# CE2004088EN.01017701.xml

| 8.4.2004 | EN | Official Journal of the European Union | CE 88/177 |
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8.4.2004

EN

Official Journal of the European Union

CE 88/177

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(2004/C 88 E/0186)

WRITTEN QUESTION E-0378/04

by Hartmut Nassauer (PPE-DE) and Bernd Lange (PSE) to the Commission

(12 February 2004)

Subject:   Planned draft second directive on limit values providing for the establishment of an indicative occupational exposure limit value, ‘inter alia’ for nitrogen monoxide (NO)

Subject:

Given that the Commission is planning to drastically reduce the occupational exposure limit value for nitrogen monoxide on the recommendation of SCOEL,

can it answer the following questions:

| 1. | What is the scientific basis for the proposal that the indicative limit value for nitrogen monoxide in the workplace should be 0,2 ppm? |
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1.

What is the scientific basis for the proposal that the indicative limit value for nitrogen monoxide in the workplace should be 0,2 ppm?

| 2. | Are conditions in the Member States, above all those in the various branches of industry, including in particular the different types of mining, taken into consideration when setting a limit value, even if it is only an indicative limit value? |
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2.

Are conditions in the Member States, above all those in the various branches of industry, including in particular the different types of mining, taken into consideration when setting a limit value, even if it is only an indicative limit value?

| 3. | To what extent are valid epidemiological investigations used when setting an occupational exposure limit value? |
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3.

To what extent are valid epidemiological investigations used when setting an occupational exposure limit value?

| 4. | What method can be used to measure nitrogen monoxide in the order of 0,2 ppm? Can this measurement method also be used underground? Which measurement method was established by the Commission as the available measurement technique, in line with Article 3(2) of the fourteenth individual directive, when it set the limit value for nitrogen monoxide? Has this method been validated? |
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4.

What method can be used to measure nitrogen monoxide in the order of 0,2 ppm? Can this measurement method also be used underground? Which measurement method was established by the Commission as the available measurement technique, in line with Article 3(2) of the fourteenth individual directive, when it set the limit value for nitrogen monoxide? Has this method been validated?

| 5. | What is the justification for reducing the occupational exposure limit value for nitrogen monoxide by a factor of 125 in comparison with the present limit values in most Member States? |
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5.

What is the justification for reducing the occupational exposure limit value for nitrogen monoxide by a factor of 125 in comparison with the present limit values in most Member States?

| 6. | Why has nitrogen monoxide been included in the second directive on limit values, although no occupational diseases have been found which are caused by the substance? |
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6.

Why has nitrogen monoxide been included in the second directive on limit values, although no occupational diseases have been found which are caused by the substance?

| 7. | What is the composition of SCOEL? Who appoints its members, and on what criteria? |
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7.

What is the composition of SCOEL? Who appoints its members, and on what criteria?

| 8. | Did those affected by the directive have an opportunity to put forward their arguments? On what grounds did the Commission reject the arguments of industry and the conclusions of the advisory committee, the SHCMOEI and the sectoral social dialogue committee on mining? |
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8.

Did those affected by the directive have an opportunity to put forward their arguments? On what grounds did the Commission reject the arguments of industry and the conclusions of the advisory committee, the SHCMOEI and the sectoral social dialogue committee on mining?

Answer given by Mr Dimas on behalf of the Commission

(20 April 2004)

(20 April 2004)

| 1. | Article 3(1) of Council Directive 98/24/EC (1) imposes on the Commission the obligation to ‘ ... evaluate the relationship between the health effects of hazardous chemical agents and the level of occupational exposure by means of an independent scientific assessment of the latest available scientific data’.
  This independent evaluation is performed by the Scientific Committee on Occupational Exposure Limits (SCOEL) set up for this purpose (2). The SCOEL is composed of 21 highly qualified independent experts, reflecting the full range of scientific expertise to fulfil its mandate, in particular chemistry, toxicology, epidemiology, occupational medicine and industrial hygiene, and general competence in setting occupational exposure limit values. The SCOEL performs its evaluations according to an established, approved and published methodology (EUR 19253-EN) which takes into account the availability of techniques for measurement.
  The scientific basis for the Commission proposal is the SCOEL/SUM/89 final document. This document has been published by the Commission in the series of SCOEL recommendations (3). All scientific studies and investigations that have been considered by SCOEL are listed in the references of the SCOEL document. |
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1.

Article 3(1) of Council Directive 98/24/EC (1) imposes on the Commission the obligation to ‘ ... evaluate the relationship between the health effects of hazardous chemical agents and the level of occupational exposure by means of an independent scientific assessment of the latest available scientific data’.

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This independent evaluation is performed by the Scientific Committee on Occupational Exposure Limits (SCOEL) set up for this purpose (2). The SCOEL is composed of 21 highly qualified independent experts, reflecting the full range of scientific expertise to fulfil its mandate, in particular chemistry, toxicology, epidemiology, occupational medicine and industrial hygiene, and general competence in setting occupational exposure limit values. The SCOEL performs its evaluations according to an established, approved and published methodology (EUR 19253-EN) which takes into account the availability of techniques for measurement.

2

The scientific basis for the Commission proposal is the SCOEL/SUM/89 final document. This document has been published by the Commission in the series of SCOEL recommendations (3). All scientific studies and investigations that have been considered by SCOEL are listed in the references of the SCOEL document.

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| 2. | According to Article 3, paragraphs 1 to 3 of Council Directive 98/24/EC, Community indicative occupational exposure limit value (IOELV) are health based, non-binding values, derived from the latest available scientific data and the availability of adequate measurement techniques, which provide for any given substance the threshold level of exposure below which no detrimental health effects are expected. They are objectives to be achieved and as such are necessary for the determination and assessment of risks by the employer, in accordance with Article 4 of Council Directive 98/24/EC.
  The technical/scientific nature of IOELV's is recognised by the legislator, since the Directive provides for adoption in accordance with the adaptation to technical progress procedures. In contrast, Community binding limit values are of a political nature: they are defined not only on the basis of health effects, but also on feasibility factors, socio-economic impact and the quantum of risk that society is ready to accept. They are established by the political authority in accordance with Article 137 of the EC Treaty.
  In the case of NO the Commission is also aware of specific measurements carried out in Member States. For example, the Chemical Agents Occupational Hygiene Unit of the Technology Division of the United Kingdom Health and Safety Executive has performed a review on the use of and exposure to nitrogen monoxide and nitrogen dioxide in United Kingdom workplaces. The overall mean occupational exposure levels measured in the mining sector were found to be in the range of 0,3 parts per million (ppm) to 0,81 ppm. The Commission has not yet assessed, to what extent these results can be taken into account when reaching a decision on a new IOELV for NO. |
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2.

According to Article 3, paragraphs 1 to 3 of Council Directive 98/24/EC, Community indicative occupational exposure limit value (IOELV) are health based, non-binding values, derived from the latest available scientific data and the availability of adequate measurement techniques, which provide for any given substance the threshold level of exposure below which no detrimental health effects are expected. They are objectives to be achieved and as such are necessary for the determination and assessment of risks by the employer, in accordance with Article 4 of Council Directive 98/24/EC.

The technical/scientific nature of IOELV's is recognised by the legislator, since the Directive provides for adoption in accordance with the adaptation to technical progress procedures. In contrast, Community binding limit values are of a political nature: they are defined not only on the basis of health effects, but also on feasibility factors, socio-economic impact and the quantum of risk that society is ready to accept. They are established by the political authority in accordance with Article 137 of the EC Treaty.

In the case of NO the Commission is also aware of specific measurements carried out in Member States. For example, the Chemical Agents Occupational Hygiene Unit of the Technology Division of the United Kingdom Health and Safety Executive has performed a review on the use of and exposure to nitrogen monoxide and nitrogen dioxide in United Kingdom workplaces. The overall mean occupational exposure levels measured in the mining sector were found to be in the range of 0,3 parts per million (ppm) to 0,81 ppm. The Commission has not yet assessed, to what extent these results can be taken into account when reaching a decision on a new IOELV for NO.

| 3. | All valid epidemological studies available are fully considered by SCOEL, together with all other relevant scientific data, when recommending an IOELV. In this context, and in the particular case of NO, SCOEL has considered the preliminary results of an occupational medicine study covering more than 400 miners from the potash industry, published in 1998 by the German Institute of Occupational Safety and Medicine (BAuA) and the research institute of the employers' occupational liability insurance for the mining industry (IGF) (1998 publication series BAuA A/FB 791) which reported no detectable effects on the lung's functional parameters. When this study is finalised and available, SCOEL will take it into consideration and revise, if appropriate, their recommendation. Furthermore, the Commission considers launching a 90 day rat test as offered to be financed by the concerned industry. It should improve the information currently available on scientific data during the next three years. This test will be consistent with the requirements of Directive 67/548/EEC (4). |
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3.

All valid epidemological studies available are fully considered by SCOEL, together with all other relevant scientific data, when recommending an IOELV. In this context, and in the particular case of NO, SCOEL has considered the preliminary results of an occupational medicine study covering more than 400 miners from the potash industry, published in 1998 by the German Institute of Occupational Safety and Medicine (BAuA) and the research institute of the employers' occupational liability insurance for the mining industry (IGF) (1998 publication series BAuA A/FB 791) which reported no detectable effects on the lung's functional parameters. When this study is finalised and available, SCOEL will take it into consideration and revise, if appropriate, their recommendation. Furthermore, the Commission considers launching a 90 day rat test as offered to be financed by the concerned industry. It should improve the information currently available on scientific data during the next three years. This test will be consistent with the requirements of Directive 67/548/EEC (4).

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| 4. | Commercial instruments for measuring NO concentrations, either outdoors or in the workplace, are available with detection limits of approximately 5 parts per billion (ppb) and response times of the order of minutes. Additionally, passive samplers for NO, often used to obtain data at a large number of sites, are available with a lower limit dosage of 0,07 ppm-h. The joint World Health Organisation-International Labour Organisation (WHO-ILO) publication ‘Environmental Health Criteria 188. — Nitrogen Oxides (Second Edition)’, produced within the framework of the International Programme on Chemical Safety (IPCS), provides a complete overview of the commercially available methodology for the analysis and sampling of NO. The draft CEN standard pr-EN 14211 ‘Ambient air quality — Measurement method for the determination of the concentration of nitrogen dioxide and nitrogen monoxide by chemiluminiscence’ and ISO 7996: 1985 Ambient air determinations of nitrogen oxides, provide harmonised measuring methodology. The Commission will further assess the practicality for workplace measurements and the conformity with the requirements of EN 482. |
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4.

Commercial instruments for measuring NO concentrations, either outdoors or in the workplace, are available with detection limits of approximately 5 parts per billion (ppb) and response times of the order of minutes. Additionally, passive samplers for NO, often used to obtain data at a large number of sites, are available with a lower limit dosage of 0,07 ppm-h. The joint World Health Organisation-International Labour Organisation (WHO-ILO) publication ‘Environmental Health Criteria 188. — Nitrogen Oxides (Second Edition)’, produced within the framework of the International Programme on Chemical Safety (IPCS), provides a complete overview of the commercially available methodology for the analysis and sampling of NO. The draft CEN standard pr-EN 14211 ‘Ambient air quality — Measurement method for the determination of the concentration of nitrogen dioxide and nitrogen monoxide by chemiluminiscence’ and ISO 7996: 1985 Ambient air determinations of nitrogen oxides, provide harmonised measuring methodology. The Commission will further assess the practicality for workplace measurements and the conformity with the requirements of EN 482.

| 5. | The existing IOELV, of 25 ppm, for nitrogen monoxide was established in 1991 (5). Since then, new scientific data, including one animal study carried out in 1995, have become available and were interpreted as indicating lung damage at exposures as low as 0,5 ppm, though these results have been evaluated by SCOEL as somewhat inconsistent and the genotoxic potential of NO in vivo as remaining uncertain. |
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5.

The existing IOELV, of 25 ppm, for nitrogen monoxide was established in 1991 (5). Since then, new scientific data, including one animal study carried out in 1995, have become available and were interpreted as indicating lung damage at exposures as low as 0,5 ppm, though these results have been evaluated by SCOEL as somewhat inconsistent and the genotoxic potential of NO in vivo as remaining uncertain.

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| 6. | Directive 98/24/EC imposes the obligation on the Commission to establish indicative exposure limit values, when it has in its possession all the elements allowing it. |
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6.

Directive 98/24/EC imposes the obligation on the Commission to establish indicative exposure limit values, when it has in its possession all the elements allowing it.

| 7. | The SCOEL composition, together with the rules of appointment and its tasks are included in the Commission Decision of 12 July 1995 mentioned above. |
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7.

The SCOEL composition, together with the rules of appointment and its tasks are included in the Commission Decision of 12 July 1995 mentioned above.

| 8. | According to the procedure followed by SCOEL, the draft Recommendation for NO has been sent out to the contact points including industrial associations for a six month period for comments. All the comments received have been carefully considered and the text of the draft recommendation has been changed accordingly.
  Furthermore, the Commission submitted the revised recommendation to the tripartite Advisory Committee and the Safety and Health Commission for the Mining and other Extractive Industries (SHCMOEI) for an opinion. The Commission is still evaluating their comments. |
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8.

According to the procedure followed by SCOEL, the draft Recommendation for NO has been sent out to the contact points including industrial associations for a six month period for comments. All the comments received have been carefully considered and the text of the draft recommendation has been changed accordingly.

Furthermore, the Commission submitted the revised recommendation to the tripartite Advisory Committee and the Safety and Health Commission for the Mining and other Extractive Industries (SHCMOEI) for an opinion. The Commission is still evaluating their comments.

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(1)  Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC), OJ L 131, 5.5.1998.

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(2)  95/320/EC: Commission Decision 95/320/EC of 12 July 1995 setting up a Scientific Committee for Occupational Exposure Limits to Chemical Agents, OJ L 188, 9.8.1995.

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(3)  http://europa.eu.int/comm/employment_social/health_safety/publicat/sum_89_nitrogen_monoxide.pdf

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http://europa.eu.int/comm/employment_social/health_safety/publicat/sum_89_nitrogen_monoxide.pdf

(4)  Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances, OJ P 196, 6.8.1967.

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(5)  Commission Directive 91/322/EEC of 29 May 1991 on establishing indicative limit values by implementing Council Directive 80/1107/EEC on the protection of workers from the risks related to exposure to chemical, physical and biological agents at work, OJ L 177, 5.7.1991.

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