S.I. No. 258/1982:

EUROPEAN COMMUNITIES (DANGEROUS SUBSTANCES) (CLASSIFICATION, PACKAGING, LABELLING AND NOTIFICATION) REGULATIONS, 1982.

EUROPEAN COMMUNITIES (DANGEROUS SUBSTANCES) (CLASSIFICATION, PACKAGING, LABELLING AND NOTIFICATION) REGULATIONS, 1982.

I, GENE FITZGERALD, Minister for Labour, 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 79/831/EEC¹, hereby make the following Regulations:

¹O.J. No. L259, 15.10.1979, pp.10-28.

1. These Regulations may be cited as the European Communities (Dangerous Substances) (Classification, Packaging, Labelling and Notification) Regulations, 1982, and shall come into operation on the 1st day of September, 1982.

2. (1) In these Regulations--

"authorised officer" means a person appointed by the Minister to be an authorised officer for the purposes of these Regulations;

"Council Directive" means Council Directive 67/548/EEC², as amended by Council Directive 79/831/EEC;

²O.J. No. 196, 16.8.1967, pp. 234-256.

"the Minister" means the Minister for Labour.

(2) A word or phrase that is used in these Regulations and is also used in the Council Directive has, unless the contrary intention appears, the meaning in these Regulations that it has in the Council Directive.

(3) A reference in these Regulations to an Annex is to an Annex to the Council Directive.

3. (1) These Regulations apply to substances (including substances dangerous to man and the environment) and preparations, but do not apply to the matters specified in Article 1.2 of the Council Directive.

(2) Regulations 10 to 12 of these Regulations do not apply to the provisions governing--

( a ) containers which contain gases compressed, liquefied or dissolved under pressure, excluding aerosols which comply with the requirements of Council Directive 75/324/EEC³;

³O.J. No. L147, 9.6.1975, p.40.

( b ) munitions and explosives placed on the market with a view to producing a practical effect by explosion or a pyrotechnic effect.

(3) Regulations 5 to 7 of these Regulations, in so far as they are concerned with notification, do not apply--

( a )--until six months after publication of the inventory referred to in Article 13.1 of the Council Directive, to substances placed on the market before the 18th day of September, 1981;

--six months after publication of that inventory, to substances which appear in that inventory;

( b ) to pesticides and fertilizers, in as far as they are subject to approval procedures which are at least equivalent or Community notification procedures or procedures which are not yet harmonized;

( c ) to substances which are already subject to similar testing and notification requirements under existing Directives.

4. For the purposes of these Regulations--

( a ) the physico-chemical properties of substances and preparations to which these Regulations apply shall be determined according to the methods specified in Annex V (A);

( b ) the toxicity of substances and preparations to which these Regulations apply shall be determined according to the methods specified in Annex V (B);

( c ) the ecotoxicity of substances and preparations to which these Regulations apply shall be determined according to the methods specified in Annex V (C);

( d ) the real or potential environmental hazard of substances and preparations to which these Regulations apply shall be assessed according to the characteristics set out in Annexes VII and VIII, on the basis of any existing internationally recognised parameters;

( e ) the general principles of the classification and labelling of substances and preparations to which these Regulations apply shall be applied according to the criteria in Annex VI, except where contrary requirements for dangerous preparations are specified in other Directives of the Communities;

(f) the classification, according to the degree of hazard and the specific nature of the risks involved, of dangerous substances to which these Regulations apply shall be based on the categories laid down in Article 2.2 of the Council Directive, for categories (a) to (j) in that Article the substances being classified according to the greatest degree of hazard in accordance with Regulation 11 (7) of these Regulations.

5. (1) Without prejudice to Regulation 8 of these Regulations and subject to paragraph (2) of this Regulation, substances to which these regulations apply shall not be placed on the market on their own or in preparations unless the substances have been--

( a ) notified to the competent authority in accordance with these Regulations, and

( b ) packaged and labelled in accordance with Regulations 10 to 13 of these Regulations and with the criteria in Annex VI and in accordance with the results of tests under Regulation 6 of these Regulations.

(2) Paragraph (1) (b) of this Regulation shall apply until a substance is listed in Annex I or until a decision not to list it has been taken in accordance with the procedure laid down in Article 21 of the Council Directive.

(3) Dangerous substances not yet appearing in Annex I but included in the list referred to in Article 13.2 of the Council Directive or already on the market before the 18th day of September, 1981, shall (in so far as the manufacturer, whether or not established in the Community, may reasonably be expected to be aware of their dangerous properties) be packaged and provisionally labelled by or on behalf of the manufacturer in accordance with the rules laid down in Regulations 10 to 13 of these Regulations and with the criteria in Annex VI.

6. (1) Without prejudice to Articles 1.4 and 8.1 of the Council Directive, a manufacturer or importer of a substance to which these Regulations apply shall submit to the competent authority not later than 45 days before the substance is placed on the market, 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 (including, if so required, a summary of such information), and containing at least the information and results of the studies referred to in Annex VII, together with a detailed and full description of the studies conducted and of the methods used or a bibliographical reference to them,

( b ) a declaration concerning the unfavourable effects of the substance in terms of the various uses envisaged,

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

( d ) proposals for any recommended precautions relating to the safe use of the substance.

(2) Notwithstanding paragraph (1) of this Regulation, in the case of a substance which has already been notified the competent authority may agree that the notifier of that substance may, for the purposes of the technical dossier, refer to the results of the studies carried out by one or more previous notifiers, if such previous notifiers have given their agreement in writing to such reference.

(3) ( a ) Notwithstanding paragraph (1) of this Regulation, if a substance is already listed in Annex 1, the notifier need not include in a notification under this Regulation the matters specified in clauses (b), (c) and (d) of that paragraph.

( b ) Notwithstanding paragraph (1) of this Regulation, a notifier need not supply the information required for the technical dossier in Annex VII (with the exception of points 1 and 2 of that Annex) if the substance was originally notified at least 10 years previously.

(4) A notifier of a substance already notified under this Regulation shall inform the competent authority of--

( a ) changes in the annual or total quantities placed on the market by him in accordance with the tonnage range laid down in Annex VII, point 2.2.1,

( b ) new knowledge of the effects of the substance on man or the environment (or on both) of which the notifier may reasonably be expected to have become aware,

( c ) new uses for which the substance is placed on the market (within the meaning of Annex VII, point 2.1.2) of which the notifier may reasonably be expected to have become aware,

( d ) any change in the properties resulting from a modification of the substance referred to in Annex VII, point 1.3, and

( e ) the results of the studies carried out in accordance with Annex VIII.

(5) The competent authority may, on submission to it of any document required to be so submitted by this Regulation, require further copies of such document.

7. (1) The competent authority may, if it can be shown to be necessary for the evaluation of the hazard which may be caused by a substance,--

( a ) ask for further information and verification tests (or further information or verification tests) concerning the substances notified (including the information referred to in Annex VIII earlier than provided for therein),

( b ) carry out such sampling as is necessary for control purposes,

( c ) take appropriate measures relating to safe use of a substance pending the introduction of Community provisions.

(2) A person to whom a request is made under this Regulation shall comply with the request.

8. (1) The substances specified in Article 8.1 of the Council Directive shall be considered as having been notified for the purposes of these Regulations when the conditions so specified are fulfilled.

(2) The substances referred to in paragraph 1 of this Regulation shall, in so far as the maufacturer may reasonably be expected to be aware of their dangerous properties, be packaged and provisionally labelled by the manufacturer or his representative in accordance with the rules laid down in Regulations 10 to 14 of these Regulations, and with the criteria imposed in Annex VI of the Council Directive.

(3) If labelling in accordance with the principles set out in Regulation 11 of these Regulations is not yet possible, the label shall bear the warning: "Caution--substance not yet fully tested".

(4) Where a substance referred to in paragraph 1 of this Regulation, labelled in accordance with the principles set out in Regulation 11 of these Regulations, is very toxic or toxic, the manufacturer or importer of such a substance shall transmit to the competent authority any appropriate information as regards Annex VII, points 2.3, 2.4 and 2.5.

(5) Substances to which these Regulations apply and which are placed on the market at the research and development stage with a limited number of registered customers, in quantities which are limited to the purpose of the research and development but which amount to more than one tonne per year per manufacturer, are exempted by the Minister from notification under Regulation 6 of these Regulations for a period of one year, provided that the manufacturer announces their identity, labelling data and quantity to the Minister, complies with any conditions imposed by the Minister on such research and development and gives an assurance to the Minister that the substance or the preparation in which it is incorporated will be handled by customers' staff only, under controlled conditions, and will not be made available to the public.

9. (1) If he considers that there is a confidentiality problem, the notifier may indicate the information required by Regulation 6 of these Regulations which he considers to be commercially sensitive and disclosure of which might harm him industrially or commercially, and which he therefore wishes to be kept secret from all persons other than the competent authority and the Commission, giving full justification in such cases.

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

( a ) the trade name of the substance,

( b ) physico-chemical data concerning the substance in connection with Annex VII, point 3,

( c ) the possible ways of rendering the substance harmless,

( d ) the interpretation of the toxicological and ecotoxicological tests and the name of the body responsible for the tests,

( e ) the recommended methods and precautions referred to in Annex VII, point 2.3 and the emergency measures referred to in Annex VII, points 2.4 and 2.5.

(3) If the notifier himself subsequently discloses previously confidential information, he shall inform the competent authority accordingly.

(4) The competent authority on receipt of a notification under Regulation 6 of these Regulations shall decide at its discretion which information is covered by industrial and commercial secrecy in accordance with paragraph 1 of this Regulation.

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

(6) In all cases such information--

( a ) may be brought to the attention only of the authorities whose responsibilities are specified in Article 7.1 of the Council Directive,

( b ) may, however, 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.

10. (1) A person shall not place dangerous substances on the market unless their packaging satisfies the following requirements:

( a ) it is so designed and constructed that its contents cannot escape; this requirement shall not apply where special safety devices are prescribed;

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

( c ) packaging and fastenings are 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 are so designed that the packaging can be repeatedly refastened without the contents escaping;

( e ) packages shall initially be closed with a seal in such a way that when the package is opened for the first time the seal is irreparably damaged;

(f) containers with a capacity not exceeding three litres which contain dangerous substances intended for domestic use shall have child-resistant fastenings;

( g ) containers with a capacity not exceeding one litre which contain very toxic, toxic or corrosive liquids intended for domestic use shall carry a tactile warning of danger.

(2) Any technical specifications which may be necessary with regard to a device referred to in paragraph (1) (e) to (1) (g) of this Regulation shall be adopted by the procedure in Article 21 of the Council Directive and shall be given in Annex IX, in particular:

in Annex IX (A) relating to child-resistant fastenings,

in Annex IX (B) relating to tactile warnings of danger.

11. (1) A person shall not place dangerous substances on the market unless the labelling on their packaging satisfies the following requirements:--

( a ) every package shows clearly and indelibly the following--

(i) the name of the substance,

(ii) the origin of the substance,

(iii) the danger symbol, when laid down, and indication of danger involved in the use of the substance,

(iv) standard phrases indicating the special risks arising from such dangers, and

(v) standard phrases indicating the safety advice relating to the use of the substance;

( b ) the name of the substance is one of the terms listed in Annex I; if this is not the case, the name shall be given in accordance with internationally recognised nomenclature;

( c ) the indication of origin includes the name and address of the manufacturer, the distributor or the importer;

( d ) the following symbols and indications of danger are used:

(i) explosive: an exploding bomb (E)

(ii) oxidizing: a flame over a circle (O)

(iii) extremely flammable: a flame (F)

(iv) highly flammable: a flame (F)

(v) very toxic: a skull and cross-bones (T)

(vi) toxic: a skull and cross-bones (T)

(vii) harmful: a St. Andrew's cross (Xn)

(viii) corrosive: the symbol showing the damaging effect of an acid (C)

(ix) irritant: a St. Andrew's cross (Xi).

(2) The symbols required by this Regulation shall conform to those in Annex II and shall be printed in black on an orange-yellow background.

(3) ( a ) The special risks involved in using the substances shall be indicated by one or more of the standard phrases which, in accordance with the references contained in Annex I, are set out in Annex III.

( b ) In the case of a substance not listed in Annex I, the reference to the special risks attributed to the dangerous substances shall comply with appropriate indications given in Annex III.

( c ) The phrases "extremely flammable" or "highly flammable" need not be indicated where they repeat the wording of an indication of danger used in accordance with paragraph (1) (d) of this Regulation.

(4) ( a ) The safety advice relating to the use of the substances shall be indicated by standard phrases which, in accordance with the references contained in the list in Annex I, are set out in Annex IV.

( b ) The packaging shall be accompanied by the safety advice required by this Regulation where it is materially impossible for this to be given on the label or package itself.

( c ) In the case of a substance not listed in Annex I safety advice relating to the dangerous substances shall comply with appropriate indications given in Annex IV.

(5) 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.

(6) ( a ) In the case of irritant, highly flammable, flammable and oxidizing substances, an indication of special risks and safety advice need not be given where the package does not contain more than 125 ml.

( b ) Clause (a) of this paragraph applies also to harmful substances to which these Regulations apply which are not sold by retail to the general public.

(7) When more than one danger symbol is assigned to a substance--

( a ) the obligation to indicate the symbol T makes the symbols X and C optional, unless Annex I includes provision to the contrary;

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

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

(8) Indications, phrases and words used on a package in pursuance of this Regulation shall be in the English language or in both the English and Irish languages.

12. (1) Where the particulars required by Regulation 11 of these Regulations 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. The dimensions of the label shall be as follows:

(2) ( a ) Each symbol required by Regulation 11 of these Regulations shall cover at least one-tenth of the surface area of the label but not be less than 1cm , and the entire surface of the label shall adhere to the package immediately containing the substance.

( b ) The dimensions specified in this Regulation are intended solely for provision of the information required by these Regulations and if necessary of any supplementary health or safety indications.

(3) A label shall not be required where the particulars are clearly shown on the package itself, as specified in this Regulation.

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

13. (1) The labelling required by Regulation 11 of these Regulations may be applied on packages which are either too small or otherwise unsuitable for labelling in accordance with Regulation 12 of these Regulations in such other appropriate manner as may be approved for the time being by the Minister.

(2) The packaging of dangerous substances to which these Regulations apply and which are not explosive, very toxic or toxic may be unlabelled or may be labelled in such other way as may be approved for the time being by the Minister if they contain such small quantities that there is no reason to fear any danger to persons handling such substances or to other persons.

14. (1) Notwithstanding anything in Regulation 11, 12 or 13 of these Regulations, a requirement in any of those Regulations relating to labelling 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 these Regulations;

( 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 11 (1) (b), 11 (1) (c), 11 (3) and 11 (4) of these Regulations, and

where dangerous substances do not leave the State, labelling may be permitted which complies with national rules instead of with international rules on the transport of dangerous substances.

15. (1) A person who contravenes Regulation 5, 6, 7, 8, 9 (5), 10 (1), 11 or 12 of these Regulations shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding £600.

(2) An offence under these Regulations may be prosecuted by the Minister.

(3) Notwithstanding section 10 (4) of the Petty Sessions (Ireland) Act, 1851, proceedings for an offence under these Regulations may be instituted at any time within the period of one year beginning on the day on which the offence was committed.

16. (1) An authorised officer may--

( a ) enter, inspect, examine and search at all reasonable times--

(i) any structure or any premises or other land which he has reasonable cause to believe is being used for or in connection with the manufacture, storage, packing or placing on the market of any substance,

(ii) any premises or other land on or in which he has reasonable cause to believe there is used any process involving the use of any substance,

(iii) any ship or other vessel, aircraft or railway wagon or other vehicle in or on which he has reasonable cause to believe any substance is present;

( b ) take with him a member of the Garda Síochána if he has reasonable cause to apprehend any serious obstruction in the execution of his duty;

( c ) in case he enters any structure, premises or other land, ship or other vessel, aircraft or railway wagon or other vehicle pursuant to this Regulation--

(i) require the person who appears to him to be in charge of the structure, premises or other land, ship or other vessel, aircraft or railway wagon or other vehicle to produce any substance which is in his possession or under his control,

(ii) require such person, or any person employed in or on such structure, premises or other land, ship or other vessel, aircraft or railway wagon or other vehicle, to produce any books, records or other documents which relate to transactions concerning any substance and which are in his possession or under his control, and

(iii) inspect any substance and any book, record or other document produced in pursuance of a requirement under this Regulation and, if he thinks fit, copy any entry in such book, record or document;

( d ) make such examination and inquiry as may be necessary to ascertain whether these Regulations are being complied with;

( e ) in case in the course of exercising a power conferred on him by subparagraph (a) of this paragraph he finds any substance in or on any structure, premises or other land, ship or other vessel, aircraft or railway wagon or other vehicle, require the person who appears to him to be in charge or control of the substance to give to him such information as it is in his power to give as to who is the owner of the substance;

(f) to examine the stock of any substance which he finds in the course of an inspection pursuant to this Regulation;

( g ) where he has reasonable cause to believe that at or on any structure, premises or other land, ship or other vessel, aircraft or railway wagon or other vehicle, a contravention of these Regulations has been or is being committed, use force where necessary in order to enter the structure, premises or other land, ship or other vessel, aircraft or railway wagon or other vehicle; provided he is so authorised by a warrant of a Justice of the District Court (which such Justice is hereby authorised to issue upon reasonable ground being assigned on oath), or, if it appears to him to be a case of emergency and that the delay in obtaining a warrant would be likely to endanger life, without being so authorised, and

( h ) for the purpose of any examination or inquiry under this Regulation, require any person whom he finds on any such structure, premises or other land, ship or other vessel, aircraft or railway wagon or other vehicle, or whom he has reasonable cause to believe to be, or to have been within the preceding two months, employed at or on the structure, premises or other land, ship or other vessel, aircraft or railway wagon or other vehicle, to answer, in the absence of persons other than a person nominated by him to be present and any other persons whom the authorised officer may allow to be present, such questions as the authorised officer thinks fit to ask; provided that any answer given by a person in pursuance of a requirement imposed under this paragraph shall not be admissible without his consent in any proceedings.

(2) Where an authorised officer in the course of exercising a power conferred on him by paragraph (1) (a) of this Regulation finds any thing which he reasonably believes to be a substance, the owner thereof, the person who appears to the authorised officer to be in charge or in control thereof and any person who is the servant or agent of such owner shall enable the authorised officer to use anything which is then under such occupier's or person's control and required by the authorised officer for the purpose of making an examination, inspection or search pursuant to this Regulation or the taking of a sample pursuant to Regulation 17 of these Regulations.

(3) If any person wilfully delays an authorised officer in the exercise of any power under this Regulation, or fails to comply with a requisition of an authorised officer made in pursuance of this Regulation or wilfully withholds any information as to who is the owner of a substance found by an authorised officer in the course of exercising a power conferred on him by paragraph (1) (a) of this Regulation, or prevents, or attempts to prevent, a person from appearing before or being examined by an authorised officer, that person shall be deemed to obstruct an authorised officer in the execution of his duties under these Regulations.

(4) An authorised officer shall be furnished with a warrant of his appointment as an authorised officer and when exercising any power conferred on him by these Regulations shall, if requested by any person concerned, produce the warrant to that person.

(5) A person who obstructs or interferes with an authorised officer when he is exercising a power conferred on him by these Regulations shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding £600.

17. (1) An authorised officer may, at any time after informing either the owner of a substance found by him in the course of exercising a power conferred on him by Regulation 16 (1) (a) of these Regulations or a person who appears to him to be in charge or in control of, or to have other responsibilities as regards such substance, take for analysis sufficient samples of the substance if the substance is one in relation to which he reasonably suspects a contravention of any of these Regulations.

(2) The owner or other person referred to in paragraph (1) of this Regulation may, at the time when a sample is being taken under this Regulation and on supplying the necessary appliances, require the authorised officer to divide the sample into three parts, to mark and seal or fasten up each part in such manner as its nature permits, and--

( a ) to deliver to him one part,

( b ) to retain one part for future comparison,

( c ) to submit one part for analysis,

and any analysis under this Regulation shall, if the person by whom the acquisition under this paragraph is made so requires, be carried out by or under the direction of the State Chemist or a person who is for the time being approved of for the purposes of this Regulation by the Minister.

(3) A certificate purporting to be a certificate by the State Chemist or a person who is for the time being approved of for the purposes of this Regulation by the Minister as to the result of an analysis of a sample taken under this Regulation shall in any proceedings for an alleged offence under these Regulations be admissible as evidence of the matters stated therein, but either party may require the person by whom the analysis was made to be called as a witness.

(4) It shall not be lawful for any person, except in so far as is necessary for the purposes of a prosecution for an offence under these Regulations, to publish or disclose to any person other than the owner of the relevant substance (at the time when the sample was taken) or the Minister the results of an analysis made under this Regulation.

18. Where the competent authority has detailed evidence that a substance, although satisfying the requirements of the Directive and these Regulations, constitutes a hazard for man or the environment by reason of its classification, packaging or labelling, the Minister may provisionally prohibit the sale of that substance, or subject it to special conditions in the State.

19. The Minister may from time to time fix a scale of fees to be paid in relation to the submission to the competent authority of any dossier, declaration, proposal or other document required to be submitted by these Regulations.

GIVEN under my Official Seal, this 30th day of July, 1982.

GENE FITZGERALD,

Minister for Labour.

EXPLANATORY NOTE.

These regulations require each manufacturer, importer or other person proposing to place a new chemical substance on the market 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 Hazardous Substances Assessment Unit of the Department of Labour is the competent authority to which such notifications should be sent. Its address is Davitt House, Mespil Road, Dublin 4.