European Communities (Classification, Packaging, Labelling and Notification of Dangerous Substances) Regulations, 2003

• Jurisdiction: Ireland
• Citation: IR SI 116/2003

ARRANGEMENT OF REGULATIONS

REGULATION. 1. Citation 2. Interpretation 3. Construction and Application 4. Exemptions 5. Competent Authority 6. Placing on the Market 7. Testing and assessment 8. Classification 9. Obligation to carry out investigations 10. Full Notification 11. Reduced Notification for substances placed on the market in quantities of less than one tonne per annum 12. Substances Notified at least 10 years previously 13. Notification of Polymers 14. Pre-marketing Notification Period 15. Exemptions from the notification requirements 16. Follow up Information 17. Re-notification of the same substance and avoidance of duplicate testing in vertebrate animals 18. Confidentiality of data 19. Packaging 20. Labelling 21. Implementation of labelling 22. Exemptions from labelling and packaging requirements 23. Advertising 24. Safety Data Sheet 25. Supply of Substances 26. Restriction on Sale 27. Fees Payable by Notifier 28. Taking and Detention of Substances 29. Offences 30. Revocations

Schedule 1

Foreword to Annex I

Schedule 2

Annex II: Symbols and Indications of Danger for dangerous substances and preparations

Schedule 3

Annex III: Nature of special risks attributed to dangerous substances and preparations

Schedule 4

Annex IV: Safety Advice concerning dangerous substances and preparations

Schedule 5

Annex VI: General Classification and Labelling Requirements for dangerous substances and preparations

Schedule 6

Annex VIIA, Annex VIIB, Annex VIIC, Annex VIID and Annex VIII: Information required for the Technical dossier

Schedule 7

Annex IX: Provisions relating to child-proof fastenings and tactile warning devices

Schedule 8

Obligatory Headings for Safety Data Sheets

Schedule 9

Fees Payable by Notifier

S.I. No. 116 of 2003

EUROPEAN COMMUNITIES (CLASSIFICATION, PACKAGING, LABELLING AND NOTIFICATION OF DANGEROUS SUBSTANCES) REGULATIONS 2003

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 Council Directives 92/32/EEC of 30 April 19921 , Directive 96/56/EC of the European Parliament and the Council of 3 September 19962 , Commission Directives 91/155/EEC of 5 March 19913 , 92/69/EEC of 31 July 19924 , 93/21/EEC of 27 April 19935 , 93/67/EEC of 20 July 19936 , 93/72/EEC of 1 September 19937 , 93/101/EC of 11 November 19938 , 93/105/EC of 25 November 19939 , 93/112/EC of 10 December 199310 , 94/69/EC of 19 December 199411 96/54/EC of 30 July 199612 , 97/69/EC of 5 December 199713 , 98/73/EC of 18 September 199814 , 98/98/EC of 15 December 199815 , 2000/32/EC of 19 May 200016 , 2000/21/EC of 25 April 200017 , 2000/33/EC of 25 April 2000 18 , 2001/58/EC of 27 July 200119 and 2001/59/EC of 6 August 200120 hereby make the following regulations: 1. Citation.

These Regulations may be cited as the European Communities (Classification, Packaging, Labelling and Notification of Dangerous Substances) Regulations 2003. 2. Interpretation.

(1) In these Regulations, unless the context otherwise requires-

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

“Annex I” means Annex I to Council Directive 67/548/EEC21 as lastly amended by Commission Directive 2001/59/EC of 6 August 2001, and any reference in the said Annex to “EEC Number” shall be construed as a reference to “EC Number” and which for convenience of reference the Foreword to Annex I is set out in Schedule 1;

“Annex II” means Annex II to Council Directive 67/548/EEC as amended by Commission Directive 93/21/EEC of 27 April 1993 and which for convenience of reference is set out in Schedule 2;

“Annex III” means Annex III to Council Directive 67/548/EEC as lastly amended by Commission Directive 2001/59/EC of 6 August 2001 and which for convenience of reference is set out in Schedule 3;

“Annex IV” means Annex IV to Council Directive 67/548/EEC as lastly amended by Commission Directive 2000/32/EC of 19 May 2000 and which for convenience of reference is set out in Schedule 4;

“Annex V” means Annex V to Council Directive 67/548/EEC as lastly amended by Commission Directive 2001/59/EC of 6 August 2001;

“Annex VI” means Annex VI to Council Directive 67/548/EEC as lastly amended by Commission Directive 2001/59/EC of 6 August 2001 and which for convenience of reference is set out in Schedule 5;

“Annex VII.A ” means Annex VII.A to Council Directive 67/548/EEC as lastly amended by Commission Directive 2001/59/EC of 6 August 2001 and which for convenience of reference is set out in Schedule 6;

“Annex VII.B” means Annex VII.B to Council Directive 67/548/EEC as lastly amended by Commission Directive 93/105/EC of 25 November, 1993 and which for convenience of reference is set out in Schedule 6;

“Annex VII.C” means Annex VII.C to Council Directive 67/548/EEC as lastly amended by Commission Directive 93/105/EC of 25 November 1993 and which for convenience of reference is set out in Schedule 6;

“Annex VII.D” means Annex VII.D to Council Directive 67/548/EEC as lastly amended by Commission Directive 93/105/EC of 25 November 1993 and which for convenience of reference is set out in Schedule 6;

“Annex VIII” means Annex VIII to Council Directive 67/548/EEC as lastly amended by Commission Directive 2001/59/EC of 6 August 2001 and which for convenience of reference is set out in Schedule 6;

“Annex IX” means Annex IX of Council Directive 67/548/EEC as lastly amended by Commission Directive 2000/32/EC of 19 May 2000 and which for convenience of reference is set out in Schedule 7.

“Authority” has the meaning assigned to it by Regulation 5;

“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;

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

“Directives” means Council Directive 92/32/EEC of 30 April 199222 , Directive 96/56/EC of the European Parliament and the Council of 3 September 199623 , Commission Directives 91/155/EEC of 5 March 199124 , 92/69/EEC of 31 July 199225 , 93/21/EEC of 27 April 199326 , 93/67/EEC of 20 July 199327 93/72/EEC of 1 September 199328 , 93/101/EC of 11 November 199329 , 93/105/EC of 25 November 199330 , 93/112/EC of 10 December 199331 , 94/69/EC of 19 December 199432 , 96/54/EC of 30 July 199633 , 97/69/EC of 5 December 199734 , 98/73/EC of 18 September 199835 , 98/98/EC of 15 December 199836 , 2000/32/EC of 19 May 200037 , 2000/21/EC of 25 April 200038 , 2000/33/EC of 25 April 200039 2001/58/EC of 27 July 200140 and 2001/59/EC of 6 August 200141 ;

“dossier” means a “notification dossier”;

“EINECS” means the European Inventory of Existing Commercial Substances42 containing the definitive list of all substances deemed to be on the market in the European Communities on 18 September 1981;

“ELINCS” means the European List of Notified Chemical Substances43 , 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;

“indication of danger” means the indication of danger specified in Schedule 2 and required to be contained on the label or marked on the package of a dangerous substance in accordance with Regulation 20;

“inspector” has the same meaning as in the Act of 1989;

“international rules on the transport of dangerous substances” means any of the following (including amendments made to any of them):

(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, and

(c) the International Maritime Dangerous Goods Code published by the International Maritime Organisation;

“label” means the label referred to in Regulations 20 and 21 and labelling shall be construed accordingly;

“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;

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