Some Insight Into the Next Edition of the GHS, Part 2

August 25th, 2014 Comments off

Some Insight Into the Next Edition of the GHS, Part 1In the previous post, we described potential changes that have a strong chance of being present in the next edition of GHS. The official text of the GHS, known as the “Purple Book”, is updated every two years. The fifth revised edition was released in 2013, therefore the next version of the GHS, the sixth edition, is planned to be released next year.

The report of the 27th session of the UN Sub-Committee of Experts on GHS held on July 2-4, 2014 provides a list of the proposed draft amendments to the fifth edition of the GHS. In this post, we describe other potential changes that have a strong chance of being present in the next edition of GHS.

Precautionary statement P233 (“Keep container tightly closed”) was originally assigned in order to align with the precautionary phrases used for pyrophoric solids and liquids. This phrase is not used for other gases, such as flammable gases, as gases are provided in cylinders or closed receptacles. The experts agreed to correct this oversight in an informal paper.

Moreover, the following text is proposed to be added in the section on the decision logic and guidance for flammable gases:

“Flammable gas mixtures, which have not been tested for pyrophoricity and contain more than one percent pyrophoric components, should be classified as a pyrophoric gas. Expert judgement on the properties and physical hazards of pyrophoric gases and their mixtures should be used in assessing the need for classification of flammable gas mixtures containing one percent or less pyrophoric components. In this case, testing need only be considered if expert judgement indicates a need for additional data to support the classification process.”

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Some Insight Into the Next Edition of the GHS, Part 1

August 6th, 2014 Comments off

Some Insight Into the Next Edition of the GHS, Part 1The official text of the GHS, known as the “Purple Book”, is updated every two years. The Fifth revised edition, which is the latest version, was released in 2013, although some countries that adopted and implemented GHS are still on previous versions.

The next version of the GHS, the sixth edition, is planned to be released next year, and there have been discussions about potential changes. The report of the 27th session of the UN Sub-Committee of Experts on GHS held on July 2-4, 2014 provides a list of the proposed draft amendments to the fifth edition of the GHS.

In this post, we will start to describe the potential changes that have a strong chance of being present in the next edition of GHS next year.

The first change we will describe is from the “informal correspondence group on practical classification issues”, which submitted proposals at the UN Sub-Committee session. Following a review of Chapter 3.8, “Specific target organ toxicity-single exposure”, the correspondence group determined that, while the additivity principle was introduced in section 3.8.3.4.5, a “relevant ingredient” for this procedure has not been established.

Therefore, the correspondence group is recommending the addition of a new paragraph 3.8.3.4.6 as follows:

“3.8.3.4.6 In cases where the additivity approach is used for Category 3 ingredients, the “relevant ingredients” of a mixture are those which are present in concentrations ≥1% (w/w for solids, liquids, dusts, mists, and vapours and v/v for gases), unless there is a reason to suspect that an ingredient present at a concentration <1% is still relevant when classifying the mixture for respiratory tract irritation or narcotic effects.”

In the next post, we will continue to give insight into the sixth edition of the GHS.

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Chemical Substances Data Available to the Public

July 15th, 2014 Comments off

Chemical Substances Data Available to the PublicIf you are creating a Safety Data Sheet (SDS), either for a substance or a mixture, you need data on substances, such as classifications, physical/chemical properties, etc. If some data is not available, there are a number of publicly available databases with relevant information. Below are links to some of these databases. These websites are listed in the “Guidance on the compilation of safety data sheets” document from ECHA.

The ECHA database on registered substances
This gives a variety of information on the substances that companies manufacture or import, such as: hazardous properties, classification and labelling, how to use the substances safely, etc. Information in the database comes from registration dossiers submitted by companies.

The ECHA classification and labelling inventory
The Classification & Labelling (C&L) Inventory is a database that contains basic classification and labelling information on notified and registered substances received from manufacturers and importers. It also contains the list of harmonized classifications (Table 3.1 of Annex VI to CLP).

GESTIS
This database of the German Berufsgenossenschaften includes more than 7,000 hazardous substances alphabetically by name, with classification, labelling, limit values, measuring methods, information on personal protection equipment, workplace limit values and occupational medicine.

International Chemical Safety Cards (ICSC)
The International Labour Organisation (ILO) provides a database of International Chemical Safety Cards on its website. The primary aim of the Cards is to promote the safe use of chemicals in the workplace and the main target users are workers and those responsible for health and safety in the workplace.

eChemPortal
The eChemPortal is an effort of the Organisation for Economic Co-operation and Development (OECD) in collaboration with the European Commission, ECHA, the U.S., Canada, Japan, the International Council of Chemical Associations (ICCA), the Business and Industry Advisory Committee (BIAC), the World Health Organization’s (WHO) International Program on Chemical Safety (IPCS), the UN Environment Programme (UNEP) and environmental NGOs. eChemPortal provides free public access to information on properties of chemicals (including physical and chemical properties, environmental fate and behavior, ecotoxicity and toxicity) via simultaneous searching of reports and datasets.

IPCS INCHEM
The International Programme on Chemical Safety (IPCS) INCHEM website gives access to internationally peer-reviewed information on chemicals commonly used throughout the world, which may also occur as contaminants in the environment and food. It consolidates information from a number of intergovernmental organizations whose goal is to assist in the sound management of chemicals.

TOXNET
Toxnet is the U.S. National Library of Medicine’s toxicology data network. It gives access to databases on toxicology, hazardous chemicals, environmental health and toxic releases.

In addition to the above resources mentioned by ECHA, you may also want to take a look at ChemView from the U.S. EPA, which is a database that provides access to health and safety data on chemicals regulated under the Toxic Substances Control Act (TSCA). It contains information that the EPA receives and develops about chemicals including those on EPA’s Safer Chemical Ingredient List.
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These Mixtures Require An SDS On Request In The EU

June 24th, 2014 Comments off

These Mixtures Require An SDS On Request In The EUThe European Union (EU) specifies the conditions under which a Safety Data Sheet (SDS) must be created and sent for substances and mixtures. There are instances where an SDS is not required for some types of mixtures, but if the recipient requests one, the supplier must create and provide one.

Below are the conditions under which you need to provide an SDS if the recipient of your product requests it, even though your mixture may not fall under the conditions where an SDS is automatically required. The information is taken from the “Guidance on the compilation of safety data sheets” document made available by ECHA.

Until June 1, 2015:

The supplier must provide the recipient at his request with an SDS, where a mixture does not meet the criteria for classification as dangerous in accordance with Articles 5, 6 and 7 of Directive 1999/45/EC, but contains one of the following:

  • At least one substance posing human health or environmental hazards in an individual concentration of ≥ 1% by weight for non-gaseous mixtures and ≥ 0,2% by volume for gaseous mixtures.
  • At least one substance that is persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB), in an individual concentration of ≥ 0,1% by weight for non-gaseous mixtures.
  • At least one substance for which there are Community workplace exposure limits.

From June 1, 2015:

The supplier must provide the recipient at his request with an SDS compiled in accordance with Annex II, where a mixture does not meet the criteria for classification as hazardous in accordance with Titles I and II of Regulation (EC) No 1272/2008, but contains one of the following:

  • At least one substance posing human health or environmental hazards in an individual concentration of ≥ 1% by weight for non-gaseous mixtures and ≥ 0,2% by volume for gaseous mixtures.
  • At least one substance that is carcinogenic category 2 or toxic to reproduction category 1A, 1B and 2, skin sensitiser category 1, respiratory sensitiser category 1, or has effects on or via lactation or is persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB), in an individual concentration of ≥ 0,1% by weight for non-gaseous mixtures.
  • At least a substance for which there are Community workplace exposure limits.

 

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Products For Which An SDS Is Not Required In The EU

June 4th, 2014 Comments off

Products For Which An SDS Is Not Required In The EUIn this post, we provide more information on the types of products for which a Safety Data Sheet (SDS) is not required in the European Union (EU). The information is taken from the “Guidance on the compilation of safety data sheets” document made available by ECHA.

In the EU, the requirements to provide an SDS are included in Article 31 of the REACH Regulation.

Certain general exemptions from the requirements to supply SDSs are given in Article 2. SDSs are not required for the following mixtures in the finished state, intended for the final user:

  • Medicinal products for human or veterinary use, within the scope of Regulation (EC) No 726/2004 and Directive 2001/82/EC and as defined in Directive 2001/83/EC.
  • Cosmetic products as defined in Directive 76/768/EEC.
  • Medical devices that are invasive or used in direct physical contact with the human body in so far as Community measures lay down provisions for the classification and labelling of dangerous substances and mixtures which ensure the same level of information provision and protection as Directive 1999/45/EC.
  • Food or feedingstuffs in accordance with Regulation (EC) No 178/2002 including use:
    • As a food additive in foodstuffs within the scope of Directive 89/107/EEC.
    • As a flavouring in foodstuffs within the scope of Directive 88/388/EEC and Decision 1999/217/EC.
    • As an additive in feedingstuffs within the scope of Regulation (EC) No 1831/2003.
    • In animal nutrition within the scope of Directive 82/471/EEC.

More general exemptions apply to other classes of products via Article 2(1) (radioactive substances, substances under customs supervision, non-isolated intermediates, and products during carriage by rail, road, inland waterway, sea or air)

Waste as defined in Directive 2006/12/EC is also exempted in general by virtue of being excluded by Article 2(2) from being defined as a substance, mixture or article within the meaning of Article 3 of the REACH Regulation.

Finally, SDSs are also not required for products that do not conform either to the criteria given in Article 31(1) (a), (b) and (c) or to those in Article 31(3) for when SDSs are required.
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What Is The Proper Sequence For Creating a GHS SDS?

May 12th, 2014 Comments off

If you need to create GHS-compliant Safety Data Sheets (SDS), it is good to know about the proper step-by-step sequence to follow. Information in some sections of the SDS needs information from other sections of the same SDS. Therefore, it is beneficial to collect some type of information first and compile the relevant SDS sections, in order to be able to complete other sections.

If you have software that automatically authors SDSs, it is still good to know about the proper sequence for creating the SDS, because it helps you understand how some output on the SDS is determined.

We found a good diagram that suggests an approach for the creation of an SDS, based on sections of the SDS. It is included in the “Guidance on the compilation of safety data sheets” document made available by ECHA:

What Is The Proper Sequence For Creating a GHS SDS?

Unsurprisingly, the product composition and hazard classifications of ingredients are some of the very important first steps. The linear process suggests that the final identification of hazards in Section 2 of the SDS is not likely to be possible until the inputs to other sections have been considered. However, ECHA says, in reality, the process is likely to be an iterative one involving consideration of some aspects in different sequences to that shown, or even in parallel.
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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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