The Control of Substances Hazardous to Health Regulations 1994

law://uk/uksi/1994/3246@2026-11-12

Contents

1Citation and commencement#

These Regulations may be cited as the Control of Substances Hazardous to Health Regulations 1994 and shall come into force on 16th January 1995.

2Interpretation#

(1)In these Regulations, unless the context otherwise requires—• “the 1974 Act” means the Health and Safety at Work etc.Act 1974;• “the 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 and adopted as respects Great Britain by the European Economic Area Act 1993;• “approved” means approved for the time being in writing;• “approved supply list” has the meaning assigned to it in regulation 4(1) of the Chemicals (Hazard Information and Packaging) Regulations 1993;• “biological agent” means any micro-organism, cell culture, or human endoparasite, including any which have been genetically modified, which may cause any infection, allergy, toxicity or otherwise create a hazard to human health;• “carcinogen” means—(a) any substance or preparation which if classified in accordance with the classification provided for by regulation 5 of the Chemicals (Hazard Information and Packaging) Regulations 1993 would be in the category of danger, carcinogenic (category 1) or carcinogenic (category 2) whether or not the substance or preparation would be required to be classified under those Regulations; or(b) any substance or preparation—(a) listed in Schedule 8; and(ii) any substance or preparation arising from a process specified in Schedule 8 which is a substance hazardous to health;• “the Executive” means the Health and Safety Executive;• “fumigation” means an operation in which a substance is released into the atmosphere so as to form a gas to control or kill pests or other undesirable organisms and “fumigate” and “fumigant” shall be construed accordingly;• “maximum exposure limit” for a substance hazardous to health means the maximum exposure limit for that substance set out in Schedule 1 in relation to the reference period specified therein when calculated by a method approved by the Health and Safety Commission;• “member State” means a State which is a Contracting Party to the Agreement, but until the Agreement comes into force in relation to Liechenstein does not include the State of Liechenstein;• “micro-organism” means a microbiological entity, cellular or non-cellular, which is capable of replication or of transferring genetic material;• “occupational exposure standard” for a substance hazardous to health means the standard approved by the Health and Safety Commission for that substance in relation to the specified reference period when calculated by a method approved by the Health and Safety Commission;• “registered dentist” has the meaning assigned to it in section 53(1) of the Dentists Act 1984;• “registered medical practitioner” means a fully registered person within the meaning of the Medical Act 1983;• “substance” means any natural or artificial substance whether in solid or liquid form or in the form of a gas or vapour (including micro-organisms);• “substance hazardous to health” means any substance (including any preparation) which is—(a) a substance which is listed in Part 1 of the approved supply list as dangerous for supply within the meaning of the Chemicals (Hazard Information and Packaging) Regulations 1993 and for which an indication of danger specified for the substance in Part V of that list is very toxic, toxic, harmful, corrosive or irritant;(b) a substance specified in Schedule 1 (which lists substances assigned maximum exposure limits) or for which the Health and Safety Commission has approved an occupational exposure standard;(c) a biological agent;(d) dust of any kind, when present at a substantial concentration in air;(e) a substance, not being a substance mentioned in sub-paragraphs (a) to (d) above, which creates a hazard to the health of any person which is comparable with the hazards created by substances mentioned in those sub-paragraphs.

(2)In these Regulations, any reference to an employee being exposed to a substance hazardous to health is a reference to the exposure of that employee to a substance hazardous to health arising out of or in connection with work which is under the control of his employer.

(3)In these Regulations, unless the context otherwise requires—

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

(b)a reference to a numbered paragraph is a reference to the paragraph so numbered in the regulation or Schedule in which that reference appears.

3Duties under these Regulations#

(1)Where any duty is placed by these Regulations on an employer in respect of his employees, he shall, so far as is reasonably practicable, be under a like duty in respect of any other person, whether at work or not, who may be affected by the work carried on by the employer except that the duties of the employer—

(a)under regulation 11 (health surveillance) shall not extend to persons who are not his employees; and

(b)under regulations 10 and 12(1) and (2) (which relate respectively to monitoring and information, training etc.) shall not extend to persons who are not his employees, unless those persons are on the premises where the work is being carried on.

(2)These Regulations shall apply to a self-employed person as they apply to an employer and an employee and as if that self-employed person were both an employer and employee, except that regulations 10 and 11 shall not apply to a self-employed person.

(3)The duties imposed by these Regulations shall not extend to the master or crew of a sea-going ship or to the employer of such persons in relation to the normal shipboard activities of a ship’s crew under the direction of the master.

4Prohibitions relating to certain substances#

(1)Those substances described in column 1 of Schedule 2 are prohibited to the extent set out in the corresponding entry in column 2 of that Schedule.

(2)The importation into the United Kingdom, other than from another member State, of the following substances and articles is prohibited, namely—

(a)2-naphthylamine, benzidine, 4-aminodiphenyl, 4-nitrodiphenyl, their salts and any substance containing any of those compounds in a total concentration equal to or greater than 0.1 per cent. by mass;

(b)matches made with white phosphorus,

and any contravention of this paragraph shall be punishable under the Customs and Excise Management Act 1979 and not as a contravention of a health and safety regulation.

(3)A person shall not supply during the course of or for use at work any substance or article specified in paragraph (2).

(4)A person shall not supply during the course of or for use at work, benzene or any substance containing benzene unless its intended use is not prohibited by item 11 of Schedule 2.

5Application of regulations 6 to 12#

(1)Regulations 6 to 12 shall have effect with a view to protecting persons against risks to their health, whether immediate or delayed, arising from exposure to substances hazardous to health except—

(a)where and to the extent that the following Regulations apply, namely—

(i)the Control of Lead at Work Regulations 1980,

(ii)the Control of Asbestos at Work Regulations 1987;

(b)where the substance is hazardous to health solely by virtue of its radioactive, explosive or flammable properties, or solely because it is at a high or low temperature or a high pressure;

(c)where the risk to health is a risk to the health of a person to whom the substance is administered in the course of his medical treatment;

(d)below ground in any mine within the meaning of section 180 of the Mines and Quarries Act 1954.

(2)In paragraph 1(c) “medical treatment” means medical or dental examination or treatment which is conducted by, or under the direction of, a registered medical practitioner or registered dentist and includes any such examination, treatment or administration of any substance conducted for the purpose of research.

(3)Nothing in these Regulations shall prejudice any requirement imposed by or under any enactment relating to public health or the protection of the environment.

6Assessment of health risks created by work involving substances hazardous to health#

(1)An employer shall not carry on any work which is liable to expose any employees to any substance hazardous to health unless he has made a suitable and sufficient assessment of the risks created by that work to the health of those employees and of the steps that need to be taken to meet the requirements of these Regulations.

(2)The assessment required by paragraph (1) shall be reviewed regularly and forthwith if—

(a)there is reason to suspect that the assessment is no longer valid; or

(b)there has been a significant change in the work to which the assessment relates,

and, where as a result of the review, changes in the assessment are required, those changes shall be made.

7Prevention or control of exposure to substances hazardous to health#

(1)Every employer shall ensure that the exposure of his employees to substances hazardous to health is either prevented or, where this is not reasonably practicable, adequately controlled.

(2)So far as is reasonably practicable, the prevention or adequate control of exposure of employees to a substance hazardous to health, except to a carcinogen or a biological agent, shall be secured by measures other than the provision of personal protective equipment.

(3)Without prejudice to the generality of paragraph (1), where the assessment made under regulation 6 shows that it is not reasonably practicable to prevent exposure to a carcinogen by using an alternative substance or process, the employer shall apply all the following measures, namely—

(a)the total enclosure of the process and handling systems unless this is not reasonably practicable;

(b)the use of plant, processes and systems of work which minimise the generation of, or suppress and contain, spills, leaks, dust, fumes and vapours of carcinogens;

(c)the limitation of the quantities of a carcinogen at the place of work;

(d)the keeping of the number of persons who might be exposed to a carcinogen to a minimum;

(e)the prohibition of eating, drinking and smoking in areas that may be contaminated by carcinogens;

(f)the provision of hygiene measures including adequate washing facilities and regular cleaning of walls and surfaces;

(g)the designation of those areas and installations which may be contaminated by carcinogens, and the use of suitable and sufficient warning signs; and

(h)the safe storage, handling and disposal of carcinogens and use of closed and clearly labelled containers.

(4)Where the measures taken in accordance with paragraph (2) or (3), as the case may be, do not prevent, or provide adequate control of, exposure to substances hazardous to health to which those paragraphs apply, then, in addition to taking those measures, the employer shall provide those employees with such suitable personal protective equipment as will adequately control their exposure to those substances.

(5)Any personal protective equipment provided by an employer in pursuance of this regulation shall comply with any enactment (whether in an Act or instrument) which implements in Great Britain any provision on design or manufacture with respect to health or safety in any relevant Community directive listed in Schedule 1 to the Personal Protective Equipment at Work Regulations 1992 which is applicable to that item of personal protective equipment.

(6)Where there is exposure to a substance for which a maximum exposure limit is specified in Schedule 1, the control of exposure shall, so far as the inhalation of that substance is concerned, only be treated as being adequate if the level of exposure is reduced so far as is reasonably practicable and in any case below the maximum exposure limit.

(7)Without prejudice to the generality of paragraph (1), where there is exposure to a substance for which an occupational exposure standard has been approved, the control of exposure shall, so far as the inhalation of that substance is concerned, be treated as being adequate if—

(a)that occupational exposure standard is not exceeded; or

(b)where that occupational exposure standard is exceeded, the employer identifies the reasons for the standard being exceeded and takes appropriate action to remedy the situation as soon as is reasonably practicable.

(8)Where respiratory protective equipment is provided in pursuance of this regulation, then it shall—

(a)be suitable for the purpose; and

(b)comply with paragraph (5) or, where no requirement is imposed by virtue of that paragraph, be of a type approved or shall conform to a standard approved, in either case, by the Executive.

(9)In the event of the failure of a control measure which might result in the escape of carcinogens into the workplace, the employer shall ensure that—

(a)only those persons who are responsible for the carrying out of repairs and other necessary work are permitted in the affected area and they are provided with suitable respiratory protective equipment and protective clothing; and

(b)employees and other persons who may be affected are informed of the failure forthwith.

(10)Schedule 9 of these Regulations shall have effect in relation to biological agents.

(11)In this regulation, “adequate” means adequate having regard only to the nature of the substance and the nature and degree of exposure to substances hazardous to health and “adequately” shall be construed accordingly.

8Use of control measures etc.#

(1)Every employer who provides any control measure, personal protective equipment or other thing or facility pursuant to these Regulations shall take all reasonable steps to ensure that it is properly used or applied as the case may be.

(2)Every employee shall make full and proper use of any control measure, personal protective equipment or other thing or facility provided pursuant to these Regulations and shall take all reasonable steps to ensure it is returned after use to any accommodation provided for it and, if he discovers any defect therein, shall report it forthwith to his employer.

9Maintenance, examination and test of control measures etc.#

(1)Every employer who provides any control measure to meet the requirements of regulation 7 shall ensure that it is maintained in an efficient state, in efficient working order and in good repair and, in the case of personal protective equipment, in a clean condition.

(2)Where engineering controls are provided to meet the requirements of regulation 7, the employer shall ensure that thorough examinations and tests of those engineering controls are carried out—

(a)in the case of local exhaust ventilation plant, at least once every 14 months, or for local exhaust ventilation plant used in conjunction with a process specified in column 1 of Schedule 3, at not more than the interval specified in the corresponding entry in column 2 of that Schedule;

(b)in any other case, at suitable intervals.

(3)Where respiratory protective equipment (other than disposable respiratory protective equipment) is provided to meet the requirements of regulation 7, the employer shall ensure that at suitable intervals thorough examinations and, where appropriate, tests of that equipment are carried out.

(4)Every employer shall keep a suitable record of the examinations and tests carried out in pursuance of paragraphs (2) and (3) and of any repairs carried out as a result of those examinations and tests, and that record or a suitable summary thereof shall be kept available for at least 5 years from the date on which it was made.

10Monitoring exposure at the workplace#

(1)In any case in which—

(a)it is requisite for ensuring the maintenance of adequate control of the exposure of employees to substances hazardous to health; or

(b)it is otherwise requisite for protecting the health of employees,

the employer shall ensure that the exposure of employees to substances hazardous to health is monitored in accordance with a suitable procedure.

(2)Where a substance or process is specified in column 1 of Schedule 4, monitoring shall be carried out at least at the frequency specified in the corresponding entry in column 2 of that Schedule.

(3)The employer shall keep a suitable record of any monitoring carried out for the purpose of this regulation and that record or a suitable summary thereof shall be kept available—

(a)where the record is representative of the personal exposures of identifiable employees, for at least 40 years;

(b)in any other case, for at least 5 years.

11Health surveillance#

(1)Where it is appropriate for the protection of the health of his employees who are, or are liable to be, exposed to a substance hazardous to health, the employer shall ensure that such employees are under suitable health surveillance.

(2)Health surveillance shall be treated as being appropriate where—

(a)the employee is exposed to one of the substances specified in Column 1 of Schedule 5 and is engaged in a process specified in Column 2 of that Schedule, unless that exposure is not significant; or

(b)the exposure of the employee to a substance hazardous to health is such that an identifiable disease or adverse health effect may be related to the exposure, there is a reasonable likelihood that the disease or effect may occur under the particular conditions of his work and there are valid techniques for detecting indications of the disease or the effect.

(3)The employer shall ensure that a health record, containing particulars approved by the Executive, in respect of each of his employees to whom paragraph (1) relates is made and maintained and that that record or a copy thereof is kept in a suitable form for at least 40 years from the date of the last entry made in it.

(4)Where an employer who holds records in accordance with paragraph (3) ceases to trade, he shall forthwith notify the Executive thereof in writing and offer those records to the Executive.

(5)If an employee is exposed to a substance specified in Schedule 5 and is engaged in a process specified therein, the health surveillance required under paragraph (1) shall include medical surveillance under the supervision of an employment medical adviser or appointed doctor at intervals of not more than 12 months or at such shorter intervals as the employment medical adviser or appointed doctor may require.

(6)Where an employee is subject to medical surveillance in accordance with paragraph (5) and an employment medical adviser or appointed doctor has certified by an entry in the health record of that employee that in his professional opinion that employee should not be engaged in work which exposes him to that substance or that he should only be so engaged under conditions specified in the record, the employer shall not permit the employee to be engaged in such work except in accordance with the conditions, if any, specified in the health record, unless that entry has been cancelled by an employment medical adviser or appointed doctor.

(7)Where an employee is subject to medical surveillance in accordance with paragraph (5) and an employment medical adviser or appointed doctor has certified by an entry in his health record that medical surveillance should be continued after his exposure to that substance has ceased, the employer shall ensure that the medical surveillance of that employee is continued in accordance with that entry while he is employed by the employer, unless that entry has been cancelled by an employment medical adviser or appointed doctor.

(8)On reasonable notice being given, the employer shall allow any of his employees access to the health record which relates to him.

(9)An employee to whom this regulation applies shall, when required by his employer and at the cost of the employer, present himself during his working hours for such health surveillance procedures as may be required for the purposes of paragraph (1) and, in the case of an employee who is subject to medical surveillance in accordance with paragraph (5), shall furnish the employment medical adviser or appointed doctor with such information concerning his health as the employment medical adviser or appointed doctor may reasonably require.

(10)Where, for the purpose of carrying out his functions under these Regulations, an employment medical adviser or appointed doctor requires to inspect any workplace or any record kept for the purposes of these Regulations, the employer shall permit him to do so.

(11)Where an employee or an employer is aggrieved by a decision recorded in the health record by an employment medical adviser or appointed doctor to suspend an employee from work which exposes him to a substance hazardous to health (or to impose conditions on such work), he may, by an application in writing to the Executive within 28 days of the date on which he was notified of the decision, apply for that decision to be reviewed in accordance with a procedure approved for the purposes of this paragraph by the Health and Safety Commission, and the result of that review shall be notified to the employee and employer and entered in the health record in accordance with the approved procedure.

(12)In this regulation—• “appointed doctor” means a registered medical practitioner who is appointed for the time being in writing by the Executive for the purposes of this regulation;• “employment medical adviser” means an employment medical adviser appointed under section 56 of the 1974 Act;• “health surveillance” includes biological monitoring.

12Information, instruction and training for persons who may be exposed to substances hazardous to health#

(1)An employer who undertakes work which may expose any of his employees to substances hazardous to health shall provide that employee with such information, instruction and training as is suitable and sufficient for him to know—

(a)the risks to health created by such exposure; and

(b)the precautions which should be taken.

(2)Without prejudice to the generality of paragraph (1), the information provided under that paragraph shall include—

(a)information on the results of any monitoring of exposure at the workplace in accordance with regulation 10 and, in particular, in the case of any substance hazardous to health specified in Schedule 1, the employee or his representatives shall be informed forthwith, if the results of such monitoring show that the maximum exposure limit has been exceeded; and

(b)information on the collective results of any health surveillance undertaken in accordance with regulation 11 in a form calculated to prevent it from being identified as relating to any particular person.

(3)Every employer shall ensure that any person (whether or not his employee) who carries out any work in connection with the employer’s duties under these Regulations has the necessary information, instruction and training.

13Provisions relating to certain fumigations#

(1)This regulation shall apply to fumigations in which the fumigant used or intended to be used is hydrogen cyanide, ethylene oxide, phosphine or methyl bromide, except that this regulation shall not apply to fumigations using the fumigant specified in column 1 of Schedule 6 when the nature of the fumigation is that specified in the corresponding entry in column 2 of that Schedule.

(2)An employer shall not undertake any fumigation to which this regulation applies unless he has—

(a)notified the persons specified in Part I of Schedule 7 of his intention to undertake the fumigation; and

(b)provided to those persons the information specified in Part II of that Schedule,

at least 24 hours in advance, or such shorter time in advance, as the persons required to be notified may agree.

(3)An employer who undertakes a fumigation to which this regulation applies shall ensure that, before the fumigant is released, suitable warning notices have been affixed at all points of reasonable access to the premises or to those parts of the premises in which the fumigation is to be carried out and that after the fumigation has been completed, and the premises are safe to enter, those warning notices are removed.

14Exemption certificates#

(1)Subject to paragraph (2) and to any of the provisions imposed by the Communities in respect of the protection of workers from the risks related to exposure to chemical, physical and biological agents at work, the Executive may, by a certificate in writing, exempt any person or class of persons or any substance or class of substances from all or any of the requirements or prohibitions imposed by these Regulations and any such exemption may be granted subject to conditions and to a limit of time and may be revoked by a certificate in writing at any time.

(2)The Executive shall not grant any such exemption unless having regard to the circumstances of the case and, in particular, to—

(a)the conditions, if any, which it proposes to attach to the exemption; and

(b)any other requirements imposed by or under any enactments which apply to the case,

it is satisfied that the health and safety of persons who are likely to be affected by the exemption will not be prejudiced in consequence of it.

15Extension outside Great Britain#

(1)Subject to paragraph (2), these Regulations shall apply to and in relation to any activity outside Great Britain to which sections 1 to 59 and 80 to 82 of the 1974 Act apply by virtue of article 4, 5 or 7 of the Health and Safety at Work etc.Act 1974 (Application outside Great Britain) Order 1989 as those provisions apply within Great Britain.

(2)These Regulations shall not extend to Northern Ireland except insofar as they relate to imports of substances and articles referred to in regulation 4(2) into the United Kingdom.

16Defence in proceedings for contravention of these Regulations#

In any proceedings for an offence consisting of a contravention of these Regulations it shall be a defence for any person to prove that he took all reasonable precautions and exercised all due diligence to avoid the commission of that offence.

17Exemptions relating to the Ministry of Defence etc.#

(1)In this regulation, any reference to—

(a)“visiting forces” is a reference to visiting forces within the meaning of any provision of Part I of the Visiting Forces Act 1952; and

(b)“headquarters or organisation” is a reference to a headquarters or organisation designated for the purposes of the International Headquarters and Defence Organisations Act 1964.

(2)The Secretary of State for Defence may, in the interests of national security, by a certificate in writing exempt—

(a)Her Majesty’s Forces;

(b)visiting forces;

(c)any member of a visiting force working in or attached to any headquarters or organisation; or

(d)any person engaged in work involving substances hazardous to health, if that person is under the direct supervision of a representative of the Secretary of State for Defence,

from all or any of the requirements or prohibitions imposed by these Regulations and any such exemption may be granted subject to conditions and to a limit of time and may be revoked at any time by a certificate in writing, except that, where any such exemption is granted, suitable arrangements shall be made for the assessment of the health risks created by the work involving substances hazardous to health and for adequately controlling the exposure to those substances of persons to whom the exemption relates.

(3)Regulation 11(11) shall not apply in relation to—

(a)Her Majesty’s Forces;

(b)visiting forces; or

(c)any member of a visiting force working in or attached to any headquarters or organisation.

18Revocations and savings#

(1)Paragraphs 19, 20 and 21 in Part VIII of Schedule 2 to the Personal Protective Equipment at Work Regulations 1992 are revoked.

(2)Regulation 3 of the Health and Safety (Miscellaneous Modifications) Regulations 1993 is revoked.

(3)Paragraph (9) of regulation 21 of the Chemicals (Hazard Information and Packaging) Regulations 1993 is revoked.

(4)The following Regulations are revoked—

(a)The Health and Safety (Dangerous Pathogens) Regulations 1981;

(b)The Control of Substances Hazardous to Health Regulations 1988;

(c)The Control of Substances Hazardous to Health (Amendment) Regulations 1991;

(d)The Control of Substances Hazardous to Health (Amendment) Regulations 1992;

(5)Any record or register required to be kept under any regulations revoked by paragraph (4) shall, notwithstanding those revocations, be kept in the same manner and for the same period as specified in those regulations as if these Regulations had not been made, except that the Executive may approve the keeping of records at a place or in a form other than at the place where, or in the form in which, records were required to be kept under the regulations so revoked.

19Extension of meaning of “work”#

For the purposes of Part I of the 1974 Act the meaning of “work” shall be extended to include any activity involving the consignment, storage or use of any of the biological agents listed in Part V of Schedule 9 and the meaning of “at work” shall be extended accordingly, and in that connection the references to employer in paragraphs 12 and 13 of that Schedule include references to any person carrying on such an activity.

20Modification of section 3(2) of the 1974 Act#

Section 3(2) of the 1974 Act shall be modified in relation to an activity involving the consignment, storage or use of any of the biological agents referred to in regulation 19 so as to have effect as if the reference therein to a self-employed person is a reference to any person who is not an employer or an employee and the reference therein to his undertaking includes a reference to such an activity.

Schedule 1 · List of substances assigned maximum exposure limits

Schedule 2 · Prohibition of certain substances hazardous to health for certain purposes

Schedule 3 · Frequency of thorough examination and test of local exhaust ventilation plant used in certain processes

Schedule 4 · Specific substances and processes for which monitoring is required

Schedule 5 · Medical surveillance

Schedule 6 · Fumigations excepted from regulation 13

Schedule 7 · Notification of certain fumigations

Part I · Persons to whom notifications must be made

(1)In the case of a fumigation to be carried out within the area of a harbour authority, advance notification of fumigation shall, for the purposes of regulation 13(2)(a), be given to—

(a)that authority;

(b)an inspector appointed under section 19 of the 1974 Act, if that inspector so requires; and

(c)where the fumigation

(i)is to be carried out on a sea-going ship, the chief fire officer of the area in which the ship is situated and the officer in charge of the office of Her Majesty’s Customs and Excise at the harbour, or

(ii)is the space fumigation of a building, the chief fire officer of the area in which the building is situated.

(2)In the case of a fumigation, other than a fumigation to which paragraph (1) applies, advance notification of fumigation shall be given to—

(a)the police officer for the time being in charge of the police station for the police district in which the fumigation is carried out;

(b)an inspector appointed under section 19 of the 1974 Act if that inspector so requires; and

(c)where the fumigation is to be carried out on a sea-going ship or is the space fumigation of a building, the chief fire officer of the area in which the ship or building is situated.

Part II · Information to be given in advance notice of fumigations

(3)The information to be given in a notification made for the purposes of regulation 13(2) shall include the following:—

(a)the name, address and place of business of the fumigator and his telephone number;

(b)the name of person requiring the fumigation to be carried out;

(c)the address and description of the premises where the fumigation is to be carried out;

(d)the date on which the fumigation is to be carried out and the estimated time of commencement and completion;

(e)the name of the operator in charge of the fumigation; and

(f)the fumigant to be used.

Schedule 8 · Other substances and processes to which the definition of “carcinogen” relates

Schedule 9 · Special provisions relating to biological agents

Part I · Provisions of general application to biological agents

(1)In this Schedule—• “cell culture” means the in-vitro growth of cells derived from multicellular organisms;• “diagnostic service” means any activity undertaken solely with the intention of—(a) testing for the presence of or identifying a biological agent,(b) isolating or identifying other organisms from specimens or samples containing or suspected of containing a biological agent,(c) analysing specimens or samples from a human patient or animal in which a biological agent is or is suspected of being present for purposes relating to the assessment of the clinical progress, or assistance in the clinical management, of that patient or animal,and “diagnosis” shall be construed accordingly;• “Group” means one of the four hazard Groups specified in paragraph 3 to which biological agents are assigned.

(2)

(1)This Schedule shall have effect with a view to protecting employees against risks to their health, whether immediate or delayed, arising from exposure to biological agents except that paragraph 11 shall not apply in relation to a particular biological agent where the results of the assessment made under regulation 6 indicate that—

(a)the activity does not involve a deliberate intention to work with or use that biological agent; and

(b)there is no significant risk to the health of employees associated with that biological agent.

(2)Unless otherwise expressly provided, the provisions of this Schedule shall have effect in addition to and not in substitution for other provisions of these Regulations.

(3)

(1)The Health and Safety Commission shall approve and publish for the purposes of this Schedule a document, which may be revised or re-issued from time to time, entitled “Categorisation of Biological Agents according to hazard and categories of containment” containing a list of biological agents together with the classification of each agent which it has approved, and any reference in this Schedule to “approved classification” in relation to a particular biological agent shall be construed as a reference to the classification of that agent which appears in the said document.

(2)Where a biological agent has an approved classification any reference in these Regulations to a particular Group in relation to that agent shall be taken as a reference to the Group to which that agent has been assigned in that approved classification.

(3)Where a biological agent does not have an approved classification, the employer shall provisionally classify that agent in accordance with sub-paragraph (4) below, having regard to the nature of the agent and the properties of which he may reasonably be expected to be aware.

(4)When provisionally classifying a biological agent the employer shall assign that agent to one of the following Groups according to its level of risk of infection and, if in doubt as to which of two alternative Groups is the most appropriate, he shall assign it to the higher of the two—

(a)Group 1 — unlikely to cause human disease;

(b)Group 2 — can cause human disease and may be a hazard to employees; it is unlikely to spread to the community and there is usually effective prophylaxis or treatment available;

(c)Group 3 — can cause severe human disease and may be a serious hazard to employees; it may spread to the community, but there is usually effective prophylaxis or treatment available;

(d)Group 4 — causes severe human disease and is a serious hazard to employees; it is likely to spread to the community and there is usually no effective prophylaxis or treatment available.

(4)Without prejudice to the generality of regulation 6, every employer who intends to carry on any work which is liable to expose his employees to any biological agent shall take account of the Group into which that agent is classified when making an assessment of the risks created by that work.

(5)Without prejudice to the generality of regulation 7(1), if the nature of the activity so permits, every employer shall ensure that the exposure of his employees to a particular biological agent is prevented by substituting a biological agent which is less hazardous.

(6)

(1)Where there is a risk of exposure to a biological agent and it is not otherwise reasonably practicable to prevent that exposure then it shall be adequately controlled, in particular by the following measures which are to be applied in the light of the results of the assessment—

(a)keeping as low as practicable the number of employees exposed or likely to be exposed to the biological agent;

(b)designing work processes and engineering control measures so as to prevent or minimise the release of biological agents into the place of work;

(c)displaying the biohazard sign shown in Part IV of this Schedule and other relevant warning signs;

(d)drawing up plans to deal with accidents involving biological agents;

(e)specifying appropriate decontamination and disinfection procedures;

(f)instituting means for the safe collection, storage and disposal of contaminated waste, including the use of secure and identifiable containers, after suitable treatment where appropriate;

(g)making arrangements for the safe handling and transport of biological agents, or materials that may contain such agents, within the workplace;

(h)specifying procedures for taking, handling and processing samples that may contain biological agents;

(i)providing collective protection measures and, where exposure cannot be adequately controlled by other means, individual protection measures including, in particular, the supply of appropriate protective clothing or other special clothing;

(j)where appropriate, making available effective vaccines for those employees who are not already immune to the biological agent to which they are exposed or are liable to be exposed;

(k)instituting hygiene measures compatible with the aim of preventing or reducing the accidental transfer or release of a biological agent from the workplace, including, in particular—

(i)the provision of appropriate and adequate washing and toilet facilities, and

(ii)the prohibition of eating, drinking, smoking and application of cosmetics in working areas where there is a risk of contamination by biological agents.

(2)In this paragraph, “appropriate” in relation to clothing and hygiene measures means appropriate for the risks involved and the conditions at the place where exposure to the risk may occur.

(7)In health and veterinary care isolation facilities where there are human patients or animals which are, or are suspected of being, infected with a Group 3 or Group 4 biological agent, the employer shall select the most suitable containment measures from those listed in Part II of this Schedule with a view to controlling adequately the risk of infection.

(8)

(1)Every employer who is engaged in any of the activities specified in sub-paragraph (3) below shall ensure that measures taken to control adequately the exposure of his employees to biological agents include, in particular, the most suitable combination of containment measures from those listed in Parts II and III of this Schedule as appropriate, taking into account—

(a)the nature of the activity specified in sub-paragraph (3) below;

(b)the minimum containment level specified in sub-paragraph (4) below;

(c)the assessment of risk made under regulation 6; and

(d)the nature of the biological agent concerned.

(2)

(a)An employer who is engaged in any of the activities specified in sub-paragraphs (a) or (b) of paragraph (3) below shall select measures from Part II of this Schedule;

(b)an employer who is engaged in the activity specified in sub-paragraph (c) of paragraph (3) below shall select measures from Part III of this Schedule and, subject to paragraph (4) below, when making that selection he may combine measures from different categories of containment on the basis of a risk assessment related to any particular process or part of a process.

(3)The activities referred to in sub-paragraph (1) above are—

(a)research, development, teaching or diagnostic work in laboratories which involves the handling of a Group 2, Group 3 or Group 4 biological agent or material containing such an agent;

(b)keeping or handling of laboratory animals which have been deliberately infected with a Group 2, Group 3 or Group 4 biological agent or which are, or are suspected of being, naturally infected with such an agent; and

(c)industrial processes which involve the use of a Group 2, Group 3 or Group 4 biological agent.

(4)The minimum containment level referred to in sub-paragraph (1) above shall be—

(a)level 2 for activities involving the handling of a Group 2 biological agent;

(b)level 3 for activities involving the handling of a Group 3 biological agent;

(c)level 4 for activities involving the handling of a Group 4 biological agent;

(d)level 2 for laboratories which do not intentionally work with biological agents but handle materials in respect of which there exist uncertainties about the presence of a Group 2, Group 3 or Group 4 biological agent;

(e)level 3 or 4, where appropriate, for laboratories which do not intentionally work with biological agents but where the employer knows or suspects that such a containment level is necessary; except where guidelines approved by the Health and Safety Commission indicate that, in the particular case, a lower containment level is appropriate; and

(f)level 3 for activities where it has not been possible to carry out a conclusive assessment but concerning which it appears that the activity might involve a serious health risk for employees.

(9)

(1)Every employer who provides personal protective equipment, including protective clothing, to meet the requirements of these Regulations as they apply to biological agents shall ensure that it is—

(a)properly stored in a well-defined place;

(b)checked and cleaned at suitable intervals; and

(c)when discovered to be defective, repaired or replaced before further use.

(2)Personal protective equipment which may be contaminated by biological agents shall be—

(a)removed on leaving the working area; and

(b)kept apart from uncontaminated clothing and equipment.

(3)The employer shall ensure that the equipment referred to in sub-paragraph (2) above is subsequently decontaminated and cleaned or, if necessary, destroyed.

(10)

(1)Every employer shall provide written instructions at the workplace and, if appropriate, display notices which shall include the procedure to be followed in the case of—

(a)an accident or incident which has or may have resulted in the release of a biological agent which could cause severe human disease;

(b)the handling of a Group 4 biological agent or material that may contain such an agent.

(2)Every employee shall report forthwith, to his employer or to any other employee of that employer with specific responsibility for the health and safety of his fellow employees, any accident or incident which has or may have resulted in the release of a biological agent which could cause severe human disease.

(3)Every employer shall inform his employees or their representatives—

(a)forthwith, of any accident or incident which has or may have resulted in the release of a biological agent which could cause severe human disease; and

(b)as soon as practicable thereafter, of

(i)the causes of such an accident or incident; and

(ii)the measures taken or to be taken to rectify the situation.

(11)

(1)Subject to paragraph 2(1), every employer shall keep a list of employees exposed to a Group 3 or Group 4 biological agent, indicating the type of work done and, where known, the biological agent to which they have been exposed, and records of exposures, accidents and incidents, as appropriate.

(2)Subject to sub-paragraph (3) below, the list shall be kept for at least 10 years following the last known exposure of the employee concerned.

(3)In the case of those exposures which may result in infections—

(a)with biological agents known to be capable of establishing persistent or latent infections;

(b)that, in the light of present knowledge, are undiagnosable until illness develops many years later;

(c)that have particularly long incubation periods before illness develops;

(d)that result in illnesses which recrudesce at times over a long period despite treatment; or

(e)that may have serious long-term sequelae,

the list shall be kept for 40 years following the last known exposure.

(4)The employment medical adviser or appointed doctor referred to in regulation 11, and any employee of that employer with specific responsibility for the health and safety of his fellow employees, shall have access to the list.

(5)Each employee shall have access to the information on the list which relates to him personally.

(12)

(1)Subject to sub-paragraphs (5) and (6) below, an employer shall not store or use for the first time one or more biological agents in Group 2, 3 or 4 at particular premises unless he has notified the Executive in writing of his intention to do so at least 30 days in advance or before such shorter time as the Executive may approve and with that notification has furnished the particulars specified in sub-paragraph (3) below.

(2)Subject to sub-paragraphs (5) and (7) below, notification in accordance with sub-paragraph (1) above shall also be made of the storage or use for the first time of—

(a)each subsequent biological agent where that agent is specified in Part V of this Schedule;

(b)each subsequent Group 3 biological agent where that agent does not have an approved classification.

(3)The particulars to be included in the notification referred to in sub-paragraphs (1) and (2) above shall be—

(a)the name and address of the employer and the address of the premises where the biological agent will be stored or used;

(b)the name, qualifications and relevant experience of any employee of that employer with specific responsibilty for the health and safety of his fellow employees;

(c)the results of the assessment made under regulation 6;

(d)the Group to which the biological agent has been assigned and, if the agent is specified in Part V of this Schedule or is a Group 3 agent which does not have an approved classification, the identity of the agent; and

(e)the preventive and protective measures that are to be taken.

(4)Where there are substantial changes to processes or procedures of importance to health or safety at work which render the original notification invalid the employer shall notify the Executive forthwith in writing of those changes.

(5)Sub-paragraphs (1) and (2) above shall not apply in relation to a particular biological agent where an intention to store or use that biological agent has been previously notified to the Executive in accordance with the Genetically Modified Organisms (Contained Use) Regulations 1992.

(6)Sub-paragraph (1) above shall not apply to an employer who intends to provide a diagnostic service in relation to Group 2 or Group 3 biological agents, other than those Group 3 agents specified in Part V of this Schedule, unless it will involve a process likely to propagate or concentrate that agent.

(7)Sub-paragraph (2) above shall not apply to an employer who intends to provide a diagnostic service unless it will involve a process likely to propagate or concentrate a biological agent which does not have an approved classification.

(13)

(1)An employer shall not consign any of the biological agents specified in Part V of this Schedule or anything containing, or suspected of containing, such an agent to any other premises, whether or not those premises are under his ownership or control, unless he has notified the Executive in writing of his intention to do so at least 30 days in advance or before such shorter time as the Executive may approve and with that notification has furnished the particulars specified in sub-paragraph (4) below.

(2)Sub-paragraph (1) above shall not apply where—

(a)the biological agent or material containing or suspected of containing such an agent is being consigned solely for the purpose of diagnosis;

(b)material containing or suspected of containing the biological agent is being consigned solely for the purpose of disposal; or

(c)the biological agent is or is suspected of being present in a human patient or animal which is being transported for the purpose of medical treatment.

(3)Where a biological agent specified in Part V of this Schedule is imported into Great Britain, the consignee shall give the notice required by sub-paragraph (1) above.

(4)The particulars to be included in the notification referred to in sub-paragraph (1) above shall be—

(a)the identity of the biological agent and the volume of the consignment;

(b)the name of the consignor;

(c)the address of the premises from which it will be transported;

(d)the name of the consignee;

(e)the address of the premises to which it shall be transported;

(f)the name of the transport operator responsible for the transportation;

(g)the name of any individual who will accompany the consignment;

(h)the method of transportation;

(i)the packaging and any containment precautions which will be taken;

(j)the route which will be taken; and

(k)the proposed date of transportation.

(14)

(1)Upon receipt of any notification submitted in accordance with paragraphs 12 or 13 concerning a biological agent specified in Part V of this Schedule, the Executive shall notify the appropriate Health Minister forthwith in writing that that agent is to be or is no longer to be stored, used or consigned.

(2)In sub-paragraph (1) above “Health Minister” means, in respect of England, Scotland or Wales, the Secretary of State concerned with health in that country.

Part V · LIST OF BIOLOGICAL AGENTS REFERRED TO IN PARAGRAPHS 12(2)(a), 13(1) AND (3) AND 14(1) OF PART I OF THIS SCHEDULE

(1)All Group 4 biological agents.

(2)Rabies virus.

(3)Simian herpes B virus.

(4)Venezuelan equine encephalitis virus.

(5)Tick-borne encephalitis group viruses in Group 3.

(6)Monkeypox virus.

(7)Mopeia virus.

Contains public sector information licensed under the Open Government Licence v3.0.

1Citation and commencement#

2Interpretation#

3Duties under these Regulations#

4Prohibitions relating to certain substances#

5Application of regulations 6 to 12#

6Assessment of health risks created by work involving substances hazardous to health#

7Prevention or control of exposure to substances hazardous to health#

8Use of control measures etc.#

9Maintenance, examination and test of control measures etc.#

10Monitoring exposure at the workplace#

11Health surveillance#

12Information, instruction and training for persons who may be exposed to substances hazardous to health#

13Provisions relating to certain fumigations#

14Exemption certificates#

15Extension outside Great Britain#

16Defence in proceedings for contravention of these Regulations#

17Exemptions relating to the Ministry of Defence etc.#

18Revocations and savings#

19Extension of meaning of “work”#

20Modification of section 3(2) of the 1974 Act#

Defined terms · 23

Connections

History · 1 version

Key facts

1Citation and commencement#

2Interpretation#

3Duties under these Regulations#

4Prohibitions relating to certain substances#

5Application of regulations 6 to 12#

6Assessment of health risks created by work involving substances hazardous to health#

7Prevention or control of exposure to substances hazardous to health#

8Use of control measures etc.#

9Maintenance, examination and test of control measures etc.#

10Monitoring exposure at the workplace#

11Health surveillance#

12Information, instruction and training for persons who may be exposed to substances hazardous to health#

13Provisions relating to certain fumigations#

14Exemption certificates#

15Extension outside Great Britain#

16Defence in proceedings for contravention of these Regulations#

17Exemptions relating to the Ministry of Defence etc.#

18Revocations and savings#

19Extension of meaning of “work”#

20Modification of section 3(2) of the 1974 Act#