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"the CDGCPL Regulations" means the Carriage of Dangerous Goods (Classification, Packaging and Labelling) and Use of Transportable Pressure Receptacles Regulations 1996[5];

"Community workplace exposure limit" means, in respect of a substance, an exposure limit for that substance established in a Community instrument;

"dangerous preparation" means a preparation which is in one of or more of the categories of danger specified in column 1 of Schedule 1;

"dangerous substance" means a substance - 

(a) which is listed in the approved supply list; or

(b) if it is not so listed, which is in one or more of the categories of danger specified in column 1 of Schedule 1;

"EC number" means - 

(a) in the case of a dangerous substance that appears in the approved supply list, the EC number specified in that list;

(b) in the case of a dangerous substance that is not included in the approved supply list or for which an EC number is not given in that list, the number for that substance specified in EINECS; or

(c) in the case of a dangerous substance that is a new substance within the meaning of the NONS Regulations, the number for that substance listed in ELINCS;

"EEA Agreement" means the Agreement on the European Economic Area signed at Oporto on 2nd May 1992, as adjusted by the Protocol signed at Brussels on 17th March 1993[6] and adopted as respects the United Kingdom by the European Economic Area Act 1993[7];

"EEA State" means a state which is a contracting party to the EEA Agreement;

"EINECS" means the European Inventory of Existing Commercial Chemical Substances[8];

"ELINCS" means the European List of Notified Chemical Substances[9] as revised or re-issued from time to time;

"enforcing authority" shall be construed in accordance with regulation 14;

"the Executive" means the Health and Safety Executive;

"indication of danger" means, in relation to a dangerous substance or dangerous preparation, one or more of the indications of danger referred to in column 1 of Schedule 2 and - 

(a) in the case of a dangerous substance listed in the approved supply list, it is one or more of the indications of danger specified for that substance by a symbol-letter in that list;

(b) in the case of any other dangerous substance or a dangerous preparation, it is one or more indications of danger determined in accordance with the classification of that substance or preparation in accordance with regulation 4 and the approved classification and labelling guide;

"the NONS Regulations" means the Notification of New Substances Regulations 1993[10];

"plant protection product" has the same meaning as it has in regulation 2(1) of the Plant Protection Products Regulations;

"the Plant Protection Products Regulations" means the Plant Protection Products Regulations 1995[11];

"preparation" means a mixture or a solution of two or more substances;

"radioactive substance" means a substance which contains one or more radionuclides whose activity or concentration cannot be disregarded as far as radiation protection is concerned;

"receptacle" means a container together with any material, wrapping and component, including any closure or fastener, associated with the container which enables the container to perform its containment function;

"risk phrase" means a risk phrase listed in the approved supply list;

"safety phrase" means a safety phrase listed in the approved supply list;

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

"supply" in relation to a substance or preparation means, except in regulation 6, making that substance or preparation available to another person and includes importation of the substance or preparation into Great Britain, and "supplier" shall be construed accordingly.

    (2) In these Regulations, "package" means - 

(a) subject to paragraph (3), the package in which a dangerous substance, dangerous preparation or preparation specified in regulation 5(3) is supplied, including the receptacle containing the dangerous substance or preparation in question; or

(b) a pallet or other device which enables more than one receptacle to be handled as a unit,

but does not include a container used to transport the dangerous substance or preparation unless that container is retained by the person to whom the dangerous substance or preparation is supplied for the purpose of storing that dangerous substance or preparation, and related expressions shall be construed accordingly.

    (3) In the case of supply by way of retail sale, a package does not include any paper or plastic bag or other form of outer wrapping in which the package is placed when it is presented to the purchaser.

    (4) In these Regulations - 

(a) where reference is made to a quantity of a dangerous substance or dangerous preparation expressed in litres, that reference shall mean - 


(i) in the case of a liquid, the volume in litres of that liquid,

(ii) in the case of a compressed gas, the volume in litres of the receptacle containing that gas, and

(iii) in the case of a compressed gas dissolved in a solvent, liquefied gas or solid, the same number of kilograms of that gas or solid; and



(b) for the purposes of aggregation, one kilogram of a solid shall be deemed to be equivalent to one litre of liquid or gas.

    (5) In these Regulations - 

(a) a risk phrase may be designated by the letter "R" followed by a distinguishing number or combination of numbers; and

(b) a safety phrase may be designated by the letter "S" followed by a distinguishing number or combination of numbers.

    (6) In these Regulations, unless the context otherwise requires, a reference to - 

(a) a numbered regulation or Schedule is a reference to the regulation or Schedule in these Regulations so numbered;

(b) a numbered paragraph is a reference to the paragraph so numbered in the regulation or Schedule in which that reference occurs; and

(c) a lettered sub-paragraph is a reference to the sub-paragraph so lettered in the paragraph in which that reference appears.

Application
     3.  - (1) Subject to paragraphs (3) to (8), these Regulations shall apply to any dangerous substance or dangerous preparation.

    (2) Subject to paragraphs (3) to (8) - 

(a) regulation 5, except paragraph (1), shall apply to the preparations specified in paragraph (3) of that regulation;

(b) regulation 7 and paragraphs (2) and (4) to (6) of regulation 11 shall apply to the preparations specified in paragraph (3) of regulation 11;

(c) paragraphs (1) and (2) of regulation 9 shall apply to a preparation to which section B or C of Part II of Schedule 5 applies; and

(d) paragraphs (4) and (5) of regulation 8 shall apply to a substance or preparation specified in those paragraphs.

    (3) These Regulations shall not apply to a substance or preparation which is - 

(a) intended for use as a medicinal product within the meaning of section 130 of the Medicines Act 1968[12];

(b) specified in an order made under section 104 or 105 of the Medicines Act 1968 which is for the time being in force and which directs that specified provisions of that Act shall have effect in relation to that dangerous substance or dangerous preparation as such provisions have effect in relation to medicinal products within the meaning of that Act;

(c) a controlled drug within the meaning of the Misuse of Drugs Act 1971[13] except that these Regulations shall apply to drugs which are excepted from section 4(1)(b) of that Act (which makes it unlawful to supply a controlled drug) by Regulations made under section 7(1)(a) of that Act;

(d) a cosmetic product within the meaning of the Cosmetic Products (Safety) Regulations 1996[14];

(e) in the form of waste to which the Waste Management Licensing Regulations 1994[15] or the Special Waste Regulations 1996[16] applies;

(f) intended for use as food within the meaning of section 1 of the Food Safety Act 1990[17];

(g) intended for use as an animal feeding stuff within the meaning of section 66(1) of the Agriculture Act 1970[18];

(h) radioactive substances or preparations containing radioactive substances; or

(i) a medical device within the meaning of the Medical Devices Regulations 2002[19] which is invasive or used in direct contact with the human body,

in the finished state, intended for the final user.

    (4) These Regulations shall not apply to - 

(a) a substance or preparation which is a sample taken by an authority responsible for the enforcement of any requirement imposed by or under any enactment;

(b) a substance or preparation which is under customs control;

(c) subject to Council Regulation EC 2455/92[20] on the export notification and information exchange of dangerous substances, a substance or preparation which is intended for export to a country which is not an EEA State; or

(d) a substance to which paragraph (7) of regulation 6 of the NONS Regulations applies (including new substances not yet fully tested) which is labelled in accordance with the provisions of that paragraph;

    (5) Regulations 7 to 11 shall only apply to dangerous substances, dangerous preparations or preparations specified in regulation 5(3) which are supplied in packages.

    (6) Regulations 7 to 11 shall not apply to munitions and explosives which are placed on the market with a view to obtaining an explosive or pyrotechnic effect.

    (7) Regulation 6 shall not apply to a plant protection product approved under the Plant Protection Products Regulations or to a product approved under the Control of Pesticides Regulations 1986[21].

    (8) These Regulations shall not apply to the carriage of substances or preparations by rail, road, inland waterway, sea or air.

unless that document has already been sent to the relevant authority in another EEA State in which the dangerous substance has been supplied.

    (7) A dangerous preparation shall be classified in accordance with Schedule 3 and, where applicable, by use of the criteria contained in the approved classification and labelling guide.

Safety data sheets for dangerous substances, dangerous preparations and certain other preparations
     5.  - (1) Subject to paragraph (7), the supplier of a dangerous substance or dangerous preparation shall provide the recipient of that dangerous substance or dangerous preparation with a safety data sheet - 

(a) which contains the information under the headings specified in Schedule 4 to enable that recipient to take the necessary measures relating to - 


(i) health and safety at work, and

(ii) the protection of the environment;



(b) which clearly shows the date of first publication, or the latest revision, as the case may be;

(c) free of charge; and

(d) no later than the date on which the dangerous substance or the dangerous preparation is supplied to that recipient for the first time.

    (2) Subject to paragraph (7), the supplier of a preparation of the type specified in paragraph (3) shall provide free of charge to a professional user a safety data sheet which - 

(a) contains proportionate information under the headings specified in Schedule 4 relating to that preparation; and

(b) clearly shows the date of first publication, or the latest revision, as the case may be,

when requested to do so by that professional user.

    (3) Paragraph (2) refers to a preparation which is not a dangerous preparation but which contains in an individual concentration of ≥1% by weight for non-gaseous preparations and ≥0.2% by volume for gaseous preparations - 

(a) a dangerous substance which has been classified in respect of its health or environmental effects; or

(b) a substance for which there is a Community workplace exposure limit.

    (4) The supplier of a dangerous substance or preparation to which this regulation applies shall keep the safety data sheet relating to that dangerous substance or preparation up to date and revise it forthwith if any significant new information relating to safety at work, risks to the health of any person or the protection of the environment becomes available in relation to that dangerous substance or preparation.

    (5) When a supplier revises a safety data sheet in accordance with paragraph (4), he shall ensure that the safety data sheet is clearly marked with the word "Revision".

    (6) When a supplier revises a safety data sheet in accordance with paragraph (4), he shall - 

(a) in respect of a dangerous substance or dangerous preparation, provide every person who has received that dangerous substance or dangerous preparation within a period of 12 months preceding the date of the revision with a copy of the revised safety data sheet free of charge; or

(b) in respect of a preparation specified in paragraph (3), provide every person who - 


(i) has received that preparation within a period of 12 months preceding the date of the revision, and

(ii) requested a copy of the safety data sheet in accordance with paragraph (2),



with a copy of the revised safety data sheet free of charge, and shall draw the attention of every such person to the revisions in the safety data sheet.

    (7) Subject to paragraph (8), a supplier shall not be required to provide a safety data sheet with a dangerous substance or preparation to which this regulation applies provided that - 

(a) the dangerous substance or preparation is sold to the general public in the circumstances to which paragraph (4) or (5) of regulation 14 applies; and

(b) sufficient information is provided to enable the user of that dangerous substance or preparation to take the necessary measures as regards the protection of health and safety.

    (8) Where a person buys a dangerous substance or preparation to which this regulation applies for use at work in the circumstances to which paragraph (4) or (5) of regulation 14 applies, when requested to do so by that person, the supplier of the dangerous substance or preparation in question shall provide that person with a copy of the safety data sheet relating to that dangerous substance or preparation free of charge.

    (9) If a supplier provides a safety data sheet in accordance with paragraph (8), paragraph (6) shall not apply.

    (10) The information contained in a safety data sheet provided under this regulation shall be in English.

    (11) A supplier may provide a safety data sheet or a revision to a safety data sheet under this regulation by electronic communication provided that he has established that the person to whom the safety data sheet, or the revision to a safety data sheet, will be provided has the equipment to enable him to receive the electronic communication.

    (12) In this regulation, "supply" shall not include supply by way of - 

(a) offer for sale, and

(b) returning a dangerous substance or preparation to which this regulation applies to the person who supplied it, provided that the properties of that dangerous substance or preparation remain unchanged,

and "supplier" shall be construed accordingly.

Advertisements for dangerous substances and dangerous preparations
     6.  - (1) Subject to paragraph (2), a person who supplies a dangerous substance or dangerous preparation shall not advertise that dangerous substance or dangerous preparation, or arrange for the production of any such advertisement, unless mention is made in the advertisement of the type of hazard indicated on the label.

    (2) Paragraph (1) shall only apply in respect of a dangerous preparation where the advertisement enables a person, otherwise than in the course of a business, to conclude a contract to purchase the dangerous preparation before that person has seen the label relating to the dangerous preparation.

    (3) In this regulation "supply" has the same meaning as it has in section 46 of the Consumer Protection Act 1987[22].

Packaging of dangerous substances and dangerous preparations
     7.  - (1) No person shall supply a dangerous substance, dangerous preparation or preparation specified in regulation 11(3) unless it is in a package and - 

(a) subject to paragraph (2), the receptacle containing the dangerous substance or dangerous preparation is designed and constructed so that its contents cannot escape;

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

(c) the packaging and fastenings are strong and solid throughout to ensure that they will not loosen and will meet the normal stresses and strains of handling; and

(d) any replaceable fastening fitted to the receptacle containing the dangerous substance or dangerous preparation is designed so that the receptacle can be repeatedly refastened without the contents of the receptacle escaping.

    (2) Paragraph (1)(a) shall not apply where a special safety device is fitted to the receptacle.

    (3) Packaging and fastenings shall be deemed to comply with the requirements of paragraph (1)(a) to (c) if they comply with the relevant requirements of - 

(a) the CDGCPL Regulations;

(b) the Merchant Shipping (Dangerous Goods and Marine Pollutants) Regulations 1997[23]; or

(c) the Air Navigation (Dangerous Goods) Regulations 1994[24].

Labelling of dangerous substances and dangerous preparations
     8.  - (1) Subject to regulations 9 and 10 of the CDGCPL Regulations (which allow combined carriage and supply labelling in certain circumstances) and paragraphs (8) to (12), no person shall supply a dangerous substance or dangerous preparation unless the particulars specified in paragraph (2) relating to a dangerous substance or paragraph (3) relating to a dangerous preparation are clearly shown in accordance with the requirements of regulation 10 - 

(a) on the receptacle containing the dangerous substance or dangerous preparation; and

(b) if that receptacle is inside one or more layers of packaging, on any such layer which is likely to be the outermost layer of packaging during the supply or use of the dangerous substance or dangerous preparation, unless such packaging permits the particulars shown on the receptacle or other packaging to be clearly seen.

    (2) The particulars required under paragraph (1) in relation to a dangerous substance shall be - 

(a) the name, full address and telephone number of a person in an EEA State who is responsible for supplying the substance, whether he be its manufacturer, importer or distributor;

(b) the name of the substance, being - 


(i) where the substance appears in the approved supply list, the name or one of the names listed therein for that substance, or

(ii) where the substance does not appear in the approved supply list, an internationally recognised name;



(c) the following particulars ascertained in accordance with Part I of Schedule 5, namely - 



(i) any indications of danger together with corresponding symbols,

(ii) the risk phrases, set out in full,

(iii) the safety phrases, set out in full, and

(iv) any EC number and, in the case of a substance which is listed in Part I of the approved supply list, the words "EC label"; and



(d) where required by paragraph (4) or (5), the labelling phrase specified therein.

    (3) The particulars required under paragraph (1) in relation to a dangerous preparation shall be - 

(a) the name, full address and telephone number of a person in an EEA State who is responsible for supplying the preparation, whether he be its manufacturer, importer or distributor;

(b) the trade name or other designation of the preparation;

(c) the following particulars ascertained in accordance with Part I of Schedule 5, namely - 


(i) identification of the constituents of the preparation which result in it being classified as a dangerous preparation,

(ii) any indications of danger together with corresponding symbols,

(iii) the risk phrases, set out in full,

(iv) the safety phrases, set out in full,

(v) in the case of a preparation intended for sale to the general public, the nominal quantity (nominal mass or nominal volume);



(d) where required by paragraph 5(4) of Part I of Schedule 3, the words specified in that paragraph; and

(e) where required by paragraph (4) or (5), the labelling phrase specified therein.

    (4) Subject to paragraph (6), and without prejudice to any other requirements in these Regulations, in respect of a substance specified in Schedule 2 to the Dangerous Substances and Preparations (Safety) (Consolidation) Regulations 1994[25] or a preparation containing such a substance, either of which is required to be classified and labelled in accordance with these Regulations, as - 

(a) carcinogenic of category 1 or 2;

(b) mutagenic of category 1 or 2; or

(c) toxic for reproduction of category 1 or 2,

the labelling phrase "Restricted to professional users" shall be included in the particulars specified in paragraph (2) or (3), as the case may be.

    (5) Without prejudice to any other requirements in these Regulations, in respect of - 

(a) a substance specified in regulation 6D of the Dangerous Substances and Preparations (Safety) (Consolidation) Regulations 1994; or

(b) a preparation containing such a substance in a concentration by weight of 0.1% or more,

whether or not that substance is a dangerous substance or that preparation is a dangerous preparation, as the case may be, the labelling phrase "For use in industrial installations only" shall be included in the particulars specified in paragraph (2) or (3), as the case may be.

    (6) Paragraph 4 shall not apply to - 

(a) petrol as defined in regulation 2 of the Motor Fuel (Composition and Content) Regulations 1999[26];

(b) mineral oil products intended for use as fuel in mobile or fixed combustion plants;

(c) fuels sold in closed systems; and

(d) artists' paints.

    (7) Without prejudice to paragraph 4 of Schedule 2 to the Plant Protection Products Regulations, indications such as "non-toxic", "non-harmful", "non-polluting", "ecological" or any other statement indicating that the dangerous substance or preparation is not dangerous or that is likely to lead to underestimation of the dangers of the dangerous substance or preparation shall not appear on the package.

    (8) Where paragraph (9) applies, the packaging of a dangerous substance or dangerous preparation classified in one or more of the categories of danger harmful, extremely flammable, highly flammable, flammable, irritant or oxidising shall not be required to be labelled in respect of that hazardous property.

    (9) This paragraph shall apply where the package contains such small quantities of that substance or preparation that there is no foreseeable risk, under conditions of supply, use and disposal, arising from that hazardous property to persons handling that substance or preparation or to other persons.

    (10) The packaging of a dangerous preparation classified in the category of danger dangerous for the environment (with or without the "N" symbol) shall not be required to be labelled in respect of its environmental hazard in accordance with this regulation provided that it contains such small quantities of that preparation that there is no foreseeable risk, under conditions of supply, use and disposal, to the environment.

    (11) Where the package in which a dangerous substance is supplied does not contain more than 125 millilitres of that substance the risk phrases and safety phrases need not be shown if the dangerous substance is classified only in one or more of the categories of danger - 

(a) highly flammable, flammable, oxidising or irritant; or

(b) harmful, provided the dangerous substance is not sold to the general public.

    (12) Where the package in which a dangerous preparation is supplied does not contain more than 125 millitres of that preparation - 

(a) the risk phrases and safety phrases need not be shown if the dangerous preparation is classified only in one or more of the categories of danger - 


(i) irritant (except those assigned the risk phrase R41),

(ii) dangerous for the environment and assigned the N symbol,

(iii) oxidising, or

(iv) highly flammable; and



(b) the safety phrases need not be shown if the dangerous preparation is classified only in one or more of the categories of danger - 



(i) flammable, or

(ii) dangerous for the environment and not assigned the N symbol.

    (13) Where a dangerous substance or dangerous preparation is required to be labelled in accordance with these Regulations and is so labelled, that labelling shall be deemed to satisfy the requirements of - 

(a) section 5 of the Petroleum (Consolidation) Act 1928[27] including that section as applied to any dangerous substance by an Order in Council made under section 19 of that Act;

(b) regulation 6 of the Highly Flammable Liquids and Liquefied Petroleum Gases Regulations 1972[28]; and

(c) regulations 3 and 4 of the Farm and Garden Chemicals Regulations 1971[29].

Particular labelling requirements for certain preparations
     9.  - (1) In the case of preparations to which Part II of Schedule 5 applies the appropriate provisions of that Part shall have effect to regulate the labelling of such preparations.

    (2) Subject to regulations 9 and 10 of the CDGCPL Regulations (which allow combined carriage and supply labelling in certain circumstances), no person shall supply a preparation to which section B or C of Part II of Schedule 5 applies unless the trade name or other designation of that preparation and the name, full address and telephone number of a person in an EEA State who is responsible for supplying that preparation (whether he be its manufacturer, importer or distributor) are clearly shown in accordance with the requirements of regulation 10 - 

(a) on the receptacle containing that preparation; and

(b) if that receptacle is inside one or more layers of packaging, on any such layer which is likely to be the outermost layer of packaging during the supply or use of that preparation, unless such packaging permits the particulars shown on the receptacle or other packaging to be clearly seen.

    (3) The supplier of an aerosol dispenser which contains a dangerous substance or dangerous preparation which has been classified in the category of danger "flammable", "highly flammable" or "extremely flammable" may choose to omit from the label - 

(a) in the case of a dangerous substance, the particulars referred to in paragraphs (i) to (iii) of regulation 8(2)(c) which relate to that category of danger; and

(b) in the case of a dangerous preparation, the particulars referred to in paragraphs (ii) to (iv) of regulation 8(3)(c) which relate to that category of danger,

provided the conditions specified in paragraph (4) are satisfied.

    (4) The conditions referred to in paragraph (3) are that the supplier - 

(a) is in possession of evidence which shows that the contents of the aerosol dispenser do not present a risk of ignition under normal or reasonably foreseeable conditions of use; and

(b) identifies the quantity of flammable material contained in the aerosol dispenser in the form of the following inscription on the label - 

     "X% by mass of the contents are flammable".

    (5) In the case of a plant protection product approved under the Plant Protection Products Regulations or a product approved under the Control of Pesticides Regulations 1986[30], the labelling information required by these Regulations shall be accompanied by the wording "To avoid risks to man and the environment, comply with the instructions for use".

Methods of marking or labelling packages
     10.  - (1) Any package which is required to be labelled in accordance with regulations 8 and 9 may carry the particulars required to be on the label clearly and indelibly marked on a part of that package reserved for that purpose and, unless the context otherwise requires, any reference in these Regulations to a label includes a reference to that part of the package so reserved.

    (2) Subject to paragraph (7), any label required to be carried on a package shall be securely fixed to the package with its entire surface in contact with it and the label shall be clearly and indelibly printed.

    (3) The colour and nature of the marking shall be such that any symbol and the wording stand out clearly from the background and the wording shall be of such size and spacing as to be easily read.

    (4) The package shall be so labelled that the particulars can be read horizontally when the package is set down normally.

    (5) Subject to paragraph (7), the dimensions of the label required under regulation 8 shall be as follows - 

	Capacity of package	Dimensions of label
(a)	not exceeding 3 litres	if possible at least 52 × 74 millimetres
(b)	exceeding 3 litres but not exceeding 50 litres	at least 74 × 105 millimetres
(c)	exceeding 50 litres but not exceeding 500 litres	at least 105 × 148 millimetres
(d)	exceeding 500 litres	at least 148 × 210 millimetres

    (6) A symbol required to be shown in accordance with regulation 8(2)(c)(i) or 8(3)(c)(ii) and specified in column 3 of Schedule 2 shall be printed in black on an orange-yellow background and its size (including the orange-yellow background) shall be at least equal to an area of one-tenth of that of a label which complies with paragraph (5) and shall not in any case be less than 100 square millimetres.

    (7) If the package is an awkward shape or so small that it is unsuitable to attach a label complying with paragraphs (2) and (5), the label shall be attached in some other appropriate manner.

Child resistant fastenings, tactile warning devices and other consumer protection measures
     11.  - (1) The British and International Standards referred to in this regulation are further described in Schedule 6.

    (2) Subject to paragraph (4) and (5), no person shall supply to the general public a substance or a preparation specified in paragraph (3) in a receptacle of any size fitted with - 

(a) a replaceable closure unless the packaging complies with the requirements of BS EN 28317 or ISO 8317; or

(b) a non-replaceable closure unless the packaging complies with the requirements of EN 862.

    (3) The substances and preparations referred to in paragraph (2) are - 

(a) dangerous substances and dangerous preparations which are required to be labelled with the indication of danger "very toxic", "toxic" or "corrosive";

(b) preparations containing methanol in a concentration equal to or more than 3% by weight;

(c) preparations containing dichloromethane in a concentration equal to or more than 1% by weight;

(d) substances which are assigned the risk phrase (R65) in the approved supply list, except where such a substance is supplied in an aerosol dispenser or a container fitted with a sealed spray attachment; and

(e) substances and preparations which are assigned the risk phrase (R65) and are classified and labelled according to the approved classification and labelling guide, except where such a substance or preparation is supplied in an aerosol dispenser or a container fitted with a sealed spray attachment.

    (4) Paragraph (2) shall not apply if the person supplying the substance or preparation in question can show that it is obvious that the packaging in which the substance or preparation is supplied is sufficiently safe for children because they cannot obtain access to the contents without the help of a tool.

    (5) If the packaging, in which a substance or preparation specified in paragraph (3) is supplied to the general public, was approved on or before 31st May 1993 by the British Standards Institution as complying with the requirements of BS 6652, that packaging shall be deemed to comply with the requirements of BS EN 28317.

    (6) No person shall supply a dangerous preparation or a preparation specified in paragraph (3) to the general public if the packaging in which that preparation is supplied has - 

(a) either a shape or a designation or both likely to attract or arouse the active curiosity of children or to mislead consumers;

(b) either a presentation or a designation or both used for - 


(i) human or animal foodstuffs,

(ii) medicinal products, or

(iii) cosmetic products.

    (7) Subject to paragraph (9), no person shall supply to the general public a dangerous substance or a dangerous preparation specified in paragraph (8) in a receptacle of any size, unless the packaging in which that dangerous substance or dangerous preparation is supplied carries a tactile warning of danger in accordance with EN ISO 11683.

    (8) The dangerous substances and the dangerous preparations referred to in paragraph (7) are those which are required to be labelled with one or more of the following indications of danger, namely - 

(a) very toxic;

(b) toxic;

(c) corrosive;

(d) harmful;

(e) extremely flammable; or

(f) highly flammable.

    (9) Paragraph (7) shall not apply to an aerosol dispenser which is classified and labelled only with the indication of danger extremely flammable or highly flammable.

    (10) For the purpose of ascertaining whether there has been a contravention of paragraph (2), a duly authorised officer of the enforcing authority may require the person supplying a substance or a preparation to which that paragraph applies to provide him with a certificate from a qualified test house stating that - 

(a) the closure is such that it is not necessary to test to BS EN 28317 or ISO 8317; or

(b) the closure has been tested and found to conform to BS EN 28317 or ISO 8317.

    (11) In this regulation, "qualified test house" means a laboratory that conforms to BS 7501 or EN 45 000.

Retention of data for dangerous preparations
     12.  - (1) The person who is responsible for first supplying a dangerous preparation shall maintain a record of the information - 

(a) used for the purposes of classifying that dangerous preparation in accordance with regulation 4;

(b) used for the purposes of labelling that dangerous preparation in accordance with regulation 8;

(c) relating to any child resistant fastening or any tactile warning which forms part of the packaging in which the dangerous preparation in question is contained; and

(d) used for the purposes of preparing the safety data sheet relating to that dangerous preparation in accordance with regulation 5,

for at least three years after the date on which that dangerous preparation was supplied by him for the last time.

    (2) When requested by the enforcing authority to do so, a person referred to in paragraph (1) shall make the record, or a copy of the record, maintained by him in accordance with that paragraph, available to the enforcing authority within 28 days of the date of the request.

    (3) When requested to do so by the enforcing authority, a person who supplies a dangerous preparation shall provide to the enforcing authority a copy of any certificate issued by a qualified test house.

it is satisfied that neither the health nor the safety of persons who are likely to be affected by the exemption will be prejudiced in consequence of it.

Enforcement
     14.  - (1) To the extent that they would not otherwise do so, sections - 

(a) 16 to 26 (approval of codes of practice and enforcement);

(b) 33 to 42 (provisions as to offences); and

(c) 47(2),

of the 1974 Act shall apply to these Regulations as if they were health and safety Regulations for the purposes of that Act.

    (2) Any function of the Health and Safety Commission under any other provision of the 1974 Act which is exercisable in relation to any function of the Executive under or in respect of health and safety Regulations (including their enforcement) shall be exercisable as if these Regulations were health and safety Regulations for the purposes of that Act to the extent that they would not otherwise be so.

    (3) Notwithstanding regulation 3 of the Health and Safety (Enforcing Authority) Regulations 1998[31] and subject to paragraphs (4) and (5), the enforcing authority for these Regulations shall be the Executive.

    (4) Subject to paragraph (5), where a dangerous substance or a dangerous preparation is supplied in or from premises which are registered under section 75 of the Medicines Act 1968[32], the enforcing authority for these Regulations shall be the Royal Pharmaceutical Society.

    (5) The enforcing authority for these Regulations shall be the local weights and measures authority - 

(a) where a dangerous substance or a dangerous preparation is supplied other than in the circumstances referred to in paragraph (4), - 


(i) in or from any shop, mobile vehicle, market stall or other retail outlet, or

(ii) otherwise to members of the public, including by way of free sample, prize or mail order;



(b) for regulations 6 and 11.

    (6) In every case where, by virtue of this regulation, these Regulations are enforced by the Royal Pharmaceutical Society or the local weights and measures authority, they shall be enforced as if they were safety regulations made under section 11 of the Consumer Protection Act 1987[33] and the provisions of section 12 of that Act shall apply to these Regulations as if they were safety regulations and as if the maximum period of imprisonment on summary conviction specified in subsection (5) thereof were 3 months instead of 6 months.

Defence
     15.  - (1) In any proceedings for an offence for a contravention of any of the provisions of these Regulations, it shall be a defence for the person charged to prove that he took all reasonable precautions and exercised all due diligence to avoid the commission of the offence.

Transitional provisions
     16.  - (1) Until 30th July 2002 it shall be sufficient compliance with the requirements of these Regulations if the requirements of the Chemicals (Hazard Information and Packaging for Supply) Regulations 1994[34] are complied with as in force immediately before these Regulations came into force.

    (2) In respect of a preparation which is a biocidal product within the meaning of the Biocidal Products Regulations 2001[35], until 30th July 2004 it shall be sufficient compliance with the requirements of these Regulations if the requirements of the Chemicals (Hazard Information and Packaging for Supply) Regulations 1994 are complied with as in force immediately before these Regulations came into force.

    (3) These Regulations shall not apply to a preparation which is - 

(a) an approved plant protection product under the Plant Protection Products Regulations; or

(b) an approved biocidal product under the Biocidal Products Regulations 2001,

until 30th July 2004.

    (4) These Regulations shall not apply to a preparation which is - 

(a) a biocidal product within the meaning of the Biocidal Products Regulations 2001; or

(b) a plant protection product,

and which is an approved product under the Control of Pesticides Regulations 1986[36] until 30th July 2004.

    (5) In this regulation, "biocidal product" does not include a biocidal product which is a basic substance as defined in article 2 of Directive 98/8[37] of the European Parliament and the Council concerning the placing of biocidal products on the market.

Extension outside Great Britain
     17. These Regulations shall apply to any activity outside Great Britain to which sections 1 to 59 and 80 to 82 of the 1974 Act apply by virtue of the Health and Safety at Work etc. Act 1974 (Application outside Great Britain) Order 2001[38] as they apply to activities within Great Britain.

Revocations and modifications
     18.  - (1) The instruments specified in column 1 of Schedule 7 shall be revoked to the extent specified in the corresponding entry in column 3 of that Schedule.

    (2) In the CDGCPL Regulations - 

(a) for regulations 9 and 10 there shall be substituted the following regulations - 

" Derogations from regulation 8 of the supply Regulations and regulation 8 of these Regulations
     9.  - (1) Where a package would otherwise be required to show the particulars required by both regulation 8 of the supply Regulations and regulation 8 of these Regulations, it shall be sufficient compliance with both of those regulations if the package shows in accordance with regulation 11 the particulars specified in the following paragraphs of this regulation.

    (2) Where the package consists of only a single receptacle, the specified particulars are the particulars required by paragraph (2)(a), (b), (c)(ii), (iii) and (iv) (or paragraph (3)(a), (b), (c)(i), (iii), (iv) and (v) in the case of preparations) of regulation 8 of the supply Regulations and paragraph (2)(b), (c) and (d) of regulation 8 of these Regulations.

    (3) Where the package consists of one or more receptacles in outer packagings, the specified particulars are either the particulars required by paragraph (2) or the particulars required by regulation 8.

    (4) Where, to facilitate handling, a package consists of two or more smaller packages held together in such a way that the labels on those smaller packages can be clearly seen, then it shall be sufficient compliance with paragraph (3) if those smaller packages are labelled in accordance with that paragraph.

    (5) In this regulation "preparations" and "indication of danger" have the same meaning as in the supply Regulations.

Derogations from regulation 8 of the supply Regulations
     10.  - (1) Where a package is required to show the particulars required by regulation 8 of the supply Regulations, but is excepted from showing the particulars required by regulation 8 of these Regulations because it shows the particulars required by any of the transport rules specified in regulation 3(1)(a) to (f), it shall be sufficient compliance with regulation 8 of the supply Regulations if the package shows the particulars specified in the following paragraphs of this regulation.

    (2) Where the package consists of only a single receptacle, the specified particulars are - 


(a) the particulars required by whichever of the transport rules is appropriate; and

(b) the particulars required by paragraph (2)(a), (b), (c)(ii), (iii) and (iv) (or paragraph (3)(a), (b), (c)(i), (iii), (iv) and (v)) of regulation 8 of the supply Regulations in accordance with regulation 11.



    (3) Where the package consists of one or more receptacles in outer packagings, the specified particulars are those required by whichever of the transport rules is appropriate.

    (4) In this regulation "indication of danger" has the same meaning as in the supply Regulations."; and

(b) in paragraph (5) of regulation 11, for the words "regulation 9 of the supply Regulations" there shall be substituted "regulation 8 of the supply Regulations".

David Jamieson
Parliamentary Under-Secretary of State, Department for Transport

28th June 2002

Regulations 2(1) and 10(6)


INDICATIONS OF DANGER AND SYMBOLS FOR DANGEROUS SUBSTANCES AND DANGEROUS PREPARATIONS

Column 1	Column 2	Column 3
Indication of danger	Symbol-letter	Symbol
Explosive	E
Oxidising	O
Extremely flammable	F+
Highly flammable	F
Very toxic	T+
Toxic	T
Harmful	Xn
Corrosive	C
Irritant	Xi
Dangerous for the environment	N

(a) none of the constituents possess such properties and that, on the basis of information available to the manufacturer, the preparation is unlikely to present dangers of this kind;

(b) in the event of a change in composition of a preparation of known composition, scientific evidence indicates that a reassessment of the hazards will not lead to a change in classification; and

(c) in the case of a preparation supplied in the form of an aerosol, that preparation satisfies the provisions of article 9a of Council Directive 75/324/EEC[39].

Classification of preparations by health effects
     4.  - (1) The health effects of a preparation shall be assessed by one or more of the following methods - 

(a) by the conventional method described in the following paragraphs using concentration limits; or

(b) by the criteria set out in the approved classification and labelling guide in relation to the preparation for an appropriate classification and label.

    (2) Any one or more of the health effects of the preparation which are not assessed by the method set out in sub-paragraph (1)(b) shall be assessed in accordance with the conventional method.

    (3) Where the health effects have been established by both methods, the results of the method set out in sub-paragraph (1)(b shall be used for classifying the preparation except in the case of carcinogenic and mutagenic effects and toxic effects for reproduction, when the conventional method set out in sub-paragraph (1)(a) shall always be used.

    (4) Where it can be demonstrated - 

(a) by epidemiological studies, by scientifically valid case studies as specified in the approved classification and labelling guide or by statistically backed experience (such as the assessment of data from poison information units or concerning occupational diseases) that toxicological effects on man differ from those suggested by the application of the methods set out in paragraph (1), then the preparation shall be classified according to its effects on man;

(b) that owing to effects such as potentiation, a conventional assessment would underestimate the toxicological hazard, those effects shall be taken into account in classifying the preparation; or

(c) that owing to effects such antagonism, a conventional assessment would overestimate the toxicological hazard, those effects shall be taken into account in classifying the preparation.

    (5) Subject to sub-paragraph (6), for preparations of a known composition, with the exception of plant protection products, classified in accordance with the method set out in sub-paragraph (1)(b), a new health effect assessment shall be performed either by the method set out in sub-paragraph (1)(a) or (1)(b) whenever - 

(a) changes of composition of the initial concentration, as a weight/weight or volume/volume percentage, of one or more of the dangerous constituents are introduced by the manufacturer which exceed the permitted variations set out in the following table - 



Initial concentration range of the constituent		Permitted variation in actual concentration of the constituent
	≤2.5%	±30%
>2.5	≤10%	±20%
>10	≤25%	±10%
>25	≤100%	±5%


(b) changes of composition involving the substitution or addition of one or more constituents, which may or may not be dangerous within the definitions in Schedule 1, are introduced by the manufacturer.

    (6) The revised assessment required by paragraph (5) shall not be required where there is a valid scientific justification for considering that a re-evaluation of the hazard will not result in a change of classification.

Classification for health effects by the conventional method
     5.  - (1) In accordance with paragraph 4(1)(a), the health effects shall be assessed by the conventional method described below using concentration limits.

    (2) Where the substances concerned are dangerous substances and are listed as dangerous substances in the approved supply list and are assigned concentration limits necessary for the application of the method of assessment described below, these concentration limits shall be used.

    (3) Where the substances concerned are dangerous substances and do not appear in the approved supply list as dangerous substances or appear there without the concentration limits necessary for the application of the method of evaluation described below, the concentration limits shall be assigned in accordance with Part II of this Schedule.

    (4) Where a preparation contains at least one substance which, in accordance with regulation 6(7) of the NONS Regulations bears the warning "Caution - Substance not yet fully tested", the label of the preparation must bear the words "Warning - This preparation contains a substance not yet tested completely" if the substance is present in a concentration equal to or in excess of 1% by weight.

    (5) A substance referred to in sub-paragraph (4) must, whatever its concentration level, be treated on the same basis as the other substances present in the preparation when applying the method of evaluation by calculation, if its labelling gives at least an indication of the health effect.

Lower limits of concentration
     6.  - (1) For preparations to which this Schedule applies, account shall be taken of dangerous substances which are classified as dangerous on the basis of their health or environmental effects (whether they are present as additives or impurities) when their concentrations are equal to or greater than those defined in the following table unless lower limits are given in the approved supply list or in Part II of this Schedule - 

Category of danger of the substance	Concentration to take into consideration for
	gaseous preparations % vol/vol	other preparations % w/w
Very toxic	≥0.02	≥0.1
Toxic	≥0.02	≥0.1
Carcinogenic Category 1 or 2	≥0.02	≥0.1
Mutagenic Category 1 or 2	≥0.02	≥0.1
Toxic for reproduction Category 1 or 2	≥0.02	≥0.1
Harmful	≥0.2	≥1
Corrosive	≥0.02	≥1
Irritant	≥0.2	≥1
Sensitising	≥0.2	≥1
Carcinogenic Category 3	≥0.2	≥1
Mutagenic Category 3	≥0.2	≥1
Toxic for reproduction Category 3	≥0.2	≥1
Dangerous for the environment N		≥0.1
Dangerous for the environment ozone	≥0.1	≥0.1
Dangerous for the environment		≥1

    (2) Some substances may have more than one health effect and each of these properties shall be characterised by its specific concentration limit.

Classification by the conventional method as very toxic
     7.  - (1) The following preparations shall be classified as very toxic owing to their acute lethal effects and assigned the symbol "T+", the indication of danger "very toxic" and the risk phrase R26, R27 or R28 - 

(a) preparations containing one or more substances classified as very toxic that produce such effects, in individual concentrations equal to or exceeding - 


(i) either the concentration specified in the approved supply list for the substance or substances under consideration, or

(ii) the concentration specified in paragraph 1 of Part II of this Schedule (Table I or Table IA) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits;



(b) preparations containing more than one substance classified as very toxic in lower individual concentrations than the limits specified in the approved supply list or in paragraph 1 of Part II of this Schedule (Table I or Table IA), if the sum of the quotients obtained by dividing the percentage weight of each very toxic substance in the preparation by the very toxic limit specified for that substance is 1 or more, i.e. - 

     Preparations containing one or more dangerous substances which produce such effects in individual concentrations equal to or exceeding - 


(i) either the concentration specified in the approved supply list for the substance or substances under consideration, or

(ii) the concentration specified in paragraph 2 of Part II of this Schedule (Table II or Table IIA) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits.

Classification by the conventional method as toxic
     8.  - (1) The following preparations shall be classified as toxic owing to their acute lethal effects and assigned the symbol "T", the indication of danger "toxic" and the risk phrase R23, R24 or R25 - 

(a) preparations containing one or more substances classified as very toxic or toxic that produce such effects in individual concentrations equal to or exceeding - 


(i) either the concentration specified in the approved supply list for the substance or substances under consideration, or

(ii) the concentration specified in paragraph 1 of Part II of this Schedule (Table I or Table IA) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits;



(b) preparations containing more than one substance classified as very toxic or toxic in lower individual concentrations than the limits specified in the approved supply list or in paragraph 1 of Part II of this Schedule (Table I or Table IA) if the sum of the quotients obtained by dividing the percentage weight of each very toxic or toxic substance in the preparation by the toxic limit specified for that substance is 1 or more, i.e. - 

(i) either the concentration specified in the approved supply list for the substance or substances under consideration, or

(ii) the concentration specified in paragraph 2 of Part II of this Schedule (Table II or Table IIA) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits.

    (3) The following preparations shall be classified as toxic owing to their long-term effects and assigned the symbol "T", the indication of danger "toxic" and the risk phrase R48/route of exposure - 

     Preparations containing one or more dangerous substances which produce such effects in individual concentrations equal to or exceeding - 


(i) either the concentration specified in the approved supply list for the substance or substances under consideration, or

(ii) the concentration specified in paragraph 3 of Part II of this Schedule (Table III or Table IIIA) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits.

Classification by the conventional method as harmful
     9.  - (1) The following preparations shall be classified as harmful owing to their acute lethal effects and assigned the symbol "X_n", the indication of danger "harmful" and the risk phrase R20, R21 or R22 - 

(a) preparations containing one or more substances classified as very toxic, toxic or harmful and that produce such effects in individual concentrations equal to or exceeding - 


(i) either the concentration specified in the approved supply list for the substance or substances under consideration, or

(ii) the concentration specified in paragraph 1 of Part II of this Schedule (Table I or Table IA) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits;



(b) preparations containing more than one substance classified as very toxic, toxic or harmful in lower individual concentrations than the limits specified in the approved supply list or in paragraph 1 of Part II of this Schedule (Table I or Table IA) if the sum of the quotients obtained by dividing the percentage weight of each very toxic, toxic or harmful substance in the preparation by the harmful limit specified for that substance is 1 or more, i.e. - 

     Preparations classified as harmful according to the criteria specified in the approved classification and labelling guide.

     In applying the conventional method according to sub-paragraph (1), no account shall be taken of the classification of a substance as R65.

    (3) The following preparations shall be classified as harmful owing to their non-lethal irreversible effects after a single exposure and assigned the symbol "X_n", the indication of danger "harmful" and the risk phrase R68/route of exposure - 

     Preparations containing one or more dangerous substances classified as very toxic, toxic or harmful which produce such effects in individual concentrations equal to or exceeding - 


(i) either the concentration specified in the approved supply list for the substance or substances under consideration, or

(ii) the concentration specified in paragraph 2 of Part II of this Schedule (Table II or Table IIA) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits;

    (4) The following preparations shall be classified as harmful owing to their long-term effects and assigned the symbol "X_n", the indication of danger "harmful" and the risk phrase R48/route of exposure - 

     Preparations containing one or more dangerous substances classified as toxic or harmful that produce such effects in individual concentrations equal to or exceeding - 


(i) either the concentration specified in the approved supply list for the substance or substances under consideration, or

(ii) the concentration specified in paragraph 3 of Part II of this Schedule (Table III or Table IIIA) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits.

Classification by the conventional method as corrosive
     10.  - (1) The following preparations shall be classified as corrosive and assigned the symbol "C", the indication of danger "corrosive" and the risk phrase R35 - 

(a) preparations containing one or more substances classified as corrosive to which is assigned the risk phrase R35 in individual concentrations equal to or exceeding - 


(i) either the concentration specified in the approved supply list for the substance or substances under consideration, or

(ii) the concentration specified in paragraph 4 of Part II of this Schedule (Table IV or Table IVA) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits;



(b) preparations containing more than one substance classified as corrosive to which is assigned the risk phrase R35 in lower individual concentrations than the limits specified either in the approved supply list or in paragraph 4 of Part II of this Schedule (Table IV or Table IVA) if the sum of the quotients obtained by dividing the percentage weight of each corrosive substance in the preparation by the corrosive limit R35 specified for that substance is 1 or more, i.e. - 

(a) preparations containing one or more substances classified as corrosive to which is assigned the risk phrase R35 or R34 in individual concentrations equal to or exceeding - 


(i) either the concentration specified in the approved supply list for the substance or substances under consideration, or

(ii) the concentration specified in paragraph 4 of Part II of this Schedule (Table IV or Table IVA) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits;



(b) preparations containing more than one substance classified as corrosive to which is assigned the risk phrase R35 or R34 in lower individual concentrations than the limits specified either in the approved supply list or in paragraph 4 of Part II of this Schedule (Table IV or Table IVA) if the sum of the quotients obtained by dividing the percentage weight of each corrosive substance in the preparation by the corrosive limit R34 specified for that substance is 1 or more, i.e. - 

(a) preparations containing one or more substances classified as irritant to which is assigned the risk phrase R41 in individual concentrations equal to or exceeding - 


(i) either the concentration specified in the approved supply list for the substance or substances under consideration, or

(ii) the concentration specified in paragraph 4 of Part II of this Schedule (Table IV or Table IVA) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits;



(b) preparations containing more than one substance classified as irritant to which is assigned the risk phrase R41, or classified as corrosive and to which is assigned the risk phrase R35 or R34, in lower individual concentrations than the limits specified either in the approved supply list or in paragraph 4 of Part II of this Schedule (Table IV or IVA) if the sum of the quotients obtained by dividing the percentage weight of each irritant substance in the preparation by the irritant limit R41 specified for that substance is 1 or more, i.e. - 

(a) preparations containing one or more substances classified as corrosive to which is assigned the risk phrase R35 or R34 or as irritant to which is assigned the risk phrase R41 or R36 in individual concentrations equal to or exceeding - 


(i) either the concentration specified in the approved supply list for the substance or substances under consideration, or

(ii) the concentration specified in paragraph 4 of Part II of this Schedule (Table IV or Table IVA) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits;



(b) preparations containing more than one substance classified as irritant to which is assigned the risk phrase R41 or R36 or as corrosive and to which is assigned the risk phrase R35 or R34, in lower individual concentrations than the limits specified either in the approved supply list or in paragraph 4 of Part II of this Schedule (Table IV or IVA) if the sum of the quotients obtained by dividing the percentage weight of each irritant substance in the preparation by the irritant limit R36 specified for that substance is 1 or more, i.e. - 

(a) preparations containing one or more substances classified as irritant and to which is assigned the risk phrase R38 or as corrosive and to which is assigned the risk phrase R35 or R34, in individual concentrations equal to or exceeding - 


(i) either the concentration specified in the approved supply list for the substance or substances under consideration, or

(ii) the concentration specified in paragraph 4 of Part II of this Schedule (Table IV or Table IVA) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits;



(b) preparations containing more than one substance classified as irritant and to which is assigned the risk phrase R38, or as corrosive and to which is assigned the risk phrase R35 or R34 in lower individual concentrations than the limits specified either in the approved supply list or in paragraph 4 of Part II of this Schedule (Table IV or Table IVA) if the sum of the quotients obtained by dividing the percentage weight of each substance in the preparation by the irritant limit R38 specified for that substance is 1 or more, i.e. - 

(a) preparations containing one or more substances classified as irritant to which is assigned the risk phrase R37 in individual concentrations equal to or exceeding - 


(i) either the concentration specified in the approved supply list for the substance or substances under consideration, or

(ii) the concentration specified in paragraph 4 of Part II of this Schedule (Table IV or Table IVA) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits;



(b) preparations containing more than one substance classified as irritant to which is assigned the risk phrase R37 in lower individual concentrations than the limits specified either in the approved supply list or in paragraph 4 of Part II of this Schedule (Table IV or Table IVA) if the sum of the quotients obtained by dividing the percentage weight of each irritant substance in the preparation by the irritant limit R37 specified for that substance is 1 or more, i.e. - 

(c) gaseous preparations containing more than one substance classified as irritant and to which is assigned the risk phrase R37 or as corrosive and to which is assigned the risk phrase R35 or R34 in lower individual concentrations than the limits specified either in the approved supply list or in paragraph 4 of Part II of this Schedule (Table IV or Table IVA) if the sum of the quotients obtained by dividing the percentage weight of each substance in the preparation by the irritant limit R37 specified for that substance is 1 or more, i.e. - 

     Preparations containing one or more substances classified as sensitising and to which is assigned risk phrase R43 that produces such effects in individual concentrations equal to or exceeding - 


(i) either the concentration specified in the approved supply list for the substance under consideration, or

(ii) the concentration specified in paragraph 5 of Part II of this Schedule (Table V or Table VA) where the substance or substances do no appear in the approved supply list or appear in it without concentration limits.

    (2) The following preparations shall be classified as sensitising by inhalation and assigned the symbol "X_n", the indication of danger "harmful" and the risk phrase R42 - 

     Preparations containing one or more substances classified as sensitising and to which is assigned risk phrase R42 that produces such effects in individual concentrations equal to or exceeding - 


(i) either the concentration specified in the approved supply list for the substance under consideration, or

(ii) the concentration specified in paragraph 5 of Part II of this Schedule (Table V or Table VA) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits.

Classification by the conventional method as carcinogenic
     13.  - (1) Preparations shall be classified as carcinogenic category 1 or 2 and assigned the symbol "T" and the risk phrase R45 or R49 if they contain one or more substances producing such effects to which is assigned the risk phrase R45 of R49 which denotes carcinogenic substances in category 1 and category 2 in individual concentrations equal to or exceeding - 

(a) either the concentration specified in the approved supply list for the substance or substances under consideration, or

(b) the concentration specified in paragraph 6 of Part II of this Schedule (Table VI or Table VIA) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits.

    (2) Preparations shall be classified as carcinogenic category 3 and assigned the symbol "X_n" and the risk phrase R40 if they contain one or more substances producing such effects to which is assigned the risk phrase R40 which denotes carcinogenic substances in category 3 in individual concentrations equal to or exceeding - 

(a) either the concentration specified in the approved supply list for the substance or substances under consideration, or

(b) the concentration specified in paragraph 6 of Part II of this Schedule (Table VI or Table VIA) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits.

Classification by the conventional method as mutagenic
     14.  - (1) Preparations shall be classified as mutagenic category 1 or 2 and assigned the symbol "T" and the risk phrase R46 if they contain one or more substances producing such effects to which is assigned the risk phrase R46 which denotes mutagenic substances in category 1 and category 2 in individual concentrations equal to or exceeding - 

(a) either the concentration specified in the approved supply list for the substance or substances under consideration, or

(b) the concentration specified in paragraph 6 of Part II of this Schedule (Table VI or Table VIA) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits.

    (2) Preparations shall be classified as mutagenic category 3 and assigned the symbol "X_n" and the risk phrase R68 if they contain one or more substances producing such effects to which is assigned the risk phrase R68 which denotes mutagenic substances in category 2 in individual concentrations equal to or exceeding - 

(a) either the concentration specified in the approved supply list for the substance or substances under consideration, or

(b) the concentration specified in paragraph 6 of Part II of this Schedule (Table VI or Table VIA) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits.

Classification by the conventional method as toxic for reproduction
     15.  - (1) Preparations shall be classified as toxic for reproduction category 1 or 2 and assigned the symbol "T" and the risk phrase R60 (fertility) if they contain one or more substances producing such effects to which is assigned the risk phrase R60 which denotes substances toxic for reproduction of category 1 and category 2 in individual concentrations equal to or exceeding - 

(a) either the concentration specified in the approved supply list for the substance or substances under consideration, or

(b) the concentration specified in paragraph 6 of Part II of this Schedule (Table VI or Table VIA) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits;

    (2) Preparations shall be classified as toxic for reproduction category 3 and assigned the symbol "X_n" and the risk phrase R62 (fertility) if they contain one or more substances producing such effects to which is assigned the risk phrase R62 which denotes substances toxic for reproduction in category 3 in individual concentrations equal to or exceeding - 

(a) either the concentration specified in the approved supply list for the substance or substances under consideration, or

(b) the concentration specified in paragraph 6 of Part II of this Schedule (Table VI or Table VIA) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits.

    (3) Preparations shall be classified as toxic for reproduction category 1 or 2 and assigned the symbol "T" and the risk phrase R61 (development) if they contain one or more substances producing such effects to which is assigned the risk phrase R61 which denotes substances toxic for reproduction of category 1 and category 2 in individual concentrations equal to or exceeding - 

(a) either the concentration specified in the approved supply list for the substance or substances under consideration, or

(b) the concentration specified in paragraph 6 of Part II of this Schedule (Table VI or Table VIA) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits;

    (4) Preparations shall be classified as toxic for reproduction category 3 and assigned the symbol "X_n" and the risk phrase R63 (development) if they contain one or more substances producing such effects to which is assigned the risk phrase R63 which denotes substances toxic for reproduction in category 3 in individual concentrations equal to or exceeding - 

(a) either the concentration specified in the approved supply list for the substance or substances under consideration, or

(b) the concentration specified in paragraph 6 of Part II of this Schedule (Table VI or Table VIA) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits.

Classification of preparations by environmental hazards
     16.  - (1) The environmental hazards of a preparation shall be assessed by one or more of the following methods - 

(a) by the conventional method described in the following paragraphs using concentration limits; or

(b) by the criteria set out in the approved classification and labelling guide in relation to the preparation for an appropriate classification and label.

    (2) Where the environmental hazards have been established by both methods, the results of the method set out in sub-paragraph (1)(b) shall be used for classifying the preparation.

    (3) Subject to sub-paragraph (4), for preparations of a known composition, with the exception of plant protection products, classified in accordance with the method set out in sub-paragraph (1)(b), a new assessment of the environmental hazards shall be performed either by the method set out in sub-paragraph (1)(a) or (1)(b) whenever - 

(a) changes of composition of the initial concentration, as a weight/weight or volume/volume percentage, of one or more of the dangerous constituents are introduced by the manufacturer which exceed the permitted variations set out in the following table - 



Initial concentration range of the constituent		Permitted variation in actual concentration of the constituent
	≤2.5%	±30%
>2.5	≤10%	±20%
>10	≤25%	±10%
>25	≤100%	±5%


(b) changes of composition involving the substitution or addition of one or more constituents, which may or may not be dangerous within the definitions in Schedule 1, are introduced by the manufacturer.

    (4) The revised assessment required by paragraph (3) shall not be required where there is a valid scientific justification for considering that a re-evaluation of the hazard will not result in a change of classification.

Classification for environmental hazards by the conventional method
     17.  - (1) In accordance with paragraph 16(1)(a), the environmental hazards shall be assessed by the conventional method described below using concentration limits.

    (2) Where the substances concerned are dangerous substances and are listed as dangerous substances in the approved supply list and are assigned concentration limits necessary for the application of the method of assessment described below, these concentration limits shall be used.

    (3) where the substances concerned are dangerous substances and do not appear in the approved supply list as dangerous substances or appear there without the concentration limits necessary for the application of the method of evaluation described below, the concentration limits shall be assigned in accordance with Part III of this Schedule.

Conventional method for the evaluation of hazards to the aquatic environment
     18.  - (1) The following preparations shall be classified as dangerous for the environment and assigned the symbol "N", the indication of danger "dangerous for the environment" and the risk phrases R50 and R53 (R50-R53) - 

(a) preparations containing one or more substances classified as dangerous to the environment and to which is assigned phrases R50-R53 in individual concentrations equal to or greater than - 


(i) either the concentration specified in the approved supply list for the substance or substances under consideration, or

(ii) the concentration specified in Part III of this Schedule (Table 1) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits;



(b) preparations containing more than one substance classified as dangerous to the environment and to which is assigned phrases R50-R53 in lower individual concentrations than the limits specified under paragraph (a) if - 

(a) preparations containing one or more substances classified as dangerous to the environment and to which is assigned phrases R50-R53 or R51-53 in individual concentrations equal to or greater than - 


(i) either the concentration specified in the approved supply list for the substance or substances under consideration, or

(ii) the concentration specified in Part III of this Schedule (Table 1) where the substance or substances do no appear in the approved supply list or appear in it without concentration limits;



(b) preparations containing more than one substance classified as dangerous to the environment and to which is assigned phrases R50-R53 or R51-53 in lower individual concentrations than the limits specified under paragraph (a) if - 

(a) preparations containing one or more substances classified as dangerous to the environment and to which is assigned phrases R50-R53 or R51-53 or R52-53 in individual concentrations equal to or greater than - 


(i) either the concentration specified in the approved supply list for the substance or substances under consideration, or

(ii) the concentration specified in Part III of this Schedule (Table 1) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits;



(b) preparations containing more than one substance classified as dangerous to the environment and to which is assigned phrases R50-R53 or R51-53 or R52-53 in lower individual concentrations that the limits specified under paragraph (a) if - 

(a) preparations containing one or more substances classified as dangerous to the environment and to which is assigned phrase R50 in individual concentrations equal to or greater than - 


(i) either the concentration specified in the approved supply list for the substance or substances under consideration, or

(ii) the concentration specified in Part III of this Schedule (Table 2) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits;



(b) preparations containing more than one substance classified as dangerous to the environment and to which is assigned phrase R50 in lower individual concentrations than the limits specified under paragraph (a) if - 

(c) preparations containing one or more substances classified as dangerous to the environment and to which is assigned phrase R50 not meeting the criteria under paragraph (a) or (b) and containing one or more substances classified as dangerous to the environment and to which is assigned phrases R50-53 if - 

(a) preparations containing one or more substances classified as dangerous to the environment and to which is assigned phrase R52 in individual concentrations equal to or greater than - 


(i) either the concentration specified in the approved supply list for the substance or substances under consideration, or

(ii) the concentration specified in Part III of this Schedule (Table 3) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits;



(b) preparations containing more than one substance classified as dangerous to the environment and to which is assigned phrase R52 in lower individual concentrations than the limits specified under paragraph (a) if - 

(a) preparations containing one or more substances classified as dangerous to the environment and to which is assigned phrase R53 in individual concentrations equal to or greater than - 


(i) either the concentration specified in the approved supply list for the substance or substances under consideration, or

(ii) the concentration specified in Part III of this Schedule (Table 4) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits;



(b) preparations containing more than one substance classified as dangerous to the environment and to which is assigned phrase R53 in lower individual concentrations than the limits specified under paragraph (a) if - 

(c) preparations containing one or more substances classified as dangerous to the environment and to which is assigned phrase R53 not meeting the criteria under paragraph (b) and containing one or more substances classified as dangerous to the environment and to which is assigned phrases R50-53, R51-53 or R52-53 if - 

(i) either the concentration specified in the approved supply list for the substance or substances under consideration, or

(ii) the concentration specified in Part III of this Schedule (Table 5) where the substance or substances do not appear in the approved supply list or appear in it without concentration limits,



shall be classified as dangerous for the environment and assigned the symbol "N", the indication of danger "dangerous for the environment" and the risk phrase R59.

    (2) Preparations containing one or more substances classified as dangerous to the environment and to which is assigned the risk phrase R59 in individual concentrations equal to or greater than - 

(i) either the concentration specified in the approved supply list for the substance or substances under consideration, or

(ii) the concentration specified in Part III of this Schedule (Table 5) where the substance or substances do no appear in the approved supply list or appear in it without concentration limits,



shall be classified as dangerous for the environment and assigned the risk phrase R59.