COMMUNICATION FROM THE COMMISSION on the Guidelines on the assessment of the chemical, physical and biological agents and industrial processes considered hazardous for the safety or health of pregnant workers and workers who have recently given birth or are breastfeeding (Council Directive 92/85/EEC)

SUMMARY

Article 3(1) of Council Directive 92/85/EEC of 19 October 1992 (OJ L 348 of 28 November 1992, p. 1) on the implementation of measures to encourage improvements in the safety and health at work of pregnant workers and workers who have recently given birth or are breastfeeding (tenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) provides that:

"In consultation with the Member States and assisted by the Advisory Committee on Safety, Hygiene and Health Protection at Work, the Commission shall draw up guidelines on the assessment of the chemical, physical and biological agents and industrial processes considered hazardous for the safety or health of workers within the meaning of Article 2.

The guidelines referred to in the first subparagraph shall also cover movements and postures, mental and physical fatigue and other types of physical and mental stress connected with the work done by workers within the meaning of Article 2."

Pursuant to Article 3(2), the purpose of the guidelines is to serve as a basis for the assessments referred to in Article 4(1), which in turn provides that "For all activities liable to involve a specific risk of exposure to the agents, processes or working conditions of which a non-exhaustive list is given in Annex I, the employer shall assess the nature, degree and duration of exposure, in the undertaking and/or establishment concerned, of workers within the meaning of Article 2, either directly or by way of the protective and preventive services referred to in Article 7 of Directive 89/391/EEC, in order to:

- assess any risks to the safety or health and any possible effect on the pregnancy or breastfeeding of workers within the meaning of Article 2,

- decide what measures should be taken".

The Commission, in consultation with the Member States and assisted by the Advisory Committee on Safety, Hygiene and Health Protection at Work, has prepared the Guidelines set out below.

The Commission attaches the greatest importance to all measures designed to protect the health and safety of workers, and notably certain groups of particularly vulnerable workers such as is clearly the case of pregnant workers and workers who have recently given birth or are breastfeeding - all the more so because the risks to which they may be exposed are liable to damage not only their own health but also that of their unborn or newborn children, given that there is a very close physiological and indeed emotional link between mother and child.

Hence the Commission considers that this Communication constitutes an effective and eminently practical tool which can serve as guidance in assessing the risks to the health and safety of pregnant workers and workers who have recently given birth or are breastfeeding. On the basis of this assessment it will be possible to take more effective measures.

For these reasons the Commission will see to it that these guidelines are disseminated as widely as possible by the bodies and persons responsible for health and safety at work.

TABLE OF CONTENTS

INTRODUCTION

The approach to risk assessment

Legal background

Previous measures connected with the present action

Specific points to be stressed

GENERAL DUTIES FOR EMPLOYERS CONCERNING RISK ASSESSMENT

RISK ASSESSMENT OF GENERIC HAZARDS AND ASSOCIATED SITUATIONS

Mental and physical fatigue and working hours

Postural problems connected with the activity of new or expectant mothers

Work at heights

Working alone

Occupational stress

Standing activities

Sitting activities

Lack of rest and other welfare facilities

Risk of infection or kidney disease as a result of inadequate hygiene facilities

Hazards as a result of inappropriate nutrition

Hazard due to unsuitable or absent facilities

RISK ASSESSMENT: SPECIFIC HAZARDS (AND WAYS OF AVOIDING RISKS)

PHYSICAL AGENTS

Shocks, vibration or movement

Noise

Ionising radiation

Non-ionising electromagnetic radiation

Extremes of cold or heat

Work in hyperbaric atmosphere, for example pressurised enclosures and underwater diving

BIOLOGICAL AGENTS

CHEMICAL AGENTS

Substances labelled R40, R45, R46, R49, R61, R63 and R64

Preparations labelled on the basis of Directive 83/379/EEC or 1999/45/EC

Mercury and mercury derivatives

Antimitotic (cytotoxic) drugs

Chemical agents of known and dangerous percutaneous absorption (i.e. that may be absorbed through the skin). This includes some pesticides.

Carbon monoxide

Lead and lead derivatives - in so far as these agents are capable of being absorbed by the human organism

Chemical agents and industrial processes in Annex 1 to Directive 90/394/EEC

WORKING CONDITIONS

Manual handling of loads

Movements and postures

Travelling either inside or outside the establishment

Underground extractive industries

Work with display screen equipment (VDUs)

Work equipment and personal protective equipment (including clothing)

ANNEX

Aspects of pregnancy which may require adjustments to work organisation

INTRODUCTION

Pregnancy should be regarded not as an illness but as part of everyday life. Protection of health and safety in respect of pregnant women can often be achieved by applying existing rules and procedures in the relevant areas. Many women work while they are pregnant, and many return to work while they are still breastfeeding. However, some hazards in the workplace may affect the health and safety of new and expectant mothers and of their children. A pregnancy entails great physiological and psychological changes. The hormonal balance is very sensitive and exposures capable of disrupting it can lead to complication, possibly resulting, for example, in miscarriage.

Conditions which may be considered acceptable in normal situations may no longer be so during pregnancy.

The approach to risk assessment

Risk assessment is a systematic examination of all aspects of work in order to identify the probable causes of injuries or damage and to establish how these causes can be contained in order to eliminate or reduce risks.

In accordance with the requirements of Directive 92/85/EEC, assessment must comprise at least three phases:

1. identification of hazards (physical, chemical and biological agents; industrial processes; movements and postures; mental and physical fatigue; other physical and mental burdens);

2. identification of worker categories (exposed pregnant workers, workers who have recently given birth or workers who are breastfeeding);

3. risk assessment in both qualitative and quantitative terms.

Hazard: the intrinsic property or ability of something (e.g. work materials, equipment, methods and practices) with the potential to cause harm;

Risk: the likelihood that the potential for harm will be attained under the conditions of use and/or exposure, and the possible extent of the harm.

As regards point 1 (identification of hazards), extensive data are already available in respect of physical agents (including ionising radiation) and chemical and biological agents.

With specific reference to chemical agents, Council Directive 67/548/EEC, as most recently amended by Commission Directive 2000/33/EC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances makes provision for the following risk phrases for substances and preparations:

- possible risks of irreversible effects (R40);

- may cause cancer (R45);

- may cause heritable genetic damage (R46);

- may cause cancer by inhalation (R49);

- may cause harm to the unborn child (R61);

- possible risk of harm to the unborn child (R63);

- may cause harm to breastfed babies (R64).

In connection with the assessment of existing substances and with the work of the SCOEL (Scientific Committee for Occupational Exposure Limits), the Commission has also produced a series of documents partly concerned with the subject.

Point 2 (identification of exposed worker category). Whereas there is no difficulty targeting workers who have recently given birth or are breastfeeding, this does not apply in the case of pregnant workers. There is a period of between 30 and 45 days during which a worker may not be aware that she is pregnant and is therefore unable or reluctant to inform her employer. However, some agents do exist, especially physical and chemical agents, which may cause harm to the unborn child during the period immediately following conception, which means that appropriate preventive measures are essential. The problem is not easy to solve, in that it requires special care to be taken in respect of all workers by reducing their exposure to these harmful agents.

Point 3 (qualitative and quantitative risk assessment) represents the most delicate phase in the process, in that the person carrying out the assessment must be competent and take due account of relevant information, including information from the pregnant woman herself or her advisors, in applying appropriate methods in order to be able to conclude whether or not the hazard identified entails a risk situation for workers.

Legal background

Article 3(1) of Council Directive 92/85/EEC of 19 October 1992 (OJ No L 348 of 28 November 1992, p. 1) on the introduction of measures to encourage improvements in the safety and health at work of pregnant workers and workers who have recently given birth or are breastfeeding (10th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) requires the Commission to draw up risk assessment guidelines in consultation with the Member States and assisted by the Advisory Committee on Safety, Hygiene and Health Protection at Work.

These guidelines will serve as a basis for the assessment referred to in Article 4(1) of the same Directive, which is an integral part of the assessment of the risks referred to in Article 9 of the "framework" Council Directive 89/391/EEC on the introduction of measures to encourage improvement in the safety and health at workers at work, which states that:

"For all activities liable to involve a specific risk of exposure to the agents, processes or working conditions of which a non-exhaustive list in given in Annex I, the employer shall assess the nature, degree and duration of exposure, in the undertaking and/or establishment concerned, of workers within the meaning of Article 2, either directly or by way of the protective and preventive services referred to in Article 7 of "framework" Council Directive 89/391/EEC, in order to:

- assess any risks to the safety or health and any possible effect on the pregnancy or breastfeeding of workers within the meaning of Article 2,

- decide what measures should be taken."

It should be noted that:

- the employer is obliged to carry out a risk assessment for all female workers who fulfil the criteria laid down in Article 2 of the Directive (see definitions on page 7). This includes those in the armed forces, the police, and certain specific activities in the civil protection services;

- the risk assessment for pregnant workers is an additional risk assessment which is to be carried out in accordance with the provisions of the framework Directive. This risk assessment must take into account the preventive aspects of the framework Directive and should also at least refer to the potential risks to pregnant workers, in so far as such risks are known (e.g. risks related to certain chemicals, etc).

Previous measures connected with the present action

In 1993-94 the Commission produced a document entitled "Guidance on risk assessment at work" [ISBN 97-727-4278-9]. This document is intended for the Member States, to be used or adapted for the purposes of providing guidelines for employers, workers, and any other parties who may be confronted with the practical aspects of rules on risk assessment laid down in Council "framework" Directive 89/391/EEC on the introduction of measures to encourage improvements in the safety and health of workers at work, particularly Articles 6(3)(a) and 9(1)(a).

This document, which was published in 1996, constitutes an ideal basis for the preparation of the guidelines referred to in Article 3(1) of Directive 92/85/EEC.

Specific points to be stressed

- In order to take the framework Directive's principle of prevention into account, if the work is reorganised the risk assessment should be revisited and workers adequately trained in the new organisation.

- It is clear that the risk assessment referred to in this Directive is of a special nature, as it is designed for a continually changing state which varies according to each individual. In addition, it does not only affect the woman herself, but also the unborn child and the breast-feeding baby. In branches where hazards for reproduction and for pregnancy can be expected it is necessary to inform all workers of the potential risks.

- A one-off assessment may not be enough, as pregnancy is a dynamic process and not a static condition. Furthermore, not only during the various stages of a pregnancy but also after delivery, different risks can affect a woman and her unborn or new-born child to a varying extent. The same also applies where there is a change in working conditions, equipment or machines.

- Medical advice, reports and certificates should take working conditions into consideration. This is of particular relevance to an individual's conditions (e.g. morning sickness, heightened sensitivity or smells such as tobacco smoke, etc.), which must be dealt with in strict confidentiality. The confidentiality concerning a woman's 'condition' must also ensure that an employer cannot make it known that a woman is pregnant if she does not wish it to be known or if she does not consent to it. Otherwise, for instance, it could lead to a considerable psychological strain for a woman who has already had one or more miscarriages.

In certain circumstances it may be necessary to take steps (including limited disclosure) to protect the woman's health, safety and welfare, but this should be done with the woman's agreement following consultation.

Risk assessments should take due account of medical advice and the concerns of the individual woman.

- In respect of chemical hazards, it should be noted that occupational exposure limits are set for adult workers, and women working with hazardous substances should therefore be made aware of the additional risks that these substances might pose to a unborn or breastfed child.

- The directive allows for some flexibility for both the Member States and the women themselves concerning maternity leave after birth (it grants compulsory maternity leave of only two weeks but a total of at least 14 weeks (divided between the time before and after giving birth) are granted). The various risks which could arise for pregnant women or women who have just given birth should be recorded and assessed.

- Since the first trimester of pregnancy is the most vulnerable period in terms of causing permanent damage to the unborn child, all necessary protection to the mother and the unborn child should be started as soon as possible.

GENERAL DUTIES FOR EMPLOYERS CONCERNING RISK ASSESSMENT

The Directives require employers to assess risks to all workers, including new and expectant mothers, and to avoid or control those risks. In carrying out the risk assessment the employer should take into account existing occupational exposure limits. Exposure limits for hazardous substances and other agents are normally set at levels which should not put a pregnant or breastfeeding worker or her child at risk. In some cases, there are lower exposure levels for pregnant workers than for other workers.

The PWD specifically requires employers to take particular account of risks to new, breastfeeding and expectant mothers when assessing risks in the work activity. If the risk cannot be avoided by other means, there will be a need to change the working conditions or hours, or offer suitable alternative work. If that is not possible the worker should be exempted from normal duties for as long as necessary to protect her health or safety or that of her child.

What must an employer do-

In addition to carrying out the general risk assessment required by the Framework Directive and Directive 92/85/EEC, on receiving notification that an employee is pregnant an employer must assess the specific risks to that employee and take action to ensure that she is not exposed to anything which will damage either her health or that of her developing child.

The employer must:

- assess the risk;

this means that he must determine:

(a) the risks to which the pregnant woman or new mother who has recently given birth or is breastfeeding is exposed;

(b) the nature, intensity and duration of the exposure.

(Appendix 1 contains references to some aspects of pregnancy which may require adjustments to the work or the organisation thereof(

- remove the hazard and avoid or reduce the risk;

- act to ensure there is no damage to health.

Damage to health means for this purpose any disease or damage to a person's physical or mental condition, or any possible effect on the pregnancy or the unborn or new-born infant, or to women who have recently given birth.

If the assessment reveals that there is a risk, the employer must inform the woman about the risk and explain the measures to be taken to ensure that the health and safety of the woman or the developing child is not adversely affected.

Definitions

For the purposes of the PW Directive:

(a) pregnant worker shall mean a pregnant worker who informs her employer of her condition, in accordance with national legislation and/or national practice;

(b) worker who has recently given birth shall mean a worker who has recently given birth within the meaning of national legislation and/or national practice and who informs her employer of her condition, in accordance with that legislation and/or practice;

(c) worker who is breastfeeding shall mean a worker who is breastfeeding within the meaning of national legislation and/or national practice and who informs her employer of her condition, in accordance with that legislation and/or practice.

Identifying the hazards

Physical, biological and chemical agents, processes and working conditions which may affect the health and safety of new or expectant mothers are set out in the chapter on specific hazards (see below). They include possible hazards listed in the Annexes to the Directive on the health and safety of pregnant workers.

Many of the hazards included in the table are already covered by specific European health and safety legislation, for example Council Directive 90/394 EEC (and its amendments) on carcinogens, Council Directive 90/679/EEC (and its amendments) on biological agents, Council Directive 80/1107/EEC on chemical, physical and biological agents, which will be repealed upon transposal by the Member States of Directive 98/24/EC (before 5 May 2001), Council Directive 82/605/EEC on lead, Council Directive 97/43/EURATOM on ionising radiation, Directive 90/269/EEC on the manual handling of loads and Directive 90/270/EEC on display screen equipment. If any of these hazards are present in the workplace, the employers should refer to the relevant legislation for information on what they should do. Hazards may be multifactorial in their effects.

Deciding who might be harmed, and how

The risk assessment may show that there is a substance, agent or work process in the workplace that could damage the health or safety of new or expectant mothers or their children. There is a need to bear in mind that there could be different risks depending on whether workers are pregnant, have recently given birth or are breastfeeding. The definition of workers includes, for example, maintenance and cleaning staff and there may need to be cooperation between employers where employees of one are working, e.g. as contractors, on the premises of another.

Informing employees of the risk

If the risk assessment does reveal a risk, the employers should inform all employees concerned of the potential risks. They should also explain what they intend to do to make sure that new and expectant mothers are not exposed to risks that could cause them harm. The information should be given also to employees' representatives.

If there is a risk, employers should inform employees of the importance of early detection of pregnancy.

Avoiding the risk

If a significant risk to the health or safety of a new or expectant mother is identified, the action to be taken to reduce this should be decided upon.

Keeping the risks under review

The employer will review the risk assessments for new or expectant mothers if he is aware of any change. Although any hazards are likely to remain constant, the possibility of damage to the unborn child as a result of a hazard will vary at different stages of pregnancy. Furthermore, there are different risks to consider for workers who have recently given birth or are breastfeeding.

Employers need to ensure that workers who are breastfeeding are not exposed to risks that could damage health or safety for as long as they continue to breastfeed. The Directive concerning the minimum safety and health requirements for the workplace (89/654/EEC) requires appropriate conditions to be provided for pregnant women and nursing mothers to rest.

Where workers continue to breastfeed for many months after birth, employers will need to review the risks regularly. Where they identify risks, there is a need to continue to follow the three steps to avoid exposure to the risks, i.e. adjustment of working hours/conditions, alternative work or exemption from normal duties, for as long as it threatens the health and safety of a breastfeeding worker or her child. The main concern is exposure to substances such as lead, organic solvents, pesticides and antimitotics, as some of the substances are excreted through the milk, and the child is assumed to be particularly sensitive. The most important aspect is "to avoid" - or to reduce - exposure. Professional advice from occupational health specialists may be required in special cases.

RISK ASSESSMENT OF GENERIC HAZARDS AND ASSOCIATED SITUATIONS

Generic hazards and associated situations which are likely to be met by most pregnant women, new/or breastfeeding mothers are listed below:

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RISK ASSESSMENT: SPECIFIC HAZARDS (AND WAYS OF AVOIDING RISKS*)

(INCLUDING PHYSICAL, CHEMICAL AND BIOLOGICAL AGENTS AND WORKING CONDITIONS LISTED IN ANNEX 1 AND 2 TO THE DIRECTIVE 92/85/EEC)

Working conditions can have important effects on the health, safety and welfare of new and expectant mothers. Sometimes it will be the relationship between the different factors involved which determines the type of risk, rather than one factor on its own.

Since pregnancy is a dynamic state involving continuous changes and developments, the same working conditions may raise different health and safety issues for different women at different stages of pregnancy, and again on returning to work after childbirth or whilst breastfeeding. Some of these issues are predictable and apply generally (such as those listed below). Others will depend on individual circumstances and personal medical history.

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ANNEX

Aspects of pregnancy which may require adjustments to work organisation

Apart from the hazards listed in the table, there are other aspects of pregnancy that may affect work. The impact will vary during the course of the pregnancy and their effect should be kept under review; for example, the posture of expectant mothers changes to cope with increasing size.

Aspects of pregnancy // Factors in work

Morning sickness // Early shift work

// Exposure to strong or nauseating smells/poor ventilation Travel/transport

Backache // Standing/manual handling/posture

Varicose veins/other circulatory problems/haemorrhoids // Prolonged standing/sitting

Rest and welfare

Frequent/urgent visits to toilet // Regular nutrition

Proximity/availability of rest/washing/eating/drinking facilities

Hygiene

// Difficulty in leaving job/work site

Comfort //

Increasing size // Use of protective clothing/work equipment

// Work in confined areas/at heights

Dexterity, agility, co-ordination, speed of movement, reach may be impaired because of increasing size // Postural demands e.g. bending over, reaching

// Manual handling

// Problems of working in restricted spaces

Fatigue/stress // Overtime

// Evening/night work

// Lack of rest breaks

// Excessive hours

// Pace/intensity of work

Balance (also relevant for breastfeeding mothers) // Problems of working on slippery, wet surfaces