STATUTORY INSTRUMENT

S.I. No. 624 of 2001

EUROPEAN COMMUNITIES (CLASSIFICATION, PACKAGING AND LABELLING OF PLANT PROTECTION PRODUCTS AND BIOCIDE PRODUCTS) REGULATIONS, 2001

S.I. No. 624 of 2001

EUROPEAN COMMUNITIES (CLASSIFICATION, PACKAGING AND LABELLING OF PLANT PROTECTION PRODUCTS AND BIOCIDE PRODUCTS) REGULATIONS, 2001

ARRANGEMENT OF REGULATIONS

S.I. No. 624 of 2001

EUROPEAN COMMUNITIES (CLASSIFICATION, PACKAGING AND LABELLING OF PLANT PROTECTION PRODUCTS AND BIOCIDE PRODUCTS) REGULATIONS, 2001

I, Joe Walsh, Minister for Agriculture, Food and Rural Development, in exercise of the powers conferred on me by Section 3 of the European Communities Act, 1972 ( No. 27 of 1972 ), and for the purpose of giving effect to Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999¹ and Commission Directive 2001/60/EC of 7 August 2001² ,

taking account of Council Directive 67/548/EEC of 27 June 1967³ , Council Directive 92/32/EEC of 30 April 1992⁴ , Council Directive 96/56/EEC of 3 September 1996⁵ , Commission Directive 88/302/EEC of 18 November 1987⁶ , the corrigendum to Commission Directive 88/302/EEC of 18 November 1987⁷ , Commission Directive 91/410/EEC of 22 July 1991⁸ , Commission Directive 92/69/EEC of 31 July 1992⁹ , Commission Directive 93/21/EEC of 27 April 1993¹⁰ , Commission Directive 93/72/EEC of 1 September 1993¹¹ , Commission Directive 93/105/EC of 25 November 1993¹² , Commission Directive 93/101/EC of 11 November 1993¹³ , Commission Directive 94/69/EC of 19 December 1994¹⁴ , Commission Directive 96/54/EC of 30 July 1996¹⁵ , Commission Directive 97/69/EC of 5 December 1997¹⁶ , Commission Directive 98/73/EC of 18 September 1998¹⁷ , the corrigendum to Commission Directive 98/73/EC of 18 September 1998¹⁸ , Commission Directive 98/98/EC of 15 December 1998¹⁹ , the corrigendum to Commission Directive 98/98/EC of 15 December 1998²⁰ , Commission Decision of 19 May 2000 correcting Commission Directive 98/98/EC of 15 December 1998²¹ , Commission Directive 2000/32/EC of 19 May 2000²² , Commission Directive 2000/33/EC of 25 April 2000²³ , Commission Directive 2001/59/EC of 6 August 2001²⁴ ,

taking account of Council Directive 91/414/EEC of 15 July 1991²⁵ ,

and further taking account of Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998²⁶ , hereby make the following Regulations:

Citation

1        (1)     These Regulations may be cited as the European Communities (Classification, Packaging and Labelling of Plant Protection Products and Biocide Products) Regulations, 2001.

(2)     These Regulations shall come into operation on the 28th day of December 2001.

Interpretation

2        (1)     In these Regulations -

“Annex I” means Annex I to the Directive of 1967, as last amended by Commission Directive 2001/59/EC of 6 August 2001²⁴ ;

“Annex II” (which is set out in the First Schedule) means Annex II to the Directive of 1967, as amended by the Directive of 1992 and Commission Directive 2001/59/EC of 6 August 2001²⁴ ;

“Annex III” (which is set out in the First Schedule) means Annex III to the Directive of 1967, as amended by the Directive of 1992 and Commission Directive 2001/59/EC of 6 August 2001²⁴ ;

“Annex IV” (which is set out in the First Schedule) means Annex IV to the Directive of 1967, as amended by the Directive of 1992 and Commission Directive 2001/59/EC of 6 August 2001²⁴ ;

“Annex V” means Annex V to the Directive of 1967, as amended by the Directive of 1992, Commission Directive 88/302/EEC of 18 November 1987⁶ , Commission Directive 92/69/EEC of 31 July 1992²⁴ , Commission Directive 93/21/EEC of 27 April 1993¹⁰ , Commission Directive 96/54/EC of 30 July 1996¹⁵ , Commission Directive 98/73/EC of 18 September 1998¹⁷ , the corrigendum to Commission Directive 98/73/EC of 18 September 1998¹⁸ , Commission Directive 2000/32/EC of 19 May 2000 ²² , Commission Directive 2000/33/EC of 25 April 2000²³ and Commission Directive 2001/59/EC of 6 August 2001²⁴ ;

“Annex VI” (which is set out in the First Schedule) means Annex VI to the Directive of 1967, as amended by the Directive of 1992 and Commission Directive 2001/59/EC of 6 August 2001²⁴ ;

“Annex VII” means Annex VII set out in the Second Schedule, comprising additional safety advice in accordance with Article 16 (5) of the Directive of 1991;

“Annex VIII” (which is set out in the Third Schedule) means Annex I to the Directive of 1999;

“Annex IX” (which is set out in the Third Schedule) means Annex II to the Directive of 1999 as amended by Commission Directive 2001/60/EC of 7 August 2001² ;

“Annex X” (which is set out in the Third Schedule) means Annex III to the Directive of 1999;

“Annex XI” (which is set out in the Third Schedule) means Annex IV to the Directive of 1999, supplemented by the technical specifications comprising Annex IX to the Directive of 1967 as amended by the Directive of 1992, Commission Directive No. 91/410/EEC of 22 July 1991⁷ , and Commission Directive 2000/32/EC of 19 May 2000 ²¹ ;

“Annex XII” (which is set out in the Third Schedule) means Annex V to the Directive of 1999 as amended by Commission Directive 2001/60/EC of 7 August 2001² ;

“Annex XIII” (which is set out in the Third Schedule) means Annex VI to the Directive of 1999;

“Annex XIV” means Annex XIV set out in the Fourth Schedule, comprising a list of preparation (formulation) types and codes;

“aircraft” includes hovercraft;

“approval” means acceptance by the Minister that, following examination, the record of studies conducted and the information, documentation, materials, labelling and packaging submitted in relation to a plant protection product or biocide product, are in compliance with the requirements of these Regulations and cognate words shall be construed accordingly;

“authorised officer” means an officer of the Minister appointed in writing by the Minister to be an authorised officer for the purpose of these Regulations;

“carcinogenic substances and preparations” means substances or preparations which, if they are inhaled or ingested or if they penetrate the skin, may induce cancer or increase its incidence;

“clearance” means clearance to market or use a plant protection product or biocide product for which the record of studies conducted, and the information, documentation, materials, labelling and packaging submitted have been approved by the Minister in accordance with the requirements of these Regulations and cognate words shall be construed accordingly;

“corrosive substances and preparations” means substances and preparations which may on contact with living tissues, destroy them;

“dangerous for the environment” means substances and preparations which, were they to enter the environment, would or could present an immediate or delayed danger for one or more components of the environment;

“dangerous substances and preparations” means substances and preparations which are flammable, highly flammable, extremely flammable, explosive, oxidising, very toxic, toxic, harmful, corrosive, irritant, sensitising, carcinogenic, mutagenic, toxic for reproduction and / or dangerous for the environment;

“designated analyst” means any appropriately qualified officer of the Minister who is authorized in writing by the Minister for the purposes of these Regulations;

“Directive of 1967” means Council Directive 67/548/EEC of 27 June 1967³ ;

“Directive of 1978” means Council Directive 78/631/EEC of 26 June 1978²⁷ ;

“Directive of 1991” means Council Directive 91/414/EEC of 15 July 1991²⁵ ;

“Directive of 1992” means Council Directive 92/32/EEC of 30 April 1992⁴ ;

“Directive of 1998” means Directive 98/8/EC of the European Parliament and the Council of 16 February 1998²⁶ ;

“Directive of 1999” means Directive 1999/45/EC of the European Parliament and the Council of 31 May 1999¹ ;

“explosive substances and preparations” means solid, liquid, pasty or gelatinous substances and preparations which may also 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;

“extremely flammable substances and preparations” means 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;

“flammable substances and preparations” means liquid substances and preparations having a low flash-point;

“harmful substances and preparations” means substances and preparations which may cause death or acute or chronic damage to health when inhaled, swallowed or absorbed via the skin;

“highly flammable substances and preparations” means:

-    substances and preparations which may become hot and finally catch fire in contact with air at ambient temperature without any application of energy, or

-    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, or

-    liquid substances and preparations having a very low flash-point, or

-    substances and preparations which, in contact with water or damp air, evolve extremely flammable gases in dangerous quantities;

“irritant substances and preparations” means non-corrosive substances and preparations, which through immediate, prolonged or repeated contact with the skin or mucous membrane may cause inflammation;

“Minister” means the Minister for Agriculture, Food and Rural Development;

“mutagenic substances and preparations” means 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;

“notified” in the case of a plant protection product to which Regulation 3 (1) (a) applies means the packaging, including any label or container used with the package, and basic information as to the nature and composition of any such plant protection product on the market on or before the second day of December 1985, and as to the manufacturer or manufacturers of each such plant protection product, has been submitted and approved by the Minister and cognate words shall be construed accordingly,

and

in the case of a biocide product to which Regulation 3 (1) (b) applies means the packaging, including any label or container used with the package of any such biocide product on the market on or before the first day of February 2002, and basic documentation and information as to the nature and composition and product type of any such biocide product, and as to the manufacturer or manufacturers of each such biocide product as set out in the Fifth Schedule, has been submitted and approved by the Minister and cognate words shall be construed accordingly,

“oxidising substances and preparations” means substances and preparations which give rise to a highly exothermic reaction in contact with other substances, particularly flammable substances;

“sensitising substances and preparations” means 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;

“State Chemist” means the Head of the State Laboratory or a member of the staff of the State Laboratory authorized by the State Chemist in writing to perform functions assigned to the State Chemist under paragraph 5 of Regulation 19;

“toxic substances and preparations” means substances and preparations which in low quantities cause death or acute or chronic damage to health when inhaled, swallowed or absorbed via the skin;

“toxic for reproduction” means 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 and / or an impairment of male or female reproductive functions or capacity;

“very toxic substances and preparations” means 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.

(2)     In these Regulations, unless otherwise indicated -

(a)      a reference to a Regulation is a reference to a Regulation of these Regulations,

(b)      a reference to a paragraph or subparagraph is a reference to a paragraph or subparagraph of the provision, in which the reference occurs,

(c)      a reference to a Schedule is a reference to a Schedule to these Regulations.

(3)     A word or expression that is used in any Council Directive of the European Communities or in any Directive of the European Parliament and of the Council mentioned in these Regulations has, unless the contrary intention appears, the meaning in these Regulations that it has in the Directive concerned.

Application

3        (1)     Subject to paragraph (2), these Regulations apply to plant protection products and biocide products, being:

(a)      any plant protection product mentioned in paragraph (1) of Article 2 of the Directive of 1991; or

(b)      any biocide product mentioned in subparagraph (1) (a) of Article 2 of the Directive of 1998.

(2)     These Regulations shall not apply to preparations in the finished state intended for the final user, that are -

(a)      medicinal products for human or veterinary use, as defined in Directive 65/65/EEC²⁸ ;

(b)      cosmetic products as defined in Directive 76/768/EEC²⁹ ;

(c)      mixtures of substances which in the form of waste are covered by Directives 75/442/EEC³⁰ and 78/319/EEC³¹ ;

(d)      foodstuffs;

(e)      animal feedingstuffs;

(f)       preparations containing radioactive substances as defined in Directive 80/836/Euratom³² ; or

(g)      medical devices which are invasive or used in direct physical contact with the human body in so far as Community measures lay down provisions for the classification and labelling of dangerous substances and preparations which ensure the same level of information provision and protection as the Directive of 1999.

(3)     These Regulations shall not apply to -

(a)      the carriage of plant protection products or biocide products by rail, road, inland waterway, sea or air; or

(b)      any plant protection product or biocide product that is under customs supervision, that does not undergo any treatment or processing.

National Authorities

4        (1)     The Pesticide Control Service of the Department of Agriculture, Food and Rural Development is hereby designated the national authority responsible for communicating and exchanging information concerning the practical application of the Directive of 1999 in relation to plant protection products and biocide products.

(2)     The Poisons Information Centre, Beaumont Hospital, Dublin 9 is hereby designated the national authority for the purposes of receiving information, including chemical composition, in relation to plant protection products and biocide products placed on the market and considered dangerous on the basis of their health effects or on the basis of their physico-chemical effects, for use solely for medical purposes in relation to formulating preventative and curative measures and in particular in case of emergency. The Poisons Information Centre shall ensure the confidentiality of information received and shall not use it for other purposes.

General requirements for placing on the market

5        (1)     The placing on the market of a plant protection product or biocide product to which these Regulations apply in the form in which it is supplied to the user and intended for use as such is hereby prohibited unless, in relation to it, the requirements of these Regulations regarding notification, clearance, classification, packaging and labelling and the provision of information, test and study reports, supporting documentation and other materials in relation to classification, packaging and labelling, are complied with.

(2)     The placing on the market of a plant protection product or biocide product to which these Regulations apply is hereby prohibited if the packaging or any label used in relation to it has such indications as “non-toxic”, “non-harmful”, “non-polluting”, “ecological” or other similar indications.

(3)     (a)      Subject to subparagraph (c), a plant protection product on the market on or before the second of December, 1985, to which Regulation 3 (1) (a) applies, shall no longer be placed on the market or used unless the package (including any label or container used with the package), and basic information as to the nature and composition of the plant protection product and as to its manufacturer or manufacturers, have been submitted for approval at a time specified by the Minister and have been approved by him, that is, the plant protection product has been duly notified.

(b)      Subject to subparagraph (c), a biocide product on the market on or before the first of February, 2002, to which Regulation 3 (1) (b) applies, shall no longer be placed on the market or used unless the package (including any label or container used with the package), and basic information as to the nature and composition and product type of the biocide product and as to its manufacturer or manufacturers, as set out in the Fifth Schedule, have been submitted for approval by the Minister on or before the first of February 2002 and have been approved by him, that is, the biocide product has been duly notified.

(c)      Persons responsible for placing plant protection products and biocide products notified in accordance with subparagraphs (a) and (b) on the market shall ensure that each such plant protection product and biocide product is classified, packaged and labelled in compliance with these Regulations.

(4)     The placing on the market of a plant protection product or biocide product to which these Regulations apply in the form in which it is supplied to the user and intended for use as such is hereby prohibited if:-

(a)      the net quantity in any container of such plant protection product or biocide product is less than the quantity stated thereon; or

(b)      the fastenings or containers used to package such plant protection product or biocide product have been tampered with.

(5)     Persons responsible for placing plant protection products and biocide products on the market shall ensure that for each such plant protection product and biocide product, the following information is provided to the national authority specified in paragraph (2) of Regulation 4, in the form specified from time to time by that authority:-

(a)      its chemical composition;

(b)      its physico-chemical effects;

(c)      its health effects;

(d)      target organs and mode of toxic action;

(e)      the symptoms and time-course of poisoning;

(f)      estimated threshold dose for toxic effects;

(g)      diagnostic measures;

(h)      therapeutic regimes and their effectiveness, including information on the use of antidotes, where available;

(i)       contact person or persons (name, address and telephone number):

-     for further information; and

-     for use in emergency situations.

Dangerous properties to be assessed and dangerous substances to be considered in the evaluation of hazards

6        (1)     Evaluation of the hazards associated with plant protection products and biocide products shall be based upon determination of their -

(a)      physico-chemical properties as provided for in Regulation 8;

(b)      properties affecting health as provided for in Regulation 9; and

(c)      environmental properties as provided for in Regulation 10.

(2)     Evaluation of the hazards associated with plant protection products and biocide products shall include consideration of the dangerous properties of all dangerous substances identified pursuant to the Directive of 1967 in accordance with the provisions of Regulations 8, 9 and 10.

(3)     Dangerous substances referred to in paragraph (2) that have been classified as being dangerous on the basis on their health and / or environmental effects, whether present as impurities or additives, shall be taken into consideration when their concentrations are equal to, or greater than those specified hereunder, unless -

(a)      lower values are given in Annex I;

(b)      lower values are given in Part B of Annex IX;

(c)      lower values are given in Part B of Annex X; or

(d)      otherwise specified in Annex XII.

General principles of classification and labelling

7        (1)     The classification of plant protection products and biocide products according to the degree and specific nature of the hazards involved shall be based upon the following categories of danger - flammable; highly flammable; extremely flammable; explosive; oxidising: corrosive; irritant: sensitising; harmful; toxic; very toxic; carcinogenic; mutagenic; toxic for reproduction; and dangerous for the environment.

(2)     The criteria set out in Annex VI shall be applied for the purposes of the classification and labelling of plant protection products and biocide products, save where alternative criteria are specified in accordance with Regulations 8, 9 and 10.

Evaluation of hazards deriving from physico-chemical properties

8        (1)     Subject to paragraph (3), the hazards associated with a plant protection product or biocide product deriving from its physico-chemical properties shall be assessed by determining, by means of the test methods specified in Part A of Annex V, the physico-chemical properties necessary for appropriate classification and labelling in accordance with the criteria laid down in Annex VI.

(2)     Notwithstanding paragraph (1):

(a)      the determination of explosive, oxidising, extremely flammable, highly flammable, or flammable properties is not necessary provided that:

-     none, of the constituents have such properties and on the basis of the information available, the plant protection product or biocide product is unlikely to present such hazards,

-     in the event of a change in the composition of a plant protection product or biocide product of known composition, scientific evidence indicates that a reassessment of the hazards will not lead to a change in classification,

-     in the case of a plant protection product or biocide product placed on the market in the form of an aerosol, it satisfies the provisions of Article 9 (a) of Directive 75/324/EEC³³ ;

(b)      in certain cases for which the methods laid down in Part A of Annex V are not appropriate, alternative calculation methods are laid down in Part B of Annex VIII; and

(c)      certain exemptions from the application of the methods laid down in Part A of Annex V are referred to in Part A of Annex VIII.

(3)     The hazards deriving from the physico-chemical properties of a plant protection product regulated in accordance with the Directive of 1991 shall be assessed by determining its physico-chemical properties necessary for classification in accordance with the criteria set out in Annex VI. These properties shall be determined by means of the test methods laid down in Part A of Annex V unless other internationally recognised test methods are acceptable in accordance with the provisions of Annex II and Annex III to the Directive of 1991.

Evaluation of health hazards

9       (1)     Subject to paragraphs (2) to (6) the health hazards associated with a plant protection product or biocide product shall be assessed by use one or more of the following procedures:

(a)      a conventional method described in Annex IX; or

(b)      the determination of the toxicological properties necessary for appropriate classification in accordance with the criteria in Annex VI. These properties shall be determined by means of the test methods laid down in Part B of Annex V, unless, in the case of plant protection products, other internationally recognised test methods are acceptable in accordance with the provisions of Annexes II and III to the Directive of 1991.

(2)     Without prejudice to the requirements of the Directive of 1991, only where it can be scientifically demonstrated that the toxicological properties of a plant protection product or biocide product cannot be determined correctly using the conventional method specified in subparagraph (1) (a), or on the basis of existing test results on animals, the test methods specified in subparagraph (1) (b) may be used.

(3)     When a toxicological property is established using the test methods specified in subparagraph (1) (b) to obtain new data, the test shall be conducted in compliance with the principles of good laboratory practice provided for in Council Directive 87/18/EEC of 18 December 1986 on the harmonisation of the laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances, provided that each such test is justified or specifically authorised in accordance with the provisions of Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental purposes³⁵ .

(4)     (a)      Subject to the provisions of paragraph (5), where a toxicological property has been established using the methods specified in both subparagraphs (1) (a) and (b), the results of testing using the test methods specified in subparagraph (1) (b) shall be used for classifying the plant protection product or biocide product, except in the case of carcinogenic, mutagenic or toxic effects for reproduction for which only the method specified in sub paragraph (1) (a) shall be used.

(b)      Any of the toxicological properties of a plant protection product or biocide product not assessed on the basis of the test methods specified in subparagraph (1) (b) shall be assessed in accordance with the method specified in subparagraph (1) (a).

(5)     Furthermore, where for any particular plant protection product or biocide product it can be demonstrated:

-     on the basis of epidemiological studies, scientifically valid case studies as specified in Annex VI, or on the basis of statistically verified experience, such as the assessment of Poison Information Centre data or occupational health surveillance data, that toxicological effects on man differ from those suggested by the application of the methods outlined in paragraph (1), the plant protection product or biocide product shall, be classified according to its effects on man,

-     that due to effects such as potentiation, a conventional assessment in accordance with subparagraph (1) (a) would underestimate the toxicological hazard, those effects shall be taken into account in classifying the preparation,

-     that due to effects such as antagonism, a conventional assessment in accordance with subparagraph (1) (a) would overestimate the toxicological hazard, those effects shall be taken into account in classifying the preparation.

(6)     For plant protection products and biocide products of known composition, with the exception of plant protection products, classified in accordance with paragraph (1) (b), a new evaluation of health hazard shall be undertaken using the methods specified in either subparagraph (1) (a) or (b) whenever:

-     changes in composition, as a weight/weight or volume/volume percentage of the plant protection product or biocide product are proposed in relation to one or more dangerous constituents, greater than the permitted variation specified in the following table:

-     changes in composition involving the substitution or addition of one or more constituents, which may or may not be dangerous.

Evaluation of environmental hazards

10      (1)     Subject to paragraphs (2) to (4) the hazards of a plant protection product or biocide product for the environment shall be assessed using one or more of the following procedures:

(a)      a conventional method described in Annex X; or

(b)      the determination of the hazardous properties for the environment necessary for appropriate classification in accordance with the criteria in Annex VI. These properties shall be determined by means of the test methods laid down in Part C of Annex V, unless, in the case of plant protection products, other internationally recognised test methods are acceptable in accordance with the provisions of Annexes II and III to the Directive of 1991.

(2)     Where an ecotoxicological property is established using the test methods specified in subparagraph (1) (b) to obtain new data, the test shall be conducted in compliance with the principles of good laboratory practice provided for in Directive 87/18/EEC³⁴ and in compliance with the provisions of Directive 86/609/EEC³⁵.

(3)     Where the environmental hazards of a plant protection product or biocide product have been established using the methods specified in both subparagraphs (1) (a) and (b), the results of testing using the methods specified in paragraph (1) (b) shall be used for classifying the plant protection product or biocide product.

(4)     For plant protection products and biocide products of known composition, with the exception of plant protection products, classified in accordance with paragraph (1) (b), a new evaluation of environmental hazard shall be undertaken using the methods specified in either subparagraph (1) (a) or (b) whenever:

-     changes in composition, as a weight/weight or volume/volume percentage of the plant protection product or biocide product are proposed in relation to one or more dangerous constituent, greater than the permitted variation specified in the following table:

-     changes in composition involving the substitution or addition of one or more constituents, which may or may not be dangerous.

Data, information, supporting documentation and materials

11      (1)     Where a plant protection product or biocide product is classified in accordance with these Regulations, the person on whose behalf the classification is made shall, whenever requested, send to the designated national authority specified in paragraph (1) of Regulation 4 for approval, an accurate record of the studies conducted and information used to support such classification or classifications and to establish the nature and extent of foreseeable risks which the handling or use of the plant protection product or biocide product entails, together with relevant supporting documentation and materials, as may be specified from time to time by the Minister, together with the particulars of any safety precautions or other recommendations and the conclusions reached as a result of the studies, information and materials.

(2)     (a)      In the case of a plant protection product to which Regulation 3 (1) (a) applies that was placed on the market on or before the second day of December 1985, the plant protection product shall not be cleared and shall no longer be placed on the market or used unless the record of the studies conducted and the information, documentation and materials to which it relates are submitted for approval at a time to be specified by the Minister and are approved by him.

(b)      In the case of a plant protection product to which Regulation 3 (1) (a) applies that was not placed on the market on or before the second day of December 1985, the plant protection product shall not be cleared and placed on the market or used unless the record of the studies conducted and the information, documentation and materials to which it relates have been approved by the Minister.

(c)      In the case of a biocide product to which Regulation 3 (1) (b) applies that was placed on the market on or before the first day of February 2002, the biocide product shall not be cleared and shall no longer be placed on the market or used unless the record of the studies conducted and the information, documentation and materials to which it relates are submitted for approval at a time to be specified by the Minister and are approved by him.

(d)      In the case of a biocide product to which Regulation 3 (1) (b) applies that was not placed on the market on or before the first day of February 2002, the biocide product shall not be cleared and placed on the market or used unless the record of the studies conducted and the information, documentation and materials to which it relates have been approved by the Minister.

(e)      In the case of a plant protection product or biocide product in relation to which the record of the studies conducted and the information, documentation and materials have neither been approved nor submitted for approval by the Minister in accordance with subparagraphs (a), (b), (c) or (d), notwithstanding non-compliance with the provisions of this Regulation, an authorised officer acting on behalf of the Minister, where there is no apparent risk to man or to the environment through the placing on the market or use of such a plant protection product or biocide, product may, by a notice in writing given to the owner or person in apparent charge or control, permit the controlled placing on the market or use of existing stocks of the plant protection product or biocide product subject to specified conditions.

(f)      The Minister may, on a request being made to him in that behalf by a person who had been granted clearance in respect of a plant protection product or biocide product, revoke any clearance granted in respect of that plant protection product or biocide product.

(3)     Notwithstanding paragraph (2) and subject to paragraph (4), in the case of a biocide product to which Regulation 3 (1) (b) applies, that was not placed on the market on or before the first day of February 2002, that contains one or more active substances not yet included in Annex I or IA of the Directive of 1998 for that product type, and that only contains active substances of biocidal products on the market on or before 14 May 2000 in a Member State of the European Union for purposes other than scientific research and development or process-oriented research and development, the biocide product may be placed on the market or used where the package (including any label or container used with the package), and basic information as to the nature and composition and product type of any such biocide product and as to its manufacturer or manufacturers, as set out in the Fifth Schedule, have been submitted for approval by the Minister and have been approved by him, that is, the biocide product has been duly notified.

(4)     Persons responsible for placing biocide products notified in accordance with paragraph (3) on the market shall ensure that each such biocide product is classified, packaged and labelled in compliance with these Regulations.

Packaging

12      (1)     Subject to paragraph (5), the packaging of a plant protection product or biocide product, together with the fastenings or containers used in such packaging and the materials constituting such packaging or fastenings, shall -

(a)      be so designed and constructed that its contents cannot escape;

(b)      not be susceptible to adverse attack by the contents, or liable to form dangerous compounds with the contents;

(c)      be strong and solid throughout such that they will not loosen and will safely meet the normal stresses and strains of handling;

(d)      in the case of containers fitted with replaceable fastening devices, be so designed that the packaging can be refastened repeatedly without the contents escaping.

(2)     The packaging of a plant protection product or biocide product shall not have -

(a)      either a shape and / or graphic decoration likely to attract or arouse the active curiosity of children or to mislead consumers; or

(b)      a presentation and / or a designation used for foodstuffs or animal feedingstuffs or medicinal or cosmetic products.

(3)     The packaging of a plant protection product or biocide product that is offered or sold to the general public, shall -

(a)      be fitted with a child-resistant fastening conforming with the technical specifications provided in Part A of Annex XI; and / or

(b)      carry a tactile warning of danger conforming to the technical specifications provided in Part B of Annex XI;

where the criteria specified in Annex XI are satisfied or although not dangerous it may nevertheless present a specific hazard.

(4)     Packaging containing a plant protection product or biocide product shall be closed with a distinctive seal in such a way that when the package is opened for the first time the seal is irreparably damaged.

(5)     Subparagraphs (a), (b) and (c) of paragraph (1) shall be deemed satisfied where the packaging of a plant protection product or biocide product to which these Regulations apply complies with the requirements for carriage of dangerous goods by rail, road, inland waterway, sea or air.

Labelling

13      (1)     The following information shall be stated clearly and in an indelible form on all packaging that is packaging mentioned in Regulation 12 (1) or on a label on or attached to such packaging in the Irish language or in the English language or in both the Irish and English languages:

(a)      the phrases and inscriptions specified in Annex XII;

(b)      in the case of plant protection products, the inscription - “To avoid risks to man and the environment, comply with the instructions for use”;

(c)      the trade name or designation of the plant protection product or biocide product;

(d)      the name, full address and telephone number of the person established in the European Union who is responsible for placing the plant protection product or biocide product on the market, whether it be the manufacturer, the importer or the distributor;

(e)      the common name of each active substance contained in the plant protection product or biocide product according to the International Standards Organisation, or, if a common name is not available, the chemical name according to rules of the International Union of Pure and Applied Chemistry;

(f)      the amount of each active substance so contained expressed:-

(i)       for solids, aerosols, volatile liquids (maximum boiling point 50 °C) or viscous liquids (lower limit 1 Past at 20 °C), as a percentage by weight;

(ii)      for other liquids, as a percentage by weight and in grams per litre at 20 °C;

(iii)     for gases, as a percentage by volume;

(iv)     for acids, their amides, esters and salts, on an acid equivalent basis;

(g)      the chemical name of each substance present in the preparation, in accordance with the designations listed in Annex I or in an internationally recognised chemical nomenclature if no corresponding designation is included in Annex I, in accordance with the following detailed rules:-

(i)       for preparations classified as very toxic, or harmful in accordance with Regulation 9 and subject to subparagraph (v), the name of every very toxic, toxic or harmful substance present in concentrations equal to, or greater than, the lowest limit (limit Xn) laid down for the substances concerned in Annex I, or failing that in Part B of Annex IX;

(ii)      for preparations classified as corrosive in accordance with Regulation 9 and subject to subparagraph (v), the name of every corrosive substance present in concentrations equal to, or greater than, the lowest limit (limit Xi) laid down for the substances concerned in Annex I, or failing that in Part B of Annex IX;

(iii)     subject to subparagraph (v), the name of every substance that has given rise to the classification of the preparation in one or more of the following danger categories:

-    carcinogen category 1, 2 or 3,

-    mutagen category 1, 2 or 3,

-    toxic for reproduction category 1, 2 or 3,

-    very toxic, toxic or harmful due to non-lethal effects after a single exposure,

-    toxic or harmful due to severe effects after repeated or prolonged exposure,

-    sensitising;

(iv)     the name of every substance that has given rise to the classification of the preparation in one or more of the following danger categories, where the name of the substance must be included on the label in accordance with subparagraphs (i), (ii) or (iii):

-    explosive,

-    oxidising,

-    extremely flammable,

-    highly flammable,

-    flammable

-    irritant,

-    dangerous for the environment;

(v)      unless more are necessary to identify the substances primarily responsible for the major health hazards that gave rise to the classification and choice of corresponding phrases in accordance with subparagraphs (i) tc (iv), a maximum of four chemical names shall suffice;

(h)      (i)       subject to subparagraphs (ii) and (iii), the danger symbols and indications of the dangers specified in Annex II and VI, selected following application of the methods for evaluation of the physico-chemical properties specified in Annex VIII, application of the methods for evaluation of the health hazards specified in Annex IX, and application of the methods for evaluation of environmental hazards specified in Annex X;

(ii)      where more than one danger symbol must be assigned to a preparation the obligation to apply the symbol:

-    T shall make use of the symbols C and X optional unless otherwise specified in Annex I,

-    C shall make use of the symbol X optional,

-     E shall make use of the symbols F and O optional,

-    Xn shall make use of the symbol Xi optional;

(iii)     the danger symbols shall be printed in black on an orange-yellow background;

(i)       (i)       Subject to subparagraphs (ii), (iii) and (iv), risk phrases (R phrases) selected from those included in Annex III and VI, assigned following application of the methods for evaluation of the physico-chemical properties specified in Annex VIII, application of the methods for evaluation of the health hazards specified in Annex IX, and application of the methods for evaluation of environmental hazards specified in Annex X;

(ii)      unless more are necessary to identify the principal hazards, a maximum of six R phrases shall suffice to describe the risks - for this purpose, the combined phrases listed in Annex III shall be regarded as single phrases;

(iii)     in the case of plant protection products and biocide products classified dangerous in more than one danger category, the R phrases selected shall cover all of the principal hazards identified;

(iv)     the R phrases “extremely flammable” or “highly flammable” need not be used where they describe an indication of danger, used in accordance with subparagraph (h);

(j)      (i)       subject to subparagraphs (iii) and (iv), safety phrases (S phrases) selected from those included in Annex IV and VI, assigned following application of the methods for evaluation of the physico-chemical properties specified in Annex VIII, application of the methods for evaluation of the health hazards specified in Annex IX, and application of the methods for evaluation of environmental hazards specified in Annex X;

(ii)      additional safety advice (additional safety phrases) selected as appropriate from the advice included in Annex VII;

(iii)     unless more are necessary to provide appropriate safety advice, a maximum of six S phrases shall suffice - for this purpose, the combined phrases listed in Annex IV shall be regarded as single phrases;

(iv)     where it is physically impossible to include the advice on the label or package itself, the package shall be accompanied by safety advice on the use of the plant protection product or biocide product;

(k)      the nominal quantity (nominal mass or nominal volume) of the contents;

(l)       the batch number of the formulation;

(m)     an indication of the nature of the formulation, using the appropriate code selected from those listed in Annex XIV; and

(n)      the reference number allocated by the national authority specified in paragraph (1) of Regulation 4.

(2)     Where the information specified in paragraph (1) appears on a label, that label shall be firmly affixed to one or more surfaces of the packaging so that those particulars can be read horizontally when the package is set down normally.

(3)     The colour and presentation of each label or packaging where the information specified in paragraph (1) is printed on the package, shall be such that the danger symbol and its background stand out clearly from it.

(4)     The information specified in paragraph (1) shall stand out clearly from its background and shall be of such size and spacing as to be easily read.

(5)     Notwithstanding subparagraphs (h), (i) and (j) of paragraph (1), where it can be demonstrated that there would be a reduction in environmental impact for plant protection products and biocide products classified as dangerous for the environment in accordance with Regulation 10, they shall be labelled in accordance with provisions to be included in Parts A or B of Annex XII.

(6)     Notwithstanding subparagraphs (i) and (j) of paragraph (1), where the contents of a package do not exceed 125 millilitres:

-     in the case of plant protection products or biocide products classified as highly flammable, oxidising or irritant, with the exception of those assigned the phrase R41, or classified as dangerous for the environment and assigned the symbol N, the labelling need not include the relevant R and S phrases, and

-     in the case of plant protection products and biocide products classified as flammable, or dangerous for the environment but not assigned the N symbol, the labelling need not include the relevant S phrases.

(7)     Notwithstanding paragraph (1), the requirements in relation to information to be included on packaging or on a label attached to such packaging shall 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 goods and the inner package or packages are labelled in accordance with paragraph (1);

(b)      in the case of a single package

-     if such a package is labelled in accordance with international rules on the transport of dangerous goods and with the requirements specified in subparagraphs (c), (d), (g), (i) and (j) of paragraph (1) - for plant protection products and biocide products classified in accordance with Regulation 10, the provisions specified in subparagraph (h) of paragraph (1) of Regulation 13 shall also apply in relation to the property in question when it has not been so identified on the label, or

-    where appropriate, for particular types of packaging such as mobile gas cylinders, the specific requirements referred to in Annex XIII are complied with.

(8)     Subject to paragraph (9), where packaging -

(a)      is either too small or is unsuitable to enable all the information required by paragraph (1) to be shown on the container itself or on a label on or attached thereto;

(b)      containing a plant protection product or biocide product classified pursuant to these Regulations as being harmful, extremely flammable, highly flammable, flammable, irritant or oxidising and the quantity so contained is small and presents no danger to persons handling the plant protection product or biocide product or who are otherwise concerned;

(c)      containing a plant protection product or biocide product classified pursuant to these Regulations as being dangerous for the environment in such small quantities that there is no reason to fear any danger to the environment; or

(d)      containing a plant protection product or biocide product not mentioned in subparagraph (b) or (c) and the quantity so contained is small and presents no danger to persons handling the plant protection product or biocide product or who are otherwise concerned;

the labelling required by paragraph (1) shall be in a manner that for the time being stands approved of for the purposes of this paragraph by the Minister and which he/she considers appropriate, subject to the symbols, indications of danger, risk phrases (R phrases) and safety phrases (S phrases) used being those specified in accordance with paragraph (1).

(9)     Where paragraph (8) is relied upon for the labelling of a plant protection product or biocide product, the national authority specified in paragraph (1) of Regulation 4 shall forthwith inform the European Commission and the Member States of the European Union thereof.

Distance selling

14      Any advertisement for a plant protection product or biocide product to which these Regulations apply, that enables a member of the general public to conclude a contract for purchase without first having sight of the label for that plant protection product or biocide product must make mention of the type or types of hazard indicated on the label. This requirement is without prejudice to Directive 97/7/EC of the European Parliament and of the Council of 20 May 1997 on the protection of consumers in respect of distance contracts³⁶ .

Safety data sheets

15      (1)     Safety data sheets intended principally for use by professional users shall be prepared by the person responsible for placing a plant protection product or biocide product on the market. Safety data sheets are intended to enable professional users to take necessary measures as regards the protection of health, safety and the environment at the place of work, and shall comply with Commission Directive 91/155/EEC³⁷ .

(2)     Persons responsible for placing a plant protection product or biocide product on the market shall ensure that a safety data sheet in accordance with paragraph (1) is supplied on request made by any professional user of a plant protection product or biocide product, where the plant protection product or biocide product:

(a)      contains at least one dangerous substance;

(b)      is classified as dangerous in accordance with Regulation 8, 9 or 10; or

(c)      although not classified as dangerous in accordance with Regulation 8, 9 or 10, contains in an individual concentration of 1% or more by weight in the case of non-gaseous preparations and 0.2% or more by volume for gaseous preparations at least:

-     one substance posing health or environmental hazards, or

-     one substance for which there is one or more EU workplace exposure limit or acceptable operator exposure level (AOEL).

(3)     Safet data sheets may be supplied on paper or in electronic form, provided that the addressee has the necessary means of receiving it.

Confidentiality of chemical names

16      (1)     Subject to paragraph (2), where the person responsible for placing a plant protection product or biocide product on the market can demonstrate that disclosure on the label or safety data sheet of the chemical identity of a substance that is classified as -

-     irritant but not assigned the phrase R41.

-     irritant and in addition, explosive, oxidising, extremely flammable, highly flammable, flammable, or dangerous for the environment,

-     harmful presenting only acute lethal effects,

-     harmful presenting only acute lethal effects, and in addition, explosive, oxidising, extremely flammable, highly flammable, flammable, or dangerous for the environment,

would put at risk his/her intellectual property, he/she may, in accordance with the procedures specified in Annex XIII, be permitted to refer to that substance either by means of a name that identifies its most important functional groups and chemical element or by means of an alternative name. This procedure may not be applied where the substance concerned has been assigned an EU workplace exposure limit or an acceptable operator exposure level (AOEL).

(2)     (a)      Where the person responsible for placing a plant protection product or biocide product on the market wishes to take advantage of the provisions of paragraph (1), a request shall be made to the competent authority of the Member State in which the preparation is to be first placed on the market. Where any such plant protection product or biocide product is first placed on the market in the territory of the State, the request shall be made to the national authority specified in paragraph (1) of Regulation 4.

(b)      Any request made pursuant to subparagraph (a) shall comply with the provisions of Annex XIII and must include the information specified in Part A of that Annex. The national authority specified in paragraph (1) of Regulation 4 may in addition request further information from the person responsible for placing on the market a plant protection product or biocide product to which paragraph (1) applies, if such information appears necessary in order to evaluate the validity of the request.

(3)     The national authority specified in paragraph (1) of Regulation 4 shall notify the applicant of its decision in relation to any request made for confidentiality. The person responsible for placing the plant protection product or biocide product on the market shall forward a copy of this decision to the national authority of each of the Member States of the European Union where he/she wishes to market the product.

(4)     Confidential information brought to the attention of the national authority specified in paragraph (1) of Regulation 4, shall be kept secret, but nevertheless may be divulged to persons directly involved in administrative or legal proceedings involving sanctions undertaken for the purpose of controlling substances, plant protection products [illegible] biocide products placed on the market and to persons who are to participate or be heard in legislative proceedings.

Emergency measures

17      (1)     Where the Minister is satisfied on the basis of detailed evidence that a plant protection product or biocide product to which these Regulations apply constitutes a hazard for man or for the environment on grounds embraced by these Regulations, he/she may either prohibit the placing on the market of such plant protection product or biocide product or permit its being so placed only if conditions specified by him/her are complied with.

(2)     Where the Minister takes action pursuant to paragraph (1), the national authority specified in paragraph (1) of Regulation 4 shall forthwith inform the European Commission and the Member States of the European Union thereof.

Notification of imports and exports

18      Persons that import plant protection products or biocide products to which these Regulations apply into the State or export such plant protection products or biocide products from the State, shall by the 1 June of each year, provide an annual return of all such imports and exports during the previous calendar year to the national authority specified in paragraph (1) of Regulation 4. Annual returns of imports and exports provided shall include the following information for each plant protection product and biocide product:-

(a)      the brand name of the plant protection product or biocide product;

(b)      the reference number allocated to the plant protection product or biocide product by the national authority specified in paragraph (1) of Regulation 4;

(c)      the number of packages of each size (specify package size by reference to volume or weight of contents); and

(d)      the total quantity (specify quantity by reference to volume or weight) imported and exported for the year for which returns are provided.

Inspections, sampling, tests and examinations

19      (1)     Subject to paragraph (7) an authorised officer may at any reasonable time enter:-

(a)      any place or premises, in which he/she has reasonable grounds for believing that a plant protection product or biocide product is being manufactured, placed on the market, stored or used;

(b)      any railway wagon, vehicle, ship, vessel, aircraft, container or other thing in which he/she has reasonable grounds for believing that a plant protection product or biocide product is being either transported, stored or used;

(c)      any premises in which he/she has reasonable grounds for believing that there are any books, documents or records relating to any business whose activities consist of or include the manufacture, placing on the market, storage, transport or use of a plant protection product or biocide product;

and there or at any other place:-

(i)       make such examinations, tests and inspections; and

(ii)      take samples in accordance with the methods described in the manual on the development and use of FAO specifications for plant protection products (Food and Agriculture Organisation of the United Nations, FAO Plant Production and Protection Paper 149, Fifth Edition), as updated from time to time, of any plant protection product or biocide product which he/she finds in the course of his/her inspection and which he/she believes is or may be a plant protection product or biocide product to which these Regulations apply; and

(iii)     take samples in accordance with Commission Directive 79/700/EEC³⁸ , or the Joint FAO/WHO Food Standards Programme, Codex Alimentarius Commission, recommended method of sampling for the determination of Pesticide Residues (Volume 2a, Codex Alimentarius, Food and Agriculture Organisation of the United Nations, World Health Organisation, “Pesticide Residues in Food, Methods of Analysis and Sampling” 2^nd edition, Rome 2000), where relevant, and in accordance with other internationally accepted procedures in other cases, of any plant, plant product, food, food product, soil, compost, or take samples from or of any other thing, which he/she finds in the course of an inspection and which he/she believes may have been treated or contaminated with a plant protection product or biocide product to which these Regulations apply;

as he/she may consider appropriate and provided the quantity which a sample taken pursuant to this Regulation comprises is reasonable.

(2)     A person who has in any place, on any premises or in any railway wagon, vehicle, ship, vessel, aircraft, container or other thing a plant protection product or biocide product to which these Regulations apply shall at all reasonable times:-

(a)      afford to an authorised officer such facilities and assistance as are reasonably necessary for an inspection and taking of samples pursuant to this Regulation;

(b)      give an authorised officer any information which he/she may reasonably require regarding the purchase, importation, sale or use of any such plant protection product or biocide product and which is within the person's knowledge or procurement; and

(c)      produce to an authorised officer any document relating to the raw materials used in the formulation of any plant protection product or biocide product which the authorised officer may reasonably require and when produced permit the officer to inspect and take extracts from the document.

(3)     In addition to the foregoing any person who carries on the business of manufacturing, formulating, packaging, processing or marketing a plant protection product or biocide product to which these Regulations apply, shall:-

(a)      keep records of all transactions regarding the plant protection product or biocide product;

(b)      produce at the request of an authorised officer any records, books or other documents relating to such business which are in his possession or under his control;

(c)      permit such an officer to inspect and take extracts from such records, books or other documents and give to the officer any information which is within his knowledge or under his control and which such officer may reasonably require in relation to any entries therein;

(d)      afford to any such an officer such facilities and assistance as are reasonably necessary for inspecting the stock of any plant protection product or biocide product on any premises on which such person carries on such a business; and

(e)      give to such an officer any information he/she may reasonably require in relation to such transactions, including, in particular, information which he/she may reasonably require regarding any plant protection product or biocide product specified by him/her.

(4)     Where a sample is taken pursuant to this Regulation, the authorised officer concerned shall:-

(a)      either:-

-     divide the sample into three or more parts, each of which he/she shall seal and mark, or

-     identify 3 or more packages or containers containing product of the same formulation batch, each package or container of which shall constitute a part which he/she shall seal and mark;

(b)      give one part thereof to a designated analyst for analysis in accordance with paragraph (5);

(c)      leave with, deliver to, or send by registered post to, the defendant or his/her agent, a second part thereof;

(d)      where there is more than one defendant, leave with, deliver to, or send by registered post to such defendant or agent of such defendant, a further part thereof; and

(e)      give the remaining part thereof to the State Chemist for analysis in accordance with paragraph 5.

(5)     Where a designated analyst or the State Chemist receives a sample from an authorized officer in pursuance of these Regulations he/she shall make analyses thereof using appropriate analytical methods.

(6)     (a)      In any proceedings for an offence under these Regulations, the result of any test, examination or analysis of, or any report on, a sample taken pursuant to this Regulation shall not be adduced unless, before the proceedings were instituted, one of the parts into which the sample was divided (as required by paragraph (4)) was left with, delivered to or sent by registered post to, the defendant or his/her agent.

(b)      In any proceedings for an offence under these Regulations, evidence of the presence of a residue of a plant protection product or biocide product to which these Regulations apply, in or on agricultural produce, in or on food or food products, in or on soil or compost or in or on surfaces or other materials which may have been treated with or exposed to the plant protection product or biocide product, shall be evidence, until the contrary is proved, of the use of the plant protection product or biocide product by the owner, occupier or person in possession, as the case may be.

(c)      In any proceedings for an offence under these Regulations, a certificate in the form set out in the Sixth or Seventh Schedule showing the results of an analysis shall, until the contrary is shown, be sufficient evidence of the facts certified to therein in relation to the presence in a plant protection product or biocide product of any substance, impurity or formulating ingredient, and the level of such presence and a document purporting to be such a certificate shall be deemed, until the contrary is shown, to be such a certificate.

(d)      In any proceedings for an offence under these Regulations, each of the documents referred to in subparagraphs (1) (ii) and (iii) may be proved by a production of a copy thereof purporting to have been published in the Official Journal of European Communities, by the Food and Agriculture Organisation of the United Nations, by the World Health Organisation, as appropriate.

(e)      For the purpose of these Regulations, the presence of a plant protection product or biocide product, to which these Regulations apply, on any premises (including any stores), shall, until the contrary is shown, be sufficient evidence that the plant protection product or biocide product in question is or was being placed on the market by the owner and by the occupier of such premises.

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

(8)     A designated analyst shall be furnished with a warrant of his/her appointment by the Minister to carry out analyses as required by these Regulations.

Seizure, retention, removal and disposal

20      (1)     An authorised officer may seize and retain, or seize, remove and retain any plant protection product or biocide product which he/she believes is a plant protection product or biocide product to which these Regulations apply and in relation to which the authorised officer has reasonable grounds for suspecting that there is or has been a failure to comply with any provision of these Regulations.

(2)     An authorised officer may by a notice in writing given to the owner or to the person in apparent charge or control of a plant protection product or biocide product that has been seized under this Regulation:-

(a)      require things specified in the notice to be done in relation to the plant protection product or biocide product before it is released by an authorised officer;

(b)      either:-

(i)       require the disposal of the plant protection product or biocide product 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 authorised officer's intention of disposing of the plant protection product or biocide product at the expense of the owner;

such disposal to be, in either case, such as will prevent the said plant protection product or biocide product from being placed on the market or used;

and in case a notice given under this paragraph requires specified things to be done in relation to a plant protection product or biocide product, the authorised officer shall retain control of the plant protection product or biocide product 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 the authorised officer by whom the notice was given sell, move, dispose of or otherwise interfere with the plant protection product or biocide product in any way pending compliance with the requirements of the notice.

(4)     Any person who is aggrieved by a notice given under paragraph (2) that either requires the plant protection product or biocide product to which it relates to be disposed of or indicates an intention to dispose of such plant protection product or biocide product may, not later than the expiration of a period of seven days beginning on the date of the notice, appeal against the notice to the District Court in the District Court District in which the notice has been served.

(5)     Disposal of a plant protection product or biocide product pursuant to a notice given under paragraph (2) shall not take place until:-

(a)      the period during which an appeal under paragraph (4) may be taken against the notice has expired; or

(b)      an appeal under that paragraph is determined or withdrawn.

(6)     (a)      Where an appeal is made to the District Court under paragraph (4) that court, if it is satisfied that:-

(i)       the plant protection product or biocide product to which the relevant notice under this Regulation relates is one to which Regulation 3 (1) applies; and

(ii)      there has been a failure to comply with the provisions of these Regulations;

shall order that the plant protection product or biocide product be disposed of in the manner specified in the notice, or in such other manner as may be specified in the court's order and which, in the opinion of the court, will prevent the plant protection product or biocide product from being used or placed on the market.

(b)      Where an order made by the District Court under this paragraph requires the plant protection product or biocide product to which it relates to be disposed of by an authorised officer, the cost of such disposal shall be recoverable by the Minister 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.

(7)     Notwithstanding paragraph (2) and the requirements of these Regulations in relation to classification, packaging and labelling, the method of disposal specified in a notice given under paragraph (2) may include its use subject to such conditions as the authorized officer may specify in the notice, provided that the officer is not aware of any apparent risk to man or the environment by such use.

(8)     In the case of a notice given under paragraph (2) which indicates an intention to dispose of a plant protection product or biocide product, the ownership of such plant protection product or biocide product shall, in the absence of an appeal by the owner against the notice to the District Court, vest in the Minister on the expiration of a period of seven days beginning on the date of the notice. In the event of an appeal by the owner against the notice to the District Court, ownership of the plant protection product or biocide product shall vest in the Minister if the court makes an order under paragraph (6) which requires the plant protection product or biocide product to be disposed of by an authorised officer.

(9)     In the case of a notice under paragraph (2) which requires the disposal at the expense of the owner of a plant protection product or biocide product that has been seized under this Regulation and where there has been a failure to pay, the cost of such disposal shall be recoverable by the Minister as a simple contract debt in any court of competent jurisdiction from the person who was the owner of the plant protection product or biocide product at the time of its seizure under this Regulation.

General offences

21      (1)     A person who contravenes Regulation 5 shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding €1,905, or to imprisonment for a term not exceeding six months, or to both.

(2)     If any person -

(a)      tampers with any plant protection product or biocide product so as to procure that any sample of it taken pursuant to Regulation 19 does not correctly represent the plant protection product or biocide product; or

(b)      tampers or interferes with any sample taken pursuant to Regulation 19,

he/she shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding €1,905 or to imprisonment for a term not exceeding six months or to both.

(3)     A person who:-

(a)      fails to comply with the requirements of Regulation 11, paragraph (1) of Regulation 17, Regulation 18, paragraphs (2) and (3) of Regulation 19, or paragraph (3) of Regulation 20;

(b)      obstructs or interferes with an authorised officer in the course of exercising a power conferred on him by Regulation 19, 20 or 26; or

(c)      gives false information when requested to provide information under Regulation 26;

shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding €1,905, or to imprisonment for a term not exceeding six months, or to both.

(4)     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/she were guilty of the first mentioned offence.

Prosecutions and specific rules of evidence

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

(2)     In proceedings for an offence under Regulation 21 (1), evidence that claims have been made that a substance or preparation -

(a)      destroys organisms harmful to plants or to plant products or protects plants and plant products form such organisms;

(b)      improves or regulates plant production, with the exception of fertilizers and soil conditioners;

(c)      preserves plant products;

(d)      destroys undesired plants;

(e)      destroys parts of plants, checks or prevents undesired growth of plants; or

(f)      renders harmless, destroys, deters, gives protection against, or prevents the action of, or otherwise exerts a controlling effect on any harmful organisms by chemical or biological means.

shall, until the contrary is shown, be sufficient evidence that it is a plant protection product or biocide product to which these Regulations apply.

Referee analysis

23      (1)     Where an appeal is made to the District Court concerning the results of any analysis made by a designated analyst under Regulation 19 (5), the results of analysis of the third part of the sample made by the State Chemist, in the form of a certificate set out in the Seventh Schedule, shall if either the District Court or the defendant so requests, be made available by the State Chemist.

(2)     Where in accordance with paragraph (1), the State Chemist is requested to make the results of an analysis carried out by him/her available, copies of the certificate in the form set out in the Seventh Schedule shall be provided to the defendant and to the designated analyst concerned.

24               The defendant shall be liable for the cost of the analysis carried out by the State Chemist under Regulation 19 (5) where a request is made by the defendant in accordance with paragraph (1) of Regulation 23 and the results of that analysis confirm that there has been a breach of these Regulations.

Fees

25      (1)     Every application for approval of documentation and materials for clearance of a plant protection product or biocide product shall be subject to the payment at the time application is made of the following fees, that is to say -

(a)      for each active substance contained in the plant protection product or biocide product, the fee set out in column (2) of Part 1A of the Eight Schedule payable to the Minister in respect of the appropriate type of clearance in relation to a category set out in column (1) of the said Part 1A;

(b)      in relation to each preparation, the fee set out in column (2) of Part 1B of the Eight Schedule payable to the Minister in respect of the appropriate type of clearance in relation to a category set out in column (1) of the said Part 1B;

(c)      a fee of €190 shall be payable in each case where application is made for minor amendment to the packaging and labelling or to the documentation and materials submitted in accordance with subparagraphs (2) (a), (b), (c) or (d) of Regulation 11, where it is considered that an evaluation of the risks arising for man, animals or the environment is not involved or required.

(2)     Every application for approval of documentation and materials, in relation to the notification of a biocide product in accordance with paragraph (3) of Regulation 11 shall be subject to the payment at the time application is made of a fee of €254.

(3)     (a)      Every grant of a clearance of a plant protection product or biocide product pursuant to paragraph (2) of Regulation 11 and every notification of a biocide product accepted pursuant to paragraph (3) of Regulation 11, shall be for 12 months from the date of such grant or acceptance and shall be renewable at the discretion of the Minister for further periods of 12 months on an application being made in that behalf to the Minister and shall be accompanied by the appropriate annual fee set out in Part 2 of the Eight Schedule. In the event of a failure to pay the annual fee set out in Part 2 of the Eight Schedule, within 30 days of the annual fee falling due, renewal of clearance or notification, as appropriate, may be granted where application is made more than 30 days but not more than 60 days after the annual fee fell due, on payment to the Minister of the late annual fee set out in Part 3 of the Eight Schedule.

(b)      Plant protection products notified as being on the market on or before the second of December 1985, in accordance with the provisions of the subparagraph (3) (a) of Regulation 5, may continue to be placed on the market and used if the annual fee set out in Part 2 of the Eight Schedule has been paid to the Minister, within 30 days of the fee falling due. Where for a particular plant protection product, the annual fee has not been paid by the date due, the notification concerned shall be revoked, but renewal of the notification may be granted where application is made more than 30 days but not more than 60 days after the annual fee fell due, on payment to the Minister of the late annual fee set out in Part 3 of the Eight Schedule.

(c)      Biocide products notified as being on the market on or before the first of February 2002, in accordance with the provisions of the subparagraph (3) (b) of Regulation 5, may continue to be placed on the market and used if the annual fee set out in Part 2 of the Eight Schedule has been paid to the Minister, within 30 days of the fee falling due. Where for a particular biocide product, the annual fee has not been paid by the date due, the notification concerned shall be revoked, but renewal of the notification may be granted where application is made more than 30 days but not more than 60 days after the annual fee fell due, on payment to the Minister of the late annual fee set out in Part 3 of the Eight Schedule.

(d)      The annual fees payable in accordance with subparagraphs (a), (b) and (c) shall be paid by 1 September of each year.

(e)      In the case of a plant protection product or biocide product already on the market for a period of one year or more prior to the calendar year for which the annual fee is payable, the Minister may reduce the level of the annual fee payable to the Minister in accordance with this paragraph, where, on the basis of an auditor's certificate furnished to him/her, he/she is satisfied that the wholesale sales of such plant protection product or biocide product during the previous calendar year did not exceed:-

(i)       in the case of a plant protection product or biocide product for household, home garden or other amateur use, €6,350; and

(ii)      in the case of any other plant protection product or biocide product, €19,050.

In all such cases, the minimum fee payable for each such plant protection product or biocide product shall be €65.

(f)      In the case of a plant protection product or biocide product on the market for less than one year prior to the calendar year for which an annual fee is payable, the Minister may refund part of the annual fee payable in accordance with this paragraph, on a request being made to him/her in that behalf, where, on the basis of an auditor's certificate furnished to him/her, he/she is satisfied that the wholesale sales of the such plant protection product or biocide product during the year for which the annual fee was paid, did not exceed -

(i)       in the case of a plant protection product or biocide product for household, home garden or other amateur use, €6,350, and

(ii)      in the case of any other plant protection product or biocide product, €19,050.

In all such cases, any refund made shall be such that for each such plant protection product or biocide product, the minimum annual fee payable shall be €65.

(4)     In the case of a plant protection product or biocide product already on the market for a period of three years or more prior to the calendar year in which the fee is payable and which is placed on the market exclusively for a specialised use or specialised uses, the fee or fees payable in accordance with paragraph (1) (a) and (b) shall be reduced by the amount specified in column (2) of Part 1C of the Eight Schedule, on a request being made to the Minister in that behalf, where, on the basis of an auditor's certificate furnished to him/her, he/she is satisfied that the wholesale sales of the plant protection product or biocide product during each of the three calendar years immediately prior to the year in which the fee or fees are payable, did not exceed the amounts specified in column (1) of the said Part 1C.

(5)     In the case of a plant protection product or biocide product on the market for a period of less than three years prior to the calendar year in which the fee is payable and which is placed on the market exclusively for a specialised use or specialised uses, the fee or fees payable in accordance with paragraph (1) (a) and (b) shall be reduced by the amount specified in column (2) of Part 1D of the Eight Schedule, on a request being made to the Minister in that behalf, where, on the basis of a market survey report provided by the applicant, he/she is satisfied that the potential annual wholesale sales of the plant protection product or biocide product do not exceed the amounts specified in column (1) of the said Part 1D. In cases, where the plant protection product or biocide product has been on the market for one or two years immediately prior to the calendar year in which the fee is payable, any application made for a reduction in fees must be supported by an auditor's certificate relating to the wholesale sales of such plant protection product or biocide product during each such year.

(6)     Each clearance of a plant protection product or biocide product and each notification accepted for a plant protection product or biocide product in accordance with the requirements of these Regulations shall be withdrawn if, in each case where such a plant protection product or biocide product continues to be placed on the market, there is a failure to pay the annual renewal fee set out in Part 2 of the Eight Schedule within 30 days of the fee falling due but an application for a renewal of clearance of a plant protection product or biocide product, or of a notification for a plant protection product or biocide product, as appropriate, may be made more than 30 but not more than 60 days after the renewal fee fell due on payment to the Minister of the late annual renewal fee set out in Part 3 of the Eight Schedule.

(7)     In the case of an application to alter the type of clearance where a clearance has been approved, the fee, or fees, payable in respect of any subsequent clearance shall be reduced by the amount already paid in accordance with paragraph (1) (a) and (b).

(8)     A fee payable under these Regulations may be recovered by the Minister as a simple contract debt in any court of competent jurisdiction.

26      A person who makes a claim for a reduction or a refund of fees in accordance with paragraphs (3), (4) or (5) of Regulation 25 shall, at all reasonable times -

(a)      produce, at the request of an authorised officer, any records, books or other documents which are in his possession or under his control which substantiate such a claim,

(b)      permit the officer to inspect and take extracts from such records, books or other documents and give to the officer any information which is within his knowledge or under his control and which such officer may reasonably require for the purpose of verifying the claim,

(c)      afford to such an officer such facilities and assistance as are reasonably necessary for inspecting the stock of the relevant plant protection product or biocide product if the officer considers such inspection is necessary for the purpose of verifying the claim.

Statutory instruments revoked

27      The following are hereby revoked -

(a)      the European Communities (Classification, Packaging and Labelling of Pesticides) Regulations, 1994 ( S.I. No. 138 of 1994 );

(b)      the European Communities (Classification, Packaging and Labelling of Pesticides) (Amendment) Regulations, 1999 ( S.I. No. 463 of 1999 ); and

(c)      the European Communities (Classification, Packaging and Labelling of Pesticides) (Amendment) Regulations, 2001 ( S.I. No. 140 of 2001 ).

FIRST SCHEDULE

Annex I

LIST OF THE DANGEROUS SUBSTANCES FOR WHICH CLASSIFICATION AND LABELLING HAVE BEEN AGREED

Comprising Annex I to the Directive of 1967, as last amended by Commission Directive 2001/59/EC of 6 August 2001 ²⁴

Annex II

(Annex II to the Directive of 1967 as amended by the Directive of 1992 and adapted by Commission Directive 2001/59/EC of 6 August 2001 ²⁴)

SYMBOLS AND INDICATIONS

Note:            The letters E, O, F, F+, T, T+, C, Xn, Xi and N do not form part of the symbol.

Annex III

(Annex III to the Directive of 1967 as amended by the Directive of 1992 and adapted by Commission Directive 2001/59/EC of 6 August 2001 ²⁴)

NATURE OF SPECIAL RISKS

Combination of R-Phrases

Annex IV

(Annex IV to the Directive of 1967 as amended by the Directive of 1992 and adapted by Commission Directive 2001/59/EC of 6 August 2001 ²⁴)

SAFETY ADVICE (PHRASES)

Combination of S-Phrases

Annex V

TEST METHODS

Comprising Annex V to the Directive of 1967, as amended by the Directive of 1992, Commission Directive 88/302/EEC of 18 November 1987 ⁶, Commission Directive 92/69/EEC of 31 July 1992 ⁹, Commission Directive 93/21/EEC of 27 April 1993 ¹⁰, Commission Directive 96/54/EC of 30 July 1996 ¹⁵, Commission Directive 98/73/EC of 18 September 1998 ¹⁷, the corrigendum to Commission Directive 98/73/EC of 18 September 1998 ¹⁸, Commission Directive 2000/32/EC of 19 May 2000 ²², Commission Directive 2000/33/EC of 25 April 2000 ²³ and Commission Directive 2001/59/EC of 6 August 2001 ²⁴

Annex VI

(Annex VI to the Directive of 1967 as amended by the Directive of 1992 and adapted by Commission Directive 2001/59/EC of 6 August 2001 ²⁴)

CLASSIFICATION AND LABELLING REQUIREMENTS FOR DANGEROUS SUBSTANCES AND PREPARATIONS

CONTENTS

1            GENERAL INTRODUCTION

1.1         The object of classification is to identify all the physico-chemical, toxicological and ecotoxicological properties of substances and preparations that may constitute a risk during normal handling or use. Having identified any hazardous properties the substance or preparation must then be labelled to indicate the hazard(s) in order to protect the user, the general public and the environment.

1.2         This Annex sets out the general principles governing the classification and labelling of substances and preparations. It is addressed to all those concerned with methods of classifying and labelling dangerous substances and preparations (manufacturers, importers, and national authorities).

1.3         The provisions of the Directive of 1967 and of these Regulations are intended to provide the primary means by which the general public and persons at work are given essential information concerning dangerous plant protection products and biocide products. The label draws the attention of persons handling or using such substances and preparations to the inherent danger of certain such materials. The label may also serve to draw attention to more comprehensive product information on safety and use available in other forms.

1.4         The label takes account of all potential hazards that are likely to be faced in the normal handling and use of dangerous substances and preparations when in the form in which they are placed on the market, but not necessarily in any different form in which they may finally be used, e.g. diluted. The most severe hazards are highlighted using symbols. Such hazards and those arising from other dangerous properties are specified using standard risk phrases. Safety phrases provide advice on necessary precautions.

In the case of substances, the information provided is completed using the name of the substance using an internationally recognised chemical nomenclature, the preferred name being the one used in the European Inventory of Existing Commercial Chemical Substances (EINECS), the European List of Notified Chemical Substances (ELINCS), the EC number and the name, address and telephone number of the person established in the Community who is responsible for placing the substance on the market.

In the case of preparations, the information provided is augmented by the:

-    designation or trade name of the preparation,

-    chemical name of the active substance(s) and dangerous substances present in the preparation in accordance Regulation 13, and

-    name, address and telephone number of the person established in the European Union who is responsible for placing the preparation on the market.

1.5         Article 6 of Directive of 1967 provides that manufacturers, distributors and importers of dangerous substances that appear in EINECS but which have not yet been introduced into Annex 1 are obliged to carry out an investigation to make themselves aware of the relevant and accessible data that exist concerning the properties of such substances. On the basis of that information, they must package and provisionally label such substances in accordance with the provisions of these Regulations and the criteria specified in this Annex.

1.6         Data required for classification and labelling

1.6.1      For substances the data required for classification and labelling may be obtained:

(a)      as regards substances for which the information specified in Annex VII of the Directive of 1967 is required, most of the necessary data for classification and labelling appear in the ‘base set’. This classification and labelling must be reviewed, if necessary, when further information is available (Annex VIII of the Directive of 1967, Annex II and Annex III of the Directive of 1991 and Annex II, Annex III and Annex IV of the Directive of 1998);

(b)      as regards other substances (e.g. those referred to in paragraph 1.5 above), the data required for classification and labelling may, if necessary, be obtained from a number of different sources, for example the results of previous tests, information required by international rules on the transport of dangerous substances, information taken from reference works and literature or information derived from practical experience. The results of validated structure-activity relationships and expert judgement may also be taken into account where appropriate.

1.6.2      For preparations, the data required for classification and labelling may be obtained:

(a)      if it concerns physico-chemical data, by the application of the test methods specified in Annex V, unless in the case of plant protection products other internationally recognised methods are acceptable in accordance with Annex II and Annex III of the Directive of 1991. For gaseous preparations a calculation method may be used for flammable and oxidising properties (see Chapter 9 of this Annex). For non-gaseous preparations containing organic peroxides a calculation method may be used for oxidising properties (see paragraph 2.2.2.1 of this Annex);

(b)      if it concerns data on health effects:

-     by the application of the test methods specified in Annex V unless in the case of plant protection products other internationally recognised methods are acceptable in accordance with Annex II and Annex III of the Directive of 1991,

-     and / or by the application of the conventional method referred to in Regulation 9, details of which are provided in Annex IX, or,

-     in the case of R65, by the application of the rules provided in paragraph 3.2.3,

-     however, if it concerns the evaluation of the carcinogenic, mutagenic and reproductive properties, by the application of the conventional method referred to in Regulation 9, details of which are provided in Annex IX;

(c)      if it concerns data on ecotoxicological properties:

(i)       for aquatic toxicity only:

-     by the application of the test methods specified in Annex V, subject to the conditions specified in Part C of Annex X, unless in the case of plant protection products other internationally recognised methods are acceptable in accordance with Annex II and Annex III of the Directive of 1991,

-    and / or by the application of the conventional method referred to in Regulation 10, details of which are provided in Annex X.;

(ii)      for the calculation of the potential for (or actual) bioaccumulation through the determination of log Pow (or BCF), or the evaluation of degradability, by application of the conventional method referred to in Regulation 10, details of which are provided in Annex X;

(iii)     for dangers to the ozone layer by the application of the conventional method referred to in Regulation 10, details of which are provided in Annex X.

1.7         Application of the criteria

Classification must cover the physico-chemical, toxicological and ecotoxicological properties of substances and preparations.

Classification of substances and preparations is made on the basis of the criteria in Chapters 2 to 5 of this Annex. All types of hazard must be considered. For instance, classification in accordance with paragraph 3.2.1 does not imply that the paragraphs such as 3.2.2 or 3.2.4 can be ignored.

The choice of symbol(s) and risk phrase(s) must be made on the basis of the classification to ensure that the specific nature of the potential dangers identified in classification is expressed on the label.

Notwithstanding the criteria specified in paragraphs 2.2.3, 2.2.4 and 2.2.5, substances and preparations in the form of aerosols shall be subject to the provisions of Directive 75/324/EEC³³ as amended and adapted to technical progress.

1.7.1.     Definitions

“Substances” means chemical elements and their compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the product, and any impurity deriving from the production process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.

A substance may be chemically very well defined (e.g. acetone) or a complex mixture of constituents of variable composition (e.g. aromatic distillates). For certain complex substances, some individual constituents have been identified.

“Preparations” means mixtures or solutions composed of two or more substances.

1.7.2      Application of the criteria for substances

The criteria set out in this Annex are directly applicable when the data in question have been obtained using test methods comparable with those described in Annex V. In other cases, the available data must be evaluated by comparing the test methods employed with those specified in Annex V, following which where appropriate the rules specified in this Annex for determining the appropriate classification and labelling may be applicable.

In some cases there may be doubt over the application of the relevant criteria, especially where these require the use of expert judgement. In such cases the manufacturer, distributor or importer should provisionally classify and label the substance on the basis of an assessment of the evidence by a competent person.

Without prejudice to Article 6 of the Directive of 1967, where the above procedure has been followed and there is concern over possible inconsistencies then a proposal may be submitted for the entry of the provisional classification into Annex I. The proposal should be made to one of the Member States and should be accompanied by appropriate scientific data (see also paragraph 4.1).

A similar procedure may be followed when information is identified which gives cause for concern over the accuracy of an existing entry in Annex I.

1.7.2.1   Classification of substances containing impurities, additives or individual constituents

Where impurities, additives or individual constituents of substances have been identified, they shall be taken into account if their concentration is greater than or equal to the limits specified:

-     0.1 % for substances classified as very toxic, toxic, carcinogenic (category 1 or 2), mutagenic (category 1 or 2) or toxic to reproduction (category 1 or 2), or dangerous for the environment (assigned the symbol “N” for the aquatic environment, dangerous for the ozone layer),

-    1% for substances classified as harmful, corrosive, irritant sensitising, carcinogenic (category 3), mutagenic (category 3), or toxic to reproduction (category 3), or dangerous for the environment (not assigned the symbol “N”, i.e. harmful to aquatic organisms, may cause long-term adverse effects),

unless lower values have been specified in Annex I.

With the exception of substances listed specifically in Annex I, classification should be carried out according to the requirements of Regulations 8, 9 and 10 and labelled according to the requirements of Regulation 13.

In the case of asbestos (650-013-00-6) this general rule does not apply until a concentration limit has been fixed in Annex I. Substances in which asbestos is present must be classified and labelled according to the principles laid down in Article 6 of the Directive of 1967.

1.7.3      Application of the criteria for preparations

The criteria set out in this Annex are directly applicable when the data in question have been obtained using test methods comparable with those described in Annex V. In the case of the criteria specified in Chapter 4, the conventional method referred to in Regulation 9 must be applied. In the case of the criteria specified in Chapter 5, a conventional method referred to in Regulation 10 is also applicable, except in the case of aquatic toxicity subject to the conditions specified in Part C of Annex X. For plant protection products, data generated in accordance with the methods specified in Annexes II and III to the Directive of 1991 may be used. In other cases, the available data must be evaluated by comparing the test methods employed with those indicated in Annex V and where appropriate applying the rules specified in this Annex for determining the appropriate classification and labelling.

If the health and environmental hazards are assessed by applying the conventional methods referred to in Regulations 9 and 10, details of which are provided in Annexes IX and X, the individual concentration limits to be used are those set out either:

-     in Annex I, or

-     in accordance with Annexes IX and X where the substance or substances do not appear in Annex I, or appear in it without concentration limits.

In the case of preparations containing mixtures of gases, classification with respect to health and environmental effects must be established using the calculation method on the basis of the individual concentration limits from Annex I or, when these limits are not in Annex I on the basis of the criteria specified in Annexes IX and X.

1.7.3.1   Preparations or substances described in paragraph 1.7.2.1 used as constituents of another preparation

The labelling of such preparations must be in conformity with the provisions of Regulation 13.

In certain cases, the information on the label of the preparation or substance described in paragraph 1.7.2.1 is insufficient to enable other manufacturers who wish to use it as a constituent of their own preparation(s) to carry out the classification and labelling of their preparation(s) correctly. In these cases, the person established within the Community responsible for placing the original preparation or substance described in paragraph 1.7.2.1 on the market whether it be the manufacturer, the importer or the distributor shall supply upon justified request and as soon as possible all necessary data concerning the dangerous substances present to enable correct classification and labelling of the new preparation. This data is also necessary to enable the person responsible for placing the new preparation on the market to comply with other provisions of these Regulations.

2            CLASSIFICATION ON THE BASIS OF PHYSICO-CHEMICAL PROPERTIES

2.1         Introduction

The test methods relating to explosive, oxidizing and flammable properties included in Annex V serve to give specific meaning to the general definitions provided in paragraph (1) of Regulation 2. Criteria follow directly from the test methods in Annex V as far as they are mentioned.

If adequate information is available to demonstrate in practice that the physico-chemical properties of substances and preparations (apart from organic peroxides) are different from those revealed by the test methods specified in Annex V, then such substances and preparations must be classified according to the hazard they present, if any, to those handling the substances and preparations or to other persons.

2.2         Criteria for classification, choice of symbols, indication of danger and choice of risk phrases

In the case of preparations, the criteria referred to in Regulation 8 must be taken into consideration.

2.2.1      Explosive

Substances and preparations shall be classified as explosive and assigned the symbol “E” and the indication of danger “explosive” in accordance with the results of the tests specified in Annex V and in so far as the substances and preparations are explosive as placed on the market. One risk phrase is obligatory, it is to be specified on the basis of the following:

R2     Risk of explosion by shock, friction, fire or other sources of ignition

-     substances and preparations except those set out below

R3     Extreme risk of explosion by shock, friction, fire or other source of ignition

-    substances and preparations which are particularly sensitive such as picric acid salts or PETN

2.2.2      Oxidizing

Substances and preparations shall be classified as oxidizing and assigned the symbol “O” and the indication of danger “oxidizing” in accordance with the results of the tests specified in Annex V. One risk phrase is obligatory, it is to be specified on the basis of the test results but subject to the following:

R7     May cause fire

-    organic peroxides which have flammable properties even when not in contact with other combustible material

R8     Contact with combustible material may cause fire

-    other oxidizing substances and preparations, including inorganic peroxides, which may cause fire or enhance the risk of fire when in contact with combustible material

R9     Explosive when mixed with combustible material

-    other substances and preparations, including inorganic peroxides, which become explosive when mixed with combustible materials, e.g. certain chlorates

2.2.2.1   Remarks concerning peroxides

In relation to explosive properties, an organic peroxide or preparation thereof in the form in which it is placed on the market must be classified according to the criteria in paragraph 2.2.1 on the basis of tests carried out in accordance with the methods specified in Annex V.

In relation to oxidising properties, the methods currently included in Annex V cannot be applied to organic peroxides.

Substances that are organic peroxides and not already classified as explosive are classified as dangerous on the basis of their structure (e.g. R-0-0-H; R₁-0-0-R₂).

Preparations not already classified as explosive must be classified using the calculation method based on the percentage of active oxygen shown in paragraph 9.5.

Any organic peroxide or preparation thereof not already classified as explosive is classified as oxidising, if the peroxide or its formulation contains:

-     more than 5% of organic peroxides, or

-     more than 0.5% available oxygen from organic peroxides, and more than 5% hydrogen peroxide

2.2.3      Extremely flammable

Substances and preparations shall be classified as extremely flammable and assigned the symbol “F+” and the indication of danger “extremely flammable” in accordance with the results of the tests specified in Annex V. The risk phrase R12 shall be assigned in accordance with the following criteria:

R12   Extremely flammable

-     liquid substances and preparations which have a flash point lower than 0°C and a boiling point (or in case of a boiling range the initial boiling point) lower than or equal to 35°C

-     gaseous substances and preparations which are flammable in contact with air at ambient temperature and pressure

2.2.4      Highly flammable

Substances and preparations shall be classified as highly flammable and assigned the symbol “F” and the indication of danger “highly flammable” in accordance with the results of the tests specified in Annex V. Risk phrases shall be assigned in accordance with the following criteria:

R11   Highly flammable

-     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

-     liquid substances and preparations having a flash point below 21°C but which are not extremely flammable.

R15   Contact with water liberates extremely flammable gases

-     substances and preparations which, in contact with water or damp air, evolve extremely flammable gases in dangerous quantities, at a minimum rate of one litre per kilogram per hour

R17   Spontaneously flammable in air

-     substances and preparations which may become hot and finally catch fire in contact with air at ambient temperature without any input of energy

2.2.5      Flammable

Substances and preparations shall be classified as flammable in accordance with the results of the tests specified in Annex V. The risk phrase shall be assigned in accordance with the criteria mentioned below.

R10   Flammable

-     liquid substances and preparations having a flash point equal to or greater than 21 °C, and less than or equal to 55 °C.

However, in practice it has been shown that a preparation having a flash point equal to or greater than 21 °C and less than or equal to 55 °C need not be classified as flammable if the preparation could not in any way support combustion, subject to there being no reason to fear risks to those handling these preparations or to other persons.

2.2.6      Other physico-chemical properties

Additional risk phrases shall be assigned to substances and preparations which have been classified in accordance with paragraphs 2.2.1 to 2.2.5 above, or in accordance with Chapters 3, 4 and 5 below, in accordance with the following criteria (based on experience obtained during compilation of Annex I):

R1     Explosive when dry

for explosive substances and preparations put on the market in solution or in a wetted form; e.g. nitro-cellulose with more than 12.6% nitrogen

R4     Forms very sensitive explosive metallic compounds

for substances and preparations which may form sensitive explosive metallic derivatives, e.g. picric acid, styphnic acid

R5     Heating may cause an explosion

for thermally unstable substances and preparations not classified as explosive, e.g. perchloric acid > 50%

R6     Explosive with or without contact with air

for substances and preparations which are unstable at ambient temperatures, e.g. acetylene

R7     May cause fire

for reactive substances and preparations: e.g. fluorine, sodium hydrosulphite.

R14   Reacts violently with water

for substances and preparations which react violently with water, e.g. acetyl chloride, alkali metals, titanium tetrachloride

R16   Explosive when mixed with oxidizing substances

for substances and preparations which react explosively with an oxidizing agent, e.g. red phosphorus

R18   In use, may form flammable / explosive vapour-air mixture

for preparations not in themselves classified as flammable, which contain volatile components that are flammable in air

R19   May form explosive peroxides

for substances and preparations which may form explosive peroxides during storage, e.g. diethyl ether, 1,4-dioxan

R30   Can become highly flammable in use

for preparations not in themselves classified as flammable, which may become flammable due to the loss of non-flammable volatile components

R44   Risk of explosion if heated under confinement

for substances and preparations not in themselves classified as explosive in accordance with paragraph 2.2.1 but which may nevertheless display explosive properties in practice if heated under sufficient confinement. For example, certain substances that would decompose explosively if heated in a steel drum do not show this effect if heated in less-strong containers

For other additional risk phrases see paragraph 3.2.8.

3            CLASSIFICATION ON THE BASIS OF TOXICOLOGICAL PROPERTIES

3.1         Introduction

3.1.1      Classification is concerned with both the acute and long-term effects of substances and preparations, whether resulting from a single instance of exposure or repeated or prolonged exposure.

If adequate evidence is available to demonstrate that in practice the toxic effect of substances and preparations on man is, or is likely to be, different from that suggested by the experimental results obtained in animal tests or by the application of the conventional method referred to in Regulation 9, details of which are provided in Annex IX, then such substances and preparations should be classified according to their toxicity in man. The evidence referred to includes epidemiological studies, scientifically valid case studies as specified in this Annex, and statistically backed experience such as the assessment of data from poison information units or concerning occupational diseases. However, tests on man are discouraged and should not normally be used to negate positive animal data.

Directive 86/609/EEC³⁵ serves to protect animal used for experimental and other scientific purposes. For several endpoints there are validated in vitro test methods in Annex V and these should be used where appropriate.

3.1.2      The classification of substances must be made on the basis of the experimental data available in accordance with the following criteria, which take into account the magnitude of these effects:

(a)      for acute toxicity (lethal and irreversible effects after a single exposure), the criteria specified in paragraphs 3.2.1 to 3.2.3 are to be used;

(b)      for subacute, subchronic or chronic toxicity the criteria specified in paragraphs 3.2.2 to 3.2.4 are to be used;

(c)      for corrosive and irritant effects the criteria specified in paragraphs 3.2.5 and 3.2.6 are to be used;

(d)      for sensitising effects the criteria specified in paragraph 3.2.7 are to be used;

(e)      for specific effects on health (carcinogenicity, mutagenicity and reproductive toxicity), the criteria specified in Chapter 4 are to be used.

3.1.3.     For preparations, classification in relation to danger for health must be carried out:

(a)      on the basis of the conventional method referred to in Regulation 9, details of which are provided in Annex IX, in the absence of experimental data. Where the conventional method is used, the classification must be based on the individual concentration limits taken from:

-     either Annex I,

-     or provided for in Annex IX, where the substance or substances do not appear in Annex I, or appear in it without concentration limits; or

(b)      when experimental data are available, in accordance with the criteria described in paragraph 3.1.2 - however carcinogenic, mutagenic and toxic to reproduction properties referred to under 3.1.2 (e) must be evaluated using the conventional method specified in Annex IX.

Whichever method is used for the evaluation of the danger of a preparation, all the dangerous effects addressed in Annex IX must be taken into consideration.

3.1.4     When the classification is to be established on the basis of experimental results obtained in animal tests the results should have validity for man in that the tests reflect, in an appropriate way, the risks to man.

3.1.5     The acute oral toxicity of substances or preparations placed on the market may be established through use of a method permitting assessment of the LD₅₀ value, by determining the discriminating dose (the fixed dose procedure) or by determining the range of exposure where lethality may be expected (the acute toxic class method).

3.1.5.1   The discriminating dose is the dose that causes evident toxicity but not mortality and must be one of the four dosage levels specified in Annex V (5, 50, 500 or 2,000 mg per kg body weight).

The concept “evident toxicity” is used to designate toxic effects, after exposure to the substance tested, which are so severe that exposure to the next highest fixed dose would probably lead to mortality.

The results of testing at a particular dose following the fixed dose method may be either:

-     less than 100 % survival,

-    100 % survival, but evident toxicity,

-    100 % survival, but no evident toxicity.

The criteria in paragraphs 3.2.1, 3.2.2 and 3.2.3 only include the final test result. The 2,000 mg/kg dose should be used primarily to obtain information on the toxic effects of substances which are of low acute toxicity and which are not classified on the basis of acute toxicity.

The test method requires in some cases testing at higher or lower doses, if not already tested at the relevant dose level. Refer also to the evaluation table in test method B.1 bis of Annex V.

3.1.5.2   The range of exposure where lethality may be expected is derived from the observed absence or presence of substance related mortality where the acute toxic class method has been used. For initial testing one of three fixed starting doses (25, 200 or 2,000 mg/kg body weight) should be used.

3.2         Criteria for classification, choice of symbols, indication of danger, choice of risk phrases

3.2.1      Very toxic

Substances and preparations shall be classified as very toxic, and assigned the symbol “T +” and the indication of danger “very toxic” in accordance with the criteria specified below.

Risk phrases shall be assigned in accordance with the following criteria:

R28   Very toxic if swallowed

acute toxicity results:

-     LD₅₀ oral, rat [not less than or equal to] 25 mg/kg

-     less than 100% survival at 5 mg/kg oral, rat using the fixed dose procedure, or

-     high mortality at doses [not less than or equal to] 25 mg/kg oral, rat, using the acute toxic class method (for test result interpretation see the flow charts in Appendix 2 to test method B.1 ter of Annex V)

R27   Very toxic in contact with skin

acute toxicity results:

-     LD₅₀ dermal, rat or rabbit: [not less than or equal to] 50 mg/kg

R26   Very toxic by inhalation

acute toxicity results:

-     LC₅₀ inhalation, rat, for aerosols or particulates: [not less than or equal to] 0.25 mg/litre/4hr

-     LC₅₀ inhalation, rat, for gases and vapours: [not less than or equal to] 0.5 mg/litre/4hr.

R39   Danger of very serious irreversible effects

-    strong evidence that irreversible damage other than the effects referred to in Chapter 4 is likely to be caused by a single exposure by an appropriate route, generally in the above mentioned dose range.

In order to indicate the route of administration/exposure one of the following combinations shall be used: R39/26, R39/27, R39/28, R39/26/27, R39/26/28, R39/27/28, R39/26/27/28.

3.2.2      Toxic

Substances and preparations shall be classified as toxic and assigned the symbol “T” and the indication of danger “toxic” in accordance with the criteria specified below. Risk phrases shall be assigned in accordance with the following criteria.

R25   Toxic if swallowed

acute toxicity results:

-     LD₅₀ oral, rat: 25 < LD₅₀ [not less than or equal to] 200 mg/kg

-     discriminating dose, oral, rat, 5 mg/kg: 100% survival but evident toxicity, or

-     high mortality at doses < 25 to [not less than or equal to] 200 mg/kg oral, rat, using the acute toxic class method (for test result interpretation see the flow charts in Appendix 2 to test method B.1 ter of Annex V)

R24   Toxic in contact with skin

acute toxicity results:

-     LD₅₀ dermal, rat or rabbit: 50 < LD₅₀ [not less than or equal to] 400 mg/kg.

R23   Toxic by inhalation

acute toxicity results:

-     LC₅₀ inhalation, rat for aerosols or particulates: 0.25 < LC₅₀ [not less than or equal to] 1 mg/litre/4hr

-     LC₅₀ inhalation, rat, for gases and vapours: 0.5 < LC₅₀ [not less than or equal to] 2 mg/litre/4hr

R39   Danger of very serious irreversible effects

-     strong evidence that irreversible damage other than the effects referred to in Chapter 4 is likely to be caused by a single exposure by an appropriate route, generally in the above mentioned dose range

In order to indicate the route of administration/exposure one of the following combinations shall be used: R39/23, R39/24, R39/25, R39/23/24, R39/23/25, R39/24/25, R39/23/24/25.

R48   Danger of serious damage to health by prolonged exposure

-     serious damage (clear functional disturbance or morphological change which has toxicological significance) is likely to be caused by repeated or prolonged exposure by an appropriate route

Substances and preparations are classified at least as Toxic when these effects are observed at levels of one order of magnitude lower (i.e. 10-fold) than those set out for R48 in paragraph 3.2.3.

In order to indicate the route of administration/exposure one of the following combinations shall be used: R48/23, R48/24, R48/25, R48/23/24, R48/23/25, R48/24/25, R48/23/24/25.

3.2.3      Harmful

Substances and preparations shall be classified as harmful and assigned the symbol “Xn” and the indication of danger “harmful” in accordance with the criteria specified below. Risk phrases shall be assigned in accordance with the following criteria:

R22   Harmful if swallowed

acute toxicity results:

-     LD₅₀ oral, rat: 200 < LD₅₀ [not less than or equal to] 2,000 mg/kg

-     discriminating dose, oral, rat, 50 mg/kg: 100% survival but evident toxicity

-     less than 100 % survival at 500 mg/kg, rat oral by the fixed dose procedure. Refer to the evaluation table in the test method B1 (a) of Annex V, or

-     high mortality at doses <200 to [not less than or equal to] 2,000 mg/kg oral, rat, using the acute toxic class method (for test result interpretation see the flow charts in Appendix 2 to test method B.1 ter of Annex V).

R21   Harmful in contact with skin

acute toxicity results:

-     LD₅₀ dermal, rat or rabbit: 400 < LD₅₀ [not less than or equal to] 2,000 mg/kg

R20   Harmful by inhalation

acute toxicity results:

-     LC₅₀ inhalation, rat, for aerosols or particulates: 1 < LC₅₀ [not less than or equal to] 5 mg/litre/4hr

-     LC₅₀ inhalation, rat, for gases or vapours: 2 < LC₅₀ [not less than or equal to] 20 mg/litre/4hr.

R65   Harmful: may cause lung damage if swallowed

liquid substances and preparations presenting an aspiration hazard in humans because of their low viscosity:

(a)      for substances and preparations containing aliphatic, alicyclic and aromatic hydrocarbons in a total concentration equal to or greater than 10% and having either

-     a flow time of less than 30 sec in a 3 mm ISO cup according to ISO 2431 (April 1996 / July 1999 edition) relating to “Paints and varnishes - Determination of flow time by use of flow cups”, or

-     a kinematic viscosity measured by a calibrated glass capillary viscometer in accordance with ISO 3104/3105 of less than 7 × 10^-6 m² / sec at 40°C (ISO 3104, 1994 edition, relating to “Petroleum products - Transparent and opaque liquids - Determination of kinematic viscosity and calculation of dynamic viscosity”: ISO 3105, 1994 edition, relating to “Glass capillary kinematic viscometers - Specifications and operating instructions”), or

-     a kinematic viscosity derived from measurements of rotational viscometry in accordance with ISO 3219 of less than 7 × 10^-6 m² / sec at 40 °C (ISO 3219, 1993 edition, relating to “Plastics - Polymers / resins in the liquid state or as emulsions or dispersions - Determination of viscosity using a rotational viscometer with defined shear rate”);

(b)      for substances and preparations, based on practical experience in humans.

R68   Possible risk of irreversible effects

-     strong evidence that irreversible damage other than the effects referred to in Chapter 4 is likely to be caused by a single exposure by an appropriate route, generally in the above mentioned dose range

In order to indicate route of administration/exposure one of the following combinations shall be used: R68/20, R68/21, R68/22, R68/20/21, R68/20/22, R68/21/22, R68/20/21/22.

R48   Danger of serious damage to health by prolonged exposure

-     serious damage (clear functional disturbance or morphological change which has toxicological significance) is likely to be caused by repeated or prolonged exposure by an appropriate route

Substances and preparations are classified at least as harmful when these effects are observed at levels of the order of.

-     oral, rat [not less than or equal to] 50 mg/kg (body weight)/day,

-     dermal, rat or rabbit [not less than or equal to] 100mg/kg (body weight)/day,

-     inhalation, rat [not less than or equal to] 0.25 mg/1, 6h/day.

These guide values can apply directly when severe lesions have been observed in a subchronic (90-day) toxicity test. When interpreting the results of a sub-acute (28-day) toxicity test these figures should be increased approximately three fold. If a chronic (2-year) toxicity test is available it should be evaluated on a case-by-case basis. If results of studies of more than one duration are available, then those from the study of the longest duration should normally be used.

In order to indicate route of administration/exposure one of the following combinations shall be used: R48/20, R48/21, R48/22, R48/20/21, R48/20/22, R48/21/22, R48/20/21/22.

3.2.3.1   Comments regarding volatile substances

For certain substances with a high saturated vapour concentration evidence may be available to indicate effects that give cause for concern. Such substances may not be classified under the criteria for health effects in this Annex (paragraph 3.2.3) or not covered by the criteria in paragraph 3.2.8. However, where there is appropriate evidence that such substances may present a risk in normal handling and use then classification on a case-by-case basis in Annex I may be necessary.

3.2.4      Comments regarding the use of R48

Use of this risk phrase refers to the specific range of biological effects as outlined hereunder. For application of this risk phrase serious damage to health is to be considered to include death, clear functional disturbance and morphological changes which are toxicologically significant. It is particularly important when these changes are irreversible. It is also important to consider not only specific severe changes in a single organ or biological system but also generalised changes of a less severe nature involving several organs, or severe changes in general health status.

When assessing whether there is evidence of such effects reference should be made to the following guidelines:

1        evidence indicating that R48 should be applied:

(a)      substance-related deaths:

(b)      (i)      major functional changes in the central or peripheral nervous systems, including sight, hearing and the sense of smell, assessed by clinical observations or other appropriate methods (e.g. electrophysiology),

(ii)      major functional changes in other organ systems (for example the lung);

(c)      any consistent changes in clinical biochemistry, haematology or urinalysis parameters which indicate severe organ dysfunction. Haematological disturbances are considered to be particularly important if the evidence suggests that they are due to decreased bone marrow production of blood cells;

(d)      severe organ damage noted on microscopic examination following autopsy.

(i)       widespread or severe necrosis, fibrosis or granuloma formation in vital organs with regenerative capacity (e.g. liver).

(ii)      severe morphological changes that are potentially reversible but are clear evidence of marked organ dysfunction (e.g. severe fatty change in the liver, severe acute tubular nephrosis in the kidney, ulcerative gastritis), or

(iii)     evidence of appreciable cell death in vital organs incapable of regeneration (e.g. fibrosis of the myocardium or dying back of a nerve) or in stem cell populations (e.g. aplasia or hypoplasia of the bone marrow).

The above evidence will most usually be obtained from animal experiments. When considering data derived from practical experience special attention should be given to exposure levels.

2        Evidence indicating that R48 should not be applied

The use of this risk phrase is restricted to “serious damage to health by prolonged exposure”. A number of substance-related effects may be observed in both humans and animals that would not justify the use of R48. These effects are relevant when attempting to determine a no-effect level for a chemical substance.

Examples of well documented changes which would not normally justify classification with R48, irrespective of their statistical significance, include:

(a)      clinical observations or changes in bodyweight gain, food consumption or water intake, which may have some toxicological importance but which do not, by themselves, indicate “serious damage”;

(b)      small changes in clinical biochemistry, haematology or urinalysis parameters which are of doubtful or minimal toxicological importance;

(c)      changes in organ weights with no evidence of organ dysfunction;

(d)      adaptative responses (e.g. macrophage migration in the lung, liver hypertrophy and enzyme induction, hyperplastic responses to irritants). Local effects on the skin produced by repeated dermal application of a substance which are more appropriately classified with R38 “irritating to skin”; or

(e)      where a species-specific mechanism of toxicity (e.g. specific metabolic pathways) has been demonstrated.

3.2.5      Corrosive

Substances and preparations shall be classified as corrosive and assigned the symbol “C” and the indication of danger “Corrosive” in accordance with the following criteria:

-     a substance or a preparation shall be considered corrosive if, when it is applied to healthy intact animal skin, it produces full thickness destruction of skin tissue on at least one animal during the test for skin irritation cited in Annex V or during an equivalent test,

-     classification can be based on the results of a validated in vitro test such as that cited in Annex V (B.40 Skin corrosion: rat skin transcutaneous electrical resistance assay and human skin model assay).

-     a substance or a preparation shall also be considered corrosive if the result can be predicted, for example from strongly acid or alkaline reactions indicated by a pH of 2 or less or 11.5 or greater. Where extreme pH is the basis for classification, alkaline / acidic reserve may also be taken into consideration (J.R. Young, M.J. How, A.P. Walker and W.M.H. Worth (1998), “Classification as corrosive or irritant to skin of preparations containing acidic or alkaline substances, without testing on animals”, Toxic. In Vitro 2(1): pp 19-26). If consideration of alkaline or acidic reserve suggests that the substance or preparation may not be corrosive then further testing should be carried out to confirm this, preferably using an appropriate validated in vitro test. Consideration of alkaline or acidic reserve should not be used alone to exonerate substances or preparations from classification as corrosive.

Risk phrases shall be assigned in accordance with the following criteria:

R35   Causes severe burns

-     if, when applied to healthy intact animal skin, full thickness destruction of skin tissue occurs as a result of up to three minutes exposure, or if this result can be predicted.

R34   Causes burns

-     if, when applied to healthy intact animal skin, full thickness destruction of skin tissue occurs as a result of up to four hours exposure, or if this result can be predicted

-     organic hydroperoxides, except where evidence to the contrary is available.

3.2.6      Irritant

Substances and preparations shall be classified as irritant and assigned the symbol “Xi” and the indication of danger “irritant” in accordance with the criteria specified hereunder.

3.2.6.1   Inflammation of the skin

The following risk phrase shall be assigned in accordance with the criteria specified:

R38   Irritating to skin

-    substances and preparations which cause significant inflammation of the skin which persists for at least 24 hours after an exposure period of up to four hours determined on the rabbit according to the cutaneous irritation test method cited in Annex V

Inflammation of the skin is significant if:

(a)      the mean value of the scores for either erythema and eschar formation or oedema formation, calculated over all the animals tested, is 2 or more, or

(b)      in the case where the Annex V test has been completed using three animals, either erythema and eschar formation or oedema formation equivalent to a mean value of 2 or more calculated for each animal separately has been observed in two or more animals.

In both cases all scores at each of the reading times (24, 48 and 72 hours) for an effect should be used in calculating respective mean values.

Inflammation of the skin is also significant if it persists in at least two animals at the end of the observation time. Particular effects e.g. hyperplasia, scaling, discoloration, fissures, scabs and alopecia should be taken into account.

Relevant data may also be available from non-acute animal studies (see comments on R48). These are considered significant if the effects seen are comparable to those described above.

-     substances and preparations that cause significant inflammation of the skin, based on practical observations in humans on immediate, prolonged or repeated contact

-     Organic peroxides, except where evidence to the contrary is available.

Paresthesia:

Paresthesia caused in humans by skin contact with pyrethroid pesticides is not regarded as an irritant effect justifying classification as Xi; R38. The S-phrase S24 should however be applied for substances seen to cause this effect.

3.2.6.2   Ocular lesions

The following risk phrases shall also be assigned in accordance with the criteria specified hereunder:

R36   Irritating to eyes

-     substances and preparations which, when applied to the eye of the animal, cause significant ocular lesions which occur within 72 hours after exposure and which persist for at least 24 hours

Ocular lesions are significant if the mean scores of the eye irritation test cited in Annex V have any of the following values:

-     cornea opacity equal to or greater than 2 but less than 3

-     iris lesion equal to or greater than 1 but not greater than 1.5

-     redness of the conjunctivae equal to or greater than 2.5

-     oedema of the conjunctivae (chemosis) equal to or greater than 2

or, in the case where the Annex V test has been completed using three animals if the lesions on two or more animals are equivalent to any of the above values, except that for iris lesion the value should be equal to or greater than 1 but less than 2 and for redness of the conjunctivae the value should be equal to or greater than 2.5

In both cases all scores at each of the reading times (24, 48 and 72 hours) for an effect should be used in calculating the respective mean values.

-     substances or preparations which cause significant ocular lesions, based on practical experience in humans

-     organic peroxides except where evidence to the contrary is available

R41   Risk of serious damage to eyes

-     substances and preparations which, when applied to the eye of the animal cause severe ocular lesions which occur within 72 hours after exposure and which persist for at least 24 hours

Ocular lesions are severe if the means of the scores of the eye irritation test in Annex V have any of the values:

-     cornea opacity equal to or greater than 3

-     iris lesion greater than 1.5

The same shall be taken to be the case where the test has been completed using three animals if these lesions, on two or more animals, have any of the values:

-     cornea opacity equal to or greater than 3

-     iris lesion equal to 2

In both cases all scores at each of the reading times (24, 48 and 72 hours) for an effect should be used in calculating the respective mean values.

Ocular lesions are also severe when they are still present at the end of the observation time.

Ocular lesions are also severe if the substance or preparation causes irreversible coloration of the eyes.

-     substances and preparations that cause severe ocular lesions, based on practical experience in humans

3.2.6.3   Respiratory system irritation

The following risk phrase shall be assigned in accordance with the criteria specified:

R37   Irritating to respiratory system

-     substances and preparations that cause serious irritation to the respiratory system based on:

-     practical observation in humans.

-     positive results from appropriate animal tests

Comments regarding the use of R37

In interpreting practical observations in humans, care should be taken to distinguish between effects which lead to classification with R48 (see paragraph 3.2.4) from those leading to classification with R37. Conditions normally leading to classification with R37 are reversible and usually limited to the upper airways.

Positive results from appropriate animal tests may include data obtained in a general toxicity test, including histopathological data relating to the respiratory system. Data from the measurement of experimental bradypnea may also be used to assess airway irritation.

3.2.7      Sensitisation

3.2.7.1   Sensitisation by inhalation

Substances and preparations shall be classified as sensitising and assigned the symbol “Xn”, the indication of danger “Harmful” and the risk phrase R42 in accordance with the criteria specified hereunder:

R42   May cause sensitisation by inhalation

-     if there is evidence that the substance or preparation can induce specific respiratory hypersensitivity,

-     where there are positive results from appropriate animal tests, or

-     if the substance is an isocyanate, unless there is evidence that the substance does not cause respiratory hypersensitivity.

Comments regarding the use of R42

Human evidence

Evidence that the substance can induce specific respiratory hypersensitivity will normally be based on human experience. In this context hypersensitivity is normally seen as asthma, but other hypersensitivity reactions such as rhinitis and alveolitis must also be considered. The condition will have the clinical character of an allergic reaction. However, immunological mechanisms need not be demonstrated.

When considering the evidence following human exposure, it is necessary for a decision on classification to take into account in addition to the evidence from the cases:

-     the size of the population exposed, and

-     the extent of exposure.

The evidence referred to above could be clinical history and data from appropriate lung function tests related to exposure to the substance, confirmed by other supportive evidence that may include:

-    a chemical structure related to substances known to cause respiratory hypersensitivity;

-     in vivo immunological test (e.g. skin prick test);

-     in vitro immunological test (e.g. serological analysis);

-    studies that may indicate other specific, but non-immunological mechanisms of action, e.g. repeated low level irritation, pharmacologically mediated effects; or

-    data from a positive bronchial challenge test with the substance, conducted according to accepted guidelines for the determination of a specific hypersensitivity reaction.

Clinical history should include both medical and occupational history to determine a relationship between exposure to a specific substance or preparation and development of respiratory hypersensitivity. Relevant information includes aggravating factors both in the home and workplace, the onset and progress of the disease, family history and medical history of the patient in question. The medical history should also include a note of other allergic or airway disorders from childhood, and smoking history.

The results of positive bronchial challenge tests are considered to provide sufficient evidence on their own for classification. It is however recognised that in practice that many of the examinations listed above will already have been carried out.

Substances that elicit symptoms of asthma by irritation only in people with bronchial hyper-reactivity should not be assigned R42.

Animal Studies

Data from tests that may be indicative of the potential of a substance to cause sensitisation by inhalation in humans may include:

-     IgE measurements (e.g. in mice), and

-     specific pulmonary responses in guinea pigs.

3.2.7.2   Sensitisation by skin contact

Substances and preparations shall be classified as sensitising and assigned the symbol “Xi”, the indication of danger “Irritant” and the risk phrase R43 in accordance with the criteria given hereunder:

R43   May cause sensitisation by skin contact

-     if practical experience shows the substance or preparation to be capable of inducing sensitisation by skin contact in a substantial number of persons,

-     where there are positive results from an appropriate animal test

Comments regarding the use of R43

Human evidence

The following evidence (practical experience) is sufficient to classify a substance or preparation with R43:

-     positive data from appropriate patch testing, normally in more than one dermatological clinic;

-     epidemiological studies showing allergic contact dermatitis caused by the substance or preparation. Situations in which a high proportion of those exposed exhibit characteristic symptoms are to be looked at with special concern, even if the number of cases is small; or

-     positive data from experimental studies in man (see also paragraph 3.1.1).

The following is sufficient to classify a substance with R43 when there is supportive evidence:

-     isolated episodes of allergic contact dermatitis; or

-     epidemiological studies where chance, bias or confounders have not been ruled out fully with reasonable confidence.

Supportive evidence may include:

-     data from animal tests performed according to existing guidelines, with a result that does not meet the criteria given in the section on animal studies but is sufficiently close to the limit to be considered significant:

-     data from non-standard methods; or

-     appropriate structure-activity relationships.

Animal studies

Positive results from appropriate animal tests are:

-     in the case of the adjuvant type test method for skin sensitisation detailed in Annex V or in the case of other adjuvant-type test methods, a response of at least 30 % of the animals considered,

-     for any other test method a response of at least 15 % of the animals is considered.

3.2.7.3   Immunological contact urticaria

Some substances or preparations that meet the criteria for R42 may in addition cause immunological contact urticaria. In these cases, information concerning contact urticaria should be included by the use of appropriate S-phrases, usually S24 and S36/37, and in the Safety Data Sheet.

For substances or preparations, which produce signs of immunological contact urticaria, which do not fulfil the criteria for R42, consideration should be given to classification with R43.

There is no recognised animal model available to identify substances that cause immunological contact urticaria. Therefore, classification is normally based on human evidence similar to that for skin sensitisation (R43).

3.2.8      Other toxicological properties

Additional risk phrases shall be assigned in accordance with the following criteria (based on experience obtained during compilation of Annex I) to substances and preparations classified by virtue of paragraphs 2.2.1 to 3.2.7 above and/or chapters 4 and 5:

R29   Contact with water liberates toxic gas

substances and preparations which in contact with water or damp air, evolve very toxic/toxic gases in potentially dangerous amounts, e.g. aluminium phosphide, phosphorus pentasulphide

R31   Contact with acids liberates toxic gas

substances and preparations which react with acids to evolve toxic gases in dangerous amounts, e.g. sodium hypochlorite, barium polysulphide. For substances used by members of the general public, the use of S50 (do not mix with ... (to be proposed by the manufacturer)) would be more suitable

R32   Contact with acids liberates very toxic gas

substances and preparations which react with acids to evolve very toxic gases in dangerous amounts; e.g. salts of hydrogen cyanide, sodium azide. For substances used by members of the general public, the use of S50 (do not mix with ... (to be proposed by the manufacturer)) would be more suitable

R33   Danger of cumulative effects

substances and preparations likely to accumulate in the human body and may cause some concern which, however, is not sufficient to justify the use of R48

For comments on use for substances of R33 see paragraph 4.2.3.3 and for preparations see paragraph 3 of Part of Annex XII

R64   May cause harm to breastfed babies

substances and preparations absorbed by women and that may interfere with lactation or that may be present (including metabolites) in breast milk in amounts sufficient to cause concern for the health of a breastfed child

For comments on the use for substances of R64 (and in some cases R33) see paragraph 4.2.3.3 and for preparations see paragraph 4 of Part A of Annex XII.

R66   Repeated exposure may cause skin dryness or cracking

substances and preparations that may cause concern as a result of skin dryness, flaking or cracking but which do not meet the criteria for R38:

based on either:

-     practical observation after normal handling and use, or

-     relevant evidence concerning their predicted effects on the skin.

See also paragraphs 1.6 and 1.7.

R67   Vapours may cause drowsiness and dizziness

volatile substances and preparations containing such substances which cause clear symptoms of central nervous system depression by inhalation and which are not already classified with respect to acute inhalation toxicity (R20, R23, R26, R68/20, R39/23 or R39/26).

The following evidence may be used:

(a)  data from animal studies showing clear signs of CNS depression such as narcotic effects, lethargy, lack of co-ordination (including loss of righting reflex) and ataxia either:

-     at concentrations/exposure times not exceeding 20 mg/l/4h or,

-     for which the ratio of the effect concentration at [not less than or equal to] 4 h to the saturated vapour concentration (SVC) at 20°C is [not less than or equal to] 1/10.

b)   practical experience in humans (e.g. narcosis, drowsiness, reduced alertness, loss of reflexes, lack of co-ordination, vertigo) from well-documented reports under comparable exposure conditions to the effects specified above for animals.

See also paragraphs 1.6 and 1.7.

For other supplementary risk phrases see paragraph 2.2.6.

4            CLASSIFICATION ON THE BASIS OF SPECIFIC EFFECTS ON HUMAN HEALTH

4.1         Introduction

4.1.1      This chapter sets out the procedure to be followed for the classification of substances which may have the effects mentioned below. For preparations see paragraph 4.2.4.

4.1.2      If a manufacturer, distributor or importer has information available which indicates that a substance should be classified and labelled in accordance with the criteria in paragraphs 4.2.1, 4.2.2 or 4.2.3, he shall provisionally label the substance in accordance with these criteria, on the basis of the assessment of the evidence by a competent person.

4.1.3      The manufacturer, distributor or importer shall submit as soon as possible a document summarising all relevant information to one Member State in which the substance is placed on the market. Relevant information in this context comprises in particular all available published and unpublished information required for appropriate classification of the substance in question, on the basis of its intrinsic properties and the criteria specified in this Annex. This summary document submitted should include a bibliography containing all relevant references, including any relevant unpublished data.

4.1.4      Furthermore, a manufacturer, distributor or importer who has new data which are relevant to the classification and labelling of a substance in accordance with the criteria in paragraphs 4.2.1, 4.2.2 or 4.2.3, shall submit this data as soon as possible to one Member State in which the substance is placed on the market.

4.1.5      In order to obtain as quickly as possible a harmonised classification for the European Union by means of the procedure defined in Article 28 of the Directive of 1967, Member States which have relevant information available justifying the classification of a substance in one of these categories, whether submitted by the manufacturer or not, should forward such information together with suggestions for classification and labelling, to the European Commission as soon as possible.

The European Commission will forward to the other Member States classification and labelling proposals that it receives. Any Member State may ask the European Commission for the information it has received.

Any Member State that has good reason to believe that the suggested classification and labelling is inappropriate as far as carcinogenic, mutagenic or reproductive toxicity effects are concerned shall notify the European Commission thereof.

4.2         Criteria for classification, indication of danger, choice of risk phrases

4.2.1      Carcinogenic substances

For the purpose of classification and labelling, and having regard to the current state of knowledge, such substances are divided into three categories:

Category 1

Substances known to be carcinogenic to man.

There is sufficient evidence to establish a causal association between human exposure to a substance and the development of cancer.

Category 2

Substances that should be regarded as if they are carcinogenic to man.

There is sufficient evidence to provide a strong presumption that human exposure to a substance may result in the development of cancer, generally on the basis of:

-     appropriate long-term animal studies,

-     other relevant information.

Category 3

Substances that cause concern for man owing to possible carcinogenic effects but in respect of which the available information is not adequate to make a satisfactory assessment.

There is some evidence from appropriate animal studies, but this is insufficient to place the substance in Category 2.

4.2.1.1   The following symbols and specific risk phrases apply:

However for substances and preparations which present a carcinogenic risk only when inhaled, for example, as dust, vapour or fumes, (other routes of exposure e.g. by swallowing or in contact with skin do not present any carcinogenic risk), the following symbol and specific risk phrase should be used:

4.2.1.2   Comments regarding the categorisation of carcinogenic substances

The placing of a substance into Category 1 is done on the basis of epidemiological data; placing into Categories 2 and 3 is based primarily on animal experiments.

For classification as a Category 2 carcinogen either positive results in two animal species should be available or clear positive evidence in one species, together with supporting evidence such as genotoxicity data, metabolic or biochemical studies, induction of benign tumours, structural relationship with other known carcinogens, or data from epidemiological studies suggesting an association.

Category 3 actually comprises 2 sub-categories:

(a)  substances which are well investigated but for which the evidence of a tumour-inducing effect is insufficient for classification in Category 2. Additional experiments would not be expected to yield further relevant information with respect to classification;

(b)  substances which are insufficiently investigated. The available data are inadequate, but they raise concern for man. This classification is provisional; further experiments are necessary before a final decision can be made.

For a distinction between Categories 2 and 3 the arguments listed below are relevant which reduce the significance of experimental tumour induction in view of possible human exposure. These arguments, especially in combination, would lead in most cases to classification in Category 3, even though tumours have been induced in animals:

-     carcinogenic effects observed only at very high dose levels exceeding the “maximal tolerated dose”. The maximal tolerated dose is characterized by toxic effects which, although not yet reducing lifespan, go along with physical changes such as about 10 % retardation in weight gain;

-     appearance of tumours, especially at high dose levels, only in particular organs of certain species known to be susceptible to a high spontaneous tumour formation;

-     appearance of tumours, only at the site of application, in very sensitive test systems (e.g. ip or sc application of certain locally active compounds), if the particular target is not relevant to man;

-     lack of genotoxicity in short-term tests in vivo and in vitro;

-     existence of a secondary mechanism of action with the implication of a practical threshold above a certain dose level (e.g. hormonal effects on target organs or on mechanisms of physiological regulation, chronic stimulation of cell proliferation);

-     existence of a species-specific mechanism of tumour formation (e.g. by specific metabolic pathways) irrelevant for man.

For a distinction between Category 3 and no classification the following arguments are relevant which exclude a concern for man:

-     a substance should not be classified in any of the categories if the mechanism of experimental tumour formation is clearly identified, with good evidence that this process cannot be extrapolated to man;

-     if the only available tumour data are liver tumours in certain sensitive strains of mice, without any other supplementary evidence, the substance may not be classified in any of the categories;

-     particular attention should be paid to cases where the only available tumour data are the occurrence of neoplasms at sites and in strains where they are well known to occur spontaneously with a high incidence.

4.2.2      Mutagenic substances

4.2.2.1   For the purposes of classification and labelling, and having regard to the current state of knowledge, such substances are divided into three categories:

Category 1

Substances known to be mutagenic to man.

There is sufficient evidence to establish a causal association between human exposure to a substance and heritable genetic damage.

Category 2

Substances which should be regarded as if they are mutagenic to man.

There is sufficient evidence to provide a strong presumption that human exposure to the substance may result in the development of heritable genetic damage, generally on the basis of:

-     appropriate animal studies,

-     other relevant information.

Category 3

Substances that cause concern for man owing to possible mutagenic effects.

There is evidence from appropriate mutagenicity studies, but this is insufficient to place the substance in Category 2.

4.2.2.2   The following symbols and specific risk phrases apply:

4.2.2.3   Comments regarding the categorisation of mutagenic substances

Definition of terms:

A mutation is a permanent change in the amount or structure of the genetic material in an organism, resulting in a change of the phenotypic characteristics of the organism. The alterations may involve a single gene, a block of genes, or a whole chromosome. Effects involving single genes may be a consequence of effects on single DNA bases (point mutations) or of large changes, including deletions, within the gene. Effects on whole chromosomes may involve structural or numerical changes. A mutation in the germ cells in sexually reproducing organisms may be transmitted to the offspring. A mutagen is an agent that gives rise to an enhanced occurrence of mutations.

It should be noted that substances are classified as mutagens with specific reference to inherited genetic damage. However, the type of results leading to classification of chemicals in Category 3: “induction of genetically relevant events in somatic cells”, is generally also regarded as an alert for possible carcinogenic activity.

Method development for mutagenicity testing is an ongoing process. For many new tests no standardised protocols and evaluation criteria are presently available. For the evaluation of mutagenicity data the quality of the test performance and the degree of validation of the test method have to be considered.

Category 1

To place a substance in Category 1, positive evidence from human mutation epidemiology studies will be needed. Examples of such substances are not known to date. It is recognised that it is extremely difficult to obtain reliable information from studies on the incidence of mutations in human populations, or on possible increases in their frequencies.

Category 2

To place a substance in Category 2, positive results are needed from assays showing (a) mutagenic effects, or (b) other cellular interactions relevant to mutagenicity, in germ cells of mammals in vivo, or (c) mutagenic effects in somatic cells of mammals in vivo in combination with clear evidence that the substance or a relevant metabolite reaches the germ cells.

With respect to placement in Category 2, at present the following methods are appropriate:

(a)  in vivo germ cell mutagenicity assays:

-     specific locus mutation test,

-     heritable translocation test,

-     dominant lethal mutation test.

These assays demonstrate the appearance of affected progeny or a defect in the developing embryo.

(b)  in vivo assays showing relevant interaction with germ cells (usually DNA):

-     assays for chromosomal abnormalities, as detected by cytogenetic analysis, including aneuploidy, caused by malsegregation of chromosomes,

-     test for sister chromatid exchanges (SCEs),

-     test for unscheduled DNA synthesis (UDS),

-     assay of (covalent) binding of mutagen to germ cell DNA,

-     assaying other kinds of DNA damage.

These assays provide evidence of a more or less indirect nature. Positive results in these assays would normally be supported by positive results from in vivo somatic cell mutagenicity assays, in mammals or in man (see under Category 3, preferably methods as under (a)).

(c)  in vivo assays showing mutagenic effects in somatic cells of mammals (see under Category 3 (a)), in combination with toxicokinetic test results, or other tests capable of demonstrating that the compound or a relevant metabolite reaches the germ cells.

In the case of the tests at (b) and (c), positive results from host-mediated assays or the demonstration of unequivocal effects in vitro can be considered supporting evidence.

Category 3

To place a substance in Category 3, positive results are needed in assays showing (a) mutagenic effects or (b) other cellular interaction relevant to mutagenicity, in somatic cells in mammals in vivo. The latter especially would normally be supported by positive results from in vitro mutagenicity assays.

For effects in somatic cells in vivo at present the following methods are appropriate:

(a)  in vivo somatic cell mutagenicity assays:

-     bone marrow micronucleus test or metaphase analysis,

-     metaphase analysis of peripheral lymphocytes,

-     mouse coat colour spot test.

(b)  in vivo somatic cell DNA interaction assays:

-     test for SCEs in somatic cells,

-     test for UDS in somatic cells,

-     assay for the (covalent) binding of mutagen to somatic cell DNA,

-     assay for DNA damage e.g. by alkaline elution, in somatic cells.

Substances showing positive results only in one or more in vitro mutagenicity assays should normally not be classified. Their further investigation using in vivo assays, however, is strongly indicated. In exceptional cases e.g. for a substance showing pronounced responses in several in vitro assays, for which no relevant in vivo data are available, and which shows resemblance to known mutagens / carcinogens, classification in Category 3 could be considered.

4.2.3      Substances toxic to reproduction

4.2.3.1   For the purposes of classification and labelling and having regard to the present state of knowledge, such substances are divided into 3 categories:

There is sufficient evidence to establish a causal relationship between human exposure to the substance and impaired fertility.

There is sufficient evidence to establish a causal relationship between human exposure to the substance and subsequent developmental toxic effects in the progeny.

There is sufficient evidence to provide a strong presumption that human exposure to the substance may result in impaired fertility on the basis of:

-    clear evidence in animal studies of impaired fertility in the absence of toxic effects, or evidence of impaired fertility occurring at around the same dose levels as other toxic effects but which is not a secondary non-specific consequence of the other toxic effects,

-    other relevant information.

There is sufficient evidence to provide a strong presumption that human exposure to the substance may result in developmental toxicity, generally on the basis of:

-     clear results in appropriate animal studies where effects have been observed in the absence of signs of marked maternal toxicity, or at around the same dose levels as other toxic effects but which are not a secondary non-specific consequence of the other toxic effects.

-    other relevant information.

Generally on the basis of:

-     results in appropriate animal studies which provide sufficient evidence to cause a strong suspicion of impaired fertility in the absence of toxic effects, or evidence of impaired fertility occurring at around the same dose levels as other toxic effects, but which is not a secondary non-specific consequence of the other toxic effects, but where the evidence is insufficient to place the substance in Category 2,

-    other relevant information.

Generally on the basis of:

-     results in appropriate animal studies which provide sufficient evidence to cause a strong suspicion of developmental toxicity in the absence of signs of marked maternal toxicity, or at around the same dose levels as other toxic effects but which are not a secondary non-specific consequence of the other toxic effects, but where the evidence is insufficient to place the substance in Category 2,

-     other relevant information.

4.2.3.2   The following symbols and specific risk phrases apply:

4.2.3.3   Comments regarding the categorisation of substances toxic to reproduction

Reproductive toxicity includes impairment of male and female reproductive functions or capacity and the induction of non-inheritable harmful effects on the progeny. This may be classified under two main headings of 1) effects on male or female fertility and 2) developmental toxicity.

1)   Effects on male or female fertility, includes adverse effects on libido, sexual behaviour, any aspect of spermatogenesis or oogenesis, or on hormonal activity or physiological response which would interfere with the capacity to fertilise, fertilisation itself or the development of the fertilised ovum up to and including implantation.

2)   Developmental toxicity, is taken in its widest sense to include any effect interfering with normal development, both before and after birth. It includes effects induced or manifested prenatally as well as those manifested postnatally. This includes embrytoxic/foetotoxic effects such as reduced body weight, growth and developmental retardation, organ toxicity, death, abortion, structural defects (teratogenic effects), functional defects, peri-postnatal defects, and impaired postnatal mental or physical development up to and including normal pubertal development.

The classification of chemicals as toxic to reproduction relates to chemicals that have an intrinsic or specific property that produce such toxic effects. Chemicals should not be classified as toxic to reproduction where such effects are solely produced as a non-specific secondary consequence of other toxic effects. Chemicals of most concern are those that are toxic to reproduction at exposure levels which do not produce other signs of toxicity.

The placing of a compound in Category 1 because of effects on fertility and/or developmental toxicity is done on the basis of epidemiological data. Placement into Categories 2 or 3 is done primarily on the basis of animal experimental data. Data from in vitro studies, or studies on avian eggs, are regarded as “supportive evidence” and would only exceptionally lead to classification in the absence of in vivo data.

In common with most other types of toxic effect, substances demonstrating reproductive toxicity are expected to have a threshold below which adverse effects would not be demonstrated. Even when clear effects have been demonstrated in animal studies the relevance for humans may be doubtful because of the doses administered, for example, where effects have been demonstrated only at high doses, or where marked toxicokinetic differences exist, or the route of administration is inappropriate. For these or similar reasons it may be that classification in Category 3, or even no classification, will be warranted.

It is specified in Annex V that a limit test be used in the case of substances of low toxicity. If a dose level of at least 1,000 mg/kg administered orally produces no evidence of effects of toxicity to reproduction, studies at other dose levels may not be considered necessary. If data are available from studies carried out with doses higher than the above limit dose, this data must be evaluated together with other relevant data. Under normal circumstances it is considered that effects seen only at doses in excess of the limit dose would not necessarily lead to classification as “Toxic to reproduction”.

Effects on fertility

For the classification of a substance into Category 2 because of impaired fertility, there should normally be clear evidence in one animal species, with supporting evidence in relation to the mechanism of action or the site of action, or chemical relationship to other known anti-fertility agents or other information from humans which would lead to the conclusion that effects would be likely to be seen in humans. Where there are studies in only one species without other relevant supporting evidence then classification in Category 3 may be appropriate.

Since impaired fertility may occur as a non-specific accompaniment to severe generalised toxicity or where there is severe inanition, classification into Category 2 should only be made where there is evidence that there is some degree of specificity of toxicity for the reproductive system. If it was demonstrated that impaired fertility in animal studies was due to failure to mate, then for classification into Category 2, it would normally be necessary to have evidence on the mechanism of action in order to interpret whether any adverse effect such as alteration in pattern of hormonal release would be likely to occur in humans.

Developmental toxicity

For classification into Category 2 there should be clear evidence of adverse effects in well conducted studies in one or more species. Since adverse effects in pregnancy or postnatally may be a secondary consequence of material toxicity, reduced food or water intake, maternal stress, lack of maternal care, specific dietary deficiencies, poor animal husbandry, intercurrent infections, and so on, it is important that the effects observed should occur in well conducted studies and at dose levels which are not associated with marked maternal toxicity. The route of exposure is also important. In particular, the injection of irritant material intraperitoneally may result in local damage to the uterus and its contents, and the results of such studies must be interpreted with caution and on their own would not normally lead to classification.

Classification into Category 3 is based on similar criteria as for Category 2 but may be used where the experimental design has deficiencies which make the conclusions less convincing, or where the possibility that the effects may have been due to non-specific influences such as generalised toxicity cannot be excluded.

In general, classification into Category 3 or no category would be assigned on an ad hoc basis where the only effects recorded are small changes in the incidences of spontaneous defects, small changes in the proportions of common variants such as are observed in skeletal examinations, or small differences in postnatal developmental assessments.

Effects during lactation

Substances that are classified as toxic to reproduction and which also cause concern due to their effects on lactation should in addition be labelled with R64 (see criteria in paragraph 3.2.8.).

For the purpose of classification, toxic effects on offspring resulting only from exposure via breast milk, or toxic effects resulting from direct exposure of children will not be regarded as “Toxic to reproduction”, unless such effects result in impaired development of the offspring.

Substances that are not classified as toxic to reproduction but which cause concern due to toxicity when transferred to the baby during the period of lactation should be labelled with R64 (see criteria in paragraph 3.2.8.). This R-phrase may also be appropriate for substances that affect the quantity or quality of the milk.

R64:   May cause harm to breastfed babies

would normally be assigned on the basis of:

(a)  toxicokinetic studies that indicate the likelihood that the substance would be present in potentially toxic levels in breast milk; and/or