Can you author a safety data sheet or product label for worldwide use?

Globally Harmonised System of Classification and Labelling (GHS)

Chances are that if you want to sell your chemical product into an industrialised country it will follow the UN guidelines for hazard classification, SDS format, and label content.

If you wish to find out more about our services for global SDSs, labelling or classification, see our services page or contact us. For help with the jargon, check our glossary.

We are regularly asked to provide an SDS for use world-wide.

This article informs you of why this is nearly, but not quite, possible.

The United Nations have provided a global template for SDSs, currently adopted by 79 countries. Chances are that if you want to sell your chemical product into an industrialised country it will follow the UN guidelines for hazard classification, SDS format, and label content, contained in the UN Globally Harmonised System of Classification and Labelling (GHS) [1].

This sounds marvellous to suppliers who want to market their chemical product in different countries with the minimum of regulatory fuss, and minimum risk of delays, fines, or forced product withdrawal.

And a global system also sounds like common sense! Surely a chemical product used in the same way in different countries will present the same hazards, require the same warnings, and the same risk management measures?

Implementation of GHS guidelines

And the problems start right there, because the GHS is just that – guidelines.

It is disappointing that the main obstacle to a true global harmonisation in hazard communication has been disagreement on the hazards presented by specific chemicals

The GHS is not written as a legal document. Countries need to adapt text of the GHS to give it legal clarity. Each country then implements the GHS into national law. The implementations for major countries for chemical production and use are given in Table 1 below.

National implementation of the GHS allows countries to remove, add, or alter the content of the GHS, providing variations between countries. GHS goes a long way to harmonisation, but many small differences make consulting national legislation necessary to get SDSs and labels correct and avoid enforcement action.

Most variation required for SDSs and labels in different countries originate for the following reasons:

• Implementation of different versions of the UN GHS
• Not including some of the building blocks of the GHS hazard classification
• Adding extra hazards to the national system that are not included in the GHS
• Use of different threshold concentrations when calculating the hazard of a mixture from its components (this uncertainty is built into the UN GHS for some hazard classes)
• Different interpretation of GHS criteria, leading to national classification inventories with wide variation of hazard classification for the same substance.

These are discussed in detail below.

It is disappointing that the main obstacle to a true global harmonisation in hazard communication has been disagreement on the hazards presented by specific chemicals, even when large amounts of data is available.

Hazard classification, the safety data sheet and labelling

The SDS is the primary tool for hazard communication, allowing suppliers to inform downstream users of the hazards, and measures required to control them during use.

The label, affixed to the product container, gives a quick summary of the hazards and precautions.

The content of the SDS and label is determined by the hazards of the product. In the GHS, these are codified into Hazard Classes, and Hazard Categories, ie hazard classification.

The GHS classification system is based on 28 Hazard Classes, eg flammable liquids, acute toxicity, acute aquatic toxicity, sub-divided into Categories depending on the severity of the hazard posed by the product.

For example, the Hazard Class ‘flammable liquids’, has 4 categories in the GHS, assigned according to the product’s boiling point and flash point (see Figure 1).

This combination of hazard class and category is sometimes called a ‘building block’ of the GHS classification system.

Variation in implementation of GHS versions

The GHS was first published in 2003. It was based on the established schemes at the time, ie those from the EU, USA, Canada, and the UN Recommendations on the Transport of Dangerous Goods (RTDG).

Like the UN RTDG, the GHS is updated every two years, and the current version is number 8 (published in 2019).

The updates for the national legislation are more haphazard. For example, in the EU, Regulation 2019/521 (so-called 12th ATP) implements the 6th and 7th amendments of the GHS. It was published March 2019 and the changes will apply from 17 October 2020. The regulation makes some changes to the classification system, particularly a new hazard class for desensitised explosives and a new Hazard Category for pyrophoric gases (within the Hazard Class for flammable gases), and many other smaller changes.

So there is always delay between the UN GHS and EU CLP. Other national implementation occur less regularly. The GHS implementations in major chemical-producing countries are given in Table 1. The hazard classification, SDS or label may be different depending on the GHS version implemented.

Variation in building blocks

Many of the national implementations for hazard classification do not use all of the GHS building blocks. This is exemplified in Figure 1, which shows the UN GHS classification of flammable liquids vs the EU implementation.

Figure 1: Building blocks for flammable liquids: GHS vs CLP [back to Hazard Classification]

The EU does not implement the GHS Flammable Liquid Category 4 building block. The EU classification for flammable liquids has only three categories, and a liquid product with a flash point greater than 60 °C does not meet the criteria for a flammable liquid.

A chemical product with a flash point of 60 to 93 °C will have a hazard classification in some countries (eg Brazil), but not in others (eg EU, Singapore).

Other common building blocks that are omitted from national implementations of the GHS are:

• Flammable liquids, Category 4
• Acute toxicity, Category 5
• Skin irritation, Category 3
• Eye irritation, Category 2 (instead splitting into sub-categories 2A and 2B)
• Aspiration hazard, Category 2
• Aquatic toxicity, acute, Categories 2 and 3

The EU do not implement any of the hazard categories listed above.

The USA do not implement any environmental hazard classes.

The SDS and label for a product that is classified for some of these hazards may need different versions for countries where the building block implementations are different. However, it is usually OK to put additional warnings into an SDS. For example you can legally indicate environmental hazards into an SDS destined for the US, but you risk getting enquiries from confused customers.

Additional hazards added by some countries

Some jurisdictions include hazards that are additional to those covered in the UN GHS. The most notable are those for the EU, and the USA and Canada.

In the EU, the CLP regulation includes many additional hazards, including for:

• Violent reactions with water
• Formation of peroxides on storage
• Contact with water or acids producing toxic gas
• Causing skin dryness or cracking
• Mixtures containing small amounts of skin sensitisers.

The full list is given in the CLP Regulation, Annex II.

The US HazCom 2012 implementation of the GHS gives additional hazard classes for:

• Simple asphyxiants (substances that displace oxygen in the atmosphere, particularly in confined spaces), eg nitrogen, carbon dioxide, helium.
• Combustible dusts (ie that present a fire or explosion hazards when suspended in air)
• Pyrophoric gases (ie catching fire on exposure to air; this has now been included in the GHS).

Different generic concentration limits for hazard classification of mixtures

These divergences from a supposedly harmonised system for hazard classification are disappointing.

Rather than testing mixtures, it is usual to classify toxicological and ecological hazards based on generic concentration limits, as described below. This is called the calculation method. Physico-chemical hazards are determined by testing.

All toxicological and ecological Hazard Categories have a generic concentration limit. If an ingredient is present above this threshold, the mixture is assigned a hazard classification.

For example, a mixture that contains an ingredient at 15 wt% with a classification including Skin Irritation Category 2 will be also classified as a Skin Irritant, Category 2, because the ingredient is present above the generic threshold concentration of 10%.

The GHS is a compromise document. For a few hazard categories, two generic concentration limits are given. The country implementing the GHS into national legislation can choose which limit applies. This can lead to different hazard classification of the same mixture in different countries, in which case different SDSs and labelling are normally required.

The hazard categories affected are:

• Skin sensitisation, Category 1: GHS allows 0.1 or 1% as the generic concentration limit
• Carcinogenicity, Category 2: GHS allows 0.1 or 1% as the generic concentration limit
• STOT SE, Category 1: GHS allows 1 or 10% as the generic concentration limit to give mixture classification of STOT SE, Category 1; if 10% is chosen, then 1 to 10% gives mixture classification of STOT SE, Category 2
• STOT SE, Category 2: GHS allows 1 or 10% as the generic concentration limit to give mixture classification of STOT SE, Category 2
• STOT RE, Category 1: GHS allows 1 or 10% as the generic concentration limit to give mixture classification of STOT RE, Category 1; if 10% is chosen, then 1 to 10% gives mixture classification of STOT RE, Category 2
• STOT RE, Category 2: GHS allows 1 or 10% as the generic concentration limit to give mixture classification of STOT RE, Category 2
• Reproductive toxicity, Category 1A or 1B, or for additional effects on or via lactation: GHS allows 0.1 or 0.3% as the generic concentration limit
• Reproductive toxicity, Category 2: GHS allows 0.1 or 3% as the generic concentration limit.

These divergences from a supposedly harmonised system for hazard classification are disappointing. GHS version 8 (ie 16 years on from the original) carries the weary expectation that ‘the situation will evolve over time to a more harmonised approach.’

US, Canada and Brazil have the lower thresholds. Most countries use the higher ones.

The EU CLP Regulation further complicates this approach to mixture classification by giving some substances specific concentration limits (SCLs). As the name suggests, these are used for specific substances in place of the generic concentration limits , usually because they are hazardous at lower concentration than the generic concentration limit provides for. Occasionally, SCLs are set higher than the generic concentration limits (eg Eye Irritation for ethanol, see below).

SCLs are sometimes given in the harmonised classification list of Annex VI of the CLP Regulation, or in publicly available REACH Registration dossiers on the ECHA website.

SCLs are specific for the EU, but the SDS author may invoke ‘expert judgement’ to use them for the classification of products in other jurisdictions.

Classification inventories

It is disappointing that the UN has so far not produced a classification inventory of its own.

Several countries have a listing or inventory for chemical classifications. Sometimes the classifications are mandatory in the specific country, and sometimes they are advisory.

The situation in the EU is complicated. Mandatory harmonised classifications for 4300 substances are given in Annex VI of the CLP Regulation. However, these are only partial, and cover a limited number of Hazard Classes (including carcinogenicity, mutagenicity, reproductive toxicity, and respiratory sensitisers). The classifier has to check whether other hazard classes apply.

Furthermore, some of the harmonised classification contain a minimum classification, and should be changed to a more severe one if data supports this. This is a relic from the pre-GHS classification system, and affects the hazard classes for acute toxicity and STOT repeated exposure.

The EU also has a Classification and Labelling Inventory (CLI). Theoretically, the CLI contains classifications for substances agreed by industry, but the reality is more like the Wild-West and it contains a variety of contradicting classifications for most substances. Suppliers are supposed to use the CLI classification (or pick the most likely of them, such as that given in the REACH Registration dossier), or submit the reason for not doing so to ECHA.

The Japanese NITE–CHRIP database is not mandatory, but influential in Japan and Asia. The database gives consistently more severe classifications compared those assigned in the EU.

For example for ethanol:

• NITE–CHRIP: Flammable Liquid, Category 2 (highly flammable liquid and vapour); Serious Eye Irritation, Category 2B (causes eye irritation); carcinogenicity, Category 1A (may cause cancer); Reproductive Toxicity, Category 1A (may damage fertility or the unborn child); STOT SE 3, Category 3 (may cause respiratory irritation and may cause drowsiness or dizziness); STOT RE, Category 1 (causes damage to liver through prolonged or repeated exposure).
• EU CLP Annex VI and REACH Registration data: Flammable Liquid, Category 2 (highly flammable liquid and vapour); Serious Eye Irritation, Category 2 (causes serious eye irritation; SCL at 50wt%).

A UN project found that none of the 89 substances common to the EU and NITE–CHRIP lists had identical sets of classifications.

These differences in substance classification may lead to irreconcilable differences for the SDS and label in different countries.

Korea, China and Malaysia have mandatory classification databases.

Taiwan, Australia, and New Zealand have advisory databases.

Most countries implementing the GHS, including the US and Canada, do not have a classification database.
Where the classification database is not mandatory, or one does not exist, then it is a choice of the SDS author which substance classification they regard as most reliable.

I recommend using the EU CLI (which also contains the harmonised classifications), in conjunction with the publicly-available data in REACH registration dossiers, to determine the hazard classification for a substance, except for supply to countries with a mandatory classification inventory.

It is disappointing that the UN has so far not produced a classification inventory of its own. One has been under discussion for years [4]. Given the different national approaches to classification, and the current diversity of classification inventories, I think it would now be too difficult to reach a consensus, but we live in hope.

Additional information, including national legislation and OELs

National legislation often requires safety data sheets and labels to include national information. Without such information, the SDS or label is not compliant and the product can be subject to enforcement actions. For the SDS, this often includes:

• National occupational exposure limits
• Local supplier name, address, and telephone number
• Emergency telephone contact to be answered in local language
• Poison centre contact details
• References to national legislation.

The EU has many additional details that should be added to SDSs or labels:

• Unique formulation identifiers (UFIs, part of the poison centre notification requirements of the CLP Regulation)
• REACH Registration numbers and EC numbers
• DNELs and PNECs (safe limits for health and the environment, respectively)
• Information on substances of very high concern: PBTs, vPvBs, endocrine disruptors (for more information see here) , and any nanoforms
• Acute toxicity estimates (see blog post on new SDS requirements in Regulation 2020/878.
• Requirements from other legislation, eg for detergents, aerosols, biocidal products.

Other countries also have additional requirements, for example:

• Chinese: labels have black borders; percentages for listed hazardous ingredients; emergency telephone number based in China; phrase ‘please refer to the Safety Data Sheet’
• Japanese labels: Fire Services Law gives a flammability classification; Pollutant Transfer and Release for reporting pollutants; Industrial Safety and Health Law gives a number of listings for worker safety; Poisonous and Deleterious Substances Control Law requires identification of certain substances for the purposes workplace safety.

Translation

Once you have compiled a safety data sheet or label and accounted for the national variations, it is usual to translate into the local language where it will be used.

Legally, it is the national importer or manufacturer who is responsible for the SDS and label, including that they are in the correct language. However, often the manufacturer or other supplier will arrange the translation as a commercial aid to sale.

Conclusions

GHS version 8 (ie 16 years on from the original) carries the weary expectation that ‘the situation will evolve over time to a more harmonised approach.’

The GHS has harmonised hazard communication for the industrialised world. SDSs and labels would be recognised in most countries, and an experienced user would understand the hazards and quickly find data in any GHS-based document, perhaps even in a foreign language.

The multitude of country-specific information for SDSs and labels, often affecting hazard classification, means that it is unusual to be able to exactly comply with legal requirements in two jurisdictions on a single document. The EU has embellished the UN requirements with many additional requirements.

In less industrially developed countries, where the UN GHS is the first hazard communication system to be implemented, it may be possible to create a generalised SDS and label (in the appropriate languages) for multiple countries.

Some companies prefer the legal certainty of having fulfilled the regulatory requirements of SDSs and labels as far as possible. Others may take a more pragmatic approach that the SDSs and labels are ‘fit for purpose’, and forego some the detail, even if this means they are not in strict compliance.

This raises the question on enforcement, and the likelihood of a faulty SDS or label causing problems with marketing, such as shipping delays or forced withdrawal from the market. In most countries, the enforcement is sporadic, and therefore unfair to all – those who get caught when others get away with non-compliance, and those who use resources to ensure compliance when others do not.

Table 1: Some implementations of the GHS in major chemical producing countries

[back to Implementation of GHS guidelines] [back to Variation in implementation of GHS versions]

Country or jurisdiction	Implementing legislation	Guidance	Based on GHS version
Australia	Work Health and Safety (WHS) Regulations.	Code of Practice: Preparation of Material Safety Data Sheets.	3
Brazil	Brazil Association of Technical Standards: standard ABNT NBR 14725:2009 (parts 1 to 4).		4
Canada	Hazardous Products Regulations (HPR)	Health Canada: Variances Between the HPR and the United States Hazard Communication Standard (2012).	5
China	Decree 591 (Regulations on the Control over Safety of Hazardous Chemicals)	Standards GB/T 16483-2008 and GB/T 17519-2013 (Guidance on the Compilation of Safety Data Sheets); classification GB 30000.2-29.	4
EU	CLP Regulation (1272/2008) [2] for classification and labelling; REACH Regulation (1907/2006) [3]	ECHA: Guidance on the Compilation of Safety Data Sheets; Guidance on Labelling and Packaging.	5 (7 from October 2020)
Japan	Industrial Safety and Health Law (ISHL), Poisonous and Deleterious Substance Control Law (PDSCL), Ordinance and Guideline under Pollutant Release and Transfer Register Law (PRTR).	JIS Z 7253:2019 Hazard Communication for GHS Labelling and SDS; JIS Z 7252:2019 11 (Chemical Classification for GHS Labelling	4
Malaysia	CLASS regulation (Classification, Labelling and Safety Data Sheet of Hazardous Chemicals).	Industry Code of Practice (on Chemical Classification and Hazard Communication).	3
Singapore	SS 586 specification for hazard communication for hazardous chemicals and dangerous goods: Part 2: Globally harmonised system of classification and labelling of chemicals; Part 3: preparation of safety data sheets (SDS)	Industry Code of Practice (on Chemical Classification and Hazard Communication).	4
South Korea	Industrial Safety & Health Law (ISHL); Standard for Classification and Labelling of Chemical Substance and Material Safety Data Sheets (MoEL Public Notice 2016-19); Chemical Control Act (CCA)	Guidebook on the Globally Harmonised System of Classification and Labelling of Chemicals; Singapore Chemical Industry Council.	4
Switzerland	Ordinance on Protection against Dangerous Substances and Preparations (ChemO) (SR 813.11)	Based on EU. An EU SDS is accepted if Section 1, 7, 8, 13 and 15 are amended for Swiss law.	5
Turkey	Turkish Regulation on Classification, Labelling and Packaging of Substances and Mixtures (SEA Regulation), Official Gazette No. 28848; SDS regulation 29204; Turkish REACH (KKDIK Regulation 30105).	[SDSs must be authored by a certified person and certificate information added to the SDS].	4
US	Hazard Communication Standard 29 CFR 1910.1200.	OSHA: Hazard Classification Guidance for Manufacturers, Importers, and Employers.	3

References

[Back to Globally Harmonised System of Classification and Labelling (GHS)] [Back to Table] [back to classification inventories]

[1] Globally Harmonized System of Classification and Labelling (GHS); Eighth Revised Edition; United Nations; 2019.

[2] Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures (as amended).

[3] Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (as amended).

[4] Report on the Pilot Project on Assessing the Potential Development of a Global List of Classified Chemicals; see, http://www.oecd.org/env/ehs/risk-management/classificationandlabellingofchemicals.htm