S.I. No. 116/2003 - European Communities (Classification, Packaging, Labelling and Notification of Dangerous Substances) Regulations 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.

1. Citation.

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

2.

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;

“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;

“safety phrase” means any phrase which is listed in Annex IV;

“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 specified in Annex II;

“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 19, and which complies with the provisions of Part B of Annex IX;

• (2) For the purposes of these Regulations the following are dangerous -

• (a) explosive substances and preparations, namely, solid, liquid, pasty or gelatinous substances and preparations which may 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 highly 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 preparations, 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 preparations 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 the 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.

• (3)
• (a) In these Regulations a reference to a Regulation or a Schedule is to a Regulation of, or to a Schedule to, these Regulations, unless it is indicated that reference to some other enactment is intended.

• (b) In these Regulations a 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.

• (c) Any requirement in these Regulations in relation to a substance shall apply to a substance to which these Regulations apply, unless otherwise indicated.

• (d) A word or expression that is used in these Regulations and is also used in the Directives has, unless the contrary intention appears, the same meaning in these Regulations as it has in the Directives.

3.

3. Construction and application.

• (1) The Act of 1989 shall 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 to the Second Schedule of that Act.

• (2) These Regulations apply to all substances, which are intended to be placed on the market either on their own or in a preparation, unless exempted under Regulation 4, 15 or 22.

• (3) The testing and notification requirements of these Regulations apply to substances not listed in the EINECS, which are intended to be placed on the market either on their own or in a preparation.

• (4) The classification requirements of these Regulations apply to all dangerous substances which are intended to be placed on the market.

• (5) The packaging, labelling and safety data sheet requirements of these Regulations apply to substances, classified as dangerous under these Regulations, which are placed on the market.

4.

4. Exemptions

• (1) These Regulations shall 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 Directive 65/65/EEC⁴⁴ as lastly amended by Commission Directive 93/39/EEC⁴⁵

• (b) cosmetic products, as defined by Directive 76/768/EEC⁴⁶ as lastly amended by Commission Directive 98/62/EC⁴⁷

• (c) mixtures of substances which, in the form of waste, are the subject of Directives 75/442/EEC⁴⁸ as lastly amended by Commission Decision 96/350/EEC⁴⁹ and 91/689/EEC⁵⁰ as lastly amended by Council Directive 94/31/EEC⁵¹ ,

• (d) foodstuffs,

• (e) animal feeding stuffs,

• (f) pesticides,

• (g) radioactive substances, as defined by Directive 80/836/EEC⁵² , and

• (h) other substances or preparations for which European Communities notification or approval procedures exist and for which requirements relating to notification or approval are equivalent to those required by these Regulations.

• (2) These Regulations shall not apply to -

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

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

5.

5. Competent authority.

The competent authority shall be the National Authority for Occupational Safety and Health established by Part III of the Act of 1989.

6.

6. Placing on the market.

• (1) A person shall not place on the market a substance to which these Regulations apply either on its own or in a preparation unless it has been notified, packaged and labelled, and safety data sheets have been provided in accordance with these Regulations.

• (2) The notification referred to in paragraph (1) shall, for substances manufactured in the State, be submitted to the competent authority by the manufacturer concerned.

• (3) The notification referred to in paragraph (1) shall, for substances manufactured outside the European Communities, be submitted to the competent authority, by any person established in the State who is responsible for placing the substance either on its own or in a preparation on the market, or by the person established within the State who is, for the purposes of submitting a notification for a given substance placed on the market, either on its own or in a preparation, designated by the manufacturer as his sole representative.

• (3) Paragraph (1) shall not apply to a substance placed on the market in quantities of less than one tonne per annum for any manufacturer which was notified under the European Communities (Dangerous Substances) (Classification, Packaging, Labelling and Notification) Regulations, 1982 ( S.I. No. 258 of 1982 ); provided that -

• (a) the substance has been notified in the State prior to the commencement of these Regulations, and

• (b) the substance concerned has been manufactured by the same manufacturer of the substance to which the notification referred to in subparagraph (a) relates.

7.

7. Testing and assessment.

• (1) For the purposes of these Regulations -

• (a) tests on substances shall as a general principle be conducted according to the methods laid down in Annex V,

• (b) the physico-chemical properties of substances shall be determined according to the methods specified in Annex V (A),

• (c) the toxicity of substances shall be determined according to the methods specified in Annex V (B),

• (d) the ecotoxicity of substances shall be determined according to the methods specified in Annex V (C),

• (e) laboratory tests on substances shall be carried out in compliance with the principles of good laboratory practice provided for in Directive 86/609/EEC⁵³ and Directive 87/18/EEC⁵⁴ , and

• (f) for substances on the EINECS, the adequacy of the data for the purposes of classification and labelling and the need to conduct new tests shall be decided on a case-by-case basis taking into account the need to minimise testing on vertebrate animals.

• (2)
• (a) Where more than one notification exists for a substance manufactured by the same manufacturer outside the European Communities, the obligation to carry out supplementary testing required under these Regulations will fall collectively on all notifiers placing that substance on the market;

• (b) For substances referred to in subparagraph (a), if the quantities detailed in Regulation 10(3) are attained, the competent authority shall each notifier and inform him of the identity of the other notifiers and shall draw his attention to the provisions of subparagraph (a).

• (3) Where it is necessary in the opinion of the competent authority for the purposes of carrying out the evaluation of the risks which may be caused by a substance in accordance with Directive 93/67/EEC, the competent authority may ask for further information, verification or confirmatory tests concerning the substances or their transformation products of which they have been notified or have received information under these Regulations and may also request information referred to in Annex VIII earlier than provided for in Regulation 10(3).

8.

8. Classification.

• (1) For the purposes of these Regulations a dangerous substance shall be classified as one or more of the following -

• (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) Dangerous substances shall be classified and labelled in accordance with the criteria in Annex VI.

• (3) In classifying a substance account shall be taken of the concentration of any impurity in as far as the latter exceeds the concentration limits specified in Annex I and Article 3(3) of Directive 1999/45/EC⁵⁵ .

9.

9. Obligation to carry out investigation

Manufacturers, distributors and importers of dangerous substances, which appear in the EINECS but which hsve not yet been introduced into Annex 1 shall carry out an investigation to make themselves aware of the relevant and accessible data existing concerning the properties of such substances, and on the basis of this information shall package and provisionally label these substances in accordance with Regulations 19 to 21 and the criteria specified in Annex VI.

10.

10. Full Notification

• (1) A notifier intending to place on the European Communities market a substance in quantities of greater than or equal to one tonne per annum per manufacturer shall submit to the competent authority, a notification including -

• (a) a technical dossier supplying the information necessary for evaluating the foreseeable risks, whether immediate or delayed, which the substance may entail for man and the environment, and containing all available relevant data for this purpose,

• (b) a declaration concerning the unfavourable effects of the substance in relation to the various foreseeable uses,

• (c) the proposed classification and labelling of the substance in accordance with these Regulations,

• (d) in the case of dangerous substances, a proposal for a safety data sheet in accordance with Regulation 24,

• (e) in the case of a manufacturer located outside the European Communities, a statement if appropriate from the manufacturer to the effect that, for the purpose of submitting a notification for the substance in question, he is designated as the manufacturer's sole representative,

• (f) if so desired by the notifier, a statement requesting on reasoned grounds that as a first notifier of a substance the notification be exempted from the provisions of Regulation 17(2) for a maximum period which shall not in any case exceed one year following the date of notification,

• (g) if so desired by the notifier, a preliminary assessment of the real or potential risk to man and the environment on the basis of the principles adopted in Directive 93/67/EEC.

• (2) A dossier required by paragraph (1) (a) shall contain the information and results of the studies referred to in Annex VII.A, together with a detailed and full description of the studies conducted and of the methods used or a bibliographical reference to them.

• (3) Notwithstanding anything in Regulation 16, a notifier of a substance already notified shall inform the competent authority -

• (a) when the quantity of the substance placed on the market reaches 10 tonnes per year per manufacturer or when the total quantity placed on the market reaches 50 tonnes per manufacturer, and in such case the competent authority may require some or all of the additional tests and studies laid down in Annex VIII, level 1, to be carried out within such period as it determines;

• (b) when the quantity of the substance placed on the market reaches 100 tonnes per year per manufacturer or when the total quantity placed on the market reaches 500 tonnes per manufacturer, and in such case the competent authority shall require the additional tests and studies laid down in Annex VIII, level 1, to be carried out within such period as it determines, unless the notifier can give good reason why a particular test or study is not appropriate or an alternative scientific test or study would be preferable;

• (c) when the quantity of a substance placed on the market reaches 1,000 tonnes per year per manufacturer or when the total quantity placed on the market reaches 5,000 tonnes per manufacturer, and in such case the competent authority shall draw up a programme of tests and studies according to Annex VIII, level 2, to be carried out by the notifier within such period as the competent authority determines.

• (4) When additional tests or studies are carried out either in accordance with the requirements of paragraph (3) or voluntarily, the notifier shall provide the competent authority with the results of such tests or studies.

• (5) Where a notifier requests the competent authority to grant permission to apply a reduced test package (RTP) for intermediates in accordance with Annex VIIA, section 7, or Annex VIII Level 1, then the notifier shall:

• (a) at any time at the request of the competent authority provide verification by an independent competent person, chosen in agreement with the competent authority and paid for by the notifier, that the conditions for application of the RTP are being applied on the site, or sites, in question, and

• (b) immediately upgrade the dossier to the appropriate level, as if the RTP criteria did not apply, if in the opinion of the competent authority such verification is not demonstrated within such period as the competent authority determines.

• (6) Notwithstanding paragraph (5) where the competent authority finds that any of the conditions for application of the RTP are not being applied on the site, or sites, for which a dossier has been accepted it shall so inform the notifier who shall upgrade the dossier to the appropriate level as if the RTP criteria did not apply.

11.

11. Reduced Notification for substances placed on the market in quantities of less than one tonne per annum

• (1) Subject to Regulation 15(2), a notifier intending to place on the European Communities market a substance in quantities of less than one tonne per annum per manufacturer shall submit to the competent authority a notification including the information referred to in Regulation 10(1).

• (2) A dossier required by paragraph (1) shall contain the information and results of the studies referred to in Annex VII.B, together with a full and detailed description of the studies conducted and of the methods used or a bibliographical reference to them if the competent authority so requires.

• (3) When the quantities to be placed on the market are below 100kg per year per manufacturer the notifier may, without prejudice to Regulation 7(3), restrict the information in the technical dossier referred to in paragraph (2) to that provided for in Annex VII.C.

• (4) In the case of a notifier who has submitted a reduced notification dossier under paragraph (3), he shall, before the quantity of the substance placed on the market reaches 100 kg per year per manufacturer or before the total quantity placed on the market reaches 500 kg per manufacturer provide the competent authority with the additional information necessary to complete the technical dossier to the level referred to in paragraph (2).

• (5) In the case of a notifier who has submitted a reduced notification dossier under paragraph (1) he shall, before the quantity of the substance placed on the market reaches 1 tonne per year per manufacturer, or before the total quantity placed on the market reaches 5 tonnes per manufacturer submit a full notification in accordance with Regulation 10.

• (6) The substances notified under paragraphs (1) and (3) shall, in so far as the notifier may reasonably be expected to be aware of their dangerous properties, be packaged and provisionally labelled in accordance with Regulations 19 to 21.

• (7) Where it is not possible to label substances in accordance with Regulation 20, because all the results of tests provided for in Annex VII.A are not available, the label shall bear, in addition to the label deriving from the tests already carried out, the warning “Caution - substance not yet fully tested”.

12.

12. Substances notified at least 10 years previously

Where the information specified in Annex VII.A, VII.B, VII.C or VII.D is required in accordance with these Regulations, a notifier need only supply items 1 and 2 of the relevant Annex in the case of a substance for which the information was originally submitted at least 10 years previously.

13.

13. Notification of Polymers

In the case of polymers, the provisions concerning the technical dossiers contained in the notifications referred to in Regulations 10(2) and 11(2) shall be construed as if the reference to Annex VII.A and Annex VII.B respectively were a reference to Annex VII.D.

14.

14. Pre-marketing Notification Period

• (1)
• (a) Substances notified under Regulation 10 may, in the absence of any indication to the contrary from the competent authority, be placed on the market no sooner than 60 days after receipt by the competent authority of a dossier in conformity with the requirements of these Regulations.

• (b) Where the competent authority considers that the dossier is not in conformity with these Regulations and advises the notifier accordingly, the substance may be placed on the market no sooner than 60 days after receipt by the competent authority of the information necessary to bring the notification into conformity with these Regulations.

• (2)
• (a) Substances notified under Regulation 11(1) or 11(3) may, in the absence of any indication to the contrary from the competent authority, be placed on the market no sooner than 30 days after receipt by the competent authority of a dossier in conformity with the requirements of these Regulations.

• (b) Where the competent authority considers that the dossier is not in conformity with these Regulations and advises the notifier accordingly, the substance may be placed on the market no sooner than 30 days after receipt by the competent authority of the information necessary to bring the notification into conformity with these Regulations.

• (c) Notwithstanding subparagraph (a) where the notifier has received notice from the competent authority of the official number which has been allocated to his notification indicating acceptance of the dossier, the substance may be placed on the market no sooner than 15 days after receipt of the dossier by the competent authority.

15.

15. Exemptions from the notification requirements

• (1) The following substances shall be exempt from the notification requirements specified in these Regulations —

• (a) substances which appear on the EINECS inventory,

• (b) additives and substances for exclusive use in animal feeding stuffs and to which Directives 70/524/EEC⁵⁶ and 82/471/EEC⁵⁷ apply,

• (c) substances used exclusively as additives in foodstuffs, to which Directive 89/107/EEC⁵⁸ applies, and substances used exclusively as flavourings in foodstuffs to which Directive 88/388/EEC⁵⁹ applies,

• (d) active ingredients used exclusively in medicinal products for human or veterinary use, as defined in Directive 65/65/EEC as amended by Commission Directive 93/39/EEC,

• (e) substances for exclusive use in other product sectors for which European Communities notification or approval procedures exist, as set out in the Annex to Commission Directive 2000/21/EC of 25 April 2000, and for which the requirements for data submission are equivalent to those laid down in these Regulations, and

• (f) substances manufactured in the European Communities, which are not included in EINECS or ELINCS but are intended solely for export outside the European Communities, provided the manufacturer notifies such substances to the competent authority, and in relation to which such notification includes the following information -

• (i) the identity of the substance in accordance with point 1 of Annex VII.C,

• (ii) the quantity of the substance to be exported,

• (iii) the country of destination of the substance,

• (iv) information on the hazards of the substance, where available,

• (v) the proposed labelling of the substance, and

the competent authority may communicate the contents of such notifications to the Commission and the competent authorities of other Member States.

• (2) The following substances shall be considered as having been notified within the meaning of these Regulations-

• (a) polymers, with the exception of those which contain in combined form 2% or more of any substance which is not on EINECS;

• (b) substances placed on the market in quantities of less than 10 kg per year per manufacturer;

• (c) substances placed on the market in quantities not exceeding 100 kg per manufacturer per year, and intended solely for purposes of scientific research and development carried out under controlled conditions, provided the manufacturer or importer maintains written records, containing the identity of the substance labelling data, quantities and a list of customers involved, which shall be made available upon request to the competent authorities of each Member State where the manufacture, importation or scientific research and development takes place; and

• (d) without prejudice to the provisions of paragraph (3)(a), substances placed on the market for the purposes of process-orientated research and development with a limited number of registered customers in quantities which are limited to the purpose of process-orientated research and development.

3(a) Substances referred to in paragraph (2)(d) shall qualify for an exemption for a period of one year if the manufacturer or importer communicates their identity, labelling data quantity, the justification for the quantity and a list of customers and the research and development programme to the competent authorities of each Member State where the manufacture, importation or process-orientated research and development takes place and complies with any conditions imposed by these authorities or the Member States on such research and development, and the conditions imposed by the competent authorities or the Member States may include information not exceeding that provided for in Annex VII.C for quantities less than 500 kg, Annex VII.B for quantities between 500 kg and less than 1 tonne, and Annex VII.A for other quantities.

• (b) The manufacturer or importer shall also give an assurance to the competent authority that the substance or the preparation in which it is incorporated will be handled only by customers' staff in controlled conditions and will not be made available to the general public at any time either on its own or in a preparation.

• (c) Where the competent authority considers that there may exist an unacceptable risk for man and the environment, it may restrict any product, containing a new substance which was produced during the process-orientated research and development.

• (d) The one-year exemption period referred to in subparagraph (a) may be extended for a further year where the notifier can demonstrate, to the satisfaction of the competent authority that such an extension is justified.

• (4)
• (a) A substance referred to in paragraph (2) shall, where the manufacturer may reasonably be expected to be aware of its dangerous properties, be packaged and provisionally labelled by the manufacturer or his representative in accordance with Regulations 19 to 21.

• (b) Where it is not possible to label the substances completely and in accordance with Regulation 20, because the results of all tests provided for in Annex VII.A are not available, the label shall bear, in addition to the label deriving from the tests already carried out, the warning “Caution - substance not yet fully tested”.

• (c) Where a substance referred to in paragraph (2) is labelled as very toxic, toxic carcinogenic, toxic for reproduction, or mutagenic in accordance with Regulation 20, the manufacturer or importer of such a substance shall submit to the competent authority any appropriate information specified in Annex VII.A Sections 2.3, 2.4 and 2.5, including, where available, acute toxicity data.

• (5) Where the information specified in Annex VII.A, VII.B, VII.C or VII.D, is required in accordance with these Regulations a notifier need only supply items 1 and 2 of the relevant Annex in the case of a substance for which the information was originally submitted at least 10 years previously.

16.

16. Follow-up Information

• (1) Any notifier of a substance already notified in conformity with Regulation 10(1) or Regulation 11(1) shall inform the competent authority in writing of any -

• (a) change in the annual or total quantities placed on the market by him or, by him or others as the case may be where he is the sole representative for a substance manufactured outside the European Communities,

• (b) new knowledge of the effects of the substance on man of which he may reasonably be expected to have become aware,

• (c) new knowledge of the effects of the substance on the environment of which he may reasonably be expected to have become aware,

• (d) new uses for which the substance is placed on the market of which he may reasonably be expected to have become aware,

• (e) change in the composition of the substance as given in section 1.3 of each of Annexes VII.A, VII.B, VII.C and VII.D,

• (f) change in his status as manufacturer or importer.

• (2) An importer of a substance produced by a manufacturer established outside the European Communities who imports the substance under a notification previously submitted by a sole representative shall ensure that the sole representative is provided with up-to-date information concerning the quantities of the substance placed on the market by him.

• (3) Where the sole representative ceases to act in that capacity the importer shall submit the information required under paragraph (2) to such other sole representative as may exist or, in his absence, to the competent authority.

17.

17. Re-notification of the same substance and avoidance of duplicate testing on vertebrate animals

• (1) In the case of a substance which has already been notified in accordance with Regulation 10(1) or 11(1), the competent authority may agree that the subsequent notifier of that substance may, for the purposes of sections 3, 4 and 5 of each of Annexes VII.A, VII.B and VII.D and sections 3 and 4 of Annex VII.C, refer to the results of the tests and studies forwarded by the first notifier, in so far as the subsequent notifier can provide evidence that the substance renotified is the same as the one previously notified, including the degree of purity and the nature of impurities, but the first notifier shall give his agreement in writing to the references to the results of the tests and studies he has forwarded before such reference can be made.

• (2) Before carrying out testing on vertebrate animals for the purpose of submitting a notification under Regulations 10(1) or 11(1) and notwithstanding paragraph (1), prospective notifiers shall enquire of the competent authority as to -

• (a) whether or not the substance they intend to notify has already been notified;

• (b) the name and address of the first notifier, and

this enquiry shall be supported by evidence that the prospective notifier intends to place the substance on the market and, specify the quantities involved.

• (3) Where a substance has been previously notified and the competent authority is satisfied with the evidence provided under paragraph (2), it shall supply the prospective notifier with the name and address of the first notifier and shall inform the first notifier of the name and address of the prospective notifier except where the first notifier has requested and been granted a temporary exemption from the provisions of this paragraph.

• (4) The first notifier and the prospective notifier shall take all reasonable steps to reach an agreement on the sharing of information so as to avoid the duplication of testing on vertebrate animals.

• (5) Notifiers of the same substance who have agreed to share information relating to Annex VII.A VII.B, VII.C or VII.D in accordance with paragraphs (1) and (4) shall take all necessary steps to reach an agreement on the sharing of information derived from testing on vertebrate animals submitted in conformity with Regulation 10(3).

• (6) Where notifiers and prospective notifiers of the same substance cannot reach an agreement on the sharing of data, the competent authority may require notifiers and prospective notifiers to share the data with a view to avoiding duplicative testing on vertebrate animals and may determine the procedure for utilizing information.

18.

18. Confidentiality of data

• (1) A notifier may, in a submission made under Regulations 10, 11 or 17, indicate the information required by these Regulations which the notifier considers to be commercially sensitive and disclosure of which could cause industrial or commercial damage to that notifier, and in respect of which that notifier requires to be kept secret from all persons other than the competent authority and the Commission, and shall give full justification in such cases.

• (2) Industrial and commercial secrecy shall not apply to -

• (a) the trade name of the substance,

• (b) the name of the manufacturer and the notifier,

• (c) physico-chemical data concerning the substance in connection with section 3 of each of Annexes VII.A, VII.B, VII.C, and VII.D,

• (d) the possible ways of rendering the substance harmless,

• (e) the summary results of the toxicological and ecotoxicological tests,

• (f) the degree of purity of the substance or the identity of impurities or additives which are known to be dangerous within the meaning of these Regulations, if essential to classification and labelling for the purpose of introducing the substance into Annex I,

• (g) the recommended methods and precautions referred to in Annexes VII.A, VII.B, VII.C and VII.D, section 2.3, and the emergency measures referred to in Annex VII.A, VII.B VII.C and VII.D, sections 2.4 and 2.5,

• (h) the information contained in the safety data sheet,

• (i) in the case of substances in Annex I, analytical methods that make it possible to detect a dangerous substance when discharged into the environment as well as to determine the direct exposure of humans.

• (3) Where the notifier, manufacturer or importer himself subsequently discloses previously confidential information, he shall inform the competent authority accordingly.

• (4) The competent authority, on receipt of information under Regulation 10, 11 or 17 shall decide at its discretion which information is covered by industrial and commercial secrecy in accordance with paragraph (1).

• (5) Confidential information brought to the attention of the competent authority shall be kept secret by it.

• (6) In all cases such confidential information -

• (a) may be brought to the attention only of the Commission and the competent authority of another Member State,

• (b) may, when administrative or legal proceedings involving sanctions are undertaken for the purpose of controlling substances placed on the market, be divulged to persons directly involved in such proceedings,

• (c) may be divulged to persons directly involved in providing medical information in the case of exposure or likely exposure of persons to the substance, especially in emergencies, and such information may only be used to formulate preventative and curative measures in relation to exposure of persons to the substance.

• (7) For a substance appearing in ELINCS which is not classified as dangerous for the purpose of these Regulations, its name may be included in the form of its trade name when requested by the competent authority.

• (8) Substances referred to in paragraph (7) may be included in ELINCS in the form of their trade name for a maximum of three years unless the competent authority considers that the publication of the chemical name in the International Union of Pure and Applied Chemistry (IUPAC nomenclature itself could reveal information concerning commercial exploitation or manufacture in which case the name of the substance may be recorded under its trade name alone for as long as the competent authority sees fit.

• (9) Dangerous substances to which these Regulations apply may, at the request of the competent authority, be entered on ELINCS in the form of their trade names alone until such time as they are introduced into Annex I.

• (10) “Industrial and commercial secrecy” shall be construed in accordance with paragraph (1).

19.

19. Packaging

A dangerous substance to which these Regulations apply shall not be placed on the market unless its packaging satisfies the following requirements -

• (a) it is so designed and constructed that its contents cannot escape, except in a case where special safety devices are prescribed by Regulations made by the Minister,

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

• (c) the packaging and fastenings are sufficiently strong and 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 fastening devices can be repeatedly refastened without the contents escaping,

• (e) containers, containing dangerous substances which are offered or sold to the general public, and which are labelled “very toxic”, “toxic” or “corrosive” as defined in these Regulations must have a child resistant fastening and bear a tactile warning of danger,

• (f) containers, containing dangerous substances which are offered or sold to the general public, and which are labelled “harmful”, “extremely flammable” or “highly flammable” as defined in these Regulations must bear a tactile warning of danger.

20.

20. Labelling

• (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,

• (c) danger symbols, if required, and an indication of the danger involved in the use of the substance,

• (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, and

• (g) for substances listed in Annex I, the words “EC label”.

• (2) Subject to paragraphs (3) and (5) -

• (a) the design of danger symbols and the wording of the indications of danger shall comply with those laid down in Annex II;

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

• (c) the danger symbols and indications of danger to be used for each 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 laid down in Annex VI.

• (3) When more than one danger symbol is assigned to a substance, the following requirements apply-

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

• (b) the obligation to indicate the symbol C makes the symbol X optional; and

• (c) the obligation to indicate the symbol E makes the symbol F and O optional.

• (4) Subject to paragraph (8) -

• (a) the wording of risk phrases shall comply with that laid down in Annex III,

• (b) the risk phrases to be used for each substance shall -

• (i) be as indicated in Annex I, and

• (ii) for dangerous substances not yet appearing in Annex I the risk phrases to be used shall be assigned according to the rules laid down 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 that laid down in Annex IV, and

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

• (i) be as indicated in Annex I,

• (ii) for dangerous substances not yet appearing in Annex I, the safety phrase to be used shall be as assigned according to the rules laid down 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 22(2)(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 24, 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, 1991, as modified by Commission Directive 93/112/EEC of 10 December, 1993 and Commission Directive 2001/58/EC of 27 July 2001.

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

21.

21. Implementation of labelling

• (1) Where the particulars required by Regulation 20 appear on a label, that label shall be firmly affixed to one or more surfaces of the packaging so that these particulars can be read horizontally when the package is set down normally.

• (2) The dimensions of such a label shall be as follows -

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

• (3) Each symbol required by Regulation 20 shall cover at least one-tenth of the surface area of the label but not be less than one square centimetre (1 cm²), and the entire surface of the label shall adhere to the package immediately containing the substance.

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

• (5) 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.

• (6) The information required on a label by Regulation 20 shall stand out clearly from its background and shall be of such size and spacing as to be easily read and shall be in accordance with the provisions of Annex VI.

22.

22. Exemptions from labelling and packaging requirements

• (1) The packaging and labelling requirements of Regulations 19 to 21 shall not apply to munitions and explosives placed on the market with a view to producing a practical effect by explosion or a pyrotechnic effect.

• (2) For the purpose of these Regulations, labelling requirements shall be deemed to be satisfied -

• (a) in the case of an outer package containing one or more inner packages, if the outer package is labelled in accordance with international rules on the transport of dangerous substances and the inner package or packages are labelled in accordance with Regulations 20 and 21; and

• (b) in the case of a single package if such a package is labelled in accordance with international rules on the transport of dangerous substances and with Regulations 20(1)(a), (b), (d), (e) and (f), and where appropriate, for particular types of packaging such as mobile gas cylinders, in accordance with the specific requirements referred to in Annex VI.

• (3) The packaging of dangerous substances which are not explosive, very toxic or toxic may be unlabelled or may be labelled in such other way as may be approved by the competent authority if they contain such small quantities that there is no reason to fear any danger to persons handling such substances or to other persons.

• (4) The packaging of dangerous substances which are explosive, very toxic or toxic may be labelled in such other way as may be approved by the competent authority if they are too small for labelling in accordance with Regulations 20 and 21 and there is no reason to fear any danger to persons handling such substances or to other persons.

• (5) The labelling required on packages which are either too small or otherwise unsuitable for labelling in accordance with Regulations 20 and 21 may be applied on packages in such other appropriate manner as may be approved by the competent authority.

• (6) A derogation under paragraph (3), (4), or (5) shall not permit the use of symbols, indications of danger, risk phrases or safety phrases different from those required by these Regulations.

• (7) Where dangerous substances do not leave the State, the competent authority may permit labelling that complies with national rules relating to the transport of dangerous substances.

23.

23. Advertising

A person shall not publish any advertisement for a substance which belongs to one or more of the categories referred to in Regulation 8(1)(a) to (o) unless mention is made in the advertisement of the category or categories concerned.

24.

24. Safety Data Sheet

• (1) A person placing a dangerous substance to which these Regulations apply on the market shall prepare a safety data sheet giving information on that substance.

• (2) A safety data sheet shall be amended by the person who provides it when any new information of a significant nature so requires.

• (3) At, or before the first delivery, following the commencement of these Regulations, the manufacturer, importer or distributor of a dangerous substance to which these Regulations apply shall communicate the safety data sheet to any recipient who is a professional or industrial user distributor, wholesaler or retailer of the substance.

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

• (5) An amended safety data sheet referred to in paragraph (2) 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.

• (6) Without prejudice to paragraphs (3) and (4), recipients or users of a dangerous substance shall on request be provided with the safety data sheet by the supplier of the substance to them.

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

• (8) 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.

• (9)
• (a) A safety data sheet required to be provided in accordance with this Regulation shall contain information on the dangerous substance under the headings set out in Schedule 8 and shall contain those headings.

• (b) The information required to be contained in the safety data sheet in accordance with subparagraph (a) shall be compiled in accordance with the guidelines laid down in the Annex to Directive 2001/58/EC.

• (c) The information required under subparagraph (a) shall include -

• (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.

25.

25. Supply of Substances

A notifier shall supply to the competent authority on request such quantities of a notified substance as the competent authority deems necessary for the carrying out of verification tests.

26.

26. Restriction on Sale

Where the competent authority is of opinion that a substance, although satisfying the requirements of these Regulations, constitutes a hazard for man or the environment by reason of its classification, packaging or labelling, the competent authority may, by notice in writing to the person who placed the substance on the market, prohibit the sale of that substance or subject its placing on the market to special conditions.

27.

27. Fees Payable by Notifier

The fee specified in column 2 of Schedule 9 shall be payable in advance by a notifier to the competent authority in relation to any matter referred to in the corresponding entry in column 1 of that Schedule.

28.

28. Taking and Detention of Substances

• (1) An inspector may, seize and retain, or seize, remove and retain any substance which he believes is a substance to which these Regulations apply and in relation to which he has reasonable grounds for suspecting that there is or has been a failure to comply with any provision of these Regulations.

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

• (a) require things specified in the notice to be done in relation to the substance before it is released by an inspector, and

• (b) may -

• (i) require the disposal of the substance 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 inspector's intention of disposing of the substance at the expense of the owner,

and such disposal to be, in either case, such as will prevent the substance from being again placed on the market, and, where a notice given under this paragraph requires specified things to be done in relation to a substance, the inspector shall retain control of the substance to which the notice relates until the requirements of the notice have 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 of or otherwise interfere with the substance in any way pending compliance with the requirements of the notice.

• (4) Any person who is aggrieved by a notice given under paragraph (2) of this Regulation which either requires the substance to which it relates to be disposed of or indicates an intention to dispose of such substances may, not later than the expiration of the period of seven 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 substance to which the relevant notice under this Regulation relates is one to which these Regulations apply,

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

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

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

• (b) Where an order made by a court under this paragraph requires the substance to which it relates to be disposed of by an inspector, the cost of such disposal shall be recoverable by the competent 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) A notice under this Regulation shall not come into force unless -

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

• (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 substance 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;

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

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

• (8)
• (a) If, in relation to an appeal under this Regulation to the District Court, that court becomes of the opinion during the hearing of the appeal that the estimated amounts aforesaid will exceed €6,348.69, it may, if it so thinks fit, transfer the appeal to the Circuit Court or the High Court, whichever it considers appropriate having regard to the estimated amounts aforesaid.

• (b) If, in relation to an appeal under this regulation to 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.

29.

29. Offences

• (1) A person shall be guilty of an offence if the person -

• (a) contravenes Regulation 6, 9, 10, 11, 16, 17 (2), 19, 20, 21, 23, 24, 25 or 28 (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 17(6), or

• (e) contravenes a prohibition, or fails to comply with a condition, imposed on that person under Regulation 26.

• (2) Where an offence under these Regulations has been 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 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, shall be 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) A person guilty of an offence under these regulations shall be liable on summary conviction to a fine not exceeding €1,904.61 or imprisonment for a term not exceeding 6 months or both.

30.

30. Revocations

The-

• (a) European Communities (Classification, Packaging, Labelling and Notification of Dangerous Substances) Regulations, 1994 ( S.I. No. 77 of 1994 ),

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