Safety data sheet and exposure scenarios

SAFETY DATA SHEET

Safety data sheets are intended to provide the users of chemicals with the necessary information to help them protect human health and the environment.

The format of the safety data sheet is defined in the REACH Regulation, the safety data sheet is divides into 16 sections.

WHEN YOU PROVIDE A SAFETY DATA SHEET

A safety data sheet should be provided when:

WHAT TO DO WHEN YOU RECEIVE THE SAFETY DATA SHEET

You need to identify and apply appropriate measures to properly control the risks at your site. You should also perform a consistency and plausibility check of the safety data sheet contents, you should compare all sections related to chemical identification, composition, classification, and safe use against on the substance or mixture. The safety data sheet must be update when:

THE 16 SECTION OF THE SAFETY DATA SHEET

1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING gives information on:

If the substance has been registered under REACH, Section 1.1 will include a REACH registration number. If the product is a mixture, the registration numbers of the substances present in the mixture will be in Section 3.2.

If no registration number is given in the safety data sheet, this indicates that the substance is exempt from the registration requirements, or is not yet registered.

When you receive a safety data sheet with exposure scenarios, you should check that your use is identified by your supplier in Section 1.2. If it is not, you can contact your supplier and ask for your use to be included you must contact the supplier so that its use is included. If your use is not recommended, you must:


2. HAZARD IDENTIFICATION gives information on

The information on classification and labelling given here must be consistent with that on the actual labels for the chemical in question. The rating information is essential for assessing the risks to workers and the environment.

The classification of substances and mixtures has to be carried out in accordance with the CLP Regulation. The classification is given in accordance with the CLP Regulation. However, for mixtures already on the
market before 1 June 2015, a transitional period allows such mixtures complying with the Dangerous Preparations Directive to remain on the market without the need to be re-labelled and re-packaged before 1 June 2017.

If you have received a REACH authorisation for your substance, on its own or in a mixture, you must include the authorisation number in section 2.2 , and provide further information on the authorisation in Section 15.

3. COMPOSITION / INFORMATION ON INGREDIENTS provide information on the composition of the chemical product.

Of each ingredient lists the following information:

A supplier can include non-hazardous constituents or components here, if choosing to list the full composition of the substance or mixture.


4. FIRST AID MEASURES give information on:

The first aid measures must be described in such a way that they can be understood and carried out by an untrained person, and should be consistent with the precautionary statements in Section 2.1.

It is useful to take the safety data sheet with you when seeking medical care after accidental exposure to the chemical. Additional information provided specifically to medical personnel may be given under a heading such as “Notes for the doctor”.


5. FIREFIGHTING MEASURES give information on:

This section may also contain specific information for firefighters, including special protective equipment to be used. Pay special attention to the unsuitable extinguishing media described in Section 5.1. Their use may cause chemical or physical reactions resulting in an additional potential hazard.

6. ACCIDENTAL RELEASE MEASURES give recommendations on how to deal with accidental spills or leaks of the chemical to prevent or minimise further adverse effects.

Recommendations include:

7. HANDLING AND STORAGE gives information on how to handle and store chemicals safely, to avoid potentially dangerous incidents.

The information is appropriate for the uses identified in Section 1.2, and It should be consistent with any exposure scenario provided.

Advice on safe handling practices includes:

Advice on safe storage practices includes:

For a substance registered above 10 tonnes/year and classified for its physicochemical properties the registrant has to assess the uses in a chemical safety report.

 

8. EXPOSURE CONTROLS / PERSONAL PROTECTION give important information on:

This information must be consistent with those reported in the exhibition scenario.


9. PHYSICAL AND CHEMICAL PROPERTIES give information on:

This information must be consistent with those reported in the exhibition scenario.

10. STABILITY AND REACTIVITY give information on:

The hazards associated with stability and reactivity are related to the physical and chemical properties it is necessary to consider that the information match those given in Section 5.7 and 9 of the SDS.


11. TOXICOLOGICAL INFORMATION is intended primarily for medical professionals, occupational health and safety professionals, and toxicologists, and gives detailed information on:

You should also find a description of how the chemical was tested for health hazards and the test results.

The content of this section provides the basis for the classification and risk management measures given in the safety data sheet. The information in Sections 2, 3, 4, 6, 7, 8, 9, 13, 14 and 15 should be consistent with the toxicological information provided here.

You can also check the information in this section against the information on ECHA’s website, such as the registration information (if applicable).

 

12. ECOLOGICAL INFORMATION gives information on:

The content of this section provides the basis for the classification and risk management measures given in the safety data sheet. The information in Sections 2, 3, 4, 6, 7, 8, 9, 13, 14, and 15 should be consistent with the ecological information provided here.

You can also check the information in this section against the information on ECHA’s website, such as the registration information (if applicable).

 

13. DISPOSAL INFORMATION gives information on:

Check that the information in this section is consistent with the classification in Section 2 and with the exposure controls in Section 8.

14. TRANSPORT INFORMATION gives information on:

Check that information is consistent with the classification and composition in Sections 2 and 3.

15. REGULATORY INFORMATION gives information on:

16. OTHER INFORMATION give information on Relevant information that has not been included in the previous sections.

This might include:


EXPOSURE SCENARIOS (ES)

An extended safety data sheet, with exposure scenarios attached, has to be supplied if a hazardous substance is registered in a quantity above 10 tonnes per year per registrant.

An exposure scenario refers to an identified use, or group of similar identified uses. Exposure scenarios may include a number of “contributing scenarios”. A contributing scenario describes each contributing activity within the identified use.

The uses are divided into:

FORMAT OF EXPOSURE SCENARIO

Unlike the main body of the safety data sheet, the format of the exposure scenario is not defined in REACH. ECHA and stakeholders have worked to harmonise the layout and the phrases used, and recommend a format for the exposure scenario which includes the following four sections:

The exposure scenarios will have for substances, many of which later end up in the formulation of mixtures. For dangerous mixtures can:

When you receive an extended safety data sheet it means that the exposure scenarios are attached, so you need to:

  1. identify the exposure scenario describing the identified use of the substance
  2. check whether the identified use and conditions of use described are consistent with the use and the conditions of use in practice. (It may happen to have the same use but different conditions of use, and then you need to prove if you fall or not in this exposure scenario.)

When you receive a safety data sheet, check if a registration number is provided in Section 1.1 (for substances) or 3.2 (for mixtures). If so, you have 12 months to implement the conditions of use included in any exposure scenarios received for your use or to take appropriate actions.

1. TITLE SECTION gives following information:

-Uses covered by the exposure scenario: This information gives a brief description of the scope of the exposure scenario in the ES name. It may provide information on the life cycle stage (e.g. use at industrial site) and market information (e.g. use in paints, use in manufacturing of electric appliances). The short title may also include additional elements such as technical process and level of containment.

-List of applicable tasks/activities covered by contributing scenarios within the exposure scenario: This information includes the name of the contributing scenario and the assigned use descriptors.

-The reference number of the exposure scenario

-The information in the Title Section usually includes use descriptors

They include information on:

2. CONDITIONS OF USE AFFECTING EXPOSURE

This section is the core of the ES. It presents the recommended operational conditions (OCs) and risk management measures (RMMs) for each contributing scenario. These define the “conditions of use” of the substance that have been assessed as being safe.

The “operational conditions” (OCs) are a set of information on the use of a substance. They describe the types of activities to which the exposure scenario relates: how much, how often and for how long a substance is used and in which types of process, at which temperatures it is used etc. The parameters that influence the exposure level are included in the exposure scenario you receive.

The term “risk management measure” (RMM) means an activity or device that reduces or avoids the exposure of humans and the environment to a substance during its use. Risk management measures applied in industrial uses include local exhaust ventilation (LEV), personal protective equipment (PPE), waste gas incinerators or onsite and municipal waste (water) treatment.

If the exposure scenario contains several contributing scenarios, section 2 will include the operational conditions and risk management measures related to each contributing scenario

3. EXPOSURE ESTIMATION gives information ob:

Exposure estimation software is used to predict exposures to workers, consumers or the environment for a given set of conditions of use. The risk characterisation ratio is obtained by dividing the exposure estimates by corresponding threshold levels (i.e. DNEL for human health or PNEC for the environment).

4. GUIDANCE FOR DOWNSTREAM USERS TO EVALUATE IF THEIR USE IS WITHIN THE BOUNDARIES OF THE ES includes advice to the downstream users on how they can verify that their use is covered by the exposure scenario if their conditions of use do not match the supplier’s ES exactly.

One of the verification methods is known as ‘scaling’.

The information provided by the supplier should include:

Scaling can only be applied if the supplier has used a modelling tool to estimate the exposure to humans and the environment.

When your conditions of use differ from those indicated in the exposure scenario, the estimated exposure levels and the risk characterisation ratio may also differ.

To apply scaling you should:

To conclude that the use is covered by the ES, the resulting level of exposure after scaling is applied has to be the same or lower than the level of exposure indicated in Section 3 of the ES (for the corresponding contributing scenario).

If the supplier does not support scaling, or scaling shows that the exposure level has increased from that in the supplier exposure scenario, you have the following options:

  1. Implement the conditions in the exposure scenario; or

  2. Ask your supplier to cover your use; or

  3. Perform a downstream user chemical safety assessment.

Scaling cannot be applied if the registrant has based the assessment on measured exposure data.

If as a registrant, you have used a modelling tool to estimate the exposure to humans and the environment then provide details of the tool here, or a simplified mathematical method that could be applied by the downstream user if you deem scaling appropriate.


CEPRA srl is able to draw even SDS in accordance with the regulations of the major markets outside the EU in order to facilitate your import / export activities (China, Korea, South America, Canada, USA ...).

Contact us for more information.