S.I. No. 317/1998 - European Communities (Classification, Packaging, Labelling and Notification of Dangerous Substances) (Amendment) Regulations, 1998

S.I. No. 317 of 1998.

EUROPEAN COMMUNITIES (CLASSIFICATION, PACKAGING, LABELLING AND NOTIFICATION OF DANGEROUS SUBSTANCES) (AMENDMENT) REGULATIONS, 1998

I, Mary Harney, Tanaiste and 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 Council Directive 96/56/EC of 3 September, 1996¹, and Commission Directives 94/69/EC of 19 December, 1994² and 96/54/EC of 30 July, 1996³, and to Article 2(2) of Commission Directive 93/21/EEC of 27 April, 1993⁴ hereby make the following Regulations:

¹OJ L236 18.9.1996 P.35

²OJ L381 31.12.1994 P.1

³OJ L248 30.9.1996 P.1

⁴OJ L110 4.5.1993 p.20 and OJ L110A 4.5.1993 P.1

1 Citation and construction

(1) These Regulations may be cited as the European Communities (Classification, Packaging, Labelling and Notification of Dangerous Substances)(Amendment) Regulations, 1998.

(2) These Regulations and the European Communities (Classification, Packaging, Labelling and Notification of Dangerous Substances) Regulations, 1994 ( S.I. No. 77 of 1994 ) shall be construed as one and may be cited together as the European Communities (Classification, Packaging, Labelling and Notification of Dangerous Substances) Regulations, 1994 and 1998.

(3) In these Regulations, "the Principal Regulations" means the European Communities (Classification, Packaging, Labelling and Notification of Dangerous Substances) Regulations, 1994 ( S.I. No. 77 of 1994 ).

2 Interpretation

The Principal Regulations are hereby amended by substituting for Regulation 2 (1) thereof Regulation 2(1) and (1A) as set out in the First Schedule to these Regulations.

3 Exemptions

The Principal Regulations are hereby amended by revoking subparagraph (b) of Regulation 4 (5).

4 Classification

The Principal Regulations are hereby amended by revoking paragraph (3) of Regulation 8

5 Labelling

The Principal Regulations are hereby amended by substituting for Regulation 19 thereof the Regulation set out in the Second Schedule to these Regulations.

6 Offences

The Principal Regulations are hereby amended by inserting the following Regulation:

"27A. A person shall be guilty of an offence if the person -

(a) contravenes Regulation 6,9,10,11,15, 16 (2), 21, 22, 23 or 26 (3),

(b) places on the market a substance to which these Regulations apply and which has not been tested and classified in accordance with these Regulations,

(c) places on the market a substance referred to in Regulation 14 (1) or (2) before the expiry of the relevant period specified in that Regulation,

(d) fails to comply with a requirement imposed on that person under Regulation 16 (6), or

(e) contravenes a prohibition, or fails to comply with a condition, imposed on that person under Regulation 24".

7 Risk Phrases

The Principal Regulations are hereby amended in Table A of Schedule 2 by-

(a) adding in the first column the reference number "R65", and

(b) adding in the second column, opposite that reference number, the risk phrase "Harmful: may cause lung damage if swallowed".

8 Fees Payable by Notifier

The Principal Regulations are hereby amended by substituting for Schedule 5 thereof the Schedule set out in the Third Schedule to these Regulations.

FIRST SCHEDULE

Amendment to Regulation 2 of the Principal Regulations

"(1) In these Regulations -

'child-resistant fastening' means the cap, lid, fastening or other means of fastening a package, which complies with the provisions of Part A of Annex IX;

'the competent authority' has the meaning assigned to it by Regulation 5;

'dossier' means a notification dossier;

'EINECS' means the European Inventory of Existing Commercial Substances ⁵ containing the definitive list of all substances deemed to be on the market in the European Communities on 18 September, 1981;

⁵OJ C146A 15.6.1990 P.1

'Elincs' means the European List of Notified Chemical Substances ⁶, 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;

⁶OJ C361 7.12.1994 P.1

'indication of danger' means the indication of danger specified in Column 3 of Schedule 4 and required to be contained on the label or marked on the package of a dangerous substance in accordance with Regulation 19;

'inspector' has the same meaning as in the Safety, Health and Welfare at Work Act, 1989 ;

'international rules on the transport of dangerous substances' means any of the following as amended:

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

(b) the International Regulations Concerning the Carriage of Dangerous Goods by Rail appended to the International Convention Concerning the Carriage of Dangerous Goods by Rail, 1980;

'label' means the label required by Regulations 19 and 20;

'Minister' means the Minister for Enterprise, Trade and Employment;

'monomer unit' means the reacted form of a monomer in a polymer;

'notification' means the documents, with the requisite information, presented to the competent authority of a Member State;

'notifier' means the person submitting a notification;

'package' means the packaging, receptacle or container containing a substance, and "packaging" shall be construed accordingly;

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

'placing on the market' means the making available to third parties, and importation into the European Communities customs territory shall be deemed to be placing on the market for the purposes of these Regulations;

'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 consisting of less than a simple weight majority of molecules of the same molecular weight, such molecules being distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units;

'preparations' means mixtures or solutions composed of two or more substances;

'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;

'risk phrase' means any phrase which is listed in Annex III and which, for convenience of reference, is set out in Schedule 2;

'safety phrase' means any phrase which is listed in Annex IV and which, for convenience of reference, is set out in Schedule 3;

'scientific research and development' means scientific experimentation, analysis or chemical research carried out under controlled conditions and includes the determination of intrinsic properties, performance and efficacy as well as scientific investigation related to product development;

'sole representative' means the person established in the European Communities who is so designated by the manufacturer of a substance manufactured outside the European Communities for the purposes of submitting a notification for that substance placed on the market, either on its own or in a preparation;

'substance' means a chemical element and its 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 which is specified in Annex II and which, for convenience of reference, is set out in column 2 of Schedule 4;

'tactile warning of danger' means a method of warning a person who has poor sight or no sight of the dangerous contents of a package referred to in Regulation 18, and which complies with the provisions of Part B of Annex IX.

(1A) In these Regulations, unless the context otherwise requires, a reference to the following Annexes shall be construed as follows:

(a) a reference to 'Annex I' as a reference to Annex I to Council Directive 67/548/EEC⁷, as amended by Commission Directives 93/72/EEC of 1 September, 1993⁸, 93/101/EC of 11 November 1993⁹, 94/69/EC of 19 December, 1994 and Commission Directive 96/54/EC of 30 July, 1996;

⁷OJ L196 16.8.1967 P.1

⁸OJ L258 16.10.1993 P.29 and OJ L258A 16.10.1993 P.1

⁹OJ L13 15.1.1994 P.1 and OJ L13A 15.1.1994 P.1

(b) a reference to 'Annex II' as a reference to Annex II to Council Directive 67/548/EEC as amended by Commission Directive 93/21/EEC of 27 April, 1993;

(c) a reference to 'Annex III' as a reference to Annex III to Council Directive 67/548/EEC as amended by Commission Directive 93/21/EEC of 27 April, 1993, and Commission Directive 96/54/EC of 30 July, 1996;

(d) a reference to 'Annex IV' as a reference to Annex IV to Council Directive 67/548/EEC, as amended by Commission Directive 93/21/EEC of 27 April, 1993;

(e) a reference to 'Annex V as a reference to Annex V to Council Directive 67/548/EEC as amended by Commission Directives 88/302/EEC of 18 November, 1987¹¹, 92/69/EEC of 31 July, 1992¹⁰, 93/21/EEC of 27 April, 1993, and Commission Directive 96/54/EC of 30 July, 1996;

¹⁰OJ L133 30.5.1988 P.1

¹¹OJ L383 29.12.1992 P.113 and OJ L383A 29.12.1992 P.1

(f) a reference to 'Annex VI' as a reference to Annex VI to Council Directive 67/548/EEC as amended by Commission Directive 93/21/EEC of 27 April, 1993, and Commission Directive 96/54/EC of 30 July, 1996;

(g) a reference to 'Annex VII.A, VII.B, VII.C and VII.D' as a reference to Annex VII.A, VII.B, VII.C or VII.D to Council Directive 67/548/EEC, as amended by Council Directive 92/32/EEC of 30 April, 1992¹² and Commission Directive 93/105/EC of 25 November, 1993¹³;

¹²OJ L154 5.6.1992 P.1 and OJ L154 5.6.1992 P.1

¹³OJ L294 30.11.1993 P.21

(h) a reference to 'Annex VIII' as a reference to Annex VIII to Council Directive 67/548/EEC as amended by Council Directive 92/32/EEC of 30 April, 1992;

(i) a reference to 'Annex IX' as a reference to Annex IX to Council Directive 67/548/EEC as amended by Commission Directive 91/410/EEC of 22 July, 1991¹⁴."

¹⁴OJ L228 17.8.1991 P.67

SECOND SCHEDULE

Amendment to Regulation 19 of the Principal Regulations

"Labelling

19.(1) A dangerous substance to which these Regulations apply shall not be placed on the market unless the labelling on its packaging shows clearly and indelibly the following :

(a) the name of the substance under one of the designations given in Annex I or, if the substance is not yet listed in Annex I, a name using an internationally recognised designation for that substance;

(b) the name and full address, including the telephone number, of the person established in the European Communities who is responsible for placing the substance on the market;

(d) standard phrases (risk phrases) indicating the special risks arising from the dangers involved in using the substance;

(e) standard phrases (safety phrases) relating to the safe use of the substance;

(f) the EC number, if allocated;

(g) for substances listed in Annex 1, the words "EC label" but until the 31st day of December, 2000, the words "EEC label" shall be deemed to satisfy this requirement.

(2) Subject to paragraphs (3) and (5)—

(a) the design of a danger symbol and the wording of the indications of danger shall comply with the requirements of Annex II,

(b) the danger symbol shall be printed in black on an orange-yellow background, and

(i) for substances listed in Annex I, be those indicated in that Annex, and

(ii) for substances not listed in Annex I, be assigned according to the rules in Annex VI.

(3) If more than one danger symbol is assigned to a substance, the following rules apply:

(a) the requirement to indicate the symbol T makes the symbols X and C optional, unless Annex I provides otherwise;

(b) the requirement to indicate the symbol C makes the symbol X optional;

(4) Subject to paragraph (8)—

(a) the wording of risk phrases shall comply with Annex III, and

(b) the risk phrases to be used for each dangerous substance shall—

(i) for substances listed in Annex I, be those indicated in that Annex, and

(ii) for substances not listed in Annex I, be assigned according to the rules in Annex VI.

(5) The requirement to label with the symbol "Xn", the indication of danger "Harmful" and the risk phrase R65 "Harmful: may cause lung damage if swallowed" shall not apply to substances which are placed on the market in aerosol containers or in containers fitted with a sealed spray attachment.

(6) Subject to paragraph (8)—

(a) the wording of safety phrases shall comply with Annex IV, and

(b) the safety phrases to be used for each dangerous substance shall—

(i) for dangerous substances listed in Annex I, be as indicated in that Annex, and

(ii) for dangerous substances not listed in Annex I, be assigned according to the rules in Annex VI.

(7) The EC number shall be obtained from the EINECS or from the Elincs.

(8) An indication of risk phrases and safety phrases need not be given if the package contains 125 millilitres or less of—

(a) an irritant, highly flammable, flammable or oxidising substance, or

(b) a harmful substance that is not retailed to the general public.

(9) Indications such as "non-toxic", "non-harmful" or any other similar indications shall not appear on the label or packaging of substances to which these Regulations apply.

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

(11) Subject to Regulation 4 (6) (b), gas cylinders placed on the market and intended for propane, butane or liquefied petroleum gas shall be labelled in accordance with the requirements of these Regulations.

(12) Information regarding effects on human health is not required on the label of gas containers intended for propane, butane or liquefied petroleum gas if—

(a) the propane, butane or liquefied petroleum gas is placed on the market in closed refillable cylinders or in non-refillable cartridges within the scope of ISEN 417 1993 as fuel gases which are only released for combustion,

(b) the information regarding effects on human health is transmitted, in the format required by Regulation 22, to professional or industrial users, distributors, wholesalers, retailers and consumers by the person placing the propane, butane or liquefied petroleum gas on the market, and

(c) sufficient information regarding effects on human health is transmitted to consumers to enable them to take all necessary measures for health and safety as indicated in Article 1 paragraph 3 of Commission Directive 91/155/EEC of 5 March, 1991¹⁵, as modified by Commission Directive 93/112/EEC of 10 December, 1993¹⁶.

¹⁵OJ L76 22.3.1991 P.35

¹⁶OJ L314 16.12.1993 P.38

(13) For the purpose of paragraph 12 (a), "ISEN 417 1993" means Irish Standard ISEN 417 1993 of the National Standards Authority of Ireland."

THIRD SCHEDULE

Amendment to Schedule 5 of the Principal Regulations

	"SCHEDULE 5
Regulation 25	Fees payable by notifier

	Column 1	Column 2
	Subject matter	Fee payable
1.	For a notification under Regulation 10 (1) ("base set") (See notes 1 and 2)	£5,000
2.	For a re-notification submitted in accordance with Regulation 16 (1)(See notes 1 and 2)	£1,000
3.	For a notification of a substance notified at least 10 years previously (Regulation 12)(See notes 1 and 2)	£1,000
4.	For additional tests submitted under Regulation 10(3)(a) (>10 tonnes per year)	£3,000
5.	For additional tests submitted under Regulation 10(3)(b) (>100 tonnes per year)	£5,000
6.	For additional tests submitted under Regulation 10(3)(c) (>1000 tonnes per year)	£10,000
7.	For a notification under Regulation 11 (see note 3)
	(a) quantity of the new substance equal to or more than 100kg (Regulation 11(1))	£1,000
	(b) quantity of the new substance up to 100kg (Regulation 11(3))	£500
8.	For a successful application made by a notifier for an exemption relating to him under Regulation 4(14)	£500
Note 1. Additional charge where notification particulars are not provided on an approved diskette		£200
Note 2. Additional charge where an adequate risk assessment is not included.		£2,000
Note 3. Additional charge where an adequate risk assessment is not included."		£500

GIVEN under my Official Seal, this 31st day of August 1998

Mary Harney, T.D.,

Tanaiste and Minister for Enterprise, Trade and Employment.

EXPLANATORY NOTE

These Regulations implement Council Directive 96/56/EC of 3 September 1996, amending for the 8th time Council Directive 67/548/EEC on the classification, packaging and labelling of dangerous substances, together with two other associated Commission Directives. They amend the European Communities (Classification, Packaging, Labelling and Notification of Dangerous Substances) Regulations of 1994, S.I. No. 77 of 1994 .

The European Communities (Classification, Packaging, Labelling and Notification of Dangerous Substances) Regulations of 1994 apply to all substances which are intended to be placed on the market either on their own or in a preparation with exceptions for certain categories of substances such as medicinal, cosmetic, pesticide, waste, etc., products which are covered by other Directives.

The aim of the Regulations is to protect man and the environment from the harmful effects of both new substances and existing dangerous substances. They require each manufacturer, importer or other person proposing to place on the market a new chemical for the first time to submit to the competent authority a notification containing details of tests to which the substance has been subjected and the proposed classification and labelling of the substance. The term "place on the market" includes importation into the territories of the European Union.

The Regulations also require suppliers to put warning labels on containers for dangerous substances placed on the market and ensure that the containers are properly designed, constructed and secured to prevent spillage or seepage during normal use, and also supply safety data sheets.

The Amending Regulations introduce the requirement for the label which is placed on a package containing a dangerous substance listed in Annex 1 of the Directive to include the words "EC label". Under the European Communities (Classification, Packaging, Labelling and Notification of Dangerous Substances) Regulations of 1994, the words required were "EEC label", and this term may continue to be used until 31 December, 2000.

The Amending Regulations also implement two Commission Directives which adapt to technical progress the Annexes to, or which expand some of the provisions of, Council Directive 67/548/EEC. These Directives are:

1. Commission Directive 94/69/EC of 19 December 1994, which adapts to technical progress Annex I of the Directive

2. Commission Directive 96/54/EC of 30 July 1996 which adapts to technical progress Annexes I, III, V & VI of the Directive.

These Directives introduce a number of new dangerous substances into Annex I, the list of dangerous substances classified in the European Community, and change the classification and labelling of other substances already included in Annex I. Commission Directive 96/54/EC additionally introduces a new labelling risk phrase, R 65, to warn about the danger of substances which can cause lung damage if accidentally introduced into the lungs after swallowing ("aspiration hazard" substances). Criteria are introduced into Annex VI of the Directive for the identification of aspiration hazard substances, and new criteria are introduced for the identification of sensitising chemicals. The Directive also introduces methods for the testing of chemicals for hazardous properties.

The labelling requirements of the European Communities (Classification, Packaging, Labelling and Notification of Dangerous Substances) Regulations of 1994 are extended to cover propane, butane and liquefied petroleum gas in cylinders. These substances were exempt from the legislation until 30 April, 1997.