How To Version Your EU Safety Data Sheets

April 23rd, 2014 Comments off

How To Version Your EU Safety Data SheetsIf you create Safety Data Sheets (SDS) for the European Union (EU), the European Chemicals Agency (ECHA) makes available a “Guidance on the compilation of safety data sheets” document.

One of the types of guidance provided is about how to version SDSs when changes are made. The guidance starts by giving the text of the REACH regulation that describes versioning:

“The date of compilation of the safety data sheet shall be given on the first page. When a safety data sheet has been revised and the new, revised version is provided to recipients, the changes shall be brought to the attention of the recipient in Section 16 of the safety data sheet, unless they have been indicated elsewhere. In that case, the date of compilation identified as “Revision: (date)” as well as a version number, revision number, supersedes date or other indication of what version is replaced shall appear on the first page”.

In EU SDSs, revisions must be identified on the first page and information on the changes must be given either in section 16 or elsewhere in the SDS. The guidance suggests that an incremental numbering system be used to identify new versions of an SDS. Changes to versions requiring provision of updates according to Article 31(9) of REACH could be identified by an increment by an integer, while other changes could be identified by an increment by a decimal, for example:

Version 1.0: Initial issue.
Version 1.1: First change(s) not requiring update and re-issue to former recipients.
Version 1.2: Second change(s) not requiring update and re-issue to former recipients.
Version 2.0: First change requiring provision of update according to Article 31(9) to former recipients.

Conditions under which an SDS must be updated according to Article 31(9) of REACH include:

  • As soon as new information which may affect risk management measures or new information on hazards becomes available.
  • Once a REACH authorization has been granted or refused.
  • Once a REACH restriction has been imposed.

Thus, for EU SDSs, if a condition described in Article 31(9) takes place, the non-decimal number must change (e.g. version 3.2 to version 4.0). Most other updates can be handled with a change to the decimal (e.g. version 3.2 to version 3.3).
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Some Guidance On Section 9 Of The GHS SDS, Part 4

March 31st, 2014 Comments off

Some Guidance On Section 9 Of The GHS SDS, Part 4In the previous post, we continued to share guidance for section 9 properties. The guidance is from the informal group on the revision of Section 9 of Annex 4, which met during the 26th session of the UN Sub-Committee of Experts on GHS on December 4-6, 2013. Section 9 of the GHS Safety Data Sheet (SDS) includes the physical/chemical properties of the product.

In this post, we conclude with guidance for the remainder of section 9 properties.

Lower and upper explosion/flammability limits:

  • Not applicable to solids.
  • For flammable liquids indicate at least the lower explosion limit.
  • If the flash point is approximately > -25 °C, it might not be possible to determine the upper explosion limit at standard temperature. In that case, it is recommended to indicate the upper explosion limit at elevated temperature.
  • If the flash point is > +20 °C, the same holds for both, the lower and upper explosion limit.

Flash point:

  • Not applicable to gases, aerosols and solids.
  • For mixtures: Indicate a value for the mixture itself if available, otherwise indicate the flash point(s) of those substances with the lowest flash point(s) as these are generally the main contributing ones.

Auto-ignition temperature:

  • Applicable to gases and liquids only.
  • For mixtures: Indicate a value for the mixture itself if available, otherwise indicate “no data available” because the auto-ignition temperature of the mixture may be lower.

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Some Guidance On Section 9 Of The GHS SDS, Part 3

March 10th, 2014 Comments off

Some Guidance On Section 9 Of The GHS SDS, Part 3In the previous post, we continued to share guidance for section 9 properties. The guidance is from the informal group on the revision of Section 9 of Annex 4, which met during the 26th session of the UN Sub-Committee of Experts on GHS on December 4-6, 2013. Section 9 of the GHS Safety Data Sheet (SDS) includes the physical/chemical properties of the product.

In this post, we continue to provide guidance for some section 9 properties.

Solubility:

  • Generally at standard temperature.
  • Indicate the solubility in water.
  • The solubility in other (non-polar) solvents may also be included.

Partition coefficient n-octanol/water (log value):

  • Not applicable to inorganic and ionic liquids.
  • Generally not applicable to mixtures.
  • May be calculated (using QSAR – Quantitative structure-activity relationship).
  • Indicate whether the value is based on testing or on calculation.

pH:

  • Not applicable to gases.
  • Applicable to aqueous liquids and solutions (the pH is linked to aqueous media by definition; Measurements carried out in other media do not give the pH).
  • Indicate the concentration of the test substance in water.

Kinematic viscosity:

  • Applicable to liquids only.
  • Use preferably mm2/s as unit (as the classification criteria for the hazard class aspiration hazard are based on this unit).
  • The dynamic viscosity may be indicated in addition. The kinematic viscosity is linked to the dynamic viscosity by the density.
  • For non-Newtonian liquids indicate thixotropic or rheopexic behavior.

Particle characteristics:

  • Applicable to solids only.
  • Indicate the particle size (median and range).
  • If available and appropriate, additional properties may also be indicated:
    • Size distribution (range)
    • Shape and aspect ratio
    • Specific surface area

In the next post, we will continue to provide guidance for additional physical/chemical properties of section 9 of the SDS.
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Some Guidance On Section 9 Of The GHS SDS, Part 2

February 17th, 2014 Comments off

Some Guidance On Section 9 Of The GHS SDS, Part 2In the last post, we started to share guidance for section 9 properties. The guidance is from the informal group on the revision of Section 9 of Annex 4, which met during the 26th session of the UN Sub-Committee of Experts on GHS that took place December 4-6, 2013. Section 9 of the GHS Safety Data Sheet (SDS) includes the physical/chemical properties of the product.

In this post, we continue to provide guidance for section 9 properties.

Melting point/freezing point:

  • Not applicable to gases.
  • At standard pressure.
  • Indicate up to which temperature no melting point was observed in case the melting point is above the measuring range of the method.
  • Indicate if decomposition or sublimation occurs prior to or during melting.
  • For waxes and pastes, the softening point/range may be indicated instead.
  • For mixtures, indicate if it is technically not possible to determine the melting point/freezing point.

Boiling point or initial boiling point and boiling range:

  • Generally at standard pressure (a boiling point at lower pressure might be indicated in case the boiling point is very high or decomposition occurs before boiling).
  • Indicate up to which temperature no boiling point was observed in case the boiling point is above the measuring range of the method.
  • Indicate if decomposition occurs prior to or during boiling.
  • For mixtures, indicate if it is technically not possible to determine the boiling point or range, in which case indicate also the boiling point of the lowest boiling ingredient.

Vapor pressure:

  • Generally at standard temperature.
  • Indicate the vapor pressure at 50°C for volatile fluids in addition, in order to enable distinction between gases and liquids.
  • In cases where one SDS is used to cover variants of a liquid mixture or liquefied gas mixture, indicate a range for the vapor pressure.
  • For liquid mixtures or liquefied gas mixtures, indicate a range for the vapor pressure or at least the vapor pressure of the most volatile ingredient(s) where the vapor pressure is predominantly determined by this/these ingredient(s).
  • For liquid mixtures or liquefied gas mixtures, the vapor pressure may be calculated using the activity coefficients of the ingredients.

In the next posts, we will continue to provide guidance for additional physical/chemical properties of section 9 of the SDS.
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Some Guidance On Section 9 Of The GHS SDS, Part 1

January 27th, 2014 Comments off

Some Guidance On Section 9 Of The GHS SDS, Part 1At the 26th session of the UN Sub-Committee of Experts on GHS, which took place December 4-6, 2013, a meeting also took place of the informal group on the revision of Section 9 of Annex 4. Section 9 of the GHS Safety Data Sheet (SDS) includes the physical/chemical properties of the product. The informal group decided to outline detailed guidance for each of the properties for which a description was required. The group intends to submit a formal document to the next session of the UN GHS Sub-Committee with proposals for amendments to the GHS based on its work.

In this post, we start to share the guidance for section 9 properties.

Physical state:

Color:

  • Indicate the color of the substance or mixture as supplied.
  • In cases where one SDS is used to cover variants of a mixture which may have different colors, the term “various” can be used to describe the color (see Annex 4.3.1.1 of the GHS for an SDS for variants of a mixture)

Odor:

  • Give a qualitative description of the odor if it is well-known or described in the literature.
  • If available, indicate the odor threshold (qualitatively or quantitatively).

Density and/or Relative density:

  • Generally at standard conditions.
  • For liquids and solids, it is recommended to indicate the density.
  • For gases, it is recommended to indicate the relative density based on air at 20°C as reference.
  • For mixtures, indicate at least a range for the density.

Relative vapor density:

  • Applicable to liquids only.

In the next posts, we will provide the guidance for additional physical/chemical properties of section 9 of the SDS.

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Latest Info On Inclusion Of Dust Explosion Hazards In GHS

January 6th, 2014 Comments off

Latest Info On Inclusion Of Dust Explosion Hazards In GHSAt the 26th session of the UN Sub-Committee of Experts on GHS, which took place December 4-6, 2013, a meeting also took place of the informal working group on dust explosion hazards. A dust explosion is the fast combustion of dust particles suspended in the air in an enclosed location.

The dust explosion hazards correspondence group discussed whether to develop an outline or work plan for guidance or a chapter in the GHS to address dust explosion hazards. If the correspondence group agreed to develop a chapter, the chair of the group suggested it would follow the normal conventions, including developing a definition, classification criteria, communication elements and other guidance.

At the meeting, several experts felt that it was important to provide guidance to better communicate the hazard. This guidance might take the form of an agreed definition and perhaps focus on better communication elements. Experts were concerned about identifying labeling elements for some substances. Experts requested that the correspondence group better define the scope of the hazard by defining the substances covered by the hazard and whether the hazard is of concern when a substance is shipped or when it is processed.

Other experts felt that a chapter in the GHS would be more beneficial in providing harmonized criteria for those jurisdictions that require classification of the hazard in order to include it in their regulations. It was noted that accidents resulting from these hazards often occur during processing. But workplaces cannot provide adequate warning and protections if they do not know that the hazard exists. The proposed chapter would focus on those substances that present a dust explosion hazard in their shipped form.

Using the definitions provided at the meeting, the correspondence group chair offered to develop a “thought starter” to better identify the scope of the hazard and include elements for a definition of the hazard.

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A Possible Solution on GHS Corrosivity Criteria

December 16th, 2013 Comments off

In an October 15, 2013 post, we described the opinions of UN experts on GHS corrosivity criteria. There were a number of options with various levels of support.

At the 26th session of the UN Sub-Committee of Experts on GHS, which took place December 4-6, 2013, UN experts continued discussions around the topic of corrosivity criteria. The Sub-Committee was informed that the “Joint TDG-GHS Working Group on corrosivity criteria” had reached an agreement on working on a possible solution on the basis of an outline developed by the Netherlands. The Sub-Committee agreed to continue working on the development of a proposal on the basis of the following outline:

  • Retaining the GHS sub-categories 1A, 1B and 1C, as these sub-categories are central to GHS corrosivity classification, and are used to establish workplace standards for storage and safe handling.
  • Confirmation of the correlation between the GHS sub-categories 1A, 1B and 1C with Packing Groups I, II and III respectively where these are based on human, animal or in vitro data. The challenge was in assigning packing groups in the transport sector when the GHS alternative methods, particularly the additivity and non-additivity approaches, were applied. A further challenge lay in identifying additional criteria for when Packing Group I should be assigned for substances and mixtures classified as GHS sub-category 1A and not included in the Dangerous Goods List.

Here is a summary of the outline from which a proposal will be developed:

A Possible Solution on GHS Corrosivity Criteria

Source: Outcome of the meeting of the joint TDG-GHS working group on corrosivity criteria, page 2.

The Sub-Committee also agreed to request the TDG Sub-Committee to consider mechanisms to address the issue outlined in the first row of the table, i.e. developing a mechanism to assign substances to Packing Group I for transport purposes on the basis of considerations that could go beyond hazard classification.
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More on Pyrophoric Gases in GHS

November 25th, 2013 Comments off

GHS_flameAt the 25th session of the UN Sub-Committee of Experts on GHS that took place July 1-3, 2013, there was a session on a proposal by the U.S. to have pyrophoric gases as a new hazard in GHS.

In the U.S., OSHA has covered pyrophoric gases in the workplace since the 1980s. It is defined as “a substance or mixture in a gaseous state that will ignite spontaneously in air at a temperature of 54.4º C (130º F) or below”.

Although pyrophoric gases generally fall in the “flammable gas” hazard class in GHS, the U.S. is proposing that a distinction between a flammable gas and a pyrophoric gas be made in GHS. All pyrophoric gases are covered under the flammable gas hazard class, but the hazard statement is considered not to be sufficient to communicate the hazard posed by pyrophoric gases, according to the U.S. proposal.

Pyrophoric gases do not appear to be a transport issue since they are transported either as flammable gases or flammable liquids, and are packaged in such way so that they are not exposed to air. However, since the Sub-Committee of Experts on the TDG (TDG Sub-Committee) is the focal point for the physical hazards, the expert from the U.S. also requested the TDG Sub-Committee’s views on the proposal.

At the UN session, there was general support for addressing pyrophoric gases in GHS. There was discussion as to whether developing a new hazard category or sub-category within the existing hazard class “flammable gases” or an entirely new hazard class was preferable. Some experts considered that the proposal should also address classification of flammable mixtures containing 1% or more of pyrophoric components and explained that the 1% cut-off value would ensure compliance with transport regulations. Others suggested that specific precautionary statements should be developed. Finally, the expert from the U.S. said that a formal document would be submitted to the next sessions of both sub-committees (GHS and TDG) for consideration.

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Opinions of UN Experts Regarding GHS and Nanomaterials

November 4th, 2013 Comments off

The 25th session of the UN Sub-Committee of Experts on GHS took place July 1-3, 2013. The session included nanomaterials on the agenda.

According to the European Commission, “Nanomaterials are chemical substances or materials that are manufactured and used at a very small scale (down to 10,000 times smaller than the diameter of a human hair). Nanomaterials are developed to exhibit novel characteristics (such as increased strength, chemical reactivity or conductivity) compared to the same material without nanoscale features.” Hundreds of products contain nanomaterials, including batteries, coatings, anti-bacterial clothing, etc. Visit the European Commission’s page on nanomaterials for more information.

The majority of experts who spoke at the UN GHS session considered that nanomaterials could be covered under the existing GHS hazard classes and categories, and therefore were not in favor of developing specific hazard classification guidance for these substances.

Most experts concurred that the specific characteristics of nanomaterials could be addressed in a more general way in the Safety Data Sheet (SDS) by including information such as particle characteristics, size, specific surface area, etc.

Others suggested that, as a first step, manufacturers could be requested to identify products containing nanomaterials, and mentioned that the general lack of information and control of their manufacture and distribution were a concern, particularly for developing countries, and had been identified as a global emerging issue during the third session of the International Conference on Chemicals Management (ICCM3) held in September 2012.

In addition, most experts did not see the need for a definition of nanomaterials and noted the different size ranges used to define nanomaterials in existing definitions developed at an international level.

Taking into account the comments made, the expert from France volunteered to lead an informal working group to see how nanomaterials could be addressed within the GHS.
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Opinions of UN Experts on GHS Corrosivity Criteria

October 15th, 2013 Comments off

The 25th session of the UN Sub-Committee of Experts on GHS took place July 1-3, 2013. The session included classification criteria and hazard communication on the agenda. Corrosivity criteria were one of the issues discussed by an informal working group.

The report of the session indicates some experts believed that the current classification scheme provided harmonized results for all sectors when based on in vivo data, and that inconsistencies occurred when classification results were derived either from translation of previous classification results into GHS hazard classes/categories or from using alternative classification methods, which usually led to over-classification. Because over-classification of corrosive substances had a direct impact on transport and storage conditions, the working group concluded that the outcomes should not lead to reclassification of Class 8 substances in transport, and should not default to more severe classification or assignment to a more onerous packing group than appropriate.

While some experts considered that deletion of sub-categories 1A, 1B and 1C in the GHS would solve the issue of over-classification within Category 1, others thought that sub-categorization was also being used in the workplace to specify appropriate engineering controls or PPE, and therefore considered that they should not be deleted. It was also noted that not all jurisdictions had adopted the sub-categories.

Several experts were in favor of option 6 as the best compromise to address the needs of all sectors (adopt GHS classification criteria in transport, including alternative methods; force alignment of PG I, PG II and PG III with hazard categories 1A, 1B, 1C for animal test data only; for alternative methods apply other criteria to assign PG), and recognized that more work was needed to define the conditions under which alternative methods (including those that did not result in sub-categorization such as pH and non-additivity methods) could be used while ensuring that the results were consistent with the requirements for transport. Option 2 (remove skin corrosion sub-categories 1A, 1B and 1C from the GHS and adopt in transport the GHS criteria as amended; include alternative methods; establish criteria for assignment of PGs I, II and III) and option 5 (adopt in transport GHS classification criteria, including alternative methods; no hazard sub-categories in both GHS and transport; assign PG separately from transport classification) also received support.

Regarding the use of expert judgment and weight of evidence, the group noted that a positive result under human exposure should always supersede the results obtained from test methods, and agreed that the concept of expert judgment needed to be further clarified.

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