L.S. 427.28 Regolamenti dwar Sustanzi u Preparamenti Perikolużu

DANGEROUS SUBSTANCES AND PREPARATIONS [ S.L.427.28 1 SUBSIDIARY LEGISLATION 427.28 DANGEROUS SUBSTANCES AND PREPARATIONS REGULATIONS 16th January, 2007 LEGAL NOTICE 10 of 2007, as amended by Legal Notices 221 and 309 of 2007, 267 of 2009 and 337 of 2013. 1. The title of these regulations is the Dangerous Substances and Preparations Regulations. Citation. 2. Preparations that fail to comply with the provisions of these regulations shall not be placed on the market by manufacturers or importers. General provision. 3. These regulations implement the provisions of Commission Directive 1999/45/EC of the 31st May, 1991 as amended by Commission Directive 2001/60/EC of the 7th August, 2001. Scope. 4.1. These regulations shall apply to: Applicability. - the classification, packaging dangerous preparations, and to and labelling of - those preparations which may present hazards, whether or not they are classified as dangerous within the meaning of those regulations, when such preparations are placed on the market. 4.2. These regulation shall apply to preparations which: - contain at least one dangerous substance within the meaning of regulation 5, and - are considered dangerous within the meaning of regulations 8, 9 or 10. 4.3. The specific provisions set out - in regulation 11 and defined in the Fourth Schedule, - in regulation 12 and defined in the Fifth Schedule, and - in regulation 16 shall also apply to preparations which are not considered dangerous within the meaning of regulations 8, 9 or 10 but may nevertheless present a specific hazard. 4.4.1 Without prejudice to other provisions implementing the requirements of the Plant Protection Products Regulations, the regulations on classification, packaging, labelling and safety datasheets of these Regulations shall apply to plant protection products. 4.4.2 Without prejudice to other provisions implementing the requirements of the Biocides Regulations, the regulations on classification, packaging, labelling and safety datasheets of these regulations shall apply to biocide products. S.L. 430.01 S.L. 430.03 2 [ S.L.427.28 DANGEROUS SUBSTANCES AND PREPARATIONS 4.5. These regulations shall not apply to the following preparations in the finished state, intended for the final user: (

1. a)medicinal products for human or veterinary use, as defined in the Act; S.L. 427.58 S.L. 435.35 (
2. b)cosmetic products as defined in the Cosmetic Products Regulations; (
3. c)mixtures of substances which, in the form of waste, are covered by provisions implementing the requirements of the Waste Management (Permit and Control) Regulations; (
4. d)foodstuffs; (
5. e)animal feedingstuffs; (
6. f)S.L. 365.15 preparations containing radioactive substances as defined by the Nuclear Safety and Radiation Protection Regulations; (
7. 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. 4.6. These regulations shall not apply to: Definitions. - 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. 5.1. In these regulations, the following definitions shall apply, unless the context otherwise requires: (
8. 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; (
9. b)"preparations" means mixtures or solutions composed of two or more substances; (
10. 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 number of monomer units. In the DANGEROUS SUBSTANCES AND PREPARATIONS [ S.L.427.28 context of this definition a "monomer unit" means the reacted form of a monomer in a polymer; (
11. 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; (
12. 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; (
13. 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; (
14. g)"Einecs" means the European Inventory of Existing Commercial Chemical Substances. This inventory contain the definitive list of all chemical substances deemed to on the market within the European Community on 18 September 1981. 5.2. The following are "dangerous" within the meaning of these regulations: (
15. 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 which, under defined test conditions, detonate, quickly deflagrate or upon heating explode when partially confined; (
16. b)oxidising substances and preparations; - substances and preparations which give rise to a highly exothermic reaction in contact with other substances, particularly flammable substances; (
17. c)extremely flammable substances and preparations: - liquid substances and preparations having an extremely low flash-point and a low boilingpoint and gaseous substances and preparations which are flammable in contact with air at ambient temperature and pressure; (
18. 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 preparations which may readily catch fire after brief contact with a source of ignition and which continue to burn or 3 4 [ S.L.427.28 DANGEROUS SUBSTANCES AND PREPARATIONS - 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; (
19. e)flammable substances and preparations: (
20. f)liquid substances and preparations having a low flash-point; 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 via the skin; (
21. 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; (
22. h)harmful substances and preparations: - (
23. i)corrosive substances and preparations: - (
24. j)substances and preparations which may cause death or acute or chronic damage to health when inhaled, swallowed or absorbed via the skin; substances and preparations which may, on contact with living tissues, destroy them; irritant substances and preparations: - non-corrosive substances and preparations which, through immediate, prolonged or repeated contact with skin or mucous membrane, may cause inflammation; (
25. k)sensitising substances and preparations: - (
26. l)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 or preparation, characteristic adverse effects are produced; 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; (
27. 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 DANGEROUS SUBSTANCES AND PREPARATIONS [ S.L.427.28 5 their incidence; (
28. 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, nonheritable adverse effects in the progeny and, or an impairment of male or female reproductive functions or capacity; (
29. 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. 5.3. "Directive 67/548/EEC" shall mean Directive 67/548/EEC of the European Community or equivalent provisions. 6.1. The evaluation of the hazards of a preparation shall be based on the determination of : - physico-chemical properties, - properties affecting health, - environmental properties. Determination of dangerous properties of preparations. Amended by: L.N. 267 of 2009. These different properties shall be determined in accordance with the provisions laid down in regulations 8, 9 and 10. Where laboratory tests are conducted, they shall be carried out on the preparation as placed on the market. 6.2. Where the determination of dangerous properties is carried out in accordance with regulations 8, 9 and 10, all dangerous substances within the meaning of regulation 5.2. and in particular those which - are listed in Part 3 of Annex VI to Regulation (EC) No. 1272/2008 of the European Parliament and of the Council of 16 December 2008 on the classification, labelling and packaging of substances and mixtures, - are listed in ELINCS in accordance with the Dangerous Substances (Notification) Regulations, - - S.L. 427.14 are classified and labelled provisionally by the person responsible for the placing on the market in accordance with the Dangerous Substances (Notification) Regulations, S.L. 427.14 are classified and labelled in accordance with the Dangerous Substances (Notification) Regulations, and are not yet included in ELINCS, S.L. 427.14 - are covered by the (Notification) Regulations, Dangerous Substances S.L. 427.14 - are classified and labelled in accordance with the Dangerous Substances (Notification) Regulations, S.L. 427.14 6 [ S.L.427.28 DANGEROUS SUBSTANCES AND PREPARATIONS shall be taken into consideration in accordance with the provisions laid down in the method used. 6.3. For preparations covered by these regulations, dangerous substances as referred to in regulation 5.2. 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 concentration are equal to, or greater than, those defined in the following table unless lower values are given in Part 3 of Annex VI to Regulation (EC) No 1272/ 2 0 08 o f t he E u r o p ean Par l iam en t an d o f t he Co u n cil of 16 December 2008 on the classification, labelling and packaging of substances and mixtures, or in Part B of the Second Schedule or in Part B of the Third Schedule, unless otherwise specified in the Fifth Schedule. Category of danger of the substance Concentration to take into consideration for Gaseous Other preparations preparations % vol/vol % w/w Very toxic > 0.02 > 0.1 Toxic > 0.02 > 0.1 Carcinogenic Category 1 or 2 > 0.02 > 0.1 Mutagenic 1 or 2 > 0.02 > 0.1 Toxic for reproduction Category 1 or 2 > 0.02 > 0.1 Harmful > 0.2 >1 Corrosive > 0.02 >1 Irritant > 0.2 >1 Sensitising > 0.2 >1 Carcinogenic Category 3 > 0.2 >1 Mutagenic Category 3 > 0.2 >1 Toxic for reproduction Category 3 > 0.2 >1 > 0.1 > 0.1 Dangerous for the environment N Dangerous for the environment ozone Dangerous for the environment General principles of classification and labelling. > 0.1 >1 7.1. The classification of dangerous preparations according to the degree and specific nature of the hazards involved shall be based on the definitions of categories of danger laid down in regulation 5.2. 7.2. 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 regulations 8, 9, 10 or 13 and the relevant Schedules of these regulations are applied. Evaluation of the hazards deriving from physicochemical properties. 8.1. The hazards of a preparation deriving from its physicochemical properties shall be assessed by determining, by means of the methods specified in Part A of Annex V to Directive 67/548/ EEC, the physico-chemical properties of the preparation necessary DANGEROUS SUBSTANCES AND PREPARATIONS [ S.L.427.28 for appropriate classification and labelling in accordance with the criteria laid down in Annex VI to that Directive. 8.2. By way of derogation from regulation 8.1: T he deter mination of the exp lo sive, ox id ising, 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, - preparation placed on the market in the form of aerosols satisfy the provisions of the Aerosol Dispensers Regulations. S.L. 427.26 8.3. 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. 8.4. 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. 8.5. The hazards deriving from the physico-chemical properties o f a p r ep a r a t io n co v er ed b y th e P l an t P r o te c ti o n P r o d u c t s R eg ul atio n s, o r eq u iv alen t p r o vi sio n s sh all be ass ess ed b y determining the physcio-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 the Second and Third Schedules to the Plant Protection Products Regulations. 9.1. The health hazards of a preparation shall be assessed by one or more of the following procedures: S.L. 430.01 Evaluation of health hazards. (
30. a)by a conventional method described in the Second Schedule; (
31. 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 the First and Second Schedules to the Plant Protection Products Regulations. S.L. 430.01 7 8 [ S.L.427.28 DANGEROUS SUBSTANCES AND PREPARATIONS Cap. 439. 9.2. Without prejudice to the requirements of the Plant Protection Products Regulations, or equivalent provisions, only w h e r e i t c a n b e s c i e n t i f ic a l l y d em o n s t r a t e d b y t h e p er s o n responsible for placing the preparation on the market that the toxicological properties of the preparation cannot correctly be determined by the method outlined in regulation 9.1.(a), or on the basis of existing test results on animals, the methods outlined in regulation 9.1.(
32. b)may be used, provided they are justified or specifically authorised under the Animal Welfare Act. S.L. 427.56 Cap. 439. 9.2.1. When a toxicological property is established by the methods outlined in regulation 7.1.(
33. b)to obtain new data, the test shall be conducted in compliance with the principles of good laboratory practice provided for in the Good Laboratory Practice Regulations, and the provisions in the Animal Welfare Act. S.L. 430.01 9.2.2. Subject to the provisions of regulation 9.3., where a toxicological property has been established on the basis of both the methods outlined in regulations 9.1.(
34. a)and (b), the results from the methods outlined in regulation 9.1.(
35. 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 9.1.(
36. a)shall be used. 9.2.3. Any of the toxicological properties of the preparation which are not assessed by the method outlined in regulation 9.1.(
37. b)shall be assessed in accordance with the method outlined in regulation 9.1.(a). 9.3. Furthermore, where it can be demonstrated - S.L. 430.01 - 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 methods outlined in regulation 9.1., 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. 9.4. For preparations of a known composition, with the exception of those covered by the Plant Protection Products Regulations, or equivalent provisions, classified in accordance with regulation 9.1.(b), a new evaluation of health hazard by the methods outlined in either regulation 9.1.(
38. a)or (
39. b)shall be performed whenever: - changes of composition of the initial concentration, as DANGEROUS SUBSTANCES AND PREPARATIONS [ S.L.427.28 a weight/weight or volume/volume percentage, of one or more of the dangerous constituents are introduced by the manufacturer, in accordance with following table: Initial concentration Permitted variation in initial range of the constituent concentration of the constituent < 2.5% ± 30 % > 2.5 < 10% ± 20% > 10 < 25% ± 10% > 25 < 100% ± 5% - changes of composition involving the substitution or addition of one or more constituents, which may or may not be dangerous within the definitions set out in regulation 5.2, 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. 10.1. The hazards of a preparation for the environment shall be assessed by one or more of the following procedures: Evaluation of environmental hazards. (
40. a)by a conventional method described in the Third Schedule; (
41. 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 provisions of the Second and Third Schedule of the Plant Protection Products Regulations. Without prejudice to the testing requirements set out in the Plant Protection Products Regulations, the conditions for application of the test methods are described in Part C of the Third Schedule. 10.2. When an ecotoxicological property is established by one of the methods outlined in regulation 10.1.(
42. b)to obtain new data, the test shall be conducted in compliance with the principles of good laboratory practice provided for in the Good Laboratory Practice Regulations and the provisions in the Animal Welfare Act. Where the environmental hazards have been assessed in compliance with both the procedures mentioned above, the results of the methods referred to in regulation 10.1.(
43. b)shall be used for classifying the preparation. 10.3. For preparations of a known composition, with the exception of those covered by the Plant Protection Products Regulations or equivalent provisions, classified in accordance with method outlined in regulation 10.1.(b), a new evaluation of environmental hazard either by the method outlined in regulation 8.1.(
44. a)or that outlined in regulation 8.1.(
45. b)shall be performed S.L. 430.01 S.L. 427.56 Cap. 439. S.L. 430.01 9 10 [ S.L.427.28 DANGEROUS SUBSTANCES AND PREPARATIONS 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 following table: Initial concentration Permitted variation in initial range of the constituent concentration of the constituent < 2.5% ± 30 % > 2.5 < 10% ± 20% > 10 < 25% ± 10% > 25 < 100% ± 5% - changes of composition involving the substitution or addition of one or more constituents, which may or may not be dangerous within the definitions set out in regulation 5.2, 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. Prohibition of marketing. 11.1. Preparations covered by these regulations cannot be placed on the market unless they comply with it. 11.2. 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. 11.3. The Director shall take all necessary measures to ensure that those responsible for placing the preparation on the market hold at his disposal: Packaging. - the data used for the classification and labelling of the preparation, - any pertinent information relating to packaging requirements in accordance with regulation 12.1.3, 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 regulation 15. 12.1. Preparations within the meaning of regulation 4.2. and preparations covered by the Fourth Schedule pursuant to regulation 4.3. 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 devices are prescribed, - the materials constituting the packaging and fastening must not be susceptible to adverse attack by the contents, or liable to form dangerous compounds with the contents, DANGEROUS SUBSTANCES AND PREPARATIONS [ S.L.427.28 - 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 fastened repeatedly without the contents escaping. 11 12.2. Containers which contain preparations within the meaning of regulation 4.2. and preparations covered by the Fourth Schedule pursuant to regulation 4.3. 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. 12.3. Containers which contain certain preparations offered or sold to the general public covered by the Fourth Schedule 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. 12.4. The packaging of preparations shall be deemed to satisfy the requirements of regulations 12.1. to 12.3. if it complies with the requirements for carriage of dangerous goods by rail, road, inland, waterway, sea or air. 13.1. Preparations within the meaning of regulation 4.2. cannot be placed on the market unless the labelling on their packaging satisfies all the requirements of regulation 13.2. and the specific provisions of Part A and B of the Fifth Schedule. Labelling. Amended by: L.N. 267 of 2009. Preparations within the meaning of regulation 4.3. as defined in Parts B and C of the Fifth Schedule cannot be placed on the market unless the labelling on their packaging satisfies the requirements of regulations 13.2.1. and 13.2.2. and the specific provisions of Parts B and C of the Fifth Schedule. 13.1.1. With respect to plant protection products subject to the Plant Protection Products Regulations, or equivalent provisions, the labelling requirements in accordance with these regulations shall be accompanied by the following wording: S.L. 430.01 "To avoid risks to man and the environment, comply with the instructions for use.". This labelling shall be without prejudice to the information required by the Plant Protection Products Regulations. 13.2. The following information shall be clearly and indelibly marked on any package: 13.2.1. the trade name or designation of the preparation; S.L. 430.01 12 [ S.L.427.28 DANGEROUS SUBSTANCES AND PREPARATIONS 13.2.2. the name, full address and telephone number of the person established in the European Community who is responsible for placing the preparation on the market, whether it be the manufacturer, the importer or the distributor; 13.2.3. the chemical name of the substance or substances present in the preparation in accordance with the following detailed rules: - for preparations classified as T+, T, Xn in accordance with regulation 9, 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 Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on the classification, labelling and packaging of substances and mixtures or, failing that, Part B of the Second Schedule have to be taken into consideration; - for preparations classified C in accordance with regulation 9, 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 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 hazard 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 hazard categories: - explosive, oxidising, extremely flammable, highly flammable, flammable, irritant, dangerous for the environment; DANGEROUS SUBSTANCES AND PREPARATIONS [ S.L.427.28 need not be mentioned on the label unless the substance has to be mentioned pursuant to the first, second or third indents of regulation 13.2.3. - 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. 13.2.4. The danger symbol(s), where specified in these regulations, and indication(
46. s)of hazards involved in the use of the preparation, shall be in accordance with the wording of Annexes II and VI to Directive 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. Where more that one danger symbol must be assigned to a preparation the obligation to apply the symbol: - T shall make the symbols C and Xn optional unless otherwise specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on the classification, labelling and packaging of substances and mixtures, - C shall make the symbol Xi optional, - E shall make the symbol F and O optional, - Xn shall make the symbol Xi optional. The symbol(
47. s)shall be printed in black on an orange-yellow background. 13.2.5. The indications concerning special risks (R phrases) shall comply with the wording in Annexes III and VI to Directive 67/548/EEC and shall be assigned in accordance with results of the hazard evaluation carried out in accordance with the First, Second and Third Schedules. 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. T h e s t a n d a r d p h r a s e s " e x t r e m e l y f l am m a b l e " o r "h i g h l y flammable" need not be used where they describe an indication of danger used in accordance with paragraph 13.2.4. 13.2.6. 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 13 14 [ S.L.427.28 DANGEROUS SUBSTANCES AND PREPARATIONS with the First, Second and Third Schedules. 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. 13.2.7. The nominal quantity (nominal mass or nominal volume) of the contents in the case of preparations offered or sold to the general public. 13.3. For certain preparations classified as dangerous within the meaning of regulation 10, by way of derogation from regulations 13.2.4., 13.2.5., and 13.2.6., exemptions to certain provisions on the environmental labelling or specific provisions in relation to the 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. 13.4. If the contents of the package do not exceed 125ml: - in the case of preparations that are classified as highly flammable, oxidising, irritant, with the exception of those assigned R41, 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. 13.5. Without prejudice to regulation 43