Fecc Guidance on Management of ES information in SDS

Presentation In cooperation with Kemi & Life Science, Brenntag Nordic developed this brochure for members of Kemi & Life Science, Brenntag’s customers and other industrial users.

Fecc has adapted the brochure for its members as well.

This brochure addresses the companies’ persons responsible for REACH who have some basic knowledge about REACH, handling of safety data sheets and exposure scenarios.

The first part of the brochure offers recommendations for a REACH compliance check; how a company can handle the received extended safety data sheets and attached exposure scenarios to check if their work is carried out within the boundaries of the scenarios.

In the second part you will find recommendations of how to handle the communication flow of safety data sheets and the attached exposure scenarios further down the supply chain. For example, when a substance is purchased from multiple manufacturers. This may be of major importance for the customers’ possibility to handle the substances safely and according to the applicable rules.

The recommendations herein are consistent with the ECHA guidelines as the suggested approach to handle exposure scenarios attached to safety data sheets

The information contained in this document is intended only for guidance purposes. Whilst the document is provided in utmost good faith and has been based on the most accurate information currently available, is cannot be interpreted as legal advice. No representations or warranties are made with regards to its completeness or accuracy and no liability will be accepted by Fecc for damages of any nature whatsoever resulting from the use of or reliance on this information. This document does not represent the views of any company represented by the Fecc. Users/Members are reminded that the text of existing international, EU and/or national legislations are the only authentic legal reference.

Fecc Guidance

Management of ES information in SDS

Presentation In cooperation with Kemi & Life Science, Brenntag Nordic developed this brochure for members of Kemi & Life Science, Brenntag’s customers and other industrial users.

Fecc has adapted the brochure for its members as well.

This brochure addresses the companies’ persons responsible for REACH who have some basic knowledge about REACH, handling of safety data sheets and exposure scenarios.

The first part of the brochure offers recommendations for a REACH compliance check; how a company can handle the received extended safety data sheets and attached exposure scenarios to check if their work is carried out within the boundaries of the scenarios.

In the second part you will find recommendations of how to handle the communication flow of safety data sheets and the attached exposure scenarios further down the supply chain. For example, when a substance is purchased from multiple manufacturers. This may be of major importance for the customers’ possibility to handle the substances safely and according to the applicable rules.

The recommendations herein are consistent with the ECHA guidelines as the suggested approach to handle exposure scenarios attached to safety data sheets

The information contained in this document is intended only for guidance purposes. Whilst the document is provided in utmost good faith and has been based on the most accurate information currently available, is cannot be interpreted as legal advice. No representations or warranties are made with regards to its completeness or accuracy and no liability will be accepted by Fecc for damages of any nature whatsoever resulting from the use of or reliance on this information. This document does not represent the views of any company represented by the Fecc. Users/Members are reminded that the text of existing international, EU and/or national legislations are the only authentic legal reference.

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Introduction Safety data sheets (SDS) together with the annexed exposure scenarios (ES) may often carry much and at the same time also complex information. It may therefore be challenging to check if your own uses are covered by the received ES and hence in compliance with the safety precautions described by the supplier.

Knowing the importance and difficulty of ES, ECHA established together with sector organisations Cefic, Concawe, Eurometaux, Fecc, A.I.S.E and DUCC the Exchange Network on Exposure Scenarios (ENES)1 with two main objectives: 1. Identify good practices on preparing and implementing exposure scenarios 2. Develop effective communication exchange between supply chain actors to improve the protection of human health and the environment.

ES format Within ENES some good practices regarding the format and content of the ES for communication have already been identified: According to ENES, ES for communication typically consists of 4 sections: 1- Title of Exposure scenario 2- Conditions of use affecting exposure: environmental contributing scenarios and Human health (worker or consumer) contributing scenarios.

3- Exposure estimation and reference to its source 4- Guidance to DU to evaluate whether he works inside the boundaries set by the ES.

ES compliance check Having this present and together with some previous groundwork to facilitate your compliance check to ensure that your uses and activities are covered, 4 steps can be defined:  Outline the groundwork  Identify the relevant ES  Check compliance for the environment  Check compliance for workers

1

http://echa.europa.eu/en/about-us/exchange-network-on-exposure-scenarios

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A.

Previous groundwork :

1. Start from the table developed by FECC2 (The European Association of Chemical Distributors) according to ECHA’s Use descriptor System3 for the core activities of chemical distributors. Map your own uses and working processes (PROCs) with this as a basis.

2. Create an overview of your operational conditions and risk management measures; and customers’ foreseeable uses and conditions as well.

3. Identify the key persons and train the staff that will be responsible for carrying out the compliance checks.

Create an overview •

Have I identified all my relevant uses?

•

Have I described the OC and identified the RMM for each use?

•

What training will be necessary for the staff?

• After you have received a safety data sheet and the attached exposure scenarios:

B.

Identify the relevant ES

Select the ES that covers your own uses and/or your customer uses based on information in the ES title section.

Section 1 Title of Exposure scenario: ES/use name •

Are all my uses and foreseeable uses of my product by my customers identified in the title section of one or more of the exposure scenarios?

•

Is the use title applicable to these uses?

Section 1 Title of Exposure scenario: scope Do the contributing exposure scenarios based on the Use Descriptors cover all tasks or processes relevant for my uses in the contributing scenarios? (matching PROCs/ERCs)

2 3

Fecc “ Mapping of uses of the chemical distribution sector” R12 Guidance on information requirements and chemical safety assessment. Chapter R.12: Use descriptor system, version 2, March 2010

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C.

Check compliance for the environment

Focus on compliance of operational conditions and check if efficient risk management measures for the environment are implemented as stipulated in the ES Check if the following parameters are defined:  

   

Daily tonnage (and annual tonnage) - for uses at industrial sites.

Conditions of use at a site :  driving the initial release from processes and  driving subsequent potential release to environment On-site risk management measures (impacting on releases to the environment) and its effectiveness – if needed.

Release rates (kg/d) to air and water alone are not sufficient.

Capacity of municipal sewage system – for uses at industrial sites Local dilution capacity – for uses at industrial sites

Section 2: Operational conditions and Technical measures 

Do the product/substance characteristics (such as form [liquid/powder/granular/pellet], volatility and viscosity, concentration of substance in mixture) match those specified in the exposure scenario?



Are the processes, technologies and the conditions which control the release of the substance into the working environment (such as amount used, transfer system, containment, frequency and duration of use,) in line with the recommendations in the exposure scenario?

D.

Check compliance for workers

Focus on compliance of operational conditions and check if efficient risk management measures for the human health are implemented as stipulated in the ES Check for the individual processes at the workplace (PROCs) if the following standard parameters are defined and as a minimum are complied with: i. ii. iii. iv. v.

Duration of working hours Substance concentration/- form/- dust/- vapour pressure Outdoor/indoor activity & ventilation Local ventilation Personal protective equipment

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The PROCs themselves may indicate how closed/open a process is. A need for training of the employees is often triggered by the use of personal protective equipment.

Section 2: Operational conditions and Risk management measures •

Are general ventilation conditions (air change rate, room volume, indoor/outdoor) met?

•

Are the risk management measures indicated in the exposure scenarios used?

•

Is the effectiveness / type of RMM in line with exposure scenario requirements?

Finally the compliance check has to be documented. The parameters could, if necessary, be incorporated in the work place instructions.

Outcomes of the checking If the check demonstrate compliance with received ES No further action is needed

If the check does not immediately demonstrate compliance with received ES you can do the following:  Scale to check/demonstrate that the conditions of use are within the boundaries of the ES, even though they appear to be slightly different from the description in the ES. Information on scaling should be provided as part of the ES. Section 4: Guidance to DU to evaluate whether he works inside the boundaries set by the ES •

Are there the scaling algorithms and scalable parameters indicated in this section?

 The PROC hierarchy may in some cases be applied to cover a PROC that is not mentioned explicitly in the ES. Some PROCs may encompass others.4  Have a supplier dialog to clarify and add any missing use or deviating operational conditions and risk management measures.

4

Cefic, Ducc, Concawe, Fecc “Messages to communicate in the supply chain on extended SDS for substances II”, Final version 13 July 2011.

Annex II.

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 Amend your own process/conditions of use to make them comply with the ES.  Make a downstream user chemical safety report for the missing use / the deviating operational conditions and risk management measures.  Check for alternative manufacturer whose ES covers your use.  Substitute to another substance.

Recommendations for communication Recommendations for communication of extended safety data sheets in the supply chain and to customers, when for example the same substance is sourced from multiple manufacturers.

The communication flow from the distributor’s suppliers via the distributor to the distributor’s customers can be performed in various ways: 1. A copy of the manufacturer’s extended safety data sheet (ext-SDS) is forwarded downstream in the supply chain by the distributor.

2. The information in the manufacturer’s ext-SDS is transferred by the distributor to the distributor’s own IT-system. The distributor communicates the manufacturer’s information downstream in the supply chain, now in the distributors own ext-SDS format.

3. The distributor purchases the same substance from multiple sources (from multiple manufacturers = REACH-registrants). The distributor chooses to align the information from the manufacturer’s ext-SDS into a consolidated version created in their IT-system. The distributor’s consolidated version is now communicated downstream in the supply chain.

The choices may depend on the operating conditions. Some examples: 

Model 3 can be relevant if the distributor purchases the same substance from multiple manufacturers and stores the substance in the same storage tank before it is tapped off.



If the distributor purchases a substance in closed contained form from multiple manufacturers, and applies batch management, then model 1 or model 2 may be relevant.



When the distributor purchases a substance from one manufacturer only, model 1 or model 2 may be relevant.



Customer specific communication can also be the case, in which case the single customer does not receive the complete information (SDS and all annexed ES), but only SDS annexed with selected ES that are relevant for the customer.

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Alignment of Exposure Scenarios into consolidated versions When aligning the ext-SDS, the distributor can compare and match information from each manufacturer and: a) Check substance ID/classification to verify that it is the same substance with the same hazard description. 

Clarify the difference, if any, and if this has an influence on the content of the ES, in a dialog with the manufacturer.



The process and the result should be documented.

b) Check if the uses covered in the ES are the same.

•

If a manufacturer has provided an ES that covers a given relevant use while another manufacturer has not included this use, the second manufacturer can be contacted to clarify if he deliberately has omitted that use for valid reasons. The use can then be included in /omitted from the consolidated version depending on the outcome of the dialog.

•

The process and the result should be documented.

c) Check if operational conditions and risk management measures for each use are consistent in the ES. •

If there are differences, the most appropriate set of operational conditions and risk management measures can be selected for the consolidated version, at least as a starting point. If the most appropriate set of operational conditions and risk management measures do not lead to the lowest exposure (are the most stringent) it is necessary to: i.

Check that the appropriate set of operational conditions and risk management measures ensure safe use even though they are less stringent compared to measures recommended by another manufacturer.

ii. Inform the manufactures of the differences for the same substance and for the same use, with a view to align their ES. iii. Ensure that a competent person performs the check and the dialog. 

The process and the result should be documented.

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References •

[1] General information on the ENES network 

•

[2] Fecc “ Mapping of uses of the chemical distribution sector” 

•

http://www.fecc.org/fecc/images/stories/downloads/SHE/2011/110817_uses%20as%20 distributor.pdf

[3] Guidance on information requirements and chemical safety assessment. Chapter R.12: Use descriptor system, version 2, March 2010. 

•

http://echa.europa.eu/en/about-us/exchange-network-on-exposure-scenarios

http://echa.europa.eu/documents/10162/13632/information_requirements_r12_en.pdf

[4] Cefic, Ducc, Concawe, Fecc “Messages to communicate in the supply chain on extended SDS for substances II”, Final version 13 July 2011 

http://www.cefic.org/Documents/IndustrySupport/Cefic%20communication%20on%20e xtSDS_130711.pdf

Useful documents •

ECHA “Guidance for downstream users” Version 2.1 October 2014 

•

http://echa.europa.eu/documents/10162/13634/du_en.pdf

ECHA “How downstream users can handle exposure scenarios”. Practical Guide 13, version 1, June 2012. 

http://echa.europa.eu/documents/10162/13655/du_practical_guide_13_en.pdf

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European Association of Chemical Distributors Rue du Luxembourg, 16b | 1000 Brussels | Belgium T: +32 (0)2 679 02 60 | F: +32 (0)2 672 73 | Website: www.fecc.org

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