Regulation 1272/2008 on thelabelling of substances and

mixtures

Safety

Adaptation of the simplified COSHH Essentials method to the new regulation on

This article deals with adaptation of the COSHH Essentials method to the

new Regulation 1272/2008 on substance labelling, by correspondence with

the former Regulation 363/95. To implement the updated method an

evaluation was made of a series of substances used in several teaching labs

of the Universidad de Sevilla. An IT tool has thereby been set up to

ascertain the hazardousness of the chemical agent being worked with and

hence the most suitable prevention methods.

By A. ÁVILA MONROY. Building engineer and higher occupational risks prevention officer.

F.J. NIETO LORITE. Occupational medicine doctor and higher occupational risks

prevention officer (fjnielo@us.es).

J. MARAÑÓN LÓPEZ. DMedical doctor, occupational medicine doctor and higher

occupational risks prevention officer.

N. ÁLVAREZ QUIRÓS. Chemistry graduate.

F. VELÁZQUEZ MOLINA. Chemistry graduate.

A. PRIETO CANO. Industrial Engineer.

C. GIL SIERRA. Company nurse and higher occupational risks prevention officer.

The Spanish Occupational Risks Prevention Act 31/1995 (Ley de Prevención de Riesgos Laborales: LPRL) of 8 November lays

down the basic set of guarantees and precise liabilities for ensuring a proper level of worker health and safety against any

risks deriving from improper working conditions. Protection of workers from occupational risks calls for employer action

that goes well beyond mere lip-service compliance with a predetermined clutch of employer duties and obligations. It puts

forward a whole new approach to the prevention of occupational risks based on the General Prevention Principles (article

15 of the LPRL).

For its part Real Decreto (Royal Decree) 374/2001 of 6 April on the protection of workers’ health and safety against

chemical-related risks at work likewise lays down the employer’s obligation of assessing the risks posed by chemical agents,

whenever it is impossible to eliminate them completely, with the purpose of implementing a preventive action plan, which

should then always be revised in line with any changes in the working conditions [1].

The first stage in the assessment of the chemical risk is the identification of the

chemical agents involved, i.e., the hazardous substances and preparations that

might be present in the workplace. An analysis of the hazardousness of the

identified agents then determines the risk to the workers’ health and safety; this

analysis includes their physicochemical and toxicological properties, specific

health effects, the body penetration routes, threshold limit values, etc., and also the set of working conditions: amount

used, working procedures, form in which the contaminant occurs (dust and aerosols, gases, vapours), existing prevention

and protection measures, exposure times, etc.

Industrial hygiene, after identification of exposures by means of the labelling and the safety data sheet and the processes

The handling of chemicalproducts and substances is rated

as a top-priority risk factor,with many procedural shortfalls

and worker ignorance of thetrue risks involved

involved, then proceeds to assess them by developing a sampling strategy and taking due readings. These readings are then

compared with the threshold limit values* to determine which preventive measures need to be set up.

In general an evaluation has to be made of inhalation exposure, doing so by measuring the ambient concentrations of the

chemical agents[2]. This process implies a certain technical complexity, including:

The sampling strategy: number of samples, duration of each one, location, sampling timing, number of workers to be

sampled, number of working days and sampling frequency.

Sample taking: choice of the instruments and suitable sampling parameters.

Chemical analysis of the samples.

Data processing and comparison with the valuation criteria.

Conclusions on the risk of exposure to the chemical agent.

The standard UNE-EN 689:1996** sets forth a general assessment system comprising identification of the chemical agents, of

the exposure-determining factors (tasks, work cycles, type of operation, prevention measures, etc.) and of the interactions

between both. The assessment can be tackled at three levels:

Initial appraisal.

Basic survey.

Detailed survey.

Only the detailed study involves a quantitative assessment of the exposure with statically representative personal

measurements. The standard UNE-EN 689:1995 indicates different procedures for carrying out these measurements and

processing them statistically, to ascertain the likelihood of exceeding the limit value.

The initial appraisal consists of culling as much information as possible on the exposure-conditioning variables (intrinsic

hazardousness and working conditions), to determine, in the officer’s judgement, an acceptable risk situation. This risk

would correspond to the slight risk (riesgo leve) mentioned in RD 374/2001.

Although it makes perfect sense to start the assessment process with a

qualitative analysis, on many occasions it is not possible to draw conclusions on

risk acceptability and a detailed survey then has to be conducted. Whether or

not conclusions can be drawn from a qualitative assessment depends on the

following variables:

The available level of information on the exposure: the uncertainty associated with the qualitative exposure

judgement will vary inversely with the amount of this information to hand; the capacity or experience of the officer

carrying out the assessment also has to be factored in.

The closeness of the exposure limit value, determined in turn by:

The level of said limit: ceteris paribus the concentration corresponding to low limit values will be approached

first; all things being equal, therefore, substances with a very low limit value pose higher qualitative assessment

uncertainty.

The amounts present or handled.

The preventive measures adopted, these two latter variables then determining how much of the agent is present

in the atmosphere.

This would be a “classical” industrial hygiene approach, validated by the abovementioned standard, as opposed to a

“future” industrial hygiene approach advocated by diverse European guides, which identify the exposures and propose the

elimination thereof by changing the products or processes; where this is impossible, an estimate of the potential risk is

made and a determination of the preventive measures to be adopted to suit the risk level, checking the efficacy thereof [3].

This would involve a simplified assessment method, an easily applicable tool for assessing and managing chemical risk,

prioritising the development of preventive measures to ensure acceptable exposure conditions. Once the corrective actions

have been carried out, risk assessment then addresses the residual risk that it has not been possible to eliminate, checking

The COSHH Essentials modelestimates the (potential) risk

and draws up a simplifiedassessment methodology to

ascertain the control measurebest suited to the operation

under assessment

that the new working conditions are valid and do not cause any health-altering effects to anyone using the laboratory.

The simplified assessment models of the exposure risk to chemical agents are used to obtain an initial risk appraisal (the

aforementioned stage 1 of the standard UNE-EN 689:1996); they also categorise the risk as acceptable or unacceptable

without any need for complex and costly sampling methods. Thus, the quantitative readings become a complement to the

simplified method rather than an alternative. This simplified method constitutes a tool for conducting initial appraisals and

for deciding on the necessary preventive measures in terms of the risk level, type of operation and assessed process.

Furthermore, the simplified methods are applicable under Spain’s current legislation. Witness article 3.5 of Real Decreto

374/2001, which lays it down that measurement will not be necessary whenever the employer clearly demonstrates by

other assessment methods that a proper prevention and protection level has been obtained.

In general the simplified methods have many advantages over the conventional methods, such as:

Quicker and more immediate implementation of the corrective measures.

Simple methodology in comparison to the correct implementation of sampling strategies, so they can be carried out by

non-experts.

Applicability to substances without any established environmental limit value.

Reduction of the cost of the assessment process.

Validity for assessing daily exposure, short-duration exposure and the accident risk deriving from the presence of

chemical agents.

Applicability to those chemical agents that lack a sampling and/or limit value analysis methodology.

Consideration and detailed knowledge of all the chemical agents present in the workplace.

Consideration, in some cases, of skin exposure (the COSHH method proposes a table for identifying skin absorption

risks even if the assessment does not go ahead).

They can facilitate the choice of the method to be used when quantitative determination is necessary.

The simplified assessment methodology is now catching on quickly, but it would be just as illogical to assume that the

quantitative exposure stage is always going to be necessary as to assume that these procedures are always capable of

completing the chemical-agent exposure assessment without the need for any measurement [4].

JustificationThe widespread use of chemical products in numerous working activities of varied ilk entails a significant risk, due to their

capacity of producing harm or undesirable effects to people, the environment or property[5]. The handling of chemical

products and substances is considered to be a top-priority risk factor [6], with many procedural shortfalls as recognised by

the European Union Commission itself [7]. Workers are also often misinformed about the risks, meaning they have to cope

on a daily basis with risk situations that are either over- or under-rated. Many queries about the hazardousness of chemical

substances and preparations and their effect on working conditions have in fact been formulated over the years by the

Delegados de Prevención, the elected union representatives for occupational prevention matters. Foremost among the

occupational activities concerned looms education, especially post-secondary education (National Classification of

Economic Activities -2009***: Section P, Class 85.43 _ University Education), in which chemical products are widely used for

general maintenance and cleansing purposes and above all for more specifically teaching and research activities in the

laboratories of the university departments and institutes. There is also a huge amount of circumstantial factors in the

exposure to chemical agents, involving such variables as the amount used, the diversity of procedures followed and the

particular conditions of the exposure, as well as the type of personnel exposed. It is therefore well worthwhile to carry out

an initial screening to filter out unacceptable situations calling for the immediate adoption of measures and set priorities

for the subsequent assessment; this initial screening will also favour identification of uniform risk groups (by agents, work

zones, etc.) with different risk profiles [1].

Along these lines there are diverse simplified assessment methods for obtaining

an initial risk appraisal. Two are worthy of special mention: the British model

COSHH Essentials, developed by the Health and Safety Executive (HSE), and the

French model of the Institut National de Recherche et de Sécurité (INRS), more

complex and ambitious in its objectives[2].

The British model comprises the (potential) risk estimation phase and draws up a

methodology to ascertain the control measure best suited to the operation under

assessment rather than strictly determining the existing risk level. This is its strong point and one of the reasons we have

chosen this method for our study since it provides practical solutions in the form of many «control guidance sheets», which

can easily be applied in frequent situations and interchanged; they are also suitable for use by semi-skilled and unskilled

personnel.

Figure 1. Scheme of the variables of the COSHH Essentials method under the old regulation. Taken from NTP 750 of INSHT.

The COSHH Essentials model breaks down the risk into diverse groups on the basis of three key variables of the operation

under assessment (the exposure time variable is not included since the model provides an initial diagnosis of the situation

from the hygiene point of view in terms of potential risk and not an assessment of the risk strictly speaking). These three

variables, as shown in figure 1, are:

Hazard banding, broken down into five categories A, B, C, D and E in order of increasing hazardousness, in terms of the

R Phrases that have to be shown on the product label and its corresponding safety data sheets, always assessing the R

phrase of the highest hazard band.

Volatility or dustiness, depending on the physical state of the chemical agent. For liquids the volatility is determined

in terms of the boiling point and working temperature, and for solids the dustiness in terms of the form of their

particles.

Amount used in the process, classified as small, medium or large accordingly.

It should be stressed here that chemical risk in particular has generated a veritable thicket of legislation, changing at a

breakneck speed in line with technical progress and research. This makes it hard at times to establish a stable reference

framework. EC Regulation 1272/2008 of the European Parliament and of the Council of 16 December 2008 on the

classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and

1999/45/EC and modifying Regulation (EC) 1907/2006, was passed with these complications in mind. The main objective of

this new regulation is to improve the communication of chemical-substance hazardousness information for everyone

exposed thereto, by means of a harmonised classification and labelling procedure. Worthy of particular note is the change

of product hazardousness and labelling classification, involving, among other things, replacement of the R Phrases by the

new H phrases or indications of hazardousness. This means that this simplified method is no longer applicable to substances

for which the new regulation is already in force (since December 2010 and as from June 2015 for mixtures).

It is therefore a question of adapting this simplified method of estimating chemical-agent exposure risk to the new

identification of hazardousness determined by H phrases, in due accordance with Regulation 1272/2008 (CLP: Classification,

Labelling and Packaging).

This adaptation will facilitate simplified assessment of inhalation exposure risk of chemical agents in light of the new

labelling agreed in the abovementioned regulation and in keeping with the stipulations laid down by the Ley de Prevención

de Riesgos Laborales and the Reglamento (Regulation) 374/200. This will also make the exposure risk assessment more

easily applicable to university laboratories.

Objetives

According to the justification set out above, our starting point here is the need of adapting a chemical risk assessment

method to the new legislation on the labelling of substances and mixtures without this involving any changes in the

response obtained or results.

Our main remit is to adapt the simplified COSHH Essentials method for assessment of exposure risk to chemical agents

according to the new regulation on the labelling of substances and mixtures (Regulation 1272/2008). In pursuit of this main

objective the following specific objectives are proposed:

Identification and listing of the chemical agents in the selected work units (university laboratories).

Review of the substances identified in the manufacturer’s safety data sheets and in the usual databases for assigning

COSHH Essentials methodadapted to the Regulation

1272/2008 on the labelling ofsubstances and mixtures

the corresponding hazardousness indications (H phrases).

Comparison of the H phrases with the former R phrases and categorisation of the hazardousness, corresponding to the

first phase of the simplified method.

Identification of the other variables of the simplified method for each substance selected: volatility or dustiness, as

the case may be, and the amount of the substance used in terms of the procedure in the chosen work units.

Creation of an IT tool for application of the adapted simplified method and carrying out of the risk estimation.

Materials and method

The project was carried out in 2011, the chosen study population being the teaching and research laboratories of

universities using chemical substances in their working methods. The chosen sample was the teaching labs of the Chemistry

School (Facultad de Química) and the various services of the Innovation, Technology and Research Centre (Centro de

Investigación, Tecnología e Innovación: CITIUS) of Universidad de Sevilla, since they use a wide range of well known

substances together with some newer substances that are less familiar. This way we cover a very wide gambit in terms of

two of the method variables: the hazardousness, which depends on the H phrases they contain, and the volatility or

dustiness.

First of all, after checking the literature on the subject and choosing the abovementioned working units, a letter of

presentation was written and data recording cards were designed for the chemical substances notified by the selected

departments.

The fieldwork followed, including lab visits, substance analyses, a bibliographical

search and assessment of exposure variables. The computer application was then

designed and worked up.

Finally, an estimate was made of the risk of the selected substances by the

adapted method and the computer application was put through its paces. Lastly

the results were interpreted.

Results

The results of this project are, on the one hand, adaptation of the COSHH Essentials method to the new regulation and, on

the other, implementation of the computer application for carrying out the risk assessment for exposure to chemical agents

according to the adapted method.

Variable 1Hazard banding by H phrasesAnalysis of the first variable of the method necessarily implies establishing the correspondence between R phrases and H

phrases. We have based this on annex VII of Regulation (EC) 1272/2008 on the classification, labelling, and packaging of

substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC and amending Regulation (EC)

1907/2006. In our case we have focused exclusively on phrases corresponding to health hazards, which are those taken into

account by the COSHH Essentials assessment method, drawing up a table with these correspondences (Table 1).

In this way the intrinsic hazardousness of the substances (Table 2) can be classed in the five categories defined by the

original method, in terms of the H phrases that have to be shown on the product label and their corresponding safety data

sheets. Should any H phrases be interpretable as different hazard bands, the highest will always be taken, designating it as

the overriding H phrase. The hazardousness increases from A to E.

In some cases it is possible to reduce the hazard band, according to the duration activity and some H phrases:

According to the duration of the activity: in light of this variable, when the activity under assessments lasts no longer

than 30 minutes it is then possible to downgrade the hazardousness, substances listed as C then being downgraded to B

and those of B to A.

According to some phrases: whenever there are no other H phrases of a higher category, the following hazardousness

downgrades can be considered, in due accordance with the limit values in force for this substance. Table 3 shows the

H phrases for which the hazard band can be reduced in terms of two parameters: the threshold limit value, time

weighted average (TLV-TWA) (valor límite ambiental de exposición diaria: TLV-TWA), which can be found in the guides

to Limits of Occupational Exposure to Chemical Agents in Spain (Límites de Exposición Profesional para Agentes

Químicos en España) published each year by the National Institute for Health and Hygiene at Work (Instituto Nacional

de Seguridad e Higiene en el Trabajo: INSHT); and the Lowest Observed Adverse Effect Level (LOAEL), which is the

minimum product dose for which an adverse health effect is observed.

Table 1. Correspondence between R phrases and H phrases

FRASES R FRASES H

R20 Harmful by inhalation H332 Harmful if inhaled

R21 Harmful in contact with skin H312 Harmful in contact with skin

R22 Harmful if swallowed H302 Harmful if swallowed

R23 Toxic by inhalation Gas H331 Toxic if inhaled

R23 Toxic by inhalation Dust or mist H331 Toxic if inhaled

R23 Toxic by inhalation Vapour H330 Fatal if inhaled

R24 Toxic in contact with skin H311 Toxic in contact with skin

R25 Toxic if swallowed H301 Toxic if swallowed

R26 Very toxic by inhalation H330 Toxic if swallowed

R27 Very toxic in contact with skin H310 Fatal in contact with skin

R28 Very toxic if swallowed H300 Fatal if swallowed

R29 Contact with water liberates toxic gas EUH029 Contact with water liberates toxic gas

R31 Contact with acids liberates toxic gas EUH031 Contact with acids liberates toxic gas

R32 Contact with acids liberates very toxic gas EUH032 Contact with acids liberates very toxic gas

R33 Danger of cumulative effects H373 May cause damage to organs (state all organs

affected if known) through prolonged or repeated

exposure (state route of exposure if it is

conclusively proven that no other routes of

exposure cause the hazard)

R34 Causes burns H314 Causes severe skin burns and eye damage

R35 Causes burns H314 Causes severe skin burns and eye damage

R36 Irritating to eyes H319 Causes serious eye irritation

R37 Irritating to respiratory system H335 May cause respiratory irritation

R38 Irritating to skin H315 Causes skin irritation

R39 Danger of very serious irreversible effects No correspondence

R39/23

R39/24

R39/25

R39/26

R39/27

R39/28

Toxic: Danger of very serious irreversible effects

by inhalation, skin contact, swallowing. Very

toxic: Danger of very serious irreversible effects

by inhalation, skin contact, swallowing

H370 Causes damage to organs (or state all organs

affected if known) (state route of exposure if it is

conclusively proven that no other routes of

exposure cause the hazard)

R40 Limited evidence of a carcinogenic effect H351 Suspected of causing cancer. (state route of

exposure if it is conclusively proven that no other

routes of exposure cause the hazard)

R41 Risk of serious damage to eyes H318 Causes serious eye damage

R42 May cause sensitisation by inhalation H334 May cause allergy or asthma symptoms or breathing

difficulties if inhaled

FRASES R FRASES H

R43 May cause sensitisation by skin contact H317 May cause an allergic skin reaction

R45 May cause cancer H350 May cause cancer. (state route of exposure if it is

conclusively proven that no other routes of

exposure cause the hazard)

R46 May cause heritable genetic damage H340 May cause genetic defects

R48 Danger of serious damage to health by prolonged

exposure

No correspondence

R48/20

R48/21

R48/22

Harmful: danger of serious health effects by

prolonged exposure (by inhalation, skin contact or

swallowing)

H373 May cause damage to organs (state all organs

affected if known) through prolonged or repeated

exposure (state route of exposure if it is

conclusively proven that no other routes of

exposure cause the hazard)

R48/23

R48/24

R48/25

Toxic: danger of serious health effects by

prolonged exposure (by inhalation, skin contact or

swallowing)

H372 Causes damage to organs (state all organs affected

if known) through prolonged or repeated exposure

(state route of exposure if it is conclusively proven

that no other routes of exposure cause the hazard)

R49 May cause cancer by inhalation H350i May cause cancer by inhalation

R60

R61

May impair fertility

May cause harm to the unborn child

H360 May damage fertility or the unborn child. (State the

specific effect, if known) (state route of exposure if

it is conclusively proven that no other routes of

exposure cause the hazard)

R62

R63

Possible risk of impaired fertility

Possible risk of harm to the unborn child

H361 Suspected of damaging fertility or the unborn child.

(State the specific effect, if known) (state route of

exposure if it is conclusively proven that no other

routes of exposure cause the hazard)

R64 May cause harm to breast-fed babies H362 May cause harm to breast-fed children

R65 Harmful: may cause lung damage if swallowed H304 May be fatal if swallowed and enters airways

R66 Repeated exposure may cause skin dryness or

cracking

EUH066 Repeated exposure may cause skin dryness or

cracking

R67 Vapours may cause drowsiness and dizziness H336 May cause drowsiness or dizziness

R68 Possible risk of irreversible effects H341 Suspected of causing genetic defects. (state route

of exposure if it is conclusively proven that no other

routes of exposure cause the hazard)

R68/20

R68/21

R68/22

Harmful. Possible risk of irreversible effects (by

inhalation, skin contact, swallowing)

H371 May cause damage to organs (or state all organs

affected if known) (state route of exposure if it is

conclusively proven that no other routes of

exposure cause the hazard)

R39-41 EUH070 Toxic by eye contact

EUH071 Corrosive to the respiratory tract

Variable 2Exposure potentialTable 2. Hazard bands by H phrases.

A H304, H315, H319, H336, EUH066 Any substance without H phrases from groups B to E

B H302, H312, H332, H371

C H301, H311, H314, H317, H318, H331, H335, H370, H373, EUH071

D H300, H310, H330, H351, H360F, H360D, H361f, H361d, H362, H372,

E H334, H340, H341, H350, H350i, EUH070

The exposure potential is classed as high, medium or low. For liquids it is measured in terms of their volatility, determined

from their boiling point (BT) and the process temperature (T), according to figure 2 obtained from the three COSHH

volatility levels. It the case of solids it is measured in terms of their dustiness, as shown in table 4. In the case of agents in

a gaseous state the COSHH technical basis always assigns them a high volatility:

Si PE ≤ (2 · T + 10), the volatility is high.

Si (2 · T + 10) ≤ PE ≥ (5 · T + 50), the volatility is medium.

Si PE ≥ (5 · T + 50), the volatility is low.

Table 3. Downgrading of hazard band by some H phrases according to limit values..

H Phrases Limit Values Downgrading

H314

H335

VLA-ED > 0,1 mg/m3 for particles

VLA-ED> 5 ppm for gases and vapoursC to B

VLA-ED> 1 mg/m3 for particles

VLA-ED> 50 ppm for gases and vapoursC to A

H361

LOAEL> 5 mg/Kg/day (oral)

LOAEL> 10 mg/Kg/day (skin)

LOAEL> 0,025 mg/L/6h (by inhalation)

D to C

LOAEL> 50 mg/Kg/day (oral)

LOAEL> 10 0mg/Kg/day (skin)

LOAEL> 0,25 mg/L/6h (by inhalation)

D to B

Table 4. Determination of dustiness for solids

Low SOLIDS (form) Medium High

Pellet form – does not break

up. No dust generation during

handling.

Granular or crystalline. Dust is produced

during handling but quickly settles,

showing on nearby surfaces.

Fine and light powder. Using them produces

visible dust clouds that remain in suspension

for several minutes.

Variable 3Amount of substance usedThis is broken down as small, medium or large, as shown in table 5.

Table 5. Amount of substance (in order of increasing magnitude).

g or mL Small

Kg or L Medium

T or m3 Large

Risk LevelAfter culling information on the three variables defined above, a determination is then made of the potential risk level as

shown in table 6. Four levels are considered and each one corresponds to a prevention strategy, as defined in NTP

(Technical Prevention Note) 750. Regardless of the risk level, the general prevention principles as laid down in article 4 of

RD 374/2001 will be applicable.

Figure 2. Determination of volatility for liquids.

Action to be takenThe action to be taken after categorising the risk depends on the level thereof, following the guidelines laid down for each

one.

Table 6. Determination of the risk level.

Hazardousness Volatility/Dustiness

Amount

used

Low volatility or

dustiness

Medium

volatility

Medium

dustiness

High volatility or

dustiness

A

Small 1 1 1 1

Medium 1 1 1 2

Large 1 1 2 2

B

Small 1 1 1 1

Medium 1 2 2 2

Large 1 2 3 3

C

Small 1 2 1 2

Medium 2 3 3 3

Large 2 4 4 4

D

Small 2 3 2 3

Medium 3 4 4 4

Large 3 4 4 4

E The risk level is considered to be 4 for all situations involving substances with this hazardousness

Table 7. Number of substances for each risk level..

Level Number of substances %

1 177 62.1

2 65 22.8

3 17 5.9

4 26 9.1

Risk level 1. In these situations the exposure can normally be controlled by means of general ventilation.

It can be assumed that this risk level would correspond to a slight risk (riesgo leve), as laid down in Real Decreto

374/200 and in the Technical Guide for developing RD 374/2001, establishing the criterion in terms of the

hazardousness of the chemical agents to determine whether the risk is slight. The COSHH Essentials model goes

somewhat further and incorporates the amount used or handled and the exposure potential of the chemical agent, to

rule on the same question.

Risk level 2. In situations of this type specific prevention measures are required to control the risk. The most usual

resource used to control exposure is localised extraction, the design and construction of which usually calls for the

intervention of specialist suppliers.

Risk level 3. In situations of this type some sort of confinement or enclosure is usually necessary, preventing the

chemical substance from escaping into the air during normal operations. In any case it will be necessary to carry out a

periodic check of the proper working of the control structures to ensure their ongoing efficacy over time.

Risk level 4. The situations of this type are those involving the use of extremely toxic substances or moderately toxic

substances in large quantities, with likelihood of release into the air. A determination has to be made of whether or

not carcinogenic and/or mutagenic substances are used, as regulated by RD 665/1997 and the two amendments

thereof. In these cases it is essential to adopt custom-designed measures for the process in question, calling in expert

advice. This level of risk calls for quantitative assessment of the exposure and frequent checks of the control

resources’ ongoing efficiency.

After adaptation of the COSHH method to the new regulation, specific data was compiled on each task: operating

temperature, amount used and dustiness; and, on the basis of the name of the agent, the CAS registry number or EC

number. The hazard phrases and boiling point were then sought in various databases, obtaining the results shown in tables

7, 8, 9 and 10 and their corresponding graphs, the figures 3, 4, 5 and 6, successively.

Table 8. Number of substances for each hazard band and level

Level Hazard band Number of substances

1

A 104

B 46

C 27

D 0

E 0

2

A 0

B 0

C 56

D 9

E 0

3

A 0

B 0

C 0

D 17

Level Hazard band Number of substances

E 0

4

A 0

B 0

C 0

D 0

E 26

Table 9. Number of substances for each dustiness category.

Level Dustiness Number of substances

1

LOW 17

MEDIUM 56

HIGH 54

2

LOW 5

MEDIUM 1

HIGH 29

3

LOW 0

MEDIUM 0

HIGH 10

4

LOW 2

MEDIUM 9

HIGH 9

«EVRIQUEX» IT ToolA Windows forms computer application has been developed using the C# programming language by means of an integrated

development environment (IDE) for Windows operating systems, Visual Studio.NET.

Table 10. Número de sustancias para cada categoría de volatilidad.

Nivel Volatilidad Número de sustancias

1

LOW 18

MEDIUM 27

HIGH 5

2

LOW 2

MEDIUM 23

HIGH 5

3

LOW 0

MEDIUM 3

HIGH 4

4

LOW 0

MEDIUM 3

HIGH 3

This programme evaluates the chemical risk for exposure by inhalation of substances and compounds based on adaptation

of the COSHH Essentials method to the new legislation on the labelling of substances and mixtures. During the assessment

process the user is presented with different windows to enter the identification details of how and where it is carried out

and who by, for a greater control over processes. An indication will then be given of which substance to choose and in

which form it should be used, doing so by means of the various options offered to the expert user, obtaining as a result its

risk level and the concomitant recommendations.

Figure 3. Number of substances per risk level.

Figure 4. Number of substances in terms of the hazard band.

Figure 5. Number of substances in terms of dustiness.

Our starting point here is theneed of adapting the COSHHEssentials method to the newRegulation 1272/2008 on thelabelling of substances and

mixtures without this involvingany changes in the response

obtained or results

Figure 6. Number of substances in terms of volatility.

An Excel data table compiling all the substances has been created for designing the IT tool. The featured data are the name

of the agent, its state (solid or liquid), chemical formula, CAS number, EC number, H phrases referring to the health

hazard, H phrase of greatest hazardous to determine the hazard band (1st method variable) and boiling point for liquids.

This data will be input by the programme itself and the rest will be entered by the user since they are specific to each

procedure, such as the amount used, operating temperature and the form of solid particles.

To assess a substance the user has to register it as a new substance on the basis

of the data featuring in the safety sheet of each substance or by means of a

search in databases such as the one run by the Instituto de Seguridad e Higiene

en el Trabajo or in RISCTOX (database of ISTAS, CCOO).

Detailed information on the operation and use of the «EVRIQUEX» programme

can be found in the user handbook written for that purpose.

Discussion

When establishing the correspondence between the R and H phrases we came

across two R phrases with no direct correspondence according to annex VII of Regulation (EC) 1272/2008. The phrases

concerned are:

R39: Danger of very serious irreversible effects.

R48: Danger of serious damage to health by prolonged exposure. Both phrases, however, do have an H phrase

correspondence if combined with these others:

R39/23, R39/24, R39/25, R39/26, R39/27 and R39/28 correspond to H370: Causes damage to organs (or state all

organs affected if known) (state route of exposure if it is conclusively proven that no other routes of exposure cause

the hazard).

R48/20, R48/and R48/22 correspond to phrase H373: May cause damage to organs (state all organs affected if known)

through prolonged or repeated exposure (state route of exposure if it is conclusively proven that no other routes of

exposure cause the hazard).

R48/23, R48/24 and R48/25 correspond to the phrase H372: Causes damage to organs (or state all organs affected if

known) through prolonged or repeated exposure (state route of exposure if it is conclusively proven that no other

routes of exposure cause the hazard).

To solve this incompatibility we turned to the technical basis of the COSHH method. In this document the R48 phrase tends

to be used in combination, in one of the abovementioned ways, and can in fact be classified in one of the hazard bands as

shown in table 2: Hazard bands by H phrases. For phrase R39, however, there is no specification about its always appearing

in combined form and, according to the technical basis, this phrase is classified in a group only when it appears in

combined form. After checking the literature and consulting various experts on the matter we came up with no solution for

the hypothetical case of finding a substance containing the phrase R39 in isolation.

As regards classification of each phrase in the different hazard bands, this has been done automatically, i.e., the H phrase

has been classified where its corresponding R phrase appeared. This accounts for most of them, barring some that were not

classified as R phrases but do now appear in the technical basis of the method classified as H phrases. Witness the cases of

the combinations R68/20-22 (H371) which are classified in group B; R39/23-28 (H370), which are classified in C; EUH066 in

A; EUH070 in E and EUH071 in C. Classification of phrase H370 raised a doubt. If its corresponding R phrases were classified

in a given manner (R48/20,21,22 in group C and R48/23,24,25 in D), why now is the phrase H370, which encompasses all of

them, classified in group C and not in D, lowering the hazardousness established by the former method?

To analyse the results shown in the previous section we have to point out that one method variable is held constant

throughout all the assessed tasks: the amount of the substance, which in all cases is small due to the fact that our work

focused on university teaching and research labs, which usually work with amounts equal to or less than grams and/or

millilitres, which the method classifies as a «small» amount. With this caveat in mind the possible results are limited to the

other two method variables, hazardousness and exposure potential (volatility for liquids and dustiness for solids), so table 6

for determination of the risk level is summed up in table 11 for small amounts.

Table 11. Determinación del nivel de peligro cuando la cantidad usada es Small.

Grado de

Peligrosidad

Volatilidad/Pulverulencia

Cantidad

usada

LOW volatilidad o

pulverulencia

Media

volatilidad

Media

pulverulencia

Alta volatilidad o

pulverulencia

A Small 1 1 1 1

B Small 1 1 1 1

C Small 1 2 1 2

D Small 2 3 2 3

E The risk level is considered to be 4 for all situations involving substances with this hazardousness.

From the results shown in Table 7 (number of substances for each risk level) and its corresponding graph (figure 3), we can

conclude that the number of substances for each level might be a reflection of the comment made for table 11

(Determination of risk level when the amount used is small), since the likelihood of obtaining a lower risk level varies

inversely with the hazardousness, except for 4, which is an exceptional case due to the fact that the risk level is considered

to be 4 for all situations involving substances with this hazardous band E, without considering the rest of the variables.

As for the results of table 8, showing the number of substances for each hazard band and risk level, different level-

dependent variations show up:

For level 1 no substance was found with a hazardousness D or E. Within this level the number of substances falls as the

hazard band rises from A to B, and falls off even more sharply from B to C; this is so because, providing that the

amount is small, the result will always be level 1 for hazard bands A and B regardless of the volatility or dustiness

value; for C, on the other hand, the result may come out as level 2, when volatility is medium or high and dustiness is

high, again for a small amount.

For level 2 there are no substances with hazardousness A, B or E, since it would be impossible to obtain this result

when working with small amounts, as shown in table 11. Most substances within this level are clustered in hazard band

The project has resulted inadaptation of the method in

question and implementation ofan IT application for assessing

exposure risk to chemical agentsbased on this method

C and some in D. There are more C-band substances with level 2 instead of level 1, suggesting that there are more of

these C-band substances with medium or high volatility and high dustiness than with low volatility and low or medium

dustiness, which would take us to level 1.

The substances determining level 3 are all D rated for the same reasons as mentioned above: it is not possible to

obtain a level 3 from a hazard band other than D when the amount involved is small. For hazard band D, with the same

probability of coming out as level 2 or 3, according to table 10, more of the substances come out with level 3, so we

reiterate the comment for band C: there are more substances with medium or high volatility and high dustiness than

with low volatility and low or medium dustiness, which would take us to level 2.

For level 4 all substances are of hazard band E, since two situations might obtain at this level: those in which

extremely toxic substances are used, involving a hazard band E, as in our case, or those situations in which substances

of moderate toxicity are used in large amounts and might easily be released into the air, of which we have no

example, as explained previously.

The observed effect when the amount used is small (as explained in each case) is

also reflected in NTP 750, which states that when the amount of the chemical

agent used or handled is low, the risk is always slight for agents of hazard bands

A and B, and is also slight for C-rated agents with low exposure potential. We

never came across a slight risk situation with D- or E-rated agents.

Initially we tried to establish a comparison between the results obtained by the

COSHH method and the French method INRS, but after detailed study of the

latter we came to the conclusion that the two methods are not comparable since

they differ in terms of the assessment variables and possible hazard levels. It is hence not logical to expect the same

results.

Conclusions

In accordance with the described methodology the COSHH Essentials model has been adapted to the new EC Regulation

1272/2008 on the labelling of substances and mixtures, facilitating its use according to the hazard banding established by

the various H phrases proposed by this regulation and applicable to this method. This enables this simplified assessment

method to be used on the basis of the product safety data sheets and in terms of the rest of the variables involved in this

method and determined by the various working procedures.

An IT tool has also been created to facilitate application of this adapted method in a simple way. This will be especially

useful for university labs that work with a wide range of procedures and substances. These can now all be assessed in a

simple way, favouring risk estimation and implementation of the preventive action. u

ACKNOWLEDGEMENTS

This study was financed by a FUNDACIÓN MAPFRE research grant.

RELEVANT LEGISLATION

Spanish Occupational Risk Prevention Act (Ley de Prevención de Riesgos Laborales) 31/1995, of 8 November, published in

the Official State Journal (BOE in Spanish initials) 269 of 10 November. Instruction of 26 February 1996 of the Secretary of

State for the General Government, for application of Ley 31/1995 (BOE 59, of 8 March).

Real Decreto 665/1997 of 12 May on the protection of workers from risks related to worktime exposure to carcinogenic

agents (BOE 124 24/05/1997).

Real Decreto 374/2001 of 6 April on the protection of workers’ health and safety against risks related to workplace

chemical agents.

Real Decreto 349/2003 of 21 March amending Real Decreto 665/1997 of 12 May, increasing the scope of application to

mutagenic agents (BOE 82 of 5 April 2003).

Real Decreto 1802/2008 of 3 November amending the regulation on notification of new substances and the classification,

labelling and packaging of hazardous substances, approved by Real Decreto 363/1995 of 10 March with the purpose of

adapting its provisions to Regulation (EC) 1907/2006 of the European Parliament and of the Council (REACH Regulation).

Real Decreto 717/2010 of 28 May amending Real Decreto 363/1995 of 10 March approving the regulation on the

classification, packaging and labelling of hazardous preparations.

Regulation (EC) 1272/2008 of the European Parliament and of the Council of 16 December 2008 on the classification,

labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/CEE and 1999/45/CE and

amending Regulation (EC) 1907/2006.

TO FIND OUT MORE

Sousa E, Tanarro C, Bernaola M, Tejedor JN. Aplicación de métodos simplificados de evaluación del riesgo químico con

efectos para la salud. Seguridad y Salud en el Trabajo, 50: 28-39. Instituto nacional de Seguridad e Higiene en el

Trabajo (INSHT-CNCT), December 2008.

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Caballé N. Evaluación del riesgo por exposición inhalatoria de agentes químicos. Metodología simplificada (NTP 750).

INSHT, 2009.

2.

Larrauri M, Prieto R. Evaluación sin medición. Sociedad de Prevención de Fremap. Congreso Nacional de Prevención de

Riesgos Laborales en la Universidad. Universidad de Sevilla, June 2010.

3.

Sousa ME, Sánchez-Cabo MT, Aguilar J, Bernaola M, Gálvez V, Rams P, Tanarro C, Tejedor JN. Evaluación simplificada

de exposición por inhalación a agentes químicos. Seguridad y Salud en el Trabajo, 58:12-27. Instituto nacional de

Seguridad e Higiene en el Trabajo (INSHT-CNCT), July 2010.

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Boix P. Tóxicos en el trabajo. ISTAS. Por experiencia. Boletín de Salud Laboral para Delegados y Delegadas de

Prevención de CC OO, nº 13, June 2001.

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Laborda R. Evaluación de la exposición a agentes químicos en el trabajo. Manual práctico. Iniciativas para la

Promoción del Desarrollo Económico, S.L.L. Ediciones Bérnia. Valencia, 2001.

6.

Calera A and Boix P. Uso controlado: la gran mentira. ISTAS. Por experiencia. Boletín de Salud Laboral para Delegados

y Delegadas de Prevención de CC OO, nº 14, October 2001.

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López MJ. ¿Qué preocupa a los delegados de prevención?. ISTAS. Por experiencia. Boletín de Salud Laboral para

Delegados y Delegadas de Prevención de CC OO, 14, October 2001.

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LEYEND

* Occupational exposure limits for chemical agents 2011. Ministry of Employment and Immigration. INSHT, 2011.

** Standard UNE-EN 689:1996. Workplace atmospheres. Guidance for the assessment of exposure by inhalation to chemical

agents for comparison with limit values and measurement strategy. AENOR 1996.