European Communities (Classification, Packaging and Labelling of Dangerous Preparations) Regulations 2004

• Statutory Instrument No.: 62/2004
• Date: 19 February 2004

ARRANGEMENT OF 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 2 METHODS FOR THE EVALUATION OF PHYSICO-CHEMICALS PROPERTIES 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 5 SPECIAL PROVISIONS FOR CONTAINERS CONTAINING PREPARATIONS OFFERED OR SOLD TO THE PUBLIC SCHEDULE 6 NAMING OF SUBSTANCES IN A PREPARATION SCHEDULE 7 SPECIAL PROVISIONS CONCERNING THE LABELLING OF CERTAIN PREPARATIONS SCHEDULE 8 SYMBOLS AND INDICATIONS OF DANGER SCHEDULE 9 RISKS PHRASES SCHEDULE 10 SAFETY PHRASES SCHEDULE 11 SPECIAL LABELLING PROVISIONS FOR SINGLE PACKAGES SCHEDULE 12 OBLIGATORY HEADINGS FOR SAFETY DATA SHEETS 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. These Regulations may be cited as the European Communities (Classification, Packaging and Labelling of Dangerous Preparations) Regulations 2004.
	Interpretation.	2. (1) In these Regulations, unless the context otherwise requires—
“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 19913 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. (1) These Regulations apply to—
(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. (1) These Regulations do not apply to the following preparations in the finished state, intended for the final user—
(a) medicinal products for human or veterinary use, as defined in 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...