1.1 The legal framework Flashcards Preview

B01. Principles of toxicology and epidemiology > 1.1 The legal framework > Flashcards

Flashcards in 1.1 The legal framework Deck (33)
Loading flashcards...

There are several pieces of legislation that control the supply and use of hazardous
substances in the UK. These are: 6

European Regulations
 Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
Regulation EC 1907/2008
 Classification, Labelling and Packaging of Substances, and Mixtures (CLP)
Regulation EC1272/2008

UK Regulations
 Chemical (Hazard, Information and Packaging for Supply) Regulations 2009
 Control of Substances Hazardous to Health Regulations 2002, as amended
 Control of Lead at Work Regulations 2002 CLAW
 Control of Asbestos Regulations 2012 CAR


Countries in the United Nations, including those in the European Union, have been
working together with industry representatives and others to agree a classification
and labelling system that can be used worldwide. The outcome is

the Globally
Harmonised System of Classification and Labelling of Chemicals, known as the
‘GHS’. The GHS provides a single system to identify hazards and to communicate
them in transporting and supplying chemicals across the world i.e. labels and safety
data sheets.


European Union (EU) Member States agreed to adopt the GHS across the EU
through a direct acting Regulation:

the Classification, Labelling and Packaging of
Substances and Mixtures. This is also known as the ‘CLP Regulation’ or just ‘CLP’.


In addition to CLP The European Commission presented a proposal for a new EU
regulatory system for chemicals:

REACH, which stands for:
 Registration
 Evaluation
 Authorisation of CHemicals.


All Chemicals will require EU authorisation by _________ before the materials are allowed to sold or imported within the EU. Their
use may also be restricted.

the European Chemical Agency


REACH is an EU Regulation that covers all chemicals (with a few exceptions) if
they are manufactured or imported into the EU in quantities of ________________

1 tonne or above.


REACH is designed to: 7

 Improve information in the supply chain - many substances are data poor and
this can lead to inadequate risk assessments.
 Promote better risk management measures.
 Facilitate compliance with CoSHH.
 Encourage the use of safer alternatives for CMR substances.
 Allow the free movement of substances on the EU market.
 Question the need for animal testing.
 Lead to improvements in occupational health.


Under REACH, each producer and importer of chemicals in volumes of 1 tonne or
more per year and will have to register each chemical with the EU Chemicals
Agency (the ECHA), submitting information on:

 properties
 uses
 safe ways of handling them.


Through REACH evaluation, public authorities will look in more detail at registration
dossiers and at substances of concern. 4

 Completeness check.
 Compliance check.
 Dossier evaluation.
 Substance evaluation.


Under REACH, Use-specific authorisation will be required for chemicals that cause: 4

 Cancer
 Mutations
 Problems with reproduction.

It is also required for those that accumulate in human bodies and the environment.


A comparison between the approach of REACH and CoSHH 4

Main obligations on manufacturer /
importer (though also on supplier and
downstream user)
All obligations on individual employer
Covers manufacture of a substance and
all identified uses across the EU >10
tonnes / year
Covers all work activities with all
hazardous substances at that site,
including process derived substances
(dust, fume etc.)
Substance driven Tends to be task/process driven
Risk management measures more likely
to be broadly based
Risk management measures more likely
to be site specific


The intention of the CLP Regulation is:

very similar to CHIP – substances and
mixtures that are placed on the market should be classified, labelled and packaged
appropriately. But because CLP adopts the GHS, in time, the same classifications
and labelling will be used throughout the world.


CHIP 4 is a set of UK Regulations that

sets out the transitional arrangements for
the implementation of CLP within the UK,



Classification is the process of: 2

 Deciding what kind of hazard the chemical has.
 Explaining the hazard by assigning a simple sentence that describes it (known
as a 
‘risk phrase’ or ‘R-phrase’ for short).



If a dangerous chemical is supplied in a package, the package must be labelled.
The aim of the label is to: 2

 Inform anyone handling the package or using the chemicals about its hazards.
 Give brief advice on what precautions are needed.



CHIP requires that the packaging used for a chemical must be suitable.

CHIP sets out special requirements for the packaging of certain chemicals that are
sold to the public: 2

 Some have to be fitted with a child-resistant closure (meeting a certain
standard) to prevent young children swallowing the contents.
 Some must have a tactile danger warning (normally a small, raised triangle) to
alert the blind and partially sighted that they are handling a dangerous product.


CoSHH defines a ‘substance hazardous to health’ as one which: 5

1) Is listed in the approved supply list (ASL) as dangerous for supply within the
meaning of the CHIP Regulations and for which an indication of danger
specified for the substance is very toxic, toxic, harmful, corrosive or irritant.
2) The Health and Safety Executive has approved a workplace exposure limit
3) Is a biological agent.
4) Is dust (other than those covered in (a) or (b) above) present at a concentration
in air equal to or greater than:
 10 mg/m
, as a time-weighted average over an 8-hour period, of inhalable
 4 mg/m
, as a time-weighted average over an 8-hour period, of respirable
5) Because of its chemical or toxicological properties and the way it is used or is
present at the workplace creates a risk to health.


A summary of the CoSHH duties

6 Risk assessment

7 Prevention or control of

8 Use of control measures

9 maintenance, examination and test of control measures

10 Monitoring exposure at workplace

11 Health surveillance

12 Information, training

13 Arrangements to deal with accidents, incidents and emergencies


Monitoring exposure (Regulation 10)

Where the risk assessment indicates it is necessary, workplace (environmental)
monitoring of exposure must be undertaken unless it is possible to demonstrate
another means of preventing or controlling exposure. Monitoring must be at regular
intervals in addition to when a change occurs that may affect exposure. There is
mandatory monitoring for:

Vinyl chloride monomer (VCM)

Spray given off from vessels at which
an electrolytic chromium process is
carried on, except trivalent chromium


Health surveillance (Regulation 11)

Health surveillance of employees should be carried out where:

 An identifiable disease or adverse health effect may be related to the exposure.
 There is a ‘reasonable likelihood’ that the disease or health effect may occur
under the particular conditions of work.
 Valid techniques exist for detecting indications of the disease of health effect.
 The technique presents a low risk to the employee.


Information, instruction and training (Regulation 12)

This regulation demands that all employees are liable to be exposed to hazardous
substances, they are provided with suitable and sufficient information, instruction
and training, including: 6

 Details of the hazardous substances including:
- Names of substances and the risk that they present to health
- Any relevant occupational exposure standard, maximum exposure limit or
similar occupational exposure limit
- Access to any relevant safety data sheet.
 Other legislative provisions which concern the hazardous properties of those
 Significant findings of risk assessment.
 Appropriate precautions and actions to be taken by the employee in order to
safeguard himself and other employees at the workplace.
 Results of any monitoring of exposure and, in particular, in the case of a
substance hazardous to health for which a maximum exposure limit has been
approved, the employee or his representatives shall be informed forthwith, if the
results of such monitoring show that the maximum exposure limit has been
 Collective results of any health surveillance undertaken in a form calculated to
prevent those results from being identified as relating to a particular person.


Accidents, incidents and emergencies (Regulation 13)

Regulation 13 requires that employers prepare for possible accidents, incidents and
emergencies involving hazardous substances by: 3

 Preparing emergency procedures, including provision of first aid.
 Making available technical information on possible accidents and hazards and
bringing it to the attention of the emergency services.
 Installing alarms and other warnings and communication systems.


An employee’s exposure to lead is significant if one of the following three conditions
is satisfied:

1) Exposure exceeds half the occupational exposure limit for lead.

2) There is a substantial risk of the employee ingesting lead.

3) If there is a risk of an employee’s skin coming into contact with lead alkyls or any other substance containing lead in a form, for example: lead naphthenate, which can also be absorbed through the skin.


Also, lead can be easily absorbed through ingestion. To avoid this risk, it is
important to

make sure that employees do not eat, drink or smoke in any place
which is liable to be contaminated by lead.


If there is significant exposure to lead, the monitoring of employees’ exposure
should be carried out by both:

 Air sampling.

 Measuring the concentration of lead in their blood or their urine (for work with lead alkyls).

These two approaches have complementary roles.


Action levels are concentrations of lead in blood set below the appropriate
suspension limit. If these are reached or exceeded, the employer must: 3

 Carry out an urgent investigation to find out why

 Review control measures

 Take steps to reduce the employee’s blood-lead concentration below 
action level, so far as is reasonably practicable.


Asbestos is classified as

a category 1 carcinogen


Since the 2006 Control of Asbestos Regulations there has been a single Control
Limit of

(equivalent to 0.1f/ml)

The Action Levels
have been withdrawn. The Short Term Exposure Limit of 0.6f/cm
over 10 minutes
is maintained, but is an ACoP standard instead of being in the regulations because
there is no requirement for a STEL in the EU Directive on Asbestos.


The duty holder has to take reasonable steps to find out if there are asbestos
containing materials (ACMs) in the premises and, if so, how much, where they are
and what condition they are in. This can, but does not have to, involve a survey. A
survey can be: 2

 Management survey: This is to locate all materials that are likely to contain
asbestos. It will usually involve the taking of samples to confirm the presence of
asbestos. If no samples have been taken then it is assumed that all materials
contain asbestos.

 Refurbishment/demolition surveys: These involve getting access full access
to all parts of the building using destructive inspection if necessary and will
involve the taking of samples which are analysed to confirm whether asbestos is
present. This type is usually used before major refurbishment or just before


No employer can carry out demolition, maintenance or any other work which
exposes, or may expose, their employees to asbestos in any premises unless they
have found out: 4

 whether asbestos is, or may be, present
 what type of asbestos it is
 what material it is in
 what condition it is in
 if there is any doubt about whether asbestos is present, the employer has
assumed that it is present and that it is not only white asbestos.