A) Preparing for Monitoring

  • How do we find the information we need in Exposure Scenarios?
    See answer
  • What OC and RMM do I need to have in place?
    See answer
  • Do we need to measure RMM efficiency?
    See answer
  • Is waste management covered under the Authorisation?
    See answer
  • What are enforcement authorities going to look at in case of an inspection?
    See answer
  • I only use a small quantity of hexavalent chromium on an infrequent basis. Am I exempted from the authorisation requirement?
    See answer

B) Developing Monitoring Plans

  • What do we need to cover in our monitoring plans?
    See answer
  • What happens if we have high testing results?
    See answer
  • We have no in-house expertise. What should we do? Who do we call?
    See answer
  • We use several products that contain different hexavalent chromates and these may be covered by more than one authorisation. How do we manage this?
    See answer
  • What should we be aiming for in terms of worker exposure? Can we cross-reference to ES?
    See answer
  • What exactly needs to be measured for worker air monitoring?
    See answer
  • Our workers use the same Authorised substance across multiple tasks (i.e., Worker Contributing Scenarios). Can we combine the worker exposure across multiple tasks?
    See answer
  • How do we develop a detailed environmental monitoring plan?
    See answer
  • We use several products that contain different hexavalent chromates and these may be covered by more than one Authorisation. How can I ensure my environmental monitoring program is designed appropriately?
    See answer
  • What exactly needs to be measured for environmental monitoring?
    See answer
  • We already carry out regular water and air monitoring as part of our environmental permit requirements. Can we just submit this report to ECHA?
    See answer

How do we find the information we need in Exposure Scenarios?

Your supplier provides you with an extended Safety Data Sheet (e-SDS) to which Exposure Scenarios (ES) are attached. You must ensure the latest version of the e-SDS for the relevant Authorisation provided by your supplier is available to you.

The ES describe the uses for which the substance or formulation may be used according to the terms of the Authorisation. Each ES is made up of several ‘contributing scenarios’. There is one environmental contributing scenario and there may be more than one worker contributing scenarios per ES.

Each contributing scenario sets out specific operational conditions (OC) and risk management measures (RMM) that MUST be in place for that activity.

You must implement the OC and RMMs set out in each contributing scenario relevant to your use. This means:

  • You must clearly identify which ES attached to the e-SDS for each Authorisation are relevant for your operations.
  • You must clearly identify which contributing scenarios described in the relevant ES are relevant for your operations.
  • For each of those contributing scenarios, you must ensure relevant operational conditions (OCs) are in place at each facility.
  • For each of those contributing scenarios, you must ensure relevant risk management measures (RMMs) are in place at each facility.

Exposure Scenarios are technical documents typically used by experts in industrial hygiene and environmental control. In case of questions, please seek expert advice.

Modified Date: 12/02/2020
ID: A101
Version: 1.0

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What OC and RMM do I need to have in place?

An explanation of OC and RMM is provided in Chapter R.13 on Risk Management Measures and Operational Conditions in ECHA’s Guidance on information requirements and chemical safety assessment.

The e-SDS set out the minimum OC and RMM that must be in place for each activity. Downstream users may select and apply additional or more stringent OC and RMM as appropriate.

Relevant OC may specify the maximum duration and frequency of the activity, the location and level of automation of the activity, and conditions such as temperature or pressure.

Please also see Q[A101].

Exposure Scenarios are technical documents typically used by experts in industrial hygiene and environmental control. In case of questions, please seek expert advice.

Modified Date: 12/02/2020
ID: A101
Version: 1.0

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Do we need to measure RMM efficiency?

In some cases, ES specify equipment with a particular operational efficiency. For example, it may specify use of LEV with an efficiency of 90% or air abatement technology with an efficiency of 99%. This refers to the design efficiency of the equipment to perform its function. LEV with an efficiency of 90% is designed to capture 90% of targeted emissions and air abatement technology with an efficiency of 99% is designed to remove 99% of targeted release. Such equipment has to be regularly maintained to ensure it operates as designed. Tests are sometimes, but not always, possible or required to check equipment is operating according to the design intent.

In general, Downstream Users should:

  • Check and document the design efficiency of equipment. When this is below the recommended efficiency in the e-SDS, a review of alternative technology may be necessary.
  • Regularly assess and maintain equipment according to applicable regulatory requirements and manufacturers’/designers’ recommendations to ensure it operates efficiently and as intended. Where methods are available to safely check the efficiency of the equipment without endangering the safety of workers or the environment, these may be implemented.

Modified Date: 12/02/2020
ID: A101
Version: 1.0

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Is waste management covered under the Authorisation?

Material meeting the definition of waste under EU law is not within the scope of REACH. However, waste management is critical to the safe use of substances. As such, some ES may include OC and RMM that have specific requirements for waste handling and management, including disposal.

The e-SDS set out the minimum OC and RMM that must be in place for each activity, including requirements for waste management. Downstream users may select and apply additional or more stringent OC and RMM, as appropriate.

Modified Date: 12/02/2020
ID: A101
Version: 1.0

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What are enforcement authorities going to look at in case of an inspection?

There is no specific format for an inspection by enforcement authorities. They may wish to carry out a site inspection and/or to review documentation including, for example, measurement data and reports, maps, mass balance calculations, sampling facilities, etc.

Downstream Users are responsible for demonstrating compliance and are strongly encouraged to document all aspects relating to Authorisation compliance in detail.

Modified Date: 12/02/2020
ID: A101
Version: 1.0

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I only use a small quantity of hexavalent chromium on an infrequent basis. Am I exempted from the authorisation requirement?

ECHA, in its Authorisation Q&A no. 0563, states that there is no tonnage threshold below which (the placing on the market) for a use of an Annex XIV substance is exempted from the authorisation requirement.

Modified Date: 12/02/2020
ID: A106
Version: 1.0

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What do we need to cover in our monitoring plans?

The scope of the worker and environmental monitoring programmes must be determined on a site by site basis, considering individual factors relevant to that site. Guidance is available in the GCCA Authorisation Toolbox to help Downstream Users identify the main considerations that determine what needs to be measured.

Support from a suitably qualified expert is advisable in relation to the specification and delivery of any program for worker or environmental monitoring.

Modified Date: 12/02/2020
ID: B201
Version: 1.0

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What happens if we have high testing results?

High measurement results can occur for a variety of reasons, for example, due to a problem with the sampling method or due to unexpected contributions from background sources. It is important that all appropriate OC and RMM are properly implemented to ensure release from the authorized use is minimised prior to measurement.

When measurement results are higher than expected, it is important to review the possible causes and rectify them. It may be necessary to refine and iterate the monitoring programme once the issue has been resolved. Adequate time should be scheduled for the monitoring programme to account for this.

When it is not possible to resolve the issue, an explanation of the high measurement data should be provided in the report submitted to ECHA. Expert advice is always advisable in such circumstances.

Modified Date: 12/02/2020
ID: B202
Version: 1.0

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We have no in-house expertise. What should we do? Who do we call?

We recommend that you hire a competent resource (e.g., occupational hygienist, environmental consultants, etc.). You might check with your Competent Authority, industry/trade associations, or contact your major customers for recommendations.

Modified Date: 12/02/2020
ID: B202
Version: 1.0

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We use several products that contain different hexavalent chromates and these may be covered by more than one authorisation. How do we manage this?

To fully inform their monitoring programme planning, DUs are advised to follow a systematic approach to identify and characterize their Cr(VI) usage at each site as follows:

  1. Identify all Cr(VI) substances or formulations used at each site. An output of this exercise will be an inventory of substances or formulations containing Cr(VI) that are purchased and/or used by the site, by supplier, including those not subject to the GCCA authorization(s).
  2. Identify the uses of each substance or formulation in the inventory. If there is more than one use for some products, they should all be identified. An output of this exercise will be a complete list of all activities involving the use of Cr(VI) substances or formulations linked to the inventory above, including the location(s) of each activity.
  3. Identify the relevant Authorisation (or pending Authorisation) covering each substance or formulation, use and supplier. An output of this exercise will be clearly identifying the relevant Authorisation linked to the inventory above. Note that some Cr(VI) substances or formulations are not subject to authorisation.

The scope of the worker and environmental monitoring programmes must be determined on a site by site basis, considering individual factors relevant to that site. As such, each DU has its own unique substance and use patterns that will inform their monitoring plans. Where possible, monitoring plans should focus on the use of individual Authorised substances. However, where this is not possible (e.g., the same chromate covered under two separate Authorisations is used in the same process by the same workers), the information gathered in steps 1 through 3 can be used to allow the calculation of the contribution of a specific authorised use.

Modified Date: 12/02/2020
ID: B204
Version: 1.0

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What should we be aiming for in terms of worker exposure? Can we cross-reference to ES?

The ES includes an upper bound indication of estimated exposure levels (based on historic measurement data and modelled estimates) when all OC and RMM are implemented. These can be used as guidelines, recognizing they should represent the upper limits of exposure.

The primary aims of Downstream Users must be to ensure that:

  1. all appropriate and necessary OC and RMM are implemented correctly; and
  2. Measurements are reliable and representative.

Modified Date: 12/02/2020
ID: B205
Version: 1.0

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What exactly needs to be measured for worker air monitoring?

Downstream users must measure occupational exposure to Cr(VI) through air monitoring programmes designed to be representative of the range of tasks undertaken where the relevant Authorised substance is used.

Modified Date: 12/02/2020
ID: B206
Version: 1.0

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Our workers use the same Authorised substance across multiple tasks (i.e., Worker Contributing Scenarios). Can we combine the worker exposure across multiple tasks?

ECHA, in its template for reporting occupational exposure measurements, provides examples where sequential tasks undertaken by the same workers are monitored together. GCCA has further customized this template to include the relevant Worker Contributing Scenarios (WCS), RMMs, OCs and specific conditions specified in the relevant e-SDS. This template is available in the GCCA Authorisation Toolbox.

Modified Date: 12/02/2020
ID: B207
Version: 1.0

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How do we develop a detailed environmental monitoring plan?

The scope of the environmental monitoring program must be determined on a site by site basis, considering individual factors relevant to that site. Guidance is available in the GCCA Authorisation Toolbox to help Downstream Users identify the main considerations that determine what needs to be measured.

Environmental monitoring plans need to allow breaking out individual Authorisations and substances. Understanding the annual use and % of total Cr(VI) used can allow the calculation of the contribution of a specific authorised use.

To this end, it may be helpful to develop a material flow (e.g. Sankey diagram). This can be helpful in terms of planning the monitoring program. It can help identify where to test and what the results represent.

Support from a suitably qualified expert is advisable in relation to the specification and delivery of any program for environmental monitoring.

Modified Date: 12/02/2020
ID: B208
Version: 1.0

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We use several products that contain different hexavalent chromates and these may be covered by more than one Authorisation. How can I ensure my environmental monitoring program is designed appropriately?

Environmental monitoring by Aerospace and Defence (A&)D organisations may be complicated by several situations. For example, Cr(VI) substances in the same use may be covered by different authorizations, or Cr(VI) substances from the same or different formulations and/or uses may be combined in wastewater or air onsite prior to treatment and/or release to the environment.

Standard analytical methods do not distinguish different Cr(VI) substances in combined wastewater or air. It is therefore not straightforward to identify contributing elements of a combined release to water or air of the same or different Cr(VI) substances.

The sampling plan must therefore identify such cases and, so far as reasonable, take them into account. Different strategies may be considered:

  1. Is it practical to run and measure one activity / operation at a time? Such an approach would allow highly reliable and representative measurements.
  2. Is it possible to conduct a mass balance analysis to understand and pro rata release based on known process characteristics (e.g. release factors)? A flow or sankey diagram may be a useful tool in such an approach. Such an approach should allow reasonably reliable and representative measurements.

Modified Date: 12/02/2020
ID: B209
Version: 1.0

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What exactly needs to be measured for environmental monitoring?

Numerous complex factors need to be considered during the design and implementation of an environmental monitoring programme. All point source releases to air and water should be monitored. Representative samples of emissions to air and water should be collected at an appropriate location using appropriate methods and submitted to a qualified laboratory for analysis by appropriate methods. Expert advice is recommended if you are in any doubt.

Modified Date: 12/02/2020
ID: B210
Version: 1.0

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We already carry out regular water and air monitoring as part of our environmental permit requirements. Can we just submit this report to ECHA?

Existing environmental monitoring programmes in place (e.g. to meet other regulatory requirements) should be reviewed to determine if they provide sufficient detail to meet the specific requirements of Authorisation. For example, analytical methods may be inappropriate for Authorisation and sampling methods may not be representative of authorized activities or specific to relevant Authorisation(s).

While there is no regulatory guidance for the scope of environmental monitoring to meet the conditions of Authorisation, the regulatory authorities expect data are suitable for the purpose of:

  1. assessing whether implemented OCs and RMMs are sufficient to minimise release to the environment or additional OCs and RMMs are required, and
  2. use in the review report requesting an extension to the Authorisation, where required.

As such, the Downstream User must ensure the environmental monitoring programme required by the Authorisation conditions is developed to meet the aims of Authorisation and in line with best practice. In case further support is needed to understand these regulatory requirements, please seek expert advice or contact your Competent Authority.

Modified Date: 12/02/2020
ID: B211
Version: 1.0

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