Most chemicals that are not dangerous if they are used properly and it is clear what to do if something goes wrong, such as a spillage. But some chemicals need more careful handling than others.
Knowing the potential for a chemical to cause harm either to people or the environment is the key to much of the current chemical legislation designed to supply, use and dispose of chemicals safely. The process that identifies the way chemicals can cause harm – the hazards – is called classification.
What is classification?
‘Classification’ of a chemical is a scientific assessment of whether it can cause harm – for example whether it has the potential to cause cancer, explode, irritate the eyes, etc.
Chemicals are classified so that people using them – either in industry or as consumers – can understand any hazardous effects they could have on human health or the environment and to protect against that harm.
Classification is about identifying intrinsic hazards, not controlling risks. It’s about getting the information needed for decisions about risk control to be made, so that chemicals can be produced, transported, used and disposed of safely.
Classification is fundamental to safe chemical management. It is vital that classification is based on accurate, robust and adequate data/information.
What is hazard?
The potential for something to cause harm is known as ‘hazard’. The intrinsic hazard of a chemical is its capacity to cause harm. All sorts of chemicals that surround us in daily life are hazardous but most of them can be used safely – being able to cause harm doesn’t mean something will cause harm.
What is risk?
Risk is the chance, high or low, of somebody or the environment being harmed by the hazard, and how serious that harm could be.
Remember! Classification must be carried out regardless of the tonnage, volume or amount of the chemical being supplied.
Who should carry out classification?
Classification is the responsibility of chemical suppliers – e.g. manufacturers, importers, downstream users, and possibly distributors.
Their conclusions are not approved or vetted by government authorities – although they might be scrutinised if there should be a problem or if particular concerns are raised.
Supply and placing on the market
Supply means making a substance or preparation/mixture available to another person and includes importing a substance or preparation/mixture into Great Britain. So a ‘supplier’ is a person who does this (i.e. manufacturer, importer, distributor, retailer and so on).
You may also see the term ‘placing on the market’. This is much the same as supply and means ‘supplying or making available, whether in return for payment or free of charge, to a third party’. Import into the European Union market is deemed to be placing on the market.
Remember! Classification must be carried out regardless of the tonnage, volume or amount of the chemical being supplied.
The basics
The basic classification requirement is for chemical suppliers to determine whether the chemicals they supply are ‘hazardous’ according to an internationally-agreed set of rules (known as ‘criteria’) to identify what harm a chemical might cause.
There are criteria for:
- physical hazards (e.g. explosivity. corrosivity. etc);
- health hazards (e.g. potential to cause cancer in humans, to irritate the skin or eyes, etc); and
- environmental hazards (e.g. harmful to the aquatic environment, etc).
When classifying a chemical, the supplier must consider:
- what sort of harm a chemical might cause – the hazards,
- how certain it is that the chemical could actually have this effect,
- how serious the effect might be, and
- how potent the chemical is.
Classification of a mixture is generally based on what is known of the constituent substances or similar products.
Gathering data, testing and scientific studies
Generally, the CLP Regulation does NOT require new studies be conducted for the purposes of classification.
Instead, suppliers have to obtain and evaluate all the ‘available’ and ‘relevant’ information to classify their substances and mixtures.
In practice this means that many mixtures can be classified on the basis of publicly available data, for example that published in the annexes of the CLP Regulation itself, or in a new database being made available by the European Chemicals Agency.
Nevertheless, some suppliers may choose to generate new information to improve their mixture classifications.
The exception is physical hazards – where no data is available, suppliers are required to generate test data for these hazard classes (such a test will not however involve the use of vertebrate animals).
As a general rule if the chemical is not hazardous there may be nothing more you need to do. The exceptions to this include several special cases where some mixtures that are not hazardous still need additional warning information, and/or for a ‘safety data sheet’ to be provided to industrial and professional users (and available for purchasing consumers on request).
Detailed guidance on how to apply the agreed classification criteria is provided by the European Chemicals Agency (ECHA):
What is self-classification?
Self-classification is the process through which the supplier classifies the chemicals directly, and where no harmonised classifications are available for the substances involved.
Self-classification is always necessary for chemical mixtures.
What is a harmonised classification?
A harmonised classification is a classification for a substance that has been agreed by independent experts at European level, and then made mandatory by law.
About 8000 of the most commonly used substances have been assigned harmonised classifications.
A harmonised classification is legally binding and suppliers are obliged to use these classifications.
The list of harmonised classifications can be found in Annex VI of the CLP Regulation. This list is amended from time to time to keep up to date with scientific and technical developments.
Classification and other chemical controls
Chemical classification is used to regulate the supply and use of chemicals.
In some cases classification can act as the basis for requiring additional chemical controls, protective measures, or restrictions on sale or use. This is usually the case where the chemicals are particularly harmful, where they may have the chance of effecting a wide population or the environment because of the volumes involved, and where the chemicals are used in the workplace.
These additional controls or restrictions appear in other more specific pieces of law. The following is not a complete list of other laws which refer to classification to establish aspects of their scope, but gives an idea of how classification acts as the basis for much wider chemical regulation and why it is important to ensure it is accurate.
- Control of Substances Hazardous to Health Regulations (COSHH)
- Control of Major Accident Hazards Regulations (COMAH)
- Management of Health and safety at Work Regulations - legislation.gov.uk (in respect of pregnant or breastfeeding employees and young people at work).
- REACH Regulation
- Biocides
Classification of articles (objects)
What is an article?
An article is an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition.
A producer of an article is any natural or legal person who makes or assembles an article within the Community.
These definitions are the same in both the CLP and the REACH Regulations.
In a general sense, an article can usually be considered to be a finished product. Some examples of articles are clear cut, for example a telephone, a chair and a car.
However, sometimes it is not as easy to tell if something meets the definition of an article. For example, a metal bar can be an article if it has already been produced with a certain shape or size so that it can be engineered into another object. However it will not be an article if it hasn’t been produced in this way and is simply to be melted to make another metallic object.
Articles and the CLP Regulation
The REACH Regulation provides a more considered understanding of what an article might be.
The guidance prepared for REACH provides an excellent overview of how suppliers can determine whether or not they are supplying an article. A discussion of this can be found at the following links:
The position under the CLP Regulation is reasonably straightforward – CLP applies to chemical substances and mixtures, and to the following specific types of article:
- explosive articles (those containing one or more explosive substances or mixtures); or
- pyrotechnic articles (articles containing one or more pyrotechnic substances or mixtures);
If a product being placed on the market does not meet the definition of an article, but is instead a chemical substance or mixture, then the full provisions of the CLP Regulation should be applied.
Confidentiality and using an alternative chemical name
Suppliers may request the use of an alternative name for a substance(s) in a mixture where commercial confidentiality is at risk.
Suppliers wanting to use an alternative chemical name must apply to the European Chemicals Agency (ECHA) and pay a fee. The fee is on a sliding scale with small and micro businesses paying the least.
Poison centres
The CLP Regulation places a duty on Member State governments to appoint a body to be responsible for receiving information about the ingredients of chemical products that are placed on the market. This information can be accessed by medical professionals in cases of a health emergency following harmful exposure to those chemicals.
These appointed bodies are often known as Poison Centres.
In the UK this obligation is met by the National Poison Information Service (NPIS). NPIS has four regional offices located in Birmingham, Cardiff, Edinburgh and Newcastle.
NPIS provides toxicological information for medical professionals to ensure that the right treatment is given to the patient as quickly as possible in incidents of excessive, inappropriate or harmful exposure through any route (inhalation, ingestion etc).
NPIS do not receive calls from the general public.
In case of a medical emergency following exposure to a chemical, the public should call NHS Direct.