the case of packages the contents of which are less than 125 millilitres, the particulars may be as follows: "Warning! Contains lead". 2. Preparations containing cyanoacrylates 2.1 Adhesives The immediate packaging of adhesives based on cyanoacrylate must bear the following inscriptions: "Cyanoacrylate Danger Bonds skin and eyes in seconds Keep out of the reach of children." Appropriate advice on safety must accompany the package. 3. Preparations containing isocyanates The package labels of preparations containing isocyanates (as monomers, oligomers, prepolymers, etc., or as mixtures thereof) must bear the following inscriptions: "Contains isocyanates. See infonnation supplied by the manufacturer." 4. Preparations containing epoxy constituents with an average molecular weight ~700 The package labels of preparations containing epoxy constituents with an average molecular weight :5; 700 must bear the following inscriptions: "Contains epoxy constituents. See information supplied by the manufacturer." B 3316 5. Preparations sold to the general public which contain active chlorine The packaging of preparations containing more than 1 % of active chlorine must bear the following particular inscriptions: "Warning! Do not use together with other products. May release dangerous gases (chlorine)." 6. Preparations containing cadmium (alloys) and intended to be used for brazing or soldering The packaging of the abovementioned preparations must bear the following inscription printed in clearly legible and indelible characters: "Warning! Contains cadmium. Dangerous fumes are formed during use. See information supplied by the manufacturer. Comply with the safety instructions." 7. Preparations available as aerosols Without prejudice to the provisions of these Regulations, preparations available as aerosols are also subject to the labelling provisions in accordance with points 2.2 and 2.3 of the Annex to Directive 75/324/EEC as last amended by Directive 94/1/EC. 8. Preparations containing substances not yet tested completely Where a preparation contains at least one substance which, in accordance with Article 13.3 of Directive 67/548/EEC, bears the inscription "Caution substance not yet fully testedn, the label of the preparation must bear the inscription ncaution - this preparation contains a substance not yet fully tested" if this substance is present in a concentration ~1 %. 9. Preparations not classified as sensitising but containing at least one sensitising substance The packaging of preparations containing at least one sub.stance classified as sensitising and being present in a concentration equal to or greater than 0,1 % or in a concentration equal to or greater than that specified under. a specific note for the substance in Annex I to Directive 67 /548/EEC must bear the inscription: "Contains (name of sensitising substance). May produce an allergic reaction." 10. Liquid preparations containing halogenated hydrocarbons B 3317 For liquid preparations which show no fl~1shpoin1 or a flashpoint higher than 55 °C and contain a halogenated hydrocarbon and more than 5 % flammable or highly flammable substances, the packaging must bear the following inscription as appropriate: "Can become highly flammable in use" or "Can become flammable in use". 11. Preparations containing a substance assigned phrase R67: vapours may cause drowsiness and dizziness When a preparation contains one or more substances assigned the phrase R67, the label of the preparation must carry the wording of this phrase as set out in Annex III lo Directive 67 /548/EEC, when the total concentration of these substances present in the preparation is equal to or higher than 15 %, unless: the preparation is already classified with phrases R20, R23, R26, R68/20, R39/23 or R39/26, or the preparation is in a package not exceeding 125 ml. 12. Cements and cement preparations The packaging of cements and cement preparations contammg more than 0,0002 % soluble chromium (VI) of the total dry weight of the cement must bear the inscription: "Contains chromium (VI). May produce an allergic reaction" unless the preparation is already classified and labelled as a sensitiser with phrase R43. C. For preparations not classified within the meaning of Articles 5, 6 and 7 but containing at least one dangerous substance 1. Preparations not intended for the general public The label on the packaging of the preparations referred to in paragraph 15 .3 must bear the following inscription: "Safety data sheet available for professional user on request". B 3318 SIXTH SCHEDULE Confidentiality for the chemical identity of a substance PART A Information to be communicated in the request for confidentiality Introductory notes A. Paragraph 16 indicates the conditions in which the person responsible for placing a preparation on the market may avail himself of the confidentiality. B. To avoid multiple requests for confidentiality relating to the same substance used in different preparations, a single request for confidentiality may suffice if a certain number of preparations have: the same dangerous constituents present in the same concentration range, the same classification and labelling, the same expected uses. A single alternative denomination must be used to mask the chemical identity of the same substance in the preparations concerned. Furthermore, the request for confidentiality must contain all information indicated in the following request, without forgetting the name or the trade name of each preparation. C. The alternative designation used on the label must be the same as that given under heading 2 "Composition/information on ingredients" of the Annex to Directive 91/155/EEC as last amended by Directive 93/112/EEC. This implies that the alternative designation used will contain enough information about the substance to ensure ris~-free handling. D. In making the request to use an alternative designation the person responsible for placing on the market must take into account the need to provide enough information for necessary health and safety precautions to be taken in the workplace and to ensure that risks from handling the preparation can be minimised. Request for confidentiality In accordance with paragraph 16 the request for confidentiality must obligatorily contain the following information: 1. Name and full address (including telephone number) of the person established in Malta or within the European Community who is responsible for placing the preparation on the market (manufacturer, importer or distributor). 2. Precise identification of the substance(s) for which confidentiality is proposed and the alternative designation. B 3319 . "- ·-· C,\S- No I Einccs N() Chemical name according to Allernative designation I inh:rnatinnal nomenclature and classification (Annex l to Council ! Directive 07/548/EEC or i provisional classification) Ji!) I (b) I (C) I NB: Where substances arc classified provisional! y. accompanying information (bib! iograph ical references) should ht.: provided as evidence that the provisional classification lakes account of all existing pertinent information available on the properties of the substance. 3. Justification for confidentiality (probability - plausibility). 4. Designation(s) or commercial namc(s) of the prcparation(s). 5. Is the designation or commercial name the same for all of the European Community'? YES □ NO □ If no, specify the dcsignation(s) or ~ommcrcial namc(s) used in the different Member States: Austria: Belgium: Denmark: Germany: Greece: Finland: France: Spain: Sweden: Ireland: Italy: Luxembourg: Netherlands: Portugal: United Kingdom: 6. Composition of the preparation(s) defined in point 2 of the Annex to Directive 91/155/EEC as last amended by Directive 93/112/EEC. 7. Classification of the preparation(s) according to paragraph 7 of these Regulations. 8. Label · g of the preparation(s) according to paragraph 11 of these Regulations. 9. Intended uses for the prcparation(s). B 3320 10. Safety data shcct(s) conforming to Directive 91/155/EEC as last amended by Di rcctivc 93/112/EEC. PART B Lexicon guide for establishing the alternative designations (generic names) 1. Introductory note The lexicon guide is based on the procedure for the classification of dangerous substances (division of substances into families) which appears in Annex I to Di rcctive 67 /548/EEC. Alternative designations to those based on this guide may be used. However, in all cases the names chosen must provide enough information to ensure the preparation can be handled without risk and that necessary health and safety precautions can be taken in the workplace. The families arc defined in the following manner: inorganic or organic substances whose properties are identified by having a common chemical element as their chief characteristic. The family name is derived from the name of the chemical element. These families are identified as in Annex I by the atomic number of the chemical element (001 to 103), organic substances whose properties are identified by having a common functional group as their chief characteristics. The family name is derived from the functional group name. These families are identified by the conventional number found in Annex I (601-650). Sub-families bringing together substances with a common specific character have been added in certain cases. 2. Establishing the generic name General principles For the purposes of establishing the generic name, the following general approach, involving two successive stages, is adopted: (i) identification of the functional groups and chemical elements present in the molecule; (ii) determination of the extent to which account should be taken of the most important functional groups and chemical elements. B 3321 The identified functional groups and clements taken into account arc the nami.!s of the families and sub-families set out in point 3 in the fom1 of a non restrictive list. 3. Division of substances into families and sub-families Family No Families & Sub-famili1:s Annex I to Directive 67/548/EEC 001 Hydrogen compounds Hvdridcs 002 Helium compounds ·--·· 003 Lithium compounds 004 Bervllium compounds 005 Boron compounds Boranes Borates 006 Carbon compounds Carbamates Inorganic carbon compounds Salts of hydrogen cyanide . Urea and derivatives 007 Nitrogen compounds Quaternary ammonium compounds Acid nitrogen compounds . Nitrates Nitrites ·---· 008 Oxygen compounds --·-· 009 Fluorine compounds . Inorganic fluorides 010 Neon compounds 011 Sodium compounds 012 Magnesium compounds . Organometallic magnesium derivatives 013 Aluminium compounds . Organometallic aluminium derivatives 014 Silicon compounds . Silicones . Silicates 015 ,Phosphorus compounds . Acid phosphorus compounds Phosphonium compounds . Phosphoric esters . Phosphates . Phosphites . Phosphoramides and derivatives 016 Sulphur compounds . Acid sulphur compounds . Mercaptans . Sulphates . Sulphites 017 Chlorine compounds . Chlorates Perchlorates 018 Argon compounds 019 Potassium compounds 020 Calcium compounds B 3322 Family No Families & Sub-families Annex l to Directive 67/548/EEC 021 Scandium compounds 022 Titanium compounds 023 Vanadium compounds 024 Chromium compounds Chromium VI compounds 025 Manl(ancsc compounds 026 Iron compounds 027 Cobalt compounds 028 Nickel compounds 029 Copper compounds 030 Zinc compounds . Organometallic zinc derivatives 031 Gallium compounds ------ .. -··--·· 032 -- Germanium compounds 033 Arsenic compounds 034 Selenium compounds 035 Bromine compounds 036 Krypton compounds 037 Rubidium compounds 038 c Strontium compounds 039 Yttrium compounds 040 Zirconium comeounds 041 Niobium compounds 042 Molybdenum compounds 043 Technetium compounds 044 Ruthenium compounds 045 Rhodium compounds 046 Palladium compounds 047 Silver compounds 048 Cadmium compounds 049 Indium compounds 050 Tin compounds Organometallic tin derivatives 051 Antimony compounds 052 Tellurium compounds 053 Iodine compounds 054 Xenon compounds 055 Caesium compounds 056 Barium compounds 057 Lanthanum compounds 058 Cerium compounds 059 Praseodymium compounds 060 Neodymium compounds 061 Promethium compounds 062 Samarium compounds 063 Europium compounds 064 Gadolinium compounds 065 Terbium compounds 066 Dysprosium compounds 067 Holmium compounds 068 Erbium compounds 069 Thulium compounds 070 Ytterbium compounds 071 - Lutetium compounds 072 Hafnium compounds B 3323 ~~---· Family Nn Families & Sub-famili~·s Annex I tn Directive 67i548/EEC on Tantalum compounds 074 Tungsten compounds 075 Rhenium compounds 076 Osmium compounds 077 Iridium compounds ~ 078 Platinum compounds 079 Gold compounds 080 Mercury compounds Organometallic mercury derivatives 081 Thallium compounds 082 Lead compounds Organometallic lead derivatives 083 Bismuth compounds ,-........----. 084 Polonium compounds 085 Astatine compounds 086 Radon compounds 087 Francium compounds 088 Radium compounds 089 Actinium compounds ~ 090 Th~j um compounds 091 Protactinium compounds 092 Uranium compounds 093 Neptunium compounds 094 Plutonium compounds 095 1-----------· Amcrici um compounds 096 Curium compounds 097 Berkelium compounds 098 Californium compounds 099 Einsteinium compounds 100 Fermium compounds 101 Mendelevium compounds 102 Nobelium compounds 103 Lawrencium compounds 601 Hydrocarbons Aliphatic hydrocarbons Aromatic hydrocarbons Alicyclic hydrocarbons Polycyclic aromatic hydrocarbons (PAH) 602 Halogenated hydrocarbons(*) Halogenated aliphatic hydrocarbons(*) Halogenated aromatic hydrocarbons (*) Halogenated alicyclic hydrocarbons(*) (*) Specify according to the family corresponding to halogen. 603 Alcohols and derivatives Aliphatic alcohols Aromatic alcohols Alicyclic alcohols Alcanolamines Epoxy derivatives Ethers Glycolethers Glycols and polyols 604 Phenols and derivatives (*) Halogenated phenol derivatives(*) (*) Specify according to the family corresponding to halogen. B 3324 Family No Families & Suh-fomilil'S Anm:x I 111 Directive <i7/5-t8/EEC 605 Ahlchydes and derivatives Aliphatic aldchydcs Aromatic aldchydcs Alicydic aldchydcs Aliphatic acctals Aromatic acctals Alicvdic acctals 606 Kctoncs and derivatives Aliphatic kctoncs . Aromatic ketones (*) . Alicyclic kctones (*) Quinones included 607 Organic acids and derivatives . Aliphatic acids . Halogenated aliphatic acids ("') . Aromatic acids . Halogenated aromatic acids (*) . Alicyclic acids . Halogenated alicyclk acids("') . Aliphatic acid anhydridcs Halogenated aliphatic acid anhydridcs ("') Aromatic acid anhydrides Halogenated aromatic acid anhydridcs (*) ; Alicyclic acid anhydrides Halogenated alicyclic acid an hydrides(*) Salts of aliphatic acid Salls of halogenated aliphatic acid(*) Salts of aromatic acid Salts of halogenated aromatic acid (*) . Salts of alicyclic acid . Salts of halogenated alicyclic acid (*) Esters of aliphatic acid Esters of halogenated aliphatic acid (*) Esters of aromatic acid Esters of halogenated aromatic acid (*) Esters of alicyclic acid (*) Esters of halogenated alicyclic acid (*) Esters of glycol ether Acrylates . Methacrylates . Lactones . Acy! halogenides (*) Specify according to the family corresnondinl!: to haloe:en. 608 Nitriles and derivatives 609 Nitro comnounds 610 Chlornitrated compounds 611 Azoxy and azo compounds 612 Amine compounds Aliphatic amines and derivatives Alicyclic amines and derivatives Aromatic amines and derivatives Aniline and its derivatives Benzidine and its derivatives 613 Heterocyclic bases and derivatives Benzimidazole and derivatives Imidazol and derivatives B 3325 . -- ------------ -r-:----:--:~-------------------------~ F;1111ily No F:unilics & Sull-familics Anno, I Ill Dirccti\'c <17S-HI/EEC ····· ------··· 61-l hl5 61 Ci 617 > 647 ···- - ........... 648 .. ---···· Pyrcthrinoids Quinolinc and derivatives Triazine and derivatives Triazole and derivatives Glycosides and alkaloids Alkaloid and derivatives Glvcosides and derivatives Cyanatcs and isocyanates cyanates isocvanates Amides ,1ml derivatives Acetamide and derivatives Anilides Organic peroxides Enzymes -------------1 Complex ,:oal derivatives Acid extract . Alkaline extract . Anthracenc oil . Anthraccne oil extract residue . Anthraccne oil fraction . Carbolic oil Carbolic oil extract residue . Coal liquids, liquid solvent extraction Coal liquids, liquid solvent extraction solvents . Coal oil . Coal tar Coal tar extract . Coal tar solids residue . Coke (coal tar) low temperature, high temperature pitch . Coke (coal tar) high temperature pitch . Coke (coal tar) mixed coal high temperature pitch . Crude benzole . Crude phenols Crude tar bases . Distillate bases Distillate phenols Distillates Distillates (coal), liquid solvent extraction, primary Distillates (coal), solvent extraction, hydrocracked . Distillates (coal), solvent extraction, hydrocracked hydrogenated middle . Distillates (coal), solvent extraction, hydrocracked middle . Extract residues (coal), low temperature coal tar alkaline . Fresh oil Fuels, diesel, coal solvent extraction, hydrocracked, hydrogenated Fuels, jet aircraft, coal solvent extraction, hydrocracked, hydrogenated Gasoline, coal solvent extraction, hydrocracked naphtha Heat treatment products . Heavy anthracene oil . Heavy anthracene oil redistillate . Light oil . Light oil extract residues, high boiling Light oil extract residues, intermediate boiling Light oil extract residues, low boilinl? B 3326 .. - - ···--- ------·---"------------ ·-·------·--· -· -··-··· - ·--~- ------- ------ -· Family No Families & Sub-families Annex I hi Diret.:tiw 67t548/FEC -- --~ Light oil rcdistillate, high hoiling Light oil rcdistillatc, intcmicdiatc boiling Light oil rcdistillatc, low boiling Meth yhrn phthalcnc oil Mcthylnaphthalcnc oil extract residue Naphtha (coal), solvent extraction, hydrocrackcd Naphthalene oil Naphthalene oil extract residue Naphthalene oil redistillate Pitch Pitch rcdistillatc Pitch residue Pitch residue, heat treated Pitch residue, oxidised Pyrolysis products Redistillatcs Residues (coal), liquid solvent extractions Tar hrown coal Tar brown coal, low temperature Tar oil, high boiling Tar oil, intcrmediat,, boiling Wash oil Wash oil extract rc:;iduc Wash oil redistillatc 649 Complex oil derivatives Crude oil Petroleum gas Low boiling point naphtha Low boiling point modified naphtha Low boiling point cat-cracked naphtha Low boiling point cat-reformed naphtha Low boiling point thennally cracked naphtha Low boiling point hydrogen treated naphtha Low boiling point naphtha - unspecified Straight-run kerosene Kerosene - unspecified Cracked gas oil . Gas oil - unspecified Heavy fuel oil Grease . Unrefined or mildly refined base oil Base oil - unspecified Distillate aromatic extract Distillate aromatic extract (treated) Foots oil Slack wax Petrolatum ---- 650 Various substances . Do not use this family. Instead, use the families or sub families mentioned above. 4. Practical application: After having conducted a search to see if the substance belongs to one or more families or sub-families on the list, the generic name can be established in the following way: B 3327 ➔ .I. If the name of a family or sub-family is sufficient to characterise the chemical clements or important functional groups. this name will be chosen as the genenc name. Examples: 1,4 dihydroxybenzene family 60..i: phenols and derivatives generic name: phenol derivatives butanol family 603: alcohols and derivatives sub-family: aliphatic alcohols generic name: aliphatic alcohol 2-Isopropoxyethanol family 603: alcohols and derivatives sub-family: glycolethers generic name: glycolethcr mcthacrylate family 607: organic acids and derivatives sub-family: acrylates generic name: acrylate 4.2. If the name of a family or sub-family is not sufficient to characterise the chemical clements of important functional groups, the generic name will be a combination of the corresponding different family or sub-family names: Examples: chlorobenzene family 602: halogenated hydrocarbons sub-family: halogenated aromatic hydrocarbons family 017: chlorine compounds generic name: chlorinated aromatic hydrocarbon 2,3 ,6-trichlorophenylacetic acid family 607: organic acids sub-family: halogenated aromatic acids family 017: chlorine compounds generic name: chlorinated aromatic acid 1-chloro-1-nitropropane family 610: chloronitrated derivatives family 601: hydrocarbons sub-family: aliphatic hydrocarbons generic name: chlorinated aliphatic hydrocarbon B 3328 tetrapropyl dithiopyrophosphatc family 015: phosphorus compounds sub-family: phosphoric esters family 016: sulphur compounds generic name: thiophosphoric ester NB: In the case of certain elements, notably metals, the name of the family or sub-family may be indicated by the words "organic" or "inorganic". Examples: dimercury chloride family 080: mercury compounds generic name; inorganic mercury compound barium acetate family 056: barium compounds generic name: organic barium compound ethyl nitrite family 007: nitrogen compounds sub-family: nitrites generic name: organic nitrite sodium hydrosulphite family 016: sulphur compounds generic name: inorganic sulphur compound (The examples cited are substances taken from Annex I to Directive 67 /548/EEC (19th adaptation) in respect of which requests for confidentiality may be submitted). SEVENTH SCHEDULE Preparations covered by paragraph 13.2 B 3329 Preparations as specified by paragraph 9.3 of Annex VI to Directive 67/548/EEC.