S.I. No. 62/2004 - European Communities (Classification, Packaging and Labelling of Dangerous Preparations) Regulations 2004

ARRANGEMENT OF REGULATIONS

Regulations	Regulations
1.	Citation.
2.	Interpretation.
3.	Application.
4.	Exemptions.
5.	Dangerous substances and preparations.
6.	Determination of dangerous properties of preparation.
7.	General principles of classification and labelling.
8.	Evaluation of the hazards deriving from physico-chemical properties.
9.	Evaluation of the health hazards of a preparation.
10.	Evaluation of the environmental hazards of a preparation.
11.	Placing on market of a preparation.
12.	Data and information on preparations.
13.	Packaging.
14.	Labelling.
15.	Implementation of labelling requirements.
16.	Exemptions from packaging and labelling requirements.
17.	Distance selling.
18.	Safety data sheets.
19.	Confidentiality of chemical names.
20.	Poison information centre.
21.	Provisional restriction on placing a preparation on market.
22.	Taking and detention of preparations.
23.	Offences.
24.	Revocations.
SCHEDULE 1 CONCENTRATIONS OF DANGEROUS SUBSTANCES TO BE TAKEN INTO ACCOUNT FOR CLASSIFICATION OF A PREPARATION	SCHEDULE 1 CONCENTRATIONS OF DANGEROUS SUBSTANCES TO BE TAKEN INTO ACCOUNT FOR CLASSIFICATION OF A PREPARATION
SCHEDULE 2 METHODS FOR THE EVALUATION OF PHYSICO-CHEMICALS PROPERTIES OF PREPARATIONS	SCHEDULE 2 METHODS FOR THE EVALUATION OF PHYSICO-CHEMICALS PROPERTIES OF PREPARATIONS
SCHEDULE 3 CONVENTIONAL METHOD FOR THE EVALUATION OF HEALTH HAZARDS OF PREPARATIONS	SCHEDULE 3 CONVENTIONAL METHOD FOR THE EVALUATION OF HEALTH HAZARDS OF PREPARATIONS
SCHEDULE 4 CONVENTIONAL METHOD FOR THE EVALUATION OF ENVIRONMENTAL HAZARDS OF PREPARATIONS	SCHEDULE 4 CONVENTIONAL METHOD FOR THE EVALUATION OF ENVIRONMENTAL HAZARDS OF PREPARATIONS
SCHEDULE 5 SPECIAL PROVISIONS FOR CONTAINERS CONTAINING PREPARATIONS OFFERED OR SOLD TO THE PUBLIC	SCHEDULE 5 SPECIAL PROVISIONS FOR CONTAINERS CONTAINING PREPARATIONS OFFERED OR SOLD TO THE PUBLIC
SCHEDULE 6 NAMING OF SUBSTANCES IN A PREPARATION	SCHEDULE 6 NAMING OF SUBSTANCES IN A PREPARATION
SCHEDULE 7 SPECIAL PROVISIONS CONCERNING THE LABELLING OF CERTAIN PREPARATIONS	SCHEDULE 7 SPECIAL PROVISIONS CONCERNING THE LABELLING OF CERTAIN PREPARATIONS
SCHEDULE 8 SYMBOLS AND INDICATIONS OF DANGER	SCHEDULE 8 SYMBOLS AND INDICATIONS OF DANGER
SCHEDULE 9 RISKS PHRASES	SCHEDULE 9 RISKS PHRASES
SCHEDULE 10 SAFETY PHRASES	SCHEDULE 10 SAFETY PHRASES
SCHEDULE 11 SPECIAL LABELLING PROVISIONS FOR SINGLE PACKAGES	SCHEDULE 11 SPECIAL LABELLING PROVISIONS FOR SINGLE PACKAGES
SCHEDULE 12 OBLIGATORY HEADINGS FOR SAFETY DATA SHEETS	SCHEDULE 12 OBLIGATORY HEADINGS FOR SAFETY DATA SHEETS
SCHEDULE 13 LABELLING OF A PLANT PROTECTION PRODUCT	SCHEDULE 13 LABELLING OF A PLANT PROTECTION PRODUCT

S.I. No. 62 of 2004.

EUROPEAN COMMUNITIES (CLASSIFICATION, PACKAGING AND LABELLING OF DANGEROUS PREPARATIONS) REGULATIONS 2004.

I, Mary Harney, Minister for Enterprise, Trade and Employment, in exercise of the powers conferred on me by section 3 of the European Communities Act 1972 (No. 27 of 1972) and for the purpose of giving effect to Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999¹ , as amended by Commission Directive 2001/60/EC of 7 August 2001² , Commission Directive 91/155/EEC of 5 March 1991³ , as amended by Commission Directive 2001/58/EC of 27 July 2001⁴ , Commission Directive 93/21/EEC of 27 April 1993⁵ and Commission Directive 93/112/EC of 10 December 1993⁶ , hereby make the following regulations:

Citation.

1.

Interpretation.

2.

“Act of 1989” means the Safety, Health and Welfare at Work Act 1989 (No. 7 of 1989);

“Annex I” means Annex I (inserted by Directive 76/907/EEC) to Directive 67/548/EEC;

“Annex II” means Annex II (inserted by Commission Directive 83/467/EEC of 29 June 1983⁷ ) to Directive 67/548/EEC, and which, for convenience of reference, is set out in Schedule 8;

“Annex III” means Annex III (inserted by Directive 76/907/EEC) to Directive 67/548/EEC, and which, for convenience of reference, is set out in Schedule 9;

“Annex IV” means Annex IV (inserted by Directive 76/907/EEC) to Directive 67/548/EEC and which, for convenience of reference, is set out in Schedule 10;

“Annex V” means Annex V (inserted by Commission Directive 84/449/EEC of 25 April 1984⁸ ) to Directive 67/548/EEC;

“Annex VI” means Annex VI (inserted by Commission Directive 79/831/EEC of 18 September 1979⁹ ) to Directive 67/548/EEC;

“Annex IX” means Annex IX (inserted by Commission Directive 91/410/EEC of 22 July 1991¹⁰ , as amended by Commission Directive 2000/32/EC of 19 May 2000¹¹ ) to Directive 67/548/EEC;

“Authority” has the meaning assigned to it under the Act of 1989;

“dangerous preparation” shall be construed in accordance with Regulation 3(2);

“Directive” means Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999¹ , as amended by Commission Directive 2001/60/EC of 7 August 2001² ;

“Directive 67/548/EEC” means Council Directive 67/548/EEC of 27 June 1967¹² ;

“Directive 76/907/EEC” means Commission Directive 76/907/EEC of 14 July 1976¹³ ;

“Directive 86/609/EEC” means Council Directive 86/609/EEC of 24 November 1986¹⁴ ;

“Directive 87/18/EEC” means Council Directive 87/18/EEC of 18 December 1986¹⁵ ;

“Directive 91/155/EEC” means Commission Directive 91/155/EEC of 5 March 1991¹⁶ as amended by Directive 2001/58/EC;

“Directive 91/414/EEC” means Council Directive 91/414/EEC of 15 July 1991¹⁶ ;

“Directive 93/112/EC” means Commission Directive 93/112//EC of 10 December 1993⁶ ;

“Directive 2001/58/EC” means Commission Directive 2001/58/EC of 27 July 2001⁴ ;

“Elincs” means the European List of Notified Chemical Substances, published from time to time, containing the list of substances placed on the market in the European Communities after 18 September 1981 and which have been the subject of a notification;

“inspector” has the meaning assigned to it by the Act of 1989;

“label” means the label required under these Regulations and cognate words shall be construed accordingly;

“Member State” means a Member State of the European Communities;

“Minister” means the Minister for Enterprise, Trade and Employment;

“monomer unit” means the reacted form of a monomer in a polymer;

“package” means the packaging, receptacle or container containing a preparation to which these Regulations apply, and cognate words shall be construed accordingly;

“person responsible for placing on the market” includes a manufacturer, importer, supplier, distributor, wholesaler or retailer established in the State, who places on the market a preparation to which these Regulations apply;

“risk phrase” means any phrase which is listed in Schedule 9;

“safety phrase” means any phrase which is listed in Schedule 10;

“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 product 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;

“symbol” means any symbol specified in Schedule 8;

“tactile warning of danger” means a method of warning of the dangerous contents of a package for a person who has poor sight or no sight that is referred to in Regulation 13, and which complies with Schedule 5.

• (2) In these Regulations—

• (a) reference to a Regulation or a Schedule is to a Regulation of, or a Schedule to, these Regulations, unless it is indicated that reference to some other Regulations is intended, and

• (b) reference to a paragraph or subparagraph is to the paragraph or subparagraph of the provision in which the reference occurs, unless it is indicated that reference to some other provision is intended.

• (3) In these Regulations a reference to—

• (a) R followed by a number or numbers means a reference to the relevant risk phrase or phrases listed in Schedule 9,

• (b) S followed by a number or numbers means a reference to the relevant safety phrase or phrases listed in Schedule 10.

• (4) A word or expression that is used in these Regulations and is also used in the Directive, Directive 67/548/EEC, Commission Directive 2001/60/EC, Directive 91/155/EEC, Directive 2001/58/EC, Directive 91/414/EEC, Commission Directive 93/21/EEC of 27 April 1993⁵ , Directive 93/112/EC, Directive 86/609/EEC and Directive 87/18/EEC has, unless the contrary intention appears, the same meaning in these Regulations as it has in the Directive concerned.

• (5) The Act of 1989 is to be construed and have effect as if these Regulations were existing enactments within the meaning of that Act and for the time being in force and specified in Part II of the Second Schedule to that Act.

Application.

3.

• (a) the classification, packaging and labelling of a preparation referred to in paragraph (2), and

• (b) a preparation referred to in paragraph (3) that may present hazards, whether or not it is classified as dangerous in accordance with these Regulations,

when such preparation is placed on the market.

• (2) These Regulations apply to a preparation—

• (a) which contains one or more than one dangerous substance, and

• (b) is considered dangerous within the meaning of and in accordance with Regulation 8, 9 or 10.

• (3) Regulations 13, 14 and 18 and Schedules 5 and 7 apply to a preparation that is not considered dangerous within the meaning of Regulation 8, 9 or 10 but which may present a specific hazard.

• (4) Without prejudice to Directive 91/414/EEC, as amended by Commission Directive 96/68/EC of 21 October 1996¹⁷ , the provisions of these Regulations concerning the classification, packaging, labelling and safety data sheets shall apply, from 30 July 2004, to plant protection products.

Exemptions.

4.

• (a) medicinal products for human or veterinary use, as defined in Council Directive 65/65/EEC of 26 January 1965¹⁸ as lastly amended by Commission Directive 93/39/EEC of 14 June 1993¹⁹ ,

• (b) cosmetic products, as defined by Council Directive 76/768/EEC of 27 July 1976²⁰ as lastly amended by Commission Directive 98/62/EC of 3 September 1998²¹ ,

• (c) mixtures of substances which, in the form of waste, are the subject of Council Directive 75/442/EEC of 15 July 1975²² as lastly amended by Commission Decision 96/350/EEC of 24 May 1996²³ and Council Directive 91/689/EEC of 12 December 1991²⁴ as lastly amended by Council Directive 94/31/EC of 27 June 1994²⁵ ,

• (d) foodstuffs,

• (e) animal feeding stuffs,

• (f) radioactive substances, within the meaning of Council Directive 80/836/Euratom of 15 July 1980²⁶ , and

• (g) medical devices, which are invasive or used in direct physical contact with the human body, within the meaning of Council Directive 93/42/EEC of 14 June 1993²⁷ .

• (2) These Regulations do not apply to—

• (a) the carriage of dangerous preparations by rail, road, inland waterway, sea or air, or

• (b) preparations in transit which are under customs supervision, provided they do not undergo any treatment or processing.

Dangerous substances and preparations.

5.

• (a) explosive substances and preparations, namely, 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,

• (b) oxidising substances and preparations, namely, 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, namely, 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, namely—

• (i) substances and preparations which may become hot and finally catch fire in contact with air at ambient temperature without any application of energy,

• (ii) solid substances and preparations which may readily catch fire after brief contact with a source of ignition and which continue to burn or to be consumed after removal of the source of ignition,

• (iii) liquid substances and preparations having a very low flash-point, or

• (iv) substances and preparations which, in contact with water or damp air, evolve extremely flammable gases in dangerous quantities,

• (e) flammable substances and preparations, namely, liquid substances and preparations having a low flash-point,

• (f) very toxic substances and preparations, namely, 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,

• (g) toxic substances and preparation, namely, 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, namely, 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, namely, substances and preparations which may, on contact with living tissues, destroy them,

• (j) irritant substances and preparations, namely, 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, namely, 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,

• (l) carcinogenic substances and preparations, namely, substances or preparation 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, namely, 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, namely, 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 progeny or an impairment of male or female reproductive functions or capacity, and

• (o) substances and preparations which are dangerous for the environment, namely, substances and preparations which, were they to enter the environment, would present or may present an immediate or delayed danger for one or more components of the environment.

Determination of dangerous properties of preparation.

6.

• (a) any physico-chemical properties of that preparation,

• (b) properties of that preparation that affect health, and

• (c) environmental properties of that preparation in accordance with the procedures laid down in Regulations 8, 9 and 10.

• (2) Where laboratory tests are conducted to determine the dangerous properties of a preparation, they shall be carried out on the preparation in the form in which it is as placed on the market.

• (3) Where the determination of the dangerous properties is carried out in accordance with the procedures laid down in Regulations 8, 9 and 10, all dangerous substances within the meaning of Regulation 5 and in particular all dangerous substances which—

• (a) are specified in Annex I,

• (b) are specified in Elincs in accordance with Article 21 of Directive 67/548/EEC,

• (c) are classified and labelled provisionally by the person responsible for placing on the market such dangerous substances in accordance with Article 6 of Directive 67/548/EEC,

• (d) are classified and labelled in accordance with Article 7 of Directive 67/548/EEC and are not yet included in Elincs,

• (e) are provided for under Article 8 of Directive 67/548/EEC, and

• (f) are classified and labelled in accordance with Article 13 of Directive 67/548/EEC,

shall be taken into consideration in accordance with the methods laid down in those Regulations.

• (4) In respect of a preparation to which these Regulations apply, dangerous substances referred to in paragraph (3) which are classified as dangerous on the basis of their health and their environmental effects or either of them, whether they are impurities or additives, shall be taken into consideration when their concentrations are equal to or greater than the concentrations set out in Schedule 1 unless lower values for concentrations are given in—

• (a) Annex I,

• (b) Part B of Schedule 3, or

• (c) Part B of Schedule 4,

unless otherwise specified in Schedule 7.

General principles of classification and labelling.

7.

• (a) explosive,

• (b) oxidising,

• (c) extremely flammable,

• (d) highly flammable,

• (e) flammable,

• (f) very toxic,

• (g) toxic,

• (h) harmful,

• (i) corrosive,

• (j) irritant,

• (k) sensitising,

• (l) carcinogenic,

• (m) mutagenic,

• (n) toxic for reproduction,

• (o) dangerous for the environment.

• (2) The general principles of the classification and labelling of preparations shall be applied in accordance with Annex VI unless the alternative criteria referred to in Regulation 8, 9, 10 or 14, including the Schedules and Annexes referred to in those Regulations, are applied.

Evaluation of the hazards deriving from physico-chemical properties.

8.

• (2) Notwithstanding paragraph (1), in an assessment of the hazards of a preparation referred to in paragraph (1)—

• (a) it is not necessary to determine the explosive, oxidising, extremely flammable, highly flammable or flammable properties of a preparation if—

• (i) none of the constituents of such preparation possess such properties and that, on the basis of the information available to the manufacturer, the preparation is unlikely to present hazards of this kind,

• (ii) 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, or

• (iii) where a preparation is placed on the market in the form of an aerosol, the preparation and aerosol complies with the European Communities (Aerosol Dispensers) Regulations 1977 ( S.I. No. 144 of 1977 ) as amended by the European Communities (Aerosol Dispensers)(Amendment) Regulations 1995 ( S.I. No. 127 of 1995 ),

• (b) in certain cases for which the methods laid down in Part A of Annex V are not appropriate, alternative calculation methods are laid down in Part B of Schedule 2, and

• (c) certain exemptions from the application of the methods laid down in Part A of Annex V are referred to in Part A of Schedule 2.

• (3) The hazards deriving from the physico-chemical properties of a preparation to which Directive 91/414/EEC applies shall be—

• (a) assessed by determining physico-chemical properties of that preparation that is necessary for appropriate classification in accordance with the criteria set out in Annex VI, and

• (b) determined by means of the methods laid down in Part A of Annex V unless other internationally recognised test methods are acceptable in accordance with Annex II and Annex III to Directive 91/414/EEC.

Evaluation of the health hazards of a preparation.

9.

• (a) a conventional method provided for in Schedule 3, or

• (b) determining the toxicological properties of the preparation that is necessary to ensure that the appropriate classification in accordance with the criteria specified in Annex VI is assigned to such preparation, and the toxicological properties concerned shall be determined by means of the methods laid down in Part B of Annex V unless, in the case of plant protection products, other internationally recognised methods are acceptable in accordance with Annexes II and III to Directive 91/414/EEC.

• (2) Without prejudice to Directive 91/414/EEC, where in the assessment of a health hazard of a preparation the methods outlined in paragraph (1)(b) may be used if they are justified or specifically authorised under Article 12 of Directive 86/609/EEC and if it can be scientifically demonstrated by the person responsible for placing on the market a preparation to which these Regulations apply that the toxicological properties of that preparation cannot be correctly determined by the method referred to in paragraph (1)(a) or on the basis of existing test results on animals, the methods referred to in paragraph (1)(b) may be used if they are justified or specifically authorised under Article 12 of Directive 86/609/EEC.

• (3) Where a toxicological property of a preparation is established by the method referred to in paragraph (1)(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 Directive 86/609/EEC and having specific regard to Articles 7 and 12 of the latter Directive.

• (4) Subject to paragraphs (6), (7) and (8), where a toxicological property has been established on the basis of both the methods referred to in paragraph (1)(a) and (b), the results from the methods referred to in paragraph (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 set out in paragraph (1)(a) shall be used.

• (5) Any of the toxicological properties of the preparation which are not assessed by the methods referred to in paragraph (1)(b) shall be assessed in accordance with the methods referred to in paragraph (1)(a).

• (6) Where, in respect of a preparation to which these Regulations apply, it can be demonstrated by epidemiological studies, by scientifically valid case studies as specified in Annex VI, or statistically backed experience, including the assessment of data from poison information centres or units of occupational disease, that the toxicological effects of such preparation on a person differ from those suggested by the application of the methods outlined in paragraph (1), then the preparation shall be classified according to the effects on a person.

• (7) Where, in respect of a preparation to which these Regulations apply, it can be demonstrated 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.

• (8) Where, in respect of a preparation to which these Regulations apply, it can be demonstrated 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) For a preparation of a known composition, other than those to which Directive 91/414/EEC applies that is classified in accordance with paragraph (1)(b), a new evaluation of health hazard by the methods referred to in paragraph (1)(a) or (b) shall be performed where there is a change in composition of the initial concentration, as a weight/weight or volume/volume percentage, of one or more of the dangerous constituents that are introduced by the manufacturer in a manner specified in the Table to this paragraph.

Initial concentration range of the constituent	Permitted variation in actual concentration of the constituent
(1)	(2)
≤ 2.5%	± 30%
> 2.5 ≤ 10%	± 20%
> 10 ≤ 25%	± 10%
> 25% ≤ 100%	± 5%

• (10) For preparations of a known composition, other than those to which Directive 91/414/EEC applies, that are classified in accordance paragraph (1)(b), a new evaluation of health hazard by the methods referred to in paragraph (1)(a) or (b) shall be performed where there are changes of composition, introduced by the manufacturer, involving the substitution or addition of one or more constituents, which may or may not be dangerous within the meaning of Regulation 5.

• (11) The evaluation pursuant to and in accordance with paragraph (9) or (10) shall apply unless there is valid scientific justification for considering that a re-evaluation of the hazard will not result in a change of classification.

Evaluation of the environmental hazards of a preparation.

10.

• (a) a conventional method referred to in Schedule 4, or

• (b) by determining the hazardous properties of the preparation for the environment that is necessary to ensure the allocation of the appropriate classification in accordance with the criteria set out in Annex VI and—

• (i) these properties shall be determined by the methods laid down in Part C of Annex V unless, in the case of plant protection products, other internationally recognised methods are acceptable in accordance with Annexes II and III of Directive 91/414/EEC, and

• (ii) without prejudice to the testing requirements set out in Directive 91/414/EEC, the conditions for application of the test methods are set out in Part C of Schedule 4.

• (2) Where an ecotoxicological property is established by one of the methods referred to in paragraph (1)(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 Directive 86/609/EEC.

• (3) Where the environmental hazards of a preparation have been assessed as required and in accordance with paragraph (2), the results of the methods referred to in paragraph (1)(b) shall be used for classifying the preparation.

• (4) For a preparation of a known composition, other than those to which Directive 91/414/EEC applies, that is classified in accordance with paragraph (1)(b), a new evaluation of environmental hazard, either by the method referred to in paragraph (1)(a) or (b) shall be performed if there is a change in composition of the initial concentration, as a weight/weight or volume/volume percentage, of one or more of the dangerous constituents that are introduced by the manufacturer in accordance with the Table to this paragraph.

TABLE

Initial concentration range of the constituent	Permitted variation in actual concentration of the constituent
(1)	(2)
≤ 2.5%	± 30%
> 2.5 ≤ 10%	± 20%
> 10 ≤ 25%	± 10%
> 25% ≤ 100%	± 5%

• (5) For a preparation of a known composition, other than those to which Directive 91/414/EEC applies, that is classified in accordance with paragraph (1)(b), a new evaluation of environmental hazard, either by the method referred to in paragraph (1)(a) or (b), shall be performed if there are changes in composition involving the substitution or addition of one or more constituents that are introduced by the manufacturer, which may or may not be dangerous within the meaning of Regulation 5.

• (6) The new evaluation made pursuant to and in accordance with paragraph (4) or (5) shall apply unless there is valid scientific justification for considering that a re-evaluation of the hazard will not result in a change of classification.

Placing on market of a preparation.

11.

Data and information on preparations.

12.

• (2) A person who places on the market a preparation to which these Regulations apply shall maintain and have available for inspection—

• (a) information concerning the composition of the preparation concerned,

• (b) any other information that relates to the composition of the preparation concerned,

• (c) the data used for the classification and labelling of the preparation concerned,

• (d) information relating to the packaging requirements under Regulation 13 and the test certificate issued in accordance with Schedule 5 for the preparation concerned, and

• (e) the data used for establishing the safety data sheet in accordance with Regulation 18.

• (3) The information referred to in paragraphs (1) and (2) shall be kept by the person who places on the market the preparation concerned for a period of not less than 5 years following the date on which that preparation was placed on the market.

• (4) The person who places a preparation to which these Regulations apply on the market shall ensure that the information referred to in paragraphs (1) and (2) shall be kept in legible form and be available for inspection by an inspector.

Packaging.

13.

• (a) the packaging of that preparation is, subject to paragraph (3), designed and constructed in such a manner that the contents cannot escape such packaging,

• (b) the materials constituting the packaging and fastening of that preparation shall not be susceptible to adverse attack by the contents or liable to form dangerous compounds with the contents,

• (c) the packaging and fastenings of that preparation shall be of sufficient and appropriate strength and be solid throughout to ensure that they will not loosen and will safely meet the normal stresses and strains of handling,

• (d) containers fitted with replaceable fastenings devices shall be designed so that the packaging can be repeatedly fastened without the contents escaping, and

• (e) the container which contains such preparation and which is offered or sold to the general public does not have—

• (i) a shape and graphic decoration, or either of them, that is likely to attract or arouse the active curiosity of children or to mislead consumers, or

• (ii) a presentation and a designation, or either of them, that is used for foodstuffs or animal feeding stuffs, medical products or cosmetic products.

• (2) A container which contains a preparation that is offered or sold to the general public and to which Schedule 5 applies shall—

• (a) be fitted with child-resistant fastenings and shall comply with the technical specifications in Part A of Annex IX, and

• (b) a container which contains a preparation that is specified in Part B of Schedule 5 and which is intended to be offered or sold to the general public shall carry a tactile warning of danger and such warning shall comply with Part B of Annex IX.

• (3) Paragraph (1) (a) does not apply to such packaging if special safety devices are required to be attached to such packaging.

• (4) Where the packaging of a preparation complies with the requirements for carriage of dangerous goods by rail, road, inland waterway, sea or air, such packaging shall be deemed to satisfy paragraph (1)(a), (b) or (c).

Labelling.

14.

• (a) a preparation referred to in Regulation 3(2) unless the labelling on the packaging of such preparation satisfies the requirements of these Regulations and Parts A and B of Schedule 7, or

• (b) a preparation referred to in Regulation 3(3), as defined in Parts B and C of Schedule 7, unless the labelling on the packaging of such preparation satisfies the requirements of paragraphs (3)(a) and (3)(b) and Parts B and C of Schedule 7.

• (2) In respect of any plant protection product to which Directive 91/414/EEC applies, and without prejudice to the requirements of Article 16 and Annex V of that Directive, a person who places on the market such products shall include the statement that is specified in Schedule 13 on the label of that plant protection product.

• (3) A person shall not place on the market a preparation referred to in paragraph (1) unless the following information is clearly and indelibly marked on the package containing that preparation—

• (a) the trade name or designation of that preparation,

• (b) the name, full address and telephone number of the person responsible for placing on the market that preparation, who is established in the European Community,

• (c) the chemical name of the substance or substances present in that preparation in accordance with Schedule 6,

• (d) the danger symbol relating to the preparation and the indication of dangers involved in the use of that preparation and the evaluation of the hazards carried out in accordance with and as required under paragraphs (4) and (5),

• (e) the relevant risk phrase or phrases or the danger involved in the use of that preparation,

• (f) the relevant safety phrase or phrases relating to the safe use of that preparation,

• (g) the special labelling, where appropriate, that is required under paragraph (1) (b), and

• (h) for preparations intended for sale to the general public, the nominal quantity, either by volume or by mass, of the preparation in the package.

• (4) The danger symbol, or where appropriate, danger symbols relating to the preparation, and the wording of the indications of danger involved in the use of the preparation that are required to be specified on the label shall—

• (a) comply with the wording set out in Annex VI and Schedule 8 and be applied in accordance with the evaluation of the hazards carried out in accordance with Schedules 2, 3, and 4, and

• (b) be printed in black on an orange-yellow background.

• (5) Where more than one danger symbol is required to be assigned to a preparation to which these Regulations apply—

• (a) the obligation to apply the symbol T shall make the application of symbols X and C optional, unless otherwise specified in Annex I,

• (b) the obligation to apply the symbol C shall make the symbol X optional,

• (c) the obligation to apply the symbol E shall make the symbols F and O optional, and

• (d) the obligation to indicate the symbol Xn makes the symbol Xi optional.

• (6) Subject to paragraph (15), indications concerning special risks (risk phrases) shall comply with the wording in Annex VI and Schedule 9 and shall be assigned in accordance with the results of the hazard evaluation carried out in accordance with Schedules 2, 3 and 4.

• (7) Subject to paragraph (8), a maximum of 6 risk phrases shall suffice to describe the risks and for this purpose, the combined phrases listed in Annex III shall be regarded as single phrases.

• (8) If a preparation falls within more than one danger category, the risk phrases shall cover each of the principal hazards associated with the preparation and in certain circumstances more than 6 risk phrases may be necessary to describe the risks for that preparation.

• (9) The risk phrases R11, highly flammable, or R12, extremely flammable, need not be used on the package of a preparation to which these Regulations apply if they describe an indication of danger used in accordance with paragraph (4).

• (10) Subject to paragraph (15)—

• (a) indications giving safety advice on a label (safety phrases) shall comply with the wording of safety phrases referred to in Schedule 10 and Annex VI,

• (b) indications giving safety advice on a label (safety phrases) shall be assigned in accordance with the results of the hazard evaluation carried out in accordance with Schedules 2, 3 and 4, and

• (c) a maximum of 6 safety phrases shall suffice to formulate the most appropriate safety advice on a label and for this purpose the combined phrases specified in Annex IV shall be taken to be single phrases.

• (11) Notwithstanding paragraph (10)(c), in certain circumstances more than 6 phrases may be necessary to formulate the most appropriate safety advice for a preparation.

• (12) Where it is physically impossible to include the safety advice on the label or package itself, the package shall be accompanied by safety advice on the use of the preparation.

• (13) Without prejudice to Article 16(4) of Directive 91/414/EEC, 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 an underestimation of the dangers of the preparation concerned shall not appear on the packaging or labelling of any preparation to which these Regulations apply.

• (14) The information referred to in paragraph (1) shall be shown on the labelling on the packaging in the English language or in both the English and Irish languages.

• (15) If the contents of a package do not exceed 125 millilitres, it shall not be necessary for the person who places on the market a preparation classified as—

• (a) highly flammable, oxidising, irritant, except a preparation so classified that is assigned R41, or dangerous for the environment and assigned the N symbol, to indicate the risk phrase or the safety phrase for such preparation,

• (b) flammable or dangerous for the environment and not assigned the N symbol to indicate the safety phrase for such preparation, but that person shall indicate the risk phrase for the preparation concerned.

• (16) A person shall not place on the market a preparation to which these Regulations apply unless the label on such preparation complies with this Regulation.

Implementation of labelling requirements.

15.

• (a) firmly affixed to one or more surfaces of the packaging so that those particulars can be read horizontally when the package is set down normally, and

• (b) intended solely for the provision of the information required by these Regulations and, if necessary, of any supplementary health or safety information.

• (2) The dimensions of a label shall comply with the dimensions, as appropriate, that are specified in the Table to this paragraph.

TABLE

Capacity of the package	Dimensions (in millimetres)
Not exceeding 3 litres	if possible at least 52 X 74
Greater than 3 litres but not exceeding 50 litres	at least 74 X 105
Greater than 50 litres but not exceeding 500 litres	at least 105 × 148
Greater than 500 litres	at least 148 X 210

• (3) A label shall not be required where the particulars are clearly shown on the package itself in accordance with this Regulation.

• (4) The colour and presentation of the label or, in the case of paragraph (3), of the package, shall be such that the danger symbol and its background stand out clearly from the label or package.

• (5) The information required on a label under Regulation 14 shall stand out clearly from its background and shall be of such size and spacing as to be easily read and shall comply with the specific provisions, where appropriate, regarding the presentation and format of this information laid down in Annex VI.

• (6) The requirements of these Regulations in relation to labelling shall be deemed to be satisfied if—

• (a) in the case of an outer package containing one or more inner packages, the outer package is labelled in accordance with the international rules on the transport of dangerous goods and the inner package is labelled in accordance with these Regulations,

• (b) in the case of a single package—

• (i) the package is labelled in accordance with international rules on the transport of dangerous goods, Regulation 14(3)(a) to (c) and Regulation 14(6) to (10), and if the package concerns a preparation classified in accordance with Regulation 10, Regulation 14(4) and (5) apply with respect to the property in question when it has not been so identified on the label, or

• (ii) where appropriate, for particular types of packaging, such as mobile gas cylinders, if the specific requirements referred to in Schedule 11 are complied with.

• (7) In this Regulation—

“international rules on the transport of dangerous goods” means the requirements arising under—

• (a) the European Agreement Concerning the International Carriage of Dangerous Goods by Road done at Geneva on 30 September 1957, and

• (b) the International Maritime Dangerous Goods Code published by the International Maritime Organisation.

• (8) In this Regulation and in Regulation 14, “label” means a label referred to in paragraph (1).

• (9) In any proceeding under these Regulations prima facie evidence of the terms of any of the international rules on the transport of dangerous goods may be given by producing a document that purports to be a copy of such rules.

Exemptions from packaging and labelling requirements.

16.

• (2) The Authority may grant at its discretion, by a certificate in writing, subject to any conditions specified in the certificate, an exemption from Regulations 14 and 15 in respect of—

• (a) the packaging, subject to paragraph (3), of a preparation referred to in Regulation 3(2) which may be unlabelled or may be labelled in such other way as may be approved by the Authority, if it contains such small quantities that there is no reason to fear any danger to persons handling such preparation or to other persons,

• (b) the packaging, subject to paragraph (3), of a preparation referred to in Regulation 3(2) which is explosive, very toxic, toxic, or sensitising which may be labelled in such other way as may be approved by the Authority if it is too small for labelling in accordance with Regulations 14 and 15 and there is no reason to fear any danger to persons handling such preparation or to other persons,

• (c) the labelling required on a package which is too small or otherwise unsuitable for labelling in accordance with Regulations 14 and 15, which labelling may be applied on packages in such other appropriate manner as may be approved by the Authority, and

• (d) the packaging of a preparation that is classified as dangerous for the environment only, which may be labelled in such other way as may be approved by the Authority if it is too small for labelling in accordance with Regulations 14 and 15 and there is no reason to fear any danger to the environment.

• (3) The Authority shall not grant a certificate under paragraph (2)(a) if the preparation concerned is explosive, very toxic or toxic.

• (4) An exemption under paragraph (2) does not permit the use of symbols, indications of danger, risk phrases or safety phrases that are different from those required by these Regulations.

• (5) An exemption, granted by the Authority under paragraph (2), may be revoked at any time.

• (6) The Authority shall inform the Commission of the European Communities of a certificate granted by it under paragraph (2).

• (7) Where a preparation referred to in Regulation 3(2) does not leave the State, labelling of that preparation which complies with the national rules on the transport of dangerous goods may be used in respect of that preparation.

• (8) Notwithstanding Regulations 14 to 16, Chapter 9 of Annex VI shall apply, in relation to any matter under any of those Regulations, to a preparation to which that Chapter is appropriate.

• (9) In this Regulation “national rules on the transport of dangerous goods” means—

• (a) Carriage of Dangerous Goods by Road Regulations 2004 ( S.I. No. 29 of 2004 ), and

• (b) European Communities (Transport of Dangerous Goods by Rail) Regulations 2001 ( S.I. No. 500 of 2001 ).

Distance selling.

17.

Safety data sheets.

18.

• (a) information that concerns that preparation for the purpose of enabling a professional user to take the necessary measures regarding the protection of health, safety and the environment at the place of work, and

• (b) information that concerns that preparation for the purpose of enabling any person, including the professional user, to take the necessary measures regarding the protection of health, safety and the environment at the place of work.

• (2) A person who places on the market a preparation referred to in Regulation 3(3) shall provide, when so requested by a professional user, a safety data sheet specifying information that is appropriate and proportionate for a preparation that is not classified as dangerous under these Regulations but which contains in an individual concentration of greater than or equal to 1 per cent by weight for a non-gaseous preparation and greater than or equal to 0.2 per cent by volume for a gaseous preparation at least—

• (a) one substance posing health or environmental hazard, or

• (b) one substance for which there is Community workplace exposure limits.

• (3) The safety data sheet shall be provided free of charge to the recipient and may be communicated on paper or electronically—

• (a) not later than the time at which the preparation is supplied to the person concerned, and

• (b) following a revision of the safety data sheet arising out of significant and new information regarding safety and protection of health and the environment.

• (4) An amended safety data sheet referred to in paragraph (3) shall be provided forthwith free of charge to all industrial or professional users, distributors, wholesalers and retailers who were supplied with the particular dangerous substance within the 12 months preceding the publication date of the amended safety data sheet.

• (5) The safety data sheet referred to in paragraph (1) shall contain such information necessary for the protection of any person and the environment as the manufacturer, importer or distributor may reasonably be expected to be aware of.

• (6) A safety data sheet referred to in paragraph (1) shall be clearly written in the English language or in both the English and Irish languages.

• (7)
• (a) A safety data sheet shall contain information relating to each of the matters specified in Schedule 12 and shall be compiled in accordance with the Annex to Directive 91/155/EEC.

• (b) The information required to be contained in the safety data sheet in accordance with subparagraph (a) shall comply with the guidelines laid down in the Annex to Directive 91/155/EEC, as amended by Directive 93/112/EC and Directive 2001/58/EC.

• (c) Without prejudice to subparagraphs (a) and (b), the safety data sheet shall specify the information concerning—

• (i) the name of the person responsible for providing the safety data sheet,

• (ii) the date of publication or the date of preparation of the safety data sheet, and

• (iii) for an amended safety data sheet, a notice of revision together with the revision date.

• (8) Paragraphs (1) to (7) do not apply where the dangerous preparation is offered or sold to the general public if—

• (a) sufficient information to enable users to take the necessary measures as regards the protection of health and safety is furnished, and

• (b) a safety data sheet is available when requested, in accordance with this Regulation.

Confidentiality of chemical names.

19.

• (i) irritant except those assigned R41 or irritant in combination with one or more of the other properties mentioned in Regulation 14 and paragraph 3 of Schedule 6, or

• (ii) harmful or harmful in combination with one or more of the properties mentioned in Regulation 14 and paragraph 3 of Schedule 6 presenting acute lethal effects,

will put at risk the confidential nature of the intellectual property concerned, that person may refer to that substance either by means of a name that identifies the most important chemical groups or by means of an alternative name in accordance with Annex VI.

• (b) Subparagraph (a) shall not apply if the substance concerned has been assigned a Community exposure limit.

• (c) Where the person responsible for placing on the market a preparation referred to in subparagraph (a) wishes to avail of the confidentiality provisions provided under this Regulation that person shall make a request—

• (i) if the preparation is to be first placed on the market in the State, to the Authority in accordance with Annex VI, and shall give the information required in the form in Part A of Annex VI and any other information which the Authority may request, or

• (ii) if the preparation is to be first placed on the market in another Member State, to the competent authorities of that other Member State.

• (d) The Authority may consent in writing to an application under this Regulation subject to any conditions which, in the opinion of the Authority, are appropriate to such confidentiality.

• (2) Where a request under paragraph (1) is made to the Authority it shall notify the person who made the request of its decision in writing.

• (3) Where the Authority has consented to an application under this Regulation, the person responsible for placing on the market the preparation concerned shall provide notification of that consent of the Authority to the competent authority of each Member State in which such person intends to market the product.

• (4) Where the Authority is of the opinion that paragraph (1) does not apply in a particular case, it may notify the person who made the application in writing that it is of that opinion.

• (5) The Authority shall ensure that confidential information that is brought to the attention of the Authority in respect of an application under this Regulation is treated in accordance with Article 19(4) of Directive 67/548/EEC, as amended by Council Directive 92/32/EEC of 30 April 1992²⁹ .

Poison information centre.

20.

• (2) The poison centre shall have power to require the person responsible for placing on the market a preparation referred to in Regulation 3(2) to provide it with information relating to the preparation.

• (3) The information to be provided in accordance with paragraph (2) shall be such as will enable the poison centre to carry out the functions assigned to it in accordance with paragraph (4) and shall include the chemical composition of the preparation, including confidential information in accordance with Regulation 19.

• (4) The poison centre may use the information obtained in accordance with paragraph (2) only to provide medical information in the case of exposure or likely exposure of persons to the preparation, especially in emergencies, and such medical information may be provided to formulate preventive and curative measures in relation to exposure of persons to the preparation.

• (5) The poison centre shall not divulge to anyone other than the Authority any information deemed to be confidential in accordance with Regulation 19.

• (6) The person responsible for placing on the market a preparation to which these Regulations apply shall, when requested to do so by the poison centre, provide the centre with information relating to the preparation in accordance with paragraph (3).

Provisional restriction on placing a preparation on market.

21.

• (2) The Authority shall immediately inform the Commission of the European Communities and other Member States of the prohibition referred to in paragraph (1) and the reasons for it.

• (3) A person shall not place on the market a preparation in respect of which a prohibition referred to in paragraph (1) exists.

• (4) Where the Authority, in accordance with paragraph (1), subjects the placing on the market of any preparation to special conditions, a person shall not place on the market the preparation concerned unless it satisfies those special conditions.

Taking and detention of preparations.

22.

• (2) An inspector may, by a notice in writing given to the owner or to the person in apparent charge or control of a preparation which has been seized under this Regulation—

• (a) require any thing specified in the notice to be done in relation to the preparation before it is released by an inspector,

• (b) either—

• (i) require the disposal of the preparation by the person to whom the notice is given, in a manner specified in the notice and at the expense of the owner, or

• (ii) indicate the intention of the inspector of disposing of the preparation at the expense of the owner, such disposal to be, in either case, such as will prevent the said preparation from being placed on the marked or used,

and, where a notice given under this paragraph requires specified things to be done in relation to a preparation, the inspector shall retain control of the preparation to which the notice relates until the notice has been complied with.

• (3) Where a notice is given under this Regulation, a person shall not, without the consent of an inspector, sell, move, dispose or of otherwise interfere with the preparation in any way pending compliance with the notice.

• (4) Any person who is aggrieved by a notice given under paragraph (2) which either requires the preparation to which it relates to be disposed of or indicates an intention to dispose of such preparation may, not later than the expiration of the period of 7 days beginning on the date of the notice, appeal to the appropriate court against the notice.

• (5)
• (a) Where an appeal is made to the appropriate court under paragraph (4) the court, if it is satisfied that—

• (i) the preparation to which the relevant notice under this Regulation relates is one to which these Regulations apply,

• (ii) if such preparation were released, it might be placed on the market, and

• (iii) there has been a failure to comply with these Regulations,

shall order that the preparation be disposed of in the manner specified in the notice, or in such other manner as may be specified by the appropriate court which, in the opinion of the court, will prevent the preparation from being used or placed on the market.

• (b) Where an order made by the appropriate court under this paragraph requires the preparation to which it relates to be disposed of by an inspector, the cost of such disposal shall be recoverable by the Authority as a simple contract debt in any court of competent jurisdiction from the person who was the owner of the product at the time of its seizure under this Regulation.

• (6) Subject to paragraph (5), a notice under this Regulation shall not come into force unless—

• (a) where an appeal is taken against the notice, the appeal is withdrawn, or

• (b) in any other case, the period within which such an appeal may be taken has expired.

• (7) In this Regulation “appropriate court” means, in relation to an appeal made under this Regulation against a notice given under paragraph (2)—

• (a) in case the estimated value of the preparation and cost of complying with the order to which the appeal relates does not exceed €6,348.69, the District Court for the district in which the goods were seized, or

• (b) in case the estimated amount aforesaid does not exceed €38,092.14, the judge of the Circuit Court for the circuit in which the goods were seized, and

• (c) in any other case, the High Court.

• (8) If, in relation to an appeal under this Regulation to—

• (a) the District Court, that court becomes of opinion during the hearing of the appeal that the estimated cost aforesaid will exceed €6,348.69, it may, if it so thinks fit, transfer the appeal to the Circuit or the High Court, whichever it considers appropriate having regard to the estimated cost aforesaid,

• (b) the Circuit Court, that court becomes of opinion during the hearing of the appeal that the estimated amounts aforesaid will exceed €38,092.14, it may, if it so thinks fit, by order transfer the appeal to the High Court.

Offences.

23.

• (2) Where an offence under these Regulations is committed by a body corporate and is proved to have been so committed with the consent or connivance of or to be attributable to any neglect on the part of any person, being a director, manager, secretary or other officer of the body corporate, or a person who was purporting to act in any such capacity, that person, as well as the body corporate, is guilty of an offence and shall be liable to be proceeded against and punished as if he or she were guilty of the first-mentioned offence.

• (3) proceedings for an offence under these Regulations may be brought and prosecuted by the Authority.

• (4) A person guilty of an offence under Regulation 11 or 21(3) or (4) is liable on summary conviction to a fine not exceeding €3,000 or imprisonment for a term not exceeding 3 months or both.

• (5) A person guilty of an offence under these Regulations (other than Regulations 11 or 21(3) or (4) is liable on summary conviction to a fine not exceeding €3,000.

Revocations.

24.

SCHEDULE 1 CONCENTRATIONS OF DANGEROUS SUBSTANCES TO BE TAKEN INTO ACCOUNT FOR CLASSIFICATION OF A PREPARATION

Concentrations of dangerous substances to be taken into account for classification of a preparation in accordance with Regulation 6.

Category of danger of the substance	Concentration to take into consideration for	Concentration to take into consideration for
Category of danger of the substance	Gaseous preparations % vol/vol	Other preparations %w/w
Very toxic	≥0.02	≥0.1
Toxic	≥0.02	≥0.1
Carcinogenic Category 1 or 2	≥0.02	≥0.1
Mutagenic Category 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
Dangerous for the environment N		≥0.1
Dangerous for the environment ozone	≥0.1	≥0.1
Dangerous for the environment		≥1

SCHEDULE 2 METHODS FOR THE EVALUATION OF PHYSICO-CHEMICALS PROPERTIES OF PREPARATIONS

For the purposes of this Schedule any reference to a section refers to a section of Annex V

PART A

Exemptions to test methods of Annex V — Part A as per point 2.2.5 of Annex V

Flammable

Substances and preparations shall be classified as flammable in accordance with the results of the tests given in Annex V. The risk phrase shall be assigned in accordance with the criteria mentioned below.

— R10 Flammable

— Liquid substances and preparations having a flash point equal to or greater than 21°C, and less than or equal to 55 °C.

However, in practice it has been shown that a preparation having a flash point equal to or greater than 21°C and less than or equal to 55°C need not be classified as flammable if the preparation could not in any way support combustion and only so long as there is no reason to fear risks to those handling these preparations or to other persons.

PART B

Alternative calculation methods

B.1. Non-gaseous preparations

Method for the determination of oxidising properties of preparations containing organic peroxides as per point 2.2.2.1 of Annex VI.

Remarks concerning peroxides

For the explosive properties, an organic peroxide or preparation thereof in the form in which it is placed on the market is classified according the criteria in section 2.2.1 on the basis of tests carried out in accordance with the methods given in Annex V.

For the oxidising properties the existing methods in Annex V cannot be applied to organic peroxides.

For substances, organic peroxides not already classified as explosive are classified as dangerous on the basis of their structure (e.g. R-O-O-H; R1-O-O-R2).

Preparations not already classified as explosive shall be classified using the calculation method based on the percentage of active oxygen shown in Section 9.5.

Any organic peroxide or preparation thereof not already classified as explosive is classified as oxidising, if the peroxide or its formulation contains:

— more than 5% of organic peroxides or,

— more than 0.5% available oxygen from the organic peroxides, and more than 5% hydrogen peroxide.

B.2. Gaseous preparations

• (1) Method for the determination of oxidising properties as per point 9.1.1.2 of Annex VI.

Oxidizing properties

Given the fact that Annex V does not contain a method to determine the oxidizing properties of gaseous mixtures, the evaluation of these properties must be realised according to the following estimation method.

The principle of the method is comparison of the oxidizing potential of gases in a mixture with that of the oxidizing potential of oxygen in air. The concentrations of gases in the mixture are expressed in % vol.

It is considered that the gas mixture is as oxidant as or more oxidant than air, if the following condition is verified:

where: Xi is the concentration of gas i in % vol,

Ci is the coefficient of oxygen equivalency.

In this case, the preparation is classified as oxidizing and the phrase R8 will be assigned.

Coefficients of equivalency between oxidizing gases and oxygen

The coefficients used in the calculation to determine the oxidizing capacity of certain gases in a mixture with respect to the oxidizing capacity of oxygen in air, listed under 5.2. in the ISO Standard ISO 10156 edition 15.12.1990, are the following.

When no value for the Ci coefficient exists for a gas in the cited standard a value of 40 is attributed to this coefficient.

• (2) Method for the determination of flammability properties as per point 9.1.1.1 of Annex VI.

Flammability

The flammable properties of these preparations are determined in accordance with Article 3(2) of Council Directive 88/379/EEC of 7 June 1988³⁰ according to the methods specified in Part A of Annex V.

These preparations will be classified according to the results of the tests carried out and with respect to the criteria of Annex V and to the criteria of the labelling guide.

However, by derogation, in the case where gaseous preparations are produced to order in small amounts, the flammability of these gaseous mixtures can be evaluated by the following calculation method:

the expression of the gaseous mixture

A1F1 + … + AiFi + … AnFn + B1I1 + … + BiIi + … BpIp

where: Ai and Bi are the molar fractions

Fi flammable gas

Ii inert gas

n number of flammable gases

p number of inert gases